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CochranePLS400
***TASK*** the task is to simplify the input abstract of a biomedical literature ***INPUT*** the input is the abstract of a biomedical literature ***OUTPUT*** the output is the simplified abstract for the input abstract of a biomedical literature ***EXAMPLES*** Input: Output: ***EXAMPLES*** Input: Two trials (n = 190), at low risk of bias, were included in the review and both presented data on first time failure at the tooth level. Pooling of the data showed a statistically significant difference in favour of molar bands, with a hazard ratio of 2.92 (95% confidence intervals (CI) 1.80 to 4.72). No statistically significant heterogeneity was shown between the two studies. Data on first time failure at the patient level were also available and showed statistically different difference in favour of molar bands (risk ratio 2.30; 95% CI 1.56 to 3.41) (risk of event for molar tubes = 57%; risk of event for molar bands 25%). One trial presented data on decalcification again showing a statistically significant difference in favour of molar bands. No other adverse events identified. From the two well-designed and low risk of bias trials included in this review it was shown that the failure of molar tubes bonded with either a chemically-cured or light-cured adhesive was considerably higher than that of molar bands cemented with glass ionomer cement. One trial indicated that there was less decalcification with molar bands cemented with glass ionomer cement than with bonded molar tubes cemented with a light-cured adhesive. However, given there are limited data for this outcome, further evidence is required to draw more robust conclusions. Output: The evidence in this review, which was carried out together with Cochrane Oral Health, is up-to-date as of 15 February 2017. We included two studies that evaluated 190 participants. Both trials were conducted in the UK and both compared bonded molar tubes with molar bands. From the limited data of two studies at low risk of bias, it would appear that bonded molar tubes are associated with a higher failure rate than with molar bands. Input: Ten studies involving 484 patients were included. There was no evidence suggesting superior efficacy of any one sclerosant over another, but there was evidence of superiority of sclerotherapy to placebo. The evidence did not suggest an increase in patient satisfaction with any one agent versus another, but there was evidence that patients were less satisfied with placebo. There was some evidence suggesting that polidocanol (POL) was more likely to cause adverse reactions at a concentration of 1% compared with lower concentrations or hypertonic saline, and that sodium tetradecyl sulfate (STS) was more likely to cause adverse reactions at a concentration of 1% compared with POL at 0.5%. There was some evidence suggesting that STS was more painful than POL, heparsal (20% saline mixed with heparin 100 units/mL) or placebo, and that POL was no more painful than placebo. Evidence from one study suggested that hypertonic saline (HS) was more painful than POL. The data were not suitable for meta-analysis. The evidence did not suggest superior efficacy or patient satisfaction for any one sclerosing agent used in the treatment of telangiectasias of the lower limbs, but the agents studied showed superiority to a normal saline placebo. However, the amount of available evidence in this field is small and the overall methodological quality of the research was poor, as was the quality of reporting. More research is needed to determine the optimal agent(s) and the ideal dosing to achieve the best results and maximize patient satisfaction. Future research efforts should incorporate more demographic data and symptom measures to allow for comparison with findings from observational studies, thereby aiding assessment of how various risk groups respond to treatment. Output:
We included 10 randomised controlled trials involving 484 people in our review. Sodium tetradecyl sulfate (STS), polidocanol (POL), and heparsal (20% saline mixed with heparin 100 units/mL) cleared the veins more effectively than an injection of normal saline. There was no evidence that one agent was better than any other sclerosant, that patients were more satisfied with one agent than another, and which dose of an agent was best. There was some evidence that POL was less painful than heparsal and STS, and that STS was more painful than heparsal. At higher doses, some of the agents appeared to cause more pain and side effects such as mild brown discoloration, a flare or blush next to the injected vein, or itching; however, we do not have enough evidence to determine the optimal concentration to use. The trials were designed in very different ways and used various agents, which meant we were unable to combine the studies to help form firm conclusions. The amount of available evidence was limited and the overall methodological quality of the research was poor, as was the quality of reporting.
CochranePLS401
***TASK*** the task is to simplify the input abstract of a biomedical literature ***INPUT*** the input is the abstract of a biomedical literature ***OUTPUT*** the output is the simplified abstract for the input abstract of a biomedical literature ***EXAMPLES*** Input: Output: ***EXAMPLES*** Input: Two trials (n = 190), at low risk of bias, were included in the review and both presented data on first time failure at the tooth level. Pooling of the data showed a statistically significant difference in favour of molar bands, with a hazard ratio of 2.92 (95% confidence intervals (CI) 1.80 to 4.72). No statistically significant heterogeneity was shown between the two studies. Data on first time failure at the patient level were also available and showed statistically different difference in favour of molar bands (risk ratio 2.30; 95% CI 1.56 to 3.41) (risk of event for molar tubes = 57%; risk of event for molar bands 25%). One trial presented data on decalcification again showing a statistically significant difference in favour of molar bands. No other adverse events identified. From the two well-designed and low risk of bias trials included in this review it was shown that the failure of molar tubes bonded with either a chemically-cured or light-cured adhesive was considerably higher than that of molar bands cemented with glass ionomer cement. One trial indicated that there was less decalcification with molar bands cemented with glass ionomer cement than with bonded molar tubes cemented with a light-cured adhesive. However, given there are limited data for this outcome, further evidence is required to draw more robust conclusions. Output: The evidence in this review, which was carried out together with Cochrane Oral Health, is up-to-date as of 15 February 2017. We included two studies that evaluated 190 participants. Both trials were conducted in the UK and both compared bonded molar tubes with molar bands. From the limited data of two studies at low risk of bias, it would appear that bonded molar tubes are associated with a higher failure rate than with molar bands. Input: We included seven studies (241 participants) in this review. Meta-analysis of these seven included studies was not possible due to heterogeneity of the treatments and because many of the studies did not provide sufficient statistical information with their results. Allocation and blinding methodology was poorly described in most studies. No study evaluated the efficacy of pharmacological interventions for preventing clinically relevant outcomes such as mortality and cardiac arrhythmias; however there is evidence that several commonly used therapies effectively reduce serum potassium levels. Salbutamol administered via either nebulizer or metered-dose inhaler (MDI) significantly reduced serum potassium compared with placebo. The peak effect of 10 mg nebulised salbutamol was seen at 120 minutes (MD -1.29 mmol/L, 95% CI -1.64 to -0.94) and at 90 minutes for 20 mg nebulised salbutamol (1 study: MD -1.18 mmol/L, 95% CI -1.54 to -0.82). One study reported 1.2 mg salbutamol via MDI 1.2 mg produced a significant decrease in serum potassium beginning at 10 minutes (MD -0.20 mmol/L, P < 0.05) and a maximal decrease at 60 minutes (MD -0.34 mmol/L, P < 0.0001). Intravenous (IV) and nebulised salbutamol produced comparable effects (2 studies). When compared to other interventions, salbutamol had similar effect to insulin-dextrose (2 studies) but was more effective than bicarbonate at 60 minutes (MD -0.46 mmol/L, 95% CI -0.82 to -0.10; 1 study). Insulin-dextrose was more effective than IV bicarbonate (1 study) and aminophylline (1 study). Insulin-dextrose, bicarbonate and aminophylline were not studied in any placebo-controlled studies. None of the included studies evaluated the effect of IV calcium or potassium binding resins in the treatment of hyperkalaemia. Evidence for the acute pharmacological management of hyperkalaemia is limited, with no clinical studies demonstrating a reduction in adverse patient outcomes. Of the studied agents, salbutamol via any route and IV insulin-dextrose appear to be most effective at reducing serum potassium. There is limited evidence to support the use of other interventions, such as IV sodium bicarbonate or aminophylline. The effectiveness of potassium binding resins and IV calcium salts has not been tested in RCTs and requires further study before firm recommendations for clinical practice can be made. Output:
We searched for all studies that tested whether therapies were effective and safe at treating high potassium published up to 18 August 2015. We found seven studies that investigated drug therapies for treating hyperkalaemia in adults which together included results from 241 participants. Most studies tested the therapies in male and female adults with kidney problems who were medically stable. We did not find any studies that looked at the serious medical complications of high potassium such as death. We found that salbutamol and insulin-dextrose were effective in reducing potassium levels in the blood. We found that salbutamol was effective whether it was given intravenously or by nebuliser. Those treatments appeared to be more effective than other treatments such as sodium bicarbonate and aminophylline. None of the studies found any serious adverse reactions to the medications. Overall, the quality of evidence was assessed as poor because the studies were small in size and the methods for how the studies were performed were not well described. None of the studies looked at the serious problems caused by hyperkalaemia and this limited the strength of the evidence.
CochranePLS402
***TASK*** the task is to simplify the input abstract of a biomedical literature ***INPUT*** the input is the abstract of a biomedical literature ***OUTPUT*** the output is the simplified abstract for the input abstract of a biomedical literature ***EXAMPLES*** Input: Output: ***EXAMPLES*** Input: Two trials (n = 190), at low risk of bias, were included in the review and both presented data on first time failure at the tooth level. Pooling of the data showed a statistically significant difference in favour of molar bands, with a hazard ratio of 2.92 (95% confidence intervals (CI) 1.80 to 4.72). No statistically significant heterogeneity was shown between the two studies. Data on first time failure at the patient level were also available and showed statistically different difference in favour of molar bands (risk ratio 2.30; 95% CI 1.56 to 3.41) (risk of event for molar tubes = 57%; risk of event for molar bands 25%). One trial presented data on decalcification again showing a statistically significant difference in favour of molar bands. No other adverse events identified. From the two well-designed and low risk of bias trials included in this review it was shown that the failure of molar tubes bonded with either a chemically-cured or light-cured adhesive was considerably higher than that of molar bands cemented with glass ionomer cement. One trial indicated that there was less decalcification with molar bands cemented with glass ionomer cement than with bonded molar tubes cemented with a light-cured adhesive. However, given there are limited data for this outcome, further evidence is required to draw more robust conclusions. Output: The evidence in this review, which was carried out together with Cochrane Oral Health, is up-to-date as of 15 February 2017. We included two studies that evaluated 190 participants. Both trials were conducted in the UK and both compared bonded molar tubes with molar bands. From the limited data of two studies at low risk of bias, it would appear that bonded molar tubes are associated with a higher failure rate than with molar bands. Input: Thirty-nine studies, enrolling 4216 participants, were included in this review, however only 30 studies, involving 3392 participants, contained enough data to be meta-analysed. Risk of bias was low or unclear for most domains in the majority of the included studies. Studies compared antimicrobial lock solutions (antibiotic and non-antibiotic) to standard sealing solutions (usually heparin) of the CVC for HD. Fifteen studies used antibiotic lock solutions, 21 used non-antibiotic antimicrobial lock solutions, and 4 used both (antibiotic and non-antibiotic) lock solutions. Studies reported the incidence of CRI, catheter thrombosis, or both. Antimicrobial lock solutions probably reduces CRI per 1000 catheter-days (27 studies: RR 0.38, 95% CI 0.27 to 0.53; I2 = 54%; low certainty evidence), however antimicrobial lock solutions probably makes little or no difference to the risk of thrombosis per 1000 catheter days (14 studies: RR 0.79, 95% CI 0.52 to 1.22; I2 = 83%; very low certainty evidence). Subgroup analysis of antibiotic and the combination of both lock solutions showed that both probably reduced CRI per 1000 catheter-days (13 studies: RR 0.30, 95% CI: 0.22 to 0.42; I2 = 47%) and risk of thrombosis per 1000 catheter-days (4 studies: RR 0.26, 95% CI: 0.14 to 0.49; I2 = 0%), respectively. Non-antibiotic antimicrobial lock solutions probably reduced CRI per 1000 catheter-days for tunnelled CVC (9 studies: RR 0.60, 95% CI 0.40 to 0.91) but probably made little or no difference with non-tunnelled CVC (4 studies: RR 0.93, 95% CI 0.48 to 1.81). Subgroup analyses showed that antibiotic (5 studies: RR 0.76, 95% CI 0.42 to 1.38), non-antibiotic (8 studies: RR 0.85, 95% CI 0.44 to 1.66), and the combination of both lock solutions (3 studies: RR 0.63, 95% CI 0.22 to 1.81) made little or no difference to thrombosis per 1000 catheter-days compared to control lock solutions. Antibiotic antimicrobial and combined (antibiotic-non antibiotic) lock solutions decreased the incidence of CRI compared to control lock solutions, whereas non-antibiotic lock solutions reduce CRI only for tunnelled CVC. The effect on thrombosis incidence is uncertain for all antimicrobial lock solutions. Our confidence in the evidence is low and very low; therefore, better-designed studies are needed to confirm the efficacy and safety of antimicrobial lock solutions. Output:
We included 39 studies, including 3,945 participants undergoing HD through a CVC. The studies compared CVC sealing solutions with heparin to antimicrobial lock solutions. Fifteen studies used only antibiotic lock solutions, 21 used non-antibiotic lock solutions, and 4 used both (antibiotic and non-antibiotic) lock solutions. Studies measured the incidence of CRIs and catheter thrombosis, or both. Overall quality of the studies was low for CRIs and very low for thrombosis. There was no information on funding sources for most of the studies. In general antimicrobial lock solutions are likely superior to standard solutions in preventing CRIs among patients undergoing HD through a CVC, but non-antibiotic solutions did not prove to reduce CRI. They are no worse than heparin at preventing thrombosis. Other adverse effects were not reported in most studies. Our confidence in these results is low due to the quality of the studies. Some antimicrobial (antibiotic and the combination of antibiotic-non antibiotic) lock solutions decrease the incidence of CRIs compared to heparin. Their effect on CVC permeability remains unclear. The quality of the studies is low and very low, respectively; therefore, more studies are needed to confirm the benefits and harms of antimicrobial lock solutions.
CochranePLS403
***TASK*** the task is to simplify the input abstract of a biomedical literature ***INPUT*** the input is the abstract of a biomedical literature ***OUTPUT*** the output is the simplified abstract for the input abstract of a biomedical literature ***EXAMPLES*** Input: Output: ***EXAMPLES*** Input: Two trials (n = 190), at low risk of bias, were included in the review and both presented data on first time failure at the tooth level. Pooling of the data showed a statistically significant difference in favour of molar bands, with a hazard ratio of 2.92 (95% confidence intervals (CI) 1.80 to 4.72). No statistically significant heterogeneity was shown between the two studies. Data on first time failure at the patient level were also available and showed statistically different difference in favour of molar bands (risk ratio 2.30; 95% CI 1.56 to 3.41) (risk of event for molar tubes = 57%; risk of event for molar bands 25%). One trial presented data on decalcification again showing a statistically significant difference in favour of molar bands. No other adverse events identified. From the two well-designed and low risk of bias trials included in this review it was shown that the failure of molar tubes bonded with either a chemically-cured or light-cured adhesive was considerably higher than that of molar bands cemented with glass ionomer cement. One trial indicated that there was less decalcification with molar bands cemented with glass ionomer cement than with bonded molar tubes cemented with a light-cured adhesive. However, given there are limited data for this outcome, further evidence is required to draw more robust conclusions. Output: The evidence in this review, which was carried out together with Cochrane Oral Health, is up-to-date as of 15 February 2017. We included two studies that evaluated 190 participants. Both trials were conducted in the UK and both compared bonded molar tubes with molar bands. From the limited data of two studies at low risk of bias, it would appear that bonded molar tubes are associated with a higher failure rate than with molar bands. Input: We identified 15 eligible studies (1098 participants). Of these, six investigated pre-emptive treatment versus placebo or treatment of CMV when disease occurred (standard care), eight looked at pre-emptive treatment versus antiviral prophylaxis, and one reported on oral versus intravenous pre-emptive treatment. Assessment of risk of bias identified that the processes reported for sequence generation and allocation concealment were at low risk of bias in only five and three studies, respectively. All studies were considered to be at low risk of attrition bias, and seven studies were considered to be at low risk of bias for selective reporting. Only one study reported adequate blinding of participants and personnel; no study reported blinding of outcome assessment. Compared with placebo or standard care, pre-emptive treatment significantly reduced the risk of CMV disease (6 studies, 288 participants: RR 0.29, 95% CI 0.11 to 0.80) but not acute rejection (3 studies, 185 participants: RR 1.21, 95% CI 0.69 to 2.12) or all-cause mortality (3 studies, 176 participants: RR 1.23, 95% CI 0.35 to 4.30). Comparative studies of pre-emptive therapy versus prophylaxis showed no significant differences in preventing CMV disease between pre-emptive and prophylactic therapy (7 studies, 753 participants: RR 1.00, 95% CI 0.36 to 2.74) but there was significant heterogeneity (I² = 63%). Leucopenia was significantly less common with pre-emptive therapy compared with prophylaxis (6 studies, 729 participants: RR 0.42, 95% CI 0.20 to 0.90). Other adverse effects did not differ significantly or were not reported. There were no significant differences in the risks of all-cause mortality, graft loss, acute rejection and infections other than CMV. Few RCTs have evaluated the effects of pre-emptive therapy to prevent CMV disease. Pre-emptive therapy is effective compared with placebo or standard care. Despite the inclusion of five additional studies in this update, the efficacy of pre-emptive therapy compared with prophylaxis to prevent CMV disease remains unclear due to significant heterogeneity between studies. Additional head-to-head studies are required to determine the relative benefits and harms of pre-emptive therapy and prophylaxis to prevent CMV disease in solid organ transplant recipients. Output:
This review looked at the benefits and harms of pre-emptive treatment with antiviral agents in preventing CMV disease in solid organ transplant recipients. We identified six studies (288 participants) that compared pre-emptive treatment with placebo or usual care. Pre-emptive treatment significantly reduced the risk of CMV disease. There were also eight studies (784 participants) that compared pre-emptive treatment with antiviral prophylaxis. There were no significant differences in the risks of CMV disease or death between pre-emptive therapy and prophylaxis. However, variation in results among studies meant that there is some uncertainty about these results. Low white blood cell counts were much less common with pre-emptive treatment. More studies comparing pre-emptive treatment with antiviral prophylaxis are still required to provide greater certainty about the relative effectiveness of pre-emptive therapy compared with prophylaxis.
CochranePLS404
***TASK*** the task is to simplify the input abstract of a biomedical literature ***INPUT*** the input is the abstract of a biomedical literature ***OUTPUT*** the output is the simplified abstract for the input abstract of a biomedical literature ***EXAMPLES*** Input: Output: ***EXAMPLES*** Input: Two trials (n = 190), at low risk of bias, were included in the review and both presented data on first time failure at the tooth level. Pooling of the data showed a statistically significant difference in favour of molar bands, with a hazard ratio of 2.92 (95% confidence intervals (CI) 1.80 to 4.72). No statistically significant heterogeneity was shown between the two studies. Data on first time failure at the patient level were also available and showed statistically different difference in favour of molar bands (risk ratio 2.30; 95% CI 1.56 to 3.41) (risk of event for molar tubes = 57%; risk of event for molar bands 25%). One trial presented data on decalcification again showing a statistically significant difference in favour of molar bands. No other adverse events identified. From the two well-designed and low risk of bias trials included in this review it was shown that the failure of molar tubes bonded with either a chemically-cured or light-cured adhesive was considerably higher than that of molar bands cemented with glass ionomer cement. One trial indicated that there was less decalcification with molar bands cemented with glass ionomer cement than with bonded molar tubes cemented with a light-cured adhesive. However, given there are limited data for this outcome, further evidence is required to draw more robust conclusions. Output: The evidence in this review, which was carried out together with Cochrane Oral Health, is up-to-date as of 15 February 2017. We included two studies that evaluated 190 participants. Both trials were conducted in the UK and both compared bonded molar tubes with molar bands. From the limited data of two studies at low risk of bias, it would appear that bonded molar tubes are associated with a higher failure rate than with molar bands. Input: Three RCTs met our inclusion criteria: these investigated a total of 140 participants and ranged from six weeks to five months in duration. All three studies were performed by the same trialist. Overall, the risk of bias of these trials was unclear or high. All RCTs compared the effect of sweet potato preparations with placebo on glycaemic control in type 2 diabetes mellitus. There was a statistically significant improvement in glycosylated haemoglobin A1c (HbA1c) at three to five months with 4 g/day sweet potato preparation compared to placebo (mean difference -0.3% (95% confidence interval -0.6 to -0.04); P = 0.02; 122 participants; 2 trials). No serious adverse effects were reported. Diabetic complications and morbidity, death from any cause, health-related quality of life, well-being, functional outcomes and costs were not investigated. There is insufficient evidence about the use of sweet potato for type 2 diabetes mellitus. In addition to improvement in trial methodology, issues of standardization and quality control of preparations - including other varieties of sweet potato - need to be addressed. Further observational trials and RCTs evaluating the effects of sweet potato are needed to guide any recommendations in clinical practice. Output:
We decided to investigate whether there is enough evidence from medical trials to show whether sweet potato works as a treatment for diabetes. This review of randomised controlled trials found only three studies (with a total of 140 participants) that evaluated the effects of sweet potato for type 2 diabetes mellitus compared with a fake medicine (placebo). All these trials were of very low quality. Two studies with 122 participants showed improved long-term metabolic control of blood sugar levels as measured by glycosylated haemoglobin A1c (HbA1c) which was moderately lowered by 0.3% in participants who were given 4 g sweet potato tablets a day for three to five months. The duration of treatment ranged from six weeks to five months. No study investigated diabetic complications, death from any cause, health-related quality of life, well-being, functional outcomes or costs. Adverse effects were mostly mild, and included abdominal distension and pain. There are many varieties of sweet potatoes and sweet potato preparations. More trials are needed to assess the quality of the various sweet potato preparations as well as to evaluate further the use of different varieties of sweet potato in the diet of diabetic people.
CochranePLS405
***TASK*** the task is to simplify the input abstract of a biomedical literature ***INPUT*** the input is the abstract of a biomedical literature ***OUTPUT*** the output is the simplified abstract for the input abstract of a biomedical literature ***EXAMPLES*** Input: Output: ***EXAMPLES*** Input: Two trials (n = 190), at low risk of bias, were included in the review and both presented data on first time failure at the tooth level. Pooling of the data showed a statistically significant difference in favour of molar bands, with a hazard ratio of 2.92 (95% confidence intervals (CI) 1.80 to 4.72). No statistically significant heterogeneity was shown between the two studies. Data on first time failure at the patient level were also available and showed statistically different difference in favour of molar bands (risk ratio 2.30; 95% CI 1.56 to 3.41) (risk of event for molar tubes = 57%; risk of event for molar bands 25%). One trial presented data on decalcification again showing a statistically significant difference in favour of molar bands. No other adverse events identified. From the two well-designed and low risk of bias trials included in this review it was shown that the failure of molar tubes bonded with either a chemically-cured or light-cured adhesive was considerably higher than that of molar bands cemented with glass ionomer cement. One trial indicated that there was less decalcification with molar bands cemented with glass ionomer cement than with bonded molar tubes cemented with a light-cured adhesive. However, given there are limited data for this outcome, further evidence is required to draw more robust conclusions. Output: The evidence in this review, which was carried out together with Cochrane Oral Health, is up-to-date as of 15 February 2017. We included two studies that evaluated 190 participants. Both trials were conducted in the UK and both compared bonded molar tubes with molar bands. From the limited data of two studies at low risk of bias, it would appear that bonded molar tubes are associated with a higher failure rate than with molar bands. Input: Our search identified 62 studies, of which 19 (440 participants) met the inclusion criteria. Five randomised controlled studies (192 participants) were included in the meta-analysis; three were of cross-over design. The 14 remaining studies were cross-over studies with inadequate reports for complete assessment. The study size ranged from seven to 65 participants. The age of the participants ranged from six to 63 years (mean age 22.33 years). In 13 studies, follow up lasted a single day. However, there were two long-term randomised controlled studies with follow up of one to three years. Most of the studies did not report on key quality items, and therefore, have an unclear risk of bias in terms of random sequence generation, allocation concealment, and outcome assessor blinding. Due to the nature of the intervention, none of the studies blinded participants or the personnel applying the interventions. However, most of the studies reported on all planned outcomes, had adequate follow up, assessed compliance, and used an intention-to-treat analysis. Included studies compared the active cycle of breathing technique with autogenic drainage, airway oscillating devices, high frequency chest compression devices, conventional chest physiotherapy, and positive expiratory pressure. Preference of technique varied: more participants preferred autogenic drainage over the active cycle of breathing technique; more preferred the active cycle of breathing technique over airway oscillating devices; and more were comfortable with the active cycle of breathing technique versus high frequency chest compression. No significant difference was seen in quality of life, sputum weight, exercise tolerance, lung function, or oxygen saturation between the active cycle of breathing technique and autogenic drainage or between the active cycle of breathing technique and airway oscillating devices. There was no significant difference in lung function and the number of pulmonary exacerbations between the active cycle of breathing technique alone or in conjunction with conventional chest physiotherapy. All other outcomes were either not measured or had insufficient data for analysis. There is insufficient evidence to support or reject the use of the active cycle of breathing technique over any other airway clearance therapy. Five studies, with data from eight different comparators, found that the active cycle of breathing technique was comparable with other therapies in outcomes such as participant preference, quality of life, exercise tolerance, lung function, sputum weight, oxygen saturation, and number of pulmonary exacerbations. Longer-term studies are needed to more adequately assess the effects of the active cycle of breathing technique on outcomes important for people with cystic fibrosis such as quality of life and preference. Output:
While 19 studies comparing the active cycle of breathing technique with other airway clearance therapies are included in the review, only five studies (192 participants) reported data that we could include in the analysis. Each of the five studies compared different techniques: the active cycle of breathing technique was compared with autogenic drainage, airway oscillating devices, high-frequency chest compression devices, positive expiratory pressure, and conventional chest physiotherapy. Most studies lasted a single day, but there were two studies that lasted between one and three years. Participants ranged in age from six to 63 years and most (63%) were male. We found that the active cycle of breathing technique was comparable with other treatments in outcomes such as quality of life, personal preference, exercise tolerance, lung function, sputum weight, oxygen saturation, and the number of pulmonary exacerbations. We were not able to show that any single technique was better than another. Longer studies are needed to better assess the effects of the active cycle of breathing technique on outcomes important for people with cystic fibrosis such as quality of life and personal preference. Many of the studies did not provide enough details of their methods to determine if there were any biases that might have affected the results. Many studies did not report how they decided who would get which treatment and how they made sure that the people who were putting people into the different treatment groups and those who were assessing the results did not know which group each individual was in. Most of the included studies had a cross-over design (where people have one treatment and then switch to the second), and many of these did not report the length of time in between different treatments. As it is possible that the first treatment might affect the results of the next treatment, we only included results from the first treatment period. Many of the studies did not report separate results for just the first treatment period, so we did not include their results in our review. All participants knew which treatment group they were in (it is not possible to disguise different physiotherapy techniques). This could have affected the results for some of the self-reported outcomes, such as quality of life, personal preference, or exercise tolerance, but is unlikely to have affected the more objective outcomes, such as lung function. Most of the studies followed those taking part for less than one month and did this for most of the participants for the entire study period. In two out of the three longer studies more than 10% of the people taking part dropped out. The study results could be affected if the people who dropped out of the studies were not evenly spread across the different treatment groups. Over half of the studies checked that participants were using the airway clearance therapy they were supposed to. Most of the studies reported on all their planned outcomes. The findings of the review were limited as not many studies made the same comparisons; also, there were not many long-term studies and the studies we included did not report enough data.
CochranePLS406
***TASK*** the task is to simplify the input abstract of a biomedical literature ***INPUT*** the input is the abstract of a biomedical literature ***OUTPUT*** the output is the simplified abstract for the input abstract of a biomedical literature ***EXAMPLES*** Input: Output: ***EXAMPLES*** Input: Two trials (n = 190), at low risk of bias, were included in the review and both presented data on first time failure at the tooth level. Pooling of the data showed a statistically significant difference in favour of molar bands, with a hazard ratio of 2.92 (95% confidence intervals (CI) 1.80 to 4.72). No statistically significant heterogeneity was shown between the two studies. Data on first time failure at the patient level were also available and showed statistically different difference in favour of molar bands (risk ratio 2.30; 95% CI 1.56 to 3.41) (risk of event for molar tubes = 57%; risk of event for molar bands 25%). One trial presented data on decalcification again showing a statistically significant difference in favour of molar bands. No other adverse events identified. From the two well-designed and low risk of bias trials included in this review it was shown that the failure of molar tubes bonded with either a chemically-cured or light-cured adhesive was considerably higher than that of molar bands cemented with glass ionomer cement. One trial indicated that there was less decalcification with molar bands cemented with glass ionomer cement than with bonded molar tubes cemented with a light-cured adhesive. However, given there are limited data for this outcome, further evidence is required to draw more robust conclusions. Output: The evidence in this review, which was carried out together with Cochrane Oral Health, is up-to-date as of 15 February 2017. We included two studies that evaluated 190 participants. Both trials were conducted in the UK and both compared bonded molar tubes with molar bands. From the limited data of two studies at low risk of bias, it would appear that bonded molar tubes are associated with a higher failure rate than with molar bands. Input: Eight RCTs with 733 women in total that compared brief co-incubation and the standard insemination protocol were included. Live birth was not reported in the included studies. For ongoing pregnancy rate, there were 127 ongoing pregnancies in two trials including 426 women. The low quality evidence showed that brief co-incubation was associated with an increased ongoing pregnancy rate compared to the standard insemination protocol (pooled odds ratio (OR) 2.42, 95% confidence interval (CI) 1.55 to 3.77; P < 0.0001, I2 = 0%). Measuring clinical pregnancy rate, there were 93 clinical pregnancies in three trials including 372 women. The low quality evidence showed that brief co-incubation was associated with a significantly higher clinical pregnancy rate than the overnight insemination protocol (pooled OR 2.36, 95% CI 1.45 to 3.85; P = 0.0006, I2 = 0%). For the miscarriage rate, there were six miscarriages in one trial including 167 women. This low quality evidence suggested no significant difference in the odds of miscarriage between brief co-incubation and standard insemination (OR 1.98, 95% CI 0.35 to 11.09; P = 0.44). This review has provided evidence that brief co-incubation of sperm and oocytes may improve the ongoing pregnancy and clinical pregnancy rates for infertile women undergoing IVF cycles. More RCTs are required to assess whether brief co-incubation would contribute to a higher live birth rate and a lower miscarriage rate compared to the standard overnight insemination protocol. Output:
This review identified eight randomized controlled trials involving 733 women. Low quality evidence showed increases in ongoing pregnancy and clinical pregnancy rates with the use of the brief co-incubation protocol. More studies are needed to assess whether brief co-incubation would contribute to a higher live-birth rate and a lower miscarriage rate compared to the standard overnight insemination protocol.
CochranePLS407
***TASK*** the task is to simplify the input abstract of a biomedical literature ***INPUT*** the input is the abstract of a biomedical literature ***OUTPUT*** the output is the simplified abstract for the input abstract of a biomedical literature ***EXAMPLES*** Input: Output: ***EXAMPLES*** Input: Two trials (n = 190), at low risk of bias, were included in the review and both presented data on first time failure at the tooth level. Pooling of the data showed a statistically significant difference in favour of molar bands, with a hazard ratio of 2.92 (95% confidence intervals (CI) 1.80 to 4.72). No statistically significant heterogeneity was shown between the two studies. Data on first time failure at the patient level were also available and showed statistically different difference in favour of molar bands (risk ratio 2.30; 95% CI 1.56 to 3.41) (risk of event for molar tubes = 57%; risk of event for molar bands 25%). One trial presented data on decalcification again showing a statistically significant difference in favour of molar bands. No other adverse events identified. From the two well-designed and low risk of bias trials included in this review it was shown that the failure of molar tubes bonded with either a chemically-cured or light-cured adhesive was considerably higher than that of molar bands cemented with glass ionomer cement. One trial indicated that there was less decalcification with molar bands cemented with glass ionomer cement than with bonded molar tubes cemented with a light-cured adhesive. However, given there are limited data for this outcome, further evidence is required to draw more robust conclusions. Output: The evidence in this review, which was carried out together with Cochrane Oral Health, is up-to-date as of 15 February 2017. We included two studies that evaluated 190 participants. Both trials were conducted in the UK and both compared bonded molar tubes with molar bands. From the limited data of two studies at low risk of bias, it would appear that bonded molar tubes are associated with a higher failure rate than with molar bands. Input: In five studies, recruiting a total of 694 infants, a long IT was associated with a significant increase in air leak [typical RR 1.56 (1.25, 1.94), RD 0.13 (0.07, 0.20), NNT 8 (5, 14)]. There was no significant difference in the incidence of BPD. Long IT was associated with an increase in mortality before hospital discharge that reached borderline statistical significance [typical RR 1.26 (1.00, 1.59), RD 0.07 (0.00, 0.13)]. Caution should be exercised in applying these results to modern neonatal intensive care, because the studies included in this review were conducted prior to the introduction of antenatal steroids, post natal surfactant and the use of synchronised modes of ventilatory support. Most of the participants had single pathology (HMD) and no studies examined the effects of IT on newborns ventilated for other reasons such as meconium aspiration and congenital heart disease (lungs with normal compliance). However, the increased rates of air leaks and deaths using long ITs are clinically important; thus, infants with poorly compliant lungs should be ventilated with a short IT. Output:
The review authors identified five randomised studies reported from 1980 to 1992. These trials recruited a total of 694 newborn infants with acute respiratory failure mainly caused by hyaline membrane disease. A long inspiratory time was associated with a significant increase in air leak from the lungs (NNT 8). There was no significant difference in the incidence of BPD but an increase in mortality before hospital discharge reached borderline statistical significance. Caution should be exercised in applying these results to modern neonatal intensive care because these studies were conducted before the introduction of antenatal steroids, postnatal surfactant and the use of synchronised modes of ventilatory support. Whilst there is increasing use of non-invasive ventilation such as nasal continuous positive airway pressure to avoid ventilator-induced lung injury, mechanical ventilation will continue to have a role in extremely immature infants and those with hyaline membrane disease complicated by apnea.
CochranePLS408
***TASK*** the task is to simplify the input abstract of a biomedical literature ***INPUT*** the input is the abstract of a biomedical literature ***OUTPUT*** the output is the simplified abstract for the input abstract of a biomedical literature ***EXAMPLES*** Input: Output: ***EXAMPLES*** Input: Two trials (n = 190), at low risk of bias, were included in the review and both presented data on first time failure at the tooth level. Pooling of the data showed a statistically significant difference in favour of molar bands, with a hazard ratio of 2.92 (95% confidence intervals (CI) 1.80 to 4.72). No statistically significant heterogeneity was shown between the two studies. Data on first time failure at the patient level were also available and showed statistically different difference in favour of molar bands (risk ratio 2.30; 95% CI 1.56 to 3.41) (risk of event for molar tubes = 57%; risk of event for molar bands 25%). One trial presented data on decalcification again showing a statistically significant difference in favour of molar bands. No other adverse events identified. From the two well-designed and low risk of bias trials included in this review it was shown that the failure of molar tubes bonded with either a chemically-cured or light-cured adhesive was considerably higher than that of molar bands cemented with glass ionomer cement. One trial indicated that there was less decalcification with molar bands cemented with glass ionomer cement than with bonded molar tubes cemented with a light-cured adhesive. However, given there are limited data for this outcome, further evidence is required to draw more robust conclusions. Output: The evidence in this review, which was carried out together with Cochrane Oral Health, is up-to-date as of 15 February 2017. We included two studies that evaluated 190 participants. Both trials were conducted in the UK and both compared bonded molar tubes with molar bands. From the limited data of two studies at low risk of bias, it would appear that bonded molar tubes are associated with a higher failure rate than with molar bands. Input: We included 33 studies involving 5110 patients. Predominantly, the studies were of low methodological quality. TFU has been applied in many patient groups. There is a large variety in the ways the TFU was performed (the health professionals who undertook the TFU, frequency, structure, duration, etc.). Many different outcomes have been measured, but only a few were measured across more than one study. Effects are not constant across studies, nor within patient groups. Due to methodological and clinical diversity, quantitative pooling could only be performed for a few outcomes. Of the eight meta-analyses in this review, five showed considerable statistical heterogeneity. Overall, there was inconclusive evidence about the effects of TFU. The low methodological quality of the included studies means that results must be considered with caution. No adverse effects were reported. Nevertheless, although some studies find that the intervention had favourable effects for some outcomes, overall the studies show clinically-equivalent results between TFU and control groups. In summary, we cannot conclude that TFU is an effective intervention. Output:
Our systematic review identified 33 relevant studies, almost all of which were of low methodological quality (a major limitation of the review). We found that telephone follow-up has been applied in many patient groups. There is great variety in the ways the telephone follow-up has been performed. Many different outcomes have been measured. Some studies found effects in favour of the telephone follow-up intervention, but overall studies identified no statistically significant differences between the telephone follow-up and control groups. For as far as the results of studies could be pooled together, we could draw no firm conclusions about the effects of telephone follow-up. No studies identified adverse effects of the intervention.
CochranePLS409
***TASK*** the task is to simplify the input abstract of a biomedical literature ***INPUT*** the input is the abstract of a biomedical literature ***OUTPUT*** the output is the simplified abstract for the input abstract of a biomedical literature ***EXAMPLES*** Input: Output: ***EXAMPLES*** Input: Two trials (n = 190), at low risk of bias, were included in the review and both presented data on first time failure at the tooth level. Pooling of the data showed a statistically significant difference in favour of molar bands, with a hazard ratio of 2.92 (95% confidence intervals (CI) 1.80 to 4.72). No statistically significant heterogeneity was shown between the two studies. Data on first time failure at the patient level were also available and showed statistically different difference in favour of molar bands (risk ratio 2.30; 95% CI 1.56 to 3.41) (risk of event for molar tubes = 57%; risk of event for molar bands 25%). One trial presented data on decalcification again showing a statistically significant difference in favour of molar bands. No other adverse events identified. From the two well-designed and low risk of bias trials included in this review it was shown that the failure of molar tubes bonded with either a chemically-cured or light-cured adhesive was considerably higher than that of molar bands cemented with glass ionomer cement. One trial indicated that there was less decalcification with molar bands cemented with glass ionomer cement than with bonded molar tubes cemented with a light-cured adhesive. However, given there are limited data for this outcome, further evidence is required to draw more robust conclusions. Output: The evidence in this review, which was carried out together with Cochrane Oral Health, is up-to-date as of 15 February 2017. We included two studies that evaluated 190 participants. Both trials were conducted in the UK and both compared bonded molar tubes with molar bands. From the limited data of two studies at low risk of bias, it would appear that bonded molar tubes are associated with a higher failure rate than with molar bands. Input: We identified 38 eligible retention trials. Included trials evaluated six broad types of strategies to improve retention. These were incentives, communication strategies, new questionnaire format, participant case management, behavioural and methodological interventions. For 34 of the included trials, retention was response to postal and electronic questionnaires with or without medical test kits. For four trials, retention was the number of participants remaining in the trial. Included trials were conducted across a spectrum of disease areas, countries, healthcare and community settings. Strategies that improved trial retention were addition of monetary incentives compared with no incentive for return of trial-related postal questionnaires (RR 1.18; 95% CI 1.09 to 1.28, P value < 0.0001), addition of an offer of monetary incentive compared with no offer for return of electronic questionnaires (RR 1.25; 95% CI 1.14 to 1.38, P value < 0.00001) and an offer of a GBP20 voucher compared with GBP10 for return of postal questionnaires and biomedical test kits (RR 1.12; 95% CI 1.04 to 1.22, P value < 0.005). The evidence that shorter questionnaires are better than longer questionnaires was unclear (RR 1.04; 95% CI 1.00 to 1.08, P value = 0.07) and the evidence for questionnaires relevant to the disease/condition was also unclear (RR 1.07; 95% CI 1.01 to 1.14). Although each was based on the results of a single trial, recorded delivery of questionnaires seemed to be more effective than telephone reminders (RR 2.08; 95% CI 1.11 to 3.87, P value = 0.02) and a 'package' of postal communication strategies with reminder letters appeared to be better than standard procedures (RR 1.43; 95% CI 1.22 to 1.67, P value < 0.0001). An open trial design also appeared more effective than a blind trial design for return of questionnaires in one fracture prevention trial (RR 1.37; 95% CI 1.16 to 1.63, P value = 0.0003). There was no good evidence that the addition of a non-monetary incentive, an offer of a non-monetary incentive, 'enhanced' letters, letters delivered by priority post, additional reminders, or questionnaire question order either increased or decreased trial questionnaire response/retention. There was also no evidence that a telephone survey was either more or less effective than a monetary incentive and a questionnaire. As our analyses are based on single trials, the effect on questionnaire response of using offers of charity donations, sending reminders to trial sites and when a questionnaire is sent, may need further evaluation. Case management and behavioural strategies used for trial retention may also warrant further evaluation. Most of the retention trials that we identified evaluated questionnaire response. There were few evaluations of ways to improve participants returning to trial sites for trial follow-up. Monetary incentives and offers of monetary incentives increased postal and electronic questionnaire response. Some other strategies evaluated in single trials looked promising but need further evaluation. Application of the findings of this review would depend on trial setting, population, disease area, data collection and follow-up procedures. Output:
This review identified methods that encouraged people to stay in trials. We searched scientific databases for randomised studies (where people are allocated to one of two or more possible treatments in a random manner) or quasi-randomised studies (where allocation is not really random, e.g. based on date of birth, order in which they attended clinic) that compared methods of increasing retention in trials. We included trials of participants from any age, gender, ethnic, cultural, language and geographic groups. The methods that appeared to work were offering or giving a small amount of money for return of a completed questionnaire and enclosing a small amount of money with a questionnaire with the promise of a further small amount of money for return of a filled in questionnaire. The effect of other ways to keep people in trials is still not clear and more research is needed to see if these really do work. Such methods are shorter questionnaires, sending questionnaires by recorded delivery, using a trial design where people know which treatment they will receive, sending specially designed letters with a reply self addressed stamped envelope followed by a number of reminders, offering a donation to charity or entry into a prize draw, sending a reminder to the study site about participants to follow-up, sending questionnaires close to the time the patient was last followed-up, managing peoples' follow-up, conducting follow-up by telephone and changing the order of questionnaire questions. The methods that we identified were tested in trials run in many different disease areas and settings and, in some cases, were tested in only one trial. Therefore, more studies are needed to help decide whether our findings could be used in other research fields.
CochranePLS410
***TASK*** the task is to simplify the input abstract of a biomedical literature ***INPUT*** the input is the abstract of a biomedical literature ***OUTPUT*** the output is the simplified abstract for the input abstract of a biomedical literature ***EXAMPLES*** Input: Output: ***EXAMPLES*** Input: Two trials (n = 190), at low risk of bias, were included in the review and both presented data on first time failure at the tooth level. Pooling of the data showed a statistically significant difference in favour of molar bands, with a hazard ratio of 2.92 (95% confidence intervals (CI) 1.80 to 4.72). No statistically significant heterogeneity was shown between the two studies. Data on first time failure at the patient level were also available and showed statistically different difference in favour of molar bands (risk ratio 2.30; 95% CI 1.56 to 3.41) (risk of event for molar tubes = 57%; risk of event for molar bands 25%). One trial presented data on decalcification again showing a statistically significant difference in favour of molar bands. No other adverse events identified. From the two well-designed and low risk of bias trials included in this review it was shown that the failure of molar tubes bonded with either a chemically-cured or light-cured adhesive was considerably higher than that of molar bands cemented with glass ionomer cement. One trial indicated that there was less decalcification with molar bands cemented with glass ionomer cement than with bonded molar tubes cemented with a light-cured adhesive. However, given there are limited data for this outcome, further evidence is required to draw more robust conclusions. Output: The evidence in this review, which was carried out together with Cochrane Oral Health, is up-to-date as of 15 February 2017. We included two studies that evaluated 190 participants. Both trials were conducted in the UK and both compared bonded molar tubes with molar bands. From the limited data of two studies at low risk of bias, it would appear that bonded molar tubes are associated with a higher failure rate than with molar bands. Input: We included eight RCTs that involved a total of 829 participants (416 and 413 participants in the pLMA and cLMA groups, respectively). We identified six cross-over studies that are awaiting classification; one is completed but has not been published, and data related to the first treatment period for the other five studies were not yet available. Seven included studies provided data related to the primary outcome, and eight studies provided data related to more than one secondary outcome. Our analysis was hampered by the fact that a large proportion of the included studies reported no events in either study arm. No studies reported significant differences between devices in relation to the primary review outcome: failure to adequately mechanically ventilate. We evaluated this outcome by assessing two variables: inadequate oxygenation (risk ratio (RR) 0.75, 95% confidence interval (CI) 0.17 to 3.31; four studies, N = 617) and inadequate ventilation (not estimable; one study, N = 80). More time was required to establish an effective airway using pLMA (mean difference (MD) 10.12 seconds, 95% CI 5.04 to 15.21; P < 0.0001; I² = 73%; two studies, N = 434). Peak airway pressure during positive pressure ventilation was lower in cLMA participants (MD 0.84, 95% CI 0.02 to 1.67; P = 0.04; I² = 0%; four studies, N = 259). Mean oropharyngeal leak (OPL) pressure was higher in pLMA participants (MD 6.93, 95% CI 4.23 to 9.62; P < 0.00001; I² = 87%; six studies, N = 709). The quality of evidence for all outcomes, as assessed by GRADE score, is low mainly owing to issues related to blinding and imprecision. Data show no important differences between devices with regard to failure to insert the device, use of an alternate device, mucosal injury, sore throat, bronchospasm, gastric insufflation, regurgitation, coughing, and excessive leak. Data were insufficient to allow estimation of differences for obstruction related to the device. None of the studies reported postoperative nausea and vomiting as an outcome. We are uncertain about the effects of either of the airway devices in terms of failure of oxygenation or ventilation because there were very few events. Results were uncertain in terms of differences for several complications. Low-quality evidence suggests that the ProSeal laryngeal mask airway makes a better seal and therefore may be more suitable than the Classic laryngeal mask airway for positive pressure ventilation. The Classic laryngeal mask airway may be quicker to insert, but this is unlikely to be clinically meaningful. Output:
We included eight randomized studies that involved a total of 829 participants 18 years of age and older. All participants had elective surgeries and needed general anaesthesia. Researchers directly compared cLMA against pLMA for providing artificial breathing during surgery. We identified six cross-over studies that are awaiting classification; one is completed but has not been published, and five other studies are gathering data related to the first treatment period that are not yet available. Five studies did not report any funding sources. Of the remaining three studies, one reported that the Laryngeal Mask Company sponsored some data but was not involved in study design, data analysis, and manuscript preparation. The Joseph Drown Foundation, in Los Angeles, Califiornia, in the USA, partially supported another study. One of the authors of the final study had received research funds from Intavent Ltd, manufacturer of both types of laryngeal mask airway, but Intavent Ltd did not sponsor this study. We are unsure whether these devices exhibit important differences in providing adequate oxygenation and ventilation because there was not enough data to enable us to draw any firm conclusions. ProSeal laryngeal mask airway may provides a better seal because it leaks at higher pressure, but Classic laryngeal mask airway may be quicker to insert. However, these findings are not important clinically. We assessed all of the included studies as providing low-quality evidence because anaesthetists knew which device was being used on which participants (although this was probably unavoidable), and because it was unclear whether the investigator who collected the data was unaware of the intervention. This fact created the potential for bias.
