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Clinical NLP Lab 23

CochranePLS700

***TASK*** the task is to simplify the input abstract of a biomedical literature ***INPUT*** the input is the abstract of a biomedical literature ***OUTPUT*** the output is the simplified abstract for the input abstract of a biomedical literature ***DOCUMENTATION*** ***EXAMPLES*** Input: This review included 63 trials which randomised 14,486 people with CHD. This latest update identified 16 new trials (3872 participants). The population included predominantly post-MI and post-revascularisation patients and the mean age of patients within the trials ranged from 47.5 to 71.0 years. Women accounted for fewer than 15% of the patients recruited. Overall trial reporting was poor, although there was evidence of an improvement in quality of reporting in more recent trials. As we found no significant difference in the impact of exercise-based CR on clinical outcomes across follow-up, we focused on reporting findings pooled across all trials at their longest follow-up (median 12 months). Exercise-based CR reduced cardiovascular mortality compared with no exercise control (27 trials; risk ratio (RR) 0.74, 95% CI 0.64 to 0.86). There was no reduction in total mortality with CR (47 trials, RR 0.96, 95% CI 0.88 to 1.04). The overall risk of hospital admissions was reduced with CR (15 trials; RR 0.82, 95% CI 0.70 to 0.96) but there was no significant impact on the risk of MI (36 trials; RR 0.90, 95% CI 0.79 to 1.04), CABG (29 trials; RR 0.96, 95% CI 0.80 to 1.16) or PCI (18 trials; RR 0.85, 95% CI 0.70 to 1.04). There was little evidence of statistical heterogeneity across trials for all event outcomes, and there was evidence of small study bias for MI and hospitalisation, but no other outcome. Predictors of clinical outcomes were examined across the longest follow-up of studies using univariate meta-regression. Results show that benefits in outcomes were independent of participants' CHD case mix (proportion of patients with MI), type of CR (exercise only vs comprehensive rehabilitation) dose of exercise, length of follow-up, trial publication date, setting (centre vs home-based), study location (continent), sample size or risk of bias. Given the heterogeneity in outcome measures and reporting methods, meta-analysis was not undertaken for HRQL. In five out of 20 trials reporting HRQL using validated measures, there was evidence of significant improvement in most or all of the sub-scales with exercise-based CR compared to control at follow-up. Four trial-based economic evaluation studies indicated exercise-based CR to be a potentially cost-effective use of resources in terms of gain in quality-adjusted life years. The quality of the evidence for outcomes reported in the review was rated using the GRADE method. The quality of the evidence varied widely by outcome and ranged from low to moderate. This updated Cochrane review supports the conclusions of the previous version of this review that, compared with no exercise control, exercise-based CR reduces the risk of cardiovascular mortality but not total mortality. We saw a significant reduction in the risk of hospitalisation with CR but not in the risk of MI or revascularisation. We identified further evidence supporting improved HRQL with exercise-based CR. More recent trials were more likely to be well reported and include older and female patients. However, the population studied in this review still consists predominantly of lower risk individuals following MI or revascularisation. Further well conducted RCTs are needed to assess the impact of exercise-based CR in higher risk CHD groups and also those presenting with stable angina. These trials should include validated HRQL outcome measures, explicitly report clinical event outcomes including mortality and hospital admissions, and assess costs and cost-effectiveness. Output:

We searched the scientific literature for randomised controlled trials (experiments that randomly allocate participants to one of two or more treatment groups) looking at the effectiveness of exercise-based treatments compared with no exercise in people of all ages with CHD. The search is current to July 2014. This latest update identified 16 trials (3872 participants). We included a total of 63 trials that studied 14,486 people with CHD, predominantly heart attack survivors and those who had undergone heart bypass surgery or angioplasty (a procedure which widens narrowed or obstructed arteries or veins). The findings of this update are consistent with the previous (2011) version of this Cochrane review and show important benefits of exercise-based cardiac rehabilitation that include a reduction in the risk of death due to a cardiovascular cause and hospital admission and improvements in health-related quality of life, compared with not undertaking exercise. There was a considerable variation across studies in the reporting of health-related quality of life outcome. A small body of economic evidence was identified indicating exercise-based cardiac rehabilitation to be cost-effective. Further evidence is needed to understand the effect of exercise training in people with CHD who are higher risk and in those with established angina (chest pain). Although the reporting of methods has improved in recent trials, lack of reporting made it difficult to assess the overall methodological quality and risk of possible bias of the evidence.

CochranePLS701

***TASK*** the task is to simplify the input abstract of a biomedical literature ***INPUT*** the input is the abstract of a biomedical literature ***OUTPUT*** the output is the simplified abstract for the input abstract of a biomedical literature ***DOCUMENTATION*** ***EXAMPLES*** Input: We included two trials (535 women) in the review. The trials found no difference between groups for the primary outcomes of pain intensity, assisted vaginal birth (risk ratio (RR) 1.04, 95% confidence interval (CI) 0.48 to 2.28, one trial, 513 women; RR 0.83, 95% CI 0.06 to 11.70, one trial, 22 women), and caesarean section (RR 0.98, 95% CI 0.49 to 1.94, one trial, 513 women; RR 2.54, 95% CI 0.11 to 56.25, one trial, 22 women); there were more babies admitted to neonatal intensive care in the control group of one trial (RR 0.08, 95% CI 0.00 to 1.42, one trial, 513 women) but this difference did not reach statistical significance. The trials found no differences between groups for the secondary outcomes of use of pharmacological pain relief (RR 0.35, 95% CI 0.04 to 3.32, one trial, 513 women; RR 2.50, 95% CI 0.31 to 20.45, one trial, 22 women), spontaneous vaginal delivery (RR 1.00, 95% CI 0.94 to 1.06, one trial, 513 women; RR 0.93, 95% CI 0.67 to 1.28, one trial, 22 women) or length of labour and augmentation (RR 1.14, 95% CI 0.90 to 1.45, one trial, 513 women). The risk of bias was low in the trials. There is a lack of studies evaluating the role of aromatherapy for pain management in labour. Further research is needed before recommendations can be made for clinical practice. Output:

The review identified two randomised controlled trials of aromatherapy. One trial involving 513 women compared one of Roman chamomile, clary sage, frankincense, lavender or mandarin essentials oils with standard care. The aromatherapy was applied using acupressure points, taper, compress, footbath, massage or a birthing pool. The second trial involved 22 women randomised to bathe for at least an hour in water with either essential oil of ginger or lemongrass added. All women received routine care and had access to pain relief. The trials found no difference between groups for pain intensity, assisted vaginal birth, caesarean section or the use of pharmacological pain relief (epidural). Overall, there is insufficient evidence from randomised controlled trials about the benefits of aromatherapy on pain management in labour. More research is needed.

CochranePLS702

***TASK*** the task is to simplify the input abstract of a biomedical literature ***INPUT*** the input is the abstract of a biomedical literature ***OUTPUT*** the output is the simplified abstract for the input abstract of a biomedical literature ***DOCUMENTATION*** ***EXAMPLES*** Input: Only six RCTs met the criteria for inclusion. The study characteristics differed substantially in terms of healthcare settings, the nature of the interventions studied and outcome measures reported. In three studies that compared the effect of an education-centred complex intervention with usual care or written instructions, only little evidence of benefit was found. Three studies compared the effect of more intensive and comprehensive complex interventions with usual care. One study found a significant and cost-effective reduction, one of lower extremity amputations (RR 0.30, 95% CI 0.31 to 0.71). One other study found a significant reduction of both amputation and foot ulcers. The last study reported improvement of patients' self care behaviour. All six included RCTs were at high risk of bias, with hardly any of the predefined quality assessment criteria met. There is no high-quality research evidence evaluating complex interventions for preventing diabetic foot ulceration and insufficient evidence of benefit. Output:

Foot ulcers not only lead to physical disability and loss of quality of life, but also to economic burden (healthcare costs, industrial disability). The aim is therefore to prevent foot ulcers occurring, for example, by showing patients with diabetes how to look after their feet or by prompting doctors to check their patients' feet more often. The results of single prevention strategies alone have so far been disappointing, therefore in clinical practice, preventive interventions directed at patients, healthcare providers and/or the structure of health care are often combined. In this review of trials of complex, preventive interventions, we found insufficient evidence that these combined approaches can be effective in reducing foot problems.

CochranePLS703

***TASK*** the task is to simplify the input abstract of a biomedical literature ***INPUT*** the input is the abstract of a biomedical literature ***OUTPUT*** the output is the simplified abstract for the input abstract of a biomedical literature ***DOCUMENTATION*** ***EXAMPLES*** Input: A total of 59 studies, mostly of low quality, were included in the review, involving multiple treatment comparisons between sertraline and other antidepressant agents. Evidence favouring sertraline over some other antidepressants for the acute phase treatment of major depression was found, either in terms of efficacy (fluoxetine) or acceptability/tolerability (amitriptyline, imipramine, paroxetine and mirtazapine). However, some differences favouring newer antidepressants in terms of efficacy (mirtazapine) and acceptability (bupropion) were also found. In terms of individual side effects, sertraline was generally associated with a higher rate of participants experiencing diarrhoea. This systematic review and meta-analysis highlighted a trend in favour of sertraline over other antidepressive agents both in terms of efficacy and acceptability, using 95% confidence intervals and a conservative approach, with a random effects analysis. However, the included studies did not report on all the outcomes that were pre-specified in the protocol of this review. Outcomes of clear relevance to patients and clinicians were not reported in any of the included studies. Output:

In the present review we assessed the evidence for the efficacy, acceptability and tolerability of sertraline in comparison with all other antidepressants in the acute-phase treatment of major depression. Fifty-nine randomised controlled trials (about 10,000 participants) were included in the review. The review showed evidence of differences in efficacy, acceptability and tolerability between sertraline and other antidepressants, with meta-analyses highlighting a trend in favour of sertraline over other antidepressants, both in terms of efficacy and acceptability, in a homogeneous sample of clinical trials, using conservative statistical methods. The included studies did not report on all the outcomes that were pre-specified in the protocol of this review. Outcomes of clear relevance to patients and clinicians, in particular, patients and their carers' attitudes to treatment, their ability to return to work and resume normal social functioning, were not reported in the included studies. Nevertheless, based on currently available evidence, results from this review suggest that sertraline might be a strong candidate as the initial choice of antidepressant in people with acute major depression.

CochranePLS704

***TASK*** the task is to simplify the input abstract of a biomedical literature ***INPUT*** the input is the abstract of a biomedical literature ***OUTPUT*** the output is the simplified abstract for the input abstract of a biomedical literature ***DOCUMENTATION*** ***EXAMPLES*** Input: The updated review included 16 new studies involving 25,819 participants, resulting in a total of 42 studies including 33,840 participants. We used the Cochrane risk of bias tool and assessed three studies at high risk of bias; the remainder were considered to have a low risk of bias. We included 26 studies that predominantly evaluated organisational interventions and 16 that evaluated educational and behavioural interventions for participants. We pooled results where appropriate, although some clinical and methodological heterogeneity was present. Educational and behavioural interventions showed no clear differences on any of the review outcomes, which include mean systolic and diastolic blood pressure, mean body mass index, achievement of HbA1c target, lipid profile, mean HbA1c level, medication adherence, or recurrent cardiovascular events. There was moderate-quality evidence that organisational interventions resulted in improved blood pressure control, in particular an improvement in achieving target blood pressure (odds ratio (OR) 1.44, 95% confidence interval (CI) 1.09 to1.90; 13 studies; 23,631 participants). However, there were no significant changes in mean systolic blood pressure (mean difference (MD), -1.58 mmHg 95% CI -4.66 to 1.51; 16 studies; 17,490 participants) and mean diastolic blood pressure (MD -0.91 mmHg 95% CI -2.75 to 0.93; 14 studies; 17,178 participants). There were no significant changes in the remaining review outcomes. We found that organisational interventions may be associated with an improvement in achieving blood pressure target but we did not find any clear evidence that these interventions improve other modifiable risk factors (lipid profile, HbA1c, medication adherence) or reduce the incidence of recurrent cardiovascular events. Interventions, including patient education alone, did not lead to improvements in modifiable risk factor control or the prevention of recurrent cardiovascular events. Output:

This updated review included 16 new studies involving 25,819 participants, resulting in a total of 42 studies including 33,840 with stroke or TIA whose average age ranged from 60 to 74.3 years. Most studies took place in primary care or community settings. Sixteen studies involved educational or behavioural interventions for participants and 26 studies mostly involved organisational interventions. Most interventions lasted for between three and 12 months, with follow-up from three months up to three years. Changes to healthcare services that looked at patient education or behaviour only, without any alterations in the organisation of patient care, showed no clear evidence of improvements in risk factors for stroke. Changes in the organisation of healthcare services resulted in improvements in blood pressure control. The effects of these interventions on changes in blood fats, blood sugar, body weight, or use of medicines were not conclusive. We identified 24 ongoing studies suggesting that research in this area is increasing. The available evidence was assessed as moderate- or low-quality because of variations in methods used and results reported.

CochranePLS705

***TASK*** the task is to simplify the input abstract of a biomedical literature ***INPUT*** the input is the abstract of a biomedical literature ***OUTPUT*** the output is the simplified abstract for the input abstract of a biomedical literature ***DOCUMENTATION*** ***EXAMPLES*** Input: We identified six randomised controlled trials that met inclusion criteria (607 participants). We found moderate quality evidence from two studies of no difference between methadone and buprenorphine in self reported opioid use (risk ratio (RR) 0.37, 95% confidence interval (CI) 0.08 to 1.63) or opioid positive urine drug tests (RR 0.81, 95% CI 0.56 to 1.18). There was low quality evidence from three studies of no difference in retention between buprenorphine and methadone maintenance treatment (RR 0.69, 95% CI 0.39 to 1.22). There was moderate quality evidence from two studies of no difference between methadone and buprenorphine on adverse events (RR 1.10, 95% CI 0.64 to 1.91). We found low quality evidence from three studies favouring maintenance buprenorphine treatment over detoxification or psychological treatment in terms of fewer opioid positive urine drug tests (RR 0.63, 95% CI 0.43 to 0.91) and self reported opioid use in the past 30 days (RR 0.54, 95% CI 0.31 to 0.93). There was no difference on days of unsanctioned opioid use (standardised mean difference (SMD) -0.31, 95% CI -0.66 to 0.04). There was moderate quality evidence favouring buprenorphine maintenance over detoxification or psychological treatment on retention in treatment (RR 0.33, 95% CI 0.23 to 0.47). There was moderate quality evidence favouring buprenorphine maintenance over detoxification or psychological treatment on adverse events (RR 0.19, 95% CI 0.06 to 0.57). The main weaknesses in the quality of the data was the use of open-label study designs. There was low to moderate quality evidence supporting the use of maintenance agonist pharmacotherapy for pharmaceutical opioid dependence. Methadone or buprenorphine appeared equally effective. Maintenance treatment with buprenorphine appeared more effective than detoxification or psychological treatments. Due to the overall low to moderate quality of the evidence and small sample sizes, there is the possibility that the further research may change these findings. Output:

We examined the scientific literature up to May 2015. We identified six randomised controlled trials (studies where people were allocated at random to one of two or more treatment or control conditions) involving 607 people who were dependent on pharmaceutical opioids. The people in the study were 77% male and had an average age of 31.6 years. The average duration of the studies comparing different opioid maintenance treatments (three studies that compared methadone to buprenorphine) was 24 weeks, and the average duration of studies comparing a maintenance treatment (three studies with buprenorphine maintenance) to detoxification or psychological treatment was 10 weeks. Five of the six studies were conducted in the US, with one study from Iran. We looked at opioid use and leaving treatment early. Five of the studies were funded by the National Institute of Health (USA), with one study not reporting the funding source. Four studies reported that a drug company provided the medicine. We found that there is probably little or no difference between how well methadone and buprenorphine worked to keep people in treatment, to reduce opioid use, or side effects. We found that buprenorphine probably keeps more people in treatment, may reduce use of opioids, and has fewer side effects compared to detoxification or psychological treatment alone. Overall, the evidence was of low to moderate quality. All studies put people into treatment groups randomly, but the participants and researchers knew which medication the participants were taking, which could bias the results and lower the quality of the evidence. Some of the studies had reasonable numbers of people who did not finish the study in both treatment groups, which means there are some missing results, but the number of people with missing results was similar in both treatment groups of the study for most studies. Most of the studies were similar in design and results were collected in a way that allowed them to compare opioid use and number of people completing the study.

CochranePLS706

***TASK*** the task is to simplify the input abstract of a biomedical literature ***INPUT*** the input is the abstract of a biomedical literature ***OUTPUT*** the output is the simplified abstract for the input abstract of a biomedical literature ***DOCUMENTATION*** ***EXAMPLES*** Input: We have included four studies, published between 1974 and 2003, randomising 276 people with schizophrenia to receive either chlorpromazine or clotiapine. The studies were poor at concealing allocation of treatment and blinding of outcome assessment. Our main outcomes of interest were clinically important change in global and mental state, specific change in negative symptoms, incidence of movement disorder (dyskinesia), leaving the study early for any reason, and costs. All reported data were short-term (under six months' follow-up). The trials did not report data for the important outcomes of clinically important change in global or mental state, or cost of care. Improvement in mental state was reported using the Positive and Negative Syndrome Scale (PANSS). When chlorpromazine was compared with clotiapine the average improvement scores for mental state using the PANSS total was higher in the clotiapine group (1 RCT, N = 31, MD 11.50 95% CI 9.42 to 13.58, very low-quality evidence). The average change scores on the PANSS negative sub-scale were similar between treatment groups (1 RCT, N = 21, MD -0.97 95% CI -2.76 to 0.82, very low-quality evidence). There was no clear difference in incidence of dyskinesia (1 RCT, N = 68, RR 3.00 95% CI 0.13 to 71.15, very low-quality evidence). Similar numbers of participants left the study early from each treatment group (3 RCTs, N = 158, RR 0.68 95% CI 0.24 to 1.88, very low-quality evidence). Clinically important changes in global and mental state were not reported. Only one trial reported the average change in overall mental state; results favour clotiapine but these limited data are very difficult to trust due to methodological limitations of the study. The comparative effectiveness of chlorpromazine compared to clotiapine on change in global state remains unanswered. Results in this review suggest chlorpromazine and clotiapine cause similar adverse effects, although again, the quality of evidence for this is poor, making firm conclusions difficult. Output:

Cochrane Schizophrenia's Information Specialist ran an electronic search in January 2016, searching their specialised register for trials that randomised people with schizophrenia to receive either chlorpromazine or clotiapine. The search identified six reports. We inspected these reports and found four trials, published between 1974 and 2003, randomising 276 participants that could be included in the review. The four included trials were poorly conducted and did not report data for clinically important change in global or mental state, or cost of care. Improvement in overall mental state was reported and participants receiving clotiapine had better improvement scores than those receiving chlorpromazine. However the trials also reported data for improvement in the negative symptoms, no difference between the two treatments was found. Clotiapine did not cause more movement disorders than chlorpromazine, and similar numbers of participants left the trials early. There is some very low-quality evidence that favours clotiapine over chlorpromazine for improving overall mental state. For other outcomes, including adverse effects, there is no evidence of a difference between these two antipsychotics. However these data are very difficult to draw conclusions from, only four small trials provided data and these were poorly conducted. We cannot draw conclusions on the comparative effectiveness of chlorpromazine versus clotiapine from such data.

CochranePLS707

***TASK*** the task is to simplify the input abstract of a biomedical literature ***INPUT*** the input is the abstract of a biomedical literature ***OUTPUT*** the output is the simplified abstract for the input abstract of a biomedical literature ***DOCUMENTATION*** ***EXAMPLES*** Input: We included 27 trials, enrolling 16,382 adults and children, and conducted between 2002 and 2010. Most trials excluded infants aged less than six months and pregnant women. DHA-P versus artemether-lumefantrine In Africa, over 28 days follow-up, DHA-P is superior to artemether-lumefantrine at preventing further parasitaemia (PCR-unadjusted treatment failure: RR 0.34, 95% CI 0.30 to 0.39, nine trials, 6200 participants, high quality evidence), and although PCR-adjusted treatment failure was below 5% for both ACTs, it was consistently lower with DHA-P (PCR-adjusted treatment failure: RR 0.42, 95% CI 0.29 to 0.62, nine trials, 5417 participants, high quality evidence). DHA-P has a longer prophylactic effect on new infections which may last for up to 63 days (PCR-unadjusted treatment failure: RR 0.71, 95% CI 0.65 to 0.78, two trials, 3200 participants, high quality evidence). In Asia and Oceania, no differences have been shown at day 28 (four trials, 1143 participants, moderate quality evidence), or day 63 (one trial, 323 participants, low quality evidence). Compared to artemether-lumefantrine, no difference was seen in prolonged QTc (low quality evidence), and no cardiac arrhythmias were reported. The frequency of other adverse events is probably similar with both combinations (moderate quality evidence). DHA-P versus artesunate plus mefloquine In Asia, over 28 days follow-up, DHA-P is as effective as artesunate plus mefloquine at preventing further parasitaemia (PCR-unadjusted treatment failure: eight trials, 3487 participants, high quality evidence). Once adjusted by PCR to exclude new infections, treatment failure at day 28 was below 5% for both ACTs in all eight trials, but lower with DHA-P in two trials (PCR-adjusted treatment failure: RR 0.41 95% CI 0.21 to 0.80, eight trials, 3482 participants, high quality evidence). Both combinations contain partner drugs with very long half-lives and no consistent benefit in preventing new infections has been seen over 63 days follow-up (PCR-unadjusted treatment failure: five trials, 2715 participants, moderate quality evidence). In the only trial from South America, there were fewer recurrent parastaemias over 63 days with artesunate plus mefloquine (PCR-unadjusted treatment failure: RR 6.19, 95% CI 1.40 to 27.35, one trial, 445 participants, low quality evidence), but no differences were seen once adjusted for new infections (PCR-adjusted treatment failure: one trial, 435 participants, low quality evidence). DHA-P is associated with less nausea, vomiting, dizziness, sleeplessness, and palpitations compared to artesunate plus mefloquine (moderate quality evidence). DHA-P was associated with more frequent prolongation of the QTc interval (low quality evidence), but no cardiac arrhythmias were reported. In Africa, dihydroartemisinin-piperaquine reduces overall treatment failure compared to artemether-lumefantrine, although both drugs have PCR-adjusted failure rates of less than 5%. In Asia, dihydroartemisinin-piperaquine is as effective as artesunate plus mefloquine, and is better tolerated. Output:

This review summarises trials evaluating the effects of dihydroartemisinin-piperaquine (DHA-P) compared to other artemisinin-based combination therapies recommended by the World Health Organization. After searching for relevant trials up to July 2013, we included 27 randomized controlled trials, enrolling 16,382 adults and children and conducted between 2002 and 2010. What is uncomplicated malaria and how might dihydroartemisinin-piperaquine work Uncomplicated malaria is the mild form of malaria which usually causes a fever, with or without headache, tiredness, muscle pains, abdominal pains, nausea, and vomiting. If left untreated, uncomplicated malaria can develop into severe malaria with kidney failure, breathing difficulties, fitting, unconsciousness, and eventually death. DHA-P is one of five artemisinin-based combination therapies the World Health Organization currently recommends to treat malaria. These combinations contain an artemisinin component (such as dihydroartemisinin) which works very quickly to clear the malaria parasite from the person's blood, and a longer acting drug (such as piperaquine) which clears the remaining parasites from the blood and may prevent new infections with malaria for several weeks. What the research says DHA-P versus artemether lumefantrine In studies of people living in Africa, both DHA-P and artemether-lumefantrine are very effective at treating malaria (high quality evidence). However, DHA-P cures slightly more patients than artemether-lumefantrine, and it also prevents further malaria infections for longer after treatment (high quality evidence). DHA-P and artemether-lumefantrine probably have similar side effects (moderate quality evidence). DHA-P versus artesunate plus mefloquine In studies of people living in Asia, DHA-P is as effective as artesunate plus mefloquine at treating malaria (moderate quality evidence). Artesunate plus mefloquine probably causes more nausea, vomiting, dizziness, sleeplessness, and palpitations than DHA-P (moderate quality evidence). Overall, in some people, DHA-P has been seen to cause short term changes in electrocardiographs tracing the conduction of the heart rhythm (low quality evidence), but these small changes on the electrocardiograph resolved within one week without serious consequences.

