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cochrane-simplification-train-1600 | cochrane-simplification-train-1600 | We included three RCTs (four reports) of 246 children aged under 16 years undergoing tonsillectomy. Children were given weight-appropriate doses of the study medication, either PRN or ATC, by a parent or carer at home for up to four days following surgery. We did not identify any studies assessing the management of postoperative pain in children in any other setting (i.e. as an inpatient). All studies included in this review were based on the use of paracetamol, and an opioid was added to paracetamol in two studies. Analgesics were administered either orally (tablet or elixir) or rectally (suppository). Reporting quality was poor and there were fewer than 50 children in each arm. Mean pain intensity scores decreased over time, as did medication use. However, children were still reporting pain at the final assessment, suggesting that no administration schedule provided adequate analgesia. There were no significant differences in pain intensity scores at any time point. The studies reported adverse events that may have been related to the study medication, such as nausea and vomiting, and constipation, but no statistically significant differences were noted between the groups. There were too few data from only three small studies and meta-analysis was not possible. One study reported that a higher amount of analgesics was consumed in the ATC group compared with the PRN group: it would have been helpful to show that the higher volume in the ATC group led to better analgesia but we were not able to demonstrate this. There was limited evidence available to draw any conclusions about the efficacy of PRN versus ATC analgesic administration for the management of postoperative pain in children. | In July 2014, we found three studies (randomised controlled trials) of 246 children under the age of 16 years. All studies compared the two ways of giving medicine for pain relief after tonsillectomy (an operation to remove the tonsils). The studies were small, and generally of low quality. One study showed that the children in the 'around the clock' group took more medication, but they did not have better pain relief. There were no differences in pain relief or side effects between the two groups. There was not enough evidence to be sure which method is better for a child's pain relief after surgery. More high quality, large studies are needed. | 10.1002/14651858.CD011404.pub2 | [
"In July 2014, we found three studies (randomised controlled trials) of 246 children under the age of 16 years. All studies compared the two ways of giving medicine for pain relief after tonsillectomy (an operation to remove the tonsils). The studies were small, and generally of low quality. One study showed that the children in the 'around the clock' group took more medication, but they did not have better pain relief. There were no differences in pain relief or side effects between the two groups. There was not enough evidence to be sure which method is better for a child's pain relief after surgery. More high quality, large studies are needed."
]
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cochrane-simplification-train-1601 | cochrane-simplification-train-1601 | Eleven RCTs, all at high risk of bias, and four economic evaluations were included. Apart from one study, the times to fracture healing were comparable between the BMP and control groups. There was some evidence for increased healing rates, without requiring a secondary procedure, of BMP compared with usual care control in acute, mainly open, tibial fractures (risk ratio (RR) 1.19, 95% CI 0.99 to 1.43). The pooled RR for achieving union for nonunited fractures was 1.02 (95% CI 0.90 to 1.15). One study found no difference in union for patients who had corrective osteotomy for radial malunions. Data from three RCTs indicated that fewer secondary procedures were required for acute fracture patients treated with BMP versus controls (RR 0.65, 95% CI 0.50 to 0.83). Adverse events experienced were infection, hardware failure, pain, donor site morbidity, heterotopic bone formation and immunogenic reactions. The evidence on costs for BMP-2 for acute open tibia fractures is from one large RCT. This indicates that the direct medical costs associated with BMP would generally be higher than treatment with standard care, but this cost difference may decrease as fracture severity increases. Limited evidence suggests that the direct medical costs associated with BMP could be offset by faster healing and reduced time off work for patients with the most severe open tibia fractures. This review highlights a paucity of data on the use of BMP in fracture healing as well as considerable industry involvement in currently available evidence. There is limited evidence to suggest that BMP may be more effective than controls for acute tibial fracture healing, however, the use of BMP for treating nonunion remains unclear. The limited available economic evidence indicates that BMP treatment for acute open tibial fractures may be more favourable economically when used in patients with the most severe fractures. | The review included 11 trials. All were flawed which means that their results may be biased. Four trials involved people with acute fractures of the tibia (shin bone). Evidence from these trials showed that BMP may enhance healing of these fractures, and that people with these fractures when treated with BMP required fewer subsequent procedures. Six trials testing BMP for fractures that had not healed during first course of treatment (nonunions) showed BMP was neither better or worse at healing than bone grafts. One small trial found no difference between BMP and done grafts in people whose bone had been cut so in order to treat a healed but misaligned fracture. Trial participants who received BMP experienced similar adverse effects to those no receiving BMP (infection, hardware failure, heterotopic bone formation and immunogenic reactions). However, patients given BMP instead of bone autografts will have avoided problems associated with extraction of the bone from another site in their body. The review also included four economic evaluations. Three of these found that the costs associated with using BMP, based on one large trial of acute open tibia fractures, were likely to be higher than standard care treatment without BMP. The difference in costs decreased with increased fracture severity. | 10.1002/14651858.CD006950.pub2 | [
"The review included 11 trials. All were flawed which means that their results may be biased. Four trials involved people with acute fractures of the tibia (shin bone). Evidence from these trials showed that BMP may enhance healing of these fractures, and that people with these fractures when treated with BMP required fewer subsequent procedures. Six trials testing BMP for fractures that had not healed during first course of treatment (nonunions) showed BMP was neither better or worse at healing than bone grafts. One small trial found no difference between BMP and done grafts in people whose bone had been cut so in order to treat a healed but misaligned fracture. Trial participants who received BMP experienced similar adverse effects to those no receiving BMP (infection, hardware failure, heterotopic bone formation and immunogenic reactions). However, patients given BMP instead of bone autografts will have avoided problems associated with extraction of the bone from another site in their body. The review also included four economic evaluations. Three of these found that the costs associated with using BMP, based on one large trial of acute open tibia fractures, were likely to be higher than standard care treatment without BMP. The difference in costs decreased with increased fracture severity."
]
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cochrane-simplification-train-1602 | cochrane-simplification-train-1602 | We included two RCTs (116 adult participants). One compared large-volume (150 ml) hypertonic (2%) saline irrigation with usual treatment over a six-month period; the other compared 5 ml nebulised saline twice a day with intranasal corticosteroids, treating participants for three months and evaluating them on completion of treatment and three months later. Large-volume, hypertonic nasal saline versus usual care One trial included 76 adult participants (52 intervention, 24 control) with or without polyps.Disease-specific HRQL was reported using the Rhinosinusitis Disability Index (RSDI; 0 to 100, 100 = best quality of life). At the end of three months of treatment, patients in the saline group were better than those in the placebo group (mean difference (MD) 6.3 points, 95% confidence interval (CI) 0.89 to 11.71) and at six months there was a greater effect (MD 13.5 points, 95% CI 9.63 to 17.37). We assessed the evidence to be of low quality for the three months follow-up and very low quality for the six months follow-up. Patient-reported disease severity was evaluated using a "single-item sinus symptom severity assessment" but the range of scores is not stated, making it impossible for us to determine the meaning of the data presented. No adverse effects data were collected in the control group but 23% of participants in the saline group experienced side effects including epistaxis. General HRQL was measured using SF-12 (0 to 100, 100 = best quality of life). No difference was found after three months of treatment (low quality evidence) but at six months there was a small difference favouring the saline group, which may not be of clinical significance and has high uncertainty (MD 10.5 points, 95% CI 0.66 to 20.34) (very low quality evidence). Low-volume, nebulised saline versus intranasal corticosteroids One trial included 40 adult participants with polyps. Our primary outcome of disease-specific HRQL was not reported. At the end of treatment (three months) the patients who had intranasal corticosteroids had less severe symptoms (MD -13.50, 95% CI -14.44 to -12.56); this corresponds to a large effect size. We assessed the evidence to be of very low quality. The two studies were very different in terms of included populations, interventions and comparisons and so it is therefore difficult to draw conclusions for practice. The evidence suggests that there is no benefit of a low-volume (5 ml) nebulised saline spray over intranasal steroids. There is some benefit of daily, large-volume (150 ml) saline irrigation with a hypertonic solution when compared with placebo, but the quality of the evidence is low for three months and very low for six months of treatment. | We included two randomised controlled trials with a total of 116 adult participants in this review. One compared large-volume (150 ml) hypertonic saline irrigation with usual treatment over a six-month period. The other compared 5 ml of nebulised saline twice a day with intranasal corticosteroids, treating participants for three months and evaluating them on completion of treatment and three months later. Both of these studies had important limitations in their methodology and we considered them to have a high risk of bias. Large-volume, hypertonic nasal saline versus usual care In the small trial of 76 participants our primary outcome of 'disease-specific health-related quality of life' was reported using a 0- to 100-point scale. At the end of three months of treatment, patients in the saline group were better than those in the placebo group and at six months of treatment there was a greater effect. We assessed the evidence to be of low quality for the three months follow-up and very low quality for the six months follow-up. Patient-reported disease severity was also evaluated but the trialists did not state the range of scores used, which made it impossible for us to determine the meaning of the data presented. No adverse effects data were collected in the control group but 23% of participants in the saline group experienced side effects including nosebleeds (epistaxis). General health-related quality of life was also measured in this study. No difference was found after three months of treatment but at six months there was a small difference (although the result is uncertain). We assessed the evidence to be of low quality. Low-volume, nebulised saline versus intranasal corticosteroids One small trial had 20 patients in each of the two arms being compared. Our primary outcome of disease-specific health-related quality of life was not reported. At the end of treatment (three months) there was an improvement in symptoms. The two studies were very different in terms of included populations, interventions and comparisons and so it is therefore difficult to draw conclusions for practice. The evidence suggests that there was no benefit of a low-volume (5 ml) nebulised saline spray over intranasal steroids, but there may be some benefit of daily, large-volume (150 ml) saline irrigation with a hypertonic solution compared with placebo, although the quality of the evidence was low for three months and very low for six months of treatment. | 10.1002/14651858.CD011995.pub2 | [
"We included two randomised controlled trials with a total of 116 adult participants in this review. One compared large-volume (150 ml) hypertonic saline irrigation with usual treatment over a six-month period. The other compared 5 ml of nebulised saline twice a day with intranasal corticosteroids, treating participants for three months and evaluating them on completion of treatment and three months later. Both of these studies had important limitations in their methodology and we considered them to have a high risk of bias. Large-volume, hypertonic nasal saline versus usual care In the small trial of 76 participants our primary outcome of 'disease-specific health-related quality of life' was reported using a 0- to 100-point scale. At the end of three months of treatment, patients in the saline group were better than those in the placebo group and at six months of treatment there was a greater effect. We assessed the evidence to be of low quality for the three months follow-up and very low quality for the six months follow-up. Patient-reported disease severity was also evaluated but the trialists did not state the range of scores used, which made it impossible for us to determine the meaning of the data presented. No adverse effects data were collected in the control group but 23% of participants in the saline group experienced side effects including nosebleeds (epistaxis). General health-related quality of life was also measured in this study. No difference was found after three months of treatment but at six months there was a small difference (although the result is uncertain). We assessed the evidence to be of low quality. Low-volume, nebulised saline versus intranasal corticosteroids One small trial had 20 patients in each of the two arms being compared. Our primary outcome of disease-specific health-related quality of life was not reported. At the end of treatment (three months) there was an improvement in symptoms. The two studies were very different in terms of included populations, interventions and comparisons and so it is therefore difficult to draw conclusions for practice. The evidence suggests that there was no benefit of a low-volume (5 ml) nebulised saline spray over intranasal steroids, but there may be some benefit of daily, large-volume (150 ml) saline irrigation with a hypertonic solution compared with placebo, although the quality of the evidence was low for three months and very low for six months of treatment."
]
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cochrane-simplification-train-1603 | cochrane-simplification-train-1603 | Sixty-two trials with 10,187 randomised participants have been included in the review. Maximum duration of intervention was 18 months. Most included trials had poor study quality. The pooled weighted mean difference (WMD) for percentage weight change showed a benefit of supplementation of 2.2% (95% confidence interval (CI) 1.8 to 2.5) from 42 trials. There was no significant reduction in mortality in the supplemented compared with control groups (relative risk (RR) 0.92, CI 0.81 to 1.04) from 42 trials. Mortality results were statistically significant when limited to trials in which participants (N = 2461) were defined as undernourished (RR 0.79, 95% CI 0.64 to 0.97). The risk of complications was reduced in 24 trials (RR 0.86, 95% CI 0.75 to 0.99). Few trials were able to suggest any functional benefit from supplementation. The WMD for length of stay from 12 trials also showed no statistically significant effect (-0.8 days, 95% CI -2.8 to 1.3). Adverse effects included nausea or diarrhoea. Supplementation produces a small but consistent weight gain in older people. Mortality may be reduced in older people who are undernourished. There may also be a beneficial effect on complications which needs to be confirmed. However, this updated review found no evidence of improvement in functional benefit or reduction in length of hospital stay with supplements. Additional data from large-scale multi-centre trials are still required. | A total of 10,187 randomised participants from the 62 trials has been included. Maximum duration of intervention was 18 months. The reviewers suggest that supplementation appears to produce a small but consistent weight gain. There was no evidence in this updated review of a beneficial effect on mortality overall, but there may be a beneficial effect on mortality in people who are undernourished. Supplementation may also reduce the number of complications. The reported acceptance of supplements was variable between trials. Some adverse effects such as nausea or diarrhoea were reported. However, there were problems of study design and quality. More studies are required to confirm the beneficial effect on the number of complications, to establish whether there is a beneficial effect on mortality for undernourished elderly people and to provide evidence about whether protein and energy supplements can improve morbidity and functional status in frail older people. | 10.1002/14651858.CD003288.pub3 | [
"A total of 10,187 randomised participants from the 62 trials has been included. Maximum duration of intervention was 18 months. The reviewers suggest that supplementation appears to produce a small but consistent weight gain. There was no evidence in this updated review of a beneficial effect on mortality overall, but there may be a beneficial effect on mortality in people who are undernourished. Supplementation may also reduce the number of complications. The reported acceptance of supplements was variable between trials. Some adverse effects such as nausea or diarrhoea were reported. However, there were problems of study design and quality. More studies are required to confirm the beneficial effect on the number of complications, to establish whether there is a beneficial effect on mortality for undernourished elderly people and to provide evidence about whether protein and energy supplements can improve morbidity and functional status in frail older people."
]
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cochrane-simplification-train-1604 | cochrane-simplification-train-1604 | We identified 25 RCTs from 27 papers (with 8453 participants) studying the effect of PPIs versus placebo, H2RAs or prokinetics for improvement of global symptoms of dyspepsia and quality of life in people with FD. Low-dose PPIs had similar efficacy as standard-dose PPIs, therefore we combined these subgroups for the analysis. PPI was more effective than placebo at relieving overall dyspepsia symptoms in people with FD (risk ratio (RR) 0.88, 95% confidence interval (CI) 0.82 to 0.94; participants = 6172; studies = 18; number needed to treat for an additional beneficial outcome (NNTB) 11; moderate quality evidence). PPIs may have little or no effect compared with H2RAs (RR 0.88, 95% CI 0.74 to 1.04; participants = 740; studies = 2; low quality evidence), and may be slightly more effective than prokinetics (RR 0.89, 95% CI 0.81 to 0.99; participants = 1033; studies = 5; NNTB 16; low quality evidence) at relieving overall dyspepsia symptoms in people with FD. PPIs plus prokinetics have probably little or no effect compared with PPIs alone at relieving overall dyspepsia symptoms (RR 0.85, 95% CI 0.68 to 1.08; participants = 407; studies = 2; moderate quality evidence). There was no difference when subgrouped by Helicobacter pylori status, country of origin, or presence of reflux or Rome III subtypes. There were no differences in the number of adverse events observed between PPIs and any of the other treatments. There were fewer adverse events in the combination of PPI plus prokinetics compared to prokinetics alone (RR 0.60, 95% CI 0.39 to 0.93; participants = 407; studies = 2; moderate quality evidence). There is evidence that PPIs are effective for the treatment of FD, independent of the dose and duration of treatment compared with placebo. PPIs may be slightly more effective than prokinetics for the treatment of FD; however, the evidence is scarce. The trials evaluating PPIs versus prokinetics are difficult to interpret as they are at risk of bias. Although the effect of these drugs seems to be small, the drugs are well tolerated. | We included 25 studies (with 8453 participants). There were six studies (2304 participants) comparing low-dose PPIs versus standard-dose PPIs (the dose used in clinical practice); 18 studies (6172 participants) comparing PPIs with placebo (pretend treatment); two studies (740 participants) comparing PPIs with H2RAs; five studies (1033 participants) comparing PPIs with prokinetics and two studies (407 participants) comparing PPIs plus prokinetics versus prokinetics alone. The duration of the treatment lasted at least two weeks. Seven studies reported treatment for two weeks, 12 studies reported treatment for four weeks and five studies reported more than six weeks of treatment. The treatment period was unclear in one study. Seventeen of the 25 studies were sponsored or funded by a pharmaceutical company and two by an institution grant. There was no information on funding in eight studies. Our review showed that PPIs are more effective than placebo, and are probably slightly more effective than prokinetics for the treatment of functional dyspepsia. Low-dose and standard-dose PPIs were similarly effective on the relief of indigestion, so we combined the results of the two doses of PPI. PPI was more effective than placebo, with 31% of the PPI group reporting no or minimal symptoms compared with 26% of the placebo group. The effect of PPI was probably slightly more effective than H2RAs; however, the two studies involved in the analysis were so different that it may have influenced the results. There was no difference in the number of reported side effects when comparing PPIs, H2RAs and prokinetics. The studies evaluating the effect of PPIs compared to placebo or PPIs combined with prokinetics versus prokinetics were in general of good quality. However, the studies that compared PPIs versus H2RAs and prokinetics had serious quality issues. | 10.1002/14651858.CD011194.pub3 | [
"We included 25 studies (with 8453 participants). There were six studies (2304 participants) comparing low-dose PPIs versus standard-dose PPIs (the dose used in clinical practice); 18 studies (6172 participants) comparing PPIs with placebo (pretend treatment); two studies (740 participants) comparing PPIs with H2RAs; five studies (1033 participants) comparing PPIs with prokinetics and two studies (407 participants) comparing PPIs plus prokinetics versus prokinetics alone. The duration of the treatment lasted at least two weeks. Seven studies reported treatment for two weeks, 12 studies reported treatment for four weeks and five studies reported more than six weeks of treatment. The treatment period was unclear in one study. Seventeen of the 25 studies were sponsored or funded by a pharmaceutical company and two by an institution grant. There was no information on funding in eight studies. Our review showed that PPIs are more effective than placebo, and are probably slightly more effective than prokinetics for the treatment of functional dyspepsia. Low-dose and standard-dose PPIs were similarly effective on the relief of indigestion, so we combined the results of the two doses of PPI. PPI was more effective than placebo, with 31% of the PPI group reporting no or minimal symptoms compared with 26% of the placebo group. The effect of PPI was probably slightly more effective than H2RAs; however, the two studies involved in the analysis were so different that it may have influenced the results. There was no difference in the number of reported side effects when comparing PPIs, H2RAs and prokinetics. The studies evaluating the effect of PPIs compared to placebo or PPIs combined with prokinetics versus prokinetics were in general of good quality. However, the studies that compared PPIs versus H2RAs and prokinetics had serious quality issues."
]
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cochrane-simplification-train-1605 | cochrane-simplification-train-1605 | No new RCTs of biopsy or resection for LGG were identified. No additional ineligible non-randomized studies (NRS) were included in this updated review. Twenty other ineligible studies were previously retrieved for further analysis despite not meeting the pre-specified criteria. Ten studies were retrospective or were literature reviews. Three studies were prospective, however they were limited to tumor recurrence and volumetric analysis and extent of resection. One study was a population-based parallel cohort in Norway, but not an RCT. Four studies were RCTs, however patients were randomized with respect to varying radiotherapy regimens to assess timing and dose of radiation. One RCT was on high-grade gliomas (HGGs) and not LGG. Finally, one RCT evaluated diffusion tensor imaging (DTI)-based neuro-navigation for surgical resection. Since the last version of this review, no new studies have been identified for inclusion and currently there are no RCTs or CCTs available on which to base definitive clinical decisions. Therefore, physicians must approach each case individually and weigh the risks and benefits of each intervention until further evidence is available. Some retrospective studies and non-randomized prospective studies do seem to suggest improved OS and seizure control correlating to higher extent of resection. Future research could focus on RCTs to determine outcomes benefits for biopsy versus resection. | Conclusions: There are no randomized clinical trials on this topic; some institutional, non-clinical trials studies have suggested improved overall survival and seizure control with higher extent of resection. However, physicians should approach each case individually and weigh the risks and benefits of biopsy versus surgical resection, as well as incorporate patient preference into their clinical decision-making. Prognostic factors such as patient age, tumor size, and tumor location as well as potential implications for quality of life should be taken into account. | 10.1002/14651858.CD009319.pub3 | [
"Conclusions: There are no randomized clinical trials on this topic; some institutional, non-clinical trials studies have suggested improved overall survival and seizure control with higher extent of resection. However, physicians should approach each case individually and weigh the risks and benefits of biopsy versus surgical resection, as well as incorporate patient preference into their clinical decision-making. Prognostic factors such as patient age, tumor size, and tumor location as well as potential implications for quality of life should be taken into account."
]
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cochrane-simplification-train-1606 | cochrane-simplification-train-1606 | Four studies, including 83 participants, are included in this review. Two studies used mantra meditation while the other two used yoga compared with drugs, relaxation training, non-specific exercises and standard treatment control. Design limitations caused high risk of bias across the studies. Only one out of four studies provided data appropriate for analysis. For this study there was no statistically significant difference between the meditation therapy group and the drug therapy group on the teacher rating ADHD scale (MD -2.72, 95% CI -8.49 to 3.05, 15 patients). Likewise, there was no statistically significant difference between the meditation therapy group and the standard therapy group on the teacher rating ADHD scale (MD -0.52, 95% CI -5.88 to 4.84, 17 patients). There was also no statistically significant difference between the meditation therapy group and the standard therapy group in the distraction test (MD -8.34, 95% CI -107.05 to 90.37, 17 patients). As a result of the limited number of included studies, the small sample sizes and the high risk of bias, we are unable to draw any conclusions regarding the effectiveness of meditation therapy for ADHD. The adverse effects of meditation have not been reported. More trials are needed. | The objective of this review was to assess the efficacy of this treatment. As a result of the small number of studies that we were able to include in this review and the limitations of those studies, we were unable to draw any conclusions regarding the effectiveness of meditation therapy for ADHD. No adverse effects of meditation in children have been reported. More trials are needed on meditation therapies for ADHD so that conclusions can be drawn regarding its effectiveness. | 10.1002/14651858.CD006507.pub2 | [
"The objective of this review was to assess the efficacy of this treatment. As a result of the small number of studies that we were able to include in this review and the limitations of those studies, we were unable to draw any conclusions regarding the effectiveness of meditation therapy for ADHD. No adverse effects of meditation in children have been reported. More trials are needed on meditation therapies for ADHD so that conclusions can be drawn regarding its effectiveness."
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cochrane-simplification-train-1607 | cochrane-simplification-train-1607 | We included 11 studies (four CTPA, five lung scintigraphy, two both) with a total of 695 CTPA and 665 lung scintigraphy results. Lung scintigraphy was applied by different techniques. No MRA studies matched our inclusion criteria. Overall, risk of bias and concerns regarding applicability were high in all studies as judged in light of the review research question, as was heterogeneity in study methods. We did not undertake meta-analysis. All studies used clinical follow-up as a reference standard, none in a manner that enabled reliable identification of false positives. Sensitivity and negative predictive value were therefore the only valid test accuracy measures. The median negative predictive value for CTPA was 100% (range 96% to 100%). Median sensitivity was 83% (range 0% to 100%). The median negative predictive value for lung scintigraphy was 100% (range 99% to 100%). Median sensitivity was 100% (range 0% to 100%). The median frequency of inconclusive results was 5.9% (range 0.9% to 36%) for CTPA and 4.0% (range 0% to 23%) for lung scintigraphy. The overall median prevalence of pulmonary embolism was 3.3% (range 0.0% to 8.7%). Both CTPA and lung scintigraphy seem appropriate for exclusion of pulmonary embolism during pregnancy. However, the quality of the evidence mandates cautious adoption of this conclusion. Important limitations included poor reference standards, necessary assumptions in the analysis regarding inconclusive test results and the inherent inability of included studies to identify false positives. It is unclear which test has the highest accuracy. There is a need for direct comparisons between diagnostic methods, including MR, in prospective randomized diagnostic studies. | We found 11 studies (current until July 2015) that described 695 computed tomography pulmonary angiography results, 665 lung scintigraphy results and no magnetic resonance angiography results. Studies on lung scintigraphy used varying techniques. Overall, these studies were of poor quality; therefore, we could not analyse results together to obtain a single estimate of their accuracy. The identified studies followed-up patients clinically to confirm the absence of pulmonary embolism as revealed on the initial scan, so information could be used to draw conclusions only on the ability of these imaging tests to exclude pulmonary embolism, not on their ability to establish the diagnosis. Both computed tomography pulmonary angiography and lung scintigraphy appear appropriate for excluding pulmonary embolism in pregnancy. Almost no cases were missed, especially when the imaging test indicated the absence of disease without a doubt. However, this result should be interpreted with care because of the low quality of and variation between identified studies. Around 5% of the scans were unclear, but this percentage was as high as 36% in one study. About 3% of all women included in the studies had pulmonary embolism. We do not know which of the tests is better because tests were not directly compared in the same patients, and because aspects besides test accuracy need to be taken into account. Major limitations of this review include the use of clinical follow-up within studies to confirm the absence of disease, unclear test results and the inability of studies to provide information on the accuracy of these tests in establishing rather than rejecting the diagnosis. High-quality research is needed to investigate the use of computed tomography pulmonary angiography, lung scintigraphy and magnetic pulmonary angiography in the same patient groups. | 10.1002/14651858.CD011053.pub2 | [
"We found 11 studies (current until July 2015) that described 695 computed tomography pulmonary angiography results, 665 lung scintigraphy results and no magnetic resonance angiography results. Studies on lung scintigraphy used varying techniques. Overall, these studies were of poor quality; therefore, we could not analyse results together to obtain a single estimate of their accuracy. The identified studies followed-up patients clinically to confirm the absence of pulmonary embolism as revealed on the initial scan, so information could be used to draw conclusions only on the ability of these imaging tests to exclude pulmonary embolism, not on their ability to establish the diagnosis. Both computed tomography pulmonary angiography and lung scintigraphy appear appropriate for excluding pulmonary embolism in pregnancy. Almost no cases were missed, especially when the imaging test indicated the absence of disease without a doubt. However, this result should be interpreted with care because of the low quality of and variation between identified studies. Around 5% of the scans were unclear, but this percentage was as high as 36% in one study. About 3% of all women included in the studies had pulmonary embolism. We do not know which of the tests is better because tests were not directly compared in the same patients, and because aspects besides test accuracy need to be taken into account. Major limitations of this review include the use of clinical follow-up within studies to confirm the absence of disease, unclear test results and the inability of studies to provide information on the accuracy of these tests in establishing rather than rejecting the diagnosis. High-quality research is needed to investigate the use of computed tomography pulmonary angiography, lung scintigraphy and magnetic pulmonary angiography in the same patient groups."
]
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cochrane-simplification-train-1608 | cochrane-simplification-train-1608 | We included one unpublished RCT, randomising 180 children aged three years at study commencement. The setting was nursery schools in an area with high prevalence of dental caries and a low level of fluoride in drinking water. Data from 166 participants were available for analysis. The study carried a high risk of bias. After three years, there was a reduction of caries in permanent teeth (mean difference (MD) −0.13, 95% confidence interval (CI) −0.24 to −0.02) and in primary teeth (MD −1.14, 95% CI −1.86 to −0.42), as measured by the decayed, missing and filled teeth index (DMFT for permanent teeth and dmft for primary teeth). For primary teeth, this is a substantial reduction, equivalent to a prevented fraction of 31%. For permanent teeth, the disease level was very low in the study, resulting in a small absolute effect size. The included study did not report any other outcomes of interest for this review (adverse events, dental pain, antibiotic use or requirement for general anaesthesia due to dental procedures). There is low-quality evidence to suggest fluoridated milk may be beneficial to schoolchildren, contributing to a substantial reduction in dental caries in primary teeth. Due to the low quality of the evidence, further research is likely to have an important impact on our confidence in the estimate of effect and is likely to change the estimate. There was only one relatively small study, which had important methodological limitations on the data for the effectiveness in reducing caries. Furthermore, there was no information about the potential harms of the intervention. Additional RCTs of high quality are needed before we can draw definitive conclusions about the benefits of milk fluoridation. | Authors from Cochrane Oral Health reviewed existing studies to find all available evidence up to November 2014. We searched scientific databases for clinical trials testing the effects of fluoridated milk compared with non-fluoridated milk. Treatment had to be used and monitored for a minimum of two years. We found one unpublished study that included 180 three-year olds who were given either fluoridated or non-fluoridated milk at nursery schools in an area with high prevalence of dental cavities and a low level of fluoride in drinking water. After three years, 92% of the children were available for analysis. The evidence suggests fluoridated milk may be beneficial to schoolchildren, substantially reducing the formation of cavities in baby teeth. There was no information available about any possible adverse events. The evidence was considered to be low quality due to the lack of relevant studies, the risk of bias in the identified study and concerns over the applicability of the results to different settings and populations. Additional studies of high quality are needed before we can draw definitive conclusions about the benefits of milk fluoridation. | 10.1002/14651858.CD003876.pub4 | [
"Authors from Cochrane Oral Health reviewed existing studies to find all available evidence up to November 2014. We searched scientific databases for clinical trials testing the effects of fluoridated milk compared with non-fluoridated milk. Treatment had to be used and monitored for a minimum of two years. We found one unpublished study that included 180 three-year olds who were given either fluoridated or non-fluoridated milk at nursery schools in an area with high prevalence of dental cavities and a low level of fluoride in drinking water. After three years, 92% of the children were available for analysis. The evidence suggests fluoridated milk may be beneficial to schoolchildren, substantially reducing the formation of cavities in baby teeth. There was no information available about any possible adverse events. The evidence was considered to be low quality due to the lack of relevant studies, the risk of bias in the identified study and concerns over the applicability of the results to different settings and populations. Additional studies of high quality are needed before we can draw definitive conclusions about the benefits of milk fluoridation."
]
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cochrane-simplification-train-1609 | cochrane-simplification-train-1609 | Two studies met the inclusion criteria, enrolling 157 participants (37 participants in one study and 120 in the other study), of whom 114 were included in the analyses. The studies compared oral dexamethasone to placebo, followed by an open-label phase in one study. One study lasted seven days, and the duration of the other study was 15 days. We were unable to conduct many of our predetermined analyses due to different agents, dosages, comparators and outcome measures, routes of drug delivery, measurement scales and time points. Subgroup analysis according to type of cancer was not possible. Primary outcomes We included two studies (114 participants) with data at one week in the meta-analysis for change in dyspnoea intensity/dyspnoea relief from baseline. Corticosteroid therapy with dexamethasone resulted in an MD of lower dyspnoea intensity compared to placebo at one week (MD –0.85 lower dyspnoea (scale 0–10; lower score = less breathlessness), 95% CI -1.73 to 0.03; very low-quality evidence), although we were uncertain as to whether corticosteroids had an important effect on dyspnoea as results were imprecise. We downgraded the quality of evidence by three levels from high to very low due to very serious study limitations and imprecision. One study measured affective distress (quality of dyspnoea) and results were similar between groups (29 participants; very low-quality evidence). We downgraded the quality of the evidence three times for imprecision, inconsistency, and serious study limitations. Both studies assessed symptom impact (burden of dyspnoea or impact on function) (113 participants; very low-quality evidence). In one study, it was unclear whether dexamethasone had an effect on dyspnoea as results were imprecise. The second study showed more improvement for physical well-being scores at days eight and 15 in the dexamethasone group compared with the control group, but there was no evidence of a difference for FACIT social/family, emotional or functional scales. We downgraded the quality of the evidence three times for imprecision, inconsistency, and serious study limitations. Secondary outcomes Due to the lack of homogenous outcome measures and inconsistency in reporting, we could not perform quantitative analysis for any secondary outcomes. In both studies, the frequency of adverse events was similar between groups, and corticosteroids were generally well tolerated. The withdrawal rates for the two studies were 15% and 36%. Reasons for withdrawal included lost to follow-up, participant or carer (or both) refusal, and death due to disease progression. We downgraded the quality of evidence for these secondary outcomes by three levels from high to very low due to serious study limitations, inconsistency and imprecision. Neither study examined participant satisfaction with treatment. There are few studies assessing the effects of systemic corticosteroids on cancer-related dyspnoea in adults with cancer. We judged the evidence to be of very low quality that neither supported nor refuted corticosteroid use in this population. Further high-quality studies are needed to determine if corticosteroids are efficacious in this setting. | We searched the literature in January 2018. We found two studies, enrolling 157 participants in total, that tested the effect of systemic corticosteroids on breathlessness in adults with cancer, compared to a dummy medicine (placebo). One study lasted seven days, and the other study lasted 15 days. Both studies compared a corticosteroid (oral (by mouth) dexamethasone) to a dummy medicine with no properties to reduce breathlessness, which we included in our analyses. We were interested in the primary outcomes of participant-reported breathlessness intensity, quality and burden. We were also interested in the secondary outcomes of serious side effects, participant satisfaction with treatment and participant withdrawal from trial. We could not complete many of our planned analyses due to the small number of studies, the different medicines and comparisons, and outcomes that the studies reported. We did conduct one analysis of 114 participants to assess change in breathlessness intensity/relief from baseline. We found that corticosteroids had no beneficial effect compared to a dummy medicine on reducing breathlessness intensity in people with cancer. We found that the frequency of side effects was similar between groups, and corticosteroids were generally well tolerated. None of the studies measured participant satisfaction with treatment. Participant withdrawals were 15% and 36% in the two studies. The current evidence was based on only two studies with a small number of participants. We rated the quality of the evidence from these studies using four levels: very low, low, moderate or high. Very low-quality evidence means that we are very uncertain about the results. High-quality evidence means that we are very confident in the results. We judged the quality of the evidence in this review to be very low, downgraded due to problems with study quality and too few data. We are very uncertain of the results. More high-quality studies are needed to determine if corticosteroids are effective for dyspnoea in people with cancer. | 10.1002/14651858.CD012704.pub2 | [
"We searched the literature in January 2018. We found two studies, enrolling 157 participants in total, that tested the effect of systemic corticosteroids on breathlessness in adults with cancer, compared to a dummy medicine (placebo). One study lasted seven days, and the other study lasted 15 days. Both studies compared a corticosteroid (oral (by mouth) dexamethasone) to a dummy medicine with no properties to reduce breathlessness, which we included in our analyses. We were interested in the primary outcomes of participant-reported breathlessness intensity, quality and burden. We were also interested in the secondary outcomes of serious side effects, participant satisfaction with treatment and participant withdrawal from trial. We could not complete many of our planned analyses due to the small number of studies, the different medicines and comparisons, and outcomes that the studies reported. We did conduct one analysis of 114 participants to assess change in breathlessness intensity/relief from baseline. We found that corticosteroids had no beneficial effect compared to a dummy medicine on reducing breathlessness intensity in people with cancer. We found that the frequency of side effects was similar between groups, and corticosteroids were generally well tolerated. None of the studies measured participant satisfaction with treatment. Participant withdrawals were 15% and 36% in the two studies. The current evidence was based on only two studies with a small number of participants. We rated the quality of the evidence from these studies using four levels: very low, low, moderate or high. Very low-quality evidence means that we are very uncertain about the results. High-quality evidence means that we are very confident in the results. We judged the quality of the evidence in this review to be very low, downgraded due to problems with study quality and too few data. We are very uncertain of the results. More high-quality studies are needed to determine if corticosteroids are effective for dyspnoea in people with cancer."
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cochrane-simplification-train-1610 | cochrane-simplification-train-1610 | Seven randomised controlled trials were identified that satisfied the inclusion criteria. In patients with moderate to severe ulcerative colitis whose disease was refractory to conventional treatment using corticosteroids and/or immunosuppressive agents, infliximab (three intravenous infusions at 0, 2, and 6 weeks) was more effective than placebo in inducing clinical remission (Relative Risk (RR) 3.22, 95% CI 2.18 to 4.76); inducing endoscopic remission (RR 1.88, 95% CI 1.54 to 2.28); and in inducing clinical response (RR 1.99, 95% CI 1.65 to 2.41) at 8 weeks. A single infusion of infliximab was also more effective than placebo in reducing the need for colectomy within 90 days after infusion (RR 0.44, 95% CI 0.22 to 0.87). In patients with moderate to severe ulcerative colitis whose disease is refractory to conventional treatment using corticosteroids and/or immunosuppressive agents, infliximab is effective in inducing clinical remission, inducing clinical response, promoting mucosal healing, and reducing the need for colectomy at least in the short term. Serious adverse events attributable to infliximab were not common in the included studies but physicians should be aware of and be prepared to deal with potential adverse events such as anaphylactic reactions and infections. | This review shows that intravenous infusions of infliximab, a TNF-α blocking agent is effective in inducing clinical remission, promoting mucosal healing, and reducing the need for colectomy in patients with active ulcerative colitis whose disease has not responded to conventional treatment. | 10.1002/14651858.CD005112.pub2 | [
"This review shows that intravenous infusions of infliximab, a TNF-α blocking agent is effective in inducing clinical remission, promoting mucosal healing, and reducing the need for colectomy in patients with active ulcerative colitis whose disease has not responded to conventional treatment."
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cochrane-simplification-train-1611 | cochrane-simplification-train-1611 | Six RCTs (n = 2324 patients) met the inclusion criteria. A low risk of bias was assigned to all studies. The two briakinumab trials were not pooled due to differences in doses and time points for analysis. In both studies there was no statistically significant difference in remission rates. One study (n = 79) compared doses of 1 mg/kg and 3 mg/kg to placebo. In the briakinumab group 70% (44/63) of patients failed to enter clinical remission at 6 or 9 weeks compared to 81% (13/16) of placebo patients (RR 0.86, 95% CI 0.65 to 1.14). Subgroup analysis revealed no significant differences by dose. The other briakinumab study (n = 230) compared intravenous doses of 200 mg, 400 mg and 700 mg with placebo. Eighty-four per cent (154/184) of briakinumab patients failed to enter clinical remission at six weeks compared to 91% (42/46) of placebo patients (RR 0.92, 95% CI 0.83 to 1.03). Subgroup analysis revealed no significant differences by dose. GRADE analyses of the briakinumab studies rated the overall quality of the evidence for the outcome clinical remission as low. Based on the results of these two studies the manufacturers of briakinumab stopped production of this medication. The ustekinumab studies were pooled despite differences in intravenous doses (i.e. 1mg/kg, 3 mg/kg, 4.5 mg/kg, and 6 mg/kg), however the subcutaneous dose group was not included in the analysis, as it was unclear if subcutaneous was equivalent to intravenous dosing. There was a statistically significant difference in remission rates. At week six, 84% (764/914) of ustekinumab patients failed to enter remission compared to 90% (367/406) of placebo patients (RR 0.92, 95% CI 0.88 to 0.96; 3 studies; high-quality evidence). Subgroup analysis showed a statistically significant difference for the 6.0 mg/kg dose group (moderate-quality evidence). There were statistically significant differences in clinical improvement between ustekinumab and placebo-treated patients. In the ustekinumab group, 55% (502/914) of patients failed to improve clinically (i.e. 70-point decline in CDAI score), compared to 71% (287/406) of placebo patients (RR 0.78, 95% CI 0.71 to 0.85; 3 studies). Subgroup analysis revealed significant differences compared to placebo for the 1 mg/kg, 4.5 mg/kg and 6 mg/kg dosage subgroups. Similarly for a 100-point decline in CDAI, 64% (588/914) of patients in the ustekinumab group failed to improve clinically compared to 78% (318/406) of placebo patients (RR 0.82, 95% CI 0.77 to 0.88; 3 studies; high-quality evidence). Subgroup analysis showed a significant difference compared to placebo for the 4.5 mg/kg and 6.0 mg/kg (high-quality evidence) dose groups. There were no statistically significant differences in the incidence of adverse events, serious adverse events or withdrawal due to adverse events. Sixty-two per cent (860/1386) of ustekinumab patients developed at least one adverse event compared to 64% (407/637) of placebo patients (RR 0.97, 95% CI 0.90 to 1.04; 4 studies; high-quality evidence). Five per cent (75/1386) of ustekinumab patients had a serious adverse event compared to 6% (41/637) of placebo patients (RR 0.83, 95% CI 0.58 to 1.20; 4 studies; moderate-quality evidence). The most common adverse events in briakinumab patients were injection site reactions and infections. Infections were the most common adverse event in ustekinumab patients. Worsening of Crohn's disease and serious infections were the most common serious adverse events. High quality evidence suggests that ustekinumab is effective for induction of clinical remission and clinical improvement in patients with moderate to severe Crohn's disease. Moderate to high quality evidence suggests that the optimal dosage of ustekinumab is 6 mg/kg. Briakinumab and ustekinumab appear to be safe. Moderate quality evidence suggests no increased risk of serious adverse events. Future studies are required to determine the long-term efficacy and safety of ustekinumab in patients with moderate to severe Crohn's disease. | The researchers identified six studies that included a total of 2324 participants. Two studies compared briakinumab to placebo (a fake medicine) and four studies compared ustekinumab to placebo. All of the studies were high quality. There was no difference in the proportion of briakinumab and placebo participants who achieved remission. An increase in side effects or severe side effects were not seen with briakinumab compared to placebo. The most common side effects in briakinumab participants were reactions at the site of injection and infections. Based on the results of these two studies the manufacturers of briakinumab stopped production of this medication. High quality evidence suggests that ustekinumab is better than placebo for helping participants achieve remission and for reducing symptoms of active Crohn's disease. Different doses of ustekinumab were investigated and moderate to high quality suggests that 6.0 mg/kg is the most effective dose. An increase in side effects or serious side effects was not seen with ustekinumab compared to placebo. Infections were the most common adverse event in ustekinumab patients. Worsening of Crohn's disease and serious infections were the most common serious side effects in the ustekinumab studies. Ustekinumab is a promising as a therapy for inducing remission and improving symptoms in people with Crohn's disease. Further studies are required to determine the long-term effectiveness and safety of ustekinumab in patients with moderate to severe Crohn's disease. The ideal dose of ustekinumab also needs to be determined. | 10.1002/14651858.CD007572.pub3 | [
"The researchers identified six studies that included a total of 2324 participants. Two studies compared briakinumab to placebo (a fake medicine) and four studies compared ustekinumab to placebo. All of the studies were high quality. There was no difference in the proportion of briakinumab and placebo participants who achieved remission. An increase in side effects or severe side effects were not seen with briakinumab compared to placebo. The most common side effects in briakinumab participants were reactions at the site of injection and infections. Based on the results of these two studies the manufacturers of briakinumab stopped production of this medication. High quality evidence suggests that ustekinumab is better than placebo for helping participants achieve remission and for reducing symptoms of active Crohn's disease. Different doses of ustekinumab were investigated and moderate to high quality suggests that 6.0 mg/kg is the most effective dose. An increase in side effects or serious side effects was not seen with ustekinumab compared to placebo. Infections were the most common adverse event in ustekinumab patients. Worsening of Crohn's disease and serious infections were the most common serious side effects in the ustekinumab studies. Ustekinumab is a promising as a therapy for inducing remission and improving symptoms in people with Crohn's disease. Further studies are required to determine the long-term effectiveness and safety of ustekinumab in patients with moderate to severe Crohn's disease. The ideal dose of ustekinumab also needs to be determined."
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cochrane-simplification-train-1612 | cochrane-simplification-train-1612 | We found five reports of two single-centre, placebo-controlled, double-blinded studies (130 participants). Participants in both studies were a mix of adults with either intermittent or persistent allergic rhinitis. Both studies had a low risk of bias. One study, with 12 weeks’ follow-up, used a single percutaneous application of 10 Necator americanus (i.e. human hookworm) larvae. The other study, with 24 weeks’ follow-up, used three-weekly oral dosing with 2500 Trichuris suis (i.e. pig whipworm) eggs in aqueous suspension. Of 17 outcomes evaluated in this review, eight were positive (i.e. favoured helminths). Participants taking helminths had no reduction in allergic rhinitis symptoms, percentage of well days (i.e. days with minimal symptoms and no use of medication for allergic rhinitis), lung function measures and quality of life scores. Total use of medication for allergic rhinitis (eye drops, nasal sprays, tablets) did not change; however, in the helminth group there was a statistically significant reduction in the percentage of days during the grass pollen season when participants needed to take tablets as rescue medication for their allergic rhinitis symptoms (MD –14.0%, 95% CI –26.6 to –1.40); in a typical 60-day pollen season this 14% reduction translates into 19 days when tablets would be needed in the helminth group versus 27 days when tablets would be needed in the placebo group. Participants taking helminths percutaneously (i.e. as hookworm larvae) had local skin itching and redness in the first few days after administration. Participants taking helminths were more likely to report any gastrointestinal adverse event (RR 1.79, 95% CI 1.31 to 2.45), moderate or severe abdominal pain (RR 7.67, 95% CI 1.87 to 31.57), moderate or severe flatulence (RR 2.01, 95% CI 1.06 to 3.81) and moderate or severe diarrhoea (RR 1.99, 95% CI 1.18 to 3.37). There was no difference between the helminth and placebo groups in the incidence of serious adverse events, and in study withdrawals. There is currently insufficient evidence on the efficacy, tolerability and likely costs of helminth therapy to support its use in the routine management of allergic rhinitis. Administered to humans in carefully measured doses, helminths appear to be safe. More preclinical studies should be performed, before larger and extended duration trials of helminths for allergic rhinitis are carried out. Future studies should collect and report comparative data on the costs of helminth therapy versus conventional pharmacotherapy. | We included two well-designed studies with a total of 130 adult participants, each study using a different species of gastrointestinal helminth (human hookworm in one study and pig whipworm in the other) as the intervention. Both studies found no significant efficacy from helminths, although one helminth species (Trichuris suis, the pig whipworm) reduced the need for participants to take tablets as ‘rescue medication’ during the grass pollen season. Adverse events such as abdominal pain and flatulence were commoner in the helminth group, but the two helminths species studied did not cause serious adverse reactions. Currently there is insufficient evidence to support the use of helminths for allergic rhinitis in routine clinical practice. More preclinical studies are needed, before larger and extended duration clinical trials of helminths for allergic rhinitis are performed. | 10.1002/14651858.CD009238.pub2 | [
"We included two well-designed studies with a total of 130 adult participants, each study using a different species of gastrointestinal helminth (human hookworm in one study and pig whipworm in the other) as the intervention. Both studies found no significant efficacy from helminths, although one helminth species (Trichuris suis, the pig whipworm) reduced the need for participants to take tablets as ‘rescue medication’ during the grass pollen season. Adverse events such as abdominal pain and flatulence were commoner in the helminth group, but the two helminths species studied did not cause serious adverse reactions. Currently there is insufficient evidence to support the use of helminths for allergic rhinitis in routine clinical practice. More preclinical studies are needed, before larger and extended duration clinical trials of helminths for allergic rhinitis are performed."
