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cochrane-simplification-train-0
cochrane-simplification-train-0
Two trials met the inclusion criteria. One compared 2% ketanserin ointment in polyethylene glycol (PEG) with PEG alone, used twice a day by 40 participants with arterial leg ulcers, for eight weeks or until healing, whichever was sooner. One compared topical application of blood-derived concentrated growth factor (CGF) with standard dressing (polyurethane film or foam); both applied weekly for six weeks by 61 participants with non-healing ulcers (venous, diabetic arterial, neuropathic, traumatic, or vasculitic). Both trials were small, reported results inadequately, and were of low methodological quality. Short follow-up times (six and eight weeks) meant it would be difficult to capture sufficient healing events to allow us to make comparisons between treatments. One trial demonstrated accelerated wound healing in the ketanserin group compared with the control group. In the trial that compared CGF with standard dressings, the number of participants with diabetic arterial ulcers were only reported in the CGF group (9/31), and the number of participants with diabetic arterial ulcers and their data were not reported separately for the standard dressing group. In the CGF group, 66.6% (6/9) of diabetic arterial ulcers showed more than a 50% decrease in ulcer size compared to 6.7% (2/30) of non-healing ulcers treated with standard dressing. We assessed this as very-low certainty evidence due to the small number of studies and arterial ulcer participants, inadequate reporting of methodology and data, and short follow-up period. Only one trial reported side effects (complications), stating that no participant experienced these during follow-up (six weeks, low-certainty evidence). It should also be noted that ketanserin is not licensed in all countries for use in humans. Neither study reported time to ulcer healing, patient satisfaction or quality of life. There is insufficient evidence to determine whether the choice of topical agent or dressing affects the healing of arterial leg ulcers.
We found two small studies that presented data for 49 participants with arterial leg ulcers (search conducted January 2019). The studies also included participants with other kinds of ulcers, and it is not clear what proportion of participants were diabetic. Neither study described the methods fully, both presented limited results for the arterial ulcer participants, and one study did not provide information on the number of participants with an arterial ulcer in the control group. The follow-up periods (six and eight weeks) were too short to measure healing. Therefore, the data that were available were incomplete and cannot be generalised to the greater population of people who suffer from arterial leg ulcers. One study randomised participants to either 2% ketanserin ointment in polyethylene glycol (PEG) or PEG alone, administered twice a day over eight weeks. This study reported increased wound healing in the ketanserin group, when compared with the control group. It should be noted that ketanserin is not licensed for use in humans in all countries. The second study randomised participants to either topically-applied growth factors isolated from the participant's own blood (concentrated growth factors (CGF)), or standard dressing; both applied weekly for six weeks. This study reported that 66.6% of CGF-treated diabetic arterial ulcers showed more than a 50% decrease in ulcer size, compared to 6.7% of non-healing ulcers treated with standard dressing. Only one study mentioned side effects, and reported that no participant experienced side effects during follow-up (six weeks). Neither of the two studies reported time to ulcer healing, patient satisfaction or quality of life measures. There is insufficient evidence to determine whether the choice of topical agent or dressing affects the healing of arterial leg ulcers. We downgraded the overall certainty of the available evidence to 'very low' and 'low', because the studies reported their methods poorly, there were only two studies and few participants with arterial disease, and because the studies were short and reported few results. This made it impossible to determine whether there was any real difference in the number of ulcers healed between the groups.
10.1002/14651858.CD001836.pub4
[ "We found two small studies that presented data for 49 participants with arterial leg ulcers (search conducted January 2019). The studies also included participants with other kinds of ulcers, and it is not clear what proportion of participants were diabetic. Neither study described the methods fully, both presented limited results for the arterial ulcer participants, and one study did not provide information on the number of participants with an arterial ulcer in the control group. The follow-up periods (six and eight weeks) were too short to measure healing. Therefore, the data that were available were incomplete and cannot be generalised to the greater population of people who suffer from arterial leg ulcers. One study randomised participants to either 2% ketanserin ointment in polyethylene glycol (PEG) or PEG alone, administered twice a day over eight weeks. This study reported increased wound healing in the ketanserin group, when compared with the control group. It should be noted that ketanserin is not licensed for use in humans in all countries. The second study randomised participants to either topically-applied growth factors isolated from the participant's own blood (concentrated growth factors (CGF)), or standard dressing; both applied weekly for six weeks. This study reported that 66.6% of CGF-treated diabetic arterial ulcers showed more than a 50% decrease in ulcer size, compared to 6.7% of non-healing ulcers treated with standard dressing. Only one study mentioned side effects, and reported that no participant experienced side effects during follow-up (six weeks). Neither of the two studies reported time to ulcer healing, patient satisfaction or quality of life measures. There is insufficient evidence to determine whether the choice of topical agent or dressing affects the healing of arterial leg ulcers. We downgraded the overall certainty of the available evidence to 'very low' and 'low', because the studies reported their methods poorly, there were only two studies and few participants with arterial disease, and because the studies were short and reported few results. This made it impossible to determine whether there was any real difference in the number of ulcers healed between the groups." ]
cochrane-simplification-train-1
cochrane-simplification-train-1
We identified one RCT that involved 40 participants, and addressed the timing of surgery for people with recently symptomatic carotid artery stenosis. It compared very early surgery with surgery performed after 14 days of the last symptomatic event. The overall quality of the evidence was very low, due to the small number of participants from only one trial, and missing outcome data. We found no statistically significant difference between the effects of very early or delayed surgery in reducing the combined risk of stroke and death within 30 days of surgery (risk ratio (RR) 3.32; confidence interval (CI) 0.38 to 29.23; very low-quality evidence), or the combined risk of perioperative death and stroke (RR 0.47; CI 0.14 to 1.58; very low-quality evidence). To date, no results are available to confirm the optimal timing for surgery. There is currently no high-quality evidence available to support either very early or delayed cerebral revascularization after a recent ischemic stroke. Hence, further randomized trials to identify which patients should undergo very urgent revascularization are needed. Future studies should stratify participants by age group, sex, grade of ischemia, and degree of stenosis. Currently, there is one ongoing RCT that is examining the timing of cerebral revascularization.
The searches are up-to-date to 26 January 2016. We found only one randomized trial that assessed the effect of the timing of surgery. It included a total of 40 participants, ranging in age from 47 to 84 years. From the limited evidence available, we cannot tell if the timing of surgery is an important factor in determining the outcome for individuals with recent symptoms from carotid artery narrowing. There is not enough evidence on the best time for surgical treatment for people with recent symptoms from carotid artery narrowing. The overall quality of the evidence was very low, due to the small number of participants from only one trial and missing outcome data. Further studies with a larger number of patients are needed.
10.1002/14651858.CD011401.pub2
[ "The searches are up-to-date to 26 January 2016. We found only one randomized trial that assessed the effect of the timing of surgery. It included a total of 40 participants, ranging in age from 47 to 84 years. From the limited evidence available, we cannot tell if the timing of surgery is an important factor in determining the outcome for individuals with recent symptoms from carotid artery narrowing. There is not enough evidence on the best time for surgical treatment for people with recent symptoms from carotid artery narrowing. The overall quality of the evidence was very low, due to the small number of participants from only one trial and missing outcome data. Further studies with a larger number of patients are needed." ]
cochrane-simplification-train-2
cochrane-simplification-train-2
We included 13 studies with a total of 721 participants in the review. The studies were observational, 12 studies had only one relevant treatment arm and no control and for the one study with a control arm, very few details were given. The risk of bias was high and the certainty of evidence was graded as very low for all outcomes. Due to heterogeneity of data, meta-analysis was not performed and therefore the data were synthesised via a narrative summary. The evidence for benefit derived from PN was very low for survival and quality of life. All the studies measured overall survival and 636 (88%) of participants were deceased at the end of the study. However there were varying definitions of overall survival that yielded median survival intervals between 15 to 155 days (range three to 1278 days). Three studies used validated measures of quality of life. The results from assessment of quality of life were equivocal; one study reported improvements up until three months and two studies reported approximately similar numbers of participants with improvements and deterioration. Different quality of life scales were used in each of the studies and quality of life was measured at different time points. Due to the very low certainty of the evidence, we are very uncertain about the adverse events related to PN use. Adverse events were measured by nine studies and data for individual participants could be extracted from eight studies. This revealed that 32 of 260 (12%) patients developed a central venous catheter infection or were hospitalised because of complications related to PN. We are very uncertain whether HPN improves survival or quality of life in people with MBO as the certainty of evidence was very low for both outcomes. As the evidence base is limited and at high risk of bias, further higher-quality prospective studies are required.
The benefits of PN are uncertain as the evidence is of very low certainty, provided mainly by studies that only looked at people who received PN rather than comparing patients who received PN with those who did not. As we found no randomised controlled trials, we have included the results from 13 observational studies with a total of 721 participants. For 12 of the studies, there was only one relevant treatment group and no control group. Therefore, the results are only for people receiving PN and we have no information about those not receiving it. The average survival time for people on PN varied from three to 1278 days. Only three studies measured quality of life using a recognised measure. One study found quality of life improved and two studies found similar numbers of people both improved and deteriorated. However, the three studies monitored quality of life at different points in time and measured it in different ways. Side effects occurred in 12% of people in the eight studies that measured them. Further research is needed to find out if PN is of benefit to people with an inoperable blockage of the bowel caused by advanced cancer.
10.1002/14651858.CD012812.pub2
[ "The benefits of PN are uncertain as the evidence is of very low certainty, provided mainly by studies that only looked at people who received PN rather than comparing patients who received PN with those who did not. As we found no randomised controlled trials, we have included the results from 13 observational studies with a total of 721 participants. For 12 of the studies, there was only one relevant treatment group and no control group. Therefore, the results are only for people receiving PN and we have no information about those not receiving it. The average survival time for people on PN varied from three to 1278 days. Only three studies measured quality of life using a recognised measure. One study found quality of life improved and two studies found similar numbers of people both improved and deteriorated. However, the three studies monitored quality of life at different points in time and measured it in different ways. Side effects occurred in 12% of people in the eight studies that measured them. Further research is needed to find out if PN is of benefit to people with an inoperable blockage of the bowel caused by advanced cancer." ]
cochrane-simplification-train-3
cochrane-simplification-train-3
We included 25 RCTs involving 4788 participants. Six of twelve trials showed that written information significantly improved knowledge about a medicine, compared with no written information. The inability to combine results means we cannot conclude whether written information was effective for increasing knowledge. The results for attitudinal and behavioural outcomes were mixed. No studies showed an adverse effect of medicines information. The combined evidence was not strong enough to say whether written medicines information is effective in changing knowledge, attitudes and behaviours related to medicine taking. There is some evidence that written information can improve knowledge. The trials were generally of poor quality, which reduces confidence in the results. Trials examining the effects of written information need to be better designed and use consistent and validated outcome measures. Trials should evaluate internet-based medicines information. It is imperative that written medicines information be based on best practice for its information design and content, which could improve its effectiveness in helping people to use medicines appropriately.
The findings of this review were inconclusive for a number of reasons. First, because the included trials measured different outcomes in different ways, we were unable to combine their results. Second, these trials presented the written information for patients in different ways, and most did not design the leaflets in a way that made them easy to read. Third, in many cases trials were not clearly reported, so we do not know if they were carried out correctly. Despite these limitations several trials, while using different types of information and different measures, found written information improved knowledge. This is encouraging for people who want to learn about their medicines from leaflets. None of the studies showed that written information was harmful. Future research needs to use improved methods, and needs to examine the same measures on many occasions. It is important that medicines information be well written and designed to maximise the possibility of improving knowledge. Consumers are increasingly seeking out health information, including information about medicines, on the internet, but we found no trials examining whether internet-based medicines information changed people's knowledge, attitudes, or behaviour.
10.1002/14651858.CD002104.pub3
[ "The findings of this review were inconclusive for a number of reasons. First, because the included trials measured different outcomes in different ways, we were unable to combine their results. Second, these trials presented the written information for patients in different ways, and most did not design the leaflets in a way that made them easy to read. Third, in many cases trials were not clearly reported, so we do not know if they were carried out correctly. Despite these limitations several trials, while using different types of information and different measures, found written information improved knowledge. This is encouraging for people who want to learn about their medicines from leaflets. None of the studies showed that written information was harmful. Future research needs to use improved methods, and needs to examine the same measures on many occasions. It is important that medicines information be well written and designed to maximise the possibility of improving knowledge. Consumers are increasingly seeking out health information, including information about medicines, on the internet, but we found no trials examining whether internet-based medicines information changed people's knowledge, attitudes, or behaviour." ]
cochrane-simplification-train-4
cochrane-simplification-train-4
We conducted this review in accordance with the published Cochrane protocol. Two randomised clinical trials with 104 participants fulfilled our inclusion criteria. Both trials were at high risk of bias (for outcomes other than overall survival), and we rated the evidence as moderate quality for overall survival and low quality for all other outcomes. One trial compared combined extrapleural pneumonectomy (EPP) plus neoadjuvant platinum-based chemotherapy plus postoperative high-dose hemithoracic radiotherapy with combined EPP plus platinum-based chemotherapy. The other trial compared EPP plus postoperative hemithoracic radiotherapy with standard (non-radical) therapy alone following platinum-based chemotherapy (patients in the standard therapy arm received continued oncological management according to local policy, which could include further chemotherapy or palliative radiotherapy). For the first trial, median overall survival calculated from registration was 20.8 months (95% confidence interval (CI) 14.4 to 27.8) in the no-radiotherapy group and 19.3 months (95% CI 11.5 to 21.8) in the radiotherapy group. For the second trial, median overall survival was 14.4 months (95% CI 5.3 to 18.7) for patients allocated to EPP and 19.5 months (95% CI 13.4 to time not yet reached) for patients randomised to standard non-radical therapy. In the second trial, 12 serious adverse events were reported during the study period: ten in the EPP group and two in the non-radical therapy group. Overall health-related quality of life scores were not different between the two arms in either study. We could not perform a meta-analysis of the two included trials due to clinical heterogeneity. We also identified three ongoing trials evaluating the topic of our review. The overall strength of the evidence gathered in this review is low and there is a lack of available evidence to support the use of radical multimodality therapy in routine clinical practice (particularly as one trial suggests greater harm). Given the added cost of multimodality treatment and the possible increase in risk of adverse effects, the lack of evidence of their effectiveness probably means that these interventions should currently be limited to clinical trials alone.
We searched published medical articles to find research papers that looked at combined treatment strategies with surgery for treating people with primary pleural cancer. We looked for randomised clinical trials (where people were allocated at random to one of two or more treatments groups) and used information from those we found to form our conclusions. We found evidence up to 21 March 2017. The review authors found two small randomised clinical trials, in which a total of 104 people with pleural mesothelioma were randomised. One trial compared the addition of surgery and radiotherapy to chemotherapy with chemotherapy alone. The other trial compared the addition of radiotherapy to chemotherapy and surgery with chemotherapy and surgery alone. These two small trials suggested that there is no added value for either radiotherapy or combined radiotherapy and surgery. We could not combine the data from the trials as we had intended, because the two trials were too different. We rated the quality of evidence as moderate for survival and low quality for all the other outcomes studied. The review authors identified three ongoing randomised clinical trials, the results of which have not been published yet. We only found two relevant trials. Both were small, which made the results uncertain. It is not clear whether giving a combination of surgery and radical radiotherapy after chemotherapy is better than giving chemotherapy alone. Radical radiotherapy does not seem to improve the results of surgery alone.
10.1002/14651858.CD012605.pub2
[ "We searched published medical articles to find research papers that looked at combined treatment strategies with surgery for treating people with primary pleural cancer. We looked for randomised clinical trials (where people were allocated at random to one of two or more treatments groups) and used information from those we found to form our conclusions. We found evidence up to 21 March 2017. The review authors found two small randomised clinical trials, in which a total of 104 people with pleural mesothelioma were randomised. One trial compared the addition of surgery and radiotherapy to chemotherapy with chemotherapy alone. The other trial compared the addition of radiotherapy to chemotherapy and surgery with chemotherapy and surgery alone. These two small trials suggested that there is no added value for either radiotherapy or combined radiotherapy and surgery. We could not combine the data from the trials as we had intended, because the two trials were too different. We rated the quality of evidence as moderate for survival and low quality for all the other outcomes studied. The review authors identified three ongoing randomised clinical trials, the results of which have not been published yet. We only found two relevant trials. Both were small, which made the results uncertain. It is not clear whether giving a combination of surgery and radical radiotherapy after chemotherapy is better than giving chemotherapy alone. Radical radiotherapy does not seem to improve the results of surgery alone." ]
cochrane-simplification-train-5
cochrane-simplification-train-5
Two cluster-randomized controlled trials (RCTs) (involving a total of 5455 women) met the inclusion criteria. The two included trials measured the effectiveness of the intervention in different ways, which meant that meta-analysis of the results was not possible. The overall quality of the two studies, as assessed using the GRADE approach, was low, with high risk of detection and attrition bias in both included trials. One trial (432 women enrolled) conducted in Canada was judged of low methodological quality. This trial did not report on any of the review's pre-specified primary outcomes and the secondary outcomes reported results only as P values. Moreover, losses to follow-up were high (34%, 147 out of 432 women initially enrolled). The authors concluded that prenatal education can effectively change pregnant women's behavior as it increased pet, personal and food hygiene. The second trial conducted in France was also judged of low methodological quality. Losses to follow-up were also high (44.5%, 2233 out of 5023 women initially enrolled) and differential (40% in the intervention group and 52% in the control group). The authors concluded that prenatal education for congenital toxoplasmoses has a significant effect on improving women's knowledge, whereas it has no effect on changing women's behavior. In this trial 17/3949 pregnant women seroconverted for toxoplasmosis: 13/2591 (0.5%) in the intervention group and 4/1358 (0.3%) in the control group. The rate of seroconversion detected during the study did not differ between groups (risk ratio (RR) 1.70, 95% confidence interval (CI) 0.56 to 5.21; participants = 3949; studies = one, low quality evidence). The number of events was too small to reach conclusions about the effect of prenatal education on seroconversion rate during pregnancy. No other randomized trials on the effect of prenatal education on congenital toxoplasmosis rate, or toxoplasmosis seroconversion rate during pregnancy were detected. Even though primary prevention of congenital toxoplasmosis is considered a desirable intervention, given the lack of related risks compared to secondary and tertiary prevention, its effectiveness has not been adequately evaluated. There is very little evidence from RCTs that prenatal education is effective in reducing congenital toxoplasmosis even though evidence from observational studies suggests it is. Given the lack of good evidence supporting prenatal education for congenital toxoplasmosis prevention, further RCTs are needed to confirm any potential benefits and to further quantify the impact of different sets of educational intervention.
This review included two randomized controlled trials (involving 5455 women). Data could not be combined because each trial measured effectiveness in different ways. One study was from Canada and involved 432 women randomly assigned to a 10-minute presentation during a prenatal class about toxoplasmosis prevention or to a usual prenatal class. Losses to follow-up were high and 285 completed the post-test questionnaire in the third trimester. Only 5% of the intervention women recalled having obtained information on toxoplasmosis prevention during prenatal classes. However, the authors concluded that prenatal education can effectively change pregnant women's behavior as it increased pet, personal and food hygiene. The other trial conducted in France involved 5023 pregnant women with no evidence of toxoplasmosis infection (seronegative) who were randomly assigned to receive a brochure and an audiotape containing information for toxoplasmosis prevention, or to a usual prenatal class. Losses to follow-up were high and 2790 completed both pre-test and post-test questionnaire on behavior (44.5% loss to follow-up), whereas 3949 women were tested for blood antibodies (22.4% loss to follow-up). Women's behavior did not change after the intervention. Similarly, the seroconversion rate did not differ between groups (13 out of 2591 women seroconverted in the intervention and four out of 1358 in the control group). Both trials were judged as having low methodological quality as assessed by the GRADE approach. This limits our confidence in the results. Evidence supporting prenatal education to prevent congenital toxoplasmosis is therefore limited.