CochranePLS708

***TASK*** the task is to simplify the input abstract of a biomedical literature ***INPUT*** the input is the abstract of a biomedical literature ***OUTPUT*** the output is the simplified abstract for the input abstract of a biomedical literature ***DOCUMENTATION*** ***EXAMPLES*** Input: We found 43 studies that met the inclusion criteria, and more evidence was provided for fluticasone (26 studies; n = 21,247) than for budesonide (17 studies; n = 10,150). Evidence from the budesonide studies was more inconsistent and less precise, and the studies were shorter. The populations within studies were more often male with a mean age of around 63, mean pack-years smoked over 40 and mean predicted forced expiratory volume of one second (FEV1) less than 50%. High or uneven dropout was considered a high risk of bias in almost 40% of the trials, but conclusions for the primary outcome did not change when the trials at high risk of bias were removed in a sensitivity analysis. Fluticasone increased non-fatal serious adverse pneumonia events (requiring hospital admission) (odds ratio (OR) 1.78, 95% confidence interval (CI) 1.50 to 2.12; 18 more per 1000 treated over 18 months; high quality), and no evidence suggested that this outcome was reduced by delivering it in combination with salmeterol or vilanterol (subgroup differences: I2 = 0%, P value 0.51), or that different doses, trial duration or baseline severity significantly affected the estimate. Budesonide also increased non-fatal serious adverse pneumonia events compared with placebo, but the effect was less precise and was based on shorter trials (OR 1.62, 95% CI 1.00 to 2.62; six more per 1000 treated over nine months; moderate quality). Some of the variation in the budesonide data could be explained by a significant difference between the two commonly used doses: 640 mcg was associated with a larger effect than 320 mcg relative to placebo (subgroup differences: I2 = 74%, P value 0.05). An indirect comparison of budesonide versus fluticasone monotherapy revealed no significant differences with respect to serious adverse events (pneumonia-related or all-cause) or mortality. The risk of any pneumonia event (i.e. less serious cases treated in the community) was higher with fluticasone than with budesonide (OR 1.86, 95% CI 1.04 to 3.34); this was the only significant difference reported between the two drugs. However, this finding should be interpreted with caution because of possible differences in the assignment of pneumonia diagnosis, and because no trials directly compared the two drugs. No significant difference in overall mortality rates was observed between either of the inhaled steroids and the control interventions (both high-quality evidence), and pneumonia-related deaths were too rare to permit conclusions to be drawn. Budesonide and fluticasone, delivered alone or in combination with a LABA, are associated with increased risk of serious adverse pneumonia events, but neither significantly affected mortality compared with controls. The safety concerns highlighted in this review should be balanced with recent cohort data and established randomised evidence of efficacy regarding exacerbations and quality of life. Comparison of the two drugs revealed no statistically significant difference in serious pneumonias, mortality or serious adverse events. Fluticasone was associated with higher risk of any pneumonia when compared with budesonide (i.e. less serious cases dealt with in the community), but variation in the definitions used by the respective manufacturers is a potential confounding factor in their comparison. Primary research should accurately measure pneumonia outcomes and should clarify both the definition and the method of diagnosis used, especially for new formulations and combinations for which little evidence of the associated pneumonia risk is currently available. Similarly, systematic reviews and cohorts should address the reliability of assigning 'pneumonia' as an adverse event or cause of death and should determine how this affects the applicability of findings. Output:

We found 43 studies including more than 30,000 people with COPD. More studies used fluticasone (26 studies; 21,247 people) than budesonide (17 studies; 10,150 people). A higher proportion of people in the studies were male (around 70%), and their COPD was generally classed as severe. The last search for studies to include in the review was done in September 2013. We compared each drug against controls and assessed separately the results of studies that compared ICS versus placebo, and an ICS/LABA combination versus LABA alone. We also conducted an indirect comparison of budesonide and fluticasone based on their effects against placebo, to explore whether one drug was safer than the other. Fluticasone increased 'serious' pneumonias (requiring hospital admission). Over 18 months, 18 more people of every 1000 treated with fluticasone were admitted to hospital for pneumonia. Budesonide also increased pneumonias that were classed as 'serious'. Over nine months, six more hospital admissions were reported for every 1000 individuals treated with budesonide. A lower dose of budesonide (320 mcg) was associated with fewer serious pneumonias than a higher dose (640 mcg). No more deaths overall were reported in the ICS groups compared with controls, and deaths related to pneumonia were too rare to tell either way. When we compared fluticasone and budesonide versus each other, the difference between them was not clear enough to tell whether one was safer (for pneumonia, requiring a hospital stay, general adverse events and death). The risk of any pneumonia event (i.e. less serious cases that could be treated without going to hospital) was higher with fluticasone than with budesonide. Evidence was rated to be of high or moderate quality for most outcomes. When an outcome is rated of high quality, further research is very unlikely to change our confidence in the estimate of effect, but moderate ratings reflect some uncertainty in the findings. Results from the budesonide studies were generally less clear because they were based on fewer people, and the studies were shorter. Budesonide and fluticasone, delivered alone or in combination with LABA, can increase serious pneumonias that result in hospitalisation of people. Neither has been shown to affect the chance of dying compared with not taking ICS. Comparison of the two drugs revealed no difference in serious pneumonias or risk of death. Fluticasone was associated with a higher risk of any pneumonia (i.e. cases that could be treated in the community) than budesonide, but potential differences in the definition used by the respective drug manufacturers reduced our confidence in this finding. These concerns need to be balanced with the known benefits of ICS (e.g. fewer exacerbations, improved lung function and quality of life). Researchers should remain aware of the risks associated with ICS and should make sure that pneumonia is properly diagnosed in studies.

CochranePLS709

***TASK*** the task is to simplify the input abstract of a biomedical literature ***INPUT*** the input is the abstract of a biomedical literature ***OUTPUT*** the output is the simplified abstract for the input abstract of a biomedical literature ***DOCUMENTATION*** ***EXAMPLES*** Input: Four studies with a total of 136 participants were included. Two studies compared the use of plugs versus no plugs, one study compared two sizes of the same brand of plug, and one study compared two brands of plugs. In all included studies there was considerable dropout (in total 48 (35%) dropped out before the end of the study) for varying reasons. Data presented are thus subject to potential bias. 'Pseudo-continence' was, however, achieved by some of those who continued to use plugs, at least in the short-term. In a comparison of two different types of plug, plug loss was less often reported and overall satisfaction was greater during use of polyurethane plugs than polyvinyl-alcohol plugs. The available data were limited and incomplete, and not all pre-specified outcomes could be evaluated. Consequently, only tentative conclusions are possible. The available data suggest that anal plugs can be difficult to tolerate. However, if they are tolerated they can be helpful in preventing incontinence. Plugs could then be useful in a selected group of people either as a substitute for other forms of management or as an adjuvant treatment option. Plugs come in different designs and sizes; the review showed that the selection of the type of plug can impact on its performance. Output:

Four studies with a total of 136 participants were included. Two studies compared the use of plugs versus no plugs. The involuntary loss of stool was effectively blocked (pseudo-continence) in six (38%) participants who continued to use the plugs, at least in the short-term. One study compared two sizes of the same brand of plug; due to the high dropout in this study and the incomplete data, no results concerning this comparison are available. In one study a comparison of two different brands of plug was made. Loss of plug was reported by 7 patients (30%) with a polyurethane (PU) plug and by 15 patients (65%) with the polyvinyl-alcohol (PVA) plug. Overall satisfaction, defined as patients' opinion that the plug was good to very good, was reported more often for the PU plug (n = 17) than for the PVA plug (n = 8). In all included studies there was considerable dropout; in total 48 participants (35%) dropped out before the end of the study for varying reasons. Data presented are thus subject to potential bias, and only tentative conclusions are possible. The available data suggest that anal plugs can be difficult to tolerate. However, if they are tolerated they can be helpful in preventing incontinence. Plugs could then be useful in a selected group of people either as a substitute for other forms of management or as an adjuvant treatment option. Plugs come in different designs and sizes; the review showed that the selection of the type of plug can impact on its performance.

CochranePLS710

***TASK*** the task is to simplify the input abstract of a biomedical literature ***INPUT*** the input is the abstract of a biomedical literature ***OUTPUT*** the output is the simplified abstract for the input abstract of a biomedical literature ***DOCUMENTATION*** ***EXAMPLES*** Input: Sixteen trials (1565 participants) met the inclusion criteria. Seven studies investigated some form of patient education. In six of these studies this education was combined with other behavioural change interventions including tailoring daily routines to promote adherence to eye drops. Eight studies compared different drug regimens (one of these trials also compared open and masked monitoring) and one study investigated a reminder device. The studies were of variable quality and some were at considerable risk of bias; in general, the length of follow-up was short at less than six months with only two studies following up to 12 months. Different interventions and outcomes were reported and so it was not possible to produce an overall estimate of effect. There was some evidence from three studies that education combined with personalised interventions, that is, more complex interventions, improved adherence to ocular hypotensive therapy. There was less information on other outcomes such as persistence and intraocular pressure, and no information on visual field defects, quality of life and cost. There was weak evidence as to whether people on simpler drug regimens were more likely to adhere and persist with their ocular hypotensive therapy. A particular problem was the interpretation of cross-over studies, which in general were not reported correctly. One study investigated a reminder device and monitoring but the study was small and inconclusive. Although complex interventions consisting of patient education combined with personalised behavioural change interventions, including tailoring daily routines to promote adherence to eye drops, may improve adherence to glaucoma medication, overall there is insufficient evidence to recommend a particular intervention. The interventions varied between studies and none of the included studies reported on the cost of the intervention. Simplified drug regimens also could be of benefit but again the current published studies do not provide conclusive evidence. Future studies should follow up for at least one year, and could benefit from standardised outcomes. Output:

This review is based on 16 studies (1565 participants) that tried out different methods to help people to use drops as prescribed. All the studies took place in industrialised countries (Belgium, Denmark, France, Greece, Iceland, Japan, Sweden, Switzerland, UK and USA) and recruited participants in outpatient clinics. The following interventions were included: simplifying drop routines, reminder devices, automated telephone service, providing information about glaucoma and offering advice regarding day to day issues with eye care. Those studies which combined the provision of information about glaucoma and eye drops with other interventions, such as helping people to fit instillation of eye drops into their daily routine, appear to be more successful. Unfortunately, not all of these studies were of high quality and, therefore, until more evidence is available we cannot recommend any particular method. Good quality research is needed in this area in order to develop a better understanding of patients' individual needs and to help us provide more effective eye care services.

CochranePLS711

***TASK*** the task is to simplify the input abstract of a biomedical literature ***INPUT*** the input is the abstract of a biomedical literature ***OUTPUT*** the output is the simplified abstract for the input abstract of a biomedical literature ***DOCUMENTATION*** ***EXAMPLES*** Input: Twelve trials (1241 patients) evaluated antibiotic prophylaxis compared with placebo or no antibiotic prophylaxis. All trials were at risk of bias. Antibiotic prophylaxis compared with no intervention or placebo was associated with beneficial effects on mortality (RR 0.79, 95% CI 0.63 to 0.98), mortality from bacterial infections (RR 0.43, 95% CI 0.19 to 0.97), bacterial infections (RR 0.36, 95% CI 0.27 to 0.49), rebleeding (RR 0.53, 95% CI 0.38 to 0.74), days of hospitalisation (MD -1.91, 95% CI -3.80 to -0.02), bacteraemia (RR 0.25, 95% CI 0.15 to 0.40), pneumonia (RR 0.45, 95% CI 0.27 to 0.75), spontaneous bacterial peritonitis (RR 0.29, 95% CI 0.15 to 0.57), and urinary tract infections (RR 0.23, 95% CI 0.12 to 0.41). No serious adverse events were reported. The trials showed no significant heterogeneity of effects. Another five trials (650 patients) compared different antibiotic regimens. Data could not be combined as each trial used different antibiotic regimen. None of the examined antibiotic regimen was superior to the control regimen regarding mortality or bacterial infections. Prophylactic antibiotic use in patients with cirrhosis and upper gastrointestinal bleeding significantly reduced bacterial infections, and seems to have reduced all-cause mortality, bacterial infection mortality, rebleeding events, and hospitalisation length. These benefits were observed independently of the type of antibiotic used; thus, no specific antibiotic can be preferred. Therefore, antibiotic selection should be made considering local conditions such as bacterial resistance profile and treatment cost. Output:

Twelve trials (1241 patients) assessing several antibiotic prophylaxis regimens versus no intervention or placebo were analysed, showing that antibiotic prophylaxis successfully reduced the incidence of bacterial infections. Antibiotic prophylaxis was also associated with a reduction in mortality, mortality from bacterial infections, rebleeding rate, and days of hospitalisation. The prophylactic treatment was not associated with important adverse effects. Five trials (650 patients) assessed one antibiotic regimen compared with another. All antibiotic regimens provided similar benefits and none seemed superior. Thus, to this point there is no evidence to recommend one specific antibiotic regimen over the other. All trials analysed were subject to bias; thus, results should be interpreted carefully.

CochranePLS712

***TASK*** the task is to simplify the input abstract of a biomedical literature ***INPUT*** the input is the abstract of a biomedical literature ***OUTPUT*** the output is the simplified abstract for the input abstract of a biomedical literature ***DOCUMENTATION*** ***EXAMPLES*** Input: Two trials (92 participants) met our inclusion criteria. Participants in both trials were followed for 12 months. Neither trial compared surgery to placebo surgery. One trial (40 randomised participants) compared open surgical excision with eccentric exercises, and the other compared arthroscopic surgery with sclerosing injections (52 randomised participants). Due to the nature of the interventions, neither the participants or the investigators were blinded to the group allocation, resulting in the potential for performance and detection bias. Some outcomes were selectively not recorded, leading to reporting bias. Overall, the certainty of the evidence from these studies was low for all outcomes due to the potential for bias, and imprecision due to small sample sizes. Compared with eccentric exercises, low-certainty evidence indicates that open surgical excision provides no clinically important benefits with respect to knee pain, function or global assessment of success. At 12 months, mean knee pain — measured by pain with standing jump on a 10-point scale (lower scores indicating less pain) — was 1.7 points (standard deviation (SD) 1.6) in the eccentric training group and 1.3 (SD 0.8) in the surgical group (one trial, 40 participants). This equates to an absolute pain reduction of 4% (ranging from 4% worse to 12% better, the minimal clinically important difference being 15%) and a relative reduction in pain of 10% better (ranging from 30% better to 10% worse) in the treatment group. At 12 months, function on the zero- to 100-point Victorian Institute of Sport Assessment (VISA) scale was 65.7 (SD 23.8) in the eccentric training group and 72.9 (SD 11.7) in the surgical group (one trial, 40 participants). This equates to an absolute change of 7% better function (ranging from 4% worse to 19% better) and relative change of 25% better (ranging from 15% worse to 65% better, the minimal clinically important difference being 13%). Participant global assessment of success was measured by the number of people with no pain at 12 months: 7/20 participants in the eccentric training group reported no pain, compared with 5/20 in the open surgical group (risk ratio (RR) 0.71 (95% CI 0.27 to 1.88); one trial, 40 participants). There were no withdrawals, but five out of 20 people from the eccentric exercise group crossed over to open surgical excision. Quality of life, adverse events and tendon ruptures were not measured. Compared with sclerosing injection, low-certainty evidence indicates that arthroscopic surgery may provide a reduction in pain and improvement in participant global assessment of success, however further studies are likely to change these results. At 12 months, mean pain with activities, measured on a 100-point scale (lower scores indicating less pain), was 41.1 (SD 28.5) in the sclerosing injection group and 12.8 (SD 19.3) in the arthroscopic surgery group (one trial, 52 participants). This equates to an absolute pain reduction of 28% better (ranging from 15% to 42% better, the minimal clinically important difference being 15%), and a relative change of 41% better (ranging from 21% to 61% better). At 12 months, the mean participant global assessment of success, measured by satisfaction on a 100-point scale (scale zero to 100, higher scores indicating greater satisfaction), was 52.9 (SD 32.6) in the sclerosing injection group and 86.8 (SD 20.8) in the arthroscopic surgery group (one trial, 52 participants). This equates to an absolute improvement of 34% (ranging from 19% to 49%). In both groups, one participant (4%) withdrew from the study. Functional outcome scores, including the VISA score, were not reported. Quality-of-life assessment, adverse events, and specifically the proportion with a tendon rupture, were not reported. We did not perform subgroup analysis to assess differences in outcome between arthroscopic or open surgical excision, as we did not identify more than one study with a common comparator. We are uncertain if surgery is beneficial over other therapeutic interventions, namely eccentric exercises or injectables. Low-certainty evidence shows that surgery for patellar tendinopathy may not provide clinically important benefits over eccentric exercise in terms of pain, function or participant-reported treatment success, but may provide clinically meaningful pain reduction and treatment success when compared with sclerosing injections. However, further research is likely to change these results. The evidence was downgraded two levels due to the small sample sizes and susceptibility to bias. We are uncertain if there are additional risks associated with surgery as study authors failed to report adverse events. Surgery seems to be embedded in clinical practice for late-stage patella tendinopathy, due to exhaustion of other therapeutic methods rather than evidence of benefit. Output:

This Cochrane Review is current to July 2018. We searched online databases for all studies (specifically randomised controlled trials) that compared surgical treatment with non-operative treatment in adults with patellar tendinopathy. We found two studies; they compared open surgical removal to eccentric exercises (one study involving 40 people) and arthroscopic surgery to sclerosing injections (these scar and block the blood vessels supplying nerve fibres to the diseased tendon) (one study involving 56 people). The studies were performed in an outpatient setting in two countries (Norway and Sweden). The majority of people in the studies were male, with a mean age ranging from 27 to 31 years, and mean symptom duration of 24 to 33 months. Trials were conducted without funding (financial support) from industry (medical or device companies), but some authors from the one study received funding from pharmaceutical companies in addition to research funding from non-industry sources. Compared with eccentric exercises, open surgery offered little benefit at 12 months (results for individual outcomes as follows). Pain (lower scores mean less pain) Improved by 4% (ranging from 4% worse to 12% better) or by 0.4 points on a scale of zero to 10 points. People who had surgery rated their pain as 1.3 points. People who had eccentric exercises rated their pain as 1.7 points. Global assessment of success (those who reported no pain at 12 months) 10% fewer people had no pain (ranging from 38% less to 18% more), or 10 fewer people out of 100. Twenty-five out of 100 people had no pain with surgery. Thirty-five out of 100 people had no pain with eccentric exercises. Withdrawals No participants in either group withdrew from the study. The study did not report on quality-of-life improvements or adverse events (including tendon ruptures). Compared with sclerosing injections, arthroscopic (keyhole) surgery offered some reduction in pain and improvement in participant global assessment of success at 12 months (results for individual outcomes as follows; further studies are likely to change these results). Pain (lower scores mean less pain) Improved by 28% (ranging from 15% to 42% better) or by 28 points on a scale of zero to 100 points. People who had surgery rated their pain as 12.8 points. People who had sclerosing injection rated their pain as 41.1 points. Global assessment of success (participant-reported success, higher score is better) Improved by 34% (ranging from 19% to 49% better) or by 33.9 points on a scale of zero to 100 points. People who had surgery rated their pain as 86.8 points. People who had sclerosing injection rated their pain as 52.9 points. Withdrawals One person from each group (4%) withdrew from the study for reasons unrelated to the treatment. The study did not report on quality-of-life improvements, functional score improvements or adverse events (including tendon ruptures). We decided the evidence was low-certainty due to flaws in the design of the studies that may over-estimate benefits of treatment. For example, people involved in the study were aware of which treatment they were receiving, the studies selectively reported some results but not others, and there was imprecision in the results due to the small number of participants and trials. Therefore, we are uncertain if surgery has any benefits over eccentric exercises or sclerosing injections for treating patellar tendinopathy in adults. Further studies are likely to change the results.

CochranePLS713

***TASK*** the task is to simplify the input abstract of a biomedical literature ***INPUT*** the input is the abstract of a biomedical literature ***OUTPUT*** the output is the simplified abstract for the input abstract of a biomedical literature ***DOCUMENTATION*** ***EXAMPLES*** Input: We included 23 studies (94 reports) that involved 3301 participants. All studies tested mycophenolate mofetil (MMF), an MPA, and 22 studies reported at least one outcome relevant for this review. Assessment of methodological quality indicated that important information on factors used to judge susceptibility for bias was infrequently and inconsistently reported. MMF treatment reduced the risk for graft loss including death (RR 0.82, 95% CI 0.67 to 1.0) and for death-censored graft loss (RR 0.78, 95% CI 0.62 to 0.99, P < 0.05). No statistically significant difference for MMF versus AZA treatment was found for all-cause mortality (16 studies, 2987 participants: RR 0.95, 95% CI 0.70 to 1.29). The risk for any acute rejection (22 studies, 3301 participants: RR 0.65, 95% CI 0.57 to 0.73, P < 0.01), biopsy-proven acute rejection (12 studies, 2696 participants: RR 0.59, 95% CI 0.52 to 0.68) and antibody-treated acute rejection (15 studies, 2914 participants: RR 0.48, 95% CI 0.36 to 0.65, P < 0.01) were reduced in MMF treated patients. Meta-regression analyses suggested that the magnitude of risk reduction of acute rejection may be dependent on the control rate (relative risk reduction (RRR) 0.34, 95% CI 0.10 to 1.09, P = 0.08), AZA dose (RRR 1.01, 95% CI 1.00 to 1.01, P = 0.10) and the use of cyclosporin A micro-emulsion (RRR 1.27, 95% CI 0.98 to 1.65, P = 0.07). Pooled analyses failed to show a significant and meaningful difference between MMF and AZA in kidney function measures. Data on malignancies and infections were sparse, except for cytomegalovirus (CMV) infections. The risk for CMV viraemia/syndrome (13 studies, 2880 participants: RR 1.06, 95% CI 0.85 to 1.32) was not statistically significantly different between MMF and AZA treated patients, whereas the likelihood of tissue-invasive CMV disease was greater with MMF therapy (7 studies, 1510 participants: RR 1.70, 95% CI 1.10 to 2.61). Adverse event profiles varied: gastrointestinal symptoms were more likely in MMF treated patients and thrombocytopenia and elevated liver enzymes were more common in AZA treatment. MMF was superior to AZA for improvement of graft survival and prevention of acute rejection after kidney transplantation. These benefits must be weighed against potential harms such as tissue-invasive CMV disease. However, assessment of the evidence on safety outcomes was limited due to rare events in the observation periods of the studies (e.g. malignancies) and inconsistent reporting and definitions (e.g. infections, adverse events). Thus, balancing benefits and harms of the two drugs remains a major task of the transplant physician to decide which agent the individual patient should be started on. Output:

Searches to 21 September 2015 identified 23 studies in which 3301 patients were treated with MPA (all studies used MMF) or AZA. Methodological quality of the studies was limited, e.g. only in two RCTs was the study medication administered in a blinded fashion. MMF was more effective than AZA for reducing the risk of graft loss (by approximately 20%) and acute rejection (by approximately 30%). No difference in mortality was observed. Moreover, graft function appeared to be similar in both treatments. When drugs are given to suppress the immune system, this can result in serious side effects such as infections and malignancies. The data on adverse events was limited by relatively short follow up in the studies as some of these side effects occur after several years of treatment. Furthermore, the studies did not focus on these harms and did not use harmonised diagnostic criteria. The incidence of cytomegalovirus infections did not differ between MMF and AZA, but there was a 1.7-fold increased risk for the more severe, tissue-invasive cytomegalovirus disease in MMF-treated patients. Information on malignancies was reported only in five studies; therefore no robust conclusions can be drawn. Gastrointestinal side effects (e.g. nausea, diarrhoea) were more common with MMF-treatment, whereas bone marrow suppression (e.g. thrombocytopenia) and elevated liver enzymes were observed more frequently in AZA treated patients. In general, evidence for efficacy outcomes is of high quality and can be seen as considerably robust, but there is less certainty on aspects of safety. Therefore, caregivers should balance potential benefits and harms of MMF and AZA according to individual patient's risks and preferences. Physicians need to individualise the decision between these agents as components of the immunosuppressive regimen.