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cochrane-simplification-train-1613 | cochrane-simplification-train-1613 | We included four randomised controlled trials (all conducted in Italy) reporting on 567 women who were less than 11 weeks' to 24 weeks' pregnant at the start of the trials. The trials had small sample sizes and one trial only reported an interim analysis. Two trials were open-label. The overall risk of bias was unclear. For the mother, supplementation with myo-inositol was associated with a reduction in the incidence of gestational diabetes compared with control (risk ratio (RR) 0.43, 95% confidence interval (CI) 0.29 to 0.64; three trials; n = 502 women). Using GRADE methods this evidence was assessed as low with downgrading due to unclear risk of bias for allocation concealment in two of the included trials and lack of generalisability of findings. For women who received myo-inositol supplementation, the incidence of GDM ranged from 8% to 18%; for women in the control group, the incidence of GDM was 28%, using International Association of Diabetes and Pregnancy Study Groups Consensus Panel 2010 criteria to diagnose GDM. Two trials reported on hypertensive disorders of pregnancy, a primary maternal outcome of this review. There was no clear difference in risk of hypertensive disorders of pregnancy between the myo-inositol and control groups (average RR 0.43, 95% CI 0.02 to 8.41; two trials; n = 398 women; Tau2 = 3.23; I2 = 69%). Using GRADE methods, this evidence was assessed as very low, with downgrading due to wide confidence intervals with very low event rates, a small sample size, and lack of blinding and unclear allocation concealment methods, and a lack of generalisability. For women who received myo-inositol the risk of hypertensive disorders of pregnancy ranged from 0% to 33%; for women in the control group the risk was 4%. For the infant, none of the included trials reported on the primary neonatal outcomes of this systematic review (large-for-gestational age, perinatal mortality, mortality or morbidity composite). In terms of this review's secondary outcomes, there was no clear difference in the risk of caesarean section between the myo-inositol and control groups (RR 0.95, 95% CI 0.76 to 1.19; two trials; n = 398 women). Using GRADE methods, this evidence was assessed as low, with downgrading due to unclear risk of bias in one trial and lack of generalisability. For women who received myo-inositol supplementation, the risk of having a caesarean section ranged from 34% to 54%; for women in the control group the was 45%. There were no maternal adverse effects of therapy in the two trials that reported on this outcome (the other two trials did not report this outcome). Two trials found no clear difference in the risk of macrosomia between infants whose mothers received myo-inositol supplementation compared with controls (average RR 0.35, 95% CI 0.02 to 6.37; two trials; n = 398 infants;Tau2 = 3.33; I2 = 73%). Similarly, there was no clear difference between groups in terms of neonatal hypoglycaemia (RR 0.36, 95% CI 0.01 to 8.66) or shoulder dystocia (average RR 2.33, 95% CI 0.12 to 44.30, Tau2 = 3.24; I2 = 72%). There was a lack of data available for a large number of maternal and neonatal secondary outcomes, and no data for any of the long-term childhood or adulthood outcomes, or for health service cost outcomes. Evidence from four trials of antenatal dietary supplementation with myo-inositol during pregnancy shows a potential benefit for reducing the incidence of gestational diabetes. No data were reported for any of this review's primary neonatal outcomes. There were very little outcome data for the majority of this review's secondary outcomes. There is no clear evidence of a difference for macrosomia when compared with control. The current evidence is based on small trials that are not powered to detect differences in outcomes including perinatal mortality and serious infant morbidity. All of the included studies were conducted in Italy which raises concerns about the lack of generalisability of the evidence to other settings. There is evidence of inconsistency and indirectness and as a result, many of the judgements on the quality of the evidence were downgraded to low or very low quality (GRADEpro Guideline Development Tool). Further trials for this promising antenatal intervention for preventing gestational diabetes are encouraged and should include pregnant women of different ethnicities and varying risk factors and use of myo-inositol (different doses, frequency and timing of administration) in comparison with placebo, diet and exercise or pharmacological interventions. Outcomes should include potential harms including adverse effects. | We searched for studies on 2 November 2015 and included four small randomised controlled trials involving a total of 567 women who were less than 11 weeks' to 24 weeks' pregnant at the start of the trials. The quality of the evidence was assessed as low or very low and the overall risk of bias was unclear. Myo-inositol was associated with a reduction in the rate of gestational diabetes (low quality evidence), reducing the incidence from 28% in women who did not take the supplement, to between 8% and 18% in the women who took it. There was no difference between groups in terms of the number of women who had hypertensive disorders of pregnancy (including pre-eclampsia, eclampsia and abnormally high blood pressure during pregnancy) (very low quality evidence). The trials did not provide any information about the number of babies that died (either before being born or shortly afterwards) or babies that were large-for-gestational age. There were no maternal adverse effects of therapy in the two trials that reported on this outcome (the other two trials did not mention this). This review did not find any impact on other outcomes such as the risk of having a caesarean section (low quality evidence), a large baby, obstructed labour when the baby's shoulder becomes stuck (shoulder dystocia) or a baby with low blood glucose levels. This may be due to the trials being too small to detect differences in these outcomes and the outcomes not being reported by all trials. All four trials were from Italy. The included trials did not report on a large number of other mother and baby outcomes listed in this review and nor were there any data relating to longer-term outcomes for the mother or the infant, or the cost of health services. Myo-inositol as a dietary supplement during pregnancy shows promise in preventing gestational diabetes but there is not enough evidence at this stage to support its routine use. Further large, well-designed, randomised controlled trials are required to assess the effectiveness of myo-inositol in preventing gestational diabetes and improving other health outcomes for mothers and their babies. Ideally, future studies should consider involving women from different ethnicities and with differing risk factors for gestational diabetes. It would be useful for future studies to consider the ways that myo-inositol can be used (different doses, frequency and when to take it) and compare the intervention with a placebo control, diet and exercise or pharmacological interventions. We recommend that future studies utilise the outcomes listed in this review and that potential harms, including adverse effects are included. | 10.1002/14651858.CD011507.pub2 | [
"We searched for studies on 2 November 2015 and included four small randomised controlled trials involving a total of 567 women who were less than 11 weeks' to 24 weeks' pregnant at the start of the trials. The quality of the evidence was assessed as low or very low and the overall risk of bias was unclear. Myo-inositol was associated with a reduction in the rate of gestational diabetes (low quality evidence), reducing the incidence from 28% in women who did not take the supplement, to between 8% and 18% in the women who took it. There was no difference between groups in terms of the number of women who had hypertensive disorders of pregnancy (including pre-eclampsia, eclampsia and abnormally high blood pressure during pregnancy) (very low quality evidence). The trials did not provide any information about the number of babies that died (either before being born or shortly afterwards) or babies that were large-for-gestational age. There were no maternal adverse effects of therapy in the two trials that reported on this outcome (the other two trials did not mention this). This review did not find any impact on other outcomes such as the risk of having a caesarean section (low quality evidence), a large baby, obstructed labour when the baby's shoulder becomes stuck (shoulder dystocia) or a baby with low blood glucose levels. This may be due to the trials being too small to detect differences in these outcomes and the outcomes not being reported by all trials. All four trials were from Italy. The included trials did not report on a large number of other mother and baby outcomes listed in this review and nor were there any data relating to longer-term outcomes for the mother or the infant, or the cost of health services. Myo-inositol as a dietary supplement during pregnancy shows promise in preventing gestational diabetes but there is not enough evidence at this stage to support its routine use. Further large, well-designed, randomised controlled trials are required to assess the effectiveness of myo-inositol in preventing gestational diabetes and improving other health outcomes for mothers and their babies. Ideally, future studies should consider involving women from different ethnicities and with differing risk factors for gestational diabetes. It would be useful for future studies to consider the ways that myo-inositol can be used (different doses, frequency and when to take it) and compare the intervention with a placebo control, diet and exercise or pharmacological interventions. We recommend that future studies utilise the outcomes listed in this review and that potential harms, including adverse effects are included."
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cochrane-simplification-train-1614 | cochrane-simplification-train-1614 | We included nine reviews with 152 included studies and 13,524 participants, but because some studies appeared in more than one review the number of unique studies and participants was smaller than this. Most participants had moderate or severe pain associated with a range of different types of cancer. Studies in the reviews typically compared one type of opioid or formulation with either a different formulation of the same opioid, or a different opioid; few included a placebo control. Typically the reviews titrated dose to effect, a balance between pain relief and adverse events. Various routes of administration of opioids were considered in the reviews; oral with most opioids, but transdermal administration with fentanyl, and buprenorphine. No review included studies of subcutaneous opioid administration. Pain outcomes reported were varied and inconsistent. The average size of included studies varied considerably between reviews: studies of older opioids, such as codeine, morphine, and methadone, had low average study sizes while those involving newer drugs tended to have larger study sizes. Six reviews reported a GRADE assessment (buprenorphine, codeine, hydromorphone, methadone, oxycodone, and tramadol), but not necessarily for all comparisons or outcomes. No comparative analyses were possible because there was no consistent placebo or active control. Cohort outcomes for opioids are therefore reported, as absolute numbers or percentages, or both. Reviews on buprenorphine, codeine with or without paracetamol, hydromorphone, methadone, tramadol with or without paracetamol, tapentadol, and oxycodone did not have information about the primary outcome of mild or no pain at 14 days, although that on oxycodone indicated that average pain scores were within that range. Two reviews, on oral morphine and transdermal fentanyl, reported that 96% of 850 participants achieved that goal. Adverse event withdrawal was reported by five reviews, at rates of between 6% and 19%. Participants with at least one adverse event were reported by three reviews, at rates of between 11% and 77%. Our GRADE assessment of evidence quality was very low for all outcomes, because many studies in the reviews were at high risk of bias from several sources, including small study size. The amount and quality of evidence around the use of opioids for treating cancer pain is disappointingly low, although the evidence we have indicates that around 19 out of 20 people with moderate or severe pain who are given opioids and can tolerate them should have that pain reduced to mild or no pain within 14 days. This accords with the clinical experience in treating many people with cancer pain, but overstates to some extent the effectiveness found for the WHO pain ladder. Most people will experience adverse events, and help may be needed to manage the more common undesirable adverse effects such as constipation and nausea. Perhaps between 1 in 10 and 2 in 10 people treated with opioids will find these adverse events intolerable, leading to a change in treatment. | In this overview of Cochrane Reviews we examined all the evidence on how well morphine-like drugs worked, mostly when taken by mouth or through a skin patch, how many people had side effects, and how severe or troublesome those side effects were — for example, whether they caused participants to stop taking their medicines. In May 2017, we found nine reviews with 152 included studies and 13,524 participants. The studies were often small, and compared many different preparations. They used different study designs and different ways of showing their pain results. Outcomes of importance to people with cancer pain were often not reported. For two drugs (morphine by mouth and fentanyl patches) more than 19 in 20 people had pain that went from moderate or severe before taking morphine-like drugs, to pain that was no worse than mild within 14 days if they can tolerate the side effects. Most people taking a morphine-like drug had at least one side effect. Only about 1 person in 10 to 2 people in 10 stopped taking it because of side effects. The most common side effects were constipation, and nausea and vomiting. At one level these are encouraging results, and generally agree with surveys of how well the WHO advice works in cancer pain. On another level, the quality of studies in the reviews was generally poor. We would like better study design, and especially better study reporting, which should include the outcome of pain reduced to a level where people with cancer can cope with it (no pain or mild pain). We found that the Cochrane Reviews were of high quality. We rated the quality of the evidence from studies using four levels: very low, low, moderate, or high. Very low quality evidence means that we are very uncertain about the results. High-quality evidence means that we are very confident in the results. We rated the evidence in the reviews as very low quality. | 10.1002/14651858.CD012592.pub2 | [
"In this overview of Cochrane Reviews we examined all the evidence on how well morphine-like drugs worked, mostly when taken by mouth or through a skin patch, how many people had side effects, and how severe or troublesome those side effects were — for example, whether they caused participants to stop taking their medicines. In May 2017, we found nine reviews with 152 included studies and 13,524 participants. The studies were often small, and compared many different preparations. They used different study designs and different ways of showing their pain results. Outcomes of importance to people with cancer pain were often not reported. For two drugs (morphine by mouth and fentanyl patches) more than 19 in 20 people had pain that went from moderate or severe before taking morphine-like drugs, to pain that was no worse than mild within 14 days if they can tolerate the side effects. Most people taking a morphine-like drug had at least one side effect. Only about 1 person in 10 to 2 people in 10 stopped taking it because of side effects. The most common side effects were constipation, and nausea and vomiting. At one level these are encouraging results, and generally agree with surveys of how well the WHO advice works in cancer pain. On another level, the quality of studies in the reviews was generally poor. We would like better study design, and especially better study reporting, which should include the outcome of pain reduced to a level where people with cancer can cope with it (no pain or mild pain). We found that the Cochrane Reviews were of high quality. We rated the quality of the evidence from studies using four levels: very low, low, moderate, or high. Very low quality evidence means that we are very uncertain about the results. High-quality evidence means that we are very confident in the results. We rated the evidence in the reviews as very low quality."
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cochrane-simplification-train-1615 | cochrane-simplification-train-1615 | We included three trials, all in women with type 1 diabetes (223 women and babies). All three trials were at high risk of bias due to lack of blinding, unclear methods of randomisation and selective reporting of outcomes. Two trials compared very tight (3.33 to 5.0 mmol/L fasting blood glucose (FBG)) with tight-moderate (4.45 to 6.38 mmol/L) glycaemic control targets, with one trial of 22 babies reporting no perinatal deaths orserious perinatal morbidity (evidence graded low for both outcomes). In the same trial, there were two congenital anomalies in the very tight, and none in the tight-moderate group, with no significant differences in caesarean section between groups (risk ratio (RR) 0.92, 95% confidence interval (CI) 0.49 to 1.73; evidence graded very low). In these two trials, glycaemic control was not significantly different between the very tight and tight-moderate groups by the third trimester, although one trial of 22 women found significantly less maternal hypoglycaemia in the tight-moderate group. In a trial of 60 women and babies comparing tight (≤ 5.6 mmol/L FBG); moderate (5.6 to 6.7 mmol/L); and loose (6.7 to 8.9 mmol/L) glycaemic control targets, there were two neonatal deaths in the loose and none in the tight or moderate groups (evidence graded very low). There were significantly fewer women with pre-eclampsia (evidence graded low), fewer caesarean sections (evidence graded low) and fewer babies with birthweights greater than 90th centile (evidence graded low) in the combined tight-moderate compared with the loose group. The quality of the evidence was graded low or very low for important outcomes, because of design limitations to the studies, the small numbers of women included, and wide confidence intervals crossing the line of no effect. Many of the important outcomes were not reported in these studies. In a very limited body of evidence, few differences in outcomes were seen between very tight and tight-moderate glycaemic control targets in pregnant women with pre-existing type 1 diabetes, including actual glycaemic control achieved. There is evidence of harm (increased pre-eclampsia, caesareans and birthweights greater than 90th centile) for 'loose' control (FBG above 7 mmol/L). Future trials comparing interventions, rather than glycaemic control targets, may be more feasible. Trials in pregnant women with pre-existing type 2 diabetes are required. | We found three small trials (in total 223 pregnant women with type 1 diabetes) looking at different blood glucose targets: very tight, tight, moderate, and loose. The quality of the studies and therefore the strength of the evidence was very low or low, so future research may change the results. There were very few differences between very tight and tight-moderate blood glucose targets in two trials, although there were more cases of low blood glucose (hypoglycaemia) and longer hospital stays for women who had very tight blood glucose control. A single trial compared tight, moderate, and loose blood glucose targets. In the loose target group, more women had pre-eclampsia, and there were more caesareans and large babies. There were few differences between the tight and moderate groups, although more women in the tight control group had low blood glucose in the first half of pregnancy. The evidence does not show much difference between moderate, tight and very tight blood glucose targets, although a loose blood glucose target may be worse for mothers and babies. However, the studies were small and the evidence is weak, so we do not yet know the best blood glucose target for women who have diabetes before becoming pregnant. | 10.1002/14651858.CD008540.pub4 | [
"We found three small trials (in total 223 pregnant women with type 1 diabetes) looking at different blood glucose targets: very tight, tight, moderate, and loose. The quality of the studies and therefore the strength of the evidence was very low or low, so future research may change the results. There were very few differences between very tight and tight-moderate blood glucose targets in two trials, although there were more cases of low blood glucose (hypoglycaemia) and longer hospital stays for women who had very tight blood glucose control. A single trial compared tight, moderate, and loose blood glucose targets. In the loose target group, more women had pre-eclampsia, and there were more caesareans and large babies. There were few differences between the tight and moderate groups, although more women in the tight control group had low blood glucose in the first half of pregnancy. The evidence does not show much difference between moderate, tight and very tight blood glucose targets, although a loose blood glucose target may be worse for mothers and babies. However, the studies were small and the evidence is weak, so we do not yet know the best blood glucose target for women who have diabetes before becoming pregnant."
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cochrane-simplification-train-1616 | cochrane-simplification-train-1616 | We included three randomised controlled trials (351 participants) investigating immediate versus delayed chemotherapy in people diagnosed with asymptomatic, metastatic, incurable colorectal cancer. Giving immediate versus delayed chemotherapy may make little or no difference to overall survival (hazard ratio (HR) 1.17, 95% confidence interval (CI) 0.93 to 1.46; 3 studies, 351 persons; low-quality evidence). For toxicity, giving immediate versus delayed chemotherapy may make little or no difference to the risk of grade 3 or 4 nausea and vomiting (risk ratio (RR) 0.84, 95% CI 0.31 to 2.25; 2 studies, 140 persons; very low-quality evidence), stomatitis (RR 1.10, 95% CI 0.47 to 2.55; 2 studies, 140 persons; very low-quality evidence), or diarrhoea (RR 0.69, 95% CI 0.34 to 1.40; 2 studies, 140 persons, very low-quality evidence). We are uncertain whether delayed chemotherapy made a difference to quality of life (very low-quality evidence), progression-free survival (low-quality evidence), or compliance with chemotherapy (low-quality evidence), as we had insufficient data to pool for these outcomes. Based on a limited number of trials, very sparse data, and uncertainty of the evidence, this review was unable to establish whether there was a difference in overall survival or other clinically relevant outcomes, between immediate or delayed chemotherapy in persons with metastatic, incurable, colorectal cancer. The results should be interpreted with caution. | We included three randomised clinical trials. In these trials, people with metastatic and incurable colorectal cancer, without symptoms, received chemotherapy straight away (standard group) or their chemotherapy was delayed (intervention group). There were a total of 176 participants In the standard groups and 175 in the intervention groups. The available data allowed us to complete analyses for overall survival and toxicities. Participants with metastatic, incurable colorectal cancer without symptoms, who received chemotherapy straight away, did not live longer than those whose chemotherapy was delayed until symptoms appeared. For toxicities measures, our findings were inconclusive due to sparse data from only two trials and few participants. There were insufficient data to compare other outcomes of interest, such as quality of life, progression-free survival (the length of time during and after treatment that a person lives with the disease, but it does not get worse), and compliance with chemotherapy (whether a participant was able to complete the chemotherapy regimen). Based on very sparse data and uncertainty of the evidence, we were unable to establish whether there was a difference in overall survival and other important outcomes in people with metastatic, incurable, colorectal cancer, who received chemotherapy either straight away or waited until after symptoms had appeared. | 10.1002/14651858.CD012326.pub2 | [
"We included three randomised clinical trials. In these trials, people with metastatic and incurable colorectal cancer, without symptoms, received chemotherapy straight away (standard group) or their chemotherapy was delayed (intervention group). There were a total of 176 participants In the standard groups and 175 in the intervention groups. The available data allowed us to complete analyses for overall survival and toxicities. Participants with metastatic, incurable colorectal cancer without symptoms, who received chemotherapy straight away, did not live longer than those whose chemotherapy was delayed until symptoms appeared. For toxicities measures, our findings were inconclusive due to sparse data from only two trials and few participants. There were insufficient data to compare other outcomes of interest, such as quality of life, progression-free survival (the length of time during and after treatment that a person lives with the disease, but it does not get worse), and compliance with chemotherapy (whether a participant was able to complete the chemotherapy regimen). Based on very sparse data and uncertainty of the evidence, we were unable to establish whether there was a difference in overall survival and other important outcomes in people with metastatic, incurable, colorectal cancer, who received chemotherapy either straight away or waited until after symptoms had appeared."
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cochrane-simplification-train-1617 | cochrane-simplification-train-1617 | Of 2029 screened records, we included seven studies in the review and six in the meta-analysis. Risk of bias varied: the randomisation and allocation process was often not clearly described, five of seven studies were double-blind and there was almost no missing data. The quality of the evidence for mortality was high. Risk ratios for overall mortality for adjunctive corticosteroids were 0.56 (95% confidence interval (CI) 0.32 to 0.98) at one month and 0.59 (95% CI 0.41 to 0.85) at three to four months of follow-up. In adults, to prevent one death, numbers needed to treat are nine patients in a setting without highly active antiretroviral therapy (HAART) available, and 23 patients with HAART available. The three largest trials provided moderate quality data on the need for mechanical ventilation, with a risk ratio of 0.38 (95% CI 0.20 to 0.73) in favour of adjunctive corticosteroids. One study was conducted in infants, suggesting a risk ratio for death in hospital of 0.81 (95% CI 0.51 to 1.29; moderate quality evidence). The number and size of trials investigating adjunctive corticosteroids for HIV-infected patients with PCP is small, but the evidence from this review suggests a beneficial effect for adult patients with substantial hypoxaemia. There is insufficient evidence on the effect of adjunctive corticosteroids on survival in infants. | The number and size of the trials investigating adjunctive corticosteroids for HIV-infected patients co-infected with PCP is small (the six trials included in the meta-analysis comprised 242 individuals in the intervention groups and 247 individuals in the control groups; the trial on infants comprised 47 individuals in the intervention group and 53 in the control group). Follow-up ranged from three to 14 months. The evidence from this review was of high quality for mortality and of moderate quality for need for mechanical ventilation and suggests a beneficial effect for adult patients with substantial hypoxaemia. For infants (18 months or younger) with HIV and suspected PCP there is insufficient evidence on whether the effect of adjunctive corticosteroids could improve survival (the confidence interval for the estimate of effect is wide, includes both clinically relevant benefit and harm and is of moderate quality). | 10.1002/14651858.CD006150.pub2 | [
"The number and size of the trials investigating adjunctive corticosteroids for HIV-infected patients co-infected with PCP is small (the six trials included in the meta-analysis comprised 242 individuals in the intervention groups and 247 individuals in the control groups; the trial on infants comprised 47 individuals in the intervention group and 53 in the control group). Follow-up ranged from three to 14 months. The evidence from this review was of high quality for mortality and of moderate quality for need for mechanical ventilation and suggests a beneficial effect for adult patients with substantial hypoxaemia. For infants (18 months or younger) with HIV and suspected PCP there is insufficient evidence on whether the effect of adjunctive corticosteroids could improve survival (the confidence interval for the estimate of effect is wide, includes both clinically relevant benefit and harm and is of moderate quality)."
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cochrane-simplification-train-1618 | cochrane-simplification-train-1618 | The searches identified 104 trial reports which represented 51 trials, of which three cross-over trials (providing data on 77 participants) met our inclusion criteria. We present three comparisons: inhalation before versus during airway clearance techniques; inhalation before versus after airway clearance techniques; and inhalation during versus after airway clearance techniques. One trial (50 participants), given its three-arm design, was eligible for all three comparisons. No trials compared morning versus evening inhalation of hypertonic saline. The evidence from the three trials was judged to be of low quality downgraded for limitations (high risk of bias due to blinding) and indirectness (all participants are adults, and therefore not applicable to children). Intervention periods ranged from one treatment to three treatments in one day. There were no clinically important differences between the timing regimens of inhaling hypertonic saline before, during or after airway clearance techniques in the mean amount of improvement in lung function or symptom scores (77 participants), with the between-group comparisons being non-significant (low-certainty evidence). While there may be little or no difference in the rating of satisfaction when hypertonic saline was inhaled before versus during the airway clearance techniques (64 participants) (with the 95% confidence interval including the possibility of both a higher and lower rating of satisfaction), satisfaction may be lower on a 100-mm scale when inhaled after the airway clearance techniques compared to before: mean difference (MD) 20.38 mm (95% confidence interval (CI) 12.10 to 28.66) and when compared to during the techniques, MD 14.80 mm (95% CI 5.70 to 23.90). Perceived effectiveness showed similar results: little or no difference for inhalation before versus during airway clearance techniques (64 participants); may be lower when inhaled after the airway clearance techniques compared to before, MD 10.62 (95% CI 2.54 to 18.70); and also when compared to during the techniques, MD 15.60 (95% CI 7.55 to 23.65). There were no quality of life or adverse events reported in any of the trials. Timing of hypertonic saline inhalation makes little or no difference to lung function (low-certainty evidence). However, inhaling hypertonic saline before or during airway clearance techniques may maximise perceived efficacy and satisfaction. The long-term efficacy of hypertonic saline has only been established for twice-daily inhalations; however, if only one dose per day is tolerated, the time of day at which it is inhaled could be based on convenience or tolerability until evidence comparing these regimens is available. The identified trials were all of very short intervention periods, so longer-term research could be conducted to establish the effects arising from regular use, which would incorporate the influence of changes in adherence with long-term use, as well as generating data on any adverse effects that occur with long-term use. | The review included three studies with 77 people with cystic fibrosis aged between 18 and 64 years of age. The studies looked at the impact of the timing of hypertonic saline inhalation in relation to airway clearance techniques. The studies reported immediate outcomes after inhalation of hypertonic saline before, during or after physical airway clearance techniques. All studies were short, involving only one to three treatments of each timing regimen. While outcomes such as lung function did not show any difference between the regimens, people with cystic fibrosis perceived that inhaling hypertonic saline before or during airway clearance techniques may be more effective and satisfying than inhaling hypertonic saline after airway clearance. No studies comparing morning and evening inhalation were found. The long-term efficacy of hypertonic saline has only been established for twice-daily inhalations; however, if only one dose per day is tolerated, the time of day at which it is inhaled could be based on convenience or tolerability until further evidence is available. Overall, the quality of the evidence was low. The only issues perhaps affecting the quality related to the fact that it was not possible for participants to be blinded to the treatment they received. However, because the studies were short-term and most of the significant results were based on perceived efficacy, timing of administration of hypertonic saline needs further study. | 10.1002/14651858.CD008816.pub4 | [
"The review included three studies with 77 people with cystic fibrosis aged between 18 and 64 years of age. The studies looked at the impact of the timing of hypertonic saline inhalation in relation to airway clearance techniques. The studies reported immediate outcomes after inhalation of hypertonic saline before, during or after physical airway clearance techniques. All studies were short, involving only one to three treatments of each timing regimen. While outcomes such as lung function did not show any difference between the regimens, people with cystic fibrosis perceived that inhaling hypertonic saline before or during airway clearance techniques may be more effective and satisfying than inhaling hypertonic saline after airway clearance. No studies comparing morning and evening inhalation were found. The long-term efficacy of hypertonic saline has only been established for twice-daily inhalations; however, if only one dose per day is tolerated, the time of day at which it is inhaled could be based on convenience or tolerability until further evidence is available. Overall, the quality of the evidence was low. The only issues perhaps affecting the quality related to the fact that it was not possible for participants to be blinded to the treatment they received. However, because the studies were short-term and most of the significant results were based on perceived efficacy, timing of administration of hypertonic saline needs further study."
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cochrane-simplification-train-1619 | cochrane-simplification-train-1619 | We included seven trials with a total of 435 participants. Three trials focused on Physalia (Bluebottle) jellyfish, one trial on Carukia jellyfish and three on Carybdea alata (Hawaiian box) jellyfish. Two ongoing trials were identified. Six of the seven trials were judged as having high risk of bias. Blinding was not feasible in four of the included trials because of the nature of the interventions. A wide range of interventions were assessed across trials, and a wide range of outcomes were measured. We reported results from the two trials for which data were available and reported the effects of interventions according to our definition of primary or secondary outcomes. Hot water immersion was superior to ice packs in achieving clinically significant (at least 50%) pain relief at 10 minutes (one trial, 96 participants, risk ratio (RR) 1.66, 95% confidence interval (CI) 1.01 to 2.72; low-quality evidence) and 20 minutes (one trial, 88 participants, RR 2.66, 95% CI 1.71 to 4.15; low-quality evidence). No statistically significant differences between hot water immersion and ice packs were demonstrated for dermatological outcomes. Treatment with vinegar or Adolph's meat tenderizer compared with hot water made skin appear worse (one trial, 25 participants, RR 0.31, 95% CI 0.14 to 0.72; low-quality evidence). Adverse events due to treatment were not reported in any trial. This review located a small number of trials that assessed a variety of different interventions applied in different ways and in different settings. Although heat appears to be an effective treatment for Physalia (Bluebottle) stings, this evidence is based on a single trial of low-quality evidence. It is still unclear what type of application, temperature, duration of treatment and type of water (salt or fresh) constitute the most effective treatment. In addition, these results may not apply to other species of jellyfish with different envenomation characteristics. Future research should further assess the most effective interventions using standardised research methodology. | This review identified seven trials on the treatment of jellyfish stings primarily involving two jellyfish species—Physalia (Bluebottle) and Carybdea alata (Hawaiian box) jellyfish—as well as two trials that are in progress. Many different types of treatments were tested in these trials. Large variation was observed between the duration of treatment among trials. Evidence of limited quality from a single study suggested that hot water immersion relieved pain. This evidence may not apply to other species of jellyfish because of large variability in the effects of stings. Further research should be conducted to help practitioners better understand the most effective treatments for jellyfish stings. | 10.1002/14651858.CD009688.pub2 | [
"This review identified seven trials on the treatment of jellyfish stings primarily involving two jellyfish species—Physalia (Bluebottle) and Carybdea alata (Hawaiian box) jellyfish—as well as two trials that are in progress. Many different types of treatments were tested in these trials. Large variation was observed between the duration of treatment among trials. Evidence of limited quality from a single study suggested that hot water immersion relieved pain. This evidence may not apply to other species of jellyfish because of large variability in the effects of stings. Further research should be conducted to help practitioners better understand the most effective treatments for jellyfish stings."
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cochrane-simplification-train-1620 | cochrane-simplification-train-1620 | We included 51 RCTs with 2793 participants; of these 45 RCTs (2491 participants: peripheral nerve block = 1288; comparators = 1203) were included in meta-analyses. There are 11 ongoing studies and three awaiting classification. Compared to systemic analgesia alone, peripheral nerve blocks reduced: pain at rest on arrival in the postoperative care unit (SMD -1.12, 95% CI -1.67 to -0.56; 9 trials, 429 participants; equivalent to 3.2 on 0 to 10 scale; moderate-quality evidence); risk of acute confusional status: risk ratio (RR) 0.10 95% CI 0.02 to 0.54; 1 trial, 225 participants; number needed to treat for additional benefit (NNTB) 12, 95% CI 11 to 22; very low-quality evidence); pruritus (RR 0.16, 95% CI 0.04 to 0.70; 2 trials, 259 participants for continuous peripheral nerve blocks; NNTB 4 (95% CI 4 to 8); very low-quality evidence); hospital length of stay (SMD -0.75, 95% CI -1.02 to -0.48; very low-quality evidence; 2 trials, 249 participants; equivalent to 0.75 day). Participant satisfaction increased (SMD 0.67, 95% CI 0.45 to 0.89; low-quality evidence; 5 trials, 363 participants; equivalent to 2.4 on 0 to 10 scale). We did not find a difference for the number of participants walking on postoperative day one (very low-quality evidence). Two nerve block-related complications were reported: one local haematoma and one delayed persistent paresis. Compared to neuraxial blocks, peripheral nerve blocks reduced the risk of pruritus (RR 0.33, 95% CI 0.19 to 0.58; 6 trials, 299 participants; moderate-quality evidence; NNTB 6 (95% CI 5 to 9). We did not find a difference for pain at rest on arrival in the postoperative care unit (moderate-quality evidence); number of nerve block-related complications (low-quality evidence); acute confusional status (very low-quality evidence); hospital length of stay (low quality-evidence); time to first walk (low-quality evidence); or participant satisfaction (high-quality evidence). We found that peripheral nerve blocks provide better pain control compared to systemic analgesia with no major differences between peripheral nerve blocks and neuraxial blocks. We also found that peripheral nerve blocks may be associated with reduced risk of postoperative acute confusional state and a modest reduction in hospital length of stay that could be meaningful in terms of cost reduction considering the increasing numbers of procedures performed annually. Compared to systemic analgesia alone, there is moderate-quality evidence that peripheral nerve blocks reduce postoperative pain, low-quality evidence that patient satisfaction is increased and very low-quality evidence for reductions in acute confusional status, pruritus and hospital length of stay . We found moderate-quality evidence that peripheral nerve blocks reduce pruritus compared with neuraxial blocks. The 11 ongoing studies, once completed, and the three studies awaiting classification may alter the conclusions of the review once assessed | We included 51 studies (2793 participants) in the review and analysed results from 45 studies (2491 participants). There are 11 ongoing studies and three awaiting classification. Funding sources included governments, charities, institutions, industry (in part, n = 1); over half were unspecified (n = 29). Compared to systemic analgesia, we found that peripheral nerve blocks reduce pain, reduce the risk of becoming confused (e.g. not knowing the date, time, or location) (for every 12 people treated one fewer will become confused), reduce itching (for every 4 people treated one fewer will develop itch), hospital length of stay (equivalent to 0.75 day) and increase patient satisfaction for pain treatment (equivalent to 2.4 points more on a 0 to 10 scale). We did not find a difference in time to first walk after surgery. Two people had complications: one local haematoma and one delayed persistent muscle weakness. The quality of evidence for peripheral nerve blocks compared with systemic pain relievers was rated as moderate to very low. The quality of evidence for peripheral nerve blocks compared to neuraxial blocks was rated as high for patient satisfaction, moderate for reducing itch, similar pain relief, low for similar block-related complications, hospital length of stay and time to first walk. Evidence for confusion was assessed as very low quality. Evidence quality was downgraded to low or very low due to flawed study designs and limited numbers of trials and participants. | 10.1002/14651858.CD011608.pub2 | [
"We included 51 studies (2793 participants) in the review and analysed results from 45 studies (2491 participants). There are 11 ongoing studies and three awaiting classification. Funding sources included governments, charities, institutions, industry (in part, n = 1); over half were unspecified (n = 29). Compared to systemic analgesia, we found that peripheral nerve blocks reduce pain, reduce the risk of becoming confused (e.g. not knowing the date, time, or location) (for every 12 people treated one fewer will become confused), reduce itching (for every 4 people treated one fewer will develop itch), hospital length of stay (equivalent to 0.75 day) and increase patient satisfaction for pain treatment (equivalent to 2.4 points more on a 0 to 10 scale). We did not find a difference in time to first walk after surgery. Two people had complications: one local haematoma and one delayed persistent muscle weakness. The quality of evidence for peripheral nerve blocks compared with systemic pain relievers was rated as moderate to very low. The quality of evidence for peripheral nerve blocks compared to neuraxial blocks was rated as high for patient satisfaction, moderate for reducing itch, similar pain relief, low for similar block-related complications, hospital length of stay and time to first walk. Evidence for confusion was assessed as very low quality. Evidence quality was downgraded to low or very low due to flawed study designs and limited numbers of trials and participants."
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cochrane-simplification-train-1621 | cochrane-simplification-train-1621 | We included 10 trials (six randomised and four quasi-randomised) involving a total of 527 children (531 fractures). All trials were at some risk of bias, including performance bias as care provider blinding was not practical, but to a differing extent. Just one trial was at low risk of selection bias. Reflecting both the risk of bias and the imprecision of findings, we judged the quality of evidence to be 'low' for most outcomes, meaning that we are unsure about the estimates of effect. Most trials failed to report on self-assessed function or when children resumed their usual activities. The trials evaluated 10 different comparisons, belonging to three main categories. Surgical versus conservative treatment Four trials presenting data for 264 children aged 4 to 12 years made this comparison. Low quality evidence (one trial, 101 children) showed children had very similar function assessed using the RAND health status score at two years after surgery (external fixation) compared with conservative treatment (spica cast): mean 69 versus 68. The other three trials did not report on function. There was moderate quality evidence (four trials, 264 children, aged 4 to 12 years, followed up 3 to 24 months) that surgery reduced the risk of malunion (risk ratio (RR) 0.29, 95% confidence interval (CI) 0.15 to 0.59, 4 trials). Assuming an illustrative baseline risk of 115 malunions per 1000 in children treated conservatively, these data equate to 81 fewer (95% CI 47 to 97 fewer) malunions per 1000 in surgically-treated children. Conversely, low quality evidence indicated that there were more serious adverse events such as infections after surgery (RR 2.39, 95% CI 1.10 to 5.17, 4 trials). Assuming an illustrative baseline risk of 40 serious adverse events per 1000 for conservative treatment, these data equate to 56 more (95% CI 4 to 167 more) serious adverse events per 1000 children treated surgically. There was low quality evidence (one trial, 101 children) of similar satisfaction levels in children and parents with surgery involving external fixation and plaster cast only. However, there was low quality evidence (one trial, 46 children) that more parents were satisfied with intramedullary nailing than with traction followed by a cast, and that surgery reduced the time taken off from school. Comparisons of different methods of conservative treatment The three trials in this category made three different comparisons. We are very unsure if unacceptable malunion rates differ between immediate hip spica versus skeletal traction followed by spica in children aged 3 to 10 years followed up for six to eight weeks (RR 4.0, 95% CI 0.5 to 32.9; one trial, 42 children; very low quality evidence). Malunion rates at 5 to 10 years may not differ between traction followed by functional orthosis versus traction followed by spica cast in children aged 5 to 13 years (RR 0.98, 95% CI 0.46 to 2.12; one trial, 43 children; low quality evidence). We are very unsure (very low quality evidence) if either function or serious adverse events (zero events reported) differ between single-leg versus double-leg spica casts (one trial, 52 young children aged two to seven years). Low quality evidence on the same comparison indicates that single-leg casts are less awkward to manage by parents, more comfortable for the child and may require less time off work by the caregiver. Comparisons of different methods of surgical treatment The three trials in this category made three different comparisons. Very low quality evidence means that we are very unsure if the rates of malunion, serious adverse events, time to return to school or parental satisfaction actually differ in children whose fractures were fixed using elastic stable intramedullary nailing or external fixation (one trial, 19 children). The same applies to the rates of serious adverse events and time to resume full weight-bearing in children treated with dynamic versus static external fixation (one trial, 52 children). Very low quality evidence (one trial, 47 children) means that we do not know if malunion, serious adverse events and time to resume weight-bearing actually differ between intramedullary nailing versus submuscular plating. However, there could be more difficulties in plate removal subsequently. There is insufficient evidence to determine if long-term function differs between surgical and conservative treatment. Surgery results in lower rates of malunion in children aged 4 to 12 years, but may increase the risk of serious adverse events. Elastic stable intramedullary nailing may reduce recovery time. There is insufficient evidence from comparisons of different methods of conservative treatment or of different methods of surgical treatment to draw conclusions on the relative effects of the treatments compared in the included trials. | We searched for studies in the medical literature until August 2013. The review includes 10 randomised or quasi-randomised controlled trials that recruited 527 children. Four trials compared different surgical versus non-surgical treatments; three compared different methods of non-surgical treatment and three compared different methods of surgical treatment. Generally we are unsure about the results of these trials because some were at risk of bias, some results were contradictory and usually there was too little evidence to rule out chance findings. Most trials failed to report on self-assessed function or when children resumed their usual activities. Comparing surgical versus non-surgical treatment Low quality evidence (one trial, 101 children) showed children had similar function at two years after having surgery, involving external fixation, compared with those treated with a plaster cast. The other three trials did not report this outcome. There was moderate quality evidence (four trials, 264 children, aged 4 to 12 years, followed up for 3 to 24 months) that surgery reduced the risk of malunion (the leg is deformed) compared with non-surgical treatment. However, low quality evidence (four trials) indicated that there were more serious adverse events such as infections after surgery. There was low quality evidence (one trial, 101 children) of similar satisfaction levels in children and parents with surgery involving external fixation and plaster cast only. However, there was low quality evidence (one trial, 46 children) that more parents were satisfied with surgery involving an internal nail than with traction followed by a cast and that surgery reduced the time taken off from school. Comparing various non-surgical treatments Very low quality evidence means that we are very unsure if the rates of malunion differ or not between children treated with immediate plaster casts versus with traction followed by plaster cast (one trial, 42 children), or between children treated with traction followed by either a functional orthosis (a brace or cast that allows some movement) or a cast (one trial, 43 children). We are very unsure if either function or serious adverse events differ between young children (aged two to seven years) immobilised in single-leg versus double-leg casts (one trial, 52 children). However, single-leg casts appear to be easier to manage by parents and more comfortable for the child. Comparing various surgical treatments Very low quality evidence means that we are very unsure if the rates of malunion, serious adverse events, time to return to school or parental satisfaction actually differ in children whose fractures were fixed using internal nails or external fixation (one trial, 19 children). The same applies to the rates of serious adverse events and time to resume full weight-bearing in children treated with dynamic (less rigid) versus static external fixation (one trial, 52 children). Very low quality evidence (one trial, 47 children) means that we do not know if malunion, serious adverse events and time to resume weight-bearing actually differ between intramedullary nailing versus submuscular plating. However, there could be more difficulties in plate removal subsequently. Conclusions This review found insufficient evidence to determine if long-term function differs between surgical and conservative treatment of thigh bone fractures in children aged 4 to 12 years. It found surgery resulted in lower rates of malunion but increased the risk of serious adverse events, such as infections. It found internal nailing may speed up recovery. The review found there was insufficient evidence from comparisons of different methods of non-surgical treatment to clearly show that any type of non-surgical treatment is better than any other. The same conclusion applies to comparisons of different methods of surgical treatment. | 10.1002/14651858.CD009076.pub2 | [
"We searched for studies in the medical literature until August 2013. The review includes 10 randomised or quasi-randomised controlled trials that recruited 527 children. Four trials compared different surgical versus non-surgical treatments; three compared different methods of non-surgical treatment and three compared different methods of surgical treatment. Generally we are unsure about the results of these trials because some were at risk of bias, some results were contradictory and usually there was too little evidence to rule out chance findings. Most trials failed to report on self-assessed function or when children resumed their usual activities. Comparing surgical versus non-surgical treatment Low quality evidence (one trial, 101 children) showed children had similar function at two years after having surgery, involving external fixation, compared with those treated with a plaster cast. The other three trials did not report this outcome. There was moderate quality evidence (four trials, 264 children, aged 4 to 12 years, followed up for 3 to 24 months) that surgery reduced the risk of malunion (the leg is deformed) compared with non-surgical treatment. However, low quality evidence (four trials) indicated that there were more serious adverse events such as infections after surgery. There was low quality evidence (one trial, 101 children) of similar satisfaction levels in children and parents with surgery involving external fixation and plaster cast only. However, there was low quality evidence (one trial, 46 children) that more parents were satisfied with surgery involving an internal nail than with traction followed by a cast and that surgery reduced the time taken off from school. Comparing various non-surgical treatments Very low quality evidence means that we are very unsure if the rates of malunion differ or not between children treated with immediate plaster casts versus with traction followed by plaster cast (one trial, 42 children), or between children treated with traction followed by either a functional orthosis (a brace or cast that allows some movement) or a cast (one trial, 43 children). We are very unsure if either function or serious adverse events differ between young children (aged two to seven years) immobilised in single-leg versus double-leg casts (one trial, 52 children). However, single-leg casts appear to be easier to manage by parents and more comfortable for the child. Comparing various surgical treatments Very low quality evidence means that we are very unsure if the rates of malunion, serious adverse events, time to return to school or parental satisfaction actually differ in children whose fractures were fixed using internal nails or external fixation (one trial, 19 children). The same applies to the rates of serious adverse events and time to resume full weight-bearing in children treated with dynamic (less rigid) versus static external fixation (one trial, 52 children). Very low quality evidence (one trial, 47 children) means that we do not know if malunion, serious adverse events and time to resume weight-bearing actually differ between intramedullary nailing versus submuscular plating. However, there could be more difficulties in plate removal subsequently. Conclusions This review found insufficient evidence to determine if long-term function differs between surgical and conservative treatment of thigh bone fractures in children aged 4 to 12 years. It found surgery resulted in lower rates of malunion but increased the risk of serious adverse events, such as infections. It found internal nailing may speed up recovery. The review found there was insufficient evidence from comparisons of different methods of non-surgical treatment to clearly show that any type of non-surgical treatment is better than any other. The same conclusion applies to comparisons of different methods of surgical treatment."
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cochrane-simplification-train-1622 | cochrane-simplification-train-1622 | We included 17 RCTs with a total of 1496 participants. Apart from two trials, the trial participants were women identified as 'poor responders' to standard IVF protocols. The included trials compared either testosterone or DHEA treatment with placebo or no treatment. When DHEA was compared with placebo or no treatment, pre-treatment with DHEA was associated with higher rates of live birth or ongoing pregnancy (OR 1.88, 95% CI 1.30 to 2.71; eight RCTs, N = 878, I² statistic = 27%, moderate quality evidence). This suggests that in women with a 12% chance of live birth/ongoing pregnancy with placebo or no treatment, the live birth/ongoing pregnancy rate in women using DHEA will be between 15% and 26%. However, in a sensitivity analysis removing trials at high risk of performance bias, the effect size was reduced and no longer reached significance (OR 1.50, 95% CI 0.88 to 2.56; five RCTs, N = 306, I² statistic = 43%). There was no evidence of a difference in miscarriage rates (OR 0.58, 95% CI 0.29 to 1.17; eight RCTs, N = 950, I² statistic = 0%, moderate quality evidence). Multiple pregnancy data were available for five trials, with one multiple pregnancy in the DHEA group of one trial (OR 3.23, 95% CI 0.13 to 81.01; five RCTs, N = 267, very low quality evidence). When testosterone was compared with placebo or no treatment we found that pre-treatment with testosterone was associated with higher live birth rates (OR 2.60, 95% CI 1.30 to 5.20; four RCTs, N = 345, I² statistic = 0%, moderate evidence). This suggests that in women with an 8% chance of live birth with placebo or no treatment, the live birth rate in women using testosterone will be between 10% and 32%. On removal of studies at high risk of performance bias in a sensitivity analysis, the remaining study showed no evidence of a difference between the groups (OR 2.00, 95% CI 0.17 to 23.49; one RCT, N = 53). There was no evidence of a difference in miscarriage rates (OR 2.04, 95% CI 0.58 to 7.13; four RCTs, N = 345, I² = 0%, low quality evidence). Multiple pregnancy data were available for three trials, with four events in the testosterone group and one in the placebo/no treatment group (OR 3.09, 95% CI 0.48 to 19.98; three RCTs, N = 292, very low quality evidence). One study compared testosterone with estradiol and reported no evidence of a difference in live birth rates (OR 2.06, 95% CI 0.43 to 9.87; one RCT, N = 46, very low quality evidence) or miscarriage rates (OR 0.70, 95% CI 0.11 to 4.64; one RCT, N = 46, very low quality evidence). The quality of the evidence was moderate, the main limitations being lack of blinding in the included trials, inadequate reporting of study methods, and low event and sample sizes in some trials. In women identified as poor responders undergoing ART, pre-treatment with DHEA or testosterone may be associated with improved live birth rates. The overall quality of the evidence is moderate. There is insufficient evidence to draw any conclusions about the safety of either androgen. Definitive conclusions regarding the clinical role of either androgen awaits evidence from further well-designed studies. | This Cochrane review included 17 randomised controlled trials which compared treatment with the androgens DHEA or T with placebo or no treatment in a total of 1496 women, almost all of whom had been identified as 'poor responders' to standard assisted reproduction protocols. The main outcomes were live birth (defined as delivery of a live baby after 20 weeks gestation) or ongoing pregnancy rates, miscarriage, clinical pregnancy rates (fetal heartbeat confirmed on ultrasound) and multiple pregnancy rates. We examined the evidence published up to 12 March 2015. DHEA and T use may be associated with increased live birth rates. The evidence for the use of DHEA suggested that in women with a 12% chance of live birth with placebo or no treatment, the live birth rate in women using DHEA will be between 15% and 26%. The evidence for the use of T suggested that in women with an 8% chance of live birth with placebo or no treatment, the live birth rate in women using T will be between 10% and 32%. When we removed from the analyses the studies at high risk of bias, this increase was no longer present for DHEA or T. There is insufficient evidence to draw any conclusions about the safety of either androgen. The quality of the trials was moderate, and the main limitations were lack of blinding, inadequate reporting of study methods and small sample sizes in some included trials. | 10.1002/14651858.CD009749.pub2 | [
"This Cochrane review included 17 randomised controlled trials which compared treatment with the androgens DHEA or T with placebo or no treatment in a total of 1496 women, almost all of whom had been identified as 'poor responders' to standard assisted reproduction protocols. The main outcomes were live birth (defined as delivery of a live baby after 20 weeks gestation) or ongoing pregnancy rates, miscarriage, clinical pregnancy rates (fetal heartbeat confirmed on ultrasound) and multiple pregnancy rates. We examined the evidence published up to 12 March 2015. DHEA and T use may be associated with increased live birth rates. The evidence for the use of DHEA suggested that in women with a 12% chance of live birth with placebo or no treatment, the live birth rate in women using DHEA will be between 15% and 26%. The evidence for the use of T suggested that in women with an 8% chance of live birth with placebo or no treatment, the live birth rate in women using T will be between 10% and 32%. When we removed from the analyses the studies at high risk of bias, this increase was no longer present for DHEA or T. There is insufficient evidence to draw any conclusions about the safety of either androgen. The quality of the trials was moderate, and the main limitations were lack of blinding, inadequate reporting of study methods and small sample sizes in some included trials."
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cochrane-simplification-train-1623 | cochrane-simplification-train-1623 | We included four trials involving 543 women and their babies (but only data from 521 women and their babies is included in our analyses). Three of the four included studies had moderate to high risk of bias and one study was at low to moderate risk of bias. Babies born to women receiving management for borderline GDM (generally dietary counselling and metabolic monitoring) were less likely to be macrosomic (birthweight greater than 4000 g) (three trials, 438 infants, risk ratio (RR) 0.38, 95% confidence interval (CI) 0.19 to 0.74) or large-for-gestational (LGA) age (three trials, 438 infants, RR 0.37, 95% CI 0.20 to 0.66) when compared with those born to women in the routine care group. There were no significant differences in rates of caesarean section (three trials, 509 women, RR 0.93, 95% CI 0.68 to 1.27) and operative vaginal birth (one trial, 83 women, RR 1.37, 95% CI 0.20 to 9.27) between the two groups. This review found interventions including providing dietary advice and blood glucose level monitoring for women with pregnancy hyperglycaemia not meeting GDM and T2DM diagnostic criteria helped reduce the number of macrosomic and LGA babies without increasing caesarean section and operative vaginal birth rates. It is important to notice that the results of this review were based on four small randomised trials with moderate to high risk of bias without follow-up outcomes for both women and their babies. | This review found dietary advice or counselling and blood glucose level monitoring for women with borderline GDM helped reduce the number of macrosomic and LGA babies. A single trial found that the interventions led to more inductions of labour. The interventions did not increase the risk of caesarean sections, operative vaginal births or women's weight gain in pregnancy. These findings were based on four small randomised controlled trials (involving 543 women). The trials were of moderate to high risk of bias and only data from 521 women and their babies is included in our analyses. Until additional evidence from large well designed randomised trials becomes available, current evidence is insufficient to make conclusive recommendations for the management of women with pregnancy high blood glucose concentrations not meeting GDM (or type 2 diabetes) diagnostic criteria. | 10.1002/14651858.CD009037.pub2 | [
"This review found dietary advice or counselling and blood glucose level monitoring for women with borderline GDM helped reduce the number of macrosomic and LGA babies. A single trial found that the interventions led to more inductions of labour. The interventions did not increase the risk of caesarean sections, operative vaginal births or women's weight gain in pregnancy. These findings were based on four small randomised controlled trials (involving 543 women). The trials were of moderate to high risk of bias and only data from 521 women and their babies is included in our analyses. Until additional evidence from large well designed randomised trials becomes available, current evidence is insufficient to make conclusive recommendations for the management of women with pregnancy high blood glucose concentrations not meeting GDM (or type 2 diabetes) diagnostic criteria."
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cochrane-simplification-train-1624 | cochrane-simplification-train-1624 | We included nine studies with 994 participants in this update. Occupational therapy targeted towards activities of daily living after stroke increased performance scores (standardised mean difference (SMD) 0.17, 95% confidence interval (CI) 0.03 to 0.31, P = 0.02; 7 studies; 749 participants; low-quality evidence) and reduced the risk of poor outcome (death, deterioration or dependency in personal activities of daily living) (odds ratio (OR) 0.71, 95% CI 0.52 to 0.96; P = 0.03; 5 studies; 771 participants; low-quality evidence). We also found that those who received occupational therapy were more independent in extended activities of daily living (OR 0.22 (95% CI 0.07 to 0.37); P = 0.005; 5 studies; 665 participants; low-quality evidence). Occupational therapy did not influence mortality (OR: 1.02 (95% CI 0.65 to 1.61); P = 0.93; 8 studies; 950 participants), or reduce the combined odds of death and institutionalisation (OR 0.89 (95% CI 0.60 to 1.32); P = 0.55; 4 studies; 671 participants), or death and dependency (OR 0.89 (95% CI 0.64 to 1.23); P = 0.47; 4 trials; 659 participants). Occupational therapy did not improve mood or distress scores (OR 0.08 (95% CI -0.09 to 0.26); P = 0.35; 4 studies; 519 participants; low-quality evidence). There were insufficient data to determine the effects of occupational therapy on health-related quality of life. We found no studies of consenting carers prior to study participation and therefore there were no carer-related outcomes in our review. There were insufficient data to determine participants' and carers' satisfaction with services. Using GRADE, the quality of evidence was low. The major limitation was the number of studies at unclear risk of selection bias and an inevitable high risk of performance and detection bias, as both participants and occupational therapists could not be blinded to the intervention. In addition, there was a sparseness of data for our outcomes of interest and we downgraded the quality of our evidence for these reasons. We found low-quality evidence that occupational therapy targeted towards activities of daily living after stroke can improve performance in activities of daily living and reduce the risk of deterioration in these abilities. Because the included studies had methodological flaws, this research does not provide a reliable indication of the likely effect of occupational therapy for adults with stroke. | We found nine studies up to January 2017, involving 994 participants, that looked at the benefits of occupational therapy interventions for adults with stroke who had problems with activities of daily living. This is an update of the Cochrane review first published in 2006. We found that occupational therapy for people with stroke can improve their ability to carry out these daily activities and stop them deteriorating in those abilities. We found no evidence that occupational therapy reduced rates of death or the need to be cared for in an institution, or affected mood or distress of the participant. We did not collect data on carer-related outcomes or participant satisfaction with the service. There were few studies measuring our outcomes of interest and we judged the quality of the evidence to be of low-quality. Many of the studies did not report methods sufficiently clearly and it was not possible to mask the occupational therapy from the person giving or receiving the treatment; this could also have influenced the results in our studies. We did not have sufficient good-quality evidence to be certain of our results and we cannot be certain that future studies will not change these conclusions. | 10.1002/14651858.CD003585.pub3 | [
"We found nine studies up to January 2017, involving 994 participants, that looked at the benefits of occupational therapy interventions for adults with stroke who had problems with activities of daily living. This is an update of the Cochrane review first published in 2006. We found that occupational therapy for people with stroke can improve their ability to carry out these daily activities and stop them deteriorating in those abilities. We found no evidence that occupational therapy reduced rates of death or the need to be cared for in an institution, or affected mood or distress of the participant. We did not collect data on carer-related outcomes or participant satisfaction with the service. There were few studies measuring our outcomes of interest and we judged the quality of the evidence to be of low-quality. Many of the studies did not report methods sufficiently clearly and it was not possible to mask the occupational therapy from the person giving or receiving the treatment; this could also have influenced the results in our studies. We did not have sufficient good-quality evidence to be certain of our results and we cannot be certain that future studies will not change these conclusions."
