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cochrane-simplification-train-1100 | cochrane-simplification-train-1100 | The current review included the eight trials from the initial review and six new trials which randomised 595 participants (< 21 years of age) with leukaemias or solid tumours undergoing chemotherapy. The trials were all of low quality with the exception of two of the trials looking at glutamine supplementation. One small trial found that compared to EN, PN significantly increased weight (mean difference (MD) 4.12, 95% CI 1.91 to 6.33), serum albumin levels (MD 0.70, 95% CI 0.14 to 1.26), calorie intake (MD 22.00, 95% CI 5.12 to 38.88) and protein intake (MD 0.80, 95% CI 0.45 to 1.15). One trial comparing peripheral PN and EN with central PN found that mean daily weight gain (MD -27.00, 95% CI -43.32 to -10.68) and energy intake (MD -15.00, 95% CI -26.81 to -3.19) were significantly less for the peripheral PN and EN group, whereas mean change in serum albumin was significantly greater for that group (MD 0.47, 95% CI 0.13 to 0.81, P = 0.008). Another trial with few participants found an increase in mean energy intake (% recommended daily amount) in children fed an energy dense feed compared to a standard calorie feed (MD +28%, 95% CI 17% to 39%). Three studies looked at glutamine supplementation. The evidence suggesting that glutamine reduces severity of mucositis was not statistically significant in two studies (RR 0.64, 95% CI 0.19 to 2.2 and RR 0.85, 95% CI 0.66 to 1.1) and differences in reduction of infection rates were also not significant in two studies (RR 1.0, 95% CI 0.72 to 1.4 and RR 0.98, 95% CI 0.63 to 1.51). Only one study compared olive oil based PN to standard lipid containing PN. Despite similar calorie contents in both feeds, the standard lipid formula lead to greater weight gain (MD -0.34 z-scores, 95% CI -0.68 to 0.00). A single study compared standard EN with fructooligosaccharide containing EN. There was no difference in weight gain between groups (mean difference -0.12, 95% CI -0.57 to 0.33), with adverse effects (nausea) occurring equally between the groups (RR 0.92, 95% CI 0.48 to 1.74). There is limited evidence from individual trials to suggest that PN is more effective than EN in well-nourished children and young people with cancer undergoing chemotherapy. The evidence for other methods of nutritional support remains unclear. Limited evidence suggests an energy dense feed increases mean daily energy intake and has a positive effect on weight gain. Evidence suggesting glutamine supplementation reduces incidence and severity of mucositis, infection rates and length of hospital stay is not statistically significant. Further research, incorporating larger sample sizes and rigorous methodology utilising valid and reliable outcome measures, is essential. | We found evidence from one small trial to suggest that parenteral nutrition may result in an increase in weight, serum albumin levels and calorie and protein intake when compared to enteral nutrition (usual food intake). However, the effect of other methods of delivery of nutritional support remains unclear. Results from another small study suggested that the use of energy dense enteral feeds resulted in greater average daily energy intake and subsequently improved weight gain. Three studies looked at glutamine supplementation and did not show a benefit from its use. One study looked at the effect of using olive oil based parenteral feeds rather than those containing standard fats and found that it lead to less weight gain. One study considered the effect of adding fructooligosaccharide to enteral feeds and found that it did not effect the amount of weight gained or how often participants felt nauseated. No studies were identified that compared the nutritional content in either the PN or EN groups of studies. The trials were all of low quality and very different in terms of outcome measures used. In the future, much larger, rigorously conducted trials are needed in order to address this important question. | 10.1002/14651858.CD003298.pub3 | [
"We found evidence from one small trial to suggest that parenteral nutrition may result in an increase in weight, serum albumin levels and calorie and protein intake when compared to enteral nutrition (usual food intake). However, the effect of other methods of delivery of nutritional support remains unclear. Results from another small study suggested that the use of energy dense enteral feeds resulted in greater average daily energy intake and subsequently improved weight gain. Three studies looked at glutamine supplementation and did not show a benefit from its use. One study looked at the effect of using olive oil based parenteral feeds rather than those containing standard fats and found that it lead to less weight gain. One study considered the effect of adding fructooligosaccharide to enteral feeds and found that it did not effect the amount of weight gained or how often participants felt nauseated. No studies were identified that compared the nutritional content in either the PN or EN groups of studies. The trials were all of low quality and very different in terms of outcome measures used. In the future, much larger, rigorously conducted trials are needed in order to address this important question."
] |
cochrane-simplification-train-1101 | cochrane-simplification-train-1101 | We identified 2292 unique records.We included 129 records reporting on 121 studies, including 12 ongoing studies and two studies awaiting classification. We judged the overall risk of bias of two studies as low. Selection bias was the most relevant risk of bias domain across the included studies, with 78 studies not clearly reporting the method used for random sequence generation. Reporting bias was the domain with least risk of bias, with 12 studies not reporting all outcomes that researchers intended to investigate. Any intervention versus placebo or no prophylaxis In comparison with placebo, any intervention seems to have a beneficial effect on the occurrence of upper GI bleeding (risk ratio (RR) 0.47, 95% confidence interval (CI) 0.39 to 0.57; moderate certainty of evidence). The use of any intervention reduced the risk of upper GI bleeding by 10% (95% CI -12.0% to -7%). The effect estimate of any intervention versus placebo or no prophylaxis with respect to the occurrence of nosocomial pneumonia, all-cause mortality in the ICU, duration of ICU stay, duration of intubation (all with low certainty of evidence), the number of participants requiring blood transfusions (moderate certainty of evidence), and the units of blood transfused was consistent with benefits and harms. None of the included studies explicitly reported on serious adverse events. Individual interventions versus placebo or no prophylaxis In comparison with placebo or no prophylaxis, antacids, H2 receptor antagonists, and sucralfate were effective in preventing upper GI bleeding in ICU patients. Researchers found that with H2 receptor antagonists compared with placebo or no prophylaxis, 11% less developed upper GI bleeding (95% CI -0.16 to -0.06; RR 0.50, 95% CI 0.36 to 0.70; 24 studies; 2149 participants; moderate certainty of evidence). Of ICU patients taking antacids versus placebo or no prophylaxis, 9% less developed upper GI bleeding (95% CI -0.17 to -0.00; RR 0.49, 95% CI 0.25 to 0.99; eight studies; 774 participants; low certainty of evidence). Among ICU patients taking sucralfate versus placebo or no prophylaxis, 5% less had upper GI bleeding (95% CI -0.10 to -0.01; RR 0.53, 95% CI 0.32 to 0.88; seven studies; 598 participants; moderate certainty of evidence). The remaining interventions including proton pump inhibitors did not show a significant effect in preventing upper GI bleeding in ICU patients when compared with placebo or no prophylaxis. Regarding the occurrence of nosocomial pneumonia, the effects of H2 receptor antagonists (RR 1.12, 95% CI 0.85 to 1.48; eight studies; 945 participants; low certainty of evidence) and of sucralfate (RR 1.33, 95% CI 0.86 to 2.04; four studies; 450 participants; low certainty of evidence) were consistent with benefits and harms when compared with placebo or no prophylaxis. None of the studies comparing antacids versus placebo or no prophylaxis provided data regarding nosocomial pneumonia. H2 receptor antagonists versus proton pump inhibitors H2 receptor antagonists and proton pump inhibitors are most commonly used in practice to prevent upper GI bleeding in ICU patients. Proton pump inhibitors significantly more often prevented upper GI bleeding in ICU patients compared with H2 receptor antagonists (RR 2.90, 95% CI 1.83 to 4.58; 18 studies; 1636 participants; low certainty of evidence). When taking H2 receptor antagonists, 4.8% more patients might experience upper GI bleeding (95% CI 2.1% to 9%). Nosocomial pneumonia occurred in similar proportions of participants taking H2 receptor antagonists and participants taking proton pump inhibitors (RR 1.02, 95% CI 0.77 to 1.35; 10 studies; 1256 participants; low certainty of evidence). This review shows that antacids, sucralfate, and H2 receptor antagonists might be more effective in preventing upper GI bleeding in ICU patients compared with placebo or no prophylaxis. The effect estimates of any treatment versus no prophylaxis on nosocomial pneumonia were consistent with benefits and harms. Evidence of low certainty suggests that proton pump inhibitors might be more effective than H2 receptor antagonists. Therefore, patient-relevant benefits and especially harms of H2 receptor antagonists compared with proton pump inhibitors need to be assessed by larger, high-quality RCTs to confirm the results of previously conducted, smaller, and older studies. | The evidence is current to August 2017. We included 106 studies with a total of 15,027 critically ill participants of any age and any gender. Relevant effects were found for the following drugs: H2 receptor antagonists, antacids, sucralfate, and proton pump inhibitors. H2 receptor antagonists inhibit gastric acid secretion by blocking histamine receptors but can cause a small number of blood platelets (thrombocytopaenia), inflammation of the kidney (interstitial nephritis), and confusion. Antacids neutralise stomach acid but may cause diarrhoea or constipation. Proton pump inhibitors inhibit the final stage of gastric acid production, and it has been found that they may be associated with increased risk of Clostridium difficile diarrhoea. Ulcer protective agents, such as sucralfate, create a barrier between the gastric acid and the gastric mucosa by coating it. They may, however, cause constipation and interfere with the absorption of certain antibacterial agents. In comparison with placebo or no preventive treatment, H2 receptor antagonists, antacids, and sucralfate might be effective in preventing clinically important upper GI bleeding in ICU patients. Hospital-acquired pneumonia was most likely to occur in ICU patients taking either H2 receptor antagonists or sucralfate when compared with patients given placebo or no preventive treatment. Evidence of low certainty suggests that proton pump inhibitors were more effective than H2 receptor antagonists in preventing upper GI bleeding in ICU patients. With proton pump inhibitors, 25 of 1000 people were likely to develop upper GI bleeding, and with H2 receptor antagonists, 73 of 1000 people (95% confidence interval 46 to 115 people) were likely to develop upper GI bleeding. The effect of H2 receptor antagonists versus proton pump inhibitors with respect to the risk for developing hospital-acquired pneumonia was consistent with benefits and harms. Our certainty in the evidence ranged from low to moderate. For effects of different interventions compared with placebo or no prophylaxis, the certainty of evidence was moderate (H2 receptor antagonists) or low (antacids and sucralfate). For effects of H2 receptor antagonists compared with placebo or no preventive treatment on risk of hospital-acquired pneumonia, the certainty of evidence was low. For effects of H2 receptor antagonists compared with proton pump inhibitors on hospital-acquired pneumonia, the certainty of evidence was also low. | 10.1002/14651858.CD008687.pub2 | [
"The evidence is current to August 2017. We included 106 studies with a total of 15,027 critically ill participants of any age and any gender. Relevant effects were found for the following drugs: H2 receptor antagonists, antacids, sucralfate, and proton pump inhibitors. H2 receptor antagonists inhibit gastric acid secretion by blocking histamine receptors but can cause a small number of blood platelets (thrombocytopaenia), inflammation of the kidney (interstitial nephritis), and confusion. Antacids neutralise stomach acid but may cause diarrhoea or constipation. Proton pump inhibitors inhibit the final stage of gastric acid production, and it has been found that they may be associated with increased risk of Clostridium difficile diarrhoea. Ulcer protective agents, such as sucralfate, create a barrier between the gastric acid and the gastric mucosa by coating it. They may, however, cause constipation and interfere with the absorption of certain antibacterial agents. In comparison with placebo or no preventive treatment, H2 receptor antagonists, antacids, and sucralfate might be effective in preventing clinically important upper GI bleeding in ICU patients. Hospital-acquired pneumonia was most likely to occur in ICU patients taking either H2 receptor antagonists or sucralfate when compared with patients given placebo or no preventive treatment. Evidence of low certainty suggests that proton pump inhibitors were more effective than H2 receptor antagonists in preventing upper GI bleeding in ICU patients. With proton pump inhibitors, 25 of 1000 people were likely to develop upper GI bleeding, and with H2 receptor antagonists, 73 of 1000 people (95% confidence interval 46 to 115 people) were likely to develop upper GI bleeding. The effect of H2 receptor antagonists versus proton pump inhibitors with respect to the risk for developing hospital-acquired pneumonia was consistent with benefits and harms. Our certainty in the evidence ranged from low to moderate. For effects of different interventions compared with placebo or no prophylaxis, the certainty of evidence was moderate (H2 receptor antagonists) or low (antacids and sucralfate). For effects of H2 receptor antagonists compared with placebo or no preventive treatment on risk of hospital-acquired pneumonia, the certainty of evidence was low. For effects of H2 receptor antagonists compared with proton pump inhibitors on hospital-acquired pneumonia, the certainty of evidence was also low."
] |
cochrane-simplification-train-1102 | cochrane-simplification-train-1102 | This review includes 11 published studies (172 participants); only one examined long-term oxygen therapy (28 participants). There was no statistically significant improvement in survival, lung, or cardiac health. There was an improvement in regular attendance at school or work in those receiving oxygen therapy at 6 and 12 months. Four studies examined the effect of oxygen supplementation during sleep by polysomnography. Although oxygenation improved, mild hypercapnia was noted. Participants fell asleep quicker and spent a reduced percentage of total sleep time in rapid eye movement sleep, but there were no demonstrable improvements in qualitative sleep parameters. Six studies evaluated oxygen supplementation during exercise. Again, oxygenation improved, but mild hypercapnia resulted. Participants receiving oxygen therapy were able to exercise for a significantly longer duration during exercise. Other exercise parameters were not altered by the use of oxygen. There are no published data to guide the prescription of chronic oxygen supplementation to people with advanced lung disease due to CF. Short-term oxygen therapy during sleep and exercise improves oxygenation but is associated with modest and probably clinically inconsequential hypercapnia. There are improvements in exercise duration, time to fall asleep and regular attendance at school or work. There is a need for larger, well-designed clinical trials to assess the benefits of long-term oxygen therapy in people with CF administered continuously or during exercise or sleep or both. However, we do not expect any new research to be undertaken in this area any time soon and do not plan to update this review again until any new evidence does become available. | We found eleven studies with 172 participants to include in the review. All studies compared low-flow oxygen to room air. Ten of the studies were short-term. Four of the studies looked at giving additional oxygen at night. At night, oxygen levels rose during both rapid eye movement (REM) sleep and non-REM sleep in those people breathing low-flow oxygen. Participants breathing oxygen at night also spent less time in REM sleep and took less time to fall asleep. Six of the studies looked at the effect of extra oxygen on exercise. The levels of oxygen and carbon dioxide in the blood of participants increased during or after exercise when they breathed in low-flow oxygen. People were able to exercise for longer if they breathed in low-flow oxygen. There was more regular attendance at school or work in those receiving long-term oxygen. There is little evidence to support or oppose the long-term use of oxygen therapy in people with advanced CF lung disease. In the short term, treatment has shown some improvement in blood oxygen levels in people with CF during sleep and exercise. This increase in oxygen also came with an increase in carbon dioxide levels, which is probably not clinically important. However, caution needs to be exercised in those with advanced lung disease where this may require further monitoring. There should be research into the effects of long-term oxygen treatment on sleep quality and exercise in people with CF. Unfortunately, we do not expect that any such research will be undertaken any time soon, so we do not plan to update this review again until we find any new trials. | 10.1002/14651858.CD003884.pub4 | [
"We found eleven studies with 172 participants to include in the review. All studies compared low-flow oxygen to room air. Ten of the studies were short-term. Four of the studies looked at giving additional oxygen at night. At night, oxygen levels rose during both rapid eye movement (REM) sleep and non-REM sleep in those people breathing low-flow oxygen. Participants breathing oxygen at night also spent less time in REM sleep and took less time to fall asleep. Six of the studies looked at the effect of extra oxygen on exercise. The levels of oxygen and carbon dioxide in the blood of participants increased during or after exercise when they breathed in low-flow oxygen. People were able to exercise for longer if they breathed in low-flow oxygen. There was more regular attendance at school or work in those receiving long-term oxygen. There is little evidence to support or oppose the long-term use of oxygen therapy in people with advanced CF lung disease. In the short term, treatment has shown some improvement in blood oxygen levels in people with CF during sleep and exercise. This increase in oxygen also came with an increase in carbon dioxide levels, which is probably not clinically important. However, caution needs to be exercised in those with advanced lung disease where this may require further monitoring. There should be research into the effects of long-term oxygen treatment on sleep quality and exercise in people with CF. Unfortunately, we do not expect that any such research will be undertaken any time soon, so we do not plan to update this review again until we find any new trials."
] |
cochrane-simplification-train-1103 | cochrane-simplification-train-1103 | We identified 10 trials that fulfilled the inclusion criteria, randomising 2751 participants; 1388 participants were randomised to receive insulin analogues and 1363 participants to receive regular human insulin. The duration of the intervention ranged from 24 to 104 weeks, with a mean of about 41 weeks. The trial populations showed diversity in disease duration, and inclusion and exclusion criteria. None of the trials were blinded, so the risk of performance bias and detection bias, especially for subjective outcomes, such as hypoglycaemia, was high in nine of 10 trials from which we extracted data. Several trials showed inconsistencies in the reporting of methods and results. None of the included trials defined all-cause mortality as a primary outcome. Six trials provided Information on the number of participants who died during the trial, with five deaths out of 1272 participants (0.4%) in the insulin analogue groups and three deaths out of 1247 participants (0.2%) in the regular human insulin groups (Peto OR 1.66, 95% CI 0.41 to 6.64; P = 0.48; moderate-certainty evidence). Six trials, with 2509 participants, assessed severe hypoglycaemia differently, therefore, we could not summarise the results with a meta-analysis. Overall, the incidence of severe hypoglycaemic events was low, and none of the trials showed a clear difference between the two intervention arms (low-certainty evidence). The MD in glycosylated haemoglobin A1c (HbA1c) change was -0.03% (95% CI -0.16 to 0.09; P = 0.60; 9 trials, 2608 participants; low-certainty evidence). The 95% prediction ranged between -0.31% and 0.25%. The MD in the overall number of non-severe hypoglycaemic episodes per participant per month was 0.08 events (95% CI 0.00 to 0.16; P = 0.05; 7 trials, 2667 participants; very low-certainty evidence). The 95% prediction interval ranged between -0.03 and 0.19 events per participant per month. The results provided for nocturnal hypoglycaemic episodes were of questionable validity. Overall, there was no clear difference between the two short-acting insulin analogues and regular human insulin. Two trials assessed health-related quality of life and treatment satisfaction, but we considered the results for both outcomes to be unreliable (very low-certainty evidence). No trial was designed to investigate possible long term effects (all-cause mortality, microvascular or macrovascular complications of diabetes), especially in participants with diabetes-related complications. No trial reported on socioeconomic effects. Our analysis found no clear benefits of short-acting insulin analogues over regular human insulin in people with type 2 diabetes. Overall, the certainty of the evidence was poor and results on patient-relevant outcomes, like all-cause mortality, microvascular or macrovascular complications and severe hypoglycaemic episodes were sparse. Long-term efficacy and safety data are needed to draw conclusions about the effects of short-acting insulin analogues on patient-relevant outcomes. | We found 10 randomised controlled trials (clinical studies where people are randomly put into one of two or more treatment groups) comparing the short-acting insulin analogues insulin lispro, insulin aspart, or insulin glulisine to regular human insulin in 2751 participants. The people in the included trials were monitored (followed) for 24 to 104 weeks. This evidence is up to date as of 31 October 2018. We are uncertain whether short-acting insulin analogues are better than regular human insulin for long-term blood glucose control or for reducing the number of times blood sugar levels drop below normal (hypoglycaemic episodes). The studies were too short to reliably investigate death from any cause. We found no clear effect of insulin analogues on health-related quality of life. We found no information on late diabetes complications, such as problems with the eyes, kidneys, or feet. No study reported on socioeconomic effects, such as costs of the intervention and absence from work. The overall certainty of the included studies was low or very low for most outcomes, mainly because all studies were carried out in an open-labelled fashion (study participants and study personnel knew who was getting which treatment). Several studies also showed inconsistencies in the reporting of methods, and results were imprecise. | 10.1002/14651858.CD013228 | [
"We found 10 randomised controlled trials (clinical studies where people are randomly put into one of two or more treatment groups) comparing the short-acting insulin analogues insulin lispro, insulin aspart, or insulin glulisine to regular human insulin in 2751 participants. The people in the included trials were monitored (followed) for 24 to 104 weeks. This evidence is up to date as of 31 October 2018. We are uncertain whether short-acting insulin analogues are better than regular human insulin for long-term blood glucose control or for reducing the number of times blood sugar levels drop below normal (hypoglycaemic episodes). The studies were too short to reliably investigate death from any cause. We found no clear effect of insulin analogues on health-related quality of life. We found no information on late diabetes complications, such as problems with the eyes, kidneys, or feet. No study reported on socioeconomic effects, such as costs of the intervention and absence from work. The overall certainty of the included studies was low or very low for most outcomes, mainly because all studies were carried out in an open-labelled fashion (study participants and study personnel knew who was getting which treatment). Several studies also showed inconsistencies in the reporting of methods, and results were imprecise."
] |
cochrane-simplification-train-1104 | cochrane-simplification-train-1104 | A total of four trials including 4265 participants were included in this review. Two of the included trials were of high quality, while two were of relatively low quality with limitations and biases in design and conduct. Analysis showed that administration of a single dose of antihelminthic in the second trimester of pregnancy is not associated with any impact on maternal anaemia in the third trimester (risk ratio (RR) 0.94; 95% confidence interval (CI) 0.81 to 1.10; 3266 participants; four trials; low quality evidence). Subgroup analysis on the basis of co-interventions other than antihelminthic, which included iron supplementation given to both groups was also not associated with any impact on maternal anaemia (RR 0.76; 95% CI 0.47 to 1.23; 1290 participants; three trials; moderate quality evidence). No impact was found for the outcomes of low birthweight (RR 1.00; 95% CI 0.79 to 1.27; 3255 participants; three trials; moderate quality evidence), preterm birth (RR 0.88; 95% CI 0.43 to 1.78; 1318 participants; two trials, moderate quality evidence) and perinatal mortality (RR 1.09; 95% CI 0.71 to 1.67; 3385 participants; two trials; moderate quality evidence). None of the included studies reported impact on infant survival at six months of age. The evidence to date is insufficient to recommend use of antihelminthic for pregnant women after the first trimester of pregnancy. More well-designed, large scale randomised controlled trials are needed to establish the benefit of antihelminthic treatment during pregnancy. | We found four studies including 4265 pregnant women. Two of the included studies were of high quality, while the other two were of relatively low quality with limitations and biases in design and conduct. The studies were conducted in Sierra Leone, Peru and Uganda. In two studies, the women were also given a daily iron or iron-folate supplement along with antihelminthic treatment. There was no effect of antihelminthic administered in second trimester of pregnancy on maternal anaemia, low birthweight, preterm births or perinatal deaths. There was no impact on maternal anaemia in studies in which iron or iron-folate was also given to pregnant women along with antihelminthic. The impact on infant survival at six months of age could not be evaluated because data were not available. Evidence provided so far from randomised controlled trials is, therefore, insufficient to recommend use of antihelminthics for pregnant women after the first trimester of pregnancy. | 10.1002/14651858.CD005547.pub3 | [
"We found four studies including 4265 pregnant women. Two of the included studies were of high quality, while the other two were of relatively low quality with limitations and biases in design and conduct. The studies were conducted in Sierra Leone, Peru and Uganda. In two studies, the women were also given a daily iron or iron-folate supplement along with antihelminthic treatment. There was no effect of antihelminthic administered in second trimester of pregnancy on maternal anaemia, low birthweight, preterm births or perinatal deaths. There was no impact on maternal anaemia in studies in which iron or iron-folate was also given to pregnant women along with antihelminthic. The impact on infant survival at six months of age could not be evaluated because data were not available. Evidence provided so far from randomised controlled trials is, therefore, insufficient to recommend use of antihelminthics for pregnant women after the first trimester of pregnancy."
] |
cochrane-simplification-train-1105 | cochrane-simplification-train-1105 | We identified seven RCTs that enrolled 372 women. We could not pool results of trials as the treatment comparisons differed. Six RCTs (n = 340) conducted over 15 years ago, evaluated adjuvant therapy (chemotherapy, pelvic external irradiation or intra-peritoneal radioactive isotope therapy) after radical surgery; over 87% of participants had Stage I tumours. Most participants were followed up for over 10 years. Overall and recurrence-free survival were similar between both arms of these trials, except that one trial (n = 66) showed a significantly lower survival (P = 0.03) in women who received chemotherapy (thio-TEPA). Adverse effects of treatment were incompletely reported and all six trials were at high risk of bias. One further trial (n = 32) that recruited participants with bilateral serous tumours who were wishing fertility preservation, revealed a significantly increased chance of pregnancy (hazard ratio (HR) = 3.3, 95% CI 1.4 to 8.0) but non-significantly earlier disease recurrence (HR = 1.5, 95% CI 0.6 to 3.8) in the women who had ultra-conservative surgery (bilateral cystectomy) than in those who had conservative surgery (cystectomy and contralateral oophorectomy). This trial was at low risk of bias. Quality of life (QoL) was not documented in any included trial. We did not find any trials that compared radical with conservative surgery or laparoscopy with laparotomy. We did not find evidence to support the use of any specific type of adjuvant therapy for borderline ovarian tumours. RCTs evaluating the benefit of adjuvant therapy with optimally dosed chemotherapy and newer targeted drugs are necessary, particularly for advanced borderline ovarian tumours. The low mortality from borderline ovarian tumours should make recurrence-free survival, time to recurrence and morbidity important end points in such trials. Bilateral cystectomy may be offered to women with bilateral borderline ovarian tumours diagnosed intra-operatively who are wishing to preserve their fertility. Similarly, women who had RCTs comparing radical with conservative surgery and comparing laparoscopy with laparotomy are needed. | In this review, we found six trials which enrolled 340 patients who had undergone surgery for borderline ovarian tumours. These trials compared the number of deaths among women who had various forms of treatment or no additional treatment after surgery. In five of the trials, the women had tumours confined to the ovaries and most were followed up for over 10 years. Only one trial enrolled women with tumours that had spread beyond the ovary, and this trial followed patients up for less than three years, which is not long enough to detect any difference between groups receiving different treatments. None of the trials found any demonstrable benefit from any of the additional forms of treatment. However, all six trials were conducted over 15 years ago and since then platinum-based chemotherapy has become widely used to treat advanced ovarian cancer. However, only one of the trials in our review assessed this more modern type of chemotherapy. Further trials of platinum-based chemotherapy and of less toxic treatments are needed, looking at the benefit of reducing the anxiety and distress of further surgery and treatment for relapse. One further trial, which recruited 32 women who had borderline ovarian tumours in both ovaries, compared conservative surgery (taking away the most diseased ovary and removing the tumour from the other ovary) with ultra-conservative surgery (removing the tumours without taking away either ovary). Nearly all the women who had ultra-conservative surgery became pregnant compared with half of those who had conservative surgery. Although about two thirds of the women in the trial developed similar tumours again, most women got pregnant before the disease recurred, all had their recurrences treated by further surgery, none developed invasive ovarian cancer nor died of their tumour. This small study suggests that ultra-conservative surgery by an experienced surgeon with careful follow up for recurrence may be recommended for women with bilateral borderline ovarian tumours who still intend to have children but, ideally, this approach should be evaluated in other independent trials. Despite rigorous searches, we did not find any trial directly comparing conservative surgery with radical surgery (surgery to remove all of the female reproductive organs) or comparing keyhole surgery (laparoscopy) with open surgery (laparotomy) for women with borderline ovarian tumours. None of these trials looked at how the various treatments affected the quality of life (QoL) of the women. | 10.1002/14651858.CD007696.pub2 | [
"In this review, we found six trials which enrolled 340 patients who had undergone surgery for borderline ovarian tumours. These trials compared the number of deaths among women who had various forms of treatment or no additional treatment after surgery. In five of the trials, the women had tumours confined to the ovaries and most were followed up for over 10 years. Only one trial enrolled women with tumours that had spread beyond the ovary, and this trial followed patients up for less than three years, which is not long enough to detect any difference between groups receiving different treatments. None of the trials found any demonstrable benefit from any of the additional forms of treatment. However, all six trials were conducted over 15 years ago and since then platinum-based chemotherapy has become widely used to treat advanced ovarian cancer. However, only one of the trials in our review assessed this more modern type of chemotherapy. Further trials of platinum-based chemotherapy and of less toxic treatments are needed, looking at the benefit of reducing the anxiety and distress of further surgery and treatment for relapse. One further trial, which recruited 32 women who had borderline ovarian tumours in both ovaries, compared conservative surgery (taking away the most diseased ovary and removing the tumour from the other ovary) with ultra-conservative surgery (removing the tumours without taking away either ovary). Nearly all the women who had ultra-conservative surgery became pregnant compared with half of those who had conservative surgery. Although about two thirds of the women in the trial developed similar tumours again, most women got pregnant before the disease recurred, all had their recurrences treated by further surgery, none developed invasive ovarian cancer nor died of their tumour. This small study suggests that ultra-conservative surgery by an experienced surgeon with careful follow up for recurrence may be recommended for women with bilateral borderline ovarian tumours who still intend to have children but, ideally, this approach should be evaluated in other independent trials. Despite rigorous searches, we did not find any trial directly comparing conservative surgery with radical surgery (surgery to remove all of the female reproductive organs) or comparing keyhole surgery (laparoscopy) with open surgery (laparotomy) for women with borderline ovarian tumours. None of these trials looked at how the various treatments affected the quality of life (QoL) of the women."
] |
cochrane-simplification-train-1106 | cochrane-simplification-train-1106 | The update search did not identify any additional studies. We identified one RCT that included people with high-risk neuroblastoma who received HDCT followed by autologous HSCT (N = 98) after a first random allocation and who received retinoic acid (13-cis-retinoic acid; N = 50) or no further therapy (N = 48) after a second random allocation. These 98 participants had no progressive disease after HDCT followed by autologous HSCT. There was no clear evidence of difference between the treatment groups either in overall survival (hazard ratio (HR) 0.87, 95% confidence interval (CI) 0.46 to 1.63; one trial; P = 0.66) or in event-free survival (HR 0.86, 95% CI 0.50 to 1.49; one trial; P = 0.59). We calculated the HR values using the complete follow-up period of the trial. The study also reported overall survival estimates at a fixed point in time. At the time point of five years, the survival estimate was reported to be 59% for the retinoic acid group and 41% for the no-further-therapy group (P value not reported). We did not identify results for treatment-related mortality, progression-free survival, early or late toxicity, or health-related quality of life. We could not rule out the possible presence of selection bias, performance bias, attrition bias, and other bias. We judged the evidence to be of low quality for overall survival and event-free survival, downgraded because of study limitations and imprecision. We identified one RCT that evaluated additional retinoic acid as part of a postconsolidation therapy after HDCT followed by autologous HSCT versus no further therapy in people with high-risk neuroblastoma. There was no clear evidence of a difference in overall survival and event-free survival between the treatment alternatives. This could be the result of low power. Information on other outcomes was not available. This trial was performed in the 1990s, since when many changes in treatment and risk classification have occurred. Based on the currently available evidence, we are therefore uncertain about the effects of retinoic acid in people with high-risk neuroblastoma. More research is needed for a definitive conclusion. | The evidence is current to 24 November 2016. We included a single randomised trial with 50 people allocated to the addition of retinoic acid after high-dose chemotherapy followed by autologous haematopoietic stem cell transplantation, and 48 people allocated to the same treatment but without the addition of retinoic acid. The update search did not identify any new studies. Overall survival and event-free survival were no different between the two treatment alternatives. Other outcomes, including those concerning adverse events, were not adequately reported. Additional retinoic acid as part of a postconsolidation therapy after high-dose chemotherapy followed by autologous haematopoietic stem cell transplantation may not improve survival in people with high-risk neuroblastoma, and we lack information on its safety. More research is needed before we can draw solid conclusions. The evidence is based on a single study. The quality of the evidence in this single included study is low. | 10.1002/14651858.CD010685.pub3 | [
"The evidence is current to 24 November 2016. We included a single randomised trial with 50 people allocated to the addition of retinoic acid after high-dose chemotherapy followed by autologous haematopoietic stem cell transplantation, and 48 people allocated to the same treatment but without the addition of retinoic acid. The update search did not identify any new studies. Overall survival and event-free survival were no different between the two treatment alternatives. Other outcomes, including those concerning adverse events, were not adequately reported. Additional retinoic acid as part of a postconsolidation therapy after high-dose chemotherapy followed by autologous haematopoietic stem cell transplantation may not improve survival in people with high-risk neuroblastoma, and we lack information on its safety. More research is needed before we can draw solid conclusions. The evidence is based on a single study. The quality of the evidence in this single included study is low."
] |
cochrane-simplification-train-1107 | cochrane-simplification-train-1107 | Three small studies have been included in this review. Prophylactic antibiotics in neonates with central venous catheters had no effect on overall mortality (typical RR 0.68, 95% confidence interval 0.31, 1.51). Prophylactic antibiotics in neonates with central venous catheters decreased the rate of proven bacterial sepsis (typical RR 0.38, 95% confidence interval 0.18, 0.82). Prophylactic antibiotics in neonates with central venous catheters decreased the rate of suspected or proven bacterial septicaemia (typical RR 0.40, 95% confidence interval 0.20, 0.78). No resistant organisms colonising infants were identified in any of the studies. No pooled data were available for other important outcome measures such as chronic lung disease or neurodevelopmental outcome. Prophylactic systemic antibiotics in neonates with a central venous catheter reduces the rate of proven or suspected septicaemia. However, this may not be clinically important in the face of no significant difference in overall mortality and the lack of data on long-term neurodevelopmental outcome. Furthermore, there is a lack of data pertaining to the potentially significant disadvantages of this approach such as the selection of resistant organisms. The routine use of prophylactic antibiotics in infants with central venous catheters in neonatal units cannot currently be recommended. | Three small trials of 271 babies were included in this review. The results of these studies show that it is possible to reduce the chance of serious blood infection occurring, but that almost 10 babies need to be given preventive antibiotics to avoid one case of infection. There was no difference in the likelihood of death. There were not enough data on other important effects of the antibiotics or on the possible serious side effects. There was not much similarity between the studies included in this review. Therefore, there is currently not enough evidence to recommend routinely using antibiotics in babies with central venous lines. | 10.1002/14651858.CD006179.pub2 | [
"Three small trials of 271 babies were included in this review. The results of these studies show that it is possible to reduce the chance of serious blood infection occurring, but that almost 10 babies need to be given preventive antibiotics to avoid one case of infection. There was no difference in the likelihood of death. There were not enough data on other important effects of the antibiotics or on the possible serious side effects. There was not much similarity between the studies included in this review. Therefore, there is currently not enough evidence to recommend routinely using antibiotics in babies with central venous lines."
] |
cochrane-simplification-train-1108 | cochrane-simplification-train-1108 | We identified one new trial for inclusion in this update. In total, the evidence for this review rests on three studies with a total of 207 participants. We found no evidence for an effect of dance/movement therapy on depression (standardized mean difference (SMD) = 0.02, 95% confidence interval (CI) -0.28 to 0.32, P = 0.89, I2 = 0%) (two studies, N = 170), stress (SMD = -0.18, 95% CI -0.48 to 0.12, P = 0.24, I2 = 0%) (two studies, N = 170), anxiety (SMD = 0.21, 95% CI -0.09 to 0.51 P = 0.18, I2 = 0%) (two studies, N = 170), fatigue (SMD = -0.36, 95% -1.26 to 0.55, P = 0.44, I² = 80%) (two studies, N = 170) and body image (SMD = -0.13, 95% CI -0.61 to 0.34, P = 0.58, I2 = 0%) (two studies, N = 68) in women with breast cancer. The data of one study with moderate risk of bias suggested that dance/movement therapy had a large beneficial effect on 37 participants' quality of life (QoL) (SMD = 0.89, 95% CI 0.21 to 1.57). One study with a high risk of bias reported greater improvements in vigor and greater reduction in somatization in the dance/movement therapy group compared to a standard care control group (N = 31). The individual studies did not find support for an effect of dance/movement therapy on mood, mental health, and pain. It is unclear whether this was due to ineffectiveness of the treatment, inappropriate outcome measures or limited power of the trials. Finally, the results of one study did not find evidence for an effect of dance/movement therapy on shoulder range of motion (ROM) or arm circumference in 37 women who underwent a lumpectomy or breast surgery. However, this was likely due to large within-group variability for shoulder ROM and a limited number of participants with lymphedema. Two studies presented moderate risk of bias and one study high risk of bias. Therefore, overall, the quality of the evidence is very low. We did not find support for an effect of dance/movement therapy on depression, stress, anxiety, fatigue and body image . The findings of individual studies suggest that dance/movement therapy may have a beneficial effect on QoL, somatization, and vigor. However, the limited number of studies prevents us from drawing conclusions concerning the effects of dance/movement therapy on psychological and physical outcomes in cancer patients. | We identified one new study for this update. The three studies included a a total of 207 participants, which were women with breast cancer. The studies were small in size. We found no evidence of an effect for depression, stress, anxiety, fatigue, and body image. The findings of individual studies suggest that dance/movement therapy may have a beneficial effect on the quality of life, somatization (i.e. distress arising from perceptions of bodily dysfunction) and vigor of women with breast cancer. No adverse effects of dance/movement therapy interventions were reported. The evidence is based on only three small studies and the quality of the evidence is not strong. No conclusions could be drawn regarding the effect of dance/movement therapy on psychological and physical outcomes in cancer patients because of an insufficient number of studies. More research is needed. We did not identify any conflicts of interests in the included studies. | 10.1002/14651858.CD007103.pub3 | [
"We identified one new study for this update. The three studies included a a total of 207 participants, which were women with breast cancer. The studies were small in size. We found no evidence of an effect for depression, stress, anxiety, fatigue, and body image. The findings of individual studies suggest that dance/movement therapy may have a beneficial effect on the quality of life, somatization (i.e. distress arising from perceptions of bodily dysfunction) and vigor of women with breast cancer. No adverse effects of dance/movement therapy interventions were reported. The evidence is based on only three small studies and the quality of the evidence is not strong. No conclusions could be drawn regarding the effect of dance/movement therapy on psychological and physical outcomes in cancer patients because of an insufficient number of studies. More research is needed. We did not identify any conflicts of interests in the included studies."
] |
cochrane-simplification-train-1109 | cochrane-simplification-train-1109 | We identified nine randomised controlled trials in which 1106 infants participated. Few participants were extremely preterm (less 28 weeks' gestation) or extremely low birth weight (less than 1000 g). The trials defined delayed introduction of progressive enteral feeds as later than four to seven days after birth and early introduction as four days or less after birth. Meta-analyses did not detect statistically significant effects on the risk of NEC (typical RR 0.93, 95% CI 0.64 to 1.34; 8 trials; 1092 infants) or all-cause mortality (typical RR 1.18, 95% CI 0.75 to 1.88; 7 trials; 967 infants). Four of the trials restricted participation to growth-restricted infants with Doppler ultrasound evidence of abnormal fetal circulatory distribution or flow. Planned subgroup analyses of these trials found no statistically significant effects on the risk of NEC or all-cause mortality. Infants who had delayed introduction of enteral feeds took longer to establish full enteral feeding (reported median differences two to four days). The evidence available from randomised controlled trials suggested that delaying the introduction of progressive enteral feeds beyond four days after birth did not reduce the risk of developing NEC in very preterm or VLBW infants, including growth-restricted infants. Delaying the introduction of progressive enteral feeds resulted in a few days' delay in establishing full enteral feeds but the clinical importance of this effect was unclear. The applicability of these findings to extremely preterm or extremely low birth weight was uncertain. Further randomised controlled trials in this population may be warranted. | We search scientific databases for clinical trials assessing the effect of delayed (more than four days after birth) versus earlier introduction of progressive enteral feeds (where breast or formula milk is fed directly by a tube into the stomach) on the incidence of necrotising enterocolitis, death and general health in very low birth weight infants. The evidence is current to September 2014. We found nine trials with 1106 infants that assessed the effect of delayed rather than early introduction of milk feeds for very preterm or very low birth weight infants. Data from these trials did not provide any evidence that delaying enteral feeding reduces the risk of necrotising enterocolitis. The included trials were generally of reasonable methodological quality but, in common with other trials of feeding interventions in infants, it was not possible to mask carers and clinical assessors to the given treatment. | 10.1002/14651858.CD001970.pub5 | [
"We search scientific databases for clinical trials assessing the effect of delayed (more than four days after birth) versus earlier introduction of progressive enteral feeds (where breast or formula milk is fed directly by a tube into the stomach) on the incidence of necrotising enterocolitis, death and general health in very low birth weight infants. The evidence is current to September 2014. We found nine trials with 1106 infants that assessed the effect of delayed rather than early introduction of milk feeds for very preterm or very low birth weight infants. Data from these trials did not provide any evidence that delaying enteral feeding reduces the risk of necrotising enterocolitis. The included trials were generally of reasonable methodological quality but, in common with other trials of feeding interventions in infants, it was not possible to mask carers and clinical assessors to the given treatment."
] |
cochrane-simplification-train-1110 | cochrane-simplification-train-1110 | Seven randomised trials were included. Four trials with 403 patients compared an antibiotic with placebo or no intervention. Three trials compared at least one antibiotic regimen with another antibiotic regimen. The trials all had high risk of bias. The trials varied in the severity of leptospirosis among trial patients. The ability to group data for meta-analysis was limited. While all four trials that compared antibiotics with placebo reported mortality and used parenteral penicillin, there were no deaths in two of them. Since odds ratio calculations cannot employ zero-event trials, only two trials contributed to this estimate. The number of deaths were 16/200 (8.0%) in the antibiotic arm versus 11/203 (5.4%) in the placebo arm giving a fixed-effect OR 1.56 (95% CI 0.70 to 3.46). The random-effects OR is 1.16 (95% CI 0.23 to 5.95). The heterogeneity among these four trials for the mortality outcome was moderate (I2= 50%). Only one trial (253 patients) reported days of hospitalisation. It compared parenteral penicillin to placebo without significant effect of therapy (8.9 versus 8.8 days; mean difference (MD) 0.10 days, 95% CI -0.83 to 1.03). The difference in days of clinical illness was reported in two of these trials (71 patients). While parenteral penicillin therapy conferred 4.7 to 5.6 days of clinical illness in contrast to 7.7 to 11.6 days in the placebo arm, the size of the estimate of effect increased but statistical significance was lost under the random-effect model (fixed-effect: MD -2.13 days, 95% CI -2.46 to -1.80; random-effects: MD -4.04, 95% CI -8.66 to 0.58). I2 for this outcome was high (81%). When duration of fever alone was assessed between antibiotics and placebo in a single trial (79 patients), no significant difference existed (6.9 versus 6.6 days; MD 0.30, 95% CI -1.26 to 1.86). Two trials with 332 patients in relatively severe and possibly late leptospirosis, resulted in trends towards increased dialysis when penicillin was used rather than placebo, but the estimate of effect was small and did not reach statistical significance (42/163 (25.8%) versus 31/169 (18.4%); OR 1.54, 95% CI 0.91 to 2.60). When one antibiotic was assessed against another antibiotic, there were no statistically significant results. For mortality in particular, these comparisons included cephalosporin versus penicillin (2 trials, 6/176 (3.4%) versus 9/175 (5.2%); fixed-effect: OR 0.65, 95% CI 0.23 to 1.87, I2= 16%), doxycycline versus penicillin (1 trial, 2/81 (2.5%) versus 4/89 (4.5); OR 0.54, 95% CI 0.10 to 3.02), cephalosporin versus doxycycline (1 trial, 1/88 (1.1%) versus 2/81 (2.5%); OR 0.45, 95% CI 0.04 to 5.10). There were no adverse events of therapy which reached statistical significance. Insufficient evidence is available to advocate for or against the use of antibiotics in the therapy for leptospirosis. Among survivors who were hospitalised for leptospirosis, use of antibiotics for leptospirosis may have decreased the duration of clinical illness by two to four days, though this result was not statistically significant. When electing to treat with an antibiotic, selection of penicillin, doxycycline, or cephalosporin does not seem to impact mortality nor duration of fever. The benefit of antibiotic therapy in the treatment of leptospirosis remains unclear, particularly for severe disease. Further clinical research is needed to include broader panels of therapy tested against placebo. | This review identified and assessed seven clinical trials that tested antibiotics in patients sick with leptospirosis. Four of these trials compared intravenous penicillin to a placebo. Three of the trials looked at differences between different antibiotics. All trials had high risk of systematic errors (bias) and of random errors (play of chance). When looked at together, these trials do not answer the basic questions about whether or not antibiotics should be used. Part of the reason for this is that there is a wide range of severity among people ill with the disease. Additional randomised clinical trials are needed. Nonetheless, these trials suggest that antibiotics administered to patients who are sick with leptospirosis may make patients feel better two days earlier than they otherwise would have improved. However, it is also possible that when patients are severely ill, penicillin therapy might increase the risk of death or dialysis in comparison to those who receive no antibiotics. Other antibiotics have not been tested in this way. Despite the lack of evidence, if a clinician chooses to treat leptospirosis with an antibiotic, there does not seem to be any difference between the appropriate use of intravenous penicillin, intravenous cephalosporin, doxycyline, or azithromycin. But, for this they have not been tested to the same extent as intravenous penicillin. | 10.1002/14651858.CD008264.pub2 | [
"This review identified and assessed seven clinical trials that tested antibiotics in patients sick with leptospirosis. Four of these trials compared intravenous penicillin to a placebo. Three of the trials looked at differences between different antibiotics. All trials had high risk of systematic errors (bias) and of random errors (play of chance). When looked at together, these trials do not answer the basic questions about whether or not antibiotics should be used. Part of the reason for this is that there is a wide range of severity among people ill with the disease. Additional randomised clinical trials are needed. Nonetheless, these trials suggest that antibiotics administered to patients who are sick with leptospirosis may make patients feel better two days earlier than they otherwise would have improved. However, it is also possible that when patients are severely ill, penicillin therapy might increase the risk of death or dialysis in comparison to those who receive no antibiotics. Other antibiotics have not been tested in this way. Despite the lack of evidence, if a clinician chooses to treat leptospirosis with an antibiotic, there does not seem to be any difference between the appropriate use of intravenous penicillin, intravenous cephalosporin, doxycyline, or azithromycin. But, for this they have not been tested to the same extent as intravenous penicillin."
] |
cochrane-simplification-train-1111 | cochrane-simplification-train-1111 | All identified studies were performed before and in the early 1990s and used various terms and criteria for cognitive decline and dementia. The three studies included in the review involved a total of 583 people with dementia treated with vinpocetine or placebo. The reports of these studies did not make possible any differentiation of effects for degenerative or vascular dementia. The results show benefit associated with treatment with vinpocetine 30 mg/day and 60 mg/day compared with placebo, but the number of patients treated for six months or more was small. Only one study extended treatment to one year. Adverse effects were inconsistently reported and without regard for relationship to dose. The available data do not demonstrate many problems of adverse effects but intention-to-treat data were not available for any of the trials. Although the basic science is interesting, the evidence for beneficial effect of vinpocetine on patients with dementia is inconclusive and does not support clinical use. The drug seems to have few adverse effects at the doses used in the studies. Large studies evaluating the use of vinpocetine for people suffering from well defined types of cognitive impairment are needed to explore possible efficacy of this treatment. | Clinical trials to test these hypotheses were performed before currently used criteria for dementia had become generally accepted. The results show improvement after the treatment with vinpocetine versus placebo, but the number of demented patients treated for at least six months was small. The available data does not demonstrate many side effect problems. Although the basic science is interesting, the evidence for beneficial effect of vinpocetine on patients with dementia is inconclusive and does not support clinical use. | 10.1002/14651858.CD003119 | [
"Clinical trials to test these hypotheses were performed before currently used criteria for dementia had become generally accepted. The results show improvement after the treatment with vinpocetine versus placebo, but the number of demented patients treated for at least six months was small. The available data does not demonstrate many side effect problems. Although the basic science is interesting, the evidence for beneficial effect of vinpocetine on patients with dementia is inconclusive and does not support clinical use."
] |
cochrane-simplification-train-1112 | cochrane-simplification-train-1112 | We identified 11 eligible RCTs which randomised a total of 3673 participants. One further trial, which was published in abstract form in 1990 but has yet to be reported fully, is currently 'awaiting assessment'. Six of the 11 included studies have been included for the first time in this latest (2012) update. The trials were heterogeneous in terms of their inclusion and exclusion criteria, the nature of the intervention, and the outcome measures assessed. We judged two of the trials to be of high quality and graded the remainder as poor quality. Meta-analyses of data on clinical and microbiological remission rates revealed that topical antibiotics were of benefit in improving 'early' (days two to five) clinical (risk ratio (RR) 1.36, 95% confidence interval (CI) 1.15 to 1.61) and microbiological (RR 1.55, 95% CI 1.37 to 1.76) remission rates. At the 'late' time point (days six to 10), antibiotics were found to still confer modest benefits in clinical remission (RR 1.21, 95% CI 1.10 to 1.33) and microbiological cure rates (RR 1.37, 95% CI 1.24 to 1.52). By days six to 10, 41% (95% CI 38 to 43) of cases had resolved in those receiving placebo. We found no data on the cost-effectiveness of antibiotics. No serious outcomes were reported in either the active or placebo arms of these trials, suggesting that important sight-threatening complications are an infrequent occurrence. Although acute bacterial conjunctivitis is frequently self limiting, the findings from this updated systematic review suggest that the use of antibiotic eye drops is associated with modestly improved rates of clinical and microbiological remission in comparison to the use of placebo. Use of antibiotic eye drops should therefore be considered in order to speed the resolution of symptoms and infection. | We found 11 randomised controlled trial (RCTs) from different parts of the world which recruited a total of 3673 participants overall. We judged two of the trials to be of high quality, and we graded the remainder as poor quality. This updated review provides clearer evidence that use of antibiotic eye drops can speed up the resolution of symptoms and infection, and that they are unlikely to be associated with any serious side effects. | 10.1002/14651858.CD001211.pub3 | [
"We found 11 randomised controlled trial (RCTs) from different parts of the world which recruited a total of 3673 participants overall. We judged two of the trials to be of high quality, and we graded the remainder as poor quality. This updated review provides clearer evidence that use of antibiotic eye drops can speed up the resolution of symptoms and infection, and that they are unlikely to be associated with any serious side effects."