CochranePLS714

***TASK*** the task is to simplify the input abstract of a biomedical literature ***INPUT*** the input is the abstract of a biomedical literature ***OUTPUT*** the output is the simplified abstract for the input abstract of a biomedical literature ***DOCUMENTATION*** ***EXAMPLES*** Input: We included two studies (involving a total of 49 women). Each study compared yoga to a different comparator, therefore we were unable to combine the data in a meta-analysis. A third study that has been completed but not yet fully reported is awaiting assessment. One included study was a six-week study comparing yoga to a waiting list in 19 women with either urgency urinary incontinence or stress urinary incontinence. We judged the certainty of the evidence for all reported outcomes as very low due to performance bias, detection bias, and imprecision. The number of women reporting cure was not reported. We are uncertain whether yoga results in satisfaction with cure or improvement of incontinence (risk ratio (RR) 6.33, 95% confidence interval (CI) 1.44 to 27.88; an increase of 592 from 111 per 1000, 95% CI 160 to 1000). We are uncertain whether there is a difference between yoga and waiting list in condition-specific quality of life as measured on the Incontinence Impact Questionnaire Short Form (mean difference (MD) 1.74, 95% CI -33.02 to 36.50); the number of micturitions (MD -0.77, 95% CI -2.13 to 0.59); the number of incontinence episodes (MD -1.57, 95% CI -2.83 to -0.31); or the bothersomeness of incontinence as measured on the Urogenital Distress Inventory 6 (MD -0.90, 95% CI -1.46 to -0.34). There was no evidence of a difference in the number of women who experienced at least one adverse event (risk difference 0%, 95% CI -38% to 38%; no difference from 222 per 1000, 95% CI 380 fewer to 380 more). The second included study was an eight-week study in 30 women with urgency urinary incontinence that compared mindfulness-based stress reduction (MBSR) to an active control intervention of yoga classes. The study was unblinded, and there was high attrition from both study arms for all outcome assessments. We judged the certainty of the evidence for all reported outcomes as very low due to performance bias, attrition bias, imprecision and indirectness. The number of women reporting cure was not reported. We are uncertain whether women in the yoga group were less likely to report improvement in incontinence at eight weeks compared to women in the MBSR group (RR 0.09, 95% CI 0.01 to 1.43; a decrease of 419 from 461 per 1000, 95% CI 5 to 660). We are uncertain about the effect of MBSR compared to yoga on reports of cure or improvement in incontinence, improvement in condition-specific quality of life measured on the Overactive Bladder Health-Related Quality of Life Scale, reduction in incontinence episodes or reduction in bothersomeness of incontinence as measured on the Overactive Bladder Symptom and Quality of Life-Short Form at eight weeks. The study did not report on adverse effects. We identified few trials on yoga for incontinence, and the existing trials were small and at high risk of bias. In addition, we did not find any studies of economic outcomes related to yoga for urinary incontinence. Due to the lack of evidence to answer the review question, we are uncertain whether yoga is useful for women with urinary incontinence. Additional, well-conducted trials with larger sample sizes are needed. Output:

We found two studies involving a total of 49 women. One was a six-week study comparing yoga to a waiting list (delayed treatment) in women with either stress or urgency urinary incontinence. The other was an eight-week study comparing yoga to mindfulness-based stress reduction (MBSR) in women with urgency urinary incontinence. We also identified an ongoing study involving 50 women that aims to compare yoga with stretching; we will include this study when the results are reported. The trial comparing yoga to a waiting list did not report the number of women reporting cure but did report on symptoms, condition-specific quality of life and adverse effects. While this comparison generally favoured the yoga intervention, we are uncertain whether yoga improves urinary incontinence due to the very low certainty of the evidence. There was no difference between groups in the number of women reporting an adverse event and no serious adverse events were reported, but we are uncertain whether yoga increases harms as the certainty of the evidence is very low. The trial comparing yoga to MBSR reported on symptoms and condition-specific quality of life but did not report the number of women reporting cure. While this comparison generally favoured the MBSR intervention, we are uncertain whether yoga improves urinary incontinence due to the very low certainty of the evidence. There was no information on adverse events. We did not find any information on the value for money of yoga for urinary incontinence. Although we identified some evidence on yoga treatment for treating urinary incontinence in women, the included studies were very small and there were issues with the way they were conducted, which limits our confidence in the results. Due to the nature of the treatments, the participants and staff of the trial comparing yoga to a waiting list were aware of which groups the participants were assigned and it is possible that the women in the yoga group reported some benefits because they expected yoga to be helpful. The trial comparing yoga to MBSR did not intend to test yoga as a treatment for incontinence. Instead, the trial tested MBSR as a treatment and used yoga classes to ensure that women in the comparison group received attention from the study staff. In addition, the trial comparing yoga to MBSR did not collect outcomes on all women and it is possible that the women who reported outcomes had either better or worse results than the women who did not report outcomes. There is currently insufficient good-quality evidence to judge whether yoga is useful for women with urinary incontinence.

CochranePLS715

***TASK*** the task is to simplify the input abstract of a biomedical literature ***INPUT*** the input is the abstract of a biomedical literature ***OUTPUT*** the output is the simplified abstract for the input abstract of a biomedical literature ***DOCUMENTATION*** ***EXAMPLES*** Input: We included three studies with a total of 83 participants. For efficacy, a greater proportion of participants in the topiramate group had a 50% or more reduction in primarily generalized tonic-clonic seizures (PGTCS) compared with participants in the placebo group. There were no significant differences between topiramate and valproate in participants responding with a 50% or more reduction in myoclonic seizures or in PGTCS, or becoming seizure-free. Concerning tolerability, we ranked AEs associated with topiramate as moderate to severe, while we ranked 59% of AEs linked to valproate as severe complaints. Moreover, systemic toxicity scores were higher in the valproate group than the topiramate group. Overall we judged all three studies to be at high risk of attrition bias and at unclear risk of reporting bias. We judged all three studies to be at low to unclear bias for the remaining risk of bias domains (random sequence, allocation, blinding). We judged the quality of the evidence from the studies to be very low. We have found no new studies since the last version of this review was published in 2017. This review does not provide sufficient evidence to support topiramate for the treatment of people with JME. Based on the current limited available data, topiramate seems to be better tolerated than valproate, but has no clear benefits over valproate in terms of efficacy. Well-designed, double-blind RCTs with large samples are required to test the efficacy and tolerability of topiramate in people with JME. Output:

We searched scientific databases for clinical trials comparing the antiepileptic medication, topiramate, with placebo (a pretend treatment) or another antiepileptic drug in people with JME. We wanted to evaluate how well topiramate worked and if it had any side effects. The evidence is current to July 2018. We included and analyzed three randomized controlled trials (clinical studies where people are randomly put into one of two or more treatment groups) with 83 participants. Based on the information in these trials, it seems that topiramate is better tolerated than valproate, but is no more effective than valproate. Topiramate seemed to work better than placebo, but this result was based on a small number of included people. The quality of the evidence from the studies was very low and the results should be interpreted with caution. More randomized controlled trials with large numbers of participants are required to test how effective and well tolerated topiramate is in people with JME. Future trials should be well-designed and double-blinded (where neither the participant nor the researcher know which treatment has been given until after the results have been collected). This review does not provide sufficient evidence to support topiramate for the treatment of people with JME.

CochranePLS716

***TASK*** the task is to simplify the input abstract of a biomedical literature ***INPUT*** the input is the abstract of a biomedical literature ***OUTPUT*** the output is the simplified abstract for the input abstract of a biomedical literature ***DOCUMENTATION*** ***EXAMPLES*** Input: Our search found 782 potentially relevant references. From these, we included three trials without a control group, with 283 participants. In addition, we identified 14 ongoing trials evaluating nivolumab, of which two are randomised. Risk of bias of the three included studies was moderate to high. All of the participants were in relapsed stage, most of them were heavily pretreated and had received at least two previous treatments, most of them had also undergone ASCT. As we did not identify any RCTs, we could not use the software RobotReviewer to assess risk of bias. The software identified correctly that one study was not an RCT and did not extract any trial data, but extracted characteristics of the other two studies (although also not RCTs) in a sufficient way. Two studies with 260 participants evaluated OS. After six months, OS was 100% in one study and median OS (the timepoint when only 50% of participants were alive) was not reached in the other trial after a median follow-up of 18 months (interquartile range (IQR) 15 to 22 months) (very low certainty evidence, due to observational trial design, heterogenous patient population in terms of pretreatments and various follow-up times (downgrading by 1 point)). In one study, one out of three cohorts reported quality of life. It was unclear whether there was an effect on quality of life as only a subset of participants filled out the follow-up questionnaire (very low certainty evidence). Three trials (283 participants) evaluated progression-free survival (PFS) (very low certainty evidence). Six-month PFS ranged between 60% and 86%, and median PFS ranged between 12 and 18 months. All three trials (283 participants) reported complete response rates, ranging from 12% to 29%, depending on inclusion criteria and participants' previous treatments (very low certainty evidence). One trial (243 participants) reported drug-related grade 3 or 4 adverse events (AEs) only after a median follow-up of 18 months (IQR 15 to 22 months); these were fatigue (23%), diarrhoea (15%), infusion reactions (14%) and rash (12%). The other two trials (40 participants) reported 23% to 52% grade 3 or 4 AEs after six months' follow-up (very low certainty evidence). Only one trial (243 participants) reported drug-related serious AEs; 2% of participants developed infusion reactions and 1% pneumonitis (very low certainty evidence). None of the studies reported treatment-related mortality. To date, data on OS, quality of life, PFS, response rate, or short- and long-term AEs are available from small uncontrolled trials only. The three trials included heavily pretreated participants, which had previously undergone regimens of BV or ASCT. For these participants, median OS was not reached after follow-up times of at least 16 months (more than 50% of participants with a limited life expectancy were alive at this timepoint). Only one cohort out of three only reported quality of life, with limited follow-up data so that meaningful conclusions were not possible. Serious adverse events occurred rarely. Currently, data are too sparse to make a clear statement on nivolumab for people with relapsed or refractory HL except for heavily pretreated people, which had previously undergone regimens of BV or ASCT. When interpreting these results, it is important to consider that proper RCTs should confirm these findings. As there are 14 ongoing trials evaluating nivolumab, of which two are RCTs, it is possible that an update of this review will be published in the near future and that this update will show different results to those reported here. Output:

We searched important medical databases for clinical trials assessing the benefits and harms of nivolumab in adults with HL. Two review authors independently screened, summarised and analysed the results. In addition, we tested the computer software RobotReviewer to extract data. Our search led to the inclusion of three studies involving 283 participants and 14 ongoing trials. The evidence provided is current to May 2018. Two studies with 260 participants evaluated survival. After six months, all participants were alive in one trial (17 participants). One trial reported quality of life for a subgroup of participants using a questionnaire but not all follow-up data were available. Although it seemed that the participants answering the questionnaire might have had a benefit, it was unclear whether this applied to all the participants. The studies also reported tumour control and tumour response, but with different results, depending on the treatment and how many previous treatments participants had received before nivolumab was given. As nivolumab is given until the disease progresses (gets worse) or until unacceptable side effects occur, people receive the drug for a long time. Therefore, reporting of side effects is related to the time the person received the medicine, with potentially more side effects with longer usage. The most commonly reported side effects were fatigue (tiredness), diarrhoea (loose stools), infusion reactions (during or shortly after giving the medicine by a vein) and rash. Only one study reported medicine-related serious side effects. They occurred rarely (infusion reactions and lung disease). Deaths related to the medicine were not reported. Due to the study design and varied type of participants with different numbers of previous treatments and various treatment options, the reliability of the evidence was low to very low. This systematic review evaluated the benefits and harms of nivolumab in adults with HL. Data on survival, quality of life, tumour response and side effects were available from small trials only. The three trials included only people different previous treatment options, very often also with a previous stem cell transplantation. In one trial, all participants were alive after six months. Quality of life data were not reported for all the included participants; moreover, data after a long period of treatment were not available for all evaluated participants, therefore meaningful conclusions were not possible. Serious side effects occurred rarely. Currently, data are too sparse to make a clear statement on nivolumab for people with relapsed or refractory HL except for those who had received several treatments before. As there are currently 14 ongoing trials evaluating nivolumab, of which two are well designed, it is possible that an update of this review will be published in the near future and that this update will show different results to those reported here.

CochranePLS717

***TASK*** the task is to simplify the input abstract of a biomedical literature ***INPUT*** the input is the abstract of a biomedical literature ***OUTPUT*** the output is the simplified abstract for the input abstract of a biomedical literature ***DOCUMENTATION*** ***EXAMPLES*** Input: Sixty-six randomised trials, involving 8302 participants, met the inclusion criteria. Methodological quality was generally low. Sixty-nine different herbal medicines were tested in the included trials, which compared herbal medicines with placebo, hypoglycaemic drugs, or herbal medicines plus hypoglycaemic drugs. Compared with placebo, Holy basil leaves, Xianzhen Pian, Qidan Tongmai, traditional Chinese formulae (TCT), Huoxue Jiangtang Pingzhi, and Inolter showed significantly hypoglycaemic response. Compared with hypoglycaemic drugs including glibenclamide, tolbutamide, or gliclazide, seven herbal medicines demonstrated a significant better metabolic control, including Bushen Jiangtang Tang, Composite Trichosanthis, Jiangtang Kang, Ketang Ling, Shenqi Jiangtang Yin, Xiaoke Tang, and Yishen Huoxue Tiaogan. In 29 trials that evaluated herbal medicines combined with hypoglycaemic drugs, 15 different herbal preparations showed additional better effects than hypoglycaemic drugs monotherapy. Two herbal therapies combined with diet and behaviour change showed better hypoglycaemic effects than diet and behaviour change alone. No serious adverse effects from the herbal medicines were reported. Some herbal medicines show hypoglycaemic effect sin type 2 diabetes. However, these findings should be carefully interpreted due to the low methodological quality, small sample size, and limited number of trials. In the light of some positive findings, some herbal medicines deserve further examination in high-quality trials. Output:

This systematic review evaluates the effects of various herbal preparations (including single herbs or mixtures of different herbs) for treating people with type 2 diabetes. The review shows that some herbal medicines lower blood sugar and relieving symptoms in patients with diabetes. However, the methodological quality of the clinical trials evaluating these herbs is generally poor. The analyses also indicate that trials with positive findings are more likely to be associated with exaggerated effects. However, the trials did not report significant adverse effects. In conclusion, herbal medicines should not be recommended for routine use in diabetic patients of type 2 diabetes until we get scientifically sound trials. Testing the herbs in larger, well-designed trials is needed in order to establish the necessary evidence for their use.

CochranePLS718

***TASK*** the task is to simplify the input abstract of a biomedical literature ***INPUT*** the input is the abstract of a biomedical literature ***OUTPUT*** the output is the simplified abstract for the input abstract of a biomedical literature ***DOCUMENTATION*** ***EXAMPLES*** Input: A total of 27 studies (1596 participants) met the inclusion criteria: 19 studies assessed evening primrose oil, and 8 studies assessed borage oil. For EPO, a meta-analysis of results from 7 studies showed that EPO failed to significantly increase improvement in global eczema symptoms as reported by participants on a visual analogue scale of 0 to 100 (MD -2.22, 95% CI -10.48 to 6.04, 176 participants, 7 trials) and a visual analogue scale of 0 to 100 for medical doctors (MD -3.26, 95% CI -6.96 to 0.45, 289 participants, 8 trials) compared to the placebo group. Treatment with BO also failed to significantly improve global eczema symptoms compared to placebo treatment as reported by both participants and medical doctors, although we could not conduct a meta-analysis as studies reported results in different ways. With regard to the risk of bias, the majority of studies were of low risk of bias; we judged 67% of the included studies as having low risk of bias for random sequence generation; 44%, for allocation concealment; 59%, for blinding; and 37%, for other biases. Implications for practice Oral borage oil and evening primrose oil lack effect on eczema; improvement was similar to respective placebos used in trials. Oral BO and EPO are not effective treatments for eczema. In these studies, along with the placebos, EPO and BO have the same, fairly common, mild, transient adverse effects, which are mainly gastrointestinal. The short-term studies included here do not examine possible adverse effects of long-term use of EPO or BO. A case report warned that if EPO is taken for a prolonged period of time (more than one year), there is a potential risk of inflammation, thrombosis, and immunosuppression; another study found that EPO may increase bleeding for people on Coumadin® (warfarin) medication. Implications for research Noting that the confidence intervals between active and placebo treatment are narrow, to exclude the possibility of any clinically useful difference, we concluded that further studies on EPO or BO for eczema would be hard to justify. This review does not provide information about long-term use of these products. Output:

We included 27 studies, with 1596 adults and children from 12 countries. Of these, 19 studies compared EPO with a placebo (dummy) treatment, and 8 used BO compared with placebo. We looked for evidence of overall improvement in eczema and in quality of life. All 27 studies evaluated overall improvement of eczema, but only 2 studies of EPO measured improvement in quality of life. There was no statistically significant advantage demonstrated for either EPO or BO compared to placebo. In summary, we did not find evidence that eczema improved by taking these products any more than it did by taking placebo. There was some evidence of mild and temporary side-effects for participants with either product or placebo, which were mainly mild, and included temporary headache and upset stomach or diarrhoea. With EPO there is an anticoagulant (blood-thinning) effect when taking these products. There is a warning with the blood thinner warfarin (Coumadin®) that taking EPO can increase bleeding. One report warns that if EPO is taken for a prolonged period of time (more than one year), there is a potential risk of inflammation, thrombosis, and immunosuppression due to slow accumulation of EPO in the tissues. Another reports a single case in which EPO was thought to have produced harms. We found no clinical evidence of such harm in these short-term trials. This systematic review found no evidence that either BO or EPO are effective in treatment of eczema. Both of these products and the placebos used in the studies had similar mild, temporary side-effects, which were mainly gastrointestinal.

CochranePLS719

***TASK*** the task is to simplify the input abstract of a biomedical literature ***INPUT*** the input is the abstract of a biomedical literature ***OUTPUT*** the output is the simplified abstract for the input abstract of a biomedical literature ***DOCUMENTATION*** ***EXAMPLES*** Input: Three randomised trials used gemcitabine plus cisplatin (GCis) as one of the arms in each trial. The first randomised trial compared GCis with MVAC (methotrexate, vinblastine, doxorubicin and cisplatin) and showed no significant difference in overall survival (hazard ratio1.09, 95% CI 0.88 to 1.34, P = 0.443) however the GCis regime had fewer incidences of neutropenic sepsis (1% versus 12%, P = 0.001) and mucositis (1% versus 22%, P = 0.001). A second randomised trial compared GCis to gemcitabine plus carboplatin (GCarbo) and reported an improved, but non-significant 1-year survival rate with GCis (64% versus 37%). A third randomised trial compared GCis with gemcitabine plus cisplatin plus paclitaxel (GCisPac) and again found no significant difference in overall survival (respective medians 49 weeks versus 61 weeks). One randomised trial evaluated GCarbo against methotrexate plus carboplatin plus vinblastine (MCarboV) in patients "unfit" for cisplatin-based chemotherapy. There were more overall responses (38% versus 20%) and less severe acute toxicities (14% versus 23%) with GCarbo. In one randomised study evaluating 3-weekly gemcitabine plus paclitaxel (GPac3) versus a 2-weekly regimen overall survival was not significantly different (respective medians 13 and 9 months) however toxicities were worse with GPac3 especially alopecia (76% versus 32%). A larger trial compared gemcitabine (1 g/m2) (grams per metre squared) plus paclitaxel (175 mg/m2) (milligrams per metre squared) as a 3-weekly schedule for 6 cycles with a 2-weekly maintenance schedule. There was no significant difference in response rates, progression-free survival, disease-specific survival, and overall survival. A review of the published evidence found that one trial reported gemcitabine plus cisplatin had a better safety profile than MVAC and may be considered the first choice for treatment of metastatic bladder cancer. However, the data are limited to one trial only. Patients unable to tolerate cisplatin may benefit from gemcitabine plus carboplatin. Output:

This review aimed to determine the effectiveness and toxicity of gemcitabine by looking at the evidence published from randomised clinical trials. Patients receiving gemcitabine combined with cisplatin had a similar overall survival but less toxicity when compared to the well-established chemotherapeutic treatment of MVAC (methotrexate, vinblastine, doxorubicin, cisplatin). This suggests that gemcitabine plus cisplatin may be considered an alternative chemotherapy schedule to MVAC for advanced bladder cancer but the evidence is limited to one trial only. For patients who have poor kidney function or poor performance status the combination of gemcitabine plus carboplatin may be considered.

CochranePLS720

***TASK*** the task is to simplify the input abstract of a biomedical literature ***INPUT*** the input is the abstract of a biomedical literature ***OUTPUT*** the output is the simplified abstract for the input abstract of a biomedical literature ***DOCUMENTATION*** ***EXAMPLES*** Input: Four trials were eligible for inclusion, one of these trials (n =24) was on children and adolescents. All used an SSRI and prolonged exposure or a cognitive behavioural intervention. Two trials compared combination treatment with pharmacological treatment and two compared combination treatment with psychological treatment. Only two trials reported a total PTSD symptom score and these data could not be combined. There was no strong evidence to show if there were differences between the group receiving combined interventions compared to the group receiving psychological therapy (mean difference 2.44, 95% CI -2.87, 7.35 one study, n=65) or pharmacotherapy (mean difference -4.70, 95% CI -10.84 to 1.44; one study, n = 25). Trialists reported no significant differences between combination and single intervention groups in the other two studies. There were very little data reported for other outcomes, and in no case were significant differences reported. There is not enough evidence available to support or refute the effectiveness of combined psychological therapy and pharmacotherapy compared to either of these interventions alone. Further large randomised controlled trials are urgently required. Output:

Both psychological therapy and pharmacotherapy have been used to treat PTSD and guidelines suggest that a combination of both may mean people recover from PTSD more effectively. Four trials including 124 participants were included in this review. One of these trials (n =24) was on children and adolescents. The trials all used SSRIs and prolonged exposure or a cognitive behavioural intervention. Only two trials reported on total PTSD symptoms but the data could not be combined. In this review, there are too few studies to be able to draw conclusions about whether a combination of psychological therapy and pharmacotherapy result in better outcomes for patients than either of these treatments alone.

CochranePLS721

***TASK*** the task is to simplify the input abstract of a biomedical literature ***INPUT*** the input is the abstract of a biomedical literature ***OUTPUT*** the output is the simplified abstract for the input abstract of a biomedical literature ***DOCUMENTATION*** ***EXAMPLES*** Input: The review includes 39 trials with a total of 3509 participants. Study duration ranged between three and 12 weeks. Amitriptyline was significantly more effective than placebo in achieving acute response (18 RCTs, n = 1987, OR 2.67, 95% CI 2.21 to 3.23). Significantly fewer participants allocated to amitriptyline than to placebo withdrew from trials due to inefficacy of treatment (19 RCTs, n = 2017, OR 0.20, 95% CI 0.14 to 0.28), but more amitriptyline-treated participants withdrew due to side effects (19 RCTs, n = 2174, OR 4.15, 95% CI 2.71 to 6.35). Amitriptyline also caused more anticholinergic side effects, tachycardia, dizziness, nervousness, sedation, tremor, dyspepsia, sedation, sexual dysfunction and weight gain. In subgroup and meta-regression analyses the results of the primary outcome were robust towards publication year (1971 to 1997), mean participant age at baseline, mean amitriptyline dose, study duration in weeks, pharmaceutical sponsor, inpatient versus outpatient setting and two-arm versus three-arm design. However, higher severity at baseline was associated with higher superiority of amitriptyline (P = 0.02), while higher responder rates in the placebo groups were associated with lower superiority of amitriptyline (P = 0.05). The results of the primary outcome were rather homogeneous, reflecting comparability of the trials. However, methods of randomisation, allocation concealment and blinding were usually poorly reported. Not all studies used intention-to-treat analyses and in many of them standard deviations were not reported and often had to be imputed. Funnel plots suggested a possible publication bias, but the trim and fill method did not change the overall effect size much (seven adjusted studies, OR 2.64, 95% CI 2.24 to 3.10). Amitriptyline is an efficacious antidepressant drug. It is, however, also associated with a number of side effects. Degree of placebo response and severity of depression at baseline may moderate drug-placebo efficacy differences. Output:

The current review includes 39 trials with a total of 3509 participants and confirms its efficacy compared to placebo or no treatment. This finding is important, because the efficacy of antidepressants has recently been questioned. However, the review also demonstrated that amitriptyline produces a number of side effects such as vision problems, constipation and sedation. It is a limitation of this review that many studies have been poorly reported, which might have led to bias.

