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CochranePLS100
***TASK*** the task is to simplify the input abstract of a biomedical literature ***INPUT*** the input is the abstract of a biomedical literature ***OUTPUT*** the output is the simplified abstract for the input abstract of a biomedical literature ***EXAMPLES*** Input: Output: ***EXAMPLES*** Input: Two trials (n = 190), at low risk of bias, were included in the review and both presented data on first time failure at the tooth level. Pooling of the data showed a statistically significant difference in favour of molar bands, with a hazard ratio of 2.92 (95% confidence intervals (CI) 1.80 to 4.72). No statistically significant heterogeneity was shown between the two studies. Data on first time failure at the patient level were also available and showed statistically different difference in favour of molar bands (risk ratio 2.30; 95% CI 1.56 to 3.41) (risk of event for molar tubes = 57%; risk of event for molar bands 25%). One trial presented data on decalcification again showing a statistically significant difference in favour of molar bands. No other adverse events identified. From the two well-designed and low risk of bias trials included in this review it was shown that the failure of molar tubes bonded with either a chemically-cured or light-cured adhesive was considerably higher than that of molar bands cemented with glass ionomer cement. One trial indicated that there was less decalcification with molar bands cemented with glass ionomer cement than with bonded molar tubes cemented with a light-cured adhesive. However, given there are limited data for this outcome, further evidence is required to draw more robust conclusions. Output: The evidence in this review, which was carried out together with Cochrane Oral Health, is up-to-date as of 15 February 2017. We included two studies that evaluated 190 participants. Both trials were conducted in the UK and both compared bonded molar tubes with molar bands. From the limited data of two studies at low risk of bias, it would appear that bonded molar tubes are associated with a higher failure rate than with molar bands. Input: We included seven trials with a total of 555 participants. Three trials compared models of enhanced care in the inpatient setting with conventional care. Two trials compared an enhanced care model provided in inpatient settings and at home after discharge with conventional care. Two trials compared geriatrician-led care in-hospital to conventional care led by the orthopaedic team. None of the interventions were designed specifically for people with dementia, therefore the data included in the review were from subgroups of people with dementia or cognitive impairment participating in randomised controlled trials investigating models of care for all older people following hip fracture. The end of follow-up in the trials ranged from the point of acute hospital discharge to 24 months after discharge. We considered all trials to be at high risk of bias in more than one domain. As subgroups of larger trials, the analyses lacked power to detect differences between the intervention groups. Furthermore, there were some important differences in baseline characteristics of participants between the experimental and control groups. Using the GRADE approach, we downgraded the certainty of the evidence for all outcomes to low or very low. The effect estimates for almost all comparisons were very imprecise, and the overall certainty for most results was very low. There were no data from any study for our primary outcome of health-related quality of life. There was only very low certainty for our other primary outcome, activities of daily living and functional performance, therefore we were unable to draw any conclusions with confidence. There was low-certainty that enhanced care and rehabilitation in-hospital may reduce rates of postoperative delirium (odds ratio 0.04, 95% confidence interval (CI) 0.01 to 0.22, 2 trials, n = 141) and very low-certainty associating it with lower rates of some other complications. There was also low-certainty that, compared to orthopaedic-led management, geriatrician-led management may lead to shorter hospital stays (mean difference 4.00 days, 95% CI 3.61 to 4.39, 1 trial, n = 162). We found limited evidence that some of the models of enhanced rehabilitation and care used in the included trials may show benefits over usual care for preventing delirium and reducing length of stay for people with dementia who have been treated for hip fracture. However, the certainty of these results is low. Data were available from only a small number of trials, and the certainty for all other results is very low. Determining the optimal strategies to improve outcomes for this growing population of patients should be a research priority. Output:
We searched for randomised controlled trials (a type of study in which participants are assigned to one of two or more treatment groups using a random method) that compared any model of enhanced care and rehabilitation for people with dementia after hip fracture versus the usual care provided in the trial setting. The latest search was performed on 16 October 2019. We identified seven trials that studied a total of 555 people with dementia following hip fracture. Five trials compared an enhanced interdisciplinary rehabilitation and care programme where the various healthcare professionals worked collaboratively across hospital and community settings or just in hospital, to usual hospital care. Two trials compared care in-hospital led by a geriatrician versus care led by an orthopaedic surgeon. People with dementia who receive enhanced care and rehabilitation in hospital after a hip fracture may be less likely to develop delirium. When care is led by a geriatrician, they may have stays in hospital that are three to four days shorter than if care is led by an orthopaedic surgeon. There was no information on the effect of any of the care models on quality of life, and we could not be certain about their effects on other important outcomes such as an individual's ability to manage their daily activities, regaining mobility, cognitive function, pain, death rates, or the likelihood of the person returning to the same place they had been living before the fracture. The main issues with the evidence were that most of the studies were small and their results may have been subject to bias. Most of the results of the review are very uncertain. None of the care models had been designed specifically for people with dementia. All of the data included in the review came from people with dementia who had been included in larger trials for all older people with hip fractures, although people with dementia may have particular needs. There may be some benefits from the care models studied, but the currently available research is insufficient to determine the best ways to care for people with dementia after a hip fracture operation.
CochranePLS101
***TASK*** the task is to simplify the input abstract of a biomedical literature ***INPUT*** the input is the abstract of a biomedical literature ***OUTPUT*** the output is the simplified abstract for the input abstract of a biomedical literature ***EXAMPLES*** Input: Output: ***EXAMPLES*** Input: Two trials (n = 190), at low risk of bias, were included in the review and both presented data on first time failure at the tooth level. Pooling of the data showed a statistically significant difference in favour of molar bands, with a hazard ratio of 2.92 (95% confidence intervals (CI) 1.80 to 4.72). No statistically significant heterogeneity was shown between the two studies. Data on first time failure at the patient level were also available and showed statistically different difference in favour of molar bands (risk ratio 2.30; 95% CI 1.56 to 3.41) (risk of event for molar tubes = 57%; risk of event for molar bands 25%). One trial presented data on decalcification again showing a statistically significant difference in favour of molar bands. No other adverse events identified. From the two well-designed and low risk of bias trials included in this review it was shown that the failure of molar tubes bonded with either a chemically-cured or light-cured adhesive was considerably higher than that of molar bands cemented with glass ionomer cement. One trial indicated that there was less decalcification with molar bands cemented with glass ionomer cement than with bonded molar tubes cemented with a light-cured adhesive. However, given there are limited data for this outcome, further evidence is required to draw more robust conclusions. Output: The evidence in this review, which was carried out together with Cochrane Oral Health, is up-to-date as of 15 February 2017. We included two studies that evaluated 190 participants. Both trials were conducted in the UK and both compared bonded molar tubes with molar bands. From the limited data of two studies at low risk of bias, it would appear that bonded molar tubes are associated with a higher failure rate than with molar bands. Input: We screened 4226 titles to yield seven RCTs with a total of 840 participants. Participants, interventions and outcomes were diverse. No significant differences were reported in health outcomes; two studies reported a reduction in the hospital stay with no difference in the hospital readmission rates. Three studies reported a reduction in parental anxiety and improvement in child behaviours was reported in three studies. Overall increased parental satisfaction was reported in three studies. Also, better parental coping and family functioning was reported in one study. By contrast, one study each reported no impact on parental burden of care or on functional status of children. Home care was reported as more costly for service providers with substantial cost savings for the family in two studies, while one study revealed no significant cost benefits for the family. Current research does not provide supporting evidence for a reduction in access to hospital services or a reduction in hospital readmission rate for children with acute and chronic illnesses using specialist home-based nursing services; however, the only summary finding across a few studies was that there is a significant decrease in length of hospitalisation. The preliminary results show no adverse impact on physical health outcomes and a number of papers reported improved satisfaction with home-based care. Further trials are required, measuring health, satisfaction, service utilisation and long-term costs. Output:
This review aimed to examine whether specialist paediatric home-based nursing services for children with acute and chronic illnesses reduce the number of hospital admissions and length of stay, enhance health care in the community and reduce stress for families at the time of their child's illness. It is an update of our original review published in 2006. We found seven relevant randomised controlled trials (RCTs) of total of 840 children aged from birth to 18 years with acute and/or chronic illnesses receiving either specialist home-based nursing services or conventional health care. The outcomes included use of health care services, physical and mental health, satisfaction, adverse health outcomes and costs. We decided not to combine the results of these RCTs because of the variety in types of services provided, types of participants and the outcome measures used. The results of individual RCTs show improved satisfaction with home-based care with no adverse impact on physical health outcomes for children. There is some evidence that specialist home-based nursing services reduce the length of hospital stay; however, there is no evidence that it leads to a reduction in use of hospital services. Further trials are required, measuring health, satisfaction, service use and long-term costs.
CochranePLS102
***TASK*** the task is to simplify the input abstract of a biomedical literature ***INPUT*** the input is the abstract of a biomedical literature ***OUTPUT*** the output is the simplified abstract for the input abstract of a biomedical literature ***EXAMPLES*** Input: Output: ***EXAMPLES*** Input: Two trials (n = 190), at low risk of bias, were included in the review and both presented data on first time failure at the tooth level. Pooling of the data showed a statistically significant difference in favour of molar bands, with a hazard ratio of 2.92 (95% confidence intervals (CI) 1.80 to 4.72). No statistically significant heterogeneity was shown between the two studies. Data on first time failure at the patient level were also available and showed statistically different difference in favour of molar bands (risk ratio 2.30; 95% CI 1.56 to 3.41) (risk of event for molar tubes = 57%; risk of event for molar bands 25%). One trial presented data on decalcification again showing a statistically significant difference in favour of molar bands. No other adverse events identified. From the two well-designed and low risk of bias trials included in this review it was shown that the failure of molar tubes bonded with either a chemically-cured or light-cured adhesive was considerably higher than that of molar bands cemented with glass ionomer cement. One trial indicated that there was less decalcification with molar bands cemented with glass ionomer cement than with bonded molar tubes cemented with a light-cured adhesive. However, given there are limited data for this outcome, further evidence is required to draw more robust conclusions. Output: The evidence in this review, which was carried out together with Cochrane Oral Health, is up-to-date as of 15 February 2017. We included two studies that evaluated 190 participants. Both trials were conducted in the UK and both compared bonded molar tubes with molar bands. From the limited data of two studies at low risk of bias, it would appear that bonded molar tubes are associated with a higher failure rate than with molar bands. Input: The 2016 update included two more studies (n = 196) and more publications with additional data for four already included studies. The updated review therefore includes 7524 participants from 40 randomised controlled trials (RCTs). We found data relevant to two comparisons: ICM versus standard care, and ICM versus non-ICM. The majority of studies had a high risk of selective reporting. No studies provided data for relapse or important improvement in mental state. 1. ICM versus standard care When ICM was compared with standard care for the outcome service use, ICM slightly reduced the number of days in hospital per month (n = 3595, 24 RCTs, MD -0.86, 95% CI -1.37 to -0.34,low-quality evidence). Similarly, for the outcome global state, ICM reduced the number of people leaving the trial early (n = 1798, 13 RCTs, RR 0.68, 95% CI 0.58 to 0.79, low-quality evidence). For the outcome adverse events, the evidence showed that ICM may make little or no difference in reducing death by suicide (n = 1456, 9 RCTs, RR 0.68, 95% CI 0.31 to 1.51, low-quality evidence). In addition, for the outcome social functioning, there was uncertainty about the effect of ICM on unemployment due to very low-quality evidence (n = 1129, 4 RCTs, RR 0.70, 95% CI 0.49 to 1.0, very low-quality evidence). 2. ICM versus non-ICM When ICM was compared with non-ICM for the outcome service use, there was moderate-quality evidence that ICM probably makes little or no difference in the average number of days in hospital per month (n = 2220, 21 RCTs, MD -0.08, 95% CI -0.37 to 0.21, moderate-quality evidence) or in the average number of admissions (n = 678, 1 RCT, MD -0.18, 95% CI -0.41 to 0.05, moderate-quality evidence) compared to non-ICM. Similarly, the results showed that ICM may reduce the number of participants leaving the intervention early (n = 1970, 7 RCTs, RR 0.70, 95% CI 0.52 to 0.95,low-quality evidence) and that ICM may make little or no difference in reducing death by suicide (n = 1152, 3 RCTs, RR 0.88, 95% CI 0.27 to 2.84, low-quality evidence). Finally, for the outcome social functioning, there was uncertainty about the effect of ICM on unemployment as compared to non-ICM (n = 73, 1 RCT, RR 1.46, 95% CI 0.45 to 4.74, very low-quality evidence). 3. Fidelity to ACT Within the meta-regression we found that i.) the more ICM is adherent to the ACT model, the better it is at decreasing time in hospital ('organisation fidelity' variable coefficient -0.36, 95% CI -0.66 to -0.07); and ii.) the higher the baseline hospital use in the population, the better ICM is at decreasing time in hospital ('baseline hospital use' variable coefficient -0.20, 95% CI -0.32 to -0.10). Combining both these variables within the model, 'organisation fidelity' is no longer significant, but the 'baseline hospital use' result still significantly influences time in hospital (regression coefficient -0.18, 95% CI -0.29 to -0.07, P = 0.0027). Based on very low- to moderate-quality evidence, ICM is effective in ameliorating many outcomes relevant to people with severe mental illness. Compared to standard care, ICM may reduce hospitalisation and increase retention in care. It also globally improved social functioning, although ICM's effect on mental state and quality of life remains unclear. Intensive Case Management is at least valuable to people with severe mental illnesses in the subgroup of those with a high level of hospitalisation (about four days per month in past two years). Intensive Case Management models with high fidelity to the original team organisation of ACT model were more effective at reducing time in hospital. However, it is unclear what overall gain ICM provides on top of a less formal non-ICM approach. We do not think that more trials comparing current ICM with standard care or non-ICM are justified, however we currently know of no review comparing non-ICM with standard care, and this should be undertaken. Output:
We carried out electronic searches for randomised controlled trials comparing ICM with non-ICM or standard care in 2009, 2012, and 2015. We included 40 trials involving 7524 people. The trials took place in Australia, Canada, China, Europe, and the USA. When ICM was compared to standard care, those in the ICM group were more likely to stay with the service, have improved general functioning, get a job, not be homeless, and have shorter stays in hospital (especially when they had had very long stays in hospital previously). When ICM was compared to non-ICM, the only clear difference was that those in the ICM group were more likely to be kept in care. None of the evidence for the main outcomes of interest was high quality; at best the evidence was of moderate quality. In addition, the healthcare and social support systems of the countries where the studies took place were quite different, so it was difficult to make valid overall conclusions. Furthermore, we were unable to use much of the data on quality of life and patient and carer satisfaction because the trials used many different scales to measure these outcomes, some of which were not validated.  The development of an overall scale and its validation would be very beneficial in producing services that people favour. (Plain language summary initially prepared for this review by Janey Antoniou of RETHINK, UK (rethink.org))
CochranePLS103
***TASK*** the task is to simplify the input abstract of a biomedical literature ***INPUT*** the input is the abstract of a biomedical literature ***OUTPUT*** the output is the simplified abstract for the input abstract of a biomedical literature ***EXAMPLES*** Input: Output: ***EXAMPLES*** Input: Two trials (n = 190), at low risk of bias, were included in the review and both presented data on first time failure at the tooth level. Pooling of the data showed a statistically significant difference in favour of molar bands, with a hazard ratio of 2.92 (95% confidence intervals (CI) 1.80 to 4.72). No statistically significant heterogeneity was shown between the two studies. Data on first time failure at the patient level were also available and showed statistically different difference in favour of molar bands (risk ratio 2.30; 95% CI 1.56 to 3.41) (risk of event for molar tubes = 57%; risk of event for molar bands 25%). One trial presented data on decalcification again showing a statistically significant difference in favour of molar bands. No other adverse events identified. From the two well-designed and low risk of bias trials included in this review it was shown that the failure of molar tubes bonded with either a chemically-cured or light-cured adhesive was considerably higher than that of molar bands cemented with glass ionomer cement. One trial indicated that there was less decalcification with molar bands cemented with glass ionomer cement than with bonded molar tubes cemented with a light-cured adhesive. However, given there are limited data for this outcome, further evidence is required to draw more robust conclusions. Output: The evidence in this review, which was carried out together with Cochrane Oral Health, is up-to-date as of 15 February 2017. We included two studies that evaluated 190 participants. Both trials were conducted in the UK and both compared bonded molar tubes with molar bands. From the limited data of two studies at low risk of bias, it would appear that bonded molar tubes are associated with a higher failure rate than with molar bands. Input: Twenty-five trials contributed data to the quantitative synthesis in this review. All but one trial were at high risk of bias. Overall, 16 trials (464 participants) provided data for meta-analysis of box training (248 participants) versus no supplementary training (216 participants). All the 16 trials in this comparison used video trainers. Overall, 14 trials (382 participants) provided data for quantitative comparison of different methods of box training. There were no trials comparing box model training versus animal model or cadaveric model training. Box model training versus no training: The meta-analysis showed that the time taken for task completion was significantly shorter in the box trainer group than the control group (8 trials; 249 participants; SMD -0.48 seconds; 95% CI -0.74 to -0.22). Compared with the control group, the box trainer group also had lower error score (3 trials; 69 participants; SMD -0.69; 95% CI -1.21 to -0.17), better accuracy score (3 trials; 73 participants; SMD 0.67; 95% CI 0.18 to 1.17), and better composite performance scores (SMD 0.65; 95% CI 0.42 to 0.88). Three trials reported movement distance but could not be meta-analysed as they were not in a format for meta-analysis. There was significantly lower movement distance in the box model training compared with no training in one trial, and there were no significant differences in the movement distance between the two groups in the other two trials. None of the remaining secondary outcomes such as mortality and morbidity were reported in the trials when animal models were used for assessment of training, error in movements, and trainee satisfaction. Different methods of box training: One trial (36 participants) found significantly shorter time taken to complete the task when box training was performed using a simple cardboard box trainer compared with the standard pelvic trainer (SMD -3.79 seconds; 95% CI -4.92 to -2.65). There was no significant difference in the time taken to complete the task in the remaining three comparisons (reverse alignment versus forward alignment box training; box trainer suturing versus box trainer drills; and single incision versus multiport box model training). There were no significant differences in the error score between the two groups in any of the comparisons (box trainer suturing versus box trainer drills; single incision versus multiport box model training; Z-maze box training versus U-maze box training). The only trial that reported accuracy score found significantly higher accuracy score with Z-maze box training than U-maze box training (1 trial; 16 participants; SMD 1.55; 95% CI 0.39 to 2.71). One trial (36 participants) found significantly higher composite score with simple cardboard box trainer compared with conventional pelvic trainer (SMD 0.87; 95% CI 0.19 to 1.56). Another trial (22 participants) found significantly higher composite score with reverse alignment compared with forward alignment box training (SMD 1.82; 95% CI 0.79 to 2.84). There were no significant differences in the composite score between the intervention and control groups in any of the remaining comparisons. None of the secondary outcomes were adequately reported in the trials. The results of this review are threatened by both risks of systematic errors (bias) and risks of random errors (play of chance). Laparoscopic box model training appears to improve technical skills compared with no training in trainees with no previous laparoscopic experience. The impacts of this decreased time on patients and healthcare funders in terms of improved outcomes or decreased costs are unknown. There appears to be no significant differences in the improvement of technical skills between different methods of box model training. Further well-designed trials of low risk of bias and random errors are necessary. Such trials should assess the impacts of box model training on surgical skills in both the short and long term, as well as clinical outcomes when the trainee becomes competent to operate on patients. Output:
The trials compared box model training versus no training (16 trials; 464 participants) or versus different types of box model training (14 trials; 382 participants) (some trials and participants were included in both comparisons as the trials compared different methods of box training versus no training). The primary outcomes investigated in this review were time taken to perform task, error score, accuracy score, and a composite (total summed) performance score. Box model training appears to decrease the time required to perform a laparoscopic task, improve the accuracy, decrease the errors, and improves the overall performance. This suggests that the box model training improves technical skills of surgical trainees with no previous experience in laparoscopic surgery. There does not appear to be any significant differences in different methods of box model training. The impact of the improved surgical skills on patients or healthcare funders in terms of improved health or decreased costs is unknown. All but one of the trials were of high risk of bias (defects in study design that can lead to arriving at incorrect conclusions with overestimation of benefits and underestimation of harms). Furthermore, our results are prone to risks of random errors. Overall, the quality of evidence was very low. Further well-designed trials with less risk of bias because of poor study design or because of chance are necessary.
CochranePLS104
***TASK*** the task is to simplify the input abstract of a biomedical literature ***INPUT*** the input is the abstract of a biomedical literature ***OUTPUT*** the output is the simplified abstract for the input abstract of a biomedical literature ***EXAMPLES*** Input: Output: ***EXAMPLES*** Input: Two trials (n = 190), at low risk of bias, were included in the review and both presented data on first time failure at the tooth level. Pooling of the data showed a statistically significant difference in favour of molar bands, with a hazard ratio of 2.92 (95% confidence intervals (CI) 1.80 to 4.72). No statistically significant heterogeneity was shown between the two studies. Data on first time failure at the patient level were also available and showed statistically different difference in favour of molar bands (risk ratio 2.30; 95% CI 1.56 to 3.41) (risk of event for molar tubes = 57%; risk of event for molar bands 25%). One trial presented data on decalcification again showing a statistically significant difference in favour of molar bands. No other adverse events identified. From the two well-designed and low risk of bias trials included in this review it was shown that the failure of molar tubes bonded with either a chemically-cured or light-cured adhesive was considerably higher than that of molar bands cemented with glass ionomer cement. One trial indicated that there was less decalcification with molar bands cemented with glass ionomer cement than with bonded molar tubes cemented with a light-cured adhesive. However, given there are limited data for this outcome, further evidence is required to draw more robust conclusions. Output: The evidence in this review, which was carried out together with Cochrane Oral Health, is up-to-date as of 15 February 2017. We included two studies that evaluated 190 participants. Both trials were conducted in the UK and both compared bonded molar tubes with molar bands. From the limited data of two studies at low risk of bias, it would appear that bonded molar tubes are associated with a higher failure rate than with molar bands. Input: Two randomised clinical trials were eligible for inclusion. One trial compared biliary lavage with hydrocortisone versus saline in 17 patients. Hydrocortisone tended to increase adverse events (pancreatitis, cholangitis with septicaemia, paranoid ideas, fluid retention) (RR 3.43, 95% CI 0.51 to 22.9) and had no cholangiographic improvement, which led to termination of the trial. The other trial compared budesonide versus prednisone in 18 patients. Patients had statistically significant higher serum bilirubin concentration after treatment with prednisone compared with budesonide (MD 10.4 µmol/litre, 95% CI 1.16 to 19.64 µmol/litre). No other statistically significant effects on clinical or biochemical outcomes were reported on any of the evaluated interventions. There is no evidence to support or refute peroral glucocorticosteroids for patients with primary sclerosing cholangitis. The intrabiliary application of corticosteroids via nasobiliary tube seems to induce severe adverse effects. Output:
Two trials on glucocorticosteroids for primary sclerosing cholangitis were identified. One trial compared biliary lavage with hydrocortisone versus saline. This trial was stopped due to adverse events. The other trial compared oral administration of budesonide versus prednisone. No statistically significant effects were found on mortality, serum activity of alkaline phosphatases, serum bilirubin, and adverse events for any of the evaluated intervention regimens.
CochranePLS105
***TASK*** the task is to simplify the input abstract of a biomedical literature ***INPUT*** the input is the abstract of a biomedical literature ***OUTPUT*** the output is the simplified abstract for the input abstract of a biomedical literature ***EXAMPLES*** Input: Output: ***EXAMPLES*** Input: Two trials (n = 190), at low risk of bias, were included in the review and both presented data on first time failure at the tooth level. Pooling of the data showed a statistically significant difference in favour of molar bands, with a hazard ratio of 2.92 (95% confidence intervals (CI) 1.80 to 4.72). No statistically significant heterogeneity was shown between the two studies. Data on first time failure at the patient level were also available and showed statistically different difference in favour of molar bands (risk ratio 2.30; 95% CI 1.56 to 3.41) (risk of event for molar tubes = 57%; risk of event for molar bands 25%). One trial presented data on decalcification again showing a statistically significant difference in favour of molar bands. No other adverse events identified. From the two well-designed and low risk of bias trials included in this review it was shown that the failure of molar tubes bonded with either a chemically-cured or light-cured adhesive was considerably higher than that of molar bands cemented with glass ionomer cement. One trial indicated that there was less decalcification with molar bands cemented with glass ionomer cement than with bonded molar tubes cemented with a light-cured adhesive. However, given there are limited data for this outcome, further evidence is required to draw more robust conclusions. Output: The evidence in this review, which was carried out together with Cochrane Oral Health, is up-to-date as of 15 February 2017. We included two studies that evaluated 190 participants. Both trials were conducted in the UK and both compared bonded molar tubes with molar bands. From the limited data of two studies at low risk of bias, it would appear that bonded molar tubes are associated with a higher failure rate than with molar bands. Input: A total of 11 trials were included. Seven trials addressed the timing of support (early versus delayed), data on mortality were obtained for all seven trials (284 participants). The relative risk (RR) for death with early nutritional support was 0.67 (95% CI 0.41 to 1.07). Data on disability were available for three trials. The RR for death or disability at the end of follow-up was 0.75 (95% CI 0.50 to 1.11). Seven trials compared parenteral versus enteral nutrition. Because early support often involves parenteral nutrition, three of the trials are also included in the previous analyses. Five trials (207 participants) reported mortality. The RR for mortality at the end of follow-up period was 0.66 (0.41 to 1.07). Two trials provided data on death and disability. The RR was 0.69 (95% Cl 0.40 to 1.19). One trial compared gastric versus jejunal enteral nutrition, there were no deaths and the RR was not estimable. This review suggests that early feeding may be associated with a trend towards better outcomes in terms of survival and disability. Further trials are required. These trials should report not only nutritional outcomes but also the effect on death and disability. Output:
The authors identified 11 eligible trials that investigated the timing and route of nutritional support in head-injured patients. These trials included a total of 534 patients. However, of the many of the trials had methodological weaknesses. The authors found that early feeding may be associated with fewer infections and a trend towards better outcomes in terms of survival and disability. However, the trials were small so any improvements detected were on a small scale. Also the focus of many of the trials was on nutritional outcomes, and many did not report the effect on death and disability. The authors were unable to obtain data for death and disability for all of the included trials so they feel there may be a possibility of bias. Further trials of nutritional support following head injury are required. These trials should report death and disability as well nutritional outcomes. They should also be large enough to detect clinically important treatment effects.
CochranePLS106
***TASK*** the task is to simplify the input abstract of a biomedical literature ***INPUT*** the input is the abstract of a biomedical literature ***OUTPUT*** the output is the simplified abstract for the input abstract of a biomedical literature ***EXAMPLES*** Input: Output: ***EXAMPLES*** Input: Two trials (n = 190), at low risk of bias, were included in the review and both presented data on first time failure at the tooth level. Pooling of the data showed a statistically significant difference in favour of molar bands, with a hazard ratio of 2.92 (95% confidence intervals (CI) 1.80 to 4.72). No statistically significant heterogeneity was shown between the two studies. Data on first time failure at the patient level were also available and showed statistically different difference in favour of molar bands (risk ratio 2.30; 95% CI 1.56 to 3.41) (risk of event for molar tubes = 57%; risk of event for molar bands 25%). One trial presented data on decalcification again showing a statistically significant difference in favour of molar bands. No other adverse events identified. From the two well-designed and low risk of bias trials included in this review it was shown that the failure of molar tubes bonded with either a chemically-cured or light-cured adhesive was considerably higher than that of molar bands cemented with glass ionomer cement. One trial indicated that there was less decalcification with molar bands cemented with glass ionomer cement than with bonded molar tubes cemented with a light-cured adhesive. However, given there are limited data for this outcome, further evidence is required to draw more robust conclusions. Output: The evidence in this review, which was carried out together with Cochrane Oral Health, is up-to-date as of 15 February 2017. We included two studies that evaluated 190 participants. Both trials were conducted in the UK and both compared bonded molar tubes with molar bands. From the limited data of two studies at low risk of bias, it would appear that bonded molar tubes are associated with a higher failure rate than with molar bands. Input: We included 57 studies which randomised a total of 34,390 participants. The main sources of bias were from attrition and participant blinding (36% and 21% of studies respectively, high risk of bias). Forty one studies (42 comparisons, 19,241 participants) provided data for the primary meta-analysis, which demonstrated that participants using a digital intervention drank approximately 23 g alcohol weekly (95% CI 15 to 30) (about 3 UK units) less than participants who received no or minimal interventions at end of follow up (moderate-quality evidence). Fifteen studies (16 comparisons, 10,862 participants) demonstrated that participants who engaged with digital interventions had less than one drinking day per month fewer than no intervention controls (moderate-quality evidence), 15 studies (3587 participants) showed about one binge drinking session less per month in the intervention group compared to no intervention controls (moderate-quality evidence), and in 15 studies (9791 participants) intervention participants drank one unit per occasion less than no intervention control participants (moderate-quality evidence). Only five small studies (390 participants) compared digital and face-to-face interventions. There was no difference in alcohol consumption at end of follow up (MD 0.52 g/week, 95% CI -24.59 to 25.63; low-quality evidence). Thus, digital alcohol interventions produced broadly similar outcomes in these studies. No studies reported whether any adverse effects resulted from the interventions. A median of nine BCTs were used in experimental arms (range = 1 to 22). 'B' is an estimate of effect (MD in quantity of drinking, expressed in g/week) per unit increase in the BCT, and is a way to report whether individual BCTs are linked to the effect of the intervention. The BCTs of goal setting (B -43.94, 95% CI -78.59 to -9.30), problem solving (B -48.03, 95% CI -77.79 to -18.27), information about antecedents (B -74.20, 95% CI -117.72 to -30.68), behaviour substitution (B -123.71, 95% CI -184.63 to -62.80) and credible source (B -39.89, 95% CI -72.66 to -7.11) were significantly associated with reduced alcohol consumption in unadjusted models. In a multivariable model that included BCTs with B > 23 in the unadjusted model, the BCTs of behaviour substitution (B -95.12, 95% CI -162.90 to -27.34), problem solving (B -45.92, 95% CI -90.97 to -0.87), and credible source (B -32.09, 95% CI -60.64 to -3.55) were associated with reduced alcohol consumption. The most frequently mentioned theories or models in the included studies were Motivational Interviewing Theory (7/20), Transtheoretical Model (6/20) and Social Norms Theory (6/20). Over half of the interventions (n = 21, 51%) made no mention of theory. Only two studies used theory to select participants or tailor the intervention. There was no evidence of an association between reporting theory use and intervention effectiveness. There is moderate-quality evidence that digital interventions may lower alcohol consumption, with an average reduction of up to three (UK) standard drinks per week compared to control participants. Substantial heterogeneity and risk of performance and publication bias may mean the reduction was lower. Low-quality evidence from fewer studies suggested there may be little or no difference in impact on alcohol consumption between digital and face-to-face interventions. The BCTs of behaviour substitution, problem solving and credible source were associated with the effectiveness of digital interventions to reduce alcohol consumption and warrant further investigation in an experimental context. Reporting of theory use was very limited and often unclear when present. Over half of the interventions made no reference to any theories. Limited reporting of theory use was unrelated to heterogeneity in intervention effectiveness. Output:
The studies included people in workplaces, colleges or health clinics and internet users. Everyone typed information about their drinking into a computer or mobile device - which then gave half the people advice about how much they drank and the effect this has on health. This group also received suggestions about how to cut down on drinking. The other group could sometimes read general health information. Between one month and one year later, everyone was asked to confirm how much they were drinking. Drinking levels in both groups were compared to each other at these time points. Many (56%) studies were funded by government or research foundation funds. Some (11%) were funded by personal awards such as PhD fellowships. The rest did not report sources of funding. We included 57 studies comparing the drinking of people getting advice about alcohol from computers or mobile devices with those who did not after one to 12 months. Of these, 41 studies (42 comparisons, 19,241 participants) focused on the actual amounts that people reported drinking each week. Most people reported drinking less if they received advice about alcohol from a computer or mobile device compared to people who did not get this advice. Evidence shows that the amount of alcohol people cut down may be about 1.5 pints (800 mL) of beer or a third of a bottle of wine (250 mL) each week. Other measures supported the effectiveness of digital alcohol interventions, although the size of the effect tended to be smaller than for overall alcohol consumption. Positive differences in measures of drinking were seen at 1, 6 and 12 months after the advice. There was not enough information to help us decide if advice was better from computers, telephones or the internet to reduce risky drinking. We do not know which pieces of advice were the most important to help people reduce problem drinking. However, advice from trusted people such as doctors seemed helpful, as did recommendations that people think about specific ways they could overcome problems that might prevent them from drinking less and suggestions about things to do instead of drinking. We included five studies which compared the drinking of people who got advice from computers or mobile devices with advice from face-to-face conversations with doctors or nurses; there may be little or no difference between these to reduce heavy drinking. No studies reported whether any harm came from the interventions. Personalised advice using computers or mobile devices may help people reduce heavy drinking better than doing nothing or providing only general health information. Personalised advice through computers or mobile devices may make little or no difference to reduce drinking compared to face-to-face conversation. Evidence was moderate-to-low quality.
CochranePLS107
***TASK*** the task is to simplify the input abstract of a biomedical literature ***INPUT*** the input is the abstract of a biomedical literature ***OUTPUT*** the output is the simplified abstract for the input abstract of a biomedical literature ***EXAMPLES*** Input: Output: ***EXAMPLES*** Input: Two trials (n = 190), at low risk of bias, were included in the review and both presented data on first time failure at the tooth level. Pooling of the data showed a statistically significant difference in favour of molar bands, with a hazard ratio of 2.92 (95% confidence intervals (CI) 1.80 to 4.72). No statistically significant heterogeneity was shown between the two studies. Data on first time failure at the patient level were also available and showed statistically different difference in favour of molar bands (risk ratio 2.30; 95% CI 1.56 to 3.41) (risk of event for molar tubes = 57%; risk of event for molar bands 25%). One trial presented data on decalcification again showing a statistically significant difference in favour of molar bands. No other adverse events identified. From the two well-designed and low risk of bias trials included in this review it was shown that the failure of molar tubes bonded with either a chemically-cured or light-cured adhesive was considerably higher than that of molar bands cemented with glass ionomer cement. One trial indicated that there was less decalcification with molar bands cemented with glass ionomer cement than with bonded molar tubes cemented with a light-cured adhesive. However, given there are limited data for this outcome, further evidence is required to draw more robust conclusions. Output: The evidence in this review, which was carried out together with Cochrane Oral Health, is up-to-date as of 15 February 2017. We included two studies that evaluated 190 participants. Both trials were conducted in the UK and both compared bonded molar tubes with molar bands. From the limited data of two studies at low risk of bias, it would appear that bonded molar tubes are associated with a higher failure rate than with molar bands. Input: We included 24 studies in the review with a total of 4233 participants, of which 2124 were randomised to benzodiazepines and 1475 to placebo. The remaining 634 participants were randomised to other active treatments in three-arm trials. We assessed the overall methodological quality of the included studies as poor. We rated all studies as at unclear risk of bias in at least three domains. In addition, we judged 20 of the 24 included studies as having a high risk of bias in at least one domain. Two primary outcomes of efficacy and acceptability showed a possible advantage of benzodiazepines over placebo. The estimated risk ratio (RR) for a response to treatment was 1.65 (95% confidence interval (CI) 1.39 to 1.96) in favour of benzodiazepines, which corresponds to an estimated number needed to treat for an additional beneficial outcome (NNTB) of 4 (95% CI 3 to 7). The dropout rate was lower among participants treated with benzodiazepines (RR 0.50, 95% CI 0.39 to 0.64); the estimated NNTB was 6 (95% CI 5 to 9). We rated the quality of the evidence as low for both primary outcomes. The possible advantage of benzodiazepine was also seen for remission (RR 1.61, 95% CI 1.38 to 1.88) and the endpoint data for social functioning (standardised mean difference (SMD) -0.53, 95% CI -0.65 to -0.42), both with low-quality evidence. We assessed the evidence for the other secondary outcomes as of very low quality. With the exception of the analyses of the change score data for depression (SMD -0.22, 95% CI -0.48 to 0.04) and social functioning (SMD -0.32, 95% CI -0.88 to 0.24), all secondary outcome analyses showed an effect in favour of benzodiazepines compared to placebo. However, the number of dropouts due to adverse effects was higher with benzodiazepines than with placebo (RR 1.58, 95% CI 1.16 to 2.15; low-quality evidence). Furthermore, our analyses of adverse events showed that a higher proportion of participants experienced at least one adverse effect when treated with benzodiazepines (RR 1.18, 95% CI 1.02 to 1.37; low-quality evidence). Low-quality evidence shows a possible superiority of benzodiazepine over placebo in the short-term treatment of panic disorders. The validity of the included studies is questionable due to possible unmasking of allocated treatments, high dropout rates, and probable publication bias. Moreover, the included studies were only short-term studies and did not examine the long-term efficacy nor the risks of dependency and withdrawal symptoms. Due to these limitations, our results regarding the efficacy of benzodiazepines versus placebo provide only limited guidance for clinical practice. Furthermore, the clinician's choice is not between benzodiazepines and placebo, but between benzodiazepines and other agents, notably SSRIs, both in terms of efficacy and adverse effects. The choice of treatment should therefore be guided by the patient's preference and should balance benefits and harms from treatment in a long-term perspective. Output:
We found consistent evidence for a possible advantage of benzodiazepines in the improvement of panic symptoms and in the number of participants dropping out of treatment. Furthermore, benzodiazepines may improve social functioning more than placebo. However, there may be more dropouts due to side effects and more participants who experience at least one side effect when treated with benzodiazepines. We found several severe limitations in the design of the included studies. For example, it seems that at least in some studies participants and physicians were able to guess to which treatment arm the participants were allocated, thus it is possible that some trials were not really blinded. These limitations may have led to an overestimation of the treatment effect. Another major limitation is that our included studies were only short-term studies and did not reflect the risks of dependency and withdrawal symptoms. Furthermore, it is unclear if the effect is maintained after the end of treatment. High-quality long-term studies should be carried out to establish whether the benefits of treatment can be maintained and to put the benefits in context of withdrawal effects and the risk of dependency. However, it is unlikely that the general conclusions regarding the short-term efficacy and the dependency potential of benzodiazepines will change. Comparisons with other active treatment including psychotherapy, for example in multiple-treatment meta-analyses, may thus be more suitable to inform clinical practise.
CochranePLS108
***TASK*** the task is to simplify the input abstract of a biomedical literature ***INPUT*** the input is the abstract of a biomedical literature ***OUTPUT*** the output is the simplified abstract for the input abstract of a biomedical literature ***EXAMPLES*** Input: Output: ***EXAMPLES*** Input: Two trials (n = 190), at low risk of bias, were included in the review and both presented data on first time failure at the tooth level. Pooling of the data showed a statistically significant difference in favour of molar bands, with a hazard ratio of 2.92 (95% confidence intervals (CI) 1.80 to 4.72). No statistically significant heterogeneity was shown between the two studies. Data on first time failure at the patient level were also available and showed statistically different difference in favour of molar bands (risk ratio 2.30; 95% CI 1.56 to 3.41) (risk of event for molar tubes = 57%; risk of event for molar bands 25%). One trial presented data on decalcification again showing a statistically significant difference in favour of molar bands. No other adverse events identified. From the two well-designed and low risk of bias trials included in this review it was shown that the failure of molar tubes bonded with either a chemically-cured or light-cured adhesive was considerably higher than that of molar bands cemented with glass ionomer cement. One trial indicated that there was less decalcification with molar bands cemented with glass ionomer cement than with bonded molar tubes cemented with a light-cured adhesive. However, given there are limited data for this outcome, further evidence is required to draw more robust conclusions. Output: The evidence in this review, which was carried out together with Cochrane Oral Health, is up-to-date as of 15 February 2017. We included two studies that evaluated 190 participants. Both trials were conducted in the UK and both compared bonded molar tubes with molar bands. From the limited data of two studies at low risk of bias, it would appear that bonded molar tubes are associated with a higher failure rate than with molar bands. Input: We identified 13 small trials (1520 participants randomised) and three ongoing trials. All studies had at least one domain with unclear risk of bias, and some studies were at high risk of bias for allocation concealment (one study) and selective reporting (two studies). Duration and style of tai chi differed between trials. Seven studies recruited 903 healthy participants, the other studies recruited people with borderline hypertension or hypertension, elderly people at high risk of falling, and people with hypertension with liver and kidney yin deficiency syndrome. No studies reported on cardiovascular mortality, all-cause mortality or non-fatal events as most studies were short term (all studies had follow-up of one year or less). There was also considerable heterogeneity between studies, which meant that it was not possible to combine studies statistically for cardiovascular risk (I2 statistic for systolic blood pressure (SBP) was 96%, for diastolic blood pressure (DBP) 96%, for total cholesterol 96%, low-density lipoprotein-cholesterol (LDL-C) 95%, high-density lipoprotein-cholesterol (HDL-C) 98%, triglycerides 75%). Nine trials measured blood pressure, six individual trials found reductions in SBP (reductions ranged from -22.0 mmHg (95% confidence interval (CI) -26.3 to -17.7) to -11.5 mmHg (95% CI -21.5 to -1.46)), two trials found no clear evidence of a difference (however, CIs were wide and an increase or decrease in SBP cannot be ruled out), and one trial found an increase in SBP with tai chi (increase 5.2 mmHg, 95% CI 3.73 to 6.67). A similar pattern was seen for DBP: three trials found a reduction in DBP (reductions ranged from -12.2 mmHg (95% CI -15.8 to -8.7) to -4.43 mmHg (95% CI -7.14 to -1.72)) and three trials found no clear evidence of a difference, however again with wide CIs. Three trials reported lipid levels and two found reductions in total cholesterol, LDL-C and triglycerides (total cholesterol reductions ranged from -1.30 mmol/L (95% CI -1.57 to -1.03) to -0.50 mmol/L (95% CI -0.74 to -0.26): LDL-C reductions ranged from -0.76 mmol/L (95% CI -0.93 to -0.59) to -0.59 mmol/L (95% CI -0.80 to -0.38): triglyceride reductions ranged from -0.46 mmol/L (95% CI -0.62 to -0.30) to -0.37 mmol/L (95% CI -0.67 to-0.07)) and increased HDL-C with the intervention (HDL-C increases ranged from 0.61 mmol/L (95% CI 0.51 to 0.71) to 0.16 mmol/L (95% CI 0.02 to 0.30)), while the third study found no clear evidence of a difference between groups on lipid levels. Quality of life was measured in one trial: tai chi improved quality of life at three months. None of the included trials reported on adverse events, costs or occurrence of type 2 diabetes. There are currently no long-term trials examining tai chi for the primary prevention of CVD. Due to the limited evidence available currently no conclusions can be drawn as to the effectiveness of tai chi on CVD risk factors. There was some suggestion of beneficial effects of tai chi on CVD risk factors but this was not consistent across all studies. There was considerable heterogeneity between the studies included in this review and studies were small and at some risk of bias. Results of the ongoing trials will add to the evidence base but additional longer-term, high-quality trials are needed. Output:
We searched scientific databases for randomised controlled trials (clinical trials where people are allocated at random to one of two or more treatments) looking at the effects of tai chi on adults at high risk of developing CVD. We did not included people who had already had CVD (e.g. heart attacks and strokes). The evidence is current to December 2013. We found 13 trials, none of them were large enough or of long enough duration to examine the effects of tai chi on reducing cardiovascular deaths or non-fatal endpoints. There were variations in the duration and style of tai chi and the follow-up of the interventions ranged from three to 12 months. Due to the small number of short-term studies and the variability between them, we were unable to determine conclusively whether or not tai chi was beneficial at reducing cardiovascular risk in healthy adults and adults at increased risk of CVD, although beneficial effects for CVD risk factors were seen in some studies. None of the included studies reported on adverse events. Longer-term, high-quality trials are needed in order to determine the effectiveness of tai chi for CVD prevention. The results of this review should be treated with caution as the studies were small, of short duration and there was some risk of bias (where there was a risk of arriving at the wrong conclusions because of favouritism by the participants or researchers).
CochranePLS109
***TASK*** the task is to simplify the input abstract of a biomedical literature ***INPUT*** the input is the abstract of a biomedical literature ***OUTPUT*** the output is the simplified abstract for the input abstract of a biomedical literature ***EXAMPLES*** Input: Output: ***EXAMPLES*** Input: Two trials (n = 190), at low risk of bias, were included in the review and both presented data on first time failure at the tooth level. Pooling of the data showed a statistically significant difference in favour of molar bands, with a hazard ratio of 2.92 (95% confidence intervals (CI) 1.80 to 4.72). No statistically significant heterogeneity was shown between the two studies. Data on first time failure at the patient level were also available and showed statistically different difference in favour of molar bands (risk ratio 2.30; 95% CI 1.56 to 3.41) (risk of event for molar tubes = 57%; risk of event for molar bands 25%). One trial presented data on decalcification again showing a statistically significant difference in favour of molar bands. No other adverse events identified. From the two well-designed and low risk of bias trials included in this review it was shown that the failure of molar tubes bonded with either a chemically-cured or light-cured adhesive was considerably higher than that of molar bands cemented with glass ionomer cement. One trial indicated that there was less decalcification with molar bands cemented with glass ionomer cement than with bonded molar tubes cemented with a light-cured adhesive. However, given there are limited data for this outcome, further evidence is required to draw more robust conclusions. Output: The evidence in this review, which was carried out together with Cochrane Oral Health, is up-to-date as of 15 February 2017. We included two studies that evaluated 190 participants. Both trials were conducted in the UK and both compared bonded molar tubes with molar bands. From the limited data of two studies at low risk of bias, it would appear that bonded molar tubes are associated with a higher failure rate than with molar bands. Input: Twenty-seven RCTs were included. The interventions were very heterogeneous in the components of the family intervention, the other risk behaviours targeted alongside tobacco, the age of children at baseline and the length of follow-up. Two interventions were tested by two RCTs, one was tested by three RCTs and the remaining 20 distinct interventions were tested only by one RCT. Twenty-three interventions were tested in the USA, two in Europe, one in Australia and one in India. The control conditions fell into two main groups: no intervention or usual care; or school-based interventions provided to all participants. These two groups of studies were considered separately. Most studies had a judgement of 'unclear' for at least one risk of bias criteria, so the quality of evidence was downgraded to moderate. Although there was heterogeneity between studies there was little evidence of statistical heterogeneity in the results. We were unable to extract data from all studies in a format that allowed inclusion in a meta-analysis. There was moderate quality evidence family-based interventions had a positive impact on preventing smoking when compared to a no intervention control. Nine studies (4810 participants) reporting smoking uptake amongst baseline non-smokers could be pooled, but eight studies with about 5000 participants could not be pooled because of insufficient data. The pooled estimate detected a significant reduction in smoking behaviour in the intervention arms (risk ratio [RR] 0.76, 95% confidence interval [CI] 0.68 to 0.84). Most of these studies used intensive interventions. Estimates for the medium and low intensity subgroups were similar but confidence intervals were wide. Two studies in which some of the 4487 participants already had smoking experience at baseline did not detect evidence of effect (RR 1.04, 95% CI 0.93 to 1.17). Eight RCTs compared a combined family plus school intervention to a school intervention only. Of the three studies with data, two RCTS with outcomes for 2301 baseline never smokers detected evidence of an effect (RR 0.85, 95% CI 0.75 to 0.96) and one study with data for 1096 participants not restricted to never users at baseline also detected a benefit (RR 0.60, 95% CI 0.38 to 0.94). The other five studies with about 18,500 participants did not report data in a format allowing meta-analysis. One RCT also compared a family intervention to a school 'good behaviour' intervention and did not detect a difference between the two types of programme (RR 1.05, 95% CI 0.80 to 1.38, n = 388). No studies identified any adverse effects of intervention. There is moderate quality evidence to suggest that family-based interventions can have a positive effect on preventing children and adolescents from starting to smoke. There were more studies of high intensity programmes compared to a control group receiving no intervention, than there were for other compairsons. The evidence is therefore strongest for high intensity programmes used independently of school interventions. Programmes typically addressed family functioning, and were introduced when children were between 11 and 14 years old. Based on this moderate quality evidence a family intervention might reduce uptake or experimentation with smoking by between 16 and 32%. However, these findings should be interpreted cautiously because effect estimates could not include data from all studies. Our interpretation is that the common feature of the effective high intensity interventions was encouraging authoritative parenting (which is usually defined as showing strong interest in and care for the adolescent, often with rule setting). This is different from authoritarian parenting (do as I say) or neglectful or unsupervised parenting. Output:
We identified 27 trials; 23 in the USA and one each in Australia, India, the Netherlands, and Norway. The focus varied amongst the studies. Fifteen trials focused on substance use prevention: six focused only on tobacco prevention; one focused on alcohol; one on general substance abuse; three on tobacco, alcohol and marijuana; two on alcohol and tobacco; and two on tobacco and cardiovascular health. Two trials focused on HIV and unsafe sex prevention. Ten trials focused on family functioning, child development and modifying adolescent behaviour. Duration of follow-up after the intervention was very varied, ranging from 6 months to over 15 years for the studies which intervened with mothers of very young children. Nine trials provided data to compare a family tobacco intervention to no intervention on future smoking behaviour for those who did not smoke at the start of the study. We could not include data from a further eight trials. The results showed a significant benefit of family-based interventions over the control comparison on preventing experimentation with or taking up regular smoking. Our estimate suggested that family interventions could reduce the number of adolescents who tried smoking at all by between 16 and 32%. Two trials provided data to compare a combined family plus school intervention to a school intervention and also favoured the family-based intervention. The estimate suggested that the addition of a family intervention might reduce the onset of smoking by between 4 and 25%. We could not include data from a further five trials. Our interpretation is that the common feature of the effective interventions was encouraging authoritative parenting (which is usually defined as showing strong interest in and care for the adolescent, often with rule setting). This is different from authoritarian parenting (do as I say) or neglectful or unsupervised parenting. Because most of the randomised controlled trials included in the review did not report their methods in sufficient detail to be confident that the results were not biased, we judged the quality of the evidence to be moderate, which means that the estimate of effect is uncertain. There is moderate quality evidence that family-based interventions can prevent children and adolescents from starting to smoke. Intensive programs may be more likely to be successful than those of lower intensity. There is also evidence to suggest that adding a family-based component to a school intervention may be effective. As the interventions and settings in the review differed considerably, it is important that family-based programmes continue to be evaluated.
CochranePLS110
***TASK*** the task is to simplify the input abstract of a biomedical literature ***INPUT*** the input is the abstract of a biomedical literature ***OUTPUT*** the output is the simplified abstract for the input abstract of a biomedical literature ***EXAMPLES*** Input: Output: ***EXAMPLES*** Input: Two trials (n = 190), at low risk of bias, were included in the review and both presented data on first time failure at the tooth level. Pooling of the data showed a statistically significant difference in favour of molar bands, with a hazard ratio of 2.92 (95% confidence intervals (CI) 1.80 to 4.72). No statistically significant heterogeneity was shown between the two studies. Data on first time failure at the patient level were also available and showed statistically different difference in favour of molar bands (risk ratio 2.30; 95% CI 1.56 to 3.41) (risk of event for molar tubes = 57%; risk of event for molar bands 25%). One trial presented data on decalcification again showing a statistically significant difference in favour of molar bands. No other adverse events identified. From the two well-designed and low risk of bias trials included in this review it was shown that the failure of molar tubes bonded with either a chemically-cured or light-cured adhesive was considerably higher than that of molar bands cemented with glass ionomer cement. One trial indicated that there was less decalcification with molar bands cemented with glass ionomer cement than with bonded molar tubes cemented with a light-cured adhesive. However, given there are limited data for this outcome, further evidence is required to draw more robust conclusions. Output: The evidence in this review, which was carried out together with Cochrane Oral Health, is up-to-date as of 15 February 2017. We included two studies that evaluated 190 participants. Both trials were conducted in the UK and both compared bonded molar tubes with molar bands. From the limited data of two studies at low risk of bias, it would appear that bonded molar tubes are associated with a higher failure rate than with molar bands. Input: Three studies met the inclusion criteria, enrolling 451 participants. The trial size varied from 51 to 280 participants. Two studies compared dexamethasone to placebo, and the third study compared a number of additional interventions in various combinations, including metoclopramide, chlorpromazine, tropisetron, and dexamethasone. The duration of the studies ranged from seven to 14 days. We included two studies (127 participants) with data at eight days in the meta-analysis for nausea intensity; no data were available that incorporated the same outcome measures for the third study. Corticosteroid therapy with dexamethasone resulted in less nausea (measured on a scale of 0 to 10, with a lower score indicating less nausea) compared to placebo at eight days (MD 0.48 lower nausea, 95% CI 1.53 lower to 0.57 higher; very low-quality evidence), although this result was not statistically significant (P = 0.37). Frequency of adverse events was not significantly different between groups, and the interventions were well tolerated. Factors limiting statistical analysis included the lack of standardised measurements of nausea, and the use of different agents, dosages, and comparisons. Subgroup analysis according to type of cancer was not possible due to insufficient data. The quality of this evidence was downgraded by three levels, from high to very low due to imprecision, likely selection bias, attrition bias, and the small number of participants in the included studies. There are few studies assessing the effects of corticosteroids on nausea and vomiting not related to chemotherapy, radiotherapy, or surgery in adult cancer patients. This review found very low-quality evidence which neither supported nor refuted corticosteroid use in this setting. Further high quality studies are needed to determine if corticosteroids are efficacious in this setting. Output:
In August 2016, we found three relevant studies with 451 participants. The trial size varied from 51 to 280 participants. The duration of the included studies ranged from seven to 14 days. Two studies compared dexamethasone to placebo. The third study compared a number of additional medicines in various combinations, including metoclopramide, chlorpromazine, tropisetron, and dexamethasone. The current evidence is based on a small number of studies with a small number of participants. We rated the quality of the evidence from studies using four levels: very low, low, moderate, or high. Very low quality evidence means that we are very uncertain about the results. High quality evidence means that we are very confident in the results. We made the following conclusions from the available evidence: 1) we found very low-quality evidence of the effects of steroids on nausea and vomiting in cancer patients; 2) there was no evidence about how steroids work in different types of cancer; and 3) there were few reported side effects, and the drugs were generally well tolerated. More high quality studies are needed to determine if steroids are effective anti-nausea agents.