10.1002/14651858.CD006171.pub4
[ "This review included two randomized controlled trials (involving 5455 women). Data could not be combined because each trial measured effectiveness in different ways. One study was from Canada and involved 432 women randomly assigned to a 10-minute presentation during a prenatal class about toxoplasmosis prevention or to a usual prenatal class. Losses to follow-up were high and 285 completed the post-test questionnaire in the third trimester. Only 5% of the intervention women recalled having obtained information on toxoplasmosis prevention during prenatal classes. However, the authors concluded that prenatal education can effectively change pregnant women's behavior as it increased pet, personal and food hygiene. The other trial conducted in France involved 5023 pregnant women with no evidence of toxoplasmosis infection (seronegative) who were randomly assigned to receive a brochure and an audiotape containing information for toxoplasmosis prevention, or to a usual prenatal class. Losses to follow-up were high and 2790 completed both pre-test and post-test questionnaire on behavior (44.5% loss to follow-up), whereas 3949 women were tested for blood antibodies (22.4% loss to follow-up). Women's behavior did not change after the intervention. Similarly, the seroconversion rate did not differ between groups (13 out of 2591 women seroconverted in the intervention and four out of 1358 in the control group). Both trials were judged as having low methodological quality as assessed by the GRADE approach. This limits our confidence in the results. Evidence supporting prenatal education to prevent congenital toxoplasmosis is therefore limited." ]
cochrane-simplification-train-6
cochrane-simplification-train-6
Of 1777 potential studies evaluated, only two Randomized Control Trials (123 patients) were included. ß-interferon treatment compared to placebo did not show differences regarding the proportion of patients with progression of the disease (RR 0.89, 95% CI 0.55 to1.43), and it was associated with a greater frequency of treatment-related adverse events (RR 1.90, 95% CI 1.45-2.48). One of the trials evaluated the MRI secondary outcome pre-specified in the protocol. This trial showed that at two years the numbers of active lesions on brain MRI scan in ß-interferon arm were significantly lower than in placebo arm (weighted mean difference -1.3, 95% CI -2.15 to -0.45, P = 0.003); also, the number of participants with active lesions was significantly higher in placebo arm vs. ß-interferon arm at two years (RR 0.43, 95% CI 0.22 to 0.86, P = 0.02). Limited data on the effect of ß-interferon treatment on PPMS exists. Only two single-centre placebo controlled trials of interferon beta have been done. Based on this review, the included studies showed that ß-interferon treatment was not associated with reduced disability progression in PPMS patients. However, the trial population was too small to allow definitive conclusions on the efficacy of ß-interferon therapy in PPMS patients. Larger research studies need to be done in patients with PPMS in order to clarify whether ß-interferon is effective in this population.
Among the pertinent medical literature only  two studies, comprising  a total of 123 participants,  met the criteria of the methodological quality necessary for their inclusion in this review. Taking into account  the disability progression, the analysis of the data showed that INF beta treatment in  patients with PPMS was  not associated with a reduction of  this parameter during the first two years of therapy. Adverse effects, mainly flu-like symptoms and injection site reactions, occurred frequently and were the same as  reported by the many studies on   IFN beta treatments in MS patients with different types of the disease. It is worth nothing that the patients’ population analysed was too small to allow a definitive conclusion on the efficacy of IFN beta therapy  in PPMS.
10.1002/14651858.CD006643.pub3
[ "Among the pertinent medical literature only  two studies, comprising  a total of 123 participants,  met the criteria of the methodological quality necessary for their inclusion in this review. Taking into account  the disability progression, the analysis of the data showed that INF beta treatment in  patients with PPMS was  not associated with a reduction of  this parameter during the first two years of therapy. Adverse effects, mainly flu-like symptoms and injection site reactions, occurred frequently and were the same as  reported by the many studies on   IFN beta treatments in MS patients with different types of the disease. It is worth nothing that the patients’ population analysed was too small to allow a definitive conclusion on the efficacy of IFN beta therapy  in PPMS." ]
cochrane-simplification-train-7
cochrane-simplification-train-7
We included two randomised controlled trials (three reports) with 1674 participants, with mean age between 64.1 and 67.8 years. Follow-up ranged from 2 years to mean 4.3 years. For primary outcome measures, effect estimates from a single study showed uncertainty for the effect of NP-guided treatment on cardiovascular mortality in patients with cardiovascular risk factors and without heart failure (RR 0.33, 95% CI 0.04 to 3.17; 1 study; 300 participants; low-quality evidence). Pooled analysis demonstrated that in comparison to standard care, NP-guided treatment probably reduces the risk of cardiovascular hospitalisation (RR 0.52, 95% CI 0.40 to 0.68; 2 studies; 1674 participants; moderate-quality evidence). This corresponds to a risk of 163 per 1000 in the control group and 85 (95% CI 65 to 111) per 1000 in the NP-guided treatment group. When secondary outcome measures were evaluated, evidence from a pooled analysis showed uncertainty for the effect of NP-guided treatment on all-cause mortality (RR 0.90, 95% CI 0.60 to 1.35; 2 studies; 1354 participants; low-quality evidence). Pooled analysis indicates that NP-guided treatment probably reduces the risk of all-cause hospitalisation (RR 0.83, 95% CI 0.75 to 0.92; 2 studies; 1354 participants; moderate-quality evidence). This corresponds to a risk of 601 per 1000 in the control group and 499 (95% CI 457 to 553) per 1000 in the NP-guided treatment group. The effect estimate from a single study indicates that NP-guided treatment reduced the risk of ventricular dysfunction (RR 0.61, 95% CI 0.41 to 0.91; 1374 participants; high-quality evidence). The risk in this study's control group was 87 per 1000, compared with 53 (95% CI 36 to 79) per 1000 with NP-guided treatment. Results from the same study show that NP-guided treatment does not affect change in NP level at the end of follow-up, relative to standard care (MD -4.06 pg/mL, 95% CI -15.07 to 6.95; 1 study; 1374 participants; moderate-quality evidence). This review shows that NP-guided treatment is likely to reduce ventricular dysfunction and cardiovascular and all-cause hospitalisation for patients who have cardiovascular risk factors and who do not have heart failure. Effects on mortality and natriuretic peptide levels are less certain. Neither of the included studies were powered to evaluate mortality. Available evidence shows uncertainty regarding the effects of NP-guided treatment on both cardiovascular mortality and all-cause mortality; very low event numbers resulted in a high degree of imprecision in these effect estimates. Evidence also shows that NP-guided treatment may not affect NP level at the end of follow-up. As both trials included in our review were pragmatic studies, non-blinding of patients and practices may have biased results towards a finding of equivalence. Further studies with more adequately powered sample sizes and longer duration of follow-up are required to evaluate the effect of NP-guided treatment on mortality. As two trials are ongoing, one of which is a large multi-centre trial, it is hoped that future iterations of this review will benefit from larger sample sizes across a wider geographical area.
Evidence in this review is current to July 2019. We included two randomised controlled trials (where participants have an equal chance of being assigned to either treatment) including 1674 adult participants who had one or more risk factors for developing CVD, which compared NP-guided treatment with standard care. We excluded patients with symptoms of heart failure. The mean age of participants varied between 64.1 and 67.8 years. Patients were followed-up for between 2 years and a mean of 4.2 years. Effects of NP-guided treatment on death due to CVD or for any other reason remain uncertain as our results were imprecise. Moderate-quality evidence suggests that NP-guided treatment probably reduces the number of hospitalisations due to cardiovascular events and due to all causes in patients with cardiovascular risk factors. We would expect that of 1000 patients who received standard care, 163 would be admitted to hospital as the result of a cardiovascular event, compared to between 65 and 111 patients who received NP-guided treatment. Out of 1000 patients with cardiovascular risk factors who received standard care, 601 would be admitted to hospital for any reason, compared to between 457 and 553 patients who received NP-guided treatment. High-quality evidence indicates that NP-guided treatment reduces the risk of ventricular dysfunction (a condition that often leads to heart failure) compared to standard care. Our results suggest that of 1000 patients with cardiovascular risk factors who received standard care, 87 would develop ventricular dysfunction, compared to between 36 and 79 patients who received NP-guided treatment. No evidence suggests that NP-guided treatment affected NP level at completion of the studies. The quality of evidence ranged from low to high across outcomes. Key reasons for concern about the quality of the evidence included risk of bias, as patients and medical staff caring for patients knew whether they were in the control or intervention group and this may have affected the care they received; some results obtained were imprecise, and it is unclear if the intervention was beneficial or harmful. As we identified only two studies that were suitable for inclusion in this review, the generalisability of the review is limited.
10.1002/14651858.CD013015.pub2
[ "Evidence in this review is current to July 2019. We included two randomised controlled trials (where participants have an equal chance of being assigned to either treatment) including 1674 adult participants who had one or more risk factors for developing CVD, which compared NP-guided treatment with standard care. We excluded patients with symptoms of heart failure. The mean age of participants varied between 64.1 and 67.8 years. Patients were followed-up for between 2 years and a mean of 4.2 years. Effects of NP-guided treatment on death due to CVD or for any other reason remain uncertain as our results were imprecise. Moderate-quality evidence suggests that NP-guided treatment probably reduces the number of hospitalisations due to cardiovascular events and due to all causes in patients with cardiovascular risk factors. We would expect that of 1000 patients who received standard care, 163 would be admitted to hospital as the result of a cardiovascular event, compared to between 65 and 111 patients who received NP-guided treatment. Out of 1000 patients with cardiovascular risk factors who received standard care, 601 would be admitted to hospital for any reason, compared to between 457 and 553 patients who received NP-guided treatment. High-quality evidence indicates that NP-guided treatment reduces the risk of ventricular dysfunction (a condition that often leads to heart failure) compared to standard care. Our results suggest that of 1000 patients with cardiovascular risk factors who received standard care, 87 would develop ventricular dysfunction, compared to between 36 and 79 patients who received NP-guided treatment. No evidence suggests that NP-guided treatment affected NP level at completion of the studies. The quality of evidence ranged from low to high across outcomes. Key reasons for concern about the quality of the evidence included risk of bias, as patients and medical staff caring for patients knew whether they were in the control or intervention group and this may have affected the care they received; some results obtained were imprecise, and it is unclear if the intervention was beneficial or harmful. As we identified only two studies that were suitable for inclusion in this review, the generalisability of the review is limited." ]
cochrane-simplification-train-8
cochrane-simplification-train-8
Three trials involving a total of 404, mainly female and older, people with displaced fractures of the distal radius were included. These failed to assess functional outcome, and only one trial reported on complications. One trial found no statistically significant differences between mechanical reduction using finger trap traction and manual reduction in anatomical outcomes. All participants of this trial were given intravenous regional anaesthesia. One trial compared a novel method of manual reduction where the non-anaesthetised patient actively provided counter-traction versus traditional manual reduction under intravenous regional anaesthesia. While participants of the novel method group suffered more, yet not intolerable, pain during the reduction procedure, the latter was shorter in duration. No differences in anatomical outcome were detected. The third study compared mechanical reduction involving a special device without anaesthesia versus manual reduction under haematoma block (local anaesthesia). Less pain during the reduction procedure was recorded for the mechanical traction group. Both methods yielded similar radiological results. Fewer participants of the mechanical traction group had signs of neurological impairment, mainly finger numbness, at five weeks but this difference was not statistically significant by one year. There was insufficient evidence from comparisons tested within randomised controlled trials to establish the relative effectiveness of different methods of closed reduction used in the treatment of displaced fractures of the distal radius in adults.
Three randomised controlled trials involving a total of 404, mainly female and older, people with displaced fractures of the distal radius are included in this review. None of the trials assessed functional outcome, and only one trial reported on complications. Each trial compared different methods of reduction. One trial, in which all participants had intravenous regional anaesthesia, found no significant differences in anatomical outcomes between mechanical reduction using finger trap traction and manual reduction. The second trial compared two methods of manual reduction. These were a novel method of manual reduction where participants actively provided counter-traction without being given anaesthesia versus traditional manual reduction under intravenous regional anaesthesia. The participants of the novel method group suffered more but not intolerable pain during the reduction procedure, which was shorter in duration. No differences in anatomical outcome were detected. The third trial compared mechanical reduction involving a special device without anaesthesia versus manual reduction under haematoma block (local anaesthesia). Less pain during the reduction procedure was recorded for the mechanical traction group. Both methods yielded similar anatomical results. Fewer participants of the mechanical traction group had signs of neurological impairment, mainly finger numbness, at five weeks but this difference was not statistically significant by one year. The review concluded that there was not enough evidence to decide whether there was any difference between the various methods tested.
10.1002/14651858.CD003763
[ "Three randomised controlled trials involving a total of 404, mainly female and older, people with displaced fractures of the distal radius are included in this review. None of the trials assessed functional outcome, and only one trial reported on complications. Each trial compared different methods of reduction. One trial, in which all participants had intravenous regional anaesthesia, found no significant differences in anatomical outcomes between mechanical reduction using finger trap traction and manual reduction. The second trial compared two methods of manual reduction. These were a novel method of manual reduction where participants actively provided counter-traction without being given anaesthesia versus traditional manual reduction under intravenous regional anaesthesia. The participants of the novel method group suffered more but not intolerable pain during the reduction procedure, which was shorter in duration. No differences in anatomical outcome were detected. The third trial compared mechanical reduction involving a special device without anaesthesia versus manual reduction under haematoma block (local anaesthesia). Less pain during the reduction procedure was recorded for the mechanical traction group. Both methods yielded similar anatomical results. Fewer participants of the mechanical traction group had signs of neurological impairment, mainly finger numbness, at five weeks but this difference was not statistically significant by one year. The review concluded that there was not enough evidence to decide whether there was any difference between the various methods tested." ]
cochrane-simplification-train-9
cochrane-simplification-train-9
Twenty-two eligible randomised trials were identified, of which 11 were crossover trials. The trials included 1099 women with 673 receiving an adrenergic drug (phenylpropanolamine in 11 trials, midodrine in two, norepinephrine in three, clenbuterol in another three, terbutaline in one, eskornade in one and Ro 115-1240 in one). No trials included men. The limited evidence suggested that an adrenergic agonist drug is better than placebo in reducing the number of pad changes and incontinence episodes, as well as improving subjective symptoms. In two small trials, the drugs also appeared to be better than pelvic floor muscle training, possibly reflecting relative acceptability of the treatments to women but perhaps due to differential withdrawal of women from the trial groups. There was not enough evidence to evaluate the use of higher compared to lower doses of adrenergic agonists nor the relative merits of an adrenergic agonist drug compared with oestrogen, whether used alone or in combination. Over a quarter of women reported adverse effects. There were similar numbers of adverse effects with adrenergics, placebo or alternative drug treatment. However, when these were due to recognised adrenergic stimulation (insomnia, restlessness and vasomotor stimulation) they were only severe enough to stop treatment in 4% of women. There was weak evidence to suggest that use of an adrenergic agonist was better than placebo treatment. There was not enough evidence to assess the effects of adrenergic agonists when compared to or combined with other treatments. Further larger trials are needed to identify when adrenergics may be useful. Patients using adrenergic agonists may suffer from minor side effects, which sometimes cause them to stop treatment. Rare but serious side effects, such as cardiac arrhythmias and hypertension, have been reported.
This review of 22 trials involving 673 women and seven different adrenergic drugs found weak evidence that adrenergic agonists may help stress urinary incontinence. Side effects do occur but are usually minor. Rarely, more serious adverse effects such as high blood pressure can occur. More evidence is needed to compare adrenergic drugs with other drugs for stress incontinence and also with pelvic floor muscle exercises.
10.1002/14651858.CD001842.pub2
[ "This review of 22 trials involving 673 women and seven different adrenergic drugs found weak evidence that adrenergic agonists may help stress urinary incontinence. Side effects do occur but are usually minor. Rarely, more serious adverse effects such as high blood pressure can occur. More evidence is needed to compare adrenergic drugs with other drugs for stress incontinence and also with pelvic floor muscle exercises." ]
cochrane-simplification-train-10
cochrane-simplification-train-10
Six studies met the inclusion criteria, including three RCTs, two cluster-RCTs and one ITS. All were conducted in the USA and comprised targeted mass media interventions for people of African descent (four studies), Spanish-language dominant Latino immigrants (one study), and Chinese immigrants (one study). The two latter studies offered the intervention in the participants’ first language (Spanish, Cantonese, or Mandarin). Three interventions targeted towards women only, one pregnant women specifically. We judged all studies as being at unclear risk of bias in at least one domain and three studies as being at high risk of bias in at least one domain. We categorised the findings into three comparisons. The first comparison examined mass media interventions targeted at ethnic minorities versus an equivalent mass media intervention intended for the general population. The one study in this category (255 participants of African decent) found little or no difference in effect on self-reported behavioural change for smoking and only small differences in attitudes to change between participants who were given a culturally specific smoking cessation booklet versus a booklet intended for the general population. We are uncertain about the effect estimates, as assessed by the GRADE methodology (very low quality evidence of effect). No study provided data for indicators of behavioural change or adverse effects. The second comparison assessed targeted mass media interventions versus no intervention. One study (154 participants of African decent) reported effects for our primary outcomes. Participants in the intervention group had access to 12 one-hour live programmes on cable TV and received print material over three months regarding nutrition and physical activity to improve health and weight control. Change in body mass index (BMI) was comparable between groups 12 months after the baseline (low quality evidence). Scores on a food habits (fat behaviours) and total leisure activity scores changed favourably for the intervention group (very low quality evidence). Two other studies exposed entire populations in geographical areas to radio advertisements targeted towards African American communities. Authors presented effects on two of our secondary outcomes, use of health promotion services and project costs. The campaign message was to call smoking quit lines. The outcome was the number of calls received. After one year, one study reported 18 calls per estimated 10,000 targeted smokers from the intervention communities (estimated target population 310,500 persons), compared to 0.2 calls per estimated 10,000 targeted smokers from the control communities (estimated target population 331,400 persons) (moderate quality evidence). The ITS study also reported an increase in the number of calls from the target population during campaigns (low quality evidence). The proportion of African American callers increased in both studies (low to very low quality evidence). No study provided data on knowledge and attitudes for change and adverse effects. Information on costs were sparse. The third comparison assessed targeted mass media interventions versus a mass media intervention plus personalised content. Findings are based on three studies (1361 participants). Participants in these comparison groups received personal feedback. Two of the studies recorded weight changes over time. Neither found significant differences between the groups (low quality evidence). Evidence on behavioural changes, and knowledge and attitudes typically found some effects in favour of receiving personalised content or no significant differences between groups (very low quality evidence). No study provided data on adverse effects. Information on costs were sparse. The available evidence is inadequate for understanding whether mass media interventions targeted toward ethnic minority populations are more effective in changing health behaviours than mass media interventions intended for the population at large. When compared to no intervention, a targeted mass media intervention may increase the number of calls to smoking quit line, but the effect on health behaviours is unclear. These studies could not distinguish the impact of different components, for instance the effect of hearing a message regarding behavioural change, the cultural adaptation to the ethnic minority group, or increase reach to the target group through more appropriate mass media channels. New studies should explore targeted interventions for ethnic minorities with a first language other than the dominant language in their resident country, as well as directly compare targeted versus general population mass media interventions.
We found six studies, all from the USA, four of which targeted African Americans and two which targeted Latino or Chinese immigrants. Of the studies, four were experimental (1693 volunteers) and two reported the results of large, targeted campaigns run in whole communities and cities. The evidence is current to August 2016. The available evidence is insufficient to conclude whether targeted mass media interventions for ethnic minority groups are more, less or equally effective in changing health behaviours than general mass media interventions. Only one study compared participants' smoking habits and intentions to quit following the receipt of either a culturally adapted smoking advice booklet or a booklet developed for the general population. They found little or no differences in smoking behaviours between the groups. When compared to no mass media intervention, a targeted mass media intervention may increase the number of calls to smoking quit lines, but the effect on health behaviours is unclear. This conclusion is based on findings from three studies. One study gave participants access to a series of 12 live shows on cable TV with information on how to maintain a healthy weight through diet and physical activity. Compared to women who did not watch the shows, participants reported slightly increased physical activity and some positive changes to their dietary patterns; however, their body weight was no different over time. Two other studies were large-scale targeted campaigns in which smokers were encouraged to call a quit line for smoking cessation advice. The number of telephone calls from the target population increased considerably during the campaign. This review also compared targeted mass media interventions versus mass media interventions with added personal interactions. These findings, based on three studies, were inconclusive. None of the studies reported whether the interventions could have had any adverse effects, such as possible stigmatisation or increased resistance to messages. Further studies directly comparing targeted mass media interventions with general mass media interventions would be useful. Few studies have investigated the effects of targeted mass media interventions for ethnic minority groups who primarily speak a non-dominant language. Our confidence in the evidence of effect on all main outcomes is low to very low. This means that the true effect may be different or substantially different from the results presented in this review. We have moderate confidence in the estimated increase in the number of calls to smoking quit lines.