CochranePLS722

***TASK*** the task is to simplify the input abstract of a biomedical literature ***INPUT*** the input is the abstract of a biomedical literature ***OUTPUT*** the output is the simplified abstract for the input abstract of a biomedical literature ***DOCUMENTATION*** ***EXAMPLES*** Input: For this update, 8 additional trials were identified giving a total of 26 included studies (n=2530). 17 studies compared open wound healing with surgical closure. Healing times were faster after surgical closure compared with open healing. Surgical site infection (SSI) rates did not differ between treatments; recurrence rates were lower in open healing than with primary closure (RR 0.60, 95% CI 0.42 to 0.87). Six studies compared surgical midline with off-midline closure. Healing times were faster after off-midline closure (MD 5.4 days, 95% CI 2.3 to 8.5). SSI rates were higher after midline closure (RR 3.72, 95% CI 1.86 to 7.42) and recurrence rates were higher after midline closure (Peto OR 4.54, 95% CI 2.30 to 8.96). No clear benefit was shown for open healing over surgical closure. A clear benefit was shown in favour of off-midline rather than midline wound closure. When closure of pilonidal sinuses is the desired surgical option, off-midline closure should be the standard management. Output:

This review of the published literature found that patients who had their wounds closed with stitches healed faster and returned to work earlier than patients whose wounds were left unstitched and allowed to heal "naturally". However, the review also found that patients who had their wounds closed with stitches were more likely to get the disease again compared to those who did not have their wounds closed by stitches. This means that each type of surgical treatment has its advantages and disadvantages, and that the decision about which type of surgical wound to select should also be guided by the patient's own desired goals for treatment. The review also found that if a decision had been made to close the wound with stitches, then the best way to reduce the risk of the disease coming back and reduce other complications (such as infection), was to use a wound technique where the line of stitches was moved away from between the buttocks. Therefore one definitive recommendation from this systematic review is that where a decision has been made to close the sinus wound using stitches, this wound should not lie in the central area of the buttocks.

CochranePLS723

***TASK*** the task is to simplify the input abstract of a biomedical literature ***INPUT*** the input is the abstract of a biomedical literature ***OUTPUT*** the output is the simplified abstract for the input abstract of a biomedical literature ***DOCUMENTATION*** ***EXAMPLES*** Input: One trial involving 92 participants with pretreated/relapsed WM compared the effect of fludarabine versus the combination of cyclophosphamide (the alkylating agent), doxorubicin and prednisone (CAP). Compared to CAP, the Hazard ratio (HR) for deaths of treatment with fludarabine was estimated to be 1.04, with a standard error of 0.30 (95% CI 0.58 to 1.48) and it indicated that the mean difference of median survival time was -4.00 months, and 16.00 months for response duration. The relative risks (RR) of response rate was 2.80 (95% CI 1.10 to 7.12). There were no statistically difference in overall survival rate and median survival months, while on the basis of response rate and response duration, fludarabine seemed to be superior to CAP for pretreated/relapsed patients with macroglobulinaemia. Although alkylating agents have been used for decades they have never actually been tested in a proper randomised trial. This review demonstrated that there is currently no evidence to suggest that alkylating agents are effective in treating Waldenstrom's macroglobulinaemia. Output:

The review authors found one randomised controlled trial with 92 participants that considered fludarabine was superior to the alkylating agents-containing regimen for pretreated/relapsed patients with Waldenstrom's macroglobulinaemia.

CochranePLS724

***TASK*** the task is to simplify the input abstract of a biomedical literature ***INPUT*** the input is the abstract of a biomedical literature ***OUTPUT*** the output is the simplified abstract for the input abstract of a biomedical literature ***DOCUMENTATION*** ***EXAMPLES*** Input: We included 11 RCTs involving 1583 participants (791 participants in the intervention group and 792 in the control group). We found that there was no difference between the treatment and control groups in the outcomes of death or dependency (OR 0.99, 95% CI 0.79 to 1.23) or final neurological deficit (SMD -0.09, 95% CI -0.19 to 0.01). The rate of symptomatic hypoglycaemia was higher in the intervention group (OR 14.6, 95% CI 6.6 to 32.2). In the subgroup analyses of diabetes mellitus (DM) versus non-DM, we found no difference for the outcomes of death and disability or neurological deficit. The number needed to treat was not significant for the outcomes of death and final neurological deficit. The number needed to harm was nine for symptomatic hypoglycaemia. After updating the results of our previous review, we found that the administration of intravenous insulin with the objective of maintaining serum glucose within a specific range in the first hours of acute ischaemic stroke does not provide benefit in terms of functional outcome, death, or improvement in final neurological deficit and significantly increased the number of hypoglycaemic episodes. Specifically, those people whose glucose levels were maintained within a tighter range with intravenous insulin experienced a greater risk of symptomatic and asymptomatic hypoglycaemia than those people in the control group. Output:

We searched for trials that compared usual care with intensive insulin treatment (trying to keep blood sugar levels within the normal range of 4 to 7.5 mmol/L) after stroke. We found 11 trials involving 1583 participants. Trying to keep the blood sugar level within a tight range immediately after a stroke did not improve the outcomes of neurological deficit and dependency. It did, however, significantly increase the chance of experiencing very low blood sugar levels (hypoglycaemia), which can be harmful and can cause brain damage and death. On balance, the trials did not show any benefit from intensive control of blood sugar levels after stroke.

CochranePLS725

***TASK*** the task is to simplify the input abstract of a biomedical literature ***INPUT*** the input is the abstract of a biomedical literature ***OUTPUT*** the output is the simplified abstract for the input abstract of a biomedical literature ***DOCUMENTATION*** ***EXAMPLES*** Input: We included a total of 52 trials (6923 participants). The psychosocial interventions considered in the studies were: cognitive behavioural therapy (19 studies), contingency management (25 studies), motivational interviewing (5 studies), interpersonal therapy (3 studies), psychodynamic therapy (1 study), 12-step facilitation (4 studies). We judged most of the studies to be at unclear risk of selection bias; blinding of personnel and participants was not possible for the type of intervention, so all the studies were at high risk of performance bias with regard to subjective outcomes; the majority of studies did not specify whether the outcome assessors were blind. We did not consider it likely that the objective outcomes were influenced by lack of blinding. The comparisons made were: any psychosocial intervention versus no intervention (32 studies), any psychosocial intervention versus TAU (6 studies), and one psychosocial intervention versus an alternative psychosocial intervention (13 studies). Five of included studies did not provide any useful data for inclusion in statistical synthesis. We found that, when compared to no intervention, any psychosocial treatment: reduced the dropout rate (risk ratio (RR): 0.83, 95% confidence interval (CI) 0.76 to −0.91, 24 studies, 3393 participants, moderate quality evidence); increased continuous abstinence at the end of treatment (RR: 2.14, 95% CI 1.27 to −3.59, 8 studies, 1241 participants, low quality evidence); did not significantly increase continuous abstinence at the longest follow-up (RR: 2.12, 95% CI 0.77 to −5.86, 4 studies, 324 participants, low quality evidence); significantly increased the longest period of abstinence: (standardised mean difference (SMD): 0.48, 95% CI 0.34 to 0.63, 10 studies, 1354 participants, high quality evidence). However, it should be noted that the in the vast majority of the studies in this comparison the specific psychosocial treatment assessed in the experimental arm was given in add on to treatment as usual or to another specific psychosocial or pharmacological treatment which was received by both groups. So, many of the control groups in this comparison were not really untreated. Receiving some amount of treatment is not the same as not receiving any intervention, so we could argue that the overall effect of the experimental psychosocial treatment could be smaller if given in add on to TAU or to another intervention than if given to participants not receiving any intervention; this could translate to a smaller magnitude of the effect of the psychosocial intervention when it is given in add on. When compared to TAU, any psychosocial treatment reduced dropout rate (RR: 0.72, 95% CI 0.59 to 0.89, 6 studies, 516 participants, moderate quality evidence), did not increase continuous abstinence at the end of treatment (RR: 1.27, 95% CI 0.94 to 1.72, 2 studies, 224 participants, low quality evidence), did not increase longest period of abstinence (MD −3.15 days, 95% CI −10.35 to 4.05, 1 study, 110 participants, low quality evidence). No studies in this comparison assessed the outcome of continuous abstinence at longest follow-up. There were few studies comparing two or more psychosocial interventions, with small sample sizes and considerable heterogeneity in terms of the types of interventions assessed. None reported significant results. None of the studies reported harms related to psychosocial interventions. The addition of any psychosocial treatment to treatment as usual (usually characterised by group counselling or case management) probably reduces the dropout rate and increases the longest period of abstinence. It may increase the number of people achieving continuous abstinence at the end of treatment, although this might not be maintained at longest follow-up. The most studied and the most promising psychosocial approach to be added to treatment as usual is probably contingency management. However, the other approaches were only analysed in a few small studies, so we cannot rule out the possibility that the results were not significant because of imprecision. When compared to TAU, any psychosocial treatment may improve adherence, but it may not improve abstinence at the end of treatment or the longest period of abstinence. The majority of the studies took place in the United States, and this could limit the generalisability of the findings, because the effects of psychosocial treatments could be strongly influenced by the social context and ethnicity. The results of our review do not answer the most relevant clinical question, demonstrating which is the most effective type of psychosocial approach. Further studies should directly compare contingency management with the other psychosocial approaches. Output:

We looked at 52 randomised controlled trials (studies where people were allocated at random to one of two or more treatment or control groups) in this review. On average, the interventions lasted about 16 weeks, while investigators followed up participants for 6 to 12 months. The studies examined different kinds of psychosocial interventions: cognitive behavioural therapy (19 studies), contingency management (25 studies), motivational interviewing (5 studies), interpersonal therapy (3 studies), psychodynamic therapy (1 study) and 12-step facilitation (4 studies). Forty-one studies took place in the United States, four in Spain, three in Australia, two in Switzerland and two in the UK. We included a total of 6923 participants with an average age of 36 years. The proportion of males is 63%. The comparisons made were: any psychosocial versus no intervention (32 studies), any psychosocial versus treatment as usual (6 studies), and one psychosocial intervention versus an alternative psychosocial intervention (13 studies). Five of the included studies did not provide any useful data for inclusion in statistical synthesis. We found that, compared to no intervention, any psychosocial intervention probably improves treatment adherence and may increase abstinence at the end of treatment; however, people may not be able to stay clean several months after the end of treatment. Finally, we found that people undergoing specific psychosocial interventions stay clean for a longer time without using stimulants. However, the vast majority of the studies we looked at assessed a specific psychosocial treatment added to treatment as usual or compared it to another specific psychosocial or pharmacological treatment. So, control groups were not really untreated. This could have led to an underestimation of the true effect of the psychosocial interventions. We found that, when compared to TAU, any psychosocial treatment probably improves adherence but may not improve abstinence at the end of treatment nor help participants to stay clean for a longer time. We could not draw any conclusions on which is the most effective psychosocial treatment based on direct comparisons. Most of the studies took place in the United States, and this could limit the generalisability of the findings, because the effects of psychosocial treatments could be strongly influenced by the social context and ethnicity. None of the studies reported harms related to psychosocial interventions. The quality of evidence was moderate for adherence to treatment but low for abstinence.

CochranePLS726

***TASK*** the task is to simplify the input abstract of a biomedical literature ***INPUT*** the input is the abstract of a biomedical literature ***OUTPUT*** the output is the simplified abstract for the input abstract of a biomedical literature ***DOCUMENTATION*** ***EXAMPLES*** Input: We included seven randomised controlled trials with 891 participants (outpatients in secondary care). We found no quasi-randomised controlled trials. Six studies (836 participants) evaluated balneotherapy versus no treatment. One study evaluated balneotherapy versus a phlebotonic drug (melilotus officinalis) (55 participants). There was a lack of blinding of participants and investigators, imprecision and inconsistency, which downgraded the certainty of the evidence. For the balneotherapy versus no treatment comparison, there probably was no improvement in favour of balneotherapy in disease severity signs and symptom score as assessed using the Venous Clinical Severity Score (VCSS) (MD –1.66, 95% CI –4.14 to 0.83; 2 studies, 484 participants; moderate-certainty evidence). Balneotherapy probably resulted in a moderate improvement in HRQoL as assessed by the Chronic Venous Insufficiency Questionnaire 2 (CVIQ2) at three months (MD –9.38, 95% CI –18.18 to –0.57; 2 studies, 149 participants; moderate-certainty evidence), nine months (MD –10.46, 95% CI –11.81 to –9.11; 1 study; 55 participants; moderate-certainty evidence), and 12 months (MD –4.99, 95% CI –9.19 to –0.78; 2 studies, 455 participants; moderate-certainty evidence). There was no clear difference in HRQoL between balneotherapy and no treatment at six months (MD –1.64, 95% CI –9.18 to 5.89; 2 studies, 445 participants; moderate-certainty evidence). Balneotherapy probably slightly improved pain compared with no treatment (MD –1.23, 95% CI –1.33 to –1.13; 1 study; 390 participants; moderate-certainty evidence). There was no clear effect related to oedema between the two groups at 24 days (MD 43.28 mL, 95% CI –102.74 to 189.30; 2 studies, 153 participants; very-low certainty evidence). There probably was no improvement in favour of balneotherapy in the incidence of leg ulcers (OR 1.69, 95% CI 0.82 to 3.48; 2 studies, 449 participants; moderate-certainty evidence). There was probably a reduction in incidence of skin pigmentation changes in favour of balneotherapy at 12 months (pigmentation index: MD –3.59, 95% CI –4.02 to –3.16; 1 study; 59 participants; low-certainty evidence). The main complications reported included erysipelas (OR 2.58, 95% CI 0.65 to 10.22; 2 studies, 519 participants; moderate-certainty evidence), thromboembolic events (OR 0.35, 95% CI 0.09 to 1.42; 3 studies, 584 participants; moderate-certainty evidence) and palpitations (OR 0.33, 95% CI 0.01 to 8.52; 1 study; 59 participants; low-certainty evidence), with no clear evidence of an increase in reported adverse effects with balneotherapy. There were no serious adverse events reported in any of the studies. For the balneotherapy versus a phlebotonic drug (melilotus officinalis) comparison, we observed no clear difference in pain symptoms (OR 0.29, 95% CI 0.03 to 2.87; 1 study; 35 participants; very low-certainty evidence) and oedema (OR 0.21, 95% CI 0.02 to 2.27; 1 study; 35 participants; very low-certainty evidence). This single study did not report on the other outcomes of interest. We identified moderate- to low-certainty evidence that suggests that balneotherapy may result in a moderate improvement in pain, quality of life and skin pigmentation changes and has no clear effect on disease severity signs and symptoms score, adverse effects, leg ulcers and oedema when compared with no treatment. For future studies, measurements of outcomes such as disease severity sign and symptom score, quality of life, pain and oedema and choice of time points during follow-up must be standardised for adequate comparison between trials. Output:

We identified seven randomised controlled trials (studies in which the participants were divided between treatment groups through random method) (most recent search August 2018). Six studies compared balneotherapy versus no treatment, and one study compared balneotherapy versus a medicine called melilotus officinalis. The studies used different types of balneotherapy and different treatment times. For the balneotherapy versus no treatment comparison there probably is no improvement in favour of balneotherapy in disease severity signs and symptoms score (moderate-certainty evidence). Balneotherapy probably improves health-related quality of life and pain (moderate-certainty evidence). There probably is no improvement in favour of balneotherapy for leg ulcers (moderate-certainty evidence). There is no clear effect related to oedema (swelling caused when fluid leaks out of the body's tiny blood vessels) between balneotherapy and no treatment (very low-certainty evidence). Balneotherapy probably reduces skin pigmentation changes (low-certainty evidence). None of the studies reported any serious adverse events. There were fewer side effects (infection and blood clots in the legs) in people receiving balneotherapy compared to no treatment. When comparing balneotherapy with melilotus officinalis, there were insufficient data to detect clear differences between the two treatments for pain and oedema in the single small study. There were no data available for the other outcomes of interest such as disease severity signs and symptoms score, quality of life, leg ulcers and skin pigmentation. The certainty of the evidence was affected by the small number of trials with few participants and the impossibility of blinding of participants and physicians conducting the balneotherapy treatment, which could have led to bias.

CochranePLS727

***TASK*** the task is to simplify the input abstract of a biomedical literature ***INPUT*** the input is the abstract of a biomedical literature ***OUTPUT*** the output is the simplified abstract for the input abstract of a biomedical literature ***DOCUMENTATION*** ***EXAMPLES*** Input: This review identified 17 randomized studies that addressed whether enhanced glucose control prevents the development of neuropathy. Seven of these studies were conducted in people with type 1 diabetes, eight in type 2 diabetes, and two in both types. A meta-analysis of the two studies that reported the primary outcome (incidence of clinical neuropathy) with a total of 1228 participants with type 1 diabetes revealed a significantly reduced risk of developing clinical neuropathy in those with enhanced glucose control, an annualized RD of -1.84% (95% confidence interval (CI) -1.11 to -2.56). In a similar analysis of four studies that reported the primary outcome, involving 6669 participants with type 2 diabetes, the annualized RD of developing clinical neuropathy was -0.58% (95% CI 0.01 to -1.17). Most secondary outcomes were significantly in favor of intensive treatment in both populations. However, both types of diabetic participants also had a significant increase in severe adverse events including hypoglycemic events. According to high-quality evidence, enhanced glucose control significantly prevents the development of clinical neuropathy and reduces nerve conduction and vibration threshold abnormalities in type 1 diabetes mellitus. In type 2 diabetes mellitus, enhanced glucose control reduces the incidence of clinical neuropathy, although this was not formally statistically significant (P = 0.06). However, enhanced glucose control does significantly reduce nerve conduction and vibration threshold abnormalities. Importantly, enhanced glucose control significantly increases the risk of severe hypoglycemic episodes, which needs to be taken into account when evaluating its risk/benefit ratio. Output:

This review identified 17 randomized studies that addressed whether more aggressive attempts to lower blood glucose levels prevent people from developing neuropathy. Seven of these studies were conducted in people with type 1 diabetes, eight in type 2 diabetes, and two in both types. However, only two studies in type 1 diabetes including 1228 participants and four studies in type 2 diabetes including 6669 participants investigated our primary outcome. In type 1 diabetes, there was a significant effect of more aggressive therapies in preventing neuropathy compared with standard treatment. In type 2 diabetes, more aggressive therapy was also beneficial in preventing symptoms and signs of clinical neuropathy, but the result was not statistically significant as measured by the primary method selected for this review. However, there was a significant positive effect on the amount of nerve damage measured with electrical nerve conduction tests and a special machine to measure the threshold of detection of vibration in both types of diabetes. Overall, the evidence indicates that more aggressive treatments of sugar levels delay the onset of neuropathy in both types of diabetes. No other treatments have proven effective to date. However, the beneficial effect has to be balanced against the significantly increased risk of dangerously low blood sugar levels that can occur in both types of diabetes and which can lead to brain injury amongst other issues.

CochranePLS728

***TASK*** the task is to simplify the input abstract of a biomedical literature ***INPUT*** the input is the abstract of a biomedical literature ***OUTPUT*** the output is the simplified abstract for the input abstract of a biomedical literature ***DOCUMENTATION*** ***EXAMPLES*** Input: Of 3840 records screened, we identified just one conference abstract that met our inclusion criteria. This prospective cohort study assessed the efficacy and acceptability of home administration of misoprostol for early medical abortion among women living with HIV who were of less than 63 days amenorrhea in Ukraine. Medical abortion was effective in 65 of 68 cases (96%) examined. The small number of failures included incomplete abortion (n = 1), heavy bleeding (n = 1), and ongoing pregnancy (n = 1). There were no serious infections. Due to the paucity of studies, we were unable to determine if outcome differences exist between women living with HIV and women without HIV who undergo medical or surgical abortion. We found no evidence suggesting that medical or surgical abortions are unsafe for women living with HIV. While additional research would strengthen the evidence base, healthcare providers should not be deterred from providing access to safe abortion to their patients living with HIV. Output:

The evidence is current to 17 April 2018. Of the 3840 records screened, we identified only one unpublished study that met our inclusion criteria. The intervention focused on women living in Ukraine with HIV undergoing medical abortion at home. The quality of evidence was low, but found that medical abortion was successful with no major complications experienced among women living with HIV. The results from this review do not provide enough evidence to determine if differences exist in abortion outcomes for women living with HIV, but also no evidence was found showing that abortion is unsafe in this population. As it is important for all women to have access to safe abortion to combat the public health threat of high rates of maternal deaths, healthcare providers should not be deterred from providing access to safe abortion to their patients living with HIV.