] |
cochrane-simplification-train-1113 | cochrane-simplification-train-1113 | We included 83 randomised trials with 12,707 patients. Most trials had unclear or high risk of bias. We did not find any significant influence of bias on our results but cannot exclude outcome measure reporting bias as many trials did not report on the primary outcomes of this review. Compared with interferon, ribavirin plus interferon had a significant beneficial effect on sustained virological response in subgroups of naive patients (RR 0.72, 95% confidence interval (CI) 0.68 to 0.75), relapsers (RR 0.62, 95% CI 0.54 to 0.70), non-responders (RR 0.89, 95% CI 0.84 to 0.93), and in all patients (RR 0.75, 95% CI 0.71 to 0.79). Combination therapy significantly reduced morbidity plus mortality in all patients (Peto OR, 0.43, 95% CI 0.23 to 0.79), but not in naive, relapsers, or non-responders individually. Combination therapy significantly increased the risk of haematological, dermatological, gastrointestinal, infectious, and miscellaneous (cough, dyspnoea, fatigue) adverse reactions. Accordingly, combination therapy significantly increased the risk of treatment discontinuation and dose reductions. Trial sequential analyses confirmed our findings regarding virological effects, but not regarding liver-related morbidity and all-cause mortality. Compared with interferon alone, ribavirin plus interferon is more effective in clearing hepatitis C virus from the blood. Combination therapy may reduce liver-related morbidity and all-cause mortality, but we need more evidence. The number needed to treat to obtain a beneficial effect is considerable considering the increased risk of several severe adverse reactions and costs. | It is known that treatment with the drug interferon clears hepatitis C virus from the blood in about 15% of patients. This review identified studies comparing ribavirin plus interferon with interferon alone in patients with chronic hepatitis C. This review shows, by combining the results from all trials, that adding ribavirin to interferon increases the number of patients who clear the hepatitis C virus to about 40% as well as the number of patients who demonstrate improved liver histology. Ribavirin and interferon may also reduce the risk of liver-related morbidity or all-cause mortality. However, the number needed to treat to prevent one patient developing morbidity or dying seems very large. Furthermore, combination therapy was associated with increased risk of anaemia and several other adverse reactions. The results gives rise to a dilemma - should we, by adding ribavirin to interferon, increase the risk of haematological, dermatological, gastrointestinal, infectious, and miscellaneous adverse reactions in a situation where it has not yet been clearly demonstrated that the antiviral effect of the intervention is directly linked to the reduction of all-cause mortality? We, therefore, suggest that the combination intervention is applied only with stringent emphasis on the individual patients' well-being. Furthermore, we suggest that all future trials within the area should focus more on adverse reactions and long-term clinical outcomes. | 10.1002/14651858.CD005445.pub2 | [
"It is known that treatment with the drug interferon clears hepatitis C virus from the blood in about 15% of patients. This review identified studies comparing ribavirin plus interferon with interferon alone in patients with chronic hepatitis C. This review shows, by combining the results from all trials, that adding ribavirin to interferon increases the number of patients who clear the hepatitis C virus to about 40% as well as the number of patients who demonstrate improved liver histology. Ribavirin and interferon may also reduce the risk of liver-related morbidity or all-cause mortality. However, the number needed to treat to prevent one patient developing morbidity or dying seems very large. Furthermore, combination therapy was associated with increased risk of anaemia and several other adverse reactions. The results gives rise to a dilemma - should we, by adding ribavirin to interferon, increase the risk of haematological, dermatological, gastrointestinal, infectious, and miscellaneous adverse reactions in a situation where it has not yet been clearly demonstrated that the antiviral effect of the intervention is directly linked to the reduction of all-cause mortality? We, therefore, suggest that the combination intervention is applied only with stringent emphasis on the individual patients' well-being. Furthermore, we suggest that all future trials within the area should focus more on adverse reactions and long-term clinical outcomes."
] |
cochrane-simplification-train-1114 | cochrane-simplification-train-1114 | We included 13 case-control and 24 cohort studies (an additional nine new cohort and two case-control studies), which included a total of 4,684,724 women. Two cohort studies reported an increased incidence of invasive ovarian cancer in exposed subfertile women compared with unexposed women. One reported a standardised incidence ratio (SIR) of 1.19 (95% confidence interval (CI) 0.54 to 2.25) based on 17 cancer cases. The other cohort study reported a hazard ratio (HR) of 1.93 (95% CI 1.18 to 3.18), and this risk was increased in women remaining nulligravid after using clomiphene citrate (HR 2.49, 95% CI 1.30 to 4.78) versus multiparous women (HR 1.52, 95% CI 0.67 to 3.42) (very low-certainty evidence). The slight increase in ovarian cancer risk among women having between one and three cycles of in vitro fertilisation (IVF) was reported, but this was not clinically significant (P = 0.18). There was no increase in risk of invasive ovarian cancer after use of infertility drugs in women with the BRCA mutation according to one cohort and one case-control study. The certainty of evidence as assessed using GRADE was very low. For borderline ovarian tumours, one cohort study reported increased risk in exposed women with an SIR of 3.61 (95% CI 1.45 to 7.44), and this risk was greater after treatment with clomiphene citrate (SIR 7.47, 95% CI 1.54 to 21.83) based on 12 cases. In another cohort study, the risk of a borderline ovarian tumour was increased, with an HR of 4.23 (95% CI 1.25 to 14.33), for subfertile women treated with IVF compared with a non-IVF-treated group with more than one year of follow-up. A large cohort reported increased risk of borderline ovarian tumours, with HR of 2.46 (95% CI 1.20 to 5.04), and this was based on 17 cases. A significant increase in serous borderline ovarian tumours was reported in one cohort study after the use of progesterone for more than four cycles (risk ratio (RR) 2.63, 95% CI 1.04 to 6.64). A case-control study reported increased risk after clomiphene citrate was taken, with an SIR of 2.5 (95% CI 1.3 to 4.5) based on 11 cases, and another reported an increase especially after human menopausal gonadotrophin was taken (odds ratio (OR) 9.38, 95% CI 1.66 to 52.08). Another study estimated an increased risk of borderline ovarian tumour, but this estimation was based on four cases with no control reporting use of fertility drugs. The certainty of evidence as assessed using GRADE was very low. However, although some studies suggested a slight increase in risks of ovarian cancer and borderline ovarian tumour, none provided moderate- or high-certainty evidence, as summarised in the GRADE tables. Since the last version of this review, only a few new relevant studies have provided additional findings with supporting evidence to suggest that infertility drugs may increase the risk of ovarian cancer slightly in subfertile women treated with infertility drugs when compared to the general population or to subfertile women not treated. The risk is slightly higher in nulliparous than in multiparous women treated with infertility drugs, and for borderline ovarian tumours. However, few studies have been conducted, the number of cancers is very small, and information on the dose or type of fertility drugs used is insufficient. | Overall, based on 37 studies, which included a total of 4,684,724 women, we did not find enough strong evidence suggesting a potentially higher risk of ovarian cancer in women treated with fertility drugs. A cumulative analysis of 12 case-control studies from the USA revealed increased risk of ovarian cancer in women using fertility drugs, and this risk was higher in nulliparous women (women who have not given birth) when compared to multiparous women (women who have given birth to more than one child). One of the 37 included studies reported a two-fold increase in development of serous borderline ovarian tumour in women after more than four cycles of progesterone; however the number of cases included in this group was very small. One cohort study also suggested an increased risk of borderline ovarian tumour in infertile women treated with clomiphene citrate when compared to infertile women who did not undergo treatment to conceive. Studies showing an increase in the risk of ovarian cancer were of low methodological quality, with short follow-up periods and with lack of adjustment for important confounding factors; therefore the results are too unreliable. However, compared with older studies, recent studies have tended to report both the dose and the number of cycles of infertility drugs and have included more contemporary drug regimens; this has made the final results more reliable. Infertility has been found to be an important risk factor for ovarian cancer. However, the association between infertility drugs and ovarian cancer needs to be addressed with consideration of other factors such as age, body mass index, parity, genetic factors (i.e. family history for ovarian cancer), and aetiology of the infertility, along with longer follow-up times. | 10.1002/14651858.CD008215.pub3 | [
"Overall, based on 37 studies, which included a total of 4,684,724 women, we did not find enough strong evidence suggesting a potentially higher risk of ovarian cancer in women treated with fertility drugs. A cumulative analysis of 12 case-control studies from the USA revealed increased risk of ovarian cancer in women using fertility drugs, and this risk was higher in nulliparous women (women who have not given birth) when compared to multiparous women (women who have given birth to more than one child). One of the 37 included studies reported a two-fold increase in development of serous borderline ovarian tumour in women after more than four cycles of progesterone; however the number of cases included in this group was very small. One cohort study also suggested an increased risk of borderline ovarian tumour in infertile women treated with clomiphene citrate when compared to infertile women who did not undergo treatment to conceive. Studies showing an increase in the risk of ovarian cancer were of low methodological quality, with short follow-up periods and with lack of adjustment for important confounding factors; therefore the results are too unreliable. However, compared with older studies, recent studies have tended to report both the dose and the number of cycles of infertility drugs and have included more contemporary drug regimens; this has made the final results more reliable. Infertility has been found to be an important risk factor for ovarian cancer. However, the association between infertility drugs and ovarian cancer needs to be addressed with consideration of other factors such as age, body mass index, parity, genetic factors (i.e. family history for ovarian cancer), and aetiology of the infertility, along with longer follow-up times."
] |
cochrane-simplification-train-1115 | cochrane-simplification-train-1115 | This review included 19 randomised trials with a total of 823 participants. Almost all included trials had several methodological weaknesses. Meta-analysis showed that oral stimulation reduced the time to transition to oral feeding compared with standard care (mean difference (MD) -4.81, 95% confidence interval (CI) -5.56 to -4.06 days) and compared with another non-oral intervention (MD -9.01, 95% CI -10.30 to -7.71 days), as well as the duration of initial hospitalisation compared with standard care (MD -5.26, 95% CI -7.34 to -3.19 days) and compared with another non-oral intervention (MD -9.01, 95% CI -10.30 to -7.71 days). Investigators reported shorter duration of parenteral nutrition for infants compared with standard care (MD -5.30, 95% CI -9.73 to -0.87 days) and compared with another non-oral intervention (MD -8.70, 95% CI -15.46 to -1.94 days). They could identify no effect on breast-feeding outcomes nor on weight gain. Although the included studies suggest that oral stimulation shortens hospital stay, days to exclusive oral feeding and duration of parenteral nutrition, one must interpret results of these studies with caution, as risk of bias and poor methodological quality are high overall. Well-designed trials of oral stimulation interventions for preterm infants are warranted. Such trials should use reliable methods of randomisation while concealing treatment allocation, blinding caregivers to treatment when possible and paying particular attention to blinding of outcome assessors. | This review included randomised controlled trials (RCTs) that explored oral stimulation by finger stimulation only in preterm infants. Review authors identified studies to be included by searching electronic databases, clinical trials registers, peer-reviewed journals and published conference proceedings. We included 19 studies of poor quality with small numbers of participants. Study findings suggest that oral stimulation interventions can shorten the transition to oral feeding, reduce length of hospital stay and decrease time spent on parenteral nutrition. No studies looked at longer-term outcomes of the interventions (i.e. beyond six months). Studies have reported no effect on breast feeding outcomes nor on weight gain. These studies were small and most were of low or very low methodological quality. Review authors identified no high-quality studies that could support the efficacy, effectiveness and safety of oral stimulation interventions. Larger, well-designed RCTs are needed to help inform parents and caregivers about the possible benefits and harms of this intervention. | 10.1002/14651858.CD009720.pub2 | [
"This review included randomised controlled trials (RCTs) that explored oral stimulation by finger stimulation only in preterm infants. Review authors identified studies to be included by searching electronic databases, clinical trials registers, peer-reviewed journals and published conference proceedings. We included 19 studies of poor quality with small numbers of participants. Study findings suggest that oral stimulation interventions can shorten the transition to oral feeding, reduce length of hospital stay and decrease time spent on parenteral nutrition. No studies looked at longer-term outcomes of the interventions (i.e. beyond six months). Studies have reported no effect on breast feeding outcomes nor on weight gain. These studies were small and most were of low or very low methodological quality. Review authors identified no high-quality studies that could support the efficacy, effectiveness and safety of oral stimulation interventions. Larger, well-designed RCTs are needed to help inform parents and caregivers about the possible benefits and harms of this intervention."
] |
cochrane-simplification-train-1116 | cochrane-simplification-train-1116 | In this update in 2017, we did not identify any new randomised controlled trials (RCT) for inclusion. We identified one ongoing trial that we are likely to include in a future update. Accordingly, our results are unchanged. The only included trial is a multicentre RCT conducted at 24 locations in North America and India that compared bone marrow injection with steroid (methylprednisolone acetate) injection for treating simple bone cysts. Up to three injections were planned for participants in each group. The trial involved 90 children (mean age 9.5 years) and presented results for 77 children at two-year follow-up. Although the trial had secure allocation concealment, it was at high risk of performance bias and from major imbalances in baseline characteristics. Reflecting these study limitations, we downgraded the quality of evidence by two levels to 'low' for most outcomes, meaning that we are unsure about the estimates of effect. For outcomes where there was serious imprecision, we downgraded the quality of evidence by a further level to 'very low'. The trial provided very low quality evidence that fewer children in the bone marrow injection group had radiographically assessed healing of bone cysts at two years than in the steroid injection group (9/39 versus 16/38; RR 0.55 favouring steroid injection, 95% CI 0.28 to 1.09). However, the result was uncertain and may be compatible with no difference or small benefit favouring bone marrow injection. Based on an illustrative success rate of 421 children with healed bone cysts per 1000 children treated with steroid injections, this equates to 189 fewer (95% CI 303 fewer to 38 more) children with healed bone cysts per 1000 children treated with bone marrow injections. There was low quality evidence of a lack of difference between the two interventions at two years in functional outcome, based on the Activity Scale for Kids function score (0 to 100; higher scores equate to better outcome: MD -0.90; 95% CI -4.26 to 2.46) or in pain assessed using the Oucher pain score. There was very low quality evidence of a lack of differences between the two interventions for adverse events: subsequent pathological fracture (9/39 versus 11/38; RR 0.80, 95% CI 0.37 to 1.70) or superficial infection (two cases in the bone marrow group). Recurrence of bone cyst, unacceptable malunion, return to normal activities, and participant satisfaction were not reported. The available evidence is insufficient to determine the relative effects of bone marrow versus steroid injections, although the bone marrow injections are more invasive. Noteably, the rate of radiographically assessed healing of the bone cyst at two years was well under 50% for both interventions. Overall, there is a lack of evidence to determine the best method for treating simple bone cysts in the long bones of children. Further RCTs of sufficient size and quality are needed to guide clinical practice. | We searched several important medical databases in April 2016, as well as trial registers, conference proceedings and reference lists. We found only one relevant medical study in which the children participating were allocated randomly to different treatments. The study compared treatments in which the simple bone cysts were injected with bone marrow or steroid (methylprednisolone acetate). Ninety children with an average age of 9.5 years participated in this study. Results were available for 77 children. Two years after treatment, X-ray examination showed that successful healing of bone cysts was more common in children who had received steroid injections; however, we are very uncertain whether this is a true finding. Low quality evidence two years after treatment showed children in the two treatment groups had similar high levels of function (measured by the Activity Scale for Kids score) and low levels of pain (measured by Oucher score). There was very low quality evidence that there was no difference between the two interventions for adverse events, including pathological fracture after treatment. As the quality of the evidence is low, or very low, we cannot definitively conclude that there are no differences between the treatments, and we do not know whether either treatment gives better results with fewer complications. This review is based on one trial with a small number of participants. Hence, at present there is insufficient evidence to determine the best method for treating simple bone cysts in the long bones of children. More studies with larger numbers of participants and that monitor children for longer follow-up periods are needed. | 10.1002/14651858.CD010847.pub3 | [
"We searched several important medical databases in April 2016, as well as trial registers, conference proceedings and reference lists. We found only one relevant medical study in which the children participating were allocated randomly to different treatments. The study compared treatments in which the simple bone cysts were injected with bone marrow or steroid (methylprednisolone acetate). Ninety children with an average age of 9.5 years participated in this study. Results were available for 77 children. Two years after treatment, X-ray examination showed that successful healing of bone cysts was more common in children who had received steroid injections; however, we are very uncertain whether this is a true finding. Low quality evidence two years after treatment showed children in the two treatment groups had similar high levels of function (measured by the Activity Scale for Kids score) and low levels of pain (measured by Oucher score). There was very low quality evidence that there was no difference between the two interventions for adverse events, including pathological fracture after treatment. As the quality of the evidence is low, or very low, we cannot definitively conclude that there are no differences between the treatments, and we do not know whether either treatment gives better results with fewer complications. This review is based on one trial with a small number of participants. Hence, at present there is insufficient evidence to determine the best method for treating simple bone cysts in the long bones of children. More studies with larger numbers of participants and that monitor children for longer follow-up periods are needed."
] |
cochrane-simplification-train-1117 | cochrane-simplification-train-1117 | This review includes 13 trials (10 RCTs and three quasi-randomised trials), as well as two economic evaluations based on two of the trials. Overall, there were 1078 participants (646 in the intervention group; 432 in the control group). The results indicate that parent training produced a statistically significant reduction in child conduct problems, whether assessed by parents (standardised mean difference (SMD) -0.53; 95% confidence interval (CI) -0.72 to -0.34) or independently assessed (SMD -0.44; 95% CI -0.77 to -0.11). The intervention led to statistically significant improvements in parental mental health (SMD -0.36; 95% CI -0.52 to -0.20) and positive parenting skills, based on both parent reports (SMD -0.53; 95% CI -0.90 to -0.16) and independent reports (SMD -0.47; 95% CI -0.65 to -0.29). Parent training also produced a statistically significant reduction in negative or harsh parenting practices according to both parent reports (SMD -0.77; 95% CI -0.96 to -0.59) and independent assessments (SMD -0.42; 95% CI -0.67 to -0.16). Moreover, the intervention demonstrated evidence of cost-effectiveness. When compared to a waiting list control group, there was a cost of approximately $2500 (GBP 1712; EUR 2217) per family to bring the average child with clinical levels of conduct problems into the non-clinical range. These costs of programme delivery are modest when compared with the long-term health, social, educational and legal costs associated with childhood conduct problems. Behavioural and cognitive-behavioural group-based parenting interventions are effective and cost-effective for improving child conduct problems, parental mental health and parenting skills in the short term. The cost of programme delivery was modest when compared with the long-term health, social, educational and legal costs associated with childhood conduct problems. Further research is needed on the long-term assessment of outcomes. | This review provides evidence that group-based parenting programmes improve childhood behaviour problems and the development of positive parenting skills in the short-term, whilst also reducing parental anxiety, stress and depression. Evidence for the longer-term effects of these programmes is unavailable. These group-based parenting programmes achieve good results at a cost of approximately $2500 (£1712 or €2217) per family. These costs are modest when compared with the long-term social, educational and legal costs associated with childhood conduct problems. | 10.1002/14651858.CD008225.pub2 | [
"This review provides evidence that group-based parenting programmes improve childhood behaviour problems and the development of positive parenting skills in the short-term, whilst also reducing parental anxiety, stress and depression. Evidence for the longer-term effects of these programmes is unavailable. These group-based parenting programmes achieve good results at a cost of approximately $2500 (£1712 or €2217) per family. These costs are modest when compared with the long-term social, educational and legal costs associated with childhood conduct problems."
] |
cochrane-simplification-train-1118 | cochrane-simplification-train-1118 | Two RCTs and one controlled before-and-after study were included (735 participants). All were conducted in the USA and had several potential sources of bias. Few outcomes for residents were assessed. One study reported higher satisfaction with care and the other found lower observed discomfort in residents with end-stage dementia. Two studies reported group differences on some process measures. Both reported higher referral to hospice services in their intervention group, one found fewer hospital admissions and days in hospital in the intervention group, the other found an increase in do-not-resuscitate orders and documented advance care plan discussions. We found few studies, and all were in the USA. Although the results are potentially promising, high quality trials of palliative care service delivery interventions which assess outcomes for residents are needed, particularly outside the USA. These should focus on measuring standard outcomes, assessing cost-effectiveness, and reducing bias. | The aim of this review was to see how effective palliative care interventions in care homes are, and to describe the outcome measures used in the studies. We found only three suitable studies (735 participants), all from the USA. There was little evidence that interventions to improve palliative care for older people in care homes improved outcomes for residents. One study found that palliative care increased bereaved family members' perceptions of the quality of care and another found lower discomfort for residents with dementia who were dying. There were problems with both of these findings. Two studies found that palliative care improved some of the ways in which care was given in the care home, however, we do not know if this resulted in better outcomes for residents. There is a need for more high quality research, particularly outside the USA. | 10.1002/14651858.CD007132.pub2 | [
"The aim of this review was to see how effective palliative care interventions in care homes are, and to describe the outcome measures used in the studies. We found only three suitable studies (735 participants), all from the USA. There was little evidence that interventions to improve palliative care for older people in care homes improved outcomes for residents. One study found that palliative care increased bereaved family members' perceptions of the quality of care and another found lower discomfort for residents with dementia who were dying. There were problems with both of these findings. Two studies found that palliative care improved some of the ways in which care was given in the care home, however, we do not know if this resulted in better outcomes for residents. There is a need for more high quality research, particularly outside the USA."
] |
cochrane-simplification-train-1119 | cochrane-simplification-train-1119 | We included ten trials in which 652 patients were randomised. The risk of bias was considered high in most trials. There was no significant effect of prostaglandins on all-cause mortality (37/298[12.4%] in prostaglandin group versus 47/312[15.1%] in control group; OR 0.84, 95% CI 0.53 to 1.37; I2 = 0%), on primary non-function of the allograft (8/238 [3.4%] versus. 16/250[6.4%] ;OR 0.55, 95% CI 0.23 to 1.33; I2 = 0%), and on liver re-transplantation (12/161[7.5%] versus 14/171[8.2%]; OR 0.99, 95% CI 0.44 to 2.25; I2 = 0%). Prostaglandins seemed to significantly decrease the risk of acute kidney failure requiring dialysis (13/158[8.2%] versus 34/171[9.9%]; OR 0.37, 95% CI 0.18 to 0.75; I2 = 0%). There was no significant increase in the risk of adverse events with prostaglandins. We found no evidence that the administration of prostaglandins to liver transplanted patients reduces the risk of death, primary non-function of the allograft, or liver re-transplantation. Prostaglandins might reduce the risk of acute kidney failure requiring dialysis, but the quality of the evidence is considered only moderate due to high risk of bias in most of the included trials. Moreover, there are risks of outcome measure reporting bias and random errors. Therefore, further randomised, placebo-controlled trials are deemed necessary. | This review summarised and meta-analysed the evidence from randomised clinical trials on the effect of prostaglandins for adult liver transplanted patients. We found ten trials randomising 652 patients. Evidence from these trials is inconclusive on the role of prostaglandins regarding outcomes such as death or liver re-transplantation. The risk of acute kidney failure requiring dialysis may be reduced by two thirds if a liver transplant patient receives prostaglandins, although the level of evidence is only moderate due to risks of systematic errors (bias) and random errors (play of chance). No severe adverse events are reported. Therefore, further randomised trials with low risk of bias and sufficient sample sizes are still needed to establish whether prostaglandins should be administered for liver transplanted patients. | 10.1002/14651858.CD006006.pub2 | [
"This review summarised and meta-analysed the evidence from randomised clinical trials on the effect of prostaglandins for adult liver transplanted patients. We found ten trials randomising 652 patients. Evidence from these trials is inconclusive on the role of prostaglandins regarding outcomes such as death or liver re-transplantation. The risk of acute kidney failure requiring dialysis may be reduced by two thirds if a liver transplant patient receives prostaglandins, although the level of evidence is only moderate due to risks of systematic errors (bias) and random errors (play of chance). No severe adverse events are reported. Therefore, further randomised trials with low risk of bias and sufficient sample sizes are still needed to establish whether prostaglandins should be administered for liver transplanted patients."
] |
cochrane-simplification-train-1120 | cochrane-simplification-train-1120 | We included eight studies with a total of 2227 women undergoing elective caesarean section. Of these, 1097 underwent intraoperative cervical dilatation with a double-gloved index finger or Hegar dilator inserted into the cervical canal to dilate, and 1130 did not undergo intraoperative cervical dilatation. Six of the eight included trials had high risk of bias for some of the risk of bias domains. Very low-quality evidence suggested it was unclear whether cervical dilatation had any impact on postpartum haemorrhage (estimated blood loss greater than 1000 mL; risk ratio (RR) 1.97, 95% confidence interval (CI) 0.48 to 8.13; 5/205 versus 3/242; one study, 447 women). Low- or very low-quality evidence showed no clear difference for the need for blood transfusion (RR 3.54, 95% CI 0.37 to 33.79; two studies, 847 women); postoperative haemoglobin (mean difference (MD -0.05, 95% CI -0.15 to 0.06; three studies, 749 women), or haematocrit (MD 0.01%, 95% CI -0.18 to 0.20; one study, 400 women); the incidence of drop from baseline haemoglobin above 0.5 g/dL (RR 0.92, 95% CI 0.64 to 1.31; two studies, 722 women), or amount of haemoglobin drop (MD -0.01 g/dL, 95% -0.14 to 0.13; three studies, 796 women); the incidence of secondary postpartum haemorrhage within six weeks (RR 1.18, 95% CI 0.07 to 18.76; one study, 447 women); febrile morbidity (RR 1.18, 95% CI 0.76 to 1.85; seven studies, 2126 women); endometritis (RR 0.94, 95% CI 0.35 to 2.52; four studies, 1536 women); or uterine subinvolution (RR 0.34, 95% CI 0.08 to 1.36; two studies, 654 women); the results crossed the line of no effect for all of the outcomes. There were no data for cervical trauma. We found a slight improvement with mechanical dilatation for these secondary outcomes, not prespecified in the protocol: mean blood loss, endometrial cavity thickness, retained products of conception, distortion of uterine incision, and healing ratio. The evidence for these outcomes was based on one or two studies. Cervical dilatation did not have a clear effect on these secondary outcomes, not prespecified in the protocol: wound infection, urinary tract infection, operative time, infectious morbidity, and integrity of uterine scar. At this time, the evidence does not support or refute the use of mechanical dilatation of the cervix during elective caesarean section for reducing postoperative morbidity. Further large, well-designed studies are required to compare the effect of intraoperative mechanical dilatation of the cervix with no intraoperative mechanical cervical dilatation for reducing postoperative morbidity. | We searched for evidence from randomised controlled trials in September 2017. We identified eight studies with a total of 2227 women undergoing elective (planned) caesarean section before the onset of labour. Of these women, 1097 underwent cervical dilatation with a double-gloved index finger, or in one study with a Hegar dilator, during surgery, while 1130 did not undergo cervical dilatation during surgery. Low- or very low-quality evidence suggested it was unclear whether cervical dilatation had any impact on postpartum haemorrhage (estimated blood loss greater than 1000 mL), the need for blood transfusion, and other measures of blood loss, postpartum haemorrhage within six weeks, febrile morbidity (infection indicated by increased temperature over a defined time period), endometritis (infection of the lining of the womb), or uterine subinvolution (uterus not returning to its normal size after childbirth). There were no data for cervical trauma. We found a slight improvement with mechanical dilatation for some outcomes that had not been specified in our original protocol, but the evidence for these outcomes was based on one or two studies (mean blood loss, endometrial cavity thickness, retained products of conception, distortion of uterine incision, and healing ratio). Cervical dilatation did not have a clear effect on other secondary outcomes, (again not specified in our original protocol): wound infection, urinary tract infection, operative time, infectious morbidity, and integrity of uterine scar. It is uncertain whether cervical dilatation has any impact on reducing postoperative problems after caesarean section. This means there is insufficient evidence to encourage or discourage the use of mechanical dilatation of the cervix at elective caesarean section for reducing postoperative ill-health. | 10.1002/14651858.CD008019.pub3 | [
"We searched for evidence from randomised controlled trials in September 2017. We identified eight studies with a total of 2227 women undergoing elective (planned) caesarean section before the onset of labour. Of these women, 1097 underwent cervical dilatation with a double-gloved index finger, or in one study with a Hegar dilator, during surgery, while 1130 did not undergo cervical dilatation during surgery. Low- or very low-quality evidence suggested it was unclear whether cervical dilatation had any impact on postpartum haemorrhage (estimated blood loss greater than 1000 mL), the need for blood transfusion, and other measures of blood loss, postpartum haemorrhage within six weeks, febrile morbidity (infection indicated by increased temperature over a defined time period), endometritis (infection of the lining of the womb), or uterine subinvolution (uterus not returning to its normal size after childbirth). There were no data for cervical trauma. We found a slight improvement with mechanical dilatation for some outcomes that had not been specified in our original protocol, but the evidence for these outcomes was based on one or two studies (mean blood loss, endometrial cavity thickness, retained products of conception, distortion of uterine incision, and healing ratio). Cervical dilatation did not have a clear effect on other secondary outcomes, (again not specified in our original protocol): wound infection, urinary tract infection, operative time, infectious morbidity, and integrity of uterine scar. It is uncertain whether cervical dilatation has any impact on reducing postoperative problems after caesarean section. This means there is insufficient evidence to encourage or discourage the use of mechanical dilatation of the cervix at elective caesarean section for reducing postoperative ill-health."
] |
cochrane-simplification-train-1121 | cochrane-simplification-train-1121 | We included 16 studies with 1750 participants. The studies were 2 to 26 weeks long and compared an oromucosal spray with a plant-derived combination of tetrahydrocannabinol (THC) and cannabidiol (CBD) (10 studies), a synthetic cannabinoid mimicking THC (nabilone) (two studies), inhaled herbal cannabis (two studies) and plant-derived THC (dronabinol) (two studies) against placebo (15 studies) and an analgesic (dihydrocodeine) (one study). We used the Cochrane 'Risk of bias' tool to assess study quality. We defined studies with zero to two unclear or high risks of bias judgements to be high-quality studies, with three to five unclear or high risks of bias to be moderate-quality studies, and with six to eight unclear or high risks of bias to be low-quality studies. Study quality was low in two studies, moderate in 12 studies and high in two studies. Nine studies were at high risk of bias for study size. We rated the quality of the evidence according to GRADE as very low to moderate. Primary outcomes Cannabis-based medicines may increase the number of people achieving 50% or greater pain relief compared with placebo (21% versus 17%; risk difference (RD) 0.05 (95% confidence interval (CI) 0.00 to 0.09); NNTB 20 (95% CI 11 to 100); 1001 participants, eight studies, low-quality evidence). We rated the evidence for improvement in Patient Global Impression of Change (PGIC) with cannabis to be of very low quality (26% versus 21%;RD 0.09 (95% CI 0.01 to 0.17); NNTB 11 (95% CI 6 to 100); 1092 participants, six studies). More participants withdrew from the studies due to adverse events with cannabis-based medicines (10% of participants) than with placebo (5% of participants) (RD 0.04 (95% CI 0.02 to 0.07); NNTH 25 (95% CI 16 to 50); 1848 participants, 13 studies, moderate-quality evidence). We did not have enough evidence to determine if cannabis-based medicines increase the frequency of serious adverse events compared with placebo (RD 0.01 (95% CI -0.01 to 0.03); 1876 participants, 13 studies, low-quality evidence). Secondary outcomes Cannabis-based medicines probably increase the number of people achieving pain relief of 30% or greater compared with placebo (39% versus 33%; RD 0.09 (95% CI 0.03 to 0.15); NNTB 11 (95% CI 7 to 33); 1586 participants, 10 studies, moderate quality evidence). Cannabis-based medicines may increase nervous system adverse events compared with placebo (61% versus 29%; RD 0.38 (95% CI 0.18 to 0.58); NNTH 3 (95% CI 2 to 6); 1304 participants, nine studies, low-quality evidence). Psychiatric disorders occurred in 17% of participants using cannabis-based medicines and in 5% using placebo (RD 0.10 (95% CI 0.06 to 0.15); NNTH 10 (95% CI 7 to 16); 1314 participants, nine studies, low-quality evidence). We found no information about long-term risks in the studies analysed. Subgroup analyses We are uncertain whether herbal cannabis reduces mean pain intensity (very low-quality evidence). Herbal cannabis and placebo did not differ in tolerability (very low-quality evidence). The potential benefits of cannabis-based medicine (herbal cannabis, plant-derived or synthetic THC, THC/CBD oromucosal spray) in chronic neuropathic pain might be outweighed by their potential harms. The quality of evidence for pain relief outcomes reflects the exclusion of participants with a history of substance abuse and other significant comorbidities from the studies, together with their small sample sizes. | Study characteristics In November 2017 we searched for clinical trials that used cannabis products to treat conditions with chronic neuropathic pain in adults. We found 16 studies involving 1750 people. Studies lasted 2 to 26 weeks. Studies compared different cannabis-based medicines. Ten studies compared an oromucosal (mouth) spray with a plant-derived combination of tetrahydrocannabinol (THC), the principal psychoactive constituent of cannabis, and cannabidiol (CBD), an anti-inflammatory ingredient of cannabis, against a fake medication (placebo). Two studies each compared inhaled herbal cannabis and cannabis plant-derived THC with placebo, and one study compared a man-made cannabinoid mimicking the effects of THC (nabilone) with placebo. One study compared nabilone with a pain killer (dihydrocodeine). 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. There was no high-quality evidence. All cannabis-based medicines pooled together were better than placebo for the outcomes substantial and moderate pain relief and global improvement. All cannabis-based medicines pooled together were better than placebo in reducing pain intensity, sleep problems and psychological distress (very low- to moderate-quality evidence). There was no difference between all cannabis-based medicines pooled together and placebo in improving health-related quality of life, stopping the medication because it was not effective, and in the frequency of serious side effects (low-quality evidence). More people reported sleepiness, dizziness and mental problems (e.g. confusion) with all cannabis-based medicines pooled together than with placebo (low-quality evidence). There was moderate-quality evidence that more people dropped out due to side effects with cannabis-based medicines than with placebo. Herbal cannabis was not different from placebo in reducing pain and the number of people who dropped out due to side effects (very low-quality evidence). | 10.1002/14651858.CD012182.pub2 | [
"Study characteristics In November 2017 we searched for clinical trials that used cannabis products to treat conditions with chronic neuropathic pain in adults. We found 16 studies involving 1750 people. Studies lasted 2 to 26 weeks. Studies compared different cannabis-based medicines. Ten studies compared an oromucosal (mouth) spray with a plant-derived combination of tetrahydrocannabinol (THC), the principal psychoactive constituent of cannabis, and cannabidiol (CBD), an anti-inflammatory ingredient of cannabis, against a fake medication (placebo). Two studies each compared inhaled herbal cannabis and cannabis plant-derived THC with placebo, and one study compared a man-made cannabinoid mimicking the effects of THC (nabilone) with placebo. One study compared nabilone with a pain killer (dihydrocodeine). 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. There was no high-quality evidence. All cannabis-based medicines pooled together were better than placebo for the outcomes substantial and moderate pain relief and global improvement. All cannabis-based medicines pooled together were better than placebo in reducing pain intensity, sleep problems and psychological distress (very low- to moderate-quality evidence). There was no difference between all cannabis-based medicines pooled together and placebo in improving health-related quality of life, stopping the medication because it was not effective, and in the frequency of serious side effects (low-quality evidence). More people reported sleepiness, dizziness and mental problems (e.g. confusion) with all cannabis-based medicines pooled together than with placebo (low-quality evidence). There was moderate-quality evidence that more people dropped out due to side effects with cannabis-based medicines than with placebo. Herbal cannabis was not different from placebo in reducing pain and the number of people who dropped out due to side effects (very low-quality evidence)."
] |
cochrane-simplification-train-1122 | cochrane-simplification-train-1122 | Three studies (one cluster-RCT and two CBAs) comprising a total of 13,885 participants (9640 children and 4245 adults) as well as 1200 households in two LMICs (Nicaragua and Niger) met the inclusion criteria. They examined five UCTs between USD 145 and USD 250 (or more, depending on household characteristics) that were provided by governmental, non-governmental or research organisations during experiments or pilot programmes in response to droughts. Two studies examined the effectiveness of UCTs, and one study examined the relative effectiveness of in-hand UCTs compared with in-kind transfers and UCTs paid via mobile phone. Due to the methodologic limitations of the retrieved records, which carried a high risk of bias and very serious indirectness, we considered the body of evidence to be of very low overall quality and thus very uncertain across all outcomes. Depending on the specific health services use and health outcomes examined, the included studies either reported no evidence that UCTs had impacted the outcome, or they reported that UCTs improved the outcome. No single outcome was reported by more than one study. There was a very small increase in the proportion of children who received vitamin or iron supplements (mean difference (MD) 0.10 standard deviations (SDs), 95% confidence interval (CI) 0.06 to 0.14) and on the child's home environment, as well as clinically meaningful, very large reductions in the chance of child death (hazard ratio (HR) 0.26, 95% CI 0.10 to 0.66) and the incidence of severe acute malnutrition (HR 0.44, 95% CI 0.24 to 0.80). There was also a moderate reduction in the number of days children spent sick in bed (MD − 0.36 SDs, 95% CI − 0.62 to − 0.10). There was no evidence for any effect on the proportion of children receiving deworming drugs, height for age among children, adults' level of depression, or the quality of parenting behaviour. No adverse effects were identified. The included comparisons did not examine several important outcomes, including food security and equity impacts. With regard to the relative effectiveness of UCTs compared with a food transfer providing a relatively high total caloric value, there was no evidence that a UCT had any effect on the chance of child death (HR 2.27, 95% CI 0.69 to 7.44) or severe acute malnutrition (HR 1.15, 95% CI 0.67 to 1.99). A UCT paid in-hand led to a clinically meaningful, moderate increase in the household dietary diversity score, compared with the same UCT paid via mobile phone (difference-in-differences estimator 0.43 scores, 95% CI 0.06 to 0.80), but there was no evidence for an effect on social determinants of health, health service expenditure, or local markets and infrastructure. Additional high-quality evidence (especially RCTs of humanitarian disaster contexts other than droughts) is required to reach clear conclusions regarding the effectiveness and relative effectiveness of UCTs for improving health services use and health outcomes in humanitarian disasters in LMICs. | We included three studies on a total of 13,885 participants (9640 children and 4245 adults) and 1200 households in Nicaragua and Niger. They examined five programmes by governmental, non-governmental or research organisations that gave recipients cash handouts worth USD 145 to USD 250 (or more, depending on household characteristics) as part of a disaster response (in these cases, to droughts). The studies had some serious methodological limitations, so we considered the evidence to be of very low quality and very uncertain. UCTs appeared to contribute to a very small increase in the proportion of children who received vitamin or iron supplements and a beneficial effect on children's home environment. They may have resulted in a very large reduction in the chance of dying, a moderate reduction in the number of days spent sick in bed, and a large reduction in children's risk of acute malnutrition. UCTs had no clear effect on the proportion of children who received deworming drugs, children's height for age, adults' level of depression, or the quality of parenting behaviour. No adverse effects were identified.The included studies did not examine several important outcomes, including food security and equity impacts. Compared with grants of food, there was no evidence that a UCT influenced the chance of child death or severe acute malnutrition. Compared with the same UCT paid via mobile phone, a UCT paid in-hand led to a moderate increase in household dietary diversity, but there was no evidence for any effect on social determinants of health, health service expenditure, or local markets and infrastructure. Additional research is required to reach clear conclusions regarding the effectiveness and relative effectiveness of UCTs in improving health services use and health outcomes in humanitarian disasters in LMICs. | 10.1002/14651858.CD011247.pub2 | [
"We included three studies on a total of 13,885 participants (9640 children and 4245 adults) and 1200 households in Nicaragua and Niger. They examined five programmes by governmental, non-governmental or research organisations that gave recipients cash handouts worth USD 145 to USD 250 (or more, depending on household characteristics) as part of a disaster response (in these cases, to droughts). The studies had some serious methodological limitations, so we considered the evidence to be of very low quality and very uncertain. UCTs appeared to contribute to a very small increase in the proportion of children who received vitamin or iron supplements and a beneficial effect on children's home environment. They may have resulted in a very large reduction in the chance of dying, a moderate reduction in the number of days spent sick in bed, and a large reduction in children's risk of acute malnutrition. UCTs had no clear effect on the proportion of children who received deworming drugs, children's height for age, adults' level of depression, or the quality of parenting behaviour. No adverse effects were identified.The included studies did not examine several important outcomes, including food security and equity impacts. Compared with grants of food, there was no evidence that a UCT influenced the chance of child death or severe acute malnutrition. Compared with the same UCT paid via mobile phone, a UCT paid in-hand led to a moderate increase in household dietary diversity, but there was no evidence for any effect on social determinants of health, health service expenditure, or local markets and infrastructure. Additional research is required to reach clear conclusions regarding the effectiveness and relative effectiveness of UCTs in improving health services use and health outcomes in humanitarian disasters in LMICs."
] |
cochrane-simplification-train-1123 | cochrane-simplification-train-1123 | We included 14 articles describing 13 studies, comprising 11 single-centre studies and two multi-centre studies. These studies involved 944 hands of 940 participants; of these, 93 participants were reported twice in separate articles describing early and late outcomes of one trial. Three papers reported the outcomes of two trials comparing different procedures. One trial compared needle fasciotomy versus fasciectomy (125 hands, 121 participants), and the other compared interposition firebreak skin grafting versus z-plasty closure of fasciectomy (79 participants). The other 11 studies reported trials of technical refinements of procedures or rehabilitation adjuncts. Of these, three investigated effects of postoperative splinting on surgical outcomes. Ten studies (11 articles) were randomised controlled trials (RCTs) of varying methodological quality; one was a controlled clinical trial. Trial design was unclear in two studies awaiting classification. All trials had high or unclear risk of at least one type of bias. High risks of performance and detection bias were particularly common. We downgraded the quality of evidence (Grades of Recommendation, Assessment, Development and Evaluation - GRADE) of outcomes to low because of concerns about risk of bias and imprecision. Outcomes measured varied between studies. Five articles assessed recurrence; two defined this as reappearance of palpable disease and two as deterioration in angular deformity; one did not explicitly define recurrence. Hand function on the Disabilities of the Arm, Shoulder and Hand (DASH) Scale (scores between 0 and 100, with higher scores indicating greater impairment) was 5 points lower after needle fasciotomy than after fasciectomy at five weeks. Patient satisfaction was better after fasciotomy at six weeks, but the magnitude of effect was not specified. Fasciectomy improved contractures more effectively in severe disease: Mean percentage reduction in total passive extension deficit at six weeks for Tubiana grades I and II was 11% lower after needle fasciotomy than after fasciectomy, whereas for grades III and IV disease, it was 29% and 32% lower. Paraesthesia (defined as subjective tingling sensation without objective evidence of altered sensation) was more common than needle fasciotomy at one week after fasciectomy (228/1000 vs 67/1000), but reporting of complications was variable. By five years, satisfaction (on a scale from 0 to 10, with higher scores showing greater satisfaction) was 2.1/10 points higher in the fasciectomy group than in the fasciotomy group, and recurrence was greater after fasciotomy (849/1000 vs 209/1000). Firebreak skin grafting did not improve outcomes more than fasciectomy alone, although this procedure took longer to perform. One trial investigated four weeks of day and night splinting followed by two months of night splinting after surgery. The other two trials investigated three months of night splinting after surgery, but participants in 'no splint' groups with early deterioration at one week were issued a splint for use. All three studies demonstrated no benefit from splinting. The two trials investigating postoperative night splinting were suitable for meta-analysis, which demonstrated no benefit from splinting: Mean DASH score in the splint groups was 1.15 points lower (95% confidence interval (CI) -2.32 to 4.62) than in the no splint groups. Mean total active extension in the splint groups was 2.21 degrees greater (95% CI -3.59 to 8.01 degrees) than in the no splint groups. Mean total active flexion in the splint groups was 8.42 degrees less (95% CI 1.78 to 15.07 degrees) than in the no splint groups. Currently, insufficient evidence is available to show the relative superiority of different surgical procedures (needle fasciotomy vs fasciectomy, or interposition firebreak skin grafting vs z-plasty closure of fasciectomy). Low-quality evidence suggests that postoperative splinting may not improve outcomes and may impair outcomes by reducing active flexion. Further trials on this topic are urgently required. | After searching for all relevant studies up to May 2015, we found 13 studies (14 articles) that met our inclusion criteria. However, only three compared different operation types. The others compared aspects of one operation type. One study presented early and late outcomes. What happens to people with Dupuytren’s disease up to five weeks after needle fasciotomy compared with fasciectomy? • Hand function may be slightly better after needle fasciotomy than after fasciectomy (low-quality evidence). • People who have had needle fasciotomy may be more satisfied than those who have had fasciectomy (low-quality evidence). • Fasciectomy probably straightens fingers better than needle fasciotomy in people with advanced disease, but probably no difference is apparent in people with milder disease (low-quality evidence). • A feeling of tingling in the fingers is probably more common after fasciectomy than after needle fasciotomy during the first week after treatment (low-quality evidence). What happens to people with Dupuytren’s disease five years after needle fasciotomy compared with fasciectomy? • Satisfaction may be better after fasciectomy than after needle fasciotomy (low-quality evidence). • Recurrence may be more common after needle fasciotomy than after fasciectomy (low-quality evidence). What happens to people with Dupuytren’s disease up to 36 months after z-plasty closure of a limited fasciectomy compared with use of small ‘firebreak’ skin grafts (a form of dermofasciectomy)? • Little or no difference in outcomes is likely between patients who had z-plasty and those who had small skin grafts, although skin graft procedures take longer to perform (low-quality evidence). What happens to people with Dupuytren’s disease who wear a splint at night after surgery? • Wearing a splint at night after surgery probably does not help to straighten fingers nor to improve hand function, and it may slightly worsen the patient's ability to make a full fist (low-quality evidence). Reporting of complications was variable. We often do not have precise information about side effects and complications, particularly rare but serious side effects. Side effects may include altered feeling in the fingers or reduced ability to make a full fist. Rare complications may include injury to the tendons that pull the fingers into the palm. | 10.1002/14651858.CD010143.pub2 | [
"After searching for all relevant studies up to May 2015, we found 13 studies (14 articles) that met our inclusion criteria. However, only three compared different operation types. The others compared aspects of one operation type. One study presented early and late outcomes. What happens to people with Dupuytren’s disease up to five weeks after needle fasciotomy compared with fasciectomy? • Hand function may be slightly better after needle fasciotomy than after fasciectomy (low-quality evidence). • People who have had needle fasciotomy may be more satisfied than those who have had fasciectomy (low-quality evidence). • Fasciectomy probably straightens fingers better than needle fasciotomy in people with advanced disease, but probably no difference is apparent in people with milder disease (low-quality evidence). • A feeling of tingling in the fingers is probably more common after fasciectomy than after needle fasciotomy during the first week after treatment (low-quality evidence). What happens to people with Dupuytren’s disease five years after needle fasciotomy compared with fasciectomy? • Satisfaction may be better after fasciectomy than after needle fasciotomy (low-quality evidence). • Recurrence may be more common after needle fasciotomy than after fasciectomy (low-quality evidence). What happens to people with Dupuytren’s disease up to 36 months after z-plasty closure of a limited fasciectomy compared with use of small ‘firebreak’ skin grafts (a form of dermofasciectomy)? • Little or no difference in outcomes is likely between patients who had z-plasty and those who had small skin grafts, although skin graft procedures take longer to perform (low-quality evidence). What happens to people with Dupuytren’s disease who wear a splint at night after surgery? • Wearing a splint at night after surgery probably does not help to straighten fingers nor to improve hand function, and it may slightly worsen the patient's ability to make a full fist (low-quality evidence). Reporting of complications was variable. We often do not have precise information about side effects and complications, particularly rare but serious side effects. Side effects may include altered feeling in the fingers or reduced ability to make a full fist. Rare complications may include injury to the tendons that pull the fingers into the palm."