10.1002/14651858.CD011683.pub2
[ "We found six studies, all from the USA, four of which targeted African Americans and two which targeted Latino or Chinese immigrants. Of the studies, four were experimental (1693 volunteers) and two reported the results of large, targeted campaigns run in whole communities and cities. The evidence is current to August 2016. The available evidence is insufficient to conclude whether targeted mass media interventions for ethnic minority groups are more, less or equally effective in changing health behaviours than general mass media interventions. Only one study compared participants' smoking habits and intentions to quit following the receipt of either a culturally adapted smoking advice booklet or a booklet developed for the general population. They found little or no differences in smoking behaviours between the groups. When compared to no mass media intervention, a targeted mass media intervention may increase the number of calls to smoking quit lines, but the effect on health behaviours is unclear. This conclusion is based on findings from three studies. One study gave participants access to a series of 12 live shows on cable TV with information on how to maintain a healthy weight through diet and physical activity. Compared to women who did not watch the shows, participants reported slightly increased physical activity and some positive changes to their dietary patterns; however, their body weight was no different over time. Two other studies were large-scale targeted campaigns in which smokers were encouraged to call a quit line for smoking cessation advice. The number of telephone calls from the target population increased considerably during the campaign. This review also compared targeted mass media interventions versus mass media interventions with added personal interactions. These findings, based on three studies, were inconclusive. None of the studies reported whether the interventions could have had any adverse effects, such as possible stigmatisation or increased resistance to messages. Further studies directly comparing targeted mass media interventions with general mass media interventions would be useful. Few studies have investigated the effects of targeted mass media interventions for ethnic minority groups who primarily speak a non-dominant language. Our confidence in the evidence of effect on all main outcomes is low to very low. This means that the true effect may be different or substantially different from the results presented in this review. We have moderate confidence in the estimated increase in the number of calls to smoking quit lines." ]
cochrane-simplification-train-11
cochrane-simplification-train-11
We identified six new trials for this update. In total, the evidence for this review rests on 14 trials (805 participants). Music listening was the main intervention used, and 13 of the studies did not include a trained music therapist. Results indicated that music listening may be beneficial for anxiety reduction in mechanically ventilated patients. Specifically, music listening resulted, on average, in an anxiety reduction that was 1.11 standard deviation units greater (95% CI -1.75 to -0.47, P = 0.0006) than in the standard care group. This is considered a large and clinically significant effect. Findings indicated that listening to music consistently reduced respiratory rate and systolic blood pressure, suggesting a relaxation response. Furthermore, one large-scale study reported greater reductions in sedative and analgesic intake in the music listening group compared to the control group, and two other studies reported trends for reduction in sedative and analgesic intake for the music group. One study found significantly higher sedation scores in the music listening group compared to the control group. No strong evidence was found for reduction in diastolic blood pressure and mean arterial pressure. Furthermore, inconsistent results were found for reduction in heart rate with seven studies reporting greater heart rate reductions in the music listening group and one study a slightly greater reduction in the control group. Music listening did not improve oxygen saturation levels. Four studies examined the effects of music listening on hormone levels but the results were mixed and no conclusions could be drawn. No strong evidence was found for an effect of music listening on mortality rate but this evidence rested on only two trials. Most trials were assessed to be at high risk of bias because of lack of blinding. Blinding of outcome assessors is often impossible in music therapy and music medicine studies that use subjective outcomes, unless the music intervention is compared to another treatment intervention. Because of the high risk of bias, these results need to be interpreted with caution. No studies could be found that examined the effects of music interventions on quality of life, patient satisfaction, post-discharge outcomes, or cost-effectiveness. No adverse events were identified. This updated systematic review indicates that music listening may have a beneficial effect on anxiety in mechanically ventilated patients. These findings are consistent with the findings of three other Cochrane systematic reviews on the use of music interventions for anxiety reduction in medical patients. The review furthermore suggests that music listening consistently reduces respiratory rate and systolic blood pressure. Finally, results indicate a possible beneficial impact on the consumption of sedatives and analgesics. Therefore, we conclude that music interventions may provide a viable anxiety management option to mechanically ventilated patients.
We included 14 controlled trials involving 805 critically ill participants on mechanical ventilation. All participants were alert. Slightly more patients (58%) included in these studies were male and their average age was 58 years. The majority of the studies examined the effects of patients listening to pre-recorded music. Most studies offered one 20 to 30-minute music session to the participants. The findings suggest that music listening may have a large anxiety-reducing effect on mechanically ventilated patients. The results furthermore suggest that music listening consistently reduces respiratory rate and systolic blood pressure, suggesting a relaxation response. No evidence of effect was found for diastolic blood pressure, mean arterial pressure, or oxygen saturation level and inconsistent results were found for heart rate and hormone levels. One large-scale study reported greater reductions in the intake of sedative and analgesic medications in the music listening group compared to the control group, and two other studies reported similar trends. Music listening did not result in any harm. Most trials presented some methodological weakness. Therefore, these results need to be interpreted with caution. However, the results are consistent with the findings of three other Cochrane systematic reviews on the use of music interventions for anxiety reduction in medical patients. Therefore, we conclude that music interventions may provide a viable anxiety management option to mechanically ventilated patients.
10.1002/14651858.CD006902.pub3
[ "We included 14 controlled trials involving 805 critically ill participants on mechanical ventilation. All participants were alert. Slightly more patients (58%) included in these studies were male and their average age was 58 years. The majority of the studies examined the effects of patients listening to pre-recorded music. Most studies offered one 20 to 30-minute music session to the participants. The findings suggest that music listening may have a large anxiety-reducing effect on mechanically ventilated patients. The results furthermore suggest that music listening consistently reduces respiratory rate and systolic blood pressure, suggesting a relaxation response. No evidence of effect was found for diastolic blood pressure, mean arterial pressure, or oxygen saturation level and inconsistent results were found for heart rate and hormone levels. One large-scale study reported greater reductions in the intake of sedative and analgesic medications in the music listening group compared to the control group, and two other studies reported similar trends. Music listening did not result in any harm. Most trials presented some methodological weakness. Therefore, these results need to be interpreted with caution. However, the results are consistent with the findings of three other Cochrane systematic reviews on the use of music interventions for anxiety reduction in medical patients. Therefore, we conclude that music interventions may provide a viable anxiety management option to mechanically ventilated patients." ]
cochrane-simplification-train-12
cochrane-simplification-train-12
We included in this updated review 33 RCTs with 3946 participants. Twenty new trials with 2780 participants had been completed since the previous review. Outcome data were available for up to 22 trials (2865 participants) that compared acupuncture with any control (open control or sham acupuncture) but for only six trials (668 participants) that compared acupuncture with sham acupuncture control. We downgraded the evidence to low or very low quality because of risk of bias in included studies, inconsistency in the acupuncture intervention and outcome measures, and imprecision in effect estimates. When compared with any control (11 trials with 1582 participants), findings of lower odds of death or dependency at the end of follow-up and over the long term (≥ three months) in the acupuncture group were uncertain (odds ratio [OR] 0.61, 95% confidence interval [CI] 0.46 to 0.79; very low-quality evidence; and OR 0.67, 95% CI 0.53 to 0.85; eight trials with 1436 participants; very low-quality evidence, respectively) and were not confirmed by trials comparing acupuncture with sham acupuncture (OR 0.71, 95% CI 0.43 to 1.18; low-quality evidence; and OR 0.67, 95% CI 0.40 to 1.12; low-quality evidence, respectively). In trials comparing acupuncture with any control, findings that acupuncture was associated with increases in the global neurological deficit score and in the motor function score were uncertain (standardized mean difference [SMD] 0.84, 95% CI 0.36 to 1.32; 12 trials with 1086 participants; very low-quality evidence; and SMD 1.08, 95% CI 0.45 to 1.71; 11 trials with 895 participants; very low-quality evidence). These findings were not confirmed in trials comparing acupuncture with sham acupuncture (SMD 0.01, 95% CI -0.55 to 0.57; low-quality evidence; and SMD 0.10, 95% CI -0.38 to 0.17; low-quality evidence, respectively). Trials comparing acupuncture with any control have reported little or no difference in death or institutional care at the end of follow-up (OR 0.78, 95% CI 0.54 to 1.12; five trials with 1120 participants; low-quality evidence), death within the first two weeks (OR 0.91, 95% CI 0.33 to 2.55; 18 trials with 1612 participants; low-quality evidence), or death at the end of follow-up (OR 1.08, 95% CI 0.74 to 1.58; 22 trials with 2865 participants; low-quality evidence). The incidence of adverse events (eg, pain, dizziness, faint) in the acupuncture arms of open and sham control trials was 6.2% (64/1037 participants), and 1.4% of these (14/1037 participants) discontinued acupuncture. When acupuncture was compared with sham acupuncture, findings for adverse events were uncertain (OR 0.58, 95% CI 0.29 to 1.16; five trials with 576 participants; low-quality evidence). This updated review indicates that apparently improved outcomes with acupuncture in acute stroke are confounded by the risk of bias related to use of open controls. Adverse events related to acupuncture were reported to be minor and usually did not result in stopping treatment. Future studies are needed to confirm or refute any effects of acupuncture in acute stroke. Trials should clearly report the method of randomization, concealment of allocation, and whether blinding of participants, personnel, and outcome assessors was achieved, while paying close attention to the effects of acupuncture on long-term functional outcomes.
We searched electronic databases and the Chinese Clinical Trial Registry up to February 2017, and two clinical trials platforms (WHO International Clinical Trials Registry Platform and Clinicaltrials.gov) up to April 2017. We included in this review 33 randomized clinical trials (RCTs) with 3946 participants. Of these, results were available for up to 22 trials (2865 participants) that compared acupuncture with any control but for only six trials (668 participants) that compared acupuncture with a sham acupuncture procedure. The effects of acupuncture in reducing death or dependency or improving neurological and movement scores at the end of follow-up, as seen in trials comparing acupuncture with any control, were not seen in trials comparing acupuncture with the more reliable control of sham acupuncture. Adverse events such as pain, dizziness, and faint were reported in 6.2% (64/1037) of participants, and 1.4% (14) of these had to discontinue acupuncture. The quality of the evidence was low or very low owing to risk of bias in the included studies and variation in the type and duration of acupuncture. Additional larger reliable research trials are required for enhanced confidence in the effects of acupuncture for acute stroke.
10.1002/14651858.CD003317.pub3
[ "We searched electronic databases and the Chinese Clinical Trial Registry up to February 2017, and two clinical trials platforms (WHO International Clinical Trials Registry Platform and Clinicaltrials.gov) up to April 2017. We included in this review 33 randomized clinical trials (RCTs) with 3946 participants. Of these, results were available for up to 22 trials (2865 participants) that compared acupuncture with any control but for only six trials (668 participants) that compared acupuncture with a sham acupuncture procedure. The effects of acupuncture in reducing death or dependency or improving neurological and movement scores at the end of follow-up, as seen in trials comparing acupuncture with any control, were not seen in trials comparing acupuncture with the more reliable control of sham acupuncture. Adverse events such as pain, dizziness, and faint were reported in 6.2% (64/1037) of participants, and 1.4% (14) of these had to discontinue acupuncture. The quality of the evidence was low or very low owing to risk of bias in the included studies and variation in the type and duration of acupuncture. Additional larger reliable research trials are required for enhanced confidence in the effects of acupuncture for acute stroke." ]
cochrane-simplification-train-13
cochrane-simplification-train-13
The search identified 14 new RCTs since the last published version of this review, resulting in 16 included RCTs involving 2091 high-risk women for this updated review. They evaluated three types of dopamine agonists: cabergoline, quinagolide and bromocriptine. When compared with placebo or no intervention, dopamine agonists seemed effective in the prevention of moderate or severe OHSS (OR 0.27, 95% CI 0.19 to 0.39; 1022 participants; 8 studies; I2 = 0%; moderate quality evidence). This suggests that if 29% of women undergoing ART experience moderate or severe OHSS, the use of dopamine agonists will lower this to 7% to 14% of women. There was no evidence of a difference in live birth rate, clinical pregnancy rate, multiple pregnancy rate or miscarriage rate (very low to moderate quality evidence). However, taking dopamine agonists (especially quinagolide) may increase the incidence of adverse events such as gastrointestinal adverse effects (OR 4.54, 95% CI 1.49 to 13.84; 264 participants; 2 studies; I2 = 49%, very low quality evidence). When we compared dopamine agonist plus co-intervention with co-intervention, there was no evidence of a difference in the outcomes of moderate or severe OHSS, live birth rate, clinical pregnancy rate, miscarriage rate or adverse events. The co-interventions were hydroxyethyl starch (two RCTs) and albumin (one RCT). Cabergoline was associated with a lower risk of moderate or severe OHSS compared with human albumin (OR 0.21, 95% CI 0.12 to 0.38; 296 participants; 3 studies; I2 = 72%). However, there was no evidence of a difference between cabergoline and hydroxyethyl starch, coasting (withholding any more ovarian stimulation for a few days) or prednisolone. There was an increased clinical pregnancy rate in the cabergoline group when cabergoline was compared with coasting (OR 2.65, 95% CI 1.13 to 6.21; 120 participants; 2 studies; I2 = 0%). In other respects, there was no evidence of a difference in clinical pregnancy rate, multiple pregnancy rate or miscarriage rate between cabergoline and other active interventions. The quality of the evidence between dopamine agonist and placebo or no intervention ranged from very low to moderate, mainly due to poor reporting of study methods (mostly a lack of details on randomisation or blinding) and serious imprecision for some comparisons. Dopamine agonists appear to reduce the incidence of moderate or severe OHSS in women at high risk of OHSS (moderate quality evidence). If a fresh embryo transfer is performed, the use of dopamine agonists does not affect the pregnancy outcome (live birth rate, clinical pregnancy rate and miscarriage rate) (very low to moderate quality evidence). However, dopamine agonists might increase the risk of adverse events, such as gastrointestinal symptoms. Further research should focus on dose-finding, comparisons with other effective treatments and consideration of combination treatments. Therefore, large, well-designed and well-executed RCTs that involve more clinical endpoints (e.g., live birth rate) are necessary to further evaluate the role of dopamine agonists in OHSS prevention.
This review included 16 randomised controlled trials involving 2091 women at high risk of OHSS, which evaluated three different dopamine agonists (cabergoline, bromocriptine and quinagolide). The main outcome measures were the number of new cases (incidence) of moderate or severe OHSS and live birth rate. The evidence is current to August 2016. Dopamine agonists appear to reduce the incidence of moderate or severe OHSS in women at high risk of OHSS (moderate quality evidence) compared with placebo or no treatment. This suggests that if 29% of women taking placebo or no treatment have moderate or severe OHSS, between 7% and 14% of women taking dopamine agonists will have moderate or severe OHSS. For women who had a fresh embryo transferred as part of their treatment cycle, there was no evidence that dopamine agonists influenced pregnancy outcomes, but they might increase the risk of side effects, such as stomach upsets. There was no evidence of a difference between a dopamine agonist plus another active treatment versus another active treatment on incidence of moderate or severe OHSS and live birth rate. There was no evidence of a difference in OHSS rates between cabergoline and placebo treatments (e.g. hydroxyethyl starch, prednisolone or 'coasting' (withholding any more ovarian stimulation for a few days)). Cabergoline was associated with an increased clinical pregnancy rate compared with coasting. The quality of the evidence ranged from very low to moderate. Limitations included poor reporting of study methods and imprecision (too few events) for some comparisons.
10.1002/14651858.CD008605.pub3
[ "This review included 16 randomised controlled trials involving 2091 women at high risk of OHSS, which evaluated three different dopamine agonists (cabergoline, bromocriptine and quinagolide). The main outcome measures were the number of new cases (incidence) of moderate or severe OHSS and live birth rate. The evidence is current to August 2016. Dopamine agonists appear to reduce the incidence of moderate or severe OHSS in women at high risk of OHSS (moderate quality evidence) compared with placebo or no treatment. This suggests that if 29% of women taking placebo or no treatment have moderate or severe OHSS, between 7% and 14% of women taking dopamine agonists will have moderate or severe OHSS. For women who had a fresh embryo transferred as part of their treatment cycle, there was no evidence that dopamine agonists influenced pregnancy outcomes, but they might increase the risk of side effects, such as stomach upsets. There was no evidence of a difference between a dopamine agonist plus another active treatment versus another active treatment on incidence of moderate or severe OHSS and live birth rate. There was no evidence of a difference in OHSS rates between cabergoline and placebo treatments (e.g. hydroxyethyl starch, prednisolone or 'coasting' (withholding any more ovarian stimulation for a few days)). Cabergoline was associated with an increased clinical pregnancy rate compared with coasting. The quality of the evidence ranged from very low to moderate. Limitations included poor reporting of study methods and imprecision (too few events) for some comparisons." ]
cochrane-simplification-train-14
cochrane-simplification-train-14
Seven studies met our eligibility criteria. All were randomized controlled trials; six assigned clusters and one randomized individuals. Sample sizes for the cluster-randomized trials ranged from 2157 to 15,614; the number of clusters ranged from 18 to 70. Four trials took place in African countries, two in the USA, and one in England. Three were based mainly in schools, two were in community settings, one took place during military training, and one was clinic-based. Five studies provided data on pregnancy, either from pregnancy tests or national records of abortions and live births. Four trials assessed the incidence or prevalence of HIV and HSV-2. Three trials examined other STI. The trials showed or reported no significant difference between study groups for pregnancy or HIV, but favorable effects were evident for some STI. Two showed a lower incidence of HSV-2 for the behavioral-intervention group compared to the usual-care group, with reported adjusted rate ratios (ARR) of 0.65 (95% CI 0.43 to 0.97) and 0.67 (95% CI 0.47 to 0.97), while HIV did not differ significantly. One also reported lower syphilis incidence and gonorrhea prevalence for the behavioral intervention plus STI management compared to the usual-care group. The reported ARR were 0.58 (95% CI 0.35 to 0.96) and 0.28 (95% CI 0.11 to 0.70), respectively. Another study reported a negative effect on gonorrhea for young women in the intervention group versus the control group (ARR 1.93; 95% CI 1.01 to 3.71). The difference occurred among those with only one year of the intervention. We found few studies and little clinical evidence of effectiveness for interventions promoting condom use for dual protection. We did not find favorable results for pregnancy or HIV, and only found some for other STI. The overall quality of evidence was moderate to low; losses to follow up were high. Effective interventions for improving condom use are needed to prevent pregnancy and HIV/STI transmission. Interventions should be feasible for resource-limited settings and tested using valid and reliable outcome measures.
Through September 2013, we did computer searches for studies of programs to improve condom use. We wrote to researchers for missing data. The studies could have various designs. The education program addressed preventing pregnancy and HIV/STI. The intervention was compared with a different program, usual care, or no intervention. The studies had a clinical outcome such as pregnancy, HIV, or STI tests. We did not use self-reports of condom use. We found seven randomized trials. Six assigned groups (clusters) and one randomized individuals. Four trials took place in African countries, two in the USA, and one in England. The studies were based in schools, community settings, a clinic, and a military training setting. Five trials examined pregnancy, four studied HIV and HSV-2 (herpes), and three assessed other STI. We found no major differences between study groups for pregnancy or HIV. Some results were seen for STI outcomes. Two studies showed fewer HSV-2 cases with the behavioral program compared to the control group. One also reported fewer cases of syphilis and gonorrhea with the behavioral program plus STI management. Another study reported a higher gonorrhea rate for the intervention group. The researchers believed the result was due to a subgroup that did not have the full program. We found little clinical effect of improving condom use. The studies provided moderate to low quality information. Losses to follow up were high. We need good programs on condom use to prevent pregnancy and HIV/STI. Programs should be useful for settings with few resources. Interventions should be tested with valid outcome measures.
10.1002/14651858.CD010662.pub2
[ "Through September 2013, we did computer searches for studies of programs to improve condom use. We wrote to researchers for missing data. The studies could have various designs. The education program addressed preventing pregnancy and HIV/STI. The intervention was compared with a different program, usual care, or no intervention. The studies had a clinical outcome such as pregnancy, HIV, or STI tests. We did not use self-reports of condom use. We found seven randomized trials. Six assigned groups (clusters) and one randomized individuals. Four trials took place in African countries, two in the USA, and one in England. The studies were based in schools, community settings, a clinic, and a military training setting. Five trials examined pregnancy, four studied HIV and HSV-2 (herpes), and three assessed other STI. We found no major differences between study groups for pregnancy or HIV. Some results were seen for STI outcomes. Two studies showed fewer HSV-2 cases with the behavioral program compared to the control group. One also reported fewer cases of syphilis and gonorrhea with the behavioral program plus STI management. Another study reported a higher gonorrhea rate for the intervention group. The researchers believed the result was due to a subgroup that did not have the full program. We found little clinical effect of improving condom use. The studies provided moderate to low quality information. Losses to follow up were high. We need good programs on condom use to prevent pregnancy and HIV/STI. Programs should be useful for settings with few resources. Interventions should be tested with valid outcome measures." ]
cochrane-simplification-train-15