CochranePLS729

***TASK*** the task is to simplify the input abstract of a biomedical literature ***INPUT*** the input is the abstract of a biomedical literature ***OUTPUT*** the output is the simplified abstract for the input abstract of a biomedical literature ***DOCUMENTATION*** ***EXAMPLES*** Input: We included a total of 16 randomised trials in this review. The results for primary outcomes are as follows. PDEI versus placebo: PDEIs may result in a small improvement in IPSS-total score (mean difference (MD) 1.89 lower, 95% confidence interval (CI) 2.27 lower to 1.50 lower; n = 4293; low-quality evidence) compared to placebo, and may reduce the BPHII score slightly (MD 0.52 lower, 95% CI 0.71 lower to 0.33 lower; n = 3646; low-quality evidence). Rates of AEs may be increased (risk ratio (RR) 1.42, 95% CI 1.21 to 1.67; n = 4386; low-quality evidence). This corresponds to 95 more AEs per 1000 participants (95% CI 47 more to 151 more per 1000). Study results were limited to a treatment duration of six to 12 weeks. PDEI versus AB: PDEIs and ABs probably provide similar improvement in IPSS-total score (MD 0.22 higher, 95% CI 0.49 lower to 0.93 higher; n = 933; moderate-quality evidence) and may have a similar effect on BPHII score (MD 0.03 higher, 95% CI 1.10 lower to 1.16 higher; n = 550; low-quality evidence) and AEs (RR 1.35, 95% CI 0.80 to 2.30; n = 936; low-quality evidence). This corresponds to 71 more AEs per 1000 participants (95% CI 41 fewer to 264 more per 1000). Study results were limited to a treatment duration of six to 12 weeks. PDEI and AB versus AB alone: the combination of PDEI and AB may provide a small improvement in IPSS-total score (MD 2.56 lower, 95% CI 3.92 lower to 1.19 lower; n = 193; low-quality evidence) compared to AB alone. We found no evidence for BPHII scores. AEs may be increased (RR 2.81, 95% CI 1.53 to 5.17; n = 194; moderate-quality evidence). This corresponds to 235 more AEs per 1000 participants (95% CI 69 more to 542 more per 1000). Study results were limited to treatment duration of four to 12 weeks. PDEI and AB versus PDEI alone: the combination of PDEI and AB may provide a small improvement in IPSS-total (MD 2.4 lower, 95% CI 6.47 lower to 1.67 higher; n = 40; low-quality evidence) compared to PDEI alone. We found no data on BPHII or AEs. Study results were limited to a treatment duration of four weeks. PDEI and 5-ARI versus 5-ARI alone: in the short term (up to 12 weeks), the combination of PDEI and 5-ARI probably results in a small improvement in IPSS-total score (MD 1.40 lower, 95% CI 2.24 lower to 0.56 lower; n = 695; moderate-quality evidence) compared to 5-ARI alone. We found no evidence on BPHII scores or AEs. In the long term (13 to 26 weeks), the combination of PDEI and 5-ARI likely results in a small reduction in IPSS-total score (MD 1.00 less, 95% CI 1.83 lower to 0.17 lower; n = 695; moderate-quality evidence). We found no evidence about effects on BPHII scores. There may be no difference in rates of AEs (RR 1.07, 95% CI 0.84 to 1.36; n = 695; low-quality evidence). This corresponds to 19 more AEs per 1000 participants (95% CI 43 fewer to 98 more per 1000). We found no trials comparing other combinations of treatments or comparing different PDEI agents. Compared to placebo, PDEI likely leads to a small reduction in IPSS-total and BPHII sores, with a possible increase in AEs. There may be no differences between PDEI and AB with regards to improvement in IPSS-total, BPHII, and incidence of AEs. There appears to be no added benefit of PDEI combined with AB compared to PDEI or AB alone or PDEI combined with 5-ARI compared to ARI alone with regards to urinary symptoms. Most evidence was limited to short-term treatment up to 12 weeks and of moderate or low certainty. Output:

We found a total of 16 studies. They included mostly men, older than 60 years of age, with moderate, to severe urinary symptoms. Most studies were funded by the companies that make these drugs. Compared to placebo, phosphodiesterase inhibitors may make urinary symptoms a little better and reduce bother, but may also cause more unwanted drug effects. There is probably no difference between phosphodiesterase inhibitors and alpha-blockers when it comes to improving urinary symptoms, and there may be no difference with regards to how bothersome symptoms are, or unwanted drug effects. Taking a phosphodiesterase inhibitor with an alpha-blocker may improve urinary symptoms slightly more than taking alpha-blockers alone. We found no evidence regarding urinary bother. However, combination treatment probably causes a lot more unwanted drug effects. Taking a phosphodiesterase inhibitor with an alpha-blocker may improve urinary symptoms slightly more than taking a phosphodiesterase inhibitor alone. We found no evidence regarding bother or unwanted drug effects. In the short term (up to 12 weeks), the combination of a phosphodiesterase inhibitor with a 5-alpha reductase inhibitor probably makes urinary symptoms a little better compared to taking a 5-alpha reductase inhibitor alone, but the effect may be too small to notice. We found no evidence on bother, nor on rates of unwanted drug effects. When taken longer (13 to 26 weeks), combination treatment probably also improves urinary symptoms slightly to a degree that may not be noticeable. We found no evidence regarding urinary bother. Unwanted drug effects may be similar. We found no evidence for other combination treatments or comparing different phosphodiesterase inhibitors. Most studies investigated only short-term use of these drugs (up to 12 weeks); therefore, long-term effects are largely unknown. We mostly rated the quality of evidence as moderate or low, meaning that we are somewhat or quite unsure of the true results. The real effects may be similar or quite different.

CochranePLS730

***TASK*** the task is to simplify the input abstract of a biomedical literature ***INPUT*** the input is the abstract of a biomedical literature ***OUTPUT*** the output is the simplified abstract for the input abstract of a biomedical literature ***DOCUMENTATION*** ***EXAMPLES*** Input: A total of seven studies of variable quality were included in this review. Only three studies assessed the effectiveness of parenting programmes on objective measures of abuse (e.g. the incidence of child abuse, number of injuries, or reported physical abuse), and only one of these found significant differences between the intervention and control groups. Data were also extracted on over fifty outcomes that are used as predictive measures of abusive parenting. These measured a range of aspects of parenting (e.g. parental child management, discipline practices, child abuse potential and mental health), child health (e.g. emotional and behavioural adjustment) and family functioning, thereby precluding the possibility of undertaking a meta-analysis for most outcomes for which data were extracted. While none of the programmes were effective across all of the outcomes measured, many appeared to have improved some outcomes for some of the participating parents, although many failed to achieve statistical significance. There is insufficient evidence to support the use of parenting programmes to treat physical abuse or neglect. There is, however, limited evidence to show that some parenting programmes may be effective in improving some outcomes that are associated with physically abusive parenting. Further research is urgently needed. Output:

This review examines the extent to which parenting programmes (relatively brief and structured interventions that are aimed at changing parenting practices) are effective in treating physically abusive or neglectful parenting. A total of seven studies of mixed quality were included in the review. The findings show that there is insufficient evidence to support the use of parenting programmes to reduce physical abuse or neglect (i.e. using objective assessments of abuse such as reports of child abuse; children on the children protection register etc). There is, however, limited evidence to show that some parenting programmes may be effective in improving some outcomes that are associated with physically abusive parenting. There is an urgent need for further rigorous evaluation of the effectiveness of parenting programmes that are specifically designed to treat physical abuse and neglect, either independently or as part of broader packages of care.

CochranePLS731

***TASK*** the task is to simplify the input abstract of a biomedical literature ***INPUT*** the input is the abstract of a biomedical literature ***OUTPUT*** the output is the simplified abstract for the input abstract of a biomedical literature ***DOCUMENTATION*** ***EXAMPLES*** Input: A total of 24 studies (1201 participants) contributed data to the review. The review authors had several concerns regarding the studies. Pharmaceutical company support for manuscript preparation was a common feature; also, because common endpoints were lacking, study populations were heterogenous and variations in study design were noted, individual drug meta-analysis was not possible. Moderate-quality evidence from individual studies suggests that proton pump inhibitors (PPIs) can reduce GOR symptoms in children with confirmed erosive oesophagitis. It was not possible to demonstrate statistical superiority of one PPI agent over another. Some evidence indicates that H₂antagonists are effective in treating children with GORD. Methodological differences precluded performance of meta-analysis on individual agents or on these agents as a class, in comparison with placebo or head-to-head versus PPIs, and additional studies are required. RCT evidence is insufficient to permit assessment of the efficacy of prokinetics. Given the diversity of study designs and the heterogeneity of outcomes, it was not possible to perform a meta-analysis of the efficacy of domperidone. In younger children, the largest RCT of 80 children (one to 18 months of age) with GOR showed no evidence of improvement in symptoms and 24-hour pH probe, but improvement in symptoms and reflux index was noted in a subgroup treated with domperidone and co-magaldrox(Maalox® ). In another RCT of 17 children, after eight weeks of therapy. 33% of participants treated with domperidone noted an improvement in symptoms (P value was not significant). In neonates, the evidence is even weaker; one RCT of 26 neonates treated with domperidone over 24 hours showed that although reflux frequency was significantly increased, reflux duration was significantly improved. Diversity of RCT evidence was found regarding efficacy of compound alginate preparations(Gaviscon Infant® ) in infants, although as a result of these studies, Gaviscon Infant® was changed to become aluminium-free and has been assessed in its current form in only two studies since 1999. Given the diversity of study designs and the heterogeneity of outcomes, as well as the evolution in formulation, it was not possible to perform a meta-analysis on the efficacy of Gaviscon Infant® . Moderate evidence indicates that Gaviscon Infant® improves symptoms in infants, including those with functional reflux; the largest study of the current formulation showed improvement in symptom control but was limited by length of follow-up. No serious side effects were reported. No RCTs on pharmacological treatments for children with neurodisability were identified. Moderate evidence was found to support the use of PPIs, along with some evidence to support the use of H₂ antagonists in older children with GORD, based on improvement in symptom scores, pH indices and endoscopic/histological appearances. However, lack of independent placebo-controlled and head-to-head trials makes conclusions as to relative efficacy difficult to determine. Further RCTs are recommended. No robust RCT evidence is available to support the use of domperidone, and further studies on prokinetics are recommended, including assessments of erythromycin. Pharmacological treatment of infants with reflux symptoms is problematic, as many infants have GOR, and little correlation has been noted between reported symptoms and endoscopic and pH findings. Better evidence has been found to support the use of PPIs in infants with GORD, but heterogeneity in outcomes and in study design impairs interpretation of placebo-controlled data regarding efficacy. Some evidence is available to support the use of Gaviscon Infant® , but further studies with longer follow-up times are recommended. Studies of omeprazole and lansoprazole in infants with functional GOR have demonstrated variable benefit, probably because of differences in inclusion criteria. No robust RCT evidence has been found regarding treatment of preterm babies with GOR/GORD or children with neurodisabilities. Initiation of RCTs with common endpoints is recommended, given the frequency of treatment and the use of multiple antireflux agents in these children. Output:

We included all studies (randomised controlled trials) comparing one type of medicine against another, or against an inactive medicine (placebo). We carefully looked at study results and tried to assess those that would be important to doctors, nurses and parents. We found a lot of differences between studies, and the small numbers of children included in the studies, the short follow-up provided and differing outcomes made combining the data (meta-analysis) in a meaningful way difficult. Overall as a result of the small numbers of children recruited to these studies, we could not be certain whether medicines improve symptoms. We found little evidence to suggest that medicines for babies younger than one year work, especially for functional reflux; mixed evidence has been found on whether Gaviscon Infant® helps, and for infants with reflux disease (changes on pH studies or on endoscopy), medicines like omeprazole and lansoprazole are likely to help. In older children, proton pump inhibitors and histamine antagonists work better to improve symptoms, endoscopy appearances and pH probe findings, but we were unable to perform a meta-analysis, or to assess further whether one medicine was superior to another. Overall available evidence was of moderate to low quality, depending on the medicine in question. We have made suggestions as to how future studies could be designed to provide better answers regarding which treatments are best for babies and children with reflux or reflux disease.

CochranePLS732

***TASK*** the task is to simplify the input abstract of a biomedical literature ***INPUT*** the input is the abstract of a biomedical literature ***OUTPUT*** the output is the simplified abstract for the input abstract of a biomedical literature ***DOCUMENTATION*** ***EXAMPLES*** Input: We included three studies that enrolled a total of 413 adult patients that compared tacrolimus with microemulsion or oral solution cyclosporin. All studies were found to be at high risk of bias. Tacrolimus seemed to be significantly superior to cyclosporin regarding the incidence of bronchiolitis obliterans syndrome (RR 0.46, 95% CI 0.29 to 0.74), lymphocytic bronchitis score (MD -0.60, 95% CI -1.04 to -0.16), treatment withdrawal (RR 0.27, 95% CI 0.16 to 0.46), and arterial hypertension (RR 0.67, 95% CI 0.50 to 0.89). However, the finding for arterial hypertension was not confirmed when analysed using a random-effects model (RR 0.54, 95% CI 0.17 to 1.73). Furthermore, trial sequential analysis found that none of the meta-analyses reached the required information sizes and cumulative Z-curves did not cross trial sequential monitoring boundaries. Diabetes mellitus occurred more frequently among people in the tacrolimus group compared with the cyclosporin group when the fixed-effect model was applied (RR 4.24, 95% CI 1.58 to 11.40), but no difference was found when the random-effects model was used for analysis (RR 4.43, 95% CI 0.75 to 26.05). Again, trial sequential analysis found that the required information threshold was not reached and cumulative Z-curve did not cross the trial sequential monitoring boundary. No significant difference between treatment groups was observed regarding mortality (RR 1.06, 95% CI 0.75 to 1.49), incidence of acute rejection (RR 0.89, 95% CI 0.77 to 1.03), numbers of infections/100 patient-days (MD -0.15, 95% CI -0.30 to 0.00), cancer (RR 0.21, 95% CI 0.04 to 1.16), kidney dysfunction (RR 1.41, 95% CI 0.93 to 2.14), kidney failure (RR 1.57, 95% CI 0.28 to 8.94), neurotoxicity (RR 7.06, 95% CI 0.37 to 135.19), and hyperlipidaemia (RR 0.60, 95% CI 0.30 to 1.20). Trial sequential analysis showed the required information thresholds were not reached for any of these outcome measures. Tacrolimus may be superior to cyclosporin regarding bronchiolitis obliterans syndrome, lymphocytic bronchitis, treatment withdrawal, and arterial hypertension, but may be inferior regarding development of diabetes. No difference in mortality and acute rejection was observed between patients treated with tacrolimus and cyclosporin. There were few studies comparing tacrolimus and cyclosporin after lung transplantation, and the numbers of patients and events in the included studies were limited. Furthermore, the included studies were deemed to be at high risk of bias. Hence, more RCTs are needed to assess the results of the present review. Such studies ought to be conducted with low risks of systematic errors (bias) and of random errors (play of chance). Output:

We identified three randomised controlled trials that compared tacrolimus with cyclosporin in patients who had received lung transplants. We found no difference in survival or rejection of the donated lungs with the drugs in lung transplant recipients. Tacrolimus seemed better in preventing serious inflammatory lung and airways diseases (bronchiolitis obliterans syndrome and lymphocytic bronchitis), and high blood pressure. Diabetes may occur more often in patients treated with tacrolimus compared with cyclosporin-treated patients. More patients who received tacrolimus continued treatment compared with those treated with cyclosporin. However, these observations should be viewed cautiously because all three trials were flawed in design, the ways they were conducted, and in random errors. There were very few trials found that compared tacrolimus and cyclosporin after lung transplantation, and the numbers of patients and events were low. Better-designed and conducted studies are needed to inform clinical decisions for people who receive lung transplants.

CochranePLS733

***TASK*** the task is to simplify the input abstract of a biomedical literature ***INPUT*** the input is the abstract of a biomedical literature ***OUTPUT*** the output is the simplified abstract for the input abstract of a biomedical literature ***DOCUMENTATION*** ***EXAMPLES*** Input: Only one trial of limited quality compared a biphasic and monophasic preparation. The study examined 533 user cycles of a biphasic pill (500 μg norethindrone plus 35 μg ethinyl estradiol (EE) for 10 days, followed by 1000 μg norethindrone plus 35 μg EE for 11 days; Ortho 10/11) and 481 user cycles of a monophasic contraceptive pill (1500 μg norethindrone acetate plus 30 μg EE daily; Loestrin). The study found no significant differences in intermenstrual bleeding, amenorrhea and study discontinuation due to intermenstrual bleeding between the biphasic and monophasic oral contraceptive pills. Conclusions are limited by the identification of only one trial, the methodological shortcomings of that trial, and the absence of data on accidental pregnancies. However, the trial found no important differences in bleeding patterns between the biphasic and monophasic preparations studied. Since no clear rationale exists for biphasic pills and since extensive evidence is available for monophasic pills, the latter are preferred. Output:

We did a computer search for studies of birth control pills with two phases versus pills with one phase. We also wrote to researchers and manufacturers to find other trials. We included randomized trials in any language. We found only one trial that looked at one-phase versus two-phase birth control pills. The study authors did not report all their methods. Many of the women dropped out of the trial, and the authors did not give the reasons. The pills did not differ in any major ways, including bleeding patterns and the numbers of women who stopped using the pills. This review did not find enough evidence to say if two-phase pills worked any better than one-phase types for birth control, bleeding patterns, or staying on the pill. The one trial report had method problems and lacked data on pregnancies. Therefore, one-phase pills are the better choice, since we have much more evidence for such pills and two-phase pills have no clear reason for use.

CochranePLS734

***TASK*** the task is to simplify the input abstract of a biomedical literature ***INPUT*** the input is the abstract of a biomedical literature ***OUTPUT*** the output is the simplified abstract for the input abstract of a biomedical literature ***DOCUMENTATION*** ***EXAMPLES*** Input: Since the last version of this review no new studies were found. Information was available from six studies with 1342 participants, using a variety of doses of ibuprofen and codeine. In four studies (443 participants) using ibuprofen 400 mg plus codeine 25.6 mg to 60 mg (high dose codeine) 64% of participants had at least 50% maximum pain relief with the combination compared to 18% with placebo. The NNT was 2.2 (95% confidence interval 1.8 to 2.6) (high quality evidence). In three studies (204 participants) ibuprofen plus codeine (any dose) was better than the same dose of ibuprofen (69% versus 55%) but the result was barely significant with a relative benefit of 1.3 (1.01 to 1.6) (moderate quality evidence). In two studies (159 participants) ibuprofen plus codeine appeared to be better than the same dose of codeine alone (69% versus 33%), but no analysis was done. There was no difference between the combination and placebo in the reporting of adverse events in these acute studies (moderate quality evidence). The combination of ibuprofen 400 mg plus codeine 25.6 mg to 60 mg demonstrates good analgesic efficacy. Very limited data suggest that the combination is better than the same dose of either drug alone, and that similar numbers of people experience adverse events with the combination as with placebo. Output:

For the original review, we found six studies with 1342 participants. For this update we searched up to December 2014, but found no additional studies. Ibuprofen 400 mg plus high doses of codeine (25.6 mg to 60 mg) provided effective pain relief for over 6 in 10 (64%) of participants, compared with just under 2 in 10 (18%) of participants with placebo (high quality evidence). Adverse events occurred at similar rates with the ibuprofen/codeine combination and placebo in these single dose studies (moderate quality evidence). No serious adverse events or withdrawals due to adverse events occurred with the combination. It is important not to exceed the recommended dose for this combination painkiller.

CochranePLS735

***TASK*** the task is to simplify the input abstract of a biomedical literature ***INPUT*** the input is the abstract of a biomedical literature ***OUTPUT*** the output is the simplified abstract for the input abstract of a biomedical literature ***DOCUMENTATION*** ***EXAMPLES*** Input: Five trials (1165 participants) were included in the review. There was no statistically significant difference between olanzapine and placebo (either alone or in combination with lithium or valproate) in terms of number of participants who experienced relapse into mood episode (random effects RR 0.68, 95% CI 0.43 to 1.07, p = 0.09; 2 studies, n=460), however restricting the analysis to the trial that compared olanzapine monotherapy versus placebo, there was a statistically significant difference in favour of olanzapine (RR 0.58, 95% CI 0.49 to 0.69, p<0.00001). No statistically significant difference was found between olanzapine and other mood stabilisers (lithium or valproate) in preventing symptomatic relapse for any mood episode, however, olanzapine was more effective than lithium in preventing symptomatic manic relapse (RR 0.59, 95% CI 0.39 to 0.89, p = 0.01; 1 study, n=361). Olanzapine either alone or as adjunctive treatment to mood stabilisers was associated with significantly greater weight gain than placebo. By contrast, olanzapine was associated with a lower rate of manic worsening, but with a higher rate of weight increase and depression than lithium. Though based on a limited amount of information, there is evidence that olanzapine may prevent further mood episodes in patients who have responded to olanzapine during an index manic or mixed episode and who have not previously had a satisfactory response to lithium or valproate. However, notwithstanding these positive results, the current evidence is stronger for lithium as first line maintenance treatment of bipolar disorder. Output:

This review considered the efficacy, acceptability and adverse effects of olanzapine in long-term treatment of bipolar disorder in comparison with placebo or other active drug comparisons. Five trials (1165 participants) met the inclusion criteria and are included in the review. Based on a limited amount of information, olanzapine may prevent further mood episodes (especially manic relapse) in patients who responded to olanzapine during an index manic or mixed episode and who have not previously had a satisfactory response to lithium or valproate. The olanzapine group had significantly fewer patients suffering from insomnia than the placebo group, but a significantly larger number of people suffering from weight gain. When compared with lithium, olanzapine caused more weight gain and depressive symptoms but fewer insomnia and nausea symptoms and a lower rate of manic worsening. However, considering the lack of clear findings of this review, conclusions on efficacy and acceptability of olanzapine compared to placebo, lithium or valproate cannot be made with any degree of confidence

CochranePLS736

***TASK*** the task is to simplify the input abstract of a biomedical literature ***INPUT*** the input is the abstract of a biomedical literature ***OUTPUT*** the output is the simplified abstract for the input abstract of a biomedical literature ***DOCUMENTATION*** ***EXAMPLES*** Input: This review includes two RCTs (154 children aged 32 months to 11 years) of communication interventions for ASD in minimally verbal children compared with a control group (treatment as usual). One RCT used a verbally based intervention (focused playtime intervention; FPI) administered by parents in the home, whereas the other used an alternative and augmentative communication (AAC) intervention (Picture Exchange Communication System; PECS) administered by teachers in a school setting. The FPI study took place in the USA and included 70 participants (64 boys) aged 32 to 82 months who were minimally verbal and had received a diagnosis of ASD. This intervention focused on developing coordinated toy play between child and parent. Participants received 12 in-home parent training sessions for 90 minutes per session for 12 weeks, and they were also invited to attend parent advocacy coaching sessions. This study was funded by the National Institute of Child Health and Human Development, the MIND Institute Research Program and a Professional Staff Congress-City University of New York grant. The PECS study included 84 minimally verbal participants (73 boys) aged 4 to 11 years who had a formal diagnosis of ASD and who were not using PECS beyond phase 1 at baseline. All children attended autism-specific classes or units, and most classes had a child to adult ratio of 2:1. Teachers and parents received PECS training (two-day workshop). PECS consultants also conducted six half-day consultations with each class once per month over five months. This study took place in the UK and was funded by the Three Guineas Trust. Both included studies had high or unclear risk of bias in at least four of the seven 'Risk of bias' categories, with a lack of blinding for participants and personnel being the most problematic area. Using the GRADE approach, we rated the overall quality of the evidence as very low due to risk of bias, imprecision (small sample sizes and wide confidence intervals) and because there was only one trial identified per type of intervention (i.e. verbally based or AAC). Both studies focused primarily on communication outcomes (verbal and non-verbal). One of the studies also collected information on social communication. The FPI study found no significant improvement in spoken communication, measured using the expressive language domain of the Mullen Scale of Early Learning expressive language, at postintervention. However, this study found that children with lower expressive language at baseline (less than 11.3 months age-equivalent) improved more than children with better expressive language and that the intervention produced expressive language gains in some children. The PECS study found that children enrolled in the AAC intervention were significantly more likely to use verbal initiations and PECS symbols immediately postintervention; however, gains were not maintained 10 months later. There was no evidence that AAC improved frequency of speech, verbal expressive vocabulary or children's social communication or pragmatic language immediately postintervention. Overall, neither of the interventions (PECS or FPI) resulted in maintained improvements in spoken or non-verbal communication in most children. Neither study collected information on adverse events, other communication skills, quality of life or behavioural outcomes. There is limited evidence that verbally based and ACC interventions improve spoken and non-verbal communication in minimally verbal children with ASD. A substantial number of studies have investigated communication interventions for minimally verbal children with ASD, yet only two studies met inclusion criteria for this review, and we considered the overall quality of the evidence to be very low. In the study that used an AAC intervention, there were significant gains in frequency of PECS use and verbal and non-verbal initiations, but not in expressive vocabulary or social communication immediately postintervention. In the study that investigated a verbally based intervention, there were no significant gains in expressive language postintervention, but children with lower expressive language at the beginning of the study improved more than those with better expressive language at baseline. Neither study investigated adverse events, other communication skills, quality of life or behavioural outcomes. Future RCTs that compare two interventions and include a control group will allow us to better understand treatment effects in the context of spontaneous maturation and will allow further comparison of different interventions as well as the investigation of moderating factors. Output:

We identified two trials involving 154 minimally verbal children who had ASD (aged 32 months to 11 years). The studies randomly divided participants into those that received a communication intervention and a control group that did not receive the intervention but received treatment as usual in the community. Both studies focused primarily on communication outcomes (verbal and non-verbal). One of the studies also collected information on social communication. Neither study collected information on adverse events, other communication skills, quality of life or behavioural outcomes. One study looked at an alternative and augmentative communication (ACC) intervention (Picture Exchange Communication System; PECS), which teachers gave the children in school. This intervention was conducted over five months and involved teacher training and consultation. PECS is a staged approach where children are taught to exchange a single picture of a desired item or action to another person who then responds to the request. The system progresses toward putting pictures together in sentences and using these sentences in a variety of ways such as commenting and answering questions. This study included 84 participants (73 boys) aged 4 to 11 years and was funded by the Three Guineas Trust. The other study looked at a verbally based intervention (focused playtime intervention; FPI), which is a home-based parent education programme that aims to promote coordinated play with toys between parents and their children. This study included 70 participants (64 boys) aged 32 months to 82 months and was funded by a Clinical and Patient Educators Association grant (HD35470) from the National Institute of Child Health and Human Development, the MIND Institute Research Program, and a Professional Staff Congress-City University of New York grant. There is limited evidence that verbally based and AAC interventions improve spoken and non-verbal communication in minimally verbal children with ASD. Both studies included in this review reported gains in aspects of verbal or non-verbal communication (or both) for some children immediately after the intervention. Neither of the interventions resulted in improvements in verbal or non-verbal communication that were maintained over time for most children. We rated the overall quality of the evidence as very low because we only found two eligible studies, and they involved few participants. Furthermore, both studies had some methodological limitations that increased their risk of bias. There is currently limited evidence that verbally based and ACC interventions improve expressive communication skills in minimally verbal children with ASD aged 32 months to 11 years. Additional trials that use communication interventions and compare the effects of these interventions to a control group are urgently required to build the evidence base.