] |
cochrane-simplification-train-1124 | cochrane-simplification-train-1124 | Overall, we included 15 reviews published in the Cochrane Library, comprising 164 randomised controlled trials (RCTs) and four controlled clinical trials, with a total of 10,396 participants. The included reviews evaluated a wide range of rehabilitation interventions, including: physical activity and exercise therapy, hyperbaric oxygen therapy (HBOT), whole-body vibration, occupational therapy, cognitive and psychological interventions, nutritional and dietary supplements, vocational rehabilitation, information provision, telerehabilitation, and interventions for the management of spasticity. We assessed all reviews to be of high to moderate methodological quality, based on R-AMSTAR criteria. Moderate-quality evidence suggested that physical therapeutic modalities (exercise and physical activities) improved functional outcomes (mobility, muscular strength), reduced impairment (fatigue), and improved participation (quality of life). Moderate-quality evidence suggested that inpatient or outpatient multidisciplinary rehabilitation programmes led to longer-term gains at the levels of activity and participation, and interventions that provided information improved patient knowledge. Low-qualitty evidence suggested that neuropsychological interventions, symptom-management programmes (spasticity), whole body vibration, and telerehabilitation improved some patient outcomes. Evidence for other rehabilitation modalities was inconclusive, due to lack of robust studies. The evidence suggests that regular specialist evaluation and follow-up to assess the needs of patients with all types of MS for appropriate rehabilitation interventions may be of benefit, although the certainty of evidence varies across the different types of interventions evaluated by the reviews. Structured, multidisciplinary rehabilitation programmes and physical therapy (exercise or physical activities) can improve functional outcomes (mobility, muscle strength, aerobic capacity), and quality of life. Overall, the evidence for many rehabilitation interventions should be interpreted cautiously, as the majority of included reviews did not include data from current studies. More studies, with appropriate design, which report the type and intensity of modalities and their cost-effectiveness are needed to address the current gaps in knowledge. | We searched for all published Cochrane Reviews of MS clinical trials that evaluated the effectiveness of rehabilitation interventions compared with various control groups (no intervention or different type of intervention). We evaluated all relevant reviews, and summarised the findings. We included a total of 15 Cochrane Reviews, which included 168 clinical trials, and a total of 10,396 people with MS. These good-quality reviews evaluated a range of rehabilitation interventions, including: physical activity and exercise therapy, hyperbaric oxygen therapy, whole-body vibration, occupational therapy, cognitive and psychological interventions, nutritional and dietary supplements, vocational rehabilitation, information provision, telerehabilitation, and interventions for the management of spasticity. The findings showed some benefits for people with MS who participated in exercise and physical activity programmes or multidisciplinary rehabilitation programmes (where the intervention is provided by a team of health professionals from different professions). They found improvements in everyday activities, function, and health-related quality of life, compared with those who were not offered rehabilitation. Evidence for other rehabilitation modalities was limited, due to lack of good-quality studies. More research is needed to determine whether various types of rehabilitation modalities are effective in reducing disability in people with MS. | 10.1002/14651858.CD012732.pub2 | [
"We searched for all published Cochrane Reviews of MS clinical trials that evaluated the effectiveness of rehabilitation interventions compared with various control groups (no intervention or different type of intervention). We evaluated all relevant reviews, and summarised the findings. We included a total of 15 Cochrane Reviews, which included 168 clinical trials, and a total of 10,396 people with MS. These good-quality reviews evaluated a range of rehabilitation interventions, including: physical activity and exercise therapy, hyperbaric oxygen therapy, whole-body vibration, occupational therapy, cognitive and psychological interventions, nutritional and dietary supplements, vocational rehabilitation, information provision, telerehabilitation, and interventions for the management of spasticity. The findings showed some benefits for people with MS who participated in exercise and physical activity programmes or multidisciplinary rehabilitation programmes (where the intervention is provided by a team of health professionals from different professions). They found improvements in everyday activities, function, and health-related quality of life, compared with those who were not offered rehabilitation. Evidence for other rehabilitation modalities was limited, due to lack of good-quality studies. More research is needed to determine whether various types of rehabilitation modalities are effective in reducing disability in people with MS."
] |
cochrane-simplification-train-1125 | cochrane-simplification-train-1125 | Due to the small numbers of trials in each category, the limited quantitative data available and the marked differences between trials in terms of participants, interventions and outcome measurement, we felt that pooling of the results was inappropriate. We included 29 trials (19 in adults, 10 in children) involving 4835 people (3799 adults and 1036 children). All studies were placebo-controlled RCTs. However, assessment of the risk of bias of the included studies was limited by poor reporting, particularly for the earlier studies. In the adult studies, six trials compared antitussives with placebo and had variable results. Three trials compared the expectorant guaifenesin with placebo; one indicated significant benefit, whereas the other two did not. One trial found that a mucolytic reduced cough frequency and symptom scores. Two studies examined antihistamine-decongestant combinations and found conflicting results. Four studies compared other combinations of drugs with placebo and indicated some benefit in reducing cough symptoms. Three trials found that antihistamines were no more effective than placebo in relieving cough symptoms. In the child studies, antitussives (data from three studies), antihistamines (data from three studies), antihistamine-decongestants (two studies) and antitussive/bronchodilator combinations (one study) were no more effective than placebo. No studies using expectorants met our inclusion criteria. The results of one trial favoured active treatment with mucolytics over placebo. One trial tested two paediatric cough syrups and both preparations showed a 'satisfactory response' in 46% and 56% of children compared to 21% of children in the placebo group. One new trial indicated that three types of honey were more effective than placebo over a three-day period. Twenty-one studies reported adverse effects. There was a wide range across studies, with higher numbers of adverse effects in participants taking preparations containing antihistamines and dextromethorphan. The results of this review have to be interpreted with caution because the number of studies in each category of cough preparations was small. Availability, dosing and duration of use of over-the-counter cough medicines vary significantly in different countries. Many studies were poorly reported making assessment of risk of bias difficult and studies were also very different from each other, making evaluation of overall efficacy difficult. There is no good evidence for or against the effectiveness of OTC medicines in acute cough. This should be taken into account when considering prescribing antihistamines and centrally active antitussive agents in children; drugs that are known to have the potential to cause serious harm. | We identified a broad range of studies of different types of preparations used at different dosages in both adults and children. The evidence is current up to March 2014. We found no good evidence for or against the effectiveness of OTC medications in acute cough. Nineteen studies reported adverse effects of these medications and described infrequent, mainly minor side effects such as nausea, vomiting, headache and drowsiness. The results of this review have to be interpreted with caution because the number of studies in each category of cough preparations was small. Many studies were poorly reported making assessment of risk of bias difficult. While all studies were placebo-controlled randomised controlled trials only a minority reported their methods of allocation and randomisation and there was lack of reporting of blinding of outcome assessors and whether cough outcome measures were validated. In addition, studies supported by pharmaceutical companies or other providers were more likely to have positive results. Studies were very different from each other in terms of treatment types, treatment duration and outcomes measured, making evaluation of overall effectiveness of OTC cough medicines difficult. | 10.1002/14651858.CD001831.pub5 | [
"We identified a broad range of studies of different types of preparations used at different dosages in both adults and children. The evidence is current up to March 2014. We found no good evidence for or against the effectiveness of OTC medications in acute cough. Nineteen studies reported adverse effects of these medications and described infrequent, mainly minor side effects such as nausea, vomiting, headache and drowsiness. The results of this review have to be interpreted with caution because the number of studies in each category of cough preparations was small. Many studies were poorly reported making assessment of risk of bias difficult. While all studies were placebo-controlled randomised controlled trials only a minority reported their methods of allocation and randomisation and there was lack of reporting of blinding of outcome assessors and whether cough outcome measures were validated. In addition, studies supported by pharmaceutical companies or other providers were more likely to have positive results. Studies were very different from each other in terms of treatment types, treatment duration and outcomes measured, making evaluation of overall effectiveness of OTC cough medicines difficult."
] |
cochrane-simplification-train-1126 | cochrane-simplification-train-1126 | Only one study (DiSessa 1981) was eligible. This study compared low dose dopamine at 2.5 mcg/kg/min with placebo (dextrose in water). This study enrolled 14 term infants with a 5 minute Apgar <6 and a systolic BP >=50 mmHg at a mean of 10 hours age. Seven infants only were randomised to treatment with dopamine and seven to receive placebo. No significant differences between these two groups were found for mortality or long term neurodevelopmental outcome. Length of hospitalisation was not significantly different between the two groups. No study was found that examined the effect of dopamine in infants with evidence of cardiovascular compromise, nor were any studies identified in which dopamine was compared to other inotropic agents for term infants with suspected asphyxia. There is currently insufficient evidence from randomised controlled trials that the use of dopamine in term infants with suspected perinatal asphyxia improves mortality or long-term neurodevelopmental outcome. The question of whether dopamine improves outcome for term infants with suspected perinatal asphyxia has not been answered. Further research is required to determine whether or not the use of dopamine improves mortality and long-term morbidity for these infants and if so, issues such as which infants, at what dose and with what co-interventions should be addressed. | The review authors searched the medical literature and were able to find only one small randomised controlled trial. The 14 infants included in the trial had a birthweight over 2000 g and were enrolled at a mean age of 10 hours. They had received ventilatory support and fluid expansion after birth. Infants treated with low dose dopamine (2.5 microg/kg/min) did not differ from the infants receiving placebo (dextrose water) in the number who died before discharge from hospital. Neurodevelopmental disability was similar in both groups, in all infants randomised and in survivors. The timing of assessments was variable. These findings are limited with only one small study in which three of 12 survivors were lost to follow up. | 10.1002/14651858.CD003484 | [
"The review authors searched the medical literature and were able to find only one small randomised controlled trial. The 14 infants included in the trial had a birthweight over 2000 g and were enrolled at a mean age of 10 hours. They had received ventilatory support and fluid expansion after birth. Infants treated with low dose dopamine (2.5 microg/kg/min) did not differ from the infants receiving placebo (dextrose water) in the number who died before discharge from hospital. Neurodevelopmental disability was similar in both groups, in all infants randomised and in survivors. The timing of assessments was variable. These findings are limited with only one small study in which three of 12 survivors were lost to follow up."
] |
cochrane-simplification-train-1127 | cochrane-simplification-train-1127 | No new trials were identified. This review includes two RCTs with low risk of bias that compared urinary human chorionic gonadotrophin (hCG) versus no treatment in anovulatory women receiving clomiphene citrate. Urinary hCG did not result in an increase in live birth rate over no hCG (OR 0.97, 95% CI 0.52 to 1.83; two trials, 305 participants, I2 = 16%; low-quality evidence), but very serious imprecision around the effect estimate reduces our confidence in the apparent lack of effect of hCG as an ovulation trigger in clomiphene-induced cycles in anovulatory women. Among this review's secondary outcomes, urinary hCG may not increase ovulation rate (OR 0.99, 95% CI 0.36 to 2.77; two trials, 305 participants, I2 = 55%; low-quality evidence), clinical pregnancy rate (OR 1.02, 95% CI 0.56 to 1.89; two trials, 305 participants, I2 = 35%; low-quality evidence) or miscarriage rate in pregnant women (OR 1.19, 95% CI 0.17 to 8.23; two trials, 54 participants, I2 = 0%; low-quality evidence). Multiple pregnancies and preterm deliveries were uncommon, and ovarian hyperstimulation syndrome, adverse events and deaths were not reported as outcomes in either trial. We found no trials evaluating other ovulation triggers. Evidence is inadequate to recommend or refute the use of urinary hCG as an ovulation trigger in anovulatory women treated with clomiphene citrate. We found no trials evaluating the use of ovulation triggers in anovulatory women treated with other ovulation-inducing agents. | The two studies included in this review randomly assigned 305 women being treated with clomiphene citrate to help eggs to develop to additionally receive a medicine (urinary hCG) to trigger their release or to receive no additional treatment. We found no trials comparing other ovulation triggers given with other medicines used for ovulation induction. The evidence is current to November 2013. Giving women on clomiphene citrate additional urinary hCG may not increase their chances of delivering live babies, ovulating or becoming pregnant. Multiple pregnancies, miscarriages and preterm deliveries were not more common with or without an ovulation trigger. No serious adverse events were reported in either study. We cannot be certain whether ovulation triggers are better or worse than no ovulation triggers in women undergoing ovulation induction because not enough women were included in the two trials for definite results to be obtained. Larger trials in women undergoing ovulation induction that compare different ovulation triggers versus no additional treatment are needed. | 10.1002/14651858.CD006900.pub3 | [
"The two studies included in this review randomly assigned 305 women being treated with clomiphene citrate to help eggs to develop to additionally receive a medicine (urinary hCG) to trigger their release or to receive no additional treatment. We found no trials comparing other ovulation triggers given with other medicines used for ovulation induction. The evidence is current to November 2013. Giving women on clomiphene citrate additional urinary hCG may not increase their chances of delivering live babies, ovulating or becoming pregnant. Multiple pregnancies, miscarriages and preterm deliveries were not more common with or without an ovulation trigger. No serious adverse events were reported in either study. We cannot be certain whether ovulation triggers are better or worse than no ovulation triggers in women undergoing ovulation induction because not enough women were included in the two trials for definite results to be obtained. Larger trials in women undergoing ovulation induction that compare different ovulation triggers versus no additional treatment are needed."
] |
cochrane-simplification-train-1128 | cochrane-simplification-train-1128 | Twelve studies conducted in China, including 762 children with nephrotic syndrome were identified. No studies were identified in adults. All studies compared one kind of prophylactic pharmacotherapy (intravenous immunoglobulin (IVIG), thymosin, oral transfer factor, mannan peptide tablet, Bacillus Calmette-Guerin (BCG) vaccine injection, polyvalent bacterial vaccine (Lantigen B) and two kinds of Chinese medicinal herbs: a compound of Chinese medicinal herbs (TIAOJINING) and Huangqi (astragalus) granules) plus baseline treatment with baseline treatment alone. No RCTs were identified comparing antibiotics, non-pharmacological prophylaxis, or pneumococcal vaccination. Four studies showed a significantly beneficial effect of IVIG on preventing nosocomial or unspecified infection in children with nephrotic syndrome (RR 0.47, 95% CI 0.31 to 0.73). Thymosin (RR 0.50, 95% CI 0.26 to 0.97), oral transfer factor (RR 0.51, 95% CI 0.35 to 0.73), BCG vaccine injection (RR 0.68, 95% CI 0.48 to 0.95), Huangqi granules (RR 0.62, 95% CI 0.47 to 0.83) and TIAOJINING (RR 0.59, 95% CI 0.43 to 0.81) were also effective in reducing the risk of infection in children with nephrotic syndrome. However mannan peptide tablet (RR 0.46, 95% CI 0.21 to 1.01) and polyvalent bacterial vaccine (RR 0.24, 95% CI 0.06 to1.00) were not superior to baseline treatment in reducing the risk of infection for nephrotic children. No serious adverse events were reported. IVIG, thymosin, oral transfer factor, BCG vaccine, Huangqi granules and TIAOJINING may have positive effects on the prevention of nosocomial or unspecified infection with no obvious serious adverse events in children with nephrotic syndrome. However the methodological quality of all studies was poor, the sample sizes small, and all studies were from China, and thus there is no strong evidence on the effectiveness of these interventions. | No studies on antibiotics, pneumococcal vaccination and any other non-drug prophylaxis were identified. This review found that intravenous immunoglobulin (IVIG), thymosin, oral transfer factor, Bacillus Calmette-Guerin (BCG) vaccine injection and two kinds of Chinese medicinal herbs (Huangqi granules and TIAOJINING) may help prevent infections in nephrotic children. These studies were methodologically poor. Currently there is no strong evidence for recommending any interventions for preventing infections in nephrotic syndrome. More research is needed. | 10.1002/14651858.CD003964.pub3 | [
"No studies on antibiotics, pneumococcal vaccination and any other non-drug prophylaxis were identified. This review found that intravenous immunoglobulin (IVIG), thymosin, oral transfer factor, Bacillus Calmette-Guerin (BCG) vaccine injection and two kinds of Chinese medicinal herbs (Huangqi granules and TIAOJINING) may help prevent infections in nephrotic children. These studies were methodologically poor. Currently there is no strong evidence for recommending any interventions for preventing infections in nephrotic syndrome. More research is needed."
] |
cochrane-simplification-train-1129 | cochrane-simplification-train-1129 | We included 7 RCTs, with a total of 249 participants, covering 6 treatments. Six of these RCTs tested the efficacy of one active intervention against placebo or another active intervention, while the other trial tested three active interventions against placebo. When compared to placebo in one trial, clobetasol propionate 0.05% was effective in treating genital lichen sclerosus in relation to the following outcomes: 'participant-rated improvement or remission of symptoms' (risk ratio (RR) 2.85, 95% confidence interval (CI) 1.45 to 5.61) and 'investigator-rated global degree of improvement' (standardised mean difference (SMD) 5.74, 95% CI 4.26 to 7.23). When mometasone furoate 0.05% was compared to placebo in another trial, there was a significant improvement in the 'investigator-rated change in clinical grade of phimosis' (SMD -1.04, 95% CI -1.77 to -0.31). Both trials found no significant differences in reported adverse drug reactions between the corticosteroid and placebo groups. The data from four trials found no significant benefit for topical testosterone, dihydrotestosterone, and progesterone. When used as maintenance therapy after an initial treatment with topical clobetasol propionate in another trial, topical testosterone worsened the symptoms (P < 0.05), but the placebo did not. One trial found no differences between pimecrolimus and clobetasol propionate in relieving symptoms through change in pruritus (itching) (SMD -0.33, 95% CI -0.99 to 0.33) and burning/pain (SMD 0.03, 95% CI -0.62 to 0.69). However, pimecrolimus was less effective than clobetasol propionate with regard to the 'investigator-rated global degree of improvement' (SMD -1.64, 95% CI -2.40 to -0.87). This trial found no significant differences in reported adverse drug reactions between the pimecrolimus and placebo groups. The current limited evidence demonstrates the efficacy of clobetasol propionate, mometasone furoate, and pimecrolimus in treating genital lichen sclerosus. Further RCTs are needed to determine the optimal potency and regimen of topical corticosteroids, examine other topical interventions, assess the duration of remission or prevention of flares, evaluate the reduction in the risk of genital squamous cell carcinoma or genital intraepithelial neoplasia, and examine the efficacy in improving the quality of the sex lives of people with this condition. | We included 7 trials, with a total of 249 participants, covering 6 treatments in this review. Topical clobetasol propionate and mometasone furoate were effective in treating genital lichen sclerosus. There was no substantial difference in the efficacy of relieving symptoms (e.g. itching and pain) between pimecrolimus cream and clobetasol propionate, but the former was less effective in improving gross appearance. More research is needed for a number of reasons: to decide the strength of steroids that should be used, as well as the frequency and length of application to the skin which gives the best results; to examine other skin treatments; to assess the long-term benefits of topical treatments with regard to relieving symptoms and reducing the risk of developing genital cancers; and to examine the benefits of treatments on the quality of the sex lives of people with this condition. | 10.1002/14651858.CD008240.pub2 | [
"We included 7 trials, with a total of 249 participants, covering 6 treatments in this review. Topical clobetasol propionate and mometasone furoate were effective in treating genital lichen sclerosus. There was no substantial difference in the efficacy of relieving symptoms (e.g. itching and pain) between pimecrolimus cream and clobetasol propionate, but the former was less effective in improving gross appearance. More research is needed for a number of reasons: to decide the strength of steroids that should be used, as well as the frequency and length of application to the skin which gives the best results; to examine other skin treatments; to assess the long-term benefits of topical treatments with regard to relieving symptoms and reducing the risk of developing genital cancers; and to examine the benefits of treatments on the quality of the sex lives of people with this condition."
] |
cochrane-simplification-train-1130 | cochrane-simplification-train-1130 | We identified 28 RCTs (3497 participants) with 1773 mortality outcomes. Six different vasopressors, given alone or in combination, were studied in 12 different comparisons. All 28 studies reported mortality outcomes; 12 studies reported length of stay. Investigators reported other morbidity outcomes in a variable and heterogeneous way. No data were available on quality of life nor on anxiety and depression outcomes. We classified 11 studies as having low risk of bias for the primary outcome of mortality; only four studies fulfilled all trial quality criteria. In summary, researchers reported no differences in total mortality in any comparisons of different vasopressors or combinations in any of the pre-defined analyses (evidence quality ranging from high to very low). More arrhythmias were observed in participants treated with dopamine than in those treated with norepinephrine (high-quality evidence). These findings were consistent among the few large studies and among studies with different levels of within-study bias risk. We found no evidence of substantial differences in total mortality between several vasopressors. Dopamine increases the risk of arrhythmia compared with norepinephrine and might increase mortality. Otherwise, evidence of any other differences between any of the six vasopressors examined is insufficient. We identified low risk of bias and high-quality evidence for the comparison of norepinephrine versus dopamine and moderate to very low-quality evidence for all other comparisons, mainly because single comparisons occasionally were based on only a few participants. Increasing evidence indicates that the treatment goals most often employed are of limited clinical value. Our findings suggest that major changes in clinical practice are not needed, but that selection of vasopressors could be better individualised and could be based on clinical variables reflecting hypoperfusion. | Review authors identified 28 randomized controlled trials involving 3497 critically ill patients with circulatory failure, among whom 1773 died. Patients were followed up to one year. The following drugs, given alone or in combination, were studied in 12 different comparisons: dopamine, norepinephrine, epinephrine, phenylephrine, vasopressin, and terlipressin. In summary, researchers found no significant differences in risk of dying in any comparisons of different drugs given alone or in combination when latest reported death was considered. Disturbances in the rhythm of the heart were observed more frequently in people treated with dopamine than in those treated with norepinephrine. The quality of the evidence was high for the comparison of norepinephrine and dopamine, and was very low to moderate for the other comparisons. Findings were consistent among the few large studies and studies of different quality. | 10.1002/14651858.CD003709.pub4 | [
"Review authors identified 28 randomized controlled trials involving 3497 critically ill patients with circulatory failure, among whom 1773 died. Patients were followed up to one year. The following drugs, given alone or in combination, were studied in 12 different comparisons: dopamine, norepinephrine, epinephrine, phenylephrine, vasopressin, and terlipressin. In summary, researchers found no significant differences in risk of dying in any comparisons of different drugs given alone or in combination when latest reported death was considered. Disturbances in the rhythm of the heart were observed more frequently in people treated with dopamine than in those treated with norepinephrine. The quality of the evidence was high for the comparison of norepinephrine and dopamine, and was very low to moderate for the other comparisons. Findings were consistent among the few large studies and studies of different quality."
] |
cochrane-simplification-train-1131 | cochrane-simplification-train-1131 | Nine trials were included in the review but only 3 trials could be included in the meta-analysis. Sufficient data to include the other trials in the meta-analysis could not be obtained. From this limited analysis it appears that TENS produced a statistically significant improvement directly after treatment in: delayed recall of 8 words in one trial, face recognition in two trials and motivation in one trial. However, no effect of TENS was found on any of the many other neuropsychological and behavioural measures evaluated either directly after TENS treatment or 6 weeks after treatment was completed. Although a number of studies suggest that TENS may produce short lived improvements in some neuropsychological or behavioural aspects of dementia, the limited presentation and availability of data from these studies does not allow definite conclusions on the possible benefits of this intervention. Since most of the currently published studies are well designed, although the numbers of subjects in each study is small, analysis of the complete original data from these and/or future studies may allow more definitive conclusions to be drawn. | Transcutaneous electrical nerve stimulation (TENS) is rarely used for the treatment of dementia but has been studied in a number of randomized controlled trials. Although the available data suggests TENS may be beneficial for some neuropsychological and/or behavioural aspects of dementia insufficient data was available to these reviewers for definitive conclusions to be drawn. | 10.1002/14651858.CD004032 | [
"Transcutaneous electrical nerve stimulation (TENS) is rarely used for the treatment of dementia but has been studied in a number of randomized controlled trials. Although the available data suggests TENS may be beneficial for some neuropsychological and/or behavioural aspects of dementia insufficient data was available to these reviewers for definitive conclusions to be drawn."
] |
cochrane-simplification-train-1132 | cochrane-simplification-train-1132 | Forty-one trials involving over 5000 patients were included. Variation in study design and quality made synthesis of the data problematic. Allocation concealment was adequate in only two trials. Most data were from areas of multidrug resistant falciparum malaria in South-East Asia. Compared with standard antimalarial treatments, artemisinin drugs showed fast parasite clearance and high cure rates at follow-up, provided the duration of treatment with artemisinin drugs was adequate. Combination with mefloquine improved sustained parasite clearance and was effective in multidrug resistant areas. When doses were adequate, the combination shortened the duration of treatment. We found no evidence that artemisinin drugs are more harmful than standard treatment drugs over a typical trial period of 28 days. The evidence suggests that artemisinin drugs are effective and safe for treating uncomplicated malaria. There is no evidence from randomised trials that one artemisinin derivative is better than the others. In areas where there is mefloquine resistance, combination therapy with an artemisinin derivative appears to improve sustained parasite clearance compared with either drug alone. This review summarizes trials up to 1999. For the reasons in the 'What's new' section, this review will no longer be updated. | The review shows that artemisinin drugs clear malaria parasites from the blood more effectively than standard treatment drugs. In areas where malaria parasites are more resistant to existing drugs, such as South-East Asia, artemisinin drugs are not better at sustained parasite clearance than standard treatment with quinine or mefloquine. Combination treatment using an artemisinin drug together with the longer-acting antimalarial drug mefloquine improves sustained clearance of parasites, but mefloquine is associated with adverse effects. There are few studies on combination treatment with longer-acting antimalarial drugs that are safer than mefloquine. There is no evidence from trials that any of the several artemisinin derivatives is better than the others. | 10.1002/14651858.CD000256 | [
"The review shows that artemisinin drugs clear malaria parasites from the blood more effectively than standard treatment drugs. In areas where malaria parasites are more resistant to existing drugs, such as South-East Asia, artemisinin drugs are not better at sustained parasite clearance than standard treatment with quinine or mefloquine. Combination treatment using an artemisinin drug together with the longer-acting antimalarial drug mefloquine improves sustained clearance of parasites, but mefloquine is associated with adverse effects. There are few studies on combination treatment with longer-acting antimalarial drugs that are safer than mefloquine. There is no evidence from trials that any of the several artemisinin derivatives is better than the others."
] |
cochrane-simplification-train-1133 | cochrane-simplification-train-1133 | We included 23 RCTs (1513 participants randomised) examining the effect of dietary fibre. The risk of bias was unclear for most studies and studies had small sample sizes. Few studies had an intervention duration of longer than 12 weeks. There was a wide variety of fibre sources used, with little similarity between groups in the choice of intervention. None of the studies reported on mortality (total or cardiovascular) or cardiovascular events. Results on lipids suggest there is a significant beneficial effect of increased fibre on total cholesterol levels (17 trials (20 comparisons), 1067 participants randomised, mean difference -0.20 mmol/L, 95% CI -0.34 to -0.06), and LDL cholesterol levels (mean difference -0.14 mmol/L, 95% CI -0.22 to -0.06) but not on triglyceride levels (mean difference 0.00 mmol/L, 95% CI -0.04 to 0.05), and there was a very small but statistically significant decrease rather than increase in HDL levels with increased fibre intake (mean difference -0.03 mmol/L, 95% CI -0.06 to -0.01). Fewer studies (10 trials, 661 participants randomised) reported blood pressure outcomes where there is a significant effect of increased fibre consumption on diastolic blood pressure (mean difference -1.77 mmHg, 95% CI -2.61 to -0.92) whilst there is a reduction in systolic blood pressure with fibre but this does not reach statistical significance (mean difference -1.92 mmHg, 95% CI -4.02 to 0.19). There did not appear to be any subgroup effects by the nature of the type of intervention (fibre supplements or provision of foods/advice to increase fibre consumption) or the type of fibre (soluble/insoluble) although the number of studies contributing to each subgroup were small. All analyses need to be viewed with caution given the risks of bias observed for total cholesterol and the statistical heterogeneity observed for systolic blood pressure. Adverse events, where reported, appeared to mostly reflect mild to moderate gastrointestinal side-effects and these were generally reported more in the fibre intervention groups than the control groups. Studies were short term and therefore did not report on our primary outcomes, CVD clinical events. The pooled analyses for CVD risk factors suggest reductions in total cholesterol and LDL cholesterol with increased fibre intake, and reductions in diastolic blood pressure. There were no obvious effects of subgroup analyses by type of intervention or fibre type but the number of studies included in each of these analyses were small. Risk of bias was unclear in the majority of studies and high for some quality domains so results need to be interpreted cautiously. There is a need for longer term, well-conducted RCTs to determine the effects of fibre type (soluble versus insoluble) and administration (supplements versus foods) on CVD events and risk factors for the primary prevention of CVD. | We searched scientific databases for randomised controlled trials (clinical trials where people are allocated at random to one of two or more treatments) looking at the effects of dietary fibre intake in healthy adults or those at high risk of developing CVD. We did not include people who already had CVD (e.g. heart attacks and strokes). The evidence is current to January 2015. Twenty three trials fulfilled our inclusion criteria. All of the trials were short term and so could not examine the effect of fibre intake on CVD events. All of the trials examined the effects of fibre intake on lipid levels (lipids are fat-like substances, including cholesterol found in the blood), blood pressure or both. Pooling the results showed a beneficial reduction in total cholesterol and LDL cholesterol (sometimes called 'bad' cholesterol), and diastolic blood pressure with increasing fibre intake. There were no clear patterns for the type of fibre used (soluble or insoluble fibre) or the way in which fibre was provided (via supplements or food stuffs) but their were few studies in each group so results are uncertain. Overall the risk of bias was unclear with few studies judged to be at low risk of bias (so less chance of arriving at the wrong conclusions because of favouritism by the participants or researchers), and for some there was a high risk of bias for some of the quality criteria. The results of this review need to be interpreted cautiously bearing this in mind. There is a need for longer-term well-conducted RCTs to determine the effects of fibre intake on CVD events and to further explore effects by the type of fibre and the way in which increased fibre is provided. | 10.1002/14651858.CD011472.pub2 | [
"We searched scientific databases for randomised controlled trials (clinical trials where people are allocated at random to one of two or more treatments) looking at the effects of dietary fibre intake in healthy adults or those at high risk of developing CVD. We did not include people who already had CVD (e.g. heart attacks and strokes). The evidence is current to January 2015. Twenty three trials fulfilled our inclusion criteria. All of the trials were short term and so could not examine the effect of fibre intake on CVD events. All of the trials examined the effects of fibre intake on lipid levels (lipids are fat-like substances, including cholesterol found in the blood), blood pressure or both. Pooling the results showed a beneficial reduction in total cholesterol and LDL cholesterol (sometimes called 'bad' cholesterol), and diastolic blood pressure with increasing fibre intake. There were no clear patterns for the type of fibre used (soluble or insoluble fibre) or the way in which fibre was provided (via supplements or food stuffs) but their were few studies in each group so results are uncertain. Overall the risk of bias was unclear with few studies judged to be at low risk of bias (so less chance of arriving at the wrong conclusions because of favouritism by the participants or researchers), and for some there was a high risk of bias for some of the quality criteria. The results of this review need to be interpreted cautiously bearing this in mind. There is a need for longer-term well-conducted RCTs to determine the effects of fibre intake on CVD events and to further explore effects by the type of fibre and the way in which increased fibre is provided."
] |
cochrane-simplification-train-1134 | cochrane-simplification-train-1134 | Of 56 trials identified, none reported data on violent injuries. Aggressive behaviour was significantly reduced in intervention groups compared to no intervention groups immediately post intervention in 34 trials with data, (Standardised Mean Difference (SMD) = -0.41; 95% confidence interval (CI) -0.56 to -0.26). This effect was maintained in the seven studies reporting 12 month follow-up (SMD = -0.40, (95% CI -0.73 to -0.06)). School or agency disciplinary actions in response to aggressive behaviour were reduced in intervention groups for nine trials with data, SMD = -0.48; 95% CI -1.16 to 0.19, although this difference may have been due to chance and was not maintained, based on two studies reporting follow-up to two to four months (SMD = 0.03; 95% CI -0.42 to 0.47). Subgroup analyses suggested that interventions designed to improve relationship or social skills may be more effective than interventions designed to teach skills of non-response to provocative situations, but that benefits were similar when delivered to children in primary versus secondary school, and to groups of mixed sex versus boys alone. School-based secondary prevention programmes to reduce aggressive behaviour appear to produce improvements in behaviour greater than would have been expected by chance. Benefits can be achieved in both primary and secondary school age groups and in both mixed sex groups and boys-only groups. Further research is required to establish whether such programmes reduce the incidence of violent injuries or if the benefits identified can be maintained beyond 12 months. | The authors found 56 studies; the overall findings show that school-based secondary prevention programmes aimed at reducing aggressive behaviour do appear to produce improvements in behaviour. The improvements can be achieved in both primary and secondary school age groups and in both mixed sex groups and boy-only groups. Further research is needed to investigate if the apparent beneficial programmes effects can be realised outside the experimental setting and in settings other than schools. None of the studies collected data on violent injury, so we can not be certain of the extent to which an improvement in behaviour translates to an actual injury reduction. In addition, more research is needed to determine if the beneficial effects can be maintained over time, and if the benefits can be justified against the costs of implementing such programmes. | 10.1002/14651858.CD004606.pub2 | [
"The authors found 56 studies; the overall findings show that school-based secondary prevention programmes aimed at reducing aggressive behaviour do appear to produce improvements in behaviour. The improvements can be achieved in both primary and secondary school age groups and in both mixed sex groups and boy-only groups. Further research is needed to investigate if the apparent beneficial programmes effects can be realised outside the experimental setting and in settings other than schools. None of the studies collected data on violent injury, so we can not be certain of the extent to which an improvement in behaviour translates to an actual injury reduction. In addition, more research is needed to determine if the beneficial effects can be maintained over time, and if the benefits can be justified against the costs of implementing such programmes."
] |
cochrane-simplification-train-1135 | cochrane-simplification-train-1135 | We included one Canadian trial of 180 women, recruited between 20 to 32 weeks' gestation, who had been diagnosed with GDM. Data from 171 of the 180 women were published as a conference abstract and no full report has been identified. The overall risk of bias of the single included study was judged to be unclear. The included trial did not report on any of this review's primary outcomes. For the mother, these were hypertension disorders of pregnancy or subsequent development of type 2 diabetes. For the infant, our primary outcomes were (perinatal (fetal and neonatal) mortality; large-for-gestational age; composite of death or severe morbidity or later childhood neurosensory disability). The trial did report data relating to some of this review's secondary outcomes. There was no clear difference in caesarean section rates for women assigned to using strict glycaemic targets (pre-prandial 5.0 mmol/L (90 mg/L) and at one-hour postprandial 6.7 mmol/L (120 mg/dL)) (28/85, 33%) when compared with women assigned to using liberal glycaemic targets (pre-prandial 5.8 mmol/L (103 mg/dL) and at one-hour postprandial 7.8 mmol/L (140 mg/dL)) (21/86, 24%) (risk ratio (RR) 1.35, 95% confidence interval (CI) 0.83 to 2.18, one trial, 171 women; very low quality). Using the GRADE approach, we found the quality of the evidence to bevery low for caesarean section due to poor reporting of risk of bias, imprecision and publication bias. Strict glycaemic targets were associated with an increase in the use of pharmacological therapy (identified as the use of insulin in this study) (33/85; 39%) compared with liberal glycaemic targets (18/86; 21%) (RR 1.85, 95% CI 1.14 to 3.03; one trial, 171 women). CIs are wide suggesting imprecision and caution is required when interpreting the data. No other secondary maternal outcome data relevant to this review were reported. For the infant, there were no clear differences between the groups of women receiving strict and liberal glycaemic targets for macrosomia (birthweight greater than 4000 g) (RR 1.35, 95% CI 0.31 to 5.85, one trial, 171 babies); small-for-gestational age (RR 1.12, 95% CI 0.48 to 2.63, one trial, 171 babies); birthweight (mean difference (MD) -92.00 g, 95% CI -241.97 to 57.97, one trial, 171 babies) or gestational age (MD -0.30 weeks, 95% CI -0.73 to 0.13, one trial, 171 babies). Adverse effects data were not reported. No other secondary neonatal outcomes relevant to this review were reported. This review is based on a single study (involving 180 women) with an unclear risk of bias. The trial (which was only reported in a conference abstract) did not provide data for any of this review's primary outcomes but did provide data for a limited number of our secondary outcomes. There is insufficient evidence to guide clinical practice for targets for glycaemic control for women with GDM to minimise adverse effects on maternal and fetal health. Glycaemic target recommendations from international professional organisations for maternal glycaemic control vary widely and are reliant on consensus given the lack of high-quality evidence. Further high-quality trials are needed, and these should compare different glycaemic targets for guiding treatment of women with GDM, assess both short-term and long-term health outcomes for women and their babies, include women's experiences and assess health services costs. Four studies are ongoing. | We searched for evidence on 31 January 2016 and found one small randomised controlled trial (abstract only) that was of poor quality and involved 180 women from Canada.The trial compared two blood sugar ranges, one strict the other more liberal, and reported a very few health outcomes for the pregnant woman and her baby. The trial did not provide any data for this review's main outcomes. For the woman, these related to the development of high blood pressure and protein in the urine during pregnancy, developing type 2 diabetes. For the baby, these outcomes related to death of the baby, increased birthweight, increased risk of birth trauma because of their size, and disability. More women were on insulin in the strictly controlled group (but this result is based on very low quality evidence). No clear differences were reported for caesarian section rates. No other secondary outcome data for women with GDM relevant to this review were reported. No differences were reported for the number of babies that had a birthweight greater than 4000 g or were small-for-gestational age. No other secondary outcomes for the babies relevant to this review were reported.The study did not report on adverse events. This review found that there is not yet enough evidence from randomised controlled trials to determine the best blood sugar range for improving health for pregnant women with GDM and their babies. Four studies are ongoing but not yet complete. More high-quality studies are needed that compare different targets for blood sugar levels and assess both short-term and long-term health outcomes for women and their babies to guide treatment. Studies should include women's experiences and assess health services costs. | 10.1002/14651858.CD011624.pub2 | [
"We searched for evidence on 31 January 2016 and found one small randomised controlled trial (abstract only) that was of poor quality and involved 180 women from Canada.The trial compared two blood sugar ranges, one strict the other more liberal, and reported a very few health outcomes for the pregnant woman and her baby. The trial did not provide any data for this review's main outcomes. For the woman, these related to the development of high blood pressure and protein in the urine during pregnancy, developing type 2 diabetes. For the baby, these outcomes related to death of the baby, increased birthweight, increased risk of birth trauma because of their size, and disability. More women were on insulin in the strictly controlled group (but this result is based on very low quality evidence). No clear differences were reported for caesarian section rates. No other secondary outcome data for women with GDM relevant to this review were reported. No differences were reported for the number of babies that had a birthweight greater than 4000 g or were small-for-gestational age. No other secondary outcomes for the babies relevant to this review were reported.The study did not report on adverse events. This review found that there is not yet enough evidence from randomised controlled trials to determine the best blood sugar range for improving health for pregnant women with GDM and their babies. Four studies are ongoing but not yet complete. More high-quality studies are needed that compare different targets for blood sugar levels and assess both short-term and long-term health outcomes for women and their babies to guide treatment. Studies should include women's experiences and assess health services costs."
] |
cochrane-simplification-train-1136 | cochrane-simplification-train-1136 | The 32 eligible studies included one randomized controlled trial, eight controlled before-after studies, 14 controlled ITS studies, six ITS studies, and three studies with both ITS and controlled before-after analyses. Most interventions targeted only alcohol-impaired driving (69%) and included additional interventions such as media campaigns or special training for police officers (91%). Only two studies reported sufficient information to assess study quality completely. Two-thirds of studies were scored 'not adequate' on at least one feature. Five of six studies evaluating traffic fatalities reported reductions with the intervention, but differences were statistically significant in only one study. Effects of intervention on traffic injuries were inconsistent in the six studies evaluating this outcome, and no results were statistically significant. All four controlled studies evaluating fatal crashes reported reductions with the intervention, which were statistically significant in one study. All 12 controlled studies assessing injury crashes reported greater reductions with the intervention, though effects were minimal or not significant in several studies. ITS studies showed less consistent effects on fatal crashes (three studies) and injury crashes (four studies), and effect estimates were typically imprecise. Thirteen of 20 studies showed reductions in total crashes and about two-thirds of these were statistically significant. Studies examining increased police patrol programs were generally consistent in reporting beneficial effects on traffic crashes and fatalities, but study quality and reporting were often poor. Methodological limitations included inadequate sample size, dissimilar baseline measures, contamination, and inadequate data analysis. Thus existing evidence, although supportive, does not firmly establish whether increased police patrols, implemented with or without other intervention elements, reduce the adverse consequences of alcohol-impaired driving. | We found 32 studies that tested the effects of increased police patrols on traffic deaths, injuries, and crashes. There was one randomized controlled trial and no quasi-randomized controlled trials. Almost all of the programs included additional interventions like community information programs, media campaigns, and special training for police officers. Most studies found that increased police patrols reduced traffic crashes and fatalities. Evidence for the effect on traffic injuries was less consistent. The detail provided on the methodology of included studies was almost uniformly poor. When this information was reported, the methodological quality was often weak. Therefore, the available evidence does not firmly establish that increased police patrols reduce the adverse consequences of alcohol-impaired driving. Good quality controlled studies with adequate sample size are needed to evaluate increased patrols. Also needed are studies assessing the cost-effectiveness of this intervention. | 10.1002/14651858.CD005242.pub2 | [
"We found 32 studies that tested the effects of increased police patrols on traffic deaths, injuries, and crashes. There was one randomized controlled trial and no quasi-randomized controlled trials. Almost all of the programs included additional interventions like community information programs, media campaigns, and special training for police officers. Most studies found that increased police patrols reduced traffic crashes and fatalities. Evidence for the effect on traffic injuries was less consistent. The detail provided on the methodology of included studies was almost uniformly poor. When this information was reported, the methodological quality was often weak. Therefore, the available evidence does not firmly establish that increased police patrols reduce the adverse consequences of alcohol-impaired driving. Good quality controlled studies with adequate sample size are needed to evaluate increased patrols. Also needed are studies assessing the cost-effectiveness of this intervention."
] |
cochrane-simplification-train-1137 | cochrane-simplification-train-1137 | Six trials involving 610 patients were included. Trial quality was generally low. Four of the trials looked at the effect of tricyclic antidepressants on tinnitus, investigating 405 patients. One trial investigated the effect of a selective serotonin reuptake inhibitor (SSRI) in a group of 120 patients. One study investigated trazodone, an atypical antidepressant, versus placebo. Only the trial using the SSRI drug reached the highest quality standard. None of the other included trials met the highest quality standard, due to use of inadequate outcome measures, large drop-out rates or failure to separate the effects on tinnitus from the effects on symptoms of anxiety and depression. All the trials assessing tricyclic antidepressants suggested that there was a slight improvement in tinnitus but these effects may have been attributable to methodological bias. The trial that investigated the SSRI drug found no overall improvement in any of the validated outcome measures that were used in the study although there was possible benefit for a subgroup that received higher doses of the drug. This observation merits further investigation. In the trial investigating trazodone, the results showed an improvement in tinnitus intensity and in quality of life after treatment, but in neither case reached statistical significance. Reports of side effects including sedation, sexual dysfunction and dry mouth were common. There is as yet insufficient evidence to say that antidepressant drug therapy improves tinnitus. | Six studies involving a total of 610 patients matched the inclusion criteria for this review. Four evaluated three tricyclic antidepressant agents (amitriptyline, nortriptyline and trimipramine) for the treatment of tinnitus. These studies did not find enough evidence to prove the efficacy of these agents in the management of tinnitus. One study evaluated paroxetine, a selective serotonin reuptake inhibitor antidepressant, and one evaluated trazodone, an atypical antidepressant. Neither of these studies showed benefit of paroxetine or trazodone in the treatment of tinnitus. Side effects, though relatively minor, were common in all groups of antidepressants. Further research is required. | 10.1002/14651858.CD003853.pub3 | [
"Six studies involving a total of 610 patients matched the inclusion criteria for this review. Four evaluated three tricyclic antidepressant agents (amitriptyline, nortriptyline and trimipramine) for the treatment of tinnitus. These studies did not find enough evidence to prove the efficacy of these agents in the management of tinnitus. One study evaluated paroxetine, a selective serotonin reuptake inhibitor antidepressant, and one evaluated trazodone, an atypical antidepressant. Neither of these studies showed benefit of paroxetine or trazodone in the treatment of tinnitus. Side effects, though relatively minor, were common in all groups of antidepressants. Further research is required."
] |
cochrane-simplification-train-1138 | cochrane-simplification-train-1138 | We included five studies (535 participants) in the review: these compared hydrocolloids with basic wound contact dressings, foam dressings, alginate dressings and a topical treatment. Meta-analysis of two studies indicated no statistically significant difference in ulcer healing between fibrous-hydrocolloids and basic wound contact dressings: risk ratio 1.01 (95% CI 0.74 to 1.38). One of these studies found that a basic wound contact dressing was more cost-effective than a fibrous-hydrocolloid dressing. One study compared a hydrocolloid-matrix dressing with a foam dressing and found no statistically significant difference in the number of ulcers healed. There was no statistically significant difference in healing between an antimicrobial (silver) fibrous-hydrocolloid dressing and standard alginate dressing; an antimicrobial dressing (iodine-impregnated) and a standard fibrous hydrocolloid dressing or a standard fibrous hydrocolloid dressing and a topical cream containing plant extracts. Currently there is no research evidence to suggest that any type of hydrocolloid wound dressing is more effective in healing diabetic foot ulcers than other types of dressing or a topical cream containing plant extracts. Decision makers may wish to consider aspects such as dressing cost and the wound management properties offered by each dressing type e.g. exudate management. | There are many types of dressings that can be used, which also vary considerably in cost.This review (four studies involving a total of 511 participants) identified no research evidence to suggest that any type of hydrocolloid wound dressing is more effective in healing diabetic foot ulcers than other types of dressing. | 10.1002/14651858.CD009099.pub3 | [
"There are many types of dressings that can be used, which also vary considerably in cost.This review (four studies involving a total of 511 participants) identified no research evidence to suggest that any type of hydrocolloid wound dressing is more effective in healing diabetic foot ulcers than other types of dressing."
] |
cochrane-simplification-train-1139 | cochrane-simplification-train-1139 | We included three randomised trials (N = 366) in this review. Two of these studies were at high risk of bias. All studies reported on prevention of ROP and compared oral propranolol with placebo or no treatment. We found no trials assessing beta-blockers in infants with established stage 2 or higher ROP with plus disease. In one trial, study medication was started after one week of life, i.e. prior to the first ROP screening. The other two trials included preterm infants if they had stage 2 or lower ROP without plus disease. Based on the GRADE assessment, we considered evidence to be of low quality for the following outcomes: rescue treatment with anti-VEGF or laser therapy; and arterial hypotension or bradycardia requiring inotropic support. Evidence was of moderate quality for the following outcomes: progression to stage 2 with plus disease; progression to stage 3 ROP; and progression to stage 4 or 5 ROP. Meta-analysis of three trials (N = 366) suggested beneficial effects of oral beta-blockers on the risk of requiring anti-VEGF agents (typical risk ratio (RR) 0.32, 95% confidence interval (CI) 0.12 to 0.86; I² = 0%; typical risk difference (RD) −0.06, 95% CI −0.10 to −0.01; I² = 75%; number needed to treat for an additional beneficial outcome (NNTB) 18, 95% CI 14 to 84) and laser therapy (typical RR 0.54, 95% CI 0.32 to 0.89; typical RD −0.09, 95% CI −0.16 to −0.02; I² = 31%; NNTB 12, 95% CI 8 to 47). Meta-analysis of two trials (N = 161) demonstrated a beneficial effect of oral beta-blockers on progression to stage 3 ROP (typical RR 0.60, 95% CI 0.37 to 0.96; I² = 0%; typical RD −0.15, 95% CI −0.28 to −0.02; I² = 73%; NNTB 7, 95% CI 5 to 67). There was no significant effect of oral beta-blockers on progression to stage 2 ROP with plus disease or to stage 4 or 5 ROP. Although meta-analysis did not indicate a significant effect of beta-blockers on arterial hypotension or bradycardia, propranolol dosage in one study was reduced by 50% in infants of less than 26 weeks' gestational age due to severe hypotension, bradycardia, and apnoea in several participants. Analyses did not indicate significant effects of beta-blockers on complications of prematurity or mortality. None of the trials reported on long-term visual impairment. Limited evidence of low-to-moderate quality suggests that prophylactic administration of oral beta-blockers might reduce progression towards stage 3 ROP and decrease the need for anti-VEGF agents or laser therapy. The clinical relevance of those findings is unclear as no data on long-term visual impairment were reported. Adverse events attributed to oral propranolol at a dose of 2 mg/kg/d raise concerns regarding systemic administration of this drug for prevention of ROP at the given dose. There is insufficient evidence to determine the efficacy and safety of beta-blockers for prevention of ROP due to high risk of bias in two included trials and the lack of long-term functional outcomes. We would encourage researchers to conduct large, well-designed trials to confirm or refute the role of beta-blockers for prevention and treatment of ROP in preterm infants. Trials should report on long-term visual impairment. Researchers should consider dose-finding studies of systemic beta-blockers and topical administration of beta-blockers, in order to optimise drug delivery and minimise adverse events. | We examined the research published to 7 August 2017. We found three clinical trials recruiting 366 preterm babies. All three studies reported on preventing severe stages of retinopathy. We found that orally administered beta-blockers may offer short-term benefits such as lower risk of progression to a more severe stage of retinopathy and less need for additional treatment. However, there were no data on long-term vision; and studies did not show an effect of beta-blockers on the most severe stages of retinopathy. On the other hand, serious adverse effects of beta-blockers were reported in one of three studies. The overall quality of evidence for outcomes in this review varied from low to moderate. Thus, our confidence in the results of this review is very limited. We cannot recommend routine use of beta-blockers for prevention or treatment of ROP in preterm infants. Future high-quality studies are necessary to determine whether benefits of beta-blockers outweigh their risks in preventing or treating ROP in preterm infants. | 10.1002/14651858.CD011893.pub2 | [
"We examined the research published to 7 August 2017. We found three clinical trials recruiting 366 preterm babies. All three studies reported on preventing severe stages of retinopathy. We found that orally administered beta-blockers may offer short-term benefits such as lower risk of progression to a more severe stage of retinopathy and less need for additional treatment. However, there were no data on long-term vision; and studies did not show an effect of beta-blockers on the most severe stages of retinopathy. On the other hand, serious adverse effects of beta-blockers were reported in one of three studies. The overall quality of evidence for outcomes in this review varied from low to moderate. Thus, our confidence in the results of this review is very limited. We cannot recommend routine use of beta-blockers for prevention or treatment of ROP in preterm infants. Future high-quality studies are necessary to determine whether benefits of beta-blockers outweigh their risks in preventing or treating ROP in preterm infants."