CochranePLS111
***TASK*** the task is to simplify the input abstract of a biomedical literature ***INPUT*** the input is the abstract of a biomedical literature ***OUTPUT*** the output is the simplified abstract for the input abstract of a biomedical literature ***EXAMPLES*** Input: Output: ***EXAMPLES*** Input: Two trials (n = 190), at low risk of bias, were included in the review and both presented data on first time failure at the tooth level. Pooling of the data showed a statistically significant difference in favour of molar bands, with a hazard ratio of 2.92 (95% confidence intervals (CI) 1.80 to 4.72). No statistically significant heterogeneity was shown between the two studies. Data on first time failure at the patient level were also available and showed statistically different difference in favour of molar bands (risk ratio 2.30; 95% CI 1.56 to 3.41) (risk of event for molar tubes = 57%; risk of event for molar bands 25%). One trial presented data on decalcification again showing a statistically significant difference in favour of molar bands. No other adverse events identified. From the two well-designed and low risk of bias trials included in this review it was shown that the failure of molar tubes bonded with either a chemically-cured or light-cured adhesive was considerably higher than that of molar bands cemented with glass ionomer cement. One trial indicated that there was less decalcification with molar bands cemented with glass ionomer cement than with bonded molar tubes cemented with a light-cured adhesive. However, given there are limited data for this outcome, further evidence is required to draw more robust conclusions. Output: The evidence in this review, which was carried out together with Cochrane Oral Health, is up-to-date as of 15 February 2017. We included two studies that evaluated 190 participants. Both trials were conducted in the UK and both compared bonded molar tubes with molar bands. From the limited data of two studies at low risk of bias, it would appear that bonded molar tubes are associated with a higher failure rate than with molar bands. Input: We included 10 RCTs of high-risk children using antibiotics (azithromycin, ciprofloxacin, co-trimoxazole, isoniazid, oral penicillin V or vancomycin) to prevent LRTIs. Three studies included HIV-infected children (n = 1345), four cystic fibrosis (n = 429) and one each sickle cell disease (n = 219), cancer (n = 160) and low birth weight neonates with underlying respiratory disorders (n = 40). The study duration ranged from seven days to three years. The quality of the evidence from studies including children with HIV infection, cystic fibrosis or cancer was moderate. Due to inadequate data, we were unable to rate the quality of the evidence for two studies: one in children with sickle cell disease (low risk of bias), and another in low birth weight neonates with underlying respiratory disorders (high risk of bias). In HIV-infected children receiving continuous isoniazid prophylaxis, there was no significant difference in the incidence of pulmonary tuberculosis (risk ratio (RR) 0.64, 95% confidence interval (CI) 0.32 to 1.29, I2 statistic = 47%, P value = 0.21). There was no significant effect on mortality with co-trimoxazole or isoniazid prophylaxis (RR 0.82, 0.46 to 1.46, I2 statistic = 76%, P value = 0.58); however, analysis of one study that used co-trimoxazole showed a significant reduction in mortality (RR 0.67, 95% CI 0.53 to 0.85, P value = 0.001). There was a significant decrease in the rates of hospital admission per child-year of follow-up with co-trimoxazole prophylaxis in one study (P value = 0.01). There was no evidence of increased adverse events due to antibiotic prophylaxis (RR 1.10, 95% CI 0.75 to 1.64, I2 statistic = 22%, P value = 0.28); however, there was scant reporting of antibiotic resistance - the one study that did assess this found no increase. In two studies of children with cystic fibrosis receiving ciprofloxacin prophylaxis, there was no significant difference in Pseudomonas infections (RR 0.76, 0.44 to 1.31, I2 statistic = 0%, P value = 0.33). In two studies assessing the benefit of azithromycin prophylaxis, there was a significant reduction in the frequency of pulmonary exacerbations (RR 0.60, 95% CI 0.48 to 0.76, I2 statistic = 0%, P value < 0.0001). The effect of antibiotic prophylaxis on growth in children with cystic fibrosis was inconsistent across the studies. There was an increased risk of emergence of pathogenic strains with either azithromycin or ciprofloxacin prophylaxis in two studies reporting this outcome. There was no significant difference in the quality of life (one study). In three studies, there was no significant increase in the frequency of adverse events with prophylaxis with azithromycin (two studies) or ciprofloxacin (one study). There was no evidence of increased antibiotic resistance in two studies. In the one study of children with sickle cell disease, a significantly lesser proportion of children with pneumococcal septicaemia was reported with penicillin V prophylaxis (P value = 0.0025). In the one study of children with cancer there was a significant decrease in Pneumocystis carinii pneumonia with trimethoprim-sulfamethoxazole prophylaxis (RR 0.03, 95% CI 0.00 to 0.47, P value < 0.01). There was no significant increase in the frequency of adverse events with antibiotic prophylaxis. In low birth weight children with underlying respiratory disorders, there was no significant difference in the proportion of children with pulmonary infection with vancomycin prophylaxis (P value = 0.18). No included studies reported time off school or carer time off work. There is inconclusive evidence that antibiotic prophylaxis in certain groups of high-risk children can reduce pneumonia, exacerbations, hospital admission and mortality in certain conditions. However, limitations in the evidence base mean more clinical trials assessing the effectiveness of antibiotics for preventing LRTIs in children at high risk should be conducted. Specifically, clinical trials assessing the effectiveness of antibiotics for preventing LRTIs in congenital heart disease, metabolic disease, endocrine and renal disorders, neurological disease or prematurity should be a priority. Output:
In February 2015, we searched for studies examining the effect of antibiotics to prevent LRTI in children aged 12 years and under with an increased risk of contracting such infections. We included 10 studies; three examined the effectiveness of antibiotics in 1345 children with HIV, four in 429 children with cystic fibrosis, one in 219 children with sickle cell disease, one in 160 children undergoing treatment for cancer, and one in 40 children who were underweight at birth with underlying breathing problems. The study duration was between 18.9 and 24.7 months for children with HIV, between six and 36 months in children with cystic fibrosis, 15 months in one study of children with sickle cell disease, 13 to 24 months in one study of children with cancer, and seven days in low birth weight newborns with underlying respiratory problems. Of three studies that included children with HIV, one was funded by an International Aid Agency, another by government and the third by a charity. Of four studies that included children with cystic fibrosis, three were funded by charities and one by government. The one study that included children with sickle cell disease was funded by government and the study that included children with cancer was funded by government, industry and charity. The funding source for the study that included newborns with underlying respiratory disorders was not specified. In children with HIV, antibiotics did not reduce the likelihood of contracting tuberculosis. Overall there was no improvement in death rates, but there was a marked reduction in hospital admission with antibiotic use in one study. In children with cystic fibrosis, antibiotics did not reduce the likelihood of infection with Pseudomonas bacteria, but there was a reduction in flare-ups, where bacterial infection makes it harder for the child to breathe. In one study of children with sickle cell disease, antibiotics reduced the likelihood of contracting blood infections. In one study of children with cancers, antibiotics reduced the likelihood of contracting Pneumocystis infection in the lungs. In low birth weight newborns with respiratory disorders, antibiotics did not reduce the likelihood of lung infections. In children with HIV, we rated the overall quality of the evidence for two studies that examined the effect of antibiotics for preventing tuberculosis as moderate because of differences in how the antibiotics were administered. We rated the quality of the evidence for antibiotic use in reducing deaths as moderate because of differences in the types of antibiotics used. Due to lack of data, we could not rate the quality of the evidence for hospital admissions. In children with cystic fibrosis, we rated the overall quality of the evidence for two studies that examined the effect of antibiotics in reducing the likelihood of Pseudomonas infection as moderate because of differences in the types of antibiotics used. We rated the quality of the evidence for the effect of antibiotics in reducing 'flare-ups' as high. In children with cancer, we rated the quality of the evidence for the effect of antibiotics in reducing the likelihood of Pneumocystis infection as moderate because of the likelihood of indirectness of the study results. Due to lack of data, we could not rate the quality of the evidence for the effect of antibiotics in reducing the likelihood of blood infections in children with sickle cell disease, or in reducing the likelihood of lung infections in low birth weight newborns with respiratory disorders; the two studies had low probability and high probability of bias respectively.
CochranePLS112
***TASK*** the task is to simplify the input abstract of a biomedical literature ***INPUT*** the input is the abstract of a biomedical literature ***OUTPUT*** the output is the simplified abstract for the input abstract of a biomedical literature ***EXAMPLES*** Input: Output: ***EXAMPLES*** Input: Two trials (n = 190), at low risk of bias, were included in the review and both presented data on first time failure at the tooth level. Pooling of the data showed a statistically significant difference in favour of molar bands, with a hazard ratio of 2.92 (95% confidence intervals (CI) 1.80 to 4.72). No statistically significant heterogeneity was shown between the two studies. Data on first time failure at the patient level were also available and showed statistically different difference in favour of molar bands (risk ratio 2.30; 95% CI 1.56 to 3.41) (risk of event for molar tubes = 57%; risk of event for molar bands 25%). One trial presented data on decalcification again showing a statistically significant difference in favour of molar bands. No other adverse events identified. From the two well-designed and low risk of bias trials included in this review it was shown that the failure of molar tubes bonded with either a chemically-cured or light-cured adhesive was considerably higher than that of molar bands cemented with glass ionomer cement. One trial indicated that there was less decalcification with molar bands cemented with glass ionomer cement than with bonded molar tubes cemented with a light-cured adhesive. However, given there are limited data for this outcome, further evidence is required to draw more robust conclusions. Output: The evidence in this review, which was carried out together with Cochrane Oral Health, is up-to-date as of 15 February 2017. We included two studies that evaluated 190 participants. Both trials were conducted in the UK and both compared bonded molar tubes with molar bands. From the limited data of two studies at low risk of bias, it would appear that bonded molar tubes are associated with a higher failure rate than with molar bands. Input: We included nine RCTs, randomising 519 participants, comparing different gases for establishing pneumoperitoneum: nitrous oxide (three trials), helium (five trials), or room air (one trial) was compared to carbon dioxide. Three trials randomised participants to nitrous oxide pneumoperitoneum (100 participants) or carbon dioxide pneumoperitoneum (96 participants). None of the trials was at low risk of bias. There was insufficient evidence to determine the effects of nitrous oxide and carbon dioxide on cardiopulmonary complications (RR 2.00, 95% CI 0.38 to 10.43; two studies; 140 participants; very low quality of evidence), or surgical morbidity (RR 1.01, 95% CI 0.18 to 5.71; two studies; 143 participants; very low quality of evidence). There were no serious adverse events related to either nitrous oxide or carbon dioxide pneumoperitoneum (three studies; 196 participants; very low quality of evidence). We could not combine data from two trials (140 participants) which individually showed lower pain scores (a difference of about one visual analogue score on a scale of 1 to 10 with lower numbers indicating less pain) with nitrous oxide pneumoperitoneum at various time points on the first postoperative day, and this was rated asvery low quality . Four trials randomised participants to helium pneumoperitoneum (69 participants) or carbon dioxide pneumoperitoneum (75 participants) and one trial involving 33 participants did not state the number of participants in each group. None of the trials was at low risk of bias. There was insufficient evidence to determine the effects of helium or carbon dioxide on cardiopulmonary complications (RR 1.46, 95% CI 0.35 to 6.12; three studies; 128 participants; very low quality of evidence) or pain scores (visual analogue score on a scale of 1 to 10 with lower numbers indicating less pain; MD 0.49 cm, 95% CI -0.28 to 1.26; two studies; 108 participants; very low quality of evidence). There were three serious adverse events (subcutaneous emphysema) related to helium pneumoperitoneum (three studies; 128 participants; very low quality of evidence). One trial randomised participants to room air pneumoperitoneum (70 participants) or carbon dioxide pneumoperitoneum (76 participants). The trial was at unclear risk of bias. There were no cardiopulmonary complications or serious adverse events observed related to either room air or carbon dioxide pneumoperitoneum (both outcomes very low quality of evidence). The evidence of lower hospital costs and reduced pain during the first postoperative day with room air pneumoperitoneum compared with carbon dioxide pneumoperitoneum (a difference of about one visual analogue score on a scale of 1 to 10 with lower numbers indicating less pain, was rated as very low quality of evidence. The quality of the current evidence is very low. The effects of nitrous oxide and helium pneumoperitoneum compared with carbon dioxide pneumoperitoneum are uncertain. Evidence from one trial of small sample size suggests that room air pneumoperitoneum may decrease hospital costs in people undergoing laparoscopic abdominal surgery. The safety of nitrous oxide, helium, and room air pneumoperitoneum has yet to be established. Further trials on this topic are needed, and should compare various gases (i.e. nitrous oxide, helium, argon, nitrogen, and room air) with carbon dioxide under standard pressure pneumoperitoneum with cold gas insufflation for people with high anaesthetic risk. Future trials should include outcomes such as complications, serious adverse events, quality of life, and pain. Output:
We searched for all relevant studies up to September 2016. We identified nine clinical trials with 519 participants, of which three trials (196 participants) compared nitrous oxide (laughing gas) with carbon dioxide, five trials (177 participants) compared helium with carbon dioxide, and one trial (146 participants) compared room air with carbon dioxide. Studies were conducted in the USA, Australia, China, Finland, and Netherlands. The age of the participants in the trials ranged from 19 to 62 years. We are uncertain as to whether there are differences in the number of people with heart or lung complications or surgical complications between nitrous oxide and carbon dioxide. We are uncertain as to whether there are any differences in heart or lung complications, surgical complications, or pain scores between helium and carbon dioxide. There were no serious side effects related to the use of carbon dioxide, nitrous oxide, or room air, but generally serious side effects are rare events and it would take larger studies with many more participants to be sure that these gases are equally safe. There were three serious side effects when helium was used. Room air seemed to be associated with lower total hospital costs compared with carbon dioxide for insufflation of the abdominal cavity. Because of the few participants included in the review, the safety of using nitrous oxide, helium, or room air is unknown. There is no evidence for any clinical improvement by using nitrous oxide, helium, or room air instead of carbon dioxide. Overall, the quality of the evidence for the results is very low. Thus, future well-designed trials examining complications, harms, quality of life, and pain are urgently needed.
CochranePLS113
***TASK*** the task is to simplify the input abstract of a biomedical literature ***INPUT*** the input is the abstract of a biomedical literature ***OUTPUT*** the output is the simplified abstract for the input abstract of a biomedical literature ***EXAMPLES*** Input: Output: ***EXAMPLES*** Input: Two trials (n = 190), at low risk of bias, were included in the review and both presented data on first time failure at the tooth level. Pooling of the data showed a statistically significant difference in favour of molar bands, with a hazard ratio of 2.92 (95% confidence intervals (CI) 1.80 to 4.72). No statistically significant heterogeneity was shown between the two studies. Data on first time failure at the patient level were also available and showed statistically different difference in favour of molar bands (risk ratio 2.30; 95% CI 1.56 to 3.41) (risk of event for molar tubes = 57%; risk of event for molar bands 25%). One trial presented data on decalcification again showing a statistically significant difference in favour of molar bands. No other adverse events identified. From the two well-designed and low risk of bias trials included in this review it was shown that the failure of molar tubes bonded with either a chemically-cured or light-cured adhesive was considerably higher than that of molar bands cemented with glass ionomer cement. One trial indicated that there was less decalcification with molar bands cemented with glass ionomer cement than with bonded molar tubes cemented with a light-cured adhesive. However, given there are limited data for this outcome, further evidence is required to draw more robust conclusions. Output: The evidence in this review, which was carried out together with Cochrane Oral Health, is up-to-date as of 15 February 2017. We included two studies that evaluated 190 participants. Both trials were conducted in the UK and both compared bonded molar tubes with molar bands. From the limited data of two studies at low risk of bias, it would appear that bonded molar tubes are associated with a higher failure rate than with molar bands. Input: Fourteen studies were included in this review. Only RCTs investigating dexamethasone were identified. Eight studies enrolling a total of 303 participants investigated the cumulative dosage administered; three studies contrasted a high versus a moderate and five studies a moderate versus a low cumulative dexamethasone dose. Analysis of the studies investigating a moderate dexamethasone dose versus a high-dosage regimen showed an increased risk of BPD (typical risk ratio (RR) 1.50, 95% confidence interval (CI) 1.01 to 2.22; typical risk difference (RD) 0.26, 95% CI 0.03 to 0.49; number needed to treat for an additional harmful outcome (NNTH) 4, 95% CI 1.9 to 23.3; I² = 0%, 2 studies, 55 infants) as well as an increased risk of abnormal neurodevelopmental outcome (typical RR 8.33, 95% CI 1.63 to 42.48; RD 0.30, 95% CI 0.14 to 0.46; NNTH 4, 95% CI 2.2 to 7.3; I² = 68%, 2 studies, 74 infants) when using a moderate cumulative-dosage regimen. The composite outcomes of death or BPD and death or abnormal neurodevelopmental outcome showed similar results although the former only reached borderline significance. There were no differences in outcomes between a moderate- and a low-dosage regimen. Four other studies enrolling 762 infants investigated early initiation of dexamethasone therapy versus a moderately early or delayed initiation and showed no significant differences in the primary outcomes. The two RCTs investigating a continuous versus a pulse dexamethasone regimen showed an increased risk of the combined outcome death or BPD when using the pulse therapy. Finally, two trials investigating a standard regimen versus a participant-individualized course of dexamethasone showed no difference in the primary outcome and long-term neurodevelopmental outcomes. The quality of evidence for all comparisons discussed above was assessed as low or very low, because the validity of all comparisons is hampered by small samples of randomized infants, heterogeneity in study population and design, non-protocolized use of ‘rescue’ corticosteroids and lack of long-term neurodevelopmental data in most studies. Despite the fact that some studies reported a modulating effect of treatment regimens in favor of higher-dosage regimens on the incidence of BPD and neurodevelopmental impairment, recommendations on the optimal type of corticosteroid, the optimal dosage, or the optimal timing of initiation for the prevention of BPD in preterm infants cannot be made based on current level of evidence. A well-designed large RCT is urgently needed to establish the optimal systemic postnatal corticosteroid dosage regimen. Output:
Searching all electronic databases to 21 March 2016 revealed 14 studies investigating two or more different corticosteroid regimens in preterm infants. The investigated regimens differed in the used cumulative dose, timing of initiation and duration of therapy. Those studies comparing a high versus a lower-dosage regimen showed an increased risk of BPD and adverse neurodevelopmental outcome for infants receiving a lower cumulative dose. Those studies investigating an early versus later administration of steroids did not show any difference in outcome. Furthermore, pulse regimens showed inferior results for the outcome BPD compared with continuous treatment. An individualized dosage regimen showed no differences compared to the standard tapering course. Most of the studies had important methodological weaknesses, preventing any recommendations on the optimal corticosteroid dosage regimen for preterm infants at risk of BPD. More studies are urgently needed.
CochranePLS114
***TASK*** the task is to simplify the input abstract of a biomedical literature ***INPUT*** the input is the abstract of a biomedical literature ***OUTPUT*** the output is the simplified abstract for the input abstract of a biomedical literature ***EXAMPLES*** Input: Output: ***EXAMPLES*** Input: Two trials (n = 190), at low risk of bias, were included in the review and both presented data on first time failure at the tooth level. Pooling of the data showed a statistically significant difference in favour of molar bands, with a hazard ratio of 2.92 (95% confidence intervals (CI) 1.80 to 4.72). No statistically significant heterogeneity was shown between the two studies. Data on first time failure at the patient level were also available and showed statistically different difference in favour of molar bands (risk ratio 2.30; 95% CI 1.56 to 3.41) (risk of event for molar tubes = 57%; risk of event for molar bands 25%). One trial presented data on decalcification again showing a statistically significant difference in favour of molar bands. No other adverse events identified. From the two well-designed and low risk of bias trials included in this review it was shown that the failure of molar tubes bonded with either a chemically-cured or light-cured adhesive was considerably higher than that of molar bands cemented with glass ionomer cement. One trial indicated that there was less decalcification with molar bands cemented with glass ionomer cement than with bonded molar tubes cemented with a light-cured adhesive. However, given there are limited data for this outcome, further evidence is required to draw more robust conclusions. Output: The evidence in this review, which was carried out together with Cochrane Oral Health, is up-to-date as of 15 February 2017. We included two studies that evaluated 190 participants. Both trials were conducted in the UK and both compared bonded molar tubes with molar bands. From the limited data of two studies at low risk of bias, it would appear that bonded molar tubes are associated with a higher failure rate than with molar bands. Input: No new studies were included in this update. Eight randomised controlled trials involving 996 people were selected for inclusion in the review. Researchers compared several steroidal agents such as corticotrophin, cortisone, hydrocortisone, dexamethasone, prednisone and intravenous immunoglobulin versus aspirin, placebo or no treatment. Six trials were conducted between 1950 and 1965; one was done in 1990 and the final study was published in 2001. Overall there were no observed significant differences in risk of cardiac disease at one year between corticosteroid-treated and aspirin-treated groups (six studies, 907 participants, risk ratio 0.87, 95% confidence interval 0.66 to 1.15). Similarly, use of prednisone (two studies, 212 participants, risk ratio 1.13, 95% confidence interval 0.52 to 2.45) compared with aspirin did not reduce the risk of heart disease after one year. Investigators in five studies did not report adverse events. The three studies reporting on adverse events reported substantial adverse events. However, all results should be interpreted with caution because of the age of the studies and the substantial risk of bias. Little evidence of benefit was found when corticosteroids or intravenous immunoglobulins were used to reduce the risk of heart valve lesions in patients with acute rheumatic fever. The antiquity of most of the trials restricted adequate statistical analysis of the data and acceptable assessment of clinical outcomes by current standards. In addition, risk of bias was substantial, so results should be viewed with caution. New randomised controlled trials in patients with acute rheumatic fever are warranted to assess the effects of corticosteroids such as oral prednisone and intravenous methylprednisolone and the effects of other new anti-inflammatory agents. Advances in echocardiography will allow more objective and precise assessments of cardiac outcomes. Output:
This is an update of a review published in 2003 and previously updated in 2009 and 2012. For this latest update, the search was rerun on 17 October 2013, and no new studies were found. Rheumatic fever is a late complication of a type of throat infection caused by streptococcal bacteria. It is an immune system disease that can lead to inflammatory disease of the heart (carditis), joints, brain and skin. Carditis can cause heart failure and death. Various anti-inflammatory drugs have been used to treat carditis, including corticosteroids, aspirin and immunoglobulins (immune therapy using antibodies). No new trials were identified in this update. This review includes eight trials with 996 participants. Evidence shows little effect of corticosteroids over aspirin in preventing cardiac disease after one year (six studies, 907 participants, risk ratio 0.87, 95% confidence interval 0.66 to 1.15). Several steroidal agents such as corticotrophin, cortisone, hydrocortisone and dexamethasone were compared with aspirin before 1966, and prednisone and immunoglobulins were compared with placebo in studies from 1990 and 2001, respectively. Most studies did not report on adverse events, but those that did reported complications due to corticosteroids including weight gain, enlarged facial features and acne. Trials were generally old (six of the eight trials were conducted between 1955 and 1965), small and of poor quality and had high risk of bias. For this reason, results should be interpreted with caution.
CochranePLS115
***TASK*** the task is to simplify the input abstract of a biomedical literature ***INPUT*** the input is the abstract of a biomedical literature ***OUTPUT*** the output is the simplified abstract for the input abstract of a biomedical literature ***EXAMPLES*** Input: Output: ***EXAMPLES*** Input: Two trials (n = 190), at low risk of bias, were included in the review and both presented data on first time failure at the tooth level. Pooling of the data showed a statistically significant difference in favour of molar bands, with a hazard ratio of 2.92 (95% confidence intervals (CI) 1.80 to 4.72). No statistically significant heterogeneity was shown between the two studies. Data on first time failure at the patient level were also available and showed statistically different difference in favour of molar bands (risk ratio 2.30; 95% CI 1.56 to 3.41) (risk of event for molar tubes = 57%; risk of event for molar bands 25%). One trial presented data on decalcification again showing a statistically significant difference in favour of molar bands. No other adverse events identified. From the two well-designed and low risk of bias trials included in this review it was shown that the failure of molar tubes bonded with either a chemically-cured or light-cured adhesive was considerably higher than that of molar bands cemented with glass ionomer cement. One trial indicated that there was less decalcification with molar bands cemented with glass ionomer cement than with bonded molar tubes cemented with a light-cured adhesive. However, given there are limited data for this outcome, further evidence is required to draw more robust conclusions. Output: The evidence in this review, which was carried out together with Cochrane Oral Health, is up-to-date as of 15 February 2017. We included two studies that evaluated 190 participants. Both trials were conducted in the UK and both compared bonded molar tubes with molar bands. From the limited data of two studies at low risk of bias, it would appear that bonded molar tubes are associated with a higher failure rate than with molar bands. Input: We included six studies with a total of 12,294 participants from 79 communities. Two studies that assessed insecticide spray as a fly control measure found that trachoma is reduced by at least 55% to 61% with this measure compared to no intervention. However, another study did not find insecticide spray to be effective in reducing trachoma. One study found that another fly control measure, latrine provision, reduced trachoma by 29.5% compared to no intervention; this was, however, not statistically significantly different and findings have not been confirmed by a more recent study. Another study revealed that health education reduced the incidence of trachoma. These findings were not confirmed by a second study, however, which found that a modest health education programme with modest water supply did not reduce trachoma. However, all the studies have some methodological concerns. There is some evidence from two trials that insecticides are effective in reducing trachoma, however, this effect was not demonstrated in another trial that used insecticides. Two trials on latrine provision as a fly control measure have not demonstrated significant trachoma reduction. Health education had shown significant reduction of trachoma in one study but another study did not demonstrate similar findings. Generally there is a dearth of data to determine the effectiveness of all aspects of environmental sanitation in the control of trachoma. Output:
We included six studies involving 12,294 participants of different ages and both sexes in this review. The trials were conducted in The Gambia, Mali, Tanzania, Niger and Ethiopia. Two studies looked at insecticide spray, one looked at insecticide spray and provision of latrines, one study looked at provision of latrines, and two studies looked at health education with one of them having health education combined with water supply. Prevalence of active trachoma, prevalence of Chlamydia trachomatis and fly count measures were the main outcomes assessed. Two studies conducted in the same area found insecticide spray effective in reducing active trachoma but one study in a different setting found the spray ineffective. A separate study found health education on personal and environmental hygiene to be effective in reducing active trachoma, however, another study found that a modest health education programme combined with a modest water supply was not effective in reducing active trachoma. One study on latrine provision found no impact on trachoma. However, more research is needed.
CochranePLS116
***TASK*** the task is to simplify the input abstract of a biomedical literature ***INPUT*** the input is the abstract of a biomedical literature ***OUTPUT*** the output is the simplified abstract for the input abstract of a biomedical literature ***EXAMPLES*** Input: Output: ***EXAMPLES*** Input: Two trials (n = 190), at low risk of bias, were included in the review and both presented data on first time failure at the tooth level. Pooling of the data showed a statistically significant difference in favour of molar bands, with a hazard ratio of 2.92 (95% confidence intervals (CI) 1.80 to 4.72). No statistically significant heterogeneity was shown between the two studies. Data on first time failure at the patient level were also available and showed statistically different difference in favour of molar bands (risk ratio 2.30; 95% CI 1.56 to 3.41) (risk of event for molar tubes = 57%; risk of event for molar bands 25%). One trial presented data on decalcification again showing a statistically significant difference in favour of molar bands. No other adverse events identified. From the two well-designed and low risk of bias trials included in this review it was shown that the failure of molar tubes bonded with either a chemically-cured or light-cured adhesive was considerably higher than that of molar bands cemented with glass ionomer cement. One trial indicated that there was less decalcification with molar bands cemented with glass ionomer cement than with bonded molar tubes cemented with a light-cured adhesive. However, given there are limited data for this outcome, further evidence is required to draw more robust conclusions. Output: The evidence in this review, which was carried out together with Cochrane Oral Health, is up-to-date as of 15 February 2017. We included two studies that evaluated 190 participants. Both trials were conducted in the UK and both compared bonded molar tubes with molar bands. From the limited data of two studies at low risk of bias, it would appear that bonded molar tubes are associated with a higher failure rate than with molar bands. Input: Fifteen studies (1043 CFS participants) were included in the review. When comparing CBT with usual care (six studies, 373 participants), the difference in fatigue mean scores at post-treatment was highly significant in favour of CBT (SMD -0.39, 95% CI -0.60 to -0.19), with 40% of CBT participants (four studies, 371 participants) showing clinical response in contrast with 26% in usual care (OR 0.47, 95% CI 0.29 to 0.76). Findings at follow-up were inconsistent. For CBT versus other psychological therapies, comprising relaxation, counselling and education/support (four studies, 313 participants), the difference in fatigue mean scores at post-treatment favoured CBT (SMD -0.43, 95% CI -0.65 to -0.20). Findings at follow-up were heterogeneous and inconsistent. Only two studies compared CBT against other interventions and one study compared CBT in combination with other interventions against usual care. CBT is effective in reducing the symptoms of fatigue at post-treatment compared with usual care, and may be more effective in reducing fatigue symptoms compared with other psychological therapies. The evidence base at follow-up is limited to a small group of studies with inconsistent findings. There is a lack of evidence on the comparative effectiveness of CBT alone or in combination with other treatments, and further studies are required to inform the development of effective treatment programmes for people with CFS. Output:
This review aimed to find out whether CBT is effective for CBT, both as a standalone treatment and in combination with other treatments, and whether it is more effective than other treatments used for CFS. The review included 15 studies, with a total of 1043 CFS participants. The review showed that people attending for CBT were more likely to have reduced fatigue symptoms at the end of treatment than people who received usual care or were on a waiting list for therapy, with 40% of people in the CBT group showing clinical improvement, in contrast with 26% in usual care. At follow-up, 1-7 months after treatment ended, people who had completed their course of CBT continued to have lower fatigue levels, but when including people who had dropped out of treatment, there was no difference between CBT and usual care. The review also compared CBT against other types of psychological therapy, including relaxation techniques, counselling and support/education, and found that people attending for CBT was more likely to have reduced fatigue symptoms at the end of treatment than those attending for other psychological therapies. Physical functioning, depression, anxiety and psychological distress symptoms were also more reduced when compared with other psychological therapies. However at follow-up, the results were inconsistent and the studies did not fit well together, making it difficult to draw any conclusions. Very few studies reported on the acceptability of CBT and no studies examined side effects. Only two studies compared the effectiveness of CBT against other treatments, both exercise therapy, and just one study compared a combination of CBT and other treatments with usual care. More studies should be carried out to establish whether CBT is more helpful than other treatments for CFS, and whether CBT in combination with other treatments is more helpful than single treatment approaches.
CochranePLS117
***TASK*** the task is to simplify the input abstract of a biomedical literature ***INPUT*** the input is the abstract of a biomedical literature ***OUTPUT*** the output is the simplified abstract for the input abstract of a biomedical literature ***EXAMPLES*** Input: Output: ***EXAMPLES*** Input: Two trials (n = 190), at low risk of bias, were included in the review and both presented data on first time failure at the tooth level. Pooling of the data showed a statistically significant difference in favour of molar bands, with a hazard ratio of 2.92 (95% confidence intervals (CI) 1.80 to 4.72). No statistically significant heterogeneity was shown between the two studies. Data on first time failure at the patient level were also available and showed statistically different difference in favour of molar bands (risk ratio 2.30; 95% CI 1.56 to 3.41) (risk of event for molar tubes = 57%; risk of event for molar bands 25%). One trial presented data on decalcification again showing a statistically significant difference in favour of molar bands. No other adverse events identified. From the two well-designed and low risk of bias trials included in this review it was shown that the failure of molar tubes bonded with either a chemically-cured or light-cured adhesive was considerably higher than that of molar bands cemented with glass ionomer cement. One trial indicated that there was less decalcification with molar bands cemented with glass ionomer cement than with bonded molar tubes cemented with a light-cured adhesive. However, given there are limited data for this outcome, further evidence is required to draw more robust conclusions. Output: The evidence in this review, which was carried out together with Cochrane Oral Health, is up-to-date as of 15 February 2017. We included two studies that evaluated 190 participants. Both trials were conducted in the UK and both compared bonded molar tubes with molar bands. From the limited data of two studies at low risk of bias, it would appear that bonded molar tubes are associated with a higher failure rate than with molar bands. Input: One double-blind randomised controlled study including 46 people with sickle cell disease (HbSS, HbSC, HbSβ+thal and HbSβ0thal) was eligible for inclusion in this review. Of the 46 enrolled participants, seven withdrew before randomisation leaving 39 participants who were randomised. Only 25 participants completed the full six months of follow up. Participants were randomised to receive oral vitamin D3 (cholecalciferol) (n = 20) or placebo (n = 19) for six weeks and were followed up to six months. Two participants from the treatment group have missing values of baseline serum 25-hydroxyvitamin D, therefore the number of samples analysed was 37 (vitamin D n = 18, placebo n = 19). The included study had a high risk of bias with regards to incomplete outcome data (high dropout rate in the placebo group), but a low risk of bias for other domains such as random sequence generation, allocation concealment, blinding of participants, personnel and outcome assessors, selective outcome reporting; and an unclear risk of other biases. Compared to the placebo group, the vitamin D group had significantly higher serum 25-hydroxyvitamin D (25(OH)D) levels at eight weeks, mean difference 29.79 (95% confidence interval 26.63 to 32.95); at 16 weeks, mean difference 12.67 (95% confidence interval 10.43 to 14.90); and at 24 weeks, mean difference 15.52 (95% confidence interval 13.50 to 17.54). We determined the quality of the evidence for this outcome to be moderate. There was no significant difference of adverse events (tingling of lips or hands) between the vitamin D and placebo groups, risk ratio 3.16 (95% confidence interval 0.14 to 72.84), but the quality of the evidence was low. Regarding the frequency of pain, the vitamin D group had significantly fewer pain days compared to the placebo group, mean difference -10.00 (95% confidence interval -16.47 to -3.53), but again the quality of the evidence was low. Furthermore, the review included physical functioning PedsQL scores which was reported as absolute change from baseline. The vitamin D group had a lower (worse) health-related quality of life score than the placebo group but this was not significant at eight weeks, mean difference -2.02 (95% confidence interval -6.34 to 2.30). However, the difference was significant at both 16 weeks, mean difference -12.56 (95% confidence interval -16.44 to -8.69) and 24 weeks, mean difference -12.59 (95% confidence interval -17.43 to -7.76). We determined the quality of evidence for this outcome to be low. We included only one low-quality clinical study which had a high risk of bias with regards to incomplete outcome data. Therefore, we consider that the evidence is not of sufficient quality to guide clinical practice. Until further evidence becomes available, clinicians should consider the relevant existing guidelines for vitamin D supplementation (e.g. the Endocrine Society Clinical Practice Guidelines) and dietary reference intakes for calcium and vitamin D (e.g. from the USA Institute of Medicine). Evidence of vitamin D supplementation in sickle cell disease from high quality studies is needed. Well-designed, randomised, placebo-controlled studies of parallel design, are required to determine the effects and the safety of vitamin D supplementation in children and adults with sickle cell disease. Output:
The review included one study which recruited 46 people with sickle cell disease aged between seven and 21 years; of these 39 people in the study were randomly selected to take vitamin D tablets or placebo tablets for six weeks and then followed up for six months. The study reported results from 37 people. People taking a vitamin D supplement had higher levels of vitamin D in their blood when it was measured after eight, 16 and 24 weeks. There were no differences in the number of people reporting side effects, such as tingling in the lips or hands between the vitamin D group and the placebo group. The vitamin D group had fewer days of pain compared to the placebo group. The study also reported on health-related quality of life (physical functioning scores). After eight weeks the vitamin D group had a slightly worse score than the placebo group, but the difference was much greater after 16 and 24 weeks. Given these results from this small single study with moderate to low quality of the evidence, we do not think the results of our review are of sufficient quality to guide clinical practice. Until further evidence becomes available, clinicians should consider relevant existing guidelines for vitamin D supplementation (e.g. the Endocrine Society Clinical Practice Guidelines), and recommendations for calcium and vitamin D intake (from e.g. the USA Institute of Medicine). High-quality studies looking at the effects of supplementing vitamin D in children and adults with sickle cell disease are needed. We do not think there are risks of bias in the way people were put into the different groups and we do not think anyone (either the participant or the doctor) could guess which group they were in once the study started. Even though the adverse events were not reported in the original report, the study author provided the information upon request. More people dropped out of the placebo group (68.4%) than the vitamin D group (5%), and two people assigned to vitamin D group but not included in the analysis. We considered there was a high risk of bias in the way the study reported results. The evidence is only applicable to people with sickle cell disease when they are in a steady state, i.e. at least 30 days from blood transfusion and at least 14 days from any acute sickle complication. The quality of evidence for the outcomes ranged from moderate to low. We considered the quality of the evidence for vitamin D blood levels to be moderate, and for adverse events, days of pain and health-related quality of life, the quality of the evidence was low.
CochranePLS118
***TASK*** the task is to simplify the input abstract of a biomedical literature ***INPUT*** the input is the abstract of a biomedical literature ***OUTPUT*** the output is the simplified abstract for the input abstract of a biomedical literature ***EXAMPLES*** Input: Output: ***EXAMPLES*** Input: Two trials (n = 190), at low risk of bias, were included in the review and both presented data on first time failure at the tooth level. Pooling of the data showed a statistically significant difference in favour of molar bands, with a hazard ratio of 2.92 (95% confidence intervals (CI) 1.80 to 4.72). No statistically significant heterogeneity was shown between the two studies. Data on first time failure at the patient level were also available and showed statistically different difference in favour of molar bands (risk ratio 2.30; 95% CI 1.56 to 3.41) (risk of event for molar tubes = 57%; risk of event for molar bands 25%). One trial presented data on decalcification again showing a statistically significant difference in favour of molar bands. No other adverse events identified. From the two well-designed and low risk of bias trials included in this review it was shown that the failure of molar tubes bonded with either a chemically-cured or light-cured adhesive was considerably higher than that of molar bands cemented with glass ionomer cement. One trial indicated that there was less decalcification with molar bands cemented with glass ionomer cement than with bonded molar tubes cemented with a light-cured adhesive. However, given there are limited data for this outcome, further evidence is required to draw more robust conclusions. Output: The evidence in this review, which was carried out together with Cochrane Oral Health, is up-to-date as of 15 February 2017. We included two studies that evaluated 190 participants. Both trials were conducted in the UK and both compared bonded molar tubes with molar bands. From the limited data of two studies at low risk of bias, it would appear that bonded molar tubes are associated with a higher failure rate than with molar bands. Input: This review includes only one RCT, funded by the Australian Research Council; the University of Sydney International Development Fund; Douglas and Lola Douglas Scholarship on Child and Adolescent Health; Nadia Verrall Memorial Scholarship; and a James Kentley Memorial Fellowship. This study recruited 26 children aged 4 to 12 years, with mild to moderate CAS of unknown cause, and compared two interventions: the Nuffield Dyspraxia Programme-3 (NDP-3); and the Rapid Syllable Transitions Treatment (ReST). Children were allocated randomly to one of the two treatments. Treatments were delivered intensively in one-hour sessions, four days a week for three weeks, in a university clinic in Australia. Speech pathology students delivered the treatments in the English language. Outcomes were assessed before therapy, immediately after therapy, at one month and four months post-therapy. Our review looked at one-month post-therapy outcomes only. A number of cases in each cohort had recommenced usual treatment by their speech and language pathologist between one month and four months post-treatment (NDP-3: 9/13 participants; ReST: 9/13 participants). Hence, maintenance of treatment effects to four months post-treatment could not be analysed without significant potential bias, and thus this time point was not included for further analysis in this review. We judged all core outcome domains to be low risk of bias. We downgraded the quality of the evidence by one level to moderate due to imprecision, given that only one RCT was identified. Both the NDP-3 and ReST therapies demonstrated improvement at one month post-treatment. For three outcomes the effect was marginally greater for NDP-3 than ReST: accuracy of production on treated words (NDP-3 mean difference (MD) = 36.0, ReST MD = 33.9; absolute MD = 2.1 between groups); speech production consistency, measured by 25 real words repeated three times using the inconsistency subtest of the Diagnostic Evaluation of Articulation and Phonology (DEAP) test (NDP-3 MD = 11.1, ReST MD = 10.9; absolute MD = 0.2 between groups); and accuracy of connected speech, assessed by imitated word accuracy in connected speech of at least three word combinations (NDP-3 MD = 14.3, ReST MD = 11.5; absolute MD = 2.8 between groups). ReST (MD = 18.3) demonstrated a marginally greater effect than NDP-3 (MD = 18.2) for accuracy of production on non-treated words at one month post-treatment (absolute MD = 0.1 between groups). The study did not assess the outcome of functional communication. There is limited evidence that, when delivered intensively, both NDP-3 and ReST may effect improvement in word accuracy in 4- to 12-year-old children with CAS, measured by the accuracy of production on treated and non-treated words, speech production consistency and the accuracy of connected speech. The study did not measure functional communication. No formal analyses were conducted to compare NDP-3 and ReST by the original study authors, hence one treatment cannot be reliably advocated over the other. We are also unable to say whether either treatment is better than no treatment or treatment as usual. No evidence currently exists to support the effectiveness of other treatments for children aged 4 to 12 years with idiopathic CAS without other comorbid neurodevelopmental disorders. Further RCTs replicating this study would strengthen the evidence base. Similarly, further RCTs are needed of other interventions, in other age ranges and populations with CAS and with co-occurring disorders. Output:
We found one study with 26 children aged 4 to 12 years with CAS. The children had mild to severe CAS without a known cause. Children were allocated randomly (using a method like coin tossing) to one of two treatments: the Nuffield Dyspraxia Programme - Third Edition (NDP-3); and the Rapid Syllable Transition treatment (ReST). Both therapies were delivered intensively in one-hour sessions, four days a week for three weeks. The treatments were delivered by speech pathology students in a university clinic. Outcomes were assessed before therapy, immediately after therapy, at one month and four months post-therapy. Our review looked at one-month post-therapy outcomes only. The included study was funded by the Australian Research Council; the University of Sydney International Development Fund; Douglas & Lola Douglas Scholarship on Child and Adolescent Health; Nadia Verrall Memorial Scholarship; and a James Kentley Memorial Fellowship. Further studies replicating these findings would strengthen available evidence. The study provides limited evidence that the NDP-3 may improve the accuracy of production on treated items and the accuracy of connected speech. There is limited evidence that the NDP-3 has a negligible effect on speech production consistency, and the ReST a negligible effect on accuracy of production on non-treated words. The study did not measure functional communication. The included study was a randomised controlled trial with an overall low risk of bias. We downgraded the quality of the evidence by one level to moderate, due to imprecision, given that only one RCT was identified. There is limited evidence that the NDP-3 or ReST may be helpful for children with CAS of unknown origin, aged 4 to 12 years, without other co-occurring conditions. We were not able to find out whether one of these treatment was better than the other, or whether either was better than no treatment or treatment as usual. There is currently no available evidence for other treatments. Further RCTs — including studies comparing treatments to a no-treatment (wait-list) control group — would strengthen the evidence base. Further research is also needed for children with CAS and other disorders or diagnoses.
CochranePLS119
***TASK*** the task is to simplify the input abstract of a biomedical literature ***INPUT*** the input is the abstract of a biomedical literature ***OUTPUT*** the output is the simplified abstract for the input abstract of a biomedical literature ***EXAMPLES*** Input: Output: ***EXAMPLES*** Input: Two trials (n = 190), at low risk of bias, were included in the review and both presented data on first time failure at the tooth level. Pooling of the data showed a statistically significant difference in favour of molar bands, with a hazard ratio of 2.92 (95% confidence intervals (CI) 1.80 to 4.72). No statistically significant heterogeneity was shown between the two studies. Data on first time failure at the patient level were also available and showed statistically different difference in favour of molar bands (risk ratio 2.30; 95% CI 1.56 to 3.41) (risk of event for molar tubes = 57%; risk of event for molar bands 25%). One trial presented data on decalcification again showing a statistically significant difference in favour of molar bands. No other adverse events identified. From the two well-designed and low risk of bias trials included in this review it was shown that the failure of molar tubes bonded with either a chemically-cured or light-cured adhesive was considerably higher than that of molar bands cemented with glass ionomer cement. One trial indicated that there was less decalcification with molar bands cemented with glass ionomer cement than with bonded molar tubes cemented with a light-cured adhesive. However, given there are limited data for this outcome, further evidence is required to draw more robust conclusions. Output: The evidence in this review, which was carried out together with Cochrane Oral Health, is up-to-date as of 15 February 2017. We included two studies that evaluated 190 participants. Both trials were conducted in the UK and both compared bonded molar tubes with molar bands. From the limited data of two studies at low risk of bias, it would appear that bonded molar tubes are associated with a higher failure rate than with molar bands. Input: Four trials that randomised a total of 268 participants met the inclusion criteria. In all four studies antibiotic was administered orally. One study conducted in Brazil in both adults and children compared trimethoprim-sulfamexacocol over 20 months to no treatment and was judged to be at high risk of performance, detection, and attrition bias. The other three studies compared antibiotic treatment to placebo. We judged these three studies to be at a mixture of low or unclear risk of bias due to poor reporting. One study conducted in the US in adults studied pyrimethamine-trisulfapyrimidine for eight weeks; one study conducted in the UK in children and adults evaluated pyrimethamine for four weeks; and one study conducted in Brazil in adults investigated trimethoprim-sulfamethoxazole for 12 months. In the last study, all participants had active retinochoroiditis and were treated with antibiotics for 45 days prior to randomisation to trimethoprim-sulfamethoxazole versus placebo. Only the study in Brazil of trimethoprim-sulfamethoxazole over 12 months, in participants with healed lesions, reported the effect of treatment on visual acuity. People treated with antibiotics may have a similar change in visual acuity compared with people treated with placebo at one year (mean difference -1.00 letters, 95% confidence interval (CI) -7.93 to 5.93 letters; 93 participants; low-quality evidence). Treatment with antibiotics probably reduces the risk of recurrent retinochoroiditis compared with placebo (risk ratio (RR) 0.26, 95% CI 0.11 to 0.63; 227 participants; 3 studies; I2 = 0%; moderate-quality evidence); similar results were seen for acute and chronic retinochoroiditis. The UK study of pyrimethamine for four weeks reported an improvement in intraocular inflammation in treated compared with control participants (RR 1.76, 95% CI 0.98 to 3.19; 29 participants; low-quality evidence). The study in Brazil of trimethoprim-sulfamethoxazole for 12 months stated that the severity of inflammation was higher in the comparator group when compared to the antibiotic-treated group but did not provide further details. In the US study of pyrimethamine-trisulfapyrimidine for eight weeks intraocular inflammation had almost completely resolved by eight weeks in all participants, however in this study all participants received steroid treatment. Two studies (UK and US studies) reported an increased risk of adverse events in treated participants. These were a fall in haemoglobin, leucocyte, and platelet count, nausea, loss of appetite, rash, and arthralgia. Treatment with antibiotics probably reduces the risk of recurrent toxoplasma retinochoroiditis, but there is currently no good evidence that this leads to better visual outcomes. However, absence of evidence of effect is not the same as evidence of no effect. Further trials of people with acute and chronic toxoplasma retinochoroiditis affecting any part of the retina are required to determine the effects of antibiotic treatment on visual outcomes. Output:
We found four studies with a total of 268 participants. These studies were conducted in Brazil, the UK, and the US. The evidence is current to 22 February 2016. Only one of the four studies compared the effect of antibiotic treatment for 12 months with placebo on visual acuity and found similar changes in both groups. Three studies examined the effect of antibiotics on reducing the number of recurring episodes of the disease. Two of these three studies were conducted in Brazil in adults infected with the more aggressive South American strains of the parasite, which can cause frequently recurring eye symptoms. The studies from Brazil found that the long-term antibiotics over 14 and 12 months, respectively, reduced the number of recurrent episodes of retinochoroiditis. The other study did not find that short-term (eight weeks) treatment with antibiotics made any difference. Two studies reported an improvement in intraocular inflammation in antibiotic-treated compared with untreated participants, and one study reported no changes. Two studies investigated side effects of giving antibiotics such as decreased white blood cells, loss of appetite, rashes and other allergic reactions and found only weak evidence that antibiotics increase the risk of side effects. There were problems with the design, conduct, and analyses of all of the studies, which could have biased the results. There was a lack of evidence about whether antibiotics (short or long term) prevent vision loss. More trials are needed, including trials of newer antibiotics.
CochranePLS120
***TASK*** the task is to simplify the input abstract of a biomedical literature ***INPUT*** the input is the abstract of a biomedical literature ***OUTPUT*** the output is the simplified abstract for the input abstract of a biomedical literature ***EXAMPLES*** Input: Output: ***EXAMPLES*** Input: Two trials (n = 190), at low risk of bias, were included in the review and both presented data on first time failure at the tooth level. Pooling of the data showed a statistically significant difference in favour of molar bands, with a hazard ratio of 2.92 (95% confidence intervals (CI) 1.80 to 4.72). No statistically significant heterogeneity was shown between the two studies. Data on first time failure at the patient level were also available and showed statistically different difference in favour of molar bands (risk ratio 2.30; 95% CI 1.56 to 3.41) (risk of event for molar tubes = 57%; risk of event for molar bands 25%). One trial presented data on decalcification again showing a statistically significant difference in favour of molar bands. No other adverse events identified. From the two well-designed and low risk of bias trials included in this review it was shown that the failure of molar tubes bonded with either a chemically-cured or light-cured adhesive was considerably higher than that of molar bands cemented with glass ionomer cement. One trial indicated that there was less decalcification with molar bands cemented with glass ionomer cement than with bonded molar tubes cemented with a light-cured adhesive. However, given there are limited data for this outcome, further evidence is required to draw more robust conclusions. Output: The evidence in this review, which was carried out together with Cochrane Oral Health, is up-to-date as of 15 February 2017. We included two studies that evaluated 190 participants. Both trials were conducted in the UK and both compared bonded molar tubes with molar bands. From the limited data of two studies at low risk of bias, it would appear that bonded molar tubes are associated with a higher failure rate than with molar bands. Input: We included 43 trials containing predominantly older people with mainly trochanteric fractures. Twenty-two trials (3749 participants) compared the Gamma nail with the sliding hip screw (SHS). The Gamma nail was associated with increased risk of operative and later fracture of the femur and increased reoperation rate. There were no major differences between implants in wound infection, mortality or medical complications. Five trials (623 participants) compared the intramedullary hip screw (IMHS) with the SHS. Fracture fixation complications were more common in the IMHS group. Results for post-operative complications, mortality and functional outcomes were similar in both groups. Three trials (394 participants) showed no difference in fracture fixation complications, reoperation, wound infection and length of hospital stay for proximal femoral nail (PFN) versus the SHS. None of the 10 trials (1491 participants) of other nail versus extramedullary implant comparisons for trochanteric fractures provided sufficient evidence to establish definite differences between the implants under test. Two trials (65 participants) found intramedullary nails were associated with fewer fracture fixation complications than fixed nail plates for unstable fractures at the level of the lesser trochanter. Two trials (124 participants) found a tendency to less fracture healing complications with the intramedullary nails compared with fixed nail plates for subtrochanteric fractures. With its lower complication rate in comparison with intramedullary nails, and absence of functional outcome data to the contrary, the SHS appears superior for trochanteric fractures. Further studies are required to confirm whether more recently developed designs of intramedullary nail avoid the complications of previous nails. Intramedullary nails may have advantages over fixed angle plates for subtrochanteric and some unstable trochanteric fractures, but further studies are required. Output:
The main results were for the comparisons of various types of intramedullary nails with the sliding hip screw. Twenty-two trials, involving 3749 participants, tested the Gamma nail. Five trials, involving 623 participants, tested the intramedullary hip screw (IMHS). Three trials, involving 394 participants, tested the proximal femoral nail. Other trials involved newer varieties of intramedullary nails. Most older trials showed a tendency for the nails to be associated with an increased risk of fracture of the thigh bone both during and after the operation. More recent trials testing newer varieties of nails seemed to avoid this specific problem to some extent. The review found that using intramedullary nails resulted in one extra reoperation in every 50 people. Mortality and, where data were available, other long-term outcomes were similar between the implants. The review concluded that current evidence supports the continued use of the sliding hip screw for fixing the more common types of extracapsular hip fractures. This may not be the case for some of the more recently developed designs of intramedullary nails or for specific fracture types, but further research is required to confirm this.
CochranePLS121
***TASK*** the task is to simplify the input abstract of a biomedical literature ***INPUT*** the input is the abstract of a biomedical literature ***OUTPUT*** the output is the simplified abstract for the input abstract of a biomedical literature ***EXAMPLES*** Input: Output: ***EXAMPLES*** Input: Two trials (n = 190), at low risk of bias, were included in the review and both presented data on first time failure at the tooth level. Pooling of the data showed a statistically significant difference in favour of molar bands, with a hazard ratio of 2.92 (95% confidence intervals (CI) 1.80 to 4.72). No statistically significant heterogeneity was shown between the two studies. Data on first time failure at the patient level were also available and showed statistically different difference in favour of molar bands (risk ratio 2.30; 95% CI 1.56 to 3.41) (risk of event for molar tubes = 57%; risk of event for molar bands 25%). One trial presented data on decalcification again showing a statistically significant difference in favour of molar bands. No other adverse events identified. From the two well-designed and low risk of bias trials included in this review it was shown that the failure of molar tubes bonded with either a chemically-cured or light-cured adhesive was considerably higher than that of molar bands cemented with glass ionomer cement. One trial indicated that there was less decalcification with molar bands cemented with glass ionomer cement than with bonded molar tubes cemented with a light-cured adhesive. However, given there are limited data for this outcome, further evidence is required to draw more robust conclusions. Output: The evidence in this review, which was carried out together with Cochrane Oral Health, is up-to-date as of 15 February 2017. We included two studies that evaluated 190 participants. Both trials were conducted in the UK and both compared bonded molar tubes with molar bands. From the limited data of two studies at low risk of bias, it would appear that bonded molar tubes are associated with a higher failure rate than with molar bands. Input: The search strategy identified 183 unique references of which 22 were identified as being potentially eligible on the basis of title and abstract. Only one study met our inclusion criteria and was included in the review. It analysed retrospective data for 47 women who received either palliative surgery (n = 27) or medical management with Octreotide (n = 20) and reported overall survival and perioperative mortality and morbidity. Women with poor performance status were excluded from surgery. Although six (22%) women who received surgery had serious complications of the operation and three (11%) died of complications, multivariable analysis found that women who received surgery had significantly (p < 0.001) better survival than women who received Octreotide, after adjustment for important prognostic factors. However, the magnitude of this effect was not reported. Quality of life (QoL) was not reported and adverse events were incompletely documented. We found only low quality evidence comparing palliative surgery and medical management for bowel obstruction in ovarian cancer. Therefore we are unable to reach definite conclusions about the relative benefits and harms of the two forms of treatment, or to identify sub-groups of women who are likely to benefit from one treatment or the other. However, there is weak evidence in support of surgical management to prolong survival. Output:
We found only one relevant study. It included only 47 cases: 27 had an operation to relieve bowel obstruction and the 20 who did not have an operation were given a drug called Octreotide to control the amount of vomiting that often results from bowel obstruction. Among the 27 women who had an operation, six women could not have their bowel obstruction corrected because the cancer had spread too far, six women had serious complications of surgery and three died of these complications.  Nevertheless, the authors of the study reported that women who had the operation survived longer, on average, than those who did not, even after allowing for their underlying better health. It was unclear how much of the difference in survival could be ascribed to the differences in treatment and how much to the better health of women undergoing surgery. Unfortunately the study did not assess their QoL or level of pain. The study reported the numbers of women who could start eating again after their treatment (surgery or Octreotide) but it didn't analyse this allowing for the underlying difference in health of women in the two groups, so it is impossible to interpret these results. We were therefore unable to reach definite conclusions about the relative benefits and harms of the two forms of treatment and we were unable to identify sub-groups of women who are likely to benefit from one treatment or the other.
CochranePLS122
***TASK*** the task is to simplify the input abstract of a biomedical literature ***INPUT*** the input is the abstract of a biomedical literature ***OUTPUT*** the output is the simplified abstract for the input abstract of a biomedical literature ***EXAMPLES*** Input: Output: ***EXAMPLES*** Input: Two trials (n = 190), at low risk of bias, were included in the review and both presented data on first time failure at the tooth level. Pooling of the data showed a statistically significant difference in favour of molar bands, with a hazard ratio of 2.92 (95% confidence intervals (CI) 1.80 to 4.72). No statistically significant heterogeneity was shown between the two studies. Data on first time failure at the patient level were also available and showed statistically different difference in favour of molar bands (risk ratio 2.30; 95% CI 1.56 to 3.41) (risk of event for molar tubes = 57%; risk of event for molar bands 25%). One trial presented data on decalcification again showing a statistically significant difference in favour of molar bands. No other adverse events identified. From the two well-designed and low risk of bias trials included in this review it was shown that the failure of molar tubes bonded with either a chemically-cured or light-cured adhesive was considerably higher than that of molar bands cemented with glass ionomer cement. One trial indicated that there was less decalcification with molar bands cemented with glass ionomer cement than with bonded molar tubes cemented with a light-cured adhesive. However, given there are limited data for this outcome, further evidence is required to draw more robust conclusions. Output: The evidence in this review, which was carried out together with Cochrane Oral Health, is up-to-date as of 15 February 2017. We included two studies that evaluated 190 participants. Both trials were conducted in the UK and both compared bonded molar tubes with molar bands. From the limited data of two studies at low risk of bias, it would appear that bonded molar tubes are associated with a higher failure rate than with molar bands. Input: Four trials fulfilled the criteria for inclusion. They comprised a total of 244 women with PCOS receiving 12 weeks or 6 weeks of treatment. Two trials (184 women randomised) studied the effects of simvastatin and two trials (60 women randomised) studied the effects of atorvastatin. There was no good evidence that statins improved menstrual regularity, spontaneous ovulation rate, hirsutism or acne, either alone or in combination with the combined oral contraceptive pill (OCP). Nor were there any significant effects on body mass index (BMI). Statins were effective in lowering testosterone levels (nmol/L) (mean difference (MD) -0.90, 95% CI -1.18 to -0.62, P < 0.00001, 3 RCTs, 105 women) when used alone or with the OCP. Statins also improved total cholesterol, low-density lipoprotein (LDL) and triglycerides but had no significant effect on high-density lipoprotein (HDL) levels, high sensitivity (HS) C-reactive protein (HS-CRP), fasting insulin or homeostatic model assessment (HOMA) insulin resistance. No serious adverse events were reported in any of the included studies. Although statins improve lipid profiles and reduce testosterone levels in women with PCOS, there is no evidence that statins improve resumption of menstrual regularity or spontaneous ovulation, nor is there any improvement of hirsutism or acne. There is a need for further research to be performed with large sample sizes and well-designed RCTs to assess clinical outcomes. Output:
There is no good evidence from this review that statins improve menstrual regularity, spontaneous ovulation rate, hirsutism or acne, either alone or in combination with the combined oral contraceptive pill. There is also no good evidence that statins have a beneficial effect on hirsutism or acne (pimples) associated with PCOS. In women with PCOS, statins are effective in reducing serum androgen levels and decreasing bad cholesterol (LDL), but statins are not effective in reducing fasting insulin or insulin resistance. There is no good evidence available on the long-term use of statins (alone or in combination) for the management of PCOS.