CochranePLS737

***TASK*** the task is to simplify the input abstract of a biomedical literature ***INPUT*** the input is the abstract of a biomedical literature ***OUTPUT*** the output is the simplified abstract for the input abstract of a biomedical literature ***DOCUMENTATION*** ***EXAMPLES*** Input: Data from 52 trials and 9387 patients were included. The results for modern regimens containing cisplatin favoured chemotherapy in all comparisons and reached conventional levels of significance when used with radical radiotherapy and with supportive care. Trials comparing surgery with surgery plus chemotherapy gave a hazard ratio of 0.87 (13% reduction in the risk of death, equivalent to an absolute benefit of 5% at 5 years). Trials comparing radical radiotherapy with radical radiotherapy plus chemotherapy gave a hazard ratio 0.87 (13% reduction in the risk of death equivalent to an absolute benefit of 4% at 2 years), and trials comparing supportive care with supportive care plus chemotherapy gave a hazard ratio of 0.73 (27% reduction in the risk of death equivalent to a 10% improvement in survival at one year). The essential drugs needed to achieve these effects were not identified. No difference in the size of effect was seen in any subgroup of patients. In all but the radical radiotherapy setting, older trials using long term alkylating agents tended to show a detrimental effect of chemotherapy. This effect reached conventional significance in the adjuvant surgical comparison. At the outset of this meta-analysis there was considerable pessimism about the role of chemotherapy in the treatment of non-small cell lung cancer. These results offer hope of progress and suggest that chemotherapy may have a role in treating this disease. Output:

Trials have tried giving chemotherapy (drugs) after these standard treatments to find out whether it can help people to live longer. This review found that giving chemotherapy after either radiotherapy or supportive care did seem to help patients live longer. Giving chemotherapy after radiotherapy to 1000 patients would mean that an extra 40 patients would be expected to be alive 2 years later, than if the chemotherapy was not given. Giving chemotherapy after supportive care to 1000 patients would mean that 100 more would be expected to be alive 2 years later, than if the chemotherapy was not given. Chemotherapy after surgery may also help patients live longer although the evidence to support this is less clear.

CochranePLS738

***TASK*** the task is to simplify the input abstract of a biomedical literature ***INPUT*** the input is the abstract of a biomedical literature ***OUTPUT*** the output is the simplified abstract for the input abstract of a biomedical literature ***DOCUMENTATION*** ***EXAMPLES*** Input: Ten reports of nine studies were identified following searching and three studies with a total of 233 participants met the inclusion criteria. Overall quality of evidence using the GRADE approach was low, predominantly due to the lack of both participant and researcher blinding in the included studies. The quality of the evidence was further limited as only three small studies contributed to the review findings. A subjective scoring system was used to obtain the symptoms of PTS so it was important that the assessors were blinded to the intervention. One study compared rutosides with placebo, one study compared rutosides with ECS and rutosides plus ECS versus ECS alone, and one study compared rutosides with an alternative venoactive remedy. Occurrence of leg ulceration was not reported in any of the included studies. There was no clear evidence to support a difference in PTS improvement between the rutosides or placebo/no treatment groups (OR 1.29, 95% CI 0.69 to 2.41; 164 participants; 2 studies; low-quality evidence); or between the rutosides and ECS groups (OR 0.80, 95% CI 0.31 to 2.03; 80 participants; 1 study ; low-quality evidence). Results from one small study reported less PTS improvement in the rutosides group compared to an alternative venoactive remedy (OR 0.18, 95% CI 0.04 to 0.94; 29 participants; 1 study; low-quality evidence). There was no clear evidence to support a difference in PTS deterioration when comparing rutosides with placebo/no treatment (OR 0.61, 95% CI 0.19 to 1.90; 80 participants; 1 study); with ECS (OR 0.61, 95% CI 0.19 to 1.90; 80 participants; 1 study); or an alternative venoactive remedy (OR 0.19, 95% CI 0.01 to 4.24; 29 participants; 1 study). No clear evidence of a difference in adverse effects between the rutosides and placebo/no treatment groups was seen ('mild side effects' reported in 7/41 and 5/42 respectively). In the study comparing rutosides with ECS, 2/80 could not tolerate ECS and 6/80 stopped medication due to side effects. The study comparing rutosides with an alternative venoactive remedy did not comment on side effects There was no evidence that rutosides were superior to the use of placebo or ECS. Overall, there is currently limited low-quality evidence that 'venoactive' or 'phlebotonic' remedies such as rutosides reduce symptoms of PTS. Mild side effects were noted in one study. The three studies included in this review provide no evidence to support the use of rutosides in the treatment of PTS. Output:

This review aimed to evaluate the existing literature to see if rutosides were useful for treating PTS. We also investigated whether there were any side effects from the treatment. We searched all existing databases for trials relating to the use of rutosides for the treatment of PTS following DVT (current until 21 August 2018). Two review authors independently assessed the trials for inclusion and extracted results in line with our prescribed criteria. We found three suitable trials, with a total of 233 patients, and six unsuitable trials that were not included in the review. The studies were small and undertaken very differently meaning they could not be combined. The studies used different comparisons with rutosides (placebo (inactive product), compression stockings alone or combined with rutosides, or hidrosmina (a venoactive drug, which acts on the vascular system). They also used different doses of rutosides (900 mg/day to 2000 mg/day). We found no clear evidence from any of the trials that treatment with rutosides improved symptoms and signs of PTS; or that there was any difference in side effects. Occurrence of leg ulceration was not reported in any of the included studies. Overall quality of evidence, using the GRADE approach, was low mainly due to the lack of both participant and researcher blinding. This means both investigators and participants knew what drug they were getting and this can effect the results. The quality of the evidence was further limited as only three small studies contributed to the review findings. A subjective scoring system was used to obtain the symptoms of PTS so it was important that the assessors were blinded to the intervention.

CochranePLS739

***TASK*** the task is to simplify the input abstract of a biomedical literature ***INPUT*** the input is the abstract of a biomedical literature ***OUTPUT*** the output is the simplified abstract for the input abstract of a biomedical literature ***DOCUMENTATION*** ***EXAMPLES*** Input: Due to the level of heterogeneity among studies, studies were divided into two groups; those conducted in Japan and those conducted outside Japan. Study length ranged between 12 and 13 weeks. Meta-analysis of six studies conducted outside Japan showed a mean difference (MD) in weight loss of -0.04 kg (95% CI -0.5 to 0.4; P = 0.88; I2 = 18%; 532 participants). The eight studies conducted in Japan were not similar enough to allow pooling of results and MD in weight loss ranged from -0.2 kg to -3.5 kg (1030 participants) in favour of green tea preparations. Meta-analysis of studies measuring change in body mass index (BMI) conducted outside Japan showed a MD in BMI of -0.2 kg/m2 (95% CI -0.5 to 0.1; P = 0.21; I2 = 38%; 222 participants). Differences among the eight studies conducted in Japan did not allow pooling of results and showed a reduction in BMI ranging from no effect to -1.3 kg/m2 (1030 participants), in favour of green tea preparations over control. Meta-analysis of five studies conducted outside Japan and measuring waist circumference reported a MD of -0.2 cm (95% CI -1.4 to 0.9; P = 0.70; I2 = 58%; 404 participants). Differences among the eight studies conducted in Japan did not allow pooling of results and showed effects on waist circumference ranging from a gain of 1 cm to a loss of 3.3 cm (1030 participants). Meta-analysis for three weight loss studies, conducted outside Japan, with waist-to-hip ratio data (144 participants) yielded no significant change (MD 0; 95% CI -0.02 to 0.01). Analysis of two studies conducted to determine if green tea could help to maintain weight after a period of weight loss (184 participants) showed a change in weight loss of 0.6 to -1.6 kg, a change in BMI from 0.2 to -0.5 kg/m2 and a change in waist circumference from 0.3 to -1.7 cm. In the eight studies that recorded adverse events, four reported adverse events that were mild to moderate, with the exception of two (green tea preparations group) that required hospitalisation (reported as not associated with the intervention). Nine studies reported on compliance/adherence, one study assessed attitude towards eating as part of the health-related quality of life outcome. No studies reported on patient satisfaction, morbidity or cost. Green tea preparations appear to induce a small, statistically non-significant weight loss in overweight or obese adults. Because the amount of weight loss is small, it is not likely to be clinically important. Green tea had no significant effect on the maintenance of weight loss. Of those studies recording information on adverse events, only two identified an adverse event requiring hospitalisation. The remaining adverse events were judged to be mild to moderate. Output:

Green tea has a long history of many uses, one of which is helping overweight people to lose weight and to maintain weight loss. Believed to be able to increase a person's energy output, green tea weight loss preparations are extracts of green tea that contain a higher concentration of ingredients (catechins and caffeine) than the typical green tea beverage prepared from a tea bag and boiling water. This review looked at 15 weight loss studies and three studies measuring weight maintenance where some form of a green tea preparation was given to one group and results compared to a group receiving a control. Neither group knew whether they were receiving the green tea preparation or the control. A total of 1945 participants completed the studies, ranging in length from 12 to 13 weeks. In summary, the loss in weight in adults who had taken a green tea preparation was statistically not significant, was very small and is not likely to be clinically important. Similar results were found in studies that used other ways to measure loss in weight (body mass index, waist circumference). Studies examining the effect of green tea preparations on weight maintenance did not show any benefit compared to the use of a control preparation. Most adverse effects, such as nausea, constipation, abdominal discomfort and increased blood pressure, were judged to be mild to moderate and to be unrelated to the green tea or control intervention. No deaths were reported, although adverse events required hospitalisation. One study attempted to look at health-related quality of life by asking participants about their attitudes towards eating. Nine studies tracked participants' compliance with green tea preparations. Studies did not include any information about the effects of green tea preparations on morbidity, costs or patient satisfaction.

CochranePLS740

***TASK*** the task is to simplify the input abstract of a biomedical literature ***INPUT*** the input is the abstract of a biomedical literature ***OUTPUT*** the output is the simplified abstract for the input abstract of a biomedical literature ***DOCUMENTATION*** ***EXAMPLES*** Input: Two RCTs including a combined total of 40 participants (35 from one study and five from a second study) met the inclusion criteria. Twenty-one participants were randomised to the exercise training group and 19 participants were randomised to the control group. The included studies evaluated the effects of exercise training compared to a control group of no exercise training in people with dust-related ILDs and ARPD. The exercise training programme in both studies was in an outpatient setting for an eight-week period. The risk of bias was low in both studies. There were no reported adverse events of exercise training. Following exercise training, six-minute walk distance (6MWD) increased with a mean difference (MD) of 53.81 metres (m) (95% CI 34.36 to 73.26 m). Improvements were also seen in the domains of health-related quality of life: Chronic Respiratory Disease Questionnaire (CRQ) Dyspnoea domain (MD 2.58, 95% CI 0.72 to 4.44); CRQ Fatigue domain (MD 1.00, 95% CI 0.11 to 1.89); CRQ Emotional Function domain (MD 2.61, 95% CI 0.74 to 4.49); and CRQ Mastery domain (MD 1.51, 95% CI 0.29 to 2.72). Improvements in exercise capacity and health-related quality of life were also evident six months following the intervention period: 6MWD (MD 52.68 m, 95% CI 27.43 to 77.93 m); CRQ Dyspnoea domain (MD 3.03, 95% CI 1.41 to 4.66); CRQ Emotional Function domain (MD 5.57, 95% CI 2.34 to 8.81); and CRQ Mastery domain (MD 2.66, 95% CI 1.08 to 4.23). Exercise training did not result in improvements in the Modified Medical Research Council (MMRC) dyspnoea scale immediately following exercise training or six months following exercise training. The improvements following exercise training were similar in a subgroup of participants with dust-related ILDs and in a subgroup of participants with ARPD compared to the control group, with no statistically significant differences in treatment effects between the subgroups. The evidence examining exercise training in people with non-malignant dust-related respiratory diseases is of very low quality. This is due to imprecision in the results from the small number of trials and the small number of participants, the indirectness of evidence due to a paucity of information on disease severity and the data from one study being from a subgroup of participants, and inconsistency from high heterogeneity in some results. Therefore, although the review findings indicate that an exercise training programme is effective in improving exercise capacity and health-related quality of life in the short-term and at six months follow-up, we remain unsure of these findings due to the very low quality evidence. Larger, high quality trials are needed to determine the strength of these findings. Output:

We included two studies with a total of 40 people (35 from one study and five from a second study). Of these people, 21 participated in exercise training and 19 did not participate in exercise training. All people were men and they were between 55 and 86 years old. Both exercise training programmes included cycling and walking and one programme also included strength training exercises. In both studies, training lasted for eight weeks with people attending two to three sessions per week. Immediately following exercise training, people walked an average of 53.81 metres further in a six-minute walk test than those who did not complete exercise training. Six months following exercise training, people walked 52.68 metres further in a six-minute walk test than those who did not complete exercise training. These improvements in exercise capacity were similar for people with dust-related interstitial lung disease and people with asbestos related pleural disease. Quality of life also improved more in people who exercised compared to those who did not. No one reported experiencing any unwanted effects due to exercise training. The quality of evidence was very low because there were only two studies and 40 people. Therefore, it is likely that these findings will change with more studies in the future. We need bigger studies that can confirm the findings of this Cochrane review.

CochranePLS741

***TASK*** the task is to simplify the input abstract of a biomedical literature ***INPUT*** the input is the abstract of a biomedical literature ***OUTPUT*** the output is the simplified abstract for the input abstract of a biomedical literature ***DOCUMENTATION*** ***EXAMPLES*** Input: Nineteen trials that involved 1496 patients were included in the analysis. There was no heterogeneity of results among the studies in any outcome except diarrhoea. There was no statistically significant difference between the groups in the risk of death (risk difference (RD) 0%; 95% confidence interval (CI) -3% to 2%), risk of deafness (RD -4%; 95% CI -9% to 1%) or risk of treatment failure (RD -1%; 95% CI -4% to 2%). However, there were significantly decreased risks of culture positivity of CSF after 10 to 48 hours (RD -6%; 95% CI -11% to 0%) and statistically significant increases in the risk of diarrhoea between the groups (RD 8%; 95% CI 3% to 13%) with the third generation cephalosporins. The risk of neutropaenia and skin rash were not significantly different between the two groups. However, due to increased antibiotic resistance since the 1980s, the finding of this review should be read with caution. The review shows no clinically important difference between third generation cephalosporins (ceftriaxone or cefotaxime) and conventional antibiotics (ampicillin-chloramphenicol combination, or chloramphenicol alone). Therefore the choice of antibiotic will depend on cost and availability. The antimicrobial resistance pattern against various antibiotics needs to be closely monitored in low- to middle-income countries as well as high-income countries. Output:

This review examined 19 studies with 1496 participants to see whether there is a difference in effectiveness between conventional and newer antibiotics. This review found no differences. Adverse effects in both approaches were similar, except for diarrhoea, which was more common in the cephalosporin group. Only three studies dealt with adults; the remaining studies recruited participants aged 15 years and younger. Therefore, we believe that the results probably pertain more to children. Conventional and newer antibiotics seem reasonable options for initial, immediate treatment. The choice may depend on availability, affordability and local policies.

CochranePLS742

***TASK*** the task is to simplify the input abstract of a biomedical literature ***INPUT*** the input is the abstract of a biomedical literature ***OUTPUT*** the output is the simplified abstract for the input abstract of a biomedical literature ***DOCUMENTATION*** ***EXAMPLES*** Input: We included 14 RCTs (2050 participants) in this review. One trial on Solidago chilensis M. (Brazilian arnica) (20 participants) found very low quality evidence of reduction in perception of pain and improved flexibility with application of Brazilian arnica-containing gel twice daily as compared to placebo gel. Capsicum frutescens cream or plaster probably produces more favourable results than placebo in people with chronic LBP (three trials, 755 participants, moderate quality evidence). Based on current evidence, it is not clear whether topical capsicum cream is more beneficial for treating people with acute LBP compared to placebo (one trial, 40 participants, low quality evidence). Another trial found equivalence of C. frutescens cream to a homeopathic ointment (one trial, 161 participants, very low quality evidence). Daily doses of Harpagophytum procumbens (devil's claw), standardized to 50 mg or 100 mg harpagoside, may be better than placebo for short-term improvements in pain and may reduce use of rescue medication (two trials, 315 participants, low quality evidence). Another H. procumbens trial demonstrated relative equivalence to 12.5 mg per day of rofecoxib (Vioxx®) but was of very low quality (one trial, 88 participants, very low quality). Daily doses of Salix alba (white willow bark), standardized to 120 mg or 240 mg salicin, are probably better than placebo for short-term improvements in pain and rescue medication (two trials, 261 participants, moderate quality evidence). An additional trial demonstrated relative equivalence to 12.5 mg per day of rofecoxib (one trial, 228 participants) but was graded as very low quality evidence. S. alba minimally affected platelet thrombosis versus a cardioprotective dose of acetylsalicylate (one trial, 51 participants). One trial (120 participants) examining Symphytum officinale L. (comfrey root extract) found low quality evidence that a Kytta-Salbe comfrey extract ointment is better than placebo ointment for short-term improvements in pain as assessed by VAS. Aromatic lavender essential oil applied by acupressure may reduce subjective pain intensity and improve lateral spine flexion and walking time compared to untreated participants (one trial, 61 participants,very low quality evidence). No significant adverse events were noted within the included trials. C. frutescens (Cayenne) reduces pain more than placebo. Although H. procumbens, S. alba, S. officinale L., S. chilensis, and lavender essential oil also seem to reduce pain more than placebo, evidence for these substances was of moderate quality at best. Additional well-designed large trials are needed to test these herbal medicines against standard treatments. In general, the completeness of reporting in these trials was poor. Trialists should refer to the CONSORT statement extension for reporting trials of herbal medicine interventions. Output:

Researchers from the Cochrane Collaboration examined the evidence available up to August 5, 2013. Fourteen studies tested six herbal medications and included 2050 adults with non-specific acute or chronic LBP. Two oral herbal medications,Harpagophytum procumbens(devil's claw) andSalix alba(white willow bark), were compared to placebo (fake or sham pills) or to rofecoxib (Vioxx®). Three topical creams, plasters, or gels,Capsicum frutescens(cayenne),Symphytum officinaleL. (comfrey), andSolidago chilensis(Brazilian arnica), were compared to placebo creams or plasters and a homeopathic gel. One essential oil, lavender, was compared to no treatment. The average age of people included in the trials was 52 years and studies usually lasted three weeks. Devil's claw, in a standardized daily dose of 50 mg or 100 mg harpagoside, may reduce pain more than placebo; a standardized daily dose of 60 mg reduced pain about the same as a daily dose of 12.5 mg of Vioxx®. While willow bark, in a standardized daily dose of 120 mg and 240 mg of salicin reduced pain more than placebo; a standardized daily dose of 240 mg reduced pain about the same as a daily dose of 12.5 mg of Vioxx® (a non-steroidal, anti-inflammatory drug). Cayenne was tested in several forms: in plaster form, it reduced pain more than placebo and about the same as the homeopathic gel Spiroflor SLR. Two other ointment-based medications,S. officinaleandS. chilensisappeared to reduce perception of pain more than placebo creams. Lavender essential oil applied by acupressure appeared effective in reducing pain and improving flexibility compared to conventional treatment. Adverse effects were reported, but appeared to be primarily confined to mild, transient gastrointestinal complaints or skin irritations. Most included trials were at low risk of bias and the quality of the evidence was mainly very low to moderate. A moderate grade of evidence was only found forC. frutescens. Trials only tested the effects of short term use (up to six weeks). Authors of eight of the included trials had a potential conflict of interest and four other authors did not disclose conflicts of interest. Vioxx® has been withdrawn from the market because of adverse effects, so all three substances should be compared to readily-available pain medications, such as nonsteroidal anti-inflammatory drugs (NSAIDs) and acetaminophen, for relative effectiveness and safety. Low to moderate quality evidence shows that four herbal medicines may reduce pain in acute and chronic LBP in the short-term and have few side effects. There is no evidence yet that any of these substances are safe or efficacious for long-term use. Large, well-designed trials are needed to further test the efficacy of these interventions.

CochranePLS743

***TASK*** the task is to simplify the input abstract of a biomedical literature ***INPUT*** the input is the abstract of a biomedical literature ***OUTPUT*** the output is the simplified abstract for the input abstract of a biomedical literature ***DOCUMENTATION*** ***EXAMPLES*** Input: Ten studies were included. Two studies assessed the effect of different ways of screening submissions, one study compared open versus blinded peer review and three studies assessed the effect of different decision making procedures. Four studies considered agreement of the results of peer review processes as the outcome measure. Screening procedures appear to have little effect on the result of the peer review process. Open peer reviewers behave differently from blinded ones. Studies on decision-making procedures gave conflicting results. Agreement among reviewers and between different ways of assigning proposals or eliciting opinions was usually high. There is little empirical evidence on the effects of grant giving peer review. No studies assessing the impact of peer review on the quality of funded research are presently available. Experimental studies assessing the effects of grant giving peer review on importance, relevance, usefulness, soundness of methods, soundness of ethics, completeness and accuracy of funded research are urgently needed. Practices aimed to control and evaluate the potentially negative effects of peer review should be implemented meanwhile. Output:

This review was carried out in order to assess the effect of the various processes of peer review on the quality of funded research. Only ten studies were included and described in the review. We were unable to find comparative studies assessing the actual effect of peer review procedures on the quality of the funded researchThere is little empirical evidence on the effects of grant giving peer review. Experimental studies assessing the effects of grant giving peer-review on importance, relevance, usefulness, soundness of methods, soundness of ethics, completeness and accuracy of funded research are urgently needed. Practices aimed to control and evaluate the potentially negative effects of peer review should be implemented meanwhile.