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cochrane-simplification-train-1625 | cochrane-simplification-train-1625 | Thirty-six trials involving 1718 people met the inclusion criteria. Study quality was mixed. Compared with control, CPAP showed significant improvements in certain objective and subjective sleepiness, measures of quality of life and cognitive function (parallel-group studies: Epworth sleepiness scale (ESS) -3.83 units, 95% CI -4.57 to -3.09; crossover studies: ESS -1.84 units, 95% CI -2.57 to -1.11). Twenty-four hour systolic and diastolic blood pressures were lower with CPAP compared with control (parallel-group trials). Compared with oral appliances, CPAP significantly reduced the apnoea and hypopnoea index (crossover studies: -7.97 events/hr, 95% CI -9.56 to -6.38) and improved sleep efficiency (crossover studies: 2.31%, 95% CI 0.02 to 4.6) and minimum oxygen saturation (4.14%, 95% CI 3.25 to 5.03). Responders to both treatments expressed a strong preference for the oral appliance. However, participants were more likely to withdraw on OA than on CPAP therapy. CPAP is effective in reducing symptoms of sleepiness and improving quality of life measures in people with moderate and severe obstructive sleep apnoea (OSA). It is more effective than oral appliances in reducing respiratory disturbances in these people but subjective outcomes are more equivocal. Certain people tend to prefer oral appliances to CPAP where both are effective. This could be because they offer a more convenient way of controlling OSA. Short-term data indicate that CPAP leads to lower blood pressure than control. Long-term data are required for all outcomes in order to determine whether the initial benefits seen in short-term clinical trials persist. | We searched and reviewed all randomised controlled trials that had been undertaken to evaluate the benefit of CPAP in adult patients with sleep apnoea. Some of the trials had methodological flaws, although more recent studies have begun to use appropriate forms of control. The overall results demonstrate that in people with moderate to severe sleep apnoea CPAP can improve measures of sleepiness, quality of life and associated daytime sleepiness. CPAP leads to lower blood pressure compared with control, although the degree to which this is achieved may depend upon whether people start treatment with raised blood pressures. Oral appliances are also used to treat sleep apnoea but, whilst some people find them more convenient to use than CPAP, they do not appear to be as effective at keeping the airway open at night. Further good quality trials are needed to define who benefits, by how much and at what cost. Further trials are also needed to evaluate the effectiveness of CPAP in comparison to other interventions, particularly those targeted at obesity. | 10.1002/14651858.CD001106.pub3 | [
"We searched and reviewed all randomised controlled trials that had been undertaken to evaluate the benefit of CPAP in adult patients with sleep apnoea. Some of the trials had methodological flaws, although more recent studies have begun to use appropriate forms of control. The overall results demonstrate that in people with moderate to severe sleep apnoea CPAP can improve measures of sleepiness, quality of life and associated daytime sleepiness. CPAP leads to lower blood pressure compared with control, although the degree to which this is achieved may depend upon whether people start treatment with raised blood pressures. Oral appliances are also used to treat sleep apnoea but, whilst some people find them more convenient to use than CPAP, they do not appear to be as effective at keeping the airway open at night. Further good quality trials are needed to define who benefits, by how much and at what cost. Further trials are also needed to evaluate the effectiveness of CPAP in comparison to other interventions, particularly those targeted at obesity."
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cochrane-simplification-train-1626 | cochrane-simplification-train-1626 | Five trials randomised 201 participants (110 participants to subcutaneous rapid-acting insulin analogues and 91 to intravenous regular insulin). The criteria for DKA were consistent with the American Diabetes Association criteria for mild or moderate DKA. The underlying cause of DKA was mostly poor compliance with diabetes therapy. Most trials did not report on type of diabetes. Younger diabetic participants and children were underrepresented in our included trials (one trial only). Four trials evaluated the effects of the rapid-acting insulin analogue lispro, and one the effects of the rapid-acting insulin analogue aspart. The mean follow-up period as measured by mean hospital stay ranged between two and seven days. Overall, risk of bias of the evaluated trials was unclear in many domains and high for performance bias for the outcome measure time to resolution of DKA. No deaths were reported in the included trials (186 participants; 3 trials; moderate- (insulin lispro) to low-quality evidence (insulin aspart)). There was very low-quality evidence to evaluate the effects of subcutaneous insulin lispro versus intravenous regular insulin on the time to resolution of DKA: mean difference (MD) 0.2 h (95% CI -1.7 to 2.1); P = 0.81; 90 participants; 2 trials. In one trial involving children with DKA, the time to reach a glucose level of 250 mg/dL was similar between insulin lispro and intravenous regular insulin. There was very low-quality evidence to evaluate the effects of subcutaneous insulin aspart versus intravenous regular insulin on the time to resolution of DKA: MD -1 h (95% CI -3.2 to 1.2); P = 0.36; 30 participants; 1 trial. There was low-quality evidence to evaluate the effects of subcutaneous rapid-acting insulin analogues versus intravenous regular insulin on hypoglycaemic episodes: 6 of 80 insulin lispro-treated participants compared with 9 of 76 regular insulin-treated participants reported hypoglycaemic events; risk ratio (RR) 0.59 (95% CI 0.23 to 1.52); P = 0.28; 156 participants; 4 trials. For insulin aspart compared with regular insulin, RR for hypoglycaemic episodes was 1.00 (95% CI 0.07 to 14.55); P = 1.0; 30 participants; 1 trial; low-quality evidence. Socioeconomic effects as measured by length of mean hospital stay for insulin lispro compared with regular insulin showed a MD of -0.4 days (95% CI -1 to 0.2); P = 0.22; 90 participants; 2 trials; low-quality evidence and for insulin aspart compared with regular insulin 1.1 days (95% CI -3.3 to 1.1); P = 0.32; low-quality evidence. Data on morbidity were limited, but no specific events were reported for the comparison of insulin lispro with regular insulin. No trial reported on adverse events other than hypoglycaemic episodes, and no trial investigated patient satisfaction. Our review, which provided mainly data on adults, suggests on the basis of mostly low- to very low-quality evidence that there are neither advantages nor disadvantages when comparing the effects of subcutaneous rapid-acting insulin analogues versus intravenous regular insulin for treating mild or moderate DKA. | We found five randomised controlled trials (clinical studies where people are randomly put into one of two or more treatment groups) with a total of 201 participants. Most trials did not report on type of diabetes. Younger diabetic participants and children were underrepresented in our included trials (one trial only). Participants in four trials received treatment with insulin lispro, and one trial with 45 participants investigated insulin aspart. The average follow-up as measured by mean hospital stay ranged between two and seven days. The study authors termed the diabetic ketoacidosis being treated with insulin analogues or regular insulin as mild or moderate. This evidence is up to date as of October 2015. Our results are most relevant for adults with mild or moderate diabetic ketoacidosis due to undertreatment of diabetes. No deaths occurred. Time to resolution of diabetic ketoacidosis from the start of therapy did not differ substantially between the two insulin treatment schemes (approximately 11 hours). Hypoglycaemic (low blood sugar) episodes were comparable: 118 per 1000 participants for intravenous insulin compared with 70 per 1000 participants for subcutaneous insulin lispro (no statistically significant difference). The mean length of hospital stay also showed no marked differences. No trial reported on side effects other than hypoglycaemic episodes or investigated patient satisfaction. No serious events associated with diabetic ketoacidosis were seen during insulin lispro treatment. Our results were limited by mostly low- to very low-quality evidence, mainly because the number of included trials and participants was low. Further research is very likely to have an important impact on our findings. | 10.1002/14651858.CD011281.pub2 | [
"We found five randomised controlled trials (clinical studies where people are randomly put into one of two or more treatment groups) with a total of 201 participants. Most trials did not report on type of diabetes. Younger diabetic participants and children were underrepresented in our included trials (one trial only). Participants in four trials received treatment with insulin lispro, and one trial with 45 participants investigated insulin aspart. The average follow-up as measured by mean hospital stay ranged between two and seven days. The study authors termed the diabetic ketoacidosis being treated with insulin analogues or regular insulin as mild or moderate. This evidence is up to date as of October 2015. Our results are most relevant for adults with mild or moderate diabetic ketoacidosis due to undertreatment of diabetes. No deaths occurred. Time to resolution of diabetic ketoacidosis from the start of therapy did not differ substantially between the two insulin treatment schemes (approximately 11 hours). Hypoglycaemic (low blood sugar) episodes were comparable: 118 per 1000 participants for intravenous insulin compared with 70 per 1000 participants for subcutaneous insulin lispro (no statistically significant difference). The mean length of hospital stay also showed no marked differences. No trial reported on side effects other than hypoglycaemic episodes or investigated patient satisfaction. No serious events associated with diabetic ketoacidosis were seen during insulin lispro treatment. Our results were limited by mostly low- to very low-quality evidence, mainly because the number of included trials and participants was low. Further research is very likely to have an important impact on our findings."
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cochrane-simplification-train-1627 | cochrane-simplification-train-1627 | Eleven studies with a total of 404 participants (337 pemphigus vulgaris, 27 pemphigus foliaceus and 40 not specified ) were identified. The quality of included studies was not high, the majority of studies did not report allocation concealment, and power was limited by very small sample sizes. Interventions assessed included prednisolone dose regimen, pulsed dexamethasone, azathioprine, cyclophosphamide, cyclosporine, dapsone, mycophenolate, plasma exchange, topical epidermal growth factor and traditional Chinese medicine. Ten studies included participants with newly diagnosed or newly active recurrent disease, and one trial included participants in maintenance phase. There was sufficient data for 4 meta-analyses, each pooling results of two studies only. For the majority of interventions, results were inconclusive. We found some interventions to be superior for certain outcomes, although we were unable to conclude which treatments are superior overall. Mycophenolate was more effective in achieving disease control than azathioprine (1 study; n=40; RR 0.72; 95% CI 0.52 to 0.99, NNT 3.7). There was evidence of a steroid-sparing benefit of azathioprine (1 study; n=57; MWD -3919 mg prednisolone; 95% CI -6712 to -1126) and cyclophosphamide (1 study; n=54; MWD -3355 mg prednisolone; 95% CI -6144 to -566) compared to glucocorticoids alone. Topical epidermal growth factor decreased time to control (1 study; n=20; HR 2.35; 95% CI 1.62 to 3.41). There is inadequate information available at present to ascertain the optimal therapy for pemphigus vulgaris or pemphigus foliaceus. Further research is required, especially to assess the optimal glucocorticoid dose, the role of adjuvant immunosuppressive medications, and long-term adverse events to improve harm:benefit analyses. | This review included data from 11 clinical trials involving 404 participants. The studies had very small numbers of participants, so can provide only limited information. Ten different active treatments were studied, including prednisolone, pulsed oral dexamethasone, azathioprine, cyclophosphamide, cyclosporine, dapsone, mycophenolate, plasma exchange, topical epidermal growth factor and traditional Chinese medicine. This review found insufficient information to conclude which is the most effective and safest treatment plan. We found that mycophenolate mofetil appears to be more effective than azathioprine in controlling disease, although no difference was seen in remission. We found that taking azathioprine and cyclophosphamide decreased the amount of glucocorticoids required. Topical epidermal growth factor decreased time required for lesions to heal by 6 days (median). We found no difference in withdrawal due to adverse events in any study, although differing adverse event profiles were observed for each intervention. We were not able to conclude which treatments are superior overall. Multiple treatments are available for pemphigus vulgaris and pemphigus foliaceus and there is a variation in dosage plan and combination of drugs used, which makes choice of treatment schedule complex. In addition, response to treatment can vary between individuals. Treatments need to be chosen after careful consideration of the potential benefits and side effects, in the context of the individual's other medical conditions. This review found insufficient information to conclude which is the most effective and safest treatment regimen. Further studies are required to determine the optimal treatment regimen, especially to assess the optimal glucocorticoid dose, the role of adjuvant immunosuppressive medications, and long-term adverse events to improve harm:benefit analyses. | 10.1002/14651858.CD006263.pub2 | [
"This review included data from 11 clinical trials involving 404 participants. The studies had very small numbers of participants, so can provide only limited information. Ten different active treatments were studied, including prednisolone, pulsed oral dexamethasone, azathioprine, cyclophosphamide, cyclosporine, dapsone, mycophenolate, plasma exchange, topical epidermal growth factor and traditional Chinese medicine. This review found insufficient information to conclude which is the most effective and safest treatment plan. We found that mycophenolate mofetil appears to be more effective than azathioprine in controlling disease, although no difference was seen in remission. We found that taking azathioprine and cyclophosphamide decreased the amount of glucocorticoids required. Topical epidermal growth factor decreased time required for lesions to heal by 6 days (median). We found no difference in withdrawal due to adverse events in any study, although differing adverse event profiles were observed for each intervention. We were not able to conclude which treatments are superior overall. Multiple treatments are available for pemphigus vulgaris and pemphigus foliaceus and there is a variation in dosage plan and combination of drugs used, which makes choice of treatment schedule complex. In addition, response to treatment can vary between individuals. Treatments need to be chosen after careful consideration of the potential benefits and side effects, in the context of the individual's other medical conditions. This review found insufficient information to conclude which is the most effective and safest treatment regimen. Further studies are required to determine the optimal treatment regimen, especially to assess the optimal glucocorticoid dose, the role of adjuvant immunosuppressive medications, and long-term adverse events to improve harm:benefit analyses."
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cochrane-simplification-train-1628 | cochrane-simplification-train-1628 | Fourteen eligible trials, which recruited patients between 1974 and 2005, were identified, eight of which compared 'more' with 'less' chemotherapy. Results from these eight trials, including 1519 patients, showed that treatment consisting of 'more' chemotherapy was associated with longer overall survival (OS) (hazard ratio (HR) 0.86; 95% confidence intervals (CI) 0.77 to 0.96; P = 0.005) and with longer progression-free survival (PFS) (n = 1526; HR 0.82; 95% CI 0.74 to 0.90; P < 0.0001). However, serious acute toxicities were more common in women randomised to the more-intense chemotherapy regimens. There was no evidence to suggest that any particular doublet chemotherapy was better (or worse) than any other, or that any single-agent chemotherapy was better (or worse) than another; however, data for these two comparisons were limited. There were no comparative trials of chemotherapy with endocrine therapy or best supportive care alone. This review suggests that more-intense chemotherapy regimens may improve both OS and PFS for women with advanced or recurrent endometrial cancer. However, owing to inconsistencies between cytotoxic drug combinations that have been assessed in randomised trials to date, the optimum regimen has still to be defined. Future trials should aim to include measures of quality of life (QoL) and symptom control in addition to survival and progression outcomes. | Using more chemotherapy drugs in combination seems to help women with advanced or recurrent endometrial cancer to live for longer and to delay the cancer from spreading or getting worse. However, giving these extra drugs may cause more serious short-term side effects. We do not know what effect using more drugs has on long-term side effects, control of symptoms or quality of life because they were poorly studied in the individual trials included in this review. | 10.1002/14651858.CD003915.pub4 | [
"Using more chemotherapy drugs in combination seems to help women with advanced or recurrent endometrial cancer to live for longer and to delay the cancer from spreading or getting worse. However, giving these extra drugs may cause more serious short-term side effects. We do not know what effect using more drugs has on long-term side effects, control of symptoms or quality of life because they were poorly studied in the individual trials included in this review."
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cochrane-simplification-train-1629 | cochrane-simplification-train-1629 | Five trials involving 213 women were included. Behavioural intervention vs control: One trial of pain management training reported reduction in pain and symptoms compared to a control. Three trials of relaxation compared to control reported varied results, two trials showed no difference in symptom severity scores however one trial reported relaxation was effective for reducing symptoms in menstrual sufferers with spasmodic symptoms. Two trials reported less restriction in daily activities following treatment with either relaxation of pain management training compared to a control. One trial also reported less time absent from school following treatment wit pain management training compared to a control. Behavioural intervention vs other behavioural interventions: Three trials showed no difference between behavioural interventions for the outcome of improvement in symptoms. One trial showed that relaxation resulted in a decrease in the need for resting time compared to the relaxation and imagery. There is some evidence from five RCTs that behavioural interventions may be effective for dysmenorrhoea. However results should be viewed with caution as they varied greatly between trials due to inconsistency in the reporting of data, small trial size, poor methodological quality and age of the trials. | This review found that progressive muscle relaxation with or without imagery and relaxation may help with spasmodic (acute, cramping pain) symptoms of period pain. Also that pain management training and relaxation plus biofeedback may help with period pain in general. The results are not conclusive due to the small number of women in the trials and the poor methods used in some of the trials. | 10.1002/14651858.CD002248.pub3 | [
"This review found that progressive muscle relaxation with or without imagery and relaxation may help with spasmodic (acute, cramping pain) symptoms of period pain. Also that pain management training and relaxation plus biofeedback may help with period pain in general. The results are not conclusive due to the small number of women in the trials and the poor methods used in some of the trials."
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cochrane-simplification-train-1630 | cochrane-simplification-train-1630 | Five trials were included in this review, representing 924 randomised children with epilepsy, all under 16 years of age at randomisation, with a median follow-up of 5.6 years. No eligible trial evaluated adults or assessed mortality or status epilepticus as outcomes. The pooled risk ratio for seizure relapse after AED withdrawal was 1.34 (95% CI 1.13 to 1.59, P = 0.0007). Conforming to this estimate, the number needed to harm, that is expose an individual to a higher risk of seizure relapse because of early withdrawal of AED, is 8 (95% CI 5 to 20). Early discontinuation was associated with greater relapse rates in people with partial seizures with a pooled risk ratio of 1.51 (95% CI 0.97 to 2.35, P = 0.07). Absence type epilepsy showed a lower risk of relapse. Variables associated with higher risk of seizure relapse were abnormal EEG findings (pooled RR 1.44, 95% CI 1.13 to 1.83, P = 0.003), especially epileptiform activity (RR 2.58, 95% CI 2.03 to 3.28, P < 0.0001); epilepsy onset before 2 years or after 10 years of age; history of status epilepticus; intellectual disability (IQ < 70); and high seizure frequency before and during treatment. Gender and family history did not show any significant influence over seizure relapse. Overall, the included trials were classified as low or unclear risk of bias where methodological information was not reported and could not be provided by original study authors. There is evidence to support waiting for at least two seizure-free years before discontinuing AEDs in children, particularly if individuals have an abnormal EEG or partial seizures, or both. There is insufficient evidence to establish when to withdraw AEDs in children with generalised seizures. There is no evidence to guide the timing of withdrawal of AEDs in seizure-free adults. Further high-quality randomised controlled trials are needed, particularly recruiting adults and recruiting those with generalised seizure types, to identify the optimal timing of AED withdrawal and risk factors predictive of relapse. | We searched electronic databases in June 2014, adding to the research done in a previous version of this review. The same five trials were included in our analysis, comprising 924 epileptic children (all below 16 years old) who were randomly assigned to either early removal of AEDs (before completing two years without seizures); or late withdrawal of AEDs (after completing two years without seizures). Considering all evidence, we found that stopping AED intake before completing two years without seizures increases the risk of seizure relapse by around 34%. This percentage is increased if the child has partial seizures (if the electrical burst only involves a part of the brain, resulting mainly in localized symptoms); or an abnormal electroencephalogram (EEG) record (unusual patterns of electrical activity in the brain). Other factors that might be related to a higher relapse rate are: age below two years or above 10 years when epilepsy started; history of status epilepticus (convulsions longer than 30 minutes); an IQ lower than 70; and high frequency of seizures before and during treatment. Overall, the included trials provided a moderate quality of evidence. The review of trials found that there is evidence to support waiting at least two years or more seizure free before discontinuing AEDs in children, especially if they had partial seizures or abnormal EEG. There is not enough evidence to show the best time to withdraw antiepileptic drugs in adults with epilepsy who are free of seizures. There is not enough evidence that demonstrates the optimal time to remove antiepileptic drugs in people (children or adults) with generalised seizures (if the electrical discharges affect the whole brain, causing global symptoms). More research is needed, particularly involving adults and those with generalised seizure types. | 10.1002/14651858.CD001902.pub2 | [
"We searched electronic databases in June 2014, adding to the research done in a previous version of this review. The same five trials were included in our analysis, comprising 924 epileptic children (all below 16 years old) who were randomly assigned to either early removal of AEDs (before completing two years without seizures); or late withdrawal of AEDs (after completing two years without seizures). Considering all evidence, we found that stopping AED intake before completing two years without seizures increases the risk of seizure relapse by around 34%. This percentage is increased if the child has partial seizures (if the electrical burst only involves a part of the brain, resulting mainly in localized symptoms); or an abnormal electroencephalogram (EEG) record (unusual patterns of electrical activity in the brain). Other factors that might be related to a higher relapse rate are: age below two years or above 10 years when epilepsy started; history of status epilepticus (convulsions longer than 30 minutes); an IQ lower than 70; and high frequency of seizures before and during treatment. Overall, the included trials provided a moderate quality of evidence. The review of trials found that there is evidence to support waiting at least two years or more seizure free before discontinuing AEDs in children, especially if they had partial seizures or abnormal EEG. There is not enough evidence to show the best time to withdraw antiepileptic drugs in adults with epilepsy who are free of seizures. There is not enough evidence that demonstrates the optimal time to remove antiepileptic drugs in people (children or adults) with generalised seizures (if the electrical discharges affect the whole brain, causing global symptoms). More research is needed, particularly involving adults and those with generalised seizure types."
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cochrane-simplification-train-1631 | cochrane-simplification-train-1631 | Our search did not yield any trial investigating treatment of VVC in HIV positive women. Two trials dealing with prophylaxis were eligible for inclusion.One trial (n= 323) favoured the use of weekly Fluconazole as compared to placebo (RR 0.68; 95% CI 0.47 to 0.97). The second trial with three arms of comparison; Clotrimazole, Lactobacillus and Placebo gave no definitive results in preventing an episode of VVC. Clotrimazole against placebo (RR 0.49; 95% CI 0.22 to 1.09), Clotrimazole against lactobacillus (RR 1.11; 95% CI 0.45 to 2.76) and lactobacillus against placebo (RR 0.54 ;95% CI 0.26 to 1.13). Implications for practice No trials were found addressing treatment of VVC in HIV positive women.In comparison to placebo,Fluconazole was found to be an effective preventative intervention. However, the potential for resistant Candida organisms to develop might impact the feasibility of implementation. Direction of findings suggests that Clotrimazole and Lactobacillus improved the prophylactic outcomes when compared to placebo. Implications for research There is a need to evaluate drugs and drug regimens for VVC treatment and prophylaxis in HIV positive women through randomised clinical trials. Development of resistance to azoles remains under-studied and more work must be done in this area, so as to determine whether routine prophylaxis for VVC is at all needed or whether adequate ART would be sufficient to prevent recurrent VVC. The viral load in vaginal secretions with or without treatment or prophylaxis has not been studied, this is very relevant to the spread of HIV. | The search yielded two studies dealing with the preventive aspect of the condition. The first trial found weekly fluconazole significantly effective in preventing clinical episodes from occurring as compared to placebo. However,this regimen lead to emergence of species resistant to azoles. The second trial with three arms of comparison; Clotrimazole, Lactobacillus and placebo gave no definitive results in preventing an episode of VVC. Neither of the included studies investigated the effects of HAART(Highly Active Antiretroviral Therapy) or any other form of antiretroviral treatment on VVC nor did they explore difference in quality of life, viral shedding in vaginal secretions (infectivity) ,patient preference for route of administration or the cost. | 10.1002/14651858.CD008739.pub2 | [
"The search yielded two studies dealing with the preventive aspect of the condition. The first trial found weekly fluconazole significantly effective in preventing clinical episodes from occurring as compared to placebo. However,this regimen lead to emergence of species resistant to azoles. The second trial with three arms of comparison; Clotrimazole, Lactobacillus and placebo gave no definitive results in preventing an episode of VVC. Neither of the included studies investigated the effects of HAART(Highly Active Antiretroviral Therapy) or any other form of antiretroviral treatment on VVC nor did they explore difference in quality of life, viral shedding in vaginal secretions (infectivity) ,patient preference for route of administration or the cost."
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cochrane-simplification-train-1632 | cochrane-simplification-train-1632 | We included 15 studies with a total of 1326 women. All included studies compared a vasodilator versus placebo or no treatment. We judged most of these studies as having unclear risk of bias. Overall, the quality of evidence was low to moderate for most outcomes. The main limitations were imprecision due to low numbers of events and participants and risk of bias due to unclear methods of randomisation. Vasodilators probably make little or no difference in rates of live birth compared with placebo or no treatment (RR 1.18, 95% confidence interval (CI) 0.83 to 1.69; three RCTs; N = 350; I² = 0%; moderate-quality evidence) but probably increase overall rates of side effects including headache and tachycardia (RR 2.35, 95% CI 1.51 to 3.66; four RCTs; N = 418; I² = 0%; moderate-quality evidence). Evidence suggests that if 236 per 1000 women achieve live birth with placebo or no treatment, then between 196 and 398 per 1000 will do so with the use of vasodilators. Compared with placebo or no treatment, vasodilators may slightly improve clinical pregnancy rates (RR 1.45, 95% CI 1.19 to 1.77; 11 RCTs; N = 1054; I² = 6%; low-quality evidence). Vasodilators probably make little or no difference in rates of multiple gestation (RR 1.15, 95% CI 0.55 to 2.42; three RCTs; N = 370; I² = 0%; low-quality evidence), miscarriage (RR 0.83, 95% CI 0.37 to 1.86; three RCTs; N = 350; I² = 0%; low-quality evidence), or ectopic pregnancy (RR 1.48, 95% CI 0.25 to 8.69; two RCTs; N = 250; I² = 5%; low-quality evidence). All studies found benefit for endometrial thickening, but reported effects varied (I² = 92%) and ranged from a mean difference of 0.80 higher (95% CI 0.18 to 1.42) to 3.57 higher (95% CI 3.01 to 4.13) with very low-quality evidence, so we are uncertain how to interpret these results. Evidence was insufficient to show whether vasodilators increase the live birth rate in women undergoing fertility treatment. However, low-quality evidence suggests that vasodilators may slightly increase clinical pregnancy rates. Moderate-quality evidence shows that vasodilators increase overall side effects in comparison with placebo or no treatment. Adequately powered studies are needed so that each treatment can be evaluated more accurately. | We found 15 randomised controlled trials (a type of experiment in which people are randomly allocated to one or more treatment groups) that compared the use of vasodilators versus placebo or no treatment in a total of 1326 women undergoing fertility treatment. The evidence is current to October 2017. Only three of the included studies reported live birth rates. Overall, vasodilators probably make little or no difference in rates of live birth. Moderate-quality evidence shows that vasodilators probably increase overall rates of side effects (including headache and tachycardia (faster than normal heartbeat)) in comparison with placebo or no treatment. However, low-quality evidence suggests that vasodilators may increase the chance of becoming pregnant. The evidence is of low to moderate quality. More research is needed (one study is ongoing and will be incorporated into this review in a subsequent update). | 10.1002/14651858.CD010001.pub3 | [
"We found 15 randomised controlled trials (a type of experiment in which people are randomly allocated to one or more treatment groups) that compared the use of vasodilators versus placebo or no treatment in a total of 1326 women undergoing fertility treatment. The evidence is current to October 2017. Only three of the included studies reported live birth rates. Overall, vasodilators probably make little or no difference in rates of live birth. Moderate-quality evidence shows that vasodilators probably increase overall rates of side effects (including headache and tachycardia (faster than normal heartbeat)) in comparison with placebo or no treatment. However, low-quality evidence suggests that vasodilators may increase the chance of becoming pregnant. The evidence is of low to moderate quality. More research is needed (one study is ongoing and will be incorporated into this review in a subsequent update)."
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cochrane-simplification-train-1633 | cochrane-simplification-train-1633 | We found three RCTs involving 1815 men. Adjuvant RT following prostatectomy did not affect overall survival at 5 years (RD (risk difference) 0.00; 95% CI -0.03 to 0.03), but improved survival at 10 years (RD -0.11; 95% CI -0.20 to -0.02). Adjuvant RT did not improve prostate cancer-specific mortality at 5 years (RD -0.01; 95% CI -0.03 to 0.00). Adjuvant RT did not reduce metastatic disease at 5 years (RD -0.00; 95% CI -0.04 to 0.03), but reduced it at 10 years (RD -0.11; 95% CI -0.20 to -0.01). It improved local control at 5 and 10 years (RD -0.10; 95% CI -0.13 to -0.06 and RD -0.14; 95% CI -0.21 to -0.07, respectively), and biochemical progression-free survival at 5 years and 10 years (RD -0.16; 95% CI -0.21 to -0.11 and RD -0.29; 95% CI -0.39 to -0.19, respectively). There were no data for clinical disease-free survival. Adjuvant RT increased acute and late gastrointestinal toxicity [do you have the rd for this?], urinary stricture (RD 0.05; 95% CI 0.01 to 0.09) and incontinence (RD 0.04; 95% CI 0.01 to 0.08). It did not increase erectile dysfunction or degrade quality of life (RD 0.01; 95% CI -0.06 to -0.26), but with limited data. Adjuvant RT after RP improves overall survival and reduces the rate of distant metastases, but these effects are only evident with longer follow up. At 5 and 10 years it improves local control and reduces the risk of biochemical failure, although the latter is not a clinical endpoint. Moderate or severe acute and late toxicity is minimal. There is an increased risk of urinary stricture and incontinence, but no detriment to quality of life, based on limited data. Given that the majority of men who have undergone a RP have a longer life expectancy, radiotherapy should be considered for those with high-risk features following radical prostatectomy. The optimal timing is unclear. | One trial with longer follow up (more than 10 years) showed improved survival with adjuvant radiotherapy but this improvement did not exist at 5 years follow up. Radiotherapy reduced the number of men whose cancer spread to other parts of the body (metastases). We found that radiotherapy improved local control in the prostate bed and did reduce the risk of cancer recurring. Radiotherapy reduced the number of men with an abnormal PSA blood test, but the importance of this is uncertain. Radiotherapy does increase the risk of side effects, (mostly mild) affecting bladder and bowel function. It is not clear from these studies whether it is better to give radiotherapy immediately after surgery when these high risk features are present, or whether it would be just as good watching for a time, and only giving radiotherapy once the PSA blood test starts to rise. This is the subject of ongoing studies. Radiotherapy after radical prostatectomy should be considered if high risk features are present, but the optimal timing is unclear. | 10.1002/14651858.CD007234.pub2 | [
"One trial with longer follow up (more than 10 years) showed improved survival with adjuvant radiotherapy but this improvement did not exist at 5 years follow up. Radiotherapy reduced the number of men whose cancer spread to other parts of the body (metastases). We found that radiotherapy improved local control in the prostate bed and did reduce the risk of cancer recurring. Radiotherapy reduced the number of men with an abnormal PSA blood test, but the importance of this is uncertain. Radiotherapy does increase the risk of side effects, (mostly mild) affecting bladder and bowel function. It is not clear from these studies whether it is better to give radiotherapy immediately after surgery when these high risk features are present, or whether it would be just as good watching for a time, and only giving radiotherapy once the PSA blood test starts to rise. This is the subject of ongoing studies. Radiotherapy after radical prostatectomy should be considered if high risk features are present, but the optimal timing is unclear."
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cochrane-simplification-train-1634 | cochrane-simplification-train-1634 | We included 43 studies with 6617 participants that evaluated the impact of an eHealth intervention in people with CKD. Included studies were heterogeneous in terms of eHealth modalities employed, type of intervention, CKD population studied and outcomes assessed. The majority of studies (39 studies) were conducted in an adult population, with 16 studies (37%) conducted in those on dialysis, 11 studies (26%) in the pre-dialysis population, 15 studies (35%) in transplant recipients and 1 studies (2%) in transplant candidates We identified six different eHealth modalities including: Telehealth; mobile or tablet application; text or email messages; electronic monitors; internet/websites; and video or DVD. Three studies used a combination of eHealth interventions. Interventions were categorised into six types: educational; reminder systems; self-monitoring; behavioural counselling; clinical decision-aid; and mixed intervention types. We identified 98 outcomes, which were categorised into nine domains: blood pressure (9 studies); biochemical parameters (6 studies); clinical end-points (16 studies); dietary intake (3 studies); quality of life (9 studies); medication adherence (10 studies); behaviour (7 studies); physical activity (1 study); and cost-effectiveness (7 studies). Only three outcomes could be meta-analysed as there was substantial heterogeneity with respect to study population and eHealth modalities utilised. There was found to be a reduction in interdialytic weight gain of 0.13kg (4 studies, 335 participants: MD -0.13, 95% CI -0.28 to 0.01; I2 = 0%) and a reduction in dietary sodium intake of 197 mg/day (2 studies, 181 participants: MD -197, 95% CI -540.7 to 146.8; I2 = 0%). Both dietary sodium and fluid management outcomes were graded as being of low evidence due to high or unclear risk of bias and indirectness (interdialytic weight gain) and high or unclear risk of bias and imprecision (dietary sodium intake). Three studies reported death (2799 participants, 146 events), with 45 deaths/1000 cases compared to standard care of 61 deaths/1000 cases (RR 0.74, CI 0.53 to 1.03; P = 0.08). We are uncertain whether using eHealth interventions, in addition to usual care, impact on the number of deaths as the certainty of this evidence was graded as low due to high or unclear risk of bias, indirectness and imprecision. eHealth interventions may improve the management of dietary sodium intake and fluid management. However, overall these data suggest that current evidence for the use of eHealth interventions in the CKD population is of low quality, with uncertain effects due to methodological limitations and heterogeneity of eHealth modalities and intervention types. Our review has highlighted the need for robust, high quality research that reports a core (minimum) data set to enable meaningful evaluation of the literature. | We found 43 studies involving 6617 people who had CKD that examined if eHealth interventions improve patient care and health outcomes. eHealth interventions used different modes of technology, such as Telehealth, electronic monitors, mobile or tablet applications, text message or emails, websites, and DVDs or videos. Interventions were classified by their intention: educational, reminder systems, self-monitoring, behavioural counselling, clinical decision-aids and mixed interventions. We categorised outcomes into nine domains: dietary intake, quality of life, blood pressure control, medication adherence, results of blood tests, cost-analysis, behaviour, physical activity and clinical end-points such as death. We found that it was uncertain whether using an eHealth interventions improved clinical and patient-centred outcomes compared with usual care. The quality of the included studies was low, meaning we could not be sure that future studies would find similar results. We are uncertain whether using eHealth interventions improves outcomes for people with CKD. We need large and good quality research studies to help understand the impact of eHealth on the health of people with CKD. | 10.1002/14651858.CD012379.pub2 | [
"We found 43 studies involving 6617 people who had CKD that examined if eHealth interventions improve patient care and health outcomes. eHealth interventions used different modes of technology, such as Telehealth, electronic monitors, mobile or tablet applications, text message or emails, websites, and DVDs or videos. Interventions were classified by their intention: educational, reminder systems, self-monitoring, behavioural counselling, clinical decision-aids and mixed interventions. We categorised outcomes into nine domains: dietary intake, quality of life, blood pressure control, medication adherence, results of blood tests, cost-analysis, behaviour, physical activity and clinical end-points such as death. We found that it was uncertain whether using an eHealth interventions improved clinical and patient-centred outcomes compared with usual care. The quality of the included studies was low, meaning we could not be sure that future studies would find similar results. We are uncertain whether using eHealth interventions improves outcomes for people with CKD. We need large and good quality research studies to help understand the impact of eHealth on the health of people with CKD."
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cochrane-simplification-train-1635 | cochrane-simplification-train-1635 | We identified 11 trials investigating a total of 742 children in treatment arms relevant to our study question. Risks of bias in the studies were mainly low or unclear, but two studies had aspects of their methodology that had a high risk of bias. Overall, the quality of the evidence from pooled studies was low or had unclear risk of bias. Four trials compared clonidine with a placebo or no treatment, six trials compared clonidine with midazolam, and one trial compared clonidine with fentanyl. There was substantial methodological heterogeneity between trials; the dose and route of clonidine administration varied as did the patient populations, the types of surgery and the outcomes measured. It was therefore difficult to combine the outcomes of some trials for meta-analysis. When clonidine was compared to placebo, pooling studies of low or unclear risk of bias, the need for additional analgesia was reduced when clonidine premedication was given orally at 4 µg/kg (risk ratio (RR) 0.24, 95% confidence interval (CI) 0.11 to 0.51). Only one small trial (15 patients per arm) compared clonidine to midazolam for the same outcome; this also found a reduction in the need for additional postoperative analgesia (RR 0.25, 95% CI 0.09 to 0.71) when clonidine premedication was given orally at 2 or 4 µg/kg compared to oral midazolam at 0.5 mg/kg. A trial comparing oral clonidine at 4 µg/kg with intravenous fentanyl at 3 µg/kg found no statistically significant difference in the need for rescue analgesia (RR 0.89, 95% CI 0.56 to 1.42). When clonidine 4 µg/kg was compared to clonidine 2 µg/kg, there was a statistically significant difference in the number of patients requiring additional analgesia, in favour of the higher dose, as reported by a single, higher-quality trial (RR 0.38, 95% CI 0.23 to 0.65). The effect of clonidine on pain scores was hard to interpret due to differences in study methodology, the doses and route of drug administration, and the pain scale used. However, when given at a dose of 4 µg/kg, clonidine may have reduced analgesia requirements after surgery. There were no significant side effects of clonidine that were reported such as severe hypotension, bradycardia, or excessive sedation requiring intervention. However, several studies used atropine prophylactically with the aim of preventing such adverse effects. There were only 11 relevant trials studying 742 children having surgery where premedication with clonidine was compared to placebo or other drug treatment. Despite heterogeneity between trials, clonidine premedication in an adequate dosage (4 µg/kg) was likely to have a beneficial effect on postoperative pain in children. Side effects were minimal, but some of the studies used atropine prophylactically with the intention of preventing bradycardia and hypotension. Further research is required to determine under what conditions clonidine premedication is most effective in providing postoperative pain relief in children. | The evidence is current to December 2012. We identified a total of 11 controlled studies, including a total of 742 children, where clonidine was compared to another medication or to a dummy treatment (placebo). We found evidence that when clonidine is given at an adequate dose (4 µg/kg) it is effective in reducing the need for pain relief after surgery for children (and probably reduces the children's pain) when compared to a placebo. The evidence is less clear when clonidine is compared to the sedative drug midazolam; this is likely to relate to differences in the design of the clinical trials. The side effects of clonidine did not seem to be a significant problem at the doses used, although in some of the studies the investigators took measures to prevent such side effects by the use of other medications. Overall, the evidence so far is of low or unclear quality. Further research is required to confirm under what conditions clonidine premedication is most effective in children. | 10.1002/14651858.CD009633.pub2 | [
"The evidence is current to December 2012. We identified a total of 11 controlled studies, including a total of 742 children, where clonidine was compared to another medication or to a dummy treatment (placebo). We found evidence that when clonidine is given at an adequate dose (4 µg/kg) it is effective in reducing the need for pain relief after surgery for children (and probably reduces the children's pain) when compared to a placebo. The evidence is less clear when clonidine is compared to the sedative drug midazolam; this is likely to relate to differences in the design of the clinical trials. The side effects of clonidine did not seem to be a significant problem at the doses used, although in some of the studies the investigators took measures to prevent such side effects by the use of other medications. Overall, the evidence so far is of low or unclear quality. Further research is required to confirm under what conditions clonidine premedication is most effective in children."
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cochrane-simplification-train-1636 | cochrane-simplification-train-1636 | Two trials of moderate quality in children (n = 134) with no evidence of airflow restriction did not find any benefits from oral beta2-agonists. Five trials in adults (n = 418) had mixed results but overall summary statistics did not reveal any significant benefits from oral (three trials) nor from inhaled (two trials) beta2-agonists. Three studies with low-quality evidence demonstrated no significant differences in daily cough scores, nor in the percentage of adults still coughing after seven days (control group 71%; risk ratio (RR) 0.86, 95% confidence interval (CI) 0.63 to 1.18; 220 participants). In one trial, subgroups with evidence of airflow limitation had lower symptom scores if given beta2-agonists. The trials that noted quicker resolution of cough with beta2-agonists were those with a higher proportion of people wheezing at baseline. Low-quality evidence suggests that adults given beta2-agonists were more likely to report tremor, shakiness or nervousness (RR 7.94, 95% CI 1.17 to 53.94; 211 participants; number needed to treat for an additional harmful outcome (NNTH) 2). There is no evidence to support the use of beta2-agonists in children with acute cough who do not have evidence of airflow restriction. There is also little evidence that the routine use of beta2-agonists is helpful for adults with acute cough. These agents may reduce symptoms, including cough, in people with evidence of airflow restriction. However, this potential benefit is not well supported by the available data and must be weighed against the adverse effects associated with their use. | Our searches are current to May 2015. We found no new trials. In previous searches, we found seven randomised controlled trials that used beta2-agonist drugs for people with acute bronchitis. Two trials studied children aged one to 10 years (134 participants) and five were conducted in adults (418 participants). None of the studies reported receiving grants from drug-making companies to conduct the study, but people who work for a drug maker were listed as authors on reports from two trials and study drugs were supplied free of charge by the company in three trials. Daily cough scores were no different between children given oral beta2-agonists and children in the placebo control groups. Daily cough scores, or the number of people still coughing after seven days, did not change in the adult trials either. However, the results were mixed. Some trials show a benefit and some show no benefit. This may be because some participants also had wheezing or other signs of narrowed airways, in which case beta2-agonists may be helpful only for them. More of the adults taking beta2-agonists had tremor, shakiness or nervousness. We rated this as low or moderate. There were few trials, with small numbers of people with acute bronchitis or cough. The trials were of short duration (three to seven days) and only two used inhaled beta2-agonists, which is now the usual way the drug is taken by adults and older children. Some important information about how the trial was done was not mentioned in the papers giving results for many of the trials. | 10.1002/14651858.CD001726.pub5 | [
"Our searches are current to May 2015. We found no new trials. In previous searches, we found seven randomised controlled trials that used beta2-agonist drugs for people with acute bronchitis. Two trials studied children aged one to 10 years (134 participants) and five were conducted in adults (418 participants). None of the studies reported receiving grants from drug-making companies to conduct the study, but people who work for a drug maker were listed as authors on reports from two trials and study drugs were supplied free of charge by the company in three trials. Daily cough scores were no different between children given oral beta2-agonists and children in the placebo control groups. Daily cough scores, or the number of people still coughing after seven days, did not change in the adult trials either. However, the results were mixed. Some trials show a benefit and some show no benefit. This may be because some participants also had wheezing or other signs of narrowed airways, in which case beta2-agonists may be helpful only for them. More of the adults taking beta2-agonists had tremor, shakiness or nervousness. We rated this as low or moderate. There were few trials, with small numbers of people with acute bronchitis or cough. The trials were of short duration (three to seven days) and only two used inhaled beta2-agonists, which is now the usual way the drug is taken by adults and older children. Some important information about how the trial was done was not mentioned in the papers giving results for many of the trials."
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cochrane-simplification-train-1637 | cochrane-simplification-train-1637 | We included seven studies (662 participants). Five were planned as RCTs and two as prospective controlled trials. One RCT failed completely, another was continued as an observational study, reporting also the results of the participants that had been randomized. There was very low quality evidence from one small RCT (111 participants) that quality of life (QoL) during treatment did not differ significantly between rigid bracing and observation (mean difference (MD) -2.10, 95% confidence interval (CI) -7.69 to 3.49). There was very low quality evidence from a subgroup of 77 adolescents from one prospective cohort study showing that QoL, back pain, psychological, and cosmetic issues did not differ significantly between rigid bracing and observation in the long term (16 years). Results of the secondary outcomes showed that there was low quality evidence that rigid bracing compared with observation significantly increased the success rate in 20° to 40° curves at two years' follow-up (one RCT, 116 participants; risk ratio (RR) 1.79, 95% CI 1.29 to 2.50). There was low quality evidence that elastic bracing increased the success rate in 15° to 30° curves at three years' follow-up (one RCT, 47 participants; RR 1.88, 95% CI 1.11 to 3.20). There is very low quality evidence from two prospective cohort studies with a control group that rigid bracing increases the success rate (curves not evolving to 50° or above) at two years' follow-up (one study, 242 participants; RR 1.50, 95% CI 1.19 to 1.89) and at three years' follow-up (one study, 240 participants; RR 1.75, 95% CI 1.42 to 2.16). There was very low quality evidence from a prospective cohort study (57 participants) that very rigid bracing increased the success rate (no progression of 5° or more, fusion, or waiting list for fusion) in adolescents with high degree curves (above 45°) (one study, 57 adolescents; RR 1.79, 95% CI 1.04 to 3.07 in the intention-to-treat (ITT) analysis). There was low quality evidence from one RCT that a rigid brace was more successful than an elastic brace at curbing curve progression when measured in Cobb degrees in low degree curves (20° to 30°), with no significant differences between the two groups in the subjective perception of daily difficulties associated with wearing the brace (43 girls; risk of success at four years' follow-up: RR 1.40, 1.03 to 1.89). Finally, there was very low quality evidence from one RCT (12 participants) that a rigid brace with a pad pressure control system is no better than a standard brace in reducing the risk of progression. Only one prospective cohort study (236 participants) assessed adverse events: neither the percentage of adolescents with any adverse event (RR 1.27, 95% CI 0.96 to 1.67) nor the percentage of adolescents reporting back pain, the most common adverse event, were different between the groups (RR 0.72, 95% CI 0.47 to 1.10). Due to the important clinical differences among the studies, it was not possible to perform a meta-analysis. Two studies showed that bracing did not change QoL during treatment (low quality), and QoL, back pain, and psychological and cosmetic issues in the long term (16 years) (very low quality). All included papers consistently showed that bracing prevented curve progression (secondary outcome). However, due to the strength of evidence (from low to very low quality), further research is very likely to have an impact on our confidence in the estimate of effect. The high rate of failure of RCTs demonstrates the huge difficulties in performing RCTs in a field where parents reject randomization of their children. This challenge may prevent us from seeing increases in the quality of the evidence over time. Other designs need to be implemented and included in future reviews, including 'expertise-based' trials, prospective controlled cohort studies, prospective studies conducted according to pre-defined criteria such as the Scoliosis Research Society (SRS) and the international Society on Scoliosis Orthopedic and Rehabilitation Treatment (SOSORT) criteria. Future studies should increase their focus on participant outcomes, adverse effects, methods to increase compliance, and usefulness of physiotherapeutic scoliosis specific exercises added to bracing. | This review included seven studies, with a total of 662 adolescents of both genders. AIS from 15° to more than 45° curves were considered. Elastic, rigid (polyethylene), and very rigid (polycarbonate) braces were studied. The evidence is current to October 2013. Funding sources were not reported or external governmental or scientific agencies. We did not find any results on pulmonary disorders and disability. Quality of life was not affected during brace treatment (very low quality evidence); quality of life, back pain, and psychological and cosmetic issues did not change in the long term (very low quality evidence). Rigid bracing seems effective in 20° to 40° curves (low quality evidence), elastic bracing in 15° to 30° curves (low quality evidence), and very rigid bracing in high degree curves above 45° (very low quality evidence); rigid was more successful than an elastic bracing (low quality evidence), and a pad pressure control system did not increase results (very low quality evidence). No specific harms were reported. Primary outcomes such as pulmonary disorders, disability, back pain, psychological and cosmetic issues, and quality of life should be better evaluated in the future. Side effects, as well as the usefulness of exercises and other adjunctive treatments to bracing should be studied too. The evidence was moderate to very low quality. Reason for downgrading were evidence coming from few randomized trials with few participants and many lost at follow-up or from observational prospective controlled studies. An issue in the field of AIS is the high rate of failure of RCTs, since parents want to choose with physicians the preferred treatment for their children. Thus, it is challenging to obtain high quality evidence in this field. | 10.1002/14651858.CD006850.pub3 | [
"This review included seven studies, with a total of 662 adolescents of both genders. AIS from 15° to more than 45° curves were considered. Elastic, rigid (polyethylene), and very rigid (polycarbonate) braces were studied. The evidence is current to October 2013. Funding sources were not reported or external governmental or scientific agencies. We did not find any results on pulmonary disorders and disability. Quality of life was not affected during brace treatment (very low quality evidence); quality of life, back pain, and psychological and cosmetic issues did not change in the long term (very low quality evidence). Rigid bracing seems effective in 20° to 40° curves (low quality evidence), elastic bracing in 15° to 30° curves (low quality evidence), and very rigid bracing in high degree curves above 45° (very low quality evidence); rigid was more successful than an elastic bracing (low quality evidence), and a pad pressure control system did not increase results (very low quality evidence). No specific harms were reported. Primary outcomes such as pulmonary disorders, disability, back pain, psychological and cosmetic issues, and quality of life should be better evaluated in the future. Side effects, as well as the usefulness of exercises and other adjunctive treatments to bracing should be studied too. The evidence was moderate to very low quality. Reason for downgrading were evidence coming from few randomized trials with few participants and many lost at follow-up or from observational prospective controlled studies. An issue in the field of AIS is the high rate of failure of RCTs, since parents want to choose with physicians the preferred treatment for their children. Thus, it is challenging to obtain high quality evidence in this field."