CochranePLS411
***TASK*** the task is to simplify the input abstract of a biomedical literature ***INPUT*** the input is the abstract of a biomedical literature ***OUTPUT*** the output is the simplified abstract for the input abstract of a biomedical literature ***EXAMPLES*** Input: Output: ***EXAMPLES*** Input: Two trials (n = 190), at low risk of bias, were included in the review and both presented data on first time failure at the tooth level. Pooling of the data showed a statistically significant difference in favour of molar bands, with a hazard ratio of 2.92 (95% confidence intervals (CI) 1.80 to 4.72). No statistically significant heterogeneity was shown between the two studies. Data on first time failure at the patient level were also available and showed statistically different difference in favour of molar bands (risk ratio 2.30; 95% CI 1.56 to 3.41) (risk of event for molar tubes = 57%; risk of event for molar bands 25%). One trial presented data on decalcification again showing a statistically significant difference in favour of molar bands. No other adverse events identified. From the two well-designed and low risk of bias trials included in this review it was shown that the failure of molar tubes bonded with either a chemically-cured or light-cured adhesive was considerably higher than that of molar bands cemented with glass ionomer cement. One trial indicated that there was less decalcification with molar bands cemented with glass ionomer cement than with bonded molar tubes cemented with a light-cured adhesive. However, given there are limited data for this outcome, further evidence is required to draw more robust conclusions. Output: The evidence in this review, which was carried out together with Cochrane Oral Health, is up-to-date as of 15 February 2017. We included two studies that evaluated 190 participants. Both trials were conducted in the UK and both compared bonded molar tubes with molar bands. From the limited data of two studies at low risk of bias, it would appear that bonded molar tubes are associated with a higher failure rate than with molar bands. Input: We included 19 RCTs, reported in 27 papers with a total of 1453 participants. Fifteen of these studies were not included in the previous review. All 19 RCTs had follow-up ranging from one to five months. Participants were aged between four and 18 years from eight different countries and were recruited largely from paediatric gastroenterology clinics. The mean age at recruitment ranged from 6.3 years to 13.1 years. Girls outnumbered boys in most trials. Fourteen trials recruited children with a diagnosis under the broad umbrella of RAP or functional gastrointestinal disorders; five trials specifically recruited only children with irritable bowel syndrome. The studies fell into four categories: trials of probiotic-based interventions (13 studies), trials of fibre-based interventions (four studies), trials of low FODMAP (fermentable oligosaccharides, disaccharides, monosaccharides and polyols) diets (one study), and trials of fructose-restricted diets (one study). We found that children treated with probiotics reported a greater reduction in pain frequency at zero to three months postintervention than those given placebo (standardised mean difference (SMD) -0.55, 95% confidence interval (CI) -0.98 to -0.12; 6 trials; 523 children). There was also a decrease in pain intensity in the intervention group at the same time point (SMD -0.50, 95% CI -0.85 to -0.15; 7 studies; 575 children). However, we judged the evidence for these outcomes to be of low quality using GRADE due to an unclear risk of bias from incomplete outcome data and significant heterogeneity. We found that children treated with probiotics were more likely to experience improvement in pain at zero to three months postintervention than those given placebo (odds ratio (OR) 1.63, 95% CI 1.07 to 2.47; 7 studies; 722 children). The estimated number needed to treat for an additional beneficial outcome (NNTB) was eight, meaning that eight children would need to receive probiotics for one to experience improvement in pain in this timescale. We judged the evidence for this outcome to be of moderate quality due to significant heterogeneity. Children with a symptom profile defined as irritable bowel syndrome treated with probiotics were more likely to experience improvement in pain at zero to three months postintervention than those given placebo (OR 3.01, 95% CI 1.77 to 5.13; 4 studies; 344 children). Children treated with probiotics were more likely to experience improvement in pain at three to six months postintervention compared to those receiving placebo (OR 1.94, 95% CI 1.10 to 3.43; 2 studies; 224 children). We judged the evidence for these two outcomes to be of moderate quality due to small numbers of participants included in the studies. We found that children treated with fibre-based interventions were not more likely to experience an improvement in pain at zero to three months postintervention than children given placebo (OR 1.83, 95% CI 0.92 to 3.65; 2 studies; 136 children). There was also no reduction in pain intensity compared to placebo at the same time point (SMD -1.24, 95% CI -3.41 to 0.94; 2 studies; 135 children). We judged the evidence for these outcomes to be of low quality due to an unclear risk of bias, imprecision, and significant heterogeneity. We found only one study of low FODMAP diets and only one trial of fructose-restricted diets, meaning no pooled analyses were possible. We were unable to perform any meta-analyses for the secondary outcomes of school performance, social or psychological functioning, or quality of daily life, as not enough studies included these outcomes or used comparable measures to assess them. With the exception of one study, all studies reported monitoring children for adverse events; no major adverse events were reported. Overall, we found moderate- to low-quality evidence suggesting that probiotics may be effective in improving pain in children with RAP. Clinicians may therefore consider probiotic interventions as part of a holistic management strategy. However, further trials are needed to examine longer-term outcomes and to improve confidence in estimating the size of the effect, as well as to determine the optimal strain and dosage. Future research should also explore the effectiveness of probiotics in children with different symptom profiles, such as those with irritable bowel syndrome. We found only a small number of trials of fibre-based interventions, with overall low-quality evidence for the outcomes. There was therefore no convincing evidence that fibre-based interventions improve pain in children with RAP. Further high-quality RCTs of fibre supplements involving larger numbers of participants are required. Future trials of low FODMAP diets and other dietary interventions are also required to facilitate evidence-based recommendations. Output:
This evidence is current to June 2016. Nineteen studies met our inclusion criteria, including 13 studies of probiotics and four studies of fibre interventions. We also found one study of a diet low in substances known as FODMAPs (fermentable oligosaccharides, disaccharides, monosaccharides and polyols) and one study of a fructose-restricted diet. All of the studies compared dietary interventions to a placebo or control. The trials were carried out in eight countries and included a total of 1453 participants, aged between five and 18 years. Most children were recruited from outpatient clinics. Most interventions lasted four to six weeks. Probiotics We found evidence from 13 studies suggesting that probiotics might be effective in improving pain in the shorter term. Most studies did not report on other areas such as quality of daily life. No harmful effects were reported, other than dry mouth in one study. We judged this evidence to be of moderate or low quality because some studies were small, showed varying results, or were at risk of bias. Fibre supplements We found no clear evidence of improvement of pain from four studies of fibre supplements. Most studies did not report on other areas such as quality of daily life. No harmful effects were reported. There were few studies of fibre supplements, and some of these studies were at risk of bias. We judged this evidence to be of low quality. Low FODMAP diets We found only one study evaluating the effectiveness of low FODMAP diets in children with RAP. Fructose-restricted diets We found only one study evaluating the effectiveness of fructose-restricted diets in children with RAP. We found some evidence suggesting that probiotics may be helpful in relieving pain in children with RAP in the short term. Clinicians may therefore consider probiotic interventions as part of the management strategy for RAP. Further trials are needed to find out how effective probiotics are over longer periods of time and which probiotics might work best. We did not find convincing evidence that fibre supplements are effective in improving pain in children with RAP. Future larger, high-quality studies are needed to test the effectiveness of fibre and low FODMAP diet treatments.
CochranePLS412
***TASK*** the task is to simplify the input abstract of a biomedical literature ***INPUT*** the input is the abstract of a biomedical literature ***OUTPUT*** the output is the simplified abstract for the input abstract of a biomedical literature ***EXAMPLES*** Input: Output: ***EXAMPLES*** Input: Two trials (n = 190), at low risk of bias, were included in the review and both presented data on first time failure at the tooth level. Pooling of the data showed a statistically significant difference in favour of molar bands, with a hazard ratio of 2.92 (95% confidence intervals (CI) 1.80 to 4.72). No statistically significant heterogeneity was shown between the two studies. Data on first time failure at the patient level were also available and showed statistically different difference in favour of molar bands (risk ratio 2.30; 95% CI 1.56 to 3.41) (risk of event for molar tubes = 57%; risk of event for molar bands 25%). One trial presented data on decalcification again showing a statistically significant difference in favour of molar bands. No other adverse events identified. From the two well-designed and low risk of bias trials included in this review it was shown that the failure of molar tubes bonded with either a chemically-cured or light-cured adhesive was considerably higher than that of molar bands cemented with glass ionomer cement. One trial indicated that there was less decalcification with molar bands cemented with glass ionomer cement than with bonded molar tubes cemented with a light-cured adhesive. However, given there are limited data for this outcome, further evidence is required to draw more robust conclusions. Output: The evidence in this review, which was carried out together with Cochrane Oral Health, is up-to-date as of 15 February 2017. We included two studies that evaluated 190 participants. Both trials were conducted in the UK and both compared bonded molar tubes with molar bands. From the limited data of two studies at low risk of bias, it would appear that bonded molar tubes are associated with a higher failure rate than with molar bands. Input: We included 22 studies involving 4490 participants. All were randomised trials (3 were cluster RCTs), and 19 of the 22 studies had analysable outcome data. Seventeen of the studies had student populations. Most of the studies were at unclear or high risk of bias for all forms of bias except detection bias. Findings from the five trials with discrimination outcomes (n = 1196) were mixed, with effects showing a reduction, increase or consistent with no evidence of effect. The median standardised mean difference (SMD) for the three trials (n = 394) with continuous outcomes was -0.25, with SMDs ranging from -0.85 (95% confidence interval (CI) -1.39 to -0.31) to -0.17 (95% CI -0.53 to 0.20). Odds ratios (OR) for the two studies (n = 802) with dichotomous discrimination outcomes showed no evidence of effect: results were 1.30 (95% CI 0.53 to 3.19) and 1.19 (95% CI 0.85 to 1.65). The 19 trials (n = 3176) with prejudice outcomes had median SMDs favouring the intervention, at the three following time periods: -0.38 (immediate), -0.38 (1 week to 2 months) and -0.49 (6 to 9 months). SMDs for prejudice outcomes across all studies ranged from -2.94 (95% CI -3.52 to -2.37) to 2.40 (95% CI 0.62 to 4.18). The median SMDs indicate that mass media interventions may have a small to medium effect in decreasing prejudice, and are equivalent to reducing the level of prejudice from that associated with schizophrenia to that associated with major depression. The studies were very heterogeneous, statistically, in their populations, interventions and outcomes, and only two meta-analyses within two subgroups were warranted. Data on secondary outcomes were sparse. Cost data were provided on request for three studies (n = 416), were highly variable, and did not address cost-effectiveness. Two studies (n = 455) contained statements about adverse effects and neither reported finding any. Mass media interventions may reduce prejudice, but there is insufficient evidence to determine their effects on discrimination. Very little is known about costs, adverse effects or other outcomes. Our review found few studies in middle- and low-income countries, or with employers or health professionals as the target group, and none targeted at children or adolescents. The findings are limited by the quality of the evidence, which was low for the primary outcomes for discrimination and prejudice, low for adverse effects and very low for costs. More research is required to establish the effects of mass media interventions on discrimination, to better understand which types of mass media intervention work best, to provide evidence about cost-effectiveness, and to fill evidence gaps about types of mass media not covered in this review. Such research should use robust methods, report data more consistently with reporting guidelines and be less reliant on student populations. Output:
We reviewed studies comparing people who saw or heard a mass media intervention about mental health problems with people who had not seen or heard any intervention, or who had seen an intervention which contained nothing about mental ill health or stigma. We aimed to find out what effects mass media interventions may have on reducing stigma towards people with mental health problems. We found 22 studies involving 4490 people.  Five of these studies had data about discrimination and 19 had data about prejudice. We found that mass media interventions may reduce, increase, or have no effect on discrimination. We found that mass media interventions may reduce prejudice. The amount of the reduction can be considered as small to medium, and is similar to reducing the level of prejudice from that associated with schizophrenia to that associated with major depression. The quality of the evidence about discrimination and prejudice was low, so we cannot be very certain about these findings. Only three studies gave any information about financial costs and two about adverse affects, and there were limitations in how they assessed these, so we cannot draw conclusions about these aspects.
CochranePLS413
***TASK*** the task is to simplify the input abstract of a biomedical literature ***INPUT*** the input is the abstract of a biomedical literature ***OUTPUT*** the output is the simplified abstract for the input abstract of a biomedical literature ***EXAMPLES*** Input: Output: ***EXAMPLES*** Input: Two trials (n = 190), at low risk of bias, were included in the review and both presented data on first time failure at the tooth level. Pooling of the data showed a statistically significant difference in favour of molar bands, with a hazard ratio of 2.92 (95% confidence intervals (CI) 1.80 to 4.72). No statistically significant heterogeneity was shown between the two studies. Data on first time failure at the patient level were also available and showed statistically different difference in favour of molar bands (risk ratio 2.30; 95% CI 1.56 to 3.41) (risk of event for molar tubes = 57%; risk of event for molar bands 25%). One trial presented data on decalcification again showing a statistically significant difference in favour of molar bands. No other adverse events identified. From the two well-designed and low risk of bias trials included in this review it was shown that the failure of molar tubes bonded with either a chemically-cured or light-cured adhesive was considerably higher than that of molar bands cemented with glass ionomer cement. One trial indicated that there was less decalcification with molar bands cemented with glass ionomer cement than with bonded molar tubes cemented with a light-cured adhesive. However, given there are limited data for this outcome, further evidence is required to draw more robust conclusions. Output: The evidence in this review, which was carried out together with Cochrane Oral Health, is up-to-date as of 15 February 2017. We included two studies that evaluated 190 participants. Both trials were conducted in the UK and both compared bonded molar tubes with molar bands. From the limited data of two studies at low risk of bias, it would appear that bonded molar tubes are associated with a higher failure rate than with molar bands. Input: We include 85 studies in our synthesis. Forty-six studies explored the views and experiences of healthy pregnant or postnatal women, 17 studies explored the views and experiences of healthcare providers and 22 studies incorporated the views of both women and healthcare providers. The studies took place in 41 countries, including eight high-income countries, 18 middle-income countries and 15 low-income countries, in rural, urban and semi-urban locations. We developed 52 findings in total and organised these into three thematic domains: socio-cultural context (11 findings, five moderate- or high-confidence); service design and provision (24 findings, 15 moderate- or high-confidence); and what matters to women and staff (17 findings, 11 moderate- or high-confidence) The third domain was sub-divided into two conceptual areas; personalised supportive care, and information and safety. We also developed two lines of argument, using high- or moderate-confidence findings: For women, initial or continued use of ANC depends on a perception that doing so will be a positive experience. This is a result of the provision of good-quality local services that are not dependent on the payment of informal fees and that include continuity of care that is authentically personalised, kind, caring, supportive, culturally sensitive, flexible, and respectful of women’s need for privacy, and that allow staff to take the time needed to provide relevant support, information and clinical safety for the woman and the baby, as and when they need it. Women’s perceptions of the value of ANC depend on their general beliefs about pregnancy as a healthy or a risky state, and on their reaction to being pregnant, as well as on local socio-cultural norms relating to the advantages or otherwise of antenatal care for healthy pregnancies, and for those with complications. Whether they continue to use ANC or not depends on their experience of ANC design and provision when they access it for the first time. The capacity of healthcare providers to deliver the kind of high-quality, relationship-based, locally accessible ANC that is likely to facilitate access by women depends on the provision of sufficient resources and staffing as well as the time to provide flexible personalised, private appointments that are not overloaded with organisational tasks. Such provision also depends on organisational norms and values that overtly value kind, caring staff who make effective, culturally-appropriate links with local communities, who respect women’s belief that pregnancy is usually a normal life event, but who can recognise and respond to complications when they arise. Healthcare providers also require sufficient training and education to do their job well, as well as an adequate salary, so that they do not need to demand extra informal funds from women and families, to supplement their income, or to fund essential supplies. This review has identified key barriers and facilitators to the uptake (or not) of ANC services by pregnant women, and in the provision (or not) of good-quality ANC by healthcare providers. It complements existing effectiveness reviews of models of ANC provision and adds essential insights into why a particular type of ANC provided in specific local contexts may or may not be acceptable, accessible, or valued by some pregnant women and their families/communities. Those providing and funding services should consider the three thematic domains identified by the review as a basis for service development and improvement. Such developments should include pregnant and postnatal women, community members and other relevant stakeholders. Output:
We include 85 studies in our synthesis. Forty-six studies explored the views and experiences of women who were pregnant or who had recently given birth. 17 studies explored the views and experiences of healthcare providers, including lay or community health workers, and 22 studies included the views of both women and healthcare providers. The studies took place in eight high-income countries, 18 middle-income countries and 12 low-income countries, in rural and urban locations. Our findings suggest that women use antenatal care if they find it is a positive experience that fits with their beliefs and values, is easy for them to access, affordable, and treats them as an individual. They want care that helps them to feel that they and their baby are safe, and that is provided by kind, caring, culturally sensitive, flexible, and respectful staff that have time to give them support and reassurance about the health and well-being of them and their babies. They also value tests and treatments that are offered when they need them, and information and advice that is relevant to them. Our findings also suggest that healthcare staff want to be able to offer this kind of care. They would like to work in antenatal services that are properly funded, and that give them proper support, pay, training and education. They believe this will help them to have enough time to treat each pregnant woman as an individual, and to have the knowledge, skills resources and equipment to do their job well. The review authors searched for studies that had been published up to February 2019.
CochranePLS414
***TASK*** the task is to simplify the input abstract of a biomedical literature ***INPUT*** the input is the abstract of a biomedical literature ***OUTPUT*** the output is the simplified abstract for the input abstract of a biomedical literature ***EXAMPLES*** Input: Output: ***EXAMPLES*** Input: Two trials (n = 190), at low risk of bias, were included in the review and both presented data on first time failure at the tooth level. Pooling of the data showed a statistically significant difference in favour of molar bands, with a hazard ratio of 2.92 (95% confidence intervals (CI) 1.80 to 4.72). No statistically significant heterogeneity was shown between the two studies. Data on first time failure at the patient level were also available and showed statistically different difference in favour of molar bands (risk ratio 2.30; 95% CI 1.56 to 3.41) (risk of event for molar tubes = 57%; risk of event for molar bands 25%). One trial presented data on decalcification again showing a statistically significant difference in favour of molar bands. No other adverse events identified. From the two well-designed and low risk of bias trials included in this review it was shown that the failure of molar tubes bonded with either a chemically-cured or light-cured adhesive was considerably higher than that of molar bands cemented with glass ionomer cement. One trial indicated that there was less decalcification with molar bands cemented with glass ionomer cement than with bonded molar tubes cemented with a light-cured adhesive. However, given there are limited data for this outcome, further evidence is required to draw more robust conclusions. Output: The evidence in this review, which was carried out together with Cochrane Oral Health, is up-to-date as of 15 February 2017. We included two studies that evaluated 190 participants. Both trials were conducted in the UK and both compared bonded molar tubes with molar bands. From the limited data of two studies at low risk of bias, it would appear that bonded molar tubes are associated with a higher failure rate than with molar bands. Input: Sixteen trials, involving 3361 patients, were included in the review; three of the studies were of magnesium sulphate in addition to nimodipine. Overall, calcium antagonists reduced the risk of poor outcome: the relative risk (RR) was 0.81 (95% confidence interval (CI) 0.72 to 0.92); the corresponding number of patients needed to treat was 19 (95% CI 1 to 51). For oral nimodipine alone the RR was 0.67 (95% CI 0.55 to 0.81), for other calcium antagonists or intravenous administration of nimodipine the results were not statistically significant. Calcium antagonists reduced the occurrence of secondary ischaemia and showed a favourable trend for case fatality. For magnesium in addition to standard treatment with nimodipine, the RR was 0.75 (95% CI 0.57 to 1.00) for a poor outcome and 0.66 (95% CI 0.45 to 0.96) for clinical signs of secondary ischaemia. Calcium antagonists reduce the risk of poor outcome and secondary ischaemia after aneurysmal SAH. The results for 'poor outcome' depend largely on a single large trial of oral nimodipine; the evidence for other calcium antagonists is inconclusive. The evidence for nimodipine is not beyond all doubt, but given the potential benefits and modest risks of this treatment, oral nimodipine is currently indicated in patients with aneurysmal SAH. Intravenous administration of calcium antagonists cannot be recommended for routine practice on the basis of the present evidence. Magnesium sulphate is a promising agent but more evidence is needed before definite conclusions can be drawn. Output:
This review of 16 trials, involving 3361 patients, has found that the outcome after subarachnoid haemorrhage, in terms of survival and being independent in activities of daily living, is improved by treatment with calcium channel blockers (antagonists). If the largest trial is excluded from the analysis, the results are no longer statistically significant, and therefore the evidence is not beyond all doubt. However, given the high likelihood of benefits and the modest risks associated with this treatment, the review authors conclude that calcium antagonists, in the form of oral nimodipine 60 mg every four hours, are useful in patients with subarachnoid haemorrhage from a ruptured aneurysm. Magnesium is another calcium antagonist with promising results, but larger trials with this drug are needed before we can be certain about a beneficial effect.
CochranePLS415
***TASK*** the task is to simplify the input abstract of a biomedical literature ***INPUT*** the input is the abstract of a biomedical literature ***OUTPUT*** the output is the simplified abstract for the input abstract of a biomedical literature ***EXAMPLES*** Input: Output: ***EXAMPLES*** Input: Two trials (n = 190), at low risk of bias, were included in the review and both presented data on first time failure at the tooth level. Pooling of the data showed a statistically significant difference in favour of molar bands, with a hazard ratio of 2.92 (95% confidence intervals (CI) 1.80 to 4.72). No statistically significant heterogeneity was shown between the two studies. Data on first time failure at the patient level were also available and showed statistically different difference in favour of molar bands (risk ratio 2.30; 95% CI 1.56 to 3.41) (risk of event for molar tubes = 57%; risk of event for molar bands 25%). One trial presented data on decalcification again showing a statistically significant difference in favour of molar bands. No other adverse events identified. From the two well-designed and low risk of bias trials included in this review it was shown that the failure of molar tubes bonded with either a chemically-cured or light-cured adhesive was considerably higher than that of molar bands cemented with glass ionomer cement. One trial indicated that there was less decalcification with molar bands cemented with glass ionomer cement than with bonded molar tubes cemented with a light-cured adhesive. However, given there are limited data for this outcome, further evidence is required to draw more robust conclusions. Output: The evidence in this review, which was carried out together with Cochrane Oral Health, is up-to-date as of 15 February 2017. We included two studies that evaluated 190 participants. Both trials were conducted in the UK and both compared bonded molar tubes with molar bands. From the limited data of two studies at low risk of bias, it would appear that bonded molar tubes are associated with a higher failure rate than with molar bands. Input: We identified three RCTs including 739 children. They all used an age of one year as the cut-off point for pre-treatment risk stratification. The first updated search identified a manuscript reporting additional follow-up data for one of these RCTs, while the second update identified an erratum of this study. There was a significant statistical difference in event-free survival in favour of myeloablative therapy over conventional chemotherapy or no further treatment (three studies, 739 patients; HR 0.78, 95% CI 0.67 to 0.90). There was a significant statistical difference in overall survival in favour of myeloablative therapy over conventional chemotherapy or no further treatment (two studies, 360 patients; HR 0.74, 95% CI 0.57 to 0.98). However, when additional follow-up data were included in the analyses the difference in event-free survival remained statistically significant (three studies, 739 patients; HR 0.79, 95% CI 0.70 to 0.90), but the difference in overall survival was no longer statistically significant (two studies, 360 patients; HR 0.86, 95% CI 0.73 to 1.01). The meta-analysis of secondary malignant disease and treatment-related death did not show any significant statistical differences between the treatment groups. Data from one study (379 patients) showed a significantly higher incidence of renal effects, interstitial pneumonitis and veno-occlusive disease in the myeloablative group compared to conventional chemotherapy, whereas for serious infections and sepsis no significant difference between the treatment groups was identified. No information on quality of life was reported. In the individual studies we evaluated different subgroups, but the results were not univocal in all studies. All studies had some methodological limitations. Based on the currently available evidence, myeloablative therapy seems to work in terms of event-free survival. For overall survival there is currently no evidence of effect when additional follow-up data are included. No definitive conclusions can be made regarding adverse effects and quality of life, although possible higher levels of adverse effects should be kept in mind. A definitive conclusion regarding the effect of myeloablative therapy in different subgroups is not possible. This systematic review only allows a conclusion on the concept of myeloablative therapy; no conclusions can be made regarding the best treatment strategy. Future trials on the use of myeloablative therapy for high-risk neuroblastoma should focus on identifying the most optimal induction and/or myeloablative regimen. The best study design to answer these questions is a RCT. These RCTs should be performed in homogeneous study populations (e.g. stage of disease and patient age) and have a long-term follow-up. Different risk groups, using the most recent definitions, should be taken into account. It should be kept in mind that recently the age cut-off for high risk disease was changed from one year to 18 months. As a result it is possible that patients with what is now classified as intermediate-risk disease have been included in the high-risk groups. Consequently the relevance of the results of these studies to the current practice can be questioned. Survival rates may be overestimated due to the inclusion of patients with intermediate-risk disease. Output:
This systematic review focused on randomised studies comparing the effectiveness of myeloablative therapy with conventional therapy in children with high-risk neuroblastoma. The authors found three studies including 739 patients. These studies provide evidence that myeloablative therapy improves event-free survival (that is, the time until a certain event, for example tumour progression, the development of a second tumour, or death from any cause occurs). For overall survival (that is, the time until a patient dies from any cause, so not only from the tumour or its treatment, but for example, also from a car accident) there is no evidence of a better outcome in patients treated with myeloablative therapy. Side effects such as renal (kidney) effects, interstitial pneumonitis (a type of lung disease) and veno-occlusive disease (a condition in which some of the small veins in the liver are obstructed) were more common in patients treated with myeloablative therapy than conventional chemotherapy. It should be noted that this systematic review only allows a conclusion on the concept of myeloablative therapy; no conclusions regarding the best treatment strategy with regard to, for example, types of chemotherapeutic agents and the use of radiation therapy, could be made. More high quality research is needed. It should be noted that recently the age cut-off for high-risk disease was changed from one year to 18 months. As a result it is possible that patients with what is now classified as intermediate-risk disease were included in the high-risk groups. Consequently the relevance of the results of these studies to the current practice can be questioned. Survival rates may be overestimated due to the inclusion of patients with intermediate-risk disease.
CochranePLS416
***TASK*** the task is to simplify the input abstract of a biomedical literature ***INPUT*** the input is the abstract of a biomedical literature ***OUTPUT*** the output is the simplified abstract for the input abstract of a biomedical literature ***EXAMPLES*** Input: Output: ***EXAMPLES*** Input: Two trials (n = 190), at low risk of bias, were included in the review and both presented data on first time failure at the tooth level. Pooling of the data showed a statistically significant difference in favour of molar bands, with a hazard ratio of 2.92 (95% confidence intervals (CI) 1.80 to 4.72). No statistically significant heterogeneity was shown between the two studies. Data on first time failure at the patient level were also available and showed statistically different difference in favour of molar bands (risk ratio 2.30; 95% CI 1.56 to 3.41) (risk of event for molar tubes = 57%; risk of event for molar bands 25%). One trial presented data on decalcification again showing a statistically significant difference in favour of molar bands. No other adverse events identified. From the two well-designed and low risk of bias trials included in this review it was shown that the failure of molar tubes bonded with either a chemically-cured or light-cured adhesive was considerably higher than that of molar bands cemented with glass ionomer cement. One trial indicated that there was less decalcification with molar bands cemented with glass ionomer cement than with bonded molar tubes cemented with a light-cured adhesive. However, given there are limited data for this outcome, further evidence is required to draw more robust conclusions. Output: The evidence in this review, which was carried out together with Cochrane Oral Health, is up-to-date as of 15 February 2017. We included two studies that evaluated 190 participants. Both trials were conducted in the UK and both compared bonded molar tubes with molar bands. From the limited data of two studies at low risk of bias, it would appear that bonded molar tubes are associated with a higher failure rate than with molar bands. Input: We identified eight randomised clinical trials (632 participants) that fulfilled our inclusion criteria. All eight trials were at high risk of bias, and we rated the evidence as low to very low certainty. The mean age ranged from 16 years to 78 years. The proportion of men ranged from 60% to 75% and the proportion of people with stage III primary hepatocellular carcinoma ranged from 22% to 85%. The median follow-up duration was 12 months (2 months to 38 months). TACE followed by 3-DCRT compared with TACE alone may have reduced all-cause mortality at three years' follow-up (risk ratio (RR) 0.80, 95% confidence interval (CI) 0.73 to 0.88; 552 participants; 7 trials; low-certainty evidence). TACE followed by 3-DCRT compared with TACE alone may reduce the proportion of participants without tumour response (complete response plus partial response) (RR 0.49, 95% CI 0.39 to 0.61; 632 participants; 8 trials; low-certainty evidence). Data, from one trial on health-related quality of life, favoured the TACE followed by 3-DCRT group, but the provided data were ill-defined (very low-certainty evidence). None of the trials reported serious adverse events. The results on non-serious adverse events were as follows: TACE followed by 3-DCRT compared with TACE alone showed no difference in the results for proportion of participants with leukopenia (RR 1.12, 95% CI 0.92 to 1.34; 438 participants; 5 trials; very low-certainty evidence) and serum transaminases elevation (RR 1.67, 95% CI 0.66 to 4.27; 280 participants; 4 trials; very low-certainty evidence). However, the proportion of participants with total bilirubin elevation was larger in the TACE followed by 3-DCRT group than in the TACE alone group (RR 2.69, 95% CI 1.34 to 5.40; 172 participants; 2 trials; very low-certainty evidence). The rate of participants with serum alpha-fetoprotein (AFP) without decline or normalisation was significantly lower in the TACE followed by 3-DCRT group than in the TACE group, but these data were from one trial only (Chi² = 7.24, P = 0.007; very low-certainty evidence). TACE followed by 3-DCRT may be associated with lower all-cause mortality and increased tumour response, despite the increased toxicity expressed by a higher rise of total bilirubin. Our review findings should be considered with caution because of the methodological weaknesses in the included trials, resulting in low- to very low-certainty evidence. Data on serious adverse events and health-related quality of life are lacking. We are also very much uncertain in the results of the reported non-serious adverse events. High-quality trials are needed to assess further the role of TACE followed by 3-DCRT for unresectable hepatocellular carcinoma. Output:
The review authors searched the medical literature in order to clarify the role of the combination of TACE followed by 3-DCRT for the treatment of primary hepatocellular carcinoma, and to compare their benefits and harms with TACE alone. We collected and analysed data from randomised clinical trials (clinical studies where people are randomly put into one of two or more treatment groups) of people with primary hepatocellular carcinoma who were able to receive TACE or 3-DCRT. Evidence is current to May 2018. The review included eight trials with 632 participants. All trials were at high risk of bias. TACE followed by 3-DCRT appeared to be superior to TACE in improving death from any cause and tumour response, despite an increased toxicity expressed by a higher rise of total bilirubin (measured by a blood test to see how well the liver is working). No trials reported serious side effects. One trial reported health-related quality of life (a measure of a person's satisfaction with their life and health), but this was ill-defined. The review findings were uncertain because the included trials had methodological weaknesses. More high-quality randomised clinical trials are needed to confirm or complete the review findings.
CochranePLS417
***TASK*** the task is to simplify the input abstract of a biomedical literature ***INPUT*** the input is the abstract of a biomedical literature ***OUTPUT*** the output is the simplified abstract for the input abstract of a biomedical literature ***EXAMPLES*** Input: Output: ***EXAMPLES*** Input: Two trials (n = 190), at low risk of bias, were included in the review and both presented data on first time failure at the tooth level. Pooling of the data showed a statistically significant difference in favour of molar bands, with a hazard ratio of 2.92 (95% confidence intervals (CI) 1.80 to 4.72). No statistically significant heterogeneity was shown between the two studies. Data on first time failure at the patient level were also available and showed statistically different difference in favour of molar bands (risk ratio 2.30; 95% CI 1.56 to 3.41) (risk of event for molar tubes = 57%; risk of event for molar bands 25%). One trial presented data on decalcification again showing a statistically significant difference in favour of molar bands. No other adverse events identified. From the two well-designed and low risk of bias trials included in this review it was shown that the failure of molar tubes bonded with either a chemically-cured or light-cured adhesive was considerably higher than that of molar bands cemented with glass ionomer cement. One trial indicated that there was less decalcification with molar bands cemented with glass ionomer cement than with bonded molar tubes cemented with a light-cured adhesive. However, given there are limited data for this outcome, further evidence is required to draw more robust conclusions. Output: The evidence in this review, which was carried out together with Cochrane Oral Health, is up-to-date as of 15 February 2017. We included two studies that evaluated 190 participants. Both trials were conducted in the UK and both compared bonded molar tubes with molar bands. From the limited data of two studies at low risk of bias, it would appear that bonded molar tubes are associated with a higher failure rate than with molar bands. Input: No eligible trials were identified. Fourteen studies that appeared to be relevant were excluded, as no study directly compared increased versus standard energy intakes in infants with CLD/BPD. However, two excluded trials provided some insights into the topic. One study showed that infants with CLD/BPD who were fed formula enriched with protein and minerals had improved growth parameters up until the cessation of the intervention at three months of corrected age. The other study compared different energy density of formula but identical energy intake by setting different feed volumes for both groups. It showed that both groups were unable to achieve the pre-designated feed volumes and that there were no differences in growth, respiratory outcomes, oedema and the diuretic requirements. To date, no randomised controlled trials are available that examine the effects of increased versus standard energy intake for preterm infants with (or developing) CLD/BPD. Research should be directed at evaluating the effects of various levels of energy intake on this group of infants on clinically important outcomes like mortality, respiratory status, growth and neurodevelopment. The benefits and harms of various ways of increasing energy intake, including higher energy density of milk feed and/or fluid volume (clinically realistic target volume should be set), parenteral nutrition, and the use of various constituents of energy like carbohydrate, protein and fat for this purpose also need to be assessed. Output:
Studies have shown that these babies have higher energy expenditure and lower energy intake compared with babies without CLD/BPD. Increasing energy intake for these babies beyond standard levels may therefore seem beneficial. However, setting high targets for energy intake for these babies may not be achievable. Furthermore, methods of increasing energy intake such as increasing the milk volume or concentration or giving intravenous nutrition may lead to complications of their own. We planned to examine whether increasing energy intake for these babies improves their breathing status, their growth and development, and reduces their risk of death without producing significant complications. Having found no suitable study to date that answers these questions, we are currently unable to provide any evidence on whether increasing the energy intake for babies with (or developing) CLD/BPD is overall beneficial.
CochranePLS418
***TASK*** the task is to simplify the input abstract of a biomedical literature ***INPUT*** the input is the abstract of a biomedical literature ***OUTPUT*** the output is the simplified abstract for the input abstract of a biomedical literature ***EXAMPLES*** Input: Output: ***EXAMPLES*** Input: Two trials (n = 190), at low risk of bias, were included in the review and both presented data on first time failure at the tooth level. Pooling of the data showed a statistically significant difference in favour of molar bands, with a hazard ratio of 2.92 (95% confidence intervals (CI) 1.80 to 4.72). No statistically significant heterogeneity was shown between the two studies. Data on first time failure at the patient level were also available and showed statistically different difference in favour of molar bands (risk ratio 2.30; 95% CI 1.56 to 3.41) (risk of event for molar tubes = 57%; risk of event for molar bands 25%). One trial presented data on decalcification again showing a statistically significant difference in favour of molar bands. No other adverse events identified. From the two well-designed and low risk of bias trials included in this review it was shown that the failure of molar tubes bonded with either a chemically-cured or light-cured adhesive was considerably higher than that of molar bands cemented with glass ionomer cement. One trial indicated that there was less decalcification with molar bands cemented with glass ionomer cement than with bonded molar tubes cemented with a light-cured adhesive. However, given there are limited data for this outcome, further evidence is required to draw more robust conclusions. Output: The evidence in this review, which was carried out together with Cochrane Oral Health, is up-to-date as of 15 February 2017. We included two studies that evaluated 190 participants. Both trials were conducted in the UK and both compared bonded molar tubes with molar bands. From the limited data of two studies at low risk of bias, it would appear that bonded molar tubes are associated with a higher failure rate than with molar bands. Input: Altogether 13 studies enrolling 2341 participants (and involving 2360 procedures) fulfilled the inclusion criteria. The quality of evidence was very low (subclavian vein N = 3) or low (subclavian vein N = 4, femoral vein N = 2) for most outcomes, moderate for one outcome (femoral vein) and high at best for two outcomes (subclavian vein N = 1, femoral vein N = 1). Most of the trials had unclear risk of bias across the six domains, and heterogeneity among the studies was significant. For the subclavian vein (nine studies, 2030 participants, 2049 procedures), two-dimensional ultrasound reduced the risk of inadvertent arterial puncture (three trials, 498 participants, risk ratio (RR) 0.21, 95% confidence interval (CI) 0.06 to 0.82; P value 0.02, I² = 0%) and haematoma formation (three trials, 498 participants, RR 0.26, 95% CI 0.09 to 0.76; P value 0.01, I² = 0%). No evidence was found of a difference in total or other complications (together, US, USD), overall (together, US, USD), number of attempts until success (US) or first-time (US) success rates or time taken to insert the catheter (US). For the femoral vein, fewer data were available for analysis (four studies, 311 participants, 311 procedures). No evidence was found of a difference in inadvertent arterial puncture or other complications. However, success on the first attempt was more likely with ultrasound (three trials, 224 participants, RR 1.73, 95% CI 1.34 to 2.22; P value < 0.0001, I² = 31%), and a small increase in the overall success rate was noted (RR 1.11, 95% CI 1.00 to 1.23; P value 0.06, I² = 50%). No data on mortality or participant-reported outcomes were provided. On the basis of available data, we conclude that two-dimensional ultrasound offers small gains in safety and quality when compared with an anatomical landmark technique for subclavian (arterial puncture, haematoma formation) or femoral vein (success on the first attempt) cannulation for central vein catheterization. Data on insertion by inexperienced or experienced users, or on patients at high risk for complications, are lacking. The results for Doppler ultrasound techniques versus anatomical landmark techniques are uncertain. Output:
This Cochrane systematic review compared landmark techniques versus ultrasound guidance. The evidence is current to´January 2013. We included in the review 13 studies enrolling 2341 participants (and involving 2360 procedures). The studies were varied, and their quality was not high. We reran the search in August 2014. We will deal with any studies of interest when we update the review. Nevertheless, ultrasound offered some benefits, as it reduced the risk of arterial puncture and severe bruising in subclavian vein catheterization. Fewer data were available for femoral vein catheterization, but success rates seemed to be higher with ultrasound. No evidence showed a significant difference in complication rates or in time taken to cannulate at either site. On the basis of available data, we conclude that two-dimensional ultrasound offers small advantages in safety and quality when compared with an anatomical landmark technique for subclavian vein (reduced arterial puncture and haematoma formation) or femoral vein (reduced success on the first attempt) cannulation for central vein catheterization, but these findings do not necessarily hold for all groups of ultrasound users or for patients at high risk for complications. The results for Doppler ultrasound techniques versus anatomical landmark techniques are uncertain.
CochranePLS419
***TASK*** the task is to simplify the input abstract of a biomedical literature ***INPUT*** the input is the abstract of a biomedical literature ***OUTPUT*** the output is the simplified abstract for the input abstract of a biomedical literature ***EXAMPLES*** Input: Output: ***EXAMPLES*** Input: Two trials (n = 190), at low risk of bias, were included in the review and both presented data on first time failure at the tooth level. Pooling of the data showed a statistically significant difference in favour of molar bands, with a hazard ratio of 2.92 (95% confidence intervals (CI) 1.80 to 4.72). No statistically significant heterogeneity was shown between the two studies. Data on first time failure at the patient level were also available and showed statistically different difference in favour of molar bands (risk ratio 2.30; 95% CI 1.56 to 3.41) (risk of event for molar tubes = 57%; risk of event for molar bands 25%). One trial presented data on decalcification again showing a statistically significant difference in favour of molar bands. No other adverse events identified. From the two well-designed and low risk of bias trials included in this review it was shown that the failure of molar tubes bonded with either a chemically-cured or light-cured adhesive was considerably higher than that of molar bands cemented with glass ionomer cement. One trial indicated that there was less decalcification with molar bands cemented with glass ionomer cement than with bonded molar tubes cemented with a light-cured adhesive. However, given there are limited data for this outcome, further evidence is required to draw more robust conclusions. Output: The evidence in this review, which was carried out together with Cochrane Oral Health, is up-to-date as of 15 February 2017. We included two studies that evaluated 190 participants. Both trials were conducted in the UK and both compared bonded molar tubes with molar bands. From the limited data of two studies at low risk of bias, it would appear that bonded molar tubes are associated with a higher failure rate than with molar bands. Input: Fifteen studies were included using four different methods of administration of physostigmine. Four studies, 29 people, used intravenous infusion; seven, 131 people, used a conventional oral form; four, 1456 people, used a controlled-release oral form, and one study of 181 people used a verum skin patch. Intravenous infusion There are no usable results from the intravenous infusion trials, Oral form The few results from the trials of the conventional oral form showed no benefit of physostigmine compared with placebo. Controlled release The results from two of the four studies of the controlled-release physostigmine apply only to a group of patients identified as responders in a pre-randomization titration period. The best dose physostigmine was associated with improvement on the ADAS-Cog score compared with placebo at 6, 12 weeks. There were statistically significantly higher numbers of patients from the physostigmine group withdrawing from the trial (22/183 vs 2/183)(OR 5.92, 95% confidence limits 2.59 to 13.54, p<0.0001) and suffering at least one event of nausea, vomiting, diarrhoea, anorexia, dizziness, stomach pain, flatulence or sweating compared with placebo at 6 weeks. There were statistically significantly higher numbers of patients from the physostigmine group withdrawing from the trial due to adverse events (13/83 vs 5/93)(OR 3.05, 95% CI 1.15 to 8.07, p=0.02) and suffering at least one event of nausea, vomiting, diarrhoea, anorexia, dizziness, stomach pain, tremor, asthenia or sweating compared with placebo at 12 weeks. When no attempt was made to identify responders and all relevant patients with Alzheimer's disease were randomized, fixed dose physostigmine (mean 33 mg/day) was associated with a statistically significantly higher number withdrawing (234/358 vs 31/117)(OR 4.82, 95% CI 3.17 to 7.33, p<0.00001), withdrawing due to adverse events (196/358 vs 10/117) (OR 6.54, 95%CI 4.29 to 9.95, p<0.00001) and suffering at least one event of nausea, vomiting, diarrhoea, anorexia, dizziness, stomach pain, dyspepsia, sweating, asthenia, dyspnoea or abnormal dreaming, but with no benefit on cognition compared with placebo at 24 weeks. Verum patch The double dose (delivering mean dose 12 mg/day) was associated with statistically significantly higher numbers suffering at least one adverse event of vomiting, nausea, or abdominal cramps, and the lower dose (delivering mean dose 5.7mg/day) was associated with statistically significantly higher numbers suffering gastrointestinal complaints compared with placebo at 24 weeks. There was no difference between physostigmine (higher and lower dose) and placebo for numbers improved (CGIC) at 24 weeks. The evidence of effectiveness of physostigmine for the symptomatic treatment of Alzheimer's disease is limited. Even in a controlled release formulation designed to overcome the short half-life, physostigmine showed no convincing benefit and adverse effects remained common leading to a high rate of withdrawal. Output:
Studies conducted more than 20 years ago suggested that physostigmine could improve memory in people with or without dementia. Investigation of this property has been limited by the very short half-life of physostigmine. Various forms of administering the drug have been tried to overcome this problem, most recently a controlled-release (CR) oral formulation, and a skin patch. An additional limiting factor has been a high incidence of adverse effects, including nausea, vomiting and diarrhoea. Physostigmine appears to have no advantage over some newer anticholinesterase drugs. The short half-life remains a serious disadvantage and requires complex forms of administration. There is no reason to recommend further research into this drug.
CochranePLS420
***TASK*** the task is to simplify the input abstract of a biomedical literature ***INPUT*** the input is the abstract of a biomedical literature ***OUTPUT*** the output is the simplified abstract for the input abstract of a biomedical literature ***EXAMPLES*** Input: Output: ***EXAMPLES*** Input: Two trials (n = 190), at low risk of bias, were included in the review and both presented data on first time failure at the tooth level. Pooling of the data showed a statistically significant difference in favour of molar bands, with a hazard ratio of 2.92 (95% confidence intervals (CI) 1.80 to 4.72). No statistically significant heterogeneity was shown between the two studies. Data on first time failure at the patient level were also available and showed statistically different difference in favour of molar bands (risk ratio 2.30; 95% CI 1.56 to 3.41) (risk of event for molar tubes = 57%; risk of event for molar bands 25%). One trial presented data on decalcification again showing a statistically significant difference in favour of molar bands. No other adverse events identified. From the two well-designed and low risk of bias trials included in this review it was shown that the failure of molar tubes bonded with either a chemically-cured or light-cured adhesive was considerably higher than that of molar bands cemented with glass ionomer cement. One trial indicated that there was less decalcification with molar bands cemented with glass ionomer cement than with bonded molar tubes cemented with a light-cured adhesive. However, given there are limited data for this outcome, further evidence is required to draw more robust conclusions. Output: The evidence in this review, which was carried out together with Cochrane Oral Health, is up-to-date as of 15 February 2017. We included two studies that evaluated 190 participants. Both trials were conducted in the UK and both compared bonded molar tubes with molar bands. From the limited data of two studies at low risk of bias, it would appear that bonded molar tubes are associated with a higher failure rate than with molar bands. Input: We included 13 trials involving a total of 16,112 participants. Eleven trials recruited participants with history of coronary heart disease, two trials recruited participants with history of stroke, and one trial recruited participants with a mix of people with CVD. We judged overall risk of bias to be moderate. The meta-analysis (including all fibrate trials) showed evidence for a protective effect of fibrates primarily compared to placebo for the primary composite outcome of non-fatal stroke, non-fatal myocardial infarction (MI), and vascular death (risk ratio (RR) 0.88, 95% confidence interval (CI) 0.83 to 0.94; participants = 16,064; studies = 12; I2 = 45%, fixed effect). Fibrates were moderately effective for preventing MI occurrence (RR 0.86, 95% CI 0.80 to 0.93; participants = 13,942; studies = 10; I2 = 24%, fixed effect). Fibrates were not effective against all-cause mortality (RR 0.98, 95% CI 0.91 to 1.06; participants = 13,653; studies = 10; I2 = 23%), death from vascular causes (RR 0.95, 95% CI 0.86 to 1.05; participants = 13,653; studies = 10; I2 = 11%, fixed effect), and stroke events (RR 1.03, 95% CI 0.91 to 1.16; participants = 11,719; studies = 6; I2 = 11%, fixed effect). Excluding clofibrate trials, as the use of clofibrate was discontinued in 2002 due to safety concerns, the remaining class of fibrates were no longer effective in preventing the primary composite outcome (RR 0.90, 95% CI 0.79 to 1.03; participants = 10,320; studies = 7; I2 = 50%, random effects). However, without clofibrate data, fibrates remained effective in preventing MI (RR 0.85, 95% CI 0.76 to 0.94; participants = 8304; studies = 6; I2 = 47%, fixed effect). There was no increase in adverse events with fibrates compared to control. Subgroup analyses showed the benefit of fibrates on the primary composite outcome to be consistent irrespective of age, gender, and diabetes mellitus. Moderate evidence showed that the fibrate class can be effective in the secondary prevention of composite outcome of non-fatal stroke, non-fatal MI, and vascular death. However, this beneficial effect relies on the inclusion of clofibrate data, a drug that was discontinued in 2002 due to its unacceptably large adverse effects. Further trials of the use of fibrates in populations with previous stroke and also against a background treatment with statins (standard of care) are required. Output:
The duration of fibrates ranged from 12 months to 8 years. We included 13 trials in this review with a total of 16,112 participants with a history of coronary heart disease or stroke. This review includes evidence identified up to October 2014. Our analysis showed that when compared primarily to placebo, fibrates can be effective for prevention of composite outcome of non-fatal stroke, non-fatal heart attack (myocardial infarction), and death due to circulatory disease. However, this beneficial effect relies on the inclusion on data from clofibrates, a drug that was discontinued in 2002 because of safety concerns. In other words, there is no good evidence to support the use of currently available fibrates in the prevention of future heart attacks, strokes, and circulatory disease death in people with existing circulatory disease. In combination with clofibrate data, quality of evidence was moderate for the composite (non-fatal stroke, non-fatal myocardial infarction (MI), and vascular death) and MI (non-fatal or fatal) outcomes and low for stroke (ischaemic or haemorrhagic, non-fatal or fatal) and death from vascular or any cause during the treatment and scheduled follow-up period. The quality of evidence without clofibrate data was moderate for MI (non-fatal or fatal) outcome and low for the composite (non-fatal stroke, non-fatal MI, and vascular death), stroke (ischaemic or haemorrhagic, non-fatal or fatal), and death from vascular or any cause outcomes during the treatment and scheduled follow-up period.