CochranePLS744

***TASK*** the task is to simplify the input abstract of a biomedical literature ***INPUT*** the input is the abstract of a biomedical literature ***OUTPUT*** the output is the simplified abstract for the input abstract of a biomedical literature ***DOCUMENTATION*** ***EXAMPLES*** Input: We included seven RCTs with a total of 1202 participants. Overall, we judged the risk of bias as low in four studies and high in three studies. We are uncertain whether Daikenchuto reduced time to first flatus (mean difference (MD) -11.32 hours, 95% confidence interval (CI) -17.45 to -5.19; two RCTs, 83 participants; very low-quality evidence), or time to first bowel movement (MD -9.44 hours, 95% CI -22.22 to 3.35; four RCTs, 500 participants; very low-quality evidence) following surgery. There was little or no difference in time to resumption of regular solid food following surgery (MD 3.64 hours, 95% CI -24.45 to 31.74; two RCTs, 258 participants; low-quality evidence). There were no adverse events in either arm of the five RCTs that reported on drug-related adverse events (risk difference (RD) 0.00, 95% CI -0.02 to 0.02, 568 participants, low-quality evidence). We are uncertain of the effect of Daikenchuto on patient satisfaction (MD 0.09, 95% CI -0.19 to 0.37; one RCT, 81 participants; very low-quality of evidence). There was little or no difference in the incidence of any re-interventions for postoperative ileus before leaving hospital (risk ratio (RR) 0.99, 95% CI 0.06 to 15.62; one RCT, 207 participants; moderate-quality evidence), or length of hospital stay (MD -0.49 days, 95% CI -1.21 to 0.22; three RCTs, 292 participants; low-quality evidence). Evidence from current literature was unclear whether Daikenchuto reduced postoperative ileus in patients undergoing elective abdominal surgery, due to the small number of participants in the meta-analyses. Very low-quality evidence means we are uncertain whether Daikenchuto improved postoperative flatus or bowel movement. Further well-designed and adequately powered studies are needed to assess the efficacy of Daikenchuto. Output:

We included seven studies (1202 participants), in which the participants were allocated at random (by chance alone) to receive one of several clinical interventions, where Daikenchuto was compared with any other medicine, placebo, or no treatment. The searches were performed 3 July 2017. We evaluated: time from completion of abdominal surgery to first flatus, time to first bowel movement, time to resumption of regular solid food intake, adverse events related to Daikenchuto, patient satisfaction, re-interventions for postoperative ileus before leaving hospital, and length of hospital stay. Overall, there were a small number of participants included in each analysis. We could not fully investigate time from surgery to first flatus, to first bowel movement, or to resumption of regular solid food intake, any medicine-related adverse events, patient satisfaction, any re-interventions for postoperative ileus before leaving hospital, or length of hospital stay. We considered the quality of evidence for all presented outcomes as moderate to very low. Based upon our findings, it was uncertain whether Daikenchuto accelerated post-surgical bowel motility in persons undergoing abdominal surgery, and thus, unclear whether Daikenchuto reduced postoperative ileus.

CochranePLS745

***TASK*** the task is to simplify the input abstract of a biomedical literature ***INPUT*** the input is the abstract of a biomedical literature ***OUTPUT*** the output is the simplified abstract for the input abstract of a biomedical literature ***DOCUMENTATION*** ***EXAMPLES*** Input: We found seven small Chinese studies (449 participants), six of which provided useable data for meta-analysis. No study compared Morita therapy with an inactive control. Unclear randomisation methods, lack of blinding and low quality reporting of outcomes were common in the included studies. We graded the overall risk of bias as high and the quality of the evidence as very low. Two social phobia studies (75 outpatients) directly compared Morita therapy with pharmacological therapy. In this comparison, the pooled RR of global state was 1.85 (95% CI 1.27 to 2.69) and the NNTB was 3 (95% CI 2 to 5), indicating a significant difference between groups favouring Morita therapy in the short term (up to 12 weeks' post-treatment). Data regarding drop-outs was insufficient and no description of adverse effects was provided. We graded the quality of the evidence for this comparison as very low, mainly due to high risk of bias in the studies and insufficient information in the results. Four studies (288 inpatients) investigated the effect of Morita therapy plus pharmacological therapy versus pharmacological therapy alone, three studies for the treatment of obsessive-compulsive disorder (OCD) (228 participants) and one study for generalised anxiety disorder (60 participants). One of the OCD studies reported incomplete data of global state while the outcome of global state was missing in the other three studies. There was no significant difference between groups for drop-outs for any reason in two OCD studies in the short term (RR 1.76, 95% CI 0.47 to 6.67; I2 = 44%). Information pertaining to drop-outs for adverse effects was unclear. We rated the risk of bias of this comparison as high. We graded the quality of the evidence as very low. The evidence base on Morita therapy for anxiety disorders was limited. All studies included in this review were conducted in China, and the results may not be applicable to Western countries. These included studies were small, provided insufficient information about drop-outs and adverse effects, and contained considerable risk of bias. Therefore, we graded the evidence as very low quality and were unable to draw conclusions on the effectiveness of Morita therapy in the treatment of anxiety disorders. Well-designed future studies that employ adequate allocation concealment, recruit large sample sizes, report drop-outs and adverse effects, and report outcomes clearly and consistently are needed to establish the effectiveness of Morita therapy for anxiety disorders. Output:

We searched scientific databases for randomised controlled trials (clinical studies where people are randomly put into one of two or more treatment groups) that compared Morita therapy with treatments with medicines or other psychological therapies (e.g. talking therapies), no treatment or wait list control (where people are waiting to receive a treatment) of adults with anxiety disorders. The evidence was current to December 2014. We found seven small Chinese studies with 449 participants to include in the review. Six of the seven studies provided useable data for us to analyse; they assessed Morita therapy for generalised anxiety disorder (a long-term illness that causes people to feel anxious about a wide range of situations and issues; one study), social phobia (a persistent fear about social situations and being around people; two studies) and obsessive-compulsive disorder (where a person has obsessive thoughts and repetitive behaviours; three studies). However, these studies were small, imprecise and contained considerable risks of bias, so we were unable to draw conclusions on the effectiveness of Morita therapy in the treatment of anxiety disorders. The review highlighted the need for high-quality studies to assess the efficacy of Morita therapy on anxiety disorders.

CochranePLS746

***TASK*** the task is to simplify the input abstract of a biomedical literature ***INPUT*** the input is the abstract of a biomedical literature ***OUTPUT*** the output is the simplified abstract for the input abstract of a biomedical literature ***DOCUMENTATION*** ***EXAMPLES*** Input: Seventeen small trials were included, involving a total of 366 participants. Study quality was low. The temperature, duration and frequency of cold-water immersion varied between the different trials as did the exercises and settings. The majority of studies failed to report active surveillance of pre-defined adverse events. Fourteen studies compared cold-water immersion with passive intervention. Pooled results for muscle soreness showed statistically significant effects in favour of cold-water immersion after exercise at 24 hour (standardised mean difference (SMD) -0.55, 95% CI -0.84 to -0.27; 10 trials), 48 hour (SMD -0.66, 95% CI -0.97 to -0.35; 8 trials), 72 hour (SMD -0.93; 95% CI -1.36 to -0.51; 4 trials) and 96 hour (SMD -0.58; 95% CI -1.00 to -0.16; 5 trials) follow-ups. These results were heterogeneous. Exploratory subgroup analyses showed that studies using cross-over designs or running based exercises showed significantly larger effects in favour of cold-water immersion. Pooled results from two studies found cold-water immersion groups had significantly lower ratings of fatigue (MD -1.70; 95% CI -2.49 to -0.90; 10 units scale, best to worst), and potentially improved ratings of physical recovery (MD 0.97; 95% CI -0.10 to 2.05; 10 units scale, worst to best) immediately after the end of cold-water immersion. Five studies compared cold-water with contrast immersion. Pooled data for pain showed no evidence of differences between the two groups at four follow-up times (immediately, 24, 48 and 72 hours after treatment). Similar findings for pooled analyses at 24, 48 and 72 hour follow-ups applied to the four studies comparing cold-water with warm-water immersion. Single trials only compared cold-water immersion with respectively active recovery, compression and a second dose of cold-water immersion at 24 hours. There was some evidence that cold-water immersion reduces delayed onset muscle soreness after exercise compared with passive interventions involving rest or no intervention. There was insufficient evidence to conclude on other outcomes or for other comparisons. The majority of trials did not undertake active surveillance of pre-defined adverse events. High quality, well reported research in this area is required. Output:

Our review included 17 small trials, involving a total of 366 participants. Study quality was low. Fourteen trials compared cold-water immersion applied after exercise with 'passive' treatment involving rest or no treatment. The temperature, duration and frequency of cold-water immersion varied between the different trials as did the exercises and settings. There was some evidence that cold-water immersion reduces muscle soreness at 24, 48, 72 and even at 96 hours after exercise compared with 'passive' treatment. Limited evidence from four trials indicated that participants considered that cold-water immersion improved recovery/reduced fatigue immediately afterwards. Most of the trials did not consider complications relating to cold-water immersion and so we cannot say whether these are a problem. There were only limited data available for other comparisons of cold-water immersion versus warm or contrasting (alternative warm/cold) water immersion, light jogging, and compression stockings. None of these showed important differences between the interventions being compared. While the evidence shows that cold-water immersion reduces delayed onset muscle soreness after exercise, the optimum method of cold-water immersion and its safety are not clear.

CochranePLS747

***TASK*** the task is to simplify the input abstract of a biomedical literature ***INPUT*** the input is the abstract of a biomedical literature ***OUTPUT*** the output is the simplified abstract for the input abstract of a biomedical literature ***DOCUMENTATION*** ***EXAMPLES*** Input: Three studies (generating four eligible study comparisons) were included. One study is ongoing. There was no statistically significant difference between azithromycin and benzathine penicillin treatment in the odds of cure (OR 1.04, 95% CI 0.69 to 1.56); nor any difference at three months (OR 0.97, 95% CI 0.62 to 1.50), six months (OR 1.09, 95% CI 0.76 to 1.54) or nine months (OR 1.45, 95% CI 0.46 to 6.42). Subgroup analysis by primary and latent syphilis and by dose of azithromycin (2 g and 4 g) did not explain the variation between the study results. The reporting of computed mild to tolerated adverse events, from two included trials, indicated no statistically significant difference between azithromycin and benzathine penicillin (OR 1.43, 95% CI 0.42 to 4.95), although with a high level of heterogeneity (P = 0.05, I2 = 74%). Differences in the odds of cure did not reach statistical significance when azithromycin was compared with benzathine penicillin for the treatment of early syphilis. No definitive conclusion can be made regarding the relative safety of benzathine penicillin G and azithromycin for early syphilis. Further studies on the utility of benzathine penicillin G for early syphilis are warranted. Output:

This review of three trials failed to identify a difference between azithromycin and benzathine penicillin G for early syphilis in the odds of cure rate, with the result being too imprecise to confidently rule out the superiority of either treatment option. Although gastrointestinal adverse effects were more common in the participants on azithromycin, than in those given benzathine penicillin G, the difference with benzathine penicillin did not reach statistical significance. More research is required in this area.

CochranePLS748

***TASK*** the task is to simplify the input abstract of a biomedical literature ***INPUT*** the input is the abstract of a biomedical literature ***OUTPUT*** the output is the simplified abstract for the input abstract of a biomedical literature ***DOCUMENTATION*** ***EXAMPLES*** Input: Nine studies enrolling 645 infants met inclusion criteria. There were substantial methodological concerns in all studies comparing an opiate with a sedative. Two small studies comparing different opiates were of good methodology. Opiate (morphine) versus supportive care (one study): A reduction in time to regain birth weight and duration of supportive care and a significant increase in hospital stay was noted. Opiate versus phenobarbitone (four studies): Meta-analysis found no significant difference in treatment failure. One study reported opiate treatment resulted in a significant reduction in treatment failure in infants of mothers using only opiates. One study reported a significant reduction in days treatment and admission to the nursery for infants receiving morphine. One study reported a reduction in seizures, of borderline statistical significance, with the use of opiate. Opiate versus diazepam (two studies): Meta-analysis found a significant reduction in treatment failure with the use of opiate. Different opiates (six studies): there is insufficient data to determine safety or efficacy of any specific opiate compared to another opiate. Opiates compared to supportive care may reduce time to regain birth weight and duration of supportive care but increase duration of hospital stay. When compared to phenobarbitone, opiates may reduce the incidence of seizures but there is no evidence of effect on treatment failure. One study reported a reduction in duration of treatment and nursery admission for infants on morphine. Compared to diazepam, opiates reduce the incidence of treatment failure. A post-hoc analysis generates the hypothesis that initial opiate treatment may be restricted to infants of mothers who used opiates only. In view of the methodologic limitations of the included studies the conclusions of this review should be treated with caution. Output:

Trials of opiates compared to sedatives or other non-pharmacological treatments have generally been of poor quality. Individual trials have reported that using an opiate compared to phenobarbitone may reduce the incidence of seizures, duration of treatment and nursery admission rate. However, no overall effect was found on treatment failure rate. When compared to diazepam, opiates reduced the incidence of treatment failure. Opiates such as morphine or dilute tincture of opium should probably be used as initial treatment for opiate withdrawal in newborn infants.

CochranePLS749

***TASK*** the task is to simplify the input abstract of a biomedical literature ***INPUT*** the input is the abstract of a biomedical literature ***OUTPUT*** the output is the simplified abstract for the input abstract of a biomedical literature ***DOCUMENTATION*** ***EXAMPLES*** Input: We included eleven randomised controlled trials involving 444 people, none of which were of high methodological quality. A large number of trials were excluded, mainly because of their non-randomised design. The randomisation procedures were either unclear or inadequate, using coin tossing, alternation, drawing lots or cards, or open tables of random numbers. The interventions and outcomes were too heterogeneous to be entered in a meta-analysis. Most trials examined a short-term effect up to six months after final treatment. There appeared to be a short-term effect of approximately 50% hair reduction with alexandrite and diode lasers up to six months after treatment, whereas little evidence was obtained for an effect of intense pulsed light, neodymium:YAG or ruby lasers. Long-term hair removal was not documented with any treatment. Pain, skin redness, swelling, burned hairs and pigmentary changes were infrequently reported adverse effects. Some treatments lead to temporary short-term hair removal. High quality research is needed on the effect of laser and photoepilation. Output:

Eleven randomised controlled trials were included in the review, none of which were of high quality. A large number of trials were excluded, mainly because of their non-randomised designs. There appeared to be a short-term effect of approximately 50% hair reduction with alexandrite and diode lasers up to six months after treatment, whereas there was little evidence for an effect with intense pulsed light, neodymium:YAG or ruby lasers. Long-term hair removal was not recorded for any treatment. Infrequently reported adverse effects were pain, skin redness, swelling, burned hairs and pigmentary changes.

CochranePLS750

***TASK*** the task is to simplify the input abstract of a biomedical literature ***INPUT*** the input is the abstract of a biomedical literature ***OUTPUT*** the output is the simplified abstract for the input abstract of a biomedical literature ***DOCUMENTATION*** ***EXAMPLES*** Input: We identified 10 trials that met the inclusion criteria. The interventions involved brief training of basic-level health workers or mothers, and most provided the antimalarial for free or at a highly subsidized cost. In eight of the studies, fevers were treated presumptively without parasitological confirmation with microscopy or a rapid diagnostic test (RDT). Two studies trained community health workers to use RDTs as a component of community management of fever. Home- or community-based strategies probably increase the number of people with fever who receive an appropriate antimalarial within 24 hours (RR 2.27, 95% CI 1.79 to 2.88 in one trial; RR 9.79, 95% CI 6.87 to 13.95 in a second trial; 3099 participants, moderate quality evidence). They may also reduce all-cause mortality, but to date this has only been demonstrated in rural Ethiopia (RR 0.58, 95% CI 0.44 to 0.77, one trial, 13,677 participants, moderate quality evidence). Hospital admissions in children were reported in one small trial from urban Uganda, with no effect detected (437 participants, very low quality evidence). No studies reported on severe malaria. For parasitaemia prevalence, the study from urban Uganda demonstrated a reduction in community parasite prevalence (RR 0.22, 95% CI 0.08 to 0.64, 365 participants), but a second study in rural Burkina Faso did not (1006 participants). Home- or community-based programmes may have little or no effect on the prevalence of anaemia (three trials, 3612 participants, low quality evidence). None of the included studies reported on adverse effects of using home- or community-based programmes for treating malaria. In two studies which trained community health workers to only prescribe antimalarials after a positive RDT, prescriptions of antimalarials were reduced compared to the control group where community health workers used clinical diagnosis (RR 0.39, 95% CI 0.18 to 0.84, two trials, 5944 participants, moderate quality evidence). In these two studies, mortality and hospitalizations remained very low in both groups despite the lower use of antimalarials (two trials, 5977 participants, low quality evidence). Home- or community-based interventions which provide antimalarial drugs free of charge probably improve prompt access to antimalarials, and there is moderate quality evidence from rural Ethiopia that they may impact on childhood mortality when implemented in appropriate settings. Programmes which treat all fevers presumptively with antimalarials lead to overuse antimalarials, and potentially undertreat other causes of fever such as pneumonia. Incorporating RDT diagnosis into home- or community-based programmes for malaria may help to reduce this overuse of antimalarials, and has been shown to be safe under trial conditions. Output:

We examined the research published up to 12 September 2012 and we identified 10 studies for inclusion in this systematic review. In eight studies all people with fever were treated with antimalarial drugs by community health workers and in two studies community health workers were trained to confirm malaria in people using RDTs. Home- or community-based strategies probably increase the number of people with fever that receive an effective antimalarial within 24 hours (moderate quality evidence). They probably reduce the number of deaths in areas where malaria is common and there is poor access to health services (moderate quality evidence) but to date this has only been demonstrated in one study from a rural setting in Ethiopia. We do not know whether they reduce the number of people requiring admission to hospital (very low quality evidence), or the number of people with evidence of malaria infection in their blood (very low quality evidence). Home- or community-based programmes may have little or no effect on the number of people with anaemia (low quality evidence). None of the included studies reported on adverse effects of using home- or community-based programmes for treating malaria. Use of RDTs instead of clinical diagnosis in home- or community-based programmes for treating malaria probably reduces the overuse of antimalarials drugs (moderate quality evidence) and may have little or no difference upon the number of childhood deaths (low quality evidence), the number of children with evidence of malaria infection in their blood (low quality evidence), or the need for children to be admitted to hospital (low quality evidence) compared to use of clinical diagnosis.

CochranePLS751

***TASK*** the task is to simplify the input abstract of a biomedical literature ***INPUT*** the input is the abstract of a biomedical literature ***OUTPUT*** the output is the simplified abstract for the input abstract of a biomedical literature ***DOCUMENTATION*** ***EXAMPLES*** Input: Seventeen studies were included. One study comparing sclerotherapy to GCS in pregnancy found that sclerotherapy improved symptoms and cosmetic appearance. Three studies comparing sodium tetradecyl sulphate (STD) to alternative sclerosants found no significant differences in outcome or complication rates; another study found that sclerotherapy with STD led to improved cosmetic appearance compared with polidocanol, although there was no difference in symptoms. Sclerosant plus local anaesthetic reduced the pain from injection (one study) but had no other effects. Two studies compared foam- to conventional sclerotherapy; one found no difference in failure rate or recurrent varicose veins; a second showed short-term benefit from foam in terms of elimination of venous reflux. The recanalisation rate was no different between the two treatments. One study comparing Molefoam and Sorbo pad pressure dressings found no difference in erythema or successful sclerosis. The degree and duration of elastic compression had no significant effect on varicose vein recurrence rates, cosmetic appearance or symptomatic improvement. Evidence from RCTs suggests that the choice of sclerosant, dose, formulation (foam versus liquid), local pressure dressing, degree and length of compression have no significant effect on the efficacy of sclerotherapy for varicose veins. The evidence supports the current place of sclerotherapy in modern clinical practice, which is usually limited to treatment of recurrent varicose veins following surgery and thread veins. Surgery versus sclerotherapy is the subject of a further Cochrane Review. Output:

Seventeen randomised controlled trials involving over 3,300 people were included in the review. One study comparing sclerotherapy to compression stockings in pregnancy found that sclerotherapy improved symptoms and cosmetic appearance. There was no overall benefit from using alternative agents to STD (four trials), or any evidence that a foam is superior to liquid (two trials). Adding local anaesthetic to the sclerosing agent did reduce the pain of injection in one study. Neither the type, nor duration of elastic compression (seven studies) or type of pressure pad (one study) after sclerotherapy had any clear effect on the effectiveness of sclerotherapy, on varicose vein recurrence rates, cosmetic appearance or symptomatic improvement, or on complications. Many of the included studies took place in the 1980s and there is very limited evidence on which to assess the merits of sclerotherapy for treatment of varicose veins or comparing graduated compression stockings to sclerotherapy. There were no controlled trials comparing sclerotherapy for thread veins with either laser treatment or simple observation; hypertonic dextrose had similar efficacy in terms of sclerosis to STD in one study.

CochranePLS752

***TASK*** the task is to simplify the input abstract of a biomedical literature ***INPUT*** the input is the abstract of a biomedical literature ***OUTPUT*** the output is the simplified abstract for the input abstract of a biomedical literature ***DOCUMENTATION*** ***EXAMPLES*** Input: We found six RCTs eligible for inclusion for three drugs: melatonin (222 participants, four studies, but only two yielded data on our primary sleep outcomes suitable for meta-analysis), trazodone (30 participants, one study), and ramelteon (74 participants, one study, no peer-reviewed publication, limited information available). The participants in the trazodone study and almost all participants in the melatonin studies had moderate-to-severe dementia due to Alzheimer's disease (AD); those in the ramelteon study had mild-to-moderate AD. Participants had a variety of common sleep problems at baseline. All primary sleep outcomes were measured using actigraphy. In one study of melatonin, drug treatment was combined with morning bright light therapy. Only two studies made a systematic assessment of adverse effects. Overall, the evidence was at low risk of bias, although there were areas of incomplete reporting, some problems with participant attrition, related largely to poor tolerance of actigraphy and technical difficulties, and a high risk of selective reporting in one trial that contributed very few participants. The risk of bias in the ramelteon study was unclear due to incomplete reporting. We found no evidence that melatonin, at doses up to 10 mg, improved any major sleep outcome over 8 to 10 weeks in patients with AD who were identified as having a sleep disturbance. We were able to synthesize data for two of our primary sleep outcomes: total nocturnal sleep time (mean difference (MD) 10.68 minutes, 95% CI -16.22 to 37.59; N = 184; two studies), and the ratio of daytime sleep to night-time sleep (MD -0.13, 95% CI -0.29 to 0.03; N = 184; two studies). From single studies, we found no difference between melatonin and placebo groups for sleep efficiency, time awake after sleep onset, or number of night-time awakenings. From two studies, we found no effect of melatonin on cognition or performance of activities of daily living (ADL). No serious adverse effects of melatonin were reported in the included studies. We considered this evidence to be of low quality. There was low-quality evidence that trazodone 50 mg given at night for two weeks improved total nocturnal sleep time (MD 42.46 minutes, 95% CI 0.9 to 84.0; N = 30; one study), and sleep efficiency (MD 8.53%, 95% CI 1.9 to 15.1; N = 30; one study) in patients with moderate-to-severe AD, but it did not affect the amount of time spent awake after sleep onset (MD -20.41, 95% CI -60.4 to 19.6; N = 30; one study), or the number of nocturnal awakenings (MD -3.71, 95% CI -8.2 to 0.8; N = 30; one study). No effect was seen on daytime sleep, cognition, or ADL. No serious adverse effects of trazodone were reported. Results from a phase 2 trial investigating ramelteon 8 mg administered at night were available in summary form in a sponsor's synopsis. Because the data were from a single, small study and reporting was incomplete, we considered this evidence to be of low quality in general terms. Ramelteon had no effect on total nocturnal sleep time at one week (primary outcome) or eight weeks (end of treatment) in patients with mild-to-moderate AD. The synopsis reported few significant differences from placebo for any sleep, behavioural, or cognitive outcomes; none were likely to be of clinical significance. There were no serious adverse effects from ramelteon. We discovered a distinct lack of evidence to help guide drug treatment of sleep problems in dementia. In particular, we found no RCTs of many drugs that are widely prescribed for sleep problems in dementia, including the benzodiazepine and non-benzodiazepine hypnotics, although there is considerable uncertainty about the balance of benefits and risks associated with these common treatments. From the studies we identified for this review, we found no evidence that melatonin (up to 10mg) helped sleep problems in patients with moderate to severe dementia due to AD. There was some evidence to support the use of a low dose (50 mg) of trazodone, although a larger trial is needed to allow a more definitive conclusion to be reached on the balance of risks and benefits. There was no evidence of any effect of ramelteon on sleep in patients with mild to moderate dementia due to AD. This is an area with a high need for pragmatic trials, particularly of those drugs that are in common clinical use for sleep problems in dementia. Systematic assessment of adverse effects is essential. Output:

We searched the medical literature up to March 2016 for all randomised trials that compared any medicine used for treating sleep problems in people with dementia with a fake medicine (placebo). We found six trials (326 participants) that investigated three medicines: melatonin (four trials), trazodone (one trial), and ramelteon (one trial). The ramelteon trial and one melatonin trial were commercially funded; the other trials had non-commercial funding sources. Limited information was available for the ramelteon trial, and it came from the trial's sponsor. Overall, the evidence was of low quality, meaning that further research is very likely to affect the results. Participants in the melatonin and trazodone trials almost all had moderate to severe dementia, while those in the ramelteon trial had mild to moderate dementia. The four melatonin trials had a total of 222 participants. From the evidence we found, we could be moderately confident that melatonin did not improve sleep in patients with dementia due to Alzheimer's disease. No serious harms were reported. The trazodone trial had 30 participants. Because it was so small, we could only have limited confidence in its results. It showed that a low dose of the sedative anti-depressant trazodone, 50 mg, given at night for two weeks, increased the total time spent asleep each night by an average of 43 minutes. This medicine improved sleep efficiency (the percentage of time in bed spent sleeping), but had no effect on the time spent awake after falling asleep, or on the number of times the participants woke up at night. No serious harms were reported. The ramelteon trial had 74 participants. The limited information available did not provide any evidence that ramelteon was better than placebo. There were no serious harms caused by ramelteon. The trials did not report on some of the outcomes which interested us, including quality of life and the impact on carers. Although we searched for them, we were unable to find any trials of other sleeping medications that are commonly prescribed to people with dementia. All of the participants had dementia due to Alzheimer's disease, although sleep problems are also common in other forms of dementia. We concluded that there is very little evidence to guide decisions about medicines for sleeping problems in dementia. Any medicine used should be used cautiously, with a careful assessment of how well it works, and its side effects in individual patients. More trials are needed to inform medical practice, with a particular need for trials investigating medicines that are commonly used for sleep problems in dementia. It is essential that trials include careful assessment of side effects.