CochranePLS123
***TASK*** the task is to simplify the input abstract of a biomedical literature ***INPUT*** the input is the abstract of a biomedical literature ***OUTPUT*** the output is the simplified abstract for the input abstract of a biomedical literature ***EXAMPLES*** Input: Output: ***EXAMPLES*** Input: Two trials (n = 190), at low risk of bias, were included in the review and both presented data on first time failure at the tooth level. Pooling of the data showed a statistically significant difference in favour of molar bands, with a hazard ratio of 2.92 (95% confidence intervals (CI) 1.80 to 4.72). No statistically significant heterogeneity was shown between the two studies. Data on first time failure at the patient level were also available and showed statistically different difference in favour of molar bands (risk ratio 2.30; 95% CI 1.56 to 3.41) (risk of event for molar tubes = 57%; risk of event for molar bands 25%). One trial presented data on decalcification again showing a statistically significant difference in favour of molar bands. No other adverse events identified. From the two well-designed and low risk of bias trials included in this review it was shown that the failure of molar tubes bonded with either a chemically-cured or light-cured adhesive was considerably higher than that of molar bands cemented with glass ionomer cement. One trial indicated that there was less decalcification with molar bands cemented with glass ionomer cement than with bonded molar tubes cemented with a light-cured adhesive. However, given there are limited data for this outcome, further evidence is required to draw more robust conclusions. Output: The evidence in this review, which was carried out together with Cochrane Oral Health, is up-to-date as of 15 February 2017. We included two studies that evaluated 190 participants. Both trials were conducted in the UK and both compared bonded molar tubes with molar bands. From the limited data of two studies at low risk of bias, it would appear that bonded molar tubes are associated with a higher failure rate than with molar bands. Input: The search strategy identified 1522 unique references of which we excluded 1330 on the basis of title and abstract. We retrieved the remaining 22 articles in full, but none satisfied the inclusion criteria. We identified only observational data from single-arm studies of women treated with formalin-soaked packs, interventional radiology or radiotherapy techniques for palliative control of vaginal bleeding in women with cervical cancer. Since the last version of this review we found no new studies. There is no evidence from controlled trials to support or refute the use of any of the proposed interventions compared with radiotherapy. Therefore, the choice of intervention will be based on local resources. Radiotherapy techniques for managing vaginal bleeding are not readily available in resource-poor settings, where advanced cases of cervical cancer are predominant. Thus, this systematic review identified the need for a randomised controlled trial assessing the benefits and risks of palliative treatments for vaginal bleeding in women with advanced cervical cancer. Output:
the searches were updated to March 2018. We found no randomised controlled trials (clinical studies where people are randomly put into one of two or more treatment groups) for inclusion, so there is an absence of evidence that tranexamic acid, vaginal packing (with or without formalin-soaked packs), interventional radiology techniques or other interventions are as effective or safe as radiotherapy for palliative control of bleeding from the vagina in advanced cervical cancer. There is a need for randomised controlled trials or good-quality non-randomised comparative studies to determine the effectiveness and safety of these interventions when compared with radiotherapy in terms of symptom control, quality of life and side events. no studies fulfilled the inclusion criteria and so there is no good-certainty evidence.
CochranePLS124
***TASK*** the task is to simplify the input abstract of a biomedical literature ***INPUT*** the input is the abstract of a biomedical literature ***OUTPUT*** the output is the simplified abstract for the input abstract of a biomedical literature ***EXAMPLES*** Input: Output: ***EXAMPLES*** Input: Two trials (n = 190), at low risk of bias, were included in the review and both presented data on first time failure at the tooth level. Pooling of the data showed a statistically significant difference in favour of molar bands, with a hazard ratio of 2.92 (95% confidence intervals (CI) 1.80 to 4.72). No statistically significant heterogeneity was shown between the two studies. Data on first time failure at the patient level were also available and showed statistically different difference in favour of molar bands (risk ratio 2.30; 95% CI 1.56 to 3.41) (risk of event for molar tubes = 57%; risk of event for molar bands 25%). One trial presented data on decalcification again showing a statistically significant difference in favour of molar bands. No other adverse events identified. From the two well-designed and low risk of bias trials included in this review it was shown that the failure of molar tubes bonded with either a chemically-cured or light-cured adhesive was considerably higher than that of molar bands cemented with glass ionomer cement. One trial indicated that there was less decalcification with molar bands cemented with glass ionomer cement than with bonded molar tubes cemented with a light-cured adhesive. However, given there are limited data for this outcome, further evidence is required to draw more robust conclusions. Output: The evidence in this review, which was carried out together with Cochrane Oral Health, is up-to-date as of 15 February 2017. We included two studies that evaluated 190 participants. Both trials were conducted in the UK and both compared bonded molar tubes with molar bands. From the limited data of two studies at low risk of bias, it would appear that bonded molar tubes are associated with a higher failure rate than with molar bands. Input: For primary therapy three RCTs were identified, enrolling a total of 745 patients, that investigated temozolomide in combination with radiotherapy versus radiotherapy alone for glioblastoma multiforme (GBM). Temozolomide increased OS (hazard ratio (HR) 0.60, 95% confidence interval (CI) 0.46 to 0.79, P value 0.0003) and increased PFS (HR 0.63, 95% CI 0.43 to 0.92, P value 0.02), when compared with radiotherapy alone, although these benefits only appear to emerge when therapy is given in both concomitant and adjuvant phases of treatment. A single RCT found that temozolomide did not have a statistically significant effect on QoL. Risk of haematological complications, fatigue and infections were increased with temozolomide. In recurrent HGG, two RCTs enrolling 672 patients in total found that temozolomide did not increase OS compared to standard chemotherapy (HR 0.9, 95% CI 0.76 to 1.06, P value 0.2) but it did increase PFS in a subgroup analysis of grade IV GBM tumours (HR 0.68, 95% CI 0.51 to 0.90, P value 0.008). Adverse events were similar between arms. In the elderly, 2 RCTs of 664 patients found OS and PFS was similar with temozolomide alone versus radiotherapy alone. QoL did not appear to differ between arms in a single trial but certain adverse events were significantly more common with temozolomide. Temozolomide when given in both concomitant and adjuvant phases is an effective primary therapy in GBM compared to radiotherapy alone. It prolongs survival and delays progression without impacting on QoL but it does increase early adverse events. In recurrent GBM, temozolomide compared with standard chemotherapy improves time-to-progression (TTP) and may have benefits on QoL without increasing adverse events but it does not improve overall. In the elderly, temozolomide alone appears comparable to radiotherapy in terms of OS and PFS but with a higher instance of adverse events. Output:
Three randomised controlled trials (RCTs) enrolling patients with newly diagnosed glioblastoma multiforme (GBM - a form of HGG) have studied chemotherapy with temozolomide during and after radiotherapy. This was compared with radiotherapy only. Those who received temozolomide had an improved survival and delayed progression of the disease. The short-term adverse events associated with temozolomide are low but can be severe, while the long-term effects are unknown. No RCTs investigated the use of temozolomide in HGGs other than GBM. In recurrent GBM, temozolomide delayed progression but did not improve overall survival. In the elderly population (age over 60 years), temozolomide alone appears to be a suitable alternative to radiotherapy alone for primary therapy of GBM. Either treatment has similar overall survival, progression-free survival and quality of life, but there are possibly more adverse events with temozolomide. All these trials enrolled highly selected patients with good prognostic features that are not entirely representative of all patients with HGG limiting the general applicability of these results.
CochranePLS125
***TASK*** the task is to simplify the input abstract of a biomedical literature ***INPUT*** the input is the abstract of a biomedical literature ***OUTPUT*** the output is the simplified abstract for the input abstract of a biomedical literature ***EXAMPLES*** Input: Output: ***EXAMPLES*** Input: Two trials (n = 190), at low risk of bias, were included in the review and both presented data on first time failure at the tooth level. Pooling of the data showed a statistically significant difference in favour of molar bands, with a hazard ratio of 2.92 (95% confidence intervals (CI) 1.80 to 4.72). No statistically significant heterogeneity was shown between the two studies. Data on first time failure at the patient level were also available and showed statistically different difference in favour of molar bands (risk ratio 2.30; 95% CI 1.56 to 3.41) (risk of event for molar tubes = 57%; risk of event for molar bands 25%). One trial presented data on decalcification again showing a statistically significant difference in favour of molar bands. No other adverse events identified. From the two well-designed and low risk of bias trials included in this review it was shown that the failure of molar tubes bonded with either a chemically-cured or light-cured adhesive was considerably higher than that of molar bands cemented with glass ionomer cement. One trial indicated that there was less decalcification with molar bands cemented with glass ionomer cement than with bonded molar tubes cemented with a light-cured adhesive. However, given there are limited data for this outcome, further evidence is required to draw more robust conclusions. Output: The evidence in this review, which was carried out together with Cochrane Oral Health, is up-to-date as of 15 February 2017. We included two studies that evaluated 190 participants. Both trials were conducted in the UK and both compared bonded molar tubes with molar bands. From the limited data of two studies at low risk of bias, it would appear that bonded molar tubes are associated with a higher failure rate than with molar bands. Input: Two studies met our inclusion criteria. The findings of one study conducted in Cambodia provide low quality evidence that private contracts with international nongovernmental organizations (NGOs) for district health systems management ('contracting-in') may improve health care access and utilization. Contracting-in increased use of antenatal care by 28% and use of public facilities by 14%. However, contracting-in was not found to have an effect on population health outcomes. The findings of the other study provide low quality evidence that intermittent training courses over 18 months may improve district health system managers’ performance. In three countries in Latin America, managers who did not receive the intermittent training courses had between 2.4 and 8.3 times more management deficiencies than managers who received the training courses. No studies that aimed to investigate interventions for retaining district health systems managers met our study selection criteria for inclusion in this review. There is low quality evidence that contracting-in may improve health care accessibility and utilization and that intermittent training courses may improve district health systems managers’ performance. More evidence is required before firm conclusions can be drawn regarding the effectiveness of these interventions in diverse settings. Other interventions that might be promising candidates for hiring and retaining (e.g., government regulations, professional support programs) as well as training district health systems managers (e.g., in-service workshops with on-site support) have not been adequately investigated. Output:
It is difficult to draw any conclusions about the effects of these types of interventions as the review only found two relevant studies. In addition, the evidence that the review did identify was of low quality. Training: The available evidence suggests that in-service district manager training: ·       may lead to more knowledge about planning processes ·       may lead to better monitoring and evaluation skills None of the studies assessed the effects of district manager training on people’s health, on their access to or use of health care, or on the quality or efficiency of care. Contracting-in: The available evidence suggests that private contracts with international NGOs for district health systems management: ·       may not affect people’s illness reporting, diarrhea incidence or infant death ·       may increase the likelihood that a health facility is open 24 hours ·       may increase the availability of medical equipment and supplies ·       may increase people’s use of antenatal care and public facilities None of the studies assessed the effects of contracting-in district management on the quality or efficiency of health care, on job vacancy rates, or on district manager knowledge and skills.
CochranePLS126
***TASK*** the task is to simplify the input abstract of a biomedical literature ***INPUT*** the input is the abstract of a biomedical literature ***OUTPUT*** the output is the simplified abstract for the input abstract of a biomedical literature ***EXAMPLES*** Input: Output: ***EXAMPLES*** Input: Two trials (n = 190), at low risk of bias, were included in the review and both presented data on first time failure at the tooth level. Pooling of the data showed a statistically significant difference in favour of molar bands, with a hazard ratio of 2.92 (95% confidence intervals (CI) 1.80 to 4.72). No statistically significant heterogeneity was shown between the two studies. Data on first time failure at the patient level were also available and showed statistically different difference in favour of molar bands (risk ratio 2.30; 95% CI 1.56 to 3.41) (risk of event for molar tubes = 57%; risk of event for molar bands 25%). One trial presented data on decalcification again showing a statistically significant difference in favour of molar bands. No other adverse events identified. From the two well-designed and low risk of bias trials included in this review it was shown that the failure of molar tubes bonded with either a chemically-cured or light-cured adhesive was considerably higher than that of molar bands cemented with glass ionomer cement. One trial indicated that there was less decalcification with molar bands cemented with glass ionomer cement than with bonded molar tubes cemented with a light-cured adhesive. However, given there are limited data for this outcome, further evidence is required to draw more robust conclusions. Output: The evidence in this review, which was carried out together with Cochrane Oral Health, is up-to-date as of 15 February 2017. We included two studies that evaluated 190 participants. Both trials were conducted in the UK and both compared bonded molar tubes with molar bands. From the limited data of two studies at low risk of bias, it would appear that bonded molar tubes are associated with a higher failure rate than with molar bands. Input: We included three studies that involved 123 people. The methods used for blinding the participants and researchers to the treatment group were not reported, but as the comparison is surgical treatment with medical treatment this bias is hard to avoid. There was no description of concealment of the randomization sequence in two studies. All three studies reported on mortality, and deaths occurred in two studies. There was no clear evidence of a difference in mortality between treatment groups (risk ratio (RR) 0.56, 95% confidence interval (CI) 0.13 to 2.42); however, the analysis was underpowered to detect a difference between groups. Out of the 123 people randomized and treated, six people died; the causes of death were pneumonia, pulmonary embolism, mediastinitis, and septic shock. Among people randomized to surgery, there were reductions in pneumonia (RR 0.36, 95% 0.15 to 0.85; three studies, 123 participants), chest deformity (RR 0.13, 95% CI 0.03 to 0.67; two studies, 86 participants), and tracheostomy (RR 0.38, 95% CI 0.14 to 1.02; two studies, 83 participants). Duration of mechanical ventilation, length of intensive care unit stay (ICU), and length of hospital stay were measured in the three studies. Due to differences in reporting, we could not combine the results and have listed them separately. Chest pain, chest tightness, bodily pain, and adverse effects were each measured in one study. There was some evidence from three small studies that showed surgical treatment was preferable to nonsurgical management in reducing pneumonia, chest deformity, tracheostomy, duration of mechanical ventilation, and length of ICU stay. Further well-designed studies with a sufficient sample size are required to confirm these results and to detect possible surgical effects on mortality. Output:
We searched scientific databases for studies comparing surgical treatment with nonsurgical treatment in adults or children with flail chest. We included three studies in this review, which involved 123 people. In these studies, people with flail chest were randomly allocated into the surgery or no surgery study groups. The results show that surgery to repair the broken ribs reduces pneumonia, chest deformity, tracheostomy, duration of mechanical ventilation and length of ICU stay. There was no difference in deaths between people treated with surgery or no surgery. Since only six people died across the three studies, due to a variety of causes, more research is needed in order to know for certain which treatment is better for reducing deaths. These three small studies have shown that surgical treatment is preferable to nonsurgical treatment in reducing pneumonia, chest deformity, tracheostomy, mechanical ventilation and length of stay in the ICU. More research is needed in order to know which treatment is better for reducing deaths. Three more studies are being undertaken by researchers in the USA and Canada at the moment, and the results will be incorporated into the review in the future.
CochranePLS127
***TASK*** the task is to simplify the input abstract of a biomedical literature ***INPUT*** the input is the abstract of a biomedical literature ***OUTPUT*** the output is the simplified abstract for the input abstract of a biomedical literature ***EXAMPLES*** Input: Output: ***EXAMPLES*** Input: Two trials (n = 190), at low risk of bias, were included in the review and both presented data on first time failure at the tooth level. Pooling of the data showed a statistically significant difference in favour of molar bands, with a hazard ratio of 2.92 (95% confidence intervals (CI) 1.80 to 4.72). No statistically significant heterogeneity was shown between the two studies. Data on first time failure at the patient level were also available and showed statistically different difference in favour of molar bands (risk ratio 2.30; 95% CI 1.56 to 3.41) (risk of event for molar tubes = 57%; risk of event for molar bands 25%). One trial presented data on decalcification again showing a statistically significant difference in favour of molar bands. No other adverse events identified. From the two well-designed and low risk of bias trials included in this review it was shown that the failure of molar tubes bonded with either a chemically-cured or light-cured adhesive was considerably higher than that of molar bands cemented with glass ionomer cement. One trial indicated that there was less decalcification with molar bands cemented with glass ionomer cement than with bonded molar tubes cemented with a light-cured adhesive. However, given there are limited data for this outcome, further evidence is required to draw more robust conclusions. Output: The evidence in this review, which was carried out together with Cochrane Oral Health, is up-to-date as of 15 February 2017. We included two studies that evaluated 190 participants. Both trials were conducted in the UK and both compared bonded molar tubes with molar bands. From the limited data of two studies at low risk of bias, it would appear that bonded molar tubes are associated with a higher failure rate than with molar bands. Input: Fifty trials (19 RCTs and 31 before-and-after studies) evaluated the dose-related efficacy of cerivastatin in 12,877 participants who had their LDL cholesterol measured. The participants were of any age with and without cardiovascular disease and the trials studied cerivastatin effects within a treatment period of three to 12 weeks. Cerivastatin 0.025 mg/day to 0.8 mg/day caused LDL cholesterol decreases of 11.0% to 40.8%, total cholesterol decreases of 8.0% to 28.8% and triglyceride decreases of 9.0% to 21.4%. We judged the certainty of evidence for these effects to be high. Log dose-response data over doses of 2.5 mg to 80 mg revealed strong linear dose-related effects on LDL cholesterol, total cholesterol and triglycerides. When compared to fluvastatin, atorvastatin and rosuvastatin, cerivastatin was about 250-fold more potent than fluvastatin, 20-fold more potent than atorvastatin and 5.5-fold more potent than rosuvastatin at reducing LDL cholesterol; 233-fold more potent than fluvastatin, 18-fold more potent than atorvastatin and six-fold more potent than rosuvastatin at reducing total cholesterol; and 125-fold more potent than fluvastatin, 11-fold more potent than atorvastatin and 13-fold more potent than rosuvastatin at reducing triglycerides. There was no dose-related effect of cerivastatin on HDL cholesterol, but overall cerivastatin increased HDL cholesterol by 5%. There was a high risk of bias for the outcome withdrawals due to adverse effects, but a low risk of bias for the lipid measurements. Withdrawals due to adverse effects were not different between cerivastatin and placebo in 11 of 19 of these short-term trials (risk ratio 1.09, 95% confidence interval 0.68 to 1.74). The LDL cholesterol, total cholesterol, and triglyceride lowering effect of cerivastatin was linearly dependent on dose. Cerivastatin log dose-response data were linear over the commonly prescribed dose range. Based on an informal comparison with fluvastatin, atorvastatin and rosuvastatin, cerivastatin was about 250-fold more potent than fluvastatin, 20-fold more potent than atorvastatin and 5.5-fold more potent than rosuvastatin in reducing LDL cholesterol, and 233-fold greater potency than fluvastatin, 18-fold greater potency than atorvastatin and six-fold greater potency than rosuvastatin at reducing total cholesterol. This review did not provide a good estimate of the incidence of harms associated with cerivastatin because of the short duration of the trials and the lack of reporting of adverse effects in 42% of the RCTs. Output:
We looked for high quality randomised trials (RCTs) and before-and-after studies with cerivastatin in different dose sizes . The trials were between three and twelve weeks long. People of any age and gender, either with or without heart disease were in these trials. Participants could be of any age and gender, with or without cardiovascular disease. We found fifty trials with 13,018 participants who had their lipid levels measured. 12,877 participants had their LDL cholesterol measured. People taking 0.025 to 0.8 mg of cerivastatin per day lowered their LDL cholesterol by 12% to 42%. The higher the dose, the lower the levels of three measures of cholesterol. HDL cholesterol increased by 5%. For lowering LDL cholesterol, cerivastatin is 250-times stronger than fluvastatin, 20-times stronger than atorvastatin and 5.5 times stronger than rosuvastatin. Only 11 of the 19 RCTs reported the number of people who dropped out of the studies because of adverse effects. The level of drop outs due to adverse effects were similar in the people who took cerivastatin and placebo. There is a high level of trust around the results  for total cholesterol and LDL cholesterol and very low to moderate for triglycerides. We have a low level of trust in the evidence around drop outs because many (8 out of 19 trials) did not report drop outs due to adverse effects.
CochranePLS128
***TASK*** the task is to simplify the input abstract of a biomedical literature ***INPUT*** the input is the abstract of a biomedical literature ***OUTPUT*** the output is the simplified abstract for the input abstract of a biomedical literature ***EXAMPLES*** Input: Output: ***EXAMPLES*** Input: Two trials (n = 190), at low risk of bias, were included in the review and both presented data on first time failure at the tooth level. Pooling of the data showed a statistically significant difference in favour of molar bands, with a hazard ratio of 2.92 (95% confidence intervals (CI) 1.80 to 4.72). No statistically significant heterogeneity was shown between the two studies. Data on first time failure at the patient level were also available and showed statistically different difference in favour of molar bands (risk ratio 2.30; 95% CI 1.56 to 3.41) (risk of event for molar tubes = 57%; risk of event for molar bands 25%). One trial presented data on decalcification again showing a statistically significant difference in favour of molar bands. No other adverse events identified. From the two well-designed and low risk of bias trials included in this review it was shown that the failure of molar tubes bonded with either a chemically-cured or light-cured adhesive was considerably higher than that of molar bands cemented with glass ionomer cement. One trial indicated that there was less decalcification with molar bands cemented with glass ionomer cement than with bonded molar tubes cemented with a light-cured adhesive. However, given there are limited data for this outcome, further evidence is required to draw more robust conclusions. Output: The evidence in this review, which was carried out together with Cochrane Oral Health, is up-to-date as of 15 February 2017. We included two studies that evaluated 190 participants. Both trials were conducted in the UK and both compared bonded molar tubes with molar bands. From the limited data of two studies at low risk of bias, it would appear that bonded molar tubes are associated with a higher failure rate than with molar bands. Input: We included 28 studies which randomised a total of 6851 patients. Risk of bias assessment indicated unclear to low risk of bias for most studies. For consistency regarding the direction of effects, continuous outcomes with negative values, and dichotomous outcomes with values less than one favour remote ischaemic preconditioning. Based on high quality evidence, remote ischaemic preconditioning made little or no difference to the reduction of serum creatinine levels at postoperative days one (14 studies, 1022 participants: MD -0.02 mg/dL, 95% CI -0.05 to 0.02; I2 = 21%), two (9 studies, 770 participants: MD -0.04 mg/dL, 95% CI -0.09 to 0.02; I2 = 31%), and three (6 studies, 417 participants: MD -0.05 mg/dL, 95% CI -0.19 to 0.10; I2 = 68%) compared to control. Serious adverse events occurred in four patients receiving remote ischaemic preconditioning by iliac clamping. It is uncertain whether remote ischaemic preconditioning by cuff inflation leads to increased adverse effects compared to control because the certainty of the evidence is low (15 studies, 3993 participants: RR 3.47, 95% CI 0.55 to 21.76; I2 = 0%); only two of 15 studies reported any adverse effects (6/1999 in the remote ischaemic preconditioning group and 1/1994 in the control group), the remaining 13 studies stated no adverse effects were observed in either group. Compared to control, remote ischaemic preconditioning made little or no difference to the need for dialysis (13 studies, 2417 participants: RR 0.85, 95% CI 0.37 to 1.94; I2 = 60%; moderate quality evidence), length of hospital stay (8 studies, 920 participants: MD 0.17 days, 95% CI -0.46 to 0.80; I2 = 49%, high quality evidence), or all-cause mortality (24 studies, 4931 participants: RR 0.86, 95% CI 0.54 to 1.37; I2 = 0%, high quality evidence). Remote ischaemic preconditioning may have slightly improved the incidence of acute kidney injury using either the AKIN (8 studies, 2364 participants: RR 0.76, 95% CI 0.57 to 1.00; I2 = 61%, high quality evidence) or RIFLE criteria (3 studies, 1586 participants: RR 0.91, 95% CI 0.75 to 1.12; I2 = 0%, moderate quality evidence). Remote ischaemic preconditioning by cuff inflation appears to be a safe method, and probably leads to little or no difference in serum creatinine, adverse effects, need for dialysis, length of hospital stay, death and in the incidence of acute kidney injury. Overall we had moderate-high certainty evidence however the available data does not confirm the efficacy of remote ischaemic preconditioning in reducing renal ischaemia reperfusion injury in patients undergoing major cardiac and vascular surgery in which renal ischaemia reperfusion injury may occur. Output:
We performed a search off all available literature on 8 August 2016 to find all randomised controlled studies. 28 studies including 6851 patients were included in this analysis. Five studies included children undergoing cardiac surgery. Adult studies included patients undergoing major vascular surgery (three studies), cardiac surgery (nine studies), coronary bypass surgery (10 studies) and partial kidney resection (one study). The overall quality of the studies was acceptable. Twenty studies were funded without economical interest. One study was funded from a source with commercial interest. The other seven studies did not report funding. Remote ischaemic preconditioning performed with a blood pressure cuff appears to be safe as only two of 15 studies reported adverse effects (6/1999 in the remote ischaemic preconditioning group and 1/1994 in the control group). However remote ischaemic preconditioning by vascular clamping may cause vascular complications. Kidney injury in patients undergoing (surgical) procedures in which kidney injury may occur, was not reduced by remote Ischaemic preconditioning measured at day one, two or three after surgery. The need for dialysis, hospital stay and death were not reduced by remote ischaemic preconditioning. Although remote ischaemic preconditioning by cuff inflation is safe, available data do not confirm the efficacy of remote ischaemic preconditioning in reducing kidney injury.
CochranePLS129
***TASK*** the task is to simplify the input abstract of a biomedical literature ***INPUT*** the input is the abstract of a biomedical literature ***OUTPUT*** the output is the simplified abstract for the input abstract of a biomedical literature ***EXAMPLES*** Input: Output: ***EXAMPLES*** Input: Two trials (n = 190), at low risk of bias, were included in the review and both presented data on first time failure at the tooth level. Pooling of the data showed a statistically significant difference in favour of molar bands, with a hazard ratio of 2.92 (95% confidence intervals (CI) 1.80 to 4.72). No statistically significant heterogeneity was shown between the two studies. Data on first time failure at the patient level were also available and showed statistically different difference in favour of molar bands (risk ratio 2.30; 95% CI 1.56 to 3.41) (risk of event for molar tubes = 57%; risk of event for molar bands 25%). One trial presented data on decalcification again showing a statistically significant difference in favour of molar bands. No other adverse events identified. From the two well-designed and low risk of bias trials included in this review it was shown that the failure of molar tubes bonded with either a chemically-cured or light-cured adhesive was considerably higher than that of molar bands cemented with glass ionomer cement. One trial indicated that there was less decalcification with molar bands cemented with glass ionomer cement than with bonded molar tubes cemented with a light-cured adhesive. However, given there are limited data for this outcome, further evidence is required to draw more robust conclusions. Output: The evidence in this review, which was carried out together with Cochrane Oral Health, is up-to-date as of 15 February 2017. We included two studies that evaluated 190 participants. Both trials were conducted in the UK and both compared bonded molar tubes with molar bands. From the limited data of two studies at low risk of bias, it would appear that bonded molar tubes are associated with a higher failure rate than with molar bands. Input: We retrieved 12,490 citations, obtained full texts for 58 studies and included 12 trials (three from the 2008 search and nine from the 2014 search) with 703 participants. Eight trials primarily investigated the efficacy in treating PSF, of which six trials with seven comparisons provided data suitable for meta-analysis (five pharmacological interventions: fluoxetine, enerion, (-)-OSU6162, citicoline and a combination of Chinese herbs; and two non-pharmacological interventions: a fatigue education programme and a mindfulness-based stress reduction programme). The fatigue severity was lower in the intervention groups than in the control groups (244 participants, pooled SMD -1.07, 95% confidence interval (CI) -1.93 to -0.21), with significant heterogeneity between trials (I2 = 87%, degrees of freedom (df) = 6, P value < 0.00001). The beneficial effect was not seen in trials that had used adequate allocation concealment (two trials, 89 participants, SMD -0.38, 95% CI -0.80 to 0.04) or trials that had used adequate blinding of outcome assessors (four trials, 198 participants, SMD -1.10, 95% CI -2.31 to 0.11). No trial primarily investigated the efficacy in preventing PSF. Four trials (248 participants) did not primarily investigate the efficacy on fatigue but other symptoms after stroke. None of these interventions showed any benefit on reducing PSF, which included tirilazad mesylate, continuous positive airway pressure for sleep apnoea, antidepressants and a self management programme for recovery from chronic diseases. There was insufficient evidence on the efficacy of any intervention to treat or prevent fatigue after stroke. Trials to date have been small and heterogeneous, and some have had a high risk of bias. Some of the interventions described were feasible in people with stroke, but their efficacy should be investigated in RCTs with a more robust study design and adequate sample sizes. Output:
The evidence is current to May 2014. We found 12 randomised controlled trials (clinical studies where people are randomly put into one of two or more treatment groups) with 703 people with stroke. Of these 12 trials, eight trials recruited only people with fatigue and were primarily intended to treat fatigue, no trial was primarily intended to prevent fatigue and the other four trials were not primarily intended to treat or prevent fatigue but reported fatigue as an outcome. There was insufficient evidence to support the use of any intervention to treat or prevent fatigue in people with stroke. The general study quality was low. The available data were limited as each identified intervention was only investigated in a single trial. In addition, some trials were small and used poor study designs. Therefore, further trials of better quality are needed.
CochranePLS130
***TASK*** the task is to simplify the input abstract of a biomedical literature ***INPUT*** the input is the abstract of a biomedical literature ***OUTPUT*** the output is the simplified abstract for the input abstract of a biomedical literature ***EXAMPLES*** Input: Output: ***EXAMPLES*** Input: Two trials (n = 190), at low risk of bias, were included in the review and both presented data on first time failure at the tooth level. Pooling of the data showed a statistically significant difference in favour of molar bands, with a hazard ratio of 2.92 (95% confidence intervals (CI) 1.80 to 4.72). No statistically significant heterogeneity was shown between the two studies. Data on first time failure at the patient level were also available and showed statistically different difference in favour of molar bands (risk ratio 2.30; 95% CI 1.56 to 3.41) (risk of event for molar tubes = 57%; risk of event for molar bands 25%). One trial presented data on decalcification again showing a statistically significant difference in favour of molar bands. No other adverse events identified. From the two well-designed and low risk of bias trials included in this review it was shown that the failure of molar tubes bonded with either a chemically-cured or light-cured adhesive was considerably higher than that of molar bands cemented with glass ionomer cement. One trial indicated that there was less decalcification with molar bands cemented with glass ionomer cement than with bonded molar tubes cemented with a light-cured adhesive. However, given there are limited data for this outcome, further evidence is required to draw more robust conclusions. Output: The evidence in this review, which was carried out together with Cochrane Oral Health, is up-to-date as of 15 February 2017. We included two studies that evaluated 190 participants. Both trials were conducted in the UK and both compared bonded molar tubes with molar bands. From the limited data of two studies at low risk of bias, it would appear that bonded molar tubes are associated with a higher failure rate than with molar bands. Input: Three randomised trials, enrolling 74 preterm infants (outcome data available on 71 infants) evaluated interventions for hyperkalaemia. Urine output was ascertained in only one study (Hu 1999). In none of the trials could we ascertain that allocation to the comparison groups was concealed. The sample sizes of the three trials were very small with 12 (Malone 1991), 19 (Singh 2002) and 40 infants enrolled (Hu 1999). The intervention and the outcome assessments could not be blinded to the clinical staff in two trials (Malone 1991; Hu 1999). One study (Malone 1991), glucose and insulin, compared to cation-exchange resin, caused a reduction in all cause mortality that was of borderline statistical significance: RR 0.18 (95% CI 0.03 to 1.15); RD -0.66 (95% CI -1.09 to -0.22); NNTB 2 (95% CI 1 to 5)]. In the study of Hu (Hu 1999), the incidence of intraventricular haemorrhage ≥ grade 2 was significantly reduced [RR 0.30 (95% CI 0.10 to 0.93); RD -0.35 (95% CI -0.62 to -0.08); NNTB 3 (95% CI 2 to 13). Albuterol inhalation versus saline inhalation changed serum K+ from baseline at four hours [WMD -0.69 mmol/L (95% CI -0.87 to -0.51)] and at eight hours [WMD -0.59 mmol/L (95% CI -0.78 to -0.40)] after initiation of treatment. No differences noted in mortality or other clinical outcomes (Singh 2002). No serious side effects were noted with either the combination of insulin and glucose or albuterol inhalation. Other interventions listed in our objectives have not been studied to date. In view of the limited information from small studies of uncertain quality, no firm recommendations for clinical practice can be made. It appears that the combination of insulin and glucose is preferred over treatment with rectal cation-resin for hyperkalaemia in preterm infants. Both the combination of insulin and glucose and albuterol inhalation deserve further study. The two interventions could possibly be tested against each other. The effectiveness of other potentially effective interventions for non-oliguric hyperkalaemia (diuretics, exchange transfusion, peritoneal dialysis and calcium) have not been tested in randomised controlled trials. Output:
The objective of this review was to determine the effectiveness and safety of interventions for this serious condition. Two studies enrolling 52 infants that assessed the use of a combination of insulin and sugar to reduce the blood levels of potassium were identified. This combination reduced the duration of high blood levels of potassium and the risk for bleeds in the brains of the infants. One study that enrolled 19 patients reported on the use of albuterol (a medication that helps to move potassium from the blood to the body cells). Albuterol lowered the blood levels of potassium both at four and at eight hours after the treatment had started. Because of the few infants enrolled in the studies to date, no firm recommendations for the treatment of too high blood levels of potassium in neonates can be made. Further research is needed.
CochranePLS131
***TASK*** the task is to simplify the input abstract of a biomedical literature ***INPUT*** the input is the abstract of a biomedical literature ***OUTPUT*** the output is the simplified abstract for the input abstract of a biomedical literature ***EXAMPLES*** Input: Output: ***EXAMPLES*** Input: Two trials (n = 190), at low risk of bias, were included in the review and both presented data on first time failure at the tooth level. Pooling of the data showed a statistically significant difference in favour of molar bands, with a hazard ratio of 2.92 (95% confidence intervals (CI) 1.80 to 4.72). No statistically significant heterogeneity was shown between the two studies. Data on first time failure at the patient level were also available and showed statistically different difference in favour of molar bands (risk ratio 2.30; 95% CI 1.56 to 3.41) (risk of event for molar tubes = 57%; risk of event for molar bands 25%). One trial presented data on decalcification again showing a statistically significant difference in favour of molar bands. No other adverse events identified. From the two well-designed and low risk of bias trials included in this review it was shown that the failure of molar tubes bonded with either a chemically-cured or light-cured adhesive was considerably higher than that of molar bands cemented with glass ionomer cement. One trial indicated that there was less decalcification with molar bands cemented with glass ionomer cement than with bonded molar tubes cemented with a light-cured adhesive. However, given there are limited data for this outcome, further evidence is required to draw more robust conclusions. Output: The evidence in this review, which was carried out together with Cochrane Oral Health, is up-to-date as of 15 February 2017. We included two studies that evaluated 190 participants. Both trials were conducted in the UK and both compared bonded molar tubes with molar bands. From the limited data of two studies at low risk of bias, it would appear that bonded molar tubes are associated with a higher failure rate than with molar bands. Input: Twelve trials were found to be eligible for inclusion in this review. Seven trials with a variable risk of bias compared IVIg with PE in 623 severely affected participants. In five trials with 536 participants for whom the outcome was available, the mean difference (MD) of change in a seven-grade disability scale after four weeks was not significantly different between the two treatments: MD of 0.02 of a grade more improvement in the intravenous immunoglobulin than the plasma exchange group; 95% confidence interval (CI) 0.25 to -0.20. There were also no statistically significant differences in the other measures considered. Three studies including a total of 75 children suggested that IVIg significantly hastens recovery compared with supportive care. The primary outcome for this review, available for only one trial with 21 mildly affected children, showed significantly more improvement in disability grade after four weeks with IVIg than supportive treatment alone, MD 1.42, 95% CI 2.57 to 0.27. In one trial involving 249 participants comparing PE followed by IVIg with PE alone, the mean grade improvement was 0.2 (95% CI -0.14 to 0.54) more in the combined treatment group than in the PE alone group; not clinically significantly different, but not excluding the possibility of significant extra benefit. Another trial with 34 participants comparing immunoabsorption followed by IVIg with immunoabsorption alone did not reveal significant extra benefit from the combined treatment. Adverse events were not significantly more frequent with either treatment, but IVIg is significantly much more likely to be completed than PE. One trial in altogether 51 children showed no significant difference when the standard dose was given over two days rather than five days. A previous Cochrane review has shown that PE hastens recovery compared with supportive treatment alone. There are no adequate comparisons of IVIg with placebo in adults, but this review provides moderate quality evidence that, in severe disease, IVIg started within two weeks from onset hastens recovery as much as PE. Adverse events were not significantly more frequent with either treatment but IVIg is significantly much more likely to be completed than PE. Also, according to moderate quality evidence, giving IVIg after PE did not confer significant extra benefit. In children, according to low quality evidence, IVIg probably hastens recovery compared with supportive care alone. More research is needed in mild disease and in patients whose treatment starts more than two weeks after onset. Dose-ranging studies are also needed and one is in progress. Output:
We included trials of IVIg compared to no treatment, dummy treatment, PE, immunoabsorption (in which specific antibodies are removed from blood) or other immune treatments. We also considered trials of IVIg added to another treatment. We found 12 trials. Some of these compared more than two treatments. - Seven trials compared IVIg with PE (in 623 participants with severe GBS). - One compared PE alone to PE followed by IVIg (in 249 participants). - Three compared IVIg with supportive care (in a total of 75 children). - One compared a two-day to a five-day IVIg treatment plan (in 51 children). - One compared IVIg with immunoabsorption (in 48 participants). - One compared IVIg plus immunoabsorption with immunoabsorption (in 34 participants). For this review, we chose change in a disability scale after four weeks’ treatment as the main measure of the effect of IVIg. Five of the trials comparing IVIg and PE measured change in disability. IVIg and PE produced a similar amount of improvement in disability in the 536 trial participants. This evidence was of moderate quality. Harmful effects were no more frequent with PE or IVIg, but people were more likely to finish a course of IVIg. In one trial involving 249 participants who received PE or PE followed by IVIg, there was slightly more improvement from PE and IVIg together. The effect was probably not large enough to be noticeable but the results do not rule out the possibility. This evidence was of moderate quality. Three studies in children suggested that IVIg speeds up recovery compared with supportive care. Only one used the disability scale. They provided low quality evidence. In one small trial in children, the effect on disability appeared similar with a standard dose over two days rather than five days. Giving IVIg after immunoabsorption provided no extra benefit over immunoabsorption alone. No conclusions can be drawn from the trial comparing IVIg with immunoabsorption. The risk of bias in the included studies was variable. More research is needed to find the best dose of IVIg in adults and children, and one trial of giving a second dose to people who otherwise would be expected to do badly is in progress. The evidence is current to December 2013.
CochranePLS132
***TASK*** the task is to simplify the input abstract of a biomedical literature ***INPUT*** the input is the abstract of a biomedical literature ***OUTPUT*** the output is the simplified abstract for the input abstract of a biomedical literature ***EXAMPLES*** Input: Output: ***EXAMPLES*** Input: Two trials (n = 190), at low risk of bias, were included in the review and both presented data on first time failure at the tooth level. Pooling of the data showed a statistically significant difference in favour of molar bands, with a hazard ratio of 2.92 (95% confidence intervals (CI) 1.80 to 4.72). No statistically significant heterogeneity was shown between the two studies. Data on first time failure at the patient level were also available and showed statistically different difference in favour of molar bands (risk ratio 2.30; 95% CI 1.56 to 3.41) (risk of event for molar tubes = 57%; risk of event for molar bands 25%). One trial presented data on decalcification again showing a statistically significant difference in favour of molar bands. No other adverse events identified. From the two well-designed and low risk of bias trials included in this review it was shown that the failure of molar tubes bonded with either a chemically-cured or light-cured adhesive was considerably higher than that of molar bands cemented with glass ionomer cement. One trial indicated that there was less decalcification with molar bands cemented with glass ionomer cement than with bonded molar tubes cemented with a light-cured adhesive. However, given there are limited data for this outcome, further evidence is required to draw more robust conclusions. Output: The evidence in this review, which was carried out together with Cochrane Oral Health, is up-to-date as of 15 February 2017. We included two studies that evaluated 190 participants. Both trials were conducted in the UK and both compared bonded molar tubes with molar bands. From the limited data of two studies at low risk of bias, it would appear that bonded molar tubes are associated with a higher failure rate than with molar bands. Input: We included 28 randomized clinical trials (9330 participants); in the 21 trials reporting relevant outcomes for this review, 7597 participants were randomly assigned to a high fraction of inspired oxygen versus a routine fraction of inspired oxygen. In trials with an overall low risk of bias, a high fraction of inspired oxygen compared with a routine fraction of inspired oxygen was not associated with all-cause mortality (random-effects model: RR 1.12, 95% confidence interval (CI) 0.93 to 1.36; GRADE: low quality) within the longest follow-up and within 30 days of follow-up (Peto odds ratio (OR) 0.99, 95% CI 0.61 to 1.60; GRADE: low quality). In a trial sequential analysis, the required information size was not reached and the analysis could not refute a 20% increase in mortality. Similarly, when all trials were included, a high fraction of inspired oxygen was not associated with all-cause mortality to the longest follow-up (RR 1.07, 95% CI 0.87 to 1.33) or within 30 days of follow-up (Peto OR 0.83, 95% CI 0.54 to 1.29), both of very low quality according to GRADE. Neither was a high fraction of inspired oxygen associated with the risk of surgical site infection in trials with low risk of bias (RR 0.86, 95% CI 0.63 to 1.17; GRADE: low quality) or in all trials (RR 0.87, 95% CI 0.71 to 1.07; GRADE: low quality). A high fraction of inspired oxygen was not associated with respiratory insufficiency (RR 1.25, 95% CI 0.79 to 1.99), serious adverse events (RR 0.96, 95% CI 0.65 to 1.43) or length of stay (mean difference -0.06 days, 95% CI -0.44 to 0.32 days). In subgroup analyses of nine trials using preoperative antibiotics, a high fraction of inspired oxygen was associated with a decrease in surgical site infections (RR 0.76, 95% CI 0.60 to 0.97; GRADE: very low quality); a similar effect was noted in the five trials adequately blinded for the outcome assessment (RR 0.79, 95% CI 0.66 to 0.96; GRADE: very low quality). We did not observe an effect of a high fraction of inspired oxygen on surgical site infections in any other subgroup analyses. As the risk of adverse events, including mortality, may be increased by a fraction of inspired oxygen of 60% or higher, and as robust evidence is lacking for a beneficial effect of a fraction of inspired oxygen of 60% or higher on surgical site infection, our overall results suggest that evidence is insufficient to support the routine use of a high fraction of inspired oxygen during anaesthesia and surgery. Given the risk of attrition and outcome reporting bias, as well as other weaknesses in the available evidence, further randomized clinical trials with low risk of bias in all bias domains, including a large sample size and long-term follow-up, are warranted. Output:
We identified 28 randomized clinical trials. Eight trials with 4918 participants reported on risk of death, and 15 trials with 7219 participants reported on surgical site infections within 14 to 30 days of surgery. Four trials reported serious adverse events, three trials respiratory insufficiency, nine trials length of stay during the associated hospital admission and one trial quality of life. All trials were conducted without direct industry funding. The number of participants in each trial ranged from 38 to 2012. The mean age of participants was 50 years (range 15 to 92 years) and 63% were women. Types of surgery included abdominal surgery (eight trials), caesarean section (four trials), breast surgery (one trial), orthopaedic surgery (two trials) and various other surgical procedures (four trials). A high percentage of inspired oxygen was not statistically associated with increased risk of death, or with a decrease in surgical site infections, in all trials that measured these outcomes, in trials of highest quality and in those with longest follow-up. An increased risk of adverse events could not be proved right or wrong for a high percentage of inspired oxygen during anaesthesia and surgery. Only five of the included trials had low risk of bias. The trials randomly assigned 9330 participants, of whom only 7537 participants provided data for this review. The number of participants required to detect or reject a 20% relative risk reduction in deaths was not reached; therefore the observed results were uncertain.
CochranePLS133
***TASK*** the task is to simplify the input abstract of a biomedical literature ***INPUT*** the input is the abstract of a biomedical literature ***OUTPUT*** the output is the simplified abstract for the input abstract of a biomedical literature ***EXAMPLES*** Input: Output: ***EXAMPLES*** Input: Two trials (n = 190), at low risk of bias, were included in the review and both presented data on first time failure at the tooth level. Pooling of the data showed a statistically significant difference in favour of molar bands, with a hazard ratio of 2.92 (95% confidence intervals (CI) 1.80 to 4.72). No statistically significant heterogeneity was shown between the two studies. Data on first time failure at the patient level were also available and showed statistically different difference in favour of molar bands (risk ratio 2.30; 95% CI 1.56 to 3.41) (risk of event for molar tubes = 57%; risk of event for molar bands 25%). One trial presented data on decalcification again showing a statistically significant difference in favour of molar bands. No other adverse events identified. From the two well-designed and low risk of bias trials included in this review it was shown that the failure of molar tubes bonded with either a chemically-cured or light-cured adhesive was considerably higher than that of molar bands cemented with glass ionomer cement. One trial indicated that there was less decalcification with molar bands cemented with glass ionomer cement than with bonded molar tubes cemented with a light-cured adhesive. However, given there are limited data for this outcome, further evidence is required to draw more robust conclusions. Output: The evidence in this review, which was carried out together with Cochrane Oral Health, is up-to-date as of 15 February 2017. We included two studies that evaluated 190 participants. Both trials were conducted in the UK and both compared bonded molar tubes with molar bands. From the limited data of two studies at low risk of bias, it would appear that bonded molar tubes are associated with a higher failure rate than with molar bands. Input: Twenty-five trials (3663 children) were eligible for inclusion. Two trials did not report on any of the outcomes of interest, leaving 23 trials (3258 children) covering a range of antibiotics, participants, outcome measures and time points for evaluation. Overall, we assessed most studies as being at low to moderate risk of bias. We found moderate quality evidence (six trials including 484 children) that children treated with oral antibiotics are more likely to have complete resolution at two to three months post-randomisation (primary outcome) than those allocated to the control treatment (risk ratio (RR) 2.00, 95% confidence interval (CI) 1.58 to 2.53; number needed to treat to benefit (NNTB) 5). However, there is evidence (albeit of low quality; five trials, 742 children) indicating that children treated with oral antibiotics are more likely to experience diarrhoea, vomiting or skin rash (primary outcome) than those allocated to control treatment (RR 2.15, 95% CI 1.29 to 3.60; number needed to treat to harm (NNTH) 20). In respect of the secondary outcome of complete resolution at any time point, we found low to moderate quality evidence from five meta-analyses, including between two and 14 trials, of a beneficial effect of antibiotics, with a NNTB ranging from 3 to 7. Time periods ranged from 10 to 14 days to six months. In terms of other secondary outcomes, only two trials (849 children) reported on hearing levels at two to four weeks and found conflicting results. None of the trials reported data on speech, language and cognitive development or quality of life. Low quality evidence did not show that oral antibiotics were associated with a decrease in the rate of ventilation tube insertion (two trials, 121 children) or in tympanic membrane sequelae (one trial, 103 children), while low quality evidence indicated that children treated with antibiotics were less likely to have acute otitis media episodes within four to eight weeks (five trials, 1086 children; NNTB 18) and within six months post-randomisation (two trials, 199 children; NNTB 5). It should, however, be noted that the beneficial effect of oral antibiotics on acute otitis media episodes within four to eight weeks was no longer significant when we excluded studies with high risk of bias. This review presents evidence of both benefits and harms associated with the use of oral antibiotics to treat children up to 16 years with OME. Although evidence indicates that oral antibiotics are associated with an increased chance of complete resolution of OME at various time points, we also found evidence that these children are more likely to experience diarrhoea, vomiting or skin rash. The impact of antibiotics on short-term hearing is uncertain and low quality evidence did not show that oral antibiotics were associated with fewer ventilation tube insertions. Furthermore, we found no data on the impact of antibiotics on other important outcomes such as speech, language and cognitive development or quality of life. Even in situations where clear and relevant benefits of oral antibiotics have been demonstrated, these must always be carefully balanced against adverse effects and the emergence of bacterial resistance. This has specifically been linked to the widespread use of antibiotics for common conditions such as otitis media. Output:
This review included evidence available up to 14 April 2016. In total 25 studies (3663 children) were eligible for inclusion. Two studies did not report on any of the outcomes of interest, leaving 23 studies (3258 children). Overall, we assessed most studies as being at low to moderate risk of bias. In the 23 studies many different antibiotics were used and the children were of different ages and had suffered from glue ear for various lengths of time. They looked at the benefits at various time points after the treatment was given. The most important outcomes that we measured were the difference in the proportion of children who no longer had glue ear two to three months after the treatment was started and adverse effects of antibiotics (diarrhoea, vomiting or skin rash). We found moderate quality evidence (six trials including 484 children) that children treated with oral antibiotics are more likely to have glue ear resolved two to three months after the treatment was started than those allocated to control treatment. The number of children needed to treat for one beneficial outcome (NNTB) was five. However, there is evidence (albeit of low quality; five trials, 742 children) indicating that children treated with oral antibiotics are more likely to experience diarrhoea, vomiting or skin rash than those allocated to control treatment. The number of children needed to treat for one harmful outcome (NNTH) was 20. In respect of the secondary outcome of having glue ear resolved at any time point, we found low to moderate quality evidence from five of our analyses where we combined data from studies (meta-analyses), which included between two and 14 studies, of a beneficial effect of antibiotics, with a NNTB ranging from three to seven. Time periods ranged from 10 to 14 days to six months. In terms of other secondary outcomes, only two trials (849 children) reported on hearing levels at two to four weeks and found conflicting results. None of the trials reported data on speech, language and cognitive development or quality of life. Low quality evidence did not show that oral antibiotics were associated with fewer ventilation tube (grommet) insertions (two trials, 121 children) or in adverse consequences for the tympanic membrane (ear drum) (one trial, 103 children). Low quality evidence indicated that children treated with oral antibiotics were less likely to have acute otitis media (ear infection) episodes within four to eight weeks (five trials, 1086 children; NNTB 18) and within six months after treatment was started (two trials, 199 children; NNTB 5). It should however be noted that the beneficial effect of oral antibiotics on ear infection episodes within four to eight weeks was no longer significant when studies with high risk of bias were excluded. Moderate quality evidence is available that children with glue ear do benefit from oral antibiotics in terms of resolving glue ear at various time points and reducing acute otitis media episodes during follow-up compared with control treatment. Low quality evidence is available that children treated with oral antibiotics are more likely to experience diarrhoea, vomiting and skin rash than those receiving the control treatment. Currently only two trials have assessed the impact of oral antibiotics on hearing and these showed conflicting results (low quality evidence). Low quality evidence did not show that oral antibiotics were associated with fewer ventilation tube insertions or in adverse consequences for the tympanic membrane.
CochranePLS134
***TASK*** the task is to simplify the input abstract of a biomedical literature ***INPUT*** the input is the abstract of a biomedical literature ***OUTPUT*** the output is the simplified abstract for the input abstract of a biomedical literature ***EXAMPLES*** Input: Output: ***EXAMPLES*** Input: Two trials (n = 190), at low risk of bias, were included in the review and both presented data on first time failure at the tooth level. Pooling of the data showed a statistically significant difference in favour of molar bands, with a hazard ratio of 2.92 (95% confidence intervals (CI) 1.80 to 4.72). No statistically significant heterogeneity was shown between the two studies. Data on first time failure at the patient level were also available and showed statistically different difference in favour of molar bands (risk ratio 2.30; 95% CI 1.56 to 3.41) (risk of event for molar tubes = 57%; risk of event for molar bands 25%). One trial presented data on decalcification again showing a statistically significant difference in favour of molar bands. No other adverse events identified. From the two well-designed and low risk of bias trials included in this review it was shown that the failure of molar tubes bonded with either a chemically-cured or light-cured adhesive was considerably higher than that of molar bands cemented with glass ionomer cement. One trial indicated that there was less decalcification with molar bands cemented with glass ionomer cement than with bonded molar tubes cemented with a light-cured adhesive. However, given there are limited data for this outcome, further evidence is required to draw more robust conclusions. Output: The evidence in this review, which was carried out together with Cochrane Oral Health, is up-to-date as of 15 February 2017. We included two studies that evaluated 190 participants. Both trials were conducted in the UK and both compared bonded molar tubes with molar bands. From the limited data of two studies at low risk of bias, it would appear that bonded molar tubes are associated with a higher failure rate than with molar bands. Input: Twelve studies were included, nine RCTs and three before and after studies. Only one study explored all-cause mortality and end-stage renal disease (ESRD) as endpoints. The relative risk (RR) of ESRD or death was 0.23 (95% confidence interval (CI) 0.07 to 0.72) for patients assigned to a low protein diet (LPD). Pooling of the seven RCTs in patients with type 1 diabetes resulted in a non-significant reduction in the decline of glomerular filtration rate (GFR) of 0.1 ml/min/month (95% CI -0.1 to 0.3) in the LPD group. For type 2 diabetes, one trial showed a small insignificant improvement in the rate of decline of GFR in the protein-restricted group and a second found a similar decline in both the intervention and control groups. Actual protein intake in the intervention groups ranged from 0.7 to 1.1 g/kg/day. One study noted malnutrition in the LPD group. We found no data on the effects of LPDs on health-related quality of life and costs. The results show that reducing protein intake appears to slightly slow progression to renal failure but not statistically significantly so. However, questions concerning the level of protein intake and compliance remain. Further longer-term research on large representative groups of patients with both type 1 and type 2 diabetes mellitus is necessary. Because of the variability amongst patients, there might perhaps be a six month therapeutic trial of protein restriction in all individuals, with continuation only in those who responded best. Trials are required of different types of protein. Output:
Based on 12 studies, including from eight to 160 people with type 1 and type 2 diabetes for at least an average four-month period, restricted protein intake appeared to slow progression of diabetic kidney disease, but not by much on average. However, individual variation existed, therefore a low-protein diet may benefit some individuals. A low-protein diet can be difficult to adhere to, especially over the long term. Reducing the amount of animal protein is the usual method but some evidence suggests that a shift from red meat to white meat and fish or vegetables may give similar results. We found no data on the effects of low-protein diet on health-related quality of life and costs.