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cochrane-simplification-train-1638 | cochrane-simplification-train-1638 | We included eight RCTs (n = 1243 children) that were at relatively high risk of bias. We found high levels of clinical heterogeneity in the participants, interventions and outcome measures across studies. Nevertheless, in order to quantify pooled effects of supplementary feeding, we decided to combine studies according to prespecified characteristics. These were the children's age (younger or older than 24 months), their nutritional status at baseline (stunted or wasted, or not stunted or wasted) and the duration of the intervention (less or more than 12 months). A statistically significant difference of effect was only found for length during the intervention in children aged less than 12 months (two studies; 795 children; mean difference 0.19 cm; 95% confidence interval (CI) 0.07 to 0.31). Based on the summary statistic calculated for each study, the mean difference (MD) between intervention and control groups ranged from 0.48 cm (95% CI 0.07 to 0.89) to 1.3 cm (95% CI 0.03 to 2.57) after 3 and 12 months of intervention, respectively. Data on potential adverse effects were lacking. The scarcity of available studies and their heterogeneity makes it difficult to reach any firm conclusions. The review findings suggest supplementary feeding has a negligible impact on child growth; however, the pooled results should be interpreted with great caution because the studies included in the review are clinically diverse. Future studies should address issues of research design, including sample size calculation, to detect meaningful clinical effects and adequate intervention allocation concealment. In the meantime, families and children in need should be provided appropriate feeding, health care and sanitation without waiting for new RCTs to establish a research basis for feeding children. | We included eight studies where the participants were randomly assigned to two groups: one group received the extra food and the other group was a control, either receiving no food or food with very low nutritional content. Although the impact of supplementary feeding on child growth appeared to be negligible, it is not possible to draw any conclusions until we have studies that involve larger numbers and do not allow assessors to know who is receiving the intervention. Although it is difficult to determine whether community-based supplementary feeding helps to promote the growth of children from birth to five years in low- and middle-income countries, it is obviously vital to continue to provide food, health care and sanitation to those who need them. | 10.1002/14651858.CD005039.pub3 | [
"We included eight studies where the participants were randomly assigned to two groups: one group received the extra food and the other group was a control, either receiving no food or food with very low nutritional content. Although the impact of supplementary feeding on child growth appeared to be negligible, it is not possible to draw any conclusions until we have studies that involve larger numbers and do not allow assessors to know who is receiving the intervention. Although it is difficult to determine whether community-based supplementary feeding helps to promote the growth of children from birth to five years in low- and middle-income countries, it is obviously vital to continue to provide food, health care and sanitation to those who need them."
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cochrane-simplification-train-1639 | cochrane-simplification-train-1639 | We included 28 studies. We found no clear-cut evidence of effect of the well-researched practice of reviewer and/or author concealment on the outcome of the quality assessment process (9 studies). Checklists and other standardisation media have some evidence to support their use (2 studies). There is no evidence that referees' training has any effect on the quality of the outcome (1 study). Different methods of communicating with reviewers and means of dissemination do not appear to have an effect on quality (3 studies). On the basis of one study, little can be said about the ability of the peer-review process to detect bias against unconventional drugs. Validity of peer review was tested by only one small study in a specialist area. Editorial peer review appears to make papers more readable and improve the general quality of reporting (2 studies), but the evidence for this has very limited generalisability. At present, little empirical evidence is available to support the use of editorial peer review as a mechanism to ensure quality of biomedical research. However, the methodological problems in studying peer review are many and complex. At present, the absence of evidence on efficacy and effectiveness cannot be interpreted as evidence of their absence. A large, well-funded programme of research on the effects of editorial peer review should be urgently launched. | Editorial peer review is used world-wide as a tool to assess and improve the quality of submissions to paper and electronic biomedical journals. As the information revolution gathers pace, an empirically proven method of quality assurance is of paramount importance. The increasing availability of empirical research on the possible effects of peer review led us to carry out a review of current evidence on the efficacy of editorial peer review. We found few studies of reasonable quality, and most of these were concerned with the effects of blinding reviewers and/or authors to each others' identity. We could not identify any methodologically convincing studies assessing the core effects of peer review. Major research is urgently needed. | 10.1002/14651858.MR000016.pub3 | [
"Editorial peer review is used world-wide as a tool to assess and improve the quality of submissions to paper and electronic biomedical journals. As the information revolution gathers pace, an empirically proven method of quality assurance is of paramount importance. The increasing availability of empirical research on the possible effects of peer review led us to carry out a review of current evidence on the efficacy of editorial peer review. We found few studies of reasonable quality, and most of these were concerned with the effects of blinding reviewers and/or authors to each others' identity. We could not identify any methodologically convincing studies assessing the core effects of peer review. Major research is urgently needed."
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cochrane-simplification-train-1640 | cochrane-simplification-train-1640 | An initial search yielded 2808 citations. After excluding studies failing to meet the inclusion criteria, 19 were deemed eligible for inclusion. Of these studies, two presented duplicate data and were removed. The remaining 17 studies were included in the qualitative synthesis and 8 studies were meta-analyzed. Twelve studies offered clinic-based VCT, 3 were employment-based, 1 involved mobile VCT, and 1 provided home-based VCT. In meta-analysis, the odds of reporting increased number of sexual partners were reduced when comparing participants who received VCT to those who did not, unadjusted random effects pooled OR= 0.69 (95% CI: 0.53-0.90, p=0.007). When stratified by serostatus, these results only remained significant for those who tested HIV-positive. There was an insignificant increase in the odds of condom use/protected sex among participants who received VCT compared to those who did not, unadjusted random effects pooled OR=1.39 (95% CI: 0.97-1.99, p=0.076). When stratified by HIV status, this effect became significant among HIV-positive participants, random effects pooled OR= 3.24 (95% CI: 2.29-4.58, p<0.001). These findings add to growing evidence that VCT can change HIV-related sexual risk behaviors thereby reducing HIV-related risk, and confirming its importance as an HIV prevention strategy. To maximize the effectiveness of VCT, more studies should be conducted to understand which modalities and counseling strategies produce significant reductions in risky behaviors and lead to the greatest uptake of VCT. | A systematic review of the literature and a quantitative assessment found that VCT is an effective strategy for reducing some HIV-related risk behaviors, including decreasing the number of sexual partners of participants. Condom use was also significantly increased among participants who tested HIV-positive during VCT. Future research is needed to understand how VCT can be delivered more effectively to maximize its potential as an HIV prevention strategy. | 10.1002/14651858.CD001224.pub4 | [
"A systematic review of the literature and a quantitative assessment found that VCT is an effective strategy for reducing some HIV-related risk behaviors, including decreasing the number of sexual partners of participants. Condom use was also significantly increased among participants who tested HIV-positive during VCT. Future research is needed to understand how VCT can be delivered more effectively to maximize its potential as an HIV prevention strategy."
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cochrane-simplification-train-1641 | cochrane-simplification-train-1641 | We pooled mortality data from eight studies and found a non-significant reduction in mortality at 12 months (OR 0.72, 95% CI 0.45 to, 1.15). We pooled four studies that assessed disease-specific heath-related quality of life (HRQL) and found a statistically significant improvement in HRQL (mean difference -2.61, 95% CI -4.82 to -0.40). Hospitalisations were reported in five studies. Although there was no statistically significant difference in the number of hospitalisations (OR 1.01, 95% CI 0.71 to 1.44), there was significant heterogeneity. Although this heterogeneity appeared to be caused by one outlying study with a statistically significant decrease in hospitalisations in patients receiving home care, whereas the other studies showed a non-significant increase in hospitalisations, we could not draw firm conclusions about why this heterogeneity exists. Data on GP visits and emergency department presentations were available, however no consistent effect in these was observed with the intervention. The intervention also incurred higher health care costs than standard care as reported in a single study. Very few studies provided data on lung function or exercise performance, so there was insufficient evidence to assess impact on these outcomes. Outreach nursing programmes for COPD improved disease-specific HRQL. However the effect on hospitalisations was heterogeneous, reducing admissions in one study, but increasing them in others, therefore we could not draw firm conclusions for this outcome. | However, this review of nine randomised controlled trial found that home care resulted in an improvement in people's quality of life, but has an unpredictable effect on the risk of being admitted to hospital. We could only find information on the cost of care from one study, but this indicated that home care was an expensive form of care. More research is needed to confirm the usefulness of home visits for people with COPD. | 10.1002/14651858.CD000994.pub3 | [
"However, this review of nine randomised controlled trial found that home care resulted in an improvement in people's quality of life, but has an unpredictable effect on the risk of being admitted to hospital. We could only find information on the cost of care from one study, but this indicated that home care was an expensive form of care. More research is needed to confirm the usefulness of home visits for people with COPD."
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cochrane-simplification-train-1642 | cochrane-simplification-train-1642 | Seven trials were identified. Two of them were at low risk of bias (the HALT-C and EPIC3 trials) and included 1676 patients. Both of these trials addressed the role of long-term low-dose pegylated interferon therapy in patients with severe fibrosis (demonstrated on liver biopsy) and were designed to assess the clinical outcomes. The remaining five trials included 300 patients and were at high risk of bias. Based on all trials reporting the outcomes, no significant difference was observed in either all-cause mortality (78/843 (9.3%) versus 62/867 (7.2%); risk ratio (RR) 1.30, 95% confidence interval (CI) 0.95 to 1.79; 3 trials) or hepatic mortality (41/532 (7.7%) versus 40/552 (7.2%); RR 1.07, 95% CI 0.70 to 1.63; 2 trials); however, when only the two trials at low risk of bias were combined, all-cause mortality was significantly higher in the recipients of the pegylated interferon (78/828 (9.4%) versus 57/848 (6.7%); RR 1.41, 95% CI 1.02 to 1.96) although trial sequential analysis could not exclude the possibility of random error. There was less variceal bleeding in the recipients of the interferon (4/843 (0.5%) versus 18/867 (2.1%); RR 0.24, 95% CI 0.09 to 0.67; 3 trials), although again trial sequential analysis could not exclude the presence of a type I error and the effect could not be confirmed in a random-effects model meta-analysis. No significant differences were seen with regard to the development of ascites, encephalopathy, hepatocellular carcinoma, or the need for liver transplantation. One trial reported quality of life data; the pain score was significantly worse in the recipients of the pegylated interferon. Adverse effects tended to be more common in the interferon recipients; the ones that were significantly more common included hematologic complications, infections, flu-like symptoms, and rash. The recipients of interferon had significantly more sustained viral responses (20/557 (3.6%) versus 1/579 (0.2%); RR 15.38, 95% CI 2.93 to 80.71; 4 trials) and a type I error was excluded by trial sequential analysis. The METAVIR activity score also improved (36/55 (65%) versus 20/46 (43.5%); RR 1.49, 95% CI 1.02 to 2.18; 2 trials). No significant differences were seen with regard to histologic fibrosis assessments. The clinical data were limited to patients with histologic evidence of severe fibrosis who were retreated with pegylated interferon. In this scenario, retreatment with interferon did not appear to provide significant clinical benefit and, when only the trials at low risk of bias were considered, retreatment for several years may even have increased all-cause mortality. Such treatment also produced adverse events. On the other hand, the treatment did result in improvement in some surrogate outcomes, namely sustained viral responses and histologic evidence of inflammation. Interferon monotherapy retreatment cannot be recommended for these patients. No clinical data are available for patients with less severe fibrosis. The sustained viral response cannot be used as a surrogate marker for hepatitis C treatment in this clinical setting with low sustained viral response rates and needs to be validated in others in which higher sustained viral response rates are reported. | However, there is no direct evidence that has proven that these outcomes are valid because there have been no long-term trials that have shown that an improvement in these tests translates into reduced mortality or morbidity. Patients who fail to have sustained viral responses after an initial course of therapy do become potential candidates for retreatment; some of them may be intolerant to ribavirin, and possibly even the newer protease inhibitors, so retreatment would have to be with interferon alone. It has also been speculated that long-term treatment (namely treatment for several years) might be beneficial; such long-term therapy would be further complicated if multiple drugs were used because of the additional drug toxicities and costs, so interferon alone could be considered. This review addressed the ability of interferon monotherapy to favorably alter the clinical course of chronic hepatitis C when it is used to retreat patients who failed at least one previous course of therapy. Seven trials were identified, including two large ones (a total of 1676 patients), known as "HALT-C" and "EPIC3", that specifically were designed to use low-dose pegylated interferon for three to five years in patients with evidence on liver biopsy of severe fibrosis and who had failed to have a sustained viral response to a course of standard combination (pegylated interferon plus ribavirin) therapy in the past. Both trials were at low risk of bias. A third trial designed to address the use of pegylated interferon monotherapy for 48 weeks in improving survival in patients with cirrhosis (Childs A or B) was terminated early because of the results of the HALT-C and EPIC3 trials, so three trials have provided mortality and hepatic morbidity data. When all three trials were considered, there was no significant effect of the treatment on either all-cause mortality (78/843 (9.3%) versus 62/867 (7.2%); risk ratio (RR) 1.30, 95% confidence interval (CI) 0.95 to 1.79; 3 trials) or hepatic mortality (41/532 (7.7%) versus 40/552 (7.2%); RR 1.07, 95% CI 0.70 to 1.63; 2 trials); however, all-cause mortality was higher in the recipients of the pegylated interferon (78/828 (9.4%) versus 5 7/848 (6.7%); RR 1.41, 95% CI 1.02 to 1.96) when only the two low risk of bias trials were considered. The excess deaths appeared to be from non-liver causes. Variceal bleeding occurred less often in the treated patients (4/843 (0.5%) versus 18/867 (2.1%); RR 0.24, 95% CI 0.09 to 0.67), but there were no differences seen with regard to the subsequent development of other manifestations of end-stage liver disease (that is, encephalopathy, ascites, hepatocellular carcinoma, liver transplantation). One trial reported quality of life data; the treated patients had increases in their pain scores. No cost data were available. The recipients of the pegylated interferon generally had more adverse events; statistically significant differences were seen for the occurrence of hematologic complications, infections, flu-like symptoms, and rashes. Those receiving interferon were more likely to have sustained viral responses (20/557 (3.6%) versus 1/579 (0.2%); RR 15.38, 95% CI 2.93 to 80.71) and were also more likely to have improvements in markers of inflammation. No difference was demonstrated regarding the effect of the treatment on markers of fibrosis. The use of longer-term (several years) interferon monotherapy in patients with severe underlying hepatic fibrosis who have failed previous courses of treatment is not supported by the evidence; no trials providing data regarding clinical outcomes were identified in other potential treatment scenarios. Two of the commonly employed surrogate markers, sustained viral response and markers of inflammation, failed to be validated since they improved even though the clinical outcomes did not (or may even have become worse). This failure to validate the sustained viral response in this group of patients with a low sustained viral response rate suggests that the presumed validity of the use of sustained viral responses in other groups of patients with chronic hepatitis C viral infections who receive treatment must be formally validated. | 10.1002/14651858.CD003617.pub2 | [
"However, there is no direct evidence that has proven that these outcomes are valid because there have been no long-term trials that have shown that an improvement in these tests translates into reduced mortality or morbidity. Patients who fail to have sustained viral responses after an initial course of therapy do become potential candidates for retreatment; some of them may be intolerant to ribavirin, and possibly even the newer protease inhibitors, so retreatment would have to be with interferon alone. It has also been speculated that long-term treatment (namely treatment for several years) might be beneficial; such long-term therapy would be further complicated if multiple drugs were used because of the additional drug toxicities and costs, so interferon alone could be considered. This review addressed the ability of interferon monotherapy to favorably alter the clinical course of chronic hepatitis C when it is used to retreat patients who failed at least one previous course of therapy. Seven trials were identified, including two large ones (a total of 1676 patients), known as \"HALT-C\" and \"EPIC3\", that specifically were designed to use low-dose pegylated interferon for three to five years in patients with evidence on liver biopsy of severe fibrosis and who had failed to have a sustained viral response to a course of standard combination (pegylated interferon plus ribavirin) therapy in the past. Both trials were at low risk of bias. A third trial designed to address the use of pegylated interferon monotherapy for 48 weeks in improving survival in patients with cirrhosis (Childs A or B) was terminated early because of the results of the HALT-C and EPIC3 trials, so three trials have provided mortality and hepatic morbidity data. When all three trials were considered, there was no significant effect of the treatment on either all-cause mortality (78/843 (9.3%) versus 62/867 (7.2%); risk ratio (RR) 1.30, 95% confidence interval (CI) 0.95 to 1.79; 3 trials) or hepatic mortality (41/532 (7.7%) versus 40/552 (7.2%); RR 1.07, 95% CI 0.70 to 1.63; 2 trials); however, all-cause mortality was higher in the recipients of the pegylated interferon (78/828 (9.4%) versus 5 7/848 (6.7%); RR 1.41, 95% CI 1.02 to 1.96) when only the two low risk of bias trials were considered. The excess deaths appeared to be from non-liver causes. Variceal bleeding occurred less often in the treated patients (4/843 (0.5%) versus 18/867 (2.1%); RR 0.24, 95% CI 0.09 to 0.67), but there were no differences seen with regard to the subsequent development of other manifestations of end-stage liver disease (that is, encephalopathy, ascites, hepatocellular carcinoma, liver transplantation). One trial reported quality of life data; the treated patients had increases in their pain scores. No cost data were available. The recipients of the pegylated interferon generally had more adverse events; statistically significant differences were seen for the occurrence of hematologic complications, infections, flu-like symptoms, and rashes. Those receiving interferon were more likely to have sustained viral responses (20/557 (3.6%) versus 1/579 (0.2%); RR 15.38, 95% CI 2.93 to 80.71) and were also more likely to have improvements in markers of inflammation. No difference was demonstrated regarding the effect of the treatment on markers of fibrosis. The use of longer-term (several years) interferon monotherapy in patients with severe underlying hepatic fibrosis who have failed previous courses of treatment is not supported by the evidence; no trials providing data regarding clinical outcomes were identified in other potential treatment scenarios. Two of the commonly employed surrogate markers, sustained viral response and markers of inflammation, failed to be validated since they improved even though the clinical outcomes did not (or may even have become worse). This failure to validate the sustained viral response in this group of patients with a low sustained viral response rate suggests that the presumed validity of the use of sustained viral responses in other groups of patients with chronic hepatitis C viral infections who receive treatment must be formally validated."
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cochrane-simplification-train-1643 | cochrane-simplification-train-1643 | We included six studies that compared early oropharyngeal colostrum versus water, saline, placebo, or donor, or versus no intervention, enrolling 335 preterm infants with gestational ages ranging from 25 to 32 weeks' gestation and birth weights of 410 to 2500 grams. Researchers found no significant differences between OPC and control for primary outcomes - incidence of NEC (typical risk ratio (RR) 1.42, 95% confidence interval (CI) 0.50 to 4.02; six studies, 335 infants; P = 0.51; I² = 0%; very low-quality evidence), incidence of late-onset infection (typical RR 0.86, 95% CI 0.56 to 1.33; six studies, 335 infants; P = 0.50; I² = 0%; very low-quality evidence), and death before hospital discharge (typical RR 0.76, 95% CI 0.34 to 1.71; six studies, 335 infants; P = 0.51; I² = 0%; very low-quality evidence). Similarly, meta-analysis showed no difference in length of hospital stay between OPC and control groups (mean difference (MD) 0.81, 95% CI -5.87 to 7.5; four studies, 293 infants; P = 0.65; I² = 49%). Days to full enteral feeds were reduced in the OPC group with MD of -2.58 days (95% CI -4.01 to -1.14; six studies, 335 infants; P = 0.0004; I² = 28%; very low-quality evidence). The effect of OPC was uncertain because of small sample sizes and imprecision in study results (very low-quality evidence). No adverse effects were associated with OPC; however, data on adverse effects were insufficient, and no numerical data were available from the included studies. Overall the quality of included studies was low to very low across all outcomes. We downgraded GRADE outcomes because of concerns about allocation concealment and blinding, reporting bias, small sample sizes with few events, and wide confidence intervals. Large, well-designed trials would be required to evaluate more precisely and reliably the effects of oropharyngeal colostrum on important outcomes for preterm infants. | We searched for both published and unpublished studies comparing oropharyngeal colostrum versus a control such as water, placebo, or no oral priming. We included only clinical trials reporting outcomes in preterm babies (< 37 weeks' gestation). The evidence is up-to-date as of August 2017. We did not limit the review to any particular region or language. Six studies were eligible for inclusion, involving 335 preterm infants with gestational ages ranging from 25 to 32 weeks' gestation and birth weights of 410 to 2500 grams. Reviewers noted no differences between OPC and control for rate of NEC, infection, or death before hospital discharge. Similarly, they observed no difference in length of hospital stay between OPC and control babies. Infants who received OPC achieved full milk feeds on average 2.5 days earlier than those given placebo or no intervention. However, included studies were small, data were insufficient, and study designs were not ideal. Combining study data did not provide sufficient evidence to recommend the use of colostrum for oral priming to prevent complications in preterm infants. Five of the included studies reported no harms (adverse effects); however, no numerical data are available from these studies. Included studies were of very low quality; therefore the effects of OPC remain uncertain. Larger, better quality clinical trials would be needed to evaluate more precisely and reliably the effects of OPC on important outcomes for preterm infants. . | 10.1002/14651858.CD011921.pub2 | [
"We searched for both published and unpublished studies comparing oropharyngeal colostrum versus a control such as water, placebo, or no oral priming. We included only clinical trials reporting outcomes in preterm babies (< 37 weeks' gestation). The evidence is up-to-date as of August 2017. We did not limit the review to any particular region or language. Six studies were eligible for inclusion, involving 335 preterm infants with gestational ages ranging from 25 to 32 weeks' gestation and birth weights of 410 to 2500 grams. Reviewers noted no differences between OPC and control for rate of NEC, infection, or death before hospital discharge. Similarly, they observed no difference in length of hospital stay between OPC and control babies. Infants who received OPC achieved full milk feeds on average 2.5 days earlier than those given placebo or no intervention. However, included studies were small, data were insufficient, and study designs were not ideal. Combining study data did not provide sufficient evidence to recommend the use of colostrum for oral priming to prevent complications in preterm infants. Five of the included studies reported no harms (adverse effects); however, no numerical data are available from these studies. Included studies were of very low quality; therefore the effects of OPC remain uncertain. Larger, better quality clinical trials would be needed to evaluate more precisely and reliably the effects of OPC on important outcomes for preterm infants. ."
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cochrane-simplification-train-1644 | cochrane-simplification-train-1644 | This review includes a total of 1897 children and 729 adults in 39 trials. Thirty-three trials were conducted in the emergency room and equivalent community settings, and six trials were on inpatients with acute asthma (207 children and 28 adults). The method of delivery of beta₂-agonist did not show a significant difference in hospital admission rates. In adults, the risk ratio (RR) of admission for spacer versus nebuliser was 0.94 (95% CI 0.61 to 1.43). The risk ratio for children was 0.71 (95% CI 0.47 to 1.08, moderate quality evidence). In children, length of stay in the emergency department was significantly shorter when the spacer was used. The mean duration in the emergency department for children given nebulised treatment was 103 minutes, and for children given treatment via spacers 33 minutes less (95% CI -43 to -24 minutes, moderate quality evidence). Length of stay in the emergency department for adults was similar for the two delivery methods. Peak flow and forced expiratory volume were also similar for the two delivery methods. Pulse rate was lower for spacer in children, mean difference -5% baseline (95% CI -8% to -2%, moderate quality evidence), as was the risk of developing tremor (RR 0.64; 95% CI 0.44 to 0.95, moderate quality evidence). Nebuliser delivery produced outcomes that were not significantly better than metered-dose inhalers delivered by spacer in adults or children, in trials where treatments were repeated and titrated to the response of the participant. Spacers may have some advantages compared to nebulisers for children with acute asthma. The studies excluded people with life-threatening asthma; therefore, the results of this meta-analysis should not be extrapolated to this patient population. | We found 39 clinical trials involving 1897 children and 729 adults. Thirty-three of the trials were conducted in an emergency room (or emergency department) and community settings (such as a GP's surgery), and six trials were on inpatients (people in hospital) with acute asthma (207 children and 28 adults). Overall we judged the quality of the evidence to be moderate. Taking beta-agonists through either a spacer or a nebuliser in the emergency department did not make a difference to the number of adults being admitted to hospital, whilst in children we can be fairly confident that nebulisers are not better than spacers at preventing admissions. In children, the length of stay in the emergency department was significantly shorter when the spacer was used instead of a nebuliser. The average stay in the emergency department for children given nebulised treatment was 103 minutes. Children given treatment via spacers spent an average of 33 minutes less. In adults, the length of stay in the emergency department was similar for the two delivery methods. However the adult studies were conducted slightly differently which may have made it more difficult to show a difference in the length of stay in the emergency department. Because all the adult studies used a so-called "double-dummy" design, the adults received a spacer AND a nebuliser (either beta-agonist in a spacer and a dummy nebuliser or vice versa) which meant both groups of people were in the emergency department for as long as it took to take both treatments. Lung function tests were also similar for the two delivery methods in both adults and children. Pulse rate was lower in children taking beta-agonists through a spacer (mean difference -5% baseline), and there was a lower risk of developing tremor. Metered-dose inhalers with a spacer can perform at least as well as wet nebulisation in delivering beta₂-agonists in children with acute asthma, but we are less certain about the results in adults. The review is current as of February 2013. | 10.1002/14651858.CD000052.pub3 | [
"We found 39 clinical trials involving 1897 children and 729 adults. Thirty-three of the trials were conducted in an emergency room (or emergency department) and community settings (such as a GP's surgery), and six trials were on inpatients (people in hospital) with acute asthma (207 children and 28 adults). Overall we judged the quality of the evidence to be moderate. Taking beta-agonists through either a spacer or a nebuliser in the emergency department did not make a difference to the number of adults being admitted to hospital, whilst in children we can be fairly confident that nebulisers are not better than spacers at preventing admissions. In children, the length of stay in the emergency department was significantly shorter when the spacer was used instead of a nebuliser. The average stay in the emergency department for children given nebulised treatment was 103 minutes. Children given treatment via spacers spent an average of 33 minutes less. In adults, the length of stay in the emergency department was similar for the two delivery methods. However the adult studies were conducted slightly differently which may have made it more difficult to show a difference in the length of stay in the emergency department. Because all the adult studies used a so-called \"double-dummy\" design, the adults received a spacer AND a nebuliser (either beta-agonist in a spacer and a dummy nebuliser or vice versa) which meant both groups of people were in the emergency department for as long as it took to take both treatments. Lung function tests were also similar for the two delivery methods in both adults and children. Pulse rate was lower in children taking beta-agonists through a spacer (mean difference -5% baseline), and there was a lower risk of developing tremor. Metered-dose inhalers with a spacer can perform at least as well as wet nebulisation in delivering beta₂-agonists in children with acute asthma, but we are less certain about the results in adults. The review is current as of February 2013."
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cochrane-simplification-train-1645 | cochrane-simplification-train-1645 | We identified eight RCTs with a total of 1183 participants. The duration of the interventions ranged from 12 to 26 weeks; in five trials, the duration of intervention was 12 or 13 weeks. The included studies had moderate risk of bias, and the overall quality of evidence was low or very low for all outcomes. We compared CCT first against active control interventions, such as watching educational videos. Negative SMDs favour CCT over control. Trial results suggest slight improvement in global cognitive function at the end of the intervention period (12 weeks) (standardised mean difference (SMD) -0.31, 95% confidence interval (CI) -0.57 to -0.05; 232 participants; 2 studies; low-quality evidence). One of these trials also assessed global cognitive function 12 months after the end of the intervention; this trial provided no clear evidence of a persistent effect (SMD -0.21, 95% CI -0.66 to 0.24; 77 participants; 1 study; low-quality evidence). CCT may result in little or no difference at the end of the intervention period in episodic memory (12 to 17 weeks) (SMD 0.06, 95% CI -0.14 to 0.26; 439 participants; 4 studies; low-quality evidence) or working memory (12 to 16 weeks) (SMD -0.17, 95% CI -0.36 to 0.02; 392 participants; 3 studies; low-quality evidence). Because of the very low quality of the evidence, we are very uncertain about the effects of CCT on speed of processing and executive function. We also compared CCT to inactive control (no interventions). We found no data on our primary outcome of global cognitive function. At the end of the intervention, CCT may lead to slight improvement in episodic memory (6 months) (mean difference (MD) in Rivermead Behavioural Memory Test (RBMT) -0.90 points, 95% confidence interval (CI) -1.73 to -0.07; 150 participants; 1 study; low-quality evidence) but can have little or no effect on executive function (12 weeks to 6 months) (SMD -0.08, 95% CI -0.31 to 0.15; 292 participants; 2 studies; low-quality evidence), working memory (16 weeks) (MD -0.08, 95% CI -0.43 to 0.27; 60 participants; 1 study; low-quality evidence), or verbal fluency (6 months) (MD -0.11, 95% CI -1.58 to 1.36; 150 participants; 1 study; low-quality evidence). We could not determine any effects on speed of processing because the evidence was of very low quality. We found no evidence on quality of life, activities of daily living, or adverse effects in either comparison. We found low-quality evidence suggesting that immediately after completion of the intervention, small benefits of CCT may be seen for global cognitive function when compared with active controls, and for episodic memory when compared with an inactive control. These benefits are of uncertain clinical importance. We found no evidence that the effect on global cognitive function persisted 12 months later. Our confidence in the results was low, reflecting the overall quality of the evidence. In five of the eight trials, the duration of the intervention was just three months. The possibility that more extensive training could yield larger benefit remains to be more fully explored. We found substantial literature on cognitive training, and collating all available scientific information posed problems. Duration of treatment may not be the best way to categorise interventions for inclusion. As the primary interest of older people and of guideline writers and policymakers involves sustained cognitive benefit, an alternative would be to categorise by length of follow-up after selecting studies that assess longer-term effects. | We found eight trials with a total of 1183 participants to include in the review. Five trials provided CCT for three months, two for four months, and one for six months. We compared CCT with other activities, such as watching educational videos, and with no activity. We looked for effects on overall cognitive function and on specific cognitive functions, such as memory and thinking speed. All of the included studies had some design problems, which could have biased the results. Overall, we thought the quality of the evidence that we found was low or very low. This means we cannot be confident in the results, and that future research might well find something different. CCT may slightly improve overall cognitive function after 12 weeks of training; however, we found no evidence of a persistent effect 12 months after the intervention. We were unable to comment or found little evidence that CCT when compared with other activities may have a relevant effect on most of the specific cognitive functions that we examined. The longest trial found that compared to doing nothing, completing six months of CCT may have had a beneficial effect on memory. None of the included trials reported effects of cognitive training on quality of life or on daily activities, and none reported harmful effects of training. Compared to other activities, CCT may lead to slightly better overall cognitive function at the end of 12 weeks of training, but we found no evidence that the effect persists a year later. Compared to doing nothing, CCT may slightly improve memory at the end of six months of training. Although we excluded trials with less than 12 weeks of training, the trials that we included were still quite short for examining long-term effects as people age. A limitation of our review is that we did not include some trials with shorter training periods that did look for long-lasting effects, so it is possible that we missed some useful evidence. Many published studies have looked at computer training. Making sense of this substantial literature is difficult. It may be more helpful in the future to categorise trials by the duration of effects of training rather than by the duration of the training itself. | 10.1002/14651858.CD012277.pub3 | [
"We found eight trials with a total of 1183 participants to include in the review. Five trials provided CCT for three months, two for four months, and one for six months. We compared CCT with other activities, such as watching educational videos, and with no activity. We looked for effects on overall cognitive function and on specific cognitive functions, such as memory and thinking speed. All of the included studies had some design problems, which could have biased the results. Overall, we thought the quality of the evidence that we found was low or very low. This means we cannot be confident in the results, and that future research might well find something different. CCT may slightly improve overall cognitive function after 12 weeks of training; however, we found no evidence of a persistent effect 12 months after the intervention. We were unable to comment or found little evidence that CCT when compared with other activities may have a relevant effect on most of the specific cognitive functions that we examined. The longest trial found that compared to doing nothing, completing six months of CCT may have had a beneficial effect on memory. None of the included trials reported effects of cognitive training on quality of life or on daily activities, and none reported harmful effects of training. Compared to other activities, CCT may lead to slightly better overall cognitive function at the end of 12 weeks of training, but we found no evidence that the effect persists a year later. Compared to doing nothing, CCT may slightly improve memory at the end of six months of training. Although we excluded trials with less than 12 weeks of training, the trials that we included were still quite short for examining long-term effects as people age. A limitation of our review is that we did not include some trials with shorter training periods that did look for long-lasting effects, so it is possible that we missed some useful evidence. Many published studies have looked at computer training. Making sense of this substantial literature is difficult. It may be more helpful in the future to categorise trials by the duration of effects of training rather than by the duration of the training itself."
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cochrane-simplification-train-1646 | cochrane-simplification-train-1646 | We included 50 studies with a total of 3704 participants. Forty studies (81%) were at high risk of bias, nine (18%) were at unclear risk of bias, with just one assessed as at low risk of bias. There were 34 different sedatives used with or without inhalational nitrous oxide. Dosages, mode of administration and time of administration varied widely. Studies were grouped into placebo-controlled, dosage and head-to-head comparisons. Meta-analysis of the available data for the primary outcome (behaviour) was possible for studies investigating oral midazolam versus placebo only. There is moderate-certainty evidence from six small clinically heterogeneous studies at high or unclear risk of bias, that the use of oral midazolam in doses between 0.25 mg/kg to 1 mg/kg is associated with more co-operative behaviour compared to placebo; standardized mean difference (SMD) favoured midazolam (SMD 1.96, 95% confidence interval (CI) 1.59 to 2.33, P < 0.0001, I2 = 90%; 6 studies; 202 participants). It was not possible to draw conclusions regarding the secondary outcomes due to inconsistent or inadequate reporting or both. There is some moderate-certainty evidence that oral midazolam is an effective sedative agent for children undergoing dental treatment. There is a need for further well-designed and well-reported clinical trials to evaluate other potential sedation agents. Further recommendations for future research are described and it is suggested that future trials evaluate experimental regimens in comparison with oral midazolam or inhaled nitrous oxide. | Authors from Cochrane Oral Health carried out this review and the evidence is up to date to 22 February 2018. A total of 50 randomised controlled trials were included with a total of 3704 participants. Within these studies 34 different sedatives were used, often with inhalational nitrous oxide as well. Dosages and delivery of these drugs varied widely. We grouped studies into those where drugs were compared to a placebo, where drugs were compared to other drugs or where different dosages of drugs were compared. Because all the studies were so different we could only carry out a meta-analysis for studies comparing oral midazolam to a placebo. The review showed that use of oral midazolam made patients more co-operative for dental treatment than a placebo drug. Where reported, adverse effects were few and minor. Oral midazolam probably improves behaviour of children during dental treatment. We evaluated other sedatives but there is insufficient evidence to draw any conclusions. There is some moderate-certainty evidence that midazolam administered in a drink of juice is effective. | 10.1002/14651858.CD003877.pub5 | [
"Authors from Cochrane Oral Health carried out this review and the evidence is up to date to 22 February 2018. A total of 50 randomised controlled trials were included with a total of 3704 participants. Within these studies 34 different sedatives were used, often with inhalational nitrous oxide as well. Dosages and delivery of these drugs varied widely. We grouped studies into those where drugs were compared to a placebo, where drugs were compared to other drugs or where different dosages of drugs were compared. Because all the studies were so different we could only carry out a meta-analysis for studies comparing oral midazolam to a placebo. The review showed that use of oral midazolam made patients more co-operative for dental treatment than a placebo drug. Where reported, adverse effects were few and minor. Oral midazolam probably improves behaviour of children during dental treatment. We evaluated other sedatives but there is insufficient evidence to draw any conclusions. There is some moderate-certainty evidence that midazolam administered in a drink of juice is effective."
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cochrane-simplification-train-1647 | cochrane-simplification-train-1647 | We included 66 RCTs of oral phlebotonics, but only 53 trials provided quantifiable data (involving 6013 participants; mean age 50 years) for the efficacy analysis: 28 for rutosides, 10 hidrosmine and diosmine, nine calcium dobesilate, two Centella asiatica, two aminaftone, two french maritime pine bark extract and one grape seed extract. No studies evaluating topical phlebotonics, chromocarbe, naftazone or disodium flavodate fulfilled the inclusion criteria. Moderate-quality evidence suggests that phlebotonics reduced oedema in the lower legs compared with placebo. Phlebotonics showed beneficial effects among participants including reduced oedema (RR 0.70, 95% CI 0.63 to 0.78; I2 = 20%; 1245 participants) and ankle circumference (MD -4.27 mm, 95% CI -5.61 to -2.93 mm; I2 = 47%; 2010 participants). Low-quality evidence reveals no difference in the proportion of ulcers cured with phlebotonics compared with placebo (RR 0.94, 95% CI 0.79 to 1.13; I2 = 5%; 461 participants). In addition, phlebotonics showed greater efficacy for trophic disorders, cramps, restless legs, swelling and paraesthesia, when compared with placebo. We identified heterogeneity for the variables of pain, itching, heaviness, quality of life and global assessment by participants. For quality of life, it was not possible to pool the studies because heterogeneity was high. However, high-quality evidence suggests no differences in quality of life for calcium dobesilate compared with placebo (MD -0.60, 95% CI -2.15 to 0.95; I2 = 40%; 617 participants), and low-quality evidence indicates that in the aminaftone group, quality of life was improved over that reported in the placebo group (MD -10.00, 95% CI -17.01 to - 2.99; 79 participants). Moderate-quality evidence shows that the phlebotonics group had greater risk of non-severe adverse events than the placebo group (RR 1.21, 95% CI 1.05 to 1.41; I2 = 0; 3975 participants). Gastrointestinal disorders were the most frequently reported adverse events. Moderate-quality evidence shows that phlebotonics may have beneficial effects on oedema and on some signs and symptoms related to CVI such as trophic disorders, cramps, restless legs, swelling and paraesthesia when compared with placebo but can produce more adverse effects. Phlebotonics showed no differences compared with placebo in ulcer healing. Additional high-quality RCTs focused on clinically important outcomes are needed to improve the evidence base. | In total, 66 studies (53 with quantifiable data, including 6013 participants; mean age 50 years) met the eligibility criteria for this review (current until August 2015). Moderate-quality evidence from 13 studies (involving 1245 people) suggests that phlebotonics reduce puffiness (oedema) compared with placebo. Low quality evidence suggests there is no difference in the proportion of healed ulcers with phlebotonics compared with placebo. For quality of life, it was not possible to combine all studies because of differences between the studies. However, individual phlebotonic treatments shows high quality evidence there is no difference in quality of life for the phlebotonic calcium dobesilate. Low-quality evidence revealed improvement of quality of life for aminaftone when compared to placebo. Furthermore evidence suggests phlebotonics have beneficial effects on trophic disorders, cramps, restless legs, swelling and tingling. However, the relevance of these findings to the overall clinical state remains unclear. Moderate-quality evidence from 33 studies (involving 3975 people) shows that phlebotonics produce more side effects, especially gastrointestinal disorders. Quality of the evidence The quality of evidence was downgraded because of selective reporting for the outcome ulcer healing, for incomplete outcome data for the outcomes ulcer healing, oedema and adverse events and for unclear randomisation and imprecision of the overall results for the outcome quality of life. | 10.1002/14651858.CD003229.pub3 | [
"In total, 66 studies (53 with quantifiable data, including 6013 participants; mean age 50 years) met the eligibility criteria for this review (current until August 2015). Moderate-quality evidence from 13 studies (involving 1245 people) suggests that phlebotonics reduce puffiness (oedema) compared with placebo. Low quality evidence suggests there is no difference in the proportion of healed ulcers with phlebotonics compared with placebo. For quality of life, it was not possible to combine all studies because of differences between the studies. However, individual phlebotonic treatments shows high quality evidence there is no difference in quality of life for the phlebotonic calcium dobesilate. Low-quality evidence revealed improvement of quality of life for aminaftone when compared to placebo. Furthermore evidence suggests phlebotonics have beneficial effects on trophic disorders, cramps, restless legs, swelling and tingling. However, the relevance of these findings to the overall clinical state remains unclear. Moderate-quality evidence from 33 studies (involving 3975 people) shows that phlebotonics produce more side effects, especially gastrointestinal disorders. Quality of the evidence The quality of evidence was downgraded because of selective reporting for the outcome ulcer healing, for incomplete outcome data for the outcomes ulcer healing, oedema and adverse events and for unclear randomisation and imprecision of the overall results for the outcome quality of life."
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cochrane-simplification-train-1648 | cochrane-simplification-train-1648 | We identified 1549 records; 85 items from electronic databases, 45 from study registries, and 1419 from congress proceedings. The revised search strategy did not identify any additional RCTs. In the previous version of the review, we identified one RCT comparing HDCT followed by autologous HSCT versus standard-dose chemotherapy (SDCT). The trial randomized 87 participants who were considerably heterogeneous with respect to 19 different tumor entities. The data from 83 participants were available for analysis. In the single included trial, overall survival at three years was 32.7% in the HDCT arm versus 49.4% in the SDCT arm and there was no difference between the treatment groups (hazard ratio (HR) 1.26, 95% confidence interval (CI) 0.70 to 2.29, P = 0.44; 1 study, 83 participants; high quality evidence). In a subgroup of participants who had a complete response before HDCT, overall survival was higher in both treatment groups and overall survival at three years was 42.8% in the HDCT arm versus 83.9% in the SDCT arm and favored the SDCT group (HR 2.92, 95% CI 1.1 to 7.6, P = 0.028; 1 study, 39 participants). In the single included trial, the authors reported one treatment-related leukemia death two years after HDCT. They also evaluated severe adverse events WHO grade 3 to 4 in 22 participants in the HDCT arm and in 51 participants in the SDCT arm. The authors reported 11 events concerning digestive-, infection-, pain-, or asthenia-related toxicity in the HDCT arm and one event in the SDCT arm (moderate quality evidence). The development of secondary neoplasia was not addressed. We judged the study to have an overall unclear risk of bias as three of seven items had unclear and four items had low risk of bias. For GRADE, we judged three items as high quality and three items were not reported. The limited data of a single RCT with an unclear risk of bias and moderate to high quality evidence showed no survival advantage for HDCT. If this treatment is offered it should only be given after careful consideration on an individual person basis and possibly only as part of a well-designed RCT. | The evidence is current to 6 September 2016. We found one RCT that compared 38 people in the high-dose chemotherapy and transplantation group versus 45 people in the chemotherapy-only group and was judged to have mainly a low risk of bias (as it was well designed). The participants were 18 to 65 years old, had various types of nonrhabdomyosarcoma soft tissue sarcomas and were monitored for about 55 months. The treatment period ranged from 2000 to 2008. The single RCT was funded by a nonprofit organization (the funder did not benefit if the trial found good results). The results of the RCT did not favor either of the two treatment arms with respect to overall survival. There was one death related to treatment in the transplantation group and none in the chemotherapy-only group. There were eight cases of severe nonhematologic (not related to the blood) side effects in the transplantation group and one in the chemotherapy-only group. The overall quality of the data was unclear and based on only one RCT. Currently, research evidence is limited for the use of high-dose chemotherapy followed by autologous hematopoietic stem cell transplantation for people with non-rhabdomyosarcoma soft tissue sarcomas. Further evidence is needed through well-designed clinical trials. | 10.1002/14651858.CD008216.pub5 | [
"The evidence is current to 6 September 2016. We found one RCT that compared 38 people in the high-dose chemotherapy and transplantation group versus 45 people in the chemotherapy-only group and was judged to have mainly a low risk of bias (as it was well designed). The participants were 18 to 65 years old, had various types of nonrhabdomyosarcoma soft tissue sarcomas and were monitored for about 55 months. The treatment period ranged from 2000 to 2008. The single RCT was funded by a nonprofit organization (the funder did not benefit if the trial found good results). The results of the RCT did not favor either of the two treatment arms with respect to overall survival. There was one death related to treatment in the transplantation group and none in the chemotherapy-only group. There were eight cases of severe nonhematologic (not related to the blood) side effects in the transplantation group and one in the chemotherapy-only group. The overall quality of the data was unclear and based on only one RCT. Currently, research evidence is limited for the use of high-dose chemotherapy followed by autologous hematopoietic stem cell transplantation for people with non-rhabdomyosarcoma soft tissue sarcomas. Further evidence is needed through well-designed clinical trials."
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cochrane-simplification-train-1649 | cochrane-simplification-train-1649 | We found no trials comparing one type of support versus another. We included seven RCTs (including one cluster-RCT) involving 831 women. The number of women in each trial ranged from 36 to 226. The trials were conducted in high-income countries: USA (5 trials); Denmark (1 trial) and Australia (1 trial), between 2006 and 2015. Three trials only included women who were obese prior to pregnancy and four trials included both women who were overweight and women who were obese. We judged risk of bias in the included trials to be mixed; only one trial was judged to be low risk of bias for random sequence generation, allocation concealment and attrition bias. Physical breastfeeding support (manual or electric breast pump) versus usual care (no breast pump) Very low-certainty evidence from one small trial (39 women) looking at a physical support intervention (manual or electric breast pump) versus usual care (no pump) means it is unclear whether physical support improves exclusive breastfeeding at four to six weeks (risk ratio (RR) 0.55, 95% confidence interval (CI) 0.20 to 1.51) or any breastfeeding at four to six weeks (RR 0.65, 95% CI 0.41 to 1.03). The trial did not report other important outcomes of interest in this review: non-initiation of breastfeeding, exclusive or any breastfeeding at six months postpartum. Multiple methods of breastfeeding support versus usual care Six trials (involving 792 women) used multiple methods of support including education and social support through telephone or face-to-face contact. One of these trials also provided physical support through providing a breast pump and a baby sling and one trial provided a small gift to the women at each trial visit. Support in the trials was provided by a professional (four trials) or a peer (two trials). One trial provided group support, with the other five trials supporting women individually. One trial (174 women) did not report on any of our main outcomes of interest. We are unclear about the effects of the intervention because we identified very low-certainty evidence for all of the important outcomes in this review: rate of non-initiation of breastfeeding (average RR 1.03, 95% CI 0.07 to 16.11; 3 trials, 380 women); exclusive breastfeeding at four to six weeks (average RR 1.21, 95% CI 0.83 to 1.77; 4 trials, 445 women); any breastfeeding at four to six weeks (average RR 1.04, 95% CI 0.57 to 1.89; 2 trials, 103 women); rate of exclusive breastfeeding at six months postpartum (RR 7.23, 95% CI 0.38 to 137.08; 1 trial, 120 women); and any breastfeeding at six months postpartum (average RR 1.42, 95% CI 1.08 to 1.87; 2 trials, 223 women). The included trials under the above comparisons also reported on some of this review's secondary outcomes but very low-certainty evidence means that we are unclear about the effects of the intervention on those outcomes. There is insufficient evidence to assess the effectiveness of physical interventions, or multiple methods of support (social, educational or physical) for supporting the initiation or continuation of breastfeeding in women who are overweight or obese. We found no RCTs comparing one type of support to another type of support. All of our GRADE assessments resulted in very low-certainty evidence, with downgrading decisions based on limitations in trial design (e.g. risk of attrition bias), imprecision, inconsistency. The available trials were mostly of variable quality with small numbers of participants, confounded by poor adherence within both the intervention and control groups. Well designed, adequately powered research is needed to answer questions about the social, educational, physical support, or any combination of these interventions that could potentially help mothers who are overweight or obese to achieve optimal breastfeeding outcomes. We need trials that examine interventions designed specifically for women who are overweight or obese, delivered by people with training about how to overcome some of the challenges these women face when establishing and maintaining breastfeeding. Particular attention could be given to the assessment of antenatal interventions aimed at improving breastfeeding initiation in women with a raised BMI, and not just focusing on recruiting women who have an intention to breastfeed. Given that the majority of current trials were undertaken in the USA, further trials in a diverse range of countries and settings are required. Future trials need to give consideration to the theoretical basis of the intervention using established frameworks to enable replicability by others and to better determine the components of effective interventions. | We searched for evidence (January 2019) and identified seven randomised controlled trials (RCTs), involving 831 women (range 36 to 226 women), conducted in high-income countries (USA, Denmark, Australia) between 2006 and 2015. Three trials only included women who were obese prior to pregnancy and four trials included women who were overweight and women who were obese. The trials compared different types of breastfeeding support to usual care. There were a limited number of trials for each type of support, and differences in how much support the women received in the support and usual care groups. One trial (39 women) used a physical support intervention through the loan of an electric or manual breast pump versus usual care (no pump). Very low-certainty evidence means it is unclear whether physical support improves exclusive breastfeeding at four to six weeks; or any breastfeeding at four to six weeks. The trial did not report other important outcomes of interest: non-initiation of breastfeeding, and exclusive or any breastfeeding at six months after birth. Six trials (792 women) used multiple methods of support (including education and social support through telephone or face-to-face contact) versus usual care. One trial (174 women) did not report on any of our main outcomes of interest. One of the trials also provided physical support through providing a breast pump and a baby sling, and another provided a small gift to the women at each trial visit. Support in these trials was provided by a professional (four trials) or a peer (two trials), either in a group (one trial) or individually (five trials). For women receiving an intervention that incorporated multiple methods of support (including social, educational or physical support) versus usual care, we are unclear about the effects of the intervention because we identified very low-certainty evidence for all of the important outcomes in this review: rate of non-initiation of breastfeeding; exclusive breastfeeding at four to six weeks; any breastfeeding at four to six weeks; rate of exclusive breastfeeding at six months after birth; and any breastfeeding at six months after birth. The effectiveness of interventions for supporting women who are overweight or obese to start and continue breastfeeding remains unclear. The methods used by the available trials varied in quality, with small numbers of participants. No trials compared one type of support to another. We need high-quality trials to evaluate whether social, educational, physical support, or any combination of these interventions can give mothers who are overweight or obese the best chance of starting and continuing to breastfeed. The interventions need to be designed specifically for this group of women and delivered by people who understand the challenges these women face when establishing and maintaining breastfeeding. | 10.1002/14651858.CD012099.pub2 | [
"We searched for evidence (January 2019) and identified seven randomised controlled trials (RCTs), involving 831 women (range 36 to 226 women), conducted in high-income countries (USA, Denmark, Australia) between 2006 and 2015. Three trials only included women who were obese prior to pregnancy and four trials included women who were overweight and women who were obese. The trials compared different types of breastfeeding support to usual care. There were a limited number of trials for each type of support, and differences in how much support the women received in the support and usual care groups. One trial (39 women) used a physical support intervention through the loan of an electric or manual breast pump versus usual care (no pump). Very low-certainty evidence means it is unclear whether physical support improves exclusive breastfeeding at four to six weeks; or any breastfeeding at four to six weeks. The trial did not report other important outcomes of interest: non-initiation of breastfeeding, and exclusive or any breastfeeding at six months after birth. Six trials (792 women) used multiple methods of support (including education and social support through telephone or face-to-face contact) versus usual care. One trial (174 women) did not report on any of our main outcomes of interest. One of the trials also provided physical support through providing a breast pump and a baby sling, and another provided a small gift to the women at each trial visit. Support in these trials was provided by a professional (four trials) or a peer (two trials), either in a group (one trial) or individually (five trials). For women receiving an intervention that incorporated multiple methods of support (including social, educational or physical support) versus usual care, we are unclear about the effects of the intervention because we identified very low-certainty evidence for all of the important outcomes in this review: rate of non-initiation of breastfeeding; exclusive breastfeeding at four to six weeks; any breastfeeding at four to six weeks; rate of exclusive breastfeeding at six months after birth; and any breastfeeding at six months after birth. The effectiveness of interventions for supporting women who are overweight or obese to start and continue breastfeeding remains unclear. The methods used by the available trials varied in quality, with small numbers of participants. No trials compared one type of support to another. We need high-quality trials to evaluate whether social, educational, physical support, or any combination of these interventions can give mothers who are overweight or obese the best chance of starting and continuing to breastfeed. The interventions need to be designed specifically for this group of women and delivered by people who understand the challenges these women face when establishing and maintaining breastfeeding."