CochranePLS421
***TASK*** the task is to simplify the input abstract of a biomedical literature ***INPUT*** the input is the abstract of a biomedical literature ***OUTPUT*** the output is the simplified abstract for the input abstract of a biomedical literature ***EXAMPLES*** Input: Output: ***EXAMPLES*** Input: Two trials (n = 190), at low risk of bias, were included in the review and both presented data on first time failure at the tooth level. Pooling of the data showed a statistically significant difference in favour of molar bands, with a hazard ratio of 2.92 (95% confidence intervals (CI) 1.80 to 4.72). No statistically significant heterogeneity was shown between the two studies. Data on first time failure at the patient level were also available and showed statistically different difference in favour of molar bands (risk ratio 2.30; 95% CI 1.56 to 3.41) (risk of event for molar tubes = 57%; risk of event for molar bands 25%). One trial presented data on decalcification again showing a statistically significant difference in favour of molar bands. No other adverse events identified. From the two well-designed and low risk of bias trials included in this review it was shown that the failure of molar tubes bonded with either a chemically-cured or light-cured adhesive was considerably higher than that of molar bands cemented with glass ionomer cement. One trial indicated that there was less decalcification with molar bands cemented with glass ionomer cement than with bonded molar tubes cemented with a light-cured adhesive. However, given there are limited data for this outcome, further evidence is required to draw more robust conclusions. Output: The evidence in this review, which was carried out together with Cochrane Oral Health, is up-to-date as of 15 February 2017. We included two studies that evaluated 190 participants. Both trials were conducted in the UK and both compared bonded molar tubes with molar bands. From the limited data of two studies at low risk of bias, it would appear that bonded molar tubes are associated with a higher failure rate than with molar bands. Input: Twelve trials involving 3285 healthy women at low risk of excessive bleeding undergoing elective CS (nine trials, 2453 participants) or spontaneous birth (three trials, 832 participants) satisfied inclusion criteria and contributed data to the analysis. All participants received routine prophylactic uterotonics in accordance with the local guideline in addition to TA or placebo or no intervention. Overall, included studies had moderate risk of bias for random sequence generation, allocation concealment, blinding, selective reporting and low risk of bias for incomplete data. The quality of evidence was also as assessed using GRADE. Blood loss greater than 400 mL or 500 mL, and more than 1000 mL was less common in women who received TA versus placebo or no intervention (risk ratio (RR) 0.52, 95% confidence interval (CI) 0.42 to 0.63, six trials, 1398 women; moderate quality evidence) and (RR 0.40, 95% CI 0.23 to 0.71, six trials, 2093 women; moderate quality evidence), respectively. TA was effective in decreasing the incidence of blood loss greater than 1000 mL in women who had undergone CS (RR 0.43, 95% CI 0.23, 0.78, four trials, 1534 women), but not vaginal birth (RR 0.28, 95% CI 0.06, 1.36, two trials 559 women). The effect of TA on blood loss greater than 500 mL or 400 mL was more pronounced in the group of women having vaginal birth than in women who had CS. Mean blood loss (from delivery until two hours postpartum) was lower in women who received TA versus placebo or no intervention (mean difference MD - 77.79 mL, 95% CI -97.95, -57.64, five trials, 1186 women) and this effect was similar following vaginal birth and CS. Additional medical interventions (moderate quality evidence) and blood transfusions were less frequent in women receiving TA versus placebo or no interventions. Mild side effects such as nausea, vomiting, dizziness were more common with the use of TA (moderate quality evidence). The effect of TA on maternal mortality, severe morbidity and thromboembolic events is uncertain (low quality evidence). TA (in addition to uterotonic medications) decreases postpartum blood loss and prevents PPH and blood transfusions following vaginal birth and CS in women at low risk of PPH based on studies of mixed quality. There is insufficient evidence to draw conclusions about serious side effects, but there is an increase in the incidence of minor side effects with the use of TA. Effects of TA on thromboembolic events and mortality as well as its use in high-risk women should be investigated further. Output:
TA decreased blood loss greater than 400 mL or greater than 500 mL and this effect was more apparent with vaginal births. The studies had methodological shortcomings. Blood loss greater than 1000 mL decreased with the use of TA in six trials (2093 women), however, the difference was most obvious in caesarean section (two trials, 1400 women) and not in vaginal birth in which there were few such outcomes (one trial, 439 women). Mean blood loss decreased with the use of TA by 77 mL, overall (five studies, 1186 women) and with both vaginal and caesarean section births. This finding was based on studies with methodological limitations. The studies were too small to detect the effect of TA on maternal death or blood clots. Mild side effects, which include diarrhoea, nausea and vomiting, were more common in women who received TA versus placebo or no intervention. No differences in blood loss and side effects were found when two different doses of TA were evaluated. Further larger studies are needed to investigate the effects of TA on maternal deaths and formation of clots in the blood (thromboembolism).
CochranePLS422
***TASK*** the task is to simplify the input abstract of a biomedical literature ***INPUT*** the input is the abstract of a biomedical literature ***OUTPUT*** the output is the simplified abstract for the input abstract of a biomedical literature ***EXAMPLES*** Input: Output: ***EXAMPLES*** Input: Two trials (n = 190), at low risk of bias, were included in the review and both presented data on first time failure at the tooth level. Pooling of the data showed a statistically significant difference in favour of molar bands, with a hazard ratio of 2.92 (95% confidence intervals (CI) 1.80 to 4.72). No statistically significant heterogeneity was shown between the two studies. Data on first time failure at the patient level were also available and showed statistically different difference in favour of molar bands (risk ratio 2.30; 95% CI 1.56 to 3.41) (risk of event for molar tubes = 57%; risk of event for molar bands 25%). One trial presented data on decalcification again showing a statistically significant difference in favour of molar bands. No other adverse events identified. From the two well-designed and low risk of bias trials included in this review it was shown that the failure of molar tubes bonded with either a chemically-cured or light-cured adhesive was considerably higher than that of molar bands cemented with glass ionomer cement. One trial indicated that there was less decalcification with molar bands cemented with glass ionomer cement than with bonded molar tubes cemented with a light-cured adhesive. However, given there are limited data for this outcome, further evidence is required to draw more robust conclusions. Output: The evidence in this review, which was carried out together with Cochrane Oral Health, is up-to-date as of 15 February 2017. We included two studies that evaluated 190 participants. Both trials were conducted in the UK and both compared bonded molar tubes with molar bands. From the limited data of two studies at low risk of bias, it would appear that bonded molar tubes are associated with a higher failure rate than with molar bands. Input: We identified 12 studies (2494 participants: 1586 children and 908 elderly) comparing amantadine and rimantadine with placebo, paracetamol (one trial: 69 children) or zanamivir (two trials: 545 elderly) to treat influenza A. Amantadine was effective in preventing influenza A in children (773 participants, risk ratio (RR) 0.11; 95% confidence interval (CI) 0.04 to 0.30). The assumed risk of influenza A in the control group was 10 per 100. The corresponding risk in the rimantadine group was one per 100 (95% CI 0 to 3). Nevertheless, the quality of the evidence was low and the safety of the drug was not well established. For treatment, rimantadine was beneficial in abating fever on day three of treatment in children: one selected study with low risk of bias, moderate evidence quality and 69 participants (RR 0.36; 95% CI 0.14 to 0.91). The assumed risk was 38 per 100. The corresponding risk in the rimantadine group was 14 per 100 (95% CI 5 to 34). Rimantadine did not show any prophylactic effect in the elderly. The quality of evidence was very low: 103 participants (RR 0.45; 95% CI 0.14 to 1.41). The assumed risk was 17 per 100. The corresponding risk in the rimantadine group was 7 per 100 (95% CI 2 to 23). There was no evidence of adverse effects caused by treatment with amantadine or rimantadine. We found no studies assessing amantadine in the elderly. The quality of the evidence combined with a lack of knowledge about the safety of amantadine and the limited benefits of rimantadine, do not indicate that amantadine and rimantadine compared to control (placebo or paracetamol) could be useful in preventing, treating and shortening the duration of influenza A in children and the elderly. Output:
We identified 12 trials (2494 participants: 1586 children and 908 elderly). We looked for trials that compared amantadine or rimantadine with no intervention, placebos or control drugs in children and the elderly. The most recent searches were completed in October 2014. We looked at several outcomes, including influenza A, fever duration, cough, headache, nausea/vomiting, dizziness and stimulation/insomnia. Although amantadine was effective in preventing influenza A in children, it would be necessary to use it in up to 17 children over a period of 14 to 18 weeks to prevent one case of influenza A. Furthermore, the safety of the drug was not well established. The quality of the evidence was low. The effectiveness of both antivirals was limited to a benefit from rimantadine in the reduction of fever by day three of treatment in children. The quality of the evidence was moderate. This benefit does not seem to justify a recommendation for using rimantadine to treat all children with influenza A. Rimantadine did not show a prophylactic (preventative) effect in the elderly. The quality of evidence was very low. The quality of the evidence combined with a lack of knowledge about the safety of amantadine and the limited benefits of rimantadine, do not indicate that amantadine and rimantadine compared to control (placebo or paracetamol) could be useful in preventing, treating and shortening the duration of influenza A in children and the elderly.
CochranePLS423
***TASK*** the task is to simplify the input abstract of a biomedical literature ***INPUT*** the input is the abstract of a biomedical literature ***OUTPUT*** the output is the simplified abstract for the input abstract of a biomedical literature ***EXAMPLES*** Input: Output: ***EXAMPLES*** Input: Two trials (n = 190), at low risk of bias, were included in the review and both presented data on first time failure at the tooth level. Pooling of the data showed a statistically significant difference in favour of molar bands, with a hazard ratio of 2.92 (95% confidence intervals (CI) 1.80 to 4.72). No statistically significant heterogeneity was shown between the two studies. Data on first time failure at the patient level were also available and showed statistically different difference in favour of molar bands (risk ratio 2.30; 95% CI 1.56 to 3.41) (risk of event for molar tubes = 57%; risk of event for molar bands 25%). One trial presented data on decalcification again showing a statistically significant difference in favour of molar bands. No other adverse events identified. From the two well-designed and low risk of bias trials included in this review it was shown that the failure of molar tubes bonded with either a chemically-cured or light-cured adhesive was considerably higher than that of molar bands cemented with glass ionomer cement. One trial indicated that there was less decalcification with molar bands cemented with glass ionomer cement than with bonded molar tubes cemented with a light-cured adhesive. However, given there are limited data for this outcome, further evidence is required to draw more robust conclusions. Output: The evidence in this review, which was carried out together with Cochrane Oral Health, is up-to-date as of 15 February 2017. We included two studies that evaluated 190 participants. Both trials were conducted in the UK and both compared bonded molar tubes with molar bands. From the limited data of two studies at low risk of bias, it would appear that bonded molar tubes are associated with a higher failure rate than with molar bands. Input: Nine trials, which included a total of 1512 women, met the inclusion criteria of this Cochrane review. Most of these studies included women with unexplained infertility. In seven studies the women were undergoing IUI and in two studies the women were trying to conceive from sexual intercourse. Eight trials compared intentional endometrial injury with no injury/placebo procedure; of these two trials also compared intentional endometrial injury in the cycle prior to IUI with intentional endometrial injury in the IUI cycle. One trial compared higher vs. lower degree of intentional endometrial injury. Intentional endometrial injury vs. either no intervention or a sham procedure We are uncertain whether endometrial injury improves live birth/ongoing pregnancy as the quality of the evidence has been assessed as very low (risk ratio (RR) 2.22, 95% confidence interval (CI) 1.56 to 3.15; six RCTs, 950 participants; I² statistic = 0%, very low quality evidence). When we restricted the analysis to only studies at low risk of bias the effect was imprecise and the evidence remained of very low quality (RR 2.64, 95% CI 1.03 to 6.82; one RCT, 105 participants; very low quality evidence). Endometrial injury may improve clinical pregnancy rates however the evidence is of low quality (RR 1.98, 95% CI 1.51 to 2.58; eight RCTs, 1180 participants; I² statistic = 0%, low quality evidence). The average pain experienced by participants undergoing endometrial injury was 6/10 on a zero-10 visual analogue scale (VAS)(standard deviation = 1.5). However, only one study reported this outcome. Higher vs. lower degree of intentional endometrial injury When we compared hysteroscopy with endometrial injury to hysteroscopy alone, there was no evidence of a difference in ongoing pregnancy rate (RR 1.29, 95% CI 0.71 to 2.35; one RCT, 332 participants; low quality evidence) or clinical pregnancy rate (RR 1.15, 95% CI 0.66 to 2.01; one RCT, 332 participants, low quality evidence). This study did not report the primary outcome of pain during the procedure. Timing of intentional endometrial injury When endometrial injury was performed in the cycle prior to IUI compared to the same cycle as the IUI, there was no evidence of a difference in ongoing pregnancy rate (RR 0.65, 95% CI 0.37 to 1.16, one RCT, 176 participants; very low quality evidence) or clinical pregnancy rate (RR 0.82, 95% CI 0.50 to 1.36; two RCTs, 276 participants; very low quality evidence). Neither of these studies reported the primary outcome of pain during the procedure. In all three comparisons there was no evidence of an effect on miscarriage, ectopic pregnancy or multiple pregnancy. No studies reported bleeding secondary to the procedure. It is uncertain whether endometrial injury improves the probability of pregnancy and live birth/ongoing pregnancy in women undergoing IUI or attempting to conceive via sexual intercourse. The pooled results should be interpreted with caution as we graded the quality of the evidence as either low or very low. The main reasons we downgraded the quality of the evidence were most included studies were at a high risk of bias and had an overall low level of precision. Further well-conducted RCTs that recruit large numbers of participants and minimise internal bias are required to confirm or refute these findings. Output:
Nine randomised controlled trials met the inclusion criteria of this review, and included a total of 1512 women. The women in seven studies were trying to get pregnant from IUI, and from intercourse in two studies. Most women had a type of subfertility known as unexplained subfertility, which means that after having all routine tests done there is no obvious explanation for why the couple has not become pregnant so far. Eight trials compared intentional endometrial injury with no injury/placebo procedure; of these two trials also compared intentional endometrial injury in the cycle prior to IUI with intentional endometrial injury in the IUI cycle. One trial compared higher vs. lower degree of intentional endometrial injury. The evidence is current to 31 October 2015. The results from the included studies suggest a beneficial effect of endometrial injury on the chance of getting pregnant, but the studies are associated with many significant limitations. Therefore, it is not possible to say with any confidence whether endometrial injury can increase the probability of pregnancy. We are uncertain whether endometrial injury increases the probability of a live birth or a pregnancy beyond 12 weeks. The endometrial injury procedure is a common procedure and is known to cause a degree of temporary pain or discomfort. Only one included study reported on whether the women experienced pain during the procedure, and the average pain experienced was six out of 10 on a visual scale from zero to 10. Endometrial injury does not seem to have an effect on miscarriage, ectopic pregnancy or multiple pregnancy. No studies reported bleeding after the procedure. The quality of the evidence was low or very low as assessed using GRADE criteria. In general, the studies included in this review were not very well designed and did not recruit a high enough number of women to provide meaningful results. This means the results must be treated cautiously, and further studies are needed to confirm the findings. There remains uncertainty about whether or not the endometrial injury procedure increases the probability of having a baby.
CochranePLS424
***TASK*** the task is to simplify the input abstract of a biomedical literature ***INPUT*** the input is the abstract of a biomedical literature ***OUTPUT*** the output is the simplified abstract for the input abstract of a biomedical literature ***EXAMPLES*** Input: Output: ***EXAMPLES*** Input: Two trials (n = 190), at low risk of bias, were included in the review and both presented data on first time failure at the tooth level. Pooling of the data showed a statistically significant difference in favour of molar bands, with a hazard ratio of 2.92 (95% confidence intervals (CI) 1.80 to 4.72). No statistically significant heterogeneity was shown between the two studies. Data on first time failure at the patient level were also available and showed statistically different difference in favour of molar bands (risk ratio 2.30; 95% CI 1.56 to 3.41) (risk of event for molar tubes = 57%; risk of event for molar bands 25%). One trial presented data on decalcification again showing a statistically significant difference in favour of molar bands. No other adverse events identified. From the two well-designed and low risk of bias trials included in this review it was shown that the failure of molar tubes bonded with either a chemically-cured or light-cured adhesive was considerably higher than that of molar bands cemented with glass ionomer cement. One trial indicated that there was less decalcification with molar bands cemented with glass ionomer cement than with bonded molar tubes cemented with a light-cured adhesive. However, given there are limited data for this outcome, further evidence is required to draw more robust conclusions. Output: The evidence in this review, which was carried out together with Cochrane Oral Health, is up-to-date as of 15 February 2017. We included two studies that evaluated 190 participants. Both trials were conducted in the UK and both compared bonded molar tubes with molar bands. From the limited data of two studies at low risk of bias, it would appear that bonded molar tubes are associated with a higher failure rate than with molar bands. Input: We included four RCTs (3905 participants), all of which were at high risk of bias. The studies all evaluated one comparison: professional oral care versus usual oral care. We did not pool the results from one study (N = 834 participants), which was stopped at interim analysis due to lack of a clear difference between groups. We were unable to determine whether professional oral care resulted in a lower incidence rate of NHAP compared with usual oral care over an 18-month period (hazard ratio 0.65, 95% CI 0.29 to 1.46; one study, 2513 participants analysed; low-quality evidence). We were also unable to determine whether professional oral care resulted in a lower number of first episodes of pneumonia compared with usual care over a 24-month period (RR 0.61, 95% CI 0.37 to 1.01; one study, 366 participants analysed; low-quality evidence). There was low-quality evidence from two studies that professional oral care may reduce the risk of pneumonia-associated mortality compared with usual oral care at 24-month follow-up (RR 0.41, 95% CI 0.24 to 0.72, 507 participants analysed). We were uncertain whether or not professional oral care may reduce all-cause mortality compared to usual care, when measured at 24-month follow-up (RR 0.55, 95% CI 0.27 to 1.15; one study, 141 participants analysed; very low-quality evidence). Only one study (834 participants randomised) measured adverse effects of the interventions. The study identified no serious events and 64 non-serious events, the most common of which were oral cavity disturbances (not defined) and dental staining. No studies evaluated oral care versus no oral care. Although low-quality evidence suggests that professional oral care could reduce mortality due to pneumonia in nursing home residents when compared to usual care, this finding must be considered with caution. Evidence for other outcomes is inconclusive. We found no high-quality evidence to determine which oral care measures are most effective for reducing nursing home-acquired pneumonia. Further trials are needed to draw reliable conclusions. Output:
This review was carried out through Cochrane Oral Health. We searched scientific databases for relevant studies, up to 15 November 2017. We included four studies, with a total of 3905 participants randomly assigned to treatment or usual care. Participants were long-term-care elderly residents in nursing homes who did not have pneumonia at the beginning of the studies. Some of the participants had dementia or systemic diseases. All studies focused on the comparison between 'professional' mouth care and 'usual' mouth care. None of the studies evaluated oral care versus no oral care. We identified four studies, all of which compared professional mouth care to usual mouth care in nursing home residents. From the limited evidence, we could not tell whether professional oral mouth care was better or worse than usual mouth care for preventing pneumonia. The evidence for death from any cause was inconclusive, but the studies did suggest that professional mouth care may reduce the number of deaths caused by pneumonia, compared to usual mouth care, when measured after 24 months. Only one study measured negative effects of the interventions, and reported that there were no serious events. The most common non-serious events reported were damage to the mouth and tooth staining. The quality of the evidence is low or very low, because of the small number of studies and problems with their design. Therefore, we cannot rely on the findings, and further research is required.
CochranePLS425
***TASK*** the task is to simplify the input abstract of a biomedical literature ***INPUT*** the input is the abstract of a biomedical literature ***OUTPUT*** the output is the simplified abstract for the input abstract of a biomedical literature ***EXAMPLES*** Input: Output: ***EXAMPLES*** Input: Two trials (n = 190), at low risk of bias, were included in the review and both presented data on first time failure at the tooth level. Pooling of the data showed a statistically significant difference in favour of molar bands, with a hazard ratio of 2.92 (95% confidence intervals (CI) 1.80 to 4.72). No statistically significant heterogeneity was shown between the two studies. Data on first time failure at the patient level were also available and showed statistically different difference in favour of molar bands (risk ratio 2.30; 95% CI 1.56 to 3.41) (risk of event for molar tubes = 57%; risk of event for molar bands 25%). One trial presented data on decalcification again showing a statistically significant difference in favour of molar bands. No other adverse events identified. From the two well-designed and low risk of bias trials included in this review it was shown that the failure of molar tubes bonded with either a chemically-cured or light-cured adhesive was considerably higher than that of molar bands cemented with glass ionomer cement. One trial indicated that there was less decalcification with molar bands cemented with glass ionomer cement than with bonded molar tubes cemented with a light-cured adhesive. However, given there are limited data for this outcome, further evidence is required to draw more robust conclusions. Output: The evidence in this review, which was carried out together with Cochrane Oral Health, is up-to-date as of 15 February 2017. We included two studies that evaluated 190 participants. Both trials were conducted in the UK and both compared bonded molar tubes with molar bands. From the limited data of two studies at low risk of bias, it would appear that bonded molar tubes are associated with a higher failure rate than with molar bands. Input: Five RCTs (149 participants) met the inclusion criteria. These studies assessed bismuth subsalicylate versus placebo, budesonide versus placebo, mesalazine versus mesalazine plus cholestyramine and beclometasone dipropionate versus mesalazine. The study which assessed mesalazine versus mesalazine plus cholestyramine and the study which assessed beclometasone dipropionate versus mesalazine were judged to be at high risk of bias due to lack of blinding. The study which compared bismuth subsalicylate versus us placebo was judged as low quality due to a very small sample size and limited data. The other 3 studies were judged to be at low risk of bias. Budesonide (9 mg/day for 6 to 8 weeks) was significantly more effective than placebo for induction of clinical and histological response. Clinical response was noted in 88% of budesonide patients compared to 38% of placebo patients (2 studies; 57 participants; RR 2.03, 95% CI 1.25 to 3.33; GRADE = low). Histological response was noted in 78% of budesonide patients compared to 33% of placebo patients (2 studies; 39 patients; RR 2.44, 95% CI 1.13 to 5.28; GRADE = low). Forty-one patients were enrolled in the study assessing mesalazine (2.4 g/day) versus mesalazine plus cholestyramine (4 g/day). Clinical response was noted in 85% of patients in the mesalazine group compared to 86% of patients in the mesalazine plus cholestyramine group (RR 0.99, 95% CI 0.77 to 1.28; GRADE = low). Five patients were enrolled in the trial studying bismuth subsalicylate (nine 262 mg tablets daily for 8 weeks versus placebo). There were no differences in clinical (P=0.10) or histological responses (P=0.71) in patients treated with bismuth subsalicylate compared with placebo (GRADE = very low). Forty-six patients were enrolled in the trial studying beclometasone dipropionate (5 mg/day or 10 mg/day) versus mesalazine (2.4 g/day). There were no differences in clinical remission at 8 weeks (RR 0.97; 95% CI 0.75 to 1.24; GRADE = low) and 12 months of treatment (RR 1.29; 95% CI 0.40 to 4.18; GRADE = very low). Although patients receiving beclometasone dipropionate (84%) and mesalazine (86%) achieved clinical remission at 8 weeks, it was not maintained at 12 months (26% and 20%, respectively). Adverse events reported in the budesonide studies include nausea, vomiting, neck pain, abdominal pain, hyperhidrosis and headache. Nausea and skin rash were reported as adverse events in the mesalazine study. Adverse events in the beclometasone dipropionate trial include nausea, sleepiness and change of mood. No adverse events were reported in the bismuth subsalicylate study. Low quality evidence suggests that budesonide may be effective for the treatment of active lymphocytic colitis. This benefit needs to be confirmed by a large placebo -controlled trial. Low quality evidence also suggests that mesalazine with or without cholestyramine and beclometasone dipropionate may be effective for the treatment of lymphocytic colitis, however this needs to be confirmed by large placebo-controlled studies. No conclusions can be made regarding bismuth subsalicylate due to the very small number of patients in the study, Further trials studying interventions for lymphocytic colitis are warranted. Output:
Five studies including 149 participants were identified. These studies assessed budesonide versus placebo (e.g. a sugar pill), mesalazine versus mesalazine plus cholestyramine and beclometasone dipropionate versus mesalazine and Pepto-Bismol® versus placebo. The study which compared mesalazine to mesalazine plus cholestyramine and the study which compared beclometasone dipropionate to mesalazine were judged to be of low quality. The study which compared Pepto-Bismol® bismuth subsalicylate to a placebo was judged as low quality due to a very small sample size (5 participants) and limited data. The other three studies were judged to be high quality. A pooled analysis of two studies (57 participants) showed that budesonide (9 mg/day for 6 to 8 weeks) was superior to placebo for improvement of diarrhea and improvement of microscopic inflammation of the bowel. Improvement in diarrhea was noted in 88% of budesonide participants compared to 38% of placebo participants. Improvement in microscopic inflammation was reported in 78% of budesonide participants compared to 33% of placebo participants. Forty-one participants were enrolled in the study that compared mesalazine (2.4. g/day) to mesalazine plus cholestyramine (4 g/day). Improvement in diarrhea was noted in 85% of participants in the mesalazine group compared to 86% of participants in the mesalazine plus cholestyramine group. Five patients were enrolled in the trial studying Pepto-Bismol® (nine 262 mg tablets daily for 8 weeks versus placebo). There were no differences in improvement of diarrhea or in improvement of microscopic inflammation of the bowel. Forty-six participants were enrolled in the trial studying beclometasone dipropionate (5 mg/day or 10 mg/day) versus mesalazine (2.4 g/day). Although participants receiving beclometasone dipropionate (84%) and mesalazine (86%) had improved diarrhea at 8 weeks, this improvement was not maintained at 12 months (26% and 20%, respectively). Side effects reported in the budesonide studies include nausea, vomiting, neck pain, abdominal pain, excessive sweating and headache. Side effects reported in the mesalazine plus cholestyramine study included nausea and skin rash. Side effects in the beclometasone dipropionate trial included nausea, sleepiness and change of mood. No side effects were reported in the Pepto-Bismol® study. Low quality evidence suggests that budesonide may be an effective therapy for the treatment of lymphocytic colitis. Low quality evidence also suggests that mesalazine with or without cholestyramine and beclometasone dipropionate may be effective for treatment of lymphocytic colitis. No conclusions can be made regarding bismuth subsalicylate due to the very small number of participants in the study. In the future, researchers should consider further large placebo-controlled trials of budesonide to confirm the suggested benefit and safety of this therapy. Bismuth subsalicylate, which has less potential for toxicity than budesonide, also warrants further study. The effectiveness and safety of mesalazine with or without cholestyramine, and beclometasone dipropionate need to be investigated in a large placebo-controlled studies.
CochranePLS426
***TASK*** the task is to simplify the input abstract of a biomedical literature ***INPUT*** the input is the abstract of a biomedical literature ***OUTPUT*** the output is the simplified abstract for the input abstract of a biomedical literature ***EXAMPLES*** Input: Output: ***EXAMPLES*** Input: Two trials (n = 190), at low risk of bias, were included in the review and both presented data on first time failure at the tooth level. Pooling of the data showed a statistically significant difference in favour of molar bands, with a hazard ratio of 2.92 (95% confidence intervals (CI) 1.80 to 4.72). No statistically significant heterogeneity was shown between the two studies. Data on first time failure at the patient level were also available and showed statistically different difference in favour of molar bands (risk ratio 2.30; 95% CI 1.56 to 3.41) (risk of event for molar tubes = 57%; risk of event for molar bands 25%). One trial presented data on decalcification again showing a statistically significant difference in favour of molar bands. No other adverse events identified. From the two well-designed and low risk of bias trials included in this review it was shown that the failure of molar tubes bonded with either a chemically-cured or light-cured adhesive was considerably higher than that of molar bands cemented with glass ionomer cement. One trial indicated that there was less decalcification with molar bands cemented with glass ionomer cement than with bonded molar tubes cemented with a light-cured adhesive. However, given there are limited data for this outcome, further evidence is required to draw more robust conclusions. Output: The evidence in this review, which was carried out together with Cochrane Oral Health, is up-to-date as of 15 February 2017. We included two studies that evaluated 190 participants. Both trials were conducted in the UK and both compared bonded molar tubes with molar bands. From the limited data of two studies at low risk of bias, it would appear that bonded molar tubes are associated with a higher failure rate than with molar bands. Input: Twelve randomised controlled trials were included and evaluated outcomes in 3259 randomised patients. Intervention duration ranged from 6 months (26 weeks) to 12 months (52 weeks). Nine trials compared SMBG with usual care without monitoring, one study compared SMBG with SMUG, one study was a three-armed trial comparing SMBG and SMUG with usual care and one study was a three-armed trial comparing less intensive SMBG and more intensive SMBG with a control group. Seven out of 11 studies had a low risk of bias for most indicators. Meta-analysis of studies including patients with a diabetes duration of one year or more showed a statistically significant SMBG induced decrease in HbA1c at up to six months follow-up (-0.3; 95% confidence interval (CI) -0.4 to -0.1; 2324 participants, nine trials), yet an overall statistically non-significant SMBG induced decrease was seen at 12 month follow-up (-0.1; 95% CI -0.3 to 0.04; 493 participants, two trials). Qualitative analysis of the effect of SMBG on well-being and quality of life showed no effect on patient satisfaction, general well-being or general health-related quality of life. Two trials reported costs of self-monitoring: One trial compared the costs of self-monitoring of blood glucose with self-monitoring of urine glucose based on nine measurements per week and with the prices in US dollars for self-monitoring in 1990. Authors concluded that total costs in the first year of self-monitoring of blood glucose, with the purchase of a reflectance meter were 12 times more expensive than self-monitoring of urine glucose ($481 or 361 EURO [11/2011 conversion] versus $40 or 30 EURO [11/2011 conversion]). Another trial reported a full economical evaluation of the costs and effects of self-monitoring. At the end of the trial, costs for the intervention were £89 (104 EURO [11/2011 conversion]) for standardized usual care (control group), £181 (212 EURO [11/2011 conversion]) for the less intensive self-monitoring group and £173 (203 EURO [11/2011 conversion]) for the more intensive self-monitoring group. Higher losses to follow-up in the more intensive self-monitoring group were responsible for the difference in costs, compared to the less intensive self-monitoring group. There were few data on the effects on other outcomes and these effects were not statistically significant. None of the studies reported data on morbidity. From this review, we conclude that when diabetes duration is over one year, the overall effect of self-monitoring of blood glucose on glycaemic control in patients with type 2 diabetes who are not using insulin is small up to six months after initiation and subsides after 12 months. Furthermore, based on a best-evidence synthesis, there is no evidence that SMBG affects patient satisfaction, general well-being or general health-related quality of life. More research is needed to explore the psychological impact of SMBG and its impact on diabetes specific quality of life and well-being, as well as the impact of SMBG on hypoglycaemia and diabetic complications. Output:
Two studies reported costs of self-monitoring: One study compared the costs of self-monitoring of blood glucose with self-monitoring of urine glucose based on nine measurements per week and with the prices in US dollars for self-monitoring in 1990. They concluded that total costs in the first year of self-monitoring of blood glucose, with the purchase of a reflectance meter were 12 times more expensive than self-monitoring of urine glucose ($481 or 361 EURO [11/2011 conversion] versus $40 or 30 EURO [11/2011 conversion]). Another study reported a full economical evaluation of the costs and effects of self-monitoring. At the end of the trial, costs for the intervention were £89 (104 EURO [11/2011 conversion]) for standardized usual care (control group), £181 (212 EURO [11/2011 conversion]) for the less intensive self-monitoring group and £173 (203 EURO [11/2011 conversion]) for the more intensive self-monitoring group. We did not find good evidence for an effect on general health-related quality of life, general well-being, patient satisfaction, or on the decrease of the number of hypoglycaemic episodes. However, hypoglycaemic episodes were more often reported in the self-monitoring blood glucose groups than in the control groups (four studies). Because patients in the self-monitoring blood glucose groups can use their device to confirm both periods of asymptomatic and symptomatic hypoglycaemic episodes, this is according to expectations.
CochranePLS427
***TASK*** the task is to simplify the input abstract of a biomedical literature ***INPUT*** the input is the abstract of a biomedical literature ***OUTPUT*** the output is the simplified abstract for the input abstract of a biomedical literature ***EXAMPLES*** Input: Output: ***EXAMPLES*** Input: Two trials (n = 190), at low risk of bias, were included in the review and both presented data on first time failure at the tooth level. Pooling of the data showed a statistically significant difference in favour of molar bands, with a hazard ratio of 2.92 (95% confidence intervals (CI) 1.80 to 4.72). No statistically significant heterogeneity was shown between the two studies. Data on first time failure at the patient level were also available and showed statistically different difference in favour of molar bands (risk ratio 2.30; 95% CI 1.56 to 3.41) (risk of event for molar tubes = 57%; risk of event for molar bands 25%). One trial presented data on decalcification again showing a statistically significant difference in favour of molar bands. No other adverse events identified. From the two well-designed and low risk of bias trials included in this review it was shown that the failure of molar tubes bonded with either a chemically-cured or light-cured adhesive was considerably higher than that of molar bands cemented with glass ionomer cement. One trial indicated that there was less decalcification with molar bands cemented with glass ionomer cement than with bonded molar tubes cemented with a light-cured adhesive. However, given there are limited data for this outcome, further evidence is required to draw more robust conclusions. Output: The evidence in this review, which was carried out together with Cochrane Oral Health, is up-to-date as of 15 February 2017. We included two studies that evaluated 190 participants. Both trials were conducted in the UK and both compared bonded molar tubes with molar bands. From the limited data of two studies at low risk of bias, it would appear that bonded molar tubes are associated with a higher failure rate than with molar bands. Input: Eleven studies involving 471 participants with AsPD met the inclusion criteria, although data were available from only five studies involving 276 participants with AsPD. Only two studies focused solely on an AsPD sample. Eleven different psychological interventions were examined. Only two studies reported on reconviction, and only one on aggression. Compared to the control condition, cognitive behaviour therapy (CBT) plus standard maintenance was superior for outpatients with cocaine dependence in one study, but CBT plus treatment as usual was not superior for male outpatients with recent verbal/physical violence in another. Contingency management plus standard maintenance was superior for drug misuse for outpatients with cocaine dependence in one study but not in another, possibly because of differences in the behavioural intervention. However, contingency management was superior in social functioning and counselling session attendance in the latter. A multi-component intervention utilising motivational interviewing principles, the ‘Driving Whilst Intoxicated program’, plus incarceration was superior to incarceration alone for imprisoned drink-driving offenders. Results suggest that there is insufficient trial evidence to justify using any psychological intervention for adults with AsPD. Disappointingly few of the included studies addressed the primary outcomes defined in this review (aggression, reconviction, global functioning, social functioning, adverse effects). Three interventions (contingency management with standard maintenance; CBT with standard maintenance; 'Driving Whilst Intoxicated program' with incarceration) appeared effective, compared to the control condition, in terms of improvement in at least one outcome in at least one study. Each of these interventions had been originally developed for people with substance misuse problems. Significant improvements were mainly confined to outcomes related to substance misuse. No study reported significant change in any specific antisocial behaviour. Further research is urgently needed for this prevalent and costly condition. Output:
We considered 11 studies, but were unable to draw any firm conclusions from the evidence available. Although several studies looked at treatments to reduce drug or alcohol misuse in people with antisocial personality disorder, few studies focused on treating the disorder itself. Only three studies reported outcome measures that were originally defined in the review protocol as being of particular importance in this disorder (reconviction and aggression). Nonetheless, there was some evidence that a type of treatment known as contingency management (which provides rewards for progress in treatment) could help people with antisocial personality disorder to reduce their misuse of drugs or alcohol. Further research is urgently needed to clarify which psychological treatments are effective for people with this disorder. This research is best carried out using carefully designed clinical trials. Such trials should focus on the key features of antisocial personality disorder. To be informative, they need to be carried out with samples of participants of sufficient size.
CochranePLS428
***TASK*** the task is to simplify the input abstract of a biomedical literature ***INPUT*** the input is the abstract of a biomedical literature ***OUTPUT*** the output is the simplified abstract for the input abstract of a biomedical literature ***EXAMPLES*** Input: Output: ***EXAMPLES*** Input: Two trials (n = 190), at low risk of bias, were included in the review and both presented data on first time failure at the tooth level. Pooling of the data showed a statistically significant difference in favour of molar bands, with a hazard ratio of 2.92 (95% confidence intervals (CI) 1.80 to 4.72). No statistically significant heterogeneity was shown between the two studies. Data on first time failure at the patient level were also available and showed statistically different difference in favour of molar bands (risk ratio 2.30; 95% CI 1.56 to 3.41) (risk of event for molar tubes = 57%; risk of event for molar bands 25%). One trial presented data on decalcification again showing a statistically significant difference in favour of molar bands. No other adverse events identified. From the two well-designed and low risk of bias trials included in this review it was shown that the failure of molar tubes bonded with either a chemically-cured or light-cured adhesive was considerably higher than that of molar bands cemented with glass ionomer cement. One trial indicated that there was less decalcification with molar bands cemented with glass ionomer cement than with bonded molar tubes cemented with a light-cured adhesive. However, given there are limited data for this outcome, further evidence is required to draw more robust conclusions. Output: The evidence in this review, which was carried out together with Cochrane Oral Health, is up-to-date as of 15 February 2017. We included two studies that evaluated 190 participants. Both trials were conducted in the UK and both compared bonded molar tubes with molar bands. From the limited data of two studies at low risk of bias, it would appear that bonded molar tubes are associated with a higher failure rate than with molar bands. Input: This updated review included 11 studies. Six studies contributed to one or more analyses related to the common cold, with up to 1047 participants. Five studies contributed to one or more analyses relating to purulent rhinitis, with up to 791 participants. One study contributed only to data on adverse events and one met the inclusion criteria but reported only summary statistics without providing any numerical data that could be included in the meta-analyses. Interpretation of the combined data is limited because some studies included only children, or only adults, or only males; a wide range of antibiotics were used and outcomes were measured in different ways. There was a moderate risk of bias because of unreported methods details or because an unknown number of participants were likely to have chest or sinus infections. Participants receiving antibiotics for the common cold did no better in terms of lack of cure or persistence of symptoms than those on placebo (risk ratio (RR) 0.95, 95% confidence interval (CI) 0.59 to 1.51, (random-effects)), based on a pooled analysis of six trials with a total of 1047 participants. The RR of adverse effects in the antibiotic group was 1.8, 95% CI 1.01 to 3.21, (random-effects). Adult participants had a significantly greater risk of adverse effects with antibiotics than with placebo (RR 2.62, 95% CI 1.32 to 5.18) (random-effects) while there was no greater risk in children (RR 0.91, 95% CI 0.51 to 1.63). The pooled RR for persisting acute purulent rhinitis with antibiotics compared to placebo was 0.73 (95% CI 0.47 to 1.13) (random-effects), based on four studies with 723 participants. There was an increase in adverse effects in the studies of antibiotics for acute purulent rhinitis (RR 1.46, 95% CI 1.10 to 1.94). There is no evidence of benefit from antibiotics for the common cold or for persisting acute purulent rhinitis in children or adults. There is evidence that antibiotics cause significant adverse effects in adults when given for the common cold and in all ages when given for acute purulent rhinitis. Routine use of antibiotics for these conditions is not recommended. Output:
To find out whether antibiotics work for the common cold we identified studies that compared one group of people taking an antibiotic with another group of people taking a medication that looked similar but contained no antibiotic (a placebo). We found six studies of the common cold, with 1047 participants and five studies of acute purulent rhinitis, with 791 participants. Many of the studies had flaws which might have biased the results, especially because many of the participants probably had chest or sinus infections that the researchers did not know about. Results suggest that antibiotics do not work for either the common cold or for acute purulent rhinitis and many people are affected by antibiotic side effects.
CochranePLS429
***TASK*** the task is to simplify the input abstract of a biomedical literature ***INPUT*** the input is the abstract of a biomedical literature ***OUTPUT*** the output is the simplified abstract for the input abstract of a biomedical literature ***EXAMPLES*** Input: Output: ***EXAMPLES*** Input: Two trials (n = 190), at low risk of bias, were included in the review and both presented data on first time failure at the tooth level. Pooling of the data showed a statistically significant difference in favour of molar bands, with a hazard ratio of 2.92 (95% confidence intervals (CI) 1.80 to 4.72). No statistically significant heterogeneity was shown between the two studies. Data on first time failure at the patient level were also available and showed statistically different difference in favour of molar bands (risk ratio 2.30; 95% CI 1.56 to 3.41) (risk of event for molar tubes = 57%; risk of event for molar bands 25%). One trial presented data on decalcification again showing a statistically significant difference in favour of molar bands. No other adverse events identified. From the two well-designed and low risk of bias trials included in this review it was shown that the failure of molar tubes bonded with either a chemically-cured or light-cured adhesive was considerably higher than that of molar bands cemented with glass ionomer cement. One trial indicated that there was less decalcification with molar bands cemented with glass ionomer cement than with bonded molar tubes cemented with a light-cured adhesive. However, given there are limited data for this outcome, further evidence is required to draw more robust conclusions. Output: The evidence in this review, which was carried out together with Cochrane Oral Health, is up-to-date as of 15 February 2017. We included two studies that evaluated 190 participants. Both trials were conducted in the UK and both compared bonded molar tubes with molar bands. From the limited data of two studies at low risk of bias, it would appear that bonded molar tubes are associated with a higher failure rate than with molar bands. Input: We included five trials (162 randomised participants); three were conducted in a hospital dermatology department. One study declared funding by a pharmaceutical company. Participants' ages ranged from 12 to 77 years; only two participants were younger than 15 years. Mean PASI score at baseline varied from 5.7 (i.e. mild) to 23 (i.e. severe) in four studies. Twenty-three of 162 participants had streptococcus-positive throat swab culture. We did not perform a meta-analysis due to heterogeneity of participants' characteristics and interventions. None of the trials measured our efficacy primary outcome, time-to-resolution, or the secondary outcome, risk of having at least one relapse at long-term follow-up. We rated the quality of the results as very low-quality evidence, due to high risk of bias (absence of blinding of participants and caregivers, and high risk of outcome reporting bias) and imprecision (single study data with a low number of events). Hence, we are very uncertain about the results presented. Guttate psoriasis One three-armed trial (N = 43) assessed penicillin (50,000 international units (IU)/kg/day in three doses) versus erythromycin (250 mg four times per day) versus no treatment (treatment for 14 days, with six-week follow-up from start of treatment). Adverse events and the proportion of participants achieving clear or almost clear skin were not measured. One trial (N = 20) assessed penicillin (1.6 MU (million units) intramuscularly once a day) versus no treatment (six weeks of treatment, with eight-week follow-up from start of treatment). At six-week (short-term) follow-up, no adverse events were observed in either group, and there was no statistically significant difference between the two groups in the proportion of participants with clear or almost clear skin (risk ratio (RR) 2.00, 95% confidence interval (CI) 0.68 to 5.85). One trial (N = 20) assessed rifampicin (300 mg twice daily) versus placebo (14-day treatment duration; six-week follow-up from start of treatment); none of the review outcomes were measured. These trials did not measure the proportion of participants achieving PASI 75 or PGA 1 to 2. Chronic plaque psoriasis One trial (N = 50) assessed long-term azithromycin treatment (500 mg daily dose) versus vitamin C. Adverse events were reported in the azithromycin group (10 out of 30 had nausea and mild abdominal upset), but not in the vitamin C group. The proportion of participants who achieved clear or almost clear skin was not measured. In the azithromycin group, 18/30 versus 0/20 participants in the vitamin C group reached PASI 75 at the end of 48 weeks of treatment (RR 25.06, 95% CI 1.60 to 393.59). One trial (N = 29) assessed tonsillectomy versus no treatment, with 24-month follow-up after surgery. One participant in the tonsillectomy group had minor bleeding. At eight-week follow-up, 1/15 in the tonsillectomy group, and 0/14 in the no treatment group achieved PASI 90; and 3/15 participants in the tonsillectomy group, and 0/14 in the no treatment group achieved PASI 75 (RR 6.56, 95% CI 0.37 to 116.7). We found only five trials (N = 162), which assessed the effects of five comparisons (systemic antibiotic treatment (penicillin, azithromycin) or tonsillectomy). Two comparisons (erythromycin compared to no treatment, and rifampicin compared to placebo) did not measure any of the outcomes of interest. There was very low-quality evidence for the outcomes that were measured, Therefore, we are uncertain of both the efficacy and safety of antistreptococcal interventions for guttate and chronic plaque psoriasis. The included trials were at unclear or high risk of bias and involved only a small number of unrepresentative participants, with limited measurement of our outcomes of interest. The studies did not allow investigation into the influence of Streptococcal infection, and a key intervention (amoxicillin) was not assessed. Further trials assessing the efficacy and tolerance of penicillin V or amoxicillin are needed in children and young adults with guttate psoriasis. Output:
The evidence is current to January 2019. We included five studies (162 participants); three were conducted in hospital dermatology departments. Participants were 12 to 77 years old (100 males; 62 females). One study was funded by a pharmaceutical company. The severity of the condition ranged from mild to severe. Streptococcus bacteria were found in the throats of 14% of people. We classed outcomes measured within eight weeks of the start of treatment as short-term, and those measured at least one year after the start of treatment as long-term. The antibiotic trials in guttate psoriasis patients were all short-term in duration; the antibiotic trial in chronic plaque psoriasis was 48 weeks long. Three studies included participants with guttate psoriasis, and assessed the short-term effects of antibiotics: penicillin (20 participants), or erythromycin compared to no treatment (43 participants), and rifampicin compared to placebo (20 participants). Two studies included participants with chronic plaque psoriasis. One study assessed azithromycin (antibiotic) versus vitamin C at 48 weeks (50 participants); one assessed tonsillectomy versus no intervention at eight weeks and 24 months (29 participants). These results are backed by very low-quality evidence, so we are not certain of their accuracy. Each result is based on only one study. No studies measured our main outcome of interest, the time taken for the skin to be clear or almost clear of lesions, or the risk of relapsing at least once during long-term follow-up. No side effects were seen when penicillin was compared with no treatment in people with guttate psoriasis. Side effects were not measured for the comparisons of rifampicin versus placebo, or erythromycin versus no treatment. In participants with chronic plaque psoriasis, one trial assessed azithromycin versus vitamin C, and 10 participants in the azithromycin group complained of nausea or mild stomach upset. A trial of tonsillectomy versus no treatment reported one case of minor bleeding in the tonsillectomy group. Two studies in participants with chronic plaque psoriasis measured the number of participants achieving a 75% reduction on the Psoriasis Area and Severity Index (PASI 75). In one, 18/30 participants in the azithromycin group reached PASI 75 versus none in the vitamin C group. In the other, 3/15 in the tonsillectomy group reached PASI 75 versus none in the no treatment group. The guttate psoriasis trials did not assess this outcome. We are uncertain whether the number of participants with guttate psoriasis achieving clear or almost clear skin differs between those given penicillin and those receiving no treatment. Only one participant with chronic plaque psoriasis achieved almost clear skin in the tonsillectomy group compared to none in the no treatment group. The other three trials did not measure this outcome. Many of our main outcomes were not assessed. Those that were assessed were based on very low-quality evidence, meaning we are not sure of their accuracy. The studies were very small, and had a high risk of bias because participants and trial assessors were aware of treatment allocation. More studies are needed to see if antibiotic treatment of Streptococcal infection shortens the duration of acute guttate psoriasis, stopping it from turning into a long-term condition (chronic plaque psoriasis).