CochranePLS135
***TASK*** the task is to simplify the input abstract of a biomedical literature ***INPUT*** the input is the abstract of a biomedical literature ***OUTPUT*** the output is the simplified abstract for the input abstract of a biomedical literature ***EXAMPLES*** Input: Output: ***EXAMPLES*** Input: Two trials (n = 190), at low risk of bias, were included in the review and both presented data on first time failure at the tooth level. Pooling of the data showed a statistically significant difference in favour of molar bands, with a hazard ratio of 2.92 (95% confidence intervals (CI) 1.80 to 4.72). No statistically significant heterogeneity was shown between the two studies. Data on first time failure at the patient level were also available and showed statistically different difference in favour of molar bands (risk ratio 2.30; 95% CI 1.56 to 3.41) (risk of event for molar tubes = 57%; risk of event for molar bands 25%). One trial presented data on decalcification again showing a statistically significant difference in favour of molar bands. No other adverse events identified. From the two well-designed and low risk of bias trials included in this review it was shown that the failure of molar tubes bonded with either a chemically-cured or light-cured adhesive was considerably higher than that of molar bands cemented with glass ionomer cement. One trial indicated that there was less decalcification with molar bands cemented with glass ionomer cement than with bonded molar tubes cemented with a light-cured adhesive. However, given there are limited data for this outcome, further evidence is required to draw more robust conclusions. Output: The evidence in this review, which was carried out together with Cochrane Oral Health, is up-to-date as of 15 February 2017. We included two studies that evaluated 190 participants. Both trials were conducted in the UK and both compared bonded molar tubes with molar bands. From the limited data of two studies at low risk of bias, it would appear that bonded molar tubes are associated with a higher failure rate than with molar bands. Input: We identified a total of 19 studies involving 3480 people. Twelve studies were of good methodological quality and seven were of lower quality, according to the van Tulder scoring system. Within the subgroup of predominantly mild brain injury, 'strong evidence' suggested that most individuals made a good recovery when appropriate information was provided, without the need for additional specific interventions. For moderate to severe injury, 'strong evidence' showed benefit from formal intervention, and 'limited evidence' indicated that commencing rehabilitation early after injury results in better outcomes. For participants with moderate to severe ABI already in rehabilitation, 'strong evidence' revealed that more intensive programmes are associated with earlier functional gains, and 'moderate evidence' suggested that continued outpatient therapy could help to sustain gains made in early post-acute rehabilitation. The context of multi-disciplinary rehabilitation appears to influence outcomes. 'Strong evidence' supports the use of a milieu-oriented model for patients with severe brain injury, in which comprehensive cognitive rehabilitation takes place in a therapeutic environment and involves a peer group of patients. 'Limited evidence' shows that specialist in-patient rehabilitation and specialist multi-disciplinary community rehabilitation may provide additional functional gains, but studies serve to highlight the particular practical and ethical restraints imposed on randomisation of severely affected individuals for whom no realistic alternatives to specialist intervention are available. Problems following ABI vary. Consequently, different interventions and combinations of interventions are required to meet the needs of patients with different problems. Patients who present acutely to hospital with mild brain injury benefit from follow-up and appropriate information and advice. Those with moderate to severe brain injury benefit from routine follow-up so their needs for rehabilitation can be assessed. Intensive intervention appears to lead to earlier gains, and earlier intervention whilst still in emergency and acute care has been supported by limited evidence. The balance between intensity and cost-effectiveness has yet to be determined. Patients discharged from in-patient rehabilitation benefit from access to out-patient or community-based services appropriate to their needs. Group-based rehabilitation in a therapeutic milieu (where patients undergo neuropsychological rehabilitation in a therapeutic environment with a peer group of individuals facing similar challenges) represents an effective approach for patients requiring neuropsychological rehabilitation following severe brain injury. Not all questions in rehabilitation can be addressed by randomised controlled trials or other experimental approaches. For example, trial-based literature does not tell us which treatments work best for which patients over the long term, and which models of service represent value for money in the context of life-long care. In the future, such questions will need to be considered alongside practice-based evidence gathered from large systematic longitudinal cohort studies conducted in the context of routine clinical practice. Output:
Studies eligible for inclusion in this review were controlled trials, in which one group of people received treatment (such as MD rehabilitation) and was compared with a similar group that received a different treatment. We found 19 relevant studies, which involved a total of 3480 people. We searched the medical literature worldwide on 14 September 2015. We used the Van Tulder system to rate the strength of the evidence as it distinguished better between trials of different quality than the standard GRADE system on criteria that are important in the context of rehabilitation. For mild brain injury, information and advice were usually more appropriate than intensive rehabilitation. As a whole, studies suggest that patients with moderate to severe brain injury who received more intensive rehabilitation showed earlier improvement, and that earlier rehabilitation was better than delayed treatment. Strong evidence supports the provision of cognitive rehabilitation in a therapeutic 'milieu', that is, an environment in which patients receive predominantly group-based rehabilitation alongside a peer group of others who are facing similar challenges. Trial-based literature provided little evidence related to other aspects of MD rehabilitation, so the review authors recommend that additional research should be done. Rehabilitation for brain injury is such an individualised and long-term process that research studies do not necessarily facilitate general conclusions. Overall the included studies were of good quality; 12 of 19 studies were judged to be of high quality according to the van Tulder scoring system. The other studies were at risk of bias because of elements of their design, for example, in one study, treatment depended on the availability of a bed in the rehabilitation unit. Bed availability is a haphazard way of allocating treatment to patients, and this makes results of the study prone to bias.
CochranePLS136
***TASK*** the task is to simplify the input abstract of a biomedical literature ***INPUT*** the input is the abstract of a biomedical literature ***OUTPUT*** the output is the simplified abstract for the input abstract of a biomedical literature ***EXAMPLES*** Input: Output: ***EXAMPLES*** Input: Two trials (n = 190), at low risk of bias, were included in the review and both presented data on first time failure at the tooth level. Pooling of the data showed a statistically significant difference in favour of molar bands, with a hazard ratio of 2.92 (95% confidence intervals (CI) 1.80 to 4.72). No statistically significant heterogeneity was shown between the two studies. Data on first time failure at the patient level were also available and showed statistically different difference in favour of molar bands (risk ratio 2.30; 95% CI 1.56 to 3.41) (risk of event for molar tubes = 57%; risk of event for molar bands 25%). One trial presented data on decalcification again showing a statistically significant difference in favour of molar bands. No other adverse events identified. From the two well-designed and low risk of bias trials included in this review it was shown that the failure of molar tubes bonded with either a chemically-cured or light-cured adhesive was considerably higher than that of molar bands cemented with glass ionomer cement. One trial indicated that there was less decalcification with molar bands cemented with glass ionomer cement than with bonded molar tubes cemented with a light-cured adhesive. However, given there are limited data for this outcome, further evidence is required to draw more robust conclusions. Output: The evidence in this review, which was carried out together with Cochrane Oral Health, is up-to-date as of 15 February 2017. We included two studies that evaluated 190 participants. Both trials were conducted in the UK and both compared bonded molar tubes with molar bands. From the limited data of two studies at low risk of bias, it would appear that bonded molar tubes are associated with a higher failure rate than with molar bands. Input: We included one trial (involving 176 women) in this review. This trial included four groups with a factorial design. The factorial design took into account two factors, i.e. infant location in relation to the mother and the type of infant apparel. We combined three of the groups as the intervention (rooming-in) group and the fourth group acted as the control (separate care) and we analysed the results as a single pair-wise comparison. Primary outcomes The primary outcome, duration of any breastfeeding, was reported by authors as median values because the distribution was found to be skewed. They reported the overall median duration of any breastfeeding to be four months, with no difference found between groups. Duration of exclusive breastfeeding and the proportion of infants being exclusively breastfed at six months of age was not reported in the trial. There was no difference found between the two groups in the proportion of infants receiving any breastfeeding at six months of age (risk ratio (RR) 0.84, 95% confidence interval (CI) 0.51 to 1.39; one trial; 137 women; low-quality evidence). Secondary outcomes The mean frequency of breastfeeds per day on day four postpartum for the rooming-in group was 8.3 (standard deviation (SD) 2.2), slightly higher than the separate care group, i.e. seven times per day. However, between-group comparison of this outcome was not appropriate since every infant in the separate care group was breastfed at a fixed schedule of seven times per day (SD = 0) resulting in no estimable comparison. The rate of exclusive breastfeeding on day four postpartum before discharge from hospital was significantly higher in the rooming-in group 86% (99 of 115) compared with separate care group, 45% (17 of 38), (RR 1.92; 95% CI 1.34 to 2.76; one trial, 153 women; low-quality evidence). None of our other pre-specified secondary outcomes were reported. We found little evidence to support or refute the practice of rooming-in versus mother-infant separation. Further well-designed RCTs to investigate full mother-infant rooming-in versus partial rooming-in or separate care including all important outcomes are needed. Output:
The latest search was done on 30th May 2016. No new studies were identified. Only one study is included in the review. One trial (involving 176 women) was analysed which provided information on the rate of exclusive breastfeeding on discharge from hospital. We found that there was low-quality evidence that keeping mother and infant together in the same room after birth until they are discharged from the hospital increased the rate of exclusive breastfeeding at four days after birth. There was no difference between the groups in the proportion of infants receiving any breastfeeding at six months of age. We found little evidence to support or refute the practice of rooming-in after birth. A randomised controlled trial is needed and it should report all important outcomes, including breastfeeding duration.
CochranePLS137
***TASK*** the task is to simplify the input abstract of a biomedical literature ***INPUT*** the input is the abstract of a biomedical literature ***OUTPUT*** the output is the simplified abstract for the input abstract of a biomedical literature ***EXAMPLES*** Input: Output: ***EXAMPLES*** Input: Two trials (n = 190), at low risk of bias, were included in the review and both presented data on first time failure at the tooth level. Pooling of the data showed a statistically significant difference in favour of molar bands, with a hazard ratio of 2.92 (95% confidence intervals (CI) 1.80 to 4.72). No statistically significant heterogeneity was shown between the two studies. Data on first time failure at the patient level were also available and showed statistically different difference in favour of molar bands (risk ratio 2.30; 95% CI 1.56 to 3.41) (risk of event for molar tubes = 57%; risk of event for molar bands 25%). One trial presented data on decalcification again showing a statistically significant difference in favour of molar bands. No other adverse events identified. From the two well-designed and low risk of bias trials included in this review it was shown that the failure of molar tubes bonded with either a chemically-cured or light-cured adhesive was considerably higher than that of molar bands cemented with glass ionomer cement. One trial indicated that there was less decalcification with molar bands cemented with glass ionomer cement than with bonded molar tubes cemented with a light-cured adhesive. However, given there are limited data for this outcome, further evidence is required to draw more robust conclusions. Output: The evidence in this review, which was carried out together with Cochrane Oral Health, is up-to-date as of 15 February 2017. We included two studies that evaluated 190 participants. Both trials were conducted in the UK and both compared bonded molar tubes with molar bands. From the limited data of two studies at low risk of bias, it would appear that bonded molar tubes are associated with a higher failure rate than with molar bands. Input: Eight trials involving 660 participants were included. Seven of the eight studies were of poor quality. Follow-up time was less than one month in six trials. Only two trials provided data for the number of participants who were dead or dependent at the end of 28 days of treatment, indicating a significantly lower rate of death and dependency in the sanchi group than in the control group (relative risk (RR) 0.63, 95% confidence interval (Cl) 0.45 to 0.88). One trial reported higher Barthel index scores in the sanchi group. Pooled analysis of seven trials indicated that sanchi might improve neurological deficit more than control with a significant difference (RR 0.29, 95%Cl 0.18 to 0.47). The total case fatality rate was lower than 1% indicating that participants probably had mild strokes. Few adverse events were reported. Data were limited in respect of stroke recurrence and quality of life. Sanchi appears to be beneficial and safe for acute ischaemic stroke in this review, but the small sample and inferior quality of studies prevented a definite conclusion. More well-designed randomised controlled trials are required. Output:
This review of eight trials, involving 660 participants, indicated that sanchi improved short-term outcome. However, the evidence from the small sample size and inferior quality of the studies does not support its routine use for acute ischaemic stroke. Well-designed trials are required.
CochranePLS138
***TASK*** the task is to simplify the input abstract of a biomedical literature ***INPUT*** the input is the abstract of a biomedical literature ***OUTPUT*** the output is the simplified abstract for the input abstract of a biomedical literature ***EXAMPLES*** Input: Output: ***EXAMPLES*** Input: Two trials (n = 190), at low risk of bias, were included in the review and both presented data on first time failure at the tooth level. Pooling of the data showed a statistically significant difference in favour of molar bands, with a hazard ratio of 2.92 (95% confidence intervals (CI) 1.80 to 4.72). No statistically significant heterogeneity was shown between the two studies. Data on first time failure at the patient level were also available and showed statistically different difference in favour of molar bands (risk ratio 2.30; 95% CI 1.56 to 3.41) (risk of event for molar tubes = 57%; risk of event for molar bands 25%). One trial presented data on decalcification again showing a statistically significant difference in favour of molar bands. No other adverse events identified. From the two well-designed and low risk of bias trials included in this review it was shown that the failure of molar tubes bonded with either a chemically-cured or light-cured adhesive was considerably higher than that of molar bands cemented with glass ionomer cement. One trial indicated that there was less decalcification with molar bands cemented with glass ionomer cement than with bonded molar tubes cemented with a light-cured adhesive. However, given there are limited data for this outcome, further evidence is required to draw more robust conclusions. Output: The evidence in this review, which was carried out together with Cochrane Oral Health, is up-to-date as of 15 February 2017. We included two studies that evaluated 190 participants. Both trials were conducted in the UK and both compared bonded molar tubes with molar bands. From the limited data of two studies at low risk of bias, it would appear that bonded molar tubes are associated with a higher failure rate than with molar bands. Input: Fourteen eligible RCTs were identified but only seven trials could be included. Four RCTs evaluated implant placement timing. Two RCTs compared immediate versus delayed implants in 126 patients and found no statistically significant differences. One RCT compared immediate-delayed versus delayed implants in 46 patients. After 2 years patients in the immediate-delayed group perceived the time to functional loading significantly shorter, were more satisfied and independent blinded assessor judged the level of the perimplant marginal mucosa in relation to that of the adjacent teeth as more appropriate (RR = 1.68; 95% CI 1.04 to 2.72). These differences disappeared 5 years after loading but significantly more complications occurred in the immediate-delayed group (RR = 4.20; 95% CI 1.01 to 17.43). One RCT compared immediate with immediately delayed implants in 16 patients for 2 years and found no differences. Three RCTs evaluated different techniques of bone grafting for implants immediately placed in extraction sockets. No statistically significant difference was observed when evaluating whether autogenous bone is needed in postextractive sites (1 trial with 26 patients) or which was the most effective augmentation technique (2 trials with 56 patients). There is insufficient evidence to determine possible advantages or disadvantages of immediate, immediate-delayed or delayed implants, therefore these preliminary conclusions are based on few underpowered trials often judged to be at high risk of bias. There is a suggestion that immediate and immediate-delayed implants may be at higher risks of implant failures and complications than delayed implants on the other hand the aesthetic outcome might be better when placing implants just after teeth extraction. There is not enough reliable evidence supporting or refuting the need for augmentation procedures at immediate implants placed in fresh extraction sockets or whether any of the augmentation techniques is superior to the others. Output:
The seven identified studies included too few patients to answer the questions. Four studies evaluated which is the best time to place implants. One study evaluated whether bone grafting is advantageous at implant placement and two studies evaluated which are the best grafting techniques. There is currently too little evidence to draw any reliable conclusions, however, the aesthetic outcome could be slightly better when placing implants early after tooth extraction, though early placed implants might be at a higher risk of failure. There is not enough evidence supporting or refusing the need of bone augmentation when extracted teeth are immediately replaced with dental implants, nor it is known whether any augmentation procedure is better than the others. Bone substitutes (anorganic bovine bone) can be used instead of self generated (autogenous) bone graft.
CochranePLS139
***TASK*** the task is to simplify the input abstract of a biomedical literature ***INPUT*** the input is the abstract of a biomedical literature ***OUTPUT*** the output is the simplified abstract for the input abstract of a biomedical literature ***EXAMPLES*** Input: Output: ***EXAMPLES*** Input: Two trials (n = 190), at low risk of bias, were included in the review and both presented data on first time failure at the tooth level. Pooling of the data showed a statistically significant difference in favour of molar bands, with a hazard ratio of 2.92 (95% confidence intervals (CI) 1.80 to 4.72). No statistically significant heterogeneity was shown between the two studies. Data on first time failure at the patient level were also available and showed statistically different difference in favour of molar bands (risk ratio 2.30; 95% CI 1.56 to 3.41) (risk of event for molar tubes = 57%; risk of event for molar bands 25%). One trial presented data on decalcification again showing a statistically significant difference in favour of molar bands. No other adverse events identified. From the two well-designed and low risk of bias trials included in this review it was shown that the failure of molar tubes bonded with either a chemically-cured or light-cured adhesive was considerably higher than that of molar bands cemented with glass ionomer cement. One trial indicated that there was less decalcification with molar bands cemented with glass ionomer cement than with bonded molar tubes cemented with a light-cured adhesive. However, given there are limited data for this outcome, further evidence is required to draw more robust conclusions. Output: The evidence in this review, which was carried out together with Cochrane Oral Health, is up-to-date as of 15 February 2017. We included two studies that evaluated 190 participants. Both trials were conducted in the UK and both compared bonded molar tubes with molar bands. From the limited data of two studies at low risk of bias, it would appear that bonded molar tubes are associated with a higher failure rate than with molar bands. Input: Two MPAC trials were identified. One trial compared clioquinol (PBT1) with placebo in 36 patients and 32 had sufficient data for per protocol analysis. There was no statistically significant difference in cognition (as measured on the Alzheimer's Disease Assessment Scale - Cognition (ADAS-Cog)) between the active treatment and placebo groups at 36 weeks. The difference in mean change from baseline ADAS-Cog score in the clioquinol arm compared with the placebo arm at weeks 24 and 36 was a difference of 7.37 (95% confidence interval (CI) 1.51 to 13.24) and 6.36 (95% CI -0.50 to 13.23), respectively.There was no significant impact on non-cognitive symptoms or clinical global impression. One participant in the active treatment group developed neurological symptoms (impaired visual acuity and colour vision) which resolved on cessation of treatment and were possibly attributable to the drug. In the second trial a successor compound, PBT2, was compared with placebo in 78 participants with mild Alzheimer's dementia; all were included in the intention-to-treat analysis. There was no significant difference in the Neuropsychological Test Battery (NTB) composite or memory between placebo and PBT2 in the least squares mean change from baseline at week 12. However, two executive function component tests of the NTB showed significant improvement over placebo in the PBT2 250 mg group from baseline to week 12: category fluency test (2.8 words, 95% CI 0.1 to 5.4; P = 0.041) and trail making part B (-48.0 s, 95% CI -83.0 to -13.0; P = 0.009). In the executive factor Z score, the difference in least squares mean change from baseline at week 12 for PBT2 250 mg compared with placebo was 0·27 (0·01 to 0·53; p=0·042).There was no significant effect on cognition on Mini-Mental State Examination (MMSE) or ADAS-Cog scales. PBT2 had a favourable safety profile. There is an absence of evidence as to whether clioquinol (PBT1) has any positive clinical benefit for patients with AD, or whether the drug is safe. We have some concerns about the quality of the study methodology; there was an imbalance in treatment and control groups after randomisation (participants in the active treatment group had a higher mean pre-morbid IQ) and the secondary analyses of results stratified by baseline dementia severity. The planned phase III trial of PBT1 has been abandoned and this compound has been withdrawn from development. The second trial of PBT2 was more rigorously conducted and showed that after 12 weeks this compound appeared to be safe and well tolerated in people with mild Alzheimer's dementia. Larger trials are now required to demonstrate cognitive efficacy. Output:
Two different types of MPAC have been used in clinical trials and the drugs are known as PBT1 and PBT2. The trial of PBT1 compared with placebo (in 36 patients) showed no statistically significant difference in cognition or memory between the active treatment and placebo groups at 36 weeks. We therefore conclude that there is no current evidence that treatment with clioquinol (PBT1) has any significant effect on cognition and in particular memory (as measured by the ADAS-Cog scale) in patients with Alzheimer's dementia. This drug has now been withdrawn from development. The trial of PBT2 showed it was safe after 12 weeks of treatment but demonstrated no overall significant effect on cognition or memory.
CochranePLS140
***TASK*** the task is to simplify the input abstract of a biomedical literature ***INPUT*** the input is the abstract of a biomedical literature ***OUTPUT*** the output is the simplified abstract for the input abstract of a biomedical literature ***EXAMPLES*** Input: Output: ***EXAMPLES*** Input: Two trials (n = 190), at low risk of bias, were included in the review and both presented data on first time failure at the tooth level. Pooling of the data showed a statistically significant difference in favour of molar bands, with a hazard ratio of 2.92 (95% confidence intervals (CI) 1.80 to 4.72). No statistically significant heterogeneity was shown between the two studies. Data on first time failure at the patient level were also available and showed statistically different difference in favour of molar bands (risk ratio 2.30; 95% CI 1.56 to 3.41) (risk of event for molar tubes = 57%; risk of event for molar bands 25%). One trial presented data on decalcification again showing a statistically significant difference in favour of molar bands. No other adverse events identified. From the two well-designed and low risk of bias trials included in this review it was shown that the failure of molar tubes bonded with either a chemically-cured or light-cured adhesive was considerably higher than that of molar bands cemented with glass ionomer cement. One trial indicated that there was less decalcification with molar bands cemented with glass ionomer cement than with bonded molar tubes cemented with a light-cured adhesive. However, given there are limited data for this outcome, further evidence is required to draw more robust conclusions. Output: The evidence in this review, which was carried out together with Cochrane Oral Health, is up-to-date as of 15 February 2017. We included two studies that evaluated 190 participants. Both trials were conducted in the UK and both compared bonded molar tubes with molar bands. From the limited data of two studies at low risk of bias, it would appear that bonded molar tubes are associated with a higher failure rate than with molar bands. Input: We included 36 studies with 2999 participants (with pulmonary hypertension from all causes) in the final review. Trials were conducted for 14 weeks on average, with some as long as 12 months. Two trials specifically included children. Nineteen trials included group 1 PAH participants. PAH participants treated with PDE5 inhibitors were more likely to improve their WHO functional class (odds ratio (OR) 8.59, 95% confidence interval (CI) 3.95 to 18.72; 4 trials, 282 participants), to walk 48 metres further in 6MWD (95% CI 40 to 56; 8 trials, 880 participants), and were 22% less likely to die over a mean duration of 14 weeks (95% CI 0.07 to 0.68; 8 trials, 1119 participants) compared to placebo (high-certainty evidence). The number needed to treat to prevent one additional death was 32 participants. There was an increased risk of adverse events with PDE5 inhibitors, especially headache (OR 1.97, 95% CI 1.33 to 2.92; 5 trials, 848 participants), gastrointestinal upset (OR 1.63, 95% CI 1.07 to 2.48; 5 trials, 848 participants), flushing (OR 4.12, 95% CI 1.83 to 9.26; 3 trials, 748 participants), and muscle aches and joint pains (OR 2.52, 95% CI 1.59 to 3.99; 4 trials, 792 participants). Data comparing PDE5 inhibitors to placebo whilst on other PAH-specific therapy were limited by the small number of included trials. Those PAH participants on PDE5 inhibitors plus combination therapy walked 19.66 metres further in six minutes (95% CI 9 to 30; 4 trials, 509 participants) compared to placebo (moderate-certainty evidence). There were limited trials comparing PDE5 inhibitors directly with other PAH-specific therapy (endothelin receptor antagonists (ERAs)). Those on PDE5 inhibitors walked 49 metres further than on ERAs (95% CI 4 to 95; 2 trials, 36 participants) (low-certainty evidence). There was no evidence of a difference in WHO functional class or mortality across both treatments. Five trials compared PDE5 inhibitors to placebo in PH secondary to left-heart disease (PH-LHD). The quality of data were low due to imprecision and inconsistency across trials. In those with PH-LHD there were reduced odds of an improvement in WHO functional class using PDE5 inhibitors compared to placebo (OR 0.53, 95% CI 0.32 to 0.87; 3 trials, 285 participants), and those using PDE5 inhibitors walked 34 metres further compared to placebo (95% CI 23 to 46; 3 trials, 284 participants). There was no evidence of a difference in mortality. Five trials compared PDE5 inhibitors to placebo in PH secondary to lung disease/hypoxia, mostly in COPD. Data were of low quality due to imprecision of effect and inconsistency across trials. There was a small improvement of 27 metres in 6MWD using PDE5 inhibitors compared to placebo in those with PH due to lung disease. There was no evidence of worsening hypoxia using PDE5 inhibitors, although data were limited. Three studies compared PDE5 inhibitors to placebo or other PAH-specific therapy in chronic thromboembolic disease. There was no significant difference in any outcomes. Data quality was low due to imprecision of effect and heterogeneity across trials. PDE5 inhibitors appear to have clear beneficial effects in group 1 PAH. Sildenafil, tadalafil and vardenafil are all efficacious in this clinical setting, and clinicians should consider the side-effect profile for each individual when choosing which PDE5 inhibitor to prescribe. While there appears to be some benefit for the use of PDE5 inhibitors in PH-left-heart disease, it is not clear based on the mostly small, short-term studies, which type of left-heart disease stands to benefit. These data suggest possible harm in valvular heart disease. There is no clear benefit for PDE5 inhibitors in pulmonary hypertension secondary to lung disease or chronic thromboembolic disease. Further research is required into the mechanisms of pulmonary hypertension secondary to left-heart disease, and cautious consideration of which subset of these patients may benefit from PDE5 inhibitors. Future trials in PH-LHD should be sufficiently powered, with long-term follow-up, and should include invasive haemodynamic data, WHO functional class, six-minute walk distance, and clinical worsening. Output:
We included 36 studies with 2999 people. Trials were conducted for 14 weeks on average, with some as long as 12 months. Most trials involved adults, and two trials specifically included children. Nineteen trials included those with group 1 pulmonary arterial hypertension (inherited, unknown, due to connective tissue diseases). People who were given PDE5 inhibitors were compared with those not given PDE5 inhibitors. This review shows that when given PDE5 inhibitors, on average people walked 48 meters further in six minutes (8 trials, 880 people). They also improved their functional class (reducing the physical limitations associated with PH), and were less likely to die (high-certainty evidence). They were also more likely to have side effects, including headache, flushing and muscle aches. Five trials included people with pulmonary hypertension due to left-heart disease. This review shows that when given PDE5 inhibitors, these people were on average able to walk 34 metres further in six minutes (3 trials, 284 people; low-certainty evidence). However, there was no difference in survival, compared to those who were not given PDE5 inhibitors. Five trials included people with pulmonary hypertension due to lung disease (mostly chronic obstructive pulmonary disease and some idiopathic pulmonary fibrosis). When given PDE5 inhibitors, they were able to walk 27 meters further in six minutes (low-certainty evidence), but with no difference in survival, compared to those who were not given PDE5 inhibitors. Three trials included people with pulmonary hypertension due to blood clots; there was no significant difference in outcomes for those who used PDE5 inhibitors compared to those who did not. There was good-quality evidence for those with pulmonary arterial hypertension, giving us some confidence that the results are correct. The evidence for those with pulmonary hypertension due to heart disease was less certain. The quality of evidence in this group was low because there were few trials, small numbers of people taking part, and the trials were quite different from each other, making it difficult to draw firm conclusions.
CochranePLS141
***TASK*** the task is to simplify the input abstract of a biomedical literature ***INPUT*** the input is the abstract of a biomedical literature ***OUTPUT*** the output is the simplified abstract for the input abstract of a biomedical literature ***EXAMPLES*** Input: Output: ***EXAMPLES*** Input: Two trials (n = 190), at low risk of bias, were included in the review and both presented data on first time failure at the tooth level. Pooling of the data showed a statistically significant difference in favour of molar bands, with a hazard ratio of 2.92 (95% confidence intervals (CI) 1.80 to 4.72). No statistically significant heterogeneity was shown between the two studies. Data on first time failure at the patient level were also available and showed statistically different difference in favour of molar bands (risk ratio 2.30; 95% CI 1.56 to 3.41) (risk of event for molar tubes = 57%; risk of event for molar bands 25%). One trial presented data on decalcification again showing a statistically significant difference in favour of molar bands. No other adverse events identified. From the two well-designed and low risk of bias trials included in this review it was shown that the failure of molar tubes bonded with either a chemically-cured or light-cured adhesive was considerably higher than that of molar bands cemented with glass ionomer cement. One trial indicated that there was less decalcification with molar bands cemented with glass ionomer cement than with bonded molar tubes cemented with a light-cured adhesive. However, given there are limited data for this outcome, further evidence is required to draw more robust conclusions. Output: The evidence in this review, which was carried out together with Cochrane Oral Health, is up-to-date as of 15 February 2017. We included two studies that evaluated 190 participants. Both trials were conducted in the UK and both compared bonded molar tubes with molar bands. From the limited data of two studies at low risk of bias, it would appear that bonded molar tubes are associated with a higher failure rate than with molar bands. Input: We included one new trial involving 45 participants in this updated review. In total we included 22 trials involving a total of 2193 participants who received regional anaesthesia for hand, wrist, forearm or elbow surgery. 'Risk of bias' assessment indicated that trial design and conduct were generally adequate; the most common areas of weakness were in blinding and allocation concealment. Nine trials comparing double versus single injections showed a statistically significant decrease in primary anaesthesia failure (risk ratio (RR) 0.55, 95% confidence interval (CI) 0.34 to 0.89, high-quality evidence). Subgroup analysis by method of nerve location showed that the effect size was greater when neurostimulation was used rather than the transarterial technique. Nine trials comparing multiple with single injections showed a statistically significant decrease in primary anaesthesia failure (RR 0.25, 95% CI 0.14 to 0.42, high-quality evidence). Pooled data from five trials also showed a significant decrease in incomplete motor block (RR 0.61, 95% CI 0.39 to 0.96, high-quality evidence) in the multiple-injection group. Twelve trials comparing multiple versus double injections showed a statistically significant decrease in primary anaesthesia failure (RR 0.27, 95% CI 0.19 to 0.39, high-quality evidence). Pooled data from six trials also showed a significant decrease in incomplete motor block (RR 0.55, 95% CI 0.36 to 0.85, high-quality evidence) in the multiple injection group. Tourniquet pain was significantly reduced with multiple injections compared with double injections (RR 0.53, 95% CI 0.33 to 0.84, high-quality evidence). Otherwise there were no statistically significant differences between groups in any of the three comparisons on secondary analgesia failure, complications and patient discomfort. Compared with multiple injections, the time for block performance was significantly shorter for single injection (MD 3.33 minutes, 95% CI 2.76 to 3.90) and double injections (MD 1.54 minutes, 95% CI 0.80 to 2.29); however there was no difference in time to readiness for surgery. This review provides evidence that multiple-injection techniques using nerve stimulation for axillary plexus block produce more effective anaesthesia than either double or single-injection techniques. However, there was insufficient evidence to draw any definitive conclusions regarding differences in other outcomes, including safety. Output:
We searched the literature up until April 2016 and identified 22 randomized controlled trials for inclusion in the review. These trials involved a total of 2193 participants who were given regional anaesthesia for hand, wrist, forearm or elbow surgery. The trials used methods that were generally adequate and did not affect the validity of the findings. Nine trials compared double versus single injections. These found that people in the double-injection group had a 45% reduction in their chance of needing additional anaesthesia. The effect was more certain in the four trials where the nerves were located using the more precise method of neurostimulation. In the nine trials comparing multiple with single injections, and the 12 trials comparing multiple with double injections, there were significant reductions in the chance of needing additional anaesthesia in the multiple-injection groups (75% and 73% reductions when compared to single and double injections respectively). In addition, people in the multiple-injection group were 47% less likely to experience pain from the surgical tourniquet compared to the double-injection group. There were no other statistically significant differences in complications or patient discomfort between the two groups for any of the three comparisons. Single and double injections took less time to perform than multiple injections, but this did not reduce the total time required for adequate surgical anaesthesia to be established. Overall, there is high-quality evidence showing that multiple injections of anaesthetic close to three or four nerves in the armpit provide more complete anaesthesia for hand and forearm surgery than one or two injections. There was, however, not enough evidence to determine if there was a significant difference in the other outcomes, including safety.
CochranePLS142
***TASK*** the task is to simplify the input abstract of a biomedical literature ***INPUT*** the input is the abstract of a biomedical literature ***OUTPUT*** the output is the simplified abstract for the input abstract of a biomedical literature ***EXAMPLES*** Input: Output: ***EXAMPLES*** Input: Two trials (n = 190), at low risk of bias, were included in the review and both presented data on first time failure at the tooth level. Pooling of the data showed a statistically significant difference in favour of molar bands, with a hazard ratio of 2.92 (95% confidence intervals (CI) 1.80 to 4.72). No statistically significant heterogeneity was shown between the two studies. Data on first time failure at the patient level were also available and showed statistically different difference in favour of molar bands (risk ratio 2.30; 95% CI 1.56 to 3.41) (risk of event for molar tubes = 57%; risk of event for molar bands 25%). One trial presented data on decalcification again showing a statistically significant difference in favour of molar bands. No other adverse events identified. From the two well-designed and low risk of bias trials included in this review it was shown that the failure of molar tubes bonded with either a chemically-cured or light-cured adhesive was considerably higher than that of molar bands cemented with glass ionomer cement. One trial indicated that there was less decalcification with molar bands cemented with glass ionomer cement than with bonded molar tubes cemented with a light-cured adhesive. However, given there are limited data for this outcome, further evidence is required to draw more robust conclusions. Output: The evidence in this review, which was carried out together with Cochrane Oral Health, is up-to-date as of 15 February 2017. We included two studies that evaluated 190 participants. Both trials were conducted in the UK and both compared bonded molar tubes with molar bands. From the limited data of two studies at low risk of bias, it would appear that bonded molar tubes are associated with a higher failure rate than with molar bands. Input: One hundred and fifty-nine citations were identified by the search strategy and bibliography review. Three studies met the inclusion criteria. All used beclomethasone 200 mcg twice daily delivered by dry powder Diskhaler to treat children with mild-moderate asthma. Study duration was 7-12 months. In all three studies, a significant decrease in linear growth occurred in children treated with beclomethasone compared to those receiving placebo or non-steroidal asthma therapy. The average decrease, calculated through meta-analysis, was -1.54 cm per year (95% CI -1.15, -1.94). In children with mild-moderate asthma, beclomethasone 200 mcg twice daily caused a decrease in linear growth of -1.54 cm per year. These studies lasted a maximum of 54 weeks, so it remains unclear whether the decrease in growth is sustained or whether it reverses with 'catch up' after therapy is discontinued. We are unable to comment on growth effects of other inhaled steroids that have potentially less systemic effects. If inhaled steroids are required to control a child's asthma, we recommend using the minimum dose that effectively controls the child's asthma and closely following growth. Output:
The review of trials found that the inhaled steroid, beclomethasone causes an average decrease in growth of about one and a half centimetres a year. However, it is not known whether there is any catch-up growth once the treatment is stopped. More research is needed.
CochranePLS143
***TASK*** the task is to simplify the input abstract of a biomedical literature ***INPUT*** the input is the abstract of a biomedical literature ***OUTPUT*** the output is the simplified abstract for the input abstract of a biomedical literature ***EXAMPLES*** Input: Output: ***EXAMPLES*** Input: Two trials (n = 190), at low risk of bias, were included in the review and both presented data on first time failure at the tooth level. Pooling of the data showed a statistically significant difference in favour of molar bands, with a hazard ratio of 2.92 (95% confidence intervals (CI) 1.80 to 4.72). No statistically significant heterogeneity was shown between the two studies. Data on first time failure at the patient level were also available and showed statistically different difference in favour of molar bands (risk ratio 2.30; 95% CI 1.56 to 3.41) (risk of event for molar tubes = 57%; risk of event for molar bands 25%). One trial presented data on decalcification again showing a statistically significant difference in favour of molar bands. No other adverse events identified. From the two well-designed and low risk of bias trials included in this review it was shown that the failure of molar tubes bonded with either a chemically-cured or light-cured adhesive was considerably higher than that of molar bands cemented with glass ionomer cement. One trial indicated that there was less decalcification with molar bands cemented with glass ionomer cement than with bonded molar tubes cemented with a light-cured adhesive. However, given there are limited data for this outcome, further evidence is required to draw more robust conclusions. Output: The evidence in this review, which was carried out together with Cochrane Oral Health, is up-to-date as of 15 February 2017. We included two studies that evaluated 190 participants. Both trials were conducted in the UK and both compared bonded molar tubes with molar bands. From the limited data of two studies at low risk of bias, it would appear that bonded molar tubes are associated with a higher failure rate than with molar bands. Input: Three trials (139 patients) were included. APD did not differ from CAPD with respect to mortality (RR 1.49, 95% CI 0.51 to 4.37), risk of peritonitis (RR 0.75, 95% CI 0.50 to 1.11), switching from original PD modality to a different dialysis modality (RR 0.50, 95% CI 0.25 to 1.02), hernias (RR 1.26, 95% interval 0.32 to 5.01), PD fluid leaks (RR 1.06, 95% CI 0.11 to 9.83), PD catheter removal (RR 0.64, 95% CI 0.27 to 1.48) or hospital admissions (RR 0.96, 95% CI 0.43 to 2.17). There was no difference between either PD modality with respect to residual renal function (MD -0.17, 95% CI -1.66 to 1.32). One study found that peritonitis rates and hospitalisation were significantly less in patients on APD when results were expressed as episodes/patient-year. Another study found that patients on APD had significantly more time for work, family and social activities. APD has not been shown to have significant advantages over CAPD in terms of important clinical outcomes. APD may however be considered advantageous in select group of patients such as in the younger PD population and those in employment or education due to its psychosocial advantages. There is a need for a RCT comparing CAPD with APD with sufficiently large patient numbers looking at important clinical outcomes including residual renal function, accompanied by an economic evaluation to clarify the relative clinical and cost-effectiveness of both modalities. Output:
The aim of this review was to compare the effectiveness of CAPD and APD. Only three small randomised controlled trials (RCTs) (139 patients) were identified after an extensive literature search, and we found no difference between CAPD and APD for clinically important outcomes. APD may however be considered advantageous in select group of patients such as in the younger PD population and those in employment or education due to its psychosocial advantages. These outcomes were only reported in one trial. Large, long-term RCTs are needed in this area.
CochranePLS144
***TASK*** the task is to simplify the input abstract of a biomedical literature ***INPUT*** the input is the abstract of a biomedical literature ***OUTPUT*** the output is the simplified abstract for the input abstract of a biomedical literature ***EXAMPLES*** Input: Output: ***EXAMPLES*** Input: Two trials (n = 190), at low risk of bias, were included in the review and both presented data on first time failure at the tooth level. Pooling of the data showed a statistically significant difference in favour of molar bands, with a hazard ratio of 2.92 (95% confidence intervals (CI) 1.80 to 4.72). No statistically significant heterogeneity was shown between the two studies. Data on first time failure at the patient level were also available and showed statistically different difference in favour of molar bands (risk ratio 2.30; 95% CI 1.56 to 3.41) (risk of event for molar tubes = 57%; risk of event for molar bands 25%). One trial presented data on decalcification again showing a statistically significant difference in favour of molar bands. No other adverse events identified. From the two well-designed and low risk of bias trials included in this review it was shown that the failure of molar tubes bonded with either a chemically-cured or light-cured adhesive was considerably higher than that of molar bands cemented with glass ionomer cement. One trial indicated that there was less decalcification with molar bands cemented with glass ionomer cement than with bonded molar tubes cemented with a light-cured adhesive. However, given there are limited data for this outcome, further evidence is required to draw more robust conclusions. Output: The evidence in this review, which was carried out together with Cochrane Oral Health, is up-to-date as of 15 February 2017. We included two studies that evaluated 190 participants. Both trials were conducted in the UK and both compared bonded molar tubes with molar bands. From the limited data of two studies at low risk of bias, it would appear that bonded molar tubes are associated with a higher failure rate than with molar bands. Input: 37 trials (9312 patients) were analysed: 15 (3343) for RT vs. CRT, 16 (2861) for CT vs. CRT, 3 (415) for RT vs. CT and 10 (3221) for IF-RT vs. EF-RT. CRT was superior to RT in terms of OS (OR=0.76, 95% CI 0.66 to 0.89, P = 0.0004), PFS (OR=0.49, 95% CI 0.43 to 0.56, P < 0.0001) and SM (OR = 0.78, 95% CI 0.62 to 0.98, P = 0.03). The superiority of CRT also applied to early and advanced stages (mainly IIIA) separately. Excess SM with RT is due mainly to ST and is apparently caused by greater need for salvage therapy after RT. CRT was superior to CT in terms of PFS (OR = 77, 95 % CI 0.68 to 0.77, P < 0.0001). OS was better with CRT for early stages only (OR=0.62, 95% CI 0.44 to 0.88, P = 0.006). SM risk was higher with CRT (OR = 1.38, 95% CI 1.00 to 1.89, P = 0.05), although not significant for early stages alone. This effect, also seen in AL and ST separately, was due directly to first-line treatment. Data were insufficient to compare RT to CT. EF-RT was superior to IF-RT (each additional to CT in most trials) in terms of PFS (OR=81, 95% CI 0.68 to 0.95, P = 0.009) but not OS. No significant difference in SM was observed. CRT seems to be optimal for most early stage (I-II) HD patients. For advanced stages (III to IV), CRT better prevents progression/relapse but CT alone seems to cause less SM. RT alone gives a higher overall SM risk than CRT due to increased need for salvage therapy. Reduced SM risk after IF-RT instead of EF-RT could not be demonstrated. Due to the large number of studies excluded because no IPD were received, to the inclusion of many outdated treatments and to the limited amount of long-term data, one must be cautious in applying these results to current therapies. Output:
A meta-analysis of data from 37 randomised trials including over 9000 patients was conducted. For early-stage patients, CRT resulted in longer survival and longer HD-free survival than either RT or CT alone. Second malignancy (SM) risk was lower with CRT than with RT (no difference in between CRT and CT was demonstrated). For advanced stages, no difference in survival between CRT and CT was established. With CRT, HD-free survival was longer but SM risk was higher.
CochranePLS145
***TASK*** the task is to simplify the input abstract of a biomedical literature ***INPUT*** the input is the abstract of a biomedical literature ***OUTPUT*** the output is the simplified abstract for the input abstract of a biomedical literature ***EXAMPLES*** Input: Output: ***EXAMPLES*** Input: Two trials (n = 190), at low risk of bias, were included in the review and both presented data on first time failure at the tooth level. Pooling of the data showed a statistically significant difference in favour of molar bands, with a hazard ratio of 2.92 (95% confidence intervals (CI) 1.80 to 4.72). No statistically significant heterogeneity was shown between the two studies. Data on first time failure at the patient level were also available and showed statistically different difference in favour of molar bands (risk ratio 2.30; 95% CI 1.56 to 3.41) (risk of event for molar tubes = 57%; risk of event for molar bands 25%). One trial presented data on decalcification again showing a statistically significant difference in favour of molar bands. No other adverse events identified. From the two well-designed and low risk of bias trials included in this review it was shown that the failure of molar tubes bonded with either a chemically-cured or light-cured adhesive was considerably higher than that of molar bands cemented with glass ionomer cement. One trial indicated that there was less decalcification with molar bands cemented with glass ionomer cement than with bonded molar tubes cemented with a light-cured adhesive. However, given there are limited data for this outcome, further evidence is required to draw more robust conclusions. Output: The evidence in this review, which was carried out together with Cochrane Oral Health, is up-to-date as of 15 February 2017. We included two studies that evaluated 190 participants. Both trials were conducted in the UK and both compared bonded molar tubes with molar bands. From the limited data of two studies at low risk of bias, it would appear that bonded molar tubes are associated with a higher failure rate than with molar bands. Input: We reviewed 26 studies with 27 treatment groups that enrolled a total of 4893 participants. Twenty five of the studies were case series or uncontrolled long-term trial continuations, the other was an RCT comparing two opioids. Opioids were administered orally (number of study treatments groups [abbreviated as "k"] = 12, n = 3040), transdermally (k = 5, n = 1628), or intrathecally (k = 10, n = 231). Many participants discontinued due to adverse effects (oral: 22.9% [95% confidence interval (CI): 15.3% to 32.8%]; transdermal: 12.1% [95% CI: 4.9% to 27.0%]; intrathecal: 8.9% [95% CI: 4.0% to 26.1%]); or insufficient pain relief (oral: 10.3% [95% CI: 7.6% to 13.9%]; intrathecal: 7.6% [95% CI: 3.7% to 14.8%]; transdermal: 5.8% [95% CI: 4.2% to 7.9%]). Signs of opioid addiction were reported in 0.27% of participants in the studies that reported that outcome. All three modes of administration were associated with clinically significant reductions in pain, but the amount of pain relief varied among studies. Findings regarding quality of life and functional status were inconclusive due to an insufficient quantity of evidence for oral administration studies and inconclusive statistical findings for transdermal and intrathecal administration studies. Many patients discontinue long-term opioid therapy (especially oral opioids) due to adverse events or insufficient pain relief; however, weak evidence suggests that patients who are able to continue opioids long-term experience clinically significant pain relief. Whether quality of life or functioning improves is inconclusive. Many minor adverse events (like nausea and headache) occurred, but serious adverse events, including iatrogenic opioid addiction, were rare. Output:
The findings of this systematic review suggest that proper management of a type of strong painkiller (opioids) in well-selected patients with no history of substance addiction or abuse can lead to long-term pain relief for some patients with a very small (though not zero) risk of developing addiction, abuse, or other serious side effects. However, the evidence supporting these conclusions is weak, and longer-term studies are needed to identify the patients who are most likely to benefit from treatment.
CochranePLS146
***TASK*** the task is to simplify the input abstract of a biomedical literature ***INPUT*** the input is the abstract of a biomedical literature ***OUTPUT*** the output is the simplified abstract for the input abstract of a biomedical literature ***EXAMPLES*** Input: Output: ***EXAMPLES*** Input: Two trials (n = 190), at low risk of bias, were included in the review and both presented data on first time failure at the tooth level. Pooling of the data showed a statistically significant difference in favour of molar bands, with a hazard ratio of 2.92 (95% confidence intervals (CI) 1.80 to 4.72). No statistically significant heterogeneity was shown between the two studies. Data on first time failure at the patient level were also available and showed statistically different difference in favour of molar bands (risk ratio 2.30; 95% CI 1.56 to 3.41) (risk of event for molar tubes = 57%; risk of event for molar bands 25%). One trial presented data on decalcification again showing a statistically significant difference in favour of molar bands. No other adverse events identified. From the two well-designed and low risk of bias trials included in this review it was shown that the failure of molar tubes bonded with either a chemically-cured or light-cured adhesive was considerably higher than that of molar bands cemented with glass ionomer cement. One trial indicated that there was less decalcification with molar bands cemented with glass ionomer cement than with bonded molar tubes cemented with a light-cured adhesive. However, given there are limited data for this outcome, further evidence is required to draw more robust conclusions. Output: The evidence in this review, which was carried out together with Cochrane Oral Health, is up-to-date as of 15 February 2017. We included two studies that evaluated 190 participants. Both trials were conducted in the UK and both compared bonded molar tubes with molar bands. From the limited data of two studies at low risk of bias, it would appear that bonded molar tubes are associated with a higher failure rate than with molar bands. Input: The review contains only one trial with a total of 212 participants, all with spinal cord injury and open pressure ulcers classed as stage III and IV. The participants were mainly male (98.2%, 106/108) with a mean age of 58.4 (standard deviation 10.4) years in the oxandrolone group and were all male (100%, 104/104) with a mean age of 57.3 (standard deviation 11.6) years in the placebo group. This trial compared oxandrolone (20 mg/day, administered orally) with a dose of placebo (an inactive substance consisting of 98% starch and 2% magnesium stearate) and reported data on complete healing of ulcers and adverse events. There was very low-certainty evidence on the relative effect of oxandrolone on complete ulcer healing at the end of a 24-week treatment period (risk ratio RR) 0.81, 95% confidence interval (CI) 0.52 to 1.26) (downgraded twice for imprecision due to an extremely wide 95% CI, which spanned both benefit and harm, and once for indirectness, as the participants were mostly male spinal cord injury patients). Thus, we are uncertain whether oxandrolone improves or reduces the complete healing of pressure ulcers, as we assessed the certainty of the evidence as very low. There was low-certainty evidence on the risk of non-serious adverse events reported in participants treated with oxandrolone compared with placebo (RR 3.85, 95% CI 1.12 to 13.26) (downgraded once for imprecision and once for indirectness, as the participants were mostly male spinal cord injury patients). Thus, the treatment with oxandrolone may increase the risk of non-serious adverse events reported in participants. There was very low-certainty evidence on the risk of serious adverse events reported in participants treated with oxandrolone compared with placebo (RR 0.54, 95% CI 0.25 to 1.17) (downgraded twice for imprecision due to an extremely wide 95% CI, which spanned both benefit and harm, and once for indirectness, as the participants were mostly male spinal cord injury patients). Of the five serious adverse events reported in the oxandrolone-treated group, none were classed by the trial teams as being related to treatment. We are uncertain whether oxandrolone increases or decreases the risk of serious adverse events as we assessed the certainty of the evidence as very low. Secondary outcomes such as pain, length of hospital stay, change in wound size or wound surface area, incidence of different type of infection, cost of treatment and quality of life were not reported in the included trial. Overall the evidence in this study was of very low quality (downgraded for imprecision and indirectness). This trial stopped early when the futility analysis (interim analysis) in the opinion of the study authors showed that oxandrolone had no benefit over placebo for improving ulcer healing. There is no high quality evidence to support the use of anabolic steroids in treating pressure ulcers. Further well-designed, multicenter trials, at low risk of bias, are necessary to assess the effect of anabolic steroids on treating pressure ulcers, but careful consideration of the current trial and its early termination are required when planning future research. Output:
In March 2017, we searched for randomised controlled trials, which compared the use of anabolic steroids with other treatments for pressure ulcers. We found only one trial involving a total of 212 participants. This trial compared the effects of an anabolic steroid (oxandrolone capsules) with a placebo (dummy treatment containing no active medicine) on pressure ulcer healing in people with spinal cord injuries. The participants were mostly male (98.2%) with a mean age of 58.4 years in the oxandrolone group, which was comparable with the participants in the placebo group (male: 100%; mean age: 57.3 years). The trial was conducted over 24 weeks with a further follow-up for eight weeks. The trial was ended early as the trial authors deemed that the interim results suggested that there was unlikely to be a benefit from treatment with oxandrolone. Because of the limited data available from one trial, we remain uncertain whether anabolic steroids have beneficial effects on pressure ulcer healing, whether the treatment causes increased serious adverse events and if the treatment may increase the risk of non-serious adverse events. Overall, the evidence from this study was judged to be of very low quality. More, better-designed studies are necessary to provide evidence as to whether anabolic steroids are beneficial or not in treating pressure ulcers. This plain language summary is up to date as of March 2017.
CochranePLS147
***TASK*** the task is to simplify the input abstract of a biomedical literature ***INPUT*** the input is the abstract of a biomedical literature ***OUTPUT*** the output is the simplified abstract for the input abstract of a biomedical literature ***EXAMPLES*** Input: Output: ***EXAMPLES*** Input: Two trials (n = 190), at low risk of bias, were included in the review and both presented data on first time failure at the tooth level. Pooling of the data showed a statistically significant difference in favour of molar bands, with a hazard ratio of 2.92 (95% confidence intervals (CI) 1.80 to 4.72). No statistically significant heterogeneity was shown between the two studies. Data on first time failure at the patient level were also available and showed statistically different difference in favour of molar bands (risk ratio 2.30; 95% CI 1.56 to 3.41) (risk of event for molar tubes = 57%; risk of event for molar bands 25%). One trial presented data on decalcification again showing a statistically significant difference in favour of molar bands. No other adverse events identified. From the two well-designed and low risk of bias trials included in this review it was shown that the failure of molar tubes bonded with either a chemically-cured or light-cured adhesive was considerably higher than that of molar bands cemented with glass ionomer cement. One trial indicated that there was less decalcification with molar bands cemented with glass ionomer cement than with bonded molar tubes cemented with a light-cured adhesive. However, given there are limited data for this outcome, further evidence is required to draw more robust conclusions. Output: The evidence in this review, which was carried out together with Cochrane Oral Health, is up-to-date as of 15 February 2017. We included two studies that evaluated 190 participants. Both trials were conducted in the UK and both compared bonded molar tubes with molar bands. From the limited data of two studies at low risk of bias, it would appear that bonded molar tubes are associated with a higher failure rate than with molar bands. Input: We included six randomised controlled trials involving 8372 people. All trials were judged to be at high risk of bias for at least one domain. Four trials compared email communication to standard mail and two compared email communication to usual care. For the primary health service outcome of uptake of preventive screening, there was no difference between email and standard mail (OR 0.93; 95% CI 0.69 to 1.24). For both comparisons (email versus standard mail and email versus usual care) there was no difference between the groups for patient or caregiver understanding and support. Results were inconclusive for patient or caregiver behaviours and actions. For email versus usual care only, there was no significant difference between groups for the primary outcome of patient health status and well-being. No data were reported relating to healthcare professionals or harms. The evidence on the use of email for the provision of information on disease prevention and health promotion was weak, and therefore inadequate to inform clinical practice. The available trials mostly provide inconclusive, or no evidence for the outcomes of interest in this review. Future research needs to use high-quality study designs that take advantage of the most recent developments in information technology, with consideration of the complexity of email as an intervention. Output:
We found that there was not much evidence on the effects of using email to give people information on disease prevention and health promotion. We found only six trials with 8372 participants in total. All of the trials had elements of bias. Four studies compared email to standard mail as a method of communication, and found that using email instead of mail did not make any difference to patient or caregiver understanding, or the uptake of preventive screening. Two studies compared email with usual care, and found that using email instead of usual methods of information delivery did make any difference to patient or caregiver understanding and support, or patient health status and well-being. We were unable to properly assess email's impact on patient or caregiver behaviours/actions as the results were mixed. As there is a lack of good quality evidence for whether email can be used by healthcare professionals to provide information to patients or caregivers on how to stay healthy and avoid disease, we need to think about how to get good measurable information on this. Future studies should follow advice on good ways of carrying out and presenting research. It would be useful if they could look at the costs of using email and take into account ongoing changes in technology.
CochranePLS148
***TASK*** the task is to simplify the input abstract of a biomedical literature ***INPUT*** the input is the abstract of a biomedical literature ***OUTPUT*** the output is the simplified abstract for the input abstract of a biomedical literature ***EXAMPLES*** Input: Output: ***EXAMPLES*** Input: Two trials (n = 190), at low risk of bias, were included in the review and both presented data on first time failure at the tooth level. Pooling of the data showed a statistically significant difference in favour of molar bands, with a hazard ratio of 2.92 (95% confidence intervals (CI) 1.80 to 4.72). No statistically significant heterogeneity was shown between the two studies. Data on first time failure at the patient level were also available and showed statistically different difference in favour of molar bands (risk ratio 2.30; 95% CI 1.56 to 3.41) (risk of event for molar tubes = 57%; risk of event for molar bands 25%). One trial presented data on decalcification again showing a statistically significant difference in favour of molar bands. No other adverse events identified. From the two well-designed and low risk of bias trials included in this review it was shown that the failure of molar tubes bonded with either a chemically-cured or light-cured adhesive was considerably higher than that of molar bands cemented with glass ionomer cement. One trial indicated that there was less decalcification with molar bands cemented with glass ionomer cement than with bonded molar tubes cemented with a light-cured adhesive. However, given there are limited data for this outcome, further evidence is required to draw more robust conclusions. Output: The evidence in this review, which was carried out together with Cochrane Oral Health, is up-to-date as of 15 February 2017. We included two studies that evaluated 190 participants. Both trials were conducted in the UK and both compared bonded molar tubes with molar bands. From the limited data of two studies at low risk of bias, it would appear that bonded molar tubes are associated with a higher failure rate than with molar bands. Input: The review includes 11 trials involving 855 participants. A total of nine studies used post-Epley postural restrictions as their modification of the Epley manoeuvre. There was no evidence of a difference in the results for post-treatment vertigo intensity or subjective assessment of improvement in individual or pooled data. All nine trials included the conversion of a positive to a negative Dix-Hallpike test as an outcome measure. Pooled data identified a significant difference from the addition of postural restrictions in the frequency of Dix-Hallpike conversion when compared to the Epley manoeuvre alone. In the experimental group 88.7% (220 out of 248) patients versus 78.2% (219 out of 280) in the control group converted from a positive to negative Dix-Hallpike test (risk ratio (RR) 1.13, 95% confidence interval (CI) 1.05 to 1.22, P = 0.002). No serious adverse effects were reported, however three studies reported minor complications such as neck stiffness, horizontal BPPV, dizziness and disequilibrium in some patients. There was no evidence of benefit of mastoid oscillation applied during the Epley manoeuvre, or of additional steps in the Epley manoeuvre. No adverse effects were reported. There is evidence supporting a statistically significant effect of post-Epley postural restrictions in comparison to the Epley manoeuvre alone. However, it important to note that this statistically significant effect only highlights a small improvement in treatment efficacy. An Epley manoeuvre alone is effective in just under 80% of patients with typical BPPV. The additional intervention of postural restrictions has a number needed to treat (NNT) of 10. The addition of postural restrictions does not expose the majority of patients to risk of harm, does not pose a major inconvenience, and can be routinely discussed and advised. Specific patients who experience discomfort due to wearing a cervical collar and inconvenience in sleeping upright may be treated with the Epley manoeuvre alone and still expect to be cured in most instances. There is insufficient evidence to support the routine application of mastoid oscillation during the Epley manoeuvre, or additional steps in an 'augmented' Epley manoeuvre. Neither treatment is associated with adverse outcomes. Further studies should employ a rigorous randomisation technique, blinded outcome assessment, a post-treatment Dix-Hallpike test as an outcome measure and longer-term follow-up of patients. Output:
We included 11 studies in this review, with a total of 855 participants. Nine studies looked at post-treatment postural restrictions (using a neck brace/head movement restrictions/instructions to sleep upright) following the Epley manoeuvre. There was a statistically significant difference found when these restrictions were compared to a control treatment of the Epley manoeuvre alone. Although there was a difference between the groups, adding postural restrictions conferred only a small additional benefit since the Epley manoeuvre was effective alone in just under 80% of patients. Four of the studies reported minor complications such as neck stiffness, horizontal BPPV (a subtype of BPPV which is similar to posterior canal BPPV, but has some distinct differences in terms of the signs and symptoms), dizziness and disequilibrium (the feeling of unsteadiness on ones feet) in some patients. Additionally, two studies looked into the application of oscillation/vibration to the mastoid region during the Epley manoeuvre compared to control; the intervention produced no difference in outcome between these groups. One study that also researched post-treatment postural restrictions looked into extra steps in the Epley manoeuvre. Compared to the control treatment there were no significant differences in outcomes. No serious adverse effects were reported in any of the studies in the review. The results should be interpreted carefully and further trials are needed.