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cochrane-simplification-train-1650 | cochrane-simplification-train-1650 | We included two trials involving 189 participants. One study, with 35 participants, compared methadone with levo-alpha-acetylmethadol (LAAM) for maintenance treatment lasting 16 weeks, after which patients were detoxified. The other study, with 154 participants, compared maintenance treatment with buprenorphine-naloxone and detoxification with buprenorphine. We did not perform meta-analysis because the two studies assessed different comparisons. In the study comparing methadone and LAAM, the authors declared that there was no difference in the use of a substance of abuse or social functioning (data not shown). The quality of the evidence was very low. No side effects, such as nausea, vomiting, constipation, weakness or fatigue, were reported by study participants. In the comparison between buprenorphine maintenance and buprenorphine detoxification, maintenance treatment appeared to be more efficacious in retaining patients in treatment (drop-out risk ratio (RR) 0.37; 95% confidence interval (CI) 0.26 to 0.54), but not in reducing the number of patients with a positive urine test at the end of the study (RR 0.97; 95% CI 0.78 to 1.22). Self reported opioid use at one-year follow-up was significantly lower in the maintenance group, even though both groups reported a high level of opioid use (RR 0.73; 95% CI 0.57 to 0.95). More patients in the maintenance group were enrolled in other addiction treatment programmes at 12-month follow-up (RR 1.33; 95% CI 0.94 to 1.88). The quality of the evidence was low. No serious side effects attributable to buprenorphine-naloxone were reported by study participants and no patients were removed from the study due to side effects. The most common side effect was headache, which was reported by 16% to 21% of patients in both groups It is difficult to draft conclusions on the basis of only two trials. One of the possible reasons for the lack of evidence could be the difficulty of conducting trials with young people for practical and ethical reasons. There is an urgent need for further randomised controlled trials comparing maintenance treatment with detoxification treatment or psychosocial treatment alone before carrying out studies that compare different pharmacological maintenance treatments. These studies should have long follow-up and measure relapse rates after the end of treatment and social functioning (integration at school or at work, family relationships). | The review authors searched the literature and identified two controlled trials from the USA that involved 187 heroin addicts, aged 14 to 21 years; the participants were treated as outpatients. One study of 37 participants compared methadone with levo-alpha-acetylmethadol (LAAM) for maintenance treatment. After 16 weeks of maintenance treatment the adolescents were detoxified. The second trial of 150 adolescents compared buprenorphine and naloxone as maintenance treatment for nine weeks followed by tapered doses for up to 12 weeks with buprenorphine detoxification over 14 days. In the first trial methadone and LAAM led to similar improvements in social functioning. No side effects were reported. In the second trial the maintenance treatment seemed to be more effective in retaining patients in treatment but not in reducing the use of drugs of abuse. At one-year follow-up, self reported opioid use was clearly less in the maintenance group and more adolescents were enrolled in other addiction programmes. The most common side effect in both groups was headache. No participants left the study because of side effects. It is difficult to draw conclusions about the use of maintenance pharmacological interventions from only two trials. Conducting trials with young people may be difficult for both practical and ethical reasons. This review was limited by the very low number of trials retrieved. The quality of the evidence was very low for the comparison between methadone and LAAM and low for the comparison between buprenorphine detoxification and buprenorphine maintenance. The evidence is current to January 2014. | 10.1002/14651858.CD007210.pub3 | [
"The review authors searched the literature and identified two controlled trials from the USA that involved 187 heroin addicts, aged 14 to 21 years; the participants were treated as outpatients. One study of 37 participants compared methadone with levo-alpha-acetylmethadol (LAAM) for maintenance treatment. After 16 weeks of maintenance treatment the adolescents were detoxified. The second trial of 150 adolescents compared buprenorphine and naloxone as maintenance treatment for nine weeks followed by tapered doses for up to 12 weeks with buprenorphine detoxification over 14 days. In the first trial methadone and LAAM led to similar improvements in social functioning. No side effects were reported. In the second trial the maintenance treatment seemed to be more effective in retaining patients in treatment but not in reducing the use of drugs of abuse. At one-year follow-up, self reported opioid use was clearly less in the maintenance group and more adolescents were enrolled in other addiction programmes. The most common side effect in both groups was headache. No participants left the study because of side effects. It is difficult to draw conclusions about the use of maintenance pharmacological interventions from only two trials. Conducting trials with young people may be difficult for both practical and ethical reasons. This review was limited by the very low number of trials retrieved. The quality of the evidence was very low for the comparison between methadone and LAAM and low for the comparison between buprenorphine detoxification and buprenorphine maintenance. The evidence is current to January 2014."
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cochrane-simplification-train-1651 | cochrane-simplification-train-1651 | At this update six trials and a new comparison (Mechanical bowel preparation versus enema) were added. Altogether eighteen trials were analysed, with 5805 participants; 2906 allocated to MBP (Group A), and 2899 to no preparation (Group B), before elective colorectal surgery. For the comparison Mechanical Bowel Preparation Versus No Mechanical Bowel Preparation results were: 1. Anastomotic leakage for low anterior resection: 8.8% (38/431) of Group A, compared with 10.3% (43/415) of Group B; Peto OR 0.88 [0.55, 1.40]. 2. Anastomotic leakage for colonic surgery: 3.0% (47/1559) of Group A, compared with 3.5% (56/1588) of Group B; Peto OR 0.85 [0.58, 1.26]. 3. Overall anastomotic leakage: 4.4% (101/2275) of Group A, compared with 4.5% (103/2258) of Group B; Peto OR 0.99 [0.74, 1.31]. 4. Wound infection: 9.6% (223/2305) of Group A, compared with 8.5% (196/2290) of Group B; Peto OR 1.16 [0.95, 1.42]. Sensitivity analyses did not produce any differences in overall results. For the comparison Mechanical Bowel Preparation (A) Versus Rectal Enema (B) results were: 1. Anastomotic leakage after rectal surgery: 7.4% (8/107) of Group A, compared with 7.9% (7/88) of Group B; Peto OR 0.93 [0.34, 2.52]. 2. Anastomotic leakage after colonic surgery: 4.0% (11/269) of Group A, compared with 2.0% (6/299) of Group B; Peto OR 2.15 [0.79, 5.84]. 3. Overall anastomotic leakage: 4.4% (27/601) of Group A, compared with 3.4% (21/609) of Group B; Peto OR 1.32 [0.74, 2.36]. 4. Wound infection: 9.9% (60/601) of Group A, compared with 8.0% (49/609) of Group B; Peto OR 1.26 [0.85, 1.88]. Despite the inclusion of more studies with a total of 5805 participants, there is no statistically significant evidence that patients benefit from mechanical bowel preparation, nor the use of rectal enemas. In colonic surgery the bowel cleansing can be safely omitted and induces no lower complication rate. The few studies focused in rectal surgery suggested that mechanical bowel preparation could be used selectively, even though no significant effect was found. Further research on patients submitted for elective rectal surgery, below the peritoneal verge, in whom bowel continuity is restored, and studies with patients submitted to laparoscopic surgeries are still warranted. | This review has identified all known trials that compared any kind of mechanical bowel preparation with no preparation (Comparison 1) and mechanical bowel preparation with rectal enema (Comparison 2) in patients submitted to elective colorectal surgery. Five new trials have been included in this third update of the review, bringing the total number of included trials to 18 (5805 participants). Analysis of these 18 trials showed no statistically significant differences in how well the three groups of patients (mechanical bowel preparation group, no preparation group and rectal enemas) did after surgery in terms of leakage at the surgical seam of the bowel ends, mortality rates, peritonitis, need for reoperation, wound infection, and other non-abdominal complications. Consequently, there is no evidence that mechanical bowel preparation improves the outcome for patients. Further research on mechanical bowel preparation or enemas versus no preparation in patients submitted for elective rectal surgery and laparoscopic colorectal surgery is warranted. | 10.1002/14651858.CD001544.pub4 | [
"This review has identified all known trials that compared any kind of mechanical bowel preparation with no preparation (Comparison 1) and mechanical bowel preparation with rectal enema (Comparison 2) in patients submitted to elective colorectal surgery. Five new trials have been included in this third update of the review, bringing the total number of included trials to 18 (5805 participants). Analysis of these 18 trials showed no statistically significant differences in how well the three groups of patients (mechanical bowel preparation group, no preparation group and rectal enemas) did after surgery in terms of leakage at the surgical seam of the bowel ends, mortality rates, peritonitis, need for reoperation, wound infection, and other non-abdominal complications. Consequently, there is no evidence that mechanical bowel preparation improves the outcome for patients. Further research on mechanical bowel preparation or enemas versus no preparation in patients submitted for elective rectal surgery and laparoscopic colorectal surgery is warranted."
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cochrane-simplification-train-1652 | cochrane-simplification-train-1652 | We included six RCTs that involved a total of 9484 participants. Mean follow-up was 3.7 years (range 1.0 to 4.7 years). All RCTs provided individual participant data. We found no change in total mortality (risk ratio (RR) 1.06, 95% confidence interval (CI) 0.91 to 1.23) or cardiovascular mortality (RR 1.03, 95% CI 0.82 to 1.29; moderate-quality evidence). Similarly, we found no differences in serious adverse events (RR 1.01, 95% CI 0.94 to 1.08; low-quality evidence) or total cardiovascular events (including myocardial infarction, stroke, sudden death, hospitalization, or death from congestive heart failure) (RR 0.89, 95% CI 0.80 to 1.00; low-quality evidence). Studies reported more participant withdrawals due to adverse effects in the lower target arm (RR 8.16, 95% CI 2.06 to 32.28; very low-quality evidence). Blood pressures were lower in the lower target group by 8.9/4.5 mmHg. More drugs were needed in the lower target group, but blood pressure targets were achieved more frequently in the standard target group. We found no evidence of a difference in total mortality, serious adverse events, or total cardiovascular events between people with hypertension and cardiovascular disease treated to a lower or to a standard blood pressure target. This suggests that no net health benefit is derived from a lower systolic blood pressure target. We found very limited evidence on adverse events, which led to high uncertainty. At present, evidence is insufficient to justify lower blood pressure targets (≤ 135/85 mmHg) in people with hypertension and established cardiovascular disease. More trials are needed to examine this topic. | For this updated review, we included six trials with 9484 participants who were followed-up from one year to 4.7 years. We analyzed data to detect differences between lower and standard blood pressure goals in terms of numbers of deaths and numbers of serious adverse events (leading to hospital admission). We found no differences in total numbers of deaths, heart or vascular deaths, total heart problems, or vascular problems, nor in total serious harms, between lower and standard blood pressure goal approaches. Based on very little information, we found more dropouts resulting from drug-related harms in the lower blood pressure target group and no overall health benefit among people in the lower target group. The best available evidence does not support lower blood pressure goals over standard goals in people with elevated blood pressure and heart or vascular problems. More new trials are needed to examine this question. Overall, the quality of evidence was assessed as low to moderate according to the GRADE assessment. | 10.1002/14651858.CD010315.pub3 | [
"For this updated review, we included six trials with 9484 participants who were followed-up from one year to 4.7 years. We analyzed data to detect differences between lower and standard blood pressure goals in terms of numbers of deaths and numbers of serious adverse events (leading to hospital admission). We found no differences in total numbers of deaths, heart or vascular deaths, total heart problems, or vascular problems, nor in total serious harms, between lower and standard blood pressure goal approaches. Based on very little information, we found more dropouts resulting from drug-related harms in the lower blood pressure target group and no overall health benefit among people in the lower target group. The best available evidence does not support lower blood pressure goals over standard goals in people with elevated blood pressure and heart or vascular problems. More new trials are needed to examine this question. Overall, the quality of evidence was assessed as low to moderate according to the GRADE assessment."
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cochrane-simplification-train-1653 | cochrane-simplification-train-1653 | No trials were included in the review. There are no published or ongoing randomised controlled clinical trials relevant to this review question. Therefore, in the absence of any high level evidence, clinicians should base their decisions on clinical experience and in conjunction with preferences of the individual where appropriate. This does not mean that carnitine is ineffective or should not be used in any inborn error of metabolism. However, given the lack of evidence both on the effectiveness and safety of carnitine and on the necessary dose and frequency to be prescribed, the current prescribing practice should continue to be observed and monitored with care until further evidence is available. Methodologically sound trials, reported according to the Consolidated Standards of Reporting Trials (CONSORT) statement, are required. It should be considered whether placebo-controlled trials in potentially lethal diseases, e.g. carnitine transporter disorder or glutaric aciduria type I, are ethical. | Unfortunately, we did not find any good quality trials to include in the review. This does not mean that carnitine is ineffective or should not be used in treating inborn errors of metabolism; however, individuals receiving carnitine should be carefully observed and monitored. Therefore, we recommend that clinicians base their decision to prescribe carnitine on clinical experience together with individual preferences. Future trials should include patient-reported outcomes using validated and internationally recognised scales. Any adverse events associated with the treatment should be reported. It should be carefully considered whether placebo-controlled trials in potentially lethal diseases, e.g. carnitine transporter disorder or glutaric aciduria type I, are ethical. | 10.1002/14651858.CD006659.pub3 | [
"Unfortunately, we did not find any good quality trials to include in the review. This does not mean that carnitine is ineffective or should not be used in treating inborn errors of metabolism; however, individuals receiving carnitine should be carefully observed and monitored. Therefore, we recommend that clinicians base their decision to prescribe carnitine on clinical experience together with individual preferences. Future trials should include patient-reported outcomes using validated and internationally recognised scales. Any adverse events associated with the treatment should be reported. It should be carefully considered whether placebo-controlled trials in potentially lethal diseases, e.g. carnitine transporter disorder or glutaric aciduria type I, are ethical."
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cochrane-simplification-train-1654 | cochrane-simplification-train-1654 | Six studies were added to this update resulting in a total of 29 included studies (n = 10,390). The quality of the studies was downgraded as there was a risk of bias in some individual studies relating to risk of attrition and reporting bias; in addition several studies did not adequately report on the randomisation methods used nor on how the treatment allocation was concealed. During the initial treatment period, the incidence of recurrent venous thromboembolic events was lower in participants treated with LMWH than in participants treated with UFH (Peto odds ratio (OR) 0.69, 95% confidence intervals (CI) 0.49 to 0.98; 6238 participants; 18 studies; P = 0.04; moderate-quality evidence). After a follow-up of three months, the period in most of the studies for which oral anticoagulant therapy was given, the incidence of recurrent VTE was lower in participants treated with LMWH than in participants with UFH (Peto OR 0.71, 95% CI 0.56 to 0.90; 6661 participants; 16 studies; P = 0.005; moderate-quality evidence). Furthermore, at the end of follow-up, LMWH was associated with a lower rate of recurrent VTE than UFH (Peto OR 0.72, 95% CI 0.59 to 0.88; 9489 participants; 22 studies; P = 0.001; moderate-quality evidence). LMWH was also associated with a reduction in thrombus size compared to UFH (Peto OR 0.71, 95% CI 0.61 to 0.82; 2909 participants; 16 studies; P < 0.00001; low-quality evidence), but there was moderate heterogeneity (I² = 56%). Major haemorrhages occurred less frequently in participants treated with LMWH than in those treated with UFH (Peto OR 0.69, 95% CI 0.50 to 0.95; 8780 participants; 25 studies; P = 0.02; moderate-quality evidence). There was no difference in overall mortality between participants treated with LMWH and those treated with UFH (Peto OR 0.84, 95% CI 0.70 to 1.01; 9663 participants; 24 studies; P = 0.07; moderate-quality evidence). This review presents moderate-quality evidence that fixed dose LMWH reduced the incidence of recurrent thrombotic complications and occurrence of major haemorrhage during initial treatment; and low-quality evidence that fixed dose LMWH reduced thrombus size when compared to UFH for the initial treatment of VTE. There was no difference in overall mortality between participants treated with LMWH and those treated with UFH (moderate-quality evidence). The quality of the evidence was assessed using GRADE criteria and downgraded due to concerns over risk of bias in individual trials together with a lack of reporting on the randomisation and concealment of treatment allocation methods used. The quality of the evidence for reduction of thrombus size was further downgraded because of heterogeneity between studies. | This review included 29 randomised controlled trials involving 10,390 participants (current to September 2016), which compared LMWH or UFH for treating people with blood clots. Pooling the results of these trials showed that fewer participants treated with LMWH formed further blood clots and that fewer cases of bleeding occurred. Use of LMWH also reduced the size of the original blood clot when compared to the UFH group. There was no difference in number of deaths between participants treated with LMWH and those treated with UFH. Quality of the evidence Results of this review indicate that LMWH may prevent further blood clots and bleeding in people with VTE. However, these findings must be interpreted with caution due to the moderate quality of the evidence as a result of lack of reporting of study methods and problems with study design. Results indicating reduced size of blood clots when taking LMWH also must be interpreted with caution due to the low quality of evidence as results were not similar across the studies. | 10.1002/14651858.CD001100.pub4 | [
"This review included 29 randomised controlled trials involving 10,390 participants (current to September 2016), which compared LMWH or UFH for treating people with blood clots. Pooling the results of these trials showed that fewer participants treated with LMWH formed further blood clots and that fewer cases of bleeding occurred. Use of LMWH also reduced the size of the original blood clot when compared to the UFH group. There was no difference in number of deaths between participants treated with LMWH and those treated with UFH. Quality of the evidence Results of this review indicate that LMWH may prevent further blood clots and bleeding in people with VTE. However, these findings must be interpreted with caution due to the moderate quality of the evidence as a result of lack of reporting of study methods and problems with study design. Results indicating reduced size of blood clots when taking LMWH also must be interpreted with caution due to the low quality of evidence as results were not similar across the studies."
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cochrane-simplification-train-1655 | cochrane-simplification-train-1655 | Ten studies were identified of which 4 met the inclusion criteria. The included studies either differed in the type of TNF-a blocking agent used or in the way outcomes were assessed to such an extent that we considered it inappropriate to combine the data statistically. There is evidence from one randomised controlled trial that suggests that a single intravenous infusion of the monoclonal antibody cA2, infliximab, may be effective for induction of remission in Crohn's disease. There was no difference in response rates among infliximab doses of 5, 10 or 20 mg/kg. The results of two other trials suggested that CDP571, the genetically engineered human TNF monoclonal antibody, may also be effective in reducing disease activity index at 2 weeks after an infusion. We did not find any evidence to support the use of etanercept in Crohn's disease. Evidence from one randomized controlled trial suggests that a single infusion of infliximab may be effective for induction of remission in Crohn's disease. Based on this study, we can recommend a dose of 5 mg/kg. There is also some evidence that CDP571 may be effective in inducing remission in Crohn's disease. We did not find any evidence that supports the use of etanercept in Crohn's disease. The period of follow up for the patients in these studies was probably too short to allow adequate assessment of recently reported serious adverse effects such as tuberculosis and lymphoma. | This review shows that a single intravenous infusion of infliximab (5 mg/kg) may be an effective treatment for patients with active Crohn's disease who no longer respond to corticosteroids or immunosuppressive drugs. There is also some evidence that CDP571, another TNF alpha blocking drug may be effective. There is no evidence to support the use of etanercept, a drug that blocks the action of TNF alpha by binding to receptors. There were no serious side effects associated with TNF blocking drugs, although the follow-up period of the studies reported in this review may have been too short to assess the development of serious side effects. | 10.1002/14651858.CD003574.pub2 | [
"This review shows that a single intravenous infusion of infliximab (5 mg/kg) may be an effective treatment for patients with active Crohn's disease who no longer respond to corticosteroids or immunosuppressive drugs. There is also some evidence that CDP571, another TNF alpha blocking drug may be effective. There is no evidence to support the use of etanercept, a drug that blocks the action of TNF alpha by binding to receptors. There were no serious side effects associated with TNF blocking drugs, although the follow-up period of the studies reported in this review may have been too short to assess the development of serious side effects."
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cochrane-simplification-train-1656 | cochrane-simplification-train-1656 | Thirty-four RCTs (enrolling 13,787 participants) fulfilled the eligibility criteria. Available evidence enabled us to address multiple clinical issues regarding the survival effects of second-line systemic therapy of people with metastatic CRC. 1. Chemotherapy (irinotecan) was more effective than best supportive care (HR for OS: 0.58, 95% CI 0.43 to 0.80; 1 RCT; moderate-quality evidence); 2. modern chemotherapy (FOLFOX (5-fluorouracil plus leucovorin plus oxaliplatin), irinotecan) is more effective than outdated chemotherapy (5-fluorouracil) (HR for PFS: 0.59, 95% CI 0.49 to 0.73; 2 RCTs; high-quality evidence) (HR for OS: 0.69, 95% CI 0.51 to 0.94; 1 RCT; moderate-quality evidence); 3. irinotecan-based combinations were more effective than irinotecan alone (HR for PFS: 0.68, 95% CI 0.60 to 0.76; 6 RCTs; moderate-quality evidence); 4. targeted agents improved the efficacy of conventional chemotherapy both when considered together (HR for OS: 0.84, 95% CI 0.77 to 0.91; 6 RCTs; high-quality evidence) and when bevacizumab was used alone (HR for PFS: 0.67, 95% CI 0.60 to 0.75; 4 RCTs; high-quality evidence). With regard to secondary endpoints, tumour response rates generally paralleled the survival results; moreover, higher anticancer efficacy was generally associated with worse treatment-related toxicity, with the important exception of bevacizumab-containing regimens, where the addition of the targeted agent to chemotherapy did not result in a significant increase in the rate of SAE. Finally, we found that oral (instead of intravenous) fluoropyrimidines significantly reduced the incidence of adverse effects (without compromising efficacy) in people treated with oxaliplatin-based regimens. We could not draw any conclusions on other debated aspects in this field of oncology, such as ranking of treatments (not all possible comparisons have been tested and many comparisons were based on single trials enrolling a small number of participants) and quality of life (virtually no data available). Systemic therapy offers a survival benefit to people with metastatic CRC who did not respond to first-line treatment, especially when targeted agents are combined with conventional chemotherapeutic drugs. Further research is needed to define the optimal regimen and to identify people who most benefit from each treatment. | The evidence is current to May 2016. In this updated review, we identified 34 clinical trials that compared second-line therapy with either no chemotherapy (best supportive care) or an alternative second-line therapy, so addressing the issue of second-line therapy performance in people with metastatic colorectal cancer. Available evidence seemed to support the use of second-line therapy because it improved survival expectations as compared to best supportive care, although this was reported in only one small trial and the result would need to be confirmed in further research. Moreover, we found that modern chemotherapy regimens were more effective than older ones that contained a drug called 5-fluorouracil, that combination chemotherapy was more effective than single agent chemotherapy and that targeted agents (so called 'smart drugs' that attack the cancer cells and do little damage to normal cells) increased the effectiveness of conventional chemotherapy. Generally, toxicity increased as effectiveness increased. The main conclusions of this review were based on moderate to high quality evidence. When the quality of the evidence was considered low or moderate, this was generally due to inconsistency in the main results (i.e. the result for progression-free survival (time from the start of second-line treatment to progression of the cancer) was not confirmed by overall survival (time from the start of second-line treatment to death from any cause)) and the low numbers of participants included in the analyses. Nevertheless, it should be remembered that progression-free survival nowadays is considered a reliable surrogate of overall survival (which includes all deaths, not just cancer-related, and requires longer follow-up to obtain an accurate estimate) in the setting of second-line therapy for metastatic colorectal cancer. Most of the trials did not report quality of life, which prevented us formally investigating the balance between survival benefits provided by second-line systemic therapy and treatment-related toxicity. | 10.1002/14651858.CD006875.pub3 | [
"The evidence is current to May 2016. In this updated review, we identified 34 clinical trials that compared second-line therapy with either no chemotherapy (best supportive care) or an alternative second-line therapy, so addressing the issue of second-line therapy performance in people with metastatic colorectal cancer. Available evidence seemed to support the use of second-line therapy because it improved survival expectations as compared to best supportive care, although this was reported in only one small trial and the result would need to be confirmed in further research. Moreover, we found that modern chemotherapy regimens were more effective than older ones that contained a drug called 5-fluorouracil, that combination chemotherapy was more effective than single agent chemotherapy and that targeted agents (so called 'smart drugs' that attack the cancer cells and do little damage to normal cells) increased the effectiveness of conventional chemotherapy. Generally, toxicity increased as effectiveness increased. The main conclusions of this review were based on moderate to high quality evidence. When the quality of the evidence was considered low or moderate, this was generally due to inconsistency in the main results (i.e. the result for progression-free survival (time from the start of second-line treatment to progression of the cancer) was not confirmed by overall survival (time from the start of second-line treatment to death from any cause)) and the low numbers of participants included in the analyses. Nevertheless, it should be remembered that progression-free survival nowadays is considered a reliable surrogate of overall survival (which includes all deaths, not just cancer-related, and requires longer follow-up to obtain an accurate estimate) in the setting of second-line therapy for metastatic colorectal cancer. Most of the trials did not report quality of life, which prevented us formally investigating the balance between survival benefits provided by second-line systemic therapy and treatment-related toxicity."
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cochrane-simplification-train-1657 | cochrane-simplification-train-1657 | In this updated review, one new eligible study was identified and included, yielding a total of two eligible studies (including a combined total of 401 participants). Of those 401 participants, 170 received 'high'-dose partial liquid ventilation (i.e. a mean dose of at least 20 mL/kg), 99 received 'low-dose' partial liquid ventilation (i.e. a dose of 10 mL/kg) and 132 received conventional mechanical ventilation (CMV). Pooled estimates of effect were calculated for all those who received 'high'-dose PLV versus conventional ventilation. No evidence indicated that 'high'-dose PLV either reduced mortality at 28 d (risk ratio (RR) 1.21, 95% confidence interval (CI) 0.79 to 1.85, P = 0.37) or increased the number of days free of CMV at 28 d (mean difference (MD) -2.24, 95% CI -4.71 to 0.23, P = 0.08). The pooled estimate of effect for bradycardia in those who received PLV was significantly greater than in those who received CMV (RR 2.51, 95% CI 1.31 to 4.81, P = 0.005). Pooled estimates of effect for the following adverse events-hypoxia, pneumothorax, hypotension and cardiac arrest-all showed a nonsignificant trend towards a higher occurrence of these events in those treated with PLV. Because neither eligible study addressed morbidity or mortality beyond 28 d, it was not possible to determine the effect of PLV on these outcomes. No evidence supports the use of PLV in ALI or ARDS; some evidence suggests an increased risk of adverse events associated with its use. | To provide the best possible answer to this question, this review was conducted in a special preplanned way with the intention of putting together the results of all selected studies to produce an overall measure of the value of partial liquid ventilation. Two eligible studies (including a total of 401 participants) were found, and a comparison was made between those who received similar doses of perfluorocarbon and those who received traditional ventilation. No evidence indicated that partial liquid ventilation reduced the risk of death or the duration of artifical ventilation, and some evidence suggested that it may increase the risk of complications, including low blood oxygen levels, low heart rate, low blood pressure, air leakage from the lungs and cardiac collapse. | 10.1002/14651858.CD003707.pub3 | [
"To provide the best possible answer to this question, this review was conducted in a special preplanned way with the intention of putting together the results of all selected studies to produce an overall measure of the value of partial liquid ventilation. Two eligible studies (including a total of 401 participants) were found, and a comparison was made between those who received similar doses of perfluorocarbon and those who received traditional ventilation. No evidence indicated that partial liquid ventilation reduced the risk of death or the duration of artifical ventilation, and some evidence suggested that it may increase the risk of complications, including low blood oxygen levels, low heart rate, low blood pressure, air leakage from the lungs and cardiac collapse."
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cochrane-simplification-train-1658 | cochrane-simplification-train-1658 | We detected four eligible trials. Two trials compared lower versus higher rates of glucose infusion in the early postnatal period. These trials were too small to assess effects on mortality or major morbidities. Two trials, one a moderately large multicentre trial (NIRTURE, Beardsall 2008), compared insulin infusion with standard care. Insulin infusion reduced hyperglycemia but increased death before 28 days and hypoglycemia. Reduction in hyperglycemia was not accompanied by significant effects on major morbidities; effects on neurodevelopment are awaited. Glucose infusion rate: There is insufficient evidence from trials comparing lower with higher glucose infusion rates to inform clinical practice. Large randomized trials are needed, powered on clinical outcomes including death, major morbidities and adverse neurodevelopment. Insulin infusion: The evidence reviewed does not support the routine use of insulin infusions to prevent hyperglycemia in VLBW neonates. Further randomized trials of insulin infusion may be justified. They should enrol extremely low birth weight neonates at very high risk for hyperglycemia and neonatal death. They might use real time glucose monitors if these are validated for clinical use. Refinement of algorithms to guide insulin infusion is needed to enable tight control of glucose concentrations within the target range. | Trials which compared lower with higher amounts of sugar delivered by vein were too small to determine effects on the health outcomes of the babies. Insulin was found to reduce the number of babies who developed high blood sugar levels, but the health outcomes of the babies were not improved. In fact, insulin infusion was associated with an increased risk of death before 28 days of age. | 10.1002/14651858.CD007615.pub3 | [
"Trials which compared lower with higher amounts of sugar delivered by vein were too small to determine effects on the health outcomes of the babies. Insulin was found to reduce the number of babies who developed high blood sugar levels, but the health outcomes of the babies were not improved. In fact, insulin infusion was associated with an increased risk of death before 28 days of age."
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cochrane-simplification-train-1659 | cochrane-simplification-train-1659 | Nine randomized placebo-controlled trials involving 499 individuals with HIV infection and AIDS met the inclusion criteria. Methodological quality of trials was assessed as adequate in five full publications and unclear in other trials. Eight different herbal medicines were tested. A compound of Chinese herbs (IGM-1) showed significantly better effect than placebo in improvement of health-related quality of life in 30 symptomatic HIV-infected patients (WMD 0.66, 95% CI 0.05 to 1.27). IGM-1 appeared not to affect overall health perception, symptom severity, CD4 count, anxiety or depression (Burack 1996a). An herbal formulation of 35 Chinese herbs did not affect CD4 cell counts, viral load, AIDS events, symptoms, psychosocial measure, or quality of life (Weber 1999). There was no statistical difference between SPV30 and placebo in new AIDS-defining events, CD4 cell counts, or viral load (Durant 1998) although an earlier pilot trial showed positive effect of SPV30 on CD4 cell count (Durant 1997). Combined treatment of Chinese herbal compound SH and antiretroviral agents showed increased antiviral benefit compared with antiretrovirals alone (Sangkitporn 2004). SP-303 appeared to reduce stool weight (p = 0.008) and abnormal stool frequency (p = 0.04) in 51 patients with AIDS and diarrhoea (Holodniy 1999). Qiankunning appeared not to affect HIV-1 RNA levels (Shi 2003), Curcumin ineffective in reducing viral load or improving CD4 cell counts (Hellinger 1996), and Capsaicin ineffective in relieving pain associated with HIV-related peripheral neuropathy (Paice 2000). The occurrence of adverse effects was higher in the 35 Chinese herbs preparation (19/24) than in placebo (11/29) (79% versus 38%, p = 0.003) (Weber 1999). Qiankunning was associated with stomach discomfort and diarrhoea (Shi 2003). There is insufficient evidence to support the use of herbal medicines in HIV-infected individuals and AIDS patients. Potential beneficial effects need to be confirmed in large, rigorous trials. | Although many trials of these therapies exist, very few meet the scientific standards necessary to support the claims of beneficial effects in the therapies studied. This review identified nine randomized clinical trials, which tested eight different herbal medicines, compared with placebo, in HIV-infected individuals or AIDS patients with diarrhoea. The results showed that a preparation called SPV30 may be helpful in delaying the progression of HIV disease in HIV-infected people who do not have any symptoms of this infection. A Chinese herbal medicine, IGM-1, seems to improve the quality of life in HIV-infected people who do have symptoms. Another herbal compound ,SH, showed an increase of antiviral benefit when combined with antiretroviral agents. A South American herb preparation, SP-303, may reduce the frequency of abnormal stools in AIDS patients with diarrhoea. Other herbs tested were no better than placebo; however, the beneficial effects need to be considered with caution because the number of patients in these trials was small and the size of the effects quite moderate. In one trial the use of medicinal herbs was related to adverse effects such as gastrointestinal discomfort. Conclusion: No compelling evidence exists to support the use of the herbal medicines identified in this review for treatment of HIV infection and AIDS. To ensure that evidence is reliable, there need to be larger and more rigorously-designed trials. | 10.1002/14651858.CD003937.pub2 | [
"Although many trials of these therapies exist, very few meet the scientific standards necessary to support the claims of beneficial effects in the therapies studied. This review identified nine randomized clinical trials, which tested eight different herbal medicines, compared with placebo, in HIV-infected individuals or AIDS patients with diarrhoea. The results showed that a preparation called SPV30 may be helpful in delaying the progression of HIV disease in HIV-infected people who do not have any symptoms of this infection. A Chinese herbal medicine, IGM-1, seems to improve the quality of life in HIV-infected people who do have symptoms. Another herbal compound ,SH, showed an increase of antiviral benefit when combined with antiretroviral agents. A South American herb preparation, SP-303, may reduce the frequency of abnormal stools in AIDS patients with diarrhoea. Other herbs tested were no better than placebo; however, the beneficial effects need to be considered with caution because the number of patients in these trials was small and the size of the effects quite moderate. In one trial the use of medicinal herbs was related to adverse effects such as gastrointestinal discomfort. Conclusion: No compelling evidence exists to support the use of the herbal medicines identified in this review for treatment of HIV infection and AIDS. To ensure that evidence is reliable, there need to be larger and more rigorously-designed trials."
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cochrane-simplification-train-1660 | cochrane-simplification-train-1660 | Four trials (2300 women) are included. The interventions ranged from brief advice through to education on health and lifestyle over several sessions. For most outcomes, data were only available from individual studies. Only one study followed up through pregnancy and there was no strong evidence of a difference between groups for preterm birth, congenital anomalies or weight for gestational age; only one finding (mean birthweight) reached statistical significance (mean difference -97.00, 95% confidence interval (CI) -168.05 to -25.95). This finding needs to be interpreted with caution as pregnancy outcome data were available for only half of the women randomised. There was some evidence that health promotion interventions were associated with positive maternal behavioural change including lower rates of binge drinking (risk ratio 1.24, 95% CI 1.06 to 1.44). Overall, there has been little research in this area and there is a lack of evidence on the effects of pre-pregnancy health promotion on pregnancy outcomes. There is little evidence on the effects of pre-pregnancy health promotion and much more research is needed in this area. There is currently insufficient evidence to recommend the widespread implementation of routine pre-pregnancy health promotion for women of childbearing age, either in the general population or between pregnancies. | The review looks at randomised controlled trials examining routine health promotion before pregnancy to see whether it changes behaviour and leads to improved health for mothers and babies. Four trials with 2300 women provided information for the review. The health promotion offered to women in these studies ranged from very brief advice on a specific topic through to more general advice and education on health and lifestyle over several sessions. In only one study were women followed up through pregnancy and there was little evidence of any differences between groups, although the babies of women who had received the health promotion intervention had slightly lower birthweights. There was some evidence that health promotion interventions encourage women to have more healthy lifestyles, such as lower rates of binge drinking. Overall, there was little evidence on the effects of pre-pregnancy health promotion on the health of mothers and babies, and more evidence is needed before its widespread implementation can be recommended. | 10.1002/14651858.CD007536.pub2 | [
"The review looks at randomised controlled trials examining routine health promotion before pregnancy to see whether it changes behaviour and leads to improved health for mothers and babies. Four trials with 2300 women provided information for the review. The health promotion offered to women in these studies ranged from very brief advice on a specific topic through to more general advice and education on health and lifestyle over several sessions. In only one study were women followed up through pregnancy and there was little evidence of any differences between groups, although the babies of women who had received the health promotion intervention had slightly lower birthweights. There was some evidence that health promotion interventions encourage women to have more healthy lifestyles, such as lower rates of binge drinking. Overall, there was little evidence on the effects of pre-pregnancy health promotion on the health of mothers and babies, and more evidence is needed before its widespread implementation can be recommended."
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cochrane-simplification-train-1661 | cochrane-simplification-train-1661 | We found two completed studies involving a total of 1136 participants that ultimately met our inclusion criteria. We also found one ongoing study and one planned study. We noted significant heterogeneity in the characteristics of interventions and outcomes measured or reported across these studies, thus we could not pool study results. One completed study considered the dispatch of police and fire service CFRs equipped with automatic external defibrillators (AEDs) in an EMS system in Amsterdam and surrounding areas. This study was an RCT with allocation made by cluster according to non-overlapping geographical regions. It was conducted between 5 January 2000 and 5 January 2002. All participants were 18 years of age or older and had experienced witnessed OHCA. The study found no difference in survival at hospital discharge (odds ratio (OR) 1.3, 95% confidence interval (CI) 0.8 to 2.2; 1 RCT; 469 participants; low-certainty evidence), despite the observation that all 72 incidences of defibrillation performed before EMS arrival occurred in the intervention group (OR and 95% CI - not applicable; 1 RCT; 469 participants; moderate-certainty evidence). This study reported increased survival to hospital admission in the intervention group (OR 1.5, 95% CI 1.1 to 2.0; 1 RCT; 469 participants; moderate-certainty evidence). The second completed study considered the dispatch of nearby lay volunteers in Stockholm, Sweden, who were trained to perform cardiopulmonary resuscitation (CPR). This represented a supplementary CFR intervention in an EMS system where police and fire services were already routinely dispatched to OHCA in addition to EMS ambulances. This study, an RCT, included both witnessed and unwitnessed OHCA and was conducted between 1 April 2012 and 1 December 2013. Participants included adults and children eight years of age and older. Researchers found no difference in 30-day survival (OR 1.34, 95% CI 0.79 to 2.29; 1 RCT; 612 participants; low-certainty evidence), despite a significant increase in CPR performed before EMS arrival (OR 1.49, 95% CI 1.09 to 2.03; 1 RCT; 665 participants; moderate-certainty evidence). Neither of the included completed studies considered neurological function at hospital discharge or at 30 days, measured by cerebral performance category or by any other means. Neither of the included completed studies considered health-related quality of life. The overall certainty of evidence for the outcomes of included studies was low to moderate. Moderate-certainty evidence shows that context-specific CFR interventions result in increased rates of CPR or defibrillation performed before EMS arrival. It remains uncertain whether this can translate to significantly increased rates of overall patient survival. When possible, further high-quality RCTs that are adequately powered to measure changes in survival should be conducted. The included studies did not consider survival with good neurological function. This outcome is likely to be important to patients and should be included routinely wherever survival is measured. We identified one ongoing study and one planned trial whose results once available may change the results of this review. As this review was limited to randomized and quasi-randomized trials, we may have missed some important data from other study types. | This review searched for high-quality research studies that considered whether mobilizing community first responders could improve survival or neurological outcome, or both, following out-of-hospital cardiac arrest in adults and children. We last searched available databases in January 2019. We found two eligible research studies with a total of 1136 participants. One study conducted in Stockholm, Sweden, and funded by the Swedish Heart-Lung Foundation, Laerdal Foundation, and Stockholm County, found that mobilizing community first responders increased the rate of CPR performed before arrival of emergency medical services (data on 665 participants). The other study was conducted in Amsterdam and surrounding areas (the Netherlands) and was funded by the Netherlands Heart Foundation and Medtronic Physio-Control. Study authors reported that when community first responders were mobilized, more patients received defibrillation before emergency medical services arrived and survived to be admitted to hospital (data on 469 participants). Neither study found that dispatching community first responders resulted in significantly more overall survivors (data on 612 participants in one study and on 469 participants in the other). Neither study reported on the neurological function of survivors or on their health-related quality of life. Further research is needed to establish whether mobilizing community first responders can yield more survivors of cardiac arrest. Future research should consider both survival and the neurological function of survivors. The certainty of available evidence in terms of overall patient survival was considered low. The certainty of available evidence in terms of performance of CPR and defibrillation before arrival of emergency medical services and in terms of survival to hospital admission was considered moderate. This evidence is current to January 2019. | 10.1002/14651858.CD012764.pub2 | [
"This review searched for high-quality research studies that considered whether mobilizing community first responders could improve survival or neurological outcome, or both, following out-of-hospital cardiac arrest in adults and children. We last searched available databases in January 2019. We found two eligible research studies with a total of 1136 participants. One study conducted in Stockholm, Sweden, and funded by the Swedish Heart-Lung Foundation, Laerdal Foundation, and Stockholm County, found that mobilizing community first responders increased the rate of CPR performed before arrival of emergency medical services (data on 665 participants). The other study was conducted in Amsterdam and surrounding areas (the Netherlands) and was funded by the Netherlands Heart Foundation and Medtronic Physio-Control. Study authors reported that when community first responders were mobilized, more patients received defibrillation before emergency medical services arrived and survived to be admitted to hospital (data on 469 participants). Neither study found that dispatching community first responders resulted in significantly more overall survivors (data on 612 participants in one study and on 469 participants in the other). Neither study reported on the neurological function of survivors or on their health-related quality of life. Further research is needed to establish whether mobilizing community first responders can yield more survivors of cardiac arrest. Future research should consider both survival and the neurological function of survivors. The certainty of available evidence in terms of overall patient survival was considered low. The certainty of available evidence in terms of performance of CPR and defibrillation before arrival of emergency medical services and in terms of survival to hospital admission was considered moderate. This evidence is current to January 2019."
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cochrane-simplification-train-1662 | cochrane-simplification-train-1662 | We found six trials of five different interventions eligible for inclusion in this review. The trials were conducted in hospitals in Canada, China, Germany, Japan and the UK, and included 151 participants in total. All trials randomised participants aged 16 years and older (mean or median age in the trials ranged from 36 to 57 years in the intervention groups and 34 to 60 years in the control groups) with severe GBS, defined by the inability to walk unaided. One trial also randomised patients with mild GBS who were still able to walk unaided. We identified two new trials at this update.The primary outcome measure for this review was improvement in disability grade four weeks after randomisation. Four of six trials had a high risk of bias in at least one respect. We assessed all evidence for the outcome mean improvement in disability grade as very low certainty, which means that we were unable to draw any conclusions from the data. One RCT with 19 participants compared interferon beta-1a (IFNb-1a) and placebo. It is uncertain whether IFNb-1a improves disability after four weeks (mean difference (MD) -0.1; 95% CI −1.58 to 1.38; very low-certainty evidence). A trial with 10 participants compared brain-derived neurotrophic factor (BNDF) and placebo. It is uncertain whether BDNF improves disability after four weeks (MD 0.75; 95% CI −1.14 to 2.64; very low-certainty evidence). A trial with 37 participants compared cerebrospinal fluid (CSF) filtration and plasma exchange. It is uncertain whether CSF filtration improves disability after four weeks (MD 0.02; 95% CI −0.62 to 0.66; very low-certainty evidence). One trial that compared the Chinese herbal medicine tripterygium polyglycoside with corticosteroids with 43 participants did not report the risk ratio (RR) for an improvement by one or more disability grade after four weeks, but did report improvement after eight weeks. It is uncertain whether tripterygium polyglycoside improves disability after eight weeks (RR 1.47; 95% CI 1.02 to 2.11; very low-certainty evidence). We performed a meta-analysis of two trials comparing eculizumab and placebo with 41 participants. It is uncertain whether eculizumab improves disability after four weeks (MD -0.23; 95% CI −1.79 to 1.34; very low-certainty evidence). Serious adverse events were uncommon in each of the trials and evidence was graded as either low or very low. It is uncertain whether serious adverse events were more common with IFNb-1a versus placebo (RR 0.92, 95% CI 0.23 to 3.72; 19 participants), BNDF versus placebo (RR 1.00, 95% CI 0.28 to 3.54; 10 participants) or CSF filtration versus plasma exchange (RR 0.13, 95% CI 0.01 to 2.25; 37 participants). The trial of tripterygium polyglycoside did not report serious adverse events. There may be no clear difference in the number of serious adverse events after eculizumab compared to placebo (RR 1.90, 0.34 to 10.50; 41 participants). We found no clinically important differences in any of the outcome measures selected for this review in any of the six trials. However, sample sizes were small and therefore clinically important benefit or harm cannot be excluded. All six RCTs were too small to exclude clinically important benefit or harm from the assessed interventions. The certainty of the evidence was low or very low for all interventions and outcomes. | Cochrane Review authors collected and analysed all relevant randomised controlled trials (RCTs) to answer the review question. In RCTs people are allocated to treatment groups at random, which reduces bias. We found six eligible RCTs testing five different treatments in a total of 151 participants. We were uncertain about the evidence from the trials. One RCT with only 19 participants compared interferon beta-1a (a drug that is beneficial in multiple sclerosis) with placebo (a sham treatment). Another, with only 10 participants, compared a nerve growth factor which, in theory, should be beneficial in people with GBS, with placebo. A third trial, with 37 participants, compared cerebrospinal fluid filtration (washing the nerve roots around the spinal cord) with plasma exchange. A fourth trial with 43 participants compared the Chinese herbal medicine tripterygium polyglycoside, which is thought to have anti-inflammatory properties, with corticosteroids. A fifth trial with eight participants and a sixth with 34 participants compared eculizumab (a drug that blocks complement, a key inflammatory component) with placebo. Five trials received commercial company support. Support for the trial of the Chinese herbal medicine is unknown. None of these trials was large enough to confirm or refute the benefit or harm of any of these drugs in the treatment of people with acute GBS. The only trial that found a difference between treatments was the Chinese herbal medicine trial: participants receiving the herbal medicine were one and a half times more likely to have improved disability after eight weeks than those receiving corticosteroids. However, this estimate was uncertain and the trial authors did not report other clinical outcomes. Serious adverse events were uncommon with each of the five treatments investigated in the identified trials and rates were not different from those in the control groups. We identified very little evidence other than that from RCTs. There is a need to develop and test new treatments for GBS, and to adopt more sensitive outcome measures. The evidence is up to date to October 2019. | 10.1002/14651858.CD008630.pub5 | [
"Cochrane Review authors collected and analysed all relevant randomised controlled trials (RCTs) to answer the review question. In RCTs people are allocated to treatment groups at random, which reduces bias. We found six eligible RCTs testing five different treatments in a total of 151 participants. We were uncertain about the evidence from the trials. One RCT with only 19 participants compared interferon beta-1a (a drug that is beneficial in multiple sclerosis) with placebo (a sham treatment). Another, with only 10 participants, compared a nerve growth factor which, in theory, should be beneficial in people with GBS, with placebo. A third trial, with 37 participants, compared cerebrospinal fluid filtration (washing the nerve roots around the spinal cord) with plasma exchange. A fourth trial with 43 participants compared the Chinese herbal medicine tripterygium polyglycoside, which is thought to have anti-inflammatory properties, with corticosteroids. A fifth trial with eight participants and a sixth with 34 participants compared eculizumab (a drug that blocks complement, a key inflammatory component) with placebo. Five trials received commercial company support. Support for the trial of the Chinese herbal medicine is unknown. None of these trials was large enough to confirm or refute the benefit or harm of any of these drugs in the treatment of people with acute GBS. The only trial that found a difference between treatments was the Chinese herbal medicine trial: participants receiving the herbal medicine were one and a half times more likely to have improved disability after eight weeks than those receiving corticosteroids. However, this estimate was uncertain and the trial authors did not report other clinical outcomes. Serious adverse events were uncommon with each of the five treatments investigated in the identified trials and rates were not different from those in the control groups. We identified very little evidence other than that from RCTs. There is a need to develop and test new treatments for GBS, and to adopt more sensitive outcome measures. The evidence is up to date to October 2019."
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cochrane-simplification-train-1663 | cochrane-simplification-train-1663 | We included two studies (212 participants) comparing antibiotics versus no treatment, and identified three on-going studies. Overall, incidence of symptomatic UTI varied between 19% and 31% in the groups not treated for asymptomatic bacteriuria. Antibiotic treatment had uncertain effects on preventing symptomatic UTI (2 studies, 200 participants: RR 0.86, 95% CI 0.51 to 1.45). Risk for selecting multidrug-resistant organisms was uncertain with antibiotic treatment (1 study, 112 participants: RR 1.21, 95% CI 0.60 to 2.41). Persistence of asymptomatic bacteriuria was high regardless of treatment. Antibiotics also have uncertain effects on other important patient and graft outcomes, for instance on all-cause mortality (1 study, 112 participants: RR 2.23, 95% CI 0.21 to 23.86), graft loss (1 study, 112 participants: RR 1.11, 95% CI 0.07 to 17.36), acute rejection (1 study, 112 participants: RR 0.93, 95% CI 0.44 to 1.97), hospitalisation for UTI (1 study, 112 participants: RR 0.74, 95% CI 0.13 to 4.27), graft function (2 studies, 200 participants, MD in serum creatinine concentration -0.06 mg/dL, 95% CI -0.19 to 0.08) and adverse reactions (1 study, 112 participants: no severe adverse event attributable to the antibiotic treatment). Evidence quality was low for all outcomes. Currently, there is insufficient evidence to support routinely treating kidney transplant recipients with antibiotics in case of asymptomatic bacteriuria after transplantation, but data are scarce. Further studies assessing routine antibiotic treatment would inform practice and we await the results of three ongoing randomised studies, which may help resolve existing uncertainties. | The bacterial infection of the urine often persisted, whether antibiotics were given or not. It was uncertain whether antibiotics prevented symptomatic urinary infection or increased the risk of selecting bacteria resistant to antibiotics, because there were too few data and several limitations in the included studies. Also, it was unclear whether the use of antibiotics in case of urinary infection without symptoms reduced the risks of graft rejection, need for hospitalisation due to symptoms of urinary infection, or mortality, or whether antibiotics improved the function of the kidney transplant. One study with 112 participants suggested there were no severe harmful reactions caused by the antibiotic treatment, and non-severe adverse events appeared to be rare. It is uncertain whether antibiotics are beneficial in kidney transplant recipients with bacteria in their urine but no symptoms. In one study, participants were assigned to antibiotics or no therapy by a method that was not random (i.e. according to patients' transplant code). In both studies, participants knew which treatment they were receiving (i.e. antibiotics or no therapy), which may have influenced the results. Last, we had not enough data to estimate with precision some effects of antibiotics. More research is needed. | 10.1002/14651858.CD011357.pub2 | [
"The bacterial infection of the urine often persisted, whether antibiotics were given or not. It was uncertain whether antibiotics prevented symptomatic urinary infection or increased the risk of selecting bacteria resistant to antibiotics, because there were too few data and several limitations in the included studies. Also, it was unclear whether the use of antibiotics in case of urinary infection without symptoms reduced the risks of graft rejection, need for hospitalisation due to symptoms of urinary infection, or mortality, or whether antibiotics improved the function of the kidney transplant. One study with 112 participants suggested there were no severe harmful reactions caused by the antibiotic treatment, and non-severe adverse events appeared to be rare. It is uncertain whether antibiotics are beneficial in kidney transplant recipients with bacteria in their urine but no symptoms. In one study, participants were assigned to antibiotics or no therapy by a method that was not random (i.e. according to patients' transplant code). In both studies, participants knew which treatment they were receiving (i.e. antibiotics or no therapy), which may have influenced the results. Last, we had not enough data to estimate with precision some effects of antibiotics. More research is needed."