CochranePLS430
***TASK*** the task is to simplify the input abstract of a biomedical literature ***INPUT*** the input is the abstract of a biomedical literature ***OUTPUT*** the output is the simplified abstract for the input abstract of a biomedical literature ***EXAMPLES*** Input: Output: ***EXAMPLES*** Input: Two trials (n = 190), at low risk of bias, were included in the review and both presented data on first time failure at the tooth level. Pooling of the data showed a statistically significant difference in favour of molar bands, with a hazard ratio of 2.92 (95% confidence intervals (CI) 1.80 to 4.72). No statistically significant heterogeneity was shown between the two studies. Data on first time failure at the patient level were also available and showed statistically different difference in favour of molar bands (risk ratio 2.30; 95% CI 1.56 to 3.41) (risk of event for molar tubes = 57%; risk of event for molar bands 25%). One trial presented data on decalcification again showing a statistically significant difference in favour of molar bands. No other adverse events identified. From the two well-designed and low risk of bias trials included in this review it was shown that the failure of molar tubes bonded with either a chemically-cured or light-cured adhesive was considerably higher than that of molar bands cemented with glass ionomer cement. One trial indicated that there was less decalcification with molar bands cemented with glass ionomer cement than with bonded molar tubes cemented with a light-cured adhesive. However, given there are limited data for this outcome, further evidence is required to draw more robust conclusions. Output: The evidence in this review, which was carried out together with Cochrane Oral Health, is up-to-date as of 15 February 2017. We included two studies that evaluated 190 participants. Both trials were conducted in the UK and both compared bonded molar tubes with molar bands. From the limited data of two studies at low risk of bias, it would appear that bonded molar tubes are associated with a higher failure rate than with molar bands. Input: We identified 12 RCTs enrolling 933 participants with MS; 464 were randomised to the vitamin D group, and 469 to the comparator group. Eleven trials tested vitamin D₃, and one trial tested vitamin D₂. Vitamin D₃ had no effect on the annualised relapse rate at 52 weeks' follow-up (rate difference -0.05, 95% CI -0.17 to 0.07; I² = 38%; five trials; 417 participants; very low-quality evidence according to the GRADE instrument); on the Expanded Disability Status Scale at 52 weeks' follow-up (MD -0.25, 95% CI -0.61 to 0.10; I² = 35%; five trials; 221 participants; very low-quality evidence according to GRADE); and on MRI gadolinium-enhancing T1 lesions at 52 weeks' follow-up (MD 0.02, 95% CI -0.45 to 0.48; I² = 12%; two trials; 256 participants; very low-quality evidence according to GRADE). Vitamin D₃ did not increase the risk of serious adverse effects within a range of 26 to 52 weeks' follow-up (RD 0.01, 95% CI -0.03 to 0.04; I² = 35%; eight trials; 621 participants; low-quality evidence according to GRADE) or minor adverse effects within a range of 26 to 96 weeks' follow-up (RD 0.02, 95% CI -0.02 to 0.06; I² = 20%; eight trials; 701 participants; low-quality evidence according to GRADE). Three studies reported health-related quality of life (HRQOL) using different HRQOL scales. One study reported that vitamin D improved ratings on the psychological and social components of the HRQOL scale but had no effects on the physical components. The other two studies found no effect of vitamin D on HRQOL. Two studies reported fatigue using different scales. One study (158 participants) reported that vitamin D₃ reduced fatigue compared with placebo at 26 weeks' follow-up. The other study (71 participants) found no effect on fatigue at 96 weeks' follow-up. Seven studies reported on cytokine levels, four on T-lymphocyte proliferation, and one on matrix metalloproteinase levels, with no consistent pattern of change in these immunological outcomes. The randomised trials included in this review provided no data on time to first treated relapse, number of participants requiring hospitalisation owing to progression of the disease, proportion of participants who remained relapse-free, cognitive function, or psychological symptoms. To date, very low-quality evidence suggests no benefit of vitamin D for patient-important outcomes among people with MS. Vitamin D appears to have no effect on recurrence of relapse, worsening of disability measured by the Expanded Disability Status Scale (EDSS), and MRI lesions. Effects on health-related quality of life and fatigue are unclear. Vitamin D₃ at the doses and treatment durations used in the included trials appears to be safe, although available data are limited. Seven ongoing studies will likely provide further evidence that can be included in a future update of this review. Output:
Our systematic search identified 12 studies enrolling 933 people with MS. Research shows that vitamin D has no effect on recurrence of relapse, worsening of disability measured by the Expanded Disability Status Scale (EDSS), or new MRI gadolinium-enhancing T1 lesions. Its effects on health-related quality of life and fatigue are unclear. Our confidence in these results is very low because vitamin D has been evaluated in only a few small trials that we judged as having high risk of bias. Vitamin D supplementation appears to be safe for people with MS included in our review, but available data are limited. For people with MS, vitamin D supplementation appears to have no effect on relevant clinical outcomes or new MRI lesions. Vitamin D supplementation at the doses and treatment durations used in the included trials appears to be safe, although available data are limited. Seven trials are ongoing; they will likely provide further evidence for a future update of this review. This evidence is up-to-date as of October 2017.
CochranePLS431
***TASK*** the task is to simplify the input abstract of a biomedical literature ***INPUT*** the input is the abstract of a biomedical literature ***OUTPUT*** the output is the simplified abstract for the input abstract of a biomedical literature ***EXAMPLES*** Input: Output: ***EXAMPLES*** Input: Two trials (n = 190), at low risk of bias, were included in the review and both presented data on first time failure at the tooth level. Pooling of the data showed a statistically significant difference in favour of molar bands, with a hazard ratio of 2.92 (95% confidence intervals (CI) 1.80 to 4.72). No statistically significant heterogeneity was shown between the two studies. Data on first time failure at the patient level were also available and showed statistically different difference in favour of molar bands (risk ratio 2.30; 95% CI 1.56 to 3.41) (risk of event for molar tubes = 57%; risk of event for molar bands 25%). One trial presented data on decalcification again showing a statistically significant difference in favour of molar bands. No other adverse events identified. From the two well-designed and low risk of bias trials included in this review it was shown that the failure of molar tubes bonded with either a chemically-cured or light-cured adhesive was considerably higher than that of molar bands cemented with glass ionomer cement. One trial indicated that there was less decalcification with molar bands cemented with glass ionomer cement than with bonded molar tubes cemented with a light-cured adhesive. However, given there are limited data for this outcome, further evidence is required to draw more robust conclusions. Output: The evidence in this review, which was carried out together with Cochrane Oral Health, is up-to-date as of 15 February 2017. We included two studies that evaluated 190 participants. Both trials were conducted in the UK and both compared bonded molar tubes with molar bands. From the limited data of two studies at low risk of bias, it would appear that bonded molar tubes are associated with a higher failure rate than with molar bands. Input: We identified seven new studies in this update. We excluded six, and one study is ongoing so also not included in this update. This review contains a total of 62 included studies, with 4241 participants. Thirty-six studies used a cross-over design ranging from one to 15 days, with the greatest number (11) for seven days for each arm of the trial. Overall we judged the included studies to be at high risk of bias because the methods of randomisation and allocation concealment were poorly reported. The primary outcomes for this review were participant-reported pain and pain relief. Fifteen studies compared oral morphine modified release (Mm/r) preparations with morphine immediate release (MIR). Fourteen studies compared Mm/r in different strengths; six of these included 24-hour modified release products. Fifteen studies compared Mm/r with other opioids. Six studies compared MIR with other opioids. Two studies compared oral Mm/r with rectal Mm/r. Three studies compared MIR with MIR by a different route of administration. Two studies compared Mm/r with Mm/r at different times and two compared MIR with MIR given at a different time. One study was found comparing each of the following: Mm/r tablet with Mm/r suspension; Mm/r with non-opioids; MIR with non-opioids; and oral morphine with epidural morphine. In the previous update, a standard of 'no worse than mild pain' was set, equivalent to a score of 30/100 mm or less on a visual analogue pain intensity scale (VAS), or the equivalent in other pain scales. Eighteen studies achieved this level of pain relief on average, and no study reported that good levels of pain relief were not attained. Where results were reported for individual participants in 17 studies, 'no worse than mild pain' was achieved by 96% of participants (362/377), and an outcome equivalent to treatment success in 63% (400/638). Morphine is an effective analgesic for cancer pain. Pain relief did not differ between Mm/r and MIR. Modified release versions of morphine were effective for 12- or 24-hour dosing depending on the formulation. Daily doses in studies ranged from 25 mg to 2000 mg with an average of between 100 mg and 250 mg. Dose titration was undertaken with both instant release and modified release products. A small number of participants did not achieve adequate analgesia with morphine. Adverse events were common, predictable, and approximately 6% of participants discontinued treatment with morphine because of intolerable adverse events. The quality of the evidence is generally poor. Studies are old, often small, and were largely carried out for registration purposes and therefore were only designed to show equivalence between different formulations. The conclusions have not changed for this update. The effectiveness of oral morphine has stood the test of time, but the randomised trial literature for morphine is small given the importance of this medicine. Most trials recruited fewer than 100 participants and did not provide appropriate data for meta-analysis. Only a few reported how many people had good pain relief, but where it was reported, over 90% had no worse than mild pain within a reasonably short time period. The review demonstrates the wide dose range of morphine used in studies, and that a small percentage of participants are unable to tolerate oral morphine. The review also shows the wide range of study designs, and inconsistency in cross-over designs. Trial design was frequently based on titration of morphine or comparator to achieve adequate analgesia, then crossing participants over in cross-over design studies. It was not clear if these trials were sufficiently powered to detect any clinical differences between formulations or comparator drugs. New studies added to the review for the previous update reinforced the view that it is possible to use modified release morphine to titrate to analgesic effect. There is qualitative evidence that oral morphine has much the same efficacy as other available opioids. Output:
In this updated review we set out to estimate how well morphine worked, how many people had side effects, and how severe those side effects were – for example, whether they were so severe that participants stopped taking their oral morphine. We found 62 studies with 4241 participants. The studies were often small, compared many different preparations, and used different study designs. This made it difficult to work out whether any one tablet or preparation of oral morphine was better than any other. There did not seem to be much difference between them. More than 9 in 10 participants had pain that went from moderate or severe before taking morphine to pain that was no worse than mild when taking morphine. More than 6 in 10 participants were very satisfied with the morphine treatment, or considered the result to be very good or excellent. Only about 1 person in 20 stopped taking morphine because of side effects. Morphine is associated with some unwanted effects, mainly constipation, and nausea and vomiting. At one level these are good results. On another level, the quality of studies is generally poor and we could wish for more consistency in study design, and especially in study reporting, which should include the outcome of pain reduced to tolerable levels – no worse than mild pain – so that people with cancer are not bothered by pain.
CochranePLS432
***TASK*** the task is to simplify the input abstract of a biomedical literature ***INPUT*** the input is the abstract of a biomedical literature ***OUTPUT*** the output is the simplified abstract for the input abstract of a biomedical literature ***EXAMPLES*** Input: Output: ***EXAMPLES*** Input: Two trials (n = 190), at low risk of bias, were included in the review and both presented data on first time failure at the tooth level. Pooling of the data showed a statistically significant difference in favour of molar bands, with a hazard ratio of 2.92 (95% confidence intervals (CI) 1.80 to 4.72). No statistically significant heterogeneity was shown between the two studies. Data on first time failure at the patient level were also available and showed statistically different difference in favour of molar bands (risk ratio 2.30; 95% CI 1.56 to 3.41) (risk of event for molar tubes = 57%; risk of event for molar bands 25%). One trial presented data on decalcification again showing a statistically significant difference in favour of molar bands. No other adverse events identified. From the two well-designed and low risk of bias trials included in this review it was shown that the failure of molar tubes bonded with either a chemically-cured or light-cured adhesive was considerably higher than that of molar bands cemented with glass ionomer cement. One trial indicated that there was less decalcification with molar bands cemented with glass ionomer cement than with bonded molar tubes cemented with a light-cured adhesive. However, given there are limited data for this outcome, further evidence is required to draw more robust conclusions. Output: The evidence in this review, which was carried out together with Cochrane Oral Health, is up-to-date as of 15 February 2017. We included two studies that evaluated 190 participants. Both trials were conducted in the UK and both compared bonded molar tubes with molar bands. From the limited data of two studies at low risk of bias, it would appear that bonded molar tubes are associated with a higher failure rate than with molar bands. Input: Fourteen trials were included, totalling 1260 participants, with 1361 trigger fingers. The age of participants included in the studies ranged from 16 to 88 years; and the majority of participants were women (approximately 70%). The average duration of symptoms ranged from three to 15 months, and the follow-up after the procedure ranged from eight weeks to 23 months. The studies reported nine types of comparisons: open surgery versus steroid injections (two studies); percutaneous surgery versus steroid injection (five studies); open surgery versus steroid injection plus ultrasound-guided hyaluronic acid injection (one study); percutaneous surgery plus steroid injection versus steroid injection (one study); percutaneous surgery versus open surgery (five studies); endoscopic surgery versus open surgery (one study); and three comparisons of types of incision for open surgery (transverse incision of the skin in the distal palmar crease, transverse incision of the skin about 2–3 mm distally from distal palmar crease, and longitudinal incision of the skin) (one study). Most studies had significant methodological flaws and were considered at high or unclear risk of selection bias, performance bias, detection bias and reporting bias. The primary comparison was open surgery versus steroid injections, because open surgery is the oldest and the most widely used treatment method and considered as standard surgery, whereas steroid injection is the least invasive control treatment method as reported in the studies in this review and is often used as first-line treatment in clinical practice. Compared with steroid injection, there was low-quality evidence that open surgery provides benefits with respect to less triggering recurrence, although it has the disadvantage of being more painful. Evidence was downgraded due to study design flaws and imprecision. Based on two trials (270 participants) from six up to 12 months, 50/130 (or 385 per 1000) individuals had recurrence of trigger finger in the steroid injection group compared with 8/140 (or 65 per 1000; range 35 to 127) in the open surgery group, RR 0.17 (95% CI 0.09 to 0.33), for an absolute risk difference that 29% fewer people had recurrence of symptoms with open surgery (60% fewer to 3% more individuals); relative change translates to improvement of 83% in the open surgery group (67% to 91% better). At one week, 9/49 (184 per 1000) people had pain on the palm of the hand in the steroid injection group compared with 38/56 (or 678 per 1000; ranging from 366 to 1000) in the open surgery group, RR 3.69 (95% CI 1.99 to 6.85), for an absolute risk difference that 49% more had pain with open surgery (33% to 66% more); relative change translates to worsening of 269% (585% to 99% worse) (one trial, 105 participants). Because of very low quality evidence from two trials we are uncertain whether open surgery improve resolution of trigger finger in the follow-up at six to 12 months, when compared with steroid injection (131/140 observed in the open surgery group compared with 80/130 in the control group; RR 1.48, 95% CI 0.79 to 2.76); evidence was downgraded due to study design flaws, inconsistency and imprecision. Low-quality evidence from two trials and few event rates (270 participants) from six up to 12 months of follow-up, we are uncertain whether open surgery increased the risk of adverse events (incidence of infection, tendon injury, flare, cutaneous discomfort and fat necrosis) (18/140 observed in the open surgery group compared with 17/130 in the control group; RR 1.02, 95% CI 0.57 to 1.84) and neurovascular injury (9/140 observed in the open surgery group compared with 4/130 in the control group; RR 2.17, 95% CI 0.7 to 6.77). Twelve participants (8 versus 4) did not complete the follow-up, and it was considered that they did not have a positive outcome in the data analysis. We are uncertain whether open surgery was more effective than steroid injection in improving hand function or participant satisfaction as studies did not report these outcomes. Low-quality evidence indicates that, compared with steroid injection, open surgical treatment in people with trigger finger, may result in a less recurrence rate from six up to 12 months following the treatment, although it increases the incidence of pain during the first follow-up week. We are uncertain about the effect of open surgery with regard to the resolution rate in follow-up at six to 12 months, compared with steroid injections, due high heterogeneity and few events occurred in the trials; we are uncertain too about the risk of adverse events and neurovascular injury because of a few events occurred in the studies. Hand function or participant satisfaction were not reported. Output:
This Cochrane Review is current to August 2017. We included 14 randomised controlled trials involving 1260 participants, totalling 1361 trigger fingers. Two studies compared open surgery versus steroid injections, five studies compared percutaneous surgery versus steroid injection, one study compared open surgery versus steroid injection plus hyaluronic acid injection, one study compared percutaneous surgery plus steroid injection versus steroid injection, five studies compared percutaneous surgery versus open surgery, one study compared endoscopic surgery versus open surgery and one study compared three types of skin incision to open surgery. The majority of participants were female (about 70%); they were aged between 16 and 88 years; and the mean follow-up of participants after the procedure was eight weeks to 23 months. Due to space constraints, the reporting of all results was limited to the main comparison — open surgery versus steroid injection — because open surgery is the oldest and the most widely used treatment method and considered as standard surgery, whereas steroid injection is the least invasive control treatment method as reported in the studies in this review and is often used as first-line treatment in clinical practice. Based on two trial (270 participants), compared with the steroid injection procedure: Resolution of trigger finger (lessening of symptoms with no recurrence): • 92 out of 100 people had resolution of symptoms with open surgery. • 61 out of 100 people had resolution of symptoms with steroid injection. Incidence of pain, assessed as the presence or absence of pain after the procedure was performed (at one week): • 49% more people had pain with open surgery (33% to 66% more). • 68 out of 100 people had pain with open surgery. • 19 out of 100 people had pain with steroid injection. Recurrence of the trigger finger (from six to 12 months): • 29% fewer people had recurrence of symptoms with open surgery (60% fewer to 3% more). • 7 out of 100 people had recurrence of symptoms with open surgery. • 39 out of 100 people had recurrence of symptoms with steroid injection. Adverse events: Adverse events including infections, tendon injuries, cutaneous discomfort, flare or fat necrosis at the procedure site, or neovascular events were uncommon in either treatment group. No study reported hand function or participant-reported treatment success or satisfaction. Very low quality evidence from two trials means we are uncertain whether open surgery improve resolution of trigger finger in comparison with steroid injection, due the risk of bias in the design of the studies, inconsistencies between studies and the small number of participants in studies. Low-quality evidence from two trials shows that open surgery may result in fewer recurrences of trigger finger compared with steroid injection procedure, although it increases the incidence of pain during the first week after the procedure. Evidence was downgraded to 'low' due to the risk of bias in the design and the small number of participants. No studies measured functional improvement or participant satisfaction in the comparison between open surgery and steroid injection. We are uncertain whether there is a difference in the risk of adverse events or neurovascular injury between treatments, as few events occurred in the studies. Only low and very low-quality evidence was found for other comparisons so we are uncertain if percutaneous surgery has any benefits over steroid injection, or if open surgery is better than steroid plus hyaluronic acid, or if one type of surgery is better than another.
CochranePLS433
***TASK*** the task is to simplify the input abstract of a biomedical literature ***INPUT*** the input is the abstract of a biomedical literature ***OUTPUT*** the output is the simplified abstract for the input abstract of a biomedical literature ***EXAMPLES*** Input: Output: ***EXAMPLES*** Input: Two trials (n = 190), at low risk of bias, were included in the review and both presented data on first time failure at the tooth level. Pooling of the data showed a statistically significant difference in favour of molar bands, with a hazard ratio of 2.92 (95% confidence intervals (CI) 1.80 to 4.72). No statistically significant heterogeneity was shown between the two studies. Data on first time failure at the patient level were also available and showed statistically different difference in favour of molar bands (risk ratio 2.30; 95% CI 1.56 to 3.41) (risk of event for molar tubes = 57%; risk of event for molar bands 25%). One trial presented data on decalcification again showing a statistically significant difference in favour of molar bands. No other adverse events identified. From the two well-designed and low risk of bias trials included in this review it was shown that the failure of molar tubes bonded with either a chemically-cured or light-cured adhesive was considerably higher than that of molar bands cemented with glass ionomer cement. One trial indicated that there was less decalcification with molar bands cemented with glass ionomer cement than with bonded molar tubes cemented with a light-cured adhesive. However, given there are limited data for this outcome, further evidence is required to draw more robust conclusions. Output: The evidence in this review, which was carried out together with Cochrane Oral Health, is up-to-date as of 15 February 2017. We included two studies that evaluated 190 participants. Both trials were conducted in the UK and both compared bonded molar tubes with molar bands. From the limited data of two studies at low risk of bias, it would appear that bonded molar tubes are associated with a higher failure rate than with molar bands. Input: Three RCTs, with 931 participants, tested different neoadjuvant treatments: RT alone; sequential RT and procarbazine, lomustine and vincristine (PCV) chemotherapy; PCV chemotherapy alone; and temozolomide chemotherapy alone. None of the studies blinded participants or personnel, and, therefore, are considered at high risk of performance and detection bias. The studies were otherwise at low risk of bias. One study, the European Organisation for Research and Treatment of Cancer (EORTC) trial, demonstrated a statistically significant overall survival (OS) benefit for RT plus PCV, with a median OS of 3.5 years compared with 2.6 years in the RT alone arm (P value = 0.018). This result was reported 10 years after the conclusion of the enrolment, and was not apparent in the original 2008 Cochrane review. Furthermore, with retrospective evaluation of biomarkers, codeletion of complete chromosome arms 1p and 19q and IDH-1 or -2 mutation were independent prognostic factors for OS in two of the RCTs (Radiation Therapy Oncology Group (RTOG) and EORTC), and were predictive for OS in one trial (RTOG). The third trial (NOA-04) evaluated these biomarkers prospectively and found them prognostic for progression-free survival. Early PCV, either before or after RT, appears to improve OS of participants with AO or AOA. Use of biomarkers including codeletion of chromosomes 1p and 19q with or without IDH-1 or -2 mutation identify a subset of people with increased sensitivity to combined PCV and RT. The important role of biomarkers was supported in all of the RCTs examined, and prospective evaluation should be undertaken in future studies. However, PCV was associated with significant grade 3 and 4 toxicities, and whether temozolomide can be substituted for this remains unclear. Output:
We searched the scientific literature up to March 2014 for studies of adults over 18 years of age with a diagnosis of anaplastic oligodendrogliomas, anaplastic oligoastrocytomas or anaplastic astrocytomas. After surgery, the participants had to have received radiotherapy alone, chemotherapy alone or radiotherapy plus chemotherapy. In the first review on this topic in 2009, we found two trials to include. In this update, we identified another trial for inclusion, and updates from the two previously included trials were taken into consideration. Three randomized controlled trials, which included 931 participants, assessed the role of chemotherapy alone or in addition to radiotherapy, or radiotherapy alone. One study was able to demonstrate a significant survival benefit for the addition of chemotherapy to radiotherapy after surgery, compared with radiotherapy alone. In addition, during examination of these brain tumour biopsy specimens, they found specific chromosome deletions and mutations in two studies, which helped to identify a group of participants with better survival outcomes. Furthermore, in one study, these specific chromosome deletions and mutations predicted which group of participants derived benefit from the addition of chemotherapy to radiotherapy after surgery. Evidence for giving radiotherapy and chemotherapy was of good quality, but sparse.
CochranePLS434
***TASK*** the task is to simplify the input abstract of a biomedical literature ***INPUT*** the input is the abstract of a biomedical literature ***OUTPUT*** the output is the simplified abstract for the input abstract of a biomedical literature ***EXAMPLES*** Input: Output: ***EXAMPLES*** Input: Two trials (n = 190), at low risk of bias, were included in the review and both presented data on first time failure at the tooth level. Pooling of the data showed a statistically significant difference in favour of molar bands, with a hazard ratio of 2.92 (95% confidence intervals (CI) 1.80 to 4.72). No statistically significant heterogeneity was shown between the two studies. Data on first time failure at the patient level were also available and showed statistically different difference in favour of molar bands (risk ratio 2.30; 95% CI 1.56 to 3.41) (risk of event for molar tubes = 57%; risk of event for molar bands 25%). One trial presented data on decalcification again showing a statistically significant difference in favour of molar bands. No other adverse events identified. From the two well-designed and low risk of bias trials included in this review it was shown that the failure of molar tubes bonded with either a chemically-cured or light-cured adhesive was considerably higher than that of molar bands cemented with glass ionomer cement. One trial indicated that there was less decalcification with molar bands cemented with glass ionomer cement than with bonded molar tubes cemented with a light-cured adhesive. However, given there are limited data for this outcome, further evidence is required to draw more robust conclusions. Output: The evidence in this review, which was carried out together with Cochrane Oral Health, is up-to-date as of 15 February 2017. We included two studies that evaluated 190 participants. Both trials were conducted in the UK and both compared bonded molar tubes with molar bands. From the limited data of two studies at low risk of bias, it would appear that bonded molar tubes are associated with a higher failure rate than with molar bands. Input: We included five trials with a total of 240 children aged one to 18 years with mild to moderate OSA (AHI 1 to 30 per hour). All trials were performed in specialised sleep medicine clinics at tertiary care centres. Follow-up time ranged from six weeks to four months. Three RCTs (n = 137) compared intranasal steroids against placebo; two RCTs compared oral montelukast against placebo (n = 103). We excluded one trial from the meta-analysis since the patients were not analysed as randomised. We also had concerns about selective reporting in another trial. We are uncertain about the difference in AHI (MD −3.18, 95% CI −8.70 to 2.35) between children receiving intranasal corticosteroids compared to placebo (2 studies, 75 participants; low-certainty evidence). In contrast, children receiving oral montelukast had a lower AHI (MD −3.41, 95% CI −5.36 to −1.45) compared to those in the placebo group (2 studies, 103 participants; moderate-certainty evidence). We are uncertain whether the secondary outcomes are different between children receiving intranasal corticosteroids compared to placebo: desaturation index (MD −2.12, 95% CI −4.27 to 0.04; 2 studies, 75 participants; moderate-certainty evidence), respiratory arousal index (MD −0.71, 95% CI −6.25 to 4.83; 2 studies, 75 participants; low-certainty evidence), and nadir oxygen saturation (MD 0.59%, 95% CI −1.09 to 2.27; 2 studies, 75 participants; moderate-certainty evidence). Children receiving oral montelukast had a lower respiratory arousal index (MD −2.89, 95% CI −4.68 to −1.10; 2 studies, 103 participants; moderate-certainty evidence) and nadir of oxygen saturation (MD 4.07, 95% CI 2.27 to 5.88; 2 studies, 103 participants; high-certainty evidence) compared to those in the placebo group. We are uncertain, however, about the difference in desaturation index (MD −2.50, 95% CI −5.53 to 0.54; 2 studies, 103 participants; low-certainty evidence) between the montelukast and placebo group. Adverse events were assessed and reported in all trials and were rare, of minor nature (e.g. nasal bleeding), and evenly distributed between study groups. No study examined the avoidance of surgical treatment for OSA as an outcome. There is insufficient evidence for the efficacy of intranasal corticosteroids for the treatment of OSA in children; they may have short-term beneficial effects on the desaturation index and oxygen saturation in children with mild to moderate OSA but the certainty of the benefit on the primary outcome AHI, as well as the respiratory arousal index, was low due to imprecision of the estimates and heterogeneity between studies. Montelukast has short-term beneficial treatment effects for OSA in otherwise healthy, non-obese, surgically untreated children (moderate certainty for primary outcome and moderate and high certainty, respectively, for two secondary outcomes) by significantly reducing the number of apnoeas, hypopnoeas, and respiratory arousals during sleep. In addition, montelukast was well tolerated in the children studied. The clinical relevance of the observed treatment effects remains unclear, however, because minimal clinically important differences are not yet established for polysomnography-based outcomes in children. Long-term efficacy and safety data on the use of anti-inflammatory medications for the treatment of OSA in childhood are still not available. In addition, patient-centred outcomes like concentration ability, vigilance, or school performance have not been investigated yet. There are currently no RCTs on the use of other kinds of anti-inflammatory medications for the treatment of OSA in children. Future RCTs should investigate sustainability of treatment effects, avoidance of surgical treatment for OSA, and long-term safety of anti-inflammatory medications for the treatment of OSA in children and include patient-centred outcomes. Output:
We included five studies in the review. These studies each included 25 to 62 children between one and 11 years of age with mild to moderate OSA treated at specialised sleep outpatient clinics. The included studies used two different types of anti-inflammatory medications. Seventy-five children were randomised to receive either intranasal corticosteroid nasal spray or placebo. One hundred and three children were randomised to either montelukast tablet or placebo. Three studies were supported by drug manufacturers. We are uncertain about the difference in the number of breathing pauses, episodes of shallow breathing, episodes with a lack of blood oxygen, or sleep disruption between children receiving corticosteroid nasal spray compared to placebo (2 studies involving 75 children). Children receiving montelukast tablets had fewer breathing pauses, fewer episodes of shallow breathing, and less sleep disruption compared to those treated with placebo (2 studies involving 103 children). However, we are uncertain about the difference in the number of episodes with a lack of blood oxygen between the montelukast and placebo group. Unintended effects were assessed in all trials, but were rare and of minor nature (e.g. nosebleeds). Serious unintended effects were not reported. The certainty of the evidence for corticosteroid nasal spray for the treatment of OSA was low for the primary outcome due to the wide range of the beneficial effect with some inconsistency of the effect between the two included studies. We excluded one study from the analysis due to serious concerns about the quality of the study results. The evidence for the use of montelukast tablets in the treatment of OSA was of moderate certainty for the primary outcome. There were concerns about the design and conduct of one study and some inconsistency of the effect between the two included studies. The evidence is current to October 2019.
CochranePLS435
***TASK*** the task is to simplify the input abstract of a biomedical literature ***INPUT*** the input is the abstract of a biomedical literature ***OUTPUT*** the output is the simplified abstract for the input abstract of a biomedical literature ***EXAMPLES*** Input: Output: ***EXAMPLES*** Input: Two trials (n = 190), at low risk of bias, were included in the review and both presented data on first time failure at the tooth level. Pooling of the data showed a statistically significant difference in favour of molar bands, with a hazard ratio of 2.92 (95% confidence intervals (CI) 1.80 to 4.72). No statistically significant heterogeneity was shown between the two studies. Data on first time failure at the patient level were also available and showed statistically different difference in favour of molar bands (risk ratio 2.30; 95% CI 1.56 to 3.41) (risk of event for molar tubes = 57%; risk of event for molar bands 25%). One trial presented data on decalcification again showing a statistically significant difference in favour of molar bands. No other adverse events identified. From the two well-designed and low risk of bias trials included in this review it was shown that the failure of molar tubes bonded with either a chemically-cured or light-cured adhesive was considerably higher than that of molar bands cemented with glass ionomer cement. One trial indicated that there was less decalcification with molar bands cemented with glass ionomer cement than with bonded molar tubes cemented with a light-cured adhesive. However, given there are limited data for this outcome, further evidence is required to draw more robust conclusions. Output: The evidence in this review, which was carried out together with Cochrane Oral Health, is up-to-date as of 15 February 2017. We included two studies that evaluated 190 participants. Both trials were conducted in the UK and both compared bonded molar tubes with molar bands. From the limited data of two studies at low risk of bias, it would appear that bonded molar tubes are associated with a higher failure rate than with molar bands. Input: Three RCTs and three CCTs (including 1291 children) investigated the prevention of VTE (low molecular weight heparin (LMWH) n = 134, antithrombin (AT) supplementation n = 37, low-dose warfarin n = 31, cryoprecipitate and/or fresh frozen plasma (FFP) supplementation n = 240, AT supplementation and LMWH n = 41). AT, cryoprecipitate and FFP were supplemented only in cases of AT or fibrinogen deficiency. Of the six included RCTs/CCTs, five investigated the prevention of VTE compared with no intervention (n = 737), and one CCT compared AT supplementation and LMWH with AT supplementation (n = 71). All studies had methodological limitations, and clinical heterogeneity between studies was noted. We found no significant effects of systemic treatments compared with no intervention in preventing (a)symptomatic VTE and no differences in adverse events (such as major and/or minor bleeding; none of the studies reported thrombocytopenia, heparin-induced thrombocytopenia (HIT), heparin-induced thrombocytopenia with thrombosis (HITT), death as a result of VTE, removal of CVC due to VTE, CVC-related infection, and post-thrombotic syndrome (PTS)) between experimental and control groups. Two studies with comparable participant groups and interventions were included for meta-analyses (n = 182). In the experimental group, 1/68 (1.5%) children were diagnosed with symptomatic VTE, as were 4/114 (3.5%) in the control group (best case scenario: risk ratio (RR) 0.65, 95% confidence interval (CI) 0.09 to 4.78). These studies also evaluated asymptomatic CVC-related VTE: In the experimental group, 22/68 (32.4%) were diagnosed with asymptomatic VTE, as were 35/114 (30.7%) in the control group (best case scenario: RR 1.02, 95% CI 0.40 to 2.55). Heterogeneity was substantial for this analysis: I2 = 73%. The attribution of LMWH to AT supplementation resulted in a significant reduction in symptomatic VTE (Fisher's exact test, two-sided P = 0.028) without bleeding complications; asymptomatic VTE, thrombocytopenia, HIT, HITT, death as a result of VTE, removal of CVC due to VTE, CVC-related infection and PTS were not assessed. Four cohort studies were included for the evaluation of adverse events. Three studies provided information on bleeding episodes: One participant developed an ischaemo-haemorrhagic stroke. One study provided information on other adverse events: None occurred. We found no significant effects of systemic treatments compared with no intervention in preventing (a)symptomatic VTE in paediatric oncology patients with CVCs. However, this could be a result of the low number of included participants, which resulted in low power. In one CCT, which compared one systemic treatment with another systemic treatment, we identified a significant reduction in symptomatic VTE with the addition of LMWH to AT supplementation. All studies investigated the prevalence of major and/or minor bleeding episodes, and none found a significant difference between study groups. None of the studies reported thrombocytopenia, HIT, HITT, death as a result of VTE, removal of CVC due to VTE, CVC-related infection or PTS among participants. On the basis of currently available evidence, we are not able to give recommendations for clinical practise. Additional well-designed international RCTs are needed to further explore the effects of systemic treatments in preventing VTE. Future studies should aim for adequate power with attainable sample sizes. The incidence of symptomatic VTE is relatively low; therefore, it might be necessary to select participants with thrombotic risk factors or to investigate asymptomatic VTE instead. Output:
In this review, we investigated whether systemic treatments can prevent thrombosis. We identified six studies; two studies investigated low molecular weight heparins, one antithrombin supplementation and one cryoprecipitate and/or fresh frozen plasma supplementation; one study compared antithrombin supplementation with low molecular weight heparin and antithrombin supplementation, and another investigated warfarin. The addition of low molecular weight heparins to antithrombin supplementation did result in a lower number of symptomatic thromboses. This was statistically significant. We could not detect an effect of systemic preventive treatments in comparison with no treatment, and no difference was noted in the number of participants who suffered from major or minor bleeding. However, the overall number of participants was very small; a similar study with a larger population of participants might yield different results.
CochranePLS436
***TASK*** the task is to simplify the input abstract of a biomedical literature ***INPUT*** the input is the abstract of a biomedical literature ***OUTPUT*** the output is the simplified abstract for the input abstract of a biomedical literature ***EXAMPLES*** Input: Output: ***EXAMPLES*** Input: Two trials (n = 190), at low risk of bias, were included in the review and both presented data on first time failure at the tooth level. Pooling of the data showed a statistically significant difference in favour of molar bands, with a hazard ratio of 2.92 (95% confidence intervals (CI) 1.80 to 4.72). No statistically significant heterogeneity was shown between the two studies. Data on first time failure at the patient level were also available and showed statistically different difference in favour of molar bands (risk ratio 2.30; 95% CI 1.56 to 3.41) (risk of event for molar tubes = 57%; risk of event for molar bands 25%). One trial presented data on decalcification again showing a statistically significant difference in favour of molar bands. No other adverse events identified. From the two well-designed and low risk of bias trials included in this review it was shown that the failure of molar tubes bonded with either a chemically-cured or light-cured adhesive was considerably higher than that of molar bands cemented with glass ionomer cement. One trial indicated that there was less decalcification with molar bands cemented with glass ionomer cement than with bonded molar tubes cemented with a light-cured adhesive. However, given there are limited data for this outcome, further evidence is required to draw more robust conclusions. Output: The evidence in this review, which was carried out together with Cochrane Oral Health, is up-to-date as of 15 February 2017. We included two studies that evaluated 190 participants. Both trials were conducted in the UK and both compared bonded molar tubes with molar bands. From the limited data of two studies at low risk of bias, it would appear that bonded molar tubes are associated with a higher failure rate than with molar bands. Input: Three trials with a total of 287 participants operated on for Type I or II TAAA were included. In the first trial of 98 participants, neurological deficits in the lower extremities occurred in 14 (30%) of CSFD group and 17 (33%) controls. The deficit was observed within 24 hours of the operation in 21 (68%), and from three to 22 days in 10 (32%) participants. CSFD did not have a significant benefit in preventing ischaemic injury to the spinal cord. The second trial of 33 participants used a combination of CSFD and intrathecal papaverine. It showed a statistically significant reduction in the rate of postoperative neurological deficit (P = 0.039), compared to controls. Analysis was undertaken after only one third of the estimated sample size had entered the trial. In the third trial TAAA repair was performed on 145 participants. CSFD was initiated during the operation and continued for 48 hours after surgery. Paraplegia or paraparesis occurred in 9 of 74 participants (12.2%) in the control group versus 2 of 82 participants (2.7%) receiving CSFD (P = 0.03). Overall, CSFD resulted in an 80% reduction in the relative risk of postoperative deficits. Meta-analysis showed an odds ratio (OR) of 0.48 (95 % confidence interval (CI) 0.25 to 0.92). For CSFD-only trials, OR was 0.57 (95% CI 0.28 to 1.17) and for intention-to-treat analysis in CSFD-only studies, the OR remained unchanged. There are limited data supporting the role of CSFD in thoracic and thoracoabdominal aneurysm surgery for prevention of neurological injury. Further clinical and experimental studies are indicated. Output:
The available evidence does not fully establish CSF drainage as a method of protection. The review authors made a thorough search of the medical literature and identified three randomised trials involving a total of 287 participants operated on for high-risk thoracoabdominal aortic aneurysms. All of the studies used CSF drainage in addition to other measures of spinal cord protection. In the first trial of 98 patients, neurological deficits in the lower extremities occurred in about one third of patients with or without drainage. The deficit was observed within 24 hours of the operation in 21 (68%), and from three to 22 days in 10 (32%). The second trial of 33 patients reported that a combination of CSF drainage and papaverine in the region of the spinal cord (intrathecally) reduced the rate of postoperative neurological deficit compared to controls. In the third trial involving 145 patients, drainage was begun during the operation and continued for 48 hours after surgery. Paraplegia or paraparesis occurred less with CSF drainage (2.7% of patients with drainage versus 12.2% in the control group).
CochranePLS437
***TASK*** the task is to simplify the input abstract of a biomedical literature ***INPUT*** the input is the abstract of a biomedical literature ***OUTPUT*** the output is the simplified abstract for the input abstract of a biomedical literature ***EXAMPLES*** Input: Output: ***EXAMPLES*** Input: Two trials (n = 190), at low risk of bias, were included in the review and both presented data on first time failure at the tooth level. Pooling of the data showed a statistically significant difference in favour of molar bands, with a hazard ratio of 2.92 (95% confidence intervals (CI) 1.80 to 4.72). No statistically significant heterogeneity was shown between the two studies. Data on first time failure at the patient level were also available and showed statistically different difference in favour of molar bands (risk ratio 2.30; 95% CI 1.56 to 3.41) (risk of event for molar tubes = 57%; risk of event for molar bands 25%). One trial presented data on decalcification again showing a statistically significant difference in favour of molar bands. No other adverse events identified. From the two well-designed and low risk of bias trials included in this review it was shown that the failure of molar tubes bonded with either a chemically-cured or light-cured adhesive was considerably higher than that of molar bands cemented with glass ionomer cement. One trial indicated that there was less decalcification with molar bands cemented with glass ionomer cement than with bonded molar tubes cemented with a light-cured adhesive. However, given there are limited data for this outcome, further evidence is required to draw more robust conclusions. Output: The evidence in this review, which was carried out together with Cochrane Oral Health, is up-to-date as of 15 February 2017. We included two studies that evaluated 190 participants. Both trials were conducted in the UK and both compared bonded molar tubes with molar bands. From the limited data of two studies at low risk of bias, it would appear that bonded molar tubes are associated with a higher failure rate than with molar bands. Input: We included 13 RCTs, with a total of 662 participants. We report the results of intention-to-treat analyses (ITT) here. Our primary outcomes of interest were as follows: Participant-rated global improvement, Percentage of participants reaching Psoriasis Area and Severity Index (PASI) 75 (which meant equal to or more than 75% reduction in PASI score), Withdrawal due to side-effects, and Clearance rate. In one RCT of NB-UVB compared with oral PUVA in participants with CPP, the difference in PASI 75 was not statistically significant (risk ratio (RR) 0.91, 95% confidence interval (CI) 0.63 to 1.32; N = 51; low quality). In three other RCTs of CPP, the clearance rates were inconsistent because in one, there was no difference between the groups (RR 1.01, 95% CI 0.91 to 1.12; N = 54), and in the other two, the clearance rates were statistically significantly in favour of oral PUVA: RR 0.66, 95% CI 0.47 to 0.93; N = 93 and RR 0.75, 95% CI 0.59 to 0.96; N = 100, respectively. Pooled data from these three studies indicated that withdrawals due to adverse events were not significantly different between either group (RR 0.71, 95% CI 0.20 to 2.54; N = 247; low quality). The evidence from the comparison of NB-UVB with bath PUVA in terms of clearance rate for CPP was also inconsistent: Pooled data from two left-right body comparison RCTs found no significant difference between the NB-UVB and bath PUVA groups (RR 1.79, 95% CI 0.46 to 6.91; N = 92; low quality), while a parallel RCT favoured bath PUVA (RR 0.18, 95% CI 0.05 to 0.71; N = 36; low quality). In participants with PPP, one RCT found there were no significant differences between NB-UVB treated sides and topical PUVA treated sides in terms of clearance rate (RR 0.09, 95% CI 0.01 to 1.56; N = 50; low quality). Two RCTs found NB-UVB plus retinoid (re-NB-UVB) and PUVA plus retinoid (re-PUVA) had similar effects for treating people with CPP or GP in terms of clearance rate (RR 0.93, 95% CI 0.79 to 1.10; N = 90; low quality). One RCT in people with CPP found no significant differences between NB-UVB and selective BB-UVB in terms of clearance rate (RR 1.40, 95% CI 0.92 to 2.13; N = 100; low quality) and withdrawals due to adverse events (RR 3.00, 95% CI 0.32 to 27.87; N = 100; low quality). No studies reported our primary outcomes for NB-UVB compared with conventional BB-UVB. Current evidence is very heterogeneous and needs to be interpreted with caution. The clearance rate between oral PUVA and NB-UVB is inconsistent among the included studies. Evidence regarding NB-UVB versus bath PUVA is also inconsistent. Re-NB-UVB and re-PUVA are similarly effective for treating people with CPP or GP. In practice, NB-UVB may be more convenient to use since exogenous photosensitiser is not required before phototherapy. NB-UVB is considered ineffective for PPP in clinical practice, and a small RCT did not detect a statistically significant difference between NB-UVB and topical PUVA for clearing PPP. NB-UVB seemed to be similar to selective BB-UVB for clearing CPP. Larger prospective studies are needed to confirm the long-term safety of NB-UVB. Output:
This review included 13 small randomised controlled trials (RCT), with a total of 662 participants. Most of these were of poor methodological quality. For treating CPP, the clearance rate between the NB-UVB and oral PUVA groups were inconsistent in three RCTs. In one, there was no difference between the groups, and in the other two, the clearance rate was in favour of oral PUVA. The evidence from the comparison of NB-UVB with bath PUVA in terms of clearance rate was also inconsistent: Pooled data from two left-right body comparison RCTs found no significant difference between the two groups, while another RCT favoured bath PUVA. Two RCTs found NB-UVB plus retinoid (re-NB-UVB) and PUVA plus retinoid (re-PUVA) had similar effects for treating people with CPP or guttate psoriasis. One RCT found no significant differences between NB-UVB and selective BB-UVB for clearing CPP or in the number of withdrawals due to side-effects. In participants with PPP, one RCT found there were no statistically significant differences between NB-UVB treated sides and topical PUVA treated sides in terms of clearance rate. In summary, NB-UVB may be preferred to oral or bath PUVA because it is more convenient to use. NB-UVB seemed to be equal to selective BB-UVB for clearing CPP. Evidence regarding NB-UVB and conventional BB-UVB is limited. The long-term safety of NB-UVB needs to be confirmed. The efficacy of NB-UVB for clearing PPP needs to be confirmed in future studies.