cochrane-simplification-train-15
Of the 2077 references identified, 24 trials were included in this review. For electrostimulation compared with no treatment this review found that electrostimulation improved some aspects of functional motor ability and some aspects of motor impairment and normality of movement. In addition, there was a significant difference in favour of no treatment compared with electrostimulation for an aspect of functional motor ability. For electrostimulation compared with placebo this review found that electrostimulation improved an aspect of functional motor ability. For electrostimulation compared with conventional physical therapy this review found that electrostimulation improved an aspect of motor impairment. There were no statistically significant differences between electrostimulation and control treatment for all other outcomes. However, these results need to be interpreted with reference to the following: (1) the majority of analyses only contained one trial; (2) variation was found between included trials in time after stroke, level of functional deficit, and dose of electrostimulation; and (3) the possibility of selection and detection bias in the majority of included trials. At present, there are insufficient robust data to inform clinical use of electrostimulation for neuromuscular re-training. Research is needed to address specific questions about the type of electrostimulation that might be most effective, in what dose and at what time after stroke.
Electrostimulation is a potential treatment to improve recovery of movement control and functional ability after stroke but the results of this review are inconclusive. After stroke many people are unable to use their affected limbs in everyday activities such as walking, ascending/descending stairs, washing hair or opening a coffee jar. One way to improve recovery might be to train affected muscles by using electrostimulation. This review examined the findings of 24 randomised controlled trials of electrostimulation provided to improve the ability to voluntarily move the affected limb and/or use the affected limb in everyday activities. The available evidence suggests that when electrostimulation is compared to no treatment then there might be a small effect on some aspects of function in favour of electrostimulation. However, the majority of findings in favour of electrostimulation were found when it was compared to a group of stroke patients who were not receiving any treatment and for all but two of the outcomes examined there were no differences between either electrostimulation and placebo or between electrostimulation and another type of physical therapy. This review also found that there were many differences between randomised controlled trials in the types of stroke patients who were included, the doses of electrostimulation and the outcome measures used. This meant that many of the comparisons made in the review related to one randomised trial rather than two or more. In addition, the numbers of participants in trials were relatively small. The results of this review therefore need to be interpreted with caution.
10.1002/14651858.CD003241.pub2
[ "Electrostimulation is a potential treatment to improve recovery of movement control and functional ability after stroke but the results of this review are inconclusive. After stroke many people are unable to use their affected limbs in everyday activities such as walking, ascending/descending stairs, washing hair or opening a coffee jar. One way to improve recovery might be to train affected muscles by using electrostimulation. This review examined the findings of 24 randomised controlled trials of electrostimulation provided to improve the ability to voluntarily move the affected limb and/or use the affected limb in everyday activities. The available evidence suggests that when electrostimulation is compared to no treatment then there might be a small effect on some aspects of function in favour of electrostimulation. However, the majority of findings in favour of electrostimulation were found when it was compared to a group of stroke patients who were not receiving any treatment and for all but two of the outcomes examined there were no differences between either electrostimulation and placebo or between electrostimulation and another type of physical therapy. This review also found that there were many differences between randomised controlled trials in the types of stroke patients who were included, the doses of electrostimulation and the outcome measures used. This meant that many of the comparisons made in the review related to one randomised trial rather than two or more. In addition, the numbers of participants in trials were relatively small. The results of this review therefore need to be interpreted with caution." ]
cochrane-simplification-train-16
cochrane-simplification-train-16
Two trials with a total of 529 patients met the inclusion criteria. Patients fulfilling the American Rheumatism Association 1987 RA diagnostic criteria were randomized to receive either infliximab 1mg/kg (with and without MTX), 3mg/kg(with and without MTX) , 10mg/kg of infliximab (with and without MTX) or placebo infusion plus MTX. Infusions were given every 4 or 8 weeks. After 6 months ACR 20, ACR 50 and ACR 70 response rates were significantly improved in all infliximab doses compared to control. The number needed to treat with infliximab to achieve an ACR 20, 50 or 70 response in patients with refractory RA under specialist care ranged from 2.94-3.33 for ACR 20, 3.57-4.76 for ACR 50 and 5.88 -12.5 for ACR 70 depending on the dose (3mg/kg or 10mg/kg given either every 4 or 8 weeks). Total withdrawals and withdrawals due to lack of efficacy were lower for all doses of infliximab versus controls. Withdrawals for adverse events and withdrawals for other reasons were not statistically significantly different for those receiving infliximab from control. Treatment with infliximab for 6 and 12 months significantly reduces RA disease activity and appeared to have an acceptable safety profile in these trials. Total radiographic scores improved, fewer patients showed radiographic progression, and more patients showed radiographic improvement with infliximab treatment at 12 months compared to controls. However, only 2 trials met the inclusion criteria, and these results are largely driven by the largest trial. The available efficacy and toxicity data is relatively short-term (6-12 months). In order to detect rare events that may be associated with infliximab, larger and longer term studies are required.
Infliximab is a relatively new disease modifying anti-rheumatic drug that inhibits tumour necrosis factor alpha. Short term (six to twelve month) studies suggest infliximab is well tolerated, and in combination with methotrexate, decreases disease activity in RA. Infliximab 3mg/kg or 10mg/kg, in combination with methotrexate, taken every 4 or 8 weeks for either 6 or 12 months, significantly improved disease activity as measured by tender and swollen joints and ACR response rates. Pain and physical function also improved compared to those taking methotrexate alone. Infliximab significantly reduced radiographic progression at 12 months.
10.1002/14651858.CD003785
[ "Infliximab is a relatively new disease modifying anti-rheumatic drug that inhibits tumour necrosis factor alpha. Short term (six to twelve month) studies suggest infliximab is well tolerated, and in combination with methotrexate, decreases disease activity in RA. Infliximab 3mg/kg or 10mg/kg, in combination with methotrexate, taken every 4 or 8 weeks for either 6 or 12 months, significantly improved disease activity as measured by tender and swollen joints and ACR response rates. Pain and physical function also improved compared to those taking methotrexate alone. Infliximab significantly reduced radiographic progression at 12 months." ]
cochrane-simplification-train-17
cochrane-simplification-train-17
Fifteen trials met the inclusion criteria (2284 participants, 69% males, 16% children). They were conducted in disparate malaria endemic areas, with the earlier studies conducted in Thailand (five) and India (two), and the more recent studies (eight) spread across three continents (South America, Africa, Asia). The 15 studies involved 41 treatment arms, 12 different drugs, and 28 different treatment regimens. Two studies examined P. vivax. Three-day azithromycin (AZ) monotherapy did not perform well for P. vivax or P. falciparum (Thailand: P. vivax failure rate 0.5 g daily, 56%, 95% CI 31 to 78. India: P. vivax failure rate 1 g daily,12%, 95% CI 7 to 21; P. falciparum failure rate 1 g daily, 64%, 95% CI 36 to 86.) A 1 g azithromycin and 0.6 g chloroquine combination daily for three days for uncomplicated P. falciparum infections was associated with increased treatment failure in India and Indonesia compared with the combination of sulphadoxine-pyrimethamine and chloroquine (pooled RR 2.66, 95% CI 1.25 to 5.67), and compared with the combination atovaquone-proguanil in a multicentre trial in Columbia and Surinam (RR 24.72, 95% CI 6.16 to 99.20). No increased risk of treatment failure was seen in two studies in Africa with mefloquine as the comparator drug (pooled RR 2.02, 95% CI 0.51 to 7.96, P = 0.3); the pooled RR for PCR-corrected data for the combination versus mefloquine was 1.01, 95% CI 0.18 to 5.84 (P = 1.0). An increased treatment failure risk was seen when comparing azithromycin in a dose of 1.2 to 1.5 mg in combination with artesunate (200 mg per day for three days) with artemether-lumefantrine (pooled RR 3.08, 95% CI 2.09 to 4.55; PCR-corrected pooled RR 3.63, 95% CI 2.02 to 6.52). Serious adverse events and treatment discontinuation were similar across treatment arms. More adverse events were reported when comparing the 1 g azithromycin/ 0.6 g chloroquine combination with mefloquine (pooled RR 1.20, 95% CI 1.06 to 1.36) or atovaquone-proguanil (RR 1.41, 95% CI 1.09 to1.83). Currently, there is no evidence for the superiority or equivalence of azithromycin monotherapy or combination therapy for the treatment of P. falciparum or P. vivax compared with other antimalarials or with the current first-line antimalarial combinations. The available evidence suggests that azithromycin is a weak antimalarial with some appealing safety characteristics. Unless the ongoing dose, formulation and product optimisation process results in a universally efficacious product, or a specific niche application is identified that is complementary to the current scala of more efficacious antimalarial combinations, azithromycin's future for the treatment of malaria does not look promising.
Our review of studies conducted over the past 14 years suggests that azithromycin is a relatively weak antimalarial whose efficacy depends on the drug dose and the partner drug in the combination therapy. The data suggest that, among adults, the higher doses needed to achieve an acceptable level of treatment success with malaria may be less well tolerated. Unless the ongoing product and dose optimisation process results in a universally efficacious product or identifies a specific niche application that is complementary to the current scala of more efficacious antimalarial combinations, azithromycin's future as an antimalarial does not look promising.
10.1002/14651858.CD006688.pub2
[ "Our review of studies conducted over the past 14 years suggests that azithromycin is a relatively weak antimalarial whose efficacy depends on the drug dose and the partner drug in the combination therapy. The data suggest that, among adults, the higher doses needed to achieve an acceptable level of treatment success with malaria may be less well tolerated. Unless the ongoing product and dose optimisation process results in a universally efficacious product or identifies a specific niche application that is complementary to the current scala of more efficacious antimalarial combinations, azithromycin's future as an antimalarial does not look promising." ]
cochrane-simplification-train-18
cochrane-simplification-train-18
We included two separate German studies involving a total of 518 participants. One study was undertaken in the inpatient treatment of schizophrenia and the other in the treatment of people newly diagnosed with depression in primary care. Regarding the primary outcomes, one study reported statistically significant increases in patient satisfaction, the other study did not. There was no evidence of effect on clinical outcomes or hospital readmission rates in either study. Regarding secondary outcomes, there was an indication that interventions to increase shared decision making increased doctor facilitation of patient involvement in decision making, and did not increase consultation times. Nor did the interventions increase patient compliance with treatment plans. Neither study reported any harms of the intervention. Definite conclusions cannot be drawn, however, on the basis of these two studies. No firm conclusions can be drawn at present about the effects of shared decision making interventions for people with mental health conditions. There is no evidence of harm, but there is an urgent need for further research in this area.
We conducted thorough searches for randomised controlled trials (RCTs), quasi-randomised controlled trials (q-RCTs), controlled before-and-after studies (CBAs); and interrupted time series (ITS) studies of interventions to increase shared decision making in people with mental health conditions. We found two studies that met the inclusion criteria. Both studies were of good quality and made attempts to reduce potential sources of bias. We examined whether interventions to increase shared decision making affected patient satisfaction with treatment or care, led to better health outcomes or to patients being less likely to be readmitted to hospital. One of the studies indicated that the intervention increased patient satisfaction in the short term. One study indicated that doctor facilitation of consumer involvement in decision making was increased by the intervention, but no effects were found on the clinical or health service outcomes in either study. Neither study reported that shared decision making for people with mental health conditions is harmful. However, no firm conclusions can be drawn from these two studies on any of the outcomes measured and further research is needed.
10.1002/14651858.CD007297.pub2
[ "We conducted thorough searches for randomised controlled trials (RCTs), quasi-randomised controlled trials (q-RCTs), controlled before-and-after studies (CBAs); and interrupted time series (ITS) studies of interventions to increase shared decision making in people with mental health conditions. We found two studies that met the inclusion criteria. Both studies were of good quality and made attempts to reduce potential sources of bias. We examined whether interventions to increase shared decision making affected patient satisfaction with treatment or care, led to better health outcomes or to patients being less likely to be readmitted to hospital. One of the studies indicated that the intervention increased patient satisfaction in the short term. One study indicated that doctor facilitation of consumer involvement in decision making was increased by the intervention, but no effects were found on the clinical or health service outcomes in either study. Neither study reported that shared decision making for people with mental health conditions is harmful. However, no firm conclusions can be drawn from these two studies on any of the outcomes measured and further research is needed." ]
cochrane-simplification-train-19
cochrane-simplification-train-19
As a group, NSAIDs were more effective than placebo at reducing HMB but less effective than tranexamic acid, danazol or the levonorgestrel-releasing intrauterine system (LNG IUS). Treatment with danazol caused a shorter duration of menstruation and more adverse events than NSAIDs, but this did not appear to affect the acceptability of treatment, based on trials from 1980 to 1990. However, currently danazol is not a usual or recommended treatment for HMB. There was no clear evidence of difference between NSAIDs and the other treatments (oral luteal progestogen, ethamsylate, an older progesterone-releasing intrauterine system and the oral contraceptive pill (OCP), but most studies were underpowered. There was no evidence of a difference between the individual NSAIDs (naproxen and mefenamic acid) in reducing HMB. The evidence quality ranged from low to moderate, the main limitations being risk of bias and imprecision. NSAIDs reduce HMB when compared with placebo, but are less effective than tranexamic acid, danazol or LNG IUS. However, adverse events are more severe with danazol therapy. In the limited number of small studies suitable for evaluation, there was no clear evidence of a difference in efficacy between NSAIDs and other medical treatments such as oral luteal progestogen, ethamsylate, OCP or the older progesterone-releasing intrauterine system.
Authors search medical databases and identified 19 randomised controlled trials (RCTs; clinical studies where people are randomly put into one of two or more treatment groups) with 759 women that could be included in the review, but data from only nine trials were suitable for analyses. Women sought help for HMB when it affected their quality of life. Levels of prostaglandin (a naturally occurring hormone) are higher in women with HMB and are reduced by NSAIDs. The review of trials found that NSAIDs were modestly effective in reducing HMB, but other medicines, such as danazol, tranexamic acid and levonorgestrel-releasing intrauterine system (LNG IUS), are more effective. These results were based on a small number of low- to moderate-quality trials. The evidence quality ranged from low to moderate, the main limitations being poor reporting of study methods and imprecision resulting from small study numbers.
10.1002/14651858.CD000400.pub4
[ "Authors search medical databases and identified 19 randomised controlled trials (RCTs; clinical studies where people are randomly put into one of two or more treatment groups) with 759 women that could be included in the review, but data from only nine trials were suitable for analyses. Women sought help for HMB when it affected their quality of life. Levels of prostaglandin (a naturally occurring hormone) are higher in women with HMB and are reduced by NSAIDs. The review of trials found that NSAIDs were modestly effective in reducing HMB, but other medicines, such as danazol, tranexamic acid and levonorgestrel-releasing intrauterine system (LNG IUS), are more effective. These results were based on a small number of low- to moderate-quality trials. The evidence quality ranged from low to moderate, the main limitations being poor reporting of study methods and imprecision resulting from small study numbers." ]
cochrane-simplification-train-20
cochrane-simplification-train-20
We included 23 studies, all of which enrolled adults with frequent episodic TTH. Twelve studies used the IHS diagnostic criteria or similar, six used the older classification of the Ad Hoc Committee, and five did not describe specific diagnostic criteria but generally excluded participants with migraines. Participants had moderate or severe pain at the start of treatment. While 8079 people with TTH participated in these studies, the numbers available for any analysis were lower than this because outcomes were inconsistently reported and because many participants received active comparators. None of the included studies were at low risk of bias across all domains considered, although for most studies and domains this was likely to be due to inadequate reporting rather than poor methods. We judged five studies to be at high risk of bias for incomplete outcome reporting, and seven due to small size. For the IHS preferred outcome of being pain free at two hours the NNT for paracetamol 1000 mg compared with placebo was 22 (95% confidence interval (CI) 15 to 40) in eight studies (5890 participants; high quality evidence), with no significant difference from placebo at one hour. The NNT was 10 (7.9 to 14) for pain-free or mild pain at two hours in five studies (5238 participants; high quality evidence). The use of rescue medication was lower with paracetamol 1000 mg than with placebo, with an NNTp to prevent an event of 7.8 (6.0 to 11) in six studies (1856 participants; moderate quality evidence). On limited data, the efficacy of paracetamol 500 mg to 650 mg was not superior to placebo, and paracetamol 1000 mg was not different from either ketoprofen 25 mg or ibuprofen 400 mg (low quality evidence). Adverse events were not different between paracetamol 1000 mg and placebo (RR 1.1 (0.94 to 1.3); 5605 participants; 11 studies; high quality evidence). Studies reported no serious adverse events. The quality of the evidence using GRADE comparing paracetamol 1000 mg with placebo was moderate to high. Where evidence was downgraded it was because a minority of studies reported the outcome. For comparisons of paracetamol 500 mg to 650 mg with placebo, and of paracetamol 1000 mg with active comparators, we downgraded the evidence to low quality or very low quality because of the small number of studies and events. Paracetamol 1000 mg provided a small benefit in terms of being pain free at two hours for people with frequent episodic TTH who have an acute headache of moderate or severe intensity.
In October 2015, we searched the medical literature and found 23 studies involving 8079 participants looking at paracetamol for frequent episodic tension-type headache. About 6000 participants were involved in comparisons between paracetamol 1000 mg and placebo (a dummy tablet). Results were usually reported two hours after taking the medicine or placebo. The International Headache Society recommends the outcome of being pain free two hours after taking a medicine, but other outcomes are also suggested. Few studies reported pain free at two hours or other outcomes, so there was limited information to analyse for some outcomes. The outcome of being pain free at two hours was reported by 24 in 100 people taking paracetamol 1000 mg, and in 19 out of 100 people taking placebo, meaning that only 5 in 100 people benefited because of paracetamol 1000 mg (high quality evidence). The outcome of being pain free or having only mild pain at two hours was reported by 59 in 100 people taking paracetamol 1000 mg, and in 49 out of 100 people taking placebo (high quality evidence), meaning that only 10 in 100 people benefited because of paracetamol 1000 mg. About 10 in 100 people taking paracetamol 1000 mg reported having a side effect, which was the same as with placebo (9 in 100 people) (high quality evidence). Most side effects were mild or moderate in intensity. No side effects were serious. We found a very small amount of information comparing paracetamol 500 mg or 650 mg with placebo, and comparing paracetamol 1000 mg with other painkillers. There was no difference between any of these treatments. The quality of the evidence was moderate or high for paracetamol 1000 mg compared with placebo, and low or very low for paracetamol 500 mg to 650 mg compared with placebo, and for paracetamol 1000 mg compared with other painkillers. High quality evidence means that we are very certain about the results. Low quality evidence means that we are very uncertain about the results.
10.1002/14651858.CD011889.pub2
[ "In October 2015, we searched the medical literature and found 23 studies involving 8079 participants looking at paracetamol for frequent episodic tension-type headache. About 6000 participants were involved in comparisons between paracetamol 1000 mg and placebo (a dummy tablet). Results were usually reported two hours after taking the medicine or placebo. The International Headache Society recommends the outcome of being pain free two hours after taking a medicine, but other outcomes are also suggested. Few studies reported pain free at two hours or other outcomes, so there was limited information to analyse for some outcomes. The outcome of being pain free at two hours was reported by 24 in 100 people taking paracetamol 1000 mg, and in 19 out of 100 people taking placebo, meaning that only 5 in 100 people benefited because of paracetamol 1000 mg (high quality evidence). The outcome of being pain free or having only mild pain at two hours was reported by 59 in 100 people taking paracetamol 1000 mg, and in 49 out of 100 people taking placebo (high quality evidence), meaning that only 10 in 100 people benefited because of paracetamol 1000 mg. About 10 in 100 people taking paracetamol 1000 mg reported having a side effect, which was the same as with placebo (9 in 100 people) (high quality evidence). Most side effects were mild or moderate in intensity. No side effects were serious. We found a very small amount of information comparing paracetamol 500 mg or 650 mg with placebo, and comparing paracetamol 1000 mg with other painkillers. There was no difference between any of these treatments. The quality of the evidence was moderate or high for paracetamol 1000 mg compared with placebo, and low or very low for paracetamol 500 mg to 650 mg compared with placebo, and for paracetamol 1000 mg compared with other painkillers. High quality evidence means that we are very certain about the results. Low quality evidence means that we are very uncertain about the results." ]
cochrane-simplification-train-21
cochrane-simplification-train-21
Ten relevant RCTs with 675 participants are included in this review. All trials were double blind except one single blind. All studies had a run-in phase to confirm they did not respond to their initial antipsychotic treatment. The trials were published between 1980 and 2016. In most studies the methods of randomisation, allocation and blinding were poorly reported. In addition sample sizes were often small, limiting the overall quality of the evidence. Overall, no clear difference was found between groups in terms of the number of participants who showed clinically relevant response (RR 1.09, 95% CI 0.86 to 1.40, 9 RCTs, N = 533, low-quality evidence), or left the study early due to adverse effects (RR 1.63, 95% CI 0.52 to 5.07, very low quality evidence), or due to any reason (RR 1.30, 95% CI 0.89 to 1.90, 5 RCTs, N = 353, low-quality evidence). Similarly, no clear difference was found in general mental state as measured by PANSS total score change (MD −1.44, 95% CI −6.85 to 3.97, 3 RCTs, N = 258, very low quality evidence). At least one adverse effect was equivocal between groups (RR 0.91, 95% CI 0.55 to 1.50, 2 RCTs, N = 191, very low quality evidence). Data were not reported for time in hospital or quality-of-life outcomes. Finally, subgroup and sensitivity analyses did not show any effect on the primary outcome but these analyses were clearly underpowered. Current data do not show any clear differences between increasing or maintaining the antipsychotic dose for people with schizophrenia who do not respond to their initial antipsychotic treatment. Adverse effect reporting was limited and poor. There is an urgent need for further trials in order to determine the optional treatment strategy in such cases.