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cochrane-simplification-train-1664 | cochrane-simplification-train-1664 | The search identified three RCTs with 138 participants. All three trials included only children with viral encephalitis, one of these included only children with Japanese encephalitis, a specific form of viral encephalitis. Only the trial of Japanese encephalitis (22 children) contributed to the primary outcome of this review and follow-up in that study was for three to six months after hospital discharge. There was no follow-up of participants in the other two studies. We identified one ongoing trial. For the primary outcomes, the results showed no significant difference between IVIG and placebo when used in the treatment of children with Japanese encephalitis: significant disability (RR 0.75, 95% CI 0.22 to 2.60; P = 0.65) and serious adverse events (RR 1.00, 95% CI 0.07 to 14.05; P = 1.00). For the secondary outcomes, the study of Japanese encephalitis showed no significant difference between IVIG and placebo when assessing significant disability at hospital discharge (RR 1.00, 95% CI 0.60 to 1.67). There was no significant difference (P = 0.53) in Glasgow Coma Score at discharge between IVIG (median score 14; range 3 to 15) and placebo (median 14 score; range 7 to 15) in the Japanese encephalitis study. The median length of hospital stay in the Japanese encephalitis study was similar for IVIG-treated (median 13 days; range 9 to 21) and placebo-treated (median 12 days; range 6 to 18) children (P = 0.59). Pooled analysis of the results of the other two studies resulted in a significantly lower mean length of hospital stay (MD -4.54 days, 95% CI -7.47 to -1.61; P = 0.002), time to resolution of fever (MD -0.97 days, 95% CI -1.25 to -0.69; P < 0.00001), time to stop spasms (MD -1.49 days, 95% CI -1.97 to -1.01; P < 0.00001), time to regain consciousness (MD -1.10 days, 95% CI -1.48 to -0.72; P < 0.00001), and time to resolution of neuropathic symptoms (MD -3.20 days, 95% CI -3.34 to -3.06; P < 0.00001) in favour of IVIG when compared with standard care. None of the included studies reported other outcomes of interest in this review including need for invasive ventilation, duration of invasive ventilation, cognitive impairment, poor adaptive functioning, quality of life, number of seizures, and new diagnosis of epilepsy. The quality of evidence was very low for all outcomes of this review. The findings suggest a clinical benefit of adjunctive IVIG treatment for children with viral encephalitis for some clinical measures (i.e. mean length of hospital stay, time (days) to stop spasms, time to regain consciousness, and time to resolution of neuropathic symptoms and fever. For children with Japanese encephalitis, IVIG had a similar effect to placebo when assessing significant disability and serious adverse events. Despite these findings, the risk of bias in the included studies and quality of the evidence make it impossible to reach any firm conclusions on the efficacy and safety of IVIG as add-on treatment for children with encephalitis. Furthermore, the included studies involved only children with viral encephalitis, therefore findings of this review cannot be generalised to all forms of encephalitis. Future well-designed RCTs are needed to assess the efficacy and safety of IVIG in the management of children with all forms of encephalitis. There is a need for internationally agreed core outcome measures for clinical trials in childhood encephalitis. | We searched medical databases for studies in which neither participants nor researchers were told which treatment was given (called a randomised double-blind trial). The effectiveness and safety of IVIG were considered in terms of the occurrence of significant disability at six months after hospital discharge and the proportion of children experiencing at least one serious side effect. Up to 30 September 2016, only three studies comprising 138 children met the criteria to be included in this review. All three studies included only children with viral encephalitis. One study of Japanese encephalitis, a specific form of viral encephalitis, analysed both effectiveness and safety, and concluded that IVIG treatment had no additional beneficial effects when compared with placebo (pretend) treatment. The other two studies analysed other measurements, such as length of hospital stay, time to resolution of spasms, symptoms arising due to nerve damage, and time to regain consciousness and concluded that adding IVIG treatment was more effective than standard care alone when these outcomes were considered. The quality of the evidence was very low due to the small number of children and studies. The quality of evidence in the included studies was very low, making it impossible to draw any firm and definite conclusions on the clinical efficacy and safety of IVIG treatment for children with encephalitis. Furthermore, there was no information on funding while, for one study, the main authors' group was affiliated to the funding body: this is a well-known potential source of conflict of interest and thus of bias. | 10.1002/14651858.CD011367.pub2 | [
"We searched medical databases for studies in which neither participants nor researchers were told which treatment was given (called a randomised double-blind trial). The effectiveness and safety of IVIG were considered in terms of the occurrence of significant disability at six months after hospital discharge and the proportion of children experiencing at least one serious side effect. Up to 30 September 2016, only three studies comprising 138 children met the criteria to be included in this review. All three studies included only children with viral encephalitis. One study of Japanese encephalitis, a specific form of viral encephalitis, analysed both effectiveness and safety, and concluded that IVIG treatment had no additional beneficial effects when compared with placebo (pretend) treatment. The other two studies analysed other measurements, such as length of hospital stay, time to resolution of spasms, symptoms arising due to nerve damage, and time to regain consciousness and concluded that adding IVIG treatment was more effective than standard care alone when these outcomes were considered. The quality of the evidence was very low due to the small number of children and studies. The quality of evidence in the included studies was very low, making it impossible to draw any firm and definite conclusions on the clinical efficacy and safety of IVIG treatment for children with encephalitis. Furthermore, there was no information on funding while, for one study, the main authors' group was affiliated to the funding body: this is a well-known potential source of conflict of interest and thus of bias."
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cochrane-simplification-train-1665 | cochrane-simplification-train-1665 | We included eight RCTs that evaluated the effects of chlorhexidine varnishes (1%, 10% or 40% concentration) and chlorhexidine gel (0.12%) on the primary or permanent teeth, or both, of children from birth to 15 years of age at the start of the study. The studies randomised a total of 2876 participants, of whom 2276 (79%) were evaluated. We assessed six studies as being at high risk of bias overall and two studies as being at unclear risk of bias overall. Follow-up assessment ranged from 6 to 36 months. Six trials compared chlorhexidine varnish with placebo or no treatment. It was possible to pool the data from two trials in the permanent dentition (one study using 10% chlorhexidine and the other, 40%). This led to an increase in the DMFS increment in the varnish group of 0.53 (95% confidence interval (CI) -0.47 to 1.53; two trials, 690 participants; very low quality evidence). Only one trial (10% concentration chlorhexidine varnish) provided usable data for elevated mutans streptococci levels > 4 with RR 0.93 (95% CI 0.80 to 1.07, 496 participants; very low quality evidence). One trial measured adverse effects (for example, ulcers or tooth staining) and reported that there were none; another trial reported that no side effects of the treatment were noted. No trials reported on pain, quality of life, patient satisfaction or costs. Two trials compared chlorhexidine gel (0.12% concentration) with no treatment in the primary dentition. The presence of new caries gave rise to a 95% confidence interval that was compatible with either an increase or a decrease in caries incidence (RR 1.00, 95% CI 0.36 to 2.77; 487 participants; very low quality evidence). Similarly, data for the effects of chlorhexidine gel on the prevalence of mutans streptococci were inconclusive (RR 1.26, 95% CI 0.95 to 1.66; two trials, 490 participants; very low quality evidence). Both trials measured adverse effects and did not observe any. Neither of these trials reported on the other secondary outcomes such as measures of pain, quality of life, patient satisfaction or direct and indirect costs of interventions. We found little evidence from the eight trials on varnishes and gels included in this review to either support or refute the assertion that chlorhexidine is more effective than placebo or no treatment in the prevention of caries or the reduction of mutans streptococci levels in children and adolescents. There were no trials on other products containing chlorhexidine such as sprays, toothpastes, chewing gums or mouthrinses. Further high quality research is required, in particular evaluating the effects on both the primary and permanent dentition and using other chlorhexidine-containing oral products. | The evidence in this review, carried out through the Cochrane Oral Health Group, is up-to-date at 25 February 2015. We found eight studies that were suitable to include in this review. The studies involved a total of 2876 children from birth to 15 years of age who were at moderate to high risk of tooth decay. Six of the studies looked at the effects of dental professionals applying different strengths of chlorhexidine varnishes to the baby teeth, permanent teeth or both types of teeth in children and adolescents. The other two studies looked at the effects of parents placing chlorhexidine gel on their children's baby teeth. There were no studies that examined other products containing chlorhexidine, such as sprays, toothpastes, chewing gums or mouthrinses. The results did not provide evidence that chlorhexidine varnish or gel reduces tooth decay or reduces the bacteria that encourage tooth decay. The studies did not evaluate other outcomes such as pain, quality of life, patient satisfaction or direct and indirect costs of interventions. Four studies measured side effects and found none were observed. Due to the lack of suitable studies and concerns about possible bias in the included studies, the evidence is very low quality. As a result, we are not able to conclude whether or not chlorhexidine is effective in preventing tooth decay in children or adolescents, when compared to placebo (an inactive substitute for chlorhexidine) or no treatment. Future research on the use of chlorhexidine to prevent tooth decay is needed and should consider both primary and permanent teeth and should assess other chlorhexidine-containing products that can be used at home, such as toothpastes or mouthrinses. | 10.1002/14651858.CD008457.pub2 | [
"The evidence in this review, carried out through the Cochrane Oral Health Group, is up-to-date at 25 February 2015. We found eight studies that were suitable to include in this review. The studies involved a total of 2876 children from birth to 15 years of age who were at moderate to high risk of tooth decay. Six of the studies looked at the effects of dental professionals applying different strengths of chlorhexidine varnishes to the baby teeth, permanent teeth or both types of teeth in children and adolescents. The other two studies looked at the effects of parents placing chlorhexidine gel on their children's baby teeth. There were no studies that examined other products containing chlorhexidine, such as sprays, toothpastes, chewing gums or mouthrinses. The results did not provide evidence that chlorhexidine varnish or gel reduces tooth decay or reduces the bacteria that encourage tooth decay. The studies did not evaluate other outcomes such as pain, quality of life, patient satisfaction or direct and indirect costs of interventions. Four studies measured side effects and found none were observed. Due to the lack of suitable studies and concerns about possible bias in the included studies, the evidence is very low quality. As a result, we are not able to conclude whether or not chlorhexidine is effective in preventing tooth decay in children or adolescents, when compared to placebo (an inactive substitute for chlorhexidine) or no treatment. Future research on the use of chlorhexidine to prevent tooth decay is needed and should consider both primary and permanent teeth and should assess other chlorhexidine-containing products that can be used at home, such as toothpastes or mouthrinses."
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cochrane-simplification-train-1666 | cochrane-simplification-train-1666 | We added nine studies to this review to bring the total number of included studies to 32 comparing an intervention tailored to address identified determinants of practice to no intervention or an intervention(s) not tailored to the determinants. The outcome was implementation of recommended practice, e.g. clinical practice guideline recommendations. Fifteen studies provided enough data to be included in the quantitative analysis. The pooled odds ratio was 1.56 (95% confidence interval (CI) 1.27 to 1.93, P value < 0.001). The 17 studies not included in the meta-analysis had findings showing variable effectiveness consistent with the findings of the meta-regression. Despite the increase in the number of new studies identified, our overall finding is similar to that of the previous review. Tailored implementation can be effective, but the effect is variable and tends to be small to moderate. The number of studies remains small and more research is needed, including trials comparing tailored interventions to no or other interventions, but also studies to develop and investigate the components of tailoring (identification of the most important determinants, selecting interventions to address the determinants). Currently available studies have used different methods to identify determinants of practice and different approaches to selecting interventions to address the determinants. It is not yet clear how best to tailor interventions and therefore not clear what the effect of an optimally tailored intervention would be. | In a previous review, we included 26 studies and we concluded that tailoring can change professional practice. However, more studies of tailoring have been published and therefore we have incorporated the new studies into an update of the review. We have included 32 studies in the new review. The findings continue to indicate that tailored interventions can change professional practice, although they are not always effective and, when they are, the effect is small to moderate. There is insufficient evidence on the most effective approaches to tailoring, including how determinants should be identified, how decisions should be made on which determinants are most important to address, and how interventions should be selected to account for the important determinants. In addition, there is no evidence about the cost-effectiveness of tailored interventions compared to other interventions to change professional practice. Therefore, future research studies should seek to develop and evaluate more systematic approaches to tailoring. | 10.1002/14651858.CD005470.pub3 | [
"In a previous review, we included 26 studies and we concluded that tailoring can change professional practice. However, more studies of tailoring have been published and therefore we have incorporated the new studies into an update of the review. We have included 32 studies in the new review. The findings continue to indicate that tailored interventions can change professional practice, although they are not always effective and, when they are, the effect is small to moderate. There is insufficient evidence on the most effective approaches to tailoring, including how determinants should be identified, how decisions should be made on which determinants are most important to address, and how interventions should be selected to account for the important determinants. In addition, there is no evidence about the cost-effectiveness of tailored interventions compared to other interventions to change professional practice. Therefore, future research studies should seek to develop and evaluate more systematic approaches to tailoring."
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cochrane-simplification-train-1667 | cochrane-simplification-train-1667 | The updated search resulted in the identification of one ongoing trial comparing surgery versus conservative treatment. Four trials, involving a total of 237 participants, were included. All four trials were methodologically flawed and potentially biased. Three trials tested conservative treatment interventions. One trial, which compared short arm (below elbow) pre-fabricated functional braces with long arm (elbow included) plaster casts, found there was no significant difference in the time it took for fracture union. Patient satisfaction and return to work during treatment were significantly better in the brace group. The other two trials, both quasi-randomised, had three treatment groups. One trial compared Ace Wrap elastic bandage versus short arm plaster cast versus long arm plaster cast. The large loss to follow-up in this trial makes any data analysis tentative. However, the need for replacement of the Ace wrap by other methods due to pain indicates the potential for a serious problem with this intervention. The other trial, which compared immediate mobilisation versus short arm plaster cast versus long arm plaster cast for minimally displaced fractures, found no significant differences in outcome between these three interventions. The fourth trial, which compared two types of plates for surgical fixation, found no significant differences in functional or anatomical outcomes nor complications between the two groups. There is insufficient evidence from randomised trials to determine which method of treatment is the most appropriate for isolated fractures of the ulnar shaft in adults. Well designed and reported randomised trials of current forms of conservative treatment are recommended. | Four trials, involving a total of 237 participants, were included in the review. These trials had methodological weaknesses that could have resulted in serious bias. One trial compared 'short arm' (splintage stopping below the elbow) pre-fabricated functional braces with 'long arm' (splintage includes the elbow) plaster casts. It found no clear difference between the two groups in the time taken for the fracture to heal. However, significantly more people in the brace group were satisfied with their treatment and significantly more returned to work during their treatment. One trial compared Ace Wrap elastic bandage, short arm plaster cast and long arm plaster cast. The large loss to follow-up in this trial makes any findings tentative. However, the need for replacement of the Ace wrap by other methods due to pain does indicate the potential for a serious problem with this intervention. The third trial, which compared immediate mobilisation versus short arm plaster cast versus long arm plaster cast for minimally displaced fractures, found no clear differences in outcome between these three interventions. The fourth trial found no significant differences in functional or anatomical outcomes nor complications between the two types of plates used for surgical fixation of the fracture. Overall, there was not enough evidence from randomised controlled trials to show which methods of treatment are better for these injuries. | 10.1002/14651858.CD000523.pub4 | [
"Four trials, involving a total of 237 participants, were included in the review. These trials had methodological weaknesses that could have resulted in serious bias. One trial compared 'short arm' (splintage stopping below the elbow) pre-fabricated functional braces with 'long arm' (splintage includes the elbow) plaster casts. It found no clear difference between the two groups in the time taken for the fracture to heal. However, significantly more people in the brace group were satisfied with their treatment and significantly more returned to work during their treatment. One trial compared Ace Wrap elastic bandage, short arm plaster cast and long arm plaster cast. The large loss to follow-up in this trial makes any findings tentative. However, the need for replacement of the Ace wrap by other methods due to pain does indicate the potential for a serious problem with this intervention. The third trial, which compared immediate mobilisation versus short arm plaster cast versus long arm plaster cast for minimally displaced fractures, found no clear differences in outcome between these three interventions. The fourth trial found no significant differences in functional or anatomical outcomes nor complications between the two types of plates used for surgical fixation of the fracture. Overall, there was not enough evidence from randomised controlled trials to show which methods of treatment are better for these injuries."
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cochrane-simplification-train-1668 | cochrane-simplification-train-1668 | The search retrieved 1585 records; from those five studies were eligible, including 351 women (intervention = 166; control = 185). All studies were judged to be at high risk of bias. All reported per-woman rather than per-cycle data. When use of low-dose hCG to replace FSH was compared with conventional COH for the outcome of live birth, confidence intervals were very wide and findings were compatible with appreciable benefit, no effect or appreciable harm for the intervention (RR 1.56, 95% CI 0.75 to 3.25, 2 studies, 130 women, I² = 0%, very-low-quality evidence). This suggests that for women with a 14% chance of achieving live birth using conventional COH, the chance of achieving live birth using low-dose hCG would be between 10% and 45%. Similarly confidence intervals were very wide for the outcome of OHSS and findings were compatible with benefit, no effect or harm for the intervention (OR 0.30, 95% CI 0.06 to 1.59, 5 studies, 351 women, I² = 59%, very-low-quality evidence). This suggests that for women with a 3% risk of OHSS using conventional COH, the risk using low-dose hCG would be between 0% and 4%. The confidence intervals were wide for the outcome of ongoing pregnancy and findings were compatible with benefit or no effect for the intervention (RR 1.14, 95% CI 0.81 to 1.60, 3 studies, 252 women, I² = 0%, low-quality evidence). This suggests that for women with a 32% chance of achieving ongoing pregnancy using conventional COH, the chance using low-dose hCG would be between 27% and 53%. The confidence intervals were wide for the outcome of clinical pregnancy and findings were compatible with benefit or no effect for the intervention (RR 1.19, 95% CI 0.92 to 1.55, 5 studies, 351 women, I² = 0%, low-quality evidence). This suggests that for women with a 35% chance of achieving clinical pregnancy using conventional COH, the chance using low-dose hCG would be between 32% and 54%. The confidence intervals were very wide for the outcome of miscarriage and findings were compatible with benefit, no effect or harm for the intervention (RR 1.08, 95% CI 0.50 to 2.31, 3 studies, 127 pregnant women, I² = 0%, very-low-quality evidence). This suggests that for pregnant women with a 16% risk of miscarriage using conventional COH, the risk using low-dose hCG would be between 8% and 36%. The findings for the outcome of FSH consumption were compatible with benefit for the intervention (MD -639 IU, 95% CI -893 to -385, 5 studies, 333 women, I² = 88%, moderate-quality evidence). The findings for the outcome of number of oocytes retrieved were compatible with no effect for the intervention (MD -0.12 oocytes, 95% CI -1.0 to 0.8 oocytes, 5 studies, 351 women, I² = 0%, moderate-quality evidence). We are very uncertain of the effect on live birth, OHSS and miscarriage of using low-dose hCG to replace FSH during the late follicular phase of COH in women undergoing ART, compared to the use of conventional COH. The current evidence suggests that this intervention does not reduce the chance of ongoing and clinical pregnancy; and that it is likely to result in an equivalent number of oocytes retrieved expending less FSH. More studies are needed to strengthen the evidence regarding the effect of this intervention on important reproductive outcomes. | Follicle-stimulating hormone (FSH) - a relatively expensive drug - is commonly used for several days to stimulate the ovaries of women undergoing assisted reproduction. Initial studies have shown that after a few days of using FSH to stimulate the ovaries, it can be replaced by human chorionic gonadotropin (hCG), which is less expensive. In addition to cost reduction, this intervention has a theoretical potential to reduce the risk of ovarian hyperstimulation syndrome (OHSS); though the underlying risk is already very low for most women. We searched the medical literature on in February 2013 for studies that evaluated the effectiveness and safety of using low-dose hCG to replace FSH during the late follicular phase in women undergoing controlled ovarian hyperstimulation (COH) for assisted reproduction, compared to the use of a conventional COH protocol. Five studies evaluating 351 women were included in this review. These studies were funded by fertility centres, universities, or both. We are very uncertain of the effect of this intervention on live birth, OHSS and miscarriage When use of low-dose hCG to replace FSH was compared with conventional COH, there was very low quality evidence compatible with appreciable benefit, no effect or appreciable harm for the intervention, suggesting that for women with a 14% chance of achieving live birth using a conventional COH, the chance of achieving live birth using low-dose hCG would be between 10% and 45%. Similarly, there was very low quality evidence suggesting that for women with a 3% risk of OHSS using a conventional COH, the risk using low-dose hCG was also compatible with either benefit or harm, and would be between 0% and 4%. Additionally we observed that there was low quality evidence suggesting that for women with a 32% chance of achieving ongoing pregnancy using a conventional COH, the chance using low-dose hCG was compatible with either benefit or no effect, and would be between 27% and 53%. There was low quality evidence suggesting that for women with a 35% chance of achieving clinical pregnancy using a conventional COH, the chance using low-dose hCG was compatible with either benefit or no effect, and would be between 32% and 54%. There was very low quality evidence suggesting that for pregnant women with a 16% risk of miscarriage using a conventional COH, the risk using low-dose hCG was compatible with either benefit or harm, and would be between 8% and 36%. We also observed that there is moderate-quality evidence that this intervention reduces the total FSH consumption and is unlikely to materially affect the number of oocytes retrieved Our conclusions are that we are very uncertain of the effect on live birth, OHSS and miscarriage of using low-dose hCG to replace FSH during the late follicular phase of COH in women undergoing ART, compared to the use of conventional COH. The current evidence suggests that this intervention does not reduce the chance of ongoing and clinical pregnancy; and that it is likely to result in an equivalent number of oocytes retrieved expending less FSH. More studies are needed to strengthen the evidence regarding the effect of this intervention on important reproductive outcomes. | 10.1002/14651858.CD010042.pub2 | [
"Follicle-stimulating hormone (FSH) - a relatively expensive drug - is commonly used for several days to stimulate the ovaries of women undergoing assisted reproduction. Initial studies have shown that after a few days of using FSH to stimulate the ovaries, it can be replaced by human chorionic gonadotropin (hCG), which is less expensive. In addition to cost reduction, this intervention has a theoretical potential to reduce the risk of ovarian hyperstimulation syndrome (OHSS); though the underlying risk is already very low for most women. We searched the medical literature on in February 2013 for studies that evaluated the effectiveness and safety of using low-dose hCG to replace FSH during the late follicular phase in women undergoing controlled ovarian hyperstimulation (COH) for assisted reproduction, compared to the use of a conventional COH protocol. Five studies evaluating 351 women were included in this review. These studies were funded by fertility centres, universities, or both. We are very uncertain of the effect of this intervention on live birth, OHSS and miscarriage When use of low-dose hCG to replace FSH was compared with conventional COH, there was very low quality evidence compatible with appreciable benefit, no effect or appreciable harm for the intervention, suggesting that for women with a 14% chance of achieving live birth using a conventional COH, the chance of achieving live birth using low-dose hCG would be between 10% and 45%. Similarly, there was very low quality evidence suggesting that for women with a 3% risk of OHSS using a conventional COH, the risk using low-dose hCG was also compatible with either benefit or harm, and would be between 0% and 4%. Additionally we observed that there was low quality evidence suggesting that for women with a 32% chance of achieving ongoing pregnancy using a conventional COH, the chance using low-dose hCG was compatible with either benefit or no effect, and would be between 27% and 53%. There was low quality evidence suggesting that for women with a 35% chance of achieving clinical pregnancy using a conventional COH, the chance using low-dose hCG was compatible with either benefit or no effect, and would be between 32% and 54%. There was very low quality evidence suggesting that for pregnant women with a 16% risk of miscarriage using a conventional COH, the risk using low-dose hCG was compatible with either benefit or harm, and would be between 8% and 36%. We also observed that there is moderate-quality evidence that this intervention reduces the total FSH consumption and is unlikely to materially affect the number of oocytes retrieved Our conclusions are that we are very uncertain of the effect on live birth, OHSS and miscarriage of using low-dose hCG to replace FSH during the late follicular phase of COH in women undergoing ART, compared to the use of conventional COH. The current evidence suggests that this intervention does not reduce the chance of ongoing and clinical pregnancy; and that it is likely to result in an equivalent number of oocytes retrieved expending less FSH. More studies are needed to strengthen the evidence regarding the effect of this intervention on important reproductive outcomes."
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cochrane-simplification-train-1669 | cochrane-simplification-train-1669 | There are 77 studies included in this updated review. We retained 12 studies from the original review and identified 65 new studies. Evidence from 21 countries is provided in this update, an increase of eight countries from the original review. The nature of the intervention precludes randomized controlled trials. Thirty-six studies used an interrupted time series study design, 23 studies use a controlled before-and-after design and 18 studies are before-and-after studies with no control group; six of these studies use a cohort design. Seventy-two studies reported health outcomes, including cardiovascular (44), respiratory (21), and perinatal outcomes (7). Eleven studies reported national mortality rates for smoking-related diseases. A number of the studies report multiple health outcomes. There is consistent evidence of a positive impact of national smoking bans on improving cardiovascular health outcomes, and reducing mortality for associated smoking-related illnesses. Effects on respiratory and perinatal health were less consistent. We found 24 studies evaluating the impact of national smoke-free legislation on smoking behaviour. Evidence of an impact of legislative bans on smoking prevalence and tobacco consumption is inconsistent, with some studies not detecting additional long-term change in existing trends in prevalence. Since the first version of this review was published, the current evidence provides more robust support for the previous conclusions that the introduction of a legislative smoking ban does lead to improved health outcomes through reduction in SHS for countries and their populations. The clearest evidence is observed in reduced admissions for acute coronary syndrome. There is evidence of reduced mortality from smoking-related illnesses at a national level. There is inconsistent evidence of an impact on respiratory and perinatal health outcomes, and on smoking prevalence and tobacco consumption. | We searched for studies that investigated the effect of introducing a ban on any measures of health, or on smoking behaviour (up to February 2015). Since the previous version of this review had shown clear evidence that introducing legislation to ban smoking in public places does reduce exposure to secondhand smoke (SHS) in those places, we did not include studies that only reported exposure to SHS. We included 77 studies from 21 countries in this updated review. Studies of health outcomes typically used data from hospitals to look for changes in rates of admissions, discharges or deaths. Most studies looked at illnesses related to the cardiovascular system (heart or blood vessels), such as heart attacks and strokes. Studies also looked at effects on respiratory health, including chronic obstructive pulmonary disease (e.g. bronchitis), asthma and lung function. Seven studies looked at the health of newborn children. Eleven studies reported death rates. The best-quality studies collected data at multiple time points before and after the introduction of a ban in order to adjust for existing time trends. Some studies could compare events rates in areas with and without bans, or where bans were introduced at different times. Key results There is evidence that countries and their populations benefit from improved health after introducing smoking bans, importantly to do with the heart and blood vessels. We found evidence of reduced deaths. The impact of bans on respiratory health, on the health of newborn children, and on reducing the number of smokers and their cigarette use is not as clear, with some studies not detecting any reduction. Quality of the evidence Legislative bans have not been evaluated by randomized trials, and the quality of the evidence from the types of studies contributing to this review is lower. Changes in health outcomes could be due to other things, such as change in healthcare practices. However, many of the studies used methods of analysis that could control for underlying trends, and increase our confidence that any changes are caused by the introduction of bans. | 10.1002/14651858.CD005992.pub3 | [
"We searched for studies that investigated the effect of introducing a ban on any measures of health, or on smoking behaviour (up to February 2015). Since the previous version of this review had shown clear evidence that introducing legislation to ban smoking in public places does reduce exposure to secondhand smoke (SHS) in those places, we did not include studies that only reported exposure to SHS. We included 77 studies from 21 countries in this updated review. Studies of health outcomes typically used data from hospitals to look for changes in rates of admissions, discharges or deaths. Most studies looked at illnesses related to the cardiovascular system (heart or blood vessels), such as heart attacks and strokes. Studies also looked at effects on respiratory health, including chronic obstructive pulmonary disease (e.g. bronchitis), asthma and lung function. Seven studies looked at the health of newborn children. Eleven studies reported death rates. The best-quality studies collected data at multiple time points before and after the introduction of a ban in order to adjust for existing time trends. Some studies could compare events rates in areas with and without bans, or where bans were introduced at different times. Key results There is evidence that countries and their populations benefit from improved health after introducing smoking bans, importantly to do with the heart and blood vessels. We found evidence of reduced deaths. The impact of bans on respiratory health, on the health of newborn children, and on reducing the number of smokers and their cigarette use is not as clear, with some studies not detecting any reduction. Quality of the evidence Legislative bans have not been evaluated by randomized trials, and the quality of the evidence from the types of studies contributing to this review is lower. Changes in health outcomes could be due to other things, such as change in healthcare practices. However, many of the studies used methods of analysis that could control for underlying trends, and increase our confidence that any changes are caused by the introduction of bans."
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cochrane-simplification-train-1670 | cochrane-simplification-train-1670 | We included a total of 18 studies involving 2366 participants (976 participants with common bile duct stones and 1390 participants without common bile duct stones). Eleven studies evaluated EUS alone, and five studies evaluated MRCP alone. Two studies evaluated both tests. Most studies included patients who were suspected of having common bile duct stones based on abnormal liver function tests; abnormal transabdominal ultrasound; symptoms such as obstructive jaundice, cholangitis, or pancreatitis; or a combination of the above. The proportion of participants who had undergone cholecystectomy varied across studies. Not one of the studies was of high methodological quality. For EUS, the sensitivities ranged between 0.75 and 1.00 and the specificities ranged between 0.85 and 1.00. The summary sensitivity (95% confidence interval (CI)) and specificity (95% CI) of the 13 studies that evaluated EUS (1537 participants; 686 cases and 851 participants without common bile duct stones) were 0.95 (95% CI 0.91 to 0.97) and 0.97 (95% CI 0.94 to 0.99). For MRCP, the sensitivities ranged between 0.77 and 1.00 and the specificities ranged between 0.73 and 0.99. The summary sensitivity and specificity of the seven studies that evaluated MRCP (996 participants; 361 cases and 635 participants without common bile duct stones) were 0.93 (95% CI 0.87 to 0.96) and 0.96 (95% CI 0.90 to 0.98). There was no evidence of a difference in sensitivity or specificity between EUS and MRCP (P value = 0.5). From the included studies, at the median pre-test probability of common bile duct stones of 41% the post-test probabilities (with 95% CI) associated with positive and negative EUS test results were 0.96 (95% CI 0.92 to 0.98) and 0.03 (95% CI 0.02 to 0.06). At the same pre-test probability, the post-test probabilities associated with positive and negative MRCP test results were 0.94 (95% CI 0.87 to 0.97) and 0.05 (95% CI 0.03 to 0.09). Both EUS and MRCP have high diagnostic accuracy for detection of common bile duct stones. People with positive EUS or MRCP should undergo endoscopic or surgical extraction of common bile duct stones and those with negative EUS or MRCP do not need further invasive tests. However, if the symptoms persist, further investigations will be indicated. The two tests are similar in terms of diagnostic accuracy and the choice of which test to use will be informed by availability and contra-indications to each test. However, it should be noted that the results are based on studies of poor methodological quality and so the results should be interpreted with caution. Further studies that are of high methodological quality are necessary to determine the diagnostic accuracy of EUS and MRCP for the diagnosis of common bile duct stones. | We performed a thorough search for studies that reported the accuracy of EUS or MRCP in the diagnosis of CBD stones. We included a total of 18 studies involving 2532 participants. Eleven studies evaluated EUS alone, five studies evaluated MRCP alone, and two studies evaluated both tests. A total of 1537 participants were included in the 13 studies that evaluated EUS and 995 participants were included in the seven studies that evaluated MRCP. Most studies included patients who were suspected of having CBD stones based on abnormal blood tests, abnormal ultrasound, or symptoms such as jaundice or pancreatitis, or a combination of the above. The proportion of participants who had undergone previous gallbladder removal varied across studies. Based on an average sensitivity of 95% for EUS, on average 95 out of 100 people with CBD stones will be detected while the remaining 5 people will be missed and will not receive appropriate treatment. The average number of people with CBD stones detected using EUS may vary between 91 and 97 out of 100 people. The average specificity of 97% for EUS means that on average 97 out of 100 people without CBD stones will be identified as not having CBD stones; 3 out of 100 would be false positives and would not receive appropriate treatment. The average number of false positives could vary between 1 and 6 out of 100 people. For MRCP, an average sensitivity of 93% means that on average 93 out of 100 people with CBD stones will be detected while the remaining 7 people will be missed and will not receive appropriate treatment. The average number of people with CBD stones detected using MRCP may vary between 87 and 96 out of 100 people. With an average specificity of 96% for MRCP, 96 out of 100 people without CBD stones will be identified as not having CBD stones; 4 out of 100 would be false positives and would not receive appropriate treatment. The average number of false positives could vary between 2 and 10 out of 100 people. This means that some people with CBD stones can be missed by EUS and MRCP. Although most people with a negative EUS or MRCP do not need to undergo further invasive tests, in the presence of persistent symptoms further testing with MRCP if the patient had undergone EUS or EUS if the patient had undergone MRCP, ERCP, or IOC may be indicated. There is little to choose between EUS and MRCP in terms of diagnostic accuracy. All the studies were of low methodological quality, which may undermine the validity of our findings. Further studies of high methodological quality are necessary. | 10.1002/14651858.CD011549 | [
"We performed a thorough search for studies that reported the accuracy of EUS or MRCP in the diagnosis of CBD stones. We included a total of 18 studies involving 2532 participants. Eleven studies evaluated EUS alone, five studies evaluated MRCP alone, and two studies evaluated both tests. A total of 1537 participants were included in the 13 studies that evaluated EUS and 995 participants were included in the seven studies that evaluated MRCP. Most studies included patients who were suspected of having CBD stones based on abnormal blood tests, abnormal ultrasound, or symptoms such as jaundice or pancreatitis, or a combination of the above. The proportion of participants who had undergone previous gallbladder removal varied across studies. Based on an average sensitivity of 95% for EUS, on average 95 out of 100 people with CBD stones will be detected while the remaining 5 people will be missed and will not receive appropriate treatment. The average number of people with CBD stones detected using EUS may vary between 91 and 97 out of 100 people. The average specificity of 97% for EUS means that on average 97 out of 100 people without CBD stones will be identified as not having CBD stones; 3 out of 100 would be false positives and would not receive appropriate treatment. The average number of false positives could vary between 1 and 6 out of 100 people. For MRCP, an average sensitivity of 93% means that on average 93 out of 100 people with CBD stones will be detected while the remaining 7 people will be missed and will not receive appropriate treatment. The average number of people with CBD stones detected using MRCP may vary between 87 and 96 out of 100 people. With an average specificity of 96% for MRCP, 96 out of 100 people without CBD stones will be identified as not having CBD stones; 4 out of 100 would be false positives and would not receive appropriate treatment. The average number of false positives could vary between 2 and 10 out of 100 people. This means that some people with CBD stones can be missed by EUS and MRCP. Although most people with a negative EUS or MRCP do not need to undergo further invasive tests, in the presence of persistent symptoms further testing with MRCP if the patient had undergone EUS or EUS if the patient had undergone MRCP, ERCP, or IOC may be indicated. There is little to choose between EUS and MRCP in terms of diagnostic accuracy. All the studies were of low methodological quality, which may undermine the validity of our findings. Further studies of high methodological quality are necessary."
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cochrane-simplification-train-1671 | cochrane-simplification-train-1671 | We found five relevant trials (total n=537), but no usable data on service outcomes, general functioning, behaviour, engagement with services, satisfaction with treatment or economic outcomes. Overall, reporting of data was poor. Those data we were able to use suggested that equal proportions of people allocated lamotrigine or placebo had no global response (n=208, 1 RCT, RR 1.06 CI 0.73 to 1.54). There was no significant difference between groups in the proportions of people whose mental state did not improve (n=297, 3 RCT, RR 1.26 CI 0.81 to 1.97). There was, however, a significant reduction in the PANSS total scores (n=67, 2 RCT, WMD -16.88 CI -8.57 to -25.18, p=0.0001), positive symptom sub-scale scores (n=65, 2 RCTs, WMD -5.10 CI -8.86 to -1.34) and negative symptom sub-scale scores (n=67, 2 RCTs, WMD -5.25, CI -7.07 to -3.43). Most cognitive measures showed no differences (n=329, 2 RCTs, RR not attaining BACS composite score of 0.5 1.10 CI 0.59 to 2.04). The proportion of participants leaving studies was about 25% at 12 weeks (n=537, 5 RCTs, RR 0.96 CI 0.71 to 1.29). The lamotrigine group did experience the outcome of any adverse effects significantly more frequent than people allocated placebo (n=429, 2 RCTs, RR 1.19 CI 1.02 to 1.38, NNH 10 CI 5 to 90). Among the many effects listed, only nausea was found to be significantly more (9%) in the lamotrigine group compared with placebo (n=465, 3 RCTs, RR 2.26 CI 1.05 to 4.88). Evidence for use of lamotrigine as an adjuvant for people with schizophrenia is not robust and large well-designed, conducted and reported real-world randomised trials are needed to determine its place in everyday clinical practice. | We searched major medical databases for studies that have examined the use of lamotrigine for people with schizophrenia. We identified five relevant studies that were conducted according to existing standards of research. A total of 537 people with schizophrenia participated in these five studies. The participants were resistant to various degrees to usual treatments and were randomised to receive either lamotrigine or placebo in addition to their usual drugs. The data regarding effectiveness could only be usefully analysed in less than 70 participants. Lamotrigine was considered to be effective if the questionnaire scores showed a greater reduction than for those who received placebo. The magnitude of this effect was small when compared to placebo. Data regarding adverse effects were available from three studies. There was a higher occurrence of nausea in those receiving lamotrigine. Apart from this the common side effects were headache and dizziness. The current evidence does not suggest that the addition of lamotrigine is a remarkable strategy for people with resistant schizophrenia, but the results are suggestive of a positive effect on the symptoms of schizophrenia. However, more studies with larger number of participants are needed to confirm the true magnitude of benefit and safety. This review is limited by the poor presentation of data from the individual studies. | 10.1002/14651858.CD005962.pub2 | [
"We searched major medical databases for studies that have examined the use of lamotrigine for people with schizophrenia. We identified five relevant studies that were conducted according to existing standards of research. A total of 537 people with schizophrenia participated in these five studies. The participants were resistant to various degrees to usual treatments and were randomised to receive either lamotrigine or placebo in addition to their usual drugs. The data regarding effectiveness could only be usefully analysed in less than 70 participants. Lamotrigine was considered to be effective if the questionnaire scores showed a greater reduction than for those who received placebo. The magnitude of this effect was small when compared to placebo. Data regarding adverse effects were available from three studies. There was a higher occurrence of nausea in those receiving lamotrigine. Apart from this the common side effects were headache and dizziness. The current evidence does not suggest that the addition of lamotrigine is a remarkable strategy for people with resistant schizophrenia, but the results are suggestive of a positive effect on the symptoms of schizophrenia. However, more studies with larger number of participants are needed to confirm the true magnitude of benefit and safety. This review is limited by the poor presentation of data from the individual studies."
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cochrane-simplification-train-1672 | cochrane-simplification-train-1672 | Primary outcomes Stenting may slightly reduce the number of unplanned return visits (16 trials with 1970 participants; very low CoE), but we are very uncertain of this finding. Pain on the day of surgery as measured on a visual analogue scale (scale 0 to 10; higher values reflect more pain) is probably similar (mean difference (MD) 0.32 higher, 95% confidence interval (CI) 0.13 lower to 0.78 higher; 4 trials with 346 participants; moderate CoE). Pain on postoperative days 1 to 3 may show little to no difference (standardised mean difference (SMD) 0.25 higher, 95% CI 0.32 lower to 0.82 higher; 8 trials with 683 participants; low CoE). On postoperative days 4 to 30, stented participants may experience more pain (8 trials with 903 participants; very low CoE), but we are very uncertain of this finding. Stenting may result in little to no difference in the need for secondary interventions (risk ratio (RR) 1.15, 95% CI 0.39 to 3.33; 10 studies with 1435 participants; low CoE); this corresponds to three more interventions per 1000 participants (95% CI 13 fewer to 48 more). Secondary outcomes Stenting may reduce the need for narcotics (7 trials with 830 participants; very low CoE), but we are very uncertain of this finding. Rates of urinary tract infection (UTI) up to 90 days are probably not substantially different (RR 0.94, 95% CI 0.59 to 1.51; 10 trials with 1207 participants; moderate CoE); this corresponds to three fewer infections per 1000 participants (95% CI 23 fewer to 29 more). Ureteral stricture rates up to 90 days may be slightly reduced (14 trials with 1625 participants; very low CoE), but we are very uncertain of this finding. Rates of hospital admission may be slightly reduced (RR 0.70, 95% CI 0.32 to 1.55; 13 studies with 1647 participants; low CoE). This corresponds to 15 fewer admissions per 1000 participants (95% CI 33 fewer to 27 more). Findings of this review illustrate the trade-offs of risks and benefits faced by urologists and their patients when it comes to decision-making about stent placement after uncomplicated ureteroscopy for stone disease. We noted that both desirable and undesirable effects were small in absolute terms, with findings based mostly on low and very low CoE. The main issues reducing our confidence in research findings were study limitations (mostly risk of performance and detection bias) and imprecision. We were unable to conduct any of the preplanned subgroup analyses, in particular those based on stone size, stone location, and use of ureteral dilation, which may be important effect modifiers. Given the importance of this question, higher-quality and sufficiently large trials are needed to better inform decision-making. | We included 23 trials with 2656 people who either had a stent or not. Whether they received a stent or not was decided by chance. A stent may make people come back to the hospital for problems less often, but we are very uncertain of this finding. Pain on the day of surgery and on days one to three after surgery may be similar. People with a stent may have more pain in the long term (days four to 30), but we are also very uncertain about this. The need for another procedure may be similar. People with a stent may be less likely to need narcotics (strong pain medications that can cause addiction), but we are very uncertain about this. There may be no difference in the risk of a urinary tract infection. Stenting may make people a little less likely to develop a narrowing of the ureter because of scarring and may make them slightly less likely to be admitted to the hospital. However, we are very uncertain of both findings. The certainty of evidence ranged from moderate to very low depending on the outcome, meaning that we have moderate, low, or very low confidence in the study results. | 10.1002/14651858.CD012703.pub2 | [
"We included 23 trials with 2656 people who either had a stent or not. Whether they received a stent or not was decided by chance. A stent may make people come back to the hospital for problems less often, but we are very uncertain of this finding. Pain on the day of surgery and on days one to three after surgery may be similar. People with a stent may have more pain in the long term (days four to 30), but we are also very uncertain about this. The need for another procedure may be similar. People with a stent may be less likely to need narcotics (strong pain medications that can cause addiction), but we are very uncertain about this. There may be no difference in the risk of a urinary tract infection. Stenting may make people a little less likely to develop a narrowing of the ureter because of scarring and may make them slightly less likely to be admitted to the hospital. However, we are very uncertain of both findings. The certainty of evidence ranged from moderate to very low depending on the outcome, meaning that we have moderate, low, or very low confidence in the study results."
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cochrane-simplification-train-1673 | cochrane-simplification-train-1673 | Four trials compared the short-term effects of ipratropium bromide versus a beta2-agonist. Short-term changes in FEV1 (up to 90 minutes) showed no significant difference between beta2-agonist and ipratropium bromide treated patients. The differences were similar among the studies and when combined: Weighted Mean Difference (WMD) 0.0 liters (95% Confidence Interval (95% CI) -0.19 to 0.19). There was no significant additional increase in change in FEV1 on adding ipratropium to beta2-agonist: WMD 0.02 liter (95% CI -0.08 to 0.12). Long-term effects (24 hours) of the ipratropium bromide and beta2-agonist treatment combination were similar: WMD 0.05 liters (95% CI -0.14 to 0.05). Neither of two studies found significant changes in PaO2, either short- or long-term, with ipratropium versus beta-agonist, although one showed an increase in PaO2 in subjects receiving ipratropium bromide at 60 minutes. Adverse drug reactions included dry mouth and tremor. There was no evidence that the degree of bronchodilation achieved with ipratropium bromide was greater than that using a short-acting beta2-agonist. The combination of a beta2-agonist and ipratropium did not appear to increase the effect on FEV1 more than either used alone. | Trials comparing ipratropium bromide versus beta-agonists showed no significant difference in short-term or long-term effects (24 hours) on ease of breathing. Side effects of these drugs were reported by only a minority of patients and include dry mouth and tremor, and a 'strange feeling' after drug administration. | 10.1002/14651858.CD003900 | [
"Trials comparing ipratropium bromide versus beta-agonists showed no significant difference in short-term or long-term effects (24 hours) on ease of breathing. Side effects of these drugs were reported by only a minority of patients and include dry mouth and tremor, and a 'strange feeling' after drug administration."
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cochrane-simplification-train-1674 | cochrane-simplification-train-1674 | Forty-five trials, studying 69 exercise interventions, were eligible for this review, including 2250 people with MS. The prescribed exercise interventions were categorised as endurance training (23 interventions), muscle power training (nine interventions), task-oriented training (five interventions), mixed training (15 interventions), or 'other' (e.g. yoga; 17 interventions). Thirty-six included trials (1603 participants) provided sufficient data on the outcome of fatigue for meta-analysis. In general, exercise interventions were studied in mostly participants with the relapsing-remitting MS phenotype, and with an Expanded Disability Status Scale less than 6.0. Based on 26 trials that used a non-exercise control, we found a significant effect on fatigue in favour of exercise therapy (standardized mean difference (SMD) -0.53, 95% confidence interval (CI) -0.73 to -0.33; P value < 0.01). However, there was significant heterogeneity between trials (I2 > 58%). The mean methodological quality, as well as the combined body of evidence, was moderate. When considering the different types of exercise therapy, we found a significant effect on fatigue in favour of exercise therapy compared to no exercise for endurance training (SMDfixed effect -0.43, 95% CI -0.69 to -0.17; P value < 0.01), mixed training (SMDrandom effect -0.73, 95% CI -1.23 to -0.23; P value < 0.01), and 'other' training (SMDfixed effect -0.54, 95% CI -0.79 to -0.29; P value < 0.01). Across all studies, one fall was reported. Given the number of MS relapses reported for the exercise condition (N = 25) and non-exercise control condition (N = 26), exercise does not seem to be associated with a significant risk of a MS relapse. However, in general, MS relapses were defined and reported poorly. Exercise therapy can be prescribed in people with MS without harm. Exercise therapy, and particularly endurance, mixed, or 'other' training, may reduce self reported fatigue. However, there are still some important methodological issues to overcome. Unfortunately, most trials did not explicitly include people who experienced fatigue, did not target the therapy on fatigue specifically, and did not use a validated measure of fatigue as the primary measurement of outcome. | We searched scientific databases for clinical trials comparing exercise to no exercise or other treatments in adults with MS. The evidence is current to October 2014. We found 45 trials, involving 2250 people with MS, assessing the effect of exercise therapy using self reported fatigue. We used 36 studies, involving 1603 people with MS, in an analysis. Combined, these 36 trials supported the idea that exercise therapy may be a promising treatment to reduce fatigue without side events. This finding seems especially true for endurance training, mixed training (i.e. muscle power training mixed with endurance training), or 'other' training (e.g. yoga, tai-chi). To assess the safety of exercise therapy we counted the number of reported MS relapses in the people receiving exercise therapy and in people in a non-exercise group and did not find a significant difference. Even though these results are promising, it is worth noting some methods used in the trials may have affected the reliability of the results. For example, most trials included a low number of participants and did not primarily aim to reduce fatigue (but, for instance, aimed to improve walking capability) with the assessment of fatigue being a secondary measure. However, in contrast, exercise therapy may also be less feasible for people with MS who are severely fatigued. In addition, the reporting and definition of MS relapses was in general poor, and lacked consistency. Future, high-quality research is warranted to elucidate the feasibility, effects, and working mechanisms of exercise therapy. Future studies may benefit from a uniform definition of fatigue, and subsequently be designed to measure fatigue specifically. | 10.1002/14651858.CD009956.pub2 | [
"We searched scientific databases for clinical trials comparing exercise to no exercise or other treatments in adults with MS. The evidence is current to October 2014. We found 45 trials, involving 2250 people with MS, assessing the effect of exercise therapy using self reported fatigue. We used 36 studies, involving 1603 people with MS, in an analysis. Combined, these 36 trials supported the idea that exercise therapy may be a promising treatment to reduce fatigue without side events. This finding seems especially true for endurance training, mixed training (i.e. muscle power training mixed with endurance training), or 'other' training (e.g. yoga, tai-chi). To assess the safety of exercise therapy we counted the number of reported MS relapses in the people receiving exercise therapy and in people in a non-exercise group and did not find a significant difference. Even though these results are promising, it is worth noting some methods used in the trials may have affected the reliability of the results. For example, most trials included a low number of participants and did not primarily aim to reduce fatigue (but, for instance, aimed to improve walking capability) with the assessment of fatigue being a secondary measure. However, in contrast, exercise therapy may also be less feasible for people with MS who are severely fatigued. In addition, the reporting and definition of MS relapses was in general poor, and lacked consistency. Future, high-quality research is warranted to elucidate the feasibility, effects, and working mechanisms of exercise therapy. Future studies may benefit from a uniform definition of fatigue, and subsequently be designed to measure fatigue specifically."