] |
cochrane-simplification-train-1140 | cochrane-simplification-train-1140 | We studied 8228 women in nine studies. Eight out of nine studies were at low or unclear risk of bias. Altered fraction size (delivering radiation therapy in larger amounts each day but over fewer days than with conventional fractionation) did not have a clinically meaningful effect on: local recurrence-free survival (Hazard Ratio (HR) 0.94, 95% CI 0.77 to 1.15, 7095 women, four studies, high-quality evidence), cosmetic outcome (Risk ratio (RR) 0.90, 95% CI 0.81 to 1.01, 2103 women, four studies, high-quality evidence) or overall survival (HR 0.91, 95% CI 0.80 to 1.03, 5685 women, three studies, high-quality evidence). Acute radiation skin toxicity (RR 0.32, 95% CI 0.22 to 0.45, 357 women, two studies) was reduced with altered fraction size. Late radiation subcutaneous toxicity did not differ with altered fraction size (RR 0.93, 95% CI 0.83 to 1.05, 5130 women, four studies, high-quality evidence). Breast cancer-specific survival (HR 0.91, 95% CI 0.78 to 1.06, 5685 women, three studies, high quality evidence) and relapse-free survival (HR 0.93, 95% CI 0.82 to 1.05, 5685 women, three studies, moderate-quality evidence) did not differ with altered fraction size. We found no data for mastectomy rate. Altered fraction size was associated with less patient-reported (P < 0.001) and physician-reported (P = 0.009) fatigue at six months (287 women, one study). We found no difference in the issue of altered fractionation for patient-reported outcomes of: physical well-being (P = 0.46), functional well-being (P = 0.38), emotional well-being (P = 0.58), social well-being (P = 0.32), breast cancer concerns (P = 0.94; 287 women, one study). We found no data with respect to costs. We found that using altered fraction size regimens (greater than 2 Gy per fraction) does not have a clinically meaningful effect on local recurrence, is associated with decreased acute toxicity and does not seem to affect breast appearance, late toxicity or patient-reported quality-of-life measures for selected women treated with breast conserving therapy. These are mostly women with node negative tumours smaller than 3 cm and negative pathological margins. | Nine studies, involving 8228 women, were included in this review. Most of the women in the studies (91%) had tumours 3 cm or less in size, all had complete removal of the tumour on pathology and 68% had no evidence of cancer in their lymph nodes. Where the breast size was known, 83% had small or medium breasts. The evidence is current up to May 2015. Local recurrence was not different for women having fewer treatments (four fewer local relapses per 1000 (where the true value may be anywhere between 16 fewer to 10 more local relapses per 1000)). Breast appearance was not different for women undergoing fewer treatments (31 fewer fair/poor breast appearance per 1000 (where the true value may be anywhere between 59 fewer to 3 more per 1000 with fair/poor breast appearance)). Survival was not altered by having fewer treatments (13 fewer deaths per 1000 (where the true value could be between 31 fewer to 5 more deaths per 1000)) and there was no significant difference in late skin toxicity (4 more episodes of toxicity per 1000; where the true value may be anywhere between 14 fewer to 36 more episodes of toxicity per 1000) or radiation toxicity. Acute skin toxicity is decreased with fewer treatments (326 fewer events per 1000 (where the true value may be anywhere between 264 fewer to 374 fewer acute skin toxicity events per 1000)). This review indicates that for women who fit these criteria, using fewer radiation treatments after tumour removal gives the same cancer control, with less skin reaction at the time and the likely the same side-effects in the long term. We found high quality evidence for the following outcomes: local recurrence-free survival, breast appearance, toxicity, overall survival and breast cancer-specific survival. We found moderate quality evidence for relapse-free survival, and no data for mastectomy rate (mastectomy may be required because of local recurrence or unacceptable treatment-related toxicity) or costs. | 10.1002/14651858.CD003860.pub4 | [
"Nine studies, involving 8228 women, were included in this review. Most of the women in the studies (91%) had tumours 3 cm or less in size, all had complete removal of the tumour on pathology and 68% had no evidence of cancer in their lymph nodes. Where the breast size was known, 83% had small or medium breasts. The evidence is current up to May 2015. Local recurrence was not different for women having fewer treatments (four fewer local relapses per 1000 (where the true value may be anywhere between 16 fewer to 10 more local relapses per 1000)). Breast appearance was not different for women undergoing fewer treatments (31 fewer fair/poor breast appearance per 1000 (where the true value may be anywhere between 59 fewer to 3 more per 1000 with fair/poor breast appearance)). Survival was not altered by having fewer treatments (13 fewer deaths per 1000 (where the true value could be between 31 fewer to 5 more deaths per 1000)) and there was no significant difference in late skin toxicity (4 more episodes of toxicity per 1000; where the true value may be anywhere between 14 fewer to 36 more episodes of toxicity per 1000) or radiation toxicity. Acute skin toxicity is decreased with fewer treatments (326 fewer events per 1000 (where the true value may be anywhere between 264 fewer to 374 fewer acute skin toxicity events per 1000)). This review indicates that for women who fit these criteria, using fewer radiation treatments after tumour removal gives the same cancer control, with less skin reaction at the time and the likely the same side-effects in the long term. We found high quality evidence for the following outcomes: local recurrence-free survival, breast appearance, toxicity, overall survival and breast cancer-specific survival. We found moderate quality evidence for relapse-free survival, and no data for mastectomy rate (mastectomy may be required because of local recurrence or unacceptable treatment-related toxicity) or costs."
] |
cochrane-simplification-train-1141 | cochrane-simplification-train-1141 | We included nine trials about CME, of which six trials with 333 patient-caregiver couples were included in the meta-analysis. The small number of studies, participants, and a variety of outcome measures rendered summarising and combining of data in meta-analysis difficult. In addition, in some studies, CME was the only intervention (CME-core), whereas in other studies, caregivers provided another, existing intervention, such as constraint-induced movement therapy. For trials in the latter category, it was difficult to separate the effects of CME from the effects of the other intervention. We found no significant effect of CME on basic ADL when pooling all trial data post intervention (4 studies; standardised mean difference (SMD) 0.21, 95% confidence interval (CI) -0.02 to 0.44; P = 0.07; moderate-quality evidence) or at follow-up (2 studies; mean difference (MD) 2.69, 95% CI -8.18 to 13.55; P = 0.63; low-quality evidence). In addition, we found no significant effects of CME on extended ADL at post intervention (two studies; SMD 0.07, 95% CI -0.21 to 0.35; P = 0.64; low-quality evidence) or at follow-up (2 studies; SMD 0.11, 95% CI -0.17 to 0.39; P = 0.45; low-quality evidence). Caregiver burden did not increase at the end of the intervention (2 studies; SMD -0.04, 95% CI -0.45 to 0.37; P = 0.86; moderate-quality evidence) or at follow-up (1 study; MD 0.60, 95% CI -0.71 to 1.91; P = 0.37; very low-quality evidence). At the end of intervention, CME significantly improved the secondary outcomes of standing balance (3 studies; SMD 0.53, 95% CI 0.19 to 0.87; P = 0.002; low-quality evidence) and quality of life (1 study; physical functioning: MD 12.40, 95% CI 1.67 to 23.13; P = 0.02; mobility: MD 18.20, 95% CI 7.54 to 28.86; P = 0.0008; general recovery: MD 15.10, 95% CI 8.44 to 21.76; P < 0.00001; very low-quality evidence). At follow-up, we found a significant effect in favour of CME for Six-Minute Walking Test distance (1 study; MD 109.50 m, 95% CI 17.12 to 201.88; P = 0.02; very low-quality evidence). We also found a significant effect in favour of the control group at the end of intervention, regarding performance time on the Wolf Motor Function test (2 studies; MD -1.72, 95% CI -2.23 to -1.21; P < 0.00001; low-quality evidence). We found no significant effects for the other secondary outcomes (i.e. patient: motor impairment, upper limb function, mood, fatigue, length of stay and adverse events; caregiver: mood and quality of life). In contrast to the primary analysis, sensitivity analysis of CME-core showed a significant effect of CME on basic ADL post intervention (2 studies; MD 9.45, 95% CI 2.11 to 16.78; P = 0.01; moderate-quality evidence). The methodological quality of the included trials and variability in interventions (e.g. content, timing, and duration), affected the validity and generalisability of these observed results. There is very low- to moderate-quality evidence that CME may be a valuable intervention to augment the pallet of therapeutic options for stroke rehabilitation. Included studies were small, heterogeneous, and some trials had an unclear or high risk of bias. Future high-quality research should determine whether CME interventions are (cost-)effective. | We identified nine clinical trials to October 2015, which all investigated some form of caregiver-mediated exercises compared with usual care, no treatment (intervention), or another intervention that was not caregiver-mediated. We included 333 patient-caregiver couples in the review. We found trials in which caregiver-mediated exercises themselves were the studied subject (called CME-core). In addition, we found trials in which the caregiver was the provider of another, already existing intervention. In the latter category, it was difficult to separate the effect of caregiver-mediated exercises from the effect of the other intervention. We found evidence that caregiver-mediated exercises could have a positive effect on patients' standing balance (low-quality evidence) and quality of life (very low-quality evidence) directly after the intervention. In the long term, we found very low-quality evidence for a positive effect on walking distance. For speed of use of the arm and hand, we found low-quality evidence in favour of the control group. We found no significant side effects or beneficial effects on caregiver strain; we judged the quality of this evidence as moderate (after intervention) to very low (long term). Furthermore, we found no significant effects for basic activities of daily living, such as dressing and bathing, after intervention (moderate-quality evidence) or follow-up (low-quality evidence). In addition, we found no significant effects for extended activities of daily living, such as cooking and gardening, after intervention or at follow-up (both low-quality evidence). In the CME-core analysis, we found moderate-quality evidence for a positive effect of caregiver-mediated exercises for basic activities of daily living. It can be concluded that caregiver-mediated exercises may be a promising form of therapy to add to usual care. The number of included trials was small and the level of evidence was of very low to moderate quality. Therefore, results should be interpreted with caution. | 10.1002/14651858.CD011058.pub2 | [
"We identified nine clinical trials to October 2015, which all investigated some form of caregiver-mediated exercises compared with usual care, no treatment (intervention), or another intervention that was not caregiver-mediated. We included 333 patient-caregiver couples in the review. We found trials in which caregiver-mediated exercises themselves were the studied subject (called CME-core). In addition, we found trials in which the caregiver was the provider of another, already existing intervention. In the latter category, it was difficult to separate the effect of caregiver-mediated exercises from the effect of the other intervention. We found evidence that caregiver-mediated exercises could have a positive effect on patients' standing balance (low-quality evidence) and quality of life (very low-quality evidence) directly after the intervention. In the long term, we found very low-quality evidence for a positive effect on walking distance. For speed of use of the arm and hand, we found low-quality evidence in favour of the control group. We found no significant side effects or beneficial effects on caregiver strain; we judged the quality of this evidence as moderate (after intervention) to very low (long term). Furthermore, we found no significant effects for basic activities of daily living, such as dressing and bathing, after intervention (moderate-quality evidence) or follow-up (low-quality evidence). In addition, we found no significant effects for extended activities of daily living, such as cooking and gardening, after intervention or at follow-up (both low-quality evidence). In the CME-core analysis, we found moderate-quality evidence for a positive effect of caregiver-mediated exercises for basic activities of daily living. It can be concluded that caregiver-mediated exercises may be a promising form of therapy to add to usual care. The number of included trials was small and the level of evidence was of very low to moderate quality. Therefore, results should be interpreted with caution."
] |
cochrane-simplification-train-1142 | cochrane-simplification-train-1142 | We identified three randomized controlled trials (855 children enrolled) in this review. These trials were all conducted in the UK with follow-up periods ranging from one to 3.5 years. We judged the included studies to be at high risk of bias, due to use of quasi-random methods for assigning children to treatment, no masking of outcomes assessors, and high proportions of drop-outs. None of the three trials accounted for missing data and analyses were limited to the available-case data (674 (79%) of 855 children enrolled for the primary outcome). These factors impair our ability to assess the effectiveness of treatment. Analyses incorporating the three trials we identified in this review (674 children) suggested the effect of spectacle correction initiated prior to the age of one year in hyperopic children between three and four years of age is uncertain with respect to preventing strabismus (risk ratio (RR) 0.71; 95% confidence interval (CI) 0.44 to 1.15; very low quality evidence). Based on a meta-analysis of three trials (664 children), the risk of having visual acuity worse than 20/30 at three years of age was also uncertain for children with spectacles compared with those without spectacle correction irrespective of compliance (RR 0.87; 95% CI 0.60 to 1.26; very low quality evidence). Emmetropization was reported in two trials: one trial suggested that spectacles impede emmetropization, and the second trial reported no difference in the rate of refractive error change. Although children who were allocated to the spectacle group were less likely to develop strabismus and less likely to have visual acuity worse than 20/30 children allocated to no spectacles, these effects may have been chance findings, or due to bias. Due to the high risk of bias and poor reporting of included trials, the true effect of spectacle correction for hyperopia on strabismus is still uncertain. | We identified results from three randomized controlled trials (RCTs; clinical studies where people are randomly put into one of two or more treatment groups) to determine whether glasses were successful in reducing the occurrence of strabismus in far-sighted infants. The trials enrolled infants ages 12 months or younger and measured outcomes between the ages of three and four years. The three trials enrolled 855 infants and included about 79% of the infants in the final analyses of different outcomes. These trials were all conducted in the UK with follow-up periods ranging from one to 3.5 years. The evidence is current up to April 2014. Combining the results of the three trials, we found the risk of strabismus with wearing glasses is uncertain. We identified several potential biases in the way these three trials were conducted. Given the high risk of bias and amount of missing data, it is possible the observed decrease in risk of developing strabismus may be an overestimate of the true effect. The evidence does not currently support the conclusion that glasses prevent strabismus in far-sighted children. More research is required to answer the question. In addition, the prescription of glasses, particularly glasses that correct all of the prescription (full correction), may prevent eyes from developing naturally and normalizing to clear visual acuity. Emmetropization (normalization of vision which usually occurs during the natural growth process) was reported in two trials: one trial suggested that spectacles impede emmetropization, and the second trial reported no difference in the rate of refractive error change. The overall quality of the evidence was very low, particularly due to improper trial design, incomplete outcome data, and the lack of power to provide an accurate estimate of the overall treatment effect of spectacle correction for preventing strabismus. | 10.1002/14651858.CD007738.pub2 | [
"We identified results from three randomized controlled trials (RCTs; clinical studies where people are randomly put into one of two or more treatment groups) to determine whether glasses were successful in reducing the occurrence of strabismus in far-sighted infants. The trials enrolled infants ages 12 months or younger and measured outcomes between the ages of three and four years. The three trials enrolled 855 infants and included about 79% of the infants in the final analyses of different outcomes. These trials were all conducted in the UK with follow-up periods ranging from one to 3.5 years. The evidence is current up to April 2014. Combining the results of the three trials, we found the risk of strabismus with wearing glasses is uncertain. We identified several potential biases in the way these three trials were conducted. Given the high risk of bias and amount of missing data, it is possible the observed decrease in risk of developing strabismus may be an overestimate of the true effect. The evidence does not currently support the conclusion that glasses prevent strabismus in far-sighted children. More research is required to answer the question. In addition, the prescription of glasses, particularly glasses that correct all of the prescription (full correction), may prevent eyes from developing naturally and normalizing to clear visual acuity. Emmetropization (normalization of vision which usually occurs during the natural growth process) was reported in two trials: one trial suggested that spectacles impede emmetropization, and the second trial reported no difference in the rate of refractive error change. The overall quality of the evidence was very low, particularly due to improper trial design, incomplete outcome data, and the lack of power to provide an accurate estimate of the overall treatment effect of spectacle correction for preventing strabismus."
] |
cochrane-simplification-train-1143 | cochrane-simplification-train-1143 | Three double-blind, parallel group, randomised, controlled trials have been conducted on 263 patients. The two phase II studies were relatively small, were conducted over the short term (12 weeks), and used relatively low doses of ropinirole (mean administered doses 3.3 and 3.5 mg/d) in a twice daily regime. In view of this clinical heterogeneity and some statistical heterogeneity, the results of these trials have not been included in a meta-analysis. The conclusions of this review are based on the evidence from a single phase III study which was medium term (26 weeks) and used ropinirole doses in line with the current UK licensed maximum in a thrice daily regime. In view of difficulties in assessing changes in off time in Leiberman 98, caused by the initial imbalance between the arms of the trial, it is unsafe to draw any firm conclusion about the effect of ropinirole on off time. However, as an adverse event, dyskinesia was significantly increased in those who received ropinirole (Leiberman 98; odds ratio 2.90; 1.36, 6.19 95% CI; Table 8). Measurements of motor impairments and disability were poor in this study with incomplete information available. Levodopa dose could be reduced in Leiberman 98 with a significantly larger reduction on ropinirole than on placebo (weighted mean difference 180 mg/d; 106, 253 95% CI; Table 2). No significant differences in the frequency of adverse event reports were noted between ropinirole and placebo apart from the increase in dyskinesia with ropinirole. There was a trend towards fewer withdrawals from ropinirole in Leiberman 98 but this did not reach statistical significance. Ropinirole therapy can reduce levodopa dose but at the expense of increased dyskinetic adverse events. No clear effect on off time reduction was found but this may have been due to the under-powering of the single evaluable trial. Inadequate data on motor impairments and disability was collected to assess these outcomes. These conclusions apply to short and medium term treatment, up to 26 weeks. Further longer term trials are required, with measurements of effectiveness, and also studies to compare the newer with the older dopamine agonists. | Three trials have compared ropinirole with an inactive placebo in 263 patients in the later stages of Parkinson's disease. Two studies were relatively small, were conducted over the short term (12 weeks), and used relatively low doses of ropinirole (maximum allowed 8 and 10 mg/d) in a twice daily administration regime. For these reasons, the results of these trials have not been included in a statistical overview. The other study was medium term (26 weeks) and used ropinirole doses in line with the current UK licensed maximum (24 mg/d) in a three times a day regime. The conclusions of this review are based on this single trial and thus should be viewed with some caution. No clear difference in the time patients spent in the immobile off state was found between ropinirole and placebo. However, this was probably due to there being too few patients in the trial. Measurements of physical difficulties and problems with activities of daily living (such as bathing, shopping, etc.) were poor in these studies with incomplete information available. Levodopa dose reduction was greater with ropinirole than placebo by 180 mg/d. However, dyskinesia was increased in those who received ropinirole (2.9 times more common with ropinirole than placebo). No other differences in side effects or withdrawals from treatment were found. Ropinirole reduces levodopa dose but at the expense of increased dyskinetic side effects. No clear effect on off time reduction was found in this single trial. Side effects were similar with ropinirole and placebo. These conclusions apply to short and medium term treatment, up to 26 weeks. Further longer term trials are required, with measurements of quality of life and costs, and also studies to compare the newer with the older dopamine agonists. | 10.1002/14651858.CD001516 | [
"Three trials have compared ropinirole with an inactive placebo in 263 patients in the later stages of Parkinson's disease. Two studies were relatively small, were conducted over the short term (12 weeks), and used relatively low doses of ropinirole (maximum allowed 8 and 10 mg/d) in a twice daily administration regime. For these reasons, the results of these trials have not been included in a statistical overview. The other study was medium term (26 weeks) and used ropinirole doses in line with the current UK licensed maximum (24 mg/d) in a three times a day regime. The conclusions of this review are based on this single trial and thus should be viewed with some caution. No clear difference in the time patients spent in the immobile off state was found between ropinirole and placebo. However, this was probably due to there being too few patients in the trial. Measurements of physical difficulties and problems with activities of daily living (such as bathing, shopping, etc.) were poor in these studies with incomplete information available. Levodopa dose reduction was greater with ropinirole than placebo by 180 mg/d. However, dyskinesia was increased in those who received ropinirole (2.9 times more common with ropinirole than placebo). No other differences in side effects or withdrawals from treatment were found. Ropinirole reduces levodopa dose but at the expense of increased dyskinetic side effects. No clear effect on off time reduction was found in this single trial. Side effects were similar with ropinirole and placebo. These conclusions apply to short and medium term treatment, up to 26 weeks. Further longer term trials are required, with measurements of quality of life and costs, and also studies to compare the newer with the older dopamine agonists."
] |
cochrane-simplification-train-1144 | cochrane-simplification-train-1144 | Six randomised controlled trials including 446 participants. Two trials compared three types of instruments (MES vs UCS vs EBVS). One trial compared MES and UCS. One trial compared UCS and EBVS. One trial compared 5 mm versus 10 mm EBVS. One trial compared the technique of laparoscopic staplers and clips versus EBVS in pedicle ligation during laparoscopic colectomy. The limitation of this review is the heterogeneity of the trials included. The measured outcomes were covered by one to three studies with small number of participants. With this in mind, there was significant less blood loss in UCS compared to MES. The operating time was significantly shorter with the use of EBVS than MES. No difference between UCS and EBVS apart from EBVS appeared to be handling better than UCS in one study. Haemostatic control was better in UCS and EBVS over MES. No definite conclusion on the cost difference between these three instrument but this would lie in the balance between the instrument cost and the operating time. The handling of 5 mm EBVS was better than 10 mm and its main advantage was trocar flexibility. Laparoscopic staplers/clips used for pedicle ligation in colectomy associated with more failure in vessel ligation and cost more when compared to EBVS. The limitations of this review is the small number of trials and heterogeneity of the studies included. With the current evidence it is not possible to demonstrate which is the best instrument in laparoscopic colectomy. Hopefully more data would follow and subsequent updates of this review could become more informative. | This review aims to examine the effectiveness and safety of these three instruments. The findings showed that UCS results in less blood loss when compared to MES. Operating time was shorter when EBVS was used compared to MES. No marked difference was observed between UCS and EBVS. No difference in complications between all three instruments were reported in the findings. However, it is recognised that more trials are needed to support the evidence provided in this report. | 10.1002/14651858.CD007886.pub2 | [
"This review aims to examine the effectiveness and safety of these three instruments. The findings showed that UCS results in less blood loss when compared to MES. Operating time was shorter when EBVS was used compared to MES. No marked difference was observed between UCS and EBVS. No difference in complications between all three instruments were reported in the findings. However, it is recognised that more trials are needed to support the evidence provided in this report."
] |
cochrane-simplification-train-1145 | cochrane-simplification-train-1145 | Seven trials involving a total of 266 participants were included. Four trials studied the effects of NSAIDs in chronic CMO while the other three examined the effect of NSAIDs in acute CMO. Of the studies examining chronic CMO, one study enrolled 120 participants, but the remainder had 34 or fewer participants. Four different NSAIDs were used and administered in different ways. Indomethacin was used orally and was found to be ineffective for chronic CMO in one trial. Topical fenoprofen appeared effective but not statistically significantly so for chronic CMO in another small trial. Treatment with topical 0.5% ketorolac for chronic CMO was found to be effective in two trials. Three trials examined the effect of topical NSAIDs on acute CMO. The comparisons among these studies were of an NSAID to placebo, prednisolone or another NSAID. The study design differed between the studies in other important aspects thus they could not be combined in a meta-analysis. This review found two trials which showed that topical NSAID (0.5% ketorolac tromethamine ophthalmic solution) has a positive effect on chronic CMO and two trials which revealed no significant difference between comparative groups. As such, the effects of NSAIDs in acute and chronic CMO remain unclear and needs further investigation. | This review included seven randomised controlled trials with a total of 266 participants. Four trials studied the effects of non-steroidal anti-inflammatory agents (NSAIDs) in chronic CMO while the other three examined the effect of NSAIDs in acute CMO. This review found two trials which showed that topical NSAID (0.5% ketorolac tromethamine ophthalmic solution) has a positive effect on chronic CMO and a third trial which was supportive of this finding (albeit not statistically significantly so). One study suggested no effect and our review suggests further work is needed for a more conclusive decision regarding use of NSAIDS in chronic CMO. Similarly, the effects of NSAIDs in acute CMO remain unclear and this too needs further investigation. | 10.1002/14651858.CD004239.pub3 | [
"This review included seven randomised controlled trials with a total of 266 participants. Four trials studied the effects of non-steroidal anti-inflammatory agents (NSAIDs) in chronic CMO while the other three examined the effect of NSAIDs in acute CMO. This review found two trials which showed that topical NSAID (0.5% ketorolac tromethamine ophthalmic solution) has a positive effect on chronic CMO and a third trial which was supportive of this finding (albeit not statistically significantly so). One study suggested no effect and our review suggests further work is needed for a more conclusive decision regarding use of NSAIDS in chronic CMO. Similarly, the effects of NSAIDs in acute CMO remain unclear and this too needs further investigation."
] |
cochrane-simplification-train-1146 | cochrane-simplification-train-1146 | We include 41 studies of either structured telephone support or non-invasive home telemonitoring for people with heart failure, of which 17 were new and 24 had been included in the previous Cochrane review. In the current review, 25 studies evaluated structured telephone support (eight new studies, plus one study previously included but classified as telemonitoring; total of 9332 participants), 18 evaluated telemonitoring (nine new studies; total of 3860 participants). Two of the included studies trialled both structured telephone support and telemonitoring compared to usual care, therefore 43 comparisons are evident. Non-invasive telemonitoring reduced all-cause mortality (RR 0.80, 95% CI 0.68 to 0.94; participants = 3740; studies = 17; I² = 24%, GRADE: moderate-quality evidence) and heart failure-related hospitalisations (RR 0.71, 95% CI 0.60 to 0.83; participants = 2148; studies = 8; I² = 20%, GRADE: moderate-quality evidence). Structured telephone support reduced all-cause mortality (RR 0.87, 95% CI 0.77 to 0.98; participants = 9222; studies = 22; I² = 0%, GRADE: moderate-quality evidence) and heart failure-related hospitalisations (RR 0.85, 95% CI 0.77 to 0.93; participants = 7030; studies = 16; I² = 27%, GRADE: moderate-quality evidence). Neither structured telephone support nor telemonitoring demonstrated effectiveness in reducing the risk of all-cause hospitalisations (structured telephone support: RR 0.95, 95% CI 0.90 to 1.00; participants = 7216; studies = 16; I² = 47%, GRADE: very low-quality evidence; non-invasive telemonitoring: RR 0.95, 95% CI 0.89 to 1.01; participants = 3332; studies = 13; I² = 71%, GRADE: very low-quality evidence). Seven structured telephone support studies reported length of stay, with one reporting a significant reduction in length of stay in hospital. Nine telemonitoring studies reported length of stay outcome, with one study reporting a significant reduction in the length of stay with the intervention. One telemonitoring study reported a large difference in the total number of hospitalisations for more than three days, but this was not an analysis of length of stay per hospitalisation. Nine of 11 structured telephone support studies and five of 11 telemonitoring studies reported significant improvements in health-related quality of life. Nine structured telephone support studies and six telemonitoring studies reported costs of the intervention or cost effectiveness. Three structured telephone support studies and one telemonitoring study reported a decrease in costs and two telemonitoring studies reported increases in cost, due both to the cost of the intervention and to increased medical management. Adherence was rated between 55.1% and 98.5% for those structured telephone support and telemonitoring studies which reported this outcome. Participant acceptance of the intervention was reported in the range of 76% to 97% for studies which evaluated this outcome. Seven of nine studies that measured these outcomes reported significant improvements in heart failure knowledge and self-care behaviours. For people with heart failure, structured telephone support and non-invasive home telemonitoring reduce the risk of all-cause mortality and heart failure-related hospitalisations; these interventions also demonstrated improvements in health-related quality of life and heart failure knowledge and self-care behaviours. Studies also demonstrated participant satisfaction with the majority of the interventions which assessed this outcome. | We include 41 full-text peer-reviewed studies of either structured telephone support or home telemonitoring in this review. Twenty-five studies evaluate structured telephone support (eight new studies, plus one previously included study now classified as telemonitoring; total of 9332 participants), 18 evaluated telemonitoring (nine new studies; total of 3860 participants) and two studies evaluated both interventions (included in listed counts). This review demonstrates that supporting people with heart failure at home using information technology can reduce the rates of death and heart failure-related hospitalisation. It can improve people's quality of life and knowledge about heart failure and self care. Most patients, even those who are elderly, learn to use the technology easily and are satisfied with these interventions. We assessed the quality of the evidence for the primary outcomes in this review (all-cause mortality, all-cause hospitalisation and heart failure-related hospitalisation) according to GRADE criteria. We rated it from very low (all-cause hospitalisations) to moderate (all-cause mortality and heart failure-related hospitalisations). | 10.1002/14651858.CD007228.pub3 | [
"We include 41 full-text peer-reviewed studies of either structured telephone support or home telemonitoring in this review. Twenty-five studies evaluate structured telephone support (eight new studies, plus one previously included study now classified as telemonitoring; total of 9332 participants), 18 evaluated telemonitoring (nine new studies; total of 3860 participants) and two studies evaluated both interventions (included in listed counts). This review demonstrates that supporting people with heart failure at home using information technology can reduce the rates of death and heart failure-related hospitalisation. It can improve people's quality of life and knowledge about heart failure and self care. Most patients, even those who are elderly, learn to use the technology easily and are satisfied with these interventions. We assessed the quality of the evidence for the primary outcomes in this review (all-cause mortality, all-cause hospitalisation and heart failure-related hospitalisation) according to GRADE criteria. We rated it from very low (all-cause hospitalisations) to moderate (all-cause mortality and heart failure-related hospitalisations)."
] |
cochrane-simplification-train-1147 | cochrane-simplification-train-1147 | Six studies were selected for inclusion (106 participants). No results were combined as the studies were all of a crossover design. EFFECTS OF NEGATIVE ION GENERATORS (five studies) No study reported a significant difference in lung function between ionised and control air (morning Peak expiratory flow (PEF) - three studies; forced expiratory flow in one second (FEV1) - one study). There were no significant differences in symptoms or beta-2 agonist usage between ionised and control air in three studies. EFFECTS OF POSITIVE ION GENERATORS (one study) This study demonstrated that although positively ionised air was associated with a larger fall in FEV1 with exercise, this did not reach statistical significance. Baseline FEV1 was not demonstrated to be significantly different between treatment groups. Based on the evidence currently available from randomised controlled trials, a recommendation cannot be given for the use of room air ionisers to reduce symptoms in patients with chronic asthma. | Although complex laboratory studies show that ion generators alter airways function, the few studies which have been conducted in the homes of people with asthma, demonstrate no significant benefit in improving lung function or symptoms. | 10.1002/14651858.CD002986.pub2 | [
"Although complex laboratory studies show that ion generators alter airways function, the few studies which have been conducted in the homes of people with asthma, demonstrate no significant benefit in improving lung function or symptoms."
] |
cochrane-simplification-train-1148 | cochrane-simplification-train-1148 | We included in the review data from one quasi-randomised trial with 88 infants from 75 families. Infants in the early discharge programme with home gavage feeding had a mean hospital stay that was 9.3 days shorter (mean difference (MD) -9.3, 95% confidence interval (CI) -18.49 to -0.11) than that of infants in the control group. Infants in the early discharge programme also had lower risk of clinical infection during the home gavage period compared with those in the control group spending corresponding time in hospital (risk ratio 0.35, 95% CI 0.17 to 0.69). No significant differences were noted between groups in duration and extent of breast feeding, weight gain, re-admission within the first 12 months post discharge from the home gavage programme or from hospital, scores reflecting parental satisfaction or overall health service use. Experimental evidence on the benefits and risks for preterm infants of early discharge from hospital with home gavage feeding compared with later discharge upon attainment of full sucking feeds is limited to the results of one small quasi-randomised controlled trial. High-quality trials with concealed allocation, complete follow-up of all randomly assigned infants and adequate sample size are needed before practice recommendations can be made. | Data from one quasi-randomised trial with 88 infants from 75 families were included in the review. Infants in the early discharge programme with home gavage feeds had a mean hospital stay that was approximately nine days shorter than that of infants in the control group. Infants in the early discharge programme also had lower risk of clinical infection during the home gavage period compared with infants in the control group during the corresponding time in hospital. No significant differences were observed between groups in duration and extent of breast feeding, weight gain, re-admission within the first 12 months post discharge from the home gavage programme or from hospital, scores reflecting parental satisfaction or health service use. Evidence is needed regarding the effects of early home discharge for preterm babies who are stable but still need gavage (tube) feeds. | 10.1002/14651858.CD003743.pub2 | [
"Data from one quasi-randomised trial with 88 infants from 75 families were included in the review. Infants in the early discharge programme with home gavage feeds had a mean hospital stay that was approximately nine days shorter than that of infants in the control group. Infants in the early discharge programme also had lower risk of clinical infection during the home gavage period compared with infants in the control group during the corresponding time in hospital. No significant differences were observed between groups in duration and extent of breast feeding, weight gain, re-admission within the first 12 months post discharge from the home gavage programme or from hospital, scores reflecting parental satisfaction or health service use. Evidence is needed regarding the effects of early home discharge for preterm babies who are stable but still need gavage (tube) feeds."
] |
cochrane-simplification-train-1149 | cochrane-simplification-train-1149 | Of 11 RCTs identified 4 were included in this review, with 8,912 participants. Treatment for 4 to 5 years with antihypertensive drugs as compared to placebo did not reduce total mortality (RR 0.85, 95% CI 0.63, 1.15). In 7,080 participants treatment with antihypertensive drugs as compared to placebo did not reduce coronary heart disease (RR 1.12, 95% CI 0.80, 1.57), stroke (RR 0.51, 95% CI 0.24, 1.08), or total cardiovascular events (RR 0.97, 95% CI 0.72, 1.32). Withdrawals due to adverse effects were increased by drug therapy (RR 4.80, 95%CI 4.14, 5.57), Absolute risk increase (ARI) 9%. Antihypertensive drugs used in the treatment of adults (primary prevention) with mild hypertension (systolic BP 140-159 mmHg and/or diastolic BP 90-99 mmHg) have not been shown to reduce mortality or morbidity in RCTs. Treatment caused 9% of patients to discontinue treatment due to adverse effects. More RCTs are needed in this prevalent population to know whether the benefits of treatment exceed the harms. | In this review, existing evidence comparing the health outcomes between treated and untreated individuals are summarized. Available data from the limited number of available trials and participants showed no difference between treated and untreated individuals in heart attack, stroke, and death. About 9% of patients treated with drugs discontinued treatment due to adverse effects. Therefore, the benefits and harms of antihypertensive drug therapy in this population need to be investigated by further research. | 10.1002/14651858.CD006742.pub2 | [
"In this review, existing evidence comparing the health outcomes between treated and untreated individuals are summarized. Available data from the limited number of available trials and participants showed no difference between treated and untreated individuals in heart attack, stroke, and death. About 9% of patients treated with drugs discontinued treatment due to adverse effects. Therefore, the benefits and harms of antihypertensive drug therapy in this population need to be investigated by further research."
] |
cochrane-simplification-train-1150 | cochrane-simplification-train-1150 | Of 23 trials included, 19 examined contraceptive effectiveness. The triphasic and monophasic preparations did not differ significantly. About half of the included trials reported favorable bleeding patterns, that is less spotting, breakthrough bleeding or amenorrhea, in triphasic versus monophasic OC users. However, meta-analysis was generally not possible due to differences in measuring and reporting the cycle disturbance data as well as differences in progestogen type and hormone dosages. No significant differences were found in the numbers of women who discontinued due to medical reasons, cycle disturbances, intermenstrual bleeding or adverse events. The available evidence is insufficient to determine whether triphasic OCs differ from monophasic OCs in effectiveness, bleeding patterns or discontinuation rates. Therefore, we recommend monophasic pills as a first choice for women starting OC use. Large, high-quality RCTs that compare triphasic and monophasic OCs with identical progestogens are needed to determine whether triphasic pills differ from monophasic OCs. Future studies should follow the recommendations of Belsey or Mishell on recording menstrual bleeding patterns and the CONSORT reporting guidelines. | We did a computer search for studies of pills with three phases versus pills with one phase in May 2011. We also wrote to researchers and manufacturers to find other trials. We included randomized trials in any language. The studies had to follow women for at least three treatment cycles. We found 23 trials that looked at three-phase versus one-phase birth control pills. Many studies did not have good methods and the authors did not always report all their methods. The two types of pills did not differ in the numbers of women who got pregnant. About half of the trials found better bleeding patterns with the three-phase pill. The numbers of women who stopped using the pills were about the same for both types of pills. The evidence was not strong enough to say whether the three-phase pill was better than the one-phase pill for pregnancy prevention, bleeding patterns, or continued use. Therefore, we recommend one-phase pills for women starting to use birth control pills. Large trials that are of good quality are needed to see if pills with three phases work better than those with one phase. | 10.1002/14651858.CD003553.pub3 | [
"We did a computer search for studies of pills with three phases versus pills with one phase in May 2011. We also wrote to researchers and manufacturers to find other trials. We included randomized trials in any language. The studies had to follow women for at least three treatment cycles. We found 23 trials that looked at three-phase versus one-phase birth control pills. Many studies did not have good methods and the authors did not always report all their methods. The two types of pills did not differ in the numbers of women who got pregnant. About half of the trials found better bleeding patterns with the three-phase pill. The numbers of women who stopped using the pills were about the same for both types of pills. The evidence was not strong enough to say whether the three-phase pill was better than the one-phase pill for pregnancy prevention, bleeding patterns, or continued use. Therefore, we recommend one-phase pills for women starting to use birth control pills. Large trials that are of good quality are needed to see if pills with three phases work better than those with one phase."
] |
cochrane-simplification-train-1151 | cochrane-simplification-train-1151 | We included 28 studies, with a total of 2306 participants. We assessed most of the studies at high 'risk of bias', particularly in blinding of participants and personnel, and there was substantial inconsistency between studies, so any positive effect of CHM must be treated with caution. We did not include the four studies from the previous version in this review, because they investigated a CHM product that has been withdrawn from the market since 2004. Four studies (three oral and one topical) compared CHM to placebo. Pooled data from 2 studies showed the total effectiveness rate in the CHM group was higher (by risk ratio (RR) 2.09, 95% confidence interval (CI) 1.32 to 3.32; 2 studies; n = 85), and the itching visual analogue score (VAS) in the CHM group was 1.53 lower (by standardised mean difference (SMD), 95% CI 2.64 to 0.41; 2 Studies; n = 94) than the placebo group, where a lower VAS score indicates reduced itch. One study of 85 participants with moderate to severe eczema who received an oral CHM formula for 12 weeks reported a quality of life (QoL) score 2.5 lower in the CHM group (by difference in means (MD), 95% CI 4.77 to 0.23; 1 study; n = 85) than the placebo group, where a lower score indicates better QoL. Twenty-two studies and 1 arm from a study with a 4-arm parallel controlled design compared CHM (5 oral, 6 topical, and 12 mixed oral and topical) to conventional medicines. The total effectiveness rate in the CHM groups was superior (RR 1.43, 95% CI 1.27 to 1.61; 21 studies; n = 1868; very low quality evidence), and the itching VAS in the CHM groups was 0.83 lower (SMD, 95% CI 1.43 to 0.22; 7 studies; n = 465) than the comparators. Two studies compared combined oral and topical CHM to the same oral CHM formula alone. The total effectiveness rate in 1 study was not statistically significant (RR 1.13, 95% CI 0.78 to 1.63; 1 study; n = 20). In the other study, the itching VAS in the CHM group was 1.05 lower (MD, 95% CI 1.75 to 0.35; 1 study; n = 23) than the control group. With regard to side-effects, four studies did not give any report of adverse events. The other 24 studies reported minor adverse events, which were reversed soon after stopping CHM. One participant withdrew from one trial because of exacerbation of their condition after using the CHM intervention. Eight studies received government funding. We could not find conclusive evidence that CHM taken by mouth or applied topically to the skin could reduce the severity of eczema in children or adults. Well-designed, adequately powered RCTs are needed to evaluate the efficacy and safety of CHM for managing eczema. | A former Cochrane review published in 2004 found some evidence of a possible benefit of using oral Chinese herbal medicine (CHM) for eczema; however, the results from only 4 included studies were inconclusive and need to be updated (those four studies have not been included in this update as they investigated a product that has been withdrawn from the market since 2004). As well as updating that review, we have also widened the scope of the review to assess the effects of topical CHM for eczema. We wrote a new protocol to expand the scope of this review. This review included 28 randomised controlled trials (RCTs), with 2306 children and adults, of which 4 compared CHM to placebo, 22 to conventional medications, and 2 to CHM taken by mouth. Most of the included studies reported a higher number of participants who had recovered and significantly improved, with less itching in the CHM groups than the control groups. Where CHM was compared to conventional drugs, although the total effectiveness rate outcome was superior with CHM, it was based on very low quality evidence. One study reported that the quality of life (QoL) score in the CHM group was better than in the placebo group after using a CHM formula taken by mouth for 12 weeks. We assessed most of the studies as at high 'risk of bias' and therefore not of good quality, and there was substantial inconsistency between the studies, so any positive effect in CHM must be treated with caution. One study reported one severe adverse event. Minor adverse events were observed in 24 studies, including temporary elevation of enzymes in 3 cases, which was reversed soon after stopping CHM. Eight included studies received government funding. We could not find conclusive evidence that CHM taken by mouth or applied to the skin was of benefit to children or adults with eczema. Well-designed, adequately powered RCTs are needed to evaluate the efficacy and safety of CHM for eczema. | 10.1002/14651858.CD008642.pub2 | [
"A former Cochrane review published in 2004 found some evidence of a possible benefit of using oral Chinese herbal medicine (CHM) for eczema; however, the results from only 4 included studies were inconclusive and need to be updated (those four studies have not been included in this update as they investigated a product that has been withdrawn from the market since 2004). As well as updating that review, we have also widened the scope of the review to assess the effects of topical CHM for eczema. We wrote a new protocol to expand the scope of this review. This review included 28 randomised controlled trials (RCTs), with 2306 children and adults, of which 4 compared CHM to placebo, 22 to conventional medications, and 2 to CHM taken by mouth. Most of the included studies reported a higher number of participants who had recovered and significantly improved, with less itching in the CHM groups than the control groups. Where CHM was compared to conventional drugs, although the total effectiveness rate outcome was superior with CHM, it was based on very low quality evidence. One study reported that the quality of life (QoL) score in the CHM group was better than in the placebo group after using a CHM formula taken by mouth for 12 weeks. We assessed most of the studies as at high 'risk of bias' and therefore not of good quality, and there was substantial inconsistency between the studies, so any positive effect in CHM must be treated with caution. One study reported one severe adverse event. Minor adverse events were observed in 24 studies, including temporary elevation of enzymes in 3 cases, which was reversed soon after stopping CHM. Eight included studies received government funding. We could not find conclusive evidence that CHM taken by mouth or applied to the skin was of benefit to children or adults with eczema. Well-designed, adequately powered RCTs are needed to evaluate the efficacy and safety of CHM for eczema."
] |
cochrane-simplification-train-1152 | cochrane-simplification-train-1152 | We included one randomised and one quasi-randomised controlled trial involving a total of 94 participants and reporting results for a maximum of 84 participants. One trial included patients with spinal cord injuries and the other included patients without spinal cord injuries. Both trials compared anterior versus posterior surgical approaches. Both trials were at high risk of bias, including selection bias (one trial), performance bias (both trials) and attrition bias (one trial). Data were pooled for one outcome only: non-union. Reflecting also the imprecision of the results, the evidence was deemed to be of very low quality for all outcomes; which means that our level of uncertainty about the estimates is high. Neither trial found differences between the two approaches in neurological recovery or status, as shown in one study by small clinically insignificant differences in NASS (Northern American Spine Society) neurological scores (0 to 100: optimal score) at one year of follow-up: anterior mean score: 85.23 versus posterior mean score: 83.86; mean difference (MD) 1.37 favouring anterior approach, 95% confidence interval (CI) -9.76 to 12.50; 33 participants; 1 study). The same trial found no relevant between-approach differences at one year in patient-reported quality of life measured using the 36-item Short Form Survey physical (MD -0.08, 95% CI -7.26 to 7.10) and mental component scores (MD 2.88, 95% CI -3.32 to 9.08). Neither trial found evidence of significant differences in long-term pain, or non-union (2/38 versus 2/46; risk ratio (RR) 1.18, 95% CI 0.04 to 34.91). One trial found better sagittal and more 'normal' alignment after the anterior approach (MD -10.31 degrees favouring anterior approach, 95% CI -14.95 degrees to -5.67 degrees), while the other trial reported no significant differences in cervical alignment. There was insufficient evidence to indicate between-group differences in medical adverse events, rates of instrumentation failure and infection. One trial found that the several participants had voice and swallowing disorders after anterior approach surgery (11/20) versus none (0/22) in the posterior approach group: RR 25.19, 95% CI 1.58 to 401.58); all had recovered by three months. Very low quality evidence from two trials indicated little difference in long-term neurological status, pain or patient-reported quality of life between anterior and posterior surgical approaches to the management of individuals with subaxial cervical spine facet dislocations. Sagittal alignment may be better achieved with the anterior approach. There was insufficient evidence available to indicate between-group differences in medical adverse events, rates of instrumentation failure and infection. The disorders of the voice and swallowing that occurred exclusively in the anterior approach group all resolved by three months. We are very uncertain about this evidence and thus we cannot say whether one approach is better than the other. There was no evidence available for other approaches. Further higher quality multicentre randomised trials are warranted. | We searched the medical literature until May 2014 and found two relevant studies that included a total of 94 adults with cervical spine facet dislocations. One trial included individuals with spinal cord injuries and the other included individuals without spinal cord injuries. Both studies compared the anterior versus posterior surgical approach. Quality of the evidence The two studies were small and both were at high risk of bias. We therefore judged the quality of the evidence to be very low. Summary of the evidence Neither study found differences between the two approaches in neurological status and pain at one year. One study also found no differences between the two approaches in patient-reported quality of life. Although one study found that the anterior approach resulted in more normal curvature of the neck, the other study reported finding no difference between the two approaches with regard to the alignment of the neck vertebrae. The evidence was insufficient to indicate differences between the two approaches in medical adverse events, rates of instrumentation failure and infection. Although over half (11) of 20 people in the anterior approach group in one study had voice and swallowing disorders, these all resolved by three months. Conclusion The quality of the evidence was very low, meaning that we are very uncertain about the direction and size of effect. Thus we are unable to say whether either an anterior or posterior approach to the surgical management of individuals with dislocations to the cervical spine facet joints is better than the other. We suggest that further research is needed to inform the choice of surgical approach. | 10.1002/14651858.CD008129.pub2 | [
"We searched the medical literature until May 2014 and found two relevant studies that included a total of 94 adults with cervical spine facet dislocations. One trial included individuals with spinal cord injuries and the other included individuals without spinal cord injuries. Both studies compared the anterior versus posterior surgical approach. Quality of the evidence The two studies were small and both were at high risk of bias. We therefore judged the quality of the evidence to be very low. Summary of the evidence Neither study found differences between the two approaches in neurological status and pain at one year. One study also found no differences between the two approaches in patient-reported quality of life. Although one study found that the anterior approach resulted in more normal curvature of the neck, the other study reported finding no difference between the two approaches with regard to the alignment of the neck vertebrae. The evidence was insufficient to indicate differences between the two approaches in medical adverse events, rates of instrumentation failure and infection. Although over half (11) of 20 people in the anterior approach group in one study had voice and swallowing disorders, these all resolved by three months. Conclusion The quality of the evidence was very low, meaning that we are very uncertain about the direction and size of effect. Thus we are unable to say whether either an anterior or posterior approach to the surgical management of individuals with dislocations to the cervical spine facet joints is better than the other. We suggest that further research is needed to inform the choice of surgical approach."