The Information Specialist of Cochrane Schizophrenia ran an electronic search of their specialised register up to 30 March 2017 for trials that randomised people with schizophrenia who were not responding to their initial antipsychotic treatment to receive either an increased antipsychotic dose or continue on the same dose. The search returned 1919 records, which were checked for eligibility by the review authors. Ten trials met the review requirements and provided usable data. No clear difference between increasing the dose of the antipsychotic drug and continuing antipsychotic treatment at the same dose was shown for any efficacy (clinical response) or safety (incidence of adverse effects) outcomes. The evidence currently available is limited and of low or very low quality. In particular, very few studies reported adverse effects adequately. The results of the present review show that there is no good-quality evidence to support or refute the hypothesis that increasing the antipsychotic dose for patients not responding to their initial antipsychotic treatment differs from continuing antipsychotic treatment at the same dose. No clear evidence regarding safety is available. Therefore, no firm conclusions can be made. Larger, well-designed trials are needed.
10.1002/14651858.CD011883.pub2
[ "The Information Specialist of Cochrane Schizophrenia ran an electronic search of their specialised register up to 30 March 2017 for trials that randomised people with schizophrenia who were not responding to their initial antipsychotic treatment to receive either an increased antipsychotic dose or continue on the same dose. The search returned 1919 records, which were checked for eligibility by the review authors. Ten trials met the review requirements and provided usable data. No clear difference between increasing the dose of the antipsychotic drug and continuing antipsychotic treatment at the same dose was shown for any efficacy (clinical response) or safety (incidence of adverse effects) outcomes. The evidence currently available is limited and of low or very low quality. In particular, very few studies reported adverse effects adequately. The results of the present review show that there is no good-quality evidence to support or refute the hypothesis that increasing the antipsychotic dose for patients not responding to their initial antipsychotic treatment differs from continuing antipsychotic treatment at the same dose. No clear evidence regarding safety is available. Therefore, no firm conclusions can be made. Larger, well-designed trials are needed." ]
cochrane-simplification-train-22
cochrane-simplification-train-22
One parallel trial and 12 cross-over trials of children and adults with cystic fibrosis were included in the review. The number of participants in each trial varied between 14 and 129 with a total of 512 participants included in the review. All the included trials were for a duration of four weeks. The included trials had mostly an unclear risk of bias from the randomisation process as the details of this were not given; they also mostly had a high risk of attrition bias and reporting bias. We could not combine data from all the trials as they compared different formulations. Findings from individual studies provided insufficient evidence to determine the size and precision of the effects of different formulations. Ten studies reported information on the review's primary outcome (nutritional status); however, we were only able to combine data from two small cross-over studies (n = 41). The estimated gain in body weight was imprecise, 0.32 kg (95% confidence interval -0.03 to 0.67; P = 0.07). Combined data from the same studies gave statistically significant results favouring enteric-coated microspheres over enteric-coated tablets for our secondary outcomes stool frequency, mean difference -0.58 (95% confidence interval -0.85 to -0.30; P < 0.0001); proportion of days with abdominal pain, mean difference -7.96% (95% confidence interval -12.97 to -2.94; P = 0.002); and fecal fat excretion, mean difference -11.79 g (95% confidence interval -17.42 to -6.15; P < 0.0001). Data from another single small cross-over study also favoured enteric-coated microspheres over non-enteric-coated tablets with adjuvant cimetidine in terms of stool frequency, mean difference -0.70 (95% confidence interval -0.90 to -0.50; P < 0.00001). There is limited evidence of benefit from enteric-coated microspheres when compared to non-enteric coated pancreatic enzyme preparations up to one month. In the only comparison where we could combine any data, the fact that these were cross-over studies is likely to underestimate the level of inconsistency between the results of the studies due to over-inflation of confidence intervals from the individual studies.There is no evidence on the long-term effectiveness and risks associated with pancreatic enzyme replacement therapy. There is also no evidence on the relative dosages of enzymes needed for people with different levels of severity of pancreatic insufficiency, optimum time to start treatment and variations based on differences in meals and meal sizes. There is a need for a properly designed study that can answer these questions.
The review included 13 studies with 512 adults and children with cystic fibrosis; in all of them treatment lasted for four weeks. Studies compared different formulations of pancreatic enzyme supplements, so we could not combine many of the results. Also the design of 12 of the studies meant that those taking part received both types of supplement for four weeks each, although the order in which they received them was chosen at random. This also made it difficult to analyse the results. Most of the studies were old; the most recent was from 2015, but the oldest was from 1986. We could only combine data from two small studies where individuals took miniature drug capsules (microspheres), which were treated so that the release of the medication is delayed until they have passed from the stomach into the intestine, and normal size tablets which were treated in the same way. The results did not clearly favour one or the other treatment for any of our most important outcomes (weight, height or body mass index). However, those taking the delayed-release microspheres had less fat in their feces than those taking delayed release tablets (normal size) as well as having less abdominal pain and not needing to go to the toilet as often. In a different study, those people taking the delayed-release microspheres also had less fat in their feces than those taking supplements that weren't treated so the release of medication was delayed. We didn't find any evidence that one type of these enteric-coated microspheres was better than another; or that enteric-coated microspheres were better than enteric-coated mini-microspheres (which are smaller). We didn't find any evidence on different doses of enzymes needed for people who produce different levels of pancreatic enzymes, on the best time for individuals to start treatment and different amounts of supplements based on differences in type of food eaten and meal sizes. A properly designed sudy is needed to answer these questions. We could not be sure that the people in the included studies had equal chances of being put into the different treatment groups as no details were published about how the decisions were made. Several studies also had large numbers of individuals who dropped out and often reasons for this were not given. In most studies, people took one treatment and then after a while swapped to the alternative treatment; we could only combine results from two studies which were designed in this way, and that design means that the results may seem to be more consistent than they really are when we analyse them. Finally, several studies did not completely report their findings in a way we could analyse in this review. We are not sure how these factors affect our confidence in the results we found.
10.1002/14651858.CD008227.pub3
[ "The review included 13 studies with 512 adults and children with cystic fibrosis; in all of them treatment lasted for four weeks. Studies compared different formulations of pancreatic enzyme supplements, so we could not combine many of the results. Also the design of 12 of the studies meant that those taking part received both types of supplement for four weeks each, although the order in which they received them was chosen at random. This also made it difficult to analyse the results. Most of the studies were old; the most recent was from 2015, but the oldest was from 1986. We could only combine data from two small studies where individuals took miniature drug capsules (microspheres), which were treated so that the release of the medication is delayed until they have passed from the stomach into the intestine, and normal size tablets which were treated in the same way. The results did not clearly favour one or the other treatment for any of our most important outcomes (weight, height or body mass index). However, those taking the delayed-release microspheres had less fat in their feces than those taking delayed release tablets (normal size) as well as having less abdominal pain and not needing to go to the toilet as often. In a different study, those people taking the delayed-release microspheres also had less fat in their feces than those taking supplements that weren't treated so the release of medication was delayed. We didn't find any evidence that one type of these enteric-coated microspheres was better than another; or that enteric-coated microspheres were better than enteric-coated mini-microspheres (which are smaller). We didn't find any evidence on different doses of enzymes needed for people who produce different levels of pancreatic enzymes, on the best time for individuals to start treatment and different amounts of supplements based on differences in type of food eaten and meal sizes. A properly designed sudy is needed to answer these questions. We could not be sure that the people in the included studies had equal chances of being put into the different treatment groups as no details were published about how the decisions were made. Several studies also had large numbers of individuals who dropped out and often reasons for this were not given. In most studies, people took one treatment and then after a while swapped to the alternative treatment; we could only combine results from two studies which were designed in this way, and that design means that the results may seem to be more consistent than they really are when we analyse them. Finally, several studies did not completely report their findings in a way we could analyse in this review. We are not sure how these factors affect our confidence in the results we found." ]
cochrane-simplification-train-23
cochrane-simplification-train-23
We identified and included five eligible trials with a total of 167 patients. The investigators administered various G-CSF preparations, at different doses and for different durations of time. Adding G-CSF did not significantly affect the likelihood of resolution of infection or wound healing, but it was associated with a significantly reduced likelihood of lower extremity surgical interventions (RR 0.38; 95 % CI 0.21 to 0.70), including amputation (RR 0.41; 95 % CI 0.18 to 0.95). Moreover, providing G-CSF reduced the duration of hospital stay (MD -1.40 days; 95% CI -2.27 to -0.53 days), but did not significantly affect the duration of systemic antibiotic therapy (MD -0.27 days; 95% CI -1.30 to 0.77 days). The available evidence is limited, but suggests that adjunctive G-CSF treatment in people with a diabetic foot infection, including infected ulcers, does not appear to increase the likelihood of resolution of infection or healing of the foot ulcer. However, it does appear to reduce the need for surgical interventions, especially amputations, and the duration of hospitalisation. Clinicians might consider adding G-CSF to the usual treatment of diabetic foot infections, especially in patients with a limb-threatening infection, but it is not clear which patients might benefit.
We found five trials which included a total of 167 people. The trials showed that adding G-CSF to usual therapy did not significantly affect the likelihood of the infection resolving or the improved healing of foot wounds, nor did it reduce the period of treatment with oral antibiotics. However, G-CSF does appear to reduce the need for surgical interventions, especially amputations, and the number of days spent in hospital. There are limitations to this analysis related to the variations in the people included in the studies (e.g. the severity of infection, the timing of the clinical assessment, the use of different G-CSF preparations, and for different lengths of time). Therefore caution is required in the interpretation of the findings.
10.1002/14651858.CD006810.pub3
[ "We found five trials which included a total of 167 people. The trials showed that adding G-CSF to usual therapy did not significantly affect the likelihood of the infection resolving or the improved healing of foot wounds, nor did it reduce the period of treatment with oral antibiotics. However, G-CSF does appear to reduce the need for surgical interventions, especially amputations, and the number of days spent in hospital. There are limitations to this analysis related to the variations in the people included in the studies (e.g. the severity of infection, the timing of the clinical assessment, the use of different G-CSF preparations, and for different lengths of time). Therefore caution is required in the interpretation of the findings." ]
cochrane-simplification-train-24
cochrane-simplification-train-24
Out of 14 717 citations, only one study met the inclusion criteria; an RCT conducted on homeless and high-risk youth between September 1998 and October 1999 in Portland, United States. Participants (n=351) were offered counselling and oral HIV testing and were randomised into face-to-face (n=187 participants) and telephone (n=167) notification groups. The telephone notification group had the option of receiving HIV test results either by telephone or face-to-face. Overall, only 48% (n=168) of participants received their HIV test results and post-test counselling. Significantly more participants received their HIV test results in the telephone notification group compared to the face-to-face notification group; 58% (n=106) vs. 37% (n=62) (p < 0.001). In the telephone notification group, the majority of participants who received their HIV test results did so by telephone (88%, n=93). The study could not offer information about the effectiveness of telephone HIV test notification with HIV-positive participants because only two youth tested positive and both were assigned to the face-to-face notification group. The study had a high risk of bias. We found only one eligible study. Although this study showed the use of the telephone for HIV test results notification was more effective than face-to-face delivery, it had a high-risk of bias. The study was conducted about 13 years ago in a high-income country, on a high-risk population, with low HIV prevalence, and the applicability of its results to other settings and contexts is unclear. The study did not provide information about telephone HIV test results notification of HIV positive people since none of the intervention group participants were HIV positive. We found no information about the acceptability of the intervention to patients’ and providers’, its economic outcomes or potential adverse effects. There is a need for robust evidence from various settings on the effectiveness of telephone use for HIV test results notification.
The aim of this review was to assess effectiveness of the telephone for HIV test result delivery, compared with face-to-face or other methods of HIV test result notification. After a comprehensive search of various scientific databases and other resources, we found only one relevant study. This study was performed in 1998-1999 in the United States on high-risk and homeless youth. The participants were offered an HIV test and told that their HIV test results would be available in two weeks. They were then divided into two groups; one that had to return to the testing site to get their HIV test results, and another that had the option of receiving HIV test results either by telephone or face-to-face at the testing site. Overall, less than half of participants received their HIV test results. Most participants in the telephone notification group opted for telephone rather than in person delivery of HIV test results.The proportion of youth receiving their HIV test results in the telephone group was significantly higher compared to the face-to-face group. However, since none of the participants in the telephone group were HIV positive, the study could not provide information about the effectiveness of telephone HIV test result delivery in people with HIV. In addition, we could not find any information about other relevant outcomes such as participants’ and providers’ satisfaction with the telephone HIV test results delivery, cost or potential harmful effects of this intervention. We urgently need more studies conducted in various settings comparing the effectiveness of telephone to other ways of HIV test result delivery and providing other relevant information in addition to the proportion of people receiving their HIV test results.
10.1002/14651858.CD009192.pub2
[ "The aim of this review was to assess effectiveness of the telephone for HIV test result delivery, compared with face-to-face or other methods of HIV test result notification. After a comprehensive search of various scientific databases and other resources, we found only one relevant study. This study was performed in 1998-1999 in the United States on high-risk and homeless youth. The participants were offered an HIV test and told that their HIV test results would be available in two weeks. They were then divided into two groups; one that had to return to the testing site to get their HIV test results, and another that had the option of receiving HIV test results either by telephone or face-to-face at the testing site. Overall, less than half of participants received their HIV test results. Most participants in the telephone notification group opted for telephone rather than in person delivery of HIV test results.The proportion of youth receiving their HIV test results in the telephone group was significantly higher compared to the face-to-face group. However, since none of the participants in the telephone group were HIV positive, the study could not provide information about the effectiveness of telephone HIV test result delivery in people with HIV. In addition, we could not find any information about other relevant outcomes such as participants’ and providers’ satisfaction with the telephone HIV test results delivery, cost or potential harmful effects of this intervention. We urgently need more studies conducted in various settings comparing the effectiveness of telephone to other ways of HIV test result delivery and providing other relevant information in addition to the proportion of people receiving their HIV test results." ]
cochrane-simplification-train-25
cochrane-simplification-train-25
We included three new trials in this update, which brings the total to 14 included studies that compared hypnotherapy with 22 different control interventions. The studies included a total of 1926 participants. Studies were diverse and a single meta-analysis was not possible. We judged only one study to be at low risk of bias overall; we judged 10 studies to be at high risk of bias and three at unclear risk. Studies did not provide reliable evidence of a greater benefit from hypnotherapy compared with other interventions or no treatment for smoking cessation. Most individual studies did not find statistically significant differences in quit rates after six months or longer, and studies that did detect differences typically had methodological limitations. Pooling small groups of relatively comparable studies did not provide reliable evidence for a specific effect of hypnotherapy relative to controls. There was low certainty evidence, limited by imprecision and risk of bias, that showed no statistically significant difference between hypnotherapy and attention-matched behavioural treatments (RR 1.21, 95% CI 0.91 to 1.61; I2 = 36%; 6 studies, 957 participants). Results were similarly imprecise, and also limited by risk of bias, when comparing hypnotherapy to intensive behavioural interventions (not matched for contact time) (RR 0.93, 95% CI 0.47 to 1.82; I2 = 0%; 2 studies, 211 participants; very low certainty evidence). Results from one small study (40 participants) detected a statistically significant benefit of hypnotherapy compared to no intervention (RR 19.00, 95% CI 1.18 to 305.88), but this evidence was judged to be of very low certainty due to high risk of bias and imprecision. No significant differences were detected in comparisons of hypnotherapy with brief behavioural interventions (RR 0.98, 95% CI 0.57 to 1.69; I² = 0%; 2 studies, 269 participants), rapid/focused smoking (RR 1.00, 95% CI 0.43 to 2.33; I2 = 65%; 2 studies, 54 participants), and pharmacotherapies (RR 1.68, 95% CI 0.88 to 3.20; I2 = 5%; 2 studies, 197 participants). When hypnotherapy was evaluated as an adjunct to other treatments, the pooled result from five studies showed a statistically significant benefit in favour of hypnotherapy (RR 2.10, 95% CI 1.31 to 3.35; I² = 62%; 224 participants); however, this result should be interpreted with caution due to the high risk of bias across studies (four had a high risk or bias, one had an unclear risk), and substantial statistical heterogeneity. Most studies did not provide information on whether data specifically relating to adverse events were collected, and whether or not any adverse events occurred. One study that did collect such data did not find a statistically significant difference in the adverse event ‘index’ between hypnotherapy and relaxation. There is insufficient evidence to determine whether hypnotherapy is more effective for smoking cessation than other forms of behavioural support or unassisted quitting. If a benefit is present, current evidence suggests the benefit is small at most. There is very little evidence on whether hypnotherapy causes adverse effects, but the existing data show no evidence that it does. Further large, high-quality randomized controlled trials, and more comprehensive assessments of safety, are needed on this topic.
We found 14 studies comparing hypnotherapy with other approaches to help people stop smoking (including brief advice, or more intensive stop-smoking counselling), or no treatment. Overall, 1926 people were included. Studies lasted at least six months. The studies varied greatly in terms of the treatments they compared, so it was difficult to combine their results. We searched for evidence up to 18 July 2018. When we combined the results of six studies (with a total of 957 people) there was no evidence that hypnotherapy helped people quit smoking more than behavioural interventions, such as counselling, when delivered over the same amount of time. There was also no evidence that there was a difference between hypnotherapy and longer counselling programmes when we combined results from two studies (269 people). One study compared hypnotherapy with no treatment and found an effect in favour of hypnotherapy, but the study was small (40 people) and had issues with its methods, which means we cannot be certain about this finding. Most of the studies did not say if they also evaluated the safety of hypnotherapy. Five studies looked at adding hypnotherapy to existing treatments and found an effect, but the studies were at high risk of bias and there were large, unexplained differences in their findings. One study that compared hypnotherapy and relaxation found no difference in side effects. The evidence in this review ranges from low to very low certainty, as there was not enough information and many of the studies had issues with their designs. There is no clear evidence that hypnotherapy is better than other approaches in helping people to stop smoking. If a benefit is present, current evidence suggests the benefit is small at most. Larger, high-quality studies are needed.
10.1002/14651858.CD001008.pub3
[ "We found 14 studies comparing hypnotherapy with other approaches to help people stop smoking (including brief advice, or more intensive stop-smoking counselling), or no treatment. Overall, 1926 people were included. Studies lasted at least six months. The studies varied greatly in terms of the treatments they compared, so it was difficult to combine their results. We searched for evidence up to 18 July 2018. When we combined the results of six studies (with a total of 957 people) there was no evidence that hypnotherapy helped people quit smoking more than behavioural interventions, such as counselling, when delivered over the same amount of time. There was also no evidence that there was a difference between hypnotherapy and longer counselling programmes when we combined results from two studies (269 people). One study compared hypnotherapy with no treatment and found an effect in favour of hypnotherapy, but the study was small (40 people) and had issues with its methods, which means we cannot be certain about this finding. Most of the studies did not say if they also evaluated the safety of hypnotherapy. Five studies looked at adding hypnotherapy to existing treatments and found an effect, but the studies were at high risk of bias and there were large, unexplained differences in their findings. One study that compared hypnotherapy and relaxation found no difference in side effects. The evidence in this review ranges from low to very low certainty, as there was not enough information and many of the studies had issues with their designs. There is no clear evidence that hypnotherapy is better than other approaches in helping people to stop smoking. If a benefit is present, current evidence suggests the benefit is small at most. Larger, high-quality studies are needed." ]
cochrane-simplification-train-26
cochrane-simplification-train-26