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cochrane-simplification-train-1675 | cochrane-simplification-train-1675 | The search identified a total of 824 citations; one study was identified for inclusion and two studies are awaiting classification. The 214 participants involved in the included study were adults with AECOPD, receiving treatment by paramedics en route to hospital. The mean age of participants was 68 years. A reduction in pre/in-hospital mortality was observed in favour of the titrated oxygen group (two deaths in the titrated oxygen group compared to 11 deaths in the high-flow control arm; risk ratio (RR) 0.22, 95% confidence interval (CI) 0.05 to 0.97; 214 participants). This translates to an absolute effect of 94 per 1000 (high-flow oxygen) compared to 21 per 1000 (titrated oxygen), and a number needed to treat for an additional beneficial outcome (NNTB) of 14 (95% CI 12 to 355) with titrated oxygen therapy. Other than mortality, no other adverse events were reported in the included study. Wide confidence intervals were observed between groups for arterial blood gas (though this may be confounded by protocol infidelity in the included study for this outcome measure), treatment failure requiring invasive or non-invasive ventilation or hospital utilisation. No data were reported for quality of life, lung function or dyspnoea. Risk of bias within the included study was largely unclear, though there was high risk of bias in domains relating to performance and attrition bias. We judged the evidence to be of low certainty, according to GRADE criteria. The one included study found a reduction in pre/in-hospital mortality for the titrated oxygen arm compared to the high-flow control arm. However, the paucity of evidence somewhat limits the reliability of these findings and generalisability to other settings. There is a need for robust, well-designed RCTs to further investigate the effect of oxygen therapies in the pre-hospital setting for people with AECOPD. | To investigate this question we looked for randomised controlled trials (RCTs), these are studies in which people involved have an equal chance of receiving the treatment or comparator. We were interested in trials that compared different flow rates (concentrations) of oxygen delivered in an ambulance to people being transferred to hospital because of sudden worsening of COPD symptoms. Only one study was found that addressed the review question. The study randomised participants to either have titrated oxygen (oxygen therapy delivered at different concentrations tailored to patient needs in order to keep the levels of oxygen in the blood between 88% and 92%) or high-flow oxygen (oxygen therapy delivered at a consistently high concentration). There were fewer deaths (two people) in the group that received titrated oxygen, compared to the control group using high-flow oxygen delivered at eight to ten litres per minute using a mask (11 people). Due to inclusion of only one study, and the small number of deaths that occurred, our confidence in the size of the difference between the two treatments is limited. We judged the evidence to be of low certainty. The one included study found that delivering individually tailored oxygen concentrations to people when they are being transported to hospital with sudden worsening of COPD, reduces the risk of death compared to using a consistently high concentration of oxygen. However, the body of evidence is too small to confidently claim that titrated oxygen is less harmful and more effective than high-flow oxygen in this group of people across the board. This plain language summary is current to September 2019. | 10.1002/14651858.CD005534.pub3 | [
"To investigate this question we looked for randomised controlled trials (RCTs), these are studies in which people involved have an equal chance of receiving the treatment or comparator. We were interested in trials that compared different flow rates (concentrations) of oxygen delivered in an ambulance to people being transferred to hospital because of sudden worsening of COPD symptoms. Only one study was found that addressed the review question. The study randomised participants to either have titrated oxygen (oxygen therapy delivered at different concentrations tailored to patient needs in order to keep the levels of oxygen in the blood between 88% and 92%) or high-flow oxygen (oxygen therapy delivered at a consistently high concentration). There were fewer deaths (two people) in the group that received titrated oxygen, compared to the control group using high-flow oxygen delivered at eight to ten litres per minute using a mask (11 people). Due to inclusion of only one study, and the small number of deaths that occurred, our confidence in the size of the difference between the two treatments is limited. We judged the evidence to be of low certainty. The one included study found that delivering individually tailored oxygen concentrations to people when they are being transported to hospital with sudden worsening of COPD, reduces the risk of death compared to using a consistently high concentration of oxygen. However, the body of evidence is too small to confidently claim that titrated oxygen is less harmful and more effective than high-flow oxygen in this group of people across the board. This plain language summary is current to September 2019."
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cochrane-simplification-train-1676 | cochrane-simplification-train-1676 | We included 14 trials involving 1014 women. The trials were small and not of high methodologic quality. Of the nine trials reporting on physical fitness, six reported significant improvement in physical fitness in the exercise group, although inconsistencies in summary statistics and measures used to assess fitness prevented quantitative pooling of results. Eleven trials reported on pregnancy outcomes. A pooled increased risk of preterm birth (risk ratio 1.82, 95% confidence interval (CI) 0.35 to 9.57) with exercise, albeit statistically non-significant, does not cohere with the absence of effect on mean gestational age (mean difference +0.10, 95% CI -0.11 to +0.30 weeks), while the results bearing on growth of the fetus are inconsistent. One small trial reported that physically fit women who increased the duration of exercise bouts in early pregnancy and then reduced that duration in later pregnancy gave birth to larger infants with larger placentas. Regular aerobic exercise during pregnancy appears to improve (or maintain) physical fitness. Available data are insufficient to infer important risks or benefits for the mother or infant. Larger and better trials are needed before confident recommendations can be made about the benefits and risk of aerobic exercise in pregnancy. | Aerobic exercise is physical activity that stimulates a person's breathing and blood circulation. The review of 14 trials, involving 1014 pregnant women, found that pregnant women who engage in vigorous exercise at least two to three times per week improve (or maintain) their physical fitness, and there is some evidence that these women have pregnancies of the same duration as those who maintain their usual activities. There is too little evidence from trials to show whether there are other effects on the woman and her baby. The trials reviewed included non-contact exercise such as swimming, static cycling and general floor exercise programs. Most of the trials were small and of insufficient methodologic quality, and larger, better trials are needed before confident recommendations can be made about the benefits and risks of aerobic exercise in pregnancy. | 10.1002/14651858.CD000180.pub2 | [
"Aerobic exercise is physical activity that stimulates a person's breathing and blood circulation. The review of 14 trials, involving 1014 pregnant women, found that pregnant women who engage in vigorous exercise at least two to three times per week improve (or maintain) their physical fitness, and there is some evidence that these women have pregnancies of the same duration as those who maintain their usual activities. There is too little evidence from trials to show whether there are other effects on the woman and her baby. The trials reviewed included non-contact exercise such as swimming, static cycling and general floor exercise programs. Most of the trials were small and of insufficient methodologic quality, and larger, better trials are needed before confident recommendations can be made about the benefits and risks of aerobic exercise in pregnancy."
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cochrane-simplification-train-1677 | cochrane-simplification-train-1677 | For this updated review, we added 24 new studies meeting the eligibility criteria to the 11 studies from prior updates. We have therefore included 35 studies, randomising 925,171 participants. Seven studies including 11,204 individuals compared adherence rates of those in an intensification of a patient care intervention (e.g. electronic reminders, pharmacist-led interventions, healthcare professional education of patients) versus usual care over the short term (six months or less), and were pooled in a meta-analysis. Participants in the intervention group had better adherence than those receiving usual care (odds ratio (OR) 1.93, 95% confidence interval (CI) 1.29 to 2.88; 7 studies; 11,204 participants; moderate-quality evidence). A separate analysis also showed improvements in long-term adherence rates (more than six months) using intensification of care (OR 2.87, 95% CI 1.91 to 4.29; 3 studies; 663 participants; high-quality evidence). Analyses of the effect on total cholesterol and LDL-cholesterol levels also showed a positive effect of intensified interventions over both short- and long-term follow-up. Over the short term, total cholesterol decreased by a mean of 17.15 mg/dL (95% CI 1.17 to 33.14; 4 studies; 430 participants; low-quality evidence) and LDL-cholesterol decreased by a mean of 19.51 mg/dL (95% CI 8.51 to 30.51; 3 studies; 333 participants; moderate-quality evidence). Over the long term (more than six months) total cholesterol decreased by a mean of 17.57 mg/dL (95% CI 14.95 to 20.19; 2 studies; 127 participants; high-quality evidence). Included studies did not report usable data for health outcome indications, adverse effects or costs/resource use, so we could not pool these outcomes. We assessed each included study for bias using methods described in the Cochrane Handbook for Systematic Reviews of Interventions. In general, the risk of bias assessment revealed a low risk of selection bias, attrition bias, and reporting bias. There was unclear risk of bias relating to blinding for most studies. The evidence in our review demonstrates that intensification of patient care interventions improves short- and long-term medication adherence, as well as total cholesterol and LDL-cholesterol levels. Healthcare systems which can implement team-based intensification of patient care interventions may be successful in improving patient adherence rates to lipid-lowering medicines. | The people included in the studies were adults over 18 years of age in outpatient settings, for whom lipid-lowering therapy was recommended. We now include 35 studies covering 925,171 participants in this review. Of the 35 included studies, 16 compared interventions categorised as 'intensified patient care' versus usual care. These interventions included electronic reminders, pharmacist-led interventions, and healthcare professional education to help people better remember to take their medications. These types of interventions when compared to standard care demonstrated significantly better adherence rates both over the short term (up to and including six months) as well as the long term (longer than six months). Additionally, cholesterol levels were better over both long- and short-term periods in those offered the intervention, compared to those receiving usual care. We considered only randomised controlled trials for this review. Given the nature of the interventions, it was not possible to keep participants unaware of which group they were in. However, analysis of other forms of bias indicated that generally the studies were at low risk of bias. We assessed the evidence for the outcomes using the GRADE system, and rated it as high quality for long-term adherence (more than six months) and for reduction in total cholesterol, and moderate quality for short-term medication adherence (up to six months) and for LDL-cholesterol levels. For the outcome total cholesterol levels at less than six months follow-up, we downgraded the evidence to low quality. | 10.1002/14651858.CD004371.pub4 | [
"The people included in the studies were adults over 18 years of age in outpatient settings, for whom lipid-lowering therapy was recommended. We now include 35 studies covering 925,171 participants in this review. Of the 35 included studies, 16 compared interventions categorised as 'intensified patient care' versus usual care. These interventions included electronic reminders, pharmacist-led interventions, and healthcare professional education to help people better remember to take their medications. These types of interventions when compared to standard care demonstrated significantly better adherence rates both over the short term (up to and including six months) as well as the long term (longer than six months). Additionally, cholesterol levels were better over both long- and short-term periods in those offered the intervention, compared to those receiving usual care. We considered only randomised controlled trials for this review. Given the nature of the interventions, it was not possible to keep participants unaware of which group they were in. However, analysis of other forms of bias indicated that generally the studies were at low risk of bias. We assessed the evidence for the outcomes using the GRADE system, and rated it as high quality for long-term adherence (more than six months) and for reduction in total cholesterol, and moderate quality for short-term medication adherence (up to six months) and for LDL-cholesterol levels. For the outcome total cholesterol levels at less than six months follow-up, we downgraded the evidence to low quality."
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cochrane-simplification-train-1678 | cochrane-simplification-train-1678 | There are sixteen included trials, all of which included participants with mild-moderate dementia or cognitive decline. All trials assessed the cognitive effects of ALC and in addition most considered severity of dementia, functional ability and clinical global impression. When considering clinical global impression (CGI-I) as a dichotomous variable (numbers improved versus numbers unchanged or worse) there were statistically significant treatment effects in favour of ALC at 12 and 24 weeks, (Peto odds ratio (OR) 1.90, 95% Confidence Interval (CI) 1.31 to 2.76) and (OR 2.33, 95% CI 1.31 to 4.14) but not at 52 weeks (OR 0.91, 95% CI 0.58 to 1.43). There was also a statistically significant treatment effect on MMSE at 24 weeks (Weighted Mean Difference (WMD) 0.69, 95% CI 0.09 to 1.29, P = 0.02), but not at 12 or 52 weeks. There was no evidence of benefit of ALC in the areas of severity of dementia, functional ability or Clinical Global Impression as a continuous measure. Various adverse events were reported, but from the meta-analyses there were no statistically significant differences between treated and placebo groups. There is evidence for benefit of ALC on clinical global impression as a categorical measure and on MMSE at 24 weeks, but there is no evidence using objective assessments in any other area of outcome. Given the large number of comparisons made, the statistically significant results may be due to chance. At present there is no evidence to recommend its routine use in clinical practice. Many of the trials used rather vague descriptions of dementia and trials using more strictly defined groups may be informative. Individual patient data may add to the findings, as would trials including other outcomes (e.g. mood and caregiver quality of life). However, the evidence does not suggest that ALC is likely to prove an important therapeutic agent. More work on the pharmacokinetics of ALC in humans is also required. | Early studies suggested a beneficial effect of ALC on cognition and behaviour in aging subjects. However, later, larger studies have not supported these findings. The early and later studies differ widely in methodology and assessment tools used, and are therefore difficult to compare. There is no evidence of benefit of ALC in the areas of cognition, severity of dementia, functional ability or Clinical Global Impression as a continuous measure. An apparent beneficial effect on Clinical Global Impression assessed as a dichotomous variable may be due to chance. There was also a significant treatment effect on the Mini Mental State Examination (MMSE) at 24 weeks, but this result must be interpreted with caution in the context of significant heterogeneity in these trials. ALC is not currently in routine clinical use. | 10.1002/14651858.CD003158 | [
"Early studies suggested a beneficial effect of ALC on cognition and behaviour in aging subjects. However, later, larger studies have not supported these findings. The early and later studies differ widely in methodology and assessment tools used, and are therefore difficult to compare. There is no evidence of benefit of ALC in the areas of cognition, severity of dementia, functional ability or Clinical Global Impression as a continuous measure. An apparent beneficial effect on Clinical Global Impression assessed as a dichotomous variable may be due to chance. There was also a significant treatment effect on the Mini Mental State Examination (MMSE) at 24 weeks, but this result must be interpreted with caution in the context of significant heterogeneity in these trials. ALC is not currently in routine clinical use."
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cochrane-simplification-train-1679 | cochrane-simplification-train-1679 | High-standard 14-day course versus standard 14-day course Two RCTs compared the high-standard 14-day regimen with the standard 14-day regimen. People with G6PD deficiency and pregnant or lactating women were excluded. We do not know if there is any difference in P vivax recurrences at 6 months with 0.5 mg/kg/day primaquine therapy for 14 days compared to 0.25 mg/kg/day primaquine therapy for 14 days (with chloroquine: RR 0.82, 95% CI 0.47 to 1.43, 639 participants, very low-certainty evidence; with chloroquine or an ACT: RR 1.11, 95% CI 0.17 to 7.09, 38 participants, very low-certainty evidence). No serious adverse events were reported. We do not know whether there is a difference in adverse events with the higher dosage (very low-certainty evidence). 0.5 mg/kg/day primaquine for 7 days versus standard 14-day course Five RCTs compared 0.5 mg/kg/day primaquine for 7 days with the standard 14-day course. There may be little or no difference in P vivax recurrences at 6 to 7 months when using the same total dose (0.5 mg/kg/day to 210 mg) over 7 days as compared to 14 days (RR 0.96, 95% CI 0.66 to 1.39; 1211 participants; low-certainty evidence). No serious adverse events were reported. There may be little or no difference in the number of adverse events known to occur with primaquine between the primaquine shorter regimen as compared to the longer regimen (RR 1.06, 95% CI 0.64 to 1.76; 1154 participants; low-certainty evidence). We do not know whether there is any difference in the frequency of anaemia or discontinuation of treatment between groups (very low-certainty evidence). Three trials excluded people with G6PD deficiency, and two did not provide this information. Pregnant and lactating women were either excluded or no details were provided regarding their inclusion or exclusion. 0.75 mg/kg primaquine/week for 8 weeks versus high-standard course One RCT compared weekly primaquine with the high-standard 14-day course. G6PD-deficient patients were not randomized but were included in the weekly primaquine group. Only one G6PD-deficient participant was detected during the trial. We do not know whether weekly primaquine increases or decreases recurrences of P vivax compared to the 14-day regimen at 11 months' follow-up (RR 3.18, 95% CI 0.37 to 27.6; 122 participants; very low-certainty evidence). No serious adverse events and no episodes of anaemia were reported. Three other RCTs evaluated different alternative regimens and doses of primaquine, but one of these RCTs did not have results available, and two used regimens that have not been widely used and the evidence was of very low certainty. Although limited data were available, the analysis did not detect a difference in recurrence between the 7-day regimen and the standard 14-day regimen of 0.5 mg/kg/day primaquine, and no serious adverse events were reported in G6PD-normal participants taking 0.5 mg/kg/day of primaquine. This shorter regimen may be useful in G6PD-normal patients if there are treatment adherence concerns. Further large high-quality RCTs are needed, such as the IMPROV trial, with more standardised comparison regimens and longer follow-up to help resolve uncertainties. | We summarized trials that compared the World Health Organization (WHO)-recommended primaquine regimen of 15 to 30 mg per day for 14 days with the same or higher doses of primaquine given over different lengths of time to determine whether alternative regimens were as successful as the recommended courses at preventing future episodes of P vivax malaria. We searched for trials up to 17 December 2018, and included nine randomized controlled trials (studies in which participants are assigned to one of two or more treatment groups in a random manner) in our analysis. When using 30 mg per day compared to 15 mg per day primaquine therapy for 14 days, we do not know if there is any difference in P vivax recurrences at 6 months (very low-certainty evidence). No serious side effects were reported, but it is unclear whether or not there is a difference in other side effects between doses (very low-certainty evidence). When using 30 mg primaquine per day for 7 days compared to 15 mg per day for 14 days, there may be no difference in P vivax recurrences at 6 to 7 months (low-certainty evidence). No serious adverse events were reported. There may be no difference in the number of side effects known to occur with primaquine between the two treatment regimens (low-certainty evidence). We do not know whether weekly primaquine increases or decreases recurrences of P vivax compared to the 14-day regimen at 11 months' follow-up (very low-certainty evidence). Further large high-quality RCTs are needed, such as the IMPROV trial, to help improve the certainty of the evidence around alternative regimens. How up-to-date is this review? The review authors searched for studies up to 17 December 2018. | 10.1002/14651858.CD012656.pub2 | [
"We summarized trials that compared the World Health Organization (WHO)-recommended primaquine regimen of 15 to 30 mg per day for 14 days with the same or higher doses of primaquine given over different lengths of time to determine whether alternative regimens were as successful as the recommended courses at preventing future episodes of P vivax malaria. We searched for trials up to 17 December 2018, and included nine randomized controlled trials (studies in which participants are assigned to one of two or more treatment groups in a random manner) in our analysis. When using 30 mg per day compared to 15 mg per day primaquine therapy for 14 days, we do not know if there is any difference in P vivax recurrences at 6 months (very low-certainty evidence). No serious side effects were reported, but it is unclear whether or not there is a difference in other side effects between doses (very low-certainty evidence). When using 30 mg primaquine per day for 7 days compared to 15 mg per day for 14 days, there may be no difference in P vivax recurrences at 6 to 7 months (low-certainty evidence). No serious adverse events were reported. There may be no difference in the number of side effects known to occur with primaquine between the two treatment regimens (low-certainty evidence). We do not know whether weekly primaquine increases or decreases recurrences of P vivax compared to the 14-day regimen at 11 months' follow-up (very low-certainty evidence). Further large high-quality RCTs are needed, such as the IMPROV trial, to help improve the certainty of the evidence around alternative regimens. How up-to-date is this review? The review authors searched for studies up to 17 December 2018."
]
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cochrane-simplification-train-1680 | cochrane-simplification-train-1680 | Two studies met the inclusion criteria. 1. Randomised comparison between operative hysteroscopy versus control for unexplained subfertility associated with suspected major uterine cavity abnormalities. In women with otherwise unexplained subfertility and submucous fibroids, we were uncertain whether hysteroscopic myomectomy improved the clinical pregnancy rate compared to expectant management (odds ratio (OR) 2.44, 95% confidence interval (CI) 0.97 to 6.17; P = 0.06, 94 women; very low-quality evidence). We are uncertain whether hysteroscopic myomectomy improves the miscarriage rate compared to expectant management (OR 1.54, 95% CI 0.47 to 5.00; P = 0.47, 94 women; very low-quality evidence). We found no data on live birth or hysteroscopy complication rates. We found no studies in women with endometrial polyps, intrauterine adhesions or uterine septum for this randomised comparison. 2. Randomised comparison between operative hysteroscopy versus control for suspected major uterine cavity abnormalities prior to medically assisted reproduction. The hysteroscopic removal of polyps prior to IUI may have improved the clinical pregnancy rate compared to diagnostic hysteroscopy only: if 28% of women achieved a clinical pregnancy without polyp removal, the evidence suggested that 63% of women (95% CI 45% to 89%) achieved a clinical pregnancy after the hysteroscopic removal of the endometrial polyps (OR 4.41, 95% CI 2.45 to 7.96; P < 0.00001, 204 women; low-quality evidence). We found no data on live birth, hysteroscopy complication or miscarriage rates in women with endometrial polyps prior to IUI. We found no studies in women with submucous fibroids, intrauterine adhesions or uterine septum prior to IUI or in women with all types of suspected uterine cavity abnormalities prior to IVF/ICSI. Uncertainty remains concerning an important benefit with the hysteroscopic removal of submucous fibroids for improving the clinical pregnancy rates in women with otherwise unexplained subfertility. The available low-quality evidence suggests that the hysteroscopic removal of endometrial polyps suspected on ultrasound in women prior to IUI may improve the clinical pregnancy rate compared to simple diagnostic hysteroscopy. More research is needed to measure the effectiveness of the hysteroscopic treatment of suspected major uterine cavity abnormalities in women with unexplained subfertility or prior to IUI, IVF or ICSI. | We found two studies. The first study compared the removal of fibroids versus no removal in 94 women wishing to become pregnant spontaneously from January 1998 to April 2005. The second study compared the removal of polyps versus simple hysteroscopy only in 204 women before insemination with husband's sperm from January 2000 to February 2004. The evidence is current to April 2018. Neither study reported funding sources. In women with fibroids wishing to become pregnant spontaneously we were uncertain whether removal of the fibroids improved the pregnancy or miscarriage rate compared to usual management: uncertainty remains because the number of women (94) and the number of pregnancies (30) were too small and the quality of the evidence was very low. We found no data on live birth or complications due to surgery. We found no studies on women with polyps, septa or adhesions. The hysteroscopic removal of polyps prior to intrauterine insemination (IUI; a fertility treatment where sperm is placed inside a woman's womb to fertilise the egg) is may improve the pregnancy rate compared to not removing polyps. If 28% of women become pregnant without surgery, the evidence suggests that about 63% of women will become pregnant following removal of polyps. We found no data on number of live births, hysteroscopy complications or miscarriage rates prior to IUI. We retrieved no studies in women before other fertility treatments. More studies are needed before hysteroscopy can be proposed as a fertility-enhancing procedure in the general population of women having difficulty becoming pregnant. The quality of the evidence retrieved was very low to low due to the limited number of participants and the poor design of the studies. | 10.1002/14651858.CD009461.pub4 | [
"We found two studies. The first study compared the removal of fibroids versus no removal in 94 women wishing to become pregnant spontaneously from January 1998 to April 2005. The second study compared the removal of polyps versus simple hysteroscopy only in 204 women before insemination with husband's sperm from January 2000 to February 2004. The evidence is current to April 2018. Neither study reported funding sources. In women with fibroids wishing to become pregnant spontaneously we were uncertain whether removal of the fibroids improved the pregnancy or miscarriage rate compared to usual management: uncertainty remains because the number of women (94) and the number of pregnancies (30) were too small and the quality of the evidence was very low. We found no data on live birth or complications due to surgery. We found no studies on women with polyps, septa or adhesions. The hysteroscopic removal of polyps prior to intrauterine insemination (IUI; a fertility treatment where sperm is placed inside a woman's womb to fertilise the egg) is may improve the pregnancy rate compared to not removing polyps. If 28% of women become pregnant without surgery, the evidence suggests that about 63% of women will become pregnant following removal of polyps. We found no data on number of live births, hysteroscopy complications or miscarriage rates prior to IUI. We retrieved no studies in women before other fertility treatments. More studies are needed before hysteroscopy can be proposed as a fertility-enhancing procedure in the general population of women having difficulty becoming pregnant. The quality of the evidence retrieved was very low to low due to the limited number of participants and the poor design of the studies."
]
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cochrane-simplification-train-1681 | cochrane-simplification-train-1681 | Three trials with 146 participants met the inclusion criteria of this review. Two parallel group trials with 100 participants provided information on one or more outcomes. The remaining trial was a cross-over trial, with no usable data for analysis. All the trials were at high risk of bias. Overall, all the evidence was of very low quality. All three trials compared erythrocytapheresis (removal of red cells only, instead of whole blood) versus phlebotomy. Two of the trials shared the same first author. The mean or median age in the three trials ranged from 42 to 55 years. None of the trials reported whether the included participants were symptomatic or asymptomatic or a mixture of both. Two trials were conducted in people who were haemochromatosis treatment-naive. The trial that provided most data for this review excluded people with malignancy, heart failure, and serious cardiac arrhythmias. We found no trials assessing iron-chelating agents. Only one of the trials with 38 participants reported no short-term mortality and no serious adverse events at the end of the short-term follow-up (eight months). Two trials reported the proportion of people with adverse events: 10/49 (20.4%) in the erythrocytapheresis group versus 11/51 (21.6%) in the phlebotomy group. One of these two trials provided data on adverse event rates (42.1 events per 100 participants with erythrocytapheresis versus 52.6 events per 100 participants with phlebotomy). There was no evidence of differences in the proportion of people with adverse events and the number of adverse events (serious and non-serious) between the groups (proportion of people with adverse events: OR 0.93, 95% CI 0.36 to 2.43; participants = 100; trials = 2; number of adverse events: rate ratio 0.80, 95% CI 0.32 to 2.03; participants = 38; trial = 1). There was no difference between the groups regarding short-term health-related quality of life (mean difference (MD) 1.00, 95% CI -10.80 to 12.80; participants = 38; trials = 1). This outcome was measured using EQ-VAS (range: 0 to 100 where a higher score indicates better health-related quality of life). None of the trials reported mortality beyond one year, health-related quality of life beyond one year, liver transplantation, decompensated liver disease, cirrhosis, hepatocellular carcinoma, diabetes, or cardiovascular complications during the long-term follow-up. The two trials that provided data for this review were funded by parties with no vested interest in the results; the source of funding of the third trial was not reported. There is currently insufficient evidence to determine whether erythrocytapheresis is beneficial or harmful compared with phlebotomy. Phlebotomy has less equipment requirements and remains the treatment of choice in people with hereditary haemochromatosis who require blood letting in some form. However, it should be noted that there is no evidence from randomised clinical trials that blood letting in any form is beneficial in people with hereditary haemochromatosis. Having said this, a trial including no treatment is unlikely to be conducted. Future trials should compare different frequencies of phlebotomy and erythrocytapheresis versus phlebotomy with and without different iron-chelating agents compared with each other, and with placebo. Such trials should include long-term follow-up of participants (e.g. using national record linkage databases) to determine whether treatments are beneficial or harmful in terms of clinical outcomes such as deaths, health-related quality of life, liver damage and its consequences, heart damage and its consequences, and other outcomes that are of importance to people with hereditary haemochromatosis. | We identified three trials. Two trials with 100 participants provided information on one or more outcomes (measures of how well the treatments worked). The trials compared phlebotomy (removal of blood or 'blood letting') versus erythrocytapheresis (removal of blood, separation of red cells (which carry oxygen in the blood), and return of the remaining parts of the blood). Two trials were conducted in people who had not undergone previous treatment for haemochromatosis. The trial that provided most data for this review excluded people with cancer, heart failure, and serious irregular heartbeats. Source of funding: the two trials that provided data for this review were funded by parties with no vested interest in the results; the source of funding of the third trial was not reported. There were no deaths or serious complications in the short term in either group in the only trial that reported this information. There was no evidence of any difference in the percentage of people with any complications, the number of complications per person, and short-term health-related quality of life (a measure of a person's satisfaction with their life and health) between the treatments. None of the trials reported deaths beyond one year, health-related quality of life beyond one year, liver transplantation, severe liver damage, liver failure, liver cancer, diabetes, heart failure, or stroke during the long term. There is currently insufficient evidence to determine whether erythrocytapheresis is beneficial or harmful compared with phlebotomy. Erythrocytapheresis requires special equipment, while phlebotomy does not. So, phlebotomy remains the treatment of choice in people with hereditary haemochromatosis even though there is no evidence from randomised clinical trials that blood letting is beneficial. Having said this, a randomised clinical trial including no treatment is unlikely to be conducted. The overall quality of evidence was very low as the trials were at high risk of bias, which means that there is possibility of making wrong conclusions overestimating benefits or underestimating harms of treatments because of the way that the studies were conducted. Further high-quality randomised clinical trials to identify how often blood letting should be performed and those comparing erythrocytapheresis versus blood letting are required. Such trials should include long-term monitoring of participants (perhaps by linking health records in some countries). | 10.1002/14651858.CD011647.pub2 | [
"We identified three trials. Two trials with 100 participants provided information on one or more outcomes (measures of how well the treatments worked). The trials compared phlebotomy (removal of blood or 'blood letting') versus erythrocytapheresis (removal of blood, separation of red cells (which carry oxygen in the blood), and return of the remaining parts of the blood). Two trials were conducted in people who had not undergone previous treatment for haemochromatosis. The trial that provided most data for this review excluded people with cancer, heart failure, and serious irregular heartbeats. Source of funding: the two trials that provided data for this review were funded by parties with no vested interest in the results; the source of funding of the third trial was not reported. There were no deaths or serious complications in the short term in either group in the only trial that reported this information. There was no evidence of any difference in the percentage of people with any complications, the number of complications per person, and short-term health-related quality of life (a measure of a person's satisfaction with their life and health) between the treatments. None of the trials reported deaths beyond one year, health-related quality of life beyond one year, liver transplantation, severe liver damage, liver failure, liver cancer, diabetes, heart failure, or stroke during the long term. There is currently insufficient evidence to determine whether erythrocytapheresis is beneficial or harmful compared with phlebotomy. Erythrocytapheresis requires special equipment, while phlebotomy does not. So, phlebotomy remains the treatment of choice in people with hereditary haemochromatosis even though there is no evidence from randomised clinical trials that blood letting is beneficial. Having said this, a randomised clinical trial including no treatment is unlikely to be conducted. The overall quality of evidence was very low as the trials were at high risk of bias, which means that there is possibility of making wrong conclusions overestimating benefits or underestimating harms of treatments because of the way that the studies were conducted. Further high-quality randomised clinical trials to identify how often blood letting should be performed and those comparing erythrocytapheresis versus blood letting are required. Such trials should include long-term monitoring of participants (perhaps by linking health records in some countries)."
]
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cochrane-simplification-train-1682 | cochrane-simplification-train-1682 | We identified no RCTs or quasi-RCTs that fulfilled the inclusion criteria. Our searches retrieved eight potentially relevant studies, but after assessment of the full-text reports we excluded all of them due to the absence of randomisation or because the patients did not have Frey's syndrome. We excluded one randomised controlled trial that compared two different doses of botulinum toxin in patients with Frey's syndrome because the comparator was not an alternative treatment. We are unable to establish the efficacy and safety of the different methods used for the treatment of Frey's syndrome. RCTs are urgently needed to assess the effectiveness of interventions for the treatment of Frey's syndrome. Future RCTs should include patients with Frey's syndrome of different ranges of severity and report these patients separately. Studies should investigate all possibly effective treatments (such as anticholinergics, antiperspirants and botulinum toxin) compared to control groups using different treatments or placebo. Subjective assessment of Frey's syndrome should be considered as one of the outcome measures. | We carried out a comprehensive search for randomised controlled trials (RCTs) in participants diagnosed with Frey's syndrome. We planned to include trials in which participants received any intervention compared to no treatment (observation) or an alternative intervention, with or without a second active treatment. Despite extensive searching, we were unable to identify any studies that met our inclusion criteria. There is no high-quality evidence to establish which type of treatment is most effective for the treatment of Frey's syndrome. High-quality clinical trials in this area should be urgently conducted. Studies should investigate all possibly effective treatments (such as anticholinergics, antiperspirants and botulinum toxin) compared to control groups using different treatments or placebo. Subjective (patient) assessment of Frey's syndrome should be one of the outcome measures used. This review is up to date to 28 April 2014. | 10.1002/14651858.CD009959.pub2 | [
"We carried out a comprehensive search for randomised controlled trials (RCTs) in participants diagnosed with Frey's syndrome. We planned to include trials in which participants received any intervention compared to no treatment (observation) or an alternative intervention, with or without a second active treatment. Despite extensive searching, we were unable to identify any studies that met our inclusion criteria. There is no high-quality evidence to establish which type of treatment is most effective for the treatment of Frey's syndrome. High-quality clinical trials in this area should be urgently conducted. Studies should investigate all possibly effective treatments (such as anticholinergics, antiperspirants and botulinum toxin) compared to control groups using different treatments or placebo. Subjective (patient) assessment of Frey's syndrome should be one of the outcome measures used. This review is up to date to 28 April 2014."
]
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cochrane-simplification-train-1683 | cochrane-simplification-train-1683 | We included seven new studies with 663 participants in the 2017 update; five RCTs and two CCTs. These were added to the nine previously included studies (six RCTs and three CCTs with a total of 373 participants) for a total of 16 included studies and 1036 participants in this updated review. The mean age and range data for all participants were not reported for all studies. We identified two registered trials that met the inclusion criteria for this review; however there are no results for these studies yet. Overall, the GRADE assessment of evidence quality ranged from moderate to very low. The method of randomization in 11 of the 12 included RCTs was explicitly stated and adequate. Incomplete or methodologically diverse reporting of data affected the completeness of the analysis. Data on additional aromatherapies were added in the 2017 update (blended aromatherapy products, and peppermint products). Heterogeneity of outcome measures and time points between studies affected the completeness of the analysis. In the summary of the findings of six studies, we did not find aromatherapy to be effective in reducing nausea severity in comparison to placebo (SMD -0.22, 95% CI -0.63 to 0.18, P value = 0.28, 241 participants, level of evidence: low). Those participants receiving aromatherapy were no more likely to be free of nausea at the end of the treatment period than those receiving placebo (RR 3.25, 95% CI 0.31 to 34.33, P value = 0.33, 4 trials, 193 participants, evidence level: very low), however they were less likely to require rescue antiemetics (RR 0.60, 95% CI 0.37 to 0.97, P value = 0.04, 7 trials, 609 participants, evidence level: low). There were no data reported on adverse events or patient satisfaction for this comparison. A specific comparison of peppermint aromatherapy to placebo did not show evidence of an effect on nausea severity at five minutes post-treatment in the pooled results (SMD -0.18, 95% CI -0.86 to 0.49, P value = 0.59, 4 trials, 115 participants, evidence level: low). There were no data reported on nausea duration, use of rescue antiemetics, adverse events or patient satisfaction for this comparison. When we pooled studies comparing isopropyl alcohol to standard antiemetic treatment in a GRADE summary of findings, in terms of nausea duration, there was a significant effect on the time in minutes to a 50% reduction in nausea scores (SMD -1.10, 95% CI -1.43 to -0.78, P value < 0.00001, 3 trials, 176 participants, evidence level: moderate). Fewer participants who received isopropyl alcohol required rescue antiemetics (RR 0.67, 95% CI 0.46 to 0.98, P value = 0.04, 215 participants, 4 trials, evidence level: moderate). Two studies with 172 participants measured patient satisfaction; there were high levels of satisfaction across both aromatherapy and standard treatment groups and no differences found (evidence level: low). There were no data reported on nausea severity or adverse events for this comparison. There was no difference in effectiveness between isopropyl alcohol vapour inhalation and placebo for reducing the proportion of participants requiring rescue antiemetics (RR 0.39, 95% CI 0.12 to 1.24, P value = 0.11, 291 participants, 4 trials, evidence level: very low). There were no data reported on nausea severity, nausea duration, adverse events or patient satisfaction for this comparison. Overall, for nausea severity at the end of treatment, aromatherapy may have similar effectiveness to placebo and similar numbers of participants were nausea-free. However, this finding is based on low-quality evidence and therefore very uncertain. Low-quality evidence also suggests that participants who received aromatherapy may need fewer antiemetic medications, but again, this is uncertain. Participants receiving either aromatherapy or antiemetic medications may report similar levels of satisfaction with their treatment, according to low-quality evidence. | We examined a total of 16 controlled clinical studies using aromatherapy for PONV with a total of 1036 participants (seven new studies from the March 2017 searches were added to nine studies from the original review). The participants were adults except for two studies in children. The studies applied aromatherapy at the first complaint of nausea in the immediate period after surgery and measured nausea for up to two days. Aromatherapy substances used were isopropyl alcohol (rubbing alcohol), peppermint oil, ginger, or mixtures that included ginger, spearmint, peppermint and cardamom; or lavender, peppermint, ginger, and spearmint oils. The studies compared aromatherapy to saline or water placebo, controlled breathing, other aromatherapy substances, anti-nausea medications, or a combination of these, with some studies having up to four groups. Overall, aromatherapy was not effective in reducing nausea severity at greater than three minutes after treatment in comparison to saline, water or controlled breathing placebo (6 studies with 241 participants) but more participants who received aromatherapy were nausea-free at the end of treatment (4 studies, 193 participants) and fewer participants who received aromatherapy required anti-nausea medications (7 studies with 609 participants). Peppermint oil did not show an effect on nausea severity at five minutes after treatment (4 studies, 115 participants). We could not pool data for a comparison of isopropyl alcohol to standard anti-nausea medications for nausea severity. In terms of nausea duration, the time to 50% relief of symptoms was faster with isopropyl alcohol vapour than with standard antiemetics (ondansetron and promethazine) (3 studies, 176 participants). Aromatherapy using isopropyl alcohol vapour inhalation provided rapid, short-term relief of nausea and reduced the need for rescue anti-nausea drugs (4 studies, 215 participants). Patient satisfaction with aromatherapy appeared high in the four studies that measured this outcome. Fewer participants who received isopropyl alcohol aromatherapy required rescue anti-nausea drugs compared with those who received saline (4 studies, 291 participants). The participants receiving aromatherapy were not more likely to be free of nausea at the end of the treatment period however they were less likely to require rescue anti-nausea drugs. All participants in these studies (treatment and comparison groups) reported high levels of satisfaction, possibly indicating that increased attention to the care of postoperative nausea and vomiting improved satisfaction with their care. Aromatherapy may provide a useful therapeutic option, particularly when the alternative is no treatment at all. None of the included studies reported adverse effects from the aromatherapies used. Overall the evidence quality ranged from moderate to very low, as assessed by GRADE. There was a high risk of bias due to the design of some studies. The included studies consisted of 12 randomized controlled trials and 4 controlled clinical trials where participants were not randomly assigned to a treatment group. In most studies, participants and researchers were aware of group allocation and this may have had an influence on the results. The strong odours involved meant that aromatherapy was a difficult intervention to conceal from participants, research staff and those assessing outcomes. The different comparisons, time points and measurement scales limited the data that could be pooled. Some data were expressed as standardized scales and measures, which enabled pooling of results in meta-analyses. The data were incomplete for effects longer than 60 minutes. | 10.1002/14651858.CD007598.pub3 | [
"We examined a total of 16 controlled clinical studies using aromatherapy for PONV with a total of 1036 participants (seven new studies from the March 2017 searches were added to nine studies from the original review). The participants were adults except for two studies in children. The studies applied aromatherapy at the first complaint of nausea in the immediate period after surgery and measured nausea for up to two days. Aromatherapy substances used were isopropyl alcohol (rubbing alcohol), peppermint oil, ginger, or mixtures that included ginger, spearmint, peppermint and cardamom; or lavender, peppermint, ginger, and spearmint oils. The studies compared aromatherapy to saline or water placebo, controlled breathing, other aromatherapy substances, anti-nausea medications, or a combination of these, with some studies having up to four groups. Overall, aromatherapy was not effective in reducing nausea severity at greater than three minutes after treatment in comparison to saline, water or controlled breathing placebo (6 studies with 241 participants) but more participants who received aromatherapy were nausea-free at the end of treatment (4 studies, 193 participants) and fewer participants who received aromatherapy required anti-nausea medications (7 studies with 609 participants). Peppermint oil did not show an effect on nausea severity at five minutes after treatment (4 studies, 115 participants). We could not pool data for a comparison of isopropyl alcohol to standard anti-nausea medications for nausea severity. In terms of nausea duration, the time to 50% relief of symptoms was faster with isopropyl alcohol vapour than with standard antiemetics (ondansetron and promethazine) (3 studies, 176 participants). Aromatherapy using isopropyl alcohol vapour inhalation provided rapid, short-term relief of nausea and reduced the need for rescue anti-nausea drugs (4 studies, 215 participants). Patient satisfaction with aromatherapy appeared high in the four studies that measured this outcome. Fewer participants who received isopropyl alcohol aromatherapy required rescue anti-nausea drugs compared with those who received saline (4 studies, 291 participants). The participants receiving aromatherapy were not more likely to be free of nausea at the end of the treatment period however they were less likely to require rescue anti-nausea drugs. All participants in these studies (treatment and comparison groups) reported high levels of satisfaction, possibly indicating that increased attention to the care of postoperative nausea and vomiting improved satisfaction with their care. Aromatherapy may provide a useful therapeutic option, particularly when the alternative is no treatment at all. None of the included studies reported adverse effects from the aromatherapies used. Overall the evidence quality ranged from moderate to very low, as assessed by GRADE. There was a high risk of bias due to the design of some studies. The included studies consisted of 12 randomized controlled trials and 4 controlled clinical trials where participants were not randomly assigned to a treatment group. In most studies, participants and researchers were aware of group allocation and this may have had an influence on the results. The strong odours involved meant that aromatherapy was a difficult intervention to conceal from participants, research staff and those assessing outcomes. The different comparisons, time points and measurement scales limited the data that could be pooled. Some data were expressed as standardized scales and measures, which enabled pooling of results in meta-analyses. The data were incomplete for effects longer than 60 minutes."
]
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cochrane-simplification-train-1684 | cochrane-simplification-train-1684 | Nine studies involving 1359 participants met the inclusion criteria. Six studies compared individual education to usual care and three compared individual education to group education (361 participants). There were no long-term studies and overall the quality of the studies was not high. In the six studies comparing individual face-to-face education to usual care, individual education did not significantly improve glycaemic control (weighted mean difference (WMD) in HbA1c -0.1% (95% confidence interval (CI) -0.3 to 0.1, P = 0.33) over a 12 to 18 month period. However, there did appear to be a significant benefit of individual education on glycaemic control in a subgroup analysis of three studies involving participants with a higher mean baseline HbA1c greater than 8% (WMD -0.3% (95% CI -0.5 to -0.1, P = 0.007). In the two studies comparing individual to group education, there was no significant difference in glycaemic control between individual or group education at 12 to 18 months with a WMD in HbA1c of 0.03% (95% CI -0.02 to 0.1, P = 0.22). There was no significant difference in the impact of individual versus usual care or group education on body mass index systolic or diastolic blood pressure. There were too few studies to perform a meta-analysis on the effect of individual education on dietary self management, diabetes knowledge, psychosocial outcomes and smoking habits. No data were available on the other main outcome measures of diabetes complications or health service utilization and cost analysis in these studies. This systematic review suggests a benefit of individual education on glycaemic control when compared with usual care in a subgroup of those with a baseline HbA1c greater than 8%. However, overall there did not appear to be a significant difference between individual education and usual care. In the small number of studies comparing group and individual education, there was an equal impact on HbA1c at 12 to 18 months. Additional studies are needed to delineate these findings further. | Nine studies involving 1359 participants met the inclusion criteria. Six studies compared individual education to usual care and three compared individual education to group education (361 participants). There were no long-term studies and overall the quality of the studies was not high. Individual face-to-face patient education for type 2 diabetes over a six to twelve month period did not significantly improve glycaemic control, body mass index (BMI - measure of overweight; body weight in kilogram divided through squared height in meters, kg/m2), blood pressure or total cholesterol in the short or medium term compared with usual care. However, there did appear to be a significant benefit of individual education on glycaemic control in a subgroup analysis of studies involving participants with a higher baseline HbA1c greater than 8% (that is, too high blood sugar levels over a couple of months or inadequate 'metabolic control'). In the studies comparing individual education to group education, there was no significant difference between individual or group education at 12 to 18 months nor a significant difference in the impact of individual education versus group education on BMI, systolic or diastolic blood pressure. An exact analysis on dietary self management, diabetes knowledge, psychosocial outcomes and smoking habits could not be performed because there were limited studies and varied measurement tools. However, descriptive evaluation suggested that there was no significant difference in quality of life, self management skills or knowledge between group and individual education. When comparing individual patient education to usual care, the limited number of studies available suggested a positive outcome on self management, smoking and knowledge, however there was conflicting evidence surrounding psychosocial outcomes. No data were available on the other main outcome measures of diabetes complications or health service utilization and cost analysis in these studies. | 10.1002/14651858.CD005268.pub2 | [
"Nine studies involving 1359 participants met the inclusion criteria. Six studies compared individual education to usual care and three compared individual education to group education (361 participants). There were no long-term studies and overall the quality of the studies was not high. Individual face-to-face patient education for type 2 diabetes over a six to twelve month period did not significantly improve glycaemic control, body mass index (BMI - measure of overweight; body weight in kilogram divided through squared height in meters, kg/m2), blood pressure or total cholesterol in the short or medium term compared with usual care. However, there did appear to be a significant benefit of individual education on glycaemic control in a subgroup analysis of studies involving participants with a higher baseline HbA1c greater than 8% (that is, too high blood sugar levels over a couple of months or inadequate 'metabolic control'). In the studies comparing individual education to group education, there was no significant difference between individual or group education at 12 to 18 months nor a significant difference in the impact of individual education versus group education on BMI, systolic or diastolic blood pressure. An exact analysis on dietary self management, diabetes knowledge, psychosocial outcomes and smoking habits could not be performed because there were limited studies and varied measurement tools. However, descriptive evaluation suggested that there was no significant difference in quality of life, self management skills or knowledge between group and individual education. When comparing individual patient education to usual care, the limited number of studies available suggested a positive outcome on self management, smoking and knowledge, however there was conflicting evidence surrounding psychosocial outcomes. No data were available on the other main outcome measures of diabetes complications or health service utilization and cost analysis in these studies."
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cochrane-simplification-train-1685 | cochrane-simplification-train-1685 | Ten trials including 657 patients compared different methods of vascular occlusion. All trials were of high risk of bias. Only one or two trials were included under each comparison. There was no statistically significant differences in mortality, liver failure, or other morbidity between any of the comparisons. Hepatic vascular occlusion does not decrease the blood transfusion requirements. It decreases the cardiac output and increases the systemic vascular resistance. In the comparison between continuous portal triad clamping and intermittent portal triad clamping, four of the five liver failures occurred in patients with chronic liver diseases undergoing the liver resections using continuous portal triad clamping. In the comparison between selective inflow occlusion and portal triad clamping, all four patients with liver failure occurred in the selective inflow occlusion group. There was no difference in any of the other important outcomes in any of the comparisons. In elective liver resection, hepatic vascular occlusion cannot be recommended over portal triad clamping. Intermittent portal triad clamping seems to be better than continuous portal triad clamping at least in patients with chronic liver disease. There is no evidence to support selective inflow occlusion over portal triad clamping. The optimal method of intermittent portal triad clamping is not clear. There is no evidence for any difference between the ischaemic preconditioning followed by vascular occlusion and intermittent vascular occlusion for liver resection in patients with non-cirrhotic livers. Further randomised trials of low risk of bias are needed to determine the optimal technique of vascular occlusion. | Ten trials including 657 patients were included in this review. All were of high risk of bias (systematic error) and play of chance (random error). Only one or two trials were included under each comparison. There was no difference in mortality, liver failure, or post-operative complications between any of the comparisons. Hepatic vascular occlusion does not decrease the blood transfusion requirements. It decreases the cardiac output (amount of blood pumped by the heart in one second) and increases the systemic vascular resistance (resistance to the flow of blood in the vessels), which may have potential problems in patients with heart disorders. Although there was no statistically significant difference in the incidence of liver failure between continuous portal triad clamping and intermittent portal triad clamping (5/60; 8.5% versus 0/61), most of them occurred in patients with chronic liver diseases undergoing the liver resections using continuous portal triad clamping. There was no benefit in selective inflow occlusion compared to portal triad clamping. There was no statistically significant difference in the incidence of liver failure between the two groups (4/41; 9.8% versus 0/39), but all patients with liver failure occurred in the selective inflow occlusion group. There were no significant differences in any of the important outcomes between the different methods of intermittent portal triad clamping or between ischaemic preconditioning followed by continuous vascular occlusion and intermittent vascular occlusion in non-cirrhotic patients undergoing liver resections. Further randomised trials of low risk of bias are needed to determine the optimal technique of vascular occlusion. | 10.1002/14651858.CD007632 | [
"Ten trials including 657 patients were included in this review. All were of high risk of bias (systematic error) and play of chance (random error). Only one or two trials were included under each comparison. There was no difference in mortality, liver failure, or post-operative complications between any of the comparisons. Hepatic vascular occlusion does not decrease the blood transfusion requirements. It decreases the cardiac output (amount of blood pumped by the heart in one second) and increases the systemic vascular resistance (resistance to the flow of blood in the vessels), which may have potential problems in patients with heart disorders. Although there was no statistically significant difference in the incidence of liver failure between continuous portal triad clamping and intermittent portal triad clamping (5/60; 8.5% versus 0/61), most of them occurred in patients with chronic liver diseases undergoing the liver resections using continuous portal triad clamping. There was no benefit in selective inflow occlusion compared to portal triad clamping. There was no statistically significant difference in the incidence of liver failure between the two groups (4/41; 9.8% versus 0/39), but all patients with liver failure occurred in the selective inflow occlusion group. There were no significant differences in any of the important outcomes between the different methods of intermittent portal triad clamping or between ischaemic preconditioning followed by continuous vascular occlusion and intermittent vascular occlusion in non-cirrhotic patients undergoing liver resections. Further randomised trials of low risk of bias are needed to determine the optimal technique of vascular occlusion."