CochranePLS438
***TASK*** the task is to simplify the input abstract of a biomedical literature ***INPUT*** the input is the abstract of a biomedical literature ***OUTPUT*** the output is the simplified abstract for the input abstract of a biomedical literature ***EXAMPLES*** Input: Output: ***EXAMPLES*** Input: Two trials (n = 190), at low risk of bias, were included in the review and both presented data on first time failure at the tooth level. Pooling of the data showed a statistically significant difference in favour of molar bands, with a hazard ratio of 2.92 (95% confidence intervals (CI) 1.80 to 4.72). No statistically significant heterogeneity was shown between the two studies. Data on first time failure at the patient level were also available and showed statistically different difference in favour of molar bands (risk ratio 2.30; 95% CI 1.56 to 3.41) (risk of event for molar tubes = 57%; risk of event for molar bands 25%). One trial presented data on decalcification again showing a statistically significant difference in favour of molar bands. No other adverse events identified. From the two well-designed and low risk of bias trials included in this review it was shown that the failure of molar tubes bonded with either a chemically-cured or light-cured adhesive was considerably higher than that of molar bands cemented with glass ionomer cement. One trial indicated that there was less decalcification with molar bands cemented with glass ionomer cement than with bonded molar tubes cemented with a light-cured adhesive. However, given there are limited data for this outcome, further evidence is required to draw more robust conclusions. Output: The evidence in this review, which was carried out together with Cochrane Oral Health, is up-to-date as of 15 February 2017. We included two studies that evaluated 190 participants. Both trials were conducted in the UK and both compared bonded molar tubes with molar bands. From the limited data of two studies at low risk of bias, it would appear that bonded molar tubes are associated with a higher failure rate than with molar bands. Input: Twenty one eligible studies were identified with a total of 1525 participants. About half of the trials had low risk of bias for randomisation and allocation concealment. One small trial showed that biofeedback plus exercises was better than exercises alone (RR for failing to achieve full continence 0.70, 95% CI 0.52 to 0.94). One small trial showed that adding biofeedback to electrical stimulation was better than electrical stimulation alone (RR for failing to achieve full continence 0.47, 95% CI 0.33 to 0.65). The combined data of two trials showed that the number of people failing to achieve full continence was significantly lower when electrical stimulation was added to biofeedback compared against biofeedback alone (RR 0.60, 95% CI 0.46 to 0.78). Sacral nerve stimulation was better than conservative management which included biofeedback and PFMT (at 12 months the incontinence episodes were significantly fewer with sacral nerve stimulation (MD 6.30, 95% CI 2.26 to 10.34). There was not enough evidence as to whether there was a difference in outcome between any method of biofeedback or exercises. There are suggestions that rectal volume discrimination training improves continence more than sham training. Further conclusions are not warranted from the available data. The limited number of identified trials together with methodological weaknesses of many do not allow a definitive assessment of the role of anal sphincter exercises and biofeedback therapy in the management of people with faecal incontinence. We found some evidence that biofeedback and electrical stimulation may enhance the outcome of treatment compared to electrical stimulation alone or exercises alone. Exercises appear to be less effective than an implanted sacral nerve stimulator. While there is a suggestion that some elements of biofeedback therapy and sphincter exercises may have a therapeutic effect, this is not certain. Larger well-designed trials are needed to enable safe conclusions. Output:
There was some evidence from trials suggesting that these treatments are helpful. If patients who have tried and failed other simpler treatments, such as changing their diet or using medications, are selected then biofeedback using computer equipment or rectal balloon is more beneficial than exercises alone. Exercises and electrical stimulation used in the anus may be more helpful than vaginal exercises for women with faecal incontinence after childbirth. About half of the 21 trials were at low risk of bias. They compared different combinations of treatments and different outcome measures, making comparison between them difficult. However, a small number of the larger recent trials provide better evidence.
CochranePLS439
***TASK*** the task is to simplify the input abstract of a biomedical literature ***INPUT*** the input is the abstract of a biomedical literature ***OUTPUT*** the output is the simplified abstract for the input abstract of a biomedical literature ***EXAMPLES*** Input: Output: ***EXAMPLES*** Input: Two trials (n = 190), at low risk of bias, were included in the review and both presented data on first time failure at the tooth level. Pooling of the data showed a statistically significant difference in favour of molar bands, with a hazard ratio of 2.92 (95% confidence intervals (CI) 1.80 to 4.72). No statistically significant heterogeneity was shown between the two studies. Data on first time failure at the patient level were also available and showed statistically different difference in favour of molar bands (risk ratio 2.30; 95% CI 1.56 to 3.41) (risk of event for molar tubes = 57%; risk of event for molar bands 25%). One trial presented data on decalcification again showing a statistically significant difference in favour of molar bands. No other adverse events identified. From the two well-designed and low risk of bias trials included in this review it was shown that the failure of molar tubes bonded with either a chemically-cured or light-cured adhesive was considerably higher than that of molar bands cemented with glass ionomer cement. One trial indicated that there was less decalcification with molar bands cemented with glass ionomer cement than with bonded molar tubes cemented with a light-cured adhesive. However, given there are limited data for this outcome, further evidence is required to draw more robust conclusions. Output: The evidence in this review, which was carried out together with Cochrane Oral Health, is up-to-date as of 15 February 2017. We included two studies that evaluated 190 participants. Both trials were conducted in the UK and both compared bonded molar tubes with molar bands. From the limited data of two studies at low risk of bias, it would appear that bonded molar tubes are associated with a higher failure rate than with molar bands. Input: Thirty nine randomised trials were identified for inclusion in the review. They were generally small and of poor or moderate quality reporting data on only few outcomes. Confidence intervals were all wide. Using a urinary catheter versus not using one The data from five trials were heterogeneous but tended to indicate a higher risk of (re)catheterisation if a catheter was not used postoperatively. The data gave only an imprecise estimate of any difference in urinary tract infection. Urethral catheterisation versus suprapubic catheterisation In six trials, a greater number of people needed to be recatheterised if a urethral catheter rather than a suprapubic one was used following surgery (RR 3.66, 95% CI 1.41 to 9.49). Shorter postoperative duration of catheter use versus longer duration In 11 trials, the seven trials with data suggested fewer urinary tract infections when a catheter was removed earlier (for example 1 versus 3 days, RR 0.50, 95% CI 0.29 to 0.87) with no pattern in respect of catheterisation. Clamp and release policies before catheter removal versus immediate catheter removal In a single small trial, the clamp-and-release group showed a significantly greater incidence of urinary tract infections (RR 4.00, 95% 1.55 to 10.29) and a delay in return to normal voiding (RR 2.50, 95% CI 1.16 to 5.39). Despite reviewing 39 eligible trials, few firm conclusions could be reached because of the multiple comparisons considered, the small size of individual trials, and their low quality. Whether or not to use a particular policy is usually a trade-off between the risks of morbidity (especially infection) and risks of recatheterisation. Output:
Five trials suggested that it might be better to use a catheter after surgery than not to use one as fewer people needed to be re-catheterised if a catheter was used at first. Information from six trials suggested that fewer people needed to be re-catheterised for urinary retention if a suprapubic catheter was used instead of a urethral one. People in up to 11 trials had fewer urinary tract infections if the catheters were removed sooner rather than later. Although 39 trials were included in the review in total, the evidence in general was poor and came from small studies, which often did not provide enough information to draw firm conclusions. Much larger trials with many more participants must be conducted.
CochranePLS440
***TASK*** the task is to simplify the input abstract of a biomedical literature ***INPUT*** the input is the abstract of a biomedical literature ***OUTPUT*** the output is the simplified abstract for the input abstract of a biomedical literature ***EXAMPLES*** Input: Output: ***EXAMPLES*** Input: Two trials (n = 190), at low risk of bias, were included in the review and both presented data on first time failure at the tooth level. Pooling of the data showed a statistically significant difference in favour of molar bands, with a hazard ratio of 2.92 (95% confidence intervals (CI) 1.80 to 4.72). No statistically significant heterogeneity was shown between the two studies. Data on first time failure at the patient level were also available and showed statistically different difference in favour of molar bands (risk ratio 2.30; 95% CI 1.56 to 3.41) (risk of event for molar tubes = 57%; risk of event for molar bands 25%). One trial presented data on decalcification again showing a statistically significant difference in favour of molar bands. No other adverse events identified. From the two well-designed and low risk of bias trials included in this review it was shown that the failure of molar tubes bonded with either a chemically-cured or light-cured adhesive was considerably higher than that of molar bands cemented with glass ionomer cement. One trial indicated that there was less decalcification with molar bands cemented with glass ionomer cement than with bonded molar tubes cemented with a light-cured adhesive. However, given there are limited data for this outcome, further evidence is required to draw more robust conclusions. Output: The evidence in this review, which was carried out together with Cochrane Oral Health, is up-to-date as of 15 February 2017. We included two studies that evaluated 190 participants. Both trials were conducted in the UK and both compared bonded molar tubes with molar bands. From the limited data of two studies at low risk of bias, it would appear that bonded molar tubes are associated with a higher failure rate than with molar bands. Input: Ten studies (3340 participants) were included in the review. Seven studies compared aripiprazole monotherapy versus placebo (2239 participants); two of these included a third comparison arm—one study used lithium (485 participants) and the other used haloperidol (480 participants). Two studies compared aripiprazole as an adjunctive treatment to valproate or lithium versus placebo as an adjunctive treatment (754 participants), and one study compared aripiprazole versus haloperidol (347 participants). The overall risk of bias was unclear. A high dropout rate from most trials (> 20% for each intervention in eight of the trials) may have affected the estimates of relative efficacy. Evidence shows that aripiprazole was more effective than placebo in reducing manic symptoms in adults and children/adolescents at three and four weeks but not at six weeks (Young Mania Rating Scale (YMRS); mean difference (MD) at three weeks (random effects) -3.66, 95% confidence interval (CI) -5.82 to -2.05; six studies; N = 1819, moderate quality evidence) - a modest difference. Aripiprazole was compared with other drug treatments in three studies in adults—lithium was used in one study and haloperidol in two studies. No statistically significant differences between aripiprazole and other drug treatments in reducing manic symptoms were noted at three weeks (YMRS MD at three weeks (random effects) 0.07, 95% CI -1.24 to 1.37; three studies; N = 972, moderate quality evidence) or at any other time point up to and including 12 weeks. Compared with placebo, aripiprazole caused more movement disorders, as measured on the Simpson Angus Scale (SAS), on the Barnes Akathisia Scale (BAS) and by participant-reported akathisia (high quality evidence), with more people requiring treatment with anticholinergic medication (risk ratios (random effects) 3.28, 95% CI 1.82 to 5.91; two studies; N = 730, high quality evidence). Aripiprazole also led to more gastrointestinal disturbances (nausea (high quality evidence), and constipation) and caused more children/adolescents to have a prolactin level that fell below the lower limit of normal. Significant heterogeneity was present in the meta-analysis of movement disorders associated with aripiprazole and other treatments and was most likely due to the different side effect profiles of lithium and haloperidol. At the three-week time point, meta-analysis was not possible because of lack of data; however, at 12 weeks, haloperidol resulted in significantly more movement disorders than aripiprazole, as measured on the SAS, the BAS and the Abnormal Involuntary Movement Scale (AIMS) and by participant-reported akathisia. By 12 weeks, investigators reported no difference between aripiprazole and lithium (SAS, BAS, AIMS), except in terms of participant-reported akathisia (RR 2.97, 95% CI 1.37 to 6.43; one study; N = 313). Aripiprazole is an effective treatment for mania in a population that includes adults, children and adolescents, although its use leads to gastrointestinal disturbances and movement disorders. Comparative trials with medicines other than haloperidol and lithium are few, so the precise place of aripiprazole in therapy remains unclear. Output:
Ten studies are included (3340 participants). Most studies compared aripiprazole versus placebo, but some researchers compared aripiprazole versus haloperidol (two studies) and versus lithium (one study). Two studies examined the effect of adding aripiprazole to another treatment (valproate or lithium) and compared this combination versus placebo combined with these other treatments. We assessed the overall risk of bias in the ten studies as unclear. The main measure of effect was the mean change on the Young Mania Rating Scale from the start to the end of the trial; this tool is used by clinicians to assess the severity of mania. After three weeks of treatment, aripiprazole was better than placebo at reducing the severity of mania when used on its own or when added to other mood stabilisers. The effect was modest. However, aripiprazole caused more inner restlessness (akathisia), nausea, and constipation than placebo. Aripiprazole was similarly effective in reducing the symptoms of mania when compared with other drug treatments (haloperidol and lithium). Aripiprazole caused fewer movement disorders and less raised prolactin (a hormone secreted by the pituitary gland) than haloperidol. People taking aripiprazole were more likely to remain on treatment than those taking haloperidol but were no more or less likely than those taking placebo or lithium. The main reason for the difference in dropouts between aripiprazole and haloperidol groups was the adverse effects associated with haloperidol. In summary, aripiprazole is an effective treatment for mania when compared with placebo. This finding is based on studies that included mixed populations (i.e. children, adolescents and adults). For the adult population, studies have directly compared aripiprazole versus haloperidol, lithium and placebo, but evidence obtained for treatment of the child and adolescent population is available only from placebo-controlled studies. Given the lack of evidence obtained by comparing aripiprazole versus other drugs, its exact place in therapy is unclear. Further studies focused on particular populations are needed to determine whether this treatment is equally effective in different age groups.
CochranePLS441
***TASK*** the task is to simplify the input abstract of a biomedical literature ***INPUT*** the input is the abstract of a biomedical literature ***OUTPUT*** the output is the simplified abstract for the input abstract of a biomedical literature ***EXAMPLES*** Input: Output: ***EXAMPLES*** Input: Two trials (n = 190), at low risk of bias, were included in the review and both presented data on first time failure at the tooth level. Pooling of the data showed a statistically significant difference in favour of molar bands, with a hazard ratio of 2.92 (95% confidence intervals (CI) 1.80 to 4.72). No statistically significant heterogeneity was shown between the two studies. Data on first time failure at the patient level were also available and showed statistically different difference in favour of molar bands (risk ratio 2.30; 95% CI 1.56 to 3.41) (risk of event for molar tubes = 57%; risk of event for molar bands 25%). One trial presented data on decalcification again showing a statistically significant difference in favour of molar bands. No other adverse events identified. From the two well-designed and low risk of bias trials included in this review it was shown that the failure of molar tubes bonded with either a chemically-cured or light-cured adhesive was considerably higher than that of molar bands cemented with glass ionomer cement. One trial indicated that there was less decalcification with molar bands cemented with glass ionomer cement than with bonded molar tubes cemented with a light-cured adhesive. However, given there are limited data for this outcome, further evidence is required to draw more robust conclusions. Output: The evidence in this review, which was carried out together with Cochrane Oral Health, is up-to-date as of 15 February 2017. We included two studies that evaluated 190 participants. Both trials were conducted in the UK and both compared bonded molar tubes with molar bands. From the limited data of two studies at low risk of bias, it would appear that bonded molar tubes are associated with a higher failure rate than with molar bands. Input: Two RCTs evaluated urokinase lock treatment with concomitant systemic antibiotics (n = 56) versus systemic antibiotics alone (n = 48), and one CCT evaluated ethanol lock treatment with concomitant systemic antibiotics (n = 15) versus systemic antibiotics alone (n = 13). No RCTs or CCTs evaluating antibiotic lock treatments were identified. All studies had methodological limitations and clinical heterogeneity between studies was present. We found no evidence of significant difference between ethanol or urokinase lock treatments with concomitant systemic antibiotics and systemic antibiotics alone regarding the number of participants cured, the number of recurrent CVC-related infections, the number of days until the first negative blood culture, the number of CVCs prematurely removed, ICU admission and sepsis. Not all studies were included in all analyses. No adverse events occurred in the five publications of cohort studies (one cohort was included in two publications) assessing this outcome; CVC malfunctioning occurred in three out of five publications of cohort studies assessing this outcome. No significant effect of urokinase or ethanol lock in addition to systemic antibiotics was found. However, this could be due to low power or a too-short follow-up. The cohort studies identified no adverse events; some cohort studies reported CVC malfunctioning. No RCTs or CCTs were published on antibiotic lock treatment alone. More well-designed RCTs are needed to further explore the effect of antibiotic or other lock treatments in the treatment of CVC-related infections in children with cancer. Output:
In this review we investigated the effect of lock treatments on CVC-related infections. We identified three studies: two investigating the effect of urokinase lock treatments in addition to antibiotics and one study investigating the effect of ethanol locks in addition to antibiotics. We could detect no effect of urokinase or ethanol locks. However, the groups were very small. A similar study with a larger participant population might have different results.
CochranePLS442
***TASK*** the task is to simplify the input abstract of a biomedical literature ***INPUT*** the input is the abstract of a biomedical literature ***OUTPUT*** the output is the simplified abstract for the input abstract of a biomedical literature ***EXAMPLES*** Input: Output: ***EXAMPLES*** Input: Two trials (n = 190), at low risk of bias, were included in the review and both presented data on first time failure at the tooth level. Pooling of the data showed a statistically significant difference in favour of molar bands, with a hazard ratio of 2.92 (95% confidence intervals (CI) 1.80 to 4.72). No statistically significant heterogeneity was shown between the two studies. Data on first time failure at the patient level were also available and showed statistically different difference in favour of molar bands (risk ratio 2.30; 95% CI 1.56 to 3.41) (risk of event for molar tubes = 57%; risk of event for molar bands 25%). One trial presented data on decalcification again showing a statistically significant difference in favour of molar bands. No other adverse events identified. From the two well-designed and low risk of bias trials included in this review it was shown that the failure of molar tubes bonded with either a chemically-cured or light-cured adhesive was considerably higher than that of molar bands cemented with glass ionomer cement. One trial indicated that there was less decalcification with molar bands cemented with glass ionomer cement than with bonded molar tubes cemented with a light-cured adhesive. However, given there are limited data for this outcome, further evidence is required to draw more robust conclusions. Output: The evidence in this review, which was carried out together with Cochrane Oral Health, is up-to-date as of 15 February 2017. We included two studies that evaluated 190 participants. Both trials were conducted in the UK and both compared bonded molar tubes with molar bands. From the limited data of two studies at low risk of bias, it would appear that bonded molar tubes are associated with a higher failure rate than with molar bands. Input: Of the 15 selected trials, three were rated low risk of bias. Three TPE themes emerged. Advice focusing on activation: There is moderate quality evidence (one trial, 348 participants) that an educational video of advice focusing on activation was more beneficial for acute whiplash-related pain when compared with no treatment at intermediate-term [RR 0.79 (95% confidence interval (CI) 0.59 to 1.06)] but not long-term follow-up [0.89 (95% CI, 0.65 to 1.21)]. There is low quality evidence (one trial, 102 participants) that a whiplash pamphlet on advice focusing on activation is less beneficial for pain reduction, or no different in improving function and global perceived improvement from generic information given out in emergency care (control) for acute whiplash at short- or intermediate-term follow-up. Low to very low quality evidence (nine trials using diverse educational approaches) showed either no evidence of benefit or difference for varied outcomes. Advice focusing on pain & stress coping skills and workplace ergonomics: Very low quality evidence (three trials, 243 participants) favoured other treatment or showed no difference spanning numerous follow-up periods and disorder subtypes.  Low quality evidence (one trial, 192 participants) favoured specific exercise training for chronic neck pain at short-term follow-up. Self-care strategies: Very low quality evidence (one trial, 58 participants) indicated that self-care strategies did not relieve pain for acute to chronic neck pain at short-term follow-up. With the exception of one trial, this review has not shown effectiveness for educational interventions, including advice to activate, advice on stress-coping skills, workplace ergonomics and self-care strategies. Future research should be founded on sound adult learning theory and learning skill acquisition. Output:
Electronic bibliographic databases were searched up to 11 July 2010. Fifteen randomised controlled trials (1660 participants) looking at the effectiveness of patient education strategies for neck disorders were included. Of the 15 selected trials, only one trial depicting moderate quality evidence favoured the educational video for acute WAD. The remaining trials showed that patient education trials did not demonstrate evidence of benefit or favoured the comparison treatment being exercise for pain. Other outcomes were less frequently reported and did not yield results that diverged from those associated with pain. Participants who received advice to stay active reported little or no difference in pain compared with those who received no treatment, treatments focusing on rest, treatments focusing on exercise, physiotherapy and cognitive behavioural therapy. Additionally, stress-management therapies, when compared with no treatment, did not seem to have an effect on pain intensity in patients with mechanical neck disorders. Finally, self-care strategies (ergonomics, exercise, self-care, relaxation) do not seem to have an effect on pain when compared with no treatment. No adverse events were reported in the trials. In summary, the review authors concluded that there is no strong evidence for the effectiveness of educational interventions in various neck disorders.
CochranePLS443
***TASK*** the task is to simplify the input abstract of a biomedical literature ***INPUT*** the input is the abstract of a biomedical literature ***OUTPUT*** the output is the simplified abstract for the input abstract of a biomedical literature ***EXAMPLES*** Input: Output: ***EXAMPLES*** Input: Two trials (n = 190), at low risk of bias, were included in the review and both presented data on first time failure at the tooth level. Pooling of the data showed a statistically significant difference in favour of molar bands, with a hazard ratio of 2.92 (95% confidence intervals (CI) 1.80 to 4.72). No statistically significant heterogeneity was shown between the two studies. Data on first time failure at the patient level were also available and showed statistically different difference in favour of molar bands (risk ratio 2.30; 95% CI 1.56 to 3.41) (risk of event for molar tubes = 57%; risk of event for molar bands 25%). One trial presented data on decalcification again showing a statistically significant difference in favour of molar bands. No other adverse events identified. From the two well-designed and low risk of bias trials included in this review it was shown that the failure of molar tubes bonded with either a chemically-cured or light-cured adhesive was considerably higher than that of molar bands cemented with glass ionomer cement. One trial indicated that there was less decalcification with molar bands cemented with glass ionomer cement than with bonded molar tubes cemented with a light-cured adhesive. However, given there are limited data for this outcome, further evidence is required to draw more robust conclusions. Output: The evidence in this review, which was carried out together with Cochrane Oral Health, is up-to-date as of 15 February 2017. We included two studies that evaluated 190 participants. Both trials were conducted in the UK and both compared bonded molar tubes with molar bands. From the limited data of two studies at low risk of bias, it would appear that bonded molar tubes are associated with a higher failure rate than with molar bands. Input: Results of the Cochrane review No studies meeting the study design criteria were identified for inclusion in this Cochrane review. Results of thematic synthesis In total, 49 studies and pieces of literature meeting the same population, intervention and outcome criteria as the Cochrane review, but identified from the broader literature providing evidence on policy implementation and consumer experiences, were included and formed the basis of a thematic synthesis, and which is presented in appendices to this Cochrane review. The thematic synthesis indicates that ideally communication may be considered as a longitudinal multicomponent programme, ensuring that notification and support are coordinated; that communication is tailored and responsive to need; and that activities to support individual risk communication, such as widespread education and monitoring of access to health care for those at risk, are in place. The thematic synthesis also indicates that poor communication practices may have negative impacts or cause harm, such as discrimination in accessing health care. There is insufficient rigorous evidence to determine the effects of interventions to notify people at CJD or vCJD risk and to support them subsequently, or to identify the best approach to communication in these situations. The thematic synthesis can be used to inform policy and practice decisions for communicating with people at risk in the absence of rigorous evaluative studies. Output:
That CJD and vCJD are very rare diseases creates challenges for researchers aiming to conduct rigorous quantitative studies in this area. Although we searched widely to identify all relevant research evaluating the effects of interventions to communicate with (notify and support) people at risk, we did not identify any studies that met the criteria for inclusion in this Cochrane review. However, systematic searches did identify a number of pieces of relevant research and literature that provided evidence about policy implementation and consumer experiences in situations of iatrogenic exposure to risk. This research formed the basis of a thematic synthesis. The synthesis identified several activities that aim to improve the experiences of people at risk of CJD and vCJD. It indicates that communication may be best considered as a longitudinal multicomponent programme occurring over time, ensuring that notification is coordinated and considers impact; that support is in place and is offered over time; that communication is flexible, tailored and responsive to need; and that supporting activities, such as widespread education of the healthcare workforce, the public and the media, and monitoring of access to health care for those at risk, are in place. The thematic synthesis also indicates that poor communication practices may have negative impacts or cause harm, such as discrimination in accessing health care. In the absence of rigorous evaluative studies the results of this thematic synthesis can be used to inform policy and practice decisions for communicating with people at risk.
CochranePLS444
***TASK*** the task is to simplify the input abstract of a biomedical literature ***INPUT*** the input is the abstract of a biomedical literature ***OUTPUT*** the output is the simplified abstract for the input abstract of a biomedical literature ***EXAMPLES*** Input: Output: ***EXAMPLES*** Input: Two trials (n = 190), at low risk of bias, were included in the review and both presented data on first time failure at the tooth level. Pooling of the data showed a statistically significant difference in favour of molar bands, with a hazard ratio of 2.92 (95% confidence intervals (CI) 1.80 to 4.72). No statistically significant heterogeneity was shown between the two studies. Data on first time failure at the patient level were also available and showed statistically different difference in favour of molar bands (risk ratio 2.30; 95% CI 1.56 to 3.41) (risk of event for molar tubes = 57%; risk of event for molar bands 25%). One trial presented data on decalcification again showing a statistically significant difference in favour of molar bands. No other adverse events identified. From the two well-designed and low risk of bias trials included in this review it was shown that the failure of molar tubes bonded with either a chemically-cured or light-cured adhesive was considerably higher than that of molar bands cemented with glass ionomer cement. One trial indicated that there was less decalcification with molar bands cemented with glass ionomer cement than with bonded molar tubes cemented with a light-cured adhesive. However, given there are limited data for this outcome, further evidence is required to draw more robust conclusions. Output: The evidence in this review, which was carried out together with Cochrane Oral Health, is up-to-date as of 15 February 2017. We included two studies that evaluated 190 participants. Both trials were conducted in the UK and both compared bonded molar tubes with molar bands. From the limited data of two studies at low risk of bias, it would appear that bonded molar tubes are associated with a higher failure rate than with molar bands. Input: We included one randomised clinical trial (N = 304 randomised; 204 completed; 276 analysed) that evaluated opioids (prolonged release oxycodone/naloxone) versus placebo. After 12 weeks, RSL symptoms had improved more in the drug group than in the placebo group (using the IRLSSS: MD -7.0; 95% CI -9.69 to -4.31 and the CGI: MD -1.11; 95% CI -1.49 to -0.73). More patients in the drug group than in the placebo group were drug responders (using the IRLSSS: RR 1.82; 95% CI 1.37 to 2.42 and the CGI: RR1.92; 95% ICI 1.49 to 2.48). The proportion of remitters was greater in the drug group than in the placebo group (using the IRLSSS: RR 2.14; 95% CI 1.45 to 3.16). Quality of life scores also improved more in the drug group than in the placebo group (MD -0.73; 95% CI -1.1 to -0.36). Quality of sleep was improved more in the drug group measured by sleep adequacy (MD -0.74; 95% CI -1.15 to -0.33), and sleep quantity (MD 0.89; 95% CI 0.52 to 1.26). There was no difference between groups for daytime somnolence, trouble staying awake during the day, or naps during the day. More adverse events were reported in the drug group (RR 1.22; 95% CI 1.07 to 1.39). The major adverse events were gastrointestinal problems, fatigue, and headache. Opioids seem to be effective for treating RLS symptoms, but there are no definitive data regarding the important problem of safety. This conclusion is based on only one study with a high dropout rate (low quality evidence). Output:
We included one randomised controlled clinical trial with moderate risk of bias that tested a combination of oxycodone and naloxone against placebo capsules, taken twice daily in participants whodid not respond to more usual medications. Researchers used the International RLS severity scale to find out if patients were improved after 12 weeks of treatment. Particpants receiving the combined oxycodone and naloxone reported improvement in RLS symptoms, Quality of life, and sleep quality; 42% of the drug group were symptom-free. Discussion The study was well designed overall, but was at a high risk of bias due to the high percentage of participants who withdrew from treatment (attrition bias). Eighty-four percent of the drug group developed adverse events, which were mostly related to the gastrointestinal system, headache, fatigue, and sleepiness (somnolence); 9.8% left the study because of the adverse events. Conclusion The use of opioids for the treatment of RLS in patients resistant to conventional treatment is supported by low-quality evidence. Prescription of these medications should be based on clinical experience, and caution used due to the potential for abuse, dependency, and adverse events. No patient on opioids complained that their symptoms worsened.
CochranePLS445
***TASK*** the task is to simplify the input abstract of a biomedical literature ***INPUT*** the input is the abstract of a biomedical literature ***OUTPUT*** the output is the simplified abstract for the input abstract of a biomedical literature ***EXAMPLES*** Input: Output: ***EXAMPLES*** Input: Two trials (n = 190), at low risk of bias, were included in the review and both presented data on first time failure at the tooth level. Pooling of the data showed a statistically significant difference in favour of molar bands, with a hazard ratio of 2.92 (95% confidence intervals (CI) 1.80 to 4.72). No statistically significant heterogeneity was shown between the two studies. Data on first time failure at the patient level were also available and showed statistically different difference in favour of molar bands (risk ratio 2.30; 95% CI 1.56 to 3.41) (risk of event for molar tubes = 57%; risk of event for molar bands 25%). One trial presented data on decalcification again showing a statistically significant difference in favour of molar bands. No other adverse events identified. From the two well-designed and low risk of bias trials included in this review it was shown that the failure of molar tubes bonded with either a chemically-cured or light-cured adhesive was considerably higher than that of molar bands cemented with glass ionomer cement. One trial indicated that there was less decalcification with molar bands cemented with glass ionomer cement than with bonded molar tubes cemented with a light-cured adhesive. However, given there are limited data for this outcome, further evidence is required to draw more robust conclusions. Output: The evidence in this review, which was carried out together with Cochrane Oral Health, is up-to-date as of 15 February 2017. We included two studies that evaluated 190 participants. Both trials were conducted in the UK and both compared bonded molar tubes with molar bands. From the limited data of two studies at low risk of bias, it would appear that bonded molar tubes are associated with a higher failure rate than with molar bands. Input: Fifteen heterogeneous trials, involving 1022 adults with dorsally displaced and potentially or evidently unstable distal radial fractures, were included. While all trials compared external fixation versus plaster cast immobilisation, there was considerable variation especially in terms of patient characteristics and interventions. Methodological weaknesses among these trials included lack of allocation concealment and inadequate outcome assessment. External fixation maintained reduced fracture positions (redisplacement requiring secondary treatment: 7/356 versus 51/338 (data from 9 trials); relative risk 0.17, 95% confidence interval 0.09 to 0.32) and prevented late collapse and malunion compared with plaster cast immobilisation. There was insufficient evidence to confirm a superior overall functional or clinical result for the external fixation group. External fixation was associated with a high number of complications, such as pin-track infection, but many of these were minor. Probably, some complications could have been avoided using a different surgical technique for pin insertion. There was insufficient evidence to establish a difference between the two groups in serious complications such as reflex sympathetic dystropy: 25/384 versus 17/347 (data from 11 trials); relative risk 1.31, 95% confidence interval 0.74 to 2.32. There is some evidence to support the use of external fixation for dorsally displaced fractures of the distal radius in adults. Though there is insufficient evidence to confirm a better functional outcome, external fixation reduces redisplacement, gives improved anatomical results and most of the excess surgically-related complications are minor. Output:
Fifteen trials, involving 1022 adults with potentially or evidently unstable fractures, were included. While all trials compared external fixation versus plaster cast immobilisation, there was considerable variation in their characteristics especially in terms of patient characteristics and the method of external fixation. Weak methodology, such as using inadequate methods of randomisation and outcome assessment, means that the possibility of serious bias can not be excluded. The review found that external fixation reduced fracture redisplacement that prompted further treatment and generally improved final anatomical outcome. It appears to improve function too but this needs to be confirmed. The complications, such a pin tract infection, associated with external fixation were many but were generally minor. Serious complications occurred in both groups. The review concludes that there is some evidence to support the use of external fixation for these fractures.
CochranePLS446
***TASK*** the task is to simplify the input abstract of a biomedical literature ***INPUT*** the input is the abstract of a biomedical literature ***OUTPUT*** the output is the simplified abstract for the input abstract of a biomedical literature ***EXAMPLES*** Input: Output: ***EXAMPLES*** Input: Two trials (n = 190), at low risk of bias, were included in the review and both presented data on first time failure at the tooth level. Pooling of the data showed a statistically significant difference in favour of molar bands, with a hazard ratio of 2.92 (95% confidence intervals (CI) 1.80 to 4.72). No statistically significant heterogeneity was shown between the two studies. Data on first time failure at the patient level were also available and showed statistically different difference in favour of molar bands (risk ratio 2.30; 95% CI 1.56 to 3.41) (risk of event for molar tubes = 57%; risk of event for molar bands 25%). One trial presented data on decalcification again showing a statistically significant difference in favour of molar bands. No other adverse events identified. From the two well-designed and low risk of bias trials included in this review it was shown that the failure of molar tubes bonded with either a chemically-cured or light-cured adhesive was considerably higher than that of molar bands cemented with glass ionomer cement. One trial indicated that there was less decalcification with molar bands cemented with glass ionomer cement than with bonded molar tubes cemented with a light-cured adhesive. However, given there are limited data for this outcome, further evidence is required to draw more robust conclusions. Output: The evidence in this review, which was carried out together with Cochrane Oral Health, is up-to-date as of 15 February 2017. We included two studies that evaluated 190 participants. Both trials were conducted in the UK and both compared bonded molar tubes with molar bands. From the limited data of two studies at low risk of bias, it would appear that bonded molar tubes are associated with a higher failure rate than with molar bands. Input: Five studies (1127 patients) were included in our analysis. Generally the risk of bias of the included studies was judged low or unclear; they addressed the research question and utilised a prospective randomised design. It is uncertain whether early stent removal verus late stent removal improved the incidence of MUC (5 studies, 1127 participants: RR 1.87, 95% CI 0.61 to 5.71; I2 = 21%; low certainty evidence). The incidence of UTI may be reduced in the early stent removal group (5 studies, 1127 participants: RR 0.49 95% CI 0.30 to 0.81; I2 = 59%; moderate certainty evidence). This possible reduction in the UTI incidence was only apparent if a BI stent was used, (3 studies, 539 participants, RR 0.45 95% CI 0.29 to 0.70; I2 = 13%; moderate certainty evidence). However, if an externalised PU stent was used there was no discernible difference in UTI incidence between the early and late group (2 studies, 588 participants: RR 0.60 95% CI 0.17, 2.03; I2 = 83%; low certainty evidence). Data on health economics and quality of life outcomes were lacking. Early removal of ureteric stents following kidney transplantation may reduce the incidence of UTI while it uncertain if there is a higher risk of MUC. BI stents are the optimum method for achieving this benefit. Output:
It is uncertain whether the number of major urological complications were different in those patients whose stent was removed early (less than 15 days post-operatively), when compared with those removed later (more than 15 days post-operatively). The number of patients suffering from a urinary tract infection may be less in the early removal group - especially if the stent was not exposed to the external environment. The studies identified for this review were generally of poor quality. It is uncertain whether a bladder indwelling ureteric stent that is removed early following kidney transplantation reduces the risk of complications, however it may prevent urine tract infections.
CochranePLS447
***TASK*** the task is to simplify the input abstract of a biomedical literature ***INPUT*** the input is the abstract of a biomedical literature ***OUTPUT*** the output is the simplified abstract for the input abstract of a biomedical literature ***EXAMPLES*** Input: Output: ***EXAMPLES*** Input: Two trials (n = 190), at low risk of bias, were included in the review and both presented data on first time failure at the tooth level. Pooling of the data showed a statistically significant difference in favour of molar bands, with a hazard ratio of 2.92 (95% confidence intervals (CI) 1.80 to 4.72). No statistically significant heterogeneity was shown between the two studies. Data on first time failure at the patient level were also available and showed statistically different difference in favour of molar bands (risk ratio 2.30; 95% CI 1.56 to 3.41) (risk of event for molar tubes = 57%; risk of event for molar bands 25%). One trial presented data on decalcification again showing a statistically significant difference in favour of molar bands. No other adverse events identified. From the two well-designed and low risk of bias trials included in this review it was shown that the failure of molar tubes bonded with either a chemically-cured or light-cured adhesive was considerably higher than that of molar bands cemented with glass ionomer cement. One trial indicated that there was less decalcification with molar bands cemented with glass ionomer cement than with bonded molar tubes cemented with a light-cured adhesive. However, given there are limited data for this outcome, further evidence is required to draw more robust conclusions. Output: The evidence in this review, which was carried out together with Cochrane Oral Health, is up-to-date as of 15 February 2017. We included two studies that evaluated 190 participants. Both trials were conducted in the UK and both compared bonded molar tubes with molar bands. From the limited data of two studies at low risk of bias, it would appear that bonded molar tubes are associated with a higher failure rate than with molar bands. Input: We included five studies that evaluated three comparisons. Four studies compared crowns with fillings; two of them compared conventional PMCs with open sandwich restorations, and two compared PMCs fitted using the Hall Technique with fillings. One of these studies included a third arm, which allowed the comparison of PMCs (fitted using the Hall Technique) versus non-restorative caries treatment. In the two studies using crowns fitted using the conventional method, all teeth had undergone pulpotomy prior to the crown being placed. The final study compared two different types of crowns: PMCs versus aesthetic stainless steel crowns with white veneers. No RCT evidence was found that compared different methods of fitting preformed metal crowns (i.e. Hall Technique versus conventional technique). We considered outcomes reported at the dental appointment or within 24 hours of it, and in the short term (less than 12 months) or long term (12 months or more). Some of our outcomes of interest were not measured in the studies: time to restoration failure or retreatment, patient satisfaction and costs. Crowns versus fillings All studies in this comparison used PMCs. One study reported outcomes in the short term and found no reports of major failure or pain in either group. There was moderate quality evidence that the risk of major failure was lower in the crowns group in the long term (risk ratio (RR) 0.18, 95% confidence interval (CI) 0.06 to 0.56; 346 teeth in three studies, one conventional and two using Hall Technique). Similarly, there was moderate quality evidence that the risk of pain was lower in the long term for the crown group (RR 0.15, 95% CI 0.04 to 0.67; 312 teeth in two studies). Discomfort associated with the procedure was lower for crowns fitted using the Hall Technique than for fillings (RR 0.56, 95% CI 0.36 to 0.87; 381 teeth) (moderate quality evidence). It is uncertain whether there is a clinically important difference in the risk of gingival bleeding when using crowns rather than fillings, either in the short term (RR 1.69, 95% CI 0.61 to 4.66; 226 teeth) or long term (RR 1.74, 95% CI 0.99 to 3.06; 195 teeth, two studies using PMCs with conventional technique at 12 months) (low quality evidence). Crowns versus non-restorative caries treatment Only one study compared PMCs (fitted with the Hall Technique) with non-restorative caries treatment; the evidence quality was very low and we are therefore we are uncertain about the estimates. Metal crowns versus aesthetic crowns One split-mouth study (11 participants) compared PMCs versus aesthetic crowns (stainless steel with white veneers). It provided very low quality evidence so no conclusions could be drawn. Crowns placed on primary molar teeth with carious lesions, or following pulp treatment, are likely to reduce the risk of major failure or pain in the long term compared to fillings. Crowns fitted using the Hall Technique may reduce discomfort at the time of treatment compared to fillings. The amount and quality of evidence for crowns compared to non-restorative caries, and for metal compared with aesthetic crowns, is very low. There are no RCTs comparing crowns fitted conventionally versus using the Hall Technique. Output:
We searched medical and dental sources for studies up to 21 January 2015. We identified five relevant studies. They were at high risk of bias because the participants knew which treatment they received and so did the people who treated them. Four studies compared crowns with fillings. Two of them compared metal crowns fitted using the conventional method with fillings and two compared metal crowns fitted using the Hall Technique with fillings. One of the studies also compared the Hall Technique with 'non-restorative caries treatment' (not using either a filling or crown but opening the cavity to make it possible to clean with a toothbrush, sealing with fluoride varnish and encouraging toothbrushing). The final study compared crowns made of two different materials (stainless steel versus stainless steel with a white covering). We looked at what happened for each treatment at the time of the dental appointment or within 24 hours of treatment, in the short term (less than 12 months) and long term (12 months to 48 months). Teeth restored with preformed crowns are less likely to develop problems (e.g. abscess) or cause pain in the long term, compared to fillings. Crowns fitted using the Hall Technique (no injections or tooth trimming) gave less discomfort at the time of the appointment, when compared with fillings. Crowns may increase the risk of gingival bleeding but this result was unclear. Only one small study compared crowns with non-restorative caries treatment and one small study compared metal and white crowns, and we could draw no reliable conclusions from these. Some of our outcomes of interest were not measured in any of the studies: these included time to restoration failure or retreatment, patient satisfaction and costs. There is moderate quality evidence that crowns are more effective than fillings for managing decay in primary molar teeth. There is moderate quality evidence that crowns fitted using the Hall Technique are less likely to cause abscesses and pain than fillings. The evidence comparing preformed crowns with non-restorative caries management, and comparing preformed metal crowns with preformed white crowns, is very low quality so we do not know which is better. Crowns placed on primary molar teeth with decay, or that have had pulp treatment, are likely to reduce the risk of major failure or pain in the long term compared to fillings. Crowns fitted using the Hall Technique may reduce discomfort at the time of treatment compared to fillings.
CochranePLS448
***TASK*** the task is to simplify the input abstract of a biomedical literature ***INPUT*** the input is the abstract of a biomedical literature ***OUTPUT*** the output is the simplified abstract for the input abstract of a biomedical literature ***EXAMPLES*** Input: Output: ***EXAMPLES*** Input: Two trials (n = 190), at low risk of bias, were included in the review and both presented data on first time failure at the tooth level. Pooling of the data showed a statistically significant difference in favour of molar bands, with a hazard ratio of 2.92 (95% confidence intervals (CI) 1.80 to 4.72). No statistically significant heterogeneity was shown between the two studies. Data on first time failure at the patient level were also available and showed statistically different difference in favour of molar bands (risk ratio 2.30; 95% CI 1.56 to 3.41) (risk of event for molar tubes = 57%; risk of event for molar bands 25%). One trial presented data on decalcification again showing a statistically significant difference in favour of molar bands. No other adverse events identified. From the two well-designed and low risk of bias trials included in this review it was shown that the failure of molar tubes bonded with either a chemically-cured or light-cured adhesive was considerably higher than that of molar bands cemented with glass ionomer cement. One trial indicated that there was less decalcification with molar bands cemented with glass ionomer cement than with bonded molar tubes cemented with a light-cured adhesive. However, given there are limited data for this outcome, further evidence is required to draw more robust conclusions. Output: The evidence in this review, which was carried out together with Cochrane Oral Health, is up-to-date as of 15 February 2017. We included two studies that evaluated 190 participants. Both trials were conducted in the UK and both compared bonded molar tubes with molar bands. From the limited data of two studies at low risk of bias, it would appear that bonded molar tubes are associated with a higher failure rate than with molar bands. Input: A total of 28 studies (involving 788 children and adults) were included in the review; 18 studies involving 296 participants were cross-over in design. Data were not published in sufficient detail in most of these studies to perform any meta-analysis. In 22 of the 28 studies the PEP technique was performed using a mask, in three of the studies a mouthpiece was used with nose clips and in three studies it was unclear whether a mask or mouthpiece was used. These studies compared PEP to ACBT, autogenic drainage (AD), oral oscillating PEP devices, high-frequency chest wall oscillation (HFCWO) and BiPaP and exercise. Forced expiratory volume in one second was the review's primary outcome and the most frequently reported outcome in the studies (24 studies, 716 participants). Single interventions or series of treatments that continued for up to three months demonstrated little or no difference in effect between PEP and other methods of airway clearance on this outcome (low- to moderate-quality evidence). However, long-term studies had equivocal or conflicting results regarding the effect on this outcome (low- to moderate-quality evidence). A second primary outcome was the number of respiratory exacerbations. There was a lower exacerbation rate in participants using PEP compared to other techniques when used with a mask for at least one year (five studies, 232 participants; moderate- to high-quality evidence). In one of the included studies which used PEP with a mouthpiece, it was reported (personal communication) that there was no difference in the number of respiratory exacerbations (66 participants, low-quality evidence). Participant preference was reported in 10 studies; and in all studies with an intervention period of at least one month, this was in favour of PEP. The results for the remaining outcome measures (including our third primary outcome of mucus clearance) were not examined or reported in sufficient detail to provide any high-quality evidence; only very low- to moderate-quality evidence was available for other outcomes. There was limited evidence reported on adverse events; these were measured in five studies, two of which found no events. In a study where infants performing either PEP or PDPV experienced some gastro-oesophageal reflux , this was more severe in the PDPV group (26 infants, low-quality evidence). In PEP versus oscillating PEP, adverse events were only reported in the flutter group (five participants complained of dizziness, which improved after further instructions on device use was provided) (22 participants, low-quality evidence). In PEP versus HFCWO, from one long-term high-quality study (107 participants) there was little or no difference in terms of number of adverse events; however, those in the PEP group had fewer adverse events related to the lower airways when compared to HFCWO (high-certainty evidence). Many studies had a risk of bias as they did not report how the randomisation sequence was either generated or concealed. Most studies reported the number of dropouts and also reported on all planned outcome measures. The evidence provided by this review is of variable quality, but suggests that all techniques and devices described may have a place in the clinical treatment of people with CF. Following meta-analyses of the effects of PEP versus other airway clearance techniques on lung function and patient preference, this Cochrane Review demonstrated that there was high-quality evidence that showed a significant reduction in pulmonary exacerbations when PEP using a mask was compared with HFCWO. It is important to note that airway clearance techniques should be individualised throughout life according to developmental stages, patient preferences, pulmonary symptoms and lung function. This also applies as conditions vary between baseline function and pulmonary exacerbations. Output:
The review includes 28 studies with 788 people (from infants to adults) with CF with mild to severe lung disease. The studies compared PEP to other methods of chest physiotherapy; the length of treatment ranged from a single session to two years of treatment. Generally, the efficacy of PEP is similar to other methods of chest physiotherapy such as postural drainage with percussion, active cycle of breathing techniques, autogenic drainage, oscillatory PEP devices such as the flutter and acapella, thoracic oscillating devices such as the 'Vest', and bilevel positive airway pressure (BiPaP) (typically used for ventilatory support, but by changing the inspiratory and expiratory pressures on the device and combining it with huffing, BiPaP has been used for airway clearance). We found no difference between PEP and other forms of chest physiotherapy in lung function, the amount of mucus cleared from the airways or its related effects on the health of people with CF. However, the rate of flare ups of respiratory symptoms decreased in people using PEP compared to other forms of physiotherapy such as a vibrating PEP device or a vibrating vest. There was some evidence that people with CF may prefer PEP to other chest physiotherapy methods. There was no evidence of PEP causing harm, except in one study where infants performing either PEP or percussion in various positions which use gravity to help drain secretions, experienced some gastro-oesophageal reflux (regurgitation of food) in head-down positions; this was more severe in the group using postural drainage with percussion. In all the other trials PEP was performed in a sitting position. In 10 of the 28 studies studied single PEP treatment sessions. The results from these studies are very limited as they could not report on the number of respiratory infections and lung function did not change with just one treatment. Two one-year studies compared PEP to postural drainage and percussion; in the study with children, PEP improved their lung function, while in the adult study, lung function declined slightly with both PEP and postural drainage and percussion. Also, the method of performing PEP was different in the two age groups. Although PEP seems to have an advantage in reducing flare ups (based on the combined results of a few studies), different physiotherapy techniques and devices may be more or less effective at varying times and in different individuals during baseline function and chest flare ups. Each person should talk to their clinician to help choose which method of airway clearance is best for them and which they will adhere to, so as to provide the best quality of life and long-term outcomes. Some studies were of low quality. These studies highlight the difficulty in comparing studies using PEP compared to other forms of chest physiotherapy. Factors such as age and severity of lung disease in the participants may affect the results as well as the method of performing each treatment. Overall, the evidence provided by this review for whether PEP reduces flare ups compared to other forms of chest physiotherapy was moderate to high quality, but evidence for other outcomes was of very low to moderate quality, as results were limited.