We identified 12 RCTs comparing BCG versus MMC in participants with intermediate- and high-risk non-muscle invasive bladder tumours (published from 1995 to 2013). In total, 2932 participants were randomised. Time to death from any cause: BCG may make little or no difference on time to death from any cause compared to MMC (hazard ratio (HR) 0.97, 95% confidence interval (CI) 0.79 to 1.20; participants = 1132, studies = 5; 567 participants in the BCG arm and 565 in the MMC arm; low-certainty evidence). This corresponds to 6 fewer deaths (40 fewer to 36 more) per 1000 participants treated with BCG at five years. We downgraded the certainty of the evidence two levels due to study limitations and imprecision. Serious adverse effects: 12/577 participants treated with BCG experienced serious non-fatal adverse effects compared to 4/447 participants in the MMC group. The pooled risk ratio (RR) is 2.31 (95% CI 0.82 to 6.52; participants = 1024, studies = 5; low-certainty evidence). Therefore, BCG may increase the risk for serious adverse effects compared to MMC. This corresponds to nine more serious adverse effects (one fewer to 37 more) with BCG. We downgraded the certainty of the evidence two levels due to study limitations and imprecision. Time to recurrence: BCG may reduce the time to recurrence compared to MMC (HR 0.88, 95% CI 0.71 to 1.09; participants = 2616, studies = 11, 1273 participants in the BCG arm and 1343 in the MMC arm; low-certainty evidence). This corresponds to 41 fewer recurrences (104 fewer to 29 more) with BCG at five years. We downgraded the certainty of the evidence two levels due to study limitations, imprecision and inconsistency. Time to progression: BCG may make little or no difference on time to progression compared to MMC (HR 0.96, 95% CI 0.73 to 1.26; participants = 1622, studies = 6; 804 participants in the BCG arm and 818 in the MMC arm; low-certainty evidence). This corresponds to four fewer progressions (29 fewer to 27 more) with BCG at five years. We downgraded the certainty of the evidence two levels due to study limitations and imprecision. Quality of life: we found very limited data for this outcomes and were unable to estimate an effect size. Based on our findings, BCG may reduce the risk of recurrence over time although the Confidence Intervals include the possibility of no difference. It may have no effect on either the risk of progression or risk of death from any cause over time. BCG may cause more serious adverse events although the Confidence Intervals once again include the possibility of no difference. We were unable to determine the impact on quality of life. The certainty of the evidence was consistently low, due to concerns that include possible selection bias, performance bias, given the lack of blinding in these studies, and imprecision.
The content of this review is current to September 2019. We included only studies where chance determined what treatment people in the study would get. We found 12 studies including 2932 people who matched our question. We found that BCG may lead to similar risk of dying from any cause over time (low-quality evidence), but may increase the risk of serious unwanted effects (low-quality evidence), although it is possible that it does not make a difference. BCG may reduce the risk that the tumour comes back over time (low-quality evidence), although it is possible that it does not make a difference. BCG may have little or no effect on the risk that the tumour gets worse over time (low-quality evidence). We found no data on quality of life. The quality of the evidence was consistently rated as low, meaning that our confidence is limited, and future research may change these findings.
10.1002/14651858.CD011935.pub2
[ "The content of this review is current to September 2019. We included only studies where chance determined what treatment people in the study would get. We found 12 studies including 2932 people who matched our question. We found that BCG may lead to similar risk of dying from any cause over time (low-quality evidence), but may increase the risk of serious unwanted effects (low-quality evidence), although it is possible that it does not make a difference. BCG may reduce the risk that the tumour comes back over time (low-quality evidence), although it is possible that it does not make a difference. BCG may have little or no effect on the risk that the tumour gets worse over time (low-quality evidence). We found no data on quality of life. The quality of the evidence was consistently rated as low, meaning that our confidence is limited, and future research may change these findings." ]
cochrane-simplification-train-27
cochrane-simplification-train-27
In this update, we identified eight new studies, thereby including a total of 22 trials (2503 participants), 10 of which had a low risk of bias. Most rehabilitation programmes were assessed in only one study. Both men and women were included, and overall mean age was 41.4 years. All participants had received standard discectomy, microdiscectomy and in one study standard laminectomy and (micro)discectomy. Mean duration of the rehabilitation intervention was 12 weeks; eight studies assessed six to eight-week exercise programmes, and eight studies assessed 12 to 13-week exercise programmes. Programmes were provided in primary and secondary care facilities and were started immediately after surgery (n = 4) or four to six weeks (n = 16) or one year after surgery (n = 2). In general, the overall quality of the evidence is low to very low. Rehabilitation programmes that started immediately after surgery were not more effective than their control interventions, which included exercise. Low- to very low-quality evidence suggests that there were no differences between specific rehabilitation programmes (multidisciplinary care, behavioural graded activity, strength and stretching) that started four to six weeks postsurgery and their comparators, which included some form of exercise. Low-quality evidence shows that physiotherapy from four to six weeks postsurgery onward led to better function than no treatment or education only, and that multidisciplinary rehabilitation co-ordinated by medical advisors led to faster return to work than usual care. Statistical pooling was performed only for three comparisons in which the rehabilitation programmes started four to six weeks postsurgery: exercise programmes versus no treatment, high- versus low-intensity exercise programmes and supervised versus home exercise programmes. Very low-quality evidence (five RCTs, N = 272) shows that exercises are more effective than no treatment for pain at short-term follow-up (standard mean difference (SMD) -0.90; 95% confidence interval (CI) -1.55 to -0.24), and low-quality evidence (four RCTs, N = 252) suggests that exercises are more effective for functional status on short-term follow-up (SMD -0.67; 95% CI -1.22 to -0.12) and that no difference in functional status was noted on long-term follow-up (three RCTs, N = 226; SMD -0.22; 95% CI -0.49 to 0.04). None of these studies reported that exercise increased the reoperation rate. Very low-quality evidence (two RCTs, N = 103) shows that high-intensity exercise programmes are more effective than low-intensity exercise programmes for pain in the short term (weighted mean difference (WMD) -10.67; 95% CI -17.04 to -4.30), and low-quality evidence (two RCTs, N = 103) shows that they are more effective for functional status in the short term (SMD -0.77; 95% CI -1.17 to -0.36). Very low-quality evidence (four RCTs, N = 154) suggests no significant differences between supervised and home exercise programmes for short-term pain relief (SMD -0.76;  95% CI -2.04 to 0.53) or functional status (four RCTs, N = 154; SMD -0.36; 95% CI -0.88 to 0.15). Considerable variation was noted in the content, duration and intensity of the rehabilitation programmes included in this review, and for none of them was high- or moderate-quality evidence identified. Exercise programmes starting four to six weeks postsurgery seem to lead to a faster decrease in pain and disability than no treatment, with small to medium effect sizes, and high-intensity exercise programmes seem to lead to a slightly faster decrease in pain and disability than is seen with low-intensity programmes, but the overall quality of the evidence is only low to very low. No significant differences were noted between supervised and home exercise programmes for pain relief, disability or global perceived effect. None of the trials reported an increase in reoperation rate after first-time lumbar surgery. High-quality randomised controlled trials are strongly needed.
This updated review evaluated the effectiveness of various rehabilitation programmes for patients who had lumbar disc surgery for the first time. We included 22 randomised controlled trials with 2503 participants, both men and women, between the ages of 18 and 65 years. The evidence is current to May 2013. Most commonly, treatment started four to six weeks after surgery, but the start of treatment ranged from two hours to 12 months after surgery. Considerable variation in the content, duration and intensity of treatments (i.e. exercise programmes) has been noted. The duration of the interventions varied from two weeks to one year; most programmes lasted six to 12 weeks. Participants reported on average serious pain intensity (56 points on a zero to 100 scale, with 100 being the worst possible pain). Most studies compared (1) exercise versus no treatment, (2) high-intensity exercise versus low-intensity exercise or (3) supervised exercise versus home exercise, most commonly starting four to six weeks after surgery. Comparisons in this review included (1) exercise versus no treatment, (2) high-intensity versus low-intensity exercise and (3) supervised versus home exercise. Patients who participated in exercise programmes four to six weeks after surgery reported slightly less short-term pain and disability than those who received no treatment. Patients who participated in high-intensity exercise programmes reported slightly less short-term pain and disability than those participating in low-intensity exercise programmes. Patients in supervised exercise programmes reported little or no difference in pain and disability compared with those in home exercise programmes. Here it was difficult to draw firm conclusions in the absence of high-quality evidence. None of the trials reported an increase in reoperation rate after first-time lumbar surgery. The evidence does not show whether all patients should be treated after surgery or only those who still have symptoms four to six weeks later. Limitations in the methods of half of the trials suggest that the results should be read with caution. Most of the treatments were assessed in only one trial. Therefore for most of the interventions, only low- to very low-quality evidence indicates that no firm conclusions can be drawn regarding their effectiveness.
10.1002/14651858.CD003007.pub3
[ "This updated review evaluated the effectiveness of various rehabilitation programmes for patients who had lumbar disc surgery for the first time. We included 22 randomised controlled trials with 2503 participants, both men and women, between the ages of 18 and 65 years. The evidence is current to May 2013. Most commonly, treatment started four to six weeks after surgery, but the start of treatment ranged from two hours to 12 months after surgery. Considerable variation in the content, duration and intensity of treatments (i.e. exercise programmes) has been noted. The duration of the interventions varied from two weeks to one year; most programmes lasted six to 12 weeks. Participants reported on average serious pain intensity (56 points on a zero to 100 scale, with 100 being the worst possible pain). Most studies compared (1) exercise versus no treatment, (2) high-intensity exercise versus low-intensity exercise or (3) supervised exercise versus home exercise, most commonly starting four to six weeks after surgery. Comparisons in this review included (1) exercise versus no treatment, (2) high-intensity versus low-intensity exercise and (3) supervised versus home exercise. Patients who participated in exercise programmes four to six weeks after surgery reported slightly less short-term pain and disability than those who received no treatment. Patients who participated in high-intensity exercise programmes reported slightly less short-term pain and disability than those participating in low-intensity exercise programmes. Patients in supervised exercise programmes reported little or no difference in pain and disability compared with those in home exercise programmes. Here it was difficult to draw firm conclusions in the absence of high-quality evidence. None of the trials reported an increase in reoperation rate after first-time lumbar surgery. The evidence does not show whether all patients should be treated after surgery or only those who still have symptoms four to six weeks later. Limitations in the methods of half of the trials suggest that the results should be read with caution. Most of the treatments were assessed in only one trial. Therefore for most of the interventions, only low- to very low-quality evidence indicates that no firm conclusions can be drawn regarding their effectiveness." ]
cochrane-simplification-train-28
cochrane-simplification-train-28
We included 23 RCTs that were published between 1968 and 2015 and included 39,195 participants in total. The mean age ranged from 33 to 71 years. The median duration of treatment was 11.5 months, and the median dose of niacin was 2 g/day. The proportion of participants with prior myocardial infarction ranged from 0% (4 trials) to 100% (2 trials, median proportion 48%); the proportion of participants taking statin ranged from 0% (4 trials) to 100% (12 trials, median proportion 100%). Using available cases, niacin did not reduce overall mortality (risk ratio (RR) 1.05, 95% confidence interval (CI) 0.97 to 1.12; participants = 35,543; studies = 12; I2 = 0%; high-quality evidence), cardiovascular mortality (RR 1.02, 95% CI 0.93 to 1.12; participants = 32,966; studies = 5; I2 = 0%; moderate-quality evidence), non-cardiovascular mortality (RR 1.12, 95% CI 0.98 to 1.28; participants = 32,966; studies = 5; I2 = 0%; high-quality evidence), the number of fatal or non-fatal myocardial infarctions (RR 0.93, 95% CI 0.87 to 1.00; participants = 34,829; studies = 9; I2 = 0%; moderate-quality evidence), nor the number of fatal or non-fatal strokes (RR 0.95, 95% CI 0.74 to 1.22; participants = 33,661; studies = 7; I2 = 42%; low-quality evidence). Participants randomised to niacin were more likely to discontinue treatment due to side effects than participants randomised to control group (RR 2.17, 95% CI 1.70 to 2.77; participants = 33,539; studies = 17; I2 = 77%; moderate-quality evidence). The results were robust to sensitivity analyses using different assumptions for missing data. Moderate- to high-quality evidence suggests that niacin does not reduce mortality, cardiovascular mortality, non-cardiovascular mortality, the number of fatal or non-fatal myocardial infarctions, nor the number of fatal or non-fatal strokes but is associated with side effects. Benefits from niacin therapy in the prevention of cardiovascular disease events are unlikely.
We found 23 studies including 39,195 participants that compared niacin to placebo. The evidence is current up to August 2016. The majority of included participants were on average 65 years old and had already experienced a myocardial infarction. The participants took niacin or placebo for a period of between six months and five years. Seventeen out of 23 studies were fully or partially funded by the drug manufacturer with a commercial interest in the results of the studies. Niacin did not reduce the number of deaths, heart attack or stroke. Many people (18%) had to stop taking niacin due to side effects. The results did not differ between participants who had or had not experienced a heart attack before taking niacin. The results did not differ between participants who were or were not taking a statin (another drug that prevents heart attack and stroke). The overall quality of evidence was moderate to high. In summary, we found no evidence of benefits from niacin therapy.
10.1002/14651858.CD009744.pub2
[ "We found 23 studies including 39,195 participants that compared niacin to placebo. The evidence is current up to August 2016. The majority of included participants were on average 65 years old and had already experienced a myocardial infarction. The participants took niacin or placebo for a period of between six months and five years. Seventeen out of 23 studies were fully or partially funded by the drug manufacturer with a commercial interest in the results of the studies. Niacin did not reduce the number of deaths, heart attack or stroke. Many people (18%) had to stop taking niacin due to side effects. The results did not differ between participants who had or had not experienced a heart attack before taking niacin. The results did not differ between participants who were or were not taking a statin (another drug that prevents heart attack and stroke). The overall quality of evidence was moderate to high. In summary, we found no evidence of benefits from niacin therapy." ]
cochrane-simplification-train-29
cochrane-simplification-train-29
Seven RCTs (1154 patients) of low or moderate quality were identified. The incidence of MUCs was significantly reduced (RR 0.24, 95% CI 0.07 to 0.77, P = 0.02, NNT 13) by universal prophylactic stenting. This was dependent on whether the same surgeon performed, or was in attendance, during the operations. Two patients lost their grafts to infective urinary tract complications in the stented group. UTIs, in general, were more common in stented patients (RR 1.49, 95% CI 1.04 to 2.15) unless the patients were prescribed cotrimoxazole 480 mg/d: in which case the incidence was equivalent (RR 0.97, 95% CI 0.71 to 1.33). Stents appeared generally well tolerated, although studies using longer stents (≥ 20 cm) for longer periods (> 6 weeks) had more problems with encrustation and migration. Routine prophylactic stenting reduces the incidence of MUCs. Studies comparing selective stenting and universal prophylactic stenting, whilst difficult to design and analyse, would address the unresolved quality of life and economic issues.
This review aimed to determine the benefit and harms of the use of routine stenting in kidney transplant recipients in the prevention of urological complications. Seven studies (1154 patients) were identified. The incidence of MUCs were significantly reduced by the use of prophylactic stenting. Urinary tract infections (UTIs) were more common in stented patients however the addition of antibiotic prophylaxis resulted in no difference in the incidence of UTIs between the two groups. More studies are needed to investigate the use of selective versus universal prophylactic stenting for the unresolved issues of quality of life and cost.
10.1002/14651858.CD004925.pub3
[ "This review aimed to determine the benefit and harms of the use of routine stenting in kidney transplant recipients in the prevention of urological complications. Seven studies (1154 patients) were identified. The incidence of MUCs were significantly reduced by the use of prophylactic stenting. Urinary tract infections (UTIs) were more common in stented patients however the addition of antibiotic prophylaxis resulted in no difference in the incidence of UTIs between the two groups. More studies are needed to investigate the use of selective versus universal prophylactic stenting for the unresolved issues of quality of life and cost." ]
cochrane-simplification-train-30
cochrane-simplification-train-30
One trial was eligible for inclusion.  All participants were age 60 years or over and had received a repeat prescription from their general practitioner of quinine for nighttime cramps in the preceding three months. This review includes data from only those participants who were advised to continue taking quinine. Forty-nine participants were advised to complete lean-to-wall calf muscle stretching held for 10 s three times per day. Forty-eight participants were allocated to a placebo stretching group. After 12 weeks, there was no statistically significant difference in recalled cramp frequency between groups. No "significant" adverse effect was reported. Limitations in the study's design impede interpretation of the results and clinical applicability. There is limited evidence on which to base clinical decisions regarding the use of non-drug therapies for the treatment of lower limb muscle cramp. Serious methodological limitations in the existing evidence hinder clinical application. There is an urgent need to carefully evaluate many of the commonly recommended and emerging non-drug therapies in well designed randomised controlled trials.
Only one randomised trial has assessed the effectiveness of a non-drug treatment for lower limb muscle cramp. This trial evaluated day-time calf muscle stretching to prevent nighttime muscle cramp in adults age 60 years and over who had received a repeat prescription of quinine for nighttime cramps in the preceding three months. Forty-nine participants were advised to complete lean-to-wall calf muscle stretching held for 10 s three times per day. Forty-eight participants were allocated to a placebo stretching group. After 12 weeks, there was no statistically significant difference in the frequency of cramps, as recalled by the participants, between groups. No "significant" adverse effect was reported. Owing to serious limitations in the design of the trial, it is impossible to determine from the available evidence whether or not calf muscle stretching can prevent recurrent lower limb muscle cramp. Further research is required to determine the effectiveness of non-drug treatments for lower limb muscle cramp.
10.1002/14651858.CD008496.pub2
[ "Only one randomised trial has assessed the effectiveness of a non-drug treatment for lower limb muscle cramp. This trial evaluated day-time calf muscle stretching to prevent nighttime muscle cramp in adults age 60 years and over who had received a repeat prescription of quinine for nighttime cramps in the preceding three months. Forty-nine participants were advised to complete lean-to-wall calf muscle stretching held for 10 s three times per day. Forty-eight participants were allocated to a placebo stretching group. After 12 weeks, there was no statistically significant difference in the frequency of cramps, as recalled by the participants, between groups. No \"significant\" adverse effect was reported. Owing to serious limitations in the design of the trial, it is impossible to determine from the available evidence whether or not calf muscle stretching can prevent recurrent lower limb muscle cramp. Further research is required to determine the effectiveness of non-drug treatments for lower limb muscle cramp." ]
cochrane-simplification-train-31
cochrane-simplification-train-31
We included 12 studies (2351 participants: range 27 to 841). Characteristics: The 12 included studies compared hypertonic (colloids) with isotonic fluids (crystalloids); of these, five studies (1420 participants) also compared 0.9% saline with another fluid. No data were available to make other comparisons. Delay from stroke to recruitment varied from less than 24 hours to 72 hours. Duration of fluid delivery was between two hours and 10 days. Bias assessment: Investigators and participants in eight of the 12 included studies were blind to treatment allocation, seven of the 12 included studies gave details of randomisation, and eight of the 12 included studies reported all outcomes measured. Results: There were no relevant completed trials that addressed the effect of volume, duration, or mode of fluid delivery on death or dependence in people with stroke. The odds of death or dependence were similar in participants allocated to colloids or crystalloid fluid regimens (odds ratio (OR) 0.97, 95% confidence interval (CI) 0.79 to 1.21, five studies, I² = 58%, low-quality evidence), and between 0.9% saline or other fluid regimens (OR 1.04, 95% CI 0.82 to 1.32, three studies, I² = 71%, low-quality evidence). There was substantial heterogeneity in these estimates. The odds of death were similar between colloids and crystalloids (OR 1.02, 95% CI 0.82 to 1.27, 12 studies, I² = 24%, moderate-quality evidence), and 0.9% saline and other fluids (OR 0.87, 95% CI 0.67 to 1.12, five studies, I² = 53%, low-quality evidence). The odds of pulmonary oedema were higher in participants allocated to colloids (OR 2.34, 95% CI 1.28 to 4.29, I² = 0%). Although the studies observed a higher risk of cerebral oedema (OR 0.20, 95% CI 0.02 to 1.74) and pneumonia (OR 0.58, 95% CI 0.17 to 2.01) with crystalloids, we could not exclude clinically important benefits or harms. We found no evidence that colloids were associated with lower odds of death or dependence in the medium term after stroke compared with crystalloids, though colloids were associated with greater odds of pulmonary oedema. We found no evidence to guide the best volume, duration, or mode of parenteral fluid delivery for people with acute stroke.
The evidence is current to May 2015. We found 12 relevant studies (with 2351 participants) comparing colloids with crystalloids. Eleven of these studies included people with ischaemic stroke (stroke sustained due to a clot), whilst one study included people with haemorrhagic stroke (stroke due to a bleed). Five of these studies (1420 participants) also made a comparison between 0.9% saline, the most commonly prescribed iv fluid, and another fluid type. The largest study had 841 participants, whilst the smallest had 27 participants. The length of time that fluids were given varied between trials, from two hours to 10 days. Ten studies revealed a source of funding. Of these, two studies were funded by fluid manufacturers. We did not find any studies that examined the best fluid volume, mode of fluid delivery, or duration of fluid treatment. We found that people with acute stroke given crystalloids (including 0.9% saline) had about the same risk of death or dependence as people given other fluid types. People given crystalloids also had a lower risk of pulmonary oedema, a complication that can lead to breathlessness due to excess collection of watery fluid in the lungs. From the evidence we obtained, it was difficult to make any concrete conclusions about which fluids were better for reducing brain swelling (cerebral oedema) or a serious lung infection (pneumonia). We found no evidence to guide the best volume, duration, or mode of parenteral fluid delivery for people with acute stroke. The majority of studies had a low to moderate risk of bias based on study limitations and inconsistency. Most studies reported the outcomes they stated they would.
10.1002/14651858.CD011138.pub2