CochranePLS149
***TASK*** the task is to simplify the input abstract of a biomedical literature ***INPUT*** the input is the abstract of a biomedical literature ***OUTPUT*** the output is the simplified abstract for the input abstract of a biomedical literature ***EXAMPLES*** Input: Output: ***EXAMPLES*** Input: Two trials (n = 190), at low risk of bias, were included in the review and both presented data on first time failure at the tooth level. Pooling of the data showed a statistically significant difference in favour of molar bands, with a hazard ratio of 2.92 (95% confidence intervals (CI) 1.80 to 4.72). No statistically significant heterogeneity was shown between the two studies. Data on first time failure at the patient level were also available and showed statistically different difference in favour of molar bands (risk ratio 2.30; 95% CI 1.56 to 3.41) (risk of event for molar tubes = 57%; risk of event for molar bands 25%). One trial presented data on decalcification again showing a statistically significant difference in favour of molar bands. No other adverse events identified. From the two well-designed and low risk of bias trials included in this review it was shown that the failure of molar tubes bonded with either a chemically-cured or light-cured adhesive was considerably higher than that of molar bands cemented with glass ionomer cement. One trial indicated that there was less decalcification with molar bands cemented with glass ionomer cement than with bonded molar tubes cemented with a light-cured adhesive. However, given there are limited data for this outcome, further evidence is required to draw more robust conclusions. Output: The evidence in this review, which was carried out together with Cochrane Oral Health, is up-to-date as of 15 February 2017. We included two studies that evaluated 190 participants. Both trials were conducted in the UK and both compared bonded molar tubes with molar bands. From the limited data of two studies at low risk of bias, it would appear that bonded molar tubes are associated with a higher failure rate than with molar bands. Input: Four studies (231 participants randomised) are included in the review. No studies were at low risk of bias. The studies compared different types of surgery versus various types and doses of systemic and topical steroids and antibiotics. There were three comparison pairs: (1) endoscopic sinus surgery (ESS) versus systemic steroids (one study, n = 109), (2) polypectomy versus systemic steroids (two studies, n = 87); (3) ESS plus topical steroid versus antibiotics plus high-dose topical steroid (one study, n = 35). All participants also received topical steroids but doses and types were the same between the treatment arms of each study, except for the study using antibiotics. In that study, the medical treatment arm had higher doses than the surgical arm. In two of the studies, the authors failed to report the outcomes of interest. Although there were important differences in the types of treatments and comparisons used in these studies, the results were similar. Primary outcomes: symptom scores and quality of life scores There were no important differences between groups in either the patient-reported disease-specific symptom scores or the health-related quality of life scores. Two studies (one comparing ESS plus topical steroid versus antibiotics plus high-dose topical steroid, the other ESS versus systemic steroids) failed to find a difference in generic health-related quality of life scores. The quality of this evidence is low or very low. Endoscopic scores and other secondary outcomes Two studies reported endoscopic scores. One study (ESS versus systemic steroids) reported a large, significant effect size in the surgical group, with a mean difference (MD) in score of -1.5 (95% confidence interval (CI) -1.78 to -1.22, n = 95) on a scale of 0 to 3 (0 = no polyposis, 3 = severe polyposis). In the other study (ESS plus topical steroid versus antibiotics plus high-dose topical steroid) no difference was found between the groups (MD 2.3%, 95% CI -17.4% to 12.8%, n = 34). None of the included studies reported recurrence rates. No differences were found for any objective measurements or olfactory tests in those studies in which they were measured. Complications Complication rates were not reported in all studies, but rates of up to 21% for medical treatment and 14.3% for surgical treatment are described. Epistaxis was the most commonly reported complication with both medical and surgical treatments, with severe complications reported rarely. The evidence relating to the effectiveness of different types of surgery versus medical treatment for adults with chronic rhinosinusitis with nasal polyps is of very low quality. The evidence does not show that one treatment is better than another in terms of patient-reported symptom scores and quality of life measurements. The one positive finding from amongst the several studies examining a number of different comparisons must be treated with appropriate caution, in particular when the clinical significance of the measure is uncertain. As the overall evidence is of very low quality (serious methodological limitations, reporting bias, indirectness and imprecision) and insufficient to draw firm conclusions, further research to investigate this problem, which has significant implications for quality of life and healthcare service usage, is justified. Output:
Four randomised controlled trials, involving a total of 231 patients with chronic rhinosinusitis with nasal polyps, are included in this review. The number of patients in each study ranged from 34 to 109. The studies took place in ENT departments in several European countries. All patients were adults and most of the studies enrolled more men than women. In all studies the patients were randomly assigned to either surgery or medical treatment (such as antibiotics or steroid tablets or injections) in addition to topical steroids given as nasal sprays or drops. Both the type of surgery performed and the medical treatments used varied widely between the studies, and did not allow all of the studies to be looked at together. Rather, we considered the treatment groups in the four studies as three separate pairs of comparisons instead of simply 'surgical' versus 'medical' treatments. The main outcome measures were patient-reported disease-specific symptom scores and health-related quality of life scores, as well as generic health-related quality of life scores. There were no important differences between groups in either the patient-reported disease-specific symptom scores or the health-related quality of life scores. Two studies (one comparing ESS plus topical steroid versus antibiotics plus high-dose topical steroid, the other ESS versus systemic steroids) did not find a difference in general health-related quality of life scores. Two studies reported changes in polyp size (when looked at with an endoscope) using a score. One study (ESS versus systemic steroids) reported a significantly better score in the surgery group than in the steroids group at 12 months. In the other study (ESS plus topical steroid versus antibiotics plus high-dose topical steroid) no difference was found between the groups. There were no reported differences between the different medical and surgical treatment groups in any study for any other objective (clinician-based) measurements. Complication rates were not reported in all studies, but nosebleeds (epistaxis) were the most commonly described complication with both medical and surgical treatment; severe complications were reported rarely in either group. The evidence does not show that one treatment is better than another in terms of patient-reported symptom scores and quality of life measurements. One positive finding (polyps size scores) from amongst the several studies examining a number of different comparisons must be treated with appropriate caution, in particular when the clinical significance of the measure is uncertain. There is not enough evidence to draw firm conclusions regarding the most appropriate treatment for this condition. Chronic rhinosinusitis with nasal polyps has significant implications for quality of life and the use of healthcare services. Further research to investigate this problem is justified. Overall, we found this evidence to be of low or very low quality. We have low confidence in the estimates of these studies; further research will very likely change these estimates. There were serious limitations in how the studies were carried out or reported (or both), and the number of participants involved was small. In addition, some of the treatment regimens used in the trials are no longer current standards of therapy for patients with chronic rhinosinusitis with nasal polyps. This evidence is up to date to 20 February 2014.
CochranePLS150
***TASK*** the task is to simplify the input abstract of a biomedical literature ***INPUT*** the input is the abstract of a biomedical literature ***OUTPUT*** the output is the simplified abstract for the input abstract of a biomedical literature ***EXAMPLES*** Input: Output: ***EXAMPLES*** Input: Two trials (n = 190), at low risk of bias, were included in the review and both presented data on first time failure at the tooth level. Pooling of the data showed a statistically significant difference in favour of molar bands, with a hazard ratio of 2.92 (95% confidence intervals (CI) 1.80 to 4.72). No statistically significant heterogeneity was shown between the two studies. Data on first time failure at the patient level were also available and showed statistically different difference in favour of molar bands (risk ratio 2.30; 95% CI 1.56 to 3.41) (risk of event for molar tubes = 57%; risk of event for molar bands 25%). One trial presented data on decalcification again showing a statistically significant difference in favour of molar bands. No other adverse events identified. From the two well-designed and low risk of bias trials included in this review it was shown that the failure of molar tubes bonded with either a chemically-cured or light-cured adhesive was considerably higher than that of molar bands cemented with glass ionomer cement. One trial indicated that there was less decalcification with molar bands cemented with glass ionomer cement than with bonded molar tubes cemented with a light-cured adhesive. However, given there are limited data for this outcome, further evidence is required to draw more robust conclusions. Output: The evidence in this review, which was carried out together with Cochrane Oral Health, is up-to-date as of 15 February 2017. We included two studies that evaluated 190 participants. Both trials were conducted in the UK and both compared bonded molar tubes with molar bands. From the limited data of two studies at low risk of bias, it would appear that bonded molar tubes are associated with a higher failure rate than with molar bands. Input: We included eight trials (709 participants); seven were from middle-income countries of Asia, Africa, Europe, and Latin America where zinc deficiency is likely to be a public health problem. Four trials compared the effect of zinc-fortified staple foods with unfortified foods (comparison 1), and four compared zinc-fortified staple foods in combination with other nutrients/factors with the same foods containing other nutrients or factors without zinc (comparison 2). The interventions lasted between one and nine months. We categorised most trials as having unclear or high risk of bias for randomisation, but low risk of bias for blinding and attrition. None of the studies in comparison 1 reported data on zinc deficiency. Foods fortified with zinc increased the serum or plasma zinc levels in comparison to foods without added zinc (mean difference (MD) 2.12 µmol/L, 95% confidence interval (CI) 1.25 to 3.00 µmol/L; 3 studies; 158 participants; low-quality evidence). Participants consuming foods fortified with zinc versus participants consuming the same food without zinc had similar risk of underweight (average risk ratio 3.10, 95% CI 0.52 to 18.38; 2 studies; 397 participants; low-quality evidence) and stunting (risk ratio (RR) 0.88, 95% CI 0.36 to 2.13; 2 studies; 397 participants; low-quality evidence). A single trial of addition of zinc to iron in wheat flour did not find a reduction in proportion of zinc deficiency (RR 0.17, 95% CI 0.01 to 3.94; very low-quality evidence). We did not find a difference in serum or plasma zinc levels in participants consuming foods fortified with zinc plus other micronutrients when compared with participants consuming the same foods with micronutrients but no added zinc (MD 0.03 µmol/L, 95% CI -0.67 to 0.72 µmol/L; 4 studies; 250 participants; low-quality evidence). No trial in comparison 2 provided information about underweight or stunting. There was no reported adverse effect of fortification of foods with zinc on indicators of iron or copper status. Fortification of foods with zinc may improve the serum zinc status of populations if zinc is the only micronutrient used for fortification. If zinc is added to food in combination with other micronutrients, it may make little or no difference to the serum zinc status. Effects of fortification of foods with zinc on other outcomes including zinc deficiency, children’s growth, cognition, work capacity of adults, or on haematological indicators are unknown. Given the small number of trials and participants in each trial, further investigation of these outcomes is required. Output:
We included eight trials (709 participants); seven were from middle-income countries of Asia, Africa, Europe, and Latin America where zinc deficiency is likely to be a public health problem. The effect of fortification of foods with zinc on incidence of zinc deficiency is uncertain. Fortification of foods with zinc may slightly improve the blood zinc levels of populations if zinc is the only micronutrient used for fortification. Zinc added to food in combination with other micronutrients may make little or no difference to blood zinc levels. The fortification of foods with zinc may make little or no difference on incidence of underweight or stunting. The effects of fortification of foods with zinc on other outcomes, including wasting and weight/height, are unknown. Fortification of foods with zinc does not seem to have any adverse effect on indicators of iron or copper status. Most studies included in this review involved a small number of participants and were judged to be at low or unclear risk of bias. There were also some inconsistencies in the results across different studies.
CochranePLS151
***TASK*** the task is to simplify the input abstract of a biomedical literature ***INPUT*** the input is the abstract of a biomedical literature ***OUTPUT*** the output is the simplified abstract for the input abstract of a biomedical literature ***EXAMPLES*** Input: Output: ***EXAMPLES*** Input: Two trials (n = 190), at low risk of bias, were included in the review and both presented data on first time failure at the tooth level. Pooling of the data showed a statistically significant difference in favour of molar bands, with a hazard ratio of 2.92 (95% confidence intervals (CI) 1.80 to 4.72). No statistically significant heterogeneity was shown between the two studies. Data on first time failure at the patient level were also available and showed statistically different difference in favour of molar bands (risk ratio 2.30; 95% CI 1.56 to 3.41) (risk of event for molar tubes = 57%; risk of event for molar bands 25%). One trial presented data on decalcification again showing a statistically significant difference in favour of molar bands. No other adverse events identified. From the two well-designed and low risk of bias trials included in this review it was shown that the failure of molar tubes bonded with either a chemically-cured or light-cured adhesive was considerably higher than that of molar bands cemented with glass ionomer cement. One trial indicated that there was less decalcification with molar bands cemented with glass ionomer cement than with bonded molar tubes cemented with a light-cured adhesive. However, given there are limited data for this outcome, further evidence is required to draw more robust conclusions. Output: The evidence in this review, which was carried out together with Cochrane Oral Health, is up-to-date as of 15 February 2017. We included two studies that evaluated 190 participants. Both trials were conducted in the UK and both compared bonded molar tubes with molar bands. From the limited data of two studies at low risk of bias, it would appear that bonded molar tubes are associated with a higher failure rate than with molar bands. Input: Eleven studies involving 3060 randomly assigned participants were included in this review. The quality of evidence is hampered by risk of bias. Use of non-steroidal antiandrogens decreased overall survival (hazard ratio (HR) 1.24, 95% confidence interval (CI) 1.05 to 1.48, six studies, 2712 participants) and increased clinical progression (one year: risk ratio (RR) 1.25, 95% CI 1.08 to 1.45, five studies, 2067 participants; 70 weeks: RR 1.26, 95% CI 1.08 to 1.45, six studies, 2373 participants; two years: RR 1.14, 95% CI 1.04 to 1.25, three studies, 1336 participants), as well as treatment failure (one year: RR 1.19, 95% CI 1.02 to 1.38, four studies, 1539 participants; 70 weeks: RR 1.27, 95% CI 1.05 to 1.52, five studies, 1845 participants; two years: RR 1.14, 95% CI 1.05 to 1.24, two studies, 808 participants), compared with medical or surgical castration. The quality of evidence for overall survival, clinical progression and treatment failure was rated as moderate according to GRADE. Predefined subgroup analyses showed that use of non-steroidal antiandrogens, compared with castration, was less favourable for overall survival, clinical progression (at one year, 70 weeks, two years) and treatment failure (at one year, 70 weeks, two years) in men with metastatic disease. Use of non-steroidal antiandrogens also increased the risk for treatment discontinuation due to adverse events (RR 1.82, 95% CI 1.13 to 2.94, eight studies, 1559 participants), including events such as breast pain (RR 22.97, 95% CI 14.79 to 35.67, eight studies, 2670 participants), gynaecomastia (RR 8.43, 95% CI 3.19 to 22.28, nine studies, 2774 participants) and asthenia (RR 1.77, 95% CI 1.36 to 2.31, five studies, 2073 participants). The risk of other adverse events, such as hot flashes (RR 0.23, 95% CI 0.19 to 0.27, nine studies, 2774 participants), haemorrhage (RR 0.07, 95% CI 0.01 to 0.54, two studies, 546 participants), nocturia (RR 0.38, 95% CI 0.20 to 0.69, one study, 480 participants), fatigue (RR 0.52, 95% CI 0.31 to 0.88, one study, 51 participants), loss of sexual interest (RR 0.50, 95% CI 0.30 to 0.83, one study, 51 participants) and urinary frequency (RR 0.22, 95% CI 0.11 to 0.47, one study, 480 participants) was decreased when non-steroidal antiandrogens were used. The quality of evidence for breast pain, gynaecomastia and hot flashes was rated as moderate according to GRADE. The effects of non-steroidal antiandrogens on cancer-specific survival and biochemical progression remained unclear. Currently available evidence suggests that use of non-steroidal antiandrogen monotherapy compared with medical or surgical castration monotherapy for advanced prostate cancer is less effective in terms of overall survival, clinical progression, treatment failure and treatment discontinuation due to adverse events. Evidence quality was rated as moderate according to GRADE. Further research is likely to have an important impact on results for patients with advanced but non-metastatic prostate cancer treated with non-steroidal antiandrogen monotherapy. However, we believe that research is likely not necessary on non-steroidal antiandrogen monotherapy for men with metastatic prostate cancer. Only high-quality, randomised controlled trials with long-term follow-up should be conducted. If further research is planned to investigate biochemical progression, studies with standardised follow-up schedules using measurements of prostate-specific antigen based on current guidelines should be conducted. Output:
The evidence is current to December 2013. We included 11 studies involving 3060 randomly assigned participants at advanced stages of prostate cancer. The follow-up period of participants ranged from six months to six years. In seven studies, authors reported possible conflicts of interest. In three studies, no conflicts of interest were declared. In one study, authors reported that they had received an educational grant from the sponsor, who had no role in any aspect of analysis or data interpretation. Use of non-steroidal antiandrogens decreased overall survival and increased clinical progression and treatment failure. Subgroup analyses showed that non-steroidal antiandrogens, compared with castration, were less favourable for overall survival, for clinical progression and for treatment failure in men with metastatic disease. Participants receiving antiandrogens were also more likely to stop treatment as the result of side effects. The risk of suffering breast pain, enlargement of breast tissue or symptoms of physical weakness was also increased with non-steroidal antiandrogens. The risks of feeling intense heat with sweating and rapid heartbeat and of bleeding, the need to get up in the night to urinate, loss of sexual interest, extreme tiredness and the need to urinate more often than usual were increased with castration. No difference was noted for other side effects. The effect of non-steroidal antiandrogens on cancer-specific survival and biochemical progression remained unclear. Included studies were poorly conducted, and the quality of evidence was rated as moderate. This means that further research is likely to have an important impact on our confidence in the accuracy of results.
CochranePLS152
***TASK*** the task is to simplify the input abstract of a biomedical literature ***INPUT*** the input is the abstract of a biomedical literature ***OUTPUT*** the output is the simplified abstract for the input abstract of a biomedical literature ***EXAMPLES*** Input: Output: ***EXAMPLES*** Input: Two trials (n = 190), at low risk of bias, were included in the review and both presented data on first time failure at the tooth level. Pooling of the data showed a statistically significant difference in favour of molar bands, with a hazard ratio of 2.92 (95% confidence intervals (CI) 1.80 to 4.72). No statistically significant heterogeneity was shown between the two studies. Data on first time failure at the patient level were also available and showed statistically different difference in favour of molar bands (risk ratio 2.30; 95% CI 1.56 to 3.41) (risk of event for molar tubes = 57%; risk of event for molar bands 25%). One trial presented data on decalcification again showing a statistically significant difference in favour of molar bands. No other adverse events identified. From the two well-designed and low risk of bias trials included in this review it was shown that the failure of molar tubes bonded with either a chemically-cured or light-cured adhesive was considerably higher than that of molar bands cemented with glass ionomer cement. One trial indicated that there was less decalcification with molar bands cemented with glass ionomer cement than with bonded molar tubes cemented with a light-cured adhesive. However, given there are limited data for this outcome, further evidence is required to draw more robust conclusions. Output: The evidence in this review, which was carried out together with Cochrane Oral Health, is up-to-date as of 15 February 2017. We included two studies that evaluated 190 participants. Both trials were conducted in the UK and both compared bonded molar tubes with molar bands. From the limited data of two studies at low risk of bias, it would appear that bonded molar tubes are associated with a higher failure rate than with molar bands. Input: Eight eligible trials were identified. We excluded a trial because the randomisation had failed to produce comparable groups.The eligible trials included 600,000 women in the analyses in the age range 39 to 74 years. Three trials with adequate randomisation did not show a statistically significant reduction in breast cancer mortality at 13 years (relative risk (RR) 0.90, 95% confidence interval (CI) 0.79 to 1.02); four trials with suboptimal randomisation showed a significant reduction in breast cancer mortality with an RR of 0.75 (95% CI 0.67 to 0.83). The RR for all seven trials combined was 0.81 (95% CI 0.74 to 0.87). We found that breast cancer mortality was an unreliable outcome that was biased in favour of screening, mainly because of differential misclassification of cause of death. The trials with adequate randomisation did not find an effect of screening on total cancer mortality, including breast cancer, after 10 years (RR 1.02, 95% CI 0.95 to 1.10) or on all-cause mortality after 13 years (RR 0.99, 95% CI 0.95 to 1.03). Total numbers of lumpectomies and mastectomies were significantly larger in the screened groups (RR 1.31, 95% CI 1.22 to 1.42), as were number of mastectomies (RR 1.20, 95% CI 1.08 to 1.32). The use of radiotherapy was similarly increased whereas there was no difference in the use of chemotherapy (data available in only two trials). If we assume that screening reduces breast cancer mortality by 15% and that overdiagnosis and overtreatment is at 30%, it means that for every 2000 women invited for screening throughout 10 years, one will avoid dying of breast cancer and 10 healthy women, who would not have been diagnosed if there had not been screening, will be treated unnecessarily. Furthermore, more than 200 women will experience important psychological distress including anxiety and uncertainty for years because of false positive findings. To help ensure that the women are fully informed before they decide whether or not to attend screening, we have written an evidence-based leaflet for lay people that is available in several languages on www.cochrane.dk. Because of substantial advances in treatment and greater breast cancer awareness since the trials were carried out, it is likely that the absolute effect of screening today is smaller than in the trials. Recent observational studies show more overdiagnosis than in the trials and very little or no reduction in the incidence of advanced cancers with screening. Output:
Screening with mammography uses X-ray imaging to find breast cancer before a lump can be felt. The goal is to treat cancer earlier, when a cure is more likely. The review includes seven trials that involved 600,000 women in the age range 39 to 74 years who were randomly assigned to receive screening mammograms or not. The studies which provided the most reliable information showed that screening did not reduce breast cancer mortality. Studies that were potentially more biased (less carefully done) found that screening reduced breast cancer mortality. However, screening will result in some women getting a cancer diagnosis even though their cancer would not have led to death or sickness. Currently, it is not possible to tell which women these are, and they are therefore likely to have breasts or lumps removed and to receive radiotherapy unnecessarily. If we assume that screening reduces breast cancer mortality by 15% after 13 years of follow-up and that overdiagnosis and overtreatment is at 30%, it means that for every 2000 women invited for screening throughout 10 years, one will avoid dying of breast cancer and 10 healthy women, who would not have been diagnosed if there had not been screening, will be treated unnecessarily. Furthermore, more than 200 women will experience important psychological distress including anxiety and uncertainty for years because of false positive findings. Women invited to screening should be fully informed of both the benefits and harms. To help ensure that the requirements for informed choice for women contemplating whether or not to attend a screening programme can be met, we have written an evidence-based leaflet for lay people that is available in several languages on www.cochrane.dk. Because of substantial advances in treatment and greater breast cancer awareness since the trials were carried out, it is likely that the absolute effect of screening today is smaller than in the trials. Recent observational studies show more overdiagnosis than in the trials and very little or no reduction in the incidence of advanced cancers with screening.
CochranePLS153
***TASK*** the task is to simplify the input abstract of a biomedical literature ***INPUT*** the input is the abstract of a biomedical literature ***OUTPUT*** the output is the simplified abstract for the input abstract of a biomedical literature ***EXAMPLES*** Input: Output: ***EXAMPLES*** Input: Two trials (n = 190), at low risk of bias, were included in the review and both presented data on first time failure at the tooth level. Pooling of the data showed a statistically significant difference in favour of molar bands, with a hazard ratio of 2.92 (95% confidence intervals (CI) 1.80 to 4.72). No statistically significant heterogeneity was shown between the two studies. Data on first time failure at the patient level were also available and showed statistically different difference in favour of molar bands (risk ratio 2.30; 95% CI 1.56 to 3.41) (risk of event for molar tubes = 57%; risk of event for molar bands 25%). One trial presented data on decalcification again showing a statistically significant difference in favour of molar bands. No other adverse events identified. From the two well-designed and low risk of bias trials included in this review it was shown that the failure of molar tubes bonded with either a chemically-cured or light-cured adhesive was considerably higher than that of molar bands cemented with glass ionomer cement. One trial indicated that there was less decalcification with molar bands cemented with glass ionomer cement than with bonded molar tubes cemented with a light-cured adhesive. However, given there are limited data for this outcome, further evidence is required to draw more robust conclusions. Output: The evidence in this review, which was carried out together with Cochrane Oral Health, is up-to-date as of 15 February 2017. We included two studies that evaluated 190 participants. Both trials were conducted in the UK and both compared bonded molar tubes with molar bands. From the limited data of two studies at low risk of bias, it would appear that bonded molar tubes are associated with a higher failure rate than with molar bands. Input: We included four studies, with a total of 522 women, in the review. One of these studies did not report outcomes per woman randomised, and so was not included in formal analysis. Three studies investigated 10,000 units hCG priming compared to no priming. One study investigated 20,000 units hCG compared to 10,000 units hCG priming. Three studies only included women with PCOS (N = 122), while this was an exclusion criteria in the fourth study (N = 400). We rated all four studies as having an unclear risk of bias in more than one of the seven domains assessed. The quality of the evidence was low, the main limitations being lack of blinding and imprecision. When 10,000 units hCG priming was compared to no priming, we found no evidence of a difference in the live birth rates per woman randomised (OR 0.65, 95% confidence intervals (CI) 0.24 to 1.74; one RCT; N = 82; low quality evidence); miscarriage rate (OR 0.60, 95% CI 0.21 to 1.72; two RCTs; N = 282; I² statistic = 21%; low quality evidence), or clinical pregnancy rate (OR 0.52, 95% CI 0.26 to 1.03; two RCTs, N = 282, I² statistic = 0%, low quality evidence). Though inconclusive, our findings suggested that hCG may be associated with a reduction in clinical pregnancy rates; 22% of women who received no priming achieved pregnancy, while between 7% and 23% of women who received hCG priming did so. The study comparing 20,000 units hCG with 10,000 units hCG did not report sufficient data to enable us to calculate odds ratios. No studies reported on adverse events (other than miscarriage) or drug reactions. This review found no conclusive evidence that hCG priming had an effect on live birth, pregnancy, or miscarriage rates in IVM. There was low quality evidence that suggested that hCG priming may reduce clinical pregnancy rates, however, these findings were limited by the small number of data included. As no data were available on adverse events (other than miscarriage) or on drug reactions, we could not adequately assess the safety of hCG priming. We need further evidence from well-designed RCTs before we can come to definitive conclusions about the role of hCG priming, and the optimal dose and timing. Output:
This review included four randomised controlled trials, with a total of 522 women. One study investigated the use of 20,000 units hCG priming compared to 10,000 units. The remaining studies investigated 10,000 units hCG priming compared to no priming. The main outcomes were live birth rate and miscarriage rate per woman randomised. Evidence published up to 29 August 2016 was examined. Only one study reported the main outcome of live birth per woman randomised; two studies reported clinical pregnancy. We found no certain evidence of a difference between 10,000 units hCG priming and no priming. However, there was some low quality evidence to suggest that hCG may be associated with a reduction in pregnancy rates; 22% of women who received no priming achieved pregnancy, while between 7% and 23% of women who received hCG priming did so. Two studies reported miscarriage rate per woman randomised, and found no evidence of a difference between 10,000 units hCG priming and no priming. No studies reported on adverse events (other than miscarriage) or drug reactions. Overall, there was insufficient evidence to draw any definite conclusions on the use of hCG priming in IVM. Further randomised trials are necessary, in particular, focusing on women with PCOS. The quality of the evidence was low, the main limitations being imprecision (random error) and lack of blinding (the process in which participant and assessor are prevented from knowing which intervention has been received).
CochranePLS154
***TASK*** the task is to simplify the input abstract of a biomedical literature ***INPUT*** the input is the abstract of a biomedical literature ***OUTPUT*** the output is the simplified abstract for the input abstract of a biomedical literature ***EXAMPLES*** Input: Output: ***EXAMPLES*** Input: Two trials (n = 190), at low risk of bias, were included in the review and both presented data on first time failure at the tooth level. Pooling of the data showed a statistically significant difference in favour of molar bands, with a hazard ratio of 2.92 (95% confidence intervals (CI) 1.80 to 4.72). No statistically significant heterogeneity was shown between the two studies. Data on first time failure at the patient level were also available and showed statistically different difference in favour of molar bands (risk ratio 2.30; 95% CI 1.56 to 3.41) (risk of event for molar tubes = 57%; risk of event for molar bands 25%). One trial presented data on decalcification again showing a statistically significant difference in favour of molar bands. No other adverse events identified. From the two well-designed and low risk of bias trials included in this review it was shown that the failure of molar tubes bonded with either a chemically-cured or light-cured adhesive was considerably higher than that of molar bands cemented with glass ionomer cement. One trial indicated that there was less decalcification with molar bands cemented with glass ionomer cement than with bonded molar tubes cemented with a light-cured adhesive. However, given there are limited data for this outcome, further evidence is required to draw more robust conclusions. Output: The evidence in this review, which was carried out together with Cochrane Oral Health, is up-to-date as of 15 February 2017. We included two studies that evaluated 190 participants. Both trials were conducted in the UK and both compared bonded molar tubes with molar bands. From the limited data of two studies at low risk of bias, it would appear that bonded molar tubes are associated with a higher failure rate than with molar bands. Input: In total, 24 trials were included, but only 16 (10,114 women) had analysable data. Meta-analyses showed no effects of either ERT or HRT on prevention of cognitive impairment after five and four years of treatment, respectively (odds ratio 1.34, 95% CI 0.95 to 1.9; odds ratio 1.05, 95% CI 0.72 to 1.54 respectively) (trend favouring control in both instances). Analyses assessing the effects of treatment over time found that both ERT and HRT did not maintain or improve cognitive function and may even adversely affect this outcome (WMD = -0.45, 95% CI -0.99 to 0.09; WMD = -0.16, 95% CI -0.58 to 0.26, respectively at maximum follow up). Negative effects were found for ERT after one year and HRT after three and four years of therapy. Results from smaller trials assessing effects on individual cognitive domains mostly reported no evidence of benefit. There is good evidence that both ERT and HRT do not prevent cognitive decline in older postmenopausal women when given as short term or longer term (up to five years) therapy. It is not known whether either specific types of ERT or HRT have specific effects in subgroups of women, although there was evidence that combined hormone therapy in similarly aged women was associated with a decrement in a number of verbal memory tests and a small improvement in a test of figural memory. There is insufficient evidence to determine whether subgroups of women using specific types of hormone therapy could benefit from treatment. It remains to be determined whether factors such as younger age (< 60 years of age), type of menopause (surgical or natural) and type of treatment (type of estrogen with or without a progestagen), mode of delivery (transdermal, oral or intramuscular) and dosage have positive effects at a clinically relevant level. In addition, whether the absence or presence of menopausal symptoms can modify treatment effects should be investigated in more detail. Large RCTs currently underway in the USA may be able to provide answers to these uncertainties by the year 2010. In the meantime, based on the available evidence, ERT or HRT cannot be recommended for overall cognitive improvement or maintenance in older postmenopausal women without cognitive impairment. Output:
Animal studies (performed both in the laboratory and on living animals) suggest that estrogen alone might protect the brain as women get older. After the menopause, levels of estrogens decline in women and estrogen therapy has been claimed to maintain or enhance cognitive function in postmenopausal women. This review found no evidence of a benefit of any types of estrogen on overall cognitive functioning in older postmenopausal women when given either as short term or longer term (up to five years) therapy. There was also no evidence of a beneficial effect of combined estrogen and progestagen therapy overall. There was insufficient evidence to determine whether any type of hormone replacement therapy had beneficial or harmful effects on specific types of cognitive ability, such as verbal or visual memory.
CochranePLS155
***TASK*** the task is to simplify the input abstract of a biomedical literature ***INPUT*** the input is the abstract of a biomedical literature ***OUTPUT*** the output is the simplified abstract for the input abstract of a biomedical literature ***EXAMPLES*** Input: Output: ***EXAMPLES*** Input: Two trials (n = 190), at low risk of bias, were included in the review and both presented data on first time failure at the tooth level. Pooling of the data showed a statistically significant difference in favour of molar bands, with a hazard ratio of 2.92 (95% confidence intervals (CI) 1.80 to 4.72). No statistically significant heterogeneity was shown between the two studies. Data on first time failure at the patient level were also available and showed statistically different difference in favour of molar bands (risk ratio 2.30; 95% CI 1.56 to 3.41) (risk of event for molar tubes = 57%; risk of event for molar bands 25%). One trial presented data on decalcification again showing a statistically significant difference in favour of molar bands. No other adverse events identified. From the two well-designed and low risk of bias trials included in this review it was shown that the failure of molar tubes bonded with either a chemically-cured or light-cured adhesive was considerably higher than that of molar bands cemented with glass ionomer cement. One trial indicated that there was less decalcification with molar bands cemented with glass ionomer cement than with bonded molar tubes cemented with a light-cured adhesive. However, given there are limited data for this outcome, further evidence is required to draw more robust conclusions. Output: The evidence in this review, which was carried out together with Cochrane Oral Health, is up-to-date as of 15 February 2017. We included two studies that evaluated 190 participants. Both trials were conducted in the UK and both compared bonded molar tubes with molar bands. From the limited data of two studies at low risk of bias, it would appear that bonded molar tubes are associated with a higher failure rate than with molar bands. Input: We included two studies with 880 participants. We identified one ongoing trial with planned recruitment of 80 participants. Included studies enrolled participants with both partially reversible and non-reversible COPD and baseline mean per cent predicted (%pred) forced expiratory volume in one second (FEV₁) of 43.4 to 49.6. Both studies lasted 12 weeks. Both studies used the same combination of inhaled ICS/LABA (fluticasone furoate and vilanterol 100/25 mcg once daily; FF/VI) versus LAMA (18 mcg tiotropium; TIO). They were published as full articles, and neither study was at low risk of bias in all domains. Compared to the TIO arm, results for pooled primary outcomes for the FF/VI arm were as follows: mortality: OR 0.20, 95% CI 0.02 to 1.73, 880 participants (deaths reported only in the TIO arm), very low-quality evidence; COPD exacerbation (requiring short-burst oral corticosteroids or antibiotics, or both): OR 0.72, 95% Cl 0.35 to 1.50, 880 participants, very low-quality evidence; pneumonia: reported in both studies only during treatment with FF/VI: OR 6.12, 95% Cl 0.73 to 51.24, 880 participants, very low-quality evidence; and total serious adverse events: OR 0.96, 95% Cl 0.50 to 1.83, 880 participants, very low-quality evidence. None of the pneumonias were fatal. Compared to the TIO arm, we found no statistically significant difference for pooled secondary outcomes, including St George's Respiratory Questionnaire (SGRQ) mean total score change; hospital admissions (all-cause); disease-specific adverse events; mean weekly rescue medication use (results available from only one of the studies); and mean weekly percentage of rescue-free days for FF/VI. We found no statistically significant differences between ICS/LABA and LAMA for improvement in symptoms measured by the COPD Assessment Test (CAT score) nor for FEV₁ (change from baseline trough in 24-hour weighted mean on treatment day 84). Many pooled estimates lacked precision. Data for other endpoints such as exacerbations leading to intubation and physical activity measures were not available in included trials. Based on analysis of primary and secondary outcomes, we are uncertain whether once-daily ICS/LABA, combined in one inhaler, has a different efficacy or adverse effect profile compared to LAMA for treatment of people with COPD. However, the current review is based on only two trials with the main focus on primary outcomes other than those considered in this review. The short follow-up period and the very low quality of evidence limit our confidence in the result and increase uncertainty. Further trials of longer duration are needed. Current evidence is not strong enough to demonstrate important differences between inhalers in terms of effects, nor to establish that once-daily fluticasone/vilanterol 100/25 mcg and tiotropium 18 mcg are equivalent. Output:
We found two studies involving 880 participants that compared the benefits and harms of once-daily inhaled ICS/LABA combined in one inhaler versus inhaled LAMA for treatment of adults with COPD. These studies lasted 12 weeks. Participants were men and women aged 40 or older who had COPD with various degrees of severity. No consistent differences were found between the two different types of inhalers included in this review. Researchers reported no major differences in death rate, numbers of COPD exacerbations, lung inflammation, or other serious unwanted events. People receiving both inhalers showed similar improvements in quality of life, symptoms, and lung function tests. Overall, we assessed the evidence presented in this review to be of very low quality, which means we have very little confidence in the findings. The main reasons for such judgement include the small number of identified studies and the fact that these studies were not focused on the outcomes of interest for this review. Also, both studies had a short observation time, which means that most of the undesired events may have occurred after the observation period was over. From this review, we did not find evidence strong enough to demonstrate major differences between inhalers or to establish that these inhalers have the same effect.
CochranePLS156
***TASK*** the task is to simplify the input abstract of a biomedical literature ***INPUT*** the input is the abstract of a biomedical literature ***OUTPUT*** the output is the simplified abstract for the input abstract of a biomedical literature ***EXAMPLES*** Input: Output: ***EXAMPLES*** Input: Two trials (n = 190), at low risk of bias, were included in the review and both presented data on first time failure at the tooth level. Pooling of the data showed a statistically significant difference in favour of molar bands, with a hazard ratio of 2.92 (95% confidence intervals (CI) 1.80 to 4.72). No statistically significant heterogeneity was shown between the two studies. Data on first time failure at the patient level were also available and showed statistically different difference in favour of molar bands (risk ratio 2.30; 95% CI 1.56 to 3.41) (risk of event for molar tubes = 57%; risk of event for molar bands 25%). One trial presented data on decalcification again showing a statistically significant difference in favour of molar bands. No other adverse events identified. From the two well-designed and low risk of bias trials included in this review it was shown that the failure of molar tubes bonded with either a chemically-cured or light-cured adhesive was considerably higher than that of molar bands cemented with glass ionomer cement. One trial indicated that there was less decalcification with molar bands cemented with glass ionomer cement than with bonded molar tubes cemented with a light-cured adhesive. However, given there are limited data for this outcome, further evidence is required to draw more robust conclusions. Output: The evidence in this review, which was carried out together with Cochrane Oral Health, is up-to-date as of 15 February 2017. We included two studies that evaluated 190 participants. Both trials were conducted in the UK and both compared bonded molar tubes with molar bands. From the limited data of two studies at low risk of bias, it would appear that bonded molar tubes are associated with a higher failure rate than with molar bands. Input: Two pharmacotherapy and three psychotherapy trials were eligible for inclusion in the review, with data from four short-term RCTs (169 participants) available for analysis. Response data from a single placebo-controlled trial of fluoxetine suggested overall superiority of medication relative to placebo (relative risk (RR) 3.07, 95% CI 1.4 to 6.72, n = 67). Symptom severity was also significantly reduced in the RCTs of fluoxetine and clomipramine (relative to desipramine), as well as in the two CBT trials (WMD -44.96, 95% CI -54.43 to -35.49, n = 73). A low relapse rate (4/22) was demonstrated in one trial of CBT. Results from the small number of available RCTs suggest that SRIs and CBT may be useful in treating patients with BDD. The findings of these studies need to be replicated. In addition, future controlled studies in other samples, such as adolescents, and using other selective SRIs, as well as a range of psychological therapy approaches and modalities (alone and in combination), are essential in supplementing the sparse data currently available. Output:
Our systematic review of randomised controlled trials assesses the effects of drug treatment or psychotherapy when used on their own or in combination. We found five eligible trials, including three of psychotherapy (cognitive behavioural therapy (CBT) and exposure and response prevention (ERP)) and two of medication (the serotonin reuptake inhibitors (SRIs) fluoxetine and clomipramine). In the only placebo-controlled medication trial included in our review, people with BDD treated with fluoxetine were more likely to respond (56%, 19 out of 34) than those allocated placebo (18%, 6 out of 33). Symptoms became less severe after treatment with both medication and psychotherapy. Adverse events were mild to moderate in severity and none of the people in the active treatment groups were reported to have dropped out of the studies because of treatment-emergent adverse events. There is preliminary evidence from one trial of CBT that the effects of CBT may persist once treatment has ended. Treatment response in the medication trials was not effected by the degree to which people had insight into their condition. Although few controlled trials have been done, and those that have been conducted were small, indicating that our findings should be used with caution unless confirmed by larger studies (some of which are ongoing), the results suggest that treatment with both medication or psychotherapy can be effective in treating the symptoms of body dysmorphic disorder.
CochranePLS157
***TASK*** the task is to simplify the input abstract of a biomedical literature ***INPUT*** the input is the abstract of a biomedical literature ***OUTPUT*** the output is the simplified abstract for the input abstract of a biomedical literature ***EXAMPLES*** Input: Output: ***EXAMPLES*** Input: Two trials (n = 190), at low risk of bias, were included in the review and both presented data on first time failure at the tooth level. Pooling of the data showed a statistically significant difference in favour of molar bands, with a hazard ratio of 2.92 (95% confidence intervals (CI) 1.80 to 4.72). No statistically significant heterogeneity was shown between the two studies. Data on first time failure at the patient level were also available and showed statistically different difference in favour of molar bands (risk ratio 2.30; 95% CI 1.56 to 3.41) (risk of event for molar tubes = 57%; risk of event for molar bands 25%). One trial presented data on decalcification again showing a statistically significant difference in favour of molar bands. No other adverse events identified. From the two well-designed and low risk of bias trials included in this review it was shown that the failure of molar tubes bonded with either a chemically-cured or light-cured adhesive was considerably higher than that of molar bands cemented with glass ionomer cement. One trial indicated that there was less decalcification with molar bands cemented with glass ionomer cement than with bonded molar tubes cemented with a light-cured adhesive. However, given there are limited data for this outcome, further evidence is required to draw more robust conclusions. Output: The evidence in this review, which was carried out together with Cochrane Oral Health, is up-to-date as of 15 February 2017. We included two studies that evaluated 190 participants. Both trials were conducted in the UK and both compared bonded molar tubes with molar bands. From the limited data of two studies at low risk of bias, it would appear that bonded molar tubes are associated with a higher failure rate than with molar bands. Input: Three trials that examined cotrimoxazole prophylaxis and involving 268 adults were included. Meta-analysis of these studies found a beneficial effect of using a desensitization protocol over a rechallenge protocol at six months of follow-up for preventing discontinuation of cotrimoxazole (number needed to treat (NNT) 7.14, 95% confidence interval (CI) 4.0-33.0), and for lower incidence of overall hypersensitivity (NNT 4.55, 95% CI 3.03-9.09). No severe hypersensitivity reactions occurred for either protocol in the three studies. In the small trials included in this review, when compared to cotrimoxazole rechallenge for prophylaxis of opportunistic infections, cotrimoxazole desensitization resulted in fewer treatment discontinuations and overall adverse reactions in HIV-infected patients with a previous history of mild or moderate hypersensitivity to cotrimoxazole. Paediatric data and trials in resource-poor settings are urgently required. Further randomised controlled trials are also needed for the treatment of opportunistic infections, treating-through, adjunctive medications, and different desensitization-dosing schedules. Output:
Three trials examining the use of cotrimoxazole in preventing opportunistic infections were included in the review. When compared to rechallenge, desensitization appeared to result in fewer treatment stoppages and side effects in HIV-infected adult patients who had a previous mild or moderate reaction to cotrimoxazole. However, more data are needed for these results to be conclusive. It is important to note that reintroduction of cotrimoxazole was usually successful using either desensitization or rechallenge, with 44.4% to 79.4% of patients still on cotrimoxazole after six months in the three studies. Furthermore, in the studies reviewed, no strategy resulted in severe hypersensitivity reactions. Severe limitations of this review included the absence of data in paediatric populations and the minimal data from resource-poor populations.
CochranePLS158
***TASK*** the task is to simplify the input abstract of a biomedical literature ***INPUT*** the input is the abstract of a biomedical literature ***OUTPUT*** the output is the simplified abstract for the input abstract of a biomedical literature ***EXAMPLES*** Input: Output: ***EXAMPLES*** Input: Two trials (n = 190), at low risk of bias, were included in the review and both presented data on first time failure at the tooth level. Pooling of the data showed a statistically significant difference in favour of molar bands, with a hazard ratio of 2.92 (95% confidence intervals (CI) 1.80 to 4.72). No statistically significant heterogeneity was shown between the two studies. Data on first time failure at the patient level were also available and showed statistically different difference in favour of molar bands (risk ratio 2.30; 95% CI 1.56 to 3.41) (risk of event for molar tubes = 57%; risk of event for molar bands 25%). One trial presented data on decalcification again showing a statistically significant difference in favour of molar bands. No other adverse events identified. From the two well-designed and low risk of bias trials included in this review it was shown that the failure of molar tubes bonded with either a chemically-cured or light-cured adhesive was considerably higher than that of molar bands cemented with glass ionomer cement. One trial indicated that there was less decalcification with molar bands cemented with glass ionomer cement than with bonded molar tubes cemented with a light-cured adhesive. However, given there are limited data for this outcome, further evidence is required to draw more robust conclusions. Output: The evidence in this review, which was carried out together with Cochrane Oral Health, is up-to-date as of 15 February 2017. We included two studies that evaluated 190 participants. Both trials were conducted in the UK and both compared bonded molar tubes with molar bands. From the limited data of two studies at low risk of bias, it would appear that bonded molar tubes are associated with a higher failure rate than with molar bands. Input: We included in the review three trials enrolling 148 neonates. We identified no new trials for this update. Using different sedation scales, each study showed a statistically significantly higher sedation level in the midazolam group compared with the placebo group. However, none of the sedation scales used have been validated in preterm infants; therefore, we could not ascertain the effectiveness of midazolam in this population. Duration of NICU stay was significantly longer in the midazolam group than in the placebo group (WMD 5.4 days, 95% CI 0.40 to 10.5; I2 = 0%; two studies, 89 infants). One study (43 infants) reported significantly lower Premature Infant Pain Profile (PIPP) scores during midazolam infusion than during dextrose (placebo) infusion (MD -3.80, 95% CI -5.93 to -1.67). Another study (46 infants) observed a higher incidence of adverse neurological events at 28 days' postnatal age (death, grade III or IV IVH or PVL) in the midazolam group compared with the morphine group (RR 7.64, 95% CI 1.02 to 57.21; RD 0.28, 95% CI 0.07 to 0.49; NNTH 4, 95% CI 2 to 14) (tests for heterogeneity not applicable). We considered these trials to be of moderate quality according to GRADE assessment based on the following outcomes: mortality during hospital stay, length of NICU stay, adequacy of analgesia according to PIPP scores and poor neurological outcomes by 28 days' postnatal age. Data are insufficient to promote the use of intravenous midazolam infusion as a sedative for neonates undergoing intensive care. This review raises concerns about the safety of midazolam in neonates. Further research on the effectiveness and safety of midazolam in neonates is needed. Output:
We have selected for inclusion in this review randomised controlled trials of continuous intravenous drip of midazolam as a sedative in babies aged 28 days or younger. We included three clinical trials in this review. Using different scales to measure level of sedation, each study showed that midazolam was effective in providing sedation to babies. However, the validity of the sedation scales used in these studies has not been proven in babies; therefore, we cannot be certain that midazolam is, in fact, an effective sedative for babies. Moreover, one study showed that babies who received midazolam had a significantly higher risk of death or brain injury, and combined results of two studies showed that midazolam use may prolong length of stay in the NICU. One of the studies included in this review received support from industry, and for the other two studies, industry provided all study drugs. We assessed the quality of the evidence on the outcomes of mortality during hospital stay, length of stay in the NICU, pain, and neurological outcomes at 28 days of life and found the evidence to be of moderate quality, as there was not enough evidence available. Therefore, we conclude there is not enough evidence to support the use of midazolam as a sedative for babies undergoing intensive care. Additional research is needed to address the safety and effectiveness of midazolam in this population.
CochranePLS159
***TASK*** the task is to simplify the input abstract of a biomedical literature ***INPUT*** the input is the abstract of a biomedical literature ***OUTPUT*** the output is the simplified abstract for the input abstract of a biomedical literature ***EXAMPLES*** Input: Output: ***EXAMPLES*** Input: Two trials (n = 190), at low risk of bias, were included in the review and both presented data on first time failure at the tooth level. Pooling of the data showed a statistically significant difference in favour of molar bands, with a hazard ratio of 2.92 (95% confidence intervals (CI) 1.80 to 4.72). No statistically significant heterogeneity was shown between the two studies. Data on first time failure at the patient level were also available and showed statistically different difference in favour of molar bands (risk ratio 2.30; 95% CI 1.56 to 3.41) (risk of event for molar tubes = 57%; risk of event for molar bands 25%). One trial presented data on decalcification again showing a statistically significant difference in favour of molar bands. No other adverse events identified. From the two well-designed and low risk of bias trials included in this review it was shown that the failure of molar tubes bonded with either a chemically-cured or light-cured adhesive was considerably higher than that of molar bands cemented with glass ionomer cement. One trial indicated that there was less decalcification with molar bands cemented with glass ionomer cement than with bonded molar tubes cemented with a light-cured adhesive. However, given there are limited data for this outcome, further evidence is required to draw more robust conclusions. Output: The evidence in this review, which was carried out together with Cochrane Oral Health, is up-to-date as of 15 February 2017. We included two studies that evaluated 190 participants. Both trials were conducted in the UK and both compared bonded molar tubes with molar bands. From the limited data of two studies at low risk of bias, it would appear that bonded molar tubes are associated with a higher failure rate than with molar bands. Input: Twelve trials involving 767 participants were included. No differences were detected between the antibiotic and placebo/no treatment arms for people with diarrhoea at two to four days after treatment (risk ratio (RR) 1.75, 95% confidence interval (CI) 0.42 to 7.21; one trial, 46 participants; very low quality evidence). No difference was detected for the presence of diarrhoea at five to seven days after treatment (RR 0.83, 95% CI 0.62 to 1.12; two trials, 192 participants; very low quality evidence), clinical failure (RR 0.88, 95% CI 0.62 to 1.25; seven trials, 440 participants; very low quality evidence). The mean difference for diarrhoea was 0 days (95% CI -0.54 to 0.54; 202 participants, four studies; low quality evidence);for fever was 0.27 days (95% CI -0.11 to 0.65; 107 participants, two studies; very low quality evidence); and for duration of illness was 0 days (95% CI -0.68 to 0.68; 116 participants, two studies; very low quality evidence). Quinolone antibiotic treatment resulted in a significantly higher number of negative stool cultures for NTS during the first week of treatment (microbiological failure: RR 0.33, 95% CI 0.20 to 0.56; 166 participants, four trials). Antibiotic treatment meant passage of the same Salmonella serovar one month after treatment was almost twice as likely (RR 1.96, 95% CI 1.29 to 2.98; 112 participants, three trials), which was statistically significant. Non-severe adverse drug reactions were more common among the patients who received antibiotic treatment. There is no evidence of benefit for antibiotics in NTS diarrhoea in otherwise healthy people. We are uncertain of the effects in very young people, very old people, and in people with severe and extraintestinal disease. A slightly higher number of adverse events were noted in people who received antibiotic treatment for NTS. Output:
In this review, we investigated the benefits and safety of antibiotics for treatment of NTS versus placebo or no antibiotic treatment. We found that in otherwise healthy people, treatment with antibiotics did not have any benefit over treatment with no antibiotics. Furthermore, treatment with antibiotics made it more likely that patients would continue to excrete the same organisms for up to one month after treatment. We are unable to comment on the use of antibiotics in very young people, very old people and people who are unable to fight off infection because the trials we identified did not include these patients.
CochranePLS160
***TASK*** the task is to simplify the input abstract of a biomedical literature ***INPUT*** the input is the abstract of a biomedical literature ***OUTPUT*** the output is the simplified abstract for the input abstract of a biomedical literature ***EXAMPLES*** Input: Output: ***EXAMPLES*** Input: Two trials (n = 190), at low risk of bias, were included in the review and both presented data on first time failure at the tooth level. Pooling of the data showed a statistically significant difference in favour of molar bands, with a hazard ratio of 2.92 (95% confidence intervals (CI) 1.80 to 4.72). No statistically significant heterogeneity was shown between the two studies. Data on first time failure at the patient level were also available and showed statistically different difference in favour of molar bands (risk ratio 2.30; 95% CI 1.56 to 3.41) (risk of event for molar tubes = 57%; risk of event for molar bands 25%). One trial presented data on decalcification again showing a statistically significant difference in favour of molar bands. No other adverse events identified. From the two well-designed and low risk of bias trials included in this review it was shown that the failure of molar tubes bonded with either a chemically-cured or light-cured adhesive was considerably higher than that of molar bands cemented with glass ionomer cement. One trial indicated that there was less decalcification with molar bands cemented with glass ionomer cement than with bonded molar tubes cemented with a light-cured adhesive. However, given there are limited data for this outcome, further evidence is required to draw more robust conclusions. Output: The evidence in this review, which was carried out together with Cochrane Oral Health, is up-to-date as of 15 February 2017. We included two studies that evaluated 190 participants. Both trials were conducted in the UK and both compared bonded molar tubes with molar bands. From the limited data of two studies at low risk of bias, it would appear that bonded molar tubes are associated with a higher failure rate than with molar bands. Input: We included 23 studies (n = 4192) assessing the accuracy of IL-6 for the diagnosis of sepsis in critically ill adults. Twenty studies that were available as conference proceedings only are awaiting classification. The included participants were heterogeneous in terms of their distribution of age, gender, main diagnosis, setting, country, positivity threshold, sepsis criteria, year of publication, and origin of infection, among other factors. Prevalence of sepsis greatly varied across studies, ranging from 12% to 78%. We considered all studies to be at high risk of bias due to issues related to the index test domain in QUADAS-2. The SROC curve showed a great dispersion in individual studies accuracy estimates (21 studies, 3650 adult patients), therefore the considerable heterogeneity in the collected data prevented us from calculating formal accuracy estimates. Using a fixed prevalence of sepsis of 50% and a fixed specificity of 74%, we found a sensitivity of 66% (95% confidence interval 60 to 72). If we test a cohort 1000 adult patients under suspicion of sepsis with IL-6, we will find that 330 patients would receive appropriate and timely antibiotic therapy, while 130 patients would be wrongly considered to have sepsis. In addition, 370 out of 1000 patients would avoid unnecessary antibiotic therapy, and 170 patients would have been undiagnosed of sepsis. This numerical approach should be interpreted with caution due to the limitations described above. Our evidence assessment of plasma interleukin-6 concentrations for the diagnosis of sepsis in critically ill adults reveals several limitations. High heterogeneity of collected evidence regarding the main diagnosis, setting, country, positivity threshold, sepsis criteria, year of publication, and the origin of infection, among other factors, along with the potential number of misclassifications, remain significant constraints for its implementation. The 20 conference proceedings assessed as studies awaiting classification may alter the conclusions of the review once they are fully published and evaluated. Further studies about the accuracy of interleukin-6 for the diagnosis of sepsis in adults that apply rigorous methodology for conducting diagnostic test accuracy studies are needed. The conclusions of the review will likely change once the 20 studies pending publication are fully published and included. Output:
We performed a thorough literature search for studies reporting the use of IL-6 levels for detection of sepsis up to January 2019. We found 23 studies enrolling 4192 severely ill adults. Our assessment of the evidence reveals the complexity of the research topic, represented in the high variability of information reported by the studies. We found the characteristics of assessed patients to vary considerably between studies in terms of age, gender, setting, initial diagnosis, indicative value for sepsis, and source of infection, among other factors. This variability in the collected data prevented a formal numerical synthesis of the findings. Using the available data to perform an approximated estimation of the consequences, we found that 700 out of 1000 patients under suspicion of sepsis might be correctly classified, but 130 out of 1000 patients would be wrongly considered as having sepsis, while 170 out of 1000 patients might be incorrectly considered as not having sepsis. These errors would result in a serious increase in the risk of further morbidity and death due to delays of adequate treatment. This information should be interpreted with caution due to limitations in the collected data. We judged the included studies to have important limitations in their validity, hence they are at high risk of providing distorted results (i.e. to be at high risk of bias).