] |
cochrane-simplification-train-1153 | cochrane-simplification-train-1153 | No new studies met the inclusion criteria for this update. We included one randomised controlled trial in the review. A subgroup of 227 participants with AAA received either metoprolol (N = 111) or placebo (N = 116). There was no clear evidence that metoprolol reduced all-cause mortality (odds ratio (OR) 0.17, 95% confidence interval (CI) 0.02 to 1.41), cardiovascular death (OR 0.20, 95% CI 0.02 to 1.76), AAA-related death (OR 1.05, 95% CI 0.06 to 16.92) or increased nonfatal cardiovascular events (OR 1.44, 95% CI 0.58 to 3.57) 30 days postoperatively. Furthermore, at six months postoperatively, estimated effects were compatible with benefit and harm for all-cause mortality (OR 0.71, 95% CI 0.26 to 1.95), cardiovascular death (OR 0.73, 95% CI 0.23 to 2.39) and nonfatal cardiovascular events (OR 1.41, 95% CI 0.59 to 3.35). Adverse drug effects were reported for the whole study population and were not available for the subgroup of participants with AAA. We considered the study to be at a generally low risk of bias. We downgraded the quality of the evidence for all outcomes to low. We downgraded the quality of evidence for imprecision as only one study with a small number of participants was available, the number of events was small and the result was consistent with benefit and harm. Due to the limited number of included trials, there is insufficient evidence to draw any conclusions about the effectiveness of cardiovascular prophylaxis in reducing mortality and cardiovascular events in people with AAA. Further good-quality randomised controlled trials that examine many types of prophylaxis with long-term follow-up are required before firm conclusions can be made. | After searching for all relevant studies (until 14 April 2016), we found one study in which a subgroup of 227 people with AAA received either the beta-blocker metoprolol (medication that reduces blood pressure) or a placebo (dummy treatment). This study's results were imprecise for all causes of death and death from cardiovascular disease or nonfatal cardiovascular events at 30 days or six months after AAA repair. Side effects from the drug were reported for the whole study population and were not available for the subgroup of participants with AAA. We judged this study to be at a generally low risk of bias. We graded the quality of the evidence to low as we only included one small sized study in the review, there were few events reported and the result was consistent with benefit and harm. Larger and longer studies are needed to find out which treatment is most effective. At present, people with AAA are offered a wide range of pharmacological treatment including antiplatelet drugs, antihypertensives and lipid-lowering drugs. Future trials should test available drugs to find the most effective strategy, whether that be one single drug or a combination of treatments. In addition, the acceptability of such interventions needs to be assessed and future studies should measure adverse side effects associated with these drugs and their impact on quality of life. | 10.1002/14651858.CD010447.pub3 | [
"After searching for all relevant studies (until 14 April 2016), we found one study in which a subgroup of 227 people with AAA received either the beta-blocker metoprolol (medication that reduces blood pressure) or a placebo (dummy treatment). This study's results were imprecise for all causes of death and death from cardiovascular disease or nonfatal cardiovascular events at 30 days or six months after AAA repair. Side effects from the drug were reported for the whole study population and were not available for the subgroup of participants with AAA. We judged this study to be at a generally low risk of bias. We graded the quality of the evidence to low as we only included one small sized study in the review, there were few events reported and the result was consistent with benefit and harm. Larger and longer studies are needed to find out which treatment is most effective. At present, people with AAA are offered a wide range of pharmacological treatment including antiplatelet drugs, antihypertensives and lipid-lowering drugs. Future trials should test available drugs to find the most effective strategy, whether that be one single drug or a combination of treatments. In addition, the acceptability of such interventions needs to be assessed and future studies should measure adverse side effects associated with these drugs and their impact on quality of life."
] |
cochrane-simplification-train-1154 | cochrane-simplification-train-1154 | Four studies, comprising 104 participants, met the inclusion criteria. One study did not report data within the appropriate follow-up timeframe and data from two studies were insufficient for analysis. The single study from which we extracted data had 47 participants and was a randomised, controlled, parallel-group trial conducted in Sweden. It tested the hypothesis that combined treatment with serial casting and botulinum toxin type A (BTX) was more effective than serial casting alone in reducing ITW gait. This study found that more participants treated with BTX improved (defined as toe walking less than 50% of the time, as reported by parents) (risk ratio (RR) 1.21, 95% confidence interval (CI) 0.57 to 2.55; 1 trial, 46 participants; very low-certainty evidence). However, there was little or no difference between groups in passive ankle joint dorsiflexion range of movement on the right with the knee extended (mean difference (MD) -1.48º, 95% CI -4.13 to 1.16; 1 trial, 47 participants), on the right with the knee flexed (MD -0.04º, 95% CI -1.80 to 1.73; 1 trial, 46 participants), on the left with the knee flexed (MD 1.07, 95% CI -1.22 to 3.37), or on the left with the knee extended (MD 0.05, 95% CI -0.91 to 1.91). Nor was there a clear difference between the groups in recurrence of toe-walking gait (assessed via severity of toe walking (graded 1 (mild), 2 (moderate), or 3 (severe)) on gait analysis, analysed as continuous data: MD 0.34 points, 95% CI -0.09 to 0.78; 46 participants). In principle, MDs greater than zero (i.e.) positive values) would favour BTX and casting and negative values would favour casting alone. We have not reported effects as better or worse because all results were from evidence of very low certainty. We downgraded the certainty of evidence because of study limitations (outcome assessment was not blinded) and imprecision. Outcomes of pain and active range of motion were not reported in the included study. In terms of adverse events, calf pain was reported twice in the casting-only group and three times in the BTX group. There were three minor skin problems in each group and one reported case of pain directly after BTX injection. The report did not state if calf pain and skin irritation were from the same or different participants. The study authors reported that adverse events did not alter treatment adherence. The certainty of evidence from one study, which compared serial casting with serial casting with BTX for ITW in children, was too low for conclusions to be drawn. A further three studies reported outcomes relating to BTX, footwear, exercises, and different types of orthoses as interventions, however the outcome data were too limited to assess their effects. | Four trials met the inclusion criteria. They included a total of 104 people; however, three trials did not provide results that we could include in the review. (One trial studied different kinds of foot orthoses, which are in-shoe devices that redistribute force and change gait), and two investigated the effects of adding botulinum toxin injections to various treatments such as stretching, exercises, splints, and footwear.) This review therefore only included the results of one trial, in which 47 children (aged between 5 and 14.5 years) received treatment with either plaster casts alone or plaster casts and injections of botulinum toxin A (BTX) into calf muscles. The study reported how much the children toe walked (based on their parents' observation), any change in ankle range of movement, and relapse (whether the children were still toe walking 12 months after treatment). The included study took place in Sweden and was not funded by anyone with a commercial interest in the results of the study. The evidence was too uncertain to determine whether or not there were differences in outcomes (amount of toe walking observed by parents, range of movement at the ankle, or recurrence of toe walking at 12 months) between children who received plaster casts and injections of BTX into calf muscles, compared to those who received plaster casts alone. There were small numbers of adverse events in both groups, including calf pain and minor skin problems during treatment. The available evidence is too uncertain to determine whether treatment with BTX injections and plaster casts are any more effective than just plaster casts in children with toe walking not associated with a medical condition. The limited evidence found in this review indicates a need for future research on treatments for this condition. | 10.1002/14651858.CD012363.pub2 | [
"Four trials met the inclusion criteria. They included a total of 104 people; however, three trials did not provide results that we could include in the review. (One trial studied different kinds of foot orthoses, which are in-shoe devices that redistribute force and change gait), and two investigated the effects of adding botulinum toxin injections to various treatments such as stretching, exercises, splints, and footwear.) This review therefore only included the results of one trial, in which 47 children (aged between 5 and 14.5 years) received treatment with either plaster casts alone or plaster casts and injections of botulinum toxin A (BTX) into calf muscles. The study reported how much the children toe walked (based on their parents' observation), any change in ankle range of movement, and relapse (whether the children were still toe walking 12 months after treatment). The included study took place in Sweden and was not funded by anyone with a commercial interest in the results of the study. The evidence was too uncertain to determine whether or not there were differences in outcomes (amount of toe walking observed by parents, range of movement at the ankle, or recurrence of toe walking at 12 months) between children who received plaster casts and injections of BTX into calf muscles, compared to those who received plaster casts alone. There were small numbers of adverse events in both groups, including calf pain and minor skin problems during treatment. The available evidence is too uncertain to determine whether treatment with BTX injections and plaster casts are any more effective than just plaster casts in children with toe walking not associated with a medical condition. The limited evidence found in this review indicates a need for future research on treatments for this condition."
] |
cochrane-simplification-train-1155 | cochrane-simplification-train-1155 | We included 15 RCTs, conducted primarily in North America and Europe, that had enrolled 4157 type 1 and 9512 type 2 diabetic participants, ranging from 16 to 2130 participants in individual trials. In 10 of the 15 RCTs, one group of participants was assigned to one or more anti-hypertensive agents and the control group received placebo. In three trials, intense blood pressure control was compared to less intense blood pressure control. In the remaining two trials, blood pressure control was compared with usual care. Five of the 15 trials enrolled type 1 diabetics, and 10 trials enrolled type 2 diabetics. Six trials were sponsored entirely by pharmaceutical companies, seven trials received partial support from pharmaceutical companies, and two studies received support from government-sponsored grants and institutional support. Study designs, populations, interventions, and lengths of follow-up (range one to nine years) varied among the included trials. Overall, the quality of the evidence for individual outcomes was low to moderate. For the primary outcomes, incidence and progression of retinopathy, the quality of evidence was downgraded due to inconsistency and imprecision of estimates from individual studies and differing characteristics of participants. For primary outcomes among type 1 diabetics, one of the five trials reported incidence of retinopathy and one trial reported progression of retinopathy after 4 to 5 years of treatment and follow-up; four of the five trials reported a combined outcome of incidence and progression over the same time interval. Among type 2 diabetics, 5 of the 10 trials reported incidence of diabetic retinopathy and 3 trials reported progression of retinopathy; one of the 10 trials reported a combined outcome of incidence and progression during a 4- to 5-year follow-up period. One trial in which type 2 diabetics participated had reported no primary (or secondary) outcome targeted for this review. The evidence from these trials supported a benefit of more intensive blood pressure control intervention with respect to 4- to 5-year incidence of diabetic retinopathy (estimated risk ratio (RR) 0.80; 95% confidence interval (CI) 0.71 to 0.92) and the combined outcome of incidence and progression (estimated RR 0.78; 95% CI 0.63 to 0.97). The available evidence provided less support for a benefit with respect to 4- to 5-year progression of diabetic retinopathy (point estimate was closer to 1 than point estimates for incidence and combined incidence and progression, and the CI overlapped 1; estimated RR 0.88; 95% CI 0.73 to 1.05). The available evidence regarding progression to proliferative diabetic retinopathy or clinically significant macular edema or moderate to severe loss of best-corrected visual acuity did not support a benefit of intervention on blood pressure: estimated RRs and 95% CIs 0.95 (0.83 to 1.09) and 1.06 (0.85 to 1.33), respectively, after 4 to 5 years of follow-up. Findings within subgroups of trial participants (type 1 and type 2 diabetics; participants with normal blood pressure levels at baseline and those with elevated levels) were similar to overall findings. The adverse event reported most often (7 of 15 trials) was death, yielding an estimated RR 0.86 (95% CI 0.64 to 1.14). Hypotension was reported from three trials; the estimated RR was 2.08 (95% CI 1.68 to 2.57). Other adverse ocular events were reported from single trials. Hypertension is a well-known risk factor for several chronic conditions in which lowering blood pressure has proven to be beneficial. The available evidence supports a beneficial effect of intervention to reduce blood pressure with respect to preventing diabetic retinopathy for up to 4 to 5 years. However, the lack of evidence to support such intervention to slow progression of diabetic retinopathy or to prevent other outcomes considered in this review, along with the relatively modest support for the beneficial effect on incidence, weakens the conclusion regarding an overall benefit of intervening on blood pressure solely to prevent diabetic retinopathy. | We found 15 randomized controlled trials, conducted primarily in North America and Europe, to investigate the effects of methods to lower blood pressure (drug-based in 14 trials; lifestyle change in 1 trial) in 4157 type 1 and 9512 type 2 diabetics, ranging from 16 to 2130 participants in individual trials. The follow-up period ranged from one to nine years for included trials. Of the 15 trials, six were funded in full by one or more drug companies. Seven more studies received drug company support, usually in the form of study medications. The remaining two studies were conducted with support from government-sponsored grants and institutional support. The evidence is current to April 2014. Overall, the included trials provided modest support for lowering blood pressure to prevent diabetic retinopathy, regardless of diabetes type or baseline blood pressure level. However, the evidence did not indicate that lowering blood pressure kept diabetic retinopathy from worsening once it had developed or that it prevented advanced stages of diabetic retinopathy that required laser or other treatment of affected eyes. Treatment to reduce the blood pressure of people with diabetes is warranted for other health reasons, but the available evidence does not justify reduction of blood pressure solely to prevent or slow diabetic retinopathy. Overall, the quality of the evidence was low to moderate based on the reported information. The quality was downgraded mainly because some studies did not report outcomes for all or most participants at follow-up time points, and results from different studies were not highly consistent. | 10.1002/14651858.CD006127.pub2 | [
"We found 15 randomized controlled trials, conducted primarily in North America and Europe, to investigate the effects of methods to lower blood pressure (drug-based in 14 trials; lifestyle change in 1 trial) in 4157 type 1 and 9512 type 2 diabetics, ranging from 16 to 2130 participants in individual trials. The follow-up period ranged from one to nine years for included trials. Of the 15 trials, six were funded in full by one or more drug companies. Seven more studies received drug company support, usually in the form of study medications. The remaining two studies were conducted with support from government-sponsored grants and institutional support. The evidence is current to April 2014. Overall, the included trials provided modest support for lowering blood pressure to prevent diabetic retinopathy, regardless of diabetes type or baseline blood pressure level. However, the evidence did not indicate that lowering blood pressure kept diabetic retinopathy from worsening once it had developed or that it prevented advanced stages of diabetic retinopathy that required laser or other treatment of affected eyes. Treatment to reduce the blood pressure of people with diabetes is warranted for other health reasons, but the available evidence does not justify reduction of blood pressure solely to prevent or slow diabetic retinopathy. Overall, the quality of the evidence was low to moderate based on the reported information. The quality was downgraded mainly because some studies did not report outcomes for all or most participants at follow-up time points, and results from different studies were not highly consistent."
] |
cochrane-simplification-train-1156 | cochrane-simplification-train-1156 | No studies of vitamin A or other retinoid supplementation were eligible for inclusion. However, one randomised study of beta (β)-carotene supplementation involving 24 people with CF who were receiving pancreatic enzyme substitution was included. The study compared successive β-carotene supplementation periods (high dose followed by low dose) compared to placebo. The results for the low-dose supplementation period should be interpreted with caution, due to the lack of a wash-out period after the high-dose supplementation. The included study did not report on two of the review's primary outcomes (vitamin A deficiency disorders and mortality); results for our third primary outcome of growth and nutritional status (reported as z score for height) showed no difference between supplementation and placebo, mean difference (MD) -0.23 (95% confidence interval (CI) -0.89 to 0.43) (low-quality evidence). With regards to secondary outcomes, supplementation with high-dose β-carotene for three months led to significantly fewer days of systemic antibiotics required to treat pulmonary exacerbations, compared to controls, MD -15 days (95% CI -27.60 to -2.40); however, this was not maintained in the second three-month section of the study when the level of β-carotene supplementation was reduced, MD -8 days (95% CI -18.80 to 2.80) (low-quality evidence). There were no statistically significant effects between groups in lung function (low-quality evidence) and no adverse events were observed (low-quality evidence). Supplementation affected levels of β-carotene in plasma, but not vitamin A levels. The study did not report on quality of life or toxicity. Since no randomised or quasi-randomised controlled studies on retinoid supplementation were identified, no conclusion on the supplementation of vitamin A in people with CF can be drawn. Additionally, due to methodological limitations in the included study, also reflected in the low-quality evidence judged following the specific evidence grading system (GRADE), no clear conclusions on β-carotene supplementation can be drawn. Until further data are available, country- or region-specific guidelines regarding these practices should be followed. | No studies comparing vitamin A or other retinoid supplements to placebo (dummy drug containing no vitamin A) were included, but we did find one study comparing beta-carotene supplementation (a precursor of vitamin A) to placebo. A total of 24 people with cystic fibrosis (aged 6.7 to 27.7 years) were put into groups at random and treated either with β-carotene capsules (at a high dose for three months followed by a low dose for a further three months) or with placebo (for six months). No studies on vitamin A supplementation were included in this review. The single included study revealed that high-dose beta-carotene supplementation for three months led to fewer days on which people with CF required antibiotics compared to placebo, but this was not the case in the following three-month section of the study when low-dose beta-carotene supplementation was compared to placebo. Other clinical outcome measures (growth, nutritional status and lung function) showed no statistical significant differences between treatment and placebo groups. No side effects were observed. The other outcomes in this review, such as vitamin A deficiency symptoms, mortality, toxicity and quality of life, were not reported. We could only include one study in this review and that study had several limitations. This is reflected in the assessment of low-quality evidence, judged using the specific evidence grading system (GRADE). So, we feel that the strength of evidence is low. Not all outcome measures were reported after each supplementation dose and results should be viewed with some caution as some beta-carotene from the high-dose period was probably still present in the blood during the low-dose supplementation period. Since no studies on vitamin A supplementation were included in the review, no conclusions can be drawn regarding the routine use of vitamin A supplements. Due to limitations of the included study of beta-carotene supplementation, no definitive conclusions regarding its use can be drawn either. Until further evidence is available, local guidelines should be followed regarding supplementation. | 10.1002/14651858.CD006751.pub5 | [
"No studies comparing vitamin A or other retinoid supplements to placebo (dummy drug containing no vitamin A) were included, but we did find one study comparing beta-carotene supplementation (a precursor of vitamin A) to placebo. A total of 24 people with cystic fibrosis (aged 6.7 to 27.7 years) were put into groups at random and treated either with β-carotene capsules (at a high dose for three months followed by a low dose for a further three months) or with placebo (for six months). No studies on vitamin A supplementation were included in this review. The single included study revealed that high-dose beta-carotene supplementation for three months led to fewer days on which people with CF required antibiotics compared to placebo, but this was not the case in the following three-month section of the study when low-dose beta-carotene supplementation was compared to placebo. Other clinical outcome measures (growth, nutritional status and lung function) showed no statistical significant differences between treatment and placebo groups. No side effects were observed. The other outcomes in this review, such as vitamin A deficiency symptoms, mortality, toxicity and quality of life, were not reported. We could only include one study in this review and that study had several limitations. This is reflected in the assessment of low-quality evidence, judged using the specific evidence grading system (GRADE). So, we feel that the strength of evidence is low. Not all outcome measures were reported after each supplementation dose and results should be viewed with some caution as some beta-carotene from the high-dose period was probably still present in the blood during the low-dose supplementation period. Since no studies on vitamin A supplementation were included in the review, no conclusions can be drawn regarding the routine use of vitamin A supplements. Due to limitations of the included study of beta-carotene supplementation, no definitive conclusions regarding its use can be drawn either. Until further evidence is available, local guidelines should be followed regarding supplementation."
] |
cochrane-simplification-train-1157 | cochrane-simplification-train-1157 | Nine trials that included 1337 participants (with 469 deaths) met the inclusion criteria. At follow-up from three to 18 months, steroids reduce deaths by almost one quarter (RR 0.75, 95% CI 0.65 to 0.87; nine trials, 1337 participants, high quality evidence). Disabling neurological deficit is not common in survivors, and steroids may have little or no effect on this outcome (RR 0.92, 95% CI 0.71 to 1.20; eight trials, 1314 participants, low quality evidence). There was no difference between groups in the incidence of adverse events, which included gastrointestinal bleeding, invasive bacterial infections, hyperglycaemia, and liver dysfunction. One trial followed up participants for five years. The effect on death was no longer apparent at this time-point (RR 0.93, 95% CI 0.78 to 1.12; one trial, 545 participants, moderate quality evidence); and there was no difference in disabling neurological deficit detected (RR 0.91, 95% CI 0.49 to 1.69; one trial, 545 participants, low quality evidence). One trial included human immunodeficiency virus (HIV)-positive people. The stratified analysis by HIV status in this trial showed no heterogeneity, with point estimates for death (RR 0.90, 95% CI 0.67 to 1.20; one trial, 98 participants) and disability (RR 1.23, 95% CI 0.08 to 19.07; one trial, 98 participants) similar to HIV-negative participants in the same trial. Corticosteroids reduce mortality from tuberculous meningitis, at least in the short term. Corticosteroids may have no effect on the number of people who survive tuberculous meningitis with disabling neurological deficit, but this outcome is less common than death, and the CI for the relative effect includes possible harm. However, this small possible harm is unlikely to be quantitatively important when compared to the reduction in mortality. The number of HIV-positive people included in the review is small, so we are not sure if the benefits in terms of reduced mortality are preserved in this group of patients. | We examined the evidence published up to 18 March 2016 and included nine trials with 1337 people that evaluated either dexamethasone, methylprednisolone, or prednisolone given in addition to antituberculous drugs; one trial was of high quality, while the other trials had uncertainties over study quality due to incomplete reporting. The analysis shows that corticosteroids reduce the risk of death by a quarter at two months to two years after treatment was started (high quality evidence). Corticosteroids make little or no difference to the number of people who survive TB meningitis with brain damage causing disability (low quality evidence); because this event is uncommon, even taking the most pessimistic estimate from the analysis of a slight increased risk with corticosteroids means this would not be quantitatively important when compared to the reduction in deaths. One trial followed up participants for five years, by which time there was no difference in the effect on death between the two groups, although the reason for this change over time is unknown. Only one trial evaluated the effects of corticosteroids in human immunodeficiency virus (HIV)-positive people but the number is small so we are not sure if the benefits in terms of fewer deaths are preserved in this group of patients. | 10.1002/14651858.CD002244.pub4 | [
"We examined the evidence published up to 18 March 2016 and included nine trials with 1337 people that evaluated either dexamethasone, methylprednisolone, or prednisolone given in addition to antituberculous drugs; one trial was of high quality, while the other trials had uncertainties over study quality due to incomplete reporting. The analysis shows that corticosteroids reduce the risk of death by a quarter at two months to two years after treatment was started (high quality evidence). Corticosteroids make little or no difference to the number of people who survive TB meningitis with brain damage causing disability (low quality evidence); because this event is uncommon, even taking the most pessimistic estimate from the analysis of a slight increased risk with corticosteroids means this would not be quantitatively important when compared to the reduction in deaths. One trial followed up participants for five years, by which time there was no difference in the effect on death between the two groups, although the reason for this change over time is unknown. Only one trial evaluated the effects of corticosteroids in human immunodeficiency virus (HIV)-positive people but the number is small so we are not sure if the benefits in terms of fewer deaths are preserved in this group of patients."
] |
cochrane-simplification-train-1158 | cochrane-simplification-train-1158 | Eight RCTs met the inclusion criteria. Six of the trials provided data for this review and all of these were at high risk of bias. Six trials randomised a total of 815 participants to subcutaneous closure (410 participants) or no subcutaneous closure (405 participants). Overall, 7.7% of participants (63/815 of participants) developed superficial surgical site infections and there was no clear evidence of a difference between the two intervention groups (RR 0.84; 95% CI 0.53 to 1.33; very low quality evidence). Only two trials reported superficial wound dehiscence, with 7.9% (17/215) of participants developing the problem. It is not clear whether the lack of reporting of this outcome in other trials was because it did not occur, or was not measured. There was no clear evidence of a between-group difference in the proportion of participants who developed superficial wound dehiscence in the trials that reported this outcome (RR 0.56; 95% CI 0.22 to 1.41; very low quality evidence). Only one trial reported deep wound dehiscence, which occurred in 8.3% (5/60) of participants. There was no clear evidence of a difference in the proportion of participants who developed deep wound dehiscence between the two groups (RR 0.25; 95% CI 0.03 to 2.11; very low quality evidence). Three trials reported the length of hospital stay and found no significant difference between groups (MD 0.10 days; 95% CI -0.45 to 0.64; very low quality evidence). We do not know whether this review reveals a lack of effect or lack of evidence of effect. The confidence intervals for these outcomes were wide, and significant benefits or harms from subcutaneous closure cannot be ruled out. In addition, none of the trials assessed the impact of subcutaneous closure on quality of life, long-term patient outcomes (the follow-up period in the trials varied between one week and two months after surgery) or financial implications to the healthcare provider. There is currently evidence of very low quality which is insufficient to support or refute subcutaneous closure after non-caesarean operations. The use of subcutaneous closure has the potential to affect patient outcomes and utilisation of healthcare resources. Further well-designed trials at low risk of bias are necessary. | We identified six randomised controlled trials that reported one or more of the outcomes we thought were important. There may have been flaws in trial conduct that could produce incorrect results. The six trials that provided data for this review included 815 participants (410 participants had subcutaneous closure of incisions and 405 participants did not). In the trials that reported the outcomes, overall 7% of participants developed superficial wound infection, 8% of participants developed superficial separation of wounds, and 8% of participants developed deeper separation of layers in both the groups but there was no clear evidence of a difference in incidence between the subcutaneous closure group and the no subcutaneous closure group. There was no clear evidence of a difference in the length of hospital stay between the groups. We do not know whether these results indicate that there is really no difference between subcutaneous closure and no subcutaneous closure, or that there are problems with study design that make it difficult to identify true differences between the two techniques. So significant benefits or harms of subcutaneous closure cannot be ruled out. Furthermore, no trial assessed the impact of subcutaneous closure on quality of life, long-term patient outcomes (trial follow-up periods varied between one week and two months after surgery) or financial implications to healthcare providers. There is currently no evidence to support or condemn subcutaneous closure after non-childbirth surgery. Further well-designed trials are necessary. | 10.1002/14651858.CD010425.pub2 | [
"We identified six randomised controlled trials that reported one or more of the outcomes we thought were important. There may have been flaws in trial conduct that could produce incorrect results. The six trials that provided data for this review included 815 participants (410 participants had subcutaneous closure of incisions and 405 participants did not). In the trials that reported the outcomes, overall 7% of participants developed superficial wound infection, 8% of participants developed superficial separation of wounds, and 8% of participants developed deeper separation of layers in both the groups but there was no clear evidence of a difference in incidence between the subcutaneous closure group and the no subcutaneous closure group. There was no clear evidence of a difference in the length of hospital stay between the groups. We do not know whether these results indicate that there is really no difference between subcutaneous closure and no subcutaneous closure, or that there are problems with study design that make it difficult to identify true differences between the two techniques. So significant benefits or harms of subcutaneous closure cannot be ruled out. Furthermore, no trial assessed the impact of subcutaneous closure on quality of life, long-term patient outcomes (trial follow-up periods varied between one week and two months after surgery) or financial implications to healthcare providers. There is currently no evidence to support or condemn subcutaneous closure after non-childbirth surgery. Further well-designed trials are necessary."
] |
cochrane-simplification-train-1159 | cochrane-simplification-train-1159 | Four studies were identified that met pre-determined eligibility criteria, evaluating a total of 342 adults. From the four studies, all assessed as at high risk of bias, three broad interventions were identified that may potentially reduce the risk of ORN development: one study showed no reduction in ORN when using platelet-rich plasma placed in the extraction sockets of prophylactically removed healthy mandibular molar teeth prior to radiotherapy (odds ratio (OR) 3.32, 95% confidence interval (CI) 0.58 to 19.09; one trial, 44 participants; very low-certainty evidence). Another study involved comparing fluoride gel and high-content fluoride toothpaste (1350 parts per million (ppm)) in prevention of post-radiation caries, and found no difference between their use as no cases of ORN were reported (one trial, 220 participants; very low-certainty evidence). The other two studies involved the use of perioperative hyperbaric oxygen (HBO) therapy and antibiotics. One study showed that treatment with HBO caused a reduction in the development of ORN in comparison to patients treated with antibiotics following dental extractions (risk ratio (RR) 0.18, 95% CI 0.43 to 0.76; one trial, 74 participants; very low-certainty evidence). Another study found no difference between combined HBO and antibiotics compared to antibiotics alone prior to dental implant placement (RR 3.00, 95% CI 0.14 to 65.16; one trial, 26 participants; very low-certainty evidence). Adverse effects of the different interventions were not reported clearly or were not important. Given the suboptimal reporting and inadequate sample sizes of the included studies, evidence regarding the interventions evaluated by the trials included in this review is uncertain. More well-designed RCTs with larger samples are required to make conclusive statements regarding the efficacy of these interventions. | This review is up-to-date as of 5 November 2019. The review includes four studies involving 342 adults who had received radiotherapy for the treatment of head and neck cancer. The review looks at three different ways to prevent ORN: - the use of platelet-rich plasma (PRP) in bone after removal of healthy teeth prior to radiotherapy. Plasma is a part of blood that contains special proteins that help the blood to clot, and PRP is concentrated plasma which supports cell growth. Injecting PRP into damaged tissue may stimulate the body to grow new, healthy cells to make it heal more quickly; - taking out teeth because of tooth decay makes the risk of developing ORN greater. Preventing tooth decay in people having radiotherapy is very important. We looked at a study comparing using fluoride gel with a toothpaste with a higher level of fluoride than normal to prevent tooth decay after radiotherapy; - hyperbaric oxygen therapy is breathing oxygen in a pressurized chamber to improve blood supply, which may help heal damaged tissue. Two studies compared the use of hyperbaric oxygen therapy for taking out teeth or placing dental implants with antibiotics. Antibiotics are drugs which stop or slow the growth of bacteria. One study showed no reduction in ORN when using platelet-rich plasma in bone after the removal of healthy teeth. Another study found no difference between fluoride gel and toothpaste with a higher level of fluoride than normal as no cases of ORN were reported. A third study showed that treatment with hyperbaric oxygen therapy caused a reduction in the development of ORN in comparison to patients treated with antibiotics following the removal of teeth. The fourth study found no difference between combined hyperbaric oxygen therapy and antibiotics compared to antibiotics alone. Harmful effects of the different interventions were not reported clearly or were not important. The level of certainty we have in these findings is very low. This was due to high risk of bias, not all studies mentioning important details, and the small number of people studied in the four included trials. We do not have enough evidence to say which intervention works better to stop ORN of the jaws from happening or making it less severe in adults receiving head and neck radiotherapy. We suggest that more, well-conducted, and bigger studies including more people, should be done in this area. | 10.1002/14651858.CD011559.pub2 | [
"This review is up-to-date as of 5 November 2019. The review includes four studies involving 342 adults who had received radiotherapy for the treatment of head and neck cancer. The review looks at three different ways to prevent ORN: - the use of platelet-rich plasma (PRP) in bone after removal of healthy teeth prior to radiotherapy. Plasma is a part of blood that contains special proteins that help the blood to clot, and PRP is concentrated plasma which supports cell growth. Injecting PRP into damaged tissue may stimulate the body to grow new, healthy cells to make it heal more quickly; - taking out teeth because of tooth decay makes the risk of developing ORN greater. Preventing tooth decay in people having radiotherapy is very important. We looked at a study comparing using fluoride gel with a toothpaste with a higher level of fluoride than normal to prevent tooth decay after radiotherapy; - hyperbaric oxygen therapy is breathing oxygen in a pressurized chamber to improve blood supply, which may help heal damaged tissue. Two studies compared the use of hyperbaric oxygen therapy for taking out teeth or placing dental implants with antibiotics. Antibiotics are drugs which stop or slow the growth of bacteria. One study showed no reduction in ORN when using platelet-rich plasma in bone after the removal of healthy teeth. Another study found no difference between fluoride gel and toothpaste with a higher level of fluoride than normal as no cases of ORN were reported. A third study showed that treatment with hyperbaric oxygen therapy caused a reduction in the development of ORN in comparison to patients treated with antibiotics following the removal of teeth. The fourth study found no difference between combined hyperbaric oxygen therapy and antibiotics compared to antibiotics alone. Harmful effects of the different interventions were not reported clearly or were not important. The level of certainty we have in these findings is very low. This was due to high risk of bias, not all studies mentioning important details, and the small number of people studied in the four included trials. We do not have enough evidence to say which intervention works better to stop ORN of the jaws from happening or making it less severe in adults receiving head and neck radiotherapy. We suggest that more, well-conducted, and bigger studies including more people, should be done in this area."
] |
cochrane-simplification-train-1160 | cochrane-simplification-train-1160 | From the three small (total n=250) short included studies, we were unable to extract any data on many broad clinically important outcomes such as global state, use of services, and satisfaction with treatment. When Ayurvedic herbs were compared with placebo, about 20% of people left the studies early (n=120, 2 RCTs, RR 0.77 CI 0.37 to 1.62). Mental state ratings were mostly equivocal with the exception of the brahmyadiyoga group using Ayurvedic assessment (n=68, 1 RCT, RR not improved 0.56 CI 0.36 to 0.88, NNT 4 CI 3 to 12). Behaviour seemed unchanged (n=43, 1 RCT, WMD Fergus Falls Behaviour Rating 1.14 CI -1.63 to 3.91). Nausea and vomiting were common in the brahmyadiyoga group (n=43, RR 13.13 CI 0.80 to 216.30). When the Ayurvedic herbs were compared with antipsychotic drugs (chlorpromazine), again, equal numbers left the study early (n=120, 2 RCTs, RR for brahmyadiyoga 0.91 CI 0.42 to 1.97) but people allocated herbs were at greater risk of no improvement in mental state compared to those allocated chlorpromazine (n=45, RR 1.82 CI 1.11 to 2.98). Again, nausea and vomiting were found with use of brahmyadiyoga (n=45, 1 RCT, RR 20.45 CI 1.09 to 383.97, NNH 2 CI 2 to 38). Finally, when Ayurvedic treatment, in this case a complex mixture of many herbs, is compared with chlorpromazine in acutely ill people with schizophrenia, it is equally (˜10% attrition, n=36, RR 0.67 CI 0.13 to 3.53), but skewed data does seem to favour the chlorpromazine group. Ayurvedic medication may have some effects for treatment of schizophrenia, but has been evaluated only in a few small pioneering trials. | This review examines randomised controlled trials which compare aspects of ayurvedic medicine with the use of antipsychotics for people with schizophrenia. All trials took place in India and were for 12 weeks or less. When the ayurvedic herbs brahmyadiyoga and tagara were compared to placebo (2 trials) there was no significant difference between the two groups in acceptability of treatment or overall improvement. The brahmyadiyoga group did, however, show some improvement when assessed ayurvedically (a combination of assessing aspects of the mind, decision, orientation, memory and habit, and looking for the absence of symptoms of illness). When these two herbs were compared to groups of people taking the antipsychotic, chlorpromazine, again there was no difference in acceptability of treatment, but in one of the two trials there was an improvement in mental state in those taking chlorpromazine. There was also a trial comparing an ayurvedic package (of herbs and other treatment) to chlorpromazine, and although both treatments were acceptable, the rest of the data were not able to be used. Brahmyadiyoga and tagara tended to have vomiting and nausea as an adverse effect, while chlorpromazine caused people to be sleepy. It may be possible that ayurvedic treatments could be used as adjuncts to antipsychotic medication. A new larger trial comparing ayurvedic herb(s) alone, chlorpromazine alone and both together would answer this question. (Plain language summary prepared for this review by Janey Antoniou of RETHINK, UK www.rethink.org). | 10.1002/14651858.CD006867 | [
"This review examines randomised controlled trials which compare aspects of ayurvedic medicine with the use of antipsychotics for people with schizophrenia. All trials took place in India and were for 12 weeks or less. When the ayurvedic herbs brahmyadiyoga and tagara were compared to placebo (2 trials) there was no significant difference between the two groups in acceptability of treatment or overall improvement. The brahmyadiyoga group did, however, show some improvement when assessed ayurvedically (a combination of assessing aspects of the mind, decision, orientation, memory and habit, and looking for the absence of symptoms of illness). When these two herbs were compared to groups of people taking the antipsychotic, chlorpromazine, again there was no difference in acceptability of treatment, but in one of the two trials there was an improvement in mental state in those taking chlorpromazine. There was also a trial comparing an ayurvedic package (of herbs and other treatment) to chlorpromazine, and although both treatments were acceptable, the rest of the data were not able to be used. Brahmyadiyoga and tagara tended to have vomiting and nausea as an adverse effect, while chlorpromazine caused people to be sleepy. It may be possible that ayurvedic treatments could be used as adjuncts to antipsychotic medication. A new larger trial comparing ayurvedic herb(s) alone, chlorpromazine alone and both together would answer this question. (Plain language summary prepared for this review by Janey Antoniou of RETHINK, UK www.rethink.org)."
] |
cochrane-simplification-train-1161 | cochrane-simplification-train-1161 | We identified six RCTs (1501 participants) that met the inclusion criteria. We evaluated risk of bias and judged it to be unclear for generation of allocation sequence in four studies and low in two studies; unclear for allocation concealment in five studies and low in one study; high for incomplete outcome data (attrition bias) in five studies and unclear in one study; unclear for blinding; high for selective reporting in four studies and unclear in two; and high for other sources of bias in three studies and unclear in the rest. The manufacturer of cerebrolysin, pharmaceutical company EVER Neuro Pharma, supported three multi-centre studies, either totally, or providing cerebrolysin and placebo, randomisation codes, research grants, or statisticians. None of the included trials reported on poor functional outcome defined as death or dependence at the end of the follow-up period or early death (within two weeks of stroke onset). All-cause death: we extracted data from five trials (1417 participants). There was no difference in the number of deaths: 46/714 in cerebrolysin group versus 47/703 in placebo group; risk ratio (RR) 0.91 95% confidence interval (CI) 0.61 to 1.35 (5 trials, 1417 participants, moderate-quality evidence). Serious adverse events (SAEs): there was no significant difference in the total number of SAEs with cerebrolysin (RR 1.16, 95% CI 0.81 to 1.67). This comprised no difference in fatal SAEs (RR 0.90, 95% CI 0.59 to 1.38) and an increase in the number of people with non-fatal SAEs (20/667 with cerebrolysin and 8/668 with placebo: RR 2.47, 95% CI 1.09 to 5.58, P = 0.03) (3 trials, 1335 participants, moderate-quality evidence). Total number of people with adverse events: three trials reported on this. There was no difference in the total number of people with adverse events: 308/667 in cerebrolysin group versus 307/668 in placebo group; RR 0.97 95% CI 0.86 to 1.09, random-effects model (3 trials, 1335 participants, moderate-quality evidence). The findings of this Cochrane Review do not demonstrate clinical benefits of cerebrolysin for treating acute ischaemic stroke. We found moderate-quality evidence of an increase in non-fatal SAEs with cerebrolysin use but not in total SAEs. | This review included six RCTs with a total of 1501 participants that compared cerebrolysin with placebo (inactive medication) added to standard treatment of acute stroke, including thrombolysis. Three of them were large multicentre studies, two were small in size and were judged to be of unclear quality, and one did not include numerical results. The evidence is current up to June 2016. This review of six trials involving 1501 participants showed no beneficial effect of cerebrolysin in terms of death in people with acute ischaemic stroke. There was no difference in the total number of people with adverse events but a concern that cerebrolysin may increase the risk of people having non-fatal serious adverse events compared with placebo. The medication and methodology of the majority of included trials were provided by the manufacturer of cerebrolysin creating a likely conflict of interest. There is moderate-quality evidence currently available that suggests cerebrolysin performs no better than placebo in terms of all-cause death when given to people with acute ischaemic stroke within 48 hours of stroke onset. There is moderate-quality evidence that raises concerns about the increase of serious adverse events with cerebrolysin use in people with acute ischaemic stroke. Further research is likely to have an important impact on our confidence in the estimate of cerebrolysin risks in contributing to serious adverse events in people with acute stroke. | 10.1002/14651858.CD007026.pub5 | [
"This review included six RCTs with a total of 1501 participants that compared cerebrolysin with placebo (inactive medication) added to standard treatment of acute stroke, including thrombolysis. Three of them were large multicentre studies, two were small in size and were judged to be of unclear quality, and one did not include numerical results. The evidence is current up to June 2016. This review of six trials involving 1501 participants showed no beneficial effect of cerebrolysin in terms of death in people with acute ischaemic stroke. There was no difference in the total number of people with adverse events but a concern that cerebrolysin may increase the risk of people having non-fatal serious adverse events compared with placebo. The medication and methodology of the majority of included trials were provided by the manufacturer of cerebrolysin creating a likely conflict of interest. There is moderate-quality evidence currently available that suggests cerebrolysin performs no better than placebo in terms of all-cause death when given to people with acute ischaemic stroke within 48 hours of stroke onset. There is moderate-quality evidence that raises concerns about the increase of serious adverse events with cerebrolysin use in people with acute ischaemic stroke. Further research is likely to have an important impact on our confidence in the estimate of cerebrolysin risks in contributing to serious adverse events in people with acute stroke."
] |
cochrane-simplification-train-1162 | cochrane-simplification-train-1162 | We included 19 studies involving 1940 participants in this updated review. Of those 1940 participants, 952 received topical or systemic lidocaine therapy and 795 were allocated to the control groups. Topical and systemic lidocaine therapy appeared to reduce the risk of postoperative sore throat (16 studies, 1774 participants, risk ratio (RR) was 0.64 (95% confidence interval (CI) 0.48 to 0.85), the quality of the evidence was low), although when only high-quality trials were included (eight studies, 814 participants) the effect was no longer significant (RR 0.71, 95% CI 0.47 to 1.09). Lidocaine given systemically in two studies (320 participants) did not reveal evidence of an effect (RR 0.44, 95% CI 0.19 to 1.05 ). The severity of sore throat as measured on a visual-analogue scale (VAS) was reduced by lidocaine therapy (six trials, 611 participants, (mean difference (MD) -10.80, 95% CI -14.63 to -6.98). The adverse effects of lidocaine were not reported in these studies, though toxicity is generally rare. In our revised systematic review, although the results of included studies show generally positive results, they should be interpreted carefully. The effect size of lidocaine appeared to be affected by study quality; drug concentration; route of administration; management of cuff pressure during anaesthesia; the included population; and the type of outcome measured. | The evidence is current to October 2013. We included 19 randomized controlled trials (1940 participants) in this updated review. (We reran the search in February 2015 and found four studies of interest. We will deal with those studies when we next update the review.) Lidocaine was either put into the cuff (the cuff makes sure that the tube stays in place), sprayed onto the person's vocal cords, or used as a gel smeared on the end of the tube. The summarized results of the included studies showed positive results. However, the interpretation of the results should be judged carefully. Though the possible adverse effects of using lidocaine were not reported in the included studies, there are a few case reports about lidocaine toxicity, although this is very rare. For lidocaine therapy versus control, the quality of the evidence for risk of sore throat was low (according to Grading of Recommendations Assessment, Development and Evaluation (GRADE)). This is because most of the trials did not describe how allocation was concealed and the results of the risk of sore throat were inconsistent, the quality of the evidence of the severity of sore throat , measured by the visual-analogue scale, was moderate (according to GRADE). | 10.1002/14651858.CD004081.pub3 | [
"The evidence is current to October 2013. We included 19 randomized controlled trials (1940 participants) in this updated review. (We reran the search in February 2015 and found four studies of interest. We will deal with those studies when we next update the review.) Lidocaine was either put into the cuff (the cuff makes sure that the tube stays in place), sprayed onto the person's vocal cords, or used as a gel smeared on the end of the tube. The summarized results of the included studies showed positive results. However, the interpretation of the results should be judged carefully. Though the possible adverse effects of using lidocaine were not reported in the included studies, there are a few case reports about lidocaine toxicity, although this is very rare. For lidocaine therapy versus control, the quality of the evidence for risk of sore throat was low (according to Grading of Recommendations Assessment, Development and Evaluation (GRADE)). This is because most of the trials did not describe how allocation was concealed and the results of the risk of sore throat were inconsistent, the quality of the evidence of the severity of sore throat , measured by the visual-analogue scale, was moderate (according to GRADE)."
] |
cochrane-simplification-train-1163 | cochrane-simplification-train-1163 | No new studies were found for this update. Thirteen studies (4222 participants) compared aspirin 900 mg or 1000 mg, alone or in combination with metoclopramide 10 mg, with placebo or other active comparators, mainly sumatriptan 50 mg or 100 mg. For all efficacy outcomes, all active treatments were superior to placebo, with NNTs of 8.1, 4.9 and 6.6 for 2-hour pain-free, 2-hour headache relief, and 24-hour headache relief with aspirin alone versus placebo, and 8.8, 3.3 and 6.2 with aspirin plus metoclopramide versus placebo. Sumatriptan 50 mg did not differ from aspirin alone for 2-hour pain-free and headache relief, while sumatriptan 100 mg was better than the combination of aspirin plus metoclopramide for 2-hour pain-free, but not headache relief; there were no data for 24-hour headache relief. Adverse events were mostly mild and transient, occurring slightly more often with aspirin than placebo. Additional metoclopramide significantly reduced nausea (P < 0.00006) and vomiting (P = 0.002) compared with aspirin alone. We found no new studies since the last version of this review. Aspirin 1000 mg is an effective treatment for acute migraine headaches, similar to sumatriptan 50 mg or 100 mg. Addition of metoclopramide 10 mg improves relief of nausea and vomiting. Adverse events were mainly mild and transient, and were slightly more common with aspirin than placebo, but less common than with sumatriptan 100 mg. | This is an updated version of the original Cochrane review published in Issue 4, 2010 (Kirthi 2010); no new studies were found. A single oral dose of 1000 mg of aspirin reduced pain from moderate or severe to none by two hours in approximately 1 in 4 people (24%) taking aspirin, compared with about 1 in 10 (11%) taking placebo. Pain was reduced from moderate or severe to no worse than mild pain by two hours in roughly 1 in 2 people (52%) taking aspirin compared with approximately 1 in 3 (32%) taking placebo. Of those who experienced effective headache relief at two hours, more had that relief sustained over 24 hours with aspirin than with placebo. Addition of 10 mg of the antiemetic metoclopramide substantially increased relief of nausea and vomiting compared with aspirin alone, but made little difference to pain. Oral sumatriptan 100 mg was better than aspirin plus metoclopramide for pain-free response at two hours, but otherwise there were no major differences between aspirin with or without metoclopramide and sumatriptan 50 mg or 100 mg. Adverse events with short-term use were mostly mild and transient, occurring slightly more often with aspirin than placebo, and more often with sumatriptan 100 mg than with aspirin. | 10.1002/14651858.CD008041.pub3 | [
"This is an updated version of the original Cochrane review published in Issue 4, 2010 (Kirthi 2010); no new studies were found. A single oral dose of 1000 mg of aspirin reduced pain from moderate or severe to none by two hours in approximately 1 in 4 people (24%) taking aspirin, compared with about 1 in 10 (11%) taking placebo. Pain was reduced from moderate or severe to no worse than mild pain by two hours in roughly 1 in 2 people (52%) taking aspirin compared with approximately 1 in 3 (32%) taking placebo. Of those who experienced effective headache relief at two hours, more had that relief sustained over 24 hours with aspirin than with placebo. Addition of 10 mg of the antiemetic metoclopramide substantially increased relief of nausea and vomiting compared with aspirin alone, but made little difference to pain. Oral sumatriptan 100 mg was better than aspirin plus metoclopramide for pain-free response at two hours, but otherwise there were no major differences between aspirin with or without metoclopramide and sumatriptan 50 mg or 100 mg. Adverse events with short-term use were mostly mild and transient, occurring slightly more often with aspirin than placebo, and more often with sumatriptan 100 mg than with aspirin."
] |
cochrane-simplification-train-1164 | cochrane-simplification-train-1164 | Seven studies met the inclusion criteria of the review (2652 participants). Monotherapy comparison (six studies): There was a significantly greater change in favour of salmeterol in morning PEF and FEV1. There were no significant differences in quality of life, exacerbations, or symptoms. Formoterol appeared to confer some benefits over ipratropium treatment in terms of morning peak flow. Combination comparison (three studies): There was a significant improvement in post-bronchodilator lung function, supplemental short-acting beta-agonist use and HRQL in favour of combination therapy compared with salmeterol alone. The available data from the trials suggest that there is little difference between regular long term use of IpB alone and salmeterol if the aim is to improve COPD symptoms and exercise tolerance. However, salmeterol was more effective in improving lung function variables. In terms of post-bronchodilator lung function, combination therapy conferred modest benefits, a significant improvement in HRQL, and reduced supplemental short-acting beta-agonist requirement, although this effect was not consistent. Additional studies are needed to assess the relative effects of combining therapies, using validated subjective measurements, and should consider concordance and the convenience of people having to use different inhaler devices. | Chronic obstructive pulmonary disease (COPD) is a condition associated with high morbidity, mortality and cost to the community. Patients often report symptomatic improvement with long acting beta-2 agonists (LABAs) and anticholinergic bronchodilator medications (ipratropium). These medications have different mechanisms of action and therefore theoretically could have an additive effect when combined. As these medications are prescribed in COPD as long term therapy, it is important to know what benefit there are, if any, of prescribing ipratropium alone or as combination therapy over LABAs. Seven studies (2652 participants) were included. Salmeterol was more effective than ipratropium on lung function, but there were no major differences seen between the responses to ipratropium and salmeterol on symptoms. When we compared the combination of these two drugs with salmeterol, combination was superior to salmeterol in terms of quality of life, but the differences between these two treatments on other measurements were small and inconsistent. The findings of the review would not support a general recommendation for the use of ipratropium bromide over a beta-2 agonist alone in COPD, but the combination does confer greater benefit in health status. At this stage, people with COPD should use the bronchodilator that gives them the most improvement in their symptoms. Combination therapy should be considered, but the relative effects of this therapy in relation to other forms of inhaled therapy such as inhaled steroids and tiotropium are unknown. Cost considerations also need to be taken into account as there are considerable variations in price of bronchodilators. | 10.1002/14651858.CD006101 | [
"Chronic obstructive pulmonary disease (COPD) is a condition associated with high morbidity, mortality and cost to the community. Patients often report symptomatic improvement with long acting beta-2 agonists (LABAs) and anticholinergic bronchodilator medications (ipratropium). These medications have different mechanisms of action and therefore theoretically could have an additive effect when combined. As these medications are prescribed in COPD as long term therapy, it is important to know what benefit there are, if any, of prescribing ipratropium alone or as combination therapy over LABAs. Seven studies (2652 participants) were included. Salmeterol was more effective than ipratropium on lung function, but there were no major differences seen between the responses to ipratropium and salmeterol on symptoms. When we compared the combination of these two drugs with salmeterol, combination was superior to salmeterol in terms of quality of life, but the differences between these two treatments on other measurements were small and inconsistent. The findings of the review would not support a general recommendation for the use of ipratropium bromide over a beta-2 agonist alone in COPD, but the combination does confer greater benefit in health status. At this stage, people with COPD should use the bronchodilator that gives them the most improvement in their symptoms. Combination therapy should be considered, but the relative effects of this therapy in relation to other forms of inhaled therapy such as inhaled steroids and tiotropium are unknown. Cost considerations also need to be taken into account as there are considerable variations in price of bronchodilators."