CochranePLS449
***TASK*** the task is to simplify the input abstract of a biomedical literature ***INPUT*** the input is the abstract of a biomedical literature ***OUTPUT*** the output is the simplified abstract for the input abstract of a biomedical literature ***EXAMPLES*** Input: Output: ***EXAMPLES*** Input: Two trials (n = 190), at low risk of bias, were included in the review and both presented data on first time failure at the tooth level. Pooling of the data showed a statistically significant difference in favour of molar bands, with a hazard ratio of 2.92 (95% confidence intervals (CI) 1.80 to 4.72). No statistically significant heterogeneity was shown between the two studies. Data on first time failure at the patient level were also available and showed statistically different difference in favour of molar bands (risk ratio 2.30; 95% CI 1.56 to 3.41) (risk of event for molar tubes = 57%; risk of event for molar bands 25%). One trial presented data on decalcification again showing a statistically significant difference in favour of molar bands. No other adverse events identified. From the two well-designed and low risk of bias trials included in this review it was shown that the failure of molar tubes bonded with either a chemically-cured or light-cured adhesive was considerably higher than that of molar bands cemented with glass ionomer cement. One trial indicated that there was less decalcification with molar bands cemented with glass ionomer cement than with bonded molar tubes cemented with a light-cured adhesive. However, given there are limited data for this outcome, further evidence is required to draw more robust conclusions. Output: The evidence in this review, which was carried out together with Cochrane Oral Health, is up-to-date as of 15 February 2017. We included two studies that evaluated 190 participants. Both trials were conducted in the UK and both compared bonded molar tubes with molar bands. From the limited data of two studies at low risk of bias, it would appear that bonded molar tubes are associated with a higher failure rate than with molar bands. Input: Four studies involving 1485 participants with moderate to severe CD met the inclusion criteria and were used in the meta-analyses. All studies included active CD patients with CDAI ranging from 220 to 450. Most patients were adults over 18 years of age. One study was identified as high risk of bias due to a non-identical placebo while the other studies were judged to be at low risk of bias. CZP (100 mg to 400 mg every 2 to 4 weeks) was shown to be superior to placebo for achieving clinical remission at week 8 (RR 1.36, 95% CI 1.11 to 1.66; moderate certainty evidence). The raw numbers of participants achieving clinical remission at week 8 were 26.9% (225/835) and 19.8% (129/650) in the CZP and the placebo groups, respectively. CZP was shown to be superior to placebo for achieving clinical response at week 8 (RR 1.29, 95% CI 1.09 to 1.53; moderate certainty evidence). In raw numbers, clinical response at week 8 was achieved in 40.2% (336/835) and 30.9% (201/650) of participants in the CZP and the placebo groups, respectively. In raw numbers, serious adverse events were observed in 8.7% (73/835) and 6.2% (40/650) of participants in the CZP and the placebo groups, respectively (RR 1.35, 95% CI 0.93 to 1.97; moderate certainty evidence). Serious adverse events included worsening Crohn's disease, infections, and malignancy. Moderate certainty evidence suggests that CZP is effective for induction of clinical remission and clinical response in participants with active CD patients. It is uncertain whether the risk of serious adverse events differs between CZP and placebo as the 95% CI includes the possibility of a small decrease or doubling of events. Future studies are needed to evaluate the long-term efficacy and safety of CZP in CD patients. Output:
The literature was searched up to 28 January 2019. Four studies involving 1485 patients compared certolizumab pegol with placebo (a dummy drug). All studies included patients with active Crohn’s disease. Most patients were adults over 18 years of age, except for six patients aged 16 or 17 years old. All studies were funded by the drug manufacturer. In a combined analysis of the four studies, patients with active Crohn’s disease who received certolizumab pegol at a dose ranging from 100 mg to 400 mg every 2 to 4 weeks, responded to the treatment and achieved remission at 8 weeks more often than patients taking placebo. No remarkable difference in the rate of serious side effects was observed between certolizumab pegol and placebo. Serious side effects included worsening Crohn's disease, infections, and malignancy (i.e. cancer). Moderate certainty evidence suggests that certolizumab pegol is beneficial in terms of achieving remission in people with moderate to severe Crohn's disease. Because of a low number of serious side effects, the certainty of evidence about harms of certolizumab pegol was moderate. Moderate certainty evidence suggests that certolizumab pegol is effective for induction of clinical remission and clinical response in people with active Crohn's disease. It is uncertain whether the risk of serious side effects differs between certolizumab pegol and placebo. Future studies are needed to evaluate the long-term benefits and harms of certolizumab pegol in people with Crohn's disease.
CochranePLS450
***TASK*** the task is to simplify the input abstract of a biomedical literature ***INPUT*** the input is the abstract of a biomedical literature ***OUTPUT*** the output is the simplified abstract for the input abstract of a biomedical literature ***EXAMPLES*** Input: Output: ***EXAMPLES*** Input: Two trials (n = 190), at low risk of bias, were included in the review and both presented data on first time failure at the tooth level. Pooling of the data showed a statistically significant difference in favour of molar bands, with a hazard ratio of 2.92 (95% confidence intervals (CI) 1.80 to 4.72). No statistically significant heterogeneity was shown between the two studies. Data on first time failure at the patient level were also available and showed statistically different difference in favour of molar bands (risk ratio 2.30; 95% CI 1.56 to 3.41) (risk of event for molar tubes = 57%; risk of event for molar bands 25%). One trial presented data on decalcification again showing a statistically significant difference in favour of molar bands. No other adverse events identified. From the two well-designed and low risk of bias trials included in this review it was shown that the failure of molar tubes bonded with either a chemically-cured or light-cured adhesive was considerably higher than that of molar bands cemented with glass ionomer cement. One trial indicated that there was less decalcification with molar bands cemented with glass ionomer cement than with bonded molar tubes cemented with a light-cured adhesive. However, given there are limited data for this outcome, further evidence is required to draw more robust conclusions. Output: The evidence in this review, which was carried out together with Cochrane Oral Health, is up-to-date as of 15 February 2017. We included two studies that evaluated 190 participants. Both trials were conducted in the UK and both compared bonded molar tubes with molar bands. From the limited data of two studies at low risk of bias, it would appear that bonded molar tubes are associated with a higher failure rate than with molar bands. Input: One hundred and twelve studies met our selection criteria: 15 were studies of adults with CKD; 16 studies were conducted in the general population but provided subgroup data for people with CKD; and 81 studies included individuals with CKD, however, data for this subgroup were not provided. The risk of bias in all 112 studies was frequently high or unclear. Of the 31 studies (23,762 participants) with data on CKD patients, follow-up ranged from three months to five years, and study size ranged from 16 to 2916 participants. In total, 26 studies (19,612 participants) reported disaggregated and extractable data on at least one outcome of interest for our review and were included in our meta-analyses. In acute heart failure, the effects of adenosine A1-receptor antagonists, dopamine, nesiritide, or serelaxin on death, hospitalisations, worsening heart failure or kidney function, hyperkalaemia, hypotension or quality of life were uncertain due to sparse data or were not reported. In chronic heart failure, the effects of angiotensin-converting enzyme inhibitors (ACEi) or angiotensin receptor blockers (ARB) (4 studies, 5003 participants: RR 0.85, 95% CI 0.70 to 1.02; I2 = 78%; low certainty evidence), aldosterone antagonists (2 studies, 34 participants: RR 0.61 95% CI 0.06 to 6.59; very low certainty evidence), and vasopressin receptor antagonists (RR 1.26, 95% CI 0.55 to 2.89; 2 studies, 1840 participants; low certainty evidence) on death (any cause) were uncertain. Treatment with beta-blockers may reduce the risk of death (any cause) (4 studies, 3136 participants: RR 0.69, 95% CI 0.60 to 0.79; I2 = 0%; moderate certainty evidence). Treatment with ACEi or ARB (2 studies, 1368 participants: RR 0.90, 95% CI 0.43 to 1.90; I2 = 97%; very low certainty evidence) had uncertain effects on hospitalisation for heart failure, as treatment estimates were consistent with either benefit or harm. Treatment with beta-blockers may decrease hospitalisation for heart failure (3 studies, 2287 participants: RR 0.67, 95% CI 0.43 to 1.05; I2 = 87%; low certainty evidence). Aldosterone antagonists may increase the risk of hyperkalaemia compared to placebo or no treatment (3 studies, 826 participants: RR 2.91, 95% CI 2.03 to 4.17; I2 = 0%; low certainty evidence). Renin inhibitors had uncertain risks of hyperkalaemia (2 studies, 142 participants: RR 0.86, 95% CI 0.49 to 1.49; I2 = 0%; very low certainty). We were unable to estimate whether treatment with sinus node inhibitors affects the risk of hyperkalaemia, as there were few studies and meta-analysis was not possible. Hyperkalaemia was not reported for the CKD subgroup in studies investigating other therapies. The effects of ACEi or ARB, or aldosterone antagonists on worsening heart failure or kidney function, hypotension, or quality of life were uncertain due to sparse data or were not reported. Effects of anti-arrhythmic agents, digoxin, phosphodiesterase inhibitors, renin inhibitors, sinus node inhibitors, vasodilators, and vasopressin receptor antagonists were very uncertain due to the paucity of studies. The effects of pharmacological interventions for heart failure in people with CKD are uncertain and there is insufficient evidence to inform clinical practice. Study data for treatment outcomes in patients with heart failure and CKD are sparse despite the potential impact of kidney impairment on the benefits and harms of treatment. Future research aimed at analysing existing data in general population HF studies to explore the effect in subgroups of patients with CKD, considering stage of disease, may yield valuable insights for the management of people with HF and CKD. Output:
We found 31 studies involving 23,762 people with heart failure and chronic kidney disease. Patients were given either a heart failure medicine compared to standard care or a placebo. The treatment they received was decided by random chance. Although there were many different treatments studied, unfortunately, few of them looked at the same type of medicine. As well, there were many different ways that researchers measured what happened when patients took these medicines. As a result, we could not combine the studies together and clarify the benefits and harms of each treatment. Existing studies cannot really tell us whether medicines used to treat heart failure in the general population are effective or safe for people who have both heart failure and chronic kidney disease. We are not able to recommend which heart failure medicines are best for people with heart failure and chronic kidney disease. We need more information from large clinical studies. Most of the heart failure studies did not report treatment effects separately based on levels of kidney function. Obtaining this information from existing studies may be helpful to learn more about how to treat heart failure in people with chronic kidney disease.
CochranePLS451
***TASK*** the task is to simplify the input abstract of a biomedical literature ***INPUT*** the input is the abstract of a biomedical literature ***OUTPUT*** the output is the simplified abstract for the input abstract of a biomedical literature ***EXAMPLES*** Input: Output: ***EXAMPLES*** Input: Two trials (n = 190), at low risk of bias, were included in the review and both presented data on first time failure at the tooth level. Pooling of the data showed a statistically significant difference in favour of molar bands, with a hazard ratio of 2.92 (95% confidence intervals (CI) 1.80 to 4.72). No statistically significant heterogeneity was shown between the two studies. Data on first time failure at the patient level were also available and showed statistically different difference in favour of molar bands (risk ratio 2.30; 95% CI 1.56 to 3.41) (risk of event for molar tubes = 57%; risk of event for molar bands 25%). One trial presented data on decalcification again showing a statistically significant difference in favour of molar bands. No other adverse events identified. From the two well-designed and low risk of bias trials included in this review it was shown that the failure of molar tubes bonded with either a chemically-cured or light-cured adhesive was considerably higher than that of molar bands cemented with glass ionomer cement. One trial indicated that there was less decalcification with molar bands cemented with glass ionomer cement than with bonded molar tubes cemented with a light-cured adhesive. However, given there are limited data for this outcome, further evidence is required to draw more robust conclusions. Output: The evidence in this review, which was carried out together with Cochrane Oral Health, is up-to-date as of 15 February 2017. We included two studies that evaluated 190 participants. Both trials were conducted in the UK and both compared bonded molar tubes with molar bands. From the limited data of two studies at low risk of bias, it would appear that bonded molar tubes are associated with a higher failure rate than with molar bands. Input: Three studies involving a total of 1945 women were included. Overall, risk of bias across the three trials was mixed. No serious complications were reported in the trials and no neonatal or maternal deaths occurred. The neonatal outcome was not statistically different between groups: Apgar score less than seven at five minutes (RR 1.78, 95% CI 0.83 to 3.83; three studies, n = 1945); umbilical artery pH less than 7.15 (RR 1.31, 95% CI 0.95 to 1.79; one study, n = 1456); umbilical artery pH less than 7.16 (RR 1.23, 95% CI 0.39 to 3.92; one study, n = 239); admission to the neonatal intensive care unit (RR 0.34, 95% CI 0.07 to 1.67; two studies, n = 489); and more than 48 hours hospitalisation (RR 0.92, 95% CI 0.71 to 1.20; one study, n = 1456). The pooled risk for instrumental delivery (including caesarean section, ventouse and forceps extraction) was not statistically significantly different (RR 1.05, 95% CI 0.91 to 1.21; three studies, n = 1945). Hyperstimulation was reported in two studies (n = 489), but there was no statistically significant difference between groups (RR 1.21, 95% CI 0.78 to 1.88). This review found no differences between the two types of monitoring (internal or external tocodynamometry) for any of the maternal or neonatal outcomes. Given that this review is based on three studies (N = 1945 women) of moderate quality, there is insufficient evidence to recommend the use of one form of tocodynamometry over another for women where intravenous oxytocin was administered for induction or augmentation of labour. Output:
The aim of this review was to compare the effectiveness of IT compared with ET. We included three randomised controlled studies (1945 women). The methodological quality of the studies was considered to be moderate. When comparing internal registration of contractions with external registration of contractions during induced or augmented labour, there were no differences in any of the outcomes for mother or child: adverse neonatal outcomes, instrumental deliveries, caesarean section, use of analgesia or time to delivery. No increased risk for infection was reported when an intrauterine catheter was used in these studies. There is insufficient evidence to recommend the use of one form of tocodynamometry over another for women where intravenous oxytocin is administered for induction or augmentation of labour.
CochranePLS452
***TASK*** the task is to simplify the input abstract of a biomedical literature ***INPUT*** the input is the abstract of a biomedical literature ***OUTPUT*** the output is the simplified abstract for the input abstract of a biomedical literature ***EXAMPLES*** Input: Output: ***EXAMPLES*** Input: Two trials (n = 190), at low risk of bias, were included in the review and both presented data on first time failure at the tooth level. Pooling of the data showed a statistically significant difference in favour of molar bands, with a hazard ratio of 2.92 (95% confidence intervals (CI) 1.80 to 4.72). No statistically significant heterogeneity was shown between the two studies. Data on first time failure at the patient level were also available and showed statistically different difference in favour of molar bands (risk ratio 2.30; 95% CI 1.56 to 3.41) (risk of event for molar tubes = 57%; risk of event for molar bands 25%). One trial presented data on decalcification again showing a statistically significant difference in favour of molar bands. No other adverse events identified. From the two well-designed and low risk of bias trials included in this review it was shown that the failure of molar tubes bonded with either a chemically-cured or light-cured adhesive was considerably higher than that of molar bands cemented with glass ionomer cement. One trial indicated that there was less decalcification with molar bands cemented with glass ionomer cement than with bonded molar tubes cemented with a light-cured adhesive. However, given there are limited data for this outcome, further evidence is required to draw more robust conclusions. Output: The evidence in this review, which was carried out together with Cochrane Oral Health, is up-to-date as of 15 February 2017. We included two studies that evaluated 190 participants. Both trials were conducted in the UK and both compared bonded molar tubes with molar bands. From the limited data of two studies at low risk of bias, it would appear that bonded molar tubes are associated with a higher failure rate than with molar bands. Input: We included two trials involving 54 participants with CVI. Many of our review outcomes were not reported or reported by only one of the two studies. The intensity of disease signs and symptoms was measured in both studies but using different scales; we were therefore unable to pool the data. One study reported no difference between the exercise and control groups whereas the second reported a reduction in symptoms in the exercise group. In one study, increases in change in ejection fraction compared with baseline (mean difference (MD) 4.88%, 95% confidence interval (CI) 3.16 to 6.60; 30 participants; P < 0.00001), half venous refilling time (MD 4.20 seconds, 95% CI 3.28 to 5.12; 23 participants; P < 0.00001) and total venous refilling time (MD 9.40 seconds, 95% CI 7.77 to 11.03; 23 participants; P < 0.00001) were observed in the exercise group compared with the control group. One study reported no difference between the exercise and control groups with regard to quality of life or ankle range of motion. Although muscle strength assessed by dynamometry at slow speed did not differ between the two groups in this study, variable peak torque at fast speed was lower in the control group than in the exercise group (2.8 ± 0.9 compared with -0.3 ± 0.6, P < 0.03). The incidence of venous leg ulcers, incidence of surgical intervention to treat symptoms related to CVI and exercise capacity were not assessed or reported in either of the included trials. We rated both included studies as at high risk of bias; hence, these data should be interpreted carefully. Due to the small number of studies and small sample size, we were not able to verify indirectness and publication bias. Therefore, we judged the overall quality of evidence as very low according to the GRADE approach. There is currently insufficient evidence available to assess the efficacy of physical exercise in people with CVI. Future research into the effect of physical exercise should consider types of exercise protocols (intensity, frequency and time), sample size, blinding and homogeneity according to the severity of disease. Output:
This review included two clinical trials, involving a total of 54 participants, that compared directly the effects of physical exercise and a control intervention (evidence current until May 2016). One study reported no difference between the exercise and control groups whereas the second reported a reduction in symptoms in the exercise group. At the end of the study, an improvement in venous blood return was observed in the exercise group compared with the control group. The included studies did not report on new cases of venous leg ulcers. No difference between the exercise and control groups was observed with regard to participants' quality of life, the range of motion of the ankle joint or overall muscle strength. The overall finding of an improvement in venous blood return in the exercise group favours the idea that physical exercise improves blood flow conditions in people with CVI, but we found the risk of bias due to blinding or randomisation to be high for both studies. We therefore consider that there is currently not enough information to determine whether physical exercise is effective in the management of CVI. Quality of the evidence We judged the overall quality of evidence as very low: the two included studies were small (54 participants in total) and were at high risk of bias based on their methods of blinding or randomisation.
CochranePLS453
***TASK*** the task is to simplify the input abstract of a biomedical literature ***INPUT*** the input is the abstract of a biomedical literature ***OUTPUT*** the output is the simplified abstract for the input abstract of a biomedical literature ***EXAMPLES*** Input: Output: ***EXAMPLES*** Input: Two trials (n = 190), at low risk of bias, were included in the review and both presented data on first time failure at the tooth level. Pooling of the data showed a statistically significant difference in favour of molar bands, with a hazard ratio of 2.92 (95% confidence intervals (CI) 1.80 to 4.72). No statistically significant heterogeneity was shown between the two studies. Data on first time failure at the patient level were also available and showed statistically different difference in favour of molar bands (risk ratio 2.30; 95% CI 1.56 to 3.41) (risk of event for molar tubes = 57%; risk of event for molar bands 25%). One trial presented data on decalcification again showing a statistically significant difference in favour of molar bands. No other adverse events identified. From the two well-designed and low risk of bias trials included in this review it was shown that the failure of molar tubes bonded with either a chemically-cured or light-cured adhesive was considerably higher than that of molar bands cemented with glass ionomer cement. One trial indicated that there was less decalcification with molar bands cemented with glass ionomer cement than with bonded molar tubes cemented with a light-cured adhesive. However, given there are limited data for this outcome, further evidence is required to draw more robust conclusions. Output: The evidence in this review, which was carried out together with Cochrane Oral Health, is up-to-date as of 15 February 2017. We included two studies that evaluated 190 participants. Both trials were conducted in the UK and both compared bonded molar tubes with molar bands. From the limited data of two studies at low risk of bias, it would appear that bonded molar tubes are associated with a higher failure rate than with molar bands. Input: Seventy-six trials with a median quality score of 3 (range 1 to 5) were identified. Follow-up periods varied between day of last injection and eighteen months. Forty trials included comparisons of hyaluronan/hylan and placebo (saline or arthrocentesis), ten trials included comparisons of intra-articular (IA) corticosteroids, six trials included comparisons of nonsteroidal anti-inflammatory drugs (NSAIDs), three trials included comparisons of physical therapy, two trials included comparisons of exercise, two trials included comparisons of arthroscopy, two trials included comparisons of conventional treatment, and fifteen trials included comparisons of other hyaluronans/hylan. The pooled analyses of the effects of viscosupplements against 'placebo' controls generally supported the efficacy of this class of intervention. In these same analyses, differential efficacy effects were observed for different products on different variables and at different timepoints. Of note is the 5 to 13 week post injection period which showed a percent improvement from baseline of 28 to 54% for pain and 9 to 32% for function. In general, comparable efficacy was noted against NSAIDs and longer-term benefits were noted in comparisons against IA corticosteroids. In general, few adverse events were reported in the hyaluronan/hylan trials included in these analyses. Based on the aforementioned analyses, viscosupplementation is an effective treatment for OA of the knee with beneficial effects: on pain, function and patient global assessment; and at different post injection periods but especially at the 5 to 13 week post injection period. It is of note that the magnitude of the clinical effect, as expressed by the WMD and standardised mean difference (SMD) from the RevMan 4.2 output, is different for different products, comparisons, timepoints, variables and trial designs. However, there are few randomised head-to-head comparisons of different viscosupplements and readers should be cautious, therefore, in drawing conclusions regarding the relative value of different products. The clinical effect for some products, against placebo, on some variables at some timepoints is in the moderate to large effect-size range. Readers should refer to relevant tables to review specific detail given the heterogeneity in effects across the product class and some discrepancies observed between the RevMan 4.2 analyses and the original publications. Overall, the analyses performed are positive for the HA class and particularly positive for some products with respect to certain variables and timepoints, such as pain on weight bearing at 5 to 13 weeks postinjection. In general, sample-size restrictions preclude any definitive comment on the safety of the HA class of products; however, within the constraints of the trial designs employed no major safety issues were detected. In some analyses viscosupplements were comparable in efficacy to systemic forms of active intervention, with more local reactions but fewer systemic adverse events. In other analyses HA products had more prolonged effects than IA corticosteroids. Overall, the aforementioned analyses support the use of the HA class of products in the treatment of knee OA. Output:
To evaluate the efficacy, effectiveness and safety of HA products, in knee OA, we have conducted a systematic review using Cochrane methodology. The analyses support the contention that the HA class of products is superior to placebo. There is considerable between-product, between-variable and time-dependent variability in the clinical response. The clinical effect for some products against placebo on some variables at some time points is in the moderate to large effect size range. In general, sample size restrictions preclude any definitive comment on the safety of the HA class of products, however, within the constraints of the trial designs employed, no major safety issues were detected. The analyses suggest that viscosupplements are comparable in efficacy to systemic forms of active intervention, with more local reactions but fewer systemic adverse events, and that HA products have more prolonged effects than IA corticosteroids. Overall, the aforementioned analyses support the use of the HA class of products in the treatment of knee OA.
CochranePLS454
***TASK*** the task is to simplify the input abstract of a biomedical literature ***INPUT*** the input is the abstract of a biomedical literature ***OUTPUT*** the output is the simplified abstract for the input abstract of a biomedical literature ***EXAMPLES*** Input: Output: ***EXAMPLES*** Input: Two trials (n = 190), at low risk of bias, were included in the review and both presented data on first time failure at the tooth level. Pooling of the data showed a statistically significant difference in favour of molar bands, with a hazard ratio of 2.92 (95% confidence intervals (CI) 1.80 to 4.72). No statistically significant heterogeneity was shown between the two studies. Data on first time failure at the patient level were also available and showed statistically different difference in favour of molar bands (risk ratio 2.30; 95% CI 1.56 to 3.41) (risk of event for molar tubes = 57%; risk of event for molar bands 25%). One trial presented data on decalcification again showing a statistically significant difference in favour of molar bands. No other adverse events identified. From the two well-designed and low risk of bias trials included in this review it was shown that the failure of molar tubes bonded with either a chemically-cured or light-cured adhesive was considerably higher than that of molar bands cemented with glass ionomer cement. One trial indicated that there was less decalcification with molar bands cemented with glass ionomer cement than with bonded molar tubes cemented with a light-cured adhesive. However, given there are limited data for this outcome, further evidence is required to draw more robust conclusions. Output: The evidence in this review, which was carried out together with Cochrane Oral Health, is up-to-date as of 15 February 2017. We included two studies that evaluated 190 participants. Both trials were conducted in the UK and both compared bonded molar tubes with molar bands. From the limited data of two studies at low risk of bias, it would appear that bonded molar tubes are associated with a higher failure rate than with molar bands. Input: Ten randomised clinical trials (RCTs) with a total of 4052 participants fulfilled our inclusion criteria and were included in this review. Four RCTs (1881 participants) compared misoprostol with placebo given in addition to conventional uterotonics. Adjunctive use of misoprostol (in the dose of 600 to 1000 mcg) with simultaneous administration of additional uterotonics did not provide additional benefit for our primary outcomes including maternal mortality (risk ratio (RR) 6.16, 95% confidence interval (CI) 0.75 to 50.85), serious maternal morbidity (RR 0.34, 95% CI 0.01 to 8.31), admission to intensive care (RR 0.79, 95% CI 0.30 to 2.11) or hysterectomy (RR 0.93, 95% CI 0.16 to 5.41). Two RCTs (1787 participants) compared 800 mcg sublingual misoprostol versus oxytocin infusion as primary PPH treatment; one trial included women who had received prophylactic uterotonics, and the other did not. Primary outcomes did not differ between the two groups, although women given sublingual misoprostol were more likely to have additional blood loss of at least 1000 mL (RR 2.65, 95% CI 1.04 to 6.75). Misoprostol was associated with a significant increase in vomiting and shivering. Two trials attempted to test the effectiveness of estrogen and tranexamic acid, respectively, but were too small for any meaningful comparisons of pre-specified outcomes. One study compared lower segment compression but was too small to assess impact on primary outcomes. We did not identify any trials evaluating surgical techniques or radiological interventions for women with primary PPH unresponsive to uterotonics and/or haemostatics. Clinical trials included in the current review were not adequately powered to assess impact on the primary outcome measures. Compared with misoprostol, oxytocin infusion is more effective and causes fewer side effects when used as first-line therapy for the treatment of primary PPH. When used after prophylactic uterotonics, misoprostol and oxytocin infusion worked similarly. The review suggests that among women who received oxytocin for the treatment of primary PPH, adjunctive use of misoprostol confers no added benefit. The role of tranexamic acid and compression methods requires further evaluation. Furthermore, future studies should focus on the best way to treat women who fail to respond to uterotonic therapy. Output:
The review identified 10 randomised controlled trials involving 4052 women. Seven of these trials looked at a drug called misoprostol, which is a prostaglandin and so works by increasing muscle contractions. Overall, the trials suggest that misoprostol does not work as well as oxytocin infusion, and it has more side effects. However, oxytocin needs to be kept in a refrigerator, and so in settings where refrigeration and infusions are not readily available, misoprostol can be used. Other clinical trials looked into using other types of drugs or squeezing the main artery that supplies blood to the woman. The number of women included in these studies was too small for any useful conclusions regarding their effectiveness and safety.
CochranePLS455
***TASK*** the task is to simplify the input abstract of a biomedical literature ***INPUT*** the input is the abstract of a biomedical literature ***OUTPUT*** the output is the simplified abstract for the input abstract of a biomedical literature ***EXAMPLES*** Input: Output: ***EXAMPLES*** Input: Two trials (n = 190), at low risk of bias, were included in the review and both presented data on first time failure at the tooth level. Pooling of the data showed a statistically significant difference in favour of molar bands, with a hazard ratio of 2.92 (95% confidence intervals (CI) 1.80 to 4.72). No statistically significant heterogeneity was shown between the two studies. Data on first time failure at the patient level were also available and showed statistically different difference in favour of molar bands (risk ratio 2.30; 95% CI 1.56 to 3.41) (risk of event for molar tubes = 57%; risk of event for molar bands 25%). One trial presented data on decalcification again showing a statistically significant difference in favour of molar bands. No other adverse events identified. From the two well-designed and low risk of bias trials included in this review it was shown that the failure of molar tubes bonded with either a chemically-cured or light-cured adhesive was considerably higher than that of molar bands cemented with glass ionomer cement. One trial indicated that there was less decalcification with molar bands cemented with glass ionomer cement than with bonded molar tubes cemented with a light-cured adhesive. However, given there are limited data for this outcome, further evidence is required to draw more robust conclusions. Output: The evidence in this review, which was carried out together with Cochrane Oral Health, is up-to-date as of 15 February 2017. We included two studies that evaluated 190 participants. Both trials were conducted in the UK and both compared bonded molar tubes with molar bands. From the limited data of two studies at low risk of bias, it would appear that bonded molar tubes are associated with a higher failure rate than with molar bands. Input: Six trials fulfilled entry criteria. The majority of patients in these trials were preterm. Five small trials evaluated short-term cysteine supplementation of cysteine-free PN. One large multicenter RCT evaluated short-term N-acetylcysteine supplementation of cysteine-containing PN in extremely low birth weight infants (≤ 1000 grams). Growth was not significantly affected by cysteine supplementation (1 trial) or by N-acetylcysteine supplementation (1 trial). Nitrogen retention was significantly increased by cysteine supplementation (4 trials) (WMD 31.8 mg/kg/day, 95% confidence interval +8.2, +55.4, n = 95, including 73 preterm infants). Plasma levels of cysteine were significantly increased by cysteine supplementation but not by N-acetylcysteine supplementation. N-acetylcysteine supplementation did not significantly affect the risks of death by 36 postmenstrual weeks, bronchopulmonary dysplasia (BPD), death or BPD, retinopathy of prematurity (ROP), severe ROP, necrotizing enterocolitis requiring surgery, periventricular leukomalacia, intraventricular hemorrhage (IVH), or severe IVH. Available evidence from RCTs shows that routine short-term cysteine chloride supplementation of cysteine-free PN in preterm infants improves nitrogen balance. However, there is insufficient evidence to assess the risks of cysteine supplementation, especially regarding metabolic acidosis, which has been reported during the first two weeks of cysteine chloride administration. Available evidence from a large RCT trial does not support routine N-acetylcysteine supplementation of cysteine-containing PN in extremely low birth weight infants. Output:
This systemic review was done to analyze whether adding cysteine (or related compounds) to intravenous nutrition affects growth and other outcomes in newborn infants. Five trials studied the effects of adding cysteine to intravenous nutrition that did not contain cysteine. Addition of cysteine significantly improved the babies' ability to build body proteins (analyzed in four studies); however, it did not improve growth (analyzed in one study); no other outcomes were available. One large randomized trial studied the effect of adding another chemical, N-acetyl-cysteine, to intravenous nutrition that already contained cysteine. This study showed no benefit and no toxicity of this intervention. We conclude that present data are insufficient to justify routine addition of cysteine to the intravenous nutrition of newborn infants that does not contain cysteine. Available evidence does not support routine addition of N-acetylcysteine to intravenous nutrition of newborn infants containing cysteine.
CochranePLS456
***TASK*** the task is to simplify the input abstract of a biomedical literature ***INPUT*** the input is the abstract of a biomedical literature ***OUTPUT*** the output is the simplified abstract for the input abstract of a biomedical literature ***EXAMPLES*** Input: Output: ***EXAMPLES*** Input: Two trials (n = 190), at low risk of bias, were included in the review and both presented data on first time failure at the tooth level. Pooling of the data showed a statistically significant difference in favour of molar bands, with a hazard ratio of 2.92 (95% confidence intervals (CI) 1.80 to 4.72). No statistically significant heterogeneity was shown between the two studies. Data on first time failure at the patient level were also available and showed statistically different difference in favour of molar bands (risk ratio 2.30; 95% CI 1.56 to 3.41) (risk of event for molar tubes = 57%; risk of event for molar bands 25%). One trial presented data on decalcification again showing a statistically significant difference in favour of molar bands. No other adverse events identified. From the two well-designed and low risk of bias trials included in this review it was shown that the failure of molar tubes bonded with either a chemically-cured or light-cured adhesive was considerably higher than that of molar bands cemented with glass ionomer cement. One trial indicated that there was less decalcification with molar bands cemented with glass ionomer cement than with bonded molar tubes cemented with a light-cured adhesive. However, given there are limited data for this outcome, further evidence is required to draw more robust conclusions. Output: The evidence in this review, which was carried out together with Cochrane Oral Health, is up-to-date as of 15 February 2017. We included two studies that evaluated 190 participants. Both trials were conducted in the UK and both compared bonded molar tubes with molar bands. From the limited data of two studies at low risk of bias, it would appear that bonded molar tubes are associated with a higher failure rate than with molar bands. Input: We identified 77 trials including 6287 participants that met the inclusion criteria of this review. Forty-one trials (3829 participants) provided information for one or more outcomes. Only one trial was at low risk of bias in all domains. All other trials were at high risk of bias in one or more domains. Overall, all the evidence was very low quality. Thirty-five trials included only participants with non-alcohol related steatohepatitis (NASH) (based on biopsy confirmation). Five trials included only participants with diabetes mellitus; 14 trials included only participants without diabetes mellitus. The follow-up in the trials ranged from one month to 24 months. We present here only the comparisons of active intervention versus no intervention in which two or more trials reported at least one of the following outcomes: mortality at maximal follow-up, serious adverse events, and health-related quality of life, the outcomes that determine whether a treatment should be used. Antioxidants versus no intervention There was no mortality in either group (87 participants; 1 trial; very low quality evidence). None of the participants developed serious adverse events in the trial which reported the proportion of people with serious adverse events (87 participants; 1 trial; very low quality evidence). There was no evidence of difference in the number of serious adverse events between antioxidants and no intervention (rate ratio 0.89, 95% CI 0.36 to 2.19; 254 participants; 2 trials; very low quality evidence). None of the trials reported health-related quality of life. Bile acids versus no intervention There was no evidence of difference in mortality at maximal follow-up (OR 5.11, 95% CI 0.24 to 107.34; 659 participants; 4 trials; very low quality evidence), proportion of people with serious adverse events (OR 1.56, 95% CI 0.84 to 2.88; 404 participants; 3 trials; very low quality evidence), or the number of serious adverse events (rate ratio 1.01, 95% CI 0.66 to 1.54; 404 participants; 3 trials; very low quality evidence) between bile acids and no intervention. None of the trials reported health-related quality of life. Thiazolidinediones versus no intervention There was no mortality in either group (74 participants; 1 trial; very low quality evidence). None of the participants developed serious adverse events in the two trials which reported the proportion of people with serious adverse events (194 participants; 2 trials; very low quality evidence). There was no evidence of difference in the number of serious adverse events between thiazolidinediones and no intervention (rate ratio 0.25, 95% CI 0.06 to 1.05; 357 participants; 3 trials; very low quality evidence). None of the trials reported health-related quality of life. Source of funding Twenty-six trials were partially- or fully-funded by pharmaceutical companies that would benefit, based on the results of the trial. Twelve trials did not receive any additional funding or were funded by parties with no vested interest in the results. The source of funding was not provided in 39 trials. Due to the very low quality evidence, we are very uncertain about the effectiveness of pharmacological treatments for people with NAFLD including those with steatohepatitis. Further well-designed randomised clinical trials with sufficiently large sample sizes are necessary. Output:
We included 77 randomised clinical trials that involved a total of 6287 participants. Of these, 41 trials (3829 participants) provided information for one or more outcomes for this review. Thirty-five trials only included participants with NASH; five included only people with diabetes mellitus; and 14 included only people who did not have diabetes mellitus. The average follow-up period in the trials ranged from one month to two years in the trials that reported this information. We excluded trials in which participants with NAFLD had undergone liver transplantation before the trial. As well as conducting standard Cochrane analysis, we also planned to conduct network meta-analysis (a technique that enables comparison of different treatments that are not directly compared to each other in the trials). However, the nature of available information meant we could not determine if the network meta-analysis results were reliable. Specific outcomes we looked for were numbers of deaths, adverse events, and assessment of health-related quality of life. Twelve trials did not receive any additional funding or were funded by sources with no vested interest in the results; 26 were funded by drug companies that could potentially benefit from trial results; and the funding source was not available from 39 trials. Included trials compared drug treatments such as bile acids, antioxidants, phosphodiesterase type 4 inhibitor, glucocorticosteroid inhibitor, anti-cholesterol drugs and anti-diabetes drugs with a fake treatment (placebo) or no treatment. There were no deaths in either group (87 participants, 1 trial). None of the participants developed serious adverse events in the trial which reported the percentage of people with serious adverse events (87 participants, 1 trial). There was no evidence of difference in the number of serious adverse events between antioxidants and no intervention (254 participants, 2 trials). There was no evidence of difference in deaths at maximal follow-up (659 participants, 4 trials), percentage of people with serious adverse events (404 participants, 3 trials), or the number of serious adverse events (404 participants, 3 trials) between bile acids and no intervention. None of the trials reported health-related quality of life. There were no deaths in either group (74 participants, 1 trial). None of the participants developed serious adverse events in the two trials which reported the percentage of people with serious adverse events (194 participants, 2 trials). There was no evidence of difference in the number of serious adverse events between thiazolidinediones and no intervention (357 participants, 3 trials). None of the trials reported health-related quality of life. We found no evidence of benefit from any of the compared interventions in people with fatty liver disease. There is significant uncertainty in this issue, and we need further high quality randomised clinical trials with sufficiently large group of participants. Evidence quality was very low overall, and there was a high risk of bias. This means there is a possibility of making conclusions that wrongly interpret benefits or harms of treatments because of the ways the studies were conducted.
CochranePLS457
***TASK*** the task is to simplify the input abstract of a biomedical literature ***INPUT*** the input is the abstract of a biomedical literature ***OUTPUT*** the output is the simplified abstract for the input abstract of a biomedical literature ***EXAMPLES*** Input: Output: ***EXAMPLES*** Input: Two trials (n = 190), at low risk of bias, were included in the review and both presented data on first time failure at the tooth level. Pooling of the data showed a statistically significant difference in favour of molar bands, with a hazard ratio of 2.92 (95% confidence intervals (CI) 1.80 to 4.72). No statistically significant heterogeneity was shown between the two studies. Data on first time failure at the patient level were also available and showed statistically different difference in favour of molar bands (risk ratio 2.30; 95% CI 1.56 to 3.41) (risk of event for molar tubes = 57%; risk of event for molar bands 25%). One trial presented data on decalcification again showing a statistically significant difference in favour of molar bands. No other adverse events identified. From the two well-designed and low risk of bias trials included in this review it was shown that the failure of molar tubes bonded with either a chemically-cured or light-cured adhesive was considerably higher than that of molar bands cemented with glass ionomer cement. One trial indicated that there was less decalcification with molar bands cemented with glass ionomer cement than with bonded molar tubes cemented with a light-cured adhesive. However, given there are limited data for this outcome, further evidence is required to draw more robust conclusions. Output: The evidence in this review, which was carried out together with Cochrane Oral Health, is up-to-date as of 15 February 2017. We included two studies that evaluated 190 participants. Both trials were conducted in the UK and both compared bonded molar tubes with molar bands. From the limited data of two studies at low risk of bias, it would appear that bonded molar tubes are associated with a higher failure rate than with molar bands. Input: In total, 1282 participants with MCI at baseline were identified in the 15 included studies of which 1172 had analysable data; 430 participants converted to Alzheimer’s disease dementia and 130 participants to other forms of dementia. Follow-up ranged from less than one year to over four years for some participants, but in the majority of studies was in the range one to three years. Conversion to Alzheimer’s disease dementia The accuracy of the CSF t-tau was evaluated in seven studies (291 cases and 418 non-cases).The sensitivity values ranged from 51% to 90% while the specificity values ranged from 48% to 88%. At the median specificity of 72%, the estimated sensitivity was 75% (95% CI 67 to 85), the positive likelihood ratio was 2.72 (95% CI 2.43 to 3.04), and the negative likelihood ratio was 0.32 (95% CI 0.22 to 0.47). Six studies (164 cases and 328 non-cases) evaluated the accuracy of the CSF p-tau. The sensitivities were between 40% and 100% while the specificities were between 22% and 86%. At the median specificity of 47.5%, the estimated sensitivity was 81% (95% CI: 64 to 91), the positive likelihood ratio was 1.55 (CI 1.31 to 1.84), and the negative likelihood ratio was 0.39 (CI: 0.19 to 0.82). Five studies (140 cases and 293 non-cases) evaluated the accuracy of the CSF p-tau/ABeta ratio. The sensitivities were between 80% and 96% while the specificities were between 33% and 95%. We did not conduct a meta-analysis because the studies were few and small. Only one study reported the accuracy of CSF t-tau/ABeta ratio. Our findings are based on studies with poor reporting. A significant number of studies had unclear risk of bias for the reference standard, participant selection and flow and timing domains. According to the assessment of index test domain, eight of 15 studies were of poor methodological quality. The accuracy of these CSF biomarkers for ‘other dementias’ had not been investigated in the included primary studies. Investigation of heterogeneity The main sources of heterogeneity were thought likely to be reference standards used for the target disorders, sources of recruitment, participant sampling, index test methodology and aspects of study quality (particularly, inadequate blinding). We were not able to formally assess the effect of each potential source of heterogeneity as planned, due to the small number of studies available to be included. The insufficiency and heterogeneity of research to date primarily leads to a state of uncertainty regarding the value of CSF testing of t-tau, p-tau or p-tau/ABeta ratio for the diagnosis of Alzheimer's disease in current clinical practice. Particular attention should be paid to the risk of misdiagnosis and overdiagnosis of dementia (and therefore over-treatment) in clinical practice. These tests, like other biomarker tests which have been subject to Cochrane DTA reviews, appear to have better sensitivity than specificity and therefore might have greater utility in ruling out Alzheimer's disease as the aetiology to the individual's evident cognitive impairment, as opposed to ruling it in. The heterogeneity observed in the few studies awaiting classification suggests our initial summary will remain valid. However, these tests may have limited clinical value until uncertainties have been addressed. Future studies with more uniformed approaches to thresholds, analysis and study conduct may provide a more homogenous estimate than the one that has been available from the included studies we have identified. Output:
The evidence is current to January 2013. We included 15 studies containing a total of 1282 participants with MCI. The majority of studies (n = 9) were published between 2010 and 2013. The remaining six studies were published between 2004 and 2009. All of the included studies were conducted in Europe. Study sizes varied and ranged from 15 to 231 participants.The mean (range) age of the youngest sample was 64 years (45 to 76) and the mean (standard deviation) age of the oldest sample was 73.4 (6.6) years. Our findings are based on studies with poor reporting, with a majority of studies at unclear risk of bias due to insufficient details given on how participants were selected and how the clinical diagnosis of dementia was established. According to the assessment of how the CSF tests were conducted and analysed, eight of 15 studies were of poor methodological quality. Below is a summary of key findings for the tests: CSF t-tau test for conversion from MCI to Alzheimer’s disease dementia The sensitivity values in seven individual studies ranged from 51% to 90% while the specificity values ranged from 48% to 88%. The statistical analysis of those studies showed that, at the fixed specificity of 72%, the estimated sensitivity was 77%, and, at the prevalence of 37%, the positive predictive value was 62% and the negative predictive value was 84%. Based on these results, on average 62 out of 100 people with MCI and a positive index test result would convert to Alzheimer's disease dementia but 38 would not; on average, 84 out of 100 people with MCI and with a negative index test result would not convert to Alzheimer's disease dementia, but 16 would. CSF p-tau test for conversion from MCI to Alzheimer’s disease dementia The sensitivity values in six individual studies ranged from 40% to 100% while the specificity values ranged from 22% to 86%. The statistical analysis of those studies showed that, at the fixed specificity of 48%, the estimated sensitivity was 81%, and, at the prevalence of 37%, the positive predictive value was 48% and the negative predictive value was 81%. Based on these results, on average 48 out of 100 people with MCI and with a positive index test result would convert to Alzheimer's disease dementia, but 52 would not; on average, 81 out of 100 people with MCI with a negative index test result would not convert to Alzheimer's disease dementia, but 19 would. We found that the cerebrospinal fluid (CSF) diagnostic test, as a single test, lacks the accuracy to identify those people with mild cognitive impairment (MCI) who would develop Alzheimer’s disease dementia or other forms of dementia over a period of time. The data suggested that a negative CSF test, in people with MCI, almost indicates the absence of Alzheimer's disease as the cause of their clinical symptoms. However, a positive CSF test does not confirm the presence of Alzheimer's disease as the aetiology (cause) of their clinical symptoms. There were methodological problems in the included studies that did not allow for a clear answer to the review question. The main limitations of the review were poor reporting in the included studies, lack of a widely accepted threshold of the CSF diagnostic tests in people with MCI, variability in length of follow-up, and the marked variation in CSF tests’ accuracy between the included studies.