CochranePLS161
***TASK*** the task is to simplify the input abstract of a biomedical literature ***INPUT*** the input is the abstract of a biomedical literature ***OUTPUT*** the output is the simplified abstract for the input abstract of a biomedical literature ***EXAMPLES*** Input: Output: ***EXAMPLES*** Input: Two trials (n = 190), at low risk of bias, were included in the review and both presented data on first time failure at the tooth level. Pooling of the data showed a statistically significant difference in favour of molar bands, with a hazard ratio of 2.92 (95% confidence intervals (CI) 1.80 to 4.72). No statistically significant heterogeneity was shown between the two studies. Data on first time failure at the patient level were also available and showed statistically different difference in favour of molar bands (risk ratio 2.30; 95% CI 1.56 to 3.41) (risk of event for molar tubes = 57%; risk of event for molar bands 25%). One trial presented data on decalcification again showing a statistically significant difference in favour of molar bands. No other adverse events identified. From the two well-designed and low risk of bias trials included in this review it was shown that the failure of molar tubes bonded with either a chemically-cured or light-cured adhesive was considerably higher than that of molar bands cemented with glass ionomer cement. One trial indicated that there was less decalcification with molar bands cemented with glass ionomer cement than with bonded molar tubes cemented with a light-cured adhesive. However, given there are limited data for this outcome, further evidence is required to draw more robust conclusions. Output: The evidence in this review, which was carried out together with Cochrane Oral Health, is up-to-date as of 15 February 2017. We included two studies that evaluated 190 participants. Both trials were conducted in the UK and both compared bonded molar tubes with molar bands. From the limited data of two studies at low risk of bias, it would appear that bonded molar tubes are associated with a higher failure rate than with molar bands. Input: We included 29 trials (5718 participants). All studies except one were at an unclear or high risk of bias. Studies were small, reported low numbers of SSI events and were often not clearly reported. There were 16 trials that included people with wounds resulting from surgical procedures with a 'clean' classification, five trials that included people undergoing what was considered 'clean/contaminated' surgery, with the remaining studies including people undergoing a variety of surgical procedures with different contamination classifications. Four trials compared wound dressings with no wound dressing (wound exposure); the remaining 25 studies compared alternative dressing types, with the majority comparing a basic wound contact dressing with film dressings, silver dressings or hydrocolloid dressings. The review contains 11 comparisons in total. Primary outcome: SSI It is uncertain whether wound exposure or any dressing reduces or increases the risk of SSI compared with alternative options investigated: we assessed the certainty of evidence as very low for most comparisons (and low for others), with downgrading (according to GRADE criteria) largely due to risk of bias and imprecision. We summarise the results of comparisons with meta-analysed data below: - film dressings compared with basic wound contact dressings following clean surgery (RR 1.34, 95% CI 0.70 to 2.55), very low certainty evidence downgraded once for risk of bias and twice for imprecision. - hydrocolloid dressings compared with basic wound contact dressings following clean surgery (RR 0.91, 95% CI 0.30 to 2.78), very low certainty evidence downgraded once for risk of bias and twice for imprecision. - hydrocolloid dressings compared with basic wound contact dressings following potentially contaminated surgery (RR 0.57, 95% CI 0.22 to 1.51), very low certainty evidence downgraded twice for risk of bias and twice for imprecision. - silver-containing dressings compared with basic wound contact dressings following clean surgery (RR 1.11, 95% CI 0.47 to 2.62), very low certainty evidence downgraded once for risk of bias and twice for imprecision. - silver-containing dressings compared with basic wound contact dressings following potentially contaminated surgery (RR 0.83, 95% CI 0.51 to 1.37), very low certainty evidence downgraded twice for risk of bias and twice for imprecision. Secondary outcomes There was limited and low or very low certainty evidence on secondary outcomes such as scarring, acceptability of dressing and ease of removal, and uncertainty whether wound dressings influenced these outcomes. It is uncertain whether covering surgical wounds healing by primary intention with wound dressings reduces the risk of SSI, or whether any particular wound dressing is more effective than others in reducing the risk of SSI, improving scarring, reducing pain, improving acceptability to patients, or is easier to remove. Most studies in this review were small and at a high or unclear risk of bias. Based on the current evidence, decision makers may wish to base decisions about how to dress a wound following surgery on dressing costs as well as patient preference. Output:
We conducted a review of all available, relevant evidence about the impact of dressings on the prevention of surgical site infections in surgical wounds healing by primary intention. This review examined data from 29 randomised controlled trials (which provide the most reliable evidence). These investigated the use of dressings in surgery that had a low risk of surgical site infection (clean surgery) and surgery with a higher risk (potentially contaminated surgery). We found no clear evidence to suggest that one dressing type was better than any other at reducing the risk of surgical site infection, nor that covering wounds with any dressing at all reduced the risk of surgical site infection. Additionally, there was no clear evidence that any dressing type improves scarring, pain control, patient acceptability or ease of removal. Currently decision makers may opt to make decisions about whether and how to dress a wound based on patient and clinician preferences and dressing costs. It is important to note that many trials in this review were small and the evidence was of low or very low certainty meaning that current information is uncertain. Assessed as up to date September 2016.
CochranePLS162
***TASK*** the task is to simplify the input abstract of a biomedical literature ***INPUT*** the input is the abstract of a biomedical literature ***OUTPUT*** the output is the simplified abstract for the input abstract of a biomedical literature ***EXAMPLES*** Input: Output: ***EXAMPLES*** Input: Two trials (n = 190), at low risk of bias, were included in the review and both presented data on first time failure at the tooth level. Pooling of the data showed a statistically significant difference in favour of molar bands, with a hazard ratio of 2.92 (95% confidence intervals (CI) 1.80 to 4.72). No statistically significant heterogeneity was shown between the two studies. Data on first time failure at the patient level were also available and showed statistically different difference in favour of molar bands (risk ratio 2.30; 95% CI 1.56 to 3.41) (risk of event for molar tubes = 57%; risk of event for molar bands 25%). One trial presented data on decalcification again showing a statistically significant difference in favour of molar bands. No other adverse events identified. From the two well-designed and low risk of bias trials included in this review it was shown that the failure of molar tubes bonded with either a chemically-cured or light-cured adhesive was considerably higher than that of molar bands cemented with glass ionomer cement. One trial indicated that there was less decalcification with molar bands cemented with glass ionomer cement than with bonded molar tubes cemented with a light-cured adhesive. However, given there are limited data for this outcome, further evidence is required to draw more robust conclusions. Output: The evidence in this review, which was carried out together with Cochrane Oral Health, is up-to-date as of 15 February 2017. We included two studies that evaluated 190 participants. Both trials were conducted in the UK and both compared bonded molar tubes with molar bands. From the limited data of two studies at low risk of bias, it would appear that bonded molar tubes are associated with a higher failure rate than with molar bands. Input: We included two randomised controlled trials. One trial compared oral 100 microgram (µg) selenium yeast tablets with placebo, taken from the first trimester until birth. The trial randomised 179 women but outcome data were only provided for 85 women. Eighty-three women were randomised to each arm of the trial. Sixty-one women completed the selenium arm, 44 of whom completed an Edinburgh Postnatal Depression Scale (EPDS). In the placebo arm, 64 women completed the trial, 41 of whom completed an EPDS. This included study (n = 85) found selenium had an effect on EPDS scores but did not reach statistical significance (P = 0.07). There was a mean difference (MD) of -1.90 (95% confidence interval (CI) -3.92 to 0.12) of the self-reported EPDS completed by participants within eight weeks of delivery. There was a high risk of attrition bias due to a large proportion of women withdrawing from the study or not completing an EPDS. This included study did not report on any of the secondary outcomes of this review. The other trial compared docosahexanoic acid (DHA) and eicosapentaenoic acid (EPA) with placebo. The trial randomised 126 women at risk of postpartum depression to three arms: 42 were allocated to EPA, 42 to DHA, and 42 to placebo. Three women in the EPA arm, four in the DHA arm, and one woman in the placebo arm were lost to follow-up. Women who were found to have major depressive disorder, bipolar disorder, current substance abuse or dependence, suicidal ideation or schizophrenia at recruitment were excluded from the study. The women who discontinued the intervention (five in the EPA arm, four in the DHA arm and seven in the placebo arm) were included in the intention-to-treat analysis, while those who were lost to follow-up were not. Women received supplements or placebo from recruitment at a gestational age of 12 to 20 weeks until their final review visit six to eight weeks postpartum. The primary outcome measure was the Beck Depression Inventory (BDI) score at the fifth visit (six to eight weeks postpartum). No benefit was found for EPA-rich fish oil (MD 0.70, 95% CI -1.78 to 3.18) or DHA-rich fish oil supplementation (MD 0.90, 95% CI -1.33 to 3.13) in preventing postpartum depression. No difference was found in the effect on postnatal depression comparing EPA with DHA (MD -0.20, 95% CI -2.61 to 2.21). No benefit or significant effect was found in terms of the secondary outcomes of the presence of major depressive disorder at six to eight weeks postpartum, the number of women who commenced antidepressants, maternal estimated blood loss at delivery or admission of neonates to the neonatal intensive care unit. There is insufficient evidence to conclude that selenium, DHA or EPA prevent postnatal depression. There is currently no evidence to recommend any other dietary supplement for prevention of postnatal depression. Output:
This review identified two randomised controlled studies. One study examined the effect of selenium supplements taken by women from the first trimester to birth in preventing postnatal depression. This study had a high risk of bias because of women withdrawing or not completing their self-scoring system for depression (Edinburgh Postnatal Depression Scale). It may also have been difficult to ensure that the women took their supplements because of concerns that exist about taking supplements during pregnancy. More high-quality studies would be required to confirm any benefit in preventing postnatal depression using selenium. This review also identified one randomised controlled study that compared docosahexanoic and eicosapentaenoic acid to placebo in women at risk of postpartum depression. This study found that neither docosahexanoic acid nor eicosapentaenoic acid prevented postpartum depression. Overall, there is not enough evidence at this stage to recommend selenium, docosahexanoic acid, eicosapentaenoic acid or any other dietary supplement for the prevention of postnatal depression. Unfortunately there were no other studies of other dietary supplements that met our selection criteria. Other dietary supplements need to be studied in trials where depressed women are excluded from entry to determine if supplements prevent postnatal depression.
CochranePLS163
***TASK*** the task is to simplify the input abstract of a biomedical literature ***INPUT*** the input is the abstract of a biomedical literature ***OUTPUT*** the output is the simplified abstract for the input abstract of a biomedical literature ***EXAMPLES*** Input: Output: ***EXAMPLES*** Input: Two trials (n = 190), at low risk of bias, were included in the review and both presented data on first time failure at the tooth level. Pooling of the data showed a statistically significant difference in favour of molar bands, with a hazard ratio of 2.92 (95% confidence intervals (CI) 1.80 to 4.72). No statistically significant heterogeneity was shown between the two studies. Data on first time failure at the patient level were also available and showed statistically different difference in favour of molar bands (risk ratio 2.30; 95% CI 1.56 to 3.41) (risk of event for molar tubes = 57%; risk of event for molar bands 25%). One trial presented data on decalcification again showing a statistically significant difference in favour of molar bands. No other adverse events identified. From the two well-designed and low risk of bias trials included in this review it was shown that the failure of molar tubes bonded with either a chemically-cured or light-cured adhesive was considerably higher than that of molar bands cemented with glass ionomer cement. One trial indicated that there was less decalcification with molar bands cemented with glass ionomer cement than with bonded molar tubes cemented with a light-cured adhesive. However, given there are limited data for this outcome, further evidence is required to draw more robust conclusions. Output: The evidence in this review, which was carried out together with Cochrane Oral Health, is up-to-date as of 15 February 2017. We included two studies that evaluated 190 participants. Both trials were conducted in the UK and both compared bonded molar tubes with molar bands. From the limited data of two studies at low risk of bias, it would appear that bonded molar tubes are associated with a higher failure rate than with molar bands. Input: We identified 11 studies: 7 evaluated different infusion durations (803 participants), and 4 evaluated different peak doses (5280 participants). Seven studies were RCTs addressing different anthracycline infusion durations; we identified long-term follow-up data for one of the trials in this update. The meta-analysis showed a statistically significant lower rate of clinical heart failure with an infusion duration of six hours or longer as compared to a shorter infusion duration (risk ratio (RR) 0.27; 95% confidence interval 0.09 to 0.81; 5 studies; 557 participants). The majority of participants included in these studies were adults with different solid tumours. For different anthracycline peak doses, we identified two RCTs addressing a doxorubicin peak dose of less than 60 mg/m2 versus 60 mg/m2 or more, one RCT addressing a liposomal doxorubicin peak dose of 25 mg/m2 versus 50 mg/m2, and one RCT addressing an epirubicin peak dose of 83 mg/m2 versus 110 mg/m2. A significant difference in the occurrence of clinical heart failure was identified in none of the studies. The participants included in these studies were adults with different solid tumours. High or unclear 'Risk of bias' issues were present in all studies. An anthracycline infusion duration of six hours or longer reduces the risk of clinical heart failure, and it seems to reduce the risk of subclinical cardiac damage. Since there is only a small amount of data for children and data obtained in adults cannot be extrapolated to children, different anthracycline infusion durations should be evaluated further in children. We identified no significant difference in the occurrence of clinical heart failure in participants treated with a doxorubicin peak dose of less than 60 mg/m2 or 60 mg/m2 or more. Only one RCT was available for the other identified peak doses, so we can make no definitive conclusions about the occurrence of cardiotoxicity. More high-quality research is needed, both in children and adults and in leukaemias and solid tumours. Output:
The evidence is current to December 2015. We found 11 studies: 7 evaluated different infusion durations (803 participants), and 4 evaluated different peak doses (5280 participants). Participants had different types of cancer. For the use of different anthracycline infusion durations, the authors found that an anthracycline infusion duration of six hours or longer reduces the risk of clinical heart failure (for example shortness of breath or leg oedema), and it seems to reduce the risk of subclinical heart failure (that is heart damage diagnosed for example by an echocardiography in people without symptoms). Only a small amount of data was available for children and individuals with leukaemia, since most studies evaluating different anthracycline infusion durations were performed in adults with solid tumours. Based on the currently available evidence, we are not able to favour either a doxorubicin peak dose of less than 60 mg/m2 or 60 mg/m2 or more. There was not enough high-quality evidence available for the use of other anthracycline peak doses to be able to draw conclusions. No data were available for children and individuals with leukaemia. Further high-quality research is needed. All studies had problems relating to quality of the evidence.
CochranePLS164
***TASK*** the task is to simplify the input abstract of a biomedical literature ***INPUT*** the input is the abstract of a biomedical literature ***OUTPUT*** the output is the simplified abstract for the input abstract of a biomedical literature ***EXAMPLES*** Input: Output: ***EXAMPLES*** Input: Two trials (n = 190), at low risk of bias, were included in the review and both presented data on first time failure at the tooth level. Pooling of the data showed a statistically significant difference in favour of molar bands, with a hazard ratio of 2.92 (95% confidence intervals (CI) 1.80 to 4.72). No statistically significant heterogeneity was shown between the two studies. Data on first time failure at the patient level were also available and showed statistically different difference in favour of molar bands (risk ratio 2.30; 95% CI 1.56 to 3.41) (risk of event for molar tubes = 57%; risk of event for molar bands 25%). One trial presented data on decalcification again showing a statistically significant difference in favour of molar bands. No other adverse events identified. From the two well-designed and low risk of bias trials included in this review it was shown that the failure of molar tubes bonded with either a chemically-cured or light-cured adhesive was considerably higher than that of molar bands cemented with glass ionomer cement. One trial indicated that there was less decalcification with molar bands cemented with glass ionomer cement than with bonded molar tubes cemented with a light-cured adhesive. However, given there are limited data for this outcome, further evidence is required to draw more robust conclusions. Output: The evidence in this review, which was carried out together with Cochrane Oral Health, is up-to-date as of 15 February 2017. We included two studies that evaluated 190 participants. Both trials were conducted in the UK and both compared bonded molar tubes with molar bands. From the limited data of two studies at low risk of bias, it would appear that bonded molar tubes are associated with a higher failure rate than with molar bands. Input: We included 37 eligible trials with a total of 3110 randomised participants; nine of these were new studies since the last update (2009) and five studies had been previously excluded but were re-assessed and included during the 2017 update. We identified two ongoing studies from searches of clinical trials registers and database searches and two studies await classification. Studies included both adults and children with TBI. Most studies commenced treatment immediately on admission to hospital or after craniotomies and all treatment was maintained for at least 24 hours. Thirty-three studies reported data for mortality, 31 studies reported data for unfavourable outcomes (death, vegetative state or severe disability), and 14 studies reported pneumonia. Visual inspection of the results for these outcomes showed inconsistencies among studies, with differences in the direction of effect, and we did not pool these data for meta-analysis. We considered duration of hypothermia therapy and the length of follow-up in collected data for these subgroups; differences in study data remained such that we did not perform meta-analysis. Studies were generally poorly reported and we were unable to assess risk of bias adequately. Heterogeneity was evident both in the trial designs and participant inclusion. Inconsistencies in results may be explained by heterogeneity among study participants or bias introduced by individual study methodology but we did not explore this in detail in subgroup or sensitivity analyses. We used the GRADE approach to judge the quality of the evidence for each outcome and downgraded the evidence for mortality and unfavourable outcome to very low. We downgraded the evidence for the pneumonia outcome to low. Despite a large number studies, there remains no high-quality evidence that hypothermia is beneficial in the treatment of people with TBI. Further research, which is methodologically robust, is required in this field to establish the effect of hypothermia for people with TBI. Output:
We included 37 studies with 3110 participants. In each trial, patients were randomly divided into two groups: one group remained at normal body temperature of 36.5 to 38 °C, and the other group was cooled to a maximum of 35 °C for at least 12 hours. We did not combine results of these studies to assess whether hypothermia improves patient outcome. This was because the results had large differences which we could not explain. We identified some differences in the ways in which the studies were carried out and the participants that study authors had recruited, but we did not assess whether this could explain the differences in results. We did not have enough good quality evidence that was sufficiently similar to be confident that treating people who have had a severe brain injury with hypothermia will reduce the incidence of death or severe disability, or increase the incidence of pneumonia. Many of the studies were not well reported and we were unable to assess whether differences between the quality of the studies may also have affected our results. We used the GRADE approach to judge the quality of evidence. We judged the evidence for death or severe disability to be very low quality, and the evidence for pneumonia to be low quality.
CochranePLS165
***TASK*** the task is to simplify the input abstract of a biomedical literature ***INPUT*** the input is the abstract of a biomedical literature ***OUTPUT*** the output is the simplified abstract for the input abstract of a biomedical literature ***EXAMPLES*** Input: Output: ***EXAMPLES*** Input: Two trials (n = 190), at low risk of bias, were included in the review and both presented data on first time failure at the tooth level. Pooling of the data showed a statistically significant difference in favour of molar bands, with a hazard ratio of 2.92 (95% confidence intervals (CI) 1.80 to 4.72). No statistically significant heterogeneity was shown between the two studies. Data on first time failure at the patient level were also available and showed statistically different difference in favour of molar bands (risk ratio 2.30; 95% CI 1.56 to 3.41) (risk of event for molar tubes = 57%; risk of event for molar bands 25%). One trial presented data on decalcification again showing a statistically significant difference in favour of molar bands. No other adverse events identified. From the two well-designed and low risk of bias trials included in this review it was shown that the failure of molar tubes bonded with either a chemically-cured or light-cured adhesive was considerably higher than that of molar bands cemented with glass ionomer cement. One trial indicated that there was less decalcification with molar bands cemented with glass ionomer cement than with bonded molar tubes cemented with a light-cured adhesive. However, given there are limited data for this outcome, further evidence is required to draw more robust conclusions. Output: The evidence in this review, which was carried out together with Cochrane Oral Health, is up-to-date as of 15 February 2017. We included two studies that evaluated 190 participants. Both trials were conducted in the UK and both compared bonded molar tubes with molar bands. From the limited data of two studies at low risk of bias, it would appear that bonded molar tubes are associated with a higher failure rate than with molar bands. Input: Three high-quality and three low-quality studies, involving 519 people with depression, were identified. The studies were very heterogeneous in terms of interventions, participants, and measuring instruments. Despite fairly good methodological quality and positive findings of some studies, evidence for the effectiveness of family therapy for depression did not exceed level 3 (limited or conflicting evidence), except for moderate evidence (level 2), based on the non-combined findings from three studies, indicating that family therapy is more effective than no treatment or waiting list condition on decreasing depression, and on increasing family functioning. The current evidence base is too heterogeneous and sparse to draw conclusions on the overall effectiveness of family therapy in the treatment of depression. At this point, use of psychological interventions for the treatment of depression for which there is already an evidence-base would seem to be preferable to family therapy. Further high quality trials examining the effectiveness and comparative effectiveness of explicitly defined forms of family therapy are required. Output:
This review looks at whether family therapy is an effective intervention in treating people of any age with depression. Family therapy for depression is widely used, especially in the United Kingdom and the United States. The small number of randomised controlled trials included in the review were very heterogeneous, and therefore difficult to synthesise. Family therapy seems more effective than no treatment or being placed on a waiting list, but it remains unclear how effective this intervention is in comparison to other interventions. Further randomised controlled trials are needed.
CochranePLS166
***TASK*** the task is to simplify the input abstract of a biomedical literature ***INPUT*** the input is the abstract of a biomedical literature ***OUTPUT*** the output is the simplified abstract for the input abstract of a biomedical literature ***EXAMPLES*** Input: Output: ***EXAMPLES*** Input: Two trials (n = 190), at low risk of bias, were included in the review and both presented data on first time failure at the tooth level. Pooling of the data showed a statistically significant difference in favour of molar bands, with a hazard ratio of 2.92 (95% confidence intervals (CI) 1.80 to 4.72). No statistically significant heterogeneity was shown between the two studies. Data on first time failure at the patient level were also available and showed statistically different difference in favour of molar bands (risk ratio 2.30; 95% CI 1.56 to 3.41) (risk of event for molar tubes = 57%; risk of event for molar bands 25%). One trial presented data on decalcification again showing a statistically significant difference in favour of molar bands. No other adverse events identified. From the two well-designed and low risk of bias trials included in this review it was shown that the failure of molar tubes bonded with either a chemically-cured or light-cured adhesive was considerably higher than that of molar bands cemented with glass ionomer cement. One trial indicated that there was less decalcification with molar bands cemented with glass ionomer cement than with bonded molar tubes cemented with a light-cured adhesive. However, given there are limited data for this outcome, further evidence is required to draw more robust conclusions. Output: The evidence in this review, which was carried out together with Cochrane Oral Health, is up-to-date as of 15 February 2017. We included two studies that evaluated 190 participants. Both trials were conducted in the UK and both compared bonded molar tubes with molar bands. From the limited data of two studies at low risk of bias, it would appear that bonded molar tubes are associated with a higher failure rate than with molar bands. Input: Three trials involving a total of 206 participants were included, all patients with vascular dementia. All three included studies were assessed as being at high risk of bias. When analysing these trials together, there was significant beneficial effect of Duxil on the improvement of cognitive function measured by MMSE (WMD 2.04, 95% CI 1.43 to 2.66). No data on behaviour and death at the end of treatment and follow-up were available from the included trials. Two trials failed to show an improvement of functional performance measured by ADL (WMD -1.68; 95% CI -3.70 to 0.35). Of the three included trials, all described the adverse events in detail, there were no statistically significant differences across the trials (OR 4.84, 95%CI 0.55 to 42.67). Behaviour disturbance, quality of life, caregiver burden were not undertaken in the included trials. Due to the low methodological quality of included trials, small number of trials and probable publication bias, this review did not provide sufficient evidence to support the routine use of Duxil for the treatment of patients with dementia. High-quality and large-scale randomised controlled trials are needed to confirm or refute these results. Output:
Duxil is described as having several properties which may be beneficial for dementia. This review looked for randomized trials comparing Duxil with control in patients with dementia. Three trials were identified. Though there was significant beneficial effect of Duxil on the improvement of cognitive function, due to the low methodological quality of included trials, small number of trials and probable publication bias, this review did not provide sufficient evidence to support the routine use of Duxil for the treatment of patients with dementia. More large, high-quality randomized trials are needed.
CochranePLS167
***TASK*** the task is to simplify the input abstract of a biomedical literature ***INPUT*** the input is the abstract of a biomedical literature ***OUTPUT*** the output is the simplified abstract for the input abstract of a biomedical literature ***EXAMPLES*** Input: Output: ***EXAMPLES*** Input: Two trials (n = 190), at low risk of bias, were included in the review and both presented data on first time failure at the tooth level. Pooling of the data showed a statistically significant difference in favour of molar bands, with a hazard ratio of 2.92 (95% confidence intervals (CI) 1.80 to 4.72). No statistically significant heterogeneity was shown between the two studies. Data on first time failure at the patient level were also available and showed statistically different difference in favour of molar bands (risk ratio 2.30; 95% CI 1.56 to 3.41) (risk of event for molar tubes = 57%; risk of event for molar bands 25%). One trial presented data on decalcification again showing a statistically significant difference in favour of molar bands. No other adverse events identified. From the two well-designed and low risk of bias trials included in this review it was shown that the failure of molar tubes bonded with either a chemically-cured or light-cured adhesive was considerably higher than that of molar bands cemented with glass ionomer cement. One trial indicated that there was less decalcification with molar bands cemented with glass ionomer cement than with bonded molar tubes cemented with a light-cured adhesive. However, given there are limited data for this outcome, further evidence is required to draw more robust conclusions. Output: The evidence in this review, which was carried out together with Cochrane Oral Health, is up-to-date as of 15 February 2017. We included two studies that evaluated 190 participants. Both trials were conducted in the UK and both compared bonded molar tubes with molar bands. From the limited data of two studies at low risk of bias, it would appear that bonded molar tubes are associated with a higher failure rate than with molar bands. Input: Seven RCTs including 960 participants were identified. The quality of trials was generally low, with several studies at risk of selection bias, and no studies used blinding during treatment or outcome assessment. There was a high level of statistical variation between the studies, which therefore reduces the reliability of the evidence. The OR for seroma formation was 0.46 (95% confidence interval (CI) 0.23 to 0.91, P = 0.03) in favour of a reduced incidence of seroma in participants with drains inserted. There was no significant difference in infection rates between drainage and no drainage groups (OR = 0.70; 95% CI 0.44 to 1.12, P = 0.14). The mean difference in length of hospital stay, reported in four trials consisting of 600 participants, was 1.47 days greater in the drained population (95% CI 0.67 to 2.28, P = 0.0003). A mean difference of 0.79 fewer postoperative seroma aspirations was found in the drained population (95% CI 1.23 to 0.35 fewer, P = 0.0004) in two trials including 212 participants. No significant difference in volume of seroma aspirations was reported (MD -19.44, 95% CI -59.45 to 20.57, P = 0.34) in three trials including 519 participants. No significant difference in the incidence of lymphoedema was noted (OR 2.31 favouring no drainage, 95% CI 0.47 to 11.37, P = 0.30), with only six instances reported in three trials of 360 participants, nor was any significant difference in the incidence of haematoma observed (OR 1.68, 95% CI 0.33 to 8.51, P = 0.53), with only five instances reported in two trials of 314 participants. There is limited quality evidence that insertion of a drain following axillary lymphadenectomy reduced the odds of developing a seroma and reduced the number of post-operative seroma aspirations. These benefits should be balanced against an increased length of hospital stay in the drained population. Output:
This Cochrane review aims to determine whether drain tube insertion reduces complication rates or is associated with any risks or harms. We analysed seven randomised controlled trials including 960 participants that compared drain insertion with no drainage after axillary lymphadenectomy for the treatment of breast cancer. We found that the chance of getting a seroma if a drain was inserted was less than if no drain was inserted (0.46 times less likely), and that the number of aspirations required (using a needle to drain seroma fluid in the outpatient clinic) was lower (on average, 0.79 fewer per participant). These benefits must be balanced against a longer average hospital stay of 1.47 days in the drained population, although increasingly patients can be discharged with their drain in place, to be removed at a later date. Risk of infection, volume of fluid aspirated and rates of lymphoedema (arm swelling) or haematoma (bruising) did not differ between drained and undrained participants.
CochranePLS168
***TASK*** the task is to simplify the input abstract of a biomedical literature ***INPUT*** the input is the abstract of a biomedical literature ***OUTPUT*** the output is the simplified abstract for the input abstract of a biomedical literature ***EXAMPLES*** Input: Output: ***EXAMPLES*** Input: Two trials (n = 190), at low risk of bias, were included in the review and both presented data on first time failure at the tooth level. Pooling of the data showed a statistically significant difference in favour of molar bands, with a hazard ratio of 2.92 (95% confidence intervals (CI) 1.80 to 4.72). No statistically significant heterogeneity was shown between the two studies. Data on first time failure at the patient level were also available and showed statistically different difference in favour of molar bands (risk ratio 2.30; 95% CI 1.56 to 3.41) (risk of event for molar tubes = 57%; risk of event for molar bands 25%). One trial presented data on decalcification again showing a statistically significant difference in favour of molar bands. No other adverse events identified. From the two well-designed and low risk of bias trials included in this review it was shown that the failure of molar tubes bonded with either a chemically-cured or light-cured adhesive was considerably higher than that of molar bands cemented with glass ionomer cement. One trial indicated that there was less decalcification with molar bands cemented with glass ionomer cement than with bonded molar tubes cemented with a light-cured adhesive. However, given there are limited data for this outcome, further evidence is required to draw more robust conclusions. Output: The evidence in this review, which was carried out together with Cochrane Oral Health, is up-to-date as of 15 February 2017. We included two studies that evaluated 190 participants. Both trials were conducted in the UK and both compared bonded molar tubes with molar bands. From the limited data of two studies at low risk of bias, it would appear that bonded molar tubes are associated with a higher failure rate than with molar bands. Input: Eight studies with 390,769 participants were included. Five studies used a prospective cohort design, two were case-control studies and one a randomised controlled trial (RCT). The methodological quality was measured using the Newcastle-Ottawa scale (NOS). The three prospective cohort studies were of high methodological quality, and two were of medium quality. The two case-control studies were of medium methodological quality. The results form the studies assessing associations between flavonoids, colorectal cancer and adenomas were contradictory. There was no evidence that total flavonoid intake reduced the risk of colorectal neoplasms. The evidence for Isoflavones, Flavonols, Flavones and Flavanones was conflicting. For Flavan-3-ols, the results from two studies suggested that increased intake of Flavan-3-ols reduced the risk of both CRC and colorectal adenomas. A statistically significant reduced risk of CRC was found with high intake of epicatechin. There was medium quality evidence to support that increased intake of procyanidin and phytoestrogen could reduced the incidence of CRC. There was no evidence that suggested that high anthocyanin intake had an inverse association with colorectal adenomas. There is insufficient and conflicting evidence regarding flavonoid intake and the prevention of colorectal neoplasms. It is difficult to determine flavonoid intake. Therefore, more evidence is needed to clarify the association between flavonoids and colorectal neoplasms. Output:
Eight studies with 390,769 participants, mainly observational, were included in this systematic review. The aim of the studies reviewed was to determine an association of the intake of total flavonoids, and eight main flavonoid subclasses, with colorectal neoplasms including CRC and adenomas. The majority of the studies were of medium to high methodological quality. The evidence that intake of dietary flavonoids reduces the risk of colorectal neoplasms was conflicting, and could partly be explained due to difficulties in quantifying the intake of flavonoids. Therefore, the association of dietary flavonoids and prevention of colorectal neoplasms remains unproven.
CochranePLS169
***TASK*** the task is to simplify the input abstract of a biomedical literature ***INPUT*** the input is the abstract of a biomedical literature ***OUTPUT*** the output is the simplified abstract for the input abstract of a biomedical literature ***EXAMPLES*** Input: Output: ***EXAMPLES*** Input: Two trials (n = 190), at low risk of bias, were included in the review and both presented data on first time failure at the tooth level. Pooling of the data showed a statistically significant difference in favour of molar bands, with a hazard ratio of 2.92 (95% confidence intervals (CI) 1.80 to 4.72). No statistically significant heterogeneity was shown between the two studies. Data on first time failure at the patient level were also available and showed statistically different difference in favour of molar bands (risk ratio 2.30; 95% CI 1.56 to 3.41) (risk of event for molar tubes = 57%; risk of event for molar bands 25%). One trial presented data on decalcification again showing a statistically significant difference in favour of molar bands. No other adverse events identified. From the two well-designed and low risk of bias trials included in this review it was shown that the failure of molar tubes bonded with either a chemically-cured or light-cured adhesive was considerably higher than that of molar bands cemented with glass ionomer cement. One trial indicated that there was less decalcification with molar bands cemented with glass ionomer cement than with bonded molar tubes cemented with a light-cured adhesive. However, given there are limited data for this outcome, further evidence is required to draw more robust conclusions. Output: The evidence in this review, which was carried out together with Cochrane Oral Health, is up-to-date as of 15 February 2017. We included two studies that evaluated 190 participants. Both trials were conducted in the UK and both compared bonded molar tubes with molar bands. From the limited data of two studies at low risk of bias, it would appear that bonded molar tubes are associated with a higher failure rate than with molar bands. Input: We included seven trials with 1369 participants. All trials had high risk of bias. Five trials used our first definition of slow responders, and three other trials (including one that used both definitions) used the second definition. None of the included trials mentioned our primary outcomes. However, regarding the secondary outcomes, extension of the treatment period to 72 weeks increased the sustained virological response according to both definitions (71/217 (32.7%) versus 52/194 (26.8%); risk ratio (RR) 1.43, 95% confidence interval (CI) 1.07 to 1.92, P = 0.02, I2 = 8%; and 265/499 (53.1%) versus 207/496 (41.7%); RR 1.27, 95% CI 1.07 to 1.50, P = 0.006, I2 = 38%), with a risk difference of 0.11 and calculated number needed to treat of nine. The end of treatment response was not significantly different between the two treatment groups. The number of participants who relapsed virologically was found to be lower in the groups that had been treated for 72 weeks using both definitions (27/84 (32.1%) versus 46/91 (50.5%); RR 0.59, 95% CI 0.40 to 0.86, P = 0.007, I2 = 18%, 3 trials; and 85/350 (24.3%) versus 146/353 (41.4%); RR 0.59, 95% CI 0.47, 0.73, P < 0.000001, I2 = 0%, 3 trials). The length of treatment did not significantly affect the adherence (247/279 (88.5%) versus 252/274 (92.0%); RR 0.95, 95% CI 0.84 to 1.07, P = 0.42, I2 = 69%, 3 trials). In the single trial that reported adverse events, no significant difference was seen between the two treatment groups. This review demonstrates higher a proportion of sustained virological response after extension of treatment from 48 weeks to 72 weeks in HCV genotype 1 infected patients in whom HCV RNA was still detectable but decreased by ≥ 2 log after 12 weeks and became negative after 24 weeks of treatment, and in patients with detectable HCV RNA after four weeks of treatment with peginterferon plus ribavirin. The observed intervention effects can be caused by both systematic error (bias) and random errors (play of chance). There was no reporting on mortality and the reporting of clinical outcomes and adverse events was insufficient. More data are needed in order to recommend or reject the policy of extending the treatment period for slow responders. Output:
We found seven randomised clinical trials that compared a treatment duration of 72 weeks with 48 weeks in 1369 participants. The quality of all trials was low. Mortality and liver-related morbidity were not reported in any of the included trials. Sustained virological response (that is, undetectable hepatitis C virus RNA after six months from the end of an entire course of treatment) was increased when the decision to prolong treatment was taken based on viral load after 12 weeks of treatment (RR 1.43, 95% CI 1.07 to 1.92) as well as when the decision to prolong treatment was taken based on the results of the viral load after four weeks of treatment (RR 1.27, 95% CI 1.07 to 1.50). The calculated number needed to treat to achieve an increase in sustained virological response proportions was nine (meaning that among nine participants treated for 72 weeks instead of 48 weeks, only one more will achieve a sustained virological response compared to the participants treated for 48 weeks). The higher sustained virological response after 72 weeks of treatment was caused by a reduction in the number of patients in this group who experienced a virological relapse after treatment. Adherence to treatment was not different between the two groups. Serious adverse events were mentioned in only one trial, and they were not different in the two treatment groups. The findings may be influenced by both risks of systematic errors (bias) and the risk of random errors (play of chance). Further large-scale, randomised trials with reporting of patient relevant outcomes are warranted.
CochranePLS170
***TASK*** the task is to simplify the input abstract of a biomedical literature ***INPUT*** the input is the abstract of a biomedical literature ***OUTPUT*** the output is the simplified abstract for the input abstract of a biomedical literature ***EXAMPLES*** Input: Output: ***EXAMPLES*** Input: Two trials (n = 190), at low risk of bias, were included in the review and both presented data on first time failure at the tooth level. Pooling of the data showed a statistically significant difference in favour of molar bands, with a hazard ratio of 2.92 (95% confidence intervals (CI) 1.80 to 4.72). No statistically significant heterogeneity was shown between the two studies. Data on first time failure at the patient level were also available and showed statistically different difference in favour of molar bands (risk ratio 2.30; 95% CI 1.56 to 3.41) (risk of event for molar tubes = 57%; risk of event for molar bands 25%). One trial presented data on decalcification again showing a statistically significant difference in favour of molar bands. No other adverse events identified. From the two well-designed and low risk of bias trials included in this review it was shown that the failure of molar tubes bonded with either a chemically-cured or light-cured adhesive was considerably higher than that of molar bands cemented with glass ionomer cement. One trial indicated that there was less decalcification with molar bands cemented with glass ionomer cement than with bonded molar tubes cemented with a light-cured adhesive. However, given there are limited data for this outcome, further evidence is required to draw more robust conclusions. Output: The evidence in this review, which was carried out together with Cochrane Oral Health, is up-to-date as of 15 February 2017. We included two studies that evaluated 190 participants. Both trials were conducted in the UK and both compared bonded molar tubes with molar bands. From the limited data of two studies at low risk of bias, it would appear that bonded molar tubes are associated with a higher failure rate than with molar bands. Input: Only two studies (34 participants) met the inclusion criteria of this systematic review. Both studies evaluated the diagnostic test accuracy of EUS in assessing the resectability with curative intent in pancreatic cancers. There was low concerns about applicability for most domains in both studies. The overall risk of bias was low in one study and unclear or high in the second study. The mean probability of unresectable disease after CT scan across studies was 60.5% (that is 61 out of 100 patients who had resectable cancer after CT scan had unresectable disease on laparotomy). The summary estimate of sensitivity of EUS for unresectability was 0.87 (95% confidence interval (CI) 0.54 to 0.97) and the summary estimate of specificity for unresectability was 0.80 (95% CI 0.40 to 0.96). The positive likelihood ratio and negative likelihood ratio were 4.3 (95% CI 1.0 to 18.6) and 0.2 (95% CI 0.0 to 0.8) respectively. At the mean pre-test probability of 60.5%, the post-test probability of unresectable disease for people with a positive EUS (EUS indicating unresectability) was 86.9% (95% CI 60.9% to 96.6%) and the post-test probability of unresectable disease for people with a negative EUS (EUS indicating resectability) was 20.0% (5.1% to 53.7%). This means that 13% of people (95% CI 3% to 39%) with positive EUS have potentially resectable cancer and 20% (5% to 53%) of people with negative EUS have unresectable cancer. Based on two small studies, there is significant uncertainty in the utility of EUS in people with pancreatic cancer found to have resectable disease on CT scan. No studies have assessed the utility of EUS in people with periampullary cancer. There is no evidence to suggest that it should be performed routinely in people with pancreatic cancer or periampullary cancer found to have resectable disease on CT scan. Output:
We included two studies with a total of 34 patients in this review. Both studies evaluated the diagnostic performance of EUS. This evidence is current to 5 November 2015. Of the two studies, one study was conducted as well as such a study could be conducted. The methodological quality of the other study was poor. The two included studies showed that in those people with pancreatic cancer in whom CT alone showed their cancer was capable of being fully surgically removed, 61% (61 out of 100) would prove to have cancer that was too fully spread to make this possible when a laparotomy was attempted. Due to the small sample size, there is significant uncertainty in the utility of EUS in people with pancreatic cancer found to have resectable disease on CT scan. There is no evidence to suggest that it should be performed routinely in people with pancreatic cancer found to have resectable disease on CT scan.
CochranePLS171
***TASK*** the task is to simplify the input abstract of a biomedical literature ***INPUT*** the input is the abstract of a biomedical literature ***OUTPUT*** the output is the simplified abstract for the input abstract of a biomedical literature ***EXAMPLES*** Input: Output: ***EXAMPLES*** Input: Two trials (n = 190), at low risk of bias, were included in the review and both presented data on first time failure at the tooth level. Pooling of the data showed a statistically significant difference in favour of molar bands, with a hazard ratio of 2.92 (95% confidence intervals (CI) 1.80 to 4.72). No statistically significant heterogeneity was shown between the two studies. Data on first time failure at the patient level were also available and showed statistically different difference in favour of molar bands (risk ratio 2.30; 95% CI 1.56 to 3.41) (risk of event for molar tubes = 57%; risk of event for molar bands 25%). One trial presented data on decalcification again showing a statistically significant difference in favour of molar bands. No other adverse events identified. From the two well-designed and low risk of bias trials included in this review it was shown that the failure of molar tubes bonded with either a chemically-cured or light-cured adhesive was considerably higher than that of molar bands cemented with glass ionomer cement. One trial indicated that there was less decalcification with molar bands cemented with glass ionomer cement than with bonded molar tubes cemented with a light-cured adhesive. However, given there are limited data for this outcome, further evidence is required to draw more robust conclusions. Output: The evidence in this review, which was carried out together with Cochrane Oral Health, is up-to-date as of 15 February 2017. We included two studies that evaluated 190 participants. Both trials were conducted in the UK and both compared bonded molar tubes with molar bands. From the limited data of two studies at low risk of bias, it would appear that bonded molar tubes are associated with a higher failure rate than with molar bands. Input: There were 34 studies (2169 participants with blepharitis) included in this review: 20 studies (14 RCTs and 6 CCTs) included 1661 participants with anterior or mixed blepharitis and 14 studies (12 RCTs and 2 CCTs) included 508 participants with posterior blepharitis (MGD). Due to the heterogeneity of study characteristics among the included studies, with respect to follow-up periods and types of interventions, comparisons, and condition of participants, our ability to perform meta-analyses was limited. Topical antibiotics were shown to provide some symptomatic relief and were effective in eradicating bacteria from the eyelid margin for anterior blepharitis. Lid hygiene may provide symptomatic relief for anterior and posterior blepharitis. The effectiveness of other treatments for blepharitis, such as topical steroids and oral antibiotics, were inconclusive. Despite identifying 34 trials related to treatments for blepharitis, there is no strong evidence for any of the treatments in terms of curing chronic blepharitis. Commercial products are marketed to consumers and prescribed to patients without substantial evidence of effectiveness. Further research is needed to evaluate the effectiveness of such treatments. Any RCT designed for this purpose should separate participants by type of condition (e.g. staphylococcal blepharitis or MGD) in order to minimize imbalances between groups (type I errors) and to achieve statistical power for analyses (prevent type II errors). Medical interventions and commercial products should be compared with conventional lid hygiene measures, such as warm compresses and eyelid margin washing, to determine effectiveness, as well as head-to-head to show comparative effectiveness between treatments. Outcomes of interest should be patient-centered and measured using validated questionnaires or scales. It is important that participants be followed long-term, at least one year, to assess chronic outcomes properly. Output:
This review focuses on chronic blepharitis and stratifies anterior and posterior blepharitis. There were 34 studies (2169 participants with blepharitis) included in the review, 20 of which included participants with anterior blepharitis and 14 of which included participants with posterior blepharitis. For anterior blepharitis, topical antibiotics provided some symptomatic relief and were effective in clearing bacteria from the eyelid margins. There was no difference between the types of topical antibiotics used. Topical steroids also provided some symptomatic relief; however, they were ineffective in eliminating bacteria. Lid hygiene, including warm compresses and lid scrubs, showed some symptomatic relief in both anterior and posterior blepharitis. Overall, there was no strong evidence for any of the treatments in terms of curing chronic blepharitis. Further research should be done to evaluate the effectiveness of treatments for blepharitis, with particular attention paid to adequate diagnosis and classification of the disease.
CochranePLS172
***TASK*** the task is to simplify the input abstract of a biomedical literature ***INPUT*** the input is the abstract of a biomedical literature ***OUTPUT*** the output is the simplified abstract for the input abstract of a biomedical literature ***EXAMPLES*** Input: Output: ***EXAMPLES*** Input: Two trials (n = 190), at low risk of bias, were included in the review and both presented data on first time failure at the tooth level. Pooling of the data showed a statistically significant difference in favour of molar bands, with a hazard ratio of 2.92 (95% confidence intervals (CI) 1.80 to 4.72). No statistically significant heterogeneity was shown between the two studies. Data on first time failure at the patient level were also available and showed statistically different difference in favour of molar bands (risk ratio 2.30; 95% CI 1.56 to 3.41) (risk of event for molar tubes = 57%; risk of event for molar bands 25%). One trial presented data on decalcification again showing a statistically significant difference in favour of molar bands. No other adverse events identified. From the two well-designed and low risk of bias trials included in this review it was shown that the failure of molar tubes bonded with either a chemically-cured or light-cured adhesive was considerably higher than that of molar bands cemented with glass ionomer cement. One trial indicated that there was less decalcification with molar bands cemented with glass ionomer cement than with bonded molar tubes cemented with a light-cured adhesive. However, given there are limited data for this outcome, further evidence is required to draw more robust conclusions. Output: The evidence in this review, which was carried out together with Cochrane Oral Health, is up-to-date as of 15 February 2017. We included two studies that evaluated 190 participants. Both trials were conducted in the UK and both compared bonded molar tubes with molar bands. From the limited data of two studies at low risk of bias, it would appear that bonded molar tubes are associated with a higher failure rate than with molar bands. Input: We included one trial with a total of 23 participants. This study was at high risk of bias. None of our primary outcomes and only one of our secondary outcomes (reduction in volume of disease, assessed endoscopically) was measured in the study. There was no significant difference between the groups (very low-quality evidence). Adverse effects reported included airway swelling requiring intubation in a child with severe RRP a few hours after photodynamic therapy. There is insufficient evidence from high-quality randomised controlled trials to determine whether photodynamic therapy alters the course of disease or provides an added benefit to surgery in patients with recurrent respiratory papillomatosis. Multicentre randomised controlled trials with appropriate sample sizes and long-term follow-up are required to evaluate whether photodynamic therapy is of benefit. Outcomes such as improvement in symptoms (respiratory function and voice quality) and quality of life should be measured in future trials. Output:
We found one randomised controlled trial with a total of 23 participants for inclusion in this review. The study took place at two centres in the USA. Six of the 23 patients did not complete the study (dropped out). Participants who completed the study were outpatients, their age range was four to 60 years and 76% were men and 24% women. The study did not measure any of the outcomes important to patients (symptom improvement - respiratory distress/dyspnoea and voice quality, quality of life improvement and recurrence-free interval). It did measure the reduction in the volume of disease (assessed with an endoscope). We found insufficient evidence from the included study that photodynamic therapy has a benefit on its own or in combination with surgery in recurrent respiratory papillomatosis. There was no clear evidence that effects observed in the treatment group were different to those in the control group. Adverse effects reported included airway swelling in a child with severe disease a few hours after photodynamic therapy, which required insertion of a breathing tube and a prolonged stay in hospital. The overall quality of the evidence is very low: there was no blinding of treatment and a high rate of drop-out. This evidence is up to date to January 2014.
CochranePLS173
***TASK*** the task is to simplify the input abstract of a biomedical literature ***INPUT*** the input is the abstract of a biomedical literature ***OUTPUT*** the output is the simplified abstract for the input abstract of a biomedical literature ***EXAMPLES*** Input: Output: ***EXAMPLES*** Input: Two trials (n = 190), at low risk of bias, were included in the review and both presented data on first time failure at the tooth level. Pooling of the data showed a statistically significant difference in favour of molar bands, with a hazard ratio of 2.92 (95% confidence intervals (CI) 1.80 to 4.72). No statistically significant heterogeneity was shown between the two studies. Data on first time failure at the patient level were also available and showed statistically different difference in favour of molar bands (risk ratio 2.30; 95% CI 1.56 to 3.41) (risk of event for molar tubes = 57%; risk of event for molar bands 25%). One trial presented data on decalcification again showing a statistically significant difference in favour of molar bands. No other adverse events identified. From the two well-designed and low risk of bias trials included in this review it was shown that the failure of molar tubes bonded with either a chemically-cured or light-cured adhesive was considerably higher than that of molar bands cemented with glass ionomer cement. One trial indicated that there was less decalcification with molar bands cemented with glass ionomer cement than with bonded molar tubes cemented with a light-cured adhesive. However, given there are limited data for this outcome, further evidence is required to draw more robust conclusions. Output: The evidence in this review, which was carried out together with Cochrane Oral Health, is up-to-date as of 15 February 2017. We included two studies that evaluated 190 participants. Both trials were conducted in the UK and both compared bonded molar tubes with molar bands. From the limited data of two studies at low risk of bias, it would appear that bonded molar tubes are associated with a higher failure rate than with molar bands. Input: We identified 42 primary studies with 4220 participants. Twenty studies provided accuracy data based on the number of individual participants (seven of which provided data with and without the use of contrast). Sixteen of these studies evaluated the accuracy of CDUS. These studies were generally of moderate to low quality: only three studies fulfilled all the QUADAS items; in six (40%) of the studies, the delay between the tests was unclear or longer than four weeks; in eight (50%), the blinding of either the index test or the reference standard was not clearly reported or was not performed; and in two studies (12%), the interpretation of the reference standard was not clearly reported. Eleven studies evaluated the accuracy of CE-CDUS. These studies were of better quality than the CDUS studies: five (45%) studies fulfilled all the QUADAS items; four (36%) did not report clearly the blinding interpretation of the reference standard; and two (18%) did not clearly report the delay between the two tests. Based on the bivariate model, the summary estimates for CDUS were 0.82 (95% confidence interval (CI) 0.66 to 0.91) for sensitivity and 0.93 (95% CI 0.87 to 0.96) for specificity whereas for CE-CDUS the estimates were 0.94 (95% CI 0.85 to 0.98) for sensitivity and 0.95 (95% CI 0.90 to 0.98) for specificity. Regression analysis showed that CE-CDUS was superior to CDUS in terms of sensitivity (LR Chi2 = 5.08, 1 degree of freedom (df); P = 0.0242 for model improvement). Seven studies provided estimates before and after administration of contrast. Sensitivity before contrast was 0.67 (95% CI 0.47 to 0.83) and after contrast was 0.97 (95% CI 0.92 to 0.99). The improvement in sensitivity with of contrast use was statistically significant (LR Chi2 = 13.47, 1 df; P = 0.0002 for model improvement). Regression testing showed evidence of statistically significant effect bias related to year of publication and study quality within individual participants based CDUS studies. Sensitivity estimates were higher in the studies published before 2006 than the estimates obtained from studies published in 2006 or later (P < 0.001); and studies judged as low/unclear quality provided higher estimates in sensitivity. When regression testing was applied to the individual based CE-CDUS studies, none of the items, namely direction of the study design, quality, and age, were identified as a source of heterogeneity. Twenty-two studies provided accuracy data based on number of scans performed (of which four provided data with and without the use of contrast). Analysis of the studies that provided scan based data showed similar results. Summary estimates for CDUS (18 studies) showed 0.72 (95% CI 0.55 to 0.85) for sensitivity and 0.95 (95% CI 0.90 to 0.96) for specificity whereas summary estimates for CE-CDUS (eight studies) were 0.91 (95% CI 0.68 to 0.98) for sensitivity and 0.89 (95% CI 0.71 to 0.96) for specificity. This review demonstrates that both ultrasound modalities (with or without contrast) showed high specificity. For ruling in endoleaks, CE-CDUS appears superior to CDUS. In an endoleak surveillance programme CE-CDUS can be introduced as a routine diagnostic modality followed by CT scan only when the ultrasound is positive to establish the type of endoleak and the subsequent therapeutic management. Output:
We collected the most recent evidence (to July 2016) and conducted a meta-analysis according to the most appropriate methods for diagnostic tests. We included 42 studies with 4220 participants in the review. The analyses measured sensitivity (how well a test identified people with endoleak correctly) and specificity (how well a test identified people without endoleak correctly). The summary accuracy estimates were sensitivity 82% (95% confidence interval 66% to 91%) and specificity 93% (95% confidence interval 87% to 96%) for ultrasonography without contrast; and sensitivity 94% (95% confidence interval 85% to 98%) and specificity 95% (95% confidence interval 90% to 98%) for ultrasonography with contrast. Use of contrast improved the sensitivity of ultrasound significantly. Based on these results, we would expect 94% of people with endoleaks will be correctly identified by contrast-enhanced ultrasound. Studies that evaluated contrast-enhanced ultrasound used better methods than the studies that evaluated ultrasound alone.
CochranePLS174
***TASK*** the task is to simplify the input abstract of a biomedical literature ***INPUT*** the input is the abstract of a biomedical literature ***OUTPUT*** the output is the simplified abstract for the input abstract of a biomedical literature ***EXAMPLES*** Input: Output: ***EXAMPLES*** Input: Two trials (n = 190), at low risk of bias, were included in the review and both presented data on first time failure at the tooth level. Pooling of the data showed a statistically significant difference in favour of molar bands, with a hazard ratio of 2.92 (95% confidence intervals (CI) 1.80 to 4.72). No statistically significant heterogeneity was shown between the two studies. Data on first time failure at the patient level were also available and showed statistically different difference in favour of molar bands (risk ratio 2.30; 95% CI 1.56 to 3.41) (risk of event for molar tubes = 57%; risk of event for molar bands 25%). One trial presented data on decalcification again showing a statistically significant difference in favour of molar bands. No other adverse events identified. From the two well-designed and low risk of bias trials included in this review it was shown that the failure of molar tubes bonded with either a chemically-cured or light-cured adhesive was considerably higher than that of molar bands cemented with glass ionomer cement. One trial indicated that there was less decalcification with molar bands cemented with glass ionomer cement than with bonded molar tubes cemented with a light-cured adhesive. However, given there are limited data for this outcome, further evidence is required to draw more robust conclusions. Output: The evidence in this review, which was carried out together with Cochrane Oral Health, is up-to-date as of 15 February 2017. We included two studies that evaluated 190 participants. Both trials were conducted in the UK and both compared bonded molar tubes with molar bands. From the limited data of two studies at low risk of bias, it would appear that bonded molar tubes are associated with a higher failure rate than with molar bands. Input: We included seven studies, with 766 participants: four used intracutaneous injections, two subcutaneous, and one both. All reported on low back pain in labour only. Methodological quality was good, but four studies were at high risk of bias due to small size of treatment groups, incomplete outcome data, and performance bias. All studies reported treatment group mean or median scores, finding greater reduction in pain for sterile water. However, failure to demonstrate a normal distribution for pain intensity or relief, and use of different scales, meant meta-analysis was inappropriate. No study reported primary dichotomous efficacy outcomes. One reported the number self-scoring 4/10 cm or more reduction in pain; significantly more had this outcome with sterile water (50% to 60%) than with placebo (20% to 25%). There was no significant difference between sterile water and saline for rates of caesarean section (risk ratio (RR) 0.58, 95% confidence interval (CI) 0.33 to 1.02), instrumental delivery (RR 1.31, 95% CI 0.79 to 2.18), rescue analgesia (RR 0.86, 95% CI 0.44 to 1.69), timing of delivery, or Apgar scores. Two studies reported that more women treated with sterile water would request the same analgesia in future. No study reported on women's satisfaction with pain relief, women's sense of control in labour, women's satisfaction with the childbirth experience, mother/baby interaction, rates of breastfeeding, maternal morbidity, infant long-term outcomes, or cost. No adverse events were reported other than transient pain with injection, which was worse with sterile water. The outcomes reported severely limit conclusions for clinical practice. We found little robust evidence that sterile water is effective for low back or any other labour pain. Neither did we find any difference in delivery or other maternal or fetal outcomes. Further large, methodologically rigorous studies are required to determine the efficacy of sterile water to relieve pain in labour. Output:
In this review we looked at the effectiveness of injections of small amounts of sterile water given into four spots on the woman’s lower back in labour. The review included seven studies with 766 participants; four used intracutaneous injections, two subcutaneous, and one both. All studies compared the injections of sterile water with injections of saline, whilst none compared the injection of sterile water with women using their own skills to manage pain in labour. Nor did the studies compare with other forms of pain management in labour, as this information is in other Cochrane reviews. We found no good quality evidence that these simple water injections could provide a significant level of pain relief compared with simple saline injection for any type of pain experienced during labour. Women did report transient pain at the injection site. More research is needed on this possible form of pain management in labour.