] |
cochrane-simplification-train-1165 | cochrane-simplification-train-1165 | Ten heterogenous trials involving 874 adults with generally unstable fractures were grouped into six comparisons. No trial had proven allocation concealment. Four trials (239 participants) found implantation of bone scaffolding (autogenous bone graft (one trial); Norian SRS - a bone substitute (two trials); methylmethacrylate cement (one trial)) improved anatomical outcomes compared with plaster cast alone; and two found it improved function. Reported complications of bone scaffolding were transient discomfort resulting from extraosseous deposits of Norian SRS; with surgical removal of one intra-articular deposit. One trial (323 participants) comparing bone substitute (Norian SRS) versus plaster cast or external fixation found no difference in functional or anatomical outcomes at one year. Statistically significant complications in the respective groups were extraosseous Norian SRS deposits and pin track infection. One trial (48 participants with external fixation) found that autogenous bone graft did not significantly change outcome. There was one serious donor-site complication. One trial (21 participants) found some indication of worse outcomes for hydroxyapatite bone cement compared with Kapandji's intrafocal pinning. Three trials (180 participants) found bone scaffolding (autogenous bone graft (one trial); Norian SRS (one trial); methylmethacrylate cement (one trial)) gave no significant difference in functional outcomes but some indication of better anatomical outcomes compared with external fixation. Most reported complications were associated with external fixation; extraosseous deposits of Norian SRS occurred in one trial. One trial (93 participants with dorsal plate fixation) found autografts slightly improved wrist function compared with allogenic bone material but with an excess of donor site complications. Bone scaffolding may improve anatomical outcome compared with plaster cast alone but there is insufficient evidence to conclude on functional outcome and safety; or for other comparisons. | Ten very different trials involving 874 adults with generally unstable fractures were grouped into six comparisons. No trial used a best-practice method for preventing selection bias. Four trials (239 participants) found implantation of bone scaffolding (autogenous - from the patient - bone graft (one trial); Norian SRS - a bone substitute (two trials); methylmethacrylate cement (one trial)) improved anatomical outcomes compared with plaster cast alone; and two found it improved function. Reported complications of bone scaffolding were transient discomfort resulting from deposits of Norian SRS outside the bone. One deposit required surgical removal. One trial (323 participants) comparing Norian SRS versus plaster cast or external fixation found no difference in functional or anatomical outcomes at one year. External deposits of bone cement and pin track infection were the only significant differences between the two groups. One trial (48 participants) found that autogenous (from the patient) bone graft in the context of external fixation did not significantly change outcome. There was one serious donor-site complication. One trial (21 participants) found some indication of worse outcomes with bone cement compared with percutaneous (through the skin) pinning. Three trials (180 participants) found bone scaffolding (autogenous bone graft (one trial); Norian SRS (one trial); methylmethacrylate cement (one trial)) gave no significant difference in functional outcomes but some indication of better anatomical outcomes compared with external fixation. Most reported complications were associated with external fixation; deposits of Norian SRS outside the bone occurred in one trial. One trial (93 participants treated with plate fixation) comparing allogenic bone material (from other people) versus autogenic bone-graft found slightly improved wrist function for the autograft group but an excess of complications relating to graft harvesting. The review concluded that while bone scaffolding may improve anatomical outcome compared with plaster cast immobilisation alone, there is insufficient evidence to conclude on function and safety; or on outcome for other comparisons. | 10.1002/14651858.CD006836.pub2 | [
"Ten very different trials involving 874 adults with generally unstable fractures were grouped into six comparisons. No trial used a best-practice method for preventing selection bias. Four trials (239 participants) found implantation of bone scaffolding (autogenous - from the patient - bone graft (one trial); Norian SRS - a bone substitute (two trials); methylmethacrylate cement (one trial)) improved anatomical outcomes compared with plaster cast alone; and two found it improved function. Reported complications of bone scaffolding were transient discomfort resulting from deposits of Norian SRS outside the bone. One deposit required surgical removal. One trial (323 participants) comparing Norian SRS versus plaster cast or external fixation found no difference in functional or anatomical outcomes at one year. External deposits of bone cement and pin track infection were the only significant differences between the two groups. One trial (48 participants) found that autogenous (from the patient) bone graft in the context of external fixation did not significantly change outcome. There was one serious donor-site complication. One trial (21 participants) found some indication of worse outcomes with bone cement compared with percutaneous (through the skin) pinning. Three trials (180 participants) found bone scaffolding (autogenous bone graft (one trial); Norian SRS (one trial); methylmethacrylate cement (one trial)) gave no significant difference in functional outcomes but some indication of better anatomical outcomes compared with external fixation. Most reported complications were associated with external fixation; deposits of Norian SRS outside the bone occurred in one trial. One trial (93 participants treated with plate fixation) comparing allogenic bone material (from other people) versus autogenic bone-graft found slightly improved wrist function for the autograft group but an excess of complications relating to graft harvesting. The review concluded that while bone scaffolding may improve anatomical outcome compared with plaster cast immobilisation alone, there is insufficient evidence to conclude on function and safety; or on outcome for other comparisons."
] |
cochrane-simplification-train-1166 | cochrane-simplification-train-1166 | We included 14 studies in this review. Thirteen were before-and-after studies and one was a cost-effectiveness analysis. Three studies each took place in Switzerland and the USA, while two studies each were from the UK, Canada, New Zealand, and Australia respectively. The majority of studies (10/14) assessed jumping means restriction interventions delivered in isolation, half of which were at bridges. Due to the observational nature of included studies, none compared comparator interventions or control conditions. During the pre- and postintervention period among the 13 before-and-after studies, a total of 742.3 suicides (5.5 suicides per year) occurred during the pre-intervention period (134.5 study years), while 70.6 suicides (0.8 suicides per year) occurred during the postintervention period (92.4 study years) - a 91% reduction in suicides. A meta-analysis of all studies assessing jumping means restriction interventions (delivered in isolation or in combination with other interventions) showed a directionality of effect in favour of the interventions, as evidenced by a reduction in the number of suicides at intervention sites (12 studies; incidence rate ratio (IRR) = 0.09, 95% confidence interval (CI) 0.03 to 0.27; P < 0.001; I2 = 88.40%). Similar findings were demonstrated for studies assessing jumping means restriction interventions delivered in isolation (9 studies; IRR = 0.05, 95% CI 0.01 to 0.16; P < 0.001; I2 = 73.67%), studies assessing jumping means restriction interventions delivered in combination with other interventions (3 studies; IRR = 0.54, 95% CI 0.31 to 0.93; P = 0.03; I2 = 40.8%), studies assessing the effectiveness of physical barriers (7 studies; IRR = 0.07, 95% CI 0.02 to 0.24; P < 0.001; I2 = 84.07%), and studies assessing the effectiveness of safety nets (2 studies; IRR = 0.09, 95% CI 0.01 to 1.30; P = 0.07; I2 = 29.3%). Data on suicide attempts were limited and none of the studies used self-harm as an outcome. There was considerable heterogeneity between studies for the primary outcome (suicide) in the majority of the analyses except those relating to jumping means restriction delivered in combination with other interventions, and safety nets. Nevertheless, every study included in the forest plots showed the same directional effects in favour of jumping means restriction. Due to methodological limitations of the included studies, we rated the quality of the evidence from these studies as low. A cost-effectiveness analysis suggested that the construction of a physical barrier on a bridge would be a highly cost-effective project in the long term as a result of overall reduced suicide mortality. The findings from this review suggest that jumping means restriction interventions are capable of reducing the frequency of suicides by jumping. However, due to methodological limitations of included studies, this finding is based on low-quality evidence. Therefore, further well-designed high-quality studies are required to further evaluate the effectiveness of these interventions, as well as other measures at jumping sites. In addition, further research is required to investigate the potential for suicide method substitution and displacement effects in populations exposed to interventions to prevent suicide by jumping. | We searched several databases (the Cochrane Library, Embase, MEDLINE, PsycINFO, and Web of Science) to find studies that assessed the impact of restricting access to means of suicide by jumping. We searched the databases up until May 2019. We included studies that assessed jumping means restriction interventions delivered on their own, such as physical barriers, fencing or safety nets on bridges, or those delivered in combination with other suicide prevention interventions, such as crisis telephones and CCTV cameras. We also searched the reference lists of all included studies and relevant systematic reviews to identify additional studies and contacted authors to obtain missing information. Our main outcomes of interest were suicide, attempted suicide or self-harm and cost-effectiveness of interventions. We found 14 relevant studies. Three studies each were from Switzerland and the USA, while two studies each were from the UK, Canada, New Zealand, and Australia respectively. The majority of studies had a before-and-after study design. Due to the observational nature of our included studies, none compared other interventions or control conditions. Jumping means restriction interventions delivered in isolation or in combination with other interventions were found to reduce the number of suicides by jumping. Data on suicide attempts were limited and no study reported self-harm. A cost-effectiveness analysis suggested that the construction of a physical barrier on a bridge would be cost-effective in the long term. The evidence for these assessments was of low quality because of weaknesses in study design and differences in findings between studies, therefore requiring the need for further high-quality studies. | 10.1002/14651858.CD013543 | [
"We searched several databases (the Cochrane Library, Embase, MEDLINE, PsycINFO, and Web of Science) to find studies that assessed the impact of restricting access to means of suicide by jumping. We searched the databases up until May 2019. We included studies that assessed jumping means restriction interventions delivered on their own, such as physical barriers, fencing or safety nets on bridges, or those delivered in combination with other suicide prevention interventions, such as crisis telephones and CCTV cameras. We also searched the reference lists of all included studies and relevant systematic reviews to identify additional studies and contacted authors to obtain missing information. Our main outcomes of interest were suicide, attempted suicide or self-harm and cost-effectiveness of interventions. We found 14 relevant studies. Three studies each were from Switzerland and the USA, while two studies each were from the UK, Canada, New Zealand, and Australia respectively. The majority of studies had a before-and-after study design. Due to the observational nature of our included studies, none compared other interventions or control conditions. Jumping means restriction interventions delivered in isolation or in combination with other interventions were found to reduce the number of suicides by jumping. Data on suicide attempts were limited and no study reported self-harm. A cost-effectiveness analysis suggested that the construction of a physical barrier on a bridge would be cost-effective in the long term. The evidence for these assessments was of low quality because of weaknesses in study design and differences in findings between studies, therefore requiring the need for further high-quality studies."
] |
cochrane-simplification-train-1167 | cochrane-simplification-train-1167 | We included a total of 20 studies with 2068 participants. We studied the anticonvulsant drugs carbamazepine, gabapentin, lamotrigine, phenytoin, tiagabine, topiramate and vigabatrin. All studies compared anticonvulsants versus placebo. Only one study had one arm by which the anticonvulsant was compared with the antidepressant desipramine. Upon comparison of anticonvulsant versus placebo, we found no significant differences for any of the efficacy and safety measures. Dropouts: risk ratio (RR) 0.95, 95% confidence interval (CI) 0.86 to 1.05, 17 studies, 20 arms, 1695 participants, moderate quality of evidence. Use of cocaine: RR 0.92, 95% CI 0.84 to 1.02, nine studies, 11 arms, 867 participants, moderate quality of evidence; side effects: RR 1.39, 95% CI 1.01 to 1.90, eight studies, 775 participants; craving: standardised mean difference (SMD) -0.25, 95% CI -0.59 to 0.09, seven studies, eight arms, 428 participants, low quality of evidence. Although caution is needed when results from a limited number of small clinical trials are assessed, no current evidence supports the clinical use of anticonvulsant medications in the treatment of patients with cocaine dependence. Although the findings of new trials will improve the quality of study results, especially in relation to specific medications, anticonvulsants as a category cannot be considered first-, second- or third-line treatment for cocaine dependence. | The review authors searched scientific databases and Internet resources to identify randomised controlled trials (in which participants were allocated at random to any anticonvulsant drug or placebo or another type of drug or non-pharmacological intervention intended to reduce,the use of cocaine). We assessed also dropout from treatment and frequency of side effects .We included people of any gender, age or ethnicity. The review authors identified 20 studies with 2068 participants, 77% male, with a mean age of 36 years. The mean duration of the trials was 11.8 weeks (range eight to 24 weeks). All but two of the trials were conducted in the USA, all with outpatients. The anticonvulsant drugs studied were carbamazepine, gabapentin, lamotrigine, phenytoin, tiagabine, topiramate and vigabatrin. All studies compared anticonvulsants versus placebo. No significant differences were found between placebo and any anticonvulsant in reducing the number of dropouts from treatment, use of cocaine, craving and severity of dependence, depression or anxiety. Side effects were slightly more frequent in the anticonvulsant groups. No current evidence supports the clinical use of anticonvulsant medications for the treatment of cocaine dependence. The quality of the evidence was moderate for the outcomes dropout and use of cocaine, and was low for the outcomes side effects and craving. The major limitation of the trials was incomplete reporting of the methods used to protect against selection bias, randomly allocate participants to groups and conceal allocation. The evidence is current to June 2014. | 10.1002/14651858.CD006754.pub4 | [
"The review authors searched scientific databases and Internet resources to identify randomised controlled trials (in which participants were allocated at random to any anticonvulsant drug or placebo or another type of drug or non-pharmacological intervention intended to reduce,the use of cocaine). We assessed also dropout from treatment and frequency of side effects .We included people of any gender, age or ethnicity. The review authors identified 20 studies with 2068 participants, 77% male, with a mean age of 36 years. The mean duration of the trials was 11.8 weeks (range eight to 24 weeks). All but two of the trials were conducted in the USA, all with outpatients. The anticonvulsant drugs studied were carbamazepine, gabapentin, lamotrigine, phenytoin, tiagabine, topiramate and vigabatrin. All studies compared anticonvulsants versus placebo. No significant differences were found between placebo and any anticonvulsant in reducing the number of dropouts from treatment, use of cocaine, craving and severity of dependence, depression or anxiety. Side effects were slightly more frequent in the anticonvulsant groups. No current evidence supports the clinical use of anticonvulsant medications for the treatment of cocaine dependence. The quality of the evidence was moderate for the outcomes dropout and use of cocaine, and was low for the outcomes side effects and craving. The major limitation of the trials was incomplete reporting of the methods used to protect against selection bias, randomly allocate participants to groups and conceal allocation. The evidence is current to June 2014."
] |
cochrane-simplification-train-1168 | cochrane-simplification-train-1168 | We identified nine trials for inclusion with all nine contributing outcome data. Two trials reported on people with thalassaemia (n = 152) and seven on sickle cell anaemia (n = 307). In people with thalassaemia, in one trial, the serum zinc level value showed no difference between the zinc supplemented group and the control group, mean difference 47.40 (95% confidence interval -12.95 to 107.99). Regarding anthropometry, in one trial, height velocity was significantly increased in patients who received zinc supplementation for one to seven years duration, mean difference 3.37 (95% confidence interval 2.36 to 4.38) (total number of participants = 26). In one trial, however, there was no difference in body mass index between treatment groups. Zinc acetate supplementation for three months (in one trial) and one year (in two trials) (total number of participants = 71) was noted to increase the serum zinc level significantly in patients with sickle cell anaemia, mean difference 14.90 (95% confidence interval 6.94 to 22.86) and 20.25 (95% confidence interval 11.73 to 28.77) respectively. There was no significant difference in haemoglobin level between intervention and control groups, at either three months (one trial) or one year (one trial), mean difference 0.06 (95% confidence interval -0.84 to 0.96) and mean difference -0.07 (95% confidence interval -1.40 to 1.26) respectively. Regarding anthropometry, one trial showed no significant changes in body mass index or weight after one year of zinc acetate supplementation. In patients with sickle cell disease, the total number of sickle cell crises at one year were significantly decreased in the zinc sulphate supplemented group as compared to controls, mean difference -2.83 (95% confidence interval -3.51 to -2.15) (total participants 130), but not in zinc acetate group, mean difference 1.54 (95% confidence interval -2.01 to 5.09) (total participants 22). In one trial at three months and another at one year, the total number of clinical infections were significantly decreased in the zinc supplemented group as compared to controls, mean difference 0.05 (95% confidence interval 0.01 - 0.43) (total number of participants = 36), and mean difference -7.64 (95% confidence interval -10.89 to -4.39) (total number of participants = 21) respectively. According to the results, there is no evidence from randomised controlled trials to indicate any benefit of zinc supplementation with regards to serum zinc level in patients with thalassaemia. However, height velocity was noted to increase among those who received this intervention. There is mixed evidence on the benefit of using zinc supplementation in people with sickle cell disease. For instance, there is evidence that zinc supplementation for one year increased the serum zinc levels in patients with sickle cell disease. However, though serum zinc level was raised in patients receiving zinc supplementation, haemoglobin level and anthropometry measurements were not significantly different between groups. Evidence of benefit is seen with the reduction in the number of sickle cell crises among sickle cell patients who received one year of zinc sulphate supplementation and with the reduction in the total number of clinical infections among sickle cell patients who received zinc supplementation for both three months and for one year. The conclusion is based on the data from a small group of trials,which were generally of good quality, with a low risk of bias. The authors recommend that more trials on zinc supplementation in thalassaemia and sickle cell disease be conducted given that the literature has shown the benefits of zinc in these types of diseases. | The review authors searched the medical literature for randomised controlled studies in which people with sickle cell disease or thalassaemia received either zinc supplements or no supplements. We included nine trials in the review (459 participants). In people with thalassaemia, there is no evidence to indicate any benefit of zinc supplements on serum zinc level. However, there was an improvement in height in those who received the supplements. There is mixed evidence on the benefit of using zinc supplements in people with sickle cell disease. For instance, there is evidence that when supplements are given for one year the serum zinc levels increased; however, haemoglobin levels and body mass index did not differ significantly between groups. We also found that people with sickle cell disease who received zinc supplements (at both three months and at one year) had fewer sickle cell crises and infections. However, given that the total number of trials is small, these results should be treated with caution. | 10.1002/14651858.CD009415.pub2 | [
"The review authors searched the medical literature for randomised controlled studies in which people with sickle cell disease or thalassaemia received either zinc supplements or no supplements. We included nine trials in the review (459 participants). In people with thalassaemia, there is no evidence to indicate any benefit of zinc supplements on serum zinc level. However, there was an improvement in height in those who received the supplements. There is mixed evidence on the benefit of using zinc supplements in people with sickle cell disease. For instance, there is evidence that when supplements are given for one year the serum zinc levels increased; however, haemoglobin levels and body mass index did not differ significantly between groups. We also found that people with sickle cell disease who received zinc supplements (at both three months and at one year) had fewer sickle cell crises and infections. However, given that the total number of trials is small, these results should be treated with caution."
] |
cochrane-simplification-train-1169 | cochrane-simplification-train-1169 | There were six eligible studies but only four had sufficient data at the time of this review. The four RCTs included in this review reported on a total of 262 participants. One study, a placebo-controlled trial with a low risk of bias, found that individuals on sulthiame were significantly more likely to remain in seizure remission during the three and six months from commencement of treatment than those on placebo (3 months: RR 2.26, 95% CI 1.48 to 3.44; 6 months: RR 2.63, 95% CI 1.43 to 4.86, 66 participants, moderate quality evidence). The other three trials, all open-labelled studies, had a high risk of bias and did not show any significant differences in terms of seizure remission between AEDs. One compared levetiracetam with oxcarbazepine (3 months: RR 1.13, 95% CI of 0.93 - 1.36; 12 months: RR of 1.29 with 95% CI of 0.89 - 1.86, 39 participants, low to very low quality evidence), one clobazam with carbamazepine (4-40 weeks: RR of 1.04, 95% CI of 0.67 - 1.62; last 9 months: RR of 1.06 with 95% CI of 0.84, 1.34, 45 participants, low quality evidence), and one carbamazepine with topiramate (28 weeks: RR 1.02 with 95% CI of 0.8 - 1.3, 112 participants, low quality evidence). Other outcome measures assessed included time to first seizure after randomisation which was only obtained in the sulthiame versus placebo study as a hazard ratio of 7.8 (95% CI 2.66 - 22.87). There were no significant differences between the proportion of participants who had adverse events, apart from a higher incidence of rash in the carbamazepine group (14.8%) when compared with topiramate (1.7%), or the proportion who withdrew from treatment due to adverse events, when this was reported. Two trials (carbamazepine versus topiramate, and clobazam versus carbamazepine) evaluated the effects on cognition. The studies were of low to very low quality evidence showing no clear difference in cognition at the end of the study periods between the AEDs compared. A meta-analysis was not performed as the RCTs evaluated different therapies. There is evidence from one trial reviewed that sulthiame is effective for seizure remission in the short term in children with BECTS although the precision of the effect estimate is uncertain due to its small sample size. There were no significant differences in the proportion of adverse events between treatment groups studied, including those resulting in withdrawal of treatment. There is insufficient evidence about the medium to longer term effects on seizure control, the optimum antiepileptic drug treatment and the effects of AED treatment on cognition. There is a need for more good quality randomised controlled trials to address these questions to aid the management of children with BECTS. | There were few studies found (searches conducted on 30th April 2013) with few antiepileptic drugs compared. One of the four studies included showed evidence that the antiepileptic drug, sulthiame, may have a positive effect in reducing seizure frequency in BECTS in the short term. There were no significant differences in the number of patients with adverse events apart from a higher risk of rash when carbamazepine was compared to topiramate. The number of patients who discontinued treatment as a result of adverse events was also not significant in the studies reviewed. There is insufficient evidence about whether or not treating with antiepileptic drugs has any effect on seizure freedom in the longer term or on a child’s cognition. The optimum treatment has yet to be identified. More research is needed to look into the effectiveness of treatment versus no treatment on seizure control and intellect, and compare the existing treatments. | 10.1002/14651858.CD006779.pub2 | [
"There were few studies found (searches conducted on 30th April 2013) with few antiepileptic drugs compared. One of the four studies included showed evidence that the antiepileptic drug, sulthiame, may have a positive effect in reducing seizure frequency in BECTS in the short term. There were no significant differences in the number of patients with adverse events apart from a higher risk of rash when carbamazepine was compared to topiramate. The number of patients who discontinued treatment as a result of adverse events was also not significant in the studies reviewed. There is insufficient evidence about whether or not treating with antiepileptic drugs has any effect on seizure freedom in the longer term or on a child’s cognition. The optimum treatment has yet to be identified. More research is needed to look into the effectiveness of treatment versus no treatment on seizure control and intellect, and compare the existing treatments."
] |
cochrane-simplification-train-1170 | cochrane-simplification-train-1170 | We included one study involving 883 women. Comparison of sonographic assessment of amniotic fluid index (AFI) on admission versus no sonographic assessment of AFI on admission. The incidence of cesarean section for fetal distress in the intervention group (29 of 447) was significantly higher than those of controls (14 of 436) (risk ratio (RR) 2.02; 95% confidence interval (CI) 1.08 to 3.77). The incidence of Apgar score less than seven at five minutes in the intervention group (10 of 447) was not significantly different from controls (seven of 436) (RR 1.39, 95% CI 0.54 to 3.63). The incidence of artificial oxytocin for augmentation of labour in the intervention group (213 of 447) was significantly higher than controls (132 of 436) (RR 1.57; 95% CI 1.32 to 1.87). The incidence of neonatal NICU admission in the intervention group (35 of 447) was not significantly different from the controls (33 of 436) (RR 1.03; 95% CI 0.66 to 1.63) There is not enough evidence to support the use of admission tests other than cardiotocography for fetal assessment during labour. Appropriate randomised controlled trials with adequate sample size of admission tests other than cardiotocography for fetal assessment during labour are required. | This review identified one randomised controlled study (involving 883 women) at 26 to 42 weeks' gestation and in early labour who were admitted to a tertiary hospital in USA (between July 1992 and January 1993). Measuring the amount of amniotic fluid when women were admitted did not improve infant outcomes but increased/doubled the caesarean section rate for fetal distress. The use of artificial oxytocin for augmentation of labour was also higher in the group of women who received the test than for those that did not. Because of the limited evidence (one study with a small sample size), we cannot make a meaningful conclusion or recommendations. More studies are needed. | 10.1002/14651858.CD008410.pub2 | [
"This review identified one randomised controlled study (involving 883 women) at 26 to 42 weeks' gestation and in early labour who were admitted to a tertiary hospital in USA (between July 1992 and January 1993). Measuring the amount of amniotic fluid when women were admitted did not improve infant outcomes but increased/doubled the caesarean section rate for fetal distress. The use of artificial oxytocin for augmentation of labour was also higher in the group of women who received the test than for those that did not. Because of the limited evidence (one study with a small sample size), we cannot make a meaningful conclusion or recommendations. More studies are needed."
] |
cochrane-simplification-train-1171 | cochrane-simplification-train-1171 | We included 10 RCTs (1611 participants) in this review with a majority of women (72%), mostly parturients (women in labour) (913), after a lumbar puncture for regional anaesthesia. Drugs assessed were epidural and spinal morphine, spinal fentanyl, oral caffeine, rectal indomethacin, intravenous cosyntropin, intravenous aminophylline and intravenous dexamethasone. All the included RCTs reported data on the primary outcome, i.e. the number of participants affected by PDPH of any severity after a lumbar puncture. Epidural morphine and intravenous cosyntropin reduced the number of participants affected by PDPH of any severity after a lumbar puncture when compared to placebo. Also, intravenous aminophylline reduced the number of participants affected by PDPH of any severity after a lumbar puncture when compared to no intervention, while intravenous dexamethasone increased it. Spinal morphine increased the number of participants affected by pruritus when compared to placebo, and epidural morphine increased the number of participants affected by nausea and vomiting when compared to placebo. Oral caffeine increased the number of participants affected by insomnia when compared to placebo. The remainder of the interventions analysed did not show any relevant effect for any of the outcomes. None of the included RCTs reported the number of days that patients stayed in hospital. Morphine and cosyntropin have shown effectiveness for reducing the number of participants affected by PDPH of any severity after a lumbar puncture, when compared to placebo, especially in patients with high risk of PDPH, such as obstetric patients who have had an inadvertent dural puncture. Aminophylline also reduced the number of participants affected by PDPH of any severity after a lumbar puncture when compared to no intervention in patients undergoing elective caesarean section. Dexamethasone increased the risk of PDPH, after spinal anaesthesia for caesarean section, when compared to placebo. Morphine also increased the number of participants affected by adverse events (pruritus and nausea and vomiting) There is a lack of conclusive evidence for the other drugs assessed (fentanyl, caffeine, indomethacin and dexamethasone). These conclusions should be interpreted with caution, owing to the lack of information, to allow correct appraisal of risk of bias and the small sample sizes of studies. | We included 10 randomised clinical trials (RCTs), with a total of 1611 participants, that assessed seven medications (epidural and spinal morphine, spinal fentanyl, oral caffeine, rectal indomethacin, intravenous cosyntropin, intravenous aminophylline and intravenous dexamethasone). Epidural morphine and intravenous cosyntropin proved to be effective at reducing the number of participants affected by PDPH of any severity after lumbar puncture compared to placebo. Aminophylline also reduced the number of participants affected by PDPH of any severity after a lumbar puncture compared to no intervention. Dexamethasone increased the risk of PDPH when compared to placebo after spinal anaesthesia for caesarean section. Morphine also increased the number of participants affected by adverse events such as itching, nausea and vomiting. The other interventions (fentanyl, caffeine, indomethacin and dexamethasone) did not show conclusive evidence of effectiveness. Combining data was possible only for subgroups of one study comparing different dosages of caffeine to placebo, because the other RCTs appraised diverse drugs, outcomes or populations. A meta-analysis (combining of data) was not possible because all the included RCTs assessed different drugs, different doses, different outcomes or different baseline participants' characteristics. These conclusions should be interpreted carefully, given the lack of information to evaluate the risk of bias properly, and the small number of participants in the included studies. | 10.1002/14651858.CD001792.pub3 | [
"We included 10 randomised clinical trials (RCTs), with a total of 1611 participants, that assessed seven medications (epidural and spinal morphine, spinal fentanyl, oral caffeine, rectal indomethacin, intravenous cosyntropin, intravenous aminophylline and intravenous dexamethasone). Epidural morphine and intravenous cosyntropin proved to be effective at reducing the number of participants affected by PDPH of any severity after lumbar puncture compared to placebo. Aminophylline also reduced the number of participants affected by PDPH of any severity after a lumbar puncture compared to no intervention. Dexamethasone increased the risk of PDPH when compared to placebo after spinal anaesthesia for caesarean section. Morphine also increased the number of participants affected by adverse events such as itching, nausea and vomiting. The other interventions (fentanyl, caffeine, indomethacin and dexamethasone) did not show conclusive evidence of effectiveness. Combining data was possible only for subgroups of one study comparing different dosages of caffeine to placebo, because the other RCTs appraised diverse drugs, outcomes or populations. A meta-analysis (combining of data) was not possible because all the included RCTs assessed different drugs, different doses, different outcomes or different baseline participants' characteristics. These conclusions should be interpreted carefully, given the lack of information to evaluate the risk of bias properly, and the small number of participants in the included studies."
] |
cochrane-simplification-train-1172 | cochrane-simplification-train-1172 | Forty-nine studies with 1725 participants receiving PCA and 1687 participants assigned to a control group met the inclusion criteria. The original review included 55 studies with 2023 patients receiving PCA and 1838 patients assigned to a control group. There were fewer included studies in our updated review due to the revised exclusion criteria. For the primary outcome, participants receiving PCA had lower VAS pain intensity scores versus non-patient controlled analgesia over most time intervals, e.g., scores over 0 to 24 hours were nine points lower (95% confidence interval (CI) -13 to -5, moderate quality evidence) and over 0 to 48 hours were 10 points lower (95% CI -12 to -7, low quality evidence). Among the secondary outcomes, participants were more satisfied with PCA (81% versus 61%, P value = 0.002) and consumed higher amounts of opioids than controls (0 to 24 hours, 7 mg more of intravenous morphine equivalents, 95% CI 1 mg to 13 mg). Those receiving PCA had a higher incidence of pruritus (15% versus 8%, P value = 0.01) but had a similar incidence of other adverse events. There was no difference in the length of hospital stay. Since the last version of this review, we have found new studies providing additional information. We reanalyzed the data but the results did not substantially alter any of our previously published conclusions. This review provides moderate to low quality evidence that PCA is an efficacious alternative to non-patient controlled systemic analgesia for postoperative pain control. | Previous studies have shown that often patients prefer PCA to traditional methods of pain management, such as a nurse administering an analgesic upon a patient's request. This review demonstrated moderate to low quality evidence that PCA provided slightly better pain control and increased patient satisfaction when compared with non-patient controlled methods. Patients tended to use slightly higher doses of medication with PCA and suffered a higher occurrence of itching, but otherwise side effects were similar between groups. | 10.1002/14651858.CD003348.pub3 | [
"Previous studies have shown that often patients prefer PCA to traditional methods of pain management, such as a nurse administering an analgesic upon a patient's request. This review demonstrated moderate to low quality evidence that PCA provided slightly better pain control and increased patient satisfaction when compared with non-patient controlled methods. Patients tended to use slightly higher doses of medication with PCA and suffered a higher occurrence of itching, but otherwise side effects were similar between groups."
] |
cochrane-simplification-train-1173 | cochrane-simplification-train-1173 | Only one study with 45 participants met the inclusion criteria. Men were divided in two sub-groups (minimal or total incontinence) and each group was randomised to artificial urethral sphincter (AUS) implantation or Macroplastique injection. Follow-up ranged from six to 120 months. In the trial as a whole, the men treated with AUS were more likely to be dry (18/20, 82%) than those who had the injectable treatment (11/23, 46%) (odds ratio (OR) 5.67, 95% confidence interval (CI) 1.28 to 25.10). However, this effect was only statistically significant for the men with more severe ('total') incontinence (OR 8.89, 95% CI 1.40 to 56.57) and the CIs were wide. There were more severe complications in the group undergoing AUS, and the costs were higher. AUS implantation was complicated in 5/22 (23%) men: the implant had to be removed from one man because of infection and in one man due to the erosion of the cuff, in one man the pump was changed due to mechanical failure, in one man there was migration to the intraperitoneal region, and one man experienced scrotal erosion. In the injectable group, 3/23 (13%) men had a complication: one man treated with Macroplastique injection had to be catheterised because of urinary retention and two men developed urinary tract infections. The evidence available at present was of very low quality because we identified only one small randomised clinical trial. Although the result was favourable for the implantation of AUS in the group with severe incontinence, this result should be considered with caution due to the small sample size and uncertain methodological quality of the study found. | We searched scientific databases for trials that had considered the effectiveness of the surgical treatments of urinary incontinence after prostate surgery in men. The trials had to compare surgical treatment versus no treatment, non-surgical treatment, or another surgical treatment. The evidence is current to April 2014. There are five main types of surgery and, despite some of them being in use since the 1990s, we found only one trial that met the inclusion criteria. There was very low quality evidence that the implantation of an artificial urinary sphincter (a manufactured device to prevent urine leaking out) might be more effective than injectable treatment, but with more adverse effects and higher costs. There was no evidence about the other types of surgery. | 10.1002/14651858.CD008306.pub3 | [
"We searched scientific databases for trials that had considered the effectiveness of the surgical treatments of urinary incontinence after prostate surgery in men. The trials had to compare surgical treatment versus no treatment, non-surgical treatment, or another surgical treatment. The evidence is current to April 2014. There are five main types of surgery and, despite some of them being in use since the 1990s, we found only one trial that met the inclusion criteria. There was very low quality evidence that the implantation of an artificial urinary sphincter (a manufactured device to prevent urine leaking out) might be more effective than injectable treatment, but with more adverse effects and higher costs. There was no evidence about the other types of surgery."
] |
cochrane-simplification-train-1174 | cochrane-simplification-train-1174 | In the original version of this review, we identified three RCTs that assessed different intervention and control diets in 192 participants (97 randomised to intervention diet; 95 to control diet) with different types of malignancies. For the update, we identified no eligible new studies. Co-interventions (e.g. protective environment, antimicrobial prophylaxis, central venous catheter care, oral care, hygiene practices, colony-stimulating factors) and outcome definitions also differed between studies. In all included studies, it was standard policy to give empirical antibiotics (and sometimes also antimycotics) to (some of) the participants diagnosed with an infection. Two studies included adults and one study included children. In all studies, only a scant description of treatment regimens was provided. All studies had methodological limitations. Pooling of results of included studies was not possible. In two individual studies, no statistically significant differences in infection rate were identified between intervention and control diets; another study showed no significant differences between treatment groups in the number of chemotherapy cycles with an infection. None of the studies mentioned infection-related mortality, but in one study, no significant difference in overall survival was observed between treatment groups. Time from onset of neutropenia to fever, duration of empirical antibiotics and antimycotics, diet acceptability (i.e. following the diet easily and following the diet throughout all chemotherapy cycles) and quality of life were all evaluated by only one study; for all outcomes, no statistically significant differences between treatment arms were identified. At the moment, no evidence from individual RCTs in children and adults with different malignancies underscores use of an LBD for prevention of infection and related outcomes. All studies differed with regard to co-interventions, outcome definitions and intervention and control diets. As pooling of results was not possible, and as all studies had serious methodological limitations, we could reach no definitive conclusions. It should be noted that 'no evidence of effect', as identified in this review, is not the same as 'evidence of no effect'. On the basis of currently available evidence, we are not able to provide recommendations for clinical practice. Additional high-quality research is needed. | Review authors identified three randomised studies comparing different diets in 192 children and adults with different types of cancer. Other interventions, such as antimicrobial prophylaxis (i.e. prevention of infection via antimicrobial therapy such as antibiotics) and hygiene practices, and definitions of study outcomes also differed between studies, and very limited information on anticancer treatment was given. All studies had methodological problems. Unfortunately, combining the results of included studies was not possible, but at the moment, no evidence from individual studies suggests that a low bacterial diet prevents infection. Data on survival, time from onset of neutropenia to start of fever, duration of empirical (i.e. start of treatment before determination of a definitive diagnosis) antibiotics and antimycotics (i.e. agents that target fungal infection), diet acceptability and quality of life all were evaluated by only one study; for all outcomes, no statistically significant differences between treatment groups were observed. None of the studies evaluated infection-related mortality. It should be noted that 'no evidence of effect', as identified in this review, is not the same as 'evidence of no effect'. No differences between diets were identified, possibly because few patients were included in these studies. On the basis of currently available evidence, the review authors were not able to give recommendations for clinical practice. Additional high-quality research is needed. | 10.1002/14651858.CD006247.pub3 | [
"Review authors identified three randomised studies comparing different diets in 192 children and adults with different types of cancer. Other interventions, such as antimicrobial prophylaxis (i.e. prevention of infection via antimicrobial therapy such as antibiotics) and hygiene practices, and definitions of study outcomes also differed between studies, and very limited information on anticancer treatment was given. All studies had methodological problems. Unfortunately, combining the results of included studies was not possible, but at the moment, no evidence from individual studies suggests that a low bacterial diet prevents infection. Data on survival, time from onset of neutropenia to start of fever, duration of empirical (i.e. start of treatment before determination of a definitive diagnosis) antibiotics and antimycotics (i.e. agents that target fungal infection), diet acceptability and quality of life all were evaluated by only one study; for all outcomes, no statistically significant differences between treatment groups were observed. None of the studies evaluated infection-related mortality. It should be noted that 'no evidence of effect', as identified in this review, is not the same as 'evidence of no effect'. No differences between diets were identified, possibly because few patients were included in these studies. On the basis of currently available evidence, the review authors were not able to give recommendations for clinical practice. Additional high-quality research is needed."
] |
cochrane-simplification-train-1175 | cochrane-simplification-train-1175 | We identified eight randomized trials with a total of 300 adult participants for our analysis. We did not identify any trials in children. Four trials assessed thermal biofeedback. One trial assessed rectosigmoidal biofeedback. Two trials assessed heart rate variability biofeedback. Two trials assessed electrocutaneous biofeedback. Comparators were: no treatment (symptom monitoring group; three studies), attention control (pseudomeditation; two studies), relaxation control (one study), counseling (two studies), hypnotherapy (one study), standard therapy (one study), and sham biofeedback (one study). We judged all trials to have a high or unclear risk of bias. Global/Clinical improvement The clinical benefit of biofeedback plus standard therapy compared to standard therapy alone was uncertain (RR 4.20, 95% CI 1.40 to 12.58; 1 study, 20 participants; very low-certainty evidence). The same study also compared biofeedback plus standard therapy to sham biofeedback plus standard therapy. The clinical benefit in the biofeedback group was uncertain (RR 2.33, 95% CI 1.13 to 4.80; 1 study, 20 participants; very low-certainty evidence). The clinical benefit of heart rate biofeedback compared to hypnotherapy was uncertain when measured with the IBS severity scoring system (IBS-SSS) (MD -58.80, 95% CI -109.11 to -8.49; 1 study, 61 participants; low-certainty evidence). Compared to counseling, the effect of heart rate biofeedback was unclear when measured with a composite symptom reduction score (MD 7.03, 95% CI -51.07 to 65.13; 1 study, 29 participants; low-certainty evidence) and when evaluated for clinical response (50% improvement) (RR 1.09, 95% CI 0.48 to 2.45; 1 study, 29 participants; low-certainty evidence). The clinical benefit of thermal biofeedback used in a multi-component psychological intervention (MCPI) compared to no treatment was uncertain when measured with a composite clinical symptom reduction score (MD 30.34, 95% CI 8.47 to 52.21; 3 studies, 101 participants; very low-certainty evidence), and when evaluated as clinical response (50% improvement) (RR 2.12, 95% CI 1.24 to 3.62; 3 studies, 101 participants; very low-certainty evidence). Compared to attention control, the effects of thermal biofeedback within an MCPI were unclear when measured with a composite clinical symptom reduction score (MD 4.02, 95% CI -21.41 to 29.45; 2 studies, 80 participants; very low-certainty evidence) and when evaluated as clinical response (50% improvement) (RR 1.10, 95% CI 0.72 to 1.69, 2 studies, 80 participants; very low-certainty evidence). Quality of life A single trial used overall quality of life as an outcome measure, and reported that both the biofeedback and cognitive therapy groups improved after treatment. The trial did not note any between-group differences, and did not report any outcome data. Adverse events Only one of the eight trials explicitly reported adverse events. This study reported no adverse events in either the biofeedback or cognitive therapy groups (RD 0.00, 95% CI -0.12 to 0.12; 29 participants; low-certainty evidence). There is currently not enough evidence to assess whether biofeedback interventions are effective for controlling symptoms of IBS. Given the positive results reported in small trials to date, biofeedback deserves further study in people with IBS. Future research should include active control groups that use high provider-participant interaction, in an attempt to balance non-specific effects of interventions between groups, and report both commonly used outcome measures (e.g. IBS-SSS) and historical outcome measures (e.g. the composite primary symptom reduction (CPSR) score) to allow for meta-analysis with previous studies. Future studies should be explicit in their reporting of adverse events. | We searched for studies that compared biofeedback to either no treatment, sham treatment, or to other active treatments for IBS. We reviewed eight trials that included 300 total participants and assessed the effect of biofeedback on IBS. Each of these studies only included adults, and was carried out in an outpatient setting. The studies ranged from eight weeks to six months in length. The types of biofeedback devices varied, and included heart rate variability, measures of skin temperature or electrical resistance, and the tension of the muscles of the anus. None of the included trials disclosed funding sources. Our primary clinical outcomes were global clinical improvement and quality of life. Regarding overall improvement, three trials compared biofeedback to no treatment and found that biofeedback as part of a relaxation training program led to better symptom control than no treatment (very low-certainty evidence). Two of these trials also compared biofeedback to an attention control and found minimal symptom improvement, but the effects of chance could not be ruled out because the evidence was of very low-certainty. One trial found a greater symptom benefit with heart rate biofeedback compared to hypnotherapy (low-certainty evidence). Of two trials comparing biofeedback to counseling, any apparent effect was minimal and the effect of chance could not be ruled out (very low-certainty evidence). When rectosigmoidal biofeedback was compared to relaxation control, the effect favored the relaxation control. The addition of biofeedback to standard medical therapy was superior to medical therapy alone and to medical therapy plus sham biofeedback (low-certainty evidence for both findings). A single trial looked specifically at overall quality of life. Quality of life improved both for those in the biofeedback group and those in the cognitive therapy group, but there was no overall difference between groups. Only one trial explicitly reported on adverse events. It reported no adverse events in either the biofeedback group or the cognitive therapy group. We used the GRADE criteria to assess the certainty of the evidence for each of these findings. These ranged from low to very low. The evidence is current up to July 2019. We conclude that the existing data on biofeedback for IBS are limited and leave us uncertain about its value in IBS symptom management. The studies currently available all have design limitations that make the results difficult to apply to clinical settings. We do, however, recommend further study in this area, as biofeedback could represent a unique approach for a difficult to manage condition. | 10.1002/14651858.CD012530.pub2 | [
"We searched for studies that compared biofeedback to either no treatment, sham treatment, or to other active treatments for IBS. We reviewed eight trials that included 300 total participants and assessed the effect of biofeedback on IBS. Each of these studies only included adults, and was carried out in an outpatient setting. The studies ranged from eight weeks to six months in length. The types of biofeedback devices varied, and included heart rate variability, measures of skin temperature or electrical resistance, and the tension of the muscles of the anus. None of the included trials disclosed funding sources. Our primary clinical outcomes were global clinical improvement and quality of life. Regarding overall improvement, three trials compared biofeedback to no treatment and found that biofeedback as part of a relaxation training program led to better symptom control than no treatment (very low-certainty evidence). Two of these trials also compared biofeedback to an attention control and found minimal symptom improvement, but the effects of chance could not be ruled out because the evidence was of very low-certainty. One trial found a greater symptom benefit with heart rate biofeedback compared to hypnotherapy (low-certainty evidence). Of two trials comparing biofeedback to counseling, any apparent effect was minimal and the effect of chance could not be ruled out (very low-certainty evidence). When rectosigmoidal biofeedback was compared to relaxation control, the effect favored the relaxation control. The addition of biofeedback to standard medical therapy was superior to medical therapy alone and to medical therapy plus sham biofeedback (low-certainty evidence for both findings). A single trial looked specifically at overall quality of life. Quality of life improved both for those in the biofeedback group and those in the cognitive therapy group, but there was no overall difference between groups. Only one trial explicitly reported on adverse events. It reported no adverse events in either the biofeedback group or the cognitive therapy group. We used the GRADE criteria to assess the certainty of the evidence for each of these findings. These ranged from low to very low. The evidence is current up to July 2019. We conclude that the existing data on biofeedback for IBS are limited and leave us uncertain about its value in IBS symptom management. The studies currently available all have design limitations that make the results difficult to apply to clinical settings. We do, however, recommend further study in this area, as biofeedback could represent a unique approach for a difficult to manage condition."
] |
cochrane-simplification-train-1176 | cochrane-simplification-train-1176 | Seventeen trials with 1466 women contribute data to the review. Thirteen examined TENS applied to the back, two to acupuncture points, and two to the cranium. Overall, there was little difference in pain ratings between TENS and control groups, although women receiving TENS to acupuncture points were less likely to report severe pain (average risk ratio 0.41, 95% confidence interval 0.31 to 0.54; measured in two studies). The majority of women using TENS said they would be willing to use it again in a future labour. Where TENS was used as an adjunct to epidural analgesia there was no evidence that it reduced pain. There was no consistent evidence that TENS had any impact on interventions and outcomes in labour. There was little information on outcomes for mothers and babies. No adverse events were reported. There is only limited evidence that TENS reduces pain in labour and it does not seem to have any impact (either positive or negative) on other outcomes for mothers or babies. The use of TENS at home in early labour has not been evaluated. TENS is widely available in hospital settings and women should have the choice of using it in labour. | The purpose of the review was to see whether TENS is effective in relieving pain in labour. The review includes results from 17 studies with a total of 1466 women. Thirteen studies examined TENS applied to the back, two to acupuncture points and two to the cranium (head). Results show that pain scores were similar in women using TENS and in control groups. There was some evidence that women using TENS were less likely to rate their pain as severe but results were not consistent. Many women said they would be willing to use TENS again in a future labour. TENS did not seem have an effect on the length of labour, interventions in labour, or the well-being of mothers and babies. It is not known whether TENS would help women to manage pain at home in early labour. Although it is not clear that it reduces pain, women should have the choice of using TENS in labour if they think it will be helpful. | 10.1002/14651858.CD007214.pub2 | [
"The purpose of the review was to see whether TENS is effective in relieving pain in labour. The review includes results from 17 studies with a total of 1466 women. Thirteen studies examined TENS applied to the back, two to acupuncture points and two to the cranium (head). Results show that pain scores were similar in women using TENS and in control groups. There was some evidence that women using TENS were less likely to rate their pain as severe but results were not consistent. Many women said they would be willing to use TENS again in a future labour. TENS did not seem have an effect on the length of labour, interventions in labour, or the well-being of mothers and babies. It is not known whether TENS would help women to manage pain at home in early labour. Although it is not clear that it reduces pain, women should have the choice of using TENS in labour if they think it will be helpful."