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cochrane-simplification-train-1686 | cochrane-simplification-train-1686 | A total of 50 trials were potentially eligible for inclusion, of which 42 trials were excluded. We included eight RCTs with a total of 233 extraction sites in 184 participants. One trial was judged to be at unclear risk of bias and the remaining trials were at high risk of bias. From two trials comparing xenograft with extraction alone (70 participants, moderate quality evidence), there was some evidence of a reduction in loss of alveolar ridge height (MD -2.60 mm; 95% CI -3.43 to -1.76) and width (MD -1.97 mm; 95% CI -2.48 to -1.46). This was also found in one trial comparing allograft with extraction (24 participants, low quality evidence): ridge height (MD -2.20 mm; 95% CI -0.75 to -3.65) and width (MD - 1.40 mm; 95% CI 0.00 to -2.80) and height. From two RCTs comparing alloplast versus xenograft no evidence was found that either ridge preservation technique caused a smaller reduction in loss of ridge height (MD -0.35 mm; 95% CI -0.86 to 0.16) or width (MD -0.44 mm; 95% CI -0.90 to 0.02; two trials (55 participants); moderate quality evidence). There was insufficient evidence to determine whether there are clinically significant differences between different ARP techniques and extraction based on the need for additional augmentation prior to implant placement, complications, implant failure, or changes in peri-implant marginal bone levels and probing depths of neighbouring teeth. We found no trials which evaluated parameters relating to clinical attachment levels, specific aesthetic or prosthodontic outcomes. There is limited evidence that ARP techniques may minimise the overall changes in residual ridge height and width six months after extraction. There is also lack of evidence of any differences in implant failure, aesthetic outcomes or any other clinical parameters due to the lack of information or long-term data. There is no convincing evidence of any clinically significant difference between different grafting materials and barriers used for ARP. Further long term RCTs that follow CONSORT guidelines (www.consort-statement.org) are necessary. | Authors from Cochrane Oral Health carried out this review and the evidence is up to date from 22 July 2014. Eight trials were included with a total of 233 extraction sites (teeth taken out) in 184 participants. Participants were adults aged 18 years or older, in good general health, needing one or more permanent teeth to be taken out and the consideration of the use of ARP (alveolar ridge preservation techniques) with the possibility of using dental implants at a later date. The review looked at the effects of four techniques and materials used for preserving the tooth extraction socket. Three studies compared socket preservation to tooth extraction alone, while five studies compared two or more different materials. There is limited evidence that socket preservation (ARP) can reduce bone loss compared to tooth extraction alone to allow for dental implant placement. There is no evidence that socket preservation makes any important differences to the look or lasting quality of crowns or bridges. There is no convincing evidence of any significant difference between different materials and barriers used for socket preservation. The quality of the evidence is judged as low due to high risk of bias of the majority of the included studies. Some evidence of reporting bias is suspected, as only two of the included trials did not receive any industry support. Further long-term randomised controlled trials that follow CONSORT guidelines (www.consort-statement.org) are required. | 10.1002/14651858.CD010176.pub2 | [
"Authors from Cochrane Oral Health carried out this review and the evidence is up to date from 22 July 2014. Eight trials were included with a total of 233 extraction sites (teeth taken out) in 184 participants. Participants were adults aged 18 years or older, in good general health, needing one or more permanent teeth to be taken out and the consideration of the use of ARP (alveolar ridge preservation techniques) with the possibility of using dental implants at a later date. The review looked at the effects of four techniques and materials used for preserving the tooth extraction socket. Three studies compared socket preservation to tooth extraction alone, while five studies compared two or more different materials. There is limited evidence that socket preservation (ARP) can reduce bone loss compared to tooth extraction alone to allow for dental implant placement. There is no evidence that socket preservation makes any important differences to the look or lasting quality of crowns or bridges. There is no convincing evidence of any significant difference between different materials and barriers used for socket preservation. The quality of the evidence is judged as low due to high risk of bias of the majority of the included studies. Some evidence of reporting bias is suspected, as only two of the included trials did not receive any industry support. Further long-term randomised controlled trials that follow CONSORT guidelines (www.consort-statement.org) are required."
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cochrane-simplification-train-1687 | cochrane-simplification-train-1687 | We did not include any new trials in this update. One randomised controlled trial of 32 patients is included. Concerning risk of bias, generation of the allocation sequence was at low risk; however, allocation concealment, blinding and selective reporting were at high risk. Treatment response, defined as 20% improvement from basal conditions by clinical, serological and specific neurological measures, was found in 94.7% (18/19) of patients using cyclophosphamide compared with 46.2% (6/13) in the methylprednisolone group at 24 months (RR 2.05, 95% CI 1.13 to 3.73). This was statistically significant and the number needed to treat for an additional beneficial outcome (NNTB) of treatment response is three. We found no statistically significant differences between the groups in damage index measurements (Systemic Lupus International Collaborating Clinics (SLICC)). The median SLE Disease Activity Index (SLEDAI) rating favoured the cyclophosphamide group. Cyclophosphamide use was associated with a reduction in prednisone requirements. All the patients in the cyclophosphamide group had electroencephalographic improvement but there was no statistically significant difference in decrease between groups in the number of monthly seizures. No statistically significant differences in adverse effects, including mortality, were reported between the groups. This systematic review found one randomised controlled trial with a small number of patients in the different clinical subgroups of neurological manifestation. There is very low-quality evidence that cyclophosphamide is more effective in reducing symptoms of neuropsychiatric involvement in SLE compared with methylprednisolone. However, properly designed randomised controlled trials that involve large numbers of individuals, with explicit clinical and laboratory diagnostic criteria, sufficient duration of follow-up and description of all relevant outcome measures, are necessary to guide practice. As we did not find any new trials to include in this review at update, the conclusions of the review did not change. | In people with central nervous system lupus: - We are uncertain whether cyclophosphamide improves signs and symptoms or disease activity compared to methylprednisolone. - No differences between the two groups were found in tissue or organ damage, or in the number of monthly seizures, but this may have happened by chance. - After six months of treatment, people who took cyclophosphamide took fewer prednisone pills than people who took methylprednisolone. - And at the end of two years, more people who took cyclophosphamide stayed on their treatment than people who took methylprednisolone. We often do not have precise information about side effects and complications. This is particularly true for rare but serious side effects. Side effects, such as infections, high blood sugar and high blood pressure, pancreas problems and death occurred about the same amount in people who took cyclophosphamide or methylprednisolone. Systemic lupus erythematosus (SLE) is a disease in which the body's immune system attacks the body. In CNS lupus (central nervous system lupus) the body may have attacked and damaged the cells in the brain and spine. This damage may cause a person to have convulsions/seizures, chronic headaches, confusion and psychosis. Drugs such as corticosteroids (prednisone or methylprednisolone) are usually used for lupus to decrease inflammation and control the immune system. Immunosuppressive agents or cytotoxics such as cyclophosphamide (CTX or Cytoxan) may also be used. - 49 more people who took cyclophosphamide improved than people who took methylprednisolone. - 95 out of 100 people had at least a 20% improvement in symptoms with cyclophosphamide. - 46 out of 100 people had at least a 20% improvement in symptoms with methylprednisolone. | 10.1002/14651858.CD002265.pub3 | [
"In people with central nervous system lupus: - We are uncertain whether cyclophosphamide improves signs and symptoms or disease activity compared to methylprednisolone. - No differences between the two groups were found in tissue or organ damage, or in the number of monthly seizures, but this may have happened by chance. - After six months of treatment, people who took cyclophosphamide took fewer prednisone pills than people who took methylprednisolone. - And at the end of two years, more people who took cyclophosphamide stayed on their treatment than people who took methylprednisolone. We often do not have precise information about side effects and complications. This is particularly true for rare but serious side effects. Side effects, such as infections, high blood sugar and high blood pressure, pancreas problems and death occurred about the same amount in people who took cyclophosphamide or methylprednisolone. Systemic lupus erythematosus (SLE) is a disease in which the body's immune system attacks the body. In CNS lupus (central nervous system lupus) the body may have attacked and damaged the cells in the brain and spine. This damage may cause a person to have convulsions/seizures, chronic headaches, confusion and psychosis. Drugs such as corticosteroids (prednisone or methylprednisolone) are usually used for lupus to decrease inflammation and control the immune system. Immunosuppressive agents or cytotoxics such as cyclophosphamide (CTX or Cytoxan) may also be used. - 49 more people who took cyclophosphamide improved than people who took methylprednisolone. - 95 out of 100 people had at least a 20% improvement in symptoms with cyclophosphamide. - 46 out of 100 people had at least a 20% improvement in symptoms with methylprednisolone."
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cochrane-simplification-train-1688 | cochrane-simplification-train-1688 | We included two trials enrolling 624 women in the review. It is uncertain whether breast surgery improves overall survival as the quality of the evidence has been assessed as very low (HR 0.83, 95% CI 0.53 to 1.31; 2 studies; 624 women). The two studies did not report quality of life. Breast surgery may improve local progression-free survival (HR 0.22, 95% CI 0.08 to 0.57; 2 studies; 607 women; low-quality evidence), while it probably worsened distant progression-free survival (HR 1.42, 95% CI 1.08 to 1.86; 1 study; 350 women; moderate-quality evidence). The two included studies did not measure breast cancer-specific survival. Toxicity from local therapy was reported by 30-day mortality and did not appear to differ between the two groups (RR 0.99, 95% CI 0.14 to 6.90; 1 study; 274 women; low-quality evidence). Based on existing evidence from two randomised clinical trials, it is not possible to make definitive conclusions on the benefits and risks of breast surgery associated with systemic treatment for women diagnosed with metastatic breast cancer. Until the ongoing clinical trials are finalised, the decision to perform breast surgery in these women should be individualised and shared between the physician and the patient considering the potential risks, benefits, and costs of each intervention. | The evidence is current to February 2016. We included only randomised clinical trials, as they are considered to be the best type of scientific study to answer questions about treatment, that compared the survival of women undergoing breast surgery combined with medical treatment versus medical treatment alone. We identified and included two randomised controlled trials involving a total of 624 women: 311 women underwent breast surgery plus medical treatment, and 313 women only received medical treatment. The review authors are uncertain whether breast surgery improves overall survival as the quality of the evidence has been assessed as very low. The included studies did not report any information relating to quality of life. Breast surgery may improve the control of local disease but it probably worsened control at distant sites. The two included studies did not measure breast cancer-specific survival. Toxicity from local therapy appeared to be the same in the group undergoing breast surgery combined with medical treatment and in the group receiving only medical treatment. It is not possible to make definitive conclusions about the benefits of breast surgery associated with medical treatment for women with metastatic breast cancer. The decision to perform surgery in such cases should be individualised and shared between the physician and the patient, considering the potential risks and benefits involved in this choice. The inclusion of results of ongoing trials involving women with these characteristics in the next update of this review will help to decrease existing uncertainties. | 10.1002/14651858.CD011276.pub2 | [
"The evidence is current to February 2016. We included only randomised clinical trials, as they are considered to be the best type of scientific study to answer questions about treatment, that compared the survival of women undergoing breast surgery combined with medical treatment versus medical treatment alone. We identified and included two randomised controlled trials involving a total of 624 women: 311 women underwent breast surgery plus medical treatment, and 313 women only received medical treatment. The review authors are uncertain whether breast surgery improves overall survival as the quality of the evidence has been assessed as very low. The included studies did not report any information relating to quality of life. Breast surgery may improve the control of local disease but it probably worsened control at distant sites. The two included studies did not measure breast cancer-specific survival. Toxicity from local therapy appeared to be the same in the group undergoing breast surgery combined with medical treatment and in the group receiving only medical treatment. It is not possible to make definitive conclusions about the benefits of breast surgery associated with medical treatment for women with metastatic breast cancer. The decision to perform surgery in such cases should be individualised and shared between the physician and the patient, considering the potential risks and benefits involved in this choice. The inclusion of results of ongoing trials involving women with these characteristics in the next update of this review will help to decrease existing uncertainties."
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cochrane-simplification-train-1689 | cochrane-simplification-train-1689 | We included eight trials, involving 952 participants, of which 64% were women. Included trials were generally of adequate quality, with six trials at low risk of bias, and two trials at high risk of bias. Three trials with 518 participants compared five different drugs with placebo; all reported the primary outcome as mean change in visual analogue scale (VAS) (0 to 100) for nausea severity from baseline to 30 minutes. Trials did not routinely report other primary outcomes of the change in nausea VAS at 60 minutes or number of vomiting episodes. Differences in mean VAS change from baseline to 30 minutes between placebo and the drugs evaluated were: metoclopramide (three trials, 301 participants; mean difference (MD) -5.27, 95% confidence interval (CI) -11.33 to 0.80), ondansetron (two trials, 250 participants; MD -4.32, 95% CI -11.20 to 2.56), prochlorperazine (one trial, 50 participants; MD -1.80, 95% CI -14.40 to 10.80), promethazine (one trial, 82 participants; MD -8.47, 95% CI -19.79 to 2.85) and droperidol (one trial, 48 participants; MD -15.8, 95% CI -26.98 to -4.62). The only statistically significant change in baseline VAS to 30 minutes was for droperidol, in a single trial of 48 participants. No other drug was statistically significantly superior to placebo. Other included trials evaluated a drug compared to "active controls" (alternative antiemetic). There was no convincing evidence of superiority of any particular drug compared to active control. All trials included in this review reported adverse events, but they were variably reported precluding meaningful pooling of results. Adverse events were generally mild, there were no reported serious adverse events. Overall, the quality of the evidence was low, mainly because there were not enough data. In an ED population, there is no definite evidence to support the superiority of any one drug over any other drug, or the superiority of any drug over placebo. Participants receiving placebo often reported clinically significant improvement in nausea, implying general supportive treatment such as intravenous fluids may be sufficient for the majority of people. If a drug is considered necessary, choice of drug may be dictated by other considerations such as a person's preference, adverse-effect profile and cost. The review was limited by the paucity of clinical trials in this setting. Future research should include the use of placebo and consider focusing on specific diagnostic groups and controlling for factors such as intravenous fluid administered. | The evidence is current to August 2014. We included eight clinical trials of 952 participants. The trials assessed many different medicines at different doses, but only three trials included a placebo group (dummy medication). Six of these trials were of high quality, with low risk of error (i.e. bias, where the true effect is exaggerated). For this review, we included the effects of the medicines on nausea and vomiting up to one hour after the medicine was given. The main results of interest were the effect on nausea between zero and 60 minutes after the medicine was given, number of vomits and side effects to medicines. Of these, only nausea at 30 minutes and side effects were reported by all trials. From all trials, only one medicine was reported to be better than placebo and other medicines. That was droperidol, which was included in one small trial of 97 participants. No other single medicine was definitely better than any other medicine, and none of the other trials that included a placebo group showed that the active medicines definitely worked better than the placebo. Side effects were mild. Our results suggest that in people in the emergency department, nausea will generally improve, whether they are treated with specific medicines or placebo. Therefore, supportive treatment, such as intravenous fluids (where fluid is given directly into a blood vessel) may be sufficient for many people. Overall, the quality of the evidence was low, mainly because there was not enough data. | 10.1002/14651858.CD010106.pub2 | [
"The evidence is current to August 2014. We included eight clinical trials of 952 participants. The trials assessed many different medicines at different doses, but only three trials included a placebo group (dummy medication). Six of these trials were of high quality, with low risk of error (i.e. bias, where the true effect is exaggerated). For this review, we included the effects of the medicines on nausea and vomiting up to one hour after the medicine was given. The main results of interest were the effect on nausea between zero and 60 minutes after the medicine was given, number of vomits and side effects to medicines. Of these, only nausea at 30 minutes and side effects were reported by all trials. From all trials, only one medicine was reported to be better than placebo and other medicines. That was droperidol, which was included in one small trial of 97 participants. No other single medicine was definitely better than any other medicine, and none of the other trials that included a placebo group showed that the active medicines definitely worked better than the placebo. Side effects were mild. Our results suggest that in people in the emergency department, nausea will generally improve, whether they are treated with specific medicines or placebo. Therefore, supportive treatment, such as intravenous fluids (where fluid is given directly into a blood vessel) may be sufficient for many people. Overall, the quality of the evidence was low, mainly because there was not enough data."
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cochrane-simplification-train-1690 | cochrane-simplification-train-1690 | Two randomized controlled trials were included, with a total of 115 participants. One study compared clonazepam to carbamazepine as monotherapy for participants with newly diagnosed psychomotor epilepsy (a condition corresponding to what is now termed mesial temporal lobe epilepsy). One study (published as abstract) compared clonazepam to ethosuximide as monotherapy for children with absence seizures. Based on the available data and the details on methodology provided, we judged both studies as being at unclear or high risk of bias for the domains assessed. In the study comparing clonazepam to carbamazepine, no difference was found between the groups regarding the proportion of participants who were seizure-free at one month after randomization (risk ratio (RR) 1.97, 95% confidence interval (CI) 0.99 to 3.94; 30 participants; very low-certainty evidence), three months after randomization (RR 1.19, 95% CI 0.62 to 2.29; 26 participants; very low-certainty evidence), and six months after randomization (RR 0.50, 95% CI 0.09 to 2.73; 9 participants; very low-certainty evidence). No statistical difference was found between clonazepam and carbamazepine in terms of proportion of participants with TEAEs leading to discontinuation (RR 2.61, 95% CI 0.80 to 8.52; 36 participants; very low-certainty evidence) and in terms of dropouts/withdrawals due to side effects, lack of efficacy or other reasons (RR 1.56, 95% CI 0.61 to 4.02; 36 participants; very low certainty evidence). The study did not provide any information on our other prespecified outcomes of interest. The study comparing clonazepam to ethosuximide did not provide any data on efficacy. The proportion of dropouts/withdrawal was higher in the group receiving clonazepam compared to the group receiving ethosuximide (RR 3.63, 95% CI 1.12 to 11.74; 79 participants; very low-certainty evidence). No information on other outcomes of interest was provided in this study. There is only limited and very low-certainty evidence from randomized controlled trials on the efficacy and tolerability of clonazepam used in monotherapy for the treatment of epilepsy. No difference in efficacy and tolerability was found in a small trial comparing clonazepam to carbamazepine for the treatment of mesial temporal lobe epilepsy. Clonazepam was less well tolerated than ethosuximide in a trial of children with absence seizures, however no comparative data on efficacy were provided. There is currently insufficient evidence to support the use of clonazepam as monotherapy treatment for epilepsy. | We identified only two small trials comparing clonazepam with a different drug in two different epileptic syndromes, mesial temporal lobe epilepsy (the most common and well-defined focal epilepsy with seizures originating in the internal part of the temporal lobe of the brain) and absence seizures (generalized seizures causing lapses of awareness). In the study conducted in mesial temporal lobe epilepsy, clonazepam was compared to carbamazepine (an antiepileptic drug used to treat focal epilepsy). In the study on absence seizures, clonazepam was compared to ethosuximide (a medication used to treat absence seizures). We judged both studies as being of poor quality. The studies did not follow the participants for long enough, and the total of participants was too low to draw definite conclusions on the role of clonazepam used in monotherapy. Results on tolerability were not reported consistently across the studies. No differences were found between clonazepam and carbamazepine in the proportion of seizure-free participants; however, this does not mean that clonazepam and carbamazepine have the same efficacy, as the lack of difference can be due to the small number of people included. The study comparing clonazepam with ethosuximide provided no results on efficacy. No differences were found between the two medications in terms of tolerability. However, the proportion of people who dropped out or withdrew from the study due to side effects, lack of efficacy or other reasons was higher in the clonazepam group compared to the ethosuximide group. So far, the evidence on the efficacy and tolerability of clonazepam used as a single antiepileptic drug for the treatment of epilepsy is scarce and of very low certainty; hence insufficient to base decisions on its use in monotherapy. | 10.1002/14651858.CD013028.pub2 | [
"We identified only two small trials comparing clonazepam with a different drug in two different epileptic syndromes, mesial temporal lobe epilepsy (the most common and well-defined focal epilepsy with seizures originating in the internal part of the temporal lobe of the brain) and absence seizures (generalized seizures causing lapses of awareness). In the study conducted in mesial temporal lobe epilepsy, clonazepam was compared to carbamazepine (an antiepileptic drug used to treat focal epilepsy). In the study on absence seizures, clonazepam was compared to ethosuximide (a medication used to treat absence seizures). We judged both studies as being of poor quality. The studies did not follow the participants for long enough, and the total of participants was too low to draw definite conclusions on the role of clonazepam used in monotherapy. Results on tolerability were not reported consistently across the studies. No differences were found between clonazepam and carbamazepine in the proportion of seizure-free participants; however, this does not mean that clonazepam and carbamazepine have the same efficacy, as the lack of difference can be due to the small number of people included. The study comparing clonazepam with ethosuximide provided no results on efficacy. No differences were found between the two medications in terms of tolerability. However, the proportion of people who dropped out or withdrew from the study due to side effects, lack of efficacy or other reasons was higher in the clonazepam group compared to the ethosuximide group. So far, the evidence on the efficacy and tolerability of clonazepam used as a single antiepileptic drug for the treatment of epilepsy is scarce and of very low certainty; hence insufficient to base decisions on its use in monotherapy."
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cochrane-simplification-train-1691 | cochrane-simplification-train-1691 | Four small randomised controlled trials involving 728 allocated/224 analysed participants met our inclusion criteria. These trials had a high risk of bias. Drug companies sponsored two of the trials. We were unable to pool the data due to the heterogeneity in outcome definitions and the different antibiotics used. The included trials compared the following antibiotic schedules. The first trial compared quinolone (levofloxacin) plus standard treatment (anti-staphylococcal penicillin (cloxacillin or dicloxacillin), aminoglycoside (tobramycin or netilmicin) and rifampicin) versus standard treatment alone reporting uncertain effects on all-cause mortality (8/31 (26%) with levofloxacin plus standard treatment versus 9/39 (23%) with standard treatment alone; RR 1.12, 95% CI 0.49 to 2.56, very low quality evidence). The second trial compared daptomycin versus low-dose gentamicin plus an anti-staphylococcal penicillin (nafcillin, oxacillin or flucloxacillin) or vancomycin. This showed uncertain effects in terms of cure rates (9/28 (32.1%) with daptomycin versus 9/25 (36%) with low-dose gentamicin plus anti-staphylococcal penicillin or vancomycin, RR 0.89 95% CI 0.42 to 1.89; very low quality evidence). The third trial compared cloxacillin plus gentamicin with a glycopeptide (vancomycin or teicoplanin) plus gentamicin. In participants receiving gentamycin plus glycopeptide only 13/23 (56%) were cured versus 11/11 (100%) receiving cloxacillin plus gentamicin (RR 0.59, 95% CI 0.40 to 0.85; very low quality evidence). The fourth trial compared ceftriaxone plus gentamicin versus ceftriaxone alone and found no conclusive differences in terms of cure (15/34 (44%) with ceftriaxone plus gentamicin versus 21/33 (64%) with ceftriaxone alone, RR 0.69, 95% CI 0.44 to 1.10; very low quality evidence). The trials reported adverse events, need for cardiac surgical interventions, uncontrolled infection and relapse of endocarditis and found no conclusive differences between comparison groups (very low quality evidence). No trials assessed septic emboli or quality of life. Limited and very low quality evidence suggested that there were no conclusive differences between antibiotic regimens in terms of cure rates or other relevant clinical outcomes. However, because of the very low quality evidence, this needs confirmation. The conclusion of this Cochrane review was based on randomised controlled trials with high risk of bias. Accordingly, current evidence does not support or reject any regimen of antibiotic therapy for treatment of infective endocarditis. | We identified only four studies that compared different antibiotic regimens. They included a limited number of people. Each trial investigated different types and doses of antibiotics. These studies were published between 1998 and 2006 and were conducted in the USA, Spain and Finland. The evidence is up to date as of 30 April 2015. One study showed imprecise results on all-cause mortality (dead from any cause). One study suggested that one antibiotic regimen was superior to another (cloxacillin plus gentamycin was superior to either vancomycin or teicoplanin plus gentamycin). Two studies did not show any difference between the antibiotic regimens. In terms of the need for cardiac surgery, uncontrolled infection or relapse from endocarditis the knowledge is imprecise. No trials assessed septic embolic complications (when infection travels around the body and causes infection in other areas, such as the spine, eyes or lungs) or quality of life. We do not know how safe these medicines are. The confidence in the results of this review is very low. Current evidence does not support or reject any regimen of antibiotic therapy for the treatment of infective endocarditis. The studies had limitations in the way they were designed and performed, and three were sponsored by the manufacturer of the medicine that was assessed. Moreover, the limited number of people included in the studies led to uncertain results. Larger studies are required to provide more information about the best antibiotic regimens to treat people with infective endocarditis. | 10.1002/14651858.CD009880.pub2 | [
"We identified only four studies that compared different antibiotic regimens. They included a limited number of people. Each trial investigated different types and doses of antibiotics. These studies were published between 1998 and 2006 and were conducted in the USA, Spain and Finland. The evidence is up to date as of 30 April 2015. One study showed imprecise results on all-cause mortality (dead from any cause). One study suggested that one antibiotic regimen was superior to another (cloxacillin plus gentamycin was superior to either vancomycin or teicoplanin plus gentamycin). Two studies did not show any difference between the antibiotic regimens. In terms of the need for cardiac surgery, uncontrolled infection or relapse from endocarditis the knowledge is imprecise. No trials assessed septic embolic complications (when infection travels around the body and causes infection in other areas, such as the spine, eyes or lungs) or quality of life. We do not know how safe these medicines are. The confidence in the results of this review is very low. Current evidence does not support or reject any regimen of antibiotic therapy for the treatment of infective endocarditis. The studies had limitations in the way they were designed and performed, and three were sponsored by the manufacturer of the medicine that was assessed. Moreover, the limited number of people included in the studies led to uncertain results. Larger studies are required to provide more information about the best antibiotic regimens to treat people with infective endocarditis."
]
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cochrane-simplification-train-1692 | cochrane-simplification-train-1692 | We included 14 trials (n = 565), 13 (n = 525) of which compared intravenous administration of amino acids to a control (usually saline solution or Ringer's lactate). The remaining trial (n = 40) compared intravenous administration of fructose versus a control. We noted much variation in these trials, which used different types of surgery, variable durations of surgery, and different types of participants. Most trials were at high or unclear risk of bias owing to inappropriate or unclear randomization methods, and to unclear participant and assessor blinding. This may have influenced results, but it is unclear how results might have been influenced. No trials reported any of our prespecified primary outcomes, which were risk of hypothermia and major cardiovascular events. Therefore, we decided to analyse data related to core body temperature instead as a primary outcome. It was not possible to conduct meta-analysis of data related to amino acid infusion for the 60-minute and 120-minute time points, as we observed significant statistical heterogeneity in the results. Some trials showed that higher temperatures were associated with amino acids, but not all trials reported statistically significant results, and some trials reported the opposite result, where the amino acid group had a lower core temperature than the control group. It was possible to conduct meta-analysis for six studies (n = 249) that provided data relating to the end of surgery. Amino acids led to a statistically significant increase in core temperature in comparison to those receiving control (MD = 0.46°C 95% CI 0.33 to 0.59; I2 0.0%; random-effects; moderate quality evidence). Three trials (n = 155) reported shivering as an outcome. Meta-analysis did not show a clear effect, and so it is uncertain whether amino acids reduce the risk of shivering (RR 0.36, 95% CI 0.13 to 1.00; I2 = 93%; random-effects model; very low-quality evidence). Intravenous amino acids may keep participants up to a half-degree C warmer than the control. This difference was statistically significant at the end of surgery, but not at other time points. However, the clinical importance of this finding remains unclear. It is also unclear whether amino acids have any effect on the risk of shivering and if intravenous nutrients confer any other benefits or harms, as high-quality data about these outcomes are lacking. | We looked for evidence up to November 2015. We included 14 randomized studies (involving 565 participants). Thirteen studies compared people who received normal care with additional intravenous amino acids against people who received normal care but no amino acids (the control group). One study compared people who received fructose with those in a control group. Studies involved adults undergoing planned or emergency surgery. We did not include studies in which participants were deliberately kept cold during surgery, were receiving skin grafts or were under local anaesthetic. We can be certain that at the end of surgery, people receiving intravenous nutrients are up to a half-degree warmer than people receiving control (based on evidence from six studies involving 249 participants). However, there was more uncertainty about the effects of intravenous nutrients at other time points, with some studies suggesting that intravenous nutrients keep participants warmer and other studies reporting that participants were colder than those receiving the control. We are uncertain if keeping people up to half a degree warmer is important to those involved in caring for people who are having surgery. We are also uncertain if giving intravenous nutrients reduces the risk of people shivering (based on evidence from three studies involving 155 participants). Most of the evidence was moderate to low in quality. The methods used to assign participants to treatment groups was often inadequate or unclear, and we were uncertain if the people assessing outcomes were aware of which treatment group participants were in. This may have biased the results, but we are unsure what effect it may have had on results overall. | 10.1002/14651858.CD009906.pub2 | [
"We looked for evidence up to November 2015. We included 14 randomized studies (involving 565 participants). Thirteen studies compared people who received normal care with additional intravenous amino acids against people who received normal care but no amino acids (the control group). One study compared people who received fructose with those in a control group. Studies involved adults undergoing planned or emergency surgery. We did not include studies in which participants were deliberately kept cold during surgery, were receiving skin grafts or were under local anaesthetic. We can be certain that at the end of surgery, people receiving intravenous nutrients are up to a half-degree warmer than people receiving control (based on evidence from six studies involving 249 participants). However, there was more uncertainty about the effects of intravenous nutrients at other time points, with some studies suggesting that intravenous nutrients keep participants warmer and other studies reporting that participants were colder than those receiving the control. We are uncertain if keeping people up to half a degree warmer is important to those involved in caring for people who are having surgery. We are also uncertain if giving intravenous nutrients reduces the risk of people shivering (based on evidence from three studies involving 155 participants). Most of the evidence was moderate to low in quality. The methods used to assign participants to treatment groups was often inadequate or unclear, and we were uncertain if the people assessing outcomes were aware of which treatment group participants were in. This may have biased the results, but we are unsure what effect it may have had on results overall."
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cochrane-simplification-train-1693 | cochrane-simplification-train-1693 | Ten studies (786 patients) were included. Mupirocin ointment reduced the risk of catheter-related bacteraemia (RR 0.17, 95%CI 0.07 to 0.43) and had a significant effect on catheter-related infections caused by S. aureus. The risk of catheter-related bacteraemia was reduced by polysporin (RR 0.40, 95%CI 0.19 to 0.86) and povidone-iodine ointment (RR 0.10, 95%CI 0.01 to 0.72). Subgroup analysis suggested mupirocin (RR 0.12, 95%CI 0.01 to 2.13) and povidone-iodine ointment (RR 0.84, 95%CI 0.24 to 2.98) had no effect on all-cause mortality while polysporin ointment showed a significant reduction (RR 0.22, 95%CI 0.07 to 0.74). Mortality related to infection was not reduced by mupirocin, polysporin or povidone-iodine ointment. Topical honey did not reduce the risk of exit site infection (RR 0.45, 95%CI 0.10 to 2.11) or catheter-related bacteraemia (RR 0.80, 95%CI 0.37 to 1.73). Transparent polyurethane dressing compared to dry gauze dressing did not reduce the risk of CVC or exit site infection, or catheter-related bacteraemia. Mupirocin ointment appears effective in reducing the risk of catheter-related bacteraemia. Insufficient reporting on mupirocin resistance was noted and needs to be considered in future studies. A lack of high quality data on the routine use of povidone-iodine ointment, polysporin ointment and topical honey warrant larger RCTs. Insufficient data were available to determine which dressing type (transparent polyurethane or dry gauze dressing) has the lowest risk of catheter-related infections. | The review of 10 studies (786 patients) found that mupirocin ointment reduced the risk of patients developing catheter-related bacteraemia (bacteria in the blood). However, monitoring of mupirocin resistance needs to be considered in future studies. There was not enough evidence to determine which ointment (povidone-iodine and polysporin) or dressing was the best in preventing infection. There was also insufficient evidence to support the use of medicinal honey for the prevention of infection. | 10.1002/14651858.CD006894.pub2 | [
"The review of 10 studies (786 patients) found that mupirocin ointment reduced the risk of patients developing catheter-related bacteraemia (bacteria in the blood). However, monitoring of mupirocin resistance needs to be considered in future studies. There was not enough evidence to determine which ointment (povidone-iodine and polysporin) or dressing was the best in preventing infection. There was also insufficient evidence to support the use of medicinal honey for the prevention of infection."
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cochrane-simplification-train-1694 | cochrane-simplification-train-1694 | We identified one RCT which met our inclusion criteria and was included in this review. Sixty-three participants with primary involutional lower eyelid entropion were randomised to everting sutures alone or everting sutures with a lateral tarsal strip. Eight participants were lost to follow-up. The trial indicates that the combined procedure for horizontal and vertical eyelid tightening in the form of everting sutures and lateral tarsal strip is highly curative for involutional entropion compared to vertical tightening in the form of everting sutures alone. The superiority of the combined approach is also supported by many good quality uncontrolled studies on specific surgical procedures but these were not included in the analysis as they were not part of the inclusion criteria. A single RCT showed that the combination of horizontal and vertical eyelid tightening with everting sutures and lateral tarsal strip is highly efficient for entropion compared to vertical tightening with everting sutures alone. Retrospective case series studies also support the combined surgical repair but details from these studies on specific surgical techniques cannot be included in the analysis. Evidence from a single RCT is unlikely to change clinical practice and thus it is still our view that there is a clear need for more randomised studies comparing two or more surgical techniques for entropion surgery addressing the recurrence and complications rate. | The review authors searched the medical literature and found a single trial that met the inclusion criteria of the review. Sixty-three participants with lower eyelid entropion were enrolled and randomised to either everting sutures alone or everting sutures and a lateral tarsal strip. Eight participants were lost to follow-up. The trial showed that the combination of horizontal and vertical eyelid tightening with everting sutures and lateral tarsal strip is highly efficient for entropion compared to vertical tightening with everting sutures alone. Further research is needed to provide more credible evidence for the comparison of surgical treatments to correct an inward turning eyelid. | 10.1002/14651858.CD002221.pub2 | [
"The review authors searched the medical literature and found a single trial that met the inclusion criteria of the review. Sixty-three participants with lower eyelid entropion were enrolled and randomised to either everting sutures alone or everting sutures and a lateral tarsal strip. Eight participants were lost to follow-up. The trial showed that the combination of horizontal and vertical eyelid tightening with everting sutures and lateral tarsal strip is highly efficient for entropion compared to vertical tightening with everting sutures alone. Further research is needed to provide more credible evidence for the comparison of surgical treatments to correct an inward turning eyelid."
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cochrane-simplification-train-1695 | cochrane-simplification-train-1695 | No randomised controlled trials or controlled trials were found that examined the efficacy of non-pharmacological swallowing therapy for the treatment of dysphagia in Parkinson's disease. However there is one large RCT currently recruiting patients that will compare 'chin down' posture with thickened liquids in the treatment of dysphagia. The main outcomes will be the rates of aspiration and pneumonia. There is currently no evidence to support or refute the efficacy of non-pharmacological swallowing therapy for dysphagia in Parkinson's disease. Large well designed placebo-controlled RCTs are required to assess the effectiveness of swallowing therapy for dysphagia in Parkinson's disease and reported according to CONSORT guidelines. Suitable outcome measures should be chosen so that the efficacy and effectiveness of non-pharmacological swallowing therapy can be assessed and an economic analysis performed. Outcomes which have meaning to patients and carers should be used wherever possible since they need to know the value of this therapy in practical terms. The patients should be followed for at least 6 months to determine the duration of any improvement. | Only randomised controlled trials (RCT) were eligible for this review. In RCTs the patients are assigned to each of the groups in a random fashion so as to reduce the potential for bias. Either one group of patients had swallowing therapy, the other had a sham treatment or no treatment, or two forms of swallowing therapy were compared to each other. There were no controlled trials, randomised or otherwise, in this field. Therefore there is no trial evidence to prove or disprove the benefit of swallowing therapy for the treatment of swallowing disorders in people with Parkinson's disease. It should be emphasised that this lack of evidence does not mean lack of effect. There is one large RCT currently recruiting patients that will compare 'chin down' posture with thickened liquids in the treatment of dysphagia. The main outcomes in this study will be the rates of aspiration and pneumonia. Large well designed placebo-controlled RCTs are needed to assess the effectiveness of swallowing therapy for swallowing disorders in Parkinson's disease. The design of the trials should minimise bias and be reported fully using CONSORT guidelines. Outcome measures with particular relevance to patients should be chosen and the patients followed for at least 6 months to determine the duration of any improvement. | 10.1002/14651858.CD002816 | [
"Only randomised controlled trials (RCT) were eligible for this review. In RCTs the patients are assigned to each of the groups in a random fashion so as to reduce the potential for bias. Either one group of patients had swallowing therapy, the other had a sham treatment or no treatment, or two forms of swallowing therapy were compared to each other. There were no controlled trials, randomised or otherwise, in this field. Therefore there is no trial evidence to prove or disprove the benefit of swallowing therapy for the treatment of swallowing disorders in people with Parkinson's disease. It should be emphasised that this lack of evidence does not mean lack of effect. There is one large RCT currently recruiting patients that will compare 'chin down' posture with thickened liquids in the treatment of dysphagia. The main outcomes in this study will be the rates of aspiration and pneumonia. Large well designed placebo-controlled RCTs are needed to assess the effectiveness of swallowing therapy for swallowing disorders in Parkinson's disease. The design of the trials should minimise bias and be reported fully using CONSORT guidelines. Outcome measures with particular relevance to patients should be chosen and the patients followed for at least 6 months to determine the duration of any improvement."
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cochrane-simplification-train-1696 | cochrane-simplification-train-1696 | The four trials examining tracheostomy-free survival included a total of 974 riluzole-treated patients and 503 placebo-treated patients. No new randomized controlled trials were found when we updated the searches for this update in 2011. The methodological quality was acceptable and three trials were easily comparable, although one trial (169 participants) included older patients in more advanced stages of amyotrophic lateral sclerosis and one (195 participants) had multiple primary endpoints. Riluzole 100 mg per day provided a benefit for the homogeneous group of patients in the first two trials (hazard ratio (HR) 0.80, 95% confidence internal (CI) 0.64 to 0.99, P= 0.042) and there was no evidence of heterogeneity (P = 0.33). When the third trial (which included older and more seriously affected patients) was added, there was evidence of heterogeneity (P < 0.0001) and the overall treatment effect was reduced but still significant (HR 0.84, 95% CI 0.698 to 0.997, P= 0.046). This represented a 9% gain in the probability of surviving one year (49% in the placebo and 58% in the riluzole group), and increased median survival from 11.8 to 14.8 months. There was a small beneficial effect on both bulbar and limb function, but not on muscle strength. A three-fold increase in serum alanine transferase was more frequent in riluzole-treated patients than controls (mean difference 2.62, 95% CI 1.59 to 4.31). Riluzole 100 mg daily is reasonably safe and probably prolongs median survival by about two to three months in patients with amyotrophic lateral sclerosis. | In this review, we examine the evidence from four randomized clinical trials involving 1477 people with ALS. The methodological quality of the trials was acceptable and three of the trials were easily comparable (although one of them included older patients with more advanced ALS). The searches for this review were last updated in 2011, when we found no new randomized controlled trials. The results indicate that riluzole 100 mg probably prolongs median survival in people with ALS by two to three months and the safety of the drug is not a major concern. The evidence from randomized controlled trials indicates that participants taking riluzole probably survive longer than participants taking placebo. The beneficial effects are very modest and the drug is expensive. There was a small beneficial effect on both bulbar and limb function, but not on muscle strength. Adverse effects from riluzole are relatively minor and for the most part reversible after stopping the drug. | 10.1002/14651858.CD001447.pub3 | [
"In this review, we examine the evidence from four randomized clinical trials involving 1477 people with ALS. The methodological quality of the trials was acceptable and three of the trials were easily comparable (although one of them included older patients with more advanced ALS). The searches for this review were last updated in 2011, when we found no new randomized controlled trials. The results indicate that riluzole 100 mg probably prolongs median survival in people with ALS by two to three months and the safety of the drug is not a major concern. The evidence from randomized controlled trials indicates that participants taking riluzole probably survive longer than participants taking placebo. The beneficial effects are very modest and the drug is expensive. There was a small beneficial effect on both bulbar and limb function, but not on muscle strength. Adverse effects from riluzole are relatively minor and for the most part reversible after stopping the drug."
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cochrane-simplification-train-1697 | cochrane-simplification-train-1697 | We included 15 trials involving 622 women who received G-CSF and 631 women who received placebo or no additional treatment during IVF. The main limitations in the quality of the evidence were inadequate reporting of study methods and high risk of performance bias due to lack of blinding. We assessed only two of the 15 included trials as at a low risk of bias. None of the trials reported the primary effectiveness outcome of live-birth rate. We are uncertain whether G-CSF administration improves ongoing pregnancy rate compared to control in subfertile women undergoing ART (RR 1.42, 95% confidence interval (CI) 0.83 to 2.42; 2 RCTs; participants = 263; I² = 0%; very low-quality evidence). For a typical clinic with 14% ongoing pregnancy rate, G-CSF administration would be expected to result in ongoing pregnancy rates between 12% and 35%. We are uncertain whether G-CSF administration reduces miscarriage rate (Peto odds ratio 0.55, 95% CI 0.17 to 1.83; 3 RCTs; participants = 391; I² = 0%; very low-quality evidence) compared to the control group in subfertile women undergoing ART. We are uncertain whether G-CSF administration improves overall clinical pregnancy rate compared to control in subfertile women undergoing ART (RR 1.63, 95% CI 1.32 to 2.01; 14 RCTs; participants = 1253; I² = 13%; very low-quality evidence). For a typical clinic with 17% clinical pregnancy rate, G-CSF administration would be expected to result in clinical pregnancy rates between 23% and 35%. In the unselected IVF population, we are uncertain whether G-CSF administration improves clinical pregnancy rate compared to the control group (RR 1.11, 95% CI 0.77 to 1.60; 3 RCTs; participants = 404; I² = 0%; low-quality evidence). G-CSF administration may improve clinical pregnancy rate in women with two or more previous IVF failures compared to the control group (RR 2.11, 95% CI 1.56 to 2.85; 7 RCTs; participants = 643; I² = 0%; low-quality evidence). In subfertile women with thin endometrium undergoing ART, we are uncertain whether G-CSF administration improves clinical pregnancy rate compared to the control group (RR 1.58, 95% CI 0.95 to 2.63; 4 RCTs; participants = 206; I² = 30%; low-quality evidence). No study reported on multiple pregnancy rate. Only four trials reported adverse events as an outcome, and none of them reported any major adverse events following either G-CSF administration or placebo/no treatment. In subfertile women undergoing ART, we are uncertain whether the administration of G-CSF improves ongoing pregnancy or overall clinical pregnancy rates or reduces miscarriage rate compared to no treatment or placebo, whether in all women or those with thin endometrium, based on very low-quality evidence. Low-quality evidence suggests that G-CSF administration may improve clinical pregnancy rate in women with two or more IVF failures, but the included studies had unclear allocation concealment or were at high risk of performance bias. | We found 15 trials (1253 women) comparing G-CSF with placebo or no treatment. Eleven trials evaluated the role of G-CSF in women undergoing IVF, with a majority of trials including those women with two or more failed attempts. The remaining four trials investigated the role of G-CSF in women with thin endometrium undergoing IVF. The evidence is current to February 2019. We are uncertain whether giving G-CSF in women undergoing IVF improves chances of ongoing pregnancy or overall clinical pregnancy rates or reduces miscarriage rate compared to placebo or no treatment. For a typical clinic with 14% ongoing pregnancy rate, G-CSF administration would be expected to result in ongoing pregnancy rates between 12% and 35%. No study reported on multiple pregnancy rate. Only four trials reported adverse events as an outcome, and none of them reported any major adverse events following either G-CSF administration or placebo/no treatment. We are uncertain whether giving G-CSF improves ongoing pregnancy or reduces miscarriage rates in women undergoing IVF based on very low-quality evidence. The quality of the evidence was reduced because of risk of bias. | 10.1002/14651858.CD013226.pub2 | [
"We found 15 trials (1253 women) comparing G-CSF with placebo or no treatment. Eleven trials evaluated the role of G-CSF in women undergoing IVF, with a majority of trials including those women with two or more failed attempts. The remaining four trials investigated the role of G-CSF in women with thin endometrium undergoing IVF. The evidence is current to February 2019. We are uncertain whether giving G-CSF in women undergoing IVF improves chances of ongoing pregnancy or overall clinical pregnancy rates or reduces miscarriage rate compared to placebo or no treatment. For a typical clinic with 14% ongoing pregnancy rate, G-CSF administration would be expected to result in ongoing pregnancy rates between 12% and 35%. No study reported on multiple pregnancy rate. Only four trials reported adverse events as an outcome, and none of them reported any major adverse events following either G-CSF administration or placebo/no treatment. We are uncertain whether giving G-CSF improves ongoing pregnancy or reduces miscarriage rates in women undergoing IVF based on very low-quality evidence. The quality of the evidence was reduced because of risk of bias."
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cochrane-simplification-train-1698 | cochrane-simplification-train-1698 | We included four studies with 166 participants. No studies compared the effects of home-based upper limb therapy programmes with placebo or no intervention. Three studies compared the effects of home-based upper limb therapy programmes with usual care. Primary outcomes: we found no statistically significant result for performance of ADL (mean difference (MD) 2.85; 95% confidence interval (CI) -1.43 to 7.14) or functional movement of the upper limb (MD 2.25; 95% CI -0.24 to 4.73)). Secondary outcomes: no statistically significant results for extended ADL (MD 0.83; 95% CI -0.51 to 2.17)) or upper limb motor impairment (MD 1.46; 95% CI -0.58 to 3.51). One study compared the effects of a home-based upper limb programme with the same upper limb programme based in hospital, measuring upper limb motor impairment only; we found no statistically significant difference between groups (MD 0.60; 95% CI -8.94 to 10.14). There is insufficient good quality evidence to make recommendations about the relative effect of home-based therapy programmes compared with placebo, no intervention or usual care. | This review of four studies with 166 relevant participants, looked at whether participating in home-based therapy programmes, targeted at the upper limb, could improve performance in activities of daily living (ADL), functional movement of the upper limb, performance in extended ADL and arm motor impairment. In comparison with usual care, home-based upper limb programmes had no difference in effect on any of the outcomes. In comparison with an upper limb programme based in hospital, we found home-based upper limb programmes to be no more or no less effective for arm motor impairment outcomes. The evidence in this area is limited. Further research is needed to determine the effects of home-based therapy programmes. | 10.1002/14651858.CD006755.pub2 | [
"This review of four studies with 166 relevant participants, looked at whether participating in home-based therapy programmes, targeted at the upper limb, could improve performance in activities of daily living (ADL), functional movement of the upper limb, performance in extended ADL and arm motor impairment. In comparison with usual care, home-based upper limb programmes had no difference in effect on any of the outcomes. In comparison with an upper limb programme based in hospital, we found home-based upper limb programmes to be no more or no less effective for arm motor impairment outcomes. The evidence in this area is limited. Further research is needed to determine the effects of home-based therapy programmes."
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cochrane-simplification-train-1699 | cochrane-simplification-train-1699 | We identified four cluster-RCTs and one cohort study (n = 12,742) of influenza vaccination for HCWs caring for individuals ≥ 60 years in LTCIs. Four cluster RCTs (5896 residents) provided outcome data that addressed the objectives of our review. The studies were comparable in their study populations, intervention and outcome measures. The studies did not report adverse events. The principal sources of bias in the studies related to attrition, lack of blinding, contamination in the control groups and low rates of vaccination coverage in the intervention arms, leading us to downgrade the quality of evidence for all outcomes due to serious risk of bias. Offering influenza vaccination to HCWs based in long term care homes may have little or no effect on the number of residents who develop laboratory-proven influenza compared with those living in care homes where no vaccination is offered (RD 0 (95% CI -0.03 to 0.03), two studies with samples taken from 752 participants; low quality evidence). HCW vaccination probably leads to a reduction in lower respiratory tract infection in residents from 6% to 4% (RD -0.02 (95% CI -0.04 to 0.01), one study of 3400 people; moderate quality evidence). HCW vaccination programmes may have little or no effect on the number of residents admitted to hospital for respiratory illness (RD 0 (95% CI -0.02 to 0.02, one study of 1059 people; low quality evidence). We decided not to combine data on deaths from lower respiratory tract infection (two studies of 4459 people) or all cause deaths (four studies of 8468 people). The direction and size of difference in risk varied between the studies. We are uncertain as to the effect of vaccination on these outcomes due to the very low quality of evidence. Adjusted analyses, which took into account the cluster design, did not differ substantively from the pooled analysis with unadjusted data. Our review findings have not identified conclusive evidence of benefit of HCW vaccination programmes on specific outcomes of laboratory-proven influenza, its complications (lower respiratory tract infection, hospitalisation or death due to lower respiratory tract illness), or all cause mortality in people over the age of 60 who live in care institutions. This review did not find information on co-interventions with healthcare worker vaccination: hand-washing, face masks, early detection of laboratory-proven influenza, quarantine, avoiding admissions, antivirals and asking healthcare workers with influenza or influenza-like illness (ILI) not to work. This review does not provide reasonable evidence to support the vaccination of healthcare workers to prevent influenza in those aged 60 years or older resident in LTCIs. High quality RCTs are required to avoid the risks of bias in methodology and conduct identified by this review and to test further these interventions in combination. | Our evidence is current to October 2015. Overall five studies were included in our review but we used data from three trials with 5896 residents . In one trial the average age was 77 and 71% were female, in another this was 82 years and 70% were female, and in the last this was 86 years and 77% were female. One study was supported by the Greater Glasgow Health Board Care of the Elderly Unit, one by the Wellcome Trust and for one there was no statement. The method of randomisation used was at low risk in two trials and unclear in one. In all three studies allocation concealment and blinding were unclear. In two studies data could not be included from everyone who was recruited and this put their results at a high risk of bias. All three studies reported outcomes completely. However, in all three trials there was performance bias due to incomplete influenza vaccination of healthcare workers in the intervention arms. No studies reported on adverse events. Offering influenza vaccination to healthcare workers who care for those aged 60 or over in LTCIs may have little or no effect on laboratory-proven influenza (low quality evidence). HCW vaccination programmes probably have a small effect on lower respiratory tract infection (moderate quality evidence), but they may have little or no effect on admission to hospital (low quality evidence). It is unclear what effect vaccination programmes have on death due to lower respiratory tract illness (very low quality evidence) or all cause deaths (very low quality evidence). This review did not find information on other interventions used in conjunction with vaccination of healthcare workers (for example, hand-washing, face masks, early detection of laboratory-proven influenza, quarantine, avoiding new admissions, prompt antiviral use, asking healthcare workers with an influenza-like illness not to work). High quality randomised controlled trials testing combinations of these interventions are needed. | 10.1002/14651858.CD005187.pub5 | [
"Our evidence is current to October 2015. Overall five studies were included in our review but we used data from three trials with 5896 residents . In one trial the average age was 77 and 71% were female, in another this was 82 years and 70% were female, and in the last this was 86 years and 77% were female. One study was supported by the Greater Glasgow Health Board Care of the Elderly Unit, one by the Wellcome Trust and for one there was no statement. The method of randomisation used was at low risk in two trials and unclear in one. In all three studies allocation concealment and blinding were unclear. In two studies data could not be included from everyone who was recruited and this put their results at a high risk of bias. All three studies reported outcomes completely. However, in all three trials there was performance bias due to incomplete influenza vaccination of healthcare workers in the intervention arms. No studies reported on adverse events. Offering influenza vaccination to healthcare workers who care for those aged 60 or over in LTCIs may have little or no effect on laboratory-proven influenza (low quality evidence). HCW vaccination programmes probably have a small effect on lower respiratory tract infection (moderate quality evidence), but they may have little or no effect on admission to hospital (low quality evidence). It is unclear what effect vaccination programmes have on death due to lower respiratory tract illness (very low quality evidence) or all cause deaths (very low quality evidence). This review did not find information on other interventions used in conjunction with vaccination of healthcare workers (for example, hand-washing, face masks, early detection of laboratory-proven influenza, quarantine, avoiding new admissions, prompt antiviral use, asking healthcare workers with an influenza-like illness not to work). High quality randomised controlled trials testing combinations of these interventions are needed."
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