CochranePLS175
***TASK*** the task is to simplify the input abstract of a biomedical literature ***INPUT*** the input is the abstract of a biomedical literature ***OUTPUT*** the output is the simplified abstract for the input abstract of a biomedical literature ***EXAMPLES*** Input: Output: ***EXAMPLES*** Input: Two trials (n = 190), at low risk of bias, were included in the review and both presented data on first time failure at the tooth level. Pooling of the data showed a statistically significant difference in favour of molar bands, with a hazard ratio of 2.92 (95% confidence intervals (CI) 1.80 to 4.72). No statistically significant heterogeneity was shown between the two studies. Data on first time failure at the patient level were also available and showed statistically different difference in favour of molar bands (risk ratio 2.30; 95% CI 1.56 to 3.41) (risk of event for molar tubes = 57%; risk of event for molar bands 25%). One trial presented data on decalcification again showing a statistically significant difference in favour of molar bands. No other adverse events identified. From the two well-designed and low risk of bias trials included in this review it was shown that the failure of molar tubes bonded with either a chemically-cured or light-cured adhesive was considerably higher than that of molar bands cemented with glass ionomer cement. One trial indicated that there was less decalcification with molar bands cemented with glass ionomer cement than with bonded molar tubes cemented with a light-cured adhesive. However, given there are limited data for this outcome, further evidence is required to draw more robust conclusions. Output: The evidence in this review, which was carried out together with Cochrane Oral Health, is up-to-date as of 15 February 2017. We included two studies that evaluated 190 participants. Both trials were conducted in the UK and both compared bonded molar tubes with molar bands. From the limited data of two studies at low risk of bias, it would appear that bonded molar tubes are associated with a higher failure rate than with molar bands. Input: Twelve trials with a total of 1932 participants were included in this review. The overall postoperative chronic pain in the glue group was reduced by 37% (OR 0.63, 95% CI 0.44 to 0.91; 10 studies, 1418 participants, low-quality evidence) compared with the suture group. However, the results changed when we conducted subgroup analysis with regard to the type of mesh. Subgroup analysis of included studies using lightweight mesh showed the reduction of chronic pain was less profound and insignificant (OR 0.77, 95% CI 0.50 to 1.17). Subgroup analysis of included studies using heavyweight mesh resulted in a significant benefit from the fixation with glue (OR 0.38, 95% CI 0.17 to 0.82). Hernia recurrence was similar between the two groups (OR 1.44, 95% CI 0.63 to 3.28; 12 studies, 1932 participants, low-quality evidence). Fixation with glue was superior to suture regarding duration of the operation (MD −3.13, 95% CI −4.48 to −1.78; 9 studies, 1790 participants, low-quality evidence); haematoma (OR 0.52, 95% CI 0.31 to 0.86; 10 studies, 1384 participants, moderate-quality evidence); and recovery time to daily activities (MD −1.26, 95% CI −1.89 to −0.63; 3 studies, 403 participants, low-quality evidence). We also investigated adverse events. There were no significant differences between the two groups. For superficial wound infection pooled analyses showed OR 1.23, 95% CI 0.37 to 4.11; 7 studies, 763 participants (low-quality evidence); for mesh/deep infection OR 0.67, 95% CI 0.16 to 2.83; 8 studies, 1393 participants (low-quality evidence). Furthermore, we investigated seroma (a postoperative swelling caused by fluid) (OR 0.83, 95% CI 0.51 to 1.33); and persisting numbness (OR 0.81, 95% CI 0.57 to 1.14). Finally, six trials involving 1009 participants reported postoperative length of stay, resulting in non-significant difference between the two groups (MD −0.12, 95% CI: −0.35 to 0.10) Due to the lack of data, it was impossible to draw any distinction between synthetic glue and biological glue. Eight out of 12 trials showed high risk of bias in at least one of the investigated domains. Two studies were quasi-randomised controlled trials and the allocation sequence of one trial was not concealed. Nearly half of the included trials either did not provide adequate information or had high risk of bias regarding blinding processes. The risk of bias for incomplete outcome data of all the included studies varied from low to high risk of bias. Two trials did not report on some important outcomes. One study was funded by the manufacturer producing the fibrin sealant. Therefore, according to the 'Summary of findings' tables, the quality of the evidence (GRADE) for the outcomes is moderate to low. Based on the short-term results, glue may reduce postoperative chronic pain and not simultaneously increase the recurrence rate, compared with sutures for mesh fixation in Lichtenstein hernia repair. Glue may therefore be a sensible alternative to suture for mesh fixation in Lichtenstein repair. Larger trials with longer follow-up and high quality are warranted. The difference between synthetic glue and biological glue should also be assessed in the future. Output:
We identified 12 relevant randomised controlled trials comparing glue versus suture for fixation of the mesh, with a total of 1932 participants. Glue fixation is superior to suture for the outcomes of chronic pain, duration of operation, haematoma and recovery time to daily activities. Glue fixation is not associated with an increased risk of infection, hernia recurrence, seroma (a collection of fluid that builds up under the surface of the skin after surgery), persisting numbness (loss of sensation or feeling), quality of life, and postoperative length of stay. We do not know the role of glue fixation in people with recurrent hernia, femoral hernia or complicated hernia. Meanwhile no conclusions could be drawn on which type of glue should be used because of lack of trials. Eight out of 12 trials showed high risk of bias in at least one of the investigated domains. Two studies were quasi-randomised controlled trials. Nearly half of the included trials either did not provide adequate information or had high risk of bias regarding blinding processes. The risk of bias for incomplete outcome data of all the included studies is low to high. Two trials did not report on some important outcomes. One study was funded by the manufacturer producing the fibrin sealant. As the quality of the evidence (GRADE) for the outcomes is moderate to low and the results of chronic pain is not robust, the findings should be interpreted with caution. However, the evidence is still sufficient to conclude that glue fixation of mesh for the Lichtenstein procedure is comparable, if not superior, to fixation with suture. Glue may be a sensible alternative to suture for mesh fixation in Lichtenstein repair.
CochranePLS176
***TASK*** the task is to simplify the input abstract of a biomedical literature ***INPUT*** the input is the abstract of a biomedical literature ***OUTPUT*** the output is the simplified abstract for the input abstract of a biomedical literature ***EXAMPLES*** Input: Output: ***EXAMPLES*** Input: Two trials (n = 190), at low risk of bias, were included in the review and both presented data on first time failure at the tooth level. Pooling of the data showed a statistically significant difference in favour of molar bands, with a hazard ratio of 2.92 (95% confidence intervals (CI) 1.80 to 4.72). No statistically significant heterogeneity was shown between the two studies. Data on first time failure at the patient level were also available and showed statistically different difference in favour of molar bands (risk ratio 2.30; 95% CI 1.56 to 3.41) (risk of event for molar tubes = 57%; risk of event for molar bands 25%). One trial presented data on decalcification again showing a statistically significant difference in favour of molar bands. No other adverse events identified. From the two well-designed and low risk of bias trials included in this review it was shown that the failure of molar tubes bonded with either a chemically-cured or light-cured adhesive was considerably higher than that of molar bands cemented with glass ionomer cement. One trial indicated that there was less decalcification with molar bands cemented with glass ionomer cement than with bonded molar tubes cemented with a light-cured adhesive. However, given there are limited data for this outcome, further evidence is required to draw more robust conclusions. Output: The evidence in this review, which was carried out together with Cochrane Oral Health, is up-to-date as of 15 February 2017. We included two studies that evaluated 190 participants. Both trials were conducted in the UK and both compared bonded molar tubes with molar bands. From the limited data of two studies at low risk of bias, it would appear that bonded molar tubes are associated with a higher failure rate than with molar bands. Input: We located 32 studies addressing technical editing and 66 surveys of reference accuracy. Only three of the studies were randomised controlled trials. A 'package' of largely unspecified editorial processes applied between acceptance and publication was associated with improved readability in two studies and improved reporting quality in another two studies, while another study showed mixed results after stricter editorial policies were introduced. More intensive editorial processes were associated with fewer errors in abstracts and references. Providing instructions to authors was associated with improved reporting of ethics requirements in one study and fewer errors in references in two studies, but no difference was seen in the quality of abstracts in one randomised controlled trial. Structuring generally improved the quality of abstracts, but increased their length. The reference accuracy studies showed a median citation error rate of 38% and a median quotation error rate of 20%. Surprisingly few studies have evaluated the effects of technical editing rigorously. However there is some evidence that the 'package' of technical editing used by biomedical journals does improve papers. A substantial number of references in biomedical articles are cited or quoted inaccurately. Output:
Most journals try to improve articles before publication by editing them to make them fit a 'house-style', and by other processes such as proof-reading. We refer to all these processes as technical editing. We identified 32 studies of the effects of technical editing from a systematic review. There is some evidence that the overall 'package' of technical editing raises the quality of articles (suggested by 'before-and-after' studies) and that structuring abstracts makes them more useful, although longer. However, there has been little rigorous research to show which processes can improve accuracy or readability the most, or if any have harmful effects or disadvantages. Over one third of references cited in articles in medical journals have some inaccuracies and one-fifth of quotations to references in these articles are not accurate
CochranePLS177
***TASK*** the task is to simplify the input abstract of a biomedical literature ***INPUT*** the input is the abstract of a biomedical literature ***OUTPUT*** the output is the simplified abstract for the input abstract of a biomedical literature ***EXAMPLES*** Input: Output: ***EXAMPLES*** Input: Two trials (n = 190), at low risk of bias, were included in the review and both presented data on first time failure at the tooth level. Pooling of the data showed a statistically significant difference in favour of molar bands, with a hazard ratio of 2.92 (95% confidence intervals (CI) 1.80 to 4.72). No statistically significant heterogeneity was shown between the two studies. Data on first time failure at the patient level were also available and showed statistically different difference in favour of molar bands (risk ratio 2.30; 95% CI 1.56 to 3.41) (risk of event for molar tubes = 57%; risk of event for molar bands 25%). One trial presented data on decalcification again showing a statistically significant difference in favour of molar bands. No other adverse events identified. From the two well-designed and low risk of bias trials included in this review it was shown that the failure of molar tubes bonded with either a chemically-cured or light-cured adhesive was considerably higher than that of molar bands cemented with glass ionomer cement. One trial indicated that there was less decalcification with molar bands cemented with glass ionomer cement than with bonded molar tubes cemented with a light-cured adhesive. However, given there are limited data for this outcome, further evidence is required to draw more robust conclusions. Output: The evidence in this review, which was carried out together with Cochrane Oral Health, is up-to-date as of 15 February 2017. We included two studies that evaluated 190 participants. Both trials were conducted in the UK and both compared bonded molar tubes with molar bands. From the limited data of two studies at low risk of bias, it would appear that bonded molar tubes are associated with a higher failure rate than with molar bands. Input: We included 15 studies including 721 participants with cancer pain due to diverse types of malignancy. All studies were performed on adults; there were no studies on children. The included studies were of adequate methodological quality, but all except for one were judged to be at a high risk of bias because of small study size, and six because of methods used to deal with missing data or high withdrawal rates. Three studies used a parallel group design; the remainder were cross-over trials in which there was an adequate washout period, but only one reported results for treatment periods separately. Twelve studies used codeine as a single agent and three combined it with paracetamol. Ten studies included a placebo arm, and 14 included one or more of 16 different active drug comparators or compared different routes of administration. Most studies investigated the effect of a single dose of medication, while five used treatment periods of one, seven or 21 days. Most studies used codeine at doses of 30 mg to 120 mg. There were insufficient data for any pooled analysis. Only two studies reported our preferred responder outcome of 'participants with at least 50% reduction in pain' and two reported 'participants with no worse than mild pain'. Eleven studies reported treatment group mean measures of pain intensity or pain relief; overall for these outcome measures, codeine or codeine plus paracetamol was numerically superior to placebo and equivalent to the active comparators. Adverse event reporting was poor: only two studies reported the number of participants with any adverse event specified by treatment group and only one reported the number of participants with any serious adverse event. In multiple-dose studies nausea, vomiting and constipation were common, with somnolence and dizziness frequent in the 21-day study. Withdrawal from the studies, where reported, was less than 10% except in two studies. There were three deaths, in all cases due to the underlying cancer. We identified only a small amount of data in studies that were both randomised and double-blind. Studies were small, of short duration, and most had significant shortcomings in reporting. The available evidence indicates that codeine is more effective against cancer pain than placebo, but with increased risk of nausea, vomiting, and constipation. Uncertainty remains as to the magnitude and time-course of the analgesic effect and the safety and tolerability in longer-term use. There were no data for children. Output:
In this review we set out to estimate how well codeine worked, how many people had side effects, and how severe those side effects were - for example, whether they were so severe that participants stopped taking their oral codeine. We included 15 studies with 721 participants. The studies we found had methodological shortcomings: they were small and of short duration. They also reported results in different ways, so that it was not possible to combine results. In seven of the eight studies that compared codeine with placebo, codeine was better than placebo. In studies that compared codeine with another drug, the results were similar. Codeine at doses of 30 mg to 120 mg, alone or in combination with paracetamol, does seem to provide a good level of pain relief for some people with cancer pain. We cannot be certain about how many people will get this benefit, and we do not know whether, or by how much, adding paracetamol increases its effect. Codeine increases nausea, vomiting, and constipation, and may cause drowsiness or dizziness if used for more than a week. Some people will stop taking codeine because of the side effects. More trials comparing codeine with other treatments and using patient-centred outcomes are needed. The role of codeine in mild cancer pain, in addition to moderate to severe cancer pain, should be investigated.
CochranePLS178
***TASK*** the task is to simplify the input abstract of a biomedical literature ***INPUT*** the input is the abstract of a biomedical literature ***OUTPUT*** the output is the simplified abstract for the input abstract of a biomedical literature ***EXAMPLES*** Input: Output: ***EXAMPLES*** Input: Two trials (n = 190), at low risk of bias, were included in the review and both presented data on first time failure at the tooth level. Pooling of the data showed a statistically significant difference in favour of molar bands, with a hazard ratio of 2.92 (95% confidence intervals (CI) 1.80 to 4.72). No statistically significant heterogeneity was shown between the two studies. Data on first time failure at the patient level were also available and showed statistically different difference in favour of molar bands (risk ratio 2.30; 95% CI 1.56 to 3.41) (risk of event for molar tubes = 57%; risk of event for molar bands 25%). One trial presented data on decalcification again showing a statistically significant difference in favour of molar bands. No other adverse events identified. From the two well-designed and low risk of bias trials included in this review it was shown that the failure of molar tubes bonded with either a chemically-cured or light-cured adhesive was considerably higher than that of molar bands cemented with glass ionomer cement. One trial indicated that there was less decalcification with molar bands cemented with glass ionomer cement than with bonded molar tubes cemented with a light-cured adhesive. However, given there are limited data for this outcome, further evidence is required to draw more robust conclusions. Output: The evidence in this review, which was carried out together with Cochrane Oral Health, is up-to-date as of 15 February 2017. We included two studies that evaluated 190 participants. Both trials were conducted in the UK and both compared bonded molar tubes with molar bands. From the limited data of two studies at low risk of bias, it would appear that bonded molar tubes are associated with a higher failure rate than with molar bands. Input: A total of 12 trials (11 randomized controlled trials and one quasi-randomized trial) of 563 people with HbSS, HbSC or HbSβthal, aged six to 35 years old, were included in the review; the majority of participants were African-American. Interventions ranged from a total of one hour to weekly sessions for eight weeks and the post-intervention assessments ranged from the end of the intervention period to 12 months after completion. The heterogeneity of the included trials, which encompasses setting, inclusion and exclusion criteria, interventional method and time of assessment, ranged from 'not important' to 'moderate to substantial' for different review outcomes. The overall risk of bias was low for selective reporting, unclear for random sequence generation, allocation concealment, blinding of participants and blinding of outcome assessment. Incomplete outcome reporting and blinding of personnel showed mixed bias representations. Patient knowledge was assessed by four trials (160 participants) with moderate to substantial heterogeneity. There was evidence that educational programs improved patient knowledge, standardised mean difference 0.87 points (95% confidence interval 0.28 to 1.45, moderate quality evidence), which improved further when a trial with high bias was removed in a sensitivity analysis. Caregiver knowledge, reported in a single trial of 20 families, also showed an improvement, standardised mean difference 0.52 points (95% confidence interval 0.03 to 1.00, moderate quality evidence). The effect on patient knowledge was sustained at longer follow-up periods, whereas the effect on caregiver knowledge was not sustained. There were two primary outcomes related to the effectiveness of educational programs on the recognition of signs and symptoms of disease-related morbidity. No comparative data were reported for patients or caregivers (or both) recognising signs and symptoms leading to self-management. Data from two trials were analysed for the utilization of health services and showed no evidence of an effect, mean difference 0.33 (95% confidence interval -0.57 to 1.23, moderate quality evidence). With regard to the review's secondary outcomes, depression showed a statistically significant decline in intervention groups, standardised mean difference -0.66 points (95% confidence interval -1.18, to -0.14, moderate quality evidence). Adherence to treatment was not assessed in any of the identified trials. No effects of interventions were seen on coping, family relationships or health-related quality of life of patients. The quality of evidence was low for positive coping and moderate for child knowledge, healthcare utilization and depression. This suggests that further research is likely to have an important impact on our confidence in the estimate of effect and may change the estimates. This review identifies important positive effects of educational interventions on improving patient knowledge of sickle cell disease and depression. Effects on patients' knowledge were maintained for longer than for caregivers. The effect on knowledge was significant but small and whether it offers any clinical benefit is uncertain. Significant factors limiting these effects could be trials being under powered as well as attrition rates. Effects were not statistically significant in assessments of secondary outcomes, possibly due to the paucity of the number of trials and patients and caregivers. Trials showed moderate to high heterogeneity which might impact the results. To better study effects on outcomes, further controlled trials are needed with rigorous attention given to improve recruitment and retention and to decrease bias. Predetermined protocols using similar measurements should be used across multiple sites. Output:
The review included 12 trials (563 people with HbSS, HbSC or HbSβthal aged six to 35 years). Participants were assigned randomly to either educational programs, no program and in some cases to a non-educational program, e.g. art therapy. Interventions ranged from a total of one hour to weekly sessions for eight weeks and post-intervention assessments ranged from the end of the intervention period to 12 months after completion. Educational programs and other interventions have resulted in improvements in patient knowledge or understanding of sickle cell disease, and a decrease in depression. Effects on patients' knowledge were maintained for longer than for caregivers. The effects are shown to be small but may result from the fact that most studies had very small numbers of participants and there was much variation between studies. The interventions studied showed no effect on patients' utilization of health services, relationships between families, caregiver or patient skills, coping or health-related quality of life of the patient. No comparative data were reported for patients or caregivers (or both) recognising signs and symptoms leading to self-management. No trials assessed the adherence to treatment. Trials varied in the interventions being studied as well as how the different outcomes were measured. The quality of evidence was low for the outcome positive coping and moderate for the outcomes child knowledge, healthcare utilization and depression. This suggests that further research is likely to have an important impact on our confidence in the effect of the treatment. Further research using randomized controlled trials with more people (including different populations) are needed to improve our understanding of which interventions are likely to be useful.
CochranePLS179
***TASK*** the task is to simplify the input abstract of a biomedical literature ***INPUT*** the input is the abstract of a biomedical literature ***OUTPUT*** the output is the simplified abstract for the input abstract of a biomedical literature ***EXAMPLES*** Input: Output: ***EXAMPLES*** Input: Two trials (n = 190), at low risk of bias, were included in the review and both presented data on first time failure at the tooth level. Pooling of the data showed a statistically significant difference in favour of molar bands, with a hazard ratio of 2.92 (95% confidence intervals (CI) 1.80 to 4.72). No statistically significant heterogeneity was shown between the two studies. Data on first time failure at the patient level were also available and showed statistically different difference in favour of molar bands (risk ratio 2.30; 95% CI 1.56 to 3.41) (risk of event for molar tubes = 57%; risk of event for molar bands 25%). One trial presented data on decalcification again showing a statistically significant difference in favour of molar bands. No other adverse events identified. From the two well-designed and low risk of bias trials included in this review it was shown that the failure of molar tubes bonded with either a chemically-cured or light-cured adhesive was considerably higher than that of molar bands cemented with glass ionomer cement. One trial indicated that there was less decalcification with molar bands cemented with glass ionomer cement than with bonded molar tubes cemented with a light-cured adhesive. However, given there are limited data for this outcome, further evidence is required to draw more robust conclusions. Output: The evidence in this review, which was carried out together with Cochrane Oral Health, is up-to-date as of 15 February 2017. We included two studies that evaluated 190 participants. Both trials were conducted in the UK and both compared bonded molar tubes with molar bands. From the limited data of two studies at low risk of bias, it would appear that bonded molar tubes are associated with a higher failure rate than with molar bands. Input: The review included six trials representing 2411 participants. Only one study included participants with both focal and generalised onset seizures; the other five trials included participants with focal onset seizures only. All six studies included adult participants between 16 and 80 years old, and treatment periods ranged from 7 to 16 weeks. We judged two studies to have low risk of bias and four to have unclear risk of bias. One study failed to provide details on the method used for allocation concealment, and one did not report all outcomes prespecified in the trial protocol. One study did not describe how blinding was maintained, and another noted discrepancies in reporting. Participants receiving brivaracetam add-on were significantly more likely to experience a 50% or greater reduction in seizure frequency than those receiving placebo (RR 1.81, 95% CI 1.53 to 2.14; 6 studies; moderate-quality evidence). Participants receiving brivaracetam were also significantly more likely to attain seizure freedom (RR 5.89, 95% CI 2.30 to 15.13; 6 studies; moderate-quality evidence). The incidence of treatment withdrawal for any reason (RR 1.27, 95% CI 0.94 to 1.74; 6 studies; low-quality evidence), as well as the risk of participants experiencing one or more adverse events (RR 1.08, 95% CI 1.00 to 1.17; 5 studies; moderate-quality evidence), was not significantly different following treatment with brivaracetam compared to placebo. However, participants receiving brivaracetam did appear to be significantly more likely to withdraw from treatment specifically because of adverse events compared with those receiving placebo (RR 1.54, 95% CI 1.02 to 2.33; 6 studies; low-quality evidence). Brivaracetam, when used as add-on therapy for patients with drug-resistant epilepsy, is effective in reducing seizure frequency and can aid patients in achieving seizure freedom. However, add-on brivaracetam is associated with a greater proportion of treatment withdrawals due to adverse events compared with placebo. It is important to note that only one of the eligible studies included participants with generalised epilepsy. None of the studies included participants under the age of 16, and all studies were of short duration. Consequently, these findings are mainly applicable to adult patients with drug-resistant focal epilepsy. Future research should thus focus on investigating the tolerability and efficacy of brivaracetam during longer-term follow-up, and should also assess the efficacy and tolerability of add-on brivaracetam in managing other types of seizures and its use in other age groups. Output:
Evidence taken from studies examining the effectiveness of brivaracetam was of moderate quality. This means that we can be fairly certain that study findings showing that brivaracetam is effective in reducing the frequency of seizures in drug-resistant epilepsy are accurate. Evidence regarding the tolerability of brivaracetam, for example, the number of people who withdrew from these studies and the number of people who experienced side effects, however, was of low quality. This means that we cannot be sure that trial findings are completely accurate, and that more research is needed to fully investigate the tolerability of brivaracetam. All study participants were adults, and most had focal epilepsy. As a result, the review cannot inform us about how effective brivaracetam is in children or in individuals with other types of epilepsy, for example, generalised epilepsy, which is epilepsy that involves the whole brain. Evidence is current to October 2018.
CochranePLS180
***TASK*** the task is to simplify the input abstract of a biomedical literature ***INPUT*** the input is the abstract of a biomedical literature ***OUTPUT*** the output is the simplified abstract for the input abstract of a biomedical literature ***EXAMPLES*** Input: Output: ***EXAMPLES*** Input: Two trials (n = 190), at low risk of bias, were included in the review and both presented data on first time failure at the tooth level. Pooling of the data showed a statistically significant difference in favour of molar bands, with a hazard ratio of 2.92 (95% confidence intervals (CI) 1.80 to 4.72). No statistically significant heterogeneity was shown between the two studies. Data on first time failure at the patient level were also available and showed statistically different difference in favour of molar bands (risk ratio 2.30; 95% CI 1.56 to 3.41) (risk of event for molar tubes = 57%; risk of event for molar bands 25%). One trial presented data on decalcification again showing a statistically significant difference in favour of molar bands. No other adverse events identified. From the two well-designed and low risk of bias trials included in this review it was shown that the failure of molar tubes bonded with either a chemically-cured or light-cured adhesive was considerably higher than that of molar bands cemented with glass ionomer cement. One trial indicated that there was less decalcification with molar bands cemented with glass ionomer cement than with bonded molar tubes cemented with a light-cured adhesive. However, given there are limited data for this outcome, further evidence is required to draw more robust conclusions. Output: The evidence in this review, which was carried out together with Cochrane Oral Health, is up-to-date as of 15 February 2017. We included two studies that evaluated 190 participants. Both trials were conducted in the UK and both compared bonded molar tubes with molar bands. From the limited data of two studies at low risk of bias, it would appear that bonded molar tubes are associated with a higher failure rate than with molar bands. Input: We included 38 studies, mostly from high-income countries, many of which explored mothers' perceptions of vaccine communication. Some focused on the MMR (measles, mumps, rubella) vaccine. In general, parents wanted more information than they were getting (high confidence in the evidence). Lack of information led to worry and regret about vaccination decisions among some parents (moderate confidence). Parents wanted balanced information about vaccination benefits and harms (high confidence), presented clearly and simply (moderate confidence) and tailored to their situation (low confidence in the evidence). Parents wanted vaccination information to be available at a wider variety of locations, including outside health services (low confidence) and in good time before each vaccination appointment (moderate confidence). Parents viewed health workers as an important source of information and had specific expectations of their interactions with them (high confidence). Poor communication and negative relationships with health workers sometimes impacted on vaccination decisions (moderate confidence). Parents generally found it difficult to know which vaccination information source to trust and challenging to find information they felt was unbiased and balanced (high confidence). The amount of information parents wanted and the sources they felt could be trusted appeared to be linked to acceptance of vaccination, with parents who were more hesitant wanting more information (low to moderate confidence). Our synthesis and comparison of the qualitative evidence shows that most of the trial interventions addressed at least one or two key aspects of communication, including the provision of information prior to the vaccination appointment and tailoring information to parents' needs. None of the interventions appeared to respond to negative media stories or address parental perceptions of health worker motives. We have high or moderate confidence in the evidence contributing to several review findings. Further research, especially in rural and low- to middle-income country settings, could strengthen evidence for the findings where we had low or very low confidence. Planners should consider the timing for making vaccination information available to parents, the settings where information is available, the provision of impartial and clear information tailored to parental needs, and parents' perceptions of health workers and the information provided. Output:
We included 38 studies in our review. Most of the studies were from high-income countries and explored mothers' perceptions of vaccine communication. Some of the studies also included the views of fathers, grandmothers and other caregivers. In general, parents wanted more information than they were getting (high confidence). For some parents, a lack of information led to worry and regret about their vaccination decision (moderate confidence). Parents wanted balanced information about both the benefits and risks of vaccination (high confidence), presented in a clear and simple manner (moderate confidence) and tailored to their situation (low confidence). Parents wanted vaccination information to be available outside of the health services (low confidence). They wanted this information in good time before each vaccination appointment and not while their child was being vaccinated (moderate confidence). Parents viewed health workers as an important source of information and had specific expectations of their interactions with them (high confidence). Poor communication and negative relationships with health workers sometimes impacted on vaccination decisions (moderate confidence). Parents generally found it difficult to know which vaccination information source to trust and found it difficult to find information that they felt was unbiased and balanced (high confidence). The amount of information parents wanted and the sources they felt they could trust seem to be linked to their acceptance of vaccination, with parents who were more hesitant wanting more information (low to moderate confidence). How up-to-date is this review? We searched for studies published before 30 August 2016.
CochranePLS181
***TASK*** the task is to simplify the input abstract of a biomedical literature ***INPUT*** the input is the abstract of a biomedical literature ***OUTPUT*** the output is the simplified abstract for the input abstract of a biomedical literature ***EXAMPLES*** Input: Output: ***EXAMPLES*** Input: Two trials (n = 190), at low risk of bias, were included in the review and both presented data on first time failure at the tooth level. Pooling of the data showed a statistically significant difference in favour of molar bands, with a hazard ratio of 2.92 (95% confidence intervals (CI) 1.80 to 4.72). No statistically significant heterogeneity was shown between the two studies. Data on first time failure at the patient level were also available and showed statistically different difference in favour of molar bands (risk ratio 2.30; 95% CI 1.56 to 3.41) (risk of event for molar tubes = 57%; risk of event for molar bands 25%). One trial presented data on decalcification again showing a statistically significant difference in favour of molar bands. No other adverse events identified. From the two well-designed and low risk of bias trials included in this review it was shown that the failure of molar tubes bonded with either a chemically-cured or light-cured adhesive was considerably higher than that of molar bands cemented with glass ionomer cement. One trial indicated that there was less decalcification with molar bands cemented with glass ionomer cement than with bonded molar tubes cemented with a light-cured adhesive. However, given there are limited data for this outcome, further evidence is required to draw more robust conclusions. Output: The evidence in this review, which was carried out together with Cochrane Oral Health, is up-to-date as of 15 February 2017. We included two studies that evaluated 190 participants. Both trials were conducted in the UK and both compared bonded molar tubes with molar bands. From the limited data of two studies at low risk of bias, it would appear that bonded molar tubes are associated with a higher failure rate than with molar bands. Input: We identified 10 trials from the search, with a total of 599 anorexia nervosa participants, and included them in the review. Seven had been identified in the previous versions of this review and we now include three new trials. We now deem one previously identified ongoing trial to be ineligible, and six ongoing trials are new for this update. Two of the 10 trials included children. Trials tested diverse psychological therapies and comparability was poor. Risks of bias were mostly evident through lack of blinded outcome assessments (in 60% of studies) and incomplete data reporting (attrition bias). The results suggest that treatment as usual (TAU) when delivered by a non-eating-disorder specialist or similar may be less efficacious than focal psychodynamic therapy. This was suggested for a primary outcome of recovery by achievement of a good or intermediate outcome on the Morgan and Russell Scale (RR 0.70, 95% confidence interval (CI) 0.51 to 0.97; 1 RCT, 40 participants; very low-quality evidence). However there were no differences between cognitive analytic therapy and TAU for this outcome (RR 0.78, 95% CI 0.61 to 1.00; 2 RCTs, 71 participants; very low-quality evidence), nor for body mass index (BMI). There were no differences in overall dropout rates between individual psychological therapies and TAU. Two trials found a non-specific specialist therapy (Specialist Supportive Clinical Management) or an Optimised TAU delivered by therapists with eating disorder expertise was similar in outcomes to cognitive behaviour therapy (BMI MD -0.00, 95% CI -0.91 to 0.91; 197 participants, low-quality evidence). When comparing individual psychological therapies with each other, no specific treatment was consistently superior to any other specific approach. Dietary advice as a control arm had a 100% non-completion rate in one trial (35 participants). None of the trials identified any adverse effects. Insufficient power was problematic for the majority of trials. There was a suggestion in one trial that focal psychodynamic therapy might be superior to TAU, but this is in the context of TAU performing poorly. An alternative control condition of dietary advice alone appeared to be unacceptable, but again this is based on just one trial. Owing to the risk of bias and limitations of studies, notably small sample sizes, we can draw no specific conclusions about the effects of specific individual psychological therapies for anorexia nervosa in adults or older adolescents. Larger RCTs of longer treatment duration and follow-up are needed. Output:
There was a limited amount of very low-quality evidence to suggest that people might do better when receiving focal psychodynamic therapy compared to no treatment or treatment as usual. With one exception, we found little difference between specific psychological therapies. Most therapies appeared as acceptable as any other approach, except for dietary advice which had a 100% non-completion rate in one small trial. Because of the risk of bias and limitations of studies, notably small sample sizes, we can draw no specific conclusions about the effects of specific individual psychological therapies for anorexia nervosa in adults or older adolescents. We need more large multicentre randomised controlled trials of commonly-used psychological therapies in older adolescents and adults with anorexia nervosa.
CochranePLS182
***TASK*** the task is to simplify the input abstract of a biomedical literature ***INPUT*** the input is the abstract of a biomedical literature ***OUTPUT*** the output is the simplified abstract for the input abstract of a biomedical literature ***EXAMPLES*** Input: Output: ***EXAMPLES*** Input: Two trials (n = 190), at low risk of bias, were included in the review and both presented data on first time failure at the tooth level. Pooling of the data showed a statistically significant difference in favour of molar bands, with a hazard ratio of 2.92 (95% confidence intervals (CI) 1.80 to 4.72). No statistically significant heterogeneity was shown between the two studies. Data on first time failure at the patient level were also available and showed statistically different difference in favour of molar bands (risk ratio 2.30; 95% CI 1.56 to 3.41) (risk of event for molar tubes = 57%; risk of event for molar bands 25%). One trial presented data on decalcification again showing a statistically significant difference in favour of molar bands. No other adverse events identified. From the two well-designed and low risk of bias trials included in this review it was shown that the failure of molar tubes bonded with either a chemically-cured or light-cured adhesive was considerably higher than that of molar bands cemented with glass ionomer cement. One trial indicated that there was less decalcification with molar bands cemented with glass ionomer cement than with bonded molar tubes cemented with a light-cured adhesive. However, given there are limited data for this outcome, further evidence is required to draw more robust conclusions. Output: The evidence in this review, which was carried out together with Cochrane Oral Health, is up-to-date as of 15 February 2017. We included two studies that evaluated 190 participants. Both trials were conducted in the UK and both compared bonded molar tubes with molar bands. From the limited data of two studies at low risk of bias, it would appear that bonded molar tubes are associated with a higher failure rate than with molar bands. Input: The review included 516 participants from three RCTs. One study was conducted in the USA and consisted of two trials: the first trial randomized 151 adults to receive either silicone oil or sulfur hexafluoride (SF6) gas tamponades; and the second trial randomized 271 adults to receive either silicone oil or perfluropropane (C3F8) gas tamponades. The third trial was a multi-center international trial and randomized 94 participants (age range not specified) to receive heavy silicone oil (a mixture of perfluorohexyloctane (F6H8) and silicone oil) versus standard silicone oil (either 1000 centistokes or 5000 centistokes, per the surgeon's preference). In participants with RD associated with PVR, outcomes after pars plana vitrectomy and infusion of either silicone oil, perfluropropane gas, or sulfur hexafluoride gas appeared comparable for a broad variety of cases. There were no significant differences between silicone oil and perfluoropropane gas in terms of the proportion of participants achieving at least 5/200 visual acuity (risk ratio (RR) 0.97; 95% confidence interval (CI) 0.73 to 1.31) or achieving macular attachment (RR 1.00; 95% CI 0.86 to 1.15) at a minimum of one year. Although sulfur hexafluoride gas was reported to be associated with significantly worse anatomic and visual outcomes than was silicone oil at one year (quantitative data not reported), there were no significant differences between silicone oil and sulfur hexafluoride gas in terms of achieving at least 5/200 visual acuity at two years (RR 1.57; 95% CI 0.93 to 2.66). For macular attachment, participants treated with silicone oil received significantly more favourable outcomes than did participants who received sulfur hexafluoride at both one year (quantitative data not reported) and two years (RR 1.37; 95% CI 1.01 to 1.86). The first two trials did not perform any sample size calculation or power detection. In the third trial, which had a power of 80% to detect differences, heavy silicone oil was not shown to be superior to standard silicone oil. There were no significant differences between standard silicone oil and heavy silicone oil in the change in visual acuity at one year using adjusted mean logMAR visual acuity (mean difference -0.03 logMAR; 95% CI -0.35 to 0.29). Adverse events were not reported for the first two trials. For the third trial, only the total number of adverse events was reported, and adverse events for each group were not specified. Of the 94 participants, four died, 26 had recurrent retinal detachment, 22 developed glaucoma, four developed a cataract, and two had capsular fibrosis. All three trials employed adequate methods for random sequence generation and allocation concealment. None of the trials employed masking of participants and surgeons, and only the third trial masked outcome assessors. The first trial had a large portion of participants excluded from the final analyses, while the other two trials were at low risk of attrition bias. All trials appear to be free of reporting bias. The first two trials were funded by the National Eye Institute, and the third trial was funded by the German Research Foundation. The use of either perfluropropane or standard silicone oil appears reasonable for most patients with RD associated with PVR. Because there do not appear to be any major differences in outcomes between the two agents, the choice of a tamponade agent should be individualized for each patient. Heavy silicone oil, which is not available for routine clinical use in the USA, has not demonstrated evidence of superiority over standard silicone oil. Output:
We found three randomized controlled trials (RCTs) involving 516 participants that compared tamponade agents. All participants underwent surgery to treat RD associated with PVR. The Silicone Study compared the use of silicone oil to either sulfur hexafluoride (SF6) gas or perfluropropane (C3F8) gas in two RCTs. Both gases and silicone oil are less dense than water, so that they float upwards or towards the top of the eye while a patient is sitting or standing. This is sometimes but not always beneficial, so a denser-than-water silicone oil called heavy silicone oil has been investigated, primarily outside the US. The Heavy Silicone Oil Study compared the use of heavy silicone oil to standard silicone oil in participants with RD involving the lower parts of the retina. The evidence was current to June 2013. When silicone oil was compared to SF6 gas, eyes randomized to receive silicone oil more often achieved a visual acuity of 5/200 or better at one year, and more often achieved macular attachment at one year but with no difference at two years. When silicone oil was compared with C3F8 gas, there were no significant differences between the groups with respect to visual acuity or macular attachment at one year. When heavy silicone oil was compared to standard silicone oil, there were no significant differences between the groups with respect to retinal re-attachment or visual acuity at one year. Heavy silicone oil did not demonstrate any significant benefit over standard silicone oil. Adverse events were only reported for the Heavy Silicone Oil Study; however, only the total number of adverse events was reported, and the numbers for each group were not specified: of the 94 participants, there were four deaths, 26 recurrent RDs, 22 patients with glaucoma, four patients with cataract, and two patients with capsular fibrosis (scarring behind a lens implant). The overall quality of these studies was moderately satisfactory. Although all trials employed proper randomization methods for participants, the masking of participants was unclear in all of the three RCTs, and masking of outcome assessors was not performed in two RCTs.
CochranePLS183
***TASK*** the task is to simplify the input abstract of a biomedical literature ***INPUT*** the input is the abstract of a biomedical literature ***OUTPUT*** the output is the simplified abstract for the input abstract of a biomedical literature ***EXAMPLES*** Input: Output: ***EXAMPLES*** Input: Two trials (n = 190), at low risk of bias, were included in the review and both presented data on first time failure at the tooth level. Pooling of the data showed a statistically significant difference in favour of molar bands, with a hazard ratio of 2.92 (95% confidence intervals (CI) 1.80 to 4.72). No statistically significant heterogeneity was shown between the two studies. Data on first time failure at the patient level were also available and showed statistically different difference in favour of molar bands (risk ratio 2.30; 95% CI 1.56 to 3.41) (risk of event for molar tubes = 57%; risk of event for molar bands 25%). One trial presented data on decalcification again showing a statistically significant difference in favour of molar bands. No other adverse events identified. From the two well-designed and low risk of bias trials included in this review it was shown that the failure of molar tubes bonded with either a chemically-cured or light-cured adhesive was considerably higher than that of molar bands cemented with glass ionomer cement. One trial indicated that there was less decalcification with molar bands cemented with glass ionomer cement than with bonded molar tubes cemented with a light-cured adhesive. However, given there are limited data for this outcome, further evidence is required to draw more robust conclusions. Output: The evidence in this review, which was carried out together with Cochrane Oral Health, is up-to-date as of 15 February 2017. We included two studies that evaluated 190 participants. Both trials were conducted in the UK and both compared bonded molar tubes with molar bands. From the limited data of two studies at low risk of bias, it would appear that bonded molar tubes are associated with a higher failure rate than with molar bands. Input: We included five studies (involving 1819 women) in this review. There was a lower risk of composite maternal mortality and severe morbidity for women randomised to receive planned early delivery (risk ratio (RR) 0.69, 95% confidence interval (CI) 0.57 to 0.83, two studies, 1459 women (evidence graded high)). There were no clear differences between subgroups based on our subgroup analysis by gestational age, gestational week or condition. Planned early delivery was associated with lower risk of HELLP syndrome (RR 0.40, 95% CI 0.17 to 0.93, 1628 women; three studies) and severe renal impairment (RR 0.36, 95% CI 0.14 to 0.92, 100 women, one study). There was not enough information to draw any conclusions about the effects on composite infant mortality and severe morbidity. We observed a high level of heterogeneity between the two studies in this analysis (two studies, 1459 infants, I2 = 87%, Tau2 = 0.98), so we did not pool data in meta-analysis. There were no clear differences between subgroups based on our subgroup analysis by gestational age, gestational week or condition. Planned early delivery was associated with higher levels of respiratory distress syndrome (RR 2.24, 95% CI 1.20 to 4.18, three studies, 1511 infants), and NICU admission (RR 1.65, 95% CI 1.13 to 2.40, four studies, 1585 infants). There was no clear difference between groups for caesarean section (RR 0.91, 95% CI 0.78 to 1.07, 1728 women, four studies, evidence graded moderate), or in the duration of hospital stay for the mother after delivery of the baby (mean difference (MD) -0.16 days, 95% CI -0.46 to 0.15, two studies, 925 women, evidence graded moderate) or for the baby (MD -0.20 days, 95% CI -0.57 to 0.17, one study, 756 infants, evidence graded moderate). Two fairly large, well-designed trials with overall low risk of bias contributed the majority of the evidence. Other studies were at low or unclear risk of bias. No studies attempted to blind participants or clinicians to group allocation, potentially introducing bias as women and staff would have been aware of the intervention and this may have affected aspects of care and decision-making. The level of evidence was graded high (composite maternal mortality and morbidity), moderate (caesarean section, duration of hospital stay after delivery for mother, and duration of hospital stay after delivery for baby) or low (composite infant mortality and morbidity). Where the evidence was downgraded, it was mostly because the confidence intervals were wide, crossing both the line of no effect and appreciable benefit or harm. For women suffering from hypertensive disorders of pregnancy after 34 weeks, planned early delivery is associated with less composite maternal morbidity and mortality. There is no clear difference in the composite outcome of infant mortality and severe morbidity; however, this is based on limited data (from two trials) assessing all hypertensive disorders as one group. Further studies are needed to look at the different types of hypertensive diseases and the optimal timing of delivery for these conditions. These studies should also include infant and maternal morbidity and mortality outcomes, caesarean section, duration of hospital stay after delivery for mother and duration of hospital stay after delivery for baby. An individual patient meta-analysis on the data currently available would provide further information on the outcomes of the different types of hypertensive disease encountered in pregnancy. Output:
We searched for evidence on 12 January 2016 and found five randomised studies, involving 1819 women. Two of the studies were large, high-quality studies, in women with gestational hypertension, mild pre-eclampsia or deteriorating existing hypertension at 34 to 37 weeks (704 women) or with gestational hypertension or mild pre-eclampsia at 36 to 41 weeks (756 women). Fewer women who received planned early delivery experienced severe adverse outcomes (1459 women, high-quality evidence). There was not enough information to draw any conclusions about the effects on the number of babies born with poor health, with a high level of variability between the two studies (1459 infants, low-quality evidence). There was no clear difference between planned early delivery and delayed delivery for the number of caesarean sections (four studies, 1728 women, moderate-quality evidence), or the duration of the mother’s hospital stay after the birth of the baby (two studies, 925 women, moderate-quality evidence) (or for the baby (one study, 756 infants, moderate-quality evidence)). More babies who were delivered early had breathing problems (respiratory distress syndrome, three studies, 1511 infants), or were admitted to the neonatal unit (four studies, 1585 infants). Fewer women who delivered early developed HELLP syndrome (three studies, 1628 women) or severe kidney problems (one study, 100 women). Two studies compared women who had labour induced at 34 to 36 weeks and at 34 to 37 weeks with a comparison group who were monitored until 37 weeks, when induction was begun if labour had not started spontaneously. Three studies compared induction of labour at term or closer to term, at 37 completed weeks and at 36 to 41 weeks, with women who were monitored until 41 weeks when induction was begun if labour had not started spontaneously. Other inclusion and exclusion criteria also differed between the five studies. No studies attempted to blind the women or their clinicians to which group they were in. Women and staff were aware of the intervention and this may have affected aspects of care and decision-making. Most of the evidence was of moderate quality, so we can be moderately certain about the findings. Overall, if a woman’s baby was delivered immediately after 34 weeks, there was less risk of a complication for the mother and no clear difference in the overall rate of complications for the baby, but information was limited. These findings are applicable to general obstetric practice when high blood pressure disorders during pregnancy are considered together. Further studies are needed to look at the different types of hypertensive disorders individually.
CochranePLS184
***TASK*** the task is to simplify the input abstract of a biomedical literature ***INPUT*** the input is the abstract of a biomedical literature ***OUTPUT*** the output is the simplified abstract for the input abstract of a biomedical literature ***EXAMPLES*** Input: Output: ***EXAMPLES*** Input: Two trials (n = 190), at low risk of bias, were included in the review and both presented data on first time failure at the tooth level. Pooling of the data showed a statistically significant difference in favour of molar bands, with a hazard ratio of 2.92 (95% confidence intervals (CI) 1.80 to 4.72). No statistically significant heterogeneity was shown between the two studies. Data on first time failure at the patient level were also available and showed statistically different difference in favour of molar bands (risk ratio 2.30; 95% CI 1.56 to 3.41) (risk of event for molar tubes = 57%; risk of event for molar bands 25%). One trial presented data on decalcification again showing a statistically significant difference in favour of molar bands. No other adverse events identified. From the two well-designed and low risk of bias trials included in this review it was shown that the failure of molar tubes bonded with either a chemically-cured or light-cured adhesive was considerably higher than that of molar bands cemented with glass ionomer cement. One trial indicated that there was less decalcification with molar bands cemented with glass ionomer cement than with bonded molar tubes cemented with a light-cured adhesive. However, given there are limited data for this outcome, further evidence is required to draw more robust conclusions. Output: The evidence in this review, which was carried out together with Cochrane Oral Health, is up-to-date as of 15 February 2017. We included two studies that evaluated 190 participants. Both trials were conducted in the UK and both compared bonded molar tubes with molar bands. From the limited data of two studies at low risk of bias, it would appear that bonded molar tubes are associated with a higher failure rate than with molar bands. Input: Six studies (including 142 participants) were eligible for inclusion. Two compared three-times-a-week prophylactic administration with on-demand treatment in children with hemophilia. Pooled results from these two studies showed a rate ratio of 0.30 (95% confidence interval; 0.12 to 0.76) for all bleedings and 0.22 (95% confidence interval 0.08 to 0.63) for joint bleedings favouring prophylaxis. Results on the number of patients with preserved joints after three to seven years of follow-up were not pooled due to significant heterogeneity. Three of the remaining four studies evaluated hemophilia A; one showed a statistically significant decrease in frequency of joint bleeds with prophylaxis compared to placebo, with a rate difference of -10.73 (95% confidence interval -16.55 to -4.91) bleeds per year. Two studies compared two prophylaxis regimens, failing to demonstrate an advantage of one regimen over the other in terms of bleeding frequency. The fourth study evaluated hemophilia B and showed fewer joint bleeds with weekly (15 IU/kg) versus bi-weekly (7.5 IU/kg) prophylaxis, rate difference -3.30 (95% confidence interval -5.50 to -1.10) bleeds per year. Non-significant increases in both inhibitor and infectious complications were observed in patients on prophylaxis, which occurred more often when using long-term venous access. There is strong evidence from randomised controlled trials and observational trials that prophylaxis preserves joint function in children with hemophilia as compared to on-demand treatment. There is insufficient evidence from randomised controlled trials to confirm the observational evidence that prophylaxis decreases bleeding and related complications in patients with existing joint damage. Well-designed randomised controlled trials and prospective observational controlled studies are needed to establish the best prophylactic regimen and to assess the effectiveness of prophylactic clotting factor concentrates in adult patients. Output:
This review includes six randomised controlled trials. Two compare the regular use of clotting factor concentrates to prevent joint bleeds with their use 'on demand'. Four compare different regimens of regular use in children and adults with hemophilia. It was clearly evident that preventative therapy, as intravenous infusion of factor concentrate repeated more times a week and started early in childhood was able to reduce joint deterioration as compared to treatment administered after bleeding occurred. This favourable effect is due to a consistent reduction in total bleeds and hemarthrosis (bleeding into joints) and leads to a significant improvement in quality of life. Preventative therapy is linked to an increased factor usage and cost of treatment. We found weaker evidence (due to lack of data) to show preventative therapy reduced joint deterioration when treatment is started after joint damage has been established. Further studies are needed to establish the best preventative regimen, i.e. for example starting time, dosage frequency, minimally effective dose.
CochranePLS185
***TASK*** the task is to simplify the input abstract of a biomedical literature ***INPUT*** the input is the abstract of a biomedical literature ***OUTPUT*** the output is the simplified abstract for the input abstract of a biomedical literature ***EXAMPLES*** Input: Output: ***EXAMPLES*** Input: Two trials (n = 190), at low risk of bias, were included in the review and both presented data on first time failure at the tooth level. Pooling of the data showed a statistically significant difference in favour of molar bands, with a hazard ratio of 2.92 (95% confidence intervals (CI) 1.80 to 4.72). No statistically significant heterogeneity was shown between the two studies. Data on first time failure at the patient level were also available and showed statistically different difference in favour of molar bands (risk ratio 2.30; 95% CI 1.56 to 3.41) (risk of event for molar tubes = 57%; risk of event for molar bands 25%). One trial presented data on decalcification again showing a statistically significant difference in favour of molar bands. No other adverse events identified. From the two well-designed and low risk of bias trials included in this review it was shown that the failure of molar tubes bonded with either a chemically-cured or light-cured adhesive was considerably higher than that of molar bands cemented with glass ionomer cement. One trial indicated that there was less decalcification with molar bands cemented with glass ionomer cement than with bonded molar tubes cemented with a light-cured adhesive. However, given there are limited data for this outcome, further evidence is required to draw more robust conclusions. Output: The evidence in this review, which was carried out together with Cochrane Oral Health, is up-to-date as of 15 February 2017. We included two studies that evaluated 190 participants. Both trials were conducted in the UK and both compared bonded molar tubes with molar bands. From the limited data of two studies at low risk of bias, it would appear that bonded molar tubes are associated with a higher failure rate than with molar bands. Input: We included one new study in this update. In total, 13 trials involving 1824 participants met the inclusion criteria for this review however, data in usable format were only available in 10 trials (732 participants). Inadequate reporting of study methodology was a common feature of the trials preventing thorough assessment of study quality. We were unable to pool data for any of the outcomes due to the differences between the interventions assessed in the studies. Eight studies aimed to induce remission; overall survival did not differ significantly between treatment groups. Five studies aimed to maintain remission. In two out of three studies reporting survival, this was substantial but the difference was not statistically significant between treatment groups. Less aggressive treatment schedules appear to produce similar effects with less adverse event profiles. This review notes a preference in more recent studies for less aggressive care options for treatment of BL. However, the evidence for the relative effectiveness of interventions to treat BL is not strong as studies were small, underpowered and prone to both systematic and random error. We included one additional trial without change of conclusions. Output:
This review aims to evaluate these treatments to assess their effectiveness especially for later stages. The review identified 13 trials involving 1824 participants. However, data presentable for the review were only available in 10 trials with 732 participants. The data were difficult to collate because of the quality of the study methods and the reporting of the results; outcome measures differed between trials and they were mainly small-sized trials. No significant differences in overall survival were seen between studies aimed at inducing remission. Adverse events reported were mostly due to infections and reductions in blood cell counts. The more recent studies were focused on using less intensive treatment regimens as they could provide similar responses with lower risk of adverse effects.
CochranePLS186
***TASK*** the task is to simplify the input abstract of a biomedical literature ***INPUT*** the input is the abstract of a biomedical literature ***OUTPUT*** the output is the simplified abstract for the input abstract of a biomedical literature ***EXAMPLES*** Input: Output: ***EXAMPLES*** Input: Two trials (n = 190), at low risk of bias, were included in the review and both presented data on first time failure at the tooth level. Pooling of the data showed a statistically significant difference in favour of molar bands, with a hazard ratio of 2.92 (95% confidence intervals (CI) 1.80 to 4.72). No statistically significant heterogeneity was shown between the two studies. Data on first time failure at the patient level were also available and showed statistically different difference in favour of molar bands (risk ratio 2.30; 95% CI 1.56 to 3.41) (risk of event for molar tubes = 57%; risk of event for molar bands 25%). One trial presented data on decalcification again showing a statistically significant difference in favour of molar bands. No other adverse events identified. From the two well-designed and low risk of bias trials included in this review it was shown that the failure of molar tubes bonded with either a chemically-cured or light-cured adhesive was considerably higher than that of molar bands cemented with glass ionomer cement. One trial indicated that there was less decalcification with molar bands cemented with glass ionomer cement than with bonded molar tubes cemented with a light-cured adhesive. However, given there are limited data for this outcome, further evidence is required to draw more robust conclusions. Output: The evidence in this review, which was carried out together with Cochrane Oral Health, is up-to-date as of 15 February 2017. We included two studies that evaluated 190 participants. Both trials were conducted in the UK and both compared bonded molar tubes with molar bands. From the limited data of two studies at low risk of bias, it would appear that bonded molar tubes are associated with a higher failure rate than with molar bands. Input: Two studies involving 447 (with sample sizes 14 and 432) RhD negative women were included. The studies compared IM and IV administration of anti-D prophylaxis. In both studies the women received a 1500 IU (300 microgram) dose of Rhophylac during week 28 of gestation. There was no incidence of RhD alloimmunization in either of the studies, as the sample size was insufficient for meaningful comparison of this uncommon outcome. One of the studies found that the mean anti-D IgG concentrations after IV and IM administration differed up to seven days (36.1 (2.6) ng/mL IV; 19.8 (8.7) ng/mL IM on day seven). However, from two to three weeks post-administration, the concentrations were similar for both routes of administration. None of the women involved in the studies developed antibodies against the RhD antigen. It appears that IM and IV administration of anti-D are equally effective. The number of included studies and the number of participants are not enough to assess whether there are any differences. Anti-D can be administered by IM or IV injection. The choice of IM or IV route of administration will depend on the available preparations, the dose to be administered and also on the patients' preferences. This review found insufficient information upon which to guide practice due to the limited number of included studies, small sample sizes and methodological limitations. Output:
We identified two completed randomized controlled studies, involving 447 RhD-negative women. The findings suggest that intramuscular and intravenous anti-D in the 28th week of pregnancy are equally effective in preventing RhD antibody formation (alloimmunization) during the pregnancy. None of the women developed antibodies against the RhD antigen. The small number of studies, low number of participants and methodological limitations mean that we do not have sufficient information to guide practice. The choice of intramuscular or intravenous route of administration will depend on available preparations, the dose to be administered and the woman's preference.
CochranePLS187
***TASK*** the task is to simplify the input abstract of a biomedical literature ***INPUT*** the input is the abstract of a biomedical literature ***OUTPUT*** the output is the simplified abstract for the input abstract of a biomedical literature ***EXAMPLES*** Input: Output: ***EXAMPLES*** Input: Two trials (n = 190), at low risk of bias, were included in the review and both presented data on first time failure at the tooth level. Pooling of the data showed a statistically significant difference in favour of molar bands, with a hazard ratio of 2.92 (95% confidence intervals (CI) 1.80 to 4.72). No statistically significant heterogeneity was shown between the two studies. Data on first time failure at the patient level were also available and showed statistically different difference in favour of molar bands (risk ratio 2.30; 95% CI 1.56 to 3.41) (risk of event for molar tubes = 57%; risk of event for molar bands 25%). One trial presented data on decalcification again showing a statistically significant difference in favour of molar bands. No other adverse events identified. From the two well-designed and low risk of bias trials included in this review it was shown that the failure of molar tubes bonded with either a chemically-cured or light-cured adhesive was considerably higher than that of molar bands cemented with glass ionomer cement. One trial indicated that there was less decalcification with molar bands cemented with glass ionomer cement than with bonded molar tubes cemented with a light-cured adhesive. However, given there are limited data for this outcome, further evidence is required to draw more robust conclusions. Output: The evidence in this review, which was carried out together with Cochrane Oral Health, is up-to-date as of 15 February 2017. We included two studies that evaluated 190 participants. Both trials were conducted in the UK and both compared bonded molar tubes with molar bands. From the limited data of two studies at low risk of bias, it would appear that bonded molar tubes are associated with a higher failure rate than with molar bands. Input: Eight studies with a total of 21,379 patients with diabetes were included. Three included studies investigated ticlopidine compared to aspirin or placebo. Five included studies investigated clopidogrel compared to aspirin or a combination of aspirin and dipyridamole, or compared clopidogrel in combination with aspirin to aspirin alone. All trials included patients with previous CVD except the CHARISMA trial which included patients with multiple risk factors for coronary artery disease. Overall the risk of bias of the trials was low. The mean duration of follow-up ranged from 365 days to 913 days. Data for diabetes patients on all-cause mortality, vascular mortality and myocardial infarction were only available for one trial (355 patients). This trial compared ticlopidine to placebo and did not demonstrate any statistically significant differences for all-cause mortality, vascular mortality or myocardial infarction. Diabetes outcome data for stroke were available in three trials (31% of total diabetes participants). Overall pooling of two (statistically heterogeneous) studies showed no statistically significant reduction in the combination of fatal and non-fatal stroke (359/3194 (11.2%) versus 356/3146 (11.3%), random effects odds ratio (OR) 0.81; 95% confidence interval (CI) 0.44 to 1.49) for ADP receptor antagonists versus other antiplatelet drugs. There were no data available from any of the trials on peripheral vascular disease, health-related quality of life, adverse events specifically for patients with diabetes, or costs. The available evidence for ADP receptor antagonists in patients with diabetes mellitus is limited and most trials do not report outcomes for patients with diabetes separately. Therefore, recommendations for the use of ADP receptor antagonists for the prevention of CVD in patients with diabetes are based on available evidence from trials including patients with and without diabetes. Trials with diabetes patients and subgroup analyses of patients with diabetes in trials with combined populations are needed to provide a more robust evidence base to guide clinical management in patients with diabetes. Output:
This review assessed if these medications would be useful in patients with diabetes. We included eight trials with 21,379 patients and a mean duration of follow-up ranging from 365 to 913 days. Specific data for patients with diabetes were only available in full for one of these trials and partial data were available for two trials. Analysis of the available data demonstrated that adenosine-diphosphate receptor antagonists (such as clopidogrel, prasugrel, ticagrelor, ticlopidine) were not more effective than other blood thinning drugs or placebo for death from any cause, death related to cardiovascular disease, heart attacks or strokes. There was no available information on the effects of adenosine-diphosphate receptor antagonists on health-related quality of life, adverse effects specially for people with diabetes, or costs. The use of adenosine-diphosphate receptor antagonists in patients with diabetes needs to be guided by the information available from trials which included patients with and without diabetes. All future trials on adenosine-diphosphate receptor antagonists should include data which relate specifically to patients with diabetes in order to inform evidence-based clinical guidelines.