[ "The evidence is current to May 2015. We found 12 relevant studies (with 2351 participants) comparing colloids with crystalloids. Eleven of these studies included people with ischaemic stroke (stroke sustained due to a clot), whilst one study included people with haemorrhagic stroke (stroke due to a bleed). Five of these studies (1420 participants) also made a comparison between 0.9% saline, the most commonly prescribed iv fluid, and another fluid type. The largest study had 841 participants, whilst the smallest had 27 participants. The length of time that fluids were given varied between trials, from two hours to 10 days. Ten studies revealed a source of funding. Of these, two studies were funded by fluid manufacturers. We did not find any studies that examined the best fluid volume, mode of fluid delivery, or duration of fluid treatment. We found that people with acute stroke given crystalloids (including 0.9% saline) had about the same risk of death or dependence as people given other fluid types. People given crystalloids also had a lower risk of pulmonary oedema, a complication that can lead to breathlessness due to excess collection of watery fluid in the lungs. From the evidence we obtained, it was difficult to make any concrete conclusions about which fluids were better for reducing brain swelling (cerebral oedema) or a serious lung infection (pneumonia). We found no evidence to guide the best volume, duration, or mode of parenteral fluid delivery for people with acute stroke. The majority of studies had a low to moderate risk of bias based on study limitations and inconsistency. Most studies reported the outcomes they stated they would." ]
cochrane-simplification-train-32
cochrane-simplification-train-32
Three trials involving 5905 participants were included. In patients with mild asthma who do not need maintenance treatment, no clinically important advantages of budesonide/formoterol as reliever were found in comparison to formoterol as reliever. Two studies enrolled patients with more severe asthma who were not controlled on high doses of inhaled corticosteroids (around 700 mcg/day in adults), and had suffered a clinically important asthma exacerbation in the past year. Hospitalisations related to asthma in the two studies comparing budesonide/formoterol for maintenance and relief with the same dose of budesonide/formoterol for maintenance with terbutaline for relief yielded an odds ratio of 0.68 (95% CI 0.40 to 1.16), which was not a statistically significant reduction. In adults there was a reduction in exacerbations requiring oral corticosteroids compared to terbutaline, odds ratio 0.54 (95% CI 0.44 to 0.65), which translates into a number needed to treat over 12 months of 15 (95% CI 13 to 21). The study in children found less serious adverse events with budesonide/formoterol used for maintenance and relief. There was no significant difference in annual growth in children using budesonide/formoterol reliever in comparison to terbutaline. In mild asthma it is not yet known whether patients who use a budesonide/formoterol inhaler for relief of asthma symptoms derive any clinically important benefits. In more severe asthma, two studies enrolled patients who were not controlled on inhaled corticosteroids, and had suffered an exacerbation in the previous year, and then had their maintenance inhaled corticosteroids reduced in both arms of the study. Under these conditions the studies demonstrated a reduction in the risk of exacerbations that require oral corticosteroids with budesonide/formoterol for maintenance and relief in comparison with budesonide/formoterol for maintenance and terbutaline or formoterol for relief. The incidence of serious adverse events in children was also less using budesonide/formoterol for maintenance and relief in one study, which similarly enrolled children who were not controlled on inhaled corticosteroids, and who had their maintenance inhaled corticosteroids reduced at the start of the study. This study also compared an explorative maintenance dose of budesonide/formoterol that is not approved for treatment.
Three trials involving 5905 participants were included. We found very little evidence in relation to the use of formoterol and budesonide for relief of symptoms in people with mild asthma, but in people with more severe asthma who had suffered exacerbations in spite of regular treatment with inhaled corticosteroids, we found that reliever formoterol and budesonide compared favourably with terbutaline in reducing asthma exacerbations that required a course of oral corticosteroids. However only a small proportion of the 'severe asthma exacerbations' as defined in the trials led to hospital admissions, and no significant overall benefit has yet been shown for this outcome. In children with asthma that was not controlled with regular inhaled corticosteroids, there were fewer serious adverse events when formoterol and budesonide were used to relieve symptoms as well as for maintenance treatment.
10.1002/14651858.CD007085.pub2
[ "Three trials involving 5905 participants were included. We found very little evidence in relation to the use of formoterol and budesonide for relief of symptoms in people with mild asthma, but in people with more severe asthma who had suffered exacerbations in spite of regular treatment with inhaled corticosteroids, we found that reliever formoterol and budesonide compared favourably with terbutaline in reducing asthma exacerbations that required a course of oral corticosteroids. However only a small proportion of the 'severe asthma exacerbations' as defined in the trials led to hospital admissions, and no significant overall benefit has yet been shown for this outcome. In children with asthma that was not controlled with regular inhaled corticosteroids, there were fewer serious adverse events when formoterol and budesonide were used to relieve symptoms as well as for maintenance treatment." ]
cochrane-simplification-train-33
cochrane-simplification-train-33
In this updated review four studies met the inclusion criteria. In total 366 participants were treated with lumiracoxib 400 mg, 51 with lumiracoxib 100 mg, and 212 with placebo. Active comparators were naproxen 500 mg, rofecoxib 50 mg, celecoxib 200 mg, celecoxib 400 mg, and ibuprofen 400 mg. With lumiracoxib 400 mg 50% of participants had at least 50% pain relief over six hours, compared with 8% given placebo; RB 6.9 (95% CI 4.1 to 12), NNT 2.4 (2.1 to 2.8). Median time to onset of analgesia was shorter for lumiracoxib 400 mg (0.6 to 1.5 hours) than placebo (>12 hours). Fewer participants needed rescue medication with lumiracoxib (64%) than with placebo (91%) over 12 to 24 hours; NNT to prevent remedication 3.7 (2.9 to 5.0). The weighted median time to use of rescue medication was 9.4 hours for lumiracoxib 400 mg and 1.7 hours for placebo. Adverse events were generally mild to moderate in severity, with one serious event reported in a placebo patient. Lumiracoxib 400 mg given as a single oral dose is an effective analgesic for acute postoperative pain, and has a relatively long duration of action. Adverse events with lumiracoxib did not differ from placebo.
Lumiracoxib 400 mg provided rapid, effective, and sustained relief of postoperative pain in four studies in dental and orthopaedic surgery. Of 366 participants treated with lumiracoxib 400 mg half experienced a high level of pain relief (at least 50% pain relief over a six hour period), compared with 8% given placebo. The duration of analgesia was relatively long at 9 hours, and fewer participants needed to use rescue medication with lumiracoxib than with placebo. Adverse event data was inconsistently reported, but no serious adverse events occurred in any patient taking lumiracoxib in these studies.
10.1002/14651858.CD006865.pub2
[ "Lumiracoxib 400 mg provided rapid, effective, and sustained relief of postoperative pain in four studies in dental and orthopaedic surgery. Of 366 participants treated with lumiracoxib 400 mg half experienced a high level of pain relief (at least 50% pain relief over a six hour period), compared with 8% given placebo. The duration of analgesia was relatively long at 9 hours, and fewer participants needed to use rescue medication with lumiracoxib than with placebo. Adverse event data was inconsistently reported, but no serious adverse events occurred in any patient taking lumiracoxib in these studies." ]
cochrane-simplification-train-34
cochrane-simplification-train-34
We found no evidence comparing slow-release fluoride devices against other types of fluoride therapy. We found only one double-blind RCT involving 174 children comparing a slow-release fluoride device (glass beads with fluoride were attached to buccal surfaces of right maxillary first permanent molar teeth) against control (glass beads without fluoride were attached to buccal surfaces of right maxillary first permanent molar teeth). This study was assessed to be at high risk of bias. The study recruited children from seven schools in an area of deprivation that had low levels of fluoride in the water. The mean age at the beginning of the study was 8.8 years and at the termination was 10.9 years. DMFT in permanent teeth or dmft in primary teeth was greater than one at the start of the study and greater than one million colony-forming units of Streptococcus mutans per millilitre of saliva. Although 132 children were still included in the trial at the two-year completion point, examination and statistical analysis was performed on only the 63 children (31 in intervention group, 32 in control group) who had retained the beads (retention rate was 47.7% at 2 years). Among these 63 children, caries increment was reported to be statistically significantly lower in the intervention group than in the control group (DMFT: mean difference -0.72, 95% confidence interval (CI) -1.23 to -0.21; DMFS: mean difference -1.52, 95% CI -2.68 to -0.36 (very low-quality evidence)). Although this difference was clinically significant, it only holds true for those children who maintain the fluoride beads; over 50% of children did not retain the beads. Harms were not reported within the trial report. Evidence for other outcomes sought in this review (progression to of caries lesion, dental pain, healthcare utilisation data) were also not reported. There is insufficient evidence to determine the caries-inhibiting effect of slow-release fluoride glass beads. The body of evidence available is of very low quality and there is a potential overestimation of benefit to the average child. The applicability of the findings to the wider population is unclear; the study had included children from a deprived area that had low levels of fluoride in drinking water, and were considered at high risk of caries. In addition, the evidence was only obtained from children who still had the bead attached at 2 years (48% of all available children); children who had lost their slow-release fluoride devices earlier might not have benefited as much from the devices.
Authors from Cochrane Oral Health carried out this review of existing studies and the evidence is current up to 23 January 2018. We searched scientific databases for clinical trials in children or adults treated with slow-release fluoride devices compared with another type of fluoride treatment (e.g. toothpaste, mouthrinse, gel, or varnish), placebo (a pretend treatment), or no treatment (usual care). Treatments had to be used and monitored for a minimum of 1 year. We found one study that randomised 174 children to either slow-dissolving, fluoride-releasing glass beads or placebo beads. The setting was an inner city school in an area served with low-fluoride water. Only 48% of children retained the beads and were available for analysis. There is insufficient evidence to determine whether slow-release fluoride devices (such as glass beads) help reduce dental decay. Retention of the beads is a problem. The evidence relating caries increment, side effects and retention was considered to be very low quality.
10.1002/14651858.CD005101.pub4
[ "Authors from Cochrane Oral Health carried out this review of existing studies and the evidence is current up to 23 January 2018. We searched scientific databases for clinical trials in children or adults treated with slow-release fluoride devices compared with another type of fluoride treatment (e.g. toothpaste, mouthrinse, gel, or varnish), placebo (a pretend treatment), or no treatment (usual care). Treatments had to be used and monitored for a minimum of 1 year. We found one study that randomised 174 children to either slow-dissolving, fluoride-releasing glass beads or placebo beads. The setting was an inner city school in an area served with low-fluoride water. Only 48% of children retained the beads and were available for analysis. There is insufficient evidence to determine whether slow-release fluoride devices (such as glass beads) help reduce dental decay. Retention of the beads is a problem. The evidence relating caries increment, side effects and retention was considered to be very low quality." ]
cochrane-simplification-train-35
cochrane-simplification-train-35
The review included six trials with a total of 361 participants. Two studies were conducted in America and one each in Germany, Greece, India, and Saudi Arabia. The participants of four trials had open-angle glaucoma; one study included participants with primary open-angle or primary closed-angle glaucoma, and one study did not specify the type of glaucoma. Three studies used a combined procedure (phacotrabeculectomy). Trabeculectomy with mitomycin C (MMC) was performed in four studies, and trabeculectomy with 5-fluorouracil (5-FU) was performed in only one study. None of the included trials reported trabeculectomy failure at 24 months. Only one trial reported the failure rate of trabeculectomy as a late complication. Failure was higher among participants randomised to the limbal-based surgery: 1/50 eyes failed trabeculectomy in the fornix group compared with 3/50 in the limbal group (risk ratio (RR) 0.33, 95% confidence interval (95% CI) 0.04 to 3.10); therefore we are very uncertain as to the relative effect of the two procedures on failure rate. Four studies including 252 participants provided measures of mean IOP at 12 months. In the fornix-based surgeries, mean IOP ranged from 12.5 to 15.5 mmHg and similar results were noted in limbal-based surgeries with mean IOP ranging from 11.7 to 15.1 mmHg without significant difference. Mean difference was 0.44 mmHg (95% CI −0.45 to 1.33) and 0.86 mmHg, (95% CI −0.52 to 2.24) at 12 and 24 months of follow-up, respectively. Neither of these pooled analyses showed a statistically significant difference in IOP between groups (moderate quality of evidence). One trial reported number of anti-glaucoma medications at 24 months of follow-up with no difference noted between surgical groups. However, three trials reported the mean number of anti-glaucoma medications at 12 months of follow-up without significant difference in the mean number of postoperative IOP-lowering medications between the two surgical techniques. Mean difference was 0.02, (95% CI −0.15 to 0.19) at 12 months of follow-up (high quality of evidence). Because of the small numbers of events and total participants, the risk of many reported adverse events were uncertain and those that were found to be statistically significant may have been due to chance. For risk of bias assessment: although all six trials were randomised selection bias was mostly unclear, with unclear random sequence generation in four of the six studies and unclear allocation concealment in five of the six studies. Attrition bias was encountered in only one trial which also suffered from reporting bias. All other trials had an unclear risk of reporting bias as there was no access to study protocols. All included trials were judged to have high risk of detection bias due to lack of masking of the outcomes. Trabeculectomy is quite a standard procedure and unlikely to induce bias due to surgeon 'performance', hence performance bias was not evaluated. The main result of this review was that there was uncertainty as to the difference between fornix- and limbal-based trabeculectomy surgeries due to the small number of events and confidence intervals that cross the null. This also applied to postoperative complications, but without any impact on long-term failure rate between the two surgical techniques.
Six randomised controlled trials (RCTs) were reviewed with a total of 361 participants consisting of adults with any type of glaucoma and follow-up of at least 24 months. We last searched the databases on 23 October 2015. Failure rate at 24 months was not reported in any included studies, and one study reported "late complications" but did not specify a time period, which favoured the fornix-based treatment. No difference was noted with respect to lowering eye pressure after 24 months (two trials) and after 12 months (four trials). The number of medications needed to control eye pressure after surgery was also similar. Moreover, most of the studies reported that the complication rates after the operation were similar except in one complication which was narrowing in the anterior part of the eye after the procedure (more common in the limbal surgery group), but this did not affect the final outcome of the surgery. Although all six trials were reported to be randomised, the procedures followed for randomisation were mostly unclear (four of the six studies). Masking of the outcomes was not clear or not addressed in all six trials. Missing information was encountered in only one trial which also suffered from bias in reporting its outcomes. All other trials had an unclear risk of reporting bias as there was no access to original data.
10.1002/14651858.CD009380.pub2
[ "Six randomised controlled trials (RCTs) were reviewed with a total of 361 participants consisting of adults with any type of glaucoma and follow-up of at least 24 months. We last searched the databases on 23 October 2015. Failure rate at 24 months was not reported in any included studies, and one study reported \"late complications\" but did not specify a time period, which favoured the fornix-based treatment. No difference was noted with respect to lowering eye pressure after 24 months (two trials) and after 12 months (four trials). The number of medications needed to control eye pressure after surgery was also similar. Moreover, most of the studies reported that the complication rates after the operation were similar except in one complication which was narrowing in the anterior part of the eye after the procedure (more common in the limbal surgery group), but this did not affect the final outcome of the surgery. Although all six trials were reported to be randomised, the procedures followed for randomisation were mostly unclear (four of the six studies). Masking of the outcomes was not clear or not addressed in all six trials. Missing information was encountered in only one trial which also suffered from bias in reporting its outcomes. All other trials had an unclear risk of reporting bias as there was no access to original data." ]
cochrane-simplification-train-36
cochrane-simplification-train-36
For this 2015 update, we did not identify any new RCTs for inclusion. The previous version of the review included seven trials with a total of 362 participants. Four trials compared the effectiveness of a steroid to placebo for short-term symptom control in glandular fever, one to aspirin, and two trials explored the effects of steroids in conjunction with an antiviral. Heterogeneity between trials prevented a combined analysis. Trials under-reported methodological design features. Three trials did not adequately describe sequence generation for randomisation. Four trials provided adequate details of allocation concealment. All trials were double-blind but four were not specific as to who was blinded. Loss to follow-up was under-reported in four trials, making it difficult to exclude attrition bias. The risk of selective reporting in the included trials was unclear. Across the trials, no benefit was found in 8/10 assessments of health improvement. Two trials found benefit of steroid therapy over placebo in reducing sore throat at 12 hours (eight-day course odds ratio (OR) 21.00, 95% confidence interval (CI) 1.94 to 227.20; one-dose OR 4.20, 95% CI 1.08 to 16.32), but the benefit was not maintained. In combination with an antiviral drug, participants in the steroid group had less pharyngeal discomfort between days two to four (OR 0.31, 95% CI 0.09 to 1.08) compared to placebo. Across the trials the effects on other common symptoms were less clear. Two trials set out to measure safety; they documented no major adverse effects. In two other trials adverse events were reported, including respiratory distress and acute onset of diabetes. However, the association of the events with the steroid is not definite. There is insufficient evidence to the efficacy of steroids for symptom control in infectious mononucleosis. There is a lack of research on the side effects and long-term complications.
Our evidence is current to August 2015. We did not identify any new trials for the update of this review. The previous publication of this review included seven trials with 362 participants. Four trials compared the effect of a steroid to a placebo, one to aspirin, and two trials explored the effects of steroids in conjunction with an antiviral. The length of treatment varied between a single dose and a 12-day course. The doses used also varied. The length of follow-up varied from short periods (i.e. days or weeks) to longer periods (i.e. six months and 12 months). Steroid treatment relieved sore throat in the short term (at 12 hours). The researchers noticed a benefit at two to four days when steroids were used in combination with an antiviral medication, but these findings are limited since researchers assessed them in one or two trials only. The findings on the effect of steroids alone or when used with an antiviral medication for other symptoms were less clear. We are unsure about adverse effects from using steroids. With the exception of two trials, most studies did not set out a prior plan to evaluate the occurrence of side effects, or other adverse events. None of the trials explored adverse effects in the longer term (over years). The quality of the included trials was generally poor. We cannot know the exact effect of using steroids for glandular fever.
10.1002/14651858.CD004402.pub3
[ "Our evidence is current to August 2015. We did not identify any new trials for the update of this review. The previous publication of this review included seven trials with 362 participants. Four trials compared the effect of a steroid to a placebo, one to aspirin, and two trials explored the effects of steroids in conjunction with an antiviral. The length of treatment varied between a single dose and a 12-day course. The doses used also varied. The length of follow-up varied from short periods (i.e. days or weeks) to longer periods (i.e. six months and 12 months). Steroid treatment relieved sore throat in the short term (at 12 hours). The researchers noticed a benefit at two to four days when steroids were used in combination with an antiviral medication, but these findings are limited since researchers assessed them in one or two trials only. The findings on the effect of steroids alone or when used with an antiviral medication for other symptoms were less clear. We are unsure about adverse effects from using steroids. With the exception of two trials, most studies did not set out a prior plan to evaluate the occurrence of side effects, or other adverse events. None of the trials explored adverse effects in the longer term (over years). The quality of the included trials was generally poor. We cannot know the exact effect of using steroids for glandular fever." ]
cochrane-simplification-train-37
cochrane-simplification-train-37
We considered twenty-four studies for inclusion in the final analysis. Twenty of these studies (enrolling a total of 2344 participants) evaluated the use of phlebotonics versus a control intervention. One of these twenty studies evaluated the use of phlebotonics with a medical intervention and another study with rubber band ligation. The remaining four studies included two which compared different forms of phlebotonics with each other, one study which evaluated phlebotonics with a medical intervention and one study which compared the use of phlebotonics with infrared photocoagulation. Eight studies were excluded for various reasons including poor methodological quality. Phlebotonics demonstrated a statistically significant beneficial effect for the outcomes of  pruritus (OR 0.23; 95% CI 0.07 to 0.79) (P=0.02), bleeding (OR 0.12; 95% CI 0.04 to 0.37) (P=0.0002), bleeding post-haemorrhoidectomy (OR 0.18; 95% 0.06 to 0.58)(P=0.004), discharge and leakage (OR 0.12; 95% CI 0.04 to 0.42) (P=0.0008) and overall symptom improvement (OR 15.99 95% CI 5.97 to 42.84) (P< 0.00001), in comparison with a control intervention. Although beneficial they did not show a statistically significant effect compared with a control intervention for pain (OR 0.11; 95% CI 0.01 to 1.11) (P=0.06), pain scores post-haemorrhoidectomy (SMD -1.04; 95% CI -3.21 to 1.12 ) (P= 0.35) or post-operative analgesic consumption (OR 0.54; 95% CI 0.30 to 0.99)(P=0.05). The evidence suggests that there is a potential benefit in using phlebotonics in treating haemorrhoidal disease as well as a benefit in alleviating post-haemorrhoidectomy symptoms. Outcomes such as bleeding and overall symptom improvement show a statistically significant beneficial effect and there were few concerns regarding their overall safety from the evidence presented in the clinical trials. However methodological limitations were encountered. In order to enhance our conclusion further, more robust clinical trials which take into account these limitations will need to be performed in the future.
We considered twenty four studies for inclusion in this review. This review identified twenty randomised controlled trials enrolling a total of (2334) participants which compared an intervention using phlebotonics with a control intervention. Of these twenty studies, one study compared phlebotonics with a medical intervention and another with rubber band ligation. Of the remaining four trials, we identified two trials which compared phlebotonics with each other, one trial which compared phlebotonics with herbal therapy and one trial which compared phlebotonics with infrared photocoagulation. The trials obtained did not show any significant adverse events or side-effects from the use of phlebotonics. The studies demonstrated a beneficial effect of phlebotonics in treating the symptoms and signs of haemorrhoidal disease as well as symptom relief post-haemorrhoidectomy.
10.1002/14651858.CD004322.pub3
[ "We considered twenty four studies for inclusion in this review. This review identified twenty randomised controlled trials enrolling a total of (2334) participants which compared an intervention using phlebotonics with a control intervention. Of these twenty studies, one study compared phlebotonics with a medical intervention and another with rubber band ligation. Of the remaining four trials, we identified two trials which compared phlebotonics with each other, one trial which compared phlebotonics with herbal therapy and one trial which compared phlebotonics with infrared photocoagulation. The trials obtained did not show any significant adverse events or side-effects from the use of phlebotonics. The studies demonstrated a beneficial effect of phlebotonics in treating the symptoms and signs of haemorrhoidal disease as well as symptom relief post-haemorrhoidectomy." ]