CochranePLS458
***TASK*** the task is to simplify the input abstract of a biomedical literature ***INPUT*** the input is the abstract of a biomedical literature ***OUTPUT*** the output is the simplified abstract for the input abstract of a biomedical literature ***EXAMPLES*** Input: Output: ***EXAMPLES*** Input: Two trials (n = 190), at low risk of bias, were included in the review and both presented data on first time failure at the tooth level. Pooling of the data showed a statistically significant difference in favour of molar bands, with a hazard ratio of 2.92 (95% confidence intervals (CI) 1.80 to 4.72). No statistically significant heterogeneity was shown between the two studies. Data on first time failure at the patient level were also available and showed statistically different difference in favour of molar bands (risk ratio 2.30; 95% CI 1.56 to 3.41) (risk of event for molar tubes = 57%; risk of event for molar bands 25%). One trial presented data on decalcification again showing a statistically significant difference in favour of molar bands. No other adverse events identified. From the two well-designed and low risk of bias trials included in this review it was shown that the failure of molar tubes bonded with either a chemically-cured or light-cured adhesive was considerably higher than that of molar bands cemented with glass ionomer cement. One trial indicated that there was less decalcification with molar bands cemented with glass ionomer cement than with bonded molar tubes cemented with a light-cured adhesive. However, given there are limited data for this outcome, further evidence is required to draw more robust conclusions. Output: The evidence in this review, which was carried out together with Cochrane Oral Health, is up-to-date as of 15 February 2017. We included two studies that evaluated 190 participants. Both trials were conducted in the UK and both compared bonded molar tubes with molar bands. From the limited data of two studies at low risk of bias, it would appear that bonded molar tubes are associated with a higher failure rate than with molar bands. Input: We included three single-centre, two-arm RCTs involving 170 participants. We found one ongoing trial. All included participants were male and were undergoing radical robotic assisted laparoscopic radical prostatectomy (RALRP). The men were between 50 and 75 years of age and met criteria for American Society of Anesthesiologists physical classification scores (ASA) I, ll and III. We found evidence showing no clinically meaningful differences in postoperative pain between the two types of anaesthetics (mean difference (MD) in visual analogue scale (VAS) scores at one to six hours was -2.20 (95% confidence interval (CI) -10.62 to 6.22; P = 0.61) in a sample of 62 participants from one study. Low-quality evidence suggests that propofol reduces postoperative nausea and vomiting (PONV) over the short term (one to six hours after surgery) after RALRP compared with inhalational anaesthesia (sevoflurane, desflurane) (MD -1.70, 95% CI -2.59 to -0.81; P = 0.0002). We found low-quality evidence suggesting that propofol may prevent an increase in intraocular pressure (IOP) after pneumoperitoneum and steep Trendelenburg positioning compared with sevoflurane (MD -3.90, 95% CI -6.34 to -1.46; P = 0.002) with increased IOP from baseline to 30 minutes in steep Trendelenburg. However, it is unclear whether this surrogate outcome translates directly to clinical avoidance of ocular complications during surgery. No studies addressed the secondary outcomes of adverse effects, all-cause mortality, respiratory or circulatory complications, cognitive dysfunction, length of stay or costs. Overall the quality of evidence was low to very low, as all studies were small, single-centre trials providing unclear descriptions of methods. It is unclear which anaesthetic technique is superior - TIVA or inhalational - for transabdominal robotic assisted surgery in urology, gynaecology and gastroenterology, as existing evidence is scarce, is of low quality and has been generated from exclusively male patients undergoing robotic radical prostatectomy. An ongoing trial, which includes participants of both genders with a focus on quality of recovery, might have an impact on future evidence related to this topic. Output:
The evidence is current to May 2016 and was provided by three small randomized controlled trials involving 170 males who had their prostate removed. These studies took place in hospitals in Korea and Turkey. We looked for differences in pain and postoperative nausea and vomiting (PONV) and changes in pressure inside the eyes between patients receiving anaesthetic via the veins or by inhalation. Study funding sources Studies were funded by the institution, or the funding sources were not stated. Key results Postoperative pain was no different between the two types of anaesthesia. Anaesthesia delivered through the veins reduced PONV at one to six hours after prostate surgery compared with anaesthesia provided via inhalation. One study showed that anaesthesia delivered through the veins prevented an increase in pressure inside the eyes during surgery compared with inhalational anaesthesia. We cannot conclude whether this means that anaesthesia provided via the veins reduces ocular complications, as no patients in this small study developed these complications. Quality of the evidence The quality of the evidence was considered low, as included studies were small and provided an unclear description of methods. All participants in these studies were men who were undergoing robotic assisted laparoscopic removal of the prostate. An ongoing trial includes men and women undergoing abdominal robotic surgery, also with a focus on the quality of recovery. Additional studies are needed.
CochranePLS459
***TASK*** the task is to simplify the input abstract of a biomedical literature ***INPUT*** the input is the abstract of a biomedical literature ***OUTPUT*** the output is the simplified abstract for the input abstract of a biomedical literature ***EXAMPLES*** Input: Output: ***EXAMPLES*** Input: Two trials (n = 190), at low risk of bias, were included in the review and both presented data on first time failure at the tooth level. Pooling of the data showed a statistically significant difference in favour of molar bands, with a hazard ratio of 2.92 (95% confidence intervals (CI) 1.80 to 4.72). No statistically significant heterogeneity was shown between the two studies. Data on first time failure at the patient level were also available and showed statistically different difference in favour of molar bands (risk ratio 2.30; 95% CI 1.56 to 3.41) (risk of event for molar tubes = 57%; risk of event for molar bands 25%). One trial presented data on decalcification again showing a statistically significant difference in favour of molar bands. No other adverse events identified. From the two well-designed and low risk of bias trials included in this review it was shown that the failure of molar tubes bonded with either a chemically-cured or light-cured adhesive was considerably higher than that of molar bands cemented with glass ionomer cement. One trial indicated that there was less decalcification with molar bands cemented with glass ionomer cement than with bonded molar tubes cemented with a light-cured adhesive. However, given there are limited data for this outcome, further evidence is required to draw more robust conclusions. Output: The evidence in this review, which was carried out together with Cochrane Oral Health, is up-to-date as of 15 February 2017. We included two studies that evaluated 190 participants. Both trials were conducted in the UK and both compared bonded molar tubes with molar bands. From the limited data of two studies at low risk of bias, it would appear that bonded molar tubes are associated with a higher failure rate than with molar bands. Input: We included 7 new observational studies in this update, bringing the total number to 14, including 5 cohort and 9 case-control studies, with 1,601,515 study subjects. Most studies found no causal associations between maternal exposure to topical corticosteroids of any potency and pregnancy outcomes when compared with no exposure. These outcomes included: mode of delivery (risk ratio (RR) 1.04, 95% confidence interval (CI) 0.95 to 1.15, 1 cohort study, n = 9904, low quality evidence); congenital abnormalities, including orofacial cleft or cleft palate and hypospadias (where the urethral opening is on the underside of the penis) (RR 0.82, 95% CI 0.34 to 1.96, 2 cohort studies, n = 9512, low quality evidence; and odds ratio (OR) 1.07, 95% CI 0.71 to 1.60, 1 case-control study, n = 56,557); low birth weight (RR 1.08, 95% CI 0.86 to 1.36; n = 59,419, 4 cohort studies; very low quality evidence); preterm delivery (RR 0.93, 95% CI 0.81 to 1.08, 4 cohort studies, n = 59,419, low quality evidence); foetal death (RR 1.02, 95% CI 0.60 to 1.73, 4 cohort studies, n = 63,885, very low quality evidence); and low Apgar score (RR 0.84, 95% CI 0.54 to 1.31, 1 cohort study, n = 9220, low quality evidence). We conducted stratified analyses of mild or moderate potency, and potent or very potent topical corticosteroids, but we found no causal associations between maternal exposure to topical corticosteroid of any potency and congenital abnormality, orofacial clefts, preterm delivery, or low Apgar score. For low birth weight, although the meta-analysis based on study-level data was not significant for either mild to moderate corticosteroids (pooled RR 0.90, 95% CI 0.74 to 1.09, 3 cohort studies, n > 55,713) or potent to very potent corticosteroids (pooled RR 1.58, 95% CI 0.96 to 2.58, 4 cohort studies, n > 47,651), there were significant differences between the two subgroups (P = 0.04). The results from three of the individual studies in the meta-analysis indicated an increased risk of low birth weight in women who received potent to very potent topical corticosteroids. Maternal use of mild to moderate potency topical steroids was associated with a decreased risk of foetal death (pooled RR 0.70, 95% CI 0.64 to 0.77, 2 studies, n = 48,749; low quality evidence), but we did not observe this effect when potent to very potent topical corticosteroids were given during pregnancy (pooled RR 1.14, 95% CI 0.69 to 1.88, 3 studies, n = 37,086, low quality evidence). We used the Grades of Recommendation, Assessment, Development and Evaluation (GRADE) Working Group approach to rate the overall quality of the evidence. Data from observational studies started at low quality. We further downgraded the evidence because of imprecision in low birth weight and inconsistency in foetal death. Lower quality evidence resulted in lower confidence in the estimate of effect for those outcomes. This update adds more evidence showing no causal associations between maternal exposure to topical corticosteroids of all potencies and pregnancy outcomes including mode of delivery, congenital abnormalities, preterm delivery, foetal death, and low Apgar score, which is consistent with the previous version of this review. This update provides stratified analyses based on steroid potency; we found no association between maternal use of topical corticosteroids of any potency and an increase in adverse pregnancy outcomes, including mode of delivery, congenital abnormality, preterm delivery, foetal death, and low Apgar score. Similar to the previous version of the review, this update identified a probable association between low birth weight and maternal use of potent to very potent topical corticosteroids, especially when the cumulative dosage of topical corticosteroids throughout the pregnancy is very large, which warrants further investigation. The finding of a possible protective effect of mild to moderate topical corticosteroids on foetal death could also be examined. Output:
We updated the review that was previously published in 2009. We examined the research published up to July 2015 and found seven new studies. All in all, this updated review included a total of 14 observational studies that assessed 1,601,515 pregnancies. Observational studies are generally regarded as less rigorous than randomised controlled clinical trials. The funding source was from academic or governmental institutions in 10 studies and was not reported in 4 studies. We found no associations between mothers' use of topical steroids of any potency and type of delivery, birth defects, premature births, or low Apgar score. There is some evidence indicating a relation between low birth weight and maternal use of potent or very potent topical steroids, especially when high doses are used in pregnancy, and this may warrant more research. On the other hand, maternal use of mild or moderate topical corticosteroids is not related to low birth weight. We even found that mild or moderately potent topical steroids protect against death of the baby, but this was not seen when the mothers used potent or very potent topical steroids. This finding needs further examination. The overall quality of evidence is low because all available studies were observational. The high quality study design of the randomised controlled trial that allocates participants to receive either topical corticosteroids or no treatment is not generally feasible in pregnant women due to ethical concerns about possible exposure of the foetus to an experimental treatment. Where we further downgraded the quality of the evidence to 'very low', it was because we had detected variation in the results from the studies that we found, which means that we have low confidence in our estimates of the effects for our outcomes.
CochranePLS460
***TASK*** the task is to simplify the input abstract of a biomedical literature ***INPUT*** the input is the abstract of a biomedical literature ***OUTPUT*** the output is the simplified abstract for the input abstract of a biomedical literature ***EXAMPLES*** Input: Output: ***EXAMPLES*** Input: Two trials (n = 190), at low risk of bias, were included in the review and both presented data on first time failure at the tooth level. Pooling of the data showed a statistically significant difference in favour of molar bands, with a hazard ratio of 2.92 (95% confidence intervals (CI) 1.80 to 4.72). No statistically significant heterogeneity was shown between the two studies. Data on first time failure at the patient level were also available and showed statistically different difference in favour of molar bands (risk ratio 2.30; 95% CI 1.56 to 3.41) (risk of event for molar tubes = 57%; risk of event for molar bands 25%). One trial presented data on decalcification again showing a statistically significant difference in favour of molar bands. No other adverse events identified. From the two well-designed and low risk of bias trials included in this review it was shown that the failure of molar tubes bonded with either a chemically-cured or light-cured adhesive was considerably higher than that of molar bands cemented with glass ionomer cement. One trial indicated that there was less decalcification with molar bands cemented with glass ionomer cement than with bonded molar tubes cemented with a light-cured adhesive. However, given there are limited data for this outcome, further evidence is required to draw more robust conclusions. Output: The evidence in this review, which was carried out together with Cochrane Oral Health, is up-to-date as of 15 February 2017. We included two studies that evaluated 190 participants. Both trials were conducted in the UK and both compared bonded molar tubes with molar bands. From the limited data of two studies at low risk of bias, it would appear that bonded molar tubes are associated with a higher failure rate than with molar bands. Input: We found four RCTs that met the inclusion criteria of this review. The total number of included participants was 611 (612 eyes), ranging from 30 to 500 participants per trial. One trial was included in the previous version of the review, and we identified three additional trials through the updated searches in July 2014. One of the three smaller trials was a pilot study of the largest study: the Steroids for Corneal Ulcers Trial (SCUT). All trials compared the treatment of bacterial keratitis with topical corticosteroid and without topical corticosteroid and had follow-up periods ranging from two months to one year. These trials were conducted in the USA, Canada, India, and South Africa. All trials reported data on visual acuity ranging from three weeks to one year, and none of them found any important difference between the corticosteroid group and the control group. The pilot study of the SCUT reported that time to re-epithelialization in the steroid group was 53% slower than the placebo group after adjusting for baseline epithelial defect size (hazard ratio (HR) 0.47; 95% confidence interval (CI) 0.23 to 0.94). However, the SCUT did not find any important difference in time to re-epithelialization (HR 0.92; 95% CI 0.76 to 1.11). For adverse events, none of the three small trials found any important difference between the two treatment groups. The investigators of the largest trial reported that more patients in the control group developed intraocular pressure (IOP) elevation (risk ratio (RR) 0.20; 95% CI 0.04 to 0.90). One trial reported quality of life and concluded that there was no difference between the two groups (data not available). We did not find any reports regarding economic outcomes. Although the four trials were generally of good methodological design, all trials had considerable losses to follow-up (10% or more) in the final analyses. Further, three of the four trials were underpowered to detect treatment effect differences between groups and inconsistency in outcome measurements precluded meta-analyses for most outcomes relevant to this review. There is inadequate evidence as to the effectiveness and safety of adjunctive topical corticosteroids compared with no topical corticosteroids in improving visual acuity, infiltrate/scar size, or adverse events among participants with bacterial keratitis. Current evidence does not support a strong effect of corticosteroid, but may be due to insufficient power to detect a treatment effect. Output:
We found four studies in which antibiotics alone had been compared with antibiotics plus corticosteroids for the treatment of bacterial keratitis. These studies were conducted in the USA, Canada, India, and South Africa, and included a total of 612 eyes of 611 participants. The largest study included 500 participants followed for one year. The three smaller studies followed participants for two to three months. The evidence is current to July 2014. None of the four studies reported an important difference between topical corticosteroid therapy and placebo or control treatment for reduction in ulcer size, change in visual acuity, adverse events, or quality of life. One study reported that healing or cure time in the steroid group was slower than the placebo group (for every 100 people cured in the control group, only 47 were cured in the steroid group during the same time period), but the largest study did not report any difference (for every 100 people cured in the control group, 92 were cured in the steroid group during the same time interval). For adverse events, none of the studies found a difference between the two groups, except that one study reported that more eyes in the control group developed intraocular pressure (IOP) elevation. We did not find any information on economic outcomes. Generally, the quality of the evidence based on the four studies we identified was moderate due to the proportions of participants who were not included in the final study analyses and the inconsistency of outcomes assessed across the four studies. In addition, three studies enrolled too few participants (30 to 42) to reach scientifically valid conclusions.
CochranePLS461
***TASK*** the task is to simplify the input abstract of a biomedical literature ***INPUT*** the input is the abstract of a biomedical literature ***OUTPUT*** the output is the simplified abstract for the input abstract of a biomedical literature ***EXAMPLES*** Input: Output: ***EXAMPLES*** Input: Two trials (n = 190), at low risk of bias, were included in the review and both presented data on first time failure at the tooth level. Pooling of the data showed a statistically significant difference in favour of molar bands, with a hazard ratio of 2.92 (95% confidence intervals (CI) 1.80 to 4.72). No statistically significant heterogeneity was shown between the two studies. Data on first time failure at the patient level were also available and showed statistically different difference in favour of molar bands (risk ratio 2.30; 95% CI 1.56 to 3.41) (risk of event for molar tubes = 57%; risk of event for molar bands 25%). One trial presented data on decalcification again showing a statistically significant difference in favour of molar bands. No other adverse events identified. From the two well-designed and low risk of bias trials included in this review it was shown that the failure of molar tubes bonded with either a chemically-cured or light-cured adhesive was considerably higher than that of molar bands cemented with glass ionomer cement. One trial indicated that there was less decalcification with molar bands cemented with glass ionomer cement than with bonded molar tubes cemented with a light-cured adhesive. However, given there are limited data for this outcome, further evidence is required to draw more robust conclusions. Output: The evidence in this review, which was carried out together with Cochrane Oral Health, is up-to-date as of 15 February 2017. We included two studies that evaluated 190 participants. Both trials were conducted in the UK and both compared bonded molar tubes with molar bands. From the limited data of two studies at low risk of bias, it would appear that bonded molar tubes are associated with a higher failure rate than with molar bands. Input: We included four trials with 450 participants. Data on functional outcome and death at end of follow-up were available for 443 participants from three trials. Compared with intravenous thrombolytic therapy, percutaneous vascular intervention did not improve the proportion of participants with good functional outcome (modified Rankin Scale score 0 to 2, risk ratio (RR) 1.01, 95% confidence interval (CI) 0.82 to 1.25, P = 0.92). The quality of evidence was low (outcome assessment was blinded, but not the treating physician or participants). At the end of follow-up, there was a non-significant increase in the proportion of participants who died in the percutaneous vascular intervention group (RR 1.34, 95% CI 0.84 to 2.14, P = 0.21). The quality of evidence was low (wide confidence interval). There was no difference in the proportion of participants with symptomatic intracranial haemorrhages between the intervention and control groups (RR 0.99, 95% CI 0.50 to 1.95, P = 0.97). The quality of evidence was low (wide confidence interval). Data on vascular status (recanalisation rate) were only available for seven participants from one trial; we considered this inadequate for statistical analyses. The present review directly compared intravenous thrombolytic treatment with percutaneous vascular interventions for ischaemic stroke. We found no evidence from RCTs that percutaneous vascular interventions are superior to intravenous thrombolytic treatment with respect to functional outcome. Quality of evidence was low (outcome assessment was blinded, but not the treating physician or participants). New trials with adequate sample sizes are warranted because of the rapid development of new techniques and devices for such interventions. Output:
We included four trials with 450 participants randomised to either percutaneous vascular intervention or clot-dissolving drugs given by injection. The evidence is current as of September 2017. Compared with clot-dissolving drugs, percutaneous vascular interventions did not increase the chance of making a good recovery by the end of the trial. There was no significant increase in the risk of dying or of suffering a brain bleed. New, larger trials are needed, particularly because of the rapid development of new techniques and devices for percutaneous vascular interventions. We judged the quality of the evidence to be low because of the limited amount of trial information available.
CochranePLS462
***TASK*** the task is to simplify the input abstract of a biomedical literature ***INPUT*** the input is the abstract of a biomedical literature ***OUTPUT*** the output is the simplified abstract for the input abstract of a biomedical literature ***EXAMPLES*** Input: Output: ***EXAMPLES*** Input: Two trials (n = 190), at low risk of bias, were included in the review and both presented data on first time failure at the tooth level. Pooling of the data showed a statistically significant difference in favour of molar bands, with a hazard ratio of 2.92 (95% confidence intervals (CI) 1.80 to 4.72). No statistically significant heterogeneity was shown between the two studies. Data on first time failure at the patient level were also available and showed statistically different difference in favour of molar bands (risk ratio 2.30; 95% CI 1.56 to 3.41) (risk of event for molar tubes = 57%; risk of event for molar bands 25%). One trial presented data on decalcification again showing a statistically significant difference in favour of molar bands. No other adverse events identified. From the two well-designed and low risk of bias trials included in this review it was shown that the failure of molar tubes bonded with either a chemically-cured or light-cured adhesive was considerably higher than that of molar bands cemented with glass ionomer cement. One trial indicated that there was less decalcification with molar bands cemented with glass ionomer cement than with bonded molar tubes cemented with a light-cured adhesive. However, given there are limited data for this outcome, further evidence is required to draw more robust conclusions. Output: The evidence in this review, which was carried out together with Cochrane Oral Health, is up-to-date as of 15 February 2017. We included two studies that evaluated 190 participants. Both trials were conducted in the UK and both compared bonded molar tubes with molar bands. From the limited data of two studies at low risk of bias, it would appear that bonded molar tubes are associated with a higher failure rate than with molar bands. Input: We included in the review one trial, involving 120 families and 143 children. Risk of bias was high because of contamination between groups, as 63% of control group participants accessed day care services separate from those offered within the intervention. No evidence suggested that centre-based day care, rather than no treatment (care at home), improved or worsened children's cognitive ability (Griffiths Mental Development Scale, standardised mean difference (SMD) 0.34, 95% confidence interval (CI) -0.01 to 0.69, 127 participants, 1 study, very low-quality evidence) or psychosocial development (parental report of abnormal development, risk ratio (RR) 1.21, 95% CI 0.25 to 5.78, 137 participants, 1 study, very low-quality evidence). No other measures of child intellectual or psychosocial development were reported in the included study. Moreover, no evidence indicated that centre-based day care, rather than no treatment (care at home), improved or worsened employment of parents, as measured by the number of mothers in full-time or part-time employment (RR 1.12, 95% CI 0.85 to 1.48, 114 participants, 1 study, very low-quality evidence) and maternal hours per week in paid employment (SMD 0.20, 95% -0.15 to 0.55, 127 participants, 1 study, very low-quality evidence) or household income above £200 per week (RR 0.86, 95% CI 0.57 to 1.29, 113 participants, 1 study, very low-quality evidence). This study did not report on long-term outcomes for children (high-school completion or income). This review includes one trial that provides inconclusive evidence as regards the effects of centre-based day care for children younger than five years of age and their families in high-income countries. Robust guidance for parents, policymakers and other stakeholders on the effects of day care cannot currently be offered on the basis of evidence from randomised controlled trials. Some trials included co-interventions that are unlikely to be found in normal day care centres. Effectiveness studies of centre-based day care without these co-interventions are few, and the need for such studies is significant. Comparisons might include home visits or alternative day care arrangements that provide special attention to children from low-income families while exploring possible mechanisms of effect. Output:
We included studies that assessed the effects of centre-based day care for children younger than five years of age in high-income countries. To isolate the effects of day care, we excluded interventions that involved medical, psychological or non–child-focused co-interventions. Electronic searches identified 34,890 citations that were screened for inclusion in the review. Only one study (120 families, 143 children), based in London, England, matched all inclusion criteria and was included in the review. Evidence is current to April 2014. Currently very limited evidence is available on the effects of centre-based day care on the cognitive and psychosocial development of children, parental employment or household income, or on long-term outcomes for children. Only one randomised controlled trial (RCT) was included in this review. In addition, a large proportion of families in the non-intervention group secured day care services for themselves. The quality of the evidence included in this review is very low, so the results must be interpreted with caution. Although RCTs do not allow conclusive judgements as regards the role of centre-based day care in the development of children and the economic situation of parents, this does not imply that these services are not important in high-income countries. The need for effectiveness studies of centre-based day care without co-interventions is significant. This review is one of a pair of reviews; researchers and practitioners may find evidence from the low- and middle-income country review to be informative also (Brown 2014).
CochranePLS463
***TASK*** the task is to simplify the input abstract of a biomedical literature ***INPUT*** the input is the abstract of a biomedical literature ***OUTPUT*** the output is the simplified abstract for the input abstract of a biomedical literature ***EXAMPLES*** Input: Output: ***EXAMPLES*** Input: Two trials (n = 190), at low risk of bias, were included in the review and both presented data on first time failure at the tooth level. Pooling of the data showed a statistically significant difference in favour of molar bands, with a hazard ratio of 2.92 (95% confidence intervals (CI) 1.80 to 4.72). No statistically significant heterogeneity was shown between the two studies. Data on first time failure at the patient level were also available and showed statistically different difference in favour of molar bands (risk ratio 2.30; 95% CI 1.56 to 3.41) (risk of event for molar tubes = 57%; risk of event for molar bands 25%). One trial presented data on decalcification again showing a statistically significant difference in favour of molar bands. No other adverse events identified. From the two well-designed and low risk of bias trials included in this review it was shown that the failure of molar tubes bonded with either a chemically-cured or light-cured adhesive was considerably higher than that of molar bands cemented with glass ionomer cement. One trial indicated that there was less decalcification with molar bands cemented with glass ionomer cement than with bonded molar tubes cemented with a light-cured adhesive. However, given there are limited data for this outcome, further evidence is required to draw more robust conclusions. Output: The evidence in this review, which was carried out together with Cochrane Oral Health, is up-to-date as of 15 February 2017. We included two studies that evaluated 190 participants. Both trials were conducted in the UK and both compared bonded molar tubes with molar bands. From the limited data of two studies at low risk of bias, it would appear that bonded molar tubes are associated with a higher failure rate than with molar bands. Input: In total, 126 reports describing 30 scoring indices were identified through the screening process. Eleven of the 30 scoring indices have undergone some form of index validation. Intra-rater reliability was assessed for eight scoring indices. Inter-rater reliability was evaluated for all 11 of the scoring indices. Three of the indices underwent content validation. Two of the included scoring indices assessed criterion validity. Six of the included scoring indices explored content validity. Two of the included scoring indices were tested for responsiveness. The Nancy Index and the Robarts Histopathology Index have undergone the most validation in that four operating properties including reliability, content validity, construct validity (hypothesis testing) and criterion validity have been tested. However, none of the currently available histologic scoring indices have been fully validated. In order to determine the optimal endpoint for histologic healing in UC, more research is required. The optimal index would need to be fully validated. Output:
The researchers found that 11 out of the 30 histologic scoring indices that exist have been partially validated. The Nancy Index and the Robarts Histopathology Index have undergone the most validation compared to the other nine indices. However, none of the currently available histologic scoring indices have been fully validated. In order to determine the ideal index to measure histologic healing in UC, more research is required. The ideal index would need to be fully validated.
CochranePLS464
***TASK*** the task is to simplify the input abstract of a biomedical literature ***INPUT*** the input is the abstract of a biomedical literature ***OUTPUT*** the output is the simplified abstract for the input abstract of a biomedical literature ***EXAMPLES*** Input: Output: ***EXAMPLES*** Input: Two trials (n = 190), at low risk of bias, were included in the review and both presented data on first time failure at the tooth level. Pooling of the data showed a statistically significant difference in favour of molar bands, with a hazard ratio of 2.92 (95% confidence intervals (CI) 1.80 to 4.72). No statistically significant heterogeneity was shown between the two studies. Data on first time failure at the patient level were also available and showed statistically different difference in favour of molar bands (risk ratio 2.30; 95% CI 1.56 to 3.41) (risk of event for molar tubes = 57%; risk of event for molar bands 25%). One trial presented data on decalcification again showing a statistically significant difference in favour of molar bands. No other adverse events identified. From the two well-designed and low risk of bias trials included in this review it was shown that the failure of molar tubes bonded with either a chemically-cured or light-cured adhesive was considerably higher than that of molar bands cemented with glass ionomer cement. One trial indicated that there was less decalcification with molar bands cemented with glass ionomer cement than with bonded molar tubes cemented with a light-cured adhesive. However, given there are limited data for this outcome, further evidence is required to draw more robust conclusions. Output: The evidence in this review, which was carried out together with Cochrane Oral Health, is up-to-date as of 15 February 2017. We included two studies that evaluated 190 participants. Both trials were conducted in the UK and both compared bonded molar tubes with molar bands. From the limited data of two studies at low risk of bias, it would appear that bonded molar tubes are associated with a higher failure rate than with molar bands. Input: We included three randomised trials that evaluated intramedullary nailing versus plating in 213 participants, with useable data from 173 participants of whom 112 were male. The mean age of participants in individual studies ranged from 41 to 44 years. There were no trials comparing surgery with non-surgical treatment. The three included trials were at high risk of performance bias, with one trial also being at high risk of selection, detection and attrition bias. Overall, the quality of available evidence was rated as very low for all outcomes, meaning that we are very unsure about the estimates for all outcomes. Although the pooled results of three different measures of foot and ankle function indicated a small difference in favour of nailing (standard mean difference 0.28, 95% CI -0.02 to 0.59; 172 participants, 3 trials), the results of individual trials indicated that this was very unlikely to be a clinically important difference. Pooled data (173 participants, 3 trials) for the need for reoperation or substantive physiotherapy for adverse events favoured nailing (4/90 versus 10/83; RR 0.37, 95% CI 0.12 to 1.12), but included the possibility of a better outcome after plating. Based on an illustrative risk of 100 re-operations for adverse outcomes within one year of plate fixation in 1000 people with these fractures, 63 fewer (95% CI 88 fewer to 12 more) people per 1000 would have re-operations after nailing. Similarly pooled data (173 participants, 3 trials) for the symptomatic nonunion or malunion, wound complications and fracture union favoured nailing but the 95% confidence intervals crossed the line of no effect and thus included the possibility of a better outcome after plating. Evidence from one trial (85 participants) showed no clinically important difference in pain between the two groups. Overall, there is either no or insufficient evidence to draw definitive conclusions on the use of surgery or the best surgical intervention for distal tibial metaphyseal fractures in adults. The available evidence, which is of very low quality, found no clinically important differences in function or pain, and did not confirm a difference in the need for re-operation or risk of complications between nailing and plating. The addition of evidence from two ongoing trials of nailing versus plating should inform this question in future updates. Further randomised trials are warranted on other issues, but should be preceded by research to identify priority questions. Output:
We searched medical databases and trials registries in December 2014. We wanted to include studies in which receiving one surgical treatment or another surgical treatment was decided by chance. This research method, termed a randomised controlled trial (RCT), is the best way to ensure that any measured improvement is caused by the treatment itself and no other factors. We found three RCTs involving 213 adults (with results available from 173) that compared nailing versus plating for treating distal tibial fractures. Overall the studies included around twice as many males as females and the average age of the study participants was just over 40 years. We found no trials comparing surgery with non-surgical treatment. We found no clear differences between the nailing and plating groups in terms of patient-reported functional outcomes, re-operations for adverse outcomes, troublesome non-healing of the bone or deformity, pain, wound problems such as infection, or the numbers of individuals with healed fractures. Only three trials were identified and the sample sizes were small, so the results are imprecise. Moreover, the results of one trial were very likely to be biased due to flawed methodology. We therefore judged the overall quality of evidence to be very low, which means that we are very unsure of these results. Overall, the evidence is of very low quality and is insufficient to draw definite conclusions about the best method of surgery, including nailing versus plating, for treating breaks of the lower end of the shin bone in adults. Future updates of this review are likely to include evidence from currently ongoing research comparing nailing versus plating. Although other RCTs are needed to address key clinical questions on surgical methods for treating these fractures, these studies should be preceded by research to determine which questions should be prioritised.
CochranePLS465
***TASK*** the task is to simplify the input abstract of a biomedical literature ***INPUT*** the input is the abstract of a biomedical literature ***OUTPUT*** the output is the simplified abstract for the input abstract of a biomedical literature ***EXAMPLES*** Input: Output: ***EXAMPLES*** Input: Two trials (n = 190), at low risk of bias, were included in the review and both presented data on first time failure at the tooth level. Pooling of the data showed a statistically significant difference in favour of molar bands, with a hazard ratio of 2.92 (95% confidence intervals (CI) 1.80 to 4.72). No statistically significant heterogeneity was shown between the two studies. Data on first time failure at the patient level were also available and showed statistically different difference in favour of molar bands (risk ratio 2.30; 95% CI 1.56 to 3.41) (risk of event for molar tubes = 57%; risk of event for molar bands 25%). One trial presented data on decalcification again showing a statistically significant difference in favour of molar bands. No other adverse events identified. From the two well-designed and low risk of bias trials included in this review it was shown that the failure of molar tubes bonded with either a chemically-cured or light-cured adhesive was considerably higher than that of molar bands cemented with glass ionomer cement. One trial indicated that there was less decalcification with molar bands cemented with glass ionomer cement than with bonded molar tubes cemented with a light-cured adhesive. However, given there are limited data for this outcome, further evidence is required to draw more robust conclusions. Output: The evidence in this review, which was carried out together with Cochrane Oral Health, is up-to-date as of 15 February 2017. We included two studies that evaluated 190 participants. Both trials were conducted in the UK and both compared bonded molar tubes with molar bands. From the limited data of two studies at low risk of bias, it would appear that bonded molar tubes are associated with a higher failure rate than with molar bands. Input: We included 11 studies involving a total of 38,742 participants: eight studies compared BPLDs versus placebo or no treatment (35,110 participants), and three studies compared different systolic blood pressure targets (3632 participants). The risk of bias varied greatly between included studies. The pooled risk ratio (RR) of BPLDs for recurrent stroke was 0.81 (95% confidence interval (CI) 0.70 to 0.93; 8 RCTs; 35,110 participants; moderate-quality evidence), for major vascular event 0.90 (95% CI 0.78 to 1.04; 4 RCTs; 28,630 participants; high-quality evidence), and for dementia 0.88 (95% CI 0.73 to 1.06; 2 RCTs; 6671 participants; high-quality evidence). We mainly observed a reduced risk of recurrent stroke in the subgroup of participants using an angiotensin-converting enzyme (ACE) inhibitor or a diuretic (I2 statistic for subgroup differences 72.1%; P = 0.006). The pooled RR of intensive blood pressure-lowering for recurrent stroke was 0.80 (95% CI 0.63 to 1.00), and for major vascular event 0.58 (95% CI 0.23 to 1.46). Our results support the use of BPLDs in people with stroke or TIA for reducing the risk of recurrent stroke. Current evidence is primarily derived from trials studying an ACE inhibitor or a diuretic. No definite conclusions can be drawn from current evidence regarding an optimal systolic blood pressure target after stroke or TIA. Output:
this review is up-to-date to August 2017. We included 11 trials involving 38,742 participants: eight trials assessed the effect of blood pressure drugs, and three trials compared different blood pressure targets. Ten studies were hospital-based and one trial was performed in a general practitioner setting. Not all trials contributed information to all outcomes. blood pressure drugs lowered the risk of recurrent stroke in patients with a stroke or TIA, whereas there is insufficient evidence to conclude whether they reduce the risk of other blood vessel diseases and dementia. There is also insufficient evidence to conclude which blood pressure target is best for patients with a stroke or TIA. overall, the quality of the trials in this review was moderate. However, we found similar results in an analysis using only high-quality trials. More research is needed to investigate whether blood pressure drugs also prevent dementia, and what blood pressure targets are best for patients with a stroke or TIA.
CochranePLS466
***TASK*** the task is to simplify the input abstract of a biomedical literature ***INPUT*** the input is the abstract of a biomedical literature ***OUTPUT*** the output is the simplified abstract for the input abstract of a biomedical literature ***EXAMPLES*** Input: Output: ***EXAMPLES*** Input: Two trials (n = 190), at low risk of bias, were included in the review and both presented data on first time failure at the tooth level. Pooling of the data showed a statistically significant difference in favour of molar bands, with a hazard ratio of 2.92 (95% confidence intervals (CI) 1.80 to 4.72). No statistically significant heterogeneity was shown between the two studies. Data on first time failure at the patient level were also available and showed statistically different difference in favour of molar bands (risk ratio 2.30; 95% CI 1.56 to 3.41) (risk of event for molar tubes = 57%; risk of event for molar bands 25%). One trial presented data on decalcification again showing a statistically significant difference in favour of molar bands. No other adverse events identified. From the two well-designed and low risk of bias trials included in this review it was shown that the failure of molar tubes bonded with either a chemically-cured or light-cured adhesive was considerably higher than that of molar bands cemented with glass ionomer cement. One trial indicated that there was less decalcification with molar bands cemented with glass ionomer cement than with bonded molar tubes cemented with a light-cured adhesive. However, given there are limited data for this outcome, further evidence is required to draw more robust conclusions. Output: The evidence in this review, which was carried out together with Cochrane Oral Health, is up-to-date as of 15 February 2017. We included two studies that evaluated 190 participants. Both trials were conducted in the UK and both compared bonded molar tubes with molar bands. From the limited data of two studies at low risk of bias, it would appear that bonded molar tubes are associated with a higher failure rate than with molar bands. Input: Five hundred nineteen men from four randomized, placebo-controlled, double-blind trials, (lasting 4 to 26 weeks) were assessed. Three trials used non-glucosidic B-sitosterols and one utilized a preparation that contained 100% B-sitosteryl-B-D-glucoside. B-Sitosterols improved urinary symptom scores and flow measures. The weighted mean difference (WMD) for the IPSS was -4.9 IPSS points (95% CI = -6.3 to -3.5, n = 2 studies). The WMD for peak urine flow was 3.91 mL/s (95% CI = 0.91 to 6.90, n = 4 studies) and the WMD for residual volume was -28.62 mL (95% CI = -41.42 to -15.83, n = 4 studies). The trial using 100% B-sitosteryl-B-D-glucoside (WA184) show improvement in urinary flow measures. B-sitosterols did not significantly reduce prostate size compared to placebo. Withdrawal rates for men assigned to B-sitosterol and placebo were 7.8% and 8.0%, respectively. The evidence suggests non-glucosidic B-sitosterols improve urinary symptoms and flow measures. Their long term effectiveness, safety and ability to prevent BPH complications are not known. Output:
The review found that beta-sitosterol treatments were well tolerated and improved urinary symptoms and flow measures in men with mild to moderate BPH. More research into long-term effects of beta-sitosterols is needed.
CochranePLS467
***TASK*** the task is to simplify the input abstract of a biomedical literature ***INPUT*** the input is the abstract of a biomedical literature ***OUTPUT*** the output is the simplified abstract for the input abstract of a biomedical literature ***EXAMPLES*** Input: Output: ***EXAMPLES*** Input: Two trials (n = 190), at low risk of bias, were included in the review and both presented data on first time failure at the tooth level. Pooling of the data showed a statistically significant difference in favour of molar bands, with a hazard ratio of 2.92 (95% confidence intervals (CI) 1.80 to 4.72). No statistically significant heterogeneity was shown between the two studies. Data on first time failure at the patient level were also available and showed statistically different difference in favour of molar bands (risk ratio 2.30; 95% CI 1.56 to 3.41) (risk of event for molar tubes = 57%; risk of event for molar bands 25%). One trial presented data on decalcification again showing a statistically significant difference in favour of molar bands. No other adverse events identified. From the two well-designed and low risk of bias trials included in this review it was shown that the failure of molar tubes bonded with either a chemically-cured or light-cured adhesive was considerably higher than that of molar bands cemented with glass ionomer cement. One trial indicated that there was less decalcification with molar bands cemented with glass ionomer cement than with bonded molar tubes cemented with a light-cured adhesive. However, given there are limited data for this outcome, further evidence is required to draw more robust conclusions. Output: The evidence in this review, which was carried out together with Cochrane Oral Health, is up-to-date as of 15 February 2017. We included two studies that evaluated 190 participants. Both trials were conducted in the UK and both compared bonded molar tubes with molar bands. From the limited data of two studies at low risk of bias, it would appear that bonded molar tubes are associated with a higher failure rate than with molar bands. Input: The review includes 26 trials comparing salmeterol to placebo and eight trials comparing with salbutamol. These included 62,815 participants with asthma (including 2,599 children). In six trials (2,766 patients), no serious adverse event data could be obtained. All-cause mortality was higher with regular salmeterol than placebo but the increase was not significant (Peto odds ratio (OR) 1.33 (95% CI 0.85 to 2.08)). Non-fatal serious adverse events were significantly increased when regular salmeterol was compared with placebo (OR 1.15 95% CI 1.02 to 1.29). One extra serious adverse event occurred over 28 weeks for every 188 people treated with regular salmeterol (95% CI 95 to 2606). There is insufficient evidence to assess whether the risk in children is higher or lower than in adults. We found no significant increase in fatal or non-fatal serious adverse events when regular salmeterol was compared with regular salbutamol. We combined individual patient data from the two largest studies (SNS: n=25,180 and SMART: n=26,355), as all the asthma-related deaths in adults occurred in these studies. In patients who were not taking inhaled corticosteroids, compared to regular salbutamol or placebo, there was a significant increase in risk of asthma-related death with regular salmeterol (Peto OR 6.15 95% CI 1.73 to 21.84). The confidence interval for patients who were taking inhaled corticosteroids is wide and cannot rule in or out an increase in asthma mortality in the presence of an inhaled corticosteroid (Peto OR 2.03 95% CI 0.82 to 5.00). In comparison with placebo, we have found an increased risk of serious adverse events with regular salmeterol. There is also a clear increase in risk of asthma-related mortality in patients not using inhaled corticosteroids in the two large surveillance studies. Although the increase in asthma-related mortality was smaller in patients taking inhaled corticosteroids at baseline, the confidence interval is wide, so we cannot conclude that the inhaled corticosteroids abolish the risks of regular salmeterol. The adverse effects of regular salmeterol in children remain uncertain due to the small number of children studied. Output:
There was no statistically significant difference in the number of people who died during treatment with salmeterol compared with placebo or salbutamol. Because so few people die of asthma, huge trials or observational studies are normally required to detect a difference in death rates from asthma. There were more non-fatal serious adverse events in people taking salmeterol compared to those on placebo; for every 188 people treated with salmeterol for 28 weeks, one extra non-fatal event occurred in comparison with placebo. There was no significant differences in serious adverse events in people on salmeterol compared to regular salbutamol. In order to obtain individual patient data on asthma deaths, we looked separately at mortality in two large trials on over 51,000 patients who were not taking inhaled corticosteroids, and found that there was an increase in the number of asthma-related deaths among people on salmeterol. We conclude that, for patients whose asthma is not well-controlled on moderate doses of inhaled corticosteroids, additional salmeterol can improve symptoms but this may be at the expense of an increased risk of serious adverse events and asthma related mortality. Salmeterol should not be used as a substitute for inhaled corticosteroids, and adherence with inhaled steroids should be kept under review if separate inhalers are used. Salmeterol should not be taken by people who are not taking regular inhaled steroids due to the increased risk of asthma-related death.
CochranePLS468
***TASK*** the task is to simplify the input abstract of a biomedical literature ***INPUT*** the input is the abstract of a biomedical literature ***OUTPUT*** the output is the simplified abstract for the input abstract of a biomedical literature ***EXAMPLES*** Input: Output: ***EXAMPLES*** Input: Two trials (n = 190), at low risk of bias, were included in the review and both presented data on first time failure at the tooth level. Pooling of the data showed a statistically significant difference in favour of molar bands, with a hazard ratio of 2.92 (95% confidence intervals (CI) 1.80 to 4.72). No statistically significant heterogeneity was shown between the two studies. Data on first time failure at the patient level were also available and showed statistically different difference in favour of molar bands (risk ratio 2.30; 95% CI 1.56 to 3.41) (risk of event for molar tubes = 57%; risk of event for molar bands 25%). One trial presented data on decalcification again showing a statistically significant difference in favour of molar bands. No other adverse events identified. From the two well-designed and low risk of bias trials included in this review it was shown that the failure of molar tubes bonded with either a chemically-cured or light-cured adhesive was considerably higher than that of molar bands cemented with glass ionomer cement. One trial indicated that there was less decalcification with molar bands cemented with glass ionomer cement than with bonded molar tubes cemented with a light-cured adhesive. However, given there are limited data for this outcome, further evidence is required to draw more robust conclusions. Output: The evidence in this review, which was carried out together with Cochrane Oral Health, is up-to-date as of 15 February 2017. We included two studies that evaluated 190 participants. Both trials were conducted in the UK and both compared bonded molar tubes with molar bands. From the limited data of two studies at low risk of bias, it would appear that bonded molar tubes are associated with a higher failure rate than with molar bands. Input: Two studies enrolled preterm infants with respiratory distress. Amato (1988) allocated infants to L-thyroxine 50 μg/dose at 1 and at 24 hours or no treatment. Amato (1989) allocated infants to L-triiodothyronine 50 μg/day in two divided doses for two days or no treatment. Both studies had methodological concerns including quasi-random methods of patient allocation, no blinding of treatment or measurement and substantial post allocation losses. Neither study reported any significant benefits in neonatal morbidity or mortality from use of thyroid hormones. Meta-analysis of two studies (80 infants) found no significant difference in mortality to discharge (typical RR 1.00, 95% CI 0.47, 2.14). Amato 1988 reported no significant difference in use of mechanical ventilation (RR 0.64, 95% CI 0.38, 1.09). No significant effects were found in use of mechanical ventilation, duration of mechanical ventilation, air leak, CLD at 28 days in survivors, patent ductus arteriosus, intraventricular haemorrhage or necrotising enterocolitis. Neurodevelopment was not reported. There is no evidence from controlled clinical trials that postnatal thyroid hormone treatment reduces the severity of respiratory distress syndrome, neonatal morbidity or mortality in preterm infants with respiratory distress syndrome. Output:
This review found two small trials that compared the use of thyroid hormones to no treatment in infants with breathing problems in the first hours after birth. No benefit was found from use of these hormones on severity of breathing problems or complications that occurred as a result of these breathing problems. The effect on longer term development was not reported.
CochranePLS469
***TASK*** the task is to simplify the input abstract of a biomedical literature ***INPUT*** the input is the abstract of a biomedical literature ***OUTPUT*** the output is the simplified abstract for the input abstract of a biomedical literature ***EXAMPLES*** Input: Output: ***EXAMPLES*** Input: Two trials (n = 190), at low risk of bias, were included in the review and both presented data on first time failure at the tooth level. Pooling of the data showed a statistically significant difference in favour of molar bands, with a hazard ratio of 2.92 (95% confidence intervals (CI) 1.80 to 4.72). No statistically significant heterogeneity was shown between the two studies. Data on first time failure at the patient level were also available and showed statistically different difference in favour of molar bands (risk ratio 2.30; 95% CI 1.56 to 3.41) (risk of event for molar tubes = 57%; risk of event for molar bands 25%). One trial presented data on decalcification again showing a statistically significant difference in favour of molar bands. No other adverse events identified. From the two well-designed and low risk of bias trials included in this review it was shown that the failure of molar tubes bonded with either a chemically-cured or light-cured adhesive was considerably higher than that of molar bands cemented with glass ionomer cement. One trial indicated that there was less decalcification with molar bands cemented with glass ionomer cement than with bonded molar tubes cemented with a light-cured adhesive. However, given there are limited data for this outcome, further evidence is required to draw more robust conclusions. Output: The evidence in this review, which was carried out together with Cochrane Oral Health, is up-to-date as of 15 February 2017. We included two studies that evaluated 190 participants. Both trials were conducted in the UK and both compared bonded molar tubes with molar bands. From the limited data of two studies at low risk of bias, it would appear that bonded molar tubes are associated with a higher failure rate than with molar bands. Input: We included 38 RCTs with a total of 1828 participants. Eight RCTs had a low risk of bias in the assessment of mortality. All trials had a high risk of bias in the assessment of the remaining outcomes. Random-effects meta-analysis showed a beneficial effect of non-absorbable disaccharides versus placebo/no intervention on mortality when including all RCTs with extractable data (RR 0.59, 95% CI 0.40 to 0.87; 1487 participants; 24 RCTs; I2 = 0%; moderate quality evidence) and in the eight RCTs with a low risk of bias (RR 0.63, 95% CI 0.41 to 0.97; 705 participants). The Trial Sequential Analysis with the relative risk reduction (RRR) reduced to 30% confirmed the findings when including all RCTs, but not when including only RCTs with a low risk of bias or when we reduced the RRR to 22%. Compared with placebo/no intervention, the non-absorbable disaccharides were associated with beneficial effects on hepatic encephalopathy (RR 0.58, 95% CI 0.50 to 0.69; 1415 participants; 22 RCTs; I2 = 32%; moderate quality evidence). Additional analyses showed that non-absorbable disaccharides can help to reduce serious adverse events associated with the underlying liver disease including liver failure, hepatorenal syndrome, and variceal bleeding (RR 0.47, 95% CI 0.36 to 0.60; 1487 participants; 24 RCTs; I2 = 0%; moderate quality evidence). We confirmed the results in Trial Sequential Analysis. Tests for subgroup differences showed no statistical differences between RCTs evaluating prevention, overt, or minimal hepatic encephalopathy. The evaluation of secondary outcomes showed a potential beneficial effect of the non-absorbable disaccharides on quality of life, but we were not able to include the data in an overall meta-analysis (very low quality evidence). Non-absorbable disaccharides were associated with non-serious (mainly gastrointestinal) adverse events (very low quality evidence). None of the RCTs comparing lactulose versus lactitol evaluated quality of life. The review found no differences between lactulose and lactitol for the remaining outcomes (very low quality evidence). This review includes a large number of RCTs evaluating the prevention or treatment of hepatic encephalopathy. The analyses found evidence that non-absorbable disaccharides may be associated with a beneficial effect on clinically relevant outcomes compared with placebo/no intervention. Output:
We included 29 RCTs comparing non-absorbable disaccharides with inactive placebo or no intervention and nine RCTs comparing lactulose with lactitol. Seven of the included RCTs evaluated the prevention of hepatic encephalopathy and 31 evaluated the treatment of hepatic encephalopathy. Sixteen of the treatment RCTs included people with overt hepatic encephalopathy while 15 included people with minimal hepatic encephalopathy. The duration of treatment varied depending on the type of hepatic encephalopathy from five days to one year. People who received non-absorbable disaccharides were less likely to die than people given a placebo or no treatment. They were also less likely to develop serious complications of their liver disease such as liver failure, bleeding, and infections. The non-absorbable disaccharides were also effective in preventing the development of hepatic encephalopathy and increased the number of participants who recovered from hepatic encephalopathy. There was some evidence from a small number of trials that lactulose has a beneficial effect on the quality of life, but we were unable to include the data in an overall analysis. The non-absorbable disaccharides were associated with adverse events including diarrhoea, nausea, bloating, and flatulence. None of the RCTs comparing lactulose versus lactitol reported quality of life. The analyses showed no differences between the two interventions for the remaining outcomes. In the comparison of non-absorbable disaccharides versus placebo/no intervention, we found moderate quality evidence of benefit for the outcomes of death, hepatic encephalopathy, and serious complications. The evidence for the remaining outcomes was of very low quality.