CochranePLS188
***TASK*** the task is to simplify the input abstract of a biomedical literature ***INPUT*** the input is the abstract of a biomedical literature ***OUTPUT*** the output is the simplified abstract for the input abstract of a biomedical literature ***EXAMPLES*** Input: Output: ***EXAMPLES*** Input: Two trials (n = 190), at low risk of bias, were included in the review and both presented data on first time failure at the tooth level. Pooling of the data showed a statistically significant difference in favour of molar bands, with a hazard ratio of 2.92 (95% confidence intervals (CI) 1.80 to 4.72). No statistically significant heterogeneity was shown between the two studies. Data on first time failure at the patient level were also available and showed statistically different difference in favour of molar bands (risk ratio 2.30; 95% CI 1.56 to 3.41) (risk of event for molar tubes = 57%; risk of event for molar bands 25%). One trial presented data on decalcification again showing a statistically significant difference in favour of molar bands. No other adverse events identified. From the two well-designed and low risk of bias trials included in this review it was shown that the failure of molar tubes bonded with either a chemically-cured or light-cured adhesive was considerably higher than that of molar bands cemented with glass ionomer cement. One trial indicated that there was less decalcification with molar bands cemented with glass ionomer cement than with bonded molar tubes cemented with a light-cured adhesive. However, given there are limited data for this outcome, further evidence is required to draw more robust conclusions. Output: The evidence in this review, which was carried out together with Cochrane Oral Health, is up-to-date as of 15 February 2017. We included two studies that evaluated 190 participants. Both trials were conducted in the UK and both compared bonded molar tubes with molar bands. From the limited data of two studies at low risk of bias, it would appear that bonded molar tubes are associated with a higher failure rate than with molar bands. Input: Ten trials met the inclusion criteria with a total of 191 participants. Seven trials evaluated single treatment sessions, one evaluated a two-week intervention, one evaluated a six-week intervention and one a three-month intervention. It is only possible to blind trials of airway clearance and overnight ventilatory support to the outcome assessors. In most of the trials we judged there was an unclear risk of bias with regards to blinding due to inadequate descriptions. The six-week trial was the only one judged to have a low risk of bias for all other domains. One single intervention trial had a low risk of bias for the randomisation procedure with the remaining trials judged to have an unclear risk of bias. Most trials had a low risk of bias with regard to incomplete outcome data and selective reporting. Six trials (151 participants) evaluated non-invasive ventilation for airway clearance compared with an alternative chest physiotherapy method such as the active cycle of breathing techniques or positive expiratory pressure. Three trials used nasal masks, one used a nasal mask or mouthpiece and one trial used a face mask and in one trial it is unclear. Three of the trials reported on one of the review's primary outcome measures (quality of life). Results for the reviews secondary outcomes showed that airway clearance may be easier with non-invasive ventilation and people with cystic fibrosis may prefer it. We were unable to find any evidence that non-invasive ventilation increases sputum expectoration, but it did improve some lung function parameters. Three trials (27 participants) evaluated non-invasive ventilation for overnight ventilatory support compared to oxygen or room air using nasal masks (two trials) and nasal masks or full face masks (one trial). Trials reported on two of the review's primary outcomes (quality of life and symptoms of sleep-disordered breathing). Results for the reviews secondary outcome measures showed that they measured lung function, gas exchange, adherence to treatment and preference, and nocturnal transcutaneous carbon dioxide. Due to the small numbers of participants and statistical issues, there were discrepancies in the results between the RevMan and the original trial analyses. No clear differences were found between non-invasive ventilation compared with oxygen or room air except for exercise performance, which significantly improved with non-invasive ventilation compared to room air over six weeks. One trial (13 participants) evaluated non-invasive ventilation on exercise capacity (interface used was unclear) and did not reported on any of the review's primary outcomes. The trial found no clear differences between non-invasive ventilation compared to no non-invasive ventilation for any of our outcomes. Three trials reported on adverse effects. One trial, evaluating non-invasive ventilation for airway clearance, reported that a participant withdrew at the start of the trial due to pain on respiratory muscle testing. One trial evaluating non-invasive ventilation for overnight support reported that one participant could not tolerate an increase in inspiratory positive airway pressure. A second trial evaluating non-invasive ventilation in this setting reported that one participant did not tolerate the non-invasive ventilation mask, one participant developed a pneumothorax when breathing room air and two participants experienced aerophagia which resolved when inspiratory positive airway pressure was decreased. Non-invasive ventilation may be a useful adjunct to other airway clearance techniques, particularly in people with cystic fibrosis who have difficulty expectorating sputum. Non-invasive ventilation, used in addition to oxygen, may improve gas exchange during sleep to a greater extent than oxygen therapy alone in moderate to severe disease. The effect of NIV on exercise is unclear. These benefits of non-invasive ventilation have largely been demonstrated in single treatment sessions with small numbers of participants. The impact of this therapy on pulmonary exacerbations and disease progression remain unclear. There is a need for long-term randomised controlled trials which are adequately powered to determine the clinical effects of non-invasive ventilation in cystic fibrosis airway clearance and exercise. Output:
This review includes 10 trials (191 people with cystic fibrosis) - seven single-treatment sessions and a two-week trial, a six-week trial and a three-month trial. Six single-treatment trials, the two-week trial and the three-month trial compared non-invasive ventilation with other airway clearance techniques. Two single-treatment trials and the six-week trial looked at non-invasive ventilation for overnight breathing support compared to oxygen or normal room air. One single-treatment trial compared non-invasive ventilation with no additional treatment during an exercise test. Single-treatment trials of non-invasive ventilation for airway clearance showed that this may be easier with non-invasive ventilation and people with cystic fibrosis may prefer it to other methods. We could not find evidence that non-invasive ventilation increased the amount of mucus coughed up, but it did improve some measures of lung function, at least in the short term. The two-week trial did not demonstrate clear benefits between groups. The original three-month trial report stated an improvement in lung clearance index. One person in one of these trials reported pain on respiratory muscle testing. The three trials comparing overnight support from non-invasive ventilation measured lung function, quality of life and carbon dioxide levels; they showed it is effective, safe and acceptable. We found no clear differences between non-invasive ventilation and oxygen or room air, except for exercise performance which improved with non-invasive ventilation compared to room air after six weeks. Two trials reported side effects. In the first trial, one person found the mask uncomfortable. In the second trial, one person in the room air group had collapsed lungs and two people could not tolerate increased pressure when breathing in. The trial comparing the effects of non-invasive ventilation to no treatment on exercise capacity found no clear differences between groups. Non-invasive ventilation may help alongside other airway clearance techniques, particularly when people with cystic fibrosis have difficulty coughing up mucus and during sleep. Long-term trials are needed with enough people to show the clinical effects of non-invasive ventilation on airway clearance, during sleep and exercise training in severe disease. The benefits of non-invasive ventilation have largely been demonstrated in single-treatment sessions with only small numbers of people. There is limited evidence of some longer-term improvement in lung function in one trial. Our results from the trials of overnight breathing support differed from those in the original analyses, this is likely due to the small numbers of participants and some statistical issues. We judged only the six-week trial to be free from any bias. In the remaining trials, we thought there were low or unclear chances of the results being affected because data were either reported only partially or not at all. We were not sure if the way in which participants were put into the different treatment groups would affect the results of the trials.
CochranePLS189
***TASK*** the task is to simplify the input abstract of a biomedical literature ***INPUT*** the input is the abstract of a biomedical literature ***OUTPUT*** the output is the simplified abstract for the input abstract of a biomedical literature ***EXAMPLES*** Input: Output: ***EXAMPLES*** Input: Two trials (n = 190), at low risk of bias, were included in the review and both presented data on first time failure at the tooth level. Pooling of the data showed a statistically significant difference in favour of molar bands, with a hazard ratio of 2.92 (95% confidence intervals (CI) 1.80 to 4.72). No statistically significant heterogeneity was shown between the two studies. Data on first time failure at the patient level were also available and showed statistically different difference in favour of molar bands (risk ratio 2.30; 95% CI 1.56 to 3.41) (risk of event for molar tubes = 57%; risk of event for molar bands 25%). One trial presented data on decalcification again showing a statistically significant difference in favour of molar bands. No other adverse events identified. From the two well-designed and low risk of bias trials included in this review it was shown that the failure of molar tubes bonded with either a chemically-cured or light-cured adhesive was considerably higher than that of molar bands cemented with glass ionomer cement. One trial indicated that there was less decalcification with molar bands cemented with glass ionomer cement than with bonded molar tubes cemented with a light-cured adhesive. However, given there are limited data for this outcome, further evidence is required to draw more robust conclusions. Output: The evidence in this review, which was carried out together with Cochrane Oral Health, is up-to-date as of 15 February 2017. We included two studies that evaluated 190 participants. Both trials were conducted in the UK and both compared bonded molar tubes with molar bands. From the limited data of two studies at low risk of bias, it would appear that bonded molar tubes are associated with a higher failure rate than with molar bands. Input: This update of the systematic review on nocturnal-NIPPV in COPD (Wijkstra 2002), has led to the inclusion of three new studies, leading to seven included studies on 245 people. We obtained IPD for all participants in all included studies. The 95% confidence interval (CI) of all outcomes included zero. These included partial pressure of CO2 and O2 in arterial blood, six-minute walking distance (6MWD), health-related quality of life (HRQoL), forced expiratory volume in one second (FEV1), forced vital capacity (FVC), maximal inspiratory pressure (PImax) and sleep efficiency. The mean effect on 6MWD was small at 27.7 m and not statistically significant. Given the width of the 95% CI (-28.1 to 66.3 m), the real effect of NIPPV on 6MWD is uncertain and we cannot exclude an effect that is clinically significant (considering that the minimal clinically difference on 6MWD is around 26 m). Nocturnal-NIPPV at home for at least three months in hypercapnic patients with stable COPD had no consistent clinically or statistically significant effect on gas exchange, exercise tolerance, HRQoL, lung function, respiratory muscle strength or sleep efficiency. Meta-analysis of the two new long-term studies did not show significant improvements in blood gases, HRQoL or lung function after 12 months of NIPPV. However, the small sample sizes of these studies preclude a definite conclusion regarding the effects of NIPPV in COPD. Output:
The evidence is current to August 2012. We found seven studies that reported the effects of NIPPV at home. Five of these studies looked at the effects after using NIPPV compared to regular treatment (without NIPPV) for at least three months. Two studies looked for a longer period of time, for at least 12 months. The mean age of all participants included in our meta-analysis was 67 years. All studies included men and women, but 77% of participants were men. We used data from 245 people for our meta-analysis. NIPPV during the night for 3 and 12 months in people with COPD who had raised levels of carbon dioxide had no clinically or statistically significant effect on gas exchange, six-minute walking distance, health-related quality of life, lung function, respiratory muscle strength and sleep efficiency. This means we found little or no difference in the outcomes. Because some trials had very small numbers of participants, our confidence in the quality of evidence is moderate when looking at the effects on gas exchange. All seven trials measured this outcome. Other outcomes were not always measured or available leading to a lower quality of evidence for the other outcomes such as six-minute walking distance, health-related quality of life, lung function, respiratory muscle function and sleep efficiency.
CochranePLS190
***TASK*** the task is to simplify the input abstract of a biomedical literature ***INPUT*** the input is the abstract of a biomedical literature ***OUTPUT*** the output is the simplified abstract for the input abstract of a biomedical literature ***EXAMPLES*** Input: Output: ***EXAMPLES*** Input: Two trials (n = 190), at low risk of bias, were included in the review and both presented data on first time failure at the tooth level. Pooling of the data showed a statistically significant difference in favour of molar bands, with a hazard ratio of 2.92 (95% confidence intervals (CI) 1.80 to 4.72). No statistically significant heterogeneity was shown between the two studies. Data on first time failure at the patient level were also available and showed statistically different difference in favour of molar bands (risk ratio 2.30; 95% CI 1.56 to 3.41) (risk of event for molar tubes = 57%; risk of event for molar bands 25%). One trial presented data on decalcification again showing a statistically significant difference in favour of molar bands. No other adverse events identified. From the two well-designed and low risk of bias trials included in this review it was shown that the failure of molar tubes bonded with either a chemically-cured or light-cured adhesive was considerably higher than that of molar bands cemented with glass ionomer cement. One trial indicated that there was less decalcification with molar bands cemented with glass ionomer cement than with bonded molar tubes cemented with a light-cured adhesive. However, given there are limited data for this outcome, further evidence is required to draw more robust conclusions. Output: The evidence in this review, which was carried out together with Cochrane Oral Health, is up-to-date as of 15 February 2017. We included two studies that evaluated 190 participants. Both trials were conducted in the UK and both compared bonded molar tubes with molar bands. From the limited data of two studies at low risk of bias, it would appear that bonded molar tubes are associated with a higher failure rate than with molar bands. Input: We included four trials, involving 1190 women. It was not possible to blind women and staff to the intervention, but for other 'Risk of bias' domains these studies were assessed as being at low or unclear risk of bias. Compared to expectant management, there was no clear effect of induction of labour for suspected macrosomia on the risk of caesarean section (risk ratio (RR) 0.91, 95% confidence interval (CI) 0.76 to 1.09; 1190 women; four trials, moderate-quality evidence) or instrumental delivery (RR 0.86, 95% CI 0.65 to 1.13; 1190 women; four trials, low-quality evidence). Shoulder dystocia (RR 0.60, 95% CI 0.37 to 0.98; 1190 women; four trials, moderate-quality evidence), and fracture (any) (RR 0.20, 95% CI 0.05 to 0.79; 1190 women; four studies, high-quality evidence) were reduced in the induction of labour group. There were no clear differences between groups for brachial plexus injury (two events were reported in the control group in one trial, low-quality evidence). There was no strong evidence of any difference between groups for measures of neonatal asphyxia; low five-minute infant Apgar scores (less than seven) or low arterial cord blood pH (RR 1.51, 95% CI 0.25 to 9.02; 858 infants; two trials, low-quality evidence; and, RR 1.01, 95% CI 0.46 to 2.22; 818 infants; one trial, moderate-quality evidence, respectively). Mean birthweight was lower in the induction group, but there was considerable heterogeneity between studies for this outcome (mean difference (MD) -178.03 g, 95% CI -315.26 to -40.81; 1190 infants; four studies; I2 = 89%). In one study with data for 818 women, third- and fourth-degree perineal tears were increased in the induction group (RR 3.70, 95% CI 1.04 to 13.17). For outcomes assessed using GRADE, we based our downgrading decisions on high risk of bias from lack of blinding and imprecision of effect estimates. Induction of labour for suspected fetal macrosomia has not been shown to alter the risk of brachial plexus injury, but the power of the included studies to show a difference for such a rare event is limited. Also antenatal estimates of fetal weight are often inaccurate so many women may be worried unnecessarily, and many inductions may not be needed. Nevertheless, induction of labour for suspected fetal macrosomia results in a lower mean birthweight, and fewer birth fractures and shoulder dystocia. The unexpected observation in the induction group of increased perineal damage, and the plausible, but of uncertain significance, observation of increased use of phototherapy, both in the largest trial, should also be kept in mind. Findings from trials included in the review suggest that to prevent one fracture it would be necessary to induce labour in 60 women. Since induction of labour does not appear to alter the rate of caesarean delivery or instrumental delivery, it is likely to be popular with many women. In settings where obstetricians can be reasonably confident about their scan assessment of fetal weight, the advantages and disadvantages of induction at or near term for fetuses suspected of being macrosomic should be discussed with parents. Although some parents and doctors may feel the evidence already justifies induction, others may justifiably disagree. Further trials of induction shortly before term for suspected fetal macrosomia are needed. Such trials should concentrate on refining the optimum gestation of induction, and improving the accuracy of the diagnosis of macrosomia. Output:
We found four trials that assessed induction of labour at 37 to 40 weeks for women when it was suspected that their baby was large. A total of 1190 pregnant, non-diabetic women were involved. We searched for evidence on 31 October 2015. The studies were of moderate or good quality although it was not possible to blind the women and staff providing care to which group women had been assigned. This may have introduced bias. The number of births where the baby's shoulder became stuck (shoulder dystocia) or a bone was fractured (usually the clavicle, which heals well without consequences) were reduced in the induction of labour group. The evidence was assessed as moderate quality for shoulder dystocia and high quality for fracture. No clear differences between groups were reported for damage to the network of nerves that send signals from the spine to the shoulder, arm and hand (brachial plexus injury) of the baby (low-quality evidence due to very few events occurring) or signs of not enough oxygen during birth. A policy of labour induction reduced the average birthweight of babies by 178 g. The trials did not show any differences in the number of women who had caesarean sections or instrumental births. There is limited evidence that more women in the induction of labour group had severe damage to the perineum. We conclude that there appear to be benefits, but there may also be some disadvantages of induction of labour shortly before term. The option of having an induction should be discussed with parents when their baby is suspected to be extra large. Although some parents and doctors may feel the existing evidence is sufficient to justify inducing labour, others may disagree. Further high-quality studies are needed in order to find out what is the best time to induce labour towards the end of pregnancy, and how to improve the accuracy in diagnosing macrosomia. A visual summary of some of the results from this review can be found here (screen view version) and (printable version here).
CochranePLS191
***TASK*** the task is to simplify the input abstract of a biomedical literature ***INPUT*** the input is the abstract of a biomedical literature ***OUTPUT*** the output is the simplified abstract for the input abstract of a biomedical literature ***EXAMPLES*** Input: Output: ***EXAMPLES*** Input: Two trials (n = 190), at low risk of bias, were included in the review and both presented data on first time failure at the tooth level. Pooling of the data showed a statistically significant difference in favour of molar bands, with a hazard ratio of 2.92 (95% confidence intervals (CI) 1.80 to 4.72). No statistically significant heterogeneity was shown between the two studies. Data on first time failure at the patient level were also available and showed statistically different difference in favour of molar bands (risk ratio 2.30; 95% CI 1.56 to 3.41) (risk of event for molar tubes = 57%; risk of event for molar bands 25%). One trial presented data on decalcification again showing a statistically significant difference in favour of molar bands. No other adverse events identified. From the two well-designed and low risk of bias trials included in this review it was shown that the failure of molar tubes bonded with either a chemically-cured or light-cured adhesive was considerably higher than that of molar bands cemented with glass ionomer cement. One trial indicated that there was less decalcification with molar bands cemented with glass ionomer cement than with bonded molar tubes cemented with a light-cured adhesive. However, given there are limited data for this outcome, further evidence is required to draw more robust conclusions. Output: The evidence in this review, which was carried out together with Cochrane Oral Health, is up-to-date as of 15 February 2017. We included two studies that evaluated 190 participants. Both trials were conducted in the UK and both compared bonded molar tubes with molar bands. From the limited data of two studies at low risk of bias, it would appear that bonded molar tubes are associated with a higher failure rate than with molar bands. Input: We identified 159 randomised clinical trials. Ninety-four trials reported no mortality, and nine trials reported mortality but did not report in which intervention group the mortality occurred. Accordingly, 56 randomised trials with 95,286 participants provided usable data on mortality. The age of participants ranged from 18 to 107 years. Most trials included women older than 70 years. The mean proportion of women was 77%. Forty-eight of the trials randomly assigned 94,491 healthy participants. Of these, four trials included healthy volunteers, nine trials included postmenopausal women and 35 trials included older people living on their own or in institutional care. The remaining eight trials randomly assigned 795 participants with neurological, cardiovascular, respiratory or rheumatoid diseases. Vitamin D was administered for a weighted mean of 4.4 years. More than half of the trials had a low risk of bias. All trials were conducted in high-income countries. Forty-five trials (80%) reported the baseline vitamin D status of participants based on serum 25-hydroxyvitamin D levels. Participants in 19 trials had vitamin D adequacy (at or above 20 ng/mL). Participants in the remaining 26 trials had vitamin D insufficiency (less than 20 ng/mL). Vitamin D decreased mortality in all 56 trials analysed together (5,920/47,472 (12.5%) vs 6,077/47,814 (12.7%); RR 0.97 (95% confidence interval (CI) 0.94 to 0.99); P = 0.02; I2 = 0%). More than 8% of participants dropped out. 'Worst-best case' and 'best-worst case' scenario analyses demonstrated that vitamin D could be associated with a dramatic increase or decrease in mortality. When different forms of vitamin D were assessed in separate analyses, only vitamin D3 decreased mortality (4,153/37,817 (11.0%) vs 4,340/38,110 (11.4%); RR 0.94 (95% CI 0.91 to 0.98); P = 0.002; I2 = 0%; 75,927 participants; 38 trials). Vitamin D2, alfacalcidol and calcitriol did not significantly affect mortality. A subgroup analysis of trials at high risk of bias suggested that vitamin D2 may even increase mortality, but this finding could be due to random errors. Trial sequential analysis supported our finding regarding vitamin D3, with the cumulative Z-score breaking the trial sequential monitoring boundary for benefit, corresponding to 150 people treated over five years to prevent one additional death. We did not observe any statistically significant differences in the effect of vitamin D on mortality in subgroup analyses of trials at low risk of bias compared with trials at high risk of bias; of trials using placebo compared with trials using no intervention in the control group; of trials with no risk of industry bias compared with trials with risk of industry bias; of trials assessing primary prevention compared with trials assessing secondary prevention; of trials including participants with vitamin D level below 20 ng/mL at entry compared with trials including participants with vitamin D levels equal to or greater than 20 ng/mL at entry; of trials including ambulatory participants compared with trials including institutionalised participants; of trials using concomitant calcium supplementation compared with trials without calcium; of trials using a dose below 800 IU per day compared with trials using doses above 800 IU per day; and of trials including only women compared with trials including both sexes or only men. Vitamin D3 statistically significantly decreased cancer mortality (RR 0.88 (95% CI 0.78 to 0.98); P = 0.02; I2 = 0%; 44,492 participants; 4 trials). Vitamin D3 combined with calcium increased the risk of nephrolithiasis (RR 1.17 (95% CI 1.02 to 1.34); P = 0.02; I2 = 0%; 42,876 participants; 4 trials). Alfacalcidol and calcitriol increased the risk of hypercalcaemia (RR 3.18 (95% CI 1.17 to 8.68); P = 0.02; I2 = 17%; 710 participants; 3 trials). Vitamin D3 seemed to decrease mortality in elderly people living independently or in institutional care. Vitamin D2, alfacalcidol and calcitriol had no statistically significant beneficial effects on mortality. Vitamin D3 combined with calcium increased nephrolithiasis. Both alfacalcidol and calcitriol increased hypercalcaemia. Because of risks of attrition bias originating from substantial dropout of participants and of outcome reporting bias due to a number of trials not reporting on mortality, as well as a number of other weaknesses in our evidence, further placebo-controlled randomised trials seem warranted. Output:
In the 56 trials that provided data for the analyses, a total of 95,286 participants were randomly assigned to vitamin D versus no treatment or placebo. More than half of the trials were considered to have low risk of bias. All trials were conducted in high-income countries. The age of participants ranged from 18 to 107 years. The mean proportion of women was 77%. Vitamin D was administered for an average of 4.4 years. This plain language summary is as current as of February 2012. This review suggests that vitamin D3 may reduce mortality, showing that about 150 participants need to be treated over five years for one additional life to be saved. We found comparable effects of vitamin D3 in studies that included only women compared with studies including both women and men. Vitamin D3 also seemed to decrease cancer mortality, showing a reduction in mortality of 4 per 1000 persons treated for five to seven years. We also observed adverse effects to vitamin D such as renal stone formation (seen for vitamin D3 combined with calcium) and elevated blood levels of calcium (seen for both alfacalcidol and calcitriol). In conclusion, we found some evidence that vitamin D3 seems to decrease mortality in elderly people not dependent on help or living in institutional care. A large number of study participants left the trial before completion, and this raises concerns regarding the validity of the results. More randomised clinical trials are needed on the effects of vitamin D3 on mortality in younger, healthy persons, as well as in elderly community-dwelling and institutionalised persons without apparent vitamin D deficiency.
CochranePLS192
***TASK*** the task is to simplify the input abstract of a biomedical literature ***INPUT*** the input is the abstract of a biomedical literature ***OUTPUT*** the output is the simplified abstract for the input abstract of a biomedical literature ***EXAMPLES*** Input: Output: ***EXAMPLES*** Input: Two trials (n = 190), at low risk of bias, were included in the review and both presented data on first time failure at the tooth level. Pooling of the data showed a statistically significant difference in favour of molar bands, with a hazard ratio of 2.92 (95% confidence intervals (CI) 1.80 to 4.72). No statistically significant heterogeneity was shown between the two studies. Data on first time failure at the patient level were also available and showed statistically different difference in favour of molar bands (risk ratio 2.30; 95% CI 1.56 to 3.41) (risk of event for molar tubes = 57%; risk of event for molar bands 25%). One trial presented data on decalcification again showing a statistically significant difference in favour of molar bands. No other adverse events identified. From the two well-designed and low risk of bias trials included in this review it was shown that the failure of molar tubes bonded with either a chemically-cured or light-cured adhesive was considerably higher than that of molar bands cemented with glass ionomer cement. One trial indicated that there was less decalcification with molar bands cemented with glass ionomer cement than with bonded molar tubes cemented with a light-cured adhesive. However, given there are limited data for this outcome, further evidence is required to draw more robust conclusions. Output: The evidence in this review, which was carried out together with Cochrane Oral Health, is up-to-date as of 15 February 2017. We included two studies that evaluated 190 participants. Both trials were conducted in the UK and both compared bonded molar tubes with molar bands. From the limited data of two studies at low risk of bias, it would appear that bonded molar tubes are associated with a higher failure rate than with molar bands. Input: A sufficient number of studies were available for a quantitative synthesis for fluoxetine, orlistat, and sibutramine. Twenty two randomized controlled trials were included in the review, with a total of 296 participants for fluoxitine, 2036 for orlistat, and 1047 for sibutramine. Pharmacotherapy produced modest reductions in weight for fluoxetine (5.1 kg (95% confidence interval [CI], 3.3 - 6.9) at 24 to 26 weeks follow up; orlistat 2.0 kg (CI, 1.3 - 2.8) at 12 to 57 weeks follow-up, and sibutramine 5.1 kg (CI, 3.2 - 7.0) at 12 to 52 weeks follow-up. Glycated hemoglobin also modestly and significantly reduced for fluoxetine and orlistat. Gastrointestinal side effects were common with orlistat; tremor, somnolence and sweating with fluoxetine; and palpitations with sibutramine. Some studies, using a variety of study designs, were available on other drugs and a significant decrease in weight was noted in three studies of mazindol, one of phenmetrazine, two of phentermine. No studies were identified that fit inclusion criteria for pseudoephedrine, ephedra, sertraline, yohimbine, amphetamine or its derivatives, bupropion, topiramate, benzocaine, threachlorocitric acid, sertraline, and bromocriptine. Fluoxetine, orlistat, and sibutramine can achieve statistically significant weight loss over 12 to 57 weeks. The magnitude of weight loss is modest, however, and the long-term health benefits remain unclear. The safety of sibutramine is uncertain. There is a paucity of data on other drugs for weight loss or control in persons with type 2 diabetes. Output:
This review of drugs for weight loss among adults with type 2 diabetes revealed weight loss of between 2.0 and 5.1 kg for fluoxetine, orlistat and sibutramine at follow-up of up to 57 weeks. The long-term effects remain uncertain. Adverse events were common in all three drugs: gastrointestinal side effects with orlistat; tremor, somnolence, and sweating with fluoxetine; and palpitations with sibutramine. There were few studies examining other drugs used for weight loss in populations with diabetes.
CochranePLS193
***TASK*** the task is to simplify the input abstract of a biomedical literature ***INPUT*** the input is the abstract of a biomedical literature ***OUTPUT*** the output is the simplified abstract for the input abstract of a biomedical literature ***EXAMPLES*** Input: Output: ***EXAMPLES*** Input: Two trials (n = 190), at low risk of bias, were included in the review and both presented data on first time failure at the tooth level. Pooling of the data showed a statistically significant difference in favour of molar bands, with a hazard ratio of 2.92 (95% confidence intervals (CI) 1.80 to 4.72). No statistically significant heterogeneity was shown between the two studies. Data on first time failure at the patient level were also available and showed statistically different difference in favour of molar bands (risk ratio 2.30; 95% CI 1.56 to 3.41) (risk of event for molar tubes = 57%; risk of event for molar bands 25%). One trial presented data on decalcification again showing a statistically significant difference in favour of molar bands. No other adverse events identified. From the two well-designed and low risk of bias trials included in this review it was shown that the failure of molar tubes bonded with either a chemically-cured or light-cured adhesive was considerably higher than that of molar bands cemented with glass ionomer cement. One trial indicated that there was less decalcification with molar bands cemented with glass ionomer cement than with bonded molar tubes cemented with a light-cured adhesive. However, given there are limited data for this outcome, further evidence is required to draw more robust conclusions. Output: The evidence in this review, which was carried out together with Cochrane Oral Health, is up-to-date as of 15 February 2017. We included two studies that evaluated 190 participants. Both trials were conducted in the UK and both compared bonded molar tubes with molar bands. From the limited data of two studies at low risk of bias, it would appear that bonded molar tubes are associated with a higher failure rate than with molar bands. Input: Five studies involving a total of 734 participants were eligible for inclusion. We assessed only one study as good quality and the other four as poor quality. However, it was difficult to perform a meta-analysis by extracting aggregate data to synthesise the results as originally planned, mainly because not all studies reported the same outcomes as those chosen for this review. No significant differences favoured VGB or CBZ in terms of time to treatment withdrawal and time to achieve six-month remission after dose stabilisation from randomisation, but results did show a disadvantage for VGB on time to first seizure after randomisation. Compared with CBZ, VGB was associated with more occurrences of weight gain and fewer occurrences of skin rash and drowsiness. No differences in visual field defects and visual disturbances were noted. Data are currently insufficient to address the risk-benefit balance of VGB versus CBZ monotherapy for epilepsy. Given the high prevalence of visual field defects reported in an existing systematic review of observational studies (Maguire 2010), VGB monotherapy should be prescribed with caution for epilepsy and should not be considered a first-line choice. If necessary, the visual field should be frequently assessed. Future research should focus on investigating the reasons for visual field defects and exploring potential prevention strategies. Moreover, future monotherapy studies of epilepsy should report results according to the recommendations of the International League Against Epilepsy (ILAE) Commission, and methodological quality should be improved. Output:
The evidence is current to July 2015. We found five trials assessing vigabatrin or carbamazepine monotherapy for newly diagnosed epilepsy, which recruited a total of 734 participants between six months and 65 years of age. Results of this review show no significant differences between vigabatrin and carbamazepine in terms of time to treatment withdrawal and time to achieve six-month remission after dose stabilisation from randomisation, but they reveal some clinical disadvantage with vigabatrin on time to first seizure. Taking vigabatrin was more likely to result in weight gain. A safety concern was the high prevalence of visual field defects, as reported in a systematic review of observational studies (Maguire 2010). One study was assessed as good quality and the other four as poor quality.
CochranePLS194
***TASK*** the task is to simplify the input abstract of a biomedical literature ***INPUT*** the input is the abstract of a biomedical literature ***OUTPUT*** the output is the simplified abstract for the input abstract of a biomedical literature ***EXAMPLES*** Input: Output: ***EXAMPLES*** Input: Two trials (n = 190), at low risk of bias, were included in the review and both presented data on first time failure at the tooth level. Pooling of the data showed a statistically significant difference in favour of molar bands, with a hazard ratio of 2.92 (95% confidence intervals (CI) 1.80 to 4.72). No statistically significant heterogeneity was shown between the two studies. Data on first time failure at the patient level were also available and showed statistically different difference in favour of molar bands (risk ratio 2.30; 95% CI 1.56 to 3.41) (risk of event for molar tubes = 57%; risk of event for molar bands 25%). One trial presented data on decalcification again showing a statistically significant difference in favour of molar bands. No other adverse events identified. From the two well-designed and low risk of bias trials included in this review it was shown that the failure of molar tubes bonded with either a chemically-cured or light-cured adhesive was considerably higher than that of molar bands cemented with glass ionomer cement. One trial indicated that there was less decalcification with molar bands cemented with glass ionomer cement than with bonded molar tubes cemented with a light-cured adhesive. However, given there are limited data for this outcome, further evidence is required to draw more robust conclusions. Output: The evidence in this review, which was carried out together with Cochrane Oral Health, is up-to-date as of 15 February 2017. We included two studies that evaluated 190 participants. Both trials were conducted in the UK and both compared bonded molar tubes with molar bands. From the limited data of two studies at low risk of bias, it would appear that bonded molar tubes are associated with a higher failure rate than with molar bands. Input: We identified four RCTs fitting the inclusion criteria. However, two of these closed prematurely due to low recruitment and did not report results. The remaining two trials evaluated 600 participants with multiple myeloma or non-Hodgkin lymphoma. In both studies the experimental group received G-CSF plus plerixafor and the control group received G-CSF plus placebo. The meta-analysis showed no evidence for differences between plerixafor and placebo group regarding mortality at 12 months (600 participants; risk ratio (RR) 1.00, 95% confidence interval (CI) 0.59 to 1.69; P = 1.00; moderate-quality evidence) and adverse events during stem cell mobilisation and collection (593 participants; RR 1.02, 95% CI 0.99 to 1.06; P = 0.19; high-quality evidence). Regarding the outcome successful stem cell collection, the meta-analysis showed an advantage for those participants randomised to the plerixafor group (600 participants; RR 2.42, 95% CI 1.98 to 2.96; P < 0.00001; high-quality evidence). As there was high heterogeneity between studies for the number of transplanted participants, we did not meta-analyse these data. In the multiple myeloma study, 95.9% (142 participants) in the plerixafor arm and 88.3% (136 participants) in the placebo arm underwent transplantation (RR 1.09, 95% CI 1.02 to 1.16); in the non-Hodgkin lymphoma trial, 90% (135 participants) in the plerixafor group versus 55.4% (82 participants) in the placebo group could be transplanted (RR 1.62, 95% CI 1.39 to 1.89). In both trials there was no evidence for a difference between participants in the plerixafor and placebo group in terms of time to neutrophil and platelet engraftment in transplanted participants. None of the trials reported on the outcomes quality of life and progression-free survival. The results of the analysed data suggest that additional plerixafor leads to increased stem cell collection in a shorter time. There was insufficient evidence to determine whether additional plerixafor affects survival or adverse events. The two trials included in the meta-analysis, both of which were conducted by the Genzyme Corporation, the manufacturer of plerixafor, were published several times. Two more RCTs examining the addition of plerixafor to a G-CSF mobilisation regimen terminated early without publishing any outcome. The trials included nine and five participants, respectively. Another RCT with 100 participants was recently completed, but has not yet published outcomes. Due to the unpublished RCTs, it is possible that our review is affected by publication bias, even though two trials failed to recruit a sufficient number of participants to analyse any data. Output:
We searched several medical databases and identified four randomised controlled trials that met our inclusion criteria. Two of the four studies terminated early due to low recruitment (14 participants included) and did not release any results. We were therefore unable to include them in our statistical analysis. The two published analysed trials included 600 participants with multiple myeloma and non-Hodgkin lymphoma. In both studies, the experimental group received G-CSF plus plerixafor subcutaneously, and the control group received G-CSF plus placebo. Both trials were sponsored by Genzyme, the manufacturer of plerixafor. We were able to conduct a meta-analysis of the data of the two studies for the outcomes mortality at 12 months, successful stem cell collection, and adverse events. We found no evidence for a difference between the plerixafor and placebo group for the outcomes mortality at 12 months and adverse events during stem cell mobilisation period. The meta-analysis showed an advantage for those participants randomised to plerixafor for the outcome successful stem cell collection. Furthermore, in both studies the time to collect a defined number of stem cells was significantly shorter in the plerixafor group compared to the placebo group. In the study that enrolled people with multiple myeloma, 95.9% of the participants in the plerixafor arm and 88.3% in the placebo arm underwent transplantation. In the study that examined people with non-Hodgkin lymphoma, 90% of the participants in the plerixafor group and only 55.4% in the placebo group could be transplanted. It seems that especially people with non-Hodgkin lymphoma benefit from the addition of plerixafor in terms of successful transplantation, but there was no evidence for a difference for time to neutrophil and platelet engraftment in transplanted participants. None of the trials reported on quality of life or progression-free survival. The quality of the evidence was high for adverse events and successful stem cell collection and moderate for mortality at 12 months. The main limitation was a wide confidence interval.
CochranePLS195
***TASK*** the task is to simplify the input abstract of a biomedical literature ***INPUT*** the input is the abstract of a biomedical literature ***OUTPUT*** the output is the simplified abstract for the input abstract of a biomedical literature ***EXAMPLES*** Input: Output: ***EXAMPLES*** Input: Two trials (n = 190), at low risk of bias, were included in the review and both presented data on first time failure at the tooth level. Pooling of the data showed a statistically significant difference in favour of molar bands, with a hazard ratio of 2.92 (95% confidence intervals (CI) 1.80 to 4.72). No statistically significant heterogeneity was shown between the two studies. Data on first time failure at the patient level were also available and showed statistically different difference in favour of molar bands (risk ratio 2.30; 95% CI 1.56 to 3.41) (risk of event for molar tubes = 57%; risk of event for molar bands 25%). One trial presented data on decalcification again showing a statistically significant difference in favour of molar bands. No other adverse events identified. From the two well-designed and low risk of bias trials included in this review it was shown that the failure of molar tubes bonded with either a chemically-cured or light-cured adhesive was considerably higher than that of molar bands cemented with glass ionomer cement. One trial indicated that there was less decalcification with molar bands cemented with glass ionomer cement than with bonded molar tubes cemented with a light-cured adhesive. However, given there are limited data for this outcome, further evidence is required to draw more robust conclusions. Output: The evidence in this review, which was carried out together with Cochrane Oral Health, is up-to-date as of 15 February 2017. We included two studies that evaluated 190 participants. Both trials were conducted in the UK and both compared bonded molar tubes with molar bands. From the limited data of two studies at low risk of bias, it would appear that bonded molar tubes are associated with a higher failure rate than with molar bands. Input: We included 23 trials involving 1806 women, of whom 717 received cones. All of the trials were small, and in many the quality was hard to judge. Outcome measures differed between trials, making the results difficult to combine. Some trials reported high drop-out rates with both cone and comparison treatments. Seven trials were published only as abstracts. Cones were better than no active treatment (rate ratio (RR) for failure to cure incontinence 0.84, 95% confidence interval (CI) 0.76 to 0.94). There was little evidence of difference for a subjective cure between cones and PFMT (RR 1.01, 95% CI 0.91 to 1.13), or between cones and electrostimulation (RR 1.26, 95% CI 0.85 to 1.87), but the confidence intervals were wide. There was not enough evidence to show that cones plus PFMT was different to either cones alone or PFMT alone. Only seven trials used a quality of life measures and no study looked at economic outcomes. Seven of the trials recruited women with symptoms of incontinence, while the others required women with urodynamic stress incontinence, apart from one where the inclusion criteria were uncertain. This review provides some evidence that weighted vaginal cones are better than no active treatment in women with SUI and may be of similar effectiveness to PFMT and electrostimulation. This conclusion must remain tentative until larger, high-quality trials, that use comparable and relevant outcomes, are completed. Cones could be offered as one treatment option, if women find them acceptable. Output:
Twenty-three small trials, involving 1806 women, were found. The results of these trials consistently showed that the use of vaginal weights is better than having no treatment. When vaginal weights were compared to other treatments, such as pelvic floor muscle training without the weights, and electrical stimulation of the pelvic floor, no clear differences between the treatments were evident. This may have been because the numbers of participants in the trials were small, and larger numbers may be required for any differences in the effectiveness of treatments to become clear. Some women find vaginal weights unpleasant or difficult to use, so this treatment may not be useful for all women. Many women with stress urinary incontinence will not be cured by these treatments, and so it is important for trials to assess quality of life during and after treatment, but few of these trials did. Most of the trials were of fairly short duration, so it is difficult to say what happens to women with stress urinary incontinence in the longer term.
CochranePLS196
***TASK*** the task is to simplify the input abstract of a biomedical literature ***INPUT*** the input is the abstract of a biomedical literature ***OUTPUT*** the output is the simplified abstract for the input abstract of a biomedical literature ***EXAMPLES*** Input: Output: ***EXAMPLES*** Input: Two trials (n = 190), at low risk of bias, were included in the review and both presented data on first time failure at the tooth level. Pooling of the data showed a statistically significant difference in favour of molar bands, with a hazard ratio of 2.92 (95% confidence intervals (CI) 1.80 to 4.72). No statistically significant heterogeneity was shown between the two studies. Data on first time failure at the patient level were also available and showed statistically different difference in favour of molar bands (risk ratio 2.30; 95% CI 1.56 to 3.41) (risk of event for molar tubes = 57%; risk of event for molar bands 25%). One trial presented data on decalcification again showing a statistically significant difference in favour of molar bands. No other adverse events identified. From the two well-designed and low risk of bias trials included in this review it was shown that the failure of molar tubes bonded with either a chemically-cured or light-cured adhesive was considerably higher than that of molar bands cemented with glass ionomer cement. One trial indicated that there was less decalcification with molar bands cemented with glass ionomer cement than with bonded molar tubes cemented with a light-cured adhesive. However, given there are limited data for this outcome, further evidence is required to draw more robust conclusions. Output: The evidence in this review, which was carried out together with Cochrane Oral Health, is up-to-date as of 15 February 2017. We included two studies that evaluated 190 participants. Both trials were conducted in the UK and both compared bonded molar tubes with molar bands. From the limited data of two studies at low risk of bias, it would appear that bonded molar tubes are associated with a higher failure rate than with molar bands. Input: Eleven trials with a total of 2246 AF patients (ranging from 14 to 712 by study) were included within the review. Studies included education, decision aids, and self-monitoring plus education interventions. The effect of self-monitoring plus education on TTR was uncertain compared with usual care (MD 6.31, 95% CI -5.63 to 18.25, I2 = 0%, 2 trials, 69 participants, very low-quality evidence). We found small but positive effects of education on anxiety (MD -0.62, 95% CI -1.21 to -0.04, I2 = 0%, 2 trials, 587 participants, low-quality evidence) and depression (MD -0.74, 95% CI -1.34 to -0.14, I2 = 0%, 2 trials, 587 participants, low-quality evidence) compared with usual care. The effect of decision aids on decision conflict favoured usual care (MD -0.1, 95% CI -0.17 to -0.02, I2 = 0%, 2 trials, 721 participants, low-quality evidence). This review demonstrates that there is insufficient evidence to draw definitive conclusions regarding the impact of educational or behavioural interventions on TTR in AF patients receiving OAT. Thus, more trials are needed to examine the impact of interventions on anticoagulation control in AF patients and the mechanisms by which they are successful. It is also important to explore the psychological implications for patients suffering from this long-term chronic condition. Output:
This is an update of the original review first published in 2013. We searched scientific databases in February 2016 and found 11 randomised clinical trials including 2246 adults with atrial fibrillation who were taking oral anticoagulant medication. The trials we found compared education, decision aids, and self-monitoring plus education to usual care, over any length of time. Few studies had comparable groups and data. There was uncertainty about the effect of self-monitoring plus education on the percentage of time the INR was within the therapeutic range because the proportion or time in the therapeutic range was similar between individuals who received self-monitoring plus education and those who did not. There were small and positive effects on anxiety and depression in individuals who received education compared to those who received usual care. There were small and negative effects on decision conflict in individuals who received decision aids compared to those who received usual care. The evidence should be interpreted with caution as the quality of the evidence ranged from very low to low across different outcomes because of the limitations of individual studies. It is likely that further high-quality trials may affect these reported results.
CochranePLS197
***TASK*** the task is to simplify the input abstract of a biomedical literature ***INPUT*** the input is the abstract of a biomedical literature ***OUTPUT*** the output is the simplified abstract for the input abstract of a biomedical literature ***EXAMPLES*** Input: Output: ***EXAMPLES*** Input: Two trials (n = 190), at low risk of bias, were included in the review and both presented data on first time failure at the tooth level. Pooling of the data showed a statistically significant difference in favour of molar bands, with a hazard ratio of 2.92 (95% confidence intervals (CI) 1.80 to 4.72). No statistically significant heterogeneity was shown between the two studies. Data on first time failure at the patient level were also available and showed statistically different difference in favour of molar bands (risk ratio 2.30; 95% CI 1.56 to 3.41) (risk of event for molar tubes = 57%; risk of event for molar bands 25%). One trial presented data on decalcification again showing a statistically significant difference in favour of molar bands. No other adverse events identified. From the two well-designed and low risk of bias trials included in this review it was shown that the failure of molar tubes bonded with either a chemically-cured or light-cured adhesive was considerably higher than that of molar bands cemented with glass ionomer cement. One trial indicated that there was less decalcification with molar bands cemented with glass ionomer cement than with bonded molar tubes cemented with a light-cured adhesive. However, given there are limited data for this outcome, further evidence is required to draw more robust conclusions. Output: The evidence in this review, which was carried out together with Cochrane Oral Health, is up-to-date as of 15 February 2017. We included two studies that evaluated 190 participants. Both trials were conducted in the UK and both compared bonded molar tubes with molar bands. From the limited data of two studies at low risk of bias, it would appear that bonded molar tubes are associated with a higher failure rate than with molar bands. Input: Seventy randomised controlled trials (RCTs) (11,487 women) are included. In this update seven new RCTs (778 women) have been added. Two of these new trials compare PGE2 with no treatment, four compare different PGE2 formulations (gels versus tablets, or sustained release pessaries) and one trial compares PGF2a with placebo. The majority of trials were at unclear risk of bias for most domains. Overall, vaginal prostaglandin E2 compared with placebo or no treatment probably reduces the likelihood of vaginal delivery not being achieved within 24 hours. The risk of uterine hyperstimulation with fetal heart rate changes is increased (4.8% versus 1.0%, risk ratio (RR) 3.16, 95% confidence interval (CI) 1.67 to 5.98, 15 trials, 1359 women). The caesarean section rate is probably reduced by about 10% (13.5% versus 14.8%, RR 0.91, 95% CI 0.81 to 1.02, 36 trials, 6599 women). The overall effect on improving maternal and fetal outcomes (across a variety of measures) is uncertain. PGE2 tablets, gels and pessaries (including sustained release preparations) appear to be as effective as each other, small differences are detected between some outcomes, but these maybe due to chance. Prostaglandins PGE2 probably increase the chance of vaginal delivery in 24 hours, they increase uterine hyperstimulation with fetal heart changes but do not effect or may reduce caesarean section rates. They increase the likelihood of cervical change, with no increase in operative delivery rates. PGE2 tablets, gels and pessaries appear to be as effective as each other, any differences between formulations are marginal but may be important. Output:
This review set out to determine the effectiveness and safety of vaginal prostaglandins for third trimester cervical ripening and induction of labour (the cervix softens, shortens and opens, the uterus starts to contract regularly). Eight different comparisons were made, different vaginal prostaglandins were compared with placebos or no treatment, or other vaginal prostaglandins (PGE2, PGF2a, except misoprostol) and different preparations and dosages were compared. We identified 70 studies involving a total of 11,487 women. Vaginal prostaglandins increase the likelihood of vaginal birth within 24 hours, but they can also stimulate the uterus to contract too much and this may cause the baby's heart to slow, however they did not increase the caesarean section rate and may reduce it. Overall, the trials do not show any effect (improvement or worsening) of many important outcomes. Prostaglandin E2 tablets, gels, or pessaries including sustained release preparations appear to be as good as each other or the differences between them are small and have not yet been detected in the trials. Lower-dose regimens, as defined in the review, appeared to be as good as higher-dose regimens (eight trials, 1615 women). Very limited data were available in the included trials on time in labour and patient satisfaction. Few studies have addressed issues relating to the safety of using vaginal prostaglandins for induction of labour as outpatients.
CochranePLS198
***TASK*** the task is to simplify the input abstract of a biomedical literature ***INPUT*** the input is the abstract of a biomedical literature ***OUTPUT*** the output is the simplified abstract for the input abstract of a biomedical literature ***EXAMPLES*** Input: Output: ***EXAMPLES*** Input: Two trials (n = 190), at low risk of bias, were included in the review and both presented data on first time failure at the tooth level. Pooling of the data showed a statistically significant difference in favour of molar bands, with a hazard ratio of 2.92 (95% confidence intervals (CI) 1.80 to 4.72). No statistically significant heterogeneity was shown between the two studies. Data on first time failure at the patient level were also available and showed statistically different difference in favour of molar bands (risk ratio 2.30; 95% CI 1.56 to 3.41) (risk of event for molar tubes = 57%; risk of event for molar bands 25%). One trial presented data on decalcification again showing a statistically significant difference in favour of molar bands. No other adverse events identified. From the two well-designed and low risk of bias trials included in this review it was shown that the failure of molar tubes bonded with either a chemically-cured or light-cured adhesive was considerably higher than that of molar bands cemented with glass ionomer cement. One trial indicated that there was less decalcification with molar bands cemented with glass ionomer cement than with bonded molar tubes cemented with a light-cured adhesive. However, given there are limited data for this outcome, further evidence is required to draw more robust conclusions. Output: The evidence in this review, which was carried out together with Cochrane Oral Health, is up-to-date as of 15 February 2017. We included two studies that evaluated 190 participants. Both trials were conducted in the UK and both compared bonded molar tubes with molar bands. From the limited data of two studies at low risk of bias, it would appear that bonded molar tubes are associated with a higher failure rate than with molar bands. Input: Eleven potential studies were identified of which five, involving 247 infants, were included in this review. When compared to incubator care, cot-nursing resulted in no significant difference in mean body temperature (MD 0.02 degrees C; 95% CI -0.02 to 0.07, four trials), though the one trial that reported on episodes of hyperthermia found this to be statistically more common in the cot-nursing group (RR 1.48; 95% CI 1.04 to 2.09). There were no statistically significant differences in weight gain. In the cot-nursing group, fewer infants were breast fed on discharge (typical RR 0.74; 95% CI 0.48 to 1.14, three trials, 150 infants) and fewer infants died prior to hospital discharge (typical RR 0.59, 95% CI 0.28 to 1.25, four trials, 235 infants) but these results failed to reach statistical significance. The comparison of cot-nursing using a heated water-filled mattress versus incubator care, which included five trials and a total of 231 infants, produced similar results. Cot-nursing with warming of the nursery resulted in statistically significantly smaller weight gain during week one compared to the incubator group in one trial that involved 38 infants (MD -5.90 g/kg/day; 95% CI -11.13 to -0.67) but no significant difference was found for weeks two and three. Cot-nursing using a heated water-filled mattress has similar effects to incubator care with regard to temperature control and weight gain. Important clinical outcomes need to be investigated further using randomised controlled trials. This is especially the case in the situation of developing countries, where differences in these outcomes are likely to be encountered. As limited data is available on cot-nursing using a space-heated room, this method is not recommended as practice. Output:
This updated review randomly assigned 247 preterm infants (in five trials), to an intervention of cot-nursing using a heated water-filled mattress. The control babies received routine care in an air heated incubator. One trial had three-arms, including cot-nursing in a room heated with a manually controlled space heater. In the included trials infants in the incubator groups were nursed naked apart from wearing a nappy, except in one trial in which the infants also wore a cotton jacket and booties. Three comparisons were undertaken: the overall comparison of cot-nursing versus incubator care, and two subgroup comparisons: cot-nursing with heated water-filled mattress versus incubator care, and cot-nursing using warming of the nursery versus incubator care. The results of the review showed no evidence of effect of cot-nursing versus incubator care on weight gain in the overall analysis, or in the subgroup analysis comparing cot-nursing using a heated water-filled mattress with incubator care. However, cot-nursing with warming of the nursery during week one when compared to incubator care revealed poorer weight gain. The primary outcomes related to temperature control (mean body temperature and episodes of cold stress) indicated on overall analysis no effect of cot-nursing compared to incubator care. Episodes of hyperthermia in the cot-nursing group were reported more frequently in one trial. The secondary outcomes of oxygen consumption, breast feeding at hospital discharge, episodes of nosocomial sepsis, maternal perceptions of infant's condition, maternal stress and anxiety and death prior to hospital discharge revealed there was no effect of cot-nursing compared to incubator care. There was, however, a strong trend towards less death prior to hospital discharge. This was largely related to the results were obtained from the trials undertaken in Turkey and Ethiopia and thus may not be applicable to neonatal nurseries in developed countries. Nevertheless the implications of these findings deserve consideration, particularly in the context of a developing country.
CochranePLS199
***TASK*** the task is to simplify the input abstract of a biomedical literature ***INPUT*** the input is the abstract of a biomedical literature ***OUTPUT*** the output is the simplified abstract for the input abstract of a biomedical literature ***EXAMPLES*** Input: Output: ***EXAMPLES*** Input: Two trials (n = 190), at low risk of bias, were included in the review and both presented data on first time failure at the tooth level. Pooling of the data showed a statistically significant difference in favour of molar bands, with a hazard ratio of 2.92 (95% confidence intervals (CI) 1.80 to 4.72). No statistically significant heterogeneity was shown between the two studies. Data on first time failure at the patient level were also available and showed statistically different difference in favour of molar bands (risk ratio 2.30; 95% CI 1.56 to 3.41) (risk of event for molar tubes = 57%; risk of event for molar bands 25%). One trial presented data on decalcification again showing a statistically significant difference in favour of molar bands. No other adverse events identified. From the two well-designed and low risk of bias trials included in this review it was shown that the failure of molar tubes bonded with either a chemically-cured or light-cured adhesive was considerably higher than that of molar bands cemented with glass ionomer cement. One trial indicated that there was less decalcification with molar bands cemented with glass ionomer cement than with bonded molar tubes cemented with a light-cured adhesive. However, given there are limited data for this outcome, further evidence is required to draw more robust conclusions. Output: The evidence in this review, which was carried out together with Cochrane Oral Health, is up-to-date as of 15 February 2017. We included two studies that evaluated 190 participants. Both trials were conducted in the UK and both compared bonded molar tubes with molar bands. From the limited data of two studies at low risk of bias, it would appear that bonded molar tubes are associated with a higher failure rate than with molar bands. Input: We included three studies, involving 146 participants. Two studies were assessed as being at high risk of bias. The main finding of the review was that the two techniques may be equally successful at exposing PDCs (risk ratio (RR) 0.99, 95% confidence interval (CI) 0.93 to 1.06; three studies, 141 participants analysed, low-quality evidence). One surgical failure was due to detachment of the gold chain (closed group). One study reported on complications following surgery and found two in the closed group: a post-operative infection requiring antibiotics and pain during alignment of the canine as the gold chain penetrated through the gum tissue of the palate. We were unable to pool data for dental aesthetics, patient-reported pain and discomfort, periodontal health and treatment time; however, individual studies did not find any differences between the surgical techniques (low- to very low-quality evidence). Currently, the evidence suggests that neither the open or closed surgical technique for exposing palatally displaced maxillary canine teeth is superior for any of the outcomes included in this review; however, we considered the evidence to be low quality, with two of the three included studies being at high risk of bias. This suggests the need for more high-quality studies. Three ongoing clinical trials have been identified and it is hoped that these will produce data that can be pooled to increase the degree of certainty in these findings. Output:
The evidence in this review is up-to-date as of February 2017. Authors with Cochrane Oral Health found three relevant studies, involving 146 participants who had eye teeth displaced in the roof of the mouth, either on one or both sides. The majority of participants were female and the average age in the studies ranged from 14 to 17 years. Two studies were designed in a way that made them likely to be biased. We combined results from three studies and found that one technique did not seem to have an advantage over the other for ensuring the movement of the tooth into the correct position without the need for repeat surgery. Five out of 141 participants analysed were surgical failures, one of which was due to the complication of detachment of the gold chain during surgery. One study reported complications after surgery and found one participant in the closed group had a post-operative infection requiring antibiotics and another participant in the closed group experienced pain during alignment of the canine as the gold chain penetrated through the gum tissue of the palate. We were unable to combine results from studies for any other outcomes, but individual studies did not show evidence of a difference between the two techniques for pain, discomfort, appearance, gum health, length of treatment time or cost (low to very low quality evidence). Overall, we assessed the quality of the evidence as low, which means we cannot be certain of the findings. It does not seem that one surgical technique is better than the other for moving displaced eye teeth into the correct position, or for other outcomes, but this finding is uncertain because the quality of the evidence is low. This suggests the need for more high-quality studies. Three studies are currently in process. When they are completed, we will include them in an update of this review and may be able to reach firmer conclusions.