] |
cochrane-simplification-train-1177 | cochrane-simplification-train-1177 | Five studies were eligible for inclusion (329 patients). Three studies (270 patients) compared low molecular weight heparin to placebo, one study (34 patients) compared LMWH in addition to standard therapy, and one study (25 patients) compared UFH to corticosteroids. The study comparing UFH to corticosteroids was rated at high risk of bias due to a single-blind design. The study that compared the addition of LMWH to standard therapy to standard therapy alone was rated at high risk of bias due to open-label design. The other three studies were rated as low risk of bias. LMWH administered subcutaneously showed no benefit over placebo for any outcome, including clinical remission (very low quality of evidence), and clinical, endoscopic, or histological improvement. High dose LMWH administered via an extended colon-release tablet demonstrated benefit over placebo for clinical remission (RR 1.39; 95% CI 1.09 to 1.77 ; P = 0.008; very low quality of evidence), clinical improvement (RR 1.28; 95% CI 1.06 to 1.55; P = 0.01; very low quality of evidence), and endoscopic improvement (RR 1.21; 95% CI 1.00 to 1.47 ; P = 0.05) but not endoscopic remission or histologic improvement. LMWH was not beneficial when added to standard therapy for clinical remission, clinical improvement, endoscopic remission or endoscopic improvement. LMWH was well-tolerated but provided no significant benefit for quality of life. One study examining UFH versus corticosteroids for the treatment of severe UC demonstrated the inferiority of UFH for clinical improvement. More patients assigned to UFH had rectal hemorrhage as an adverse event. There is evidence to suggest that LMWH may be effective for the treatment of active UC. When administered by extended colon-release tablets, LMWH was more effective than placebo for treating outpatients with mild to moderate disease. This benefit needs to be confirmed by further randomized controlled studies. The same benefits were not seen when LMWH was administered subcutaneously at lower doses. There is no evidence to support the use of UFH for the treatment of active UC. A further trial of UFH in patients with mild disease may also be justified. Any benefit found would need to be weighed against a possible increased risk of rectal bleeding in patients with active UC. | The researchers identified five studies that included a total of 329 patients. Three studies (270 patients) compared low molecular weight heparin to placebo (e.g. a sugar pill), one study (34 patients) compared low molecular weight heparin in addition to standard therapy, and one study (25 patients) compared unfractionated heparin to steroids. The study comparing unfractionated heparin to steroids and the study that compared the addition of low molecular weight heparin to standard therapy to standard therapy alone was judged to be of low quality. The three placebo-controlled studies were judged to be of high quality. In one small study, unfractionated heparin was worse than steroids for inducing clinical improvement (i.e. reduction of symptoms) in people with severe ulcerative colitis. In addition, rectal bleeding was more frequent among people who received unfractionated heparin. In another small study low molecular weight heparin used with standard therapy provided no additional benefit over standard therapy alone in adults with active ulcerative colitis. Low molecular weight heparin administered by injection showed no benefit over placebo for any outcome, including clinical remission (very low quality of evidence), clinical improvement and endoscopic improvement (i.e. healing of inflammation). High dose low molecular weight heparin administered via an extended colon-release tablet demonstrated benefit over placebo for clinical remission, clinical improvement. and endoscopic improvement. This result suggests that high dose low molecular weight heparin administered by extended-release capsules may be effective for the treatment of active ulcerative colitis. However, this result needs to be verified by future clinical trials. | 10.1002/14651858.CD006774.pub4 | [
"The researchers identified five studies that included a total of 329 patients. Three studies (270 patients) compared low molecular weight heparin to placebo (e.g. a sugar pill), one study (34 patients) compared low molecular weight heparin in addition to standard therapy, and one study (25 patients) compared unfractionated heparin to steroids. The study comparing unfractionated heparin to steroids and the study that compared the addition of low molecular weight heparin to standard therapy to standard therapy alone was judged to be of low quality. The three placebo-controlled studies were judged to be of high quality. In one small study, unfractionated heparin was worse than steroids for inducing clinical improvement (i.e. reduction of symptoms) in people with severe ulcerative colitis. In addition, rectal bleeding was more frequent among people who received unfractionated heparin. In another small study low molecular weight heparin used with standard therapy provided no additional benefit over standard therapy alone in adults with active ulcerative colitis. Low molecular weight heparin administered by injection showed no benefit over placebo for any outcome, including clinical remission (very low quality of evidence), clinical improvement and endoscopic improvement (i.e. healing of inflammation). High dose low molecular weight heparin administered via an extended colon-release tablet demonstrated benefit over placebo for clinical remission, clinical improvement. and endoscopic improvement. This result suggests that high dose low molecular weight heparin administered by extended-release capsules may be effective for the treatment of active ulcerative colitis. However, this result needs to be verified by future clinical trials."
] |
cochrane-simplification-train-1178 | cochrane-simplification-train-1178 | We included 27 RCTs (4349 couples) in this systematic review and 24 RCTs (3983 couples) in a subsequent network meta-analysis. Overall, the certainty of evidence was low to moderate: the main limitations were imprecision and/or heterogeneity. Ten RCTs including 2725 couples reported on live birth. Evidence of differences between OS, IUI, OS-IUI, or IVF/ICSI versus expectant management was insufficient (OR 1.01, 95% CI 0.51 to 1.98; low-certainty evidence; OR 1.21, 95% CI 0.61 to 2.43; low-certainty evidence; OR 1.61, 95% CI 0.88 to 2.94; low-certainty evidence; OR 1.88, 95 CI 0.81 to 4.38; low-certainty evidence). This suggests that if the chance of live birth following expectant management is assumed to be 17%, the chance following OS, IUI, OS-IUI, and IVF would be 9% to 28%, 11% to 33%, 15% to 37%, and 14% to 47%, respectively. When only including couples with poor prognosis of natural conception (3 trials, 725 couples) we found OS-IUI and IVF/ICSI increased live birth rate compared to expectant management (OR 4.48, 95% CI 2.00 to 10.1; moderate-certainty evidence; OR 4.99, 95 CI 2.07 to 12.04; moderate-certainty evidence), while there was insufficient evidence of a difference between IVF/ICSI and OS-IUI (OR 1.11, 95% CI 0.78 to 1.60; low-certainty evidence). Eleven RCTs including 2564 couples reported on multiple pregnancy. Compared to expectant management/IUI, OS (OR 3.07, 95% CI 1.00 to 9.41; low-certainty evidence) and OS-IUI (OR 3.34 95% CI 1.09 to 10.29; moderate-certainty evidence) increased the odds of multiple pregnancy, and there was insufficient evidence of a difference between IVF/ICSI and expectant management/IUI (OR 2.66, 95% CI 0.68 to 10.43; low-certainty evidence). These findings suggest that if the chance of multiple pregnancy following expectant management or IUI is assumed to be 0.6%, the chance following OS, OS-IUI, and IVF/ICSI would be 0.6% to 5.0%, 0.6% to 5.4%, and 0.4% to 5.5%, respectively. Trial results show insufficient evidence of a difference between IVF/ICSI and OS-IUI for moderate/severe ovarian hyperstimulation syndrome (OHSS) (OR 2.50, 95% CI 0.92 to 6.76; 5 studies; 985 women; moderate-certainty evidence). This suggests that if the chance of moderate/severe OHSS following OS-IUI is assumed to be 1.1%, the chance following IVF/ICSI would be between 1.0% and 7.2%. There is insufficient evidence of differences in live birth between expectant management and the other four interventions (OS, IUI, OS-IUI, and IVF/ICSI). Compared to expectant management/IUI, OS may increase the odds of multiple pregnancy, and OS-IUI probably increases the odds of multiple pregnancy. Evidence on differences between IVF/ICSI and expectant management for multiple pregnancy is insufficient, as is evidence of a difference for moderate or severe OHSS between IVF/ICSI and OS-IUI. | We found 27 randomised controlled trials comparing these treatments with each other in a total of 4349 couples with unexplained infertility. The evidence is current to September 2018. Evidence of differences in live birth between expectant management and the other four treatments (OS, IUI, OS-IUI, and IVF/ICSI) was insufficient. If the chance of live birth following expectant management is assumed to be 17%, the chance following OS, IUI, OS-IUI, and IVF would be 9% to 28%, 11% to 33%, 15% to 37%, and 14% to 47%, respectively. Compared to expectant management/IUI, OS may increase the chances of multiple pregnancy, and OS-IUI probably increases the chances of multiple pregnancy. Evidence showing differences between IVF/ICSI and expectant management for multiple pregnancy was insufficient. If the chance of multiple pregnancy following expectant management/IUI is assumed to be 1%, the chance following OS, OS-IUI, and IVF/ICSI would be 1% to 5%, 1% to 5%, and 0% to 6%, respectively. The certainty of evidence overall was low to moderate. The main limitations were imprecision (not enough couples have been studied) and heterogeneity (couples in existing studies had different clinical characteristics). | 10.1002/14651858.CD012692.pub2 | [
"We found 27 randomised controlled trials comparing these treatments with each other in a total of 4349 couples with unexplained infertility. The evidence is current to September 2018. Evidence of differences in live birth between expectant management and the other four treatments (OS, IUI, OS-IUI, and IVF/ICSI) was insufficient. If the chance of live birth following expectant management is assumed to be 17%, the chance following OS, IUI, OS-IUI, and IVF would be 9% to 28%, 11% to 33%, 15% to 37%, and 14% to 47%, respectively. Compared to expectant management/IUI, OS may increase the chances of multiple pregnancy, and OS-IUI probably increases the chances of multiple pregnancy. Evidence showing differences between IVF/ICSI and expectant management for multiple pregnancy was insufficient. If the chance of multiple pregnancy following expectant management/IUI is assumed to be 1%, the chance following OS, OS-IUI, and IVF/ICSI would be 1% to 5%, 1% to 5%, and 0% to 6%, respectively. The certainty of evidence overall was low to moderate. The main limitations were imprecision (not enough couples have been studied) and heterogeneity (couples in existing studies had different clinical characteristics)."
] |
cochrane-simplification-train-1179 | cochrane-simplification-train-1179 | Six randomised trials involving 206 patients with acute hepatitis C met the inclusion criteria. Four trials assessing interferon alfa-2b in 141 patients, all with transfusion-acquired acute hepatitis C, were included. They demonstrated no significant heterogeneity in the outcomes assessed. When compared with no treatment, interferon alfa-2b was associated with an increase in the rates of virologic ETR and SR by 45% (95% CI 31-59%, P < 0.00001) and 29% (95% CI 14-44%, P = 0.0002), respectively. The virologic ETR was 42% (95% CI: 30-56%) in the interferon alfa-2b group versus 4% (95% CI 0-13%, P < 0.00001) in the control group. At the end of follow-up, a virologic SR was seen in 32% (95% CI 21-46%) of interferon-treated patients versus only 4% (95% CI 0-13%, P = 0.00007) of controls. Interferon also improved liver biochemistry to a similar extent. The tolerability of therapy, or the impact of interferon alfa-2b on hepatic histology, was not reported. Two trials assessed interferon beta in a total 65 patients. The efficacy of interferon beta could not be assessed, however, due to heterogeneity of these trials. Interferon alfa is effective in improving biochemical outcomes and achieving sustained virologic clearance in patients with transfusion-acquired acute hepatitis C. The effect on long-term clinical outcomes could not be assessed due to limitations in the current data. | In this review, treatment with interferon alfa in the acute stage of transfusion-acquired hepatitis C infection improved liver biochemistry and enhanced viral clearance compared to the natural history of the disease. We cannot ascertain, however, the effect of interferon on clinical outcomes due to a lack of data. Because of the effect of therapy on biochemical and virologic outcomes, we recommend the treatment of acute hepatitis C with at least interferon alfa at a dosage of three million units thrice weekly for three months. Future trials should focus on the efficacy of combination therapy with ribavirin and pegylated interferons, which have shown superiority to interferon alfa in chronic hepatitis C. | 10.1002/14651858.CD000369 | [
"In this review, treatment with interferon alfa in the acute stage of transfusion-acquired hepatitis C infection improved liver biochemistry and enhanced viral clearance compared to the natural history of the disease. We cannot ascertain, however, the effect of interferon on clinical outcomes due to a lack of data. Because of the effect of therapy on biochemical and virologic outcomes, we recommend the treatment of acute hepatitis C with at least interferon alfa at a dosage of three million units thrice weekly for three months. Future trials should focus on the efficacy of combination therapy with ribavirin and pegylated interferons, which have shown superiority to interferon alfa in chronic hepatitis C."
] |
cochrane-simplification-train-1180 | cochrane-simplification-train-1180 | We included 23 studies (from 35 reports) with a total of 11,170 caregiver-infant pairs who were randomly assigned to receive an educational intervention delivered to the caregiver or usual care. Nineteen of the included studies were community-based studies while four were facility-based studies. In addition, 13 of the included studies were cluster-randomised while the others were individually randomised. Generally, the interventions were focused on the introduction of complementary feeding at the appropriate time, the types and amount of complementary foods to be fed to infants, and hygiene. Using the GRADE criteria, we assessed the quality of the evidence as moderate, mostly due to inadequate allocation concealment and insufficient blinding. Educational interventions led to improvements in complementary feeding practices for age at introduction of complementary foods (average RR 0.88, 95% CI 0.83 to 0.94; 4 studies, 1738 children; moderate-quality evidence) and hygiene practices (average RR 1.38, 95% CI 1.23 to 1.55; 4 studies, 2029 participants; moderate-quality evidence). For duration of exclusive breastfeeding, pooled results were compatible with both a reduction and an increase in the outcome (average RR 1.58, 95% CI 0.77 to 3.22; 3 studies, 1544 children; very low-quality evidence). There was limited (low to very low-quality) evidence of an effect for all growth outcomes. Quality of evidence There is moderate to very low-quality evidence that educational interventions can improve complementary feeding practices but insufficient evidence to conclude that it impacts growth outcomes. Overall, we found evidence that education improves complementary feeding practices. | We searched for randomised controlled trials (a type of experiment in which people are randomly allocated to one or more treatment groups) up until November 2017. The search identified 23 studies involving a total of 11,170 caregivers and their children. The ages of the children ranged from birth to 24 months. The caregivers received educational interventions alone while the control group received no intervention, usual care or any other non-educational intervention. The educational methods included printed materials such as leaflets, counselling, teaching sessions, peer support, videos and practical demonstrations. Generally, the education messages were focused on the introduction of semi-solid foods at the appropriate age, the types and amount of complementary foods to be fed to infants, and hygiene. Education reduced the number of caregivers that introduced semi-solid foods to their infants before six months of age by up to 12% (moderate-quality evidence). Hygiene practices of caregivers who received education also showed some improvement compared to those that did not (moderate-quality evidence). In studies conducted in the community, education increased the duration of exclusive breastfeeding, but not in studies conducted in health facilities. There was no convincing evidence of an effect of education on the growth of children (low to very low-quality evidence). We could not combine the results from different studies for diarrhoea, knowledge of caregivers and adequacy of complementary food. However, from the individual reports of the study authors, education led to a reduction in diarrhoea and an improvement in the knowledge of caregivers. It also led to improvement in the quality and quantity of complementary foods fed to infants. Overall, we found evidence that education improves complementary feeding practices. | 10.1002/14651858.CD011768.pub2 | [
"We searched for randomised controlled trials (a type of experiment in which people are randomly allocated to one or more treatment groups) up until November 2017. The search identified 23 studies involving a total of 11,170 caregivers and their children. The ages of the children ranged from birth to 24 months. The caregivers received educational interventions alone while the control group received no intervention, usual care or any other non-educational intervention. The educational methods included printed materials such as leaflets, counselling, teaching sessions, peer support, videos and practical demonstrations. Generally, the education messages were focused on the introduction of semi-solid foods at the appropriate age, the types and amount of complementary foods to be fed to infants, and hygiene. Education reduced the number of caregivers that introduced semi-solid foods to their infants before six months of age by up to 12% (moderate-quality evidence). Hygiene practices of caregivers who received education also showed some improvement compared to those that did not (moderate-quality evidence). In studies conducted in the community, education increased the duration of exclusive breastfeeding, but not in studies conducted in health facilities. There was no convincing evidence of an effect of education on the growth of children (low to very low-quality evidence). We could not combine the results from different studies for diarrhoea, knowledge of caregivers and adequacy of complementary food. However, from the individual reports of the study authors, education led to a reduction in diarrhoea and an improvement in the knowledge of caregivers. It also led to improvement in the quality and quantity of complementary foods fed to infants. Overall, we found evidence that education improves complementary feeding practices."
] |
cochrane-simplification-train-1181 | cochrane-simplification-train-1181 | Our search led to 5518 potentially relevant references. From these, we included seven RCTs in the analyses involving 2564 patients. In contrast to the first version of this review including five trials, we excluded trials randomising children. As a result, we excluded one trial from the former analyses and we identified three new trials. Five trials with 1388 patients compared the combination of chemotherapy alone and chemotherapy plus radiotherapy, with the same number of chemotherapy cycles in both arms. The addition of radiotherapy to chemotherapy has probably little or no difference on OS (HR 0.48; 95% confidence interval (CI) 0.22 to 1.06; P = 0.07, moderate- quality evidence), however two included trials had potential other high risk of bias due to a high number of patients not receiving planned radiotherapy. After excluding these trials in a sensitivity analysis, the results showed that the combination of chemotherapy and radiotherapy improved OS compared to chemotherapy alone (HR 0.31; 95% CI 0.19 to 0.52; P <0.00001, moderate- quality evidence). In contrast to chemotherapy alone the use of chemotherapy and radiotherapy improved PFS (HR 0.42; 95% CI 0.25 to 0.72; P = 0.001; moderate- quality evidence). Regarding infection- related mortality (RR 0.33; 95% CI 0.01 to 8.06; P = 0.5; low- quality evidence), second cancer- related mortality (RR 0.53; 95% CI 0.07 to 4.29; P = 0.55; low- quality evidence) and cardiac disease- related mortality (RR 2.94; 95% CI 0.31 to 27.55; P = 0.35;low- quality evidence), there is no evidence for a difference between the use of chemotherapy alone and chemotherapy plus radiotherapy. For complete response rate (CRR) (RR 1.08; 95% CI 0.93 to 1.25; P = 0.33; low- quality evidence), there is also no evidence for a difference between treatment groups. Two trials with 1176 patients compared the combination of chemotherapy alone and chemotherapy plus radiotherapy, with different numbers of chemotherapy cycles in both arms. OS is reported in one trial only, the use of chemotherapy alone (more chemotherapy cycles) may improve OS compared to chemotherapy plus radiotherapy (HR 2.12; 95% CI 1.03 to 4.37; P = 0.04; low- quality evidence). This trial also had a potential other high risk of bias due to a high number of patients not receiving planned therapy. There is no evidence for a difference between chemotherapy alone and chemotherapy plus radiotherapy regarding PFS (HR 0.42; 95% CI 0.14 to 1.24; P = 0.12; low- quality evidence). After excluding the trial with patients not receiving the planned therapy in a sensitivity analysis, the results showed that the combination of chemotherapy and radiotherapy improved PFS compared to chemotherapy alone (HR 0.24; 95% CI 0.070 to 0.88; P = 0.03, based on one trial). For infection- related mortality (RR 6.90; 95% CI 0.36 to 132.34; P = 0.2; low- quality evidence), second cancer- related mortality (RR 2.22; 95% CI 0.7 to 7.03; P = 0.18; low- quality evidence) and cardiac disease-related mortality (RR 0.99; 95% CI 0.14 to 6.90; P = 0.99; low-quality evidence), there is no evidence for a difference between the use of chemotherapy alone and chemotherapy plus radiotherapy. CRR rate was not reported. This systematic review compared the effects of chemotherapy alone and chemotherapy plus radiotherapy in adults with early stage HL . For the comparison with same numbers of chemotherapy cycles in both arms, we found moderate- quality evidence that PFS is superior in patients receiving chemotherapy plus radiotherapy than in those receiving chemotherapy alone. The addition of radiotherapy to chemotherapy has probably little or no difference on OS . The sensitivity analysis without the trials with potential other high risk of bias showed that chemotherapy plus radiotherapy improves OS compared to chemotherapy alone. For the comparison with different numbers of chemotherapy cycles between the arms there are no implications for OS and PFS possible, because of the low quality of evidence of the results. | We searched important medical databases such as the Cochrane Central Register of Controlled Trials and MEDLINE. Two review authors independently screened, summarised and analysed the results. This led to the inclusion of seven randomised controlled trials involving with 2564 patients. The evidence provided is current to December 2016. For the comparison of chemotherapy alone and chemotherapy plus radiotherapy with the same number of chemotherapy cycles in both arms, this systematic review found no evidence for a difference regarding OS between the interventions, however, two included trials had potential other high risk of bias due to a high number of patients not receiving radiotherapy as planned beforehand. After excluding these trials in a further analysis, OS was superior in adults receiving chemotherapy plus radiotherapy than in those receiving chemotherapy alone. PFS was also superior in adults receiving chemotherapy plus radiotherapy. Most trials reported adverse events (AEs), but in different ways. Because of insufficient comparable data we focused on adverse events considered of particular interest. For infection- related mortality, second cancer- related mortality and cardiac disease- related mortality, there was no evidence for a difference between treatment groups. For complete response rate (CRR) there was no evidence for a difference between treatment groups either. For the comparison of chemotherapy alone and chemotherapy plus radiotherapy with different numbers of chemotherapy cycles in the arms, OS was reported in one trial only. The use of chemotherapy alone may improve OS compared to chemotherapy plus radiotherapy. There was no evidence for a difference between treatment groups regarding PFS. After excluding one trial with patients not receiving the planned therapy the results showed that chemotherapy plus radiotherapy improved PFS. For infection- related mortality, second cancer- related mortality and cardiac disease- related mortality, there is no evidence for a difference between treatment groups. CR was not reported. For the same number of chemotherapy cycles in both arms, we judged the quality of evidence for OS and PFS as moderate, for AEs and CR as low. For different numbers of chemotherapy cycles in the arms, we considered the quality of evidence for OS, PFS and AEs to be low. This systematic review compared the effects of chemotherapy alone and chemotherapy plus radiotherapy in adults with early stage HL . For the comparison with same numbers of chemotherapy cycles in both arms we found moderate- quality evidence that PFS is superior in patients receiving chemotherapy plus radiotherapy than in those receiving chemotherapy alone. The addition of radiotherapy to chemotherapy has probably little or no difference on OS. A further analysis without the trials with potential other high risk of bias showed that chemotherapy plus radiotherapy improves OS (both analyses moderate- quality evidence). For the comparison of chemotherapy alone and chemotherapy plus radiotherapy with different numbers of chemotherapy cycles between the arms there were no implications for OS and PFS possible, because of the low quality of evidence of the results. | 10.1002/14651858.CD007110.pub3 | [
"We searched important medical databases such as the Cochrane Central Register of Controlled Trials and MEDLINE. Two review authors independently screened, summarised and analysed the results. This led to the inclusion of seven randomised controlled trials involving with 2564 patients. The evidence provided is current to December 2016. For the comparison of chemotherapy alone and chemotherapy plus radiotherapy with the same number of chemotherapy cycles in both arms, this systematic review found no evidence for a difference regarding OS between the interventions, however, two included trials had potential other high risk of bias due to a high number of patients not receiving radiotherapy as planned beforehand. After excluding these trials in a further analysis, OS was superior in adults receiving chemotherapy plus radiotherapy than in those receiving chemotherapy alone. PFS was also superior in adults receiving chemotherapy plus radiotherapy. Most trials reported adverse events (AEs), but in different ways. Because of insufficient comparable data we focused on adverse events considered of particular interest. For infection- related mortality, second cancer- related mortality and cardiac disease- related mortality, there was no evidence for a difference between treatment groups. For complete response rate (CRR) there was no evidence for a difference between treatment groups either. For the comparison of chemotherapy alone and chemotherapy plus radiotherapy with different numbers of chemotherapy cycles in the arms, OS was reported in one trial only. The use of chemotherapy alone may improve OS compared to chemotherapy plus radiotherapy. There was no evidence for a difference between treatment groups regarding PFS. After excluding one trial with patients not receiving the planned therapy the results showed that chemotherapy plus radiotherapy improved PFS. For infection- related mortality, second cancer- related mortality and cardiac disease- related mortality, there is no evidence for a difference between treatment groups. CR was not reported. For the same number of chemotherapy cycles in both arms, we judged the quality of evidence for OS and PFS as moderate, for AEs and CR as low. For different numbers of chemotherapy cycles in the arms, we considered the quality of evidence for OS, PFS and AEs to be low. This systematic review compared the effects of chemotherapy alone and chemotherapy plus radiotherapy in adults with early stage HL . For the comparison with same numbers of chemotherapy cycles in both arms we found moderate- quality evidence that PFS is superior in patients receiving chemotherapy plus radiotherapy than in those receiving chemotherapy alone. The addition of radiotherapy to chemotherapy has probably little or no difference on OS. A further analysis without the trials with potential other high risk of bias showed that chemotherapy plus radiotherapy improves OS (both analyses moderate- quality evidence). For the comparison of chemotherapy alone and chemotherapy plus radiotherapy with different numbers of chemotherapy cycles between the arms there were no implications for OS and PFS possible, because of the low quality of evidence of the results."
] |
cochrane-simplification-train-1182 | cochrane-simplification-train-1182 | We added 10 RCTs to this updated review. The review now includes 54 published trials (45 fully published reports, four abstracts, and five subsets of data from previously published RCTs) involving 11,898 participants. Lower biological WBRT doses versus control The hazard ratio (HR) for overall survival (OS) with lower biological WBRT doses as compared with control (3000 cGy in 10 daily fractions) was 1.21 (95% confidence interval (CI) 1.04 to 1.40; P = 0.01; moderate-certainty evidence) in favour of control. The HR for neurological function improvement (NFI) was 1.74 (95% CI 1.06 to 2.84; P = 0.03; moderate-certainty evidence) in favour of control fractionation. Higher biological WBRT doses versus control The HR for OS with higher biological WBRT doses as compared with control (3000 cGy in 10 daily fractions) was 0.97 (95% CI 0.83 to 1.12; P = 0.65; moderate-certainty evidence). The HR for NFI was 1.14 (95% CI 0.92 to 1.42; P = 0.23; moderate-certainty evidence). WBRT and radiosensitisers The addition of radiosensitisers to WBRT did not confer additional benefit for OS (HR 1.05, 95% CI 0.99 to 1.12; P = 0.12; moderate-certainty evidence) or for brain tumour response rates (odds ratio (OR) 0.84, 95% CI 0.63 to 1.11; P = 0.22; high-certainty evidence). Radiosurgery and WBRT versus WBRT alone The HR for OS with use of WBRT and radiosurgery boost as compared with WBRT alone for selected participants was 0.61 (95% CI 0.27 to 1.39; P = 0.24; moderate-certainty evidence). For overall brain control at one year, the HR was 0.39 (95% CI 0.25 to 0.60; P < 0.0001; high-certainty evidence) favouring the WBRT and radiosurgery boost group. Radiosurgery alone versus radiosurgery and WBRT The HR for local brain control was 2.73 (95% CI 1.87 to 3.99; P < 0.00001; high-certainty evidence)favouring the addition of WBRT to radiosurgery. The HR for distant brain control was 2.34 (95% CI 1.73 to 3.18; P < 0.00001; high-certainty evidence) favouring WBRT and radiosurgery. The HR for OS was 1.00 (95% CI 0.80 to 1.25; P = 0.99; moderate-certainty evidence). Two trials reported worse neurocognitive outcomes and one trial reported worse quality of life outcomes when WBRT was added to radiosurgery. We could not pool data from trials related to chemotherapy, optimal supportive care (OSC), molecular targeted agents, neurocognitive protective agents, and hippocampal sparing WBRT. However, one trial reported no differences in quality-adjusted life-years for selected participants with brain metastases from non-small-cell lung cancer randomised to OSC and WBRT versus OSC alone. None of the trials with altered higher biological WBRT dose-fractionation schemes reported benefit for OS, NFI, or symptom control compared with standard care. However, OS and NFI were worse for lower biological WBRT dose-fractionation schemes than for standard dose schedules. The addition of WBRT to radiosurgery improved local and distant brain control in selected people with brain metastases, but data show worse neurocognitive outcomes and no differences in OS. Selected people with multiple brain metastases from non-small-cell lung cancer may show no difference in OS when OSC is given and WBRT is omitted. Use of radiosensitisers, chemotherapy, or molecular targeted agents in conjunction with WBRT remains experimental. Further trials are needed to evaluate the use of neurocognitive protective agents and hippocampal sparing with WBRT. As well, future trials should examine homogeneous participants with brain metastases with focus on prognostic features and molecular markers. | This review includes 54 published trials involving 11,898 participants. Data show no apparent additional benefit of altered WBRT dose schedules compared with standard dose schedules. Use of other treatments such as chemotherapy, radiosensitisers, and molecular targeted agents in conjunction with WBRT has not yet been shown to be of benefit. Radiosurgery boost with WBRT does not improve survival among selected people with multiple brain metastases. WBRT when added to radiosurgery improves local and distant brain control. However, neurocognitive outcomes are better for selected people treated with radiosurgery alone as compared with WBRT and radiosurgery. For selected individuals with metastatic non-small-cell lung cancer to brain, survival may not be better with WBRT and optimal supportive care than with optimal supportive care alone. Studies have provided evidence of moderate to high certainty. Altered higher biological WBRT dose-fractionation schemes, as reported in randomised trials, did not confer benefit for overall survival, neurological function, or symptom control compared with standard treatment (3000 cGy in 10 daily fractions, or 2000 cGy in 4 or 5 daily fractions). However, overall survival and neurological function were worse for lower biological WBRT dose-fractionation schemes than for standard dose schedules. The addition of WBRT to radiosurgery improved local and distant brain control (i.e. absence of new intracranial lesions at the site or outside of treated lesions after treatment) among selected people with brain metastases, but investigators reported worse cognitive outcomes and no differences in overall survival. Selected people with multiple brain metastases from non-small-cell lung cancer may show no difference in overall survival when optimal supportive care is given and WBRT is omitted. Use of other treatments (radiosensitisers, chemotherapy, or molecular targeted agents) in conjunction with WBRT remains experimental. Additional trials are needed to evaluate strategies to protect cognitive decline associated with WBRT. As well, future trials should examine people with brain metastases with focus on prognostic features and tumour characteristics. | 10.1002/14651858.CD003869.pub4 | [
"This review includes 54 published trials involving 11,898 participants. Data show no apparent additional benefit of altered WBRT dose schedules compared with standard dose schedules. Use of other treatments such as chemotherapy, radiosensitisers, and molecular targeted agents in conjunction with WBRT has not yet been shown to be of benefit. Radiosurgery boost with WBRT does not improve survival among selected people with multiple brain metastases. WBRT when added to radiosurgery improves local and distant brain control. However, neurocognitive outcomes are better for selected people treated with radiosurgery alone as compared with WBRT and radiosurgery. For selected individuals with metastatic non-small-cell lung cancer to brain, survival may not be better with WBRT and optimal supportive care than with optimal supportive care alone. Studies have provided evidence of moderate to high certainty. Altered higher biological WBRT dose-fractionation schemes, as reported in randomised trials, did not confer benefit for overall survival, neurological function, or symptom control compared with standard treatment (3000 cGy in 10 daily fractions, or 2000 cGy in 4 or 5 daily fractions). However, overall survival and neurological function were worse for lower biological WBRT dose-fractionation schemes than for standard dose schedules. The addition of WBRT to radiosurgery improved local and distant brain control (i.e. absence of new intracranial lesions at the site or outside of treated lesions after treatment) among selected people with brain metastases, but investigators reported worse cognitive outcomes and no differences in overall survival. Selected people with multiple brain metastases from non-small-cell lung cancer may show no difference in overall survival when optimal supportive care is given and WBRT is omitted. Use of other treatments (radiosensitisers, chemotherapy, or molecular targeted agents) in conjunction with WBRT remains experimental. Additional trials are needed to evaluate strategies to protect cognitive decline associated with WBRT. As well, future trials should examine people with brain metastases with focus on prognostic features and tumour characteristics."
] |
cochrane-simplification-train-1183 | cochrane-simplification-train-1183 | We identified 14 trials evaluating surgery versus surgery plus radiotherapy. Individual participant data were available for 11 of these trials, and our analyses are based on 2343 participants (1511 deaths). Results show a significant adverse effect of PORT on survival, with a hazard ratio of 1.18, or an 18% relative increase in risk of death. This is equivalent to an absolute detriment of 5% at two years (95% confidence interval (CI) 2% to 9%), reducing overall survival from 58% to 53%. Subgroup analyses showed no differences in effects of PORT by any participant subgroup covariate. We did not undertake analysis of the effects of PORT on quality of life and adverse events. Investigators did not routinely collect quality of life information during these trials, and it was unlikely that any benefit of PORT would offset the observed survival disadvantage. We considered risk of bias in the included trials to be low. Results from 11 trials and 2343 participants show that PORT is detrimental to those with completely resected non-small cell lung cancer and should not be used in the routine treatment of such patients. Results of ongoing RCTs will clarify the effects of modern radiotherapy in patients with N2 tumours. | We searched for relevant trials up to 8 July 2016. These studies brought together available trial data from all over the world, with 11 trials and 2343 patients. Trials were carried out between 1966 and 1998. Results showed that fewer people given PORT treatment lived for two years after the operation (53 out of every 100 patients) than those not given PORT after the operation (58 out of every 100 patients). Researchers reported no difference in effects of PORT by types of patients included in trials. Researchers did not routinely collect quality of life information during the trials, and it was unlikely that any benefit of PORT would offset the observed survival disadvantage. Radiotherapy given after successful removal of tumour at operation is not beneficial for patients with non-small cell lung cancer and should not be used as routine treatment; however, further research into new types of radiotherapy for patients at higher risk of recurrence is ongoing. These systematic reviews and meta-analyses use individual participant data, which are considered the gold standard for this type of review. We included all eligible trials, if possible, no matter what language they were published in, or whether or not they were published. This meta-analysis included 88% of all participants in eligible trials. Studies were well designed and conducted and addressed the review question, with consistent effects noted across trials. The impact of any data not included in our analyses is small. | 10.1002/14651858.CD002142.pub4 | [
"We searched for relevant trials up to 8 July 2016. These studies brought together available trial data from all over the world, with 11 trials and 2343 patients. Trials were carried out between 1966 and 1998. Results showed that fewer people given PORT treatment lived for two years after the operation (53 out of every 100 patients) than those not given PORT after the operation (58 out of every 100 patients). Researchers reported no difference in effects of PORT by types of patients included in trials. Researchers did not routinely collect quality of life information during the trials, and it was unlikely that any benefit of PORT would offset the observed survival disadvantage. Radiotherapy given after successful removal of tumour at operation is not beneficial for patients with non-small cell lung cancer and should not be used as routine treatment; however, further research into new types of radiotherapy for patients at higher risk of recurrence is ongoing. These systematic reviews and meta-analyses use individual participant data, which are considered the gold standard for this type of review. We included all eligible trials, if possible, no matter what language they were published in, or whether or not they were published. This meta-analysis included 88% of all participants in eligible trials. Studies were well designed and conducted and addressed the review question, with consistent effects noted across trials. The impact of any data not included in our analyses is small."
] |
cochrane-simplification-train-1184 | cochrane-simplification-train-1184 | The risk of bias was high in many of the included studies. Random sequence generation and allocation concealment was reported in three (12%) and four studies (16%), respectively. Participants and personnel were blinded in 13 studies (52%), and outcome assessors were blinded in five studies (20%). Complete outcome reporting occurred in nine studies (36%). Adverse events were only reported in nine studies (36%); 11 studies (44%) reported industry funding. We included 25 studies (8289 participants) in this latest update; 23 studies (24 comparisons, 8166 participants) compared statins with placebo or no treatment, and two studies (123 participants) compared statins directly with one or more other statins. Statins had little or no effect on major cardiovascular events (4 studies, 7084 participants: RR 0.95, 95% CI 0.88 to 1.03), all-cause mortality (13 studies, 4705 participants: RR 0.96, 95% CI 0.90 to 1.02), cardiovascular mortality (13 studies, 4627 participants: RR 0.94, 95% CI 0.84 to 1.06) and myocardial infarction (3 studies, 4047 participants: RR 0.87, 95% CI 0.71 to 1.07); and uncertain effects on stroke (2 studies, 4018 participants: RR 1.29, 95% CI 0.96 to 1.72). Risks of adverse events from statin therapy were uncertain; these included effects on elevated creatine kinase (5 studies, 3067 participants: RR 1.25, 95% CI 0.55 to 2.83) or liver function enzymes (4 studies, 3044 participants; RR 1.09, 95% CI 0.41 to 1.25), withdrawal due to adverse events (9 studies, 1832 participants: RR 1.04, 95% CI 0.87 to 1.25) or cancer (2 studies, 4012 participants: RR 0.90, 95% CI 0.72 to 1.11). Statins reduced total serum cholesterol (14 studies, 1803 participants; MD -44.86 mg/dL, 95% CI -55.19 to -34.53) and low-density lipoprotein cholesterol (12 studies, 1747 participants: MD -39.99 mg/dL, 95% CI -52.46 to -27.52) levels. Data comparing statin therapy directly with another statin were sparse. Statins have little or no beneficial effects on mortality or cardiovascular events and uncertain adverse effects in adults treated with dialysis despite clinically relevant reductions in serum cholesterol levels. | In 2009 we identified 14 studies, enrolling 2086 patients, and found that while statins were generally safe and reduced cholesterol levels, they did not prevent death or clinical cardiac events in people treated with dialysis. This latest update analysed a total or 25 studies (8289 patients), and included the results from two new large studies. We found that statins lowered cholesterol in people treated with dialysis but did not prevent death, heart attack, or stroke. Evidence for side-effects was incomplete, and potential harms from statin therapy remain uncertain. Current study data did not address whether statin treatment should be stopped when a person starts dialysis, although the benefits associated with continued treatment are likely to be small. Limited information was available for people treated with peritoneal dialysis, suggesting that more research is needed in this setting. | 10.1002/14651858.CD004289.pub5 | [
"In 2009 we identified 14 studies, enrolling 2086 patients, and found that while statins were generally safe and reduced cholesterol levels, they did not prevent death or clinical cardiac events in people treated with dialysis. This latest update analysed a total or 25 studies (8289 patients), and included the results from two new large studies. We found that statins lowered cholesterol in people treated with dialysis but did not prevent death, heart attack, or stroke. Evidence for side-effects was incomplete, and potential harms from statin therapy remain uncertain. Current study data did not address whether statin treatment should be stopped when a person starts dialysis, although the benefits associated with continued treatment are likely to be small. Limited information was available for people treated with peritoneal dialysis, suggesting that more research is needed in this setting."
] |
cochrane-simplification-train-1185 | cochrane-simplification-train-1185 | We included six RCTs with a total of 421 patients with various types of atrial fibrillation. All trials were conducted between 2006 and 2016, and had short follow-up (eight weeks to six months). Risks of bias ranged from high risk to low risk.The exercise-based programmes in four trials consisted of both aerobic exercise and resistance training, in one trial consisted of Qi-gong (slow and graceful movements), and in another trial, consisted of inspiratory muscle training. For mortality, very low-quality evidence from six trials suggested no clear difference in deaths between the exercise and no-exercise groups (relative risk (RR) 1.00, 95% confidence interval (CI) 0.06 to 15.78; participants = 421; I² = 0%; deaths = 2). Very low-quality evidence from five trials suggested no clear difference between groups for serious adverse events (RR 1.01, 95% CI 0.98 to 1.05; participants = 381; I² = 0%; events = 8). Low-quality evidence from two trials suggested no clear difference in health-related quality of life for the Short Form-36 (SF-36) physical component summary measure (mean difference (MD) 1.96, 95% CI -2.50 to 6.42; participants = 224; I² = 69%), or the SF-36 mental component summary measure (MD 1.99, 95% CI -0.48 to 4.46; participants = 224; I² = 0%). Exercise capacity was assessed by cumulated work, or maximal power (Watt), obtained by cycle ergometer, or by six minute walking test, or ergospirometry testing measuring VO2 peak. We found moderate-quality evidence from two studies that exercise-based rehabilitation increased exercise capacity, measured by VO2 peak, more than no exercise (MD 3.76, 95% CI 1.37 to 6.15; participants = 208; I² = 0%); and very low-quality evidence from four studies that exercise-based rehabilitation increased exercise capacity more than no exercise, measured by the six-minute walking test (MD 75.76, 95% CI 14.00 to 137.53; participants = 272; I² = 85%). When we combined the different assessment tools for exercise capacity, we found very low-quality evidence from six trials that exercise-based rehabilitation increased exercise capacity more than no exercise (standardised mean difference (SMD) 0.86, 95% CI 0.46 to 1.26; participants = 359; I² = 65%). Overall, the quality of the evidence for the outcomes ranged from moderate to very-low. Due to few randomised patients and outcomes, we could not evaluate the real impact of exercise-based cardiac rehabilitation on mortality or serious adverse events. The evidence showed no clinically relevant effect on health-related quality of life. Pooled data showed a positive effect on the surrogate outcome of physical exercise capacity, but due to the low number of patients and the moderate to very low-quality of the underpinning evidence, we could not be certain of the magnitude of the effect. Future high-quality randomised trials are needed to assess the benefits and harms of exercise-based cardiac rehabilitation for adults with atrial fibrillation on patient-relevant outcomes. | We included six randomised trials with a total of 421 participants. The evidence is current to July 2016. There were two deaths and eight serious adverse events (harmful side effects) reported in the six trials, therefore, we had insufficient data to conclude whether exercise-based cardiac rehabilitation improved outcomes that matter the most to patients, such as death and serious adverse events (e.g. hospitalisation). Exercise-based rehabilitation was not found to have a clinically relevant impact on quality of life for the patient group, but may increase exercise capacity. The quality of the evidence ranged from moderate to very low for all outcomes. It was possible for people in the trials to know to which intervention group they were randomised, the reporting of the results was not complete in many trials, and for some outcomes, the results varied across trials. These considerations limit our confidence in the overall results of the review. Further randomised clinical trials that are conducted with low risks of bias and low risks of the play of chance, in a broader population of patients with AF, are needed to assess the impact of exercise-based interventions. | 10.1002/14651858.CD011197.pub2 | [
"We included six randomised trials with a total of 421 participants. The evidence is current to July 2016. There were two deaths and eight serious adverse events (harmful side effects) reported in the six trials, therefore, we had insufficient data to conclude whether exercise-based cardiac rehabilitation improved outcomes that matter the most to patients, such as death and serious adverse events (e.g. hospitalisation). Exercise-based rehabilitation was not found to have a clinically relevant impact on quality of life for the patient group, but may increase exercise capacity. The quality of the evidence ranged from moderate to very low for all outcomes. It was possible for people in the trials to know to which intervention group they were randomised, the reporting of the results was not complete in many trials, and for some outcomes, the results varied across trials. These considerations limit our confidence in the overall results of the review. Further randomised clinical trials that are conducted with low risks of bias and low risks of the play of chance, in a broader population of patients with AF, are needed to assess the impact of exercise-based interventions."
] |
cochrane-simplification-train-1186 | cochrane-simplification-train-1186 | This review included two studies of good methodological quality that enrolled 1073 participants with COPD. The studies used a similar design and inclusion criteria and were of at least 12 weeks duration; the participants had a mean forced expiratory volume in one second (FEV1) of 40% predicted value at baseline. One study used tiotropium via the HandiHaler (18 µg) for 12 months and the other via the Respimat device (5 µg and 10 µg) for 12 weeks. In general, the treatment groups were well matched at baseline but not all outcomes were reported for both studies. Overall the risk of bias across the included RCTs was low. For primary outcomes this review found that at the three months trough (the lowest level measured before treatment) FEV1 significantly increased with tiotropium compared to ipratropium bromide (mean difference (MD) 109 mL; 95% confidence interval (CI) 81 to 137, moderate quality evidence, I2 = 62%). There were fewer people experiencing one or more non-fatal serious adverse events on tiotropium compared to ipratropium (odds ratio (OR) 0.5; 95% CI 0.34 to 0.73, high quality evidence). This represents an absolute reduction in risk from 176 to 97 per 1000 people over three to 12 months. Concerning disease specific adverse events, the tiotropium group were also less likely to experience a COPD-related serious adverse event when compared to ipratropium bromide (OR 0.59; 95% CI 0.41 to 0.85, moderate quality evidence). For secondary outcomes, both studies reported fewer hospital admissions in the tiotropium group (OR 0.34; 95% CI 0.15 to 0.70, moderate quality evidence); as well as fewer patients experiencing one or more exacerbations leading to hospitalisation in the people on tiotropium in both studies (OR 0.56; 95% CI 0.31 to 0.99, moderate quality evidence). There was no significant difference in mortality between the treatments (OR 1.39; 95% CI 0.44 to 4.39, moderate quality evidence). One study measured quality of life using the St George's Respiratory Questionnaire (SGRQ); the mean SGRQ score at 52 weeks was lower in the tiotropium group than the ipratropium group (lower on the scale is favourable) (MD -3.30; 95% CI -5.63 to -0.97, moderate quality evidence). There were fewer participants suffering one of more exacerbations in the tiotropium arm (OR 0.71; 95% CI 0.52 to 0.95, high quality evidence) and there was also a reported difference in the mean number of exacerbations per person per year which reached statistical significance (MD -0.23; 95% CI -0.39 to -0.07, P = 0.006, moderate quality evidence). From the 1073 participants there were significantly fewer withdrawals from the tiotropium group (OR 0.58; 95% CI 0.41 to 0.83, high quality evidence). This review shows that tiotropium treatment, when compared with ipratropium bromide, was associated with improved lung function, fewer hospital admissions (including those for exacerbations of COPD), fewer exacerbations of COPD and improved quality of life. There were both fewer serious adverse events and disease specific events in the tiotropium group, but no significant difference in deaths with ipratropium bromide when compared to tiotropium. Thus, tiotropium appears to be a reasonable choice (instead of ipratropium bromide) for patients with stable COPD, as proposed in guidelines. A recent large double-blind trial of the two delivery devices found no substantial difference in mortality using 2.5 µg or 5 µg of tiotropium via Respimat in comparison to 18 µg via Handihaler. | We found two studies including 1073 participants that compared the long-term effectiveness and side effects of tiotropium compared to ipratropium bromide. One trial was 12 weeks long and one was a year long. The people included in the studies had moderate to severe COPD (average forced expiratory volume in one second (FEV1) was 40% the predicted value). Compared to ipratropium bromide, tiotropium treatment led to improved lung function, fewer COPD exacerbations, fewer hospital admissions (including those for exacerbations of COPD) and improved quality of life. Tiotropium appears to be safer with fewer adverse events, but there was no significant difference in deaths with ipratropium bromide when compared to tiotropium. Overall the evidence was of moderate to high quality. Tiotrpium is available in two different inhalers, Respimat and Handihaler. A recent large double-blind trial of the two delivery devices found no substantial difference in mortality using 2.5 µg or 5 µg of tiotropium via Respimat in comparison to 18 µg via Handihaler. Based on this review, tiotropium has more benefits than ipratropium bromide for people with stable moderate to severe COPD. The review was current as of August 2015. | 10.1002/14651858.CD009552.pub3 | [
"We found two studies including 1073 participants that compared the long-term effectiveness and side effects of tiotropium compared to ipratropium bromide. One trial was 12 weeks long and one was a year long. The people included in the studies had moderate to severe COPD (average forced expiratory volume in one second (FEV1) was 40% the predicted value). Compared to ipratropium bromide, tiotropium treatment led to improved lung function, fewer COPD exacerbations, fewer hospital admissions (including those for exacerbations of COPD) and improved quality of life. Tiotropium appears to be safer with fewer adverse events, but there was no significant difference in deaths with ipratropium bromide when compared to tiotropium. Overall the evidence was of moderate to high quality. Tiotrpium is available in two different inhalers, Respimat and Handihaler. A recent large double-blind trial of the two delivery devices found no substantial difference in mortality using 2.5 µg or 5 µg of tiotropium via Respimat in comparison to 18 µg via Handihaler. Based on this review, tiotropium has more benefits than ipratropium bromide for people with stable moderate to severe COPD. The review was current as of August 2015."
] |
cochrane-simplification-train-1187 | cochrane-simplification-train-1187 | This review includes eight studies conducted in 22,604 participants (mostly adults). Six studies compared formoterol as-needed to terbutaline whilst two studies compared formoterol with salbutamol as-needed. Background maintenance therapy varied across the trials. Asthma exacerbations and serious adverse events showed a direction of treatment effect favouring formoterol, of which one outcome reached statistical significance (exacerbations requiring a course of oral corticosteroids). In patients on short-acting beta2-agonists, 117 people out of 1000 had exacerbations requiring oral corticosteroids over 30 weeks, compared to 101 (95% CI 93 to 108) out of 1000 for patients on formoterol as-needed. In patients on maintenance inhaled corticosteroids there were also significantly fewer exacerbations requiring a course of oral corticosteroids on formoterol as-needed (Peto OR 0.75; 95% CI 0.62 to 0.91). There was one death per 1000 people on formoterol or on short-acting beta2-agonists. In adults, formoterol was similar to short-acting beta2-agonists when used as a reliever, and showed a reduction in the number of exacerbations requiring a course of oral corticosteroids. Clinicians should weigh the relatively modest benefits of formoterol as-needed against the benefits of single inhaler therapy and the potential danger of long-term use of long-acting beta2-agonists in some patients. We did not find evidence to recommend changes to guidelines that suggest that long-acting beta2-agonists should be given only to patients already taking inhaled corticosteroids. There was insufficient information reported from children in the included trials to come to any conclusion on the safety or efficacy of formoterol as relief medication for children with asthma. | We found eight trials involving a total of 22,604 patients. We found that taking formoterol reduced the risk of having an exacerbation that was treated with oral corticosteroids, but none of the other benefits from taking formoterol were statistically significant. Guidelines suggest that long-acting beta-agonists should be given only to patients already taking an inhaled corticosteroid. We could not find enough trials conducted in children to reach a conclusion on the benefits and harms in children, so we do not recommend using the results to make recommendations on treatment of children with asthma. | 10.1002/14651858.CD008418.pub2 | [
"We found eight trials involving a total of 22,604 patients. We found that taking formoterol reduced the risk of having an exacerbation that was treated with oral corticosteroids, but none of the other benefits from taking formoterol were statistically significant. Guidelines suggest that long-acting beta-agonists should be given only to patients already taking an inhaled corticosteroid. We could not find enough trials conducted in children to reach a conclusion on the benefits and harms in children, so we do not recommend using the results to make recommendations on treatment of children with asthma."