CochranePLS470
***TASK*** the task is to simplify the input abstract of a biomedical literature ***INPUT*** the input is the abstract of a biomedical literature ***OUTPUT*** the output is the simplified abstract for the input abstract of a biomedical literature ***EXAMPLES*** Input: Output: ***EXAMPLES*** Input: Two trials (n = 190), at low risk of bias, were included in the review and both presented data on first time failure at the tooth level. Pooling of the data showed a statistically significant difference in favour of molar bands, with a hazard ratio of 2.92 (95% confidence intervals (CI) 1.80 to 4.72). No statistically significant heterogeneity was shown between the two studies. Data on first time failure at the patient level were also available and showed statistically different difference in favour of molar bands (risk ratio 2.30; 95% CI 1.56 to 3.41) (risk of event for molar tubes = 57%; risk of event for molar bands 25%). One trial presented data on decalcification again showing a statistically significant difference in favour of molar bands. No other adverse events identified. From the two well-designed and low risk of bias trials included in this review it was shown that the failure of molar tubes bonded with either a chemically-cured or light-cured adhesive was considerably higher than that of molar bands cemented with glass ionomer cement. One trial indicated that there was less decalcification with molar bands cemented with glass ionomer cement than with bonded molar tubes cemented with a light-cured adhesive. However, given there are limited data for this outcome, further evidence is required to draw more robust conclusions. Output: The evidence in this review, which was carried out together with Cochrane Oral Health, is up-to-date as of 15 February 2017. We included two studies that evaluated 190 participants. Both trials were conducted in the UK and both compared bonded molar tubes with molar bands. From the limited data of two studies at low risk of bias, it would appear that bonded molar tubes are associated with a higher failure rate than with molar bands. Input: In this 2019 update, 65 studies (involving 3598 participants) were eligible; 45 studies contributed data to our meta-analyses (2698 participants). Treatments included bisphosphonates, vitamin D compounds, teriparatide, denosumab, cinacalcet, parathyroidectomy, and calcitonin. Median duration of follow-up was 12 months. Forty-three studies evaluated bone density or bone-related biomarkers, with more recent studies evaluating proteinuria and hyperparathyroidism. Bisphosphonate therapy was usually commenced in the perioperative transplantation period (within 3 weeks) and regardless of BMD. Risks of bias were generally high or unclear leading to lower certainty in the results. A single study reported outcomes among 60 children and adolescents. Studies were not designed to measure treatment effects on fracture, death or cardiovascular outcomes, or graft loss. Compared to placebo, bisphosphonate therapy administered over 12 months in transplant recipients may prevent fracture (RR 0.62, 95% CI 0.38 to 1.01; low certainty evidence) although the 95% CI included the possibility that bisphosphonate therapy might make little or no difference. Fracture events were principally vertebral fractures identified during routine radiographic surveillance. It was uncertain whether any other drug class decreased fracture (low or very low certainty evidence). It was uncertain whether interventions for bone disease in kidney transplantation reduce all-cause or cardiovascular death, myocardial infarction or stroke, or graft loss in very low certainty evidence. Bisphosphonate therapy may decrease acute graft rejection (RR 0.70, 95% CI 0.55 to 0.89; low certainty evidence), while it is uncertain whether any other treatment impacts graft rejection (very low certainty evidence). Bisphosphonate therapy may reduce bone pain (RR 0.20, 95% CI 0.04 to 0.93; very low certainty evidence), while it was very uncertain whether bisphosphonates prevent spinal deformity or avascular bone necrosis (very low certainty evidence). Bisphosphonates may increase to risk of hypocalcaemia (RR 5.59, 95% CI 1.00 to 31.06; low certainty evidence). It was uncertain whether vitamin D compounds had any effect on skeletal, cardiovascular, death, or transplant function outcomes (very low certainty or absence of evidence). Evidence for the benefits and harms of all other treatments was of very low certainty. Evidence for children and young adolescents was sparse. Bisphosphonate therapy may reduce fracture and bone pain after kidney transplantation, however low certainty in the evidence indicates it is possible that treatment may make little or no difference. It is uncertain whether bisphosphonate therapy or other bone treatments prevent other skeletal complications after kidney transplantation, including spinal deformity or avascular bone necrosis. The effects of bone treatment for children and adolescents after kidney transplantation are very uncertain. Output:
In 2019, there are 65 research studies (involving 3598 people) that looked at whether medicines can prevent bone fractures after kidney transplant. The most common medicine in the studies was a bisphosphonate which slows bone breakdown. Bisphosphonates were given at around the time of kidney transplantation (generally just before or within a few weeks) and continued for about one year on average. Other treatment options in the studies were vitamin D, calcitonin, denosumab, teriparatide, or cinacalcet. Bisphosphonate treatment given after a transplant possibly prevents fractures and bone pain, however the range where the actual effect of treatment might be (the "margin of error") indicates that treatment might make little or no difference. Bisphosphonates possibly lower the chances of a rejection of the transplant kidney but because of problems with the research studies, we can't be very certain that this is true. Bisphosphonates caused low blood calcium levels for some people. There was low or very low confidence in the information about all the other possible treatments for bone fractures after a kidney transplant, as the studies were often too small. There was only one study for medicines in children so we don't know whether these drugs are useful and safe for younger people. It is still unclear whether bisphosphonate therapy makes any difference to bone fractures or are safe for both adults and children with a kidney transplant.
CochranePLS471
***TASK*** the task is to simplify the input abstract of a biomedical literature ***INPUT*** the input is the abstract of a biomedical literature ***OUTPUT*** the output is the simplified abstract for the input abstract of a biomedical literature ***EXAMPLES*** Input: Output: ***EXAMPLES*** Input: Two trials (n = 190), at low risk of bias, were included in the review and both presented data on first time failure at the tooth level. Pooling of the data showed a statistically significant difference in favour of molar bands, with a hazard ratio of 2.92 (95% confidence intervals (CI) 1.80 to 4.72). No statistically significant heterogeneity was shown between the two studies. Data on first time failure at the patient level were also available and showed statistically different difference in favour of molar bands (risk ratio 2.30; 95% CI 1.56 to 3.41) (risk of event for molar tubes = 57%; risk of event for molar bands 25%). One trial presented data on decalcification again showing a statistically significant difference in favour of molar bands. No other adverse events identified. From the two well-designed and low risk of bias trials included in this review it was shown that the failure of molar tubes bonded with either a chemically-cured or light-cured adhesive was considerably higher than that of molar bands cemented with glass ionomer cement. One trial indicated that there was less decalcification with molar bands cemented with glass ionomer cement than with bonded molar tubes cemented with a light-cured adhesive. However, given there are limited data for this outcome, further evidence is required to draw more robust conclusions. Output: The evidence in this review, which was carried out together with Cochrane Oral Health, is up-to-date as of 15 February 2017. We included two studies that evaluated 190 participants. Both trials were conducted in the UK and both compared bonded molar tubes with molar bands. From the limited data of two studies at low risk of bias, it would appear that bonded molar tubes are associated with a higher failure rate than with molar bands. Input: Four trials involving 317 people met the inclusion criteria. Three trials studied oral magnesium, with doses ranging from 12.5 mmol/day to 20 mmol/day. One trial studied parenteral magnesium (16.24 mEq q6h for 24 hours). Each trial demonstrated a high risk of bias in at least one domain. There was significant clinical and methodological variation between trials. We found no study that measured all of the identified primary outcomes and met the objectives of this review. Only one trial measured clinical symptoms of seizure, delirium tremens or components of the Clinical Institute Withdrawal Assessment for Alcohol (CIWA) score. A single outcome (handgrip strength) in three trials (113 people), was amenable to meta-analysis. There was no significant increase in handgrip strength in the magnesium group (SMD 0.04; 95% CI -0.22 to 0.30). No clinically important changes in adverse events were reported. There is insufficient evidence to determine whether magnesium is beneficial or harmful for the treatment or prevention of alcohol withdrawal syndrome. Output:
Alcohol withdrawal syndrome (AWS) is a set of symptoms experienced when one reduces or stops alcohol consumption after prolonged periods of alcohol intake. Some studies show that AWS coincides with low levels of magnesium in the blood. Since magnesium may play a role in dampening the excitability of the central nervous system, some researchers believe that low levels of magnesium may make the central nervous system 'hyper-excitable' and may cause AWS symptoms, which include sleeplessness, tremors, anxiety, headache, excessive sweating and reduced appetite. Many AWS treatment protocols therefore recommend magnesium supplementation. The goal of our review was to determine whether magnesium supplementation prevents or treats AWS in adults. Our review of four trials covering 317 participants determined that there is not enough evidence about the benefits or harms of using magnesium supplements to prevent or treat AWS in adults.
CochranePLS472
***TASK*** the task is to simplify the input abstract of a biomedical literature ***INPUT*** the input is the abstract of a biomedical literature ***OUTPUT*** the output is the simplified abstract for the input abstract of a biomedical literature ***EXAMPLES*** Input: Output: ***EXAMPLES*** Input: Two trials (n = 190), at low risk of bias, were included in the review and both presented data on first time failure at the tooth level. Pooling of the data showed a statistically significant difference in favour of molar bands, with a hazard ratio of 2.92 (95% confidence intervals (CI) 1.80 to 4.72). No statistically significant heterogeneity was shown between the two studies. Data on first time failure at the patient level were also available and showed statistically different difference in favour of molar bands (risk ratio 2.30; 95% CI 1.56 to 3.41) (risk of event for molar tubes = 57%; risk of event for molar bands 25%). One trial presented data on decalcification again showing a statistically significant difference in favour of molar bands. No other adverse events identified. From the two well-designed and low risk of bias trials included in this review it was shown that the failure of molar tubes bonded with either a chemically-cured or light-cured adhesive was considerably higher than that of molar bands cemented with glass ionomer cement. One trial indicated that there was less decalcification with molar bands cemented with glass ionomer cement than with bonded molar tubes cemented with a light-cured adhesive. However, given there are limited data for this outcome, further evidence is required to draw more robust conclusions. Output: The evidence in this review, which was carried out together with Cochrane Oral Health, is up-to-date as of 15 February 2017. We included two studies that evaluated 190 participants. Both trials were conducted in the UK and both compared bonded molar tubes with molar bands. From the limited data of two studies at low risk of bias, it would appear that bonded molar tubes are associated with a higher failure rate than with molar bands. Input: We included 15 trials involving 3057 participants. Of the 15 included trials, 10 appeared in our 2012 review, and five (631 participants) are legacy trials from merging two reviews. No new studies were included from searches for this update. Overall, risk of bias was low. Without antibiotics, 46% of participants with rhinosinusitis, whether or not confirmed by radiography, were cured after 1 week and 64% after 14 days. Antibiotics can shorten time to cure, but only 5 to 11 more people per 100 will be cured faster if they receive antibiotics instead of placebo or no treatment: clinical diagnosis (odds ratio (OR) 1.25, 95% confidence interval (CI) 1.02 to 1.54; number needed to treat for an additional beneficial outcome (NNTB) 19, 95% CI 10 to 205; I² = 0%; 8 trials; high-quality evidence) and diagnosis confirmed by radiography (OR 1.57, 95% CI 1.03 to 2.39; NNTB 10, 95% CI 5 to 136; I² = 0%; 3 trials; moderate-quality evidence). Cure rates with antibiotics were higher when a fluid level or total opacification in any sinus was found on computed tomography (OR 4.89, 95% CI 1.75 to 13.72; NNTB 4, 95% CI 2 to 15; 1 trial; moderate-quality evidence). Purulent secretion resolved faster with antibiotics (OR 1.58, 95% CI 1.13 to 2.22; NNTB 10, 95% CI 6 to 35; I² = 0%; 3 trials; high-quality evidence). However, 13 more people experienced side effects with antibiotics compared to placebo or no treatment (OR 2.21, 95% CI 1.74 to 2.82; number needed to treat for an additional harmful outcome (NNTH) 8, 95% CI 6 to 12; I² = 16%; 10 trials; high-quality evidence). Five fewer people per 100 will experience clinical failure if they receive antibiotics instead of placebo or no treatment (Peto OR 0.48, 95% CI 0.36 to 0.63; NNTH 19, 95% CI 15 to 27; I² = 21%; 12 trials; high-quality evidence). A disease-related complication (brain abscess) occurred in one participant (of 3057) one week after receiving open antibiotic therapy (clinical failure, control group). The potential benefit of antibiotics to treat acute rhinosinusitis diagnosed either clinically (low risk of bias, high-quality evidence) or confirmed by imaging (low to unclear risk of bias, moderate-quality evidence) is marginal and needs to be seen in the context of the risk of adverse effects. Considering antibiotic resistance, and the very low incidence of serious complications, we conclude there is no place for antibiotics for people with uncomplicated acute rhinosinusitis. We could not draw conclusions about children, people with suppressed immune systems, and those with severe sinusitis, because these populations were not included in the available trials. Output:
We included 15 studies in which adults with short-duration sinus infection, whether or not confirmed by imaging, randomly received antibiotics, or a dummy drug or no treatment, in ambulatory care settings. The studies included a total of 3057 adults whose average age was 36 years; about 60% were female. Participants were followed until they were cured. Trial duration ranged from 8 to 28 days. Seven studies received financial support from government or academic institutions; six received grants from the pharmaceutical industry; and five did not state sources of support. Without antibiotics, almost half of all participants were cured after one week, and two out of three were cured after 14 days. Five (diagnosis based on symptoms described to a doctor) to 11 (diagnosis confirmed by x-ray) more people per 100 were cured faster with antibiotics. A computed tomography (CT) scan could better predict who would benefit from antibiotics, but routine use would cause health problems related to radiation exposure. Ten more people per 100 were relieved faster of thick, yellow discharge from the nose with antibiotics compared to a dummy drug or no treatment. Thirteen more people per 100 experienced side effects (mostly concerning stomach or intestines) with antibiotics compared to a dummy drug or no treatment. Compared with people who initially started antibiotics, five more people per 100 in the dummy drug or no treatment group had to start antibiotics because their condition worsened. Serious complications (e.g. brain abscess) were rare. We found that antibiotics are not a first-choice treatment for adults with short-duration sinus infection. We found no evidence relating to adults with severe sinusitis or with reduced immunity, or to children. We found high-quality evidence when the diagnosis was based on symptoms described to a doctor. We downgraded evidence quality to moderate when diagnosis was confirmed by x-ray or CT scan because the number of participants was small, which makes the estimates less reliable.
CochranePLS473
***TASK*** the task is to simplify the input abstract of a biomedical literature ***INPUT*** the input is the abstract of a biomedical literature ***OUTPUT*** the output is the simplified abstract for the input abstract of a biomedical literature ***EXAMPLES*** Input: Output: ***EXAMPLES*** Input: Two trials (n = 190), at low risk of bias, were included in the review and both presented data on first time failure at the tooth level. Pooling of the data showed a statistically significant difference in favour of molar bands, with a hazard ratio of 2.92 (95% confidence intervals (CI) 1.80 to 4.72). No statistically significant heterogeneity was shown between the two studies. Data on first time failure at the patient level were also available and showed statistically different difference in favour of molar bands (risk ratio 2.30; 95% CI 1.56 to 3.41) (risk of event for molar tubes = 57%; risk of event for molar bands 25%). One trial presented data on decalcification again showing a statistically significant difference in favour of molar bands. No other adverse events identified. From the two well-designed and low risk of bias trials included in this review it was shown that the failure of molar tubes bonded with either a chemically-cured or light-cured adhesive was considerably higher than that of molar bands cemented with glass ionomer cement. One trial indicated that there was less decalcification with molar bands cemented with glass ionomer cement than with bonded molar tubes cemented with a light-cured adhesive. However, given there are limited data for this outcome, further evidence is required to draw more robust conclusions. Output: The evidence in this review, which was carried out together with Cochrane Oral Health, is up-to-date as of 15 February 2017. We included two studies that evaluated 190 participants. Both trials were conducted in the UK and both compared bonded molar tubes with molar bands. From the limited data of two studies at low risk of bias, it would appear that bonded molar tubes are associated with a higher failure rate than with molar bands. Input: Eight RCTs (enrolling 2515 patients) met the inclusion criteria. Three RCTs (all performed in Asian countries) compared D3 with D2 lymphadenectomy: data suggested no significant difference in OS between these two types of lymph node dissection (HR 0.99, 95% CI 0.81 to 1.21), with no significant difference in postoperative mortality (RR 1.67, 95% CI 0.41 to 6.73). Data for DFS were available only from one trial and for no trial were DSS data available. Five RCTs (n = 3 European; n = 2 Asian) compared D2 to D1 lymphadenectomy: OS (n = 5; HR 0.91, 95% CI 0.71 to 1.17) and DFS (n=3; HR 0.95, 95% CI 0.84 to 1.07) findings suggested no significant difference between these two types of lymph node dissection. In contrast, D2 lymphadenectomy was associated with a significantly better DSS compared to D1 lymphadenectomy (HR 0.81, 95% CI 0.71 to 0.92), the quality of the body of evidence being moderate; however, D2 lymphadenectomy was also associated with a higher postoperative mortality rate (RR 2.02, 95% CI 1.34 to 3.04). D2 lymphadenectomy can improve DSS in patients with resectable carcinoma of the stomach, although the increased incidence of postoperative mortality reduces its therapeutic benefit. Output:
We collected data from eight randomized controlled trials addressing this issue and enrolling a total of 2515 patients. We found that D2 lymphadenectomy can reduce the number of deaths due to disease progression as compared to D1 lymphadenectomy. However, D2 lymphadenectomy was also associated with a higher rate of postoperative mortality. In addition, available evidence does not support the superiority of D3 versus D2 lymphadenectomy. In conclusion, our findings support the use of D2 lymphadenectomy in patients with resectable carcinoma of the stomach, although the increased incidence of postoperative mortality reduces its therapeutic effect. The quality of the evidence was moderate due to an intermediate level of result heterogeneity across the included trials.
CochranePLS474
***TASK*** the task is to simplify the input abstract of a biomedical literature ***INPUT*** the input is the abstract of a biomedical literature ***OUTPUT*** the output is the simplified abstract for the input abstract of a biomedical literature ***EXAMPLES*** Input: Output: ***EXAMPLES*** Input: Two trials (n = 190), at low risk of bias, were included in the review and both presented data on first time failure at the tooth level. Pooling of the data showed a statistically significant difference in favour of molar bands, with a hazard ratio of 2.92 (95% confidence intervals (CI) 1.80 to 4.72). No statistically significant heterogeneity was shown between the two studies. Data on first time failure at the patient level were also available and showed statistically different difference in favour of molar bands (risk ratio 2.30; 95% CI 1.56 to 3.41) (risk of event for molar tubes = 57%; risk of event for molar bands 25%). One trial presented data on decalcification again showing a statistically significant difference in favour of molar bands. No other adverse events identified. From the two well-designed and low risk of bias trials included in this review it was shown that the failure of molar tubes bonded with either a chemically-cured or light-cured adhesive was considerably higher than that of molar bands cemented with glass ionomer cement. One trial indicated that there was less decalcification with molar bands cemented with glass ionomer cement than with bonded molar tubes cemented with a light-cured adhesive. However, given there are limited data for this outcome, further evidence is required to draw more robust conclusions. Output: The evidence in this review, which was carried out together with Cochrane Oral Health, is up-to-date as of 15 February 2017. We included two studies that evaluated 190 participants. Both trials were conducted in the UK and both compared bonded molar tubes with molar bands. From the limited data of two studies at low risk of bias, it would appear that bonded molar tubes are associated with a higher failure rate than with molar bands. Input: Thirteen studies, 1158 participants, met the criteria for inclusion in this review. Comparing naltrexone versus placebo or no pharmacological treatments, no statistically significant difference were noted for all the primary outcomes considered. The only outcome statistically significant in favour of naltrexone is re incarceration, RR 0.47 (95%CI 0.26-0.84), but results come only from two studies. Considering only studies were patients were forced to adherence a statistical significant difference in favour of naltrexone was found for retention and abstinence, RR 2.93 (95%CI 1.66-5.18). Comparing naltrexone versus psychotherapy, in the two considered outcomes, no statistically significant difference was found in the single study considered. Naltrexone was not superior to benzodiazepines and to buprenorphine for retention and abstinence and side effects. Results come from single studies. The findings of this review suggest that oral naltrexone did not perform better than treatment with placebo or no pharmacological agent with respect to the number of participants re-incarcerated during the study period. If oral naltrexone is compared with other pharmacological treatments such as benzodiazepine and buprenorphine, no statistically significant difference was found. The percentage of people retained in treatment in the included studies is however low (28%). The conclusion of this review is that the studies conducted have not allowed an adequate evaluation of oral naltrexone treatment in the field of opioid dependence. Consequently, maintenance therapy with naltrexone cannot yet be considered a treatment which has been scientifically proved to be superior to other kinds of treatment. Output:
In this review of the medical literature oral naltrexone, with or without psychotherapy, was no better than placebo or no pharmacological treatments with regard to retention in treatment, use of the primary substance of abuse or side effects. The only outcome that was clearly in favour of naltrexone was a reduction of re incarcerations by about a half but these results were from only two studies. In single studies naltrexone was not superior to benzodiazepines or buprenorphine for retention, abstinence or side effects. The review authors identified a total of 13 randomised controlled studies that involved 1158 opioid addicts treated as outpatients following detoxification. Less than a third of participants were retained in treatment over the duration of the included studies. The mean duration was six months (range one to 10 months). None of included studies considered deaths from fatal overdoses in people treated with naltrexone.
CochranePLS475
***TASK*** the task is to simplify the input abstract of a biomedical literature ***INPUT*** the input is the abstract of a biomedical literature ***OUTPUT*** the output is the simplified abstract for the input abstract of a biomedical literature ***EXAMPLES*** Input: Output: ***EXAMPLES*** Input: Two trials (n = 190), at low risk of bias, were included in the review and both presented data on first time failure at the tooth level. Pooling of the data showed a statistically significant difference in favour of molar bands, with a hazard ratio of 2.92 (95% confidence intervals (CI) 1.80 to 4.72). No statistically significant heterogeneity was shown between the two studies. Data on first time failure at the patient level were also available and showed statistically different difference in favour of molar bands (risk ratio 2.30; 95% CI 1.56 to 3.41) (risk of event for molar tubes = 57%; risk of event for molar bands 25%). One trial presented data on decalcification again showing a statistically significant difference in favour of molar bands. No other adverse events identified. From the two well-designed and low risk of bias trials included in this review it was shown that the failure of molar tubes bonded with either a chemically-cured or light-cured adhesive was considerably higher than that of molar bands cemented with glass ionomer cement. One trial indicated that there was less decalcification with molar bands cemented with glass ionomer cement than with bonded molar tubes cemented with a light-cured adhesive. However, given there are limited data for this outcome, further evidence is required to draw more robust conclusions. Output: The evidence in this review, which was carried out together with Cochrane Oral Health, is up-to-date as of 15 February 2017. We included two studies that evaluated 190 participants. Both trials were conducted in the UK and both compared bonded molar tubes with molar bands. From the limited data of two studies at low risk of bias, it would appear that bonded molar tubes are associated with a higher failure rate than with molar bands. Input: No trials on modification of food met the inclusion criteria. We included two studies that examined modification to fluids. Both were part of the same large multicentre trial and included people with dementia and people with or without dementia and Parkinson's disease. Participation in the second trial was determined by results from the first trial. With unpublished data supplied by study authors, we examined data from participants with dementia only. The first study, a cross-over trial, investigated the immediate effects on aspiration of two viscosities of liquids (nectar thick and honey thick) compared to regular liquids in 351 participants with dementia using videofluoroscopy. Regular liquids with a chin down head posture, as well as regular liquids without any intervention were also compared. The sequence of interventions during videofluoroscopy may have influenced response to intervention. The second study, a parallel designed RCT, compared the effect of nectar and honey thick liquids with a chin down head posture over a three-month period in a subgroup of 260 participants with dementia. Outcomes were pneumonia and adverse intervention effects. Honey thick liquids, which are more consistent with descriptors for 'spoon thick' or 'extremely thick' liquids, showed a more positive impact on immediate elimination of aspiration during videofluoroscopy, but this consistency showed more adverse effects in the second follow-up study. During the second three-month follow-up trial, there were a greater number of incidents of pneumonia in participants receiving honey thick liquids than those receiving nectar thick liquids or taking regular liquids with a chin down posture. There were no deaths classified as 'definitely related' to the type of fluids prescribed. Neither trial addressed quality of life. Risk of bias for both studies is high. The overall quality of evidence for outcomes in this review is low. We are uncertain about the immediate and long-term effects of modifying the consistency of fluid for swallowing difficulties in dementia as too few studies have been completed. There may be differences in outcomes depending on the grade of thickness of fluids and the sequence of interventions trialled in videofluoroscopy for people with dementia. Clinicians should be aware that while thickening fluids may have an immediate positive effect on swallowing, the long-term impact of thickened fluids on the health of the person with dementia should be considered. Further high-quality clinical trials are required. Output:
We found two studies, which were both part of the same multicentre trial and included people with dementia and people with or without dementia and Parkinson's disease. We included data on people with dementia only. The first of the two studies looked at the immediate effects of two viscosities of liquids compared to regular thin liquids on aspiration (entry of food or fluid into the lungs) in 351 people with dementia. This study also compared drinking regular thin liquids using a chin down head posture as well as drinking regular thin liquids without any changes to head position; the main outcome was fluid entering the lungs. Using a subgroup of 260 people with dementia from the first study, the second study compared the effect of the same liquid viscosities with a chin down head posture. The effectiveness of these interventions on the incidence of pneumonia and adverse effects of these interventions was examined over a three-month period. Honey thick viscosity liquids, which clinically are similar to descriptions of 'very thick liquids', had a more positive immediate impact on preventing fluid entering the lungs when examined during videofluoroscopy (specialised swallow x-ray) examination. However, during the three-month follow-up period there were a greater number of incidents of pneumonia in the group of people with dementia receiving these honey thick liquids, than those receiving nectar thick liquids and those receiving regular thin liquids with a chin down posture. There were no deaths classified as 'definitely related' to the type of liquids that the person with dementia was receiving. There were a number of methodological flaws in both studies in this review and these were acknowledged by the authors. While thickening fluids may have an immediate positive effect on swallow function, clinicians should consider the effects of this intervention on the person with dementia in the longer-term. People with dementia on thickened fluids require long-term follow-up. The overall risk of bias of included studies is high. The quality of evidence is low. Further well-designed research is needed.
CochranePLS476
***TASK*** the task is to simplify the input abstract of a biomedical literature ***INPUT*** the input is the abstract of a biomedical literature ***OUTPUT*** the output is the simplified abstract for the input abstract of a biomedical literature ***EXAMPLES*** Input: Output: ***EXAMPLES*** Input: Two trials (n = 190), at low risk of bias, were included in the review and both presented data on first time failure at the tooth level. Pooling of the data showed a statistically significant difference in favour of molar bands, with a hazard ratio of 2.92 (95% confidence intervals (CI) 1.80 to 4.72). No statistically significant heterogeneity was shown between the two studies. Data on first time failure at the patient level were also available and showed statistically different difference in favour of molar bands (risk ratio 2.30; 95% CI 1.56 to 3.41) (risk of event for molar tubes = 57%; risk of event for molar bands 25%). One trial presented data on decalcification again showing a statistically significant difference in favour of molar bands. No other adverse events identified. From the two well-designed and low risk of bias trials included in this review it was shown that the failure of molar tubes bonded with either a chemically-cured or light-cured adhesive was considerably higher than that of molar bands cemented with glass ionomer cement. One trial indicated that there was less decalcification with molar bands cemented with glass ionomer cement than with bonded molar tubes cemented with a light-cured adhesive. However, given there are limited data for this outcome, further evidence is required to draw more robust conclusions. Output: The evidence in this review, which was carried out together with Cochrane Oral Health, is up-to-date as of 15 February 2017. We included two studies that evaluated 190 participants. Both trials were conducted in the UK and both compared bonded molar tubes with molar bands. From the limited data of two studies at low risk of bias, it would appear that bonded molar tubes are associated with a higher failure rate than with molar bands. Input: Six randomised controlled trials with a total of 788 women were included. The largest of these trials included 396 women eligible for this review. No evidence of a statistically significant difference was found between natural cycle and standard IVF in live birth rates (OR 0.68, 95% CI 0.46 to 1.01, two studies, 425 women, I2= 0%, moderate quality evidence). The evidence suggests that for a woman with a 53% chance of live birth using standard IVF, the chance using natural cycle IVF would range from 34% to 53%. There was no evidence of a statistically significant difference between natural cycle and standard IVF in rates of OHSS (OR 0.19, 95% CI 0.01 to 4.06, one study, 60 women, very low quality evidence), clinical pregnancy (OR 0.52 95% CI 0.17 to 1.61, 4 studies, 351 women, I2=63%, low quality evidence), ongoing pregnancy (OR 0.72, 95% CI 0.50 to 1.05, three studies, 485 women, I2=0%, moderate quality evidence), multiple pregnancy (OR 0.76, 95% CI 0.25 to 2.31, 2 studies, 527 women, I2=0%, very low quality evidence), gestational abnormalities (OR 0.44 95% CI 0.03 to 5.93, 1 study, 18 women, very low quality evidence) or cycle cancellations (OR 8.98, 95% CI 0.20 to 393.66, 2 studies, 159 women, I2=83%, very low quality evidence). One trial reported that the oocyte retrieval rate was significantly lower in the natural cycle group (MD -4.40, 95% CI -7.87 to -0.93, 60 women, very low quality evidence). There were insufficient data to draw any conclusions about rates of treatment cancellation. Findings on treatment costs were inconsistent and more data are awaited. The evidence was limited by imprecision. Findings for pregnancy rate and for cycle cancellation were sensitive to the choice of statistical model: for these outcomes, use of a fixed effect model suggested a benefit for the standard IVF group. Moreover the largest trial has not yet completed follow up, though data have been reported for over 95% of women. Further evidence from well conducted large trials is awaited on natural cycle IVF treatment. Future trials should compare natural cycle IVF with standard IVF. Outcomes should include cumulative live birth and pregnancy rates, the number of treatment cycles necessary to reach live birth, treatment costs and adverse effects. Output:
Six trials were included, with a total of 788 women undergoing an IVF treatment. The evidence is current to 31st July 2013. The largest trial in the review (with 396 women) has not yet reported full results. The evidence suggested that for a woman with a 53% chance of live birth using standard IVF, the chance using natural cycle IVF ranges from 34% to 53%. No significant difference was found in rates of clinical pregnancy, ongoing pregnancy, multiple pregnancy, incidence of ovarian hyperstimulation syndrome, gestational abnormalities or cancellations of treatment. However findings were imprecise for all outcomes and further evidence from larger studies is awaited. There was evidence from single studies that a lower number of oocytes was retrieved in the natural cycle group. Findings on cost-effectiveness were inconsistent. Quality ratings for the evidence ranged from very low to moderate, the main limitation being imprecision due to insufficient data. When the review authors checked the effect of using an alternative method of analysis the findings suggested higher rates of clinical pregnancy with standard IVF than with natural cycle IVF.
CochranePLS477
***TASK*** the task is to simplify the input abstract of a biomedical literature ***INPUT*** the input is the abstract of a biomedical literature ***OUTPUT*** the output is the simplified abstract for the input abstract of a biomedical literature ***EXAMPLES*** Input: Output: ***EXAMPLES*** Input: Two trials (n = 190), at low risk of bias, were included in the review and both presented data on first time failure at the tooth level. Pooling of the data showed a statistically significant difference in favour of molar bands, with a hazard ratio of 2.92 (95% confidence intervals (CI) 1.80 to 4.72). No statistically significant heterogeneity was shown between the two studies. Data on first time failure at the patient level were also available and showed statistically different difference in favour of molar bands (risk ratio 2.30; 95% CI 1.56 to 3.41) (risk of event for molar tubes = 57%; risk of event for molar bands 25%). One trial presented data on decalcification again showing a statistically significant difference in favour of molar bands. No other adverse events identified. From the two well-designed and low risk of bias trials included in this review it was shown that the failure of molar tubes bonded with either a chemically-cured or light-cured adhesive was considerably higher than that of molar bands cemented with glass ionomer cement. One trial indicated that there was less decalcification with molar bands cemented with glass ionomer cement than with bonded molar tubes cemented with a light-cured adhesive. However, given there are limited data for this outcome, further evidence is required to draw more robust conclusions. Output: The evidence in this review, which was carried out together with Cochrane Oral Health, is up-to-date as of 15 February 2017. We included two studies that evaluated 190 participants. Both trials were conducted in the UK and both compared bonded molar tubes with molar bands. From the limited data of two studies at low risk of bias, it would appear that bonded molar tubes are associated with a higher failure rate than with molar bands. Input: We included a total of 984 participants from 12 studies (23 references) in this analysis. We included only those involved in Tai Chi and the control group (i.e. 811 participants) in the final analysis. Study sample size ranged from 10 to 206, and mean age ranged from 61 to 74 years. Programmes lasted for six weeks to one year. All included studies were RCTs; three studies used allocation concealment, six reported blinded outcome assessors and three studies adopted an intention-to-treat approach to statistical analysis. No adverse events were reported. Quality of evidence of the outcomes ranged from very low to moderate. Analysis was split into three comparisons: (1) Tai Chi versus usual care; (2) Tai Chi and breathing exercise versus breathing exercise alone; and (3) Tai Chi and exercise versus exercise alone. Comparison of Tai Chi versus usual care revealed that Tai Chi demonstrated a longer six-minute walk distance (mean difference (MD) 29.64 metres, 95% confidence interval (CI) 10.52 to 48.77 metres; participants = 318; I2 = 59%) and better pulmonary function (i.e. forced expiratory volume in one second, MD 0.11 L, 95% CI 0.02 to 0.20 L; participants = 258; I2 = 0%) in post-programme data. However, the effects of Tai Chi in reducing dyspnoea level and improving quality of life remain inconclusive. Data are currently insufficient for evaluating the impact of Tai Chi on maximal exercise capacity, balance and muscle strength in people with COPD. Comparison of Tai Chi and other interventions (i.e. breathing exercise or exercise) versus other interventions shows no superiority and no additional effects on symptom improvement nor on physical and psychosocial outcomes with Tai Chi. No adverse events were reported, implying that Tai Chi is safe to practise in people with COPD. Evidence of very low to moderate quality suggests better functional capacity and pulmonary function in post-programme data for Tai Chi versus usual care. When Tai Chi in addition to other interventions was compared with other interventions alone, Tai Chi did not show superiority and showed no additional effects on symptoms nor on physical and psychosocial function improvement in people with COPD. With the diverse style and number of forms being adopted in different studies, the most beneficial protocol of Tai Chi style and number of forms could not be commented upon. Hence, future studies are warranted to address these topics. Output:
We included a total of 811 participants from 12 studies in the final analysis of this review. The number of participants in each study ranged from 10 to 206, and mean age ranged from 61 to 74 years. The programme lasted for six weeks to one year. Included studies adopted different styles and numerous forms of Tai Chi. The most commonly reported form is the simplified 24-form Yang-style Tai Chi. No unwanted events or side effects were reported throughout the study period. Quality of evidence of all outcomes of interest ranged from very low to moderate. After training was completed, levels of shortness of breath in Tai Chi and control (i.e. usual care) groups were similar. Participants in the Tai Chi group walked farther, by 29.64 metres in six minutes, and had better pulmonary function, than those who received usual care. However, changes in quality of life were not apparent. When the effect of Tai Chi used in addition to another intervention (i.e. breathing exercise or exercise) was examined, we did not find that Tai Chi offered additional benefit in terms of shortness of breath or functional and psychosocial well-being. Currently, only one study has investigated the beneficial effects of Tai Chi on muscle strength and balance; investigators provided insufficient information to allow comment on the data in this review. Future studies addressing these topics are warranted.
CochranePLS478
***TASK*** the task is to simplify the input abstract of a biomedical literature ***INPUT*** the input is the abstract of a biomedical literature ***OUTPUT*** the output is the simplified abstract for the input abstract of a biomedical literature ***EXAMPLES*** Input: Output: ***EXAMPLES*** Input: Two trials (n = 190), at low risk of bias, were included in the review and both presented data on first time failure at the tooth level. Pooling of the data showed a statistically significant difference in favour of molar bands, with a hazard ratio of 2.92 (95% confidence intervals (CI) 1.80 to 4.72). No statistically significant heterogeneity was shown between the two studies. Data on first time failure at the patient level were also available and showed statistically different difference in favour of molar bands (risk ratio 2.30; 95% CI 1.56 to 3.41) (risk of event for molar tubes = 57%; risk of event for molar bands 25%). One trial presented data on decalcification again showing a statistically significant difference in favour of molar bands. No other adverse events identified. From the two well-designed and low risk of bias trials included in this review it was shown that the failure of molar tubes bonded with either a chemically-cured or light-cured adhesive was considerably higher than that of molar bands cemented with glass ionomer cement. One trial indicated that there was less decalcification with molar bands cemented with glass ionomer cement than with bonded molar tubes cemented with a light-cured adhesive. However, given there are limited data for this outcome, further evidence is required to draw more robust conclusions. Output: The evidence in this review, which was carried out together with Cochrane Oral Health, is up-to-date as of 15 February 2017. We included two studies that evaluated 190 participants. Both trials were conducted in the UK and both compared bonded molar tubes with molar bands. From the limited data of two studies at low risk of bias, it would appear that bonded molar tubes are associated with a higher failure rate than with molar bands. Input: We included 72 trials that involved 2470 participants. This review includes 35 new studies in addition to the studies included in the previous version of this review. Study sample sizes were generally small and interventions varied in terms of both the goals of treatment and the virtual reality devices used. The risk of bias present in many studies was unclear due to poor reporting. Thus, while there are a large number of randomised controlled trials, the evidence remains mostly low quality when rated using the GRADE system. Control groups usually received no intervention or therapy based on a standard-care approach. Primary outcome: results were not statistically significant for upper limb function (standardised mean difference (SMD) 0.07, 95% confidence intervals (CI) -0.05 to 0.20, 22 studies, 1038 participants, low-quality evidence) when comparing virtual reality to conventional therapy. However, when virtual reality was used in addition to usual care (providing a higher dose of therapy for those in the intervention group) there was a statistically significant difference between groups (SMD 0.49, 0.21 to 0.77, 10 studies, 210 participants, low-quality evidence). Secondary outcomes: when compared to conventional therapy approaches there were no statistically significant effects for gait speed or balance. Results were statistically significant for the activities of daily living (ADL) outcome (SMD 0.25, 95% CI 0.06 to 0.43, 10 studies, 466 participants, moderate-quality evidence); however, we were unable to pool results for cognitive function, participation restriction, or quality of life. Twenty-three studies reported that they monitored for adverse events; across these studies there were few adverse events and those reported were relatively mild. We found evidence that the use of virtual reality and interactive video gaming was not more beneficial than conventional therapy approaches in improving upper limb function. Virtual reality may be beneficial in improving upper limb function and activities of daily living function when used as an adjunct to usual care (to increase overall therapy time). There was insufficient evidence to reach conclusions about the effect of virtual reality and interactive video gaming on gait speed, balance, participation, or quality of life. This review found that time since onset of stroke, severity of impairment, and the type of device (commercial or customised) were not strong influencers of outcome. There was a trend suggesting that higher dose (more than 15 hours of total intervention) was preferable as were customised virtual reality programs; however, these findings were not statistically significant. Output:
We identified 72 studies involving 2470 people after stroke. A wide range of virtual reality programs were used, with most aimed to improve either arm function or walking ability. The evidence is current to April 2017. Twenty-two trials tested whether the use of virtual reality compared with conventional therapy resulted in an improved ability to use one's arm and found that the use of virtual reality did not result in better function (low-quality evidence). When virtual reality was used in addition to usual care or rehabilitation to increase the amount of time the person spent in therapy there were improvements in the functioning of the arm (low-quality evidence). Six trials tested whether the use of virtual reality compared with conventional therapy resulted in improved walking speed. There was no evidence that virtual reality was more effective in this case (low-quality evidence). Ten trials found that there was some evidence that virtual reality resulted in a slightly better ability to manage everyday activities such as showering and dressing (moderate-quality evidence). However, these positive effects were found soon after the end of the treatment and it is not clear whether the effects are long lasting. Results should be interpreted with caution as, while there are a large number of studies, the studies are generally small and not of high quality. A small number of people using virtual reality reported pain, headaches, or dizziness. No serious adverse events were reported. The quality of the evidence was generally of low or moderate quality. The quality of the evidence for each outcome was limited due to small numbers of study participants, inconsistent results across studies, and poor reporting of study details.
CochranePLS479
***TASK*** the task is to simplify the input abstract of a biomedical literature ***INPUT*** the input is the abstract of a biomedical literature ***OUTPUT*** the output is the simplified abstract for the input abstract of a biomedical literature ***EXAMPLES*** Input: Output: ***EXAMPLES*** Input: Two trials (n = 190), at low risk of bias, were included in the review and both presented data on first time failure at the tooth level. Pooling of the data showed a statistically significant difference in favour of molar bands, with a hazard ratio of 2.92 (95% confidence intervals (CI) 1.80 to 4.72). No statistically significant heterogeneity was shown between the two studies. Data on first time failure at the patient level were also available and showed statistically different difference in favour of molar bands (risk ratio 2.30; 95% CI 1.56 to 3.41) (risk of event for molar tubes = 57%; risk of event for molar bands 25%). One trial presented data on decalcification again showing a statistically significant difference in favour of molar bands. No other adverse events identified. From the two well-designed and low risk of bias trials included in this review it was shown that the failure of molar tubes bonded with either a chemically-cured or light-cured adhesive was considerably higher than that of molar bands cemented with glass ionomer cement. One trial indicated that there was less decalcification with molar bands cemented with glass ionomer cement than with bonded molar tubes cemented with a light-cured adhesive. However, given there are limited data for this outcome, further evidence is required to draw more robust conclusions. Output: The evidence in this review, which was carried out together with Cochrane Oral Health, is up-to-date as of 15 February 2017. We included two studies that evaluated 190 participants. Both trials were conducted in the UK and both compared bonded molar tubes with molar bands. From the limited data of two studies at low risk of bias, it would appear that bonded molar tubes are associated with a higher failure rate than with molar bands. Input: We identified five RCTs (1330 participants) that met the inclusion criteria. None of the included trials examined regimens of less than six months duration. Fluoroquinolones added to standard regimens A single trial (174 participants) added levofloxacin to the standard first-line regimen. Relapse and treatment failure were not reported. For death, sputum conversion, and adverse events we are uncertain if there is an effect (one trial, 174 participants, very low quality evidence for all three outcomes). Fluoroquinolones substituted for ethambutol in standard regimens Three trials (723 participants) substituted ethambutol with moxifloxacin, gatifloxacin, and ofloxacin into the standard first-line regimen. For relapse, we are uncertain if there is an effect (one trial, 170 participants, very low quality evidence). No trials reported on treatment failure. For death, sputum culture conversion at eight weeks, or serious adverse events we do not know if there was an effect (three trials, 723 participants, very low quality evidence for all three outcomes). Fluoroquinolones substituted for isoniazid in standard regimens A single trial (433 participants) substituted moxifloxacin for isoniazid. Treatment failure and relapse were not reported. For death, sputum culture conversion, or serious adverse events the substitution may have little or no difference (one trial, 433 participants, low quality evidence for all three outcomes). Fluoroquinolines in four month regimens Six trials are currently in progress testing shorter regimens with fluoroquinolones. Ofloxacin, levofloxacin, moxifloxacin, and gatifloxacin have been tested in RCTs of standard first-line regimens based on rifampicin and pyrazinamide for treating drug-sensitive TB. There is insufficient evidence to be clear whether addition or substitution of fluoroquinolones for ethambutol or isoniazid in the first-line regimen reduces death or relapse, or increases culture conversion at eight weeks. Much larger trials with fluoroquinolones in short course regimens of four months are currently in progress. Output:
We examined the research published up to 6 March 2013 and we identified five randomised controlled trials (1330 people) that met the inclusion criteria. The trials were performed in low- and middle-income countries located in geographically diverse areas but there was a lack of studies conducted in Asia. We found no studies that examined the effect of including fluoroquinolones in a standard six month TB treatment regimen on treatment failure. We do not know whether adding fluoroquinolones or substituting fluoroquinolones for ethambutol in a standard six month TB treatment regimen reduces treatment failure, relapse, death, or adverse events. Substituting fluoroquinolones for isoniazid in a standard six month TB treatment regimen may have little or no difference upon death and adverse events. Currently, there are nine randomised controlled trials ongoing. HIV-positive participants were relatively well-represented in the included trials but none of the included trials stratified outcomes by HIV status. Also, the primary outcomes of all the included trials were reached before initiation of antiretroviral treatment. Evidence is generally lacking on the safety and efficacy of fluoroquinolone additions or substitutions in children (< 18 years) and in pregnant and lactating women.