Dataset Card for GEM/cochrane-simplification

Link to Main Data Card

You can find the main data card on the GEM Website.

Dataset Summary

Cochrane is an English dataset for paragraph-level simplification of medical texts. Cochrane is a database of systematic reviews of clinical questions, many of which have summaries in plain English targeting readers without a university education. The dataset comprises about 4,500 of such pairs.

You can load the dataset via:

import datasets
data = datasets.load_dataset('GEM/cochrane-simplification')

The data loader can be found here.

website

Link

paper

Link

authors

Ashwin Devaraj (The University of Texas at Austin), Iain J. Marshall (King's College London), Byron C. Wallace (Northeastern University), Junyi Jessy Li (The University of Texas at Austin)

Dataset Overview

Where to find the Data and its Documentation

Webpage

Link

Download

Link

Paper

Link

BibTex

@inproceedings{devaraj-etal-2021-paragraph,
    title = "Paragraph-level Simplification of Medical Texts",
    author = "Devaraj, Ashwin  and
      Marshall, Iain  and
      Wallace, Byron  and
      Li, Junyi Jessy",
    booktitle = "Proceedings of the 2021 Conference of the North American Chapter of the Association for Computational Linguistics: Human Language Technologies",
    month = jun,
    year = "2021",
    address = "Online",
    publisher = "Association for Computational Linguistics",
    url = "https://aclanthology.org/2021.naacl-main.395",
    doi = "10.18653/v1/2021.naacl-main.395",
    pages = "4972--4984",
}

Contact Name

Ashwin Devaraj

Contact Email

ashwin.devaraj@utexas.edu

Has a Leaderboard?

no

Languages and Intended Use

Multilingual?

no

Covered Languages

English

License

cc-by-4.0: Creative Commons Attribution 4.0 International

Intended Use

The intended use of this dataset is to train models that simplify medical text at the paragraph level so that it may be more accessible to the lay reader.

Primary Task

Simplification

Communicative Goal

A model trained on this dataset can be used to simplify medical texts to make them more accessible to readers without medical expertise.

Credit

Curation Organization Type(s)

academic

Curation Organization(s)

The University of Texas at Austin, King's College London, Northeastern University

Dataset Creators

Ashwin Devaraj (The University of Texas at Austin), Iain J. Marshall (King's College London), Byron C. Wallace (Northeastern University), Junyi Jessy Li (The University of Texas at Austin)

Funding

National Institutes of Health (NIH) grant R01-LM012086, National Science Foundation (NSF) grant IIS-1850153, Texas Advanced Computing Center (TACC) computational resources

Who added the Dataset to GEM?

Ashwin Devaraj (The University of Texas at Austin)

Dataset Structure

Data Fields

  • gem_id: string, a unique identifier for the example
  • doi: string, DOI identifier for the Cochrane review from which the example was generated
  • source: string, an excerpt from an abstract of a Cochrane review
  • target: string, an excerpt from the plain-language summary of a Cochrane review that roughly aligns with the source text

Example Instance

{
    "gem_id": "gem-cochrane-simplification-train-766",
    "doi": "10.1002/14651858.CD002173.pub2",
    "source": "Of 3500 titles retrieved from the literature, 24 papers reporting on 23 studies could be included in the review. The studies were published between 1970 and 1997 and together included 1026 participants. Most were cross-over studies. Few studies provided sufficient information to judge the concealment of allocation. Four studies provided results for the percentage of symptom-free days. Pooling the results did not reveal a statistically significant difference between sodium cromoglycate and placebo. For the other pooled outcomes, most of the symptom-related outcomes and bronchodilator use showed statistically significant results, but treatment effects were small. Considering the confidence intervals of the outcome measures, a clinically relevant effect of sodium cromoglycate cannot be excluded. The funnel plot showed an under-representation of small studies with negative results, suggesting publication bias. There is insufficient evidence to be sure about the efficacy of sodium cromoglycate over placebo. Publication bias is likely to have overestimated the beneficial effects of sodium cromoglycate as maintenance therapy in childhood asthma.",
    "target": "In this review we aimed to determine whether there is evidence for the effectiveness of inhaled sodium cromoglycate as maintenance treatment in children with chronic asthma. Most of the studies were carried out in small groups of patients. Furthermore, we suspect that not all studies undertaken have been published. The results show that there is insufficient evidence to be sure about the beneficial effect of sodium cromoglycate compared to placebo. However, for several outcome measures the results favoured sodium cromoglycate."
}

Data Splits

  • train: 3568 examples
  • validation: 411 examples
  • test: 480 examples

Dataset in GEM

Rationale for Inclusion in GEM

Why is the Dataset in GEM?

This dataset is the first paragraph-level simplification dataset published (as prior work had primarily focused on simplifying individual sentences). Furthermore, this dataset is in the medical domain, which is an especially useful domain for text simplification.

Similar Datasets

no

Ability that the Dataset measures

This dataset measures the ability for a model to simplify paragraphs of medical text through the omission non-salient information and simplification of medical jargon.

GEM-Specific Curation

Modificatied for GEM?

no

Additional Splits?

no

Getting Started with the Task

Previous Results

Previous Results

Measured Model Abilities

This dataset measures the ability for a model to simplify paragraphs of medical text through the omission non-salient information and simplification of medical jargon.

Metrics

Other: Other Metrics, BLEU

Other Metrics

SARI measures the quality of text simplification

Previous results available?

yes

Relevant Previous Results

The paper which introduced this dataset trained BART models (pretrained on XSum) with unlikelihood training to produce simplification models achieving maximum SARI and BLEU scores of 40 and 43 respectively.

Dataset Curation

Original Curation

Sourced from Different Sources

no

Language Data

Data Validation

not validated

Was Data Filtered?

not filtered

Structured Annotations

Additional Annotations?

none

Annotation Service?

no

Consent

Any Consent Policy?

no

Private Identifying Information (PII)

Contains PII?

yes/very likely

Any PII Identification?

no identification

Maintenance

Any Maintenance Plan?

no

Broader Social Context

Previous Work on the Social Impact of the Dataset

Usage of Models based on the Data

no

Impact on Under-Served Communities

Addresses needs of underserved Communities?

yes

Details on how Dataset Addresses the Needs

This dataset can be used to simplify medical texts that may otherwise be inaccessible to those without medical training.

Discussion of Biases

Any Documented Social Biases?

unsure

Are the Language Producers Representative of the Language?

The dataset was generated from abstracts and plain-language summaries of medical literature reviews that were written by medical professionals and thus does was not generated by people representative of the entire English-speaking population.

Considerations for Using the Data

PII Risks and Liability

Licenses

Known Technical Limitations

Technical Limitations

The main limitation of this dataset is that the information alignment between the abstract and plain-language summary is often rough, so the plain-language summary may contain information that isn't found in the abstract. Furthermore, the plain-language targets often contain formulaic statements like "this evidence is current to [month][year]" not found in the abstracts. Another limitation is that some plain-language summaries do not simplify the technical abstracts very much and still contain medical jargon.

Unsuited Applications

The main pitfall to look out for is errors in factuality. Simplification work so far has not placed a strong emphasis on the logical fidelity of model generations with the input text, and the paper introducing this dataset does not explore modeling techniques to combat this. These kinds of errors are especially pernicious in the medical domain, and the models introduced in the paper do occasionally alter entities like disease and medication names.

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