] |
cochrane-simplification-train-1188 | cochrane-simplification-train-1188 | These results include data from one extra trial and so update those in the original publication ABC 2003. Platinum based combination chemotherapy showed a significant benefit on overall survival with a combined hazard ratio (HR) 0.86 (95% CI 0.77 to 0.95, P = 0.003); 14% reduction in the risk of death; 5% absolute benefit at 5 years (95% CI 1% to 7%); overall survival increased from 45% to 50%. This effect was observed irrespective of the type of local treatment and did not vary between subgroups of patients. The HR for all trials, including those that used single-agent cisplatin, tended to favour neoadjuvant chemotherapy (HR= 0.89, 95% CI 0.81 to 0.98, P = 0.022). Although platinum based combination chemotherapy was beneficial, there was no clear evidence to support the use of single-agent platinum, indeed there was significant difference in the effect between these groups of trials (P = 0.029). This improvement in survival encourages the use of platinum based combination chemotherapy for patients with invasive bladder cancer. | This review suggests that 50 out of 100 patients will be alive at five years, when they are given chemotherapy using a platinum drug in combination with other drugs, before having surgery and/or radiotherapy. This is compared to 45 out of every 100 patients who were given surgery and/or radiotherapy without chemotherapy. This benefit of platinum-based combination chemotherapy was seen in all types of patients and encourages its use for the treatment of invasive bladder cancer. However, chemotherapy based on a single platinum drug did not help patients live longer, and is not recommended. | 10.1002/14651858.CD005246 | [
"This review suggests that 50 out of 100 patients will be alive at five years, when they are given chemotherapy using a platinum drug in combination with other drugs, before having surgery and/or radiotherapy. This is compared to 45 out of every 100 patients who were given surgery and/or radiotherapy without chemotherapy. This benefit of platinum-based combination chemotherapy was seen in all types of patients and encourages its use for the treatment of invasive bladder cancer. However, chemotherapy based on a single platinum drug did not help patients live longer, and is not recommended."
] |
cochrane-simplification-train-1189 | cochrane-simplification-train-1189 | We included eight studies (334 participants, 9 references) in this review. Twelve studies are ongoing and will be considered in future versions of this review as appropriate. We have been unable to obtain full-text versions of a further 12 studies and have designated them as 'awaiting classification'. Four studies were at a low risk of bias for randomization; two at a low risk of bias for allocation concealment. Four studies were at a low risk of bias for blinding of participants and personnel. We considered three studies at a low risk of bias for blinding of outcome assessors. We considered most studies at a high risk of selective reporting bias. We report results for the following four main comparisons. Sumatriptan versus placebo (1 parallel study; 102 participants) Data on sumatriptan showed a reduction of the risk of AMS when compared with a placebo (risk ratio (RR) = 0.43, CI 95% 0.21 to 0.84; 1 study, 102 participants; low quality of evidence). The one included study did not report events of HAPE, HACE or adverse events related to administrations of sumatriptan. Magnesium citrate versus placebo (1 parallel study; 70 participants) The estimated RR for AMS, comparing magnesium citrate tablets versus placebo, was 1.09 (95% CI 0.55 to 2.13; 1 study; 70 participants; low quality of evidence). In addition, the estimated RR for loose stools was 3.25 (95% CI 1.17 to 8.99; 1 study; 70 participants; low quality of evidence). The one included study did not report events of HAPE or HACE. Spironolactone versus placebo (2 parallel studies; 205 participants) Pooled estimation of RR for AMS was not performed due to considerable heterogeneity between the included studies (I² = 72%). RR from individual studies was 0.40 (95% CI 0.12 to 1.31) and 1.44 (95% CI 0.79 to 2.01; very low quality of evidence). No events of HAPE or HACE were reported. Adverse events were not evaluated. Acetazolamide versus spironolactone (1 parallel study; 232 participants) Data on acetazolamide compared with spironolactone showed a reduction of the risk of AMS with the administration of acetazolamide (RR = 0.36, 95% CI 0.18 to 0.70; 232 participants; low quality of evidence). No events of HAPE or HACE were reported. Adverse events were not evaluated. This Cochrane Review is the second in a series of three providing relevant information to clinicians and other interested parties on how to prevent high altitude illness. The assessment of five of the less commonly used classes of drugs suggests that there is a scarcity of evidence related to these interventions. Clinical benefits and harms related to potential interventions such as sumatriptan are still unclear. Overall, the evidence is limited due to the low number of studies identified (for most of the comparison only one study was identified); limitations in the quality of the evidence (moderate to low); and the number of studies pending classification (24 studies awaiting classification or ongoing). We lack the large and methodologically sound studies required to establish or refute the efficacy and safety of most of the pharmacological agents evaluated in this review. | The evidence is current to May 2017. We included eight studies and 334 participants related to five different classes of medicines sometimes recommended for HAI prevention. These medicines included those that mimic the action of serotonin at selected sites (selective 5-hydroxytryptamine(1) receptor agonists), medicines that regulate the action of calcium (N-methyl-D-aspartate (NMDA) antagonist), medicines that promote dilation of the blood vessels (endothelin-1 antagonist), medicines that prevent a neuron (nerve cell) from 'firing' (initiating an action) and convulsions from developing (anticonvulsant medicines), as well as medicines that regulate the body´s sodium and water levels (spironolactone). All studies were undertaken in high altitude mountain areas. The participants ranged between 16 and 65 years of age. Only one study included people at a high risk of this condition due to their history of HAI. Four trials provided the intervention between one to three days prior to the ascent (50%), and three trials less than 24 hours prior (37.5%). The participants in all these studies reached a final altitude of between 3500 and 5895 metres above sea level. Only one of the eight included studies did not provide clear information about the source of funding (12.5%). Twenty-four additional studies were classified as ongoing (12), or awaiting classification (12; unable to obtain full texts). The assessment of the less commonly used pharmacological interventions suggest that there is a scarcity of evidence related to these interventions. For most of the assessed comparisons, we only found evidence from a single study. Clinical benefits and harms related to potential interventions such as sumatriptan are still unclear. The quality of the evidence was rated from low to very low. Several studies had quality shortcomings such as only having small sample sizes and therefore generating uncertain results. For most of the medicines evaluated, additional research is required to clarify their effectiveness and safety. | 10.1002/14651858.CD012983 | [
"The evidence is current to May 2017. We included eight studies and 334 participants related to five different classes of medicines sometimes recommended for HAI prevention. These medicines included those that mimic the action of serotonin at selected sites (selective 5-hydroxytryptamine(1) receptor agonists), medicines that regulate the action of calcium (N-methyl-D-aspartate (NMDA) antagonist), medicines that promote dilation of the blood vessels (endothelin-1 antagonist), medicines that prevent a neuron (nerve cell) from 'firing' (initiating an action) and convulsions from developing (anticonvulsant medicines), as well as medicines that regulate the body´s sodium and water levels (spironolactone). All studies were undertaken in high altitude mountain areas. The participants ranged between 16 and 65 years of age. Only one study included people at a high risk of this condition due to their history of HAI. Four trials provided the intervention between one to three days prior to the ascent (50%), and three trials less than 24 hours prior (37.5%). The participants in all these studies reached a final altitude of between 3500 and 5895 metres above sea level. Only one of the eight included studies did not provide clear information about the source of funding (12.5%). Twenty-four additional studies were classified as ongoing (12), or awaiting classification (12; unable to obtain full texts). The assessment of the less commonly used pharmacological interventions suggest that there is a scarcity of evidence related to these interventions. For most of the assessed comparisons, we only found evidence from a single study. Clinical benefits and harms related to potential interventions such as sumatriptan are still unclear. The quality of the evidence was rated from low to very low. Several studies had quality shortcomings such as only having small sample sizes and therefore generating uncertain results. For most of the medicines evaluated, additional research is required to clarify their effectiveness and safety."
] |
cochrane-simplification-train-1190 | cochrane-simplification-train-1190 | We included 21 trials in this review. The 21 included studies investigated a range of technologies aiming to support the provision of care from a distance. These included: telephone (n = 9); video-conferencing (n = 2); Internet (n = 2); other networked communications (n = 6); text Short Messaging Service (n = 1); or a combination of text and Internet (n = 1). Meta-analysis showed that these interventions did not result in clinically important improvements in asthma quality of life (minimum clinically important difference = 0.5): mean difference in Juniper's Asthma Quality of Life Questionnaire (AQLQ) 0.08 (95% CI 0.01 to 0.16). Telehealthcare for asthma resulted in a non-significant increase in the odds of emergency department visits over a 12-month period: OR 1.16 (95% CI 0.52 to 2.58). There was, however, a significant reduction in hospitalisations over a 12-month period: OR 0.21 (95% CI 0.07 to 0.61), the effect being most marked in people with more severe asthma managed predominantly in secondary care settings. Telehealthcare interventions are unlikely to result in clinically relevant improvements in health outcomes in those with relatively mild asthma, but they may have a role in those with more severe disease who are at high risk of hospital admission. Further trials evaluating the effectiveness and cost-effectiveness of a range of telehealthcare interventions are needed. | Our searches identified a large body of trial evidence and also a substantial body of work in progress. This revealed that telehealthcare initiatives are unlikely to be of benefit in improving quality of life for the majority of people with relatively mild asthma, but that these interventions may prove useful in preventing exacerbations and hospital admissions in people with more severe asthma. We believe it is important for more research to be done to establish the cost-effectiveness of these interventions. | 10.1002/14651858.CD007717.pub2 | [
"Our searches identified a large body of trial evidence and also a substantial body of work in progress. This revealed that telehealthcare initiatives are unlikely to be of benefit in improving quality of life for the majority of people with relatively mild asthma, but that these interventions may prove useful in preventing exacerbations and hospital admissions in people with more severe asthma. We believe it is important for more research to be done to establish the cost-effectiveness of these interventions."
] |
cochrane-simplification-train-1191 | cochrane-simplification-train-1191 | Twenty-five studies met the inclusion criteria (3615 randomly assigned participants). Only 12 of these studies were randomised controlled trials with appropriate allocation concealment. Variability was evident with regard to focus and intensity of the intervention, participant characteristics and length of follow-up. Meta-analysis led to the conclusion that intervention improved cognitive outcomes at infancy (developmental quotient (DQ): standardised mean difference (SMD) 0.32 standard deviations (SDs), 95% confidence interval (CI) 0.16 to 0.47; P value < 0.001; 16 studies; 2372 participants) and at preschool age (intelligence quotient (IQ); SMD 0.43 SDs, 95% CI 0.32 to 0.54; P value < 0.001; eight studies; 1436 participants). However, this effect was not sustained at school age (IQ: SMD 0.18 SDs, 95% CI -0.08 to 0.43; P value = 0.17; five studies; 1372 participants). Heterogeneity between studies for cognitive outcomes at infancy and at school age was significant. With regards to motor outcomes, meta-analysis of 12 studies showed a significant effect in favour of early developmental interventions at infancy only; however, this effect was small (motor scale DQ: SMD 0.10 SDs, 95% CI 0.01 to 0.19; P value = 0.03; 12 studies; 1895 participants). No effect was noted on the rate of cerebral palsy among survivors (risk ratio (RR) 0.82, 95% CI 0.52 to 1.27; seven studies; 985 participants). Little evidence showed a positive effect on motor outcomes in the long term, but only five included studies reported outcomes at preschool age (n = 3) or at school age (n = 2). Early intervention programmes for preterm infants have a positive influence on cognitive and motor outcomes during infancy, with cognitive benefits persisting into preschool age. A great deal of heterogeneity between studies was due to the variety of early developmental intervention programmes tested and to gestational ages of included preterm infants; thus, comparisons of intervention programmes were limited. Further research is needed to determine which early developmental interventions are most effective in improving cognitive and motor outcomes, and to discern the longer-term effects of these programmes. | Twenty-five studies met the inclusion criteria (3615 randomly assigned participants). Only 12 of these studies were randomised controlled trials with appropriate allocation concealment. Variability was noted with regard to focus and intensity of the intervention, participant characteristics and length of follow-up. Evidence suggests that early developmental interventions improve cognitive outcomes up to preschool age. Evidence also indicates that early developmental interventions improve motor outcomes during infancy; however, these effects are small. Little evidence was found of an effect on long-term cognitive or motor outcomes (up to school age). The early developmental intervention programmes described in this review had to begin within the first 12 months of life, had to focus on the parent-infant relationship and/or infant development and, although they could begin while the baby was still in hospital, had to include a component that was delivered post discharge from hospital. The early developmental intervention programmes included in this review vary by content and by frequency and focus of the intervention. This review of 25 trials supports early developmental intervention programmes provided to preterm infants post hospital discharge with the goal of improving cognitive development over the short to medium term (up to preschool age). Variability among these early developmental intervention programmes limits the conclusions that can be drawn about their effectiveness. | 10.1002/14651858.CD005495.pub4 | [
"Twenty-five studies met the inclusion criteria (3615 randomly assigned participants). Only 12 of these studies were randomised controlled trials with appropriate allocation concealment. Variability was noted with regard to focus and intensity of the intervention, participant characteristics and length of follow-up. Evidence suggests that early developmental interventions improve cognitive outcomes up to preschool age. Evidence also indicates that early developmental interventions improve motor outcomes during infancy; however, these effects are small. Little evidence was found of an effect on long-term cognitive or motor outcomes (up to school age). The early developmental intervention programmes described in this review had to begin within the first 12 months of life, had to focus on the parent-infant relationship and/or infant development and, although they could begin while the baby was still in hospital, had to include a component that was delivered post discharge from hospital. The early developmental intervention programmes included in this review vary by content and by frequency and focus of the intervention. This review of 25 trials supports early developmental intervention programmes provided to preterm infants post hospital discharge with the goal of improving cognitive development over the short to medium term (up to preschool age). Variability among these early developmental intervention programmes limits the conclusions that can be drawn about their effectiveness."
] |
cochrane-simplification-train-1192 | cochrane-simplification-train-1192 | We included five randomised clinical trials with 517 participants (257 underwent a laparoscopic-endoscopic rendezvous technique versus 260 underwent a sequential approach), which fulfilled our inclusion criteria and provided data for analysis. Trial participants were scheduled for laparoscopic cholecystectomy because of suspected cholecysto-choledocholithiasis. Male/female ratio was 0.7; age of men and women ranged from 21 years to 87 years. The run-in and follow-up periods of the trials ranged from 32 months to 84 months. Overall, the five trials were judged at high risk of bias. Athough all trials measured mortality, there was just one death reported in one trial, in the laparoscopic-endoscopic rendezvous group (low-quality evidence). The overall morbidity (surgical morbidity plus general morbidity) may be lower with laparoscopic rendezvous (RR 0.59, 95% CI 0.29 to 1.20; participants = 434, trials = 4; I² = 28%; low-quality evidence); the effect was a little more certain when a fixed-effect model was used (RR 0.56, 95% CI 0.32 to 0.99). There was insufficient evidence to determine the effects of the two approaches on the failure of primary clearance of the bile duct (RR 0.55, 95% CI 0.22 to 1.38; participants = 517; trials = 5; I² = 58%; very low-quality evidence). The effects of either approach on clinical post-operative pancreatitis were unclear (RR 0.29, 95% CI 0.07 to 1.12; participants = 517, trials = 5; I² = 24%; low-quality evidence). Hospital stay appeared to be lower in the laparoscopic-endoscopic rendezvous group by about three days (95% CI 3.51 to 2.50 days shorter; 515 participants in five trials; low-quality evidence). There was very low-quality evidence that suggested longer operative time with laparoscopic-endoscopic rendezvous (MD 34.07 minutes, 95% CI 11.41 to 56.74; participants = 313; trials = 3; I² = 93%). The Trial Sequential Analyses of operating time and the length of hospital stay indicated that all the trials crossed the conventional boundaries, suggesting that the sample sizes were adequate, with a low risk of random error. There was insufficient evidence to determine the effects of the laparoscopic-endoscopic rendezvous versus preoperative endoscopic sphincterotomy techniques in people undergoing laparoscopic cholecystectomy on mortality and morbidity. The laparoscopic-endoscopic rendezvous procedure may lead to longer operating times, but it may reduce the length of the hospital stay when compared with preoperative endoscopic sphincterotomy followed by laparoscopic cholecystectomy. However, no firm conclusions could be drawn because the quality of evidence was low or very low. If confirmed by future trials, these data might re-design the scenario of treatment of this condition, albeit requiring greater organisational effort. Future trials should also address issues such as quality of life and cost analysis. | This review compared the benefits and harms of laparoscopic-endoscopic rendezvous versus preoperative endoscopic sphincterotomy (cutting the muscle between the bile and pancreatic ducts) procedures followed by laparoscopic cholecystectomy to remove stones from the gallbladder and bile duct. By searching scientific databases and trials registers, we found five randomised clinical trials that compared the two approaches, and involved a total of 516 participants. The majority of the participants were females and the age of both men and women ranged from 21 years to 87 years. Only one trial stated they had not received industry sponsorship or other for-profit support. None of the other trials disclosed information about funding. Three trials stated the investigators had no competing interest; the other two trials did not provide information on competing interests. The laparoscopic-endoscopic rendezvous approach could be associated with a lower rate of overall morbidity and clinical post-operative pancreatitis, and a shorter hospital stay. We found no clear differences in overall mortality between the two techniques. Total operative time was longer with the rendezvous approach. We were unable to draw firm conclusions because of the lack of data. Further research is needed to confirm whether the single-stage approach is safer and more efficacious than the two-stage approach, and to address other important issues, such as quality of life and cost analysis. The quality of the evidence was low or very low, because of small numbers of participants, high risk of bias, and inconsistent and imprecise results across trials. The evidence is current to February 2017. | 10.1002/14651858.CD010507.pub2 | [
"This review compared the benefits and harms of laparoscopic-endoscopic rendezvous versus preoperative endoscopic sphincterotomy (cutting the muscle between the bile and pancreatic ducts) procedures followed by laparoscopic cholecystectomy to remove stones from the gallbladder and bile duct. By searching scientific databases and trials registers, we found five randomised clinical trials that compared the two approaches, and involved a total of 516 participants. The majority of the participants were females and the age of both men and women ranged from 21 years to 87 years. Only one trial stated they had not received industry sponsorship or other for-profit support. None of the other trials disclosed information about funding. Three trials stated the investigators had no competing interest; the other two trials did not provide information on competing interests. The laparoscopic-endoscopic rendezvous approach could be associated with a lower rate of overall morbidity and clinical post-operative pancreatitis, and a shorter hospital stay. We found no clear differences in overall mortality between the two techniques. Total operative time was longer with the rendezvous approach. We were unable to draw firm conclusions because of the lack of data. Further research is needed to confirm whether the single-stage approach is safer and more efficacious than the two-stage approach, and to address other important issues, such as quality of life and cost analysis. The quality of the evidence was low or very low, because of small numbers of participants, high risk of bias, and inconsistent and imprecise results across trials. The evidence is current to February 2017."
] |
cochrane-simplification-train-1193 | cochrane-simplification-train-1193 | We included nine RCTs with 1208 patients; 622 patients were randomized to a PS spontaneous breathing trial (SBT) and 586 to a T-tube SBT. The studies were classified into three categories of weaning: simple, difficult, and prolonged. Four studies placed patients in two categories of weaning. Pressure support ventilation (PSV) and a T-tube were used directly as SBTs in four studies (844 patients, 69.9% of the sample). In 186 patients (15.4%) both interventions were used along with gradual weaning from mechanical ventilation; the PS was gradually decreased, twice a day, until it was minimal and periods with a T-tube were gradually increased to two and eight hours for patients with difficult and prolonged weaning. In two studies (14.7% of patients) the PS was lowered to 2 to 4 cm H2O and 3 to 5 cm H2O based on ventilatory parameters until the minimal PS levels were reached. PS was then compared to the trial with the T-tube (TT). We identified 33 different reported outcomes in the included studies; we took 14 of them into consideration and performed meta-analyses on nine. With regard to the sequence of allocation generation, allocation concealment, selective reporting and attrition bias, no study presented a high risk of bias. We found no clear evidence of a difference between PS and TT for weaning success (RR 1.07, 95% CI 0.97 to 1.17, 9 studies, low quality of evidence), intensive care unit (ICU) mortality (RR 0.81, 95% CI 0.53 to 1.23, 5 studies, low quality of evidence), reintubation (RR 0.92, 95% CI 0.66 to 1.26, 7 studies, low quality evidence), ICU and long-term weaning unit (LWU) length of stay (MD -7.08 days, 95% CI -16.26 to 2.1, 2 studies, low quality of evidence) and pneumonia (RR 0.67, 95% CI 0.08 to 5.85, 2 studies, low quality of evidence). PS was significantly superior to the TT for successful SBTs (RR 1.09, 95% CI 1.02 to 1.17, 4 studies, moderate quality of evidence). Four studies reported on weaning duration, however we were unable to combined the study data because of differences in how the studies presented their data. One study was at high risk of other bias and four studies were at high risk for detection bias. Three studies reported that the weaning duration was shorter with PS, and in one study the duration was shorter in patients with a TT. To date, we have found evidence of generally low quality from studies comparing pressure support ventilation (PSV) and with a T-tube. The effects on weaning success, ICU mortality, reintubation, ICU and LWU length of stay, and pneumonia were imprecise. However, PSV was more effective than a T-tube for successful spontaneous breathing trials (SBTs) among patients with simple weaning. Based on the findings of single trials, three studies presented a shorter weaning duration in the group undergoing PS SBT, however a fourth study found a shorter weaning duration with a T-tube. | Previous studies and systematic reviews suggest that a weaning protocol should be implemented in order to make daily assessments of patients who may be ready for weaning from mechanical ventilation. The ability to breathe spontaneously can be assessed with a spontaneous breathing trial using a T-tube (T-piece) or by reducing the applied airway pressure to provide low levels of pressure support (PS) (5 to 10 cm H2O). After removal of the endotracheal tube (extubation) the patients are monitored for 48 hours. If over this period ventilatory support does not need to be reintroduced, this is taken to indicate successful weaning. For this Cochrane systematic review we searched the medical literature databases until June 2012 and included nine studies with 1208 adult patients who had been on invasive mechanical ventilation for at least 24 hours. The trials compared pressure support (PS) and the use of a T-tube (622 patients randomized to PS and 586 randomized to a T-tube). There was no clear evidence to confirm that PS was superior to a T-tube with regard to the success of weaning, need for reintubation, ICU mortality, and other factors including long-term weaning unit (LWU) length of stay, pneumonia and a rapid shallow breathing index. Among patients who received PS, a greater number of patients had a successful spontaneous breathing trial and the airway tube was removed. For respiratory rate and tidal volume outcomes PS was superior to using a T-tube in two trials. Three studies reported that the weaning duration was shorter during PS, and in one study in which patients submitted to a T-tube the weaning time was shorter. Because of limitations in the design of the studies and imprecision in the effect estimates we have rated the quality of the evidence to be low. We reran the search in December 2013. We will deal with any studies of interest when we update the review. | 10.1002/14651858.CD006056.pub2 | [
"Previous studies and systematic reviews suggest that a weaning protocol should be implemented in order to make daily assessments of patients who may be ready for weaning from mechanical ventilation. The ability to breathe spontaneously can be assessed with a spontaneous breathing trial using a T-tube (T-piece) or by reducing the applied airway pressure to provide low levels of pressure support (PS) (5 to 10 cm H2O). After removal of the endotracheal tube (extubation) the patients are monitored for 48 hours. If over this period ventilatory support does not need to be reintroduced, this is taken to indicate successful weaning. For this Cochrane systematic review we searched the medical literature databases until June 2012 and included nine studies with 1208 adult patients who had been on invasive mechanical ventilation for at least 24 hours. The trials compared pressure support (PS) and the use of a T-tube (622 patients randomized to PS and 586 randomized to a T-tube). There was no clear evidence to confirm that PS was superior to a T-tube with regard to the success of weaning, need for reintubation, ICU mortality, and other factors including long-term weaning unit (LWU) length of stay, pneumonia and a rapid shallow breathing index. Among patients who received PS, a greater number of patients had a successful spontaneous breathing trial and the airway tube was removed. For respiratory rate and tidal volume outcomes PS was superior to using a T-tube in two trials. Three studies reported that the weaning duration was shorter during PS, and in one study in which patients submitted to a T-tube the weaning time was shorter. Because of limitations in the design of the studies and imprecision in the effect estimates we have rated the quality of the evidence to be low. We reran the search in December 2013. We will deal with any studies of interest when we update the review."
] |
cochrane-simplification-train-1194 | cochrane-simplification-train-1194 | Although eight trials involving 1301 participants were included in this review, only 919 (71%) contributed to the results concerning exacerbations and progression of the disease at two years. Specifically interferon significantly reduced the occurrence of exacerbations (Relative risk [RR] 0.80, 95% confidence interval [CI] 0.73 to 0.88, p < 0.001) and progression of the disease (RR 0.69, 95% CI 0.55 to 0.87, p = 0.002) two years after randomisation. However, the correct assignment of dropouts was essential to the demonstration of efficacy, most conspicuously concerning the effect of the drug on disease progression. If interferon-treated participants who dropped out were deemed to have progressed (worst case scenario) the significance of these effects was lost (RR 1.31, 95% CI 0.60 to 2.89, p = 0.5). The evolution in magnetic resonance imaging (MRI) technology in the decade in which these trials were performed and different reporting of data among trials made it impossible to perform a quantitative analysis of the MRI results. Both clinical and laboratory side effects reported in the trials were more frequent in treated participants than in controls; there was no information after two years of follow-up. The impact of interferon treatment (and its side effects) on the quality of life of patients was not reported in any trial included in this review. The efficacy of interferon on exacerbations and disease progression in patients with relapsing remitting MS was modest after one and two years of treatment. Interferon administered by the oral route was not effective for prevention of relapses. Longer follow-up and more uniform reporting of clinical and MRI outcomes among these trials might have allowed for a more convincing conclusion. | The review of trials found that interferons administered intramuscularly or subcutaneously can lead to a moderate reduction in recurrences and disability in people who have MS with remissions. Interferon-1a administered by the oral route was not effective for prevention of relapses. Side effects were usually influenza-like symptoms, injection site-reactions, pains in the joints and muscles, fatigue and headache. | 10.1002/14651858.CD002002 | [
"The review of trials found that interferons administered intramuscularly or subcutaneously can lead to a moderate reduction in recurrences and disability in people who have MS with remissions. Interferon-1a administered by the oral route was not effective for prevention of relapses. Side effects were usually influenza-like symptoms, injection site-reactions, pains in the joints and muscles, fatigue and headache."
] |
cochrane-simplification-train-1195 | cochrane-simplification-train-1195 | Twenty-three studies met the inclusion criteria. Overall methodological quality was poor. Five studies used an injury outcome measure; one of these studies was randomised, the remaining four where CBA studies. The RCT targeting the alcohol server setting environment with an injury outcome compared the introduction of toughened glassware (experimental) to annealed glassware (control) on the number of bar staff injuries; a greater number of injuries were detected in the experimental group (relative risk 1.72, 95% CI 1.15 to 2.59). One CBA study investigated server training and estimated a reduction of 23% in single-vehicle, night-time crashes in the experimental area (controlled for crashes in the control area). Another CBA study examined the impact of a drink driving service, and reported a reduction in injury road crashes of 15% in the experimental area, with no change in the control; no difference was found for fatal crashes. In a CBA study investigating the impact of an intervention aiming to reduce crime in drinking premises, the study authors found a lower rate of all crime in the experimental premises (rate ratio 4.6, 95% CI 1.7 to 12, P = 0.01); no difference was found for injury (rate ratio 1.1 95% CI 0.1 to 10, P = 0.093). A CBA study investigating the impact of a policy intervention reported that pre-intervention the serious assault rate in the experimental area was 52% higher than the rate in the control area. After intervention, the serious assault rate in the experimental area was 37% lower than in the control area. The effects of such interventions on patron alcohol consumption is inconclusive. One randomised trial found a statistically significant reduction in observed severe aggression exhibited by patrons. There is some indication of improved server behaviour but it is difficult to predict what effect this might have on injury risk. There is insufficient evidence from randomised controlled trials and well conducted controlled before and after studies to determine the effect of interventions administered in the alcohol server setting on injuries. Compliance with interventions appears to be a problem; hence mandated interventions may be more likely to show an effect. Randomised controlled trials, with adequate allocation concealment and blinding are required to improve the evidence base. Further well-conducted, non-randomised trials are also needed when random allocation is not feasible. | The authors found 23 studies; only five of these measured the effect on injury, the remaining 18 measured the effect on behaviour (by the patrons and/or the servers of the alcohol within the premises). The studies investigated a range of interventions involving server training, health promotion initiatives, a drink driving service, a policy intervention and interventions that targeted the server setting environment. The authors concluded that there is insufficient high quality evidence that interventions in the alcohol server setting are effective in preventing injuries. The evidence for the effectiveness of the interventions on patron alcohol consumption was found to be inconclusive. There is conflicting evidence as to whether server behaviour is improved and it is difficult to predict what effect this might have on actual injury risk. Lack of compliance with interventions seems to be a particular problem; hence mandated interventions or those with associated incentives for compliance, may be more likely to show an effect. The methodology of future evaluations needs to be improved. The focus of research should be broadened to investigate the effectiveness of interventions other than server training, where previous research dominates. When the collection of injury outcome data is not feasible, research is needed to identify the most useful proxy indicators. | 10.1002/14651858.CD005244.pub3 | [
"The authors found 23 studies; only five of these measured the effect on injury, the remaining 18 measured the effect on behaviour (by the patrons and/or the servers of the alcohol within the premises). The studies investigated a range of interventions involving server training, health promotion initiatives, a drink driving service, a policy intervention and interventions that targeted the server setting environment. The authors concluded that there is insufficient high quality evidence that interventions in the alcohol server setting are effective in preventing injuries. The evidence for the effectiveness of the interventions on patron alcohol consumption was found to be inconclusive. There is conflicting evidence as to whether server behaviour is improved and it is difficult to predict what effect this might have on actual injury risk. Lack of compliance with interventions seems to be a particular problem; hence mandated interventions or those with associated incentives for compliance, may be more likely to show an effect. The methodology of future evaluations needs to be improved. The focus of research should be broadened to investigate the effectiveness of interventions other than server training, where previous research dominates. When the collection of injury outcome data is not feasible, research is needed to identify the most useful proxy indicators."
] |
cochrane-simplification-train-1196 | cochrane-simplification-train-1196 | We retrieved 11 studies. We included one trial that evaluated screening hysteroscopy versus no hysteroscopy, in women with unexplained subfertility, who were trying to conceive spontaneously. We are uncertain whether ongoing pregnancy rate improves following a screening hysteroscopy in women with at least two years of unexplained subfertility (RR 4.30, 95% CI 2.29 to 8.07; 1 RCT; participants = 200; very low-quality evidence). For a typical clinic with a 10% ongoing pregnancy rate without hysteroscopy, performing a screening hysteroscopy would be expected to result in ongoing pregnancy rates between 23% and 81%. The included study reported no adverse events in either treatment arm. We are uncertain whether clinical pregnancy rate is improved (RR 3.80, 95% CI 2.31 to 6.24; 1 RCT; participants = 200; very low-quality evidence), or miscarriage rate increases (RR 2.80, 95% CI 1.05 to 7.48; 1 RCT; participants = 200; very low-quality evidence), following screening hysteroscopy in women with at least two years of unexplained subfertility. We included ten trials that included 1836 women who had a screening hysteroscopy and 1914 women who had no hysteroscopy prior to IVF. Main limitations in the quality of evidence were inadequate reporting of study methods and higher statistical heterogeneity. Eight of the ten trials had unclear risk of bias for allocation concealment. Performing a screening hysteroscopy before IVF may increase live birth rate (RR 1.26, 95% CI 1.11 to 1.43; 6 RCTs; participants = 2745; I² = 69 %; low-quality evidence). For a typical clinic with a 22% live birth rate, performing a screening hysteroscopy would be expected to result in live birth rates between 25% and 32%. However, sensitivity analysis done by pooling results from trials at low risk of bias showed no increase in live birth rate following a screening hysteroscopy (RR 0.99, 95% CI 0.82 to 1.18; 2 RCTs; participants = 1452; I² = 0%). Only four trials reported complications following hysteroscopy; of these, three trials recorded no events in either group. We are uncertain whether a screening hysteroscopy is associated with higher adverse events (Peto odds ratio 7.47, 95% CI 0.15 to 376.42; 4 RCTs; participants = 1872; I² = not applicable; very low-quality evidence). Performing a screening hysteroscopy before IVF may increase clinical pregnancy rate (RR 1.32, 95% CI 1.20 to 1.45; 10 RCTs; participants = 3750; I² = 49%; low-quality evidence). For a typical clinic with a 28% clinical pregnancy rate, performing a screening hysteroscopy would be expected to result in clinical pregnancy rates between 33% and 40%. There may be little or no difference in miscarriage rate following screening hysteroscopy (RR 1.01, 95% CI 0.67 to 1.50; 3 RCTs; participants = 1669; I² = 0%; low-quality evidence). We found no trials that compared a screening hysteroscopy versus no hysteroscopy before IUI. At present, there is no high-quality evidence to support the routine use of hysteroscopy as a screening tool in the general population of subfertile women with a normal ultrasound or hysterosalpingogram in the basic fertility work-up for improving reproductive success rates. In women undergoing IVF, low-quality evidence, including all of the studies reporting these outcomes, suggests that performing a screening hysteroscopy before IVF may increase live birth and clinical pregnancy rates. However, pooled results from the only two trials with a low risk of bias did not show a benefit of screening hysteroscopy before IVF. Since the studies showing an effect are those with unclear allocation concealment, we are uncertain whether a routine screening hysteroscopy increases live birth and clinical pregnancy, be it for all women, or those with two or more failed IVF attempts. There is insufficient data to draw conclusions about the safety of screening hysteroscopy. | For women wishing to become pregnant spontaneously, we found one trial (200 women). For women undergoing IVF, we included ten trials (3750 women). All trials evaluated the effects of screening hysteroscopy compared to no hysteroscopy. The evidence is current to September 2018. In women wishing to become pregnant spontaneously, hysteroscopy was associated with a higher chance for an ongoing and clinical pregnancy in one study at high risk of bias. The trial reported no adverse events following hysteroscopy. The miscarriage rate was higher following hysteroscopy. In women undergoing IVF, the included studies suggested that performing a screening hysteroscopy first, improved the chances of live birth or clinical pregnancy. However, adverse events following hysteroscopy were poorly reported, and therefore, we were unable to assess the safety of this intervention. For women at a typical clinic with a 22% live birth rate, performing a screening hysteroscopy would be expected to result in live birth rates between 25% and 32%. There was no increased risk of miscarriage following hysteroscopy. We found no trials with women who were seeking intrauterine insemination. There was very low-quality evidence from one study in women who were trying to become pregnant spontaneously. There was low-quality evidence that a screening hysteroscopy, performed prior to IVF, may increase the chance of live birth or clinical pregnancy, and very low-quality evidence about adverse events following hysteroscopy. The quality of the evidence was reduced because of risk of bias and statistical heterogeneity. | 10.1002/14651858.CD012856.pub2 | [
"For women wishing to become pregnant spontaneously, we found one trial (200 women). For women undergoing IVF, we included ten trials (3750 women). All trials evaluated the effects of screening hysteroscopy compared to no hysteroscopy. The evidence is current to September 2018. In women wishing to become pregnant spontaneously, hysteroscopy was associated with a higher chance for an ongoing and clinical pregnancy in one study at high risk of bias. The trial reported no adverse events following hysteroscopy. The miscarriage rate was higher following hysteroscopy. In women undergoing IVF, the included studies suggested that performing a screening hysteroscopy first, improved the chances of live birth or clinical pregnancy. However, adverse events following hysteroscopy were poorly reported, and therefore, we were unable to assess the safety of this intervention. For women at a typical clinic with a 22% live birth rate, performing a screening hysteroscopy would be expected to result in live birth rates between 25% and 32%. There was no increased risk of miscarriage following hysteroscopy. We found no trials with women who were seeking intrauterine insemination. There was very low-quality evidence from one study in women who were trying to become pregnant spontaneously. There was low-quality evidence that a screening hysteroscopy, performed prior to IVF, may increase the chance of live birth or clinical pregnancy, and very low-quality evidence about adverse events following hysteroscopy. The quality of the evidence was reduced because of risk of bias and statistical heterogeneity."
] |
cochrane-simplification-train-1197 | cochrane-simplification-train-1197 | We included one study that analysed 185 participants. The study compared the effects of a clinical examination every 12 months with a clinical examination every 24 months on the outcomes of caries (decayed, missing, filled surfaces (dmfs/DMFS) increment) and economic cost outcomes (total time used per person). As the study was at high risk of bias, had a small sample size and only included low-risk participants, we rated the quality of the body of evidence for these outcomes as very low. For three to five-year olds with primary teeth, the mean difference (MD) in dmfs increment was -0.90 (95% CI -1.96 to 0.16) in favour of 12-month recall. For 16 to 20-year olds with permanent teeth, the MD in DMFS increment was -0.86 (95% CI -1.75 to 0.03) also in favour of 12-month recall. There is insufficient evidence to determine whether 12 or 24-month recall with clinical examination results in better caries outcomes. For three to five-year olds with primary teeth, the MD in time used by each participant was 10 minutes (95% CI -6.7 to 26.7) in favour of 24-month recall. For 16 to 20-year olds with permanent teeth, the MD was 23.7 minutes (95% CI 4.12 to 43.28) also in favour of 24-month recall. This single study at high risk of bias represents insufficient evidence to determine whether 12 or 24-month recall with clinical examination results in better time/cost outcomes. There is a very low quality body of evidence from one RCT which is insufficient to draw any conclusions regarding the potential beneficial and harmful effects of altering the recall interval between dental check-ups. There is no evidence to support or refute the practice of encouraging patients to attend for dental check-ups at six-monthly intervals. It is important that high quality RCTs are conducted for the outcomes listed in this review in order to address the objectives of this review. | The Cochrane Oral Health Group carried out this review of existing studies, which includes evidence current up to 27 September 2013. This review includes one published study in which a total of 185 children and young adults were randomly chosen to have a clinical examination every 12 months or every 24 months. The study measured what effects the two different check-up times had on tooth decay and total time used per person (which could then be used to measure costs to the healthcare system). The limited results did not enable a conclusion to be made about whether or not extending the time to the next dental check-up can reduce tooth decay or costs. The evidence presented is of very low quality due to there only being one study and issues with the way it was conducted. | 10.1002/14651858.CD004346.pub4 | [
"The Cochrane Oral Health Group carried out this review of existing studies, which includes evidence current up to 27 September 2013. This review includes one published study in which a total of 185 children and young adults were randomly chosen to have a clinical examination every 12 months or every 24 months. The study measured what effects the two different check-up times had on tooth decay and total time used per person (which could then be used to measure costs to the healthcare system). The limited results did not enable a conclusion to be made about whether or not extending the time to the next dental check-up can reduce tooth decay or costs. The evidence presented is of very low quality due to there only being one study and issues with the way it was conducted."
] |
cochrane-simplification-train-1198 | cochrane-simplification-train-1198 | The search identified 77 trials. We included 34 trials in the review involving 69,338 babies, five studies are awaiting classification and there are two ongoing community trials. Included studies were conducted in both developed and developing countries. Among the 34 included trials, three were large, cluster-randomized trials conducted in community settings in developing countries and 31 studies were conducted in hospital settings mostly in developed countries. Data for community and hospital studies were analyzed separately. The three trials conducted in community settings contributed 78% of the total number of children included in this review. Of the trials conducted in hospital settings, the majority had small sample sizes. There were 22 different interventions studied across the included trials and the most commonly studied antiseptics were 70% alcohol, triple dye and chlorhexidine. Only one antiseptic, chlorhexidine was studied in community settings for umbilical cord care. Three community trials reported data on all-cause mortality that comprised 1325 deaths in 54,624 participants and combined results showed a reduction of 23% (average risk ratio (RR) 0.77, 95% confidence interval (CI) 0.63 to 0.94, random-effects, T² = 0.02, I² = 50%) in the chlorhexidine group compared with control. The reduction in omphalitis ranged from 27% to 56% depending on the severity of infection. Cord separation time was increased by 1.7 days in the chlorhexidine group compared with dry cord care (mean difference (MD) 1.75 days, 95% CI 0.44 to 3.05, random-effects, T² = 0.88, I² = 100%). Washing of umbilical cord with soap and water was not advantageous compared with dry cord care in community settings. Among studies conducted in hospital settings, no study reported data for mortality or tetanus. No antiseptic was advantageous to reduce the incidence of omphalitis compared with dry cord care in hospital settings. Topical triple dye application reduced bacterial colonization with Staphylococcus aureus compared with dry cord care (average RR 0.15, 95% CI 0.10 to 0.22, four studies, n = 1319, random-effects, T² = 0.04, I² = 24%) or alcohol application (average RR 0.45, 95% CI 0.25 to 0.80, two studies, n = 487, random-effects, T² = 0.00, I² = 0%). There was no advantage of application of alcohol and triple dye for reduction of colonization with streptococcus. Topical alcohol application was advantageous in reduction of colonization with Enterococcus coli compared with dry cord care (average RR 0.73, 95% CI 0.58 to 0.92, two studies, n = 432, random-effects, T² = 0.00, I² = 0%) and in a separate analysis, triple dye increased the risk of colonization compared with alcohol (RR 3.44, 95% CI 2.10 to 5.64, one study, n = 373). Cord separation time was significantly increased with topical application of alcohol (MD 1.76 days, 95% CI 0.03 to 3.48, nine studies, n = 2921, random-effects, T² = 6.54, I² = 97%) and triple dye (MD 4.10 days, 95% CI 3.07 to 5.13, one study, n = 372) compared with dry cord care in hospital settings. The number of studies was insufficient to make any inference about the efficacy of other antiseptics. There is significant evidence to suggest that topical application of chlorhexidine to umbilical cord reduces neonatal mortality and omphalitis in community and primary care settings in developing countries. It may increase cord separation time however, there is no evidence that it increases risk of subsequent morbidity or infection. There is insufficient evidence to support the application of an antiseptic to umbilical cord in hospital settings compared with dry cord care in developed countries. | The umbilical cord connects the baby and mother during pregnancy. The cord is cut after birth. The cord stump then dries and falls off, generally within five to 15 days. Infection of the umbilical cord stump (omphalitis), caused by skin bacteria, is a significant cause of illness and death in newborn babies in developing countries. This review evaluated all studies that assessed antiseptics applied topically to the umbilical cord to determine if they reduce the risk of cord infection and death. Thirty-four randomised controlled studies were included involving 69,338 babies. There were 22 different interventions studied. The most commonly studied antiseptics in the included studies were 70% alcohol, triple dye and chlorhexidine. Three studies were conducted in community settings in developing countries; the remainder were conducted in hospital settings, mostly in developed countries. Studies conducted in community settings were large and contributed about 78% of all the participants included in this review. Hospital-based studies were small and had limitations. Studies conducted in community settings evaluated the effectiveness of topical application of chlorhexidine and combined results showed that chlorhexidine reduced risk of death by 23% and the risk of cord infection ranging from 27% to 56%, depending on the severity of infection. Topical application of chlorhexidine may increase cord separation time by about 1.7 days, however, this does not increase subsequent risk of cord infection or death. None of the studies conducted in hospital settings reported data for risk of death or tetanus. No antiseptic was found to be advantageous for the prevention of cord infection compared with dry cord care in hospital settings. Topical triple dye application reduced bacterial colonization with Staphylococcus aureus compared to both dry cord care and alcohol application. There was no advantage of application of alcohol and triple dye for reduction of colonization with streptococcus. Topical alcohol application was advantageous in the reduction of colonization with Enterococcus coli compared with dry cord care and triple dye application. Cord separation time was increased with topical application of alcohol and triple dye compared with dry cord care in hospital settings. There were insufficient studies to determine the efficacy of other antiseptics. | 10.1002/14651858.CD008635.pub2 | [
"The umbilical cord connects the baby and mother during pregnancy. The cord is cut after birth. The cord stump then dries and falls off, generally within five to 15 days. Infection of the umbilical cord stump (omphalitis), caused by skin bacteria, is a significant cause of illness and death in newborn babies in developing countries. This review evaluated all studies that assessed antiseptics applied topically to the umbilical cord to determine if they reduce the risk of cord infection and death. Thirty-four randomised controlled studies were included involving 69,338 babies. There were 22 different interventions studied. The most commonly studied antiseptics in the included studies were 70% alcohol, triple dye and chlorhexidine. Three studies were conducted in community settings in developing countries; the remainder were conducted in hospital settings, mostly in developed countries. Studies conducted in community settings were large and contributed about 78% of all the participants included in this review. Hospital-based studies were small and had limitations. Studies conducted in community settings evaluated the effectiveness of topical application of chlorhexidine and combined results showed that chlorhexidine reduced risk of death by 23% and the risk of cord infection ranging from 27% to 56%, depending on the severity of infection. Topical application of chlorhexidine may increase cord separation time by about 1.7 days, however, this does not increase subsequent risk of cord infection or death. None of the studies conducted in hospital settings reported data for risk of death or tetanus. No antiseptic was found to be advantageous for the prevention of cord infection compared with dry cord care in hospital settings. Topical triple dye application reduced bacterial colonization with Staphylococcus aureus compared to both dry cord care and alcohol application. There was no advantage of application of alcohol and triple dye for reduction of colonization with streptococcus. Topical alcohol application was advantageous in the reduction of colonization with Enterococcus coli compared with dry cord care and triple dye application. Cord separation time was increased with topical application of alcohol and triple dye compared with dry cord care in hospital settings. There were insufficient studies to determine the efficacy of other antiseptics."
] |
cochrane-simplification-train-1199 | cochrane-simplification-train-1199 | Twenty trials comparing open mesh with open non-mesh repair were identified. Open mesh methods, on average, took 7-10 minutes less to perform than Shouldice procedures, but took 1-4 minutes longer than other non-mesh methods. There were no clear differences between mesh and non-mesh groups for haematomas, seromas or wound/superficial infections. Three serious operative compications were reported after open mesh repair and three following non-mesh repair. Overall, those in the mesh groups had a shorter length of hospital stay and quicker return to usual activities, but this pattern was not observed for all trials. There was a suggestion that persisting pain was less frequent after mesh repair than after non-mesh repair but this result was dependent on one trial and data were not available for 11 trials. There was no evidence of a difference between the groups with respect to persisting numbness. Fewer hernia recurrences were reported after mesh repair (Peto OR: 0.37, 95% CI: 0.26 to 0.51). There were too few data to reliably address differential effects for patients with recurrent, bilateral or femoral hernias. Two trials comparing flat mesh with plug and mesh were identified. There was no clear evidence of differences between the groups. There is evidence that the use of open mesh repair is associated with a reduction in the risk of recurrence of between 50% and 75%. Although the trials were heterogenous there is also some evidence of quicker return to work and of lower rates of persisting pain following mesh repair. | This review examines the evidence from studies comparing different types of open surgery for people with groin hernia. We included only randomised studies comparing either 1) methods using synthetic mesh versus methods without mesh or 2) flat mesh methods versus plug and mesh methods. We divided mesh methods into flat mesh, plug and mesh or preperitoneal mesh and non-mesh methods into Shouldice or other non-mesh repair. We found 20 studies comparing mesh with non-mesh repair and two studies comparing flat mesh with plug and mesh. For 13 studies we re-analysed data supplied by the study author, for four studies we received additional results from the study author and for five studies only published information was used. There was strong evidence that fewer hernias recur after mesh repair than following non-mesh repair. There was a suggestion that people had less persisting pain after mesh repair but results were only available for nine out of 20 trials. Open mesh methods were shorter to perform than Shouldice procedures, but took longer than other types of non-mesh repair. We found no clear differences between mesh and non-mesh methods for operative complications and persisting numbness. Overall, people spent less time in hospital and returned to their usual activities quicker after mesh repair but this pattern was not observed for all studies. We did not find clear evidence of differences between flat mesh repair and plug and mesh repair. | 10.1002/14651858.CD002197 | [
"This review examines the evidence from studies comparing different types of open surgery for people with groin hernia. We included only randomised studies comparing either 1) methods using synthetic mesh versus methods without mesh or 2) flat mesh methods versus plug and mesh methods. We divided mesh methods into flat mesh, plug and mesh or preperitoneal mesh and non-mesh methods into Shouldice or other non-mesh repair. We found 20 studies comparing mesh with non-mesh repair and two studies comparing flat mesh with plug and mesh. For 13 studies we re-analysed data supplied by the study author, for four studies we received additional results from the study author and for five studies only published information was used. There was strong evidence that fewer hernias recur after mesh repair than following non-mesh repair. There was a suggestion that people had less persisting pain after mesh repair but results were only available for nine out of 20 trials. Open mesh methods were shorter to perform than Shouldice procedures, but took longer than other types of non-mesh repair. We found no clear differences between mesh and non-mesh methods for operative complications and persisting numbness. Overall, people spent less time in hospital and returned to their usual activities quicker after mesh repair but this pattern was not observed for all studies. We did not find clear evidence of differences between flat mesh repair and plug and mesh repair."
] |
Subsets and Splits