CochranePLS753

***TASK*** the task is to simplify the input abstract of a biomedical literature ***INPUT*** the input is the abstract of a biomedical literature ***OUTPUT*** the output is the simplified abstract for the input abstract of a biomedical literature ***DOCUMENTATION*** ***EXAMPLES*** Input: We included 26 RCTs (total participants = 6070), nine of which had a low risk of bias. Approximately two-thirds of the included studies (N = 18) were not evaluated in the previous review. In general, there is high quality evidence that SMT has a small, statistically significant but not clinically relevant, short-term effect on pain relief (MD: -4.16, 95% CI -6.97 to -1.36) and functional status (SMD: -0.22, 95% CI -0.36 to -0.07) compared to other interventions. Sensitivity analyses confirmed the robustness of these findings. There is varying quality of evidence (ranging from low to high) that SMT has a statistically significant short-term effect on pain relief and functional status when added to another intervention. There is very low quality evidence that SMT is not statistically significantly more effective than inert interventions or sham SMT for short-term pain relief or functional status. Data were particularly sparse for recovery, return-to-work, quality of life, and costs of care. No serious complications were observed with SMT. High quality evidence suggests that there is no clinically relevant difference between SMT and other interventions for reducing pain and improving function in patients with chronic low-back pain. Determining cost-effectiveness of care has high priority. Further research is likely to have an important impact on our confidence in the estimate of effect in relation to inert interventions and sham SMT, and data related to recovery. Output:

In this updated review, we identified 26 randomised controlled trials (represented by 6070 participants) that assessed the effects of SMT in patients with chronic low-back pain. Treatment was delivered by a variety of practitioners, including chiropractors, manual therapists and osteopaths. Only nine trials were considered to have a low risk of bias. In other words, results in which we could put some confidence. The results of this review demonstrate that SMT appears to be as effective as other common therapies prescribed for chronic low-back pain, such as, exercise therapy, standard medical care or physiotherapy. However, it is less clear how it compares to inert interventions or sham (placebo) treatment because there are only a few studies, typically with a high risk of bias, which investigated these factors. Approximately two-thirds of the studies had a high risk of bias, which means we cannot be completely confident with their results. Furthermore, no serious complications were observed with SMT. In summary, SMT appears to be no better or worse than other existing therapies for patients with chronic low-back pain.

CochranePLS754

***TASK*** the task is to simplify the input abstract of a biomedical literature ***INPUT*** the input is the abstract of a biomedical literature ***OUTPUT*** the output is the simplified abstract for the input abstract of a biomedical literature ***DOCUMENTATION*** ***EXAMPLES*** Input: No new trials were identified in March of 2012. Two high quality randomised double-blind controlled studies enrolling 262 infants were identified. A non-significant reduction in the 'Use of one or more RBC transfusions' [two studies 262 infants; typical RR 0.91 (95% CI 0.78 to 1.06); typical RD -0.07 (95% CI -0.18 to 0.04; I2 = 0% for both RR and RD] favouring early EPO was noted. Early EPO administration resulted in a non-significant reduction in the "number of transfusions per infant" compared with late EPO [typical MD - 0.32 (95% CI -0.92 to 0.29)]. There was no significant reduction in total volume of blood transfused per infant or in the number of donors to whom the infant was exposed. Early EPO led to a significant increase in the risk of retinopathy of prematurity (ROP) (all stages) [two studies, 191 infants; typical RR 1.40 (95% CI 1.05 to 1.86); typical RD 0.16 (95% CI 0.03 to 0.29); NNTH 6 (95% CI 3 to 33)]. There was high heterogeneity for this outcome (I2 = 86% for RR and 81% for RD). Both studies (191 infants) reported on ROP stage > 3. No statistically significant increase in risk was noted [typical RR 1.56 (95% CI 0.71 to 3.41); typical RD 0.05 (-0.04 to 0.14)] There was no heterogeneity for this outcome (0% for both RR and RD). No other important favourable or adverse neonatal outcomes or side effects were reported. The use of early EPO did not significantly reduce the 'Use of one or more RBC transfusions' or the 'Number of transfusions per infant" compared with late EPO administration. The finding of a statistically significant increased risk of ROP (any grade) and a similar trend for ROP stage > 3 with early EPO treatment is of great concern. Output:

A total of 262 infants born preterm have been enrolled in two studies of early versus late administration of EPO to prevent blood transfusions. There were no demonstrable benefits of early versus late administration of EPO with regards to reduction in the use of red blood cell transfusions, number of transfusions, the amount of red cells transfused or number of donor exposures per infant. However, the use of early EPO compared with late EPO administration increases the risk of retinopathy of prematurity, a serious complication in babies born before term. Currently, there is a lack of evidence that either treatment confers any substantial benefits with regard to any donor blood exposure, as many infants enrolled in both studies were exposed to donor blood prior to study entry, and early EPO increases the risk of retinopathy of prematurity. Neither early nor late administration of EPO is recommended.

CochranePLS755

***TASK*** the task is to simplify the input abstract of a biomedical literature ***INPUT*** the input is the abstract of a biomedical literature ***OUTPUT*** the output is the simplified abstract for the input abstract of a biomedical literature ***DOCUMENTATION*** ***EXAMPLES*** Input: We included 33 studies involving 4002 shoulders in 3852 patients. Although 28 studies were prospective, study quality was still generally poor. Mainly reflecting the use of surgery as a reference test in most studies, all but two studies were judged as not meeting the criteria for having a representative spectrum of patients. However, even these two studies only partly recruited from primary care. The target conditions assessed in the 33 studies were grouped under five main categories: subacromial or internal impingement, rotator cuff tendinopathy or tears, long head of biceps tendinopathy or tears, glenoid labral lesions and multiple undifferentiated target conditions. The majority of studies used arthroscopic surgery as the reference standard. Eight studies utilised reference standards which were potentially applicable to primary care (local anaesthesia, one study; ultrasound, three studies) or the hospital outpatient setting (magnetic resonance imaging, four studies). One study used a variety of reference standards, some applicable to primary care or the hospital outpatient setting. In two of these studies the reference standard used was acceptable for identifying the target condition, but in six it was only partially so. The studies evaluated numerous standard, modified, or combination index tests and 14 novel index tests. There were 170 target condition/index test combinations, but only six instances of any index test being performed and interpreted similarly in two studies. Only two studies of a modified empty can test for full thickness tear of the rotator cuff, and two studies of a modified anterior slide test for type II superior labrum anterior to posterior (SLAP) lesions, were clinically homogenous. Due to the limited number of studies, meta-analyses were considered inappropriate. Sensitivity and specificity estimates from each study are presented on forest plots for the 170 target condition/index test combinations grouped according to target condition. There is insufficient evidence upon which to base selection of physical tests for shoulder impingements, and local lesions of bursa, tendon or labrum that may accompany impingement, in primary care. The large body of literature revealed extreme diversity in the performance and interpretation of tests, which hinders synthesis of the evidence and/or clinical applicability. Output:

We reviewed original research papers for evidence on the accuracy of physical tests for shoulder impingement or associated damage, in people whose symptoms and/or history suggest any of these disorders. To find the research papers, we searched the main electronic databases of medical and allied literature up to 2010. Two review authors screened assessed the quality of each research paper and extracted important information. If multiple research papers reported using the same test for the same condition, we intended to combine their results to gain a more precise estimate of the test's accuracy. We included 33 research papers. These related to studies of 4002 shoulders in 3852 patients. None of the studies exclusively looked at patients from primary care, though two recruited some of their patients from primary care. The majority of studies used arthroscopic surgery as the reference standard. There were 170 different target condition/index test combinations but only six instances where the same test was used in the same way, and for the same reason, in two studies. For this reason combining results was not appropriate. We concluded that there is insufficient evidence upon which to base selection of physical tests for shoulder impingement, and potentially related conditions, in primary care.

CochranePLS756

***TASK*** the task is to simplify the input abstract of a biomedical literature ***INPUT*** the input is the abstract of a biomedical literature ***OUTPUT*** the output is the simplified abstract for the input abstract of a biomedical literature ***DOCUMENTATION*** ***EXAMPLES*** Input: We identified three eligible studies after screening a total of 255 unique records. All three were performed in the United States of America and recruited substance-abusing male and female adolescents (total N=615) through homeless shelters into randomised controlled trials of independent and non-overlapping behavioural interventions. The three trials differed in theoretical background, delivery method, dosage (number of sessions,) content and outcome assessments. Overall, the variability in delivery and outcomes precluded estimation of summary of effect measures. We assessed the risk of bias to be high for each of the studies. Whilst some effect of the interventions on outcome measures were reported, heterogeneity and lack of robustness in these studies necessitate caution in interpreting the effectiveness of these interventions. The body of evidence does not permit conclusions on the impact of interventions to modify sexual risk behaviour in homeless youth; more research is required. While the psychosocial and contextual factors that fuel sexual risk behaviours among homeless youth challenge stringent methodologies of RCT's, novel ways for program delivery and trial retention are in need of development. Future trials should comply with rigorous methodology in design, delivery, outcome measurement and reporting. Output:

In this review, we systematically searched published and unpublished accounts of interventions that had been rigorously tested . We found three eligible independently conducted randomised controlled trials testing three different interventions. All three were conducted in the United States, amongst a total of 615 homeless, male and female youth. Due to the varied delivery of interventions, outcome measurement and reporting, we were unable to aggregate outcomes to estimate summary of effect measures. The significant risk of bias associated with the three included studies and their heterogeneity necessitate caution in interpreting the effectiveness of interventions to modify sexual risk behaviour for preventing HIV in homeless youth. While studies among homeless youth are highly challenging, future trials should comply with rigorous methodology in design, delivery, outcome measurement and reporting as well as consider the changing facets of homeless youth when designing HIV prevention tools.

CochranePLS757

***TASK*** the task is to simplify the input abstract of a biomedical literature ***INPUT*** the input is the abstract of a biomedical literature ***OUTPUT*** the output is the simplified abstract for the input abstract of a biomedical literature ***DOCUMENTATION*** ***EXAMPLES*** Input: We identified 26 studies that enrolling 61,264 participants. Angiotensin-converting enzyme inhibitors (ACEi) reduced the risk of new onset of microalbuminuria, macroalbuminuria or both when compared to placebo (8 studies, 11,906 patients: RR 0.71, 95% CI 0.56 to 0.89), with similar benefits in people with and without hypertension (P = 0.74), and when compared to calcium channel blockers (5 studies, 1253 participants: RR 0.60, 95% CI 0.42 to 0.85). ACEi reduced the risk of death when compared to placebo (6 studies, 11,350 participants: RR 0.84, 95% CI 0.73 to 0.97). No effect was observed for angiotensin receptor blockers (ARB) when compared to placebo for new microalbuminuria, macroalbuminuria or both (5 studies, 7653 participants: RR 0.90, 95% CI 0.68 to 1.19) or death (5 studies, 7653 participants: RR 1.12, 95% CI 0.88 to 1.41); however, meta-regression suggested possible benefits from ARB for preventing kidney disease in high risk patients. There was a trend towards benefit from use of combined ACEi and ARB for prevention of DKD compared with ACEi alone (2 studies, 4171 participants: RR 0.88, 95% CI 0.78 to 1.00).The risk of cough was significantly increased with ACEi when compared to placebo (6 studies, 11,791 patients: RR 1.84, 95% CI 1.24 to 2.72), however there was no significant difference in the risk of headache or hyperkalaemia. There was no significant difference in the risk of cough, headache or hyperkalaemia when ARB was to placebo. On average risk of bias was judged to be either low (27% to 69%) or unclear (i.e. no information available) (8% to 73%). Blinding of participants, incomplete outcome data and selective reporting were judged to be high in 23%, 31% and 31% of studies, respectively. ACEi were found to prevent new onset DKD and death in normoalbuminuric people with diabetes, and could therefore be used in this population. More data are needed to clarify the role of ARB and other drug classes in preventing DKD. Output:

We reviewed the literature to determine the benefits and harms of antihypertensive treatment in people with diabetes who did not have signs of kidney disease. We found 26 studies involving 61,264 participants that compared antihypertensive drugs with placebo (an neutral agent with no therapeutic benefits or harms), no treatment, and other antihypertensive drugs. A family of drugs called ACEi (angiotensin-converting enzyme inhibitors) has been shown to prevent new onset of kidney disease and reduce the numbers of deaths in people with diabetes who have normal levels of albumin in their urine compared with placebo or calcium channel blocking drugs. We found no significant effect from angiotensin receptor blocker (ARB) drugs on either development of ESKD or death. Subgroup analyses that suggested similar benefits from ARB for people with type 2 diabetes who were at high risk of heart disease or should be interpreted cautiously. Direct comparison of ACEi and ARB in this population showed no difference in preventing DKD. The benefits of ACEi are consistent, and ACEi could be the first choice intervention for primary prevention of DKD.

CochranePLS758

***TASK*** the task is to simplify the input abstract of a biomedical literature ***INPUT*** the input is the abstract of a biomedical literature ***OUTPUT*** the output is the simplified abstract for the input abstract of a biomedical literature ***DOCUMENTATION*** ***EXAMPLES*** Input: We included 10 trials in the review. Generally, we were unable to assess methodological quality; only one trial reported sufficient detail for analysis. Drugs used were piracetam, bifemalane, piribedil, bromocriptine, idebenone, and Dextran 40. We found weak evidence that patients were more likely to have improved on any language measure at the end of the trial if they had received treatment with piracetam (odds ratio (OR) 0.46, 95% confidence interval (CI) 0.3 to 0.7). Patients who were treated with piracetam were no more likely than those who took a placebo to experience unwanted effects, including death (OR 1.29, 95% CI 0.9 to 1.7). However, the differences in death rates between the two groups give rise to some concerns that there may be an increased risk of death from taking piracetam. We could not determine if drug treatment is more effective than speech and language therapy. We could not determine whether one drug is more effective than another. Drug treatment with piracetam may be effective in the treatment of aphasia after stroke. Further research is needed to explore the effects of drugs for aphasia, in particular piracetam. The safety of the drug should be of primary interest. Researchers should examine the long-term effects and whether it is more effective than speech and language therapy. Output:

This review of 10 studies evaluated six different drugs. The only drug for which there was any evidence of benefit was piracetam, but the evidence of benefit was weak and there were concerns about its safety. It was not possible to conclude whether piracetam was more effective than speech and language therapy in treating aphasia after stroke. More research is needed into the effects of piracetam on aphasia, and its safety, before it can be recommended for routine use.

CochranePLS759

***TASK*** the task is to simplify the input abstract of a biomedical literature ***INPUT*** the input is the abstract of a biomedical literature ***OUTPUT*** the output is the simplified abstract for the input abstract of a biomedical literature ***DOCUMENTATION*** ***EXAMPLES*** Input: 12 trials were included with a total of 8578 randomized participants. TB preventive therapy (any anti-TB drug) versus placebo was associated with a lower incidence of active TB (RR 0.68, 95% CI 0.54 to 0.85). This benefit was more pronounced in individuals with a positive tuberculin skin test (RR 0.38, 95% CI 0.25 to 0.57) than in those who had a negative test (RR 0.89, 95% CI 0.64 to 1.24). Efficacy was similar for all regimens (regardless of drug type, frequency or duration of treatment). However, compared to INH monotherapy, short-course multi-drug regimens were much more likely to require discontinuation of treatment due to adverse effects. Although there was reduction in mortality with INH monotherapy versus placebo among individuals with a positive tuberculin skin test (RR 0.74, 95% CI 0.55 to 1.00) and with INH plus rifampicin versus placebo regardless of tuberculin skin test status (RR 0.69, 95% CI 0.50 to 0.95), overall, there was no evidence that TB preventive therapy versus placebo reduced all-cause mortality (RR 0.94, 95% CI 0.85 to 1.05). Treatment of latent tuberculosis infection reduces the risk of active TB in HIV positive individuals especially in those with a positive tuberculin skin test. The choice of regimen will depend on factors such as availability, cost, adverse effects, adherence and drug resistance. Future studies should assess these aspects. In addition, trials evaluating the long-term effects of anti-tuberculosis chemoprophylaxis, the optimal duration of TB preventive therapy, the influence of level of immunocompromise on effectiveness and combination of anti-tuberculosis chemoprophylaxis with antiretroviral therapy are needed. Output:

This update of the review of available clinical trials found that the risk of developing active TB was reduced when people infected with both HIV and TB used isoniazid. Isoniazid for latent TB is usually taken for six to 12 months, but more research is still needed to show optimal duration of treatment, the best treatment regime for people with HIV, and especially the best regimen in combination with HIV drugs.

CochranePLS760

***TASK*** the task is to simplify the input abstract of a biomedical literature ***INPUT*** the input is the abstract of a biomedical literature ***OUTPUT*** the output is the simplified abstract for the input abstract of a biomedical literature ***DOCUMENTATION*** ***EXAMPLES*** Input: We identified 15 RCTs of ICBI conducted in various settings and populations (3917 participants). Comparing ICBI to 'minimal interventions' such as usual practice, meta-analyses showed statistically significant effects as follows: moderate effect on sexual health knowledge (SMD 0.72, 95% CI 0.27 to 1.18); small effect on safer sex self-efficacy (SMD 0.17, 95% CI 0.05 to 0.29); small effect on safer-sex intentions (SMD 0.16, 95% CI 0.02 to 0.30); and also an effect on sexual behaviour (OR 1.75, 95% CI 1.18 to 2.59). Data were insufficient for meta-analysis of biological outcomes and analysis of cost-effectiveness. In comparison with face-to-face sexual health interventions, meta-analysis was only possible for sexual health knowledge, showing that ICBI were more effective (SMD 0.36, 95% CI 0.13 to 0.58). Two further trials reported no difference in knowledge between ICBI and face-to-face intervention, but data were not available for pooling. There were insufficient data to analyse other types of outcome. No studies measured potential harms (apart from reporting any deterioration in measured outcomes). ICBI are effective tools for learning about sexual health, and they also show positive effects on self-efficacy, intention and sexual behaviour. More research is needed to establish whether ICBI can impact on biological outcomes, to understand how interventions might work, and whether they are cost-effective. Output:

We searched databases for studies which were randomised controlled trials (RCTs) of computer/Internet-based interventions which aimed to improve sexual health. We included trials of computer-based interventions delivered to people of any age, gender, sexual orientation, ethnicity or nationality. The review evaluated 15 RCTs involving 3917 participants. Results showed that computer-based interventions have a moderate effect in improving people's knowledge about sexual health in comparison to minimal interventions such as ‘usual practice' or a leaflet. We also found a small effect on safer sex self-efficacy (a person's belief in their capacity to carry out a specific action), a small effect on safer-sex intentions, and also an effect on sexual behaviour (such as condom use for sexual intercourse). We found that computer-based interventions seem better than face-to-face interventions at improving sexual health knowledge, but there were insufficient data to analyse other outcomes. No studies measured potential harms (apart from reporting any deterioration in outcomes). Interactive computer-based interventions for sexual health promotion are feasible in a variety of settings. They are effective tools for learning about sexual health, and they also improve self-efficacy, intention and sexual behaviour, but more research is needed to establish whether computer-based interventions can change outcomes such as sexually transmitted infections and pregnancy, to understand how interventions might work, and to assess whether they are cost-effective.

CochranePLS761

***TASK*** the task is to simplify the input abstract of a biomedical literature ***INPUT*** the input is the abstract of a biomedical literature ***OUTPUT*** the output is the simplified abstract for the input abstract of a biomedical literature ***DOCUMENTATION*** ***EXAMPLES*** Input: A total of 703 unique items was identified. We included 19 RCTs. There was evidence of small study biases (Egger test, P = 0.002). In 15 placebo-controlled RCTs there was an effect of antibiotic prophylaxis (pooled RR 0.59, 95% CI 0.46 to 0.75, 95% PI 0.30 to 1.14, I2 = 39%). There were insufficient data (three trials) to determine whether one regimen was superior to another. In one trial, the incidence of post-abortal upper genital tract infection was higher in women allocated to the screen-and-treat strategy (RR 1.53, 95% CI 0.99 to 2.36). Antibiotic prophylaxis at the time of first trimester surgical abortion is effective in preventing post-abortal upper genital tract infection. Evidence of between trial heterogeneity suggests that the effect might not apply to all settings, population groups or interventions. This review did not determine the most effective antibiotic prophylaxis regimen. Antibiotic choice should take into account the local epidemiology of genital tract infections, including sexually transmitted infections. Further RCTs comparing different antibiotics or combinations of antibiotics with each other would be useful. Such trials could be done in low and middle income countries and where the prevalence of genital tract infections in women presenting for abortion is high. Output:

We found 19 randomised controlled trials that looked at the effect of antibiotic prophylaxis on post-abortal upper genital tract infection amongst women requesting induced abortion in the first trimester of pregnancy. We looked at the effect of any antibiotic prophylaxis regimen on the outcome. Overall, the risk of post-abortal upper genital tract infection in women receiving antibiotics was 59% that of women who received placebo. There were, however, differences between the trial results over and above what would be expected by chance alone. It should be noted that, if the infection is caused by a sexually transmitted organism, antibiotic prophylaxis will not protect the woman from becoming re-infected if her sexual partner has not been treated. None of the trials was done in lower or middle income countries, which is where the risk of post-abortal complications is highest. Further trials are needed to determine whether combinations of antibiotics can prevent more infections than single antibiotics, or whether antibiotic prophylaxis should be restricted to women with positive results of screening tests before the abortion.

CochranePLS762

***TASK*** the task is to simplify the input abstract of a biomedical literature ***INPUT*** the input is the abstract of a biomedical literature ***OUTPUT*** the output is the simplified abstract for the input abstract of a biomedical literature ***DOCUMENTATION*** ***EXAMPLES*** Input: The review currently includes seven randomised trials and 1567 participants that compared fluphenazine with low-potency antipsychotic drugs. The size of the included studies was between 40 and 438 participants. Overall, sequence generation, allocation procedures and blinding were poorly reported. Fluphenazine was not significantly different from low-potency antipsychotic drugs in terms of response to treatment (fluphenazine 55%, low-potency drug 55%, 2 RCTs, n = 105, RR 1.06 CI 0.75 to 1.50, moderate quality evidence). There was also no significant difference in acceptability of treatment with equivocal numbers of participants leaving the studies early due to any reason (fluphenazine 36%, low-potency antipsychotics 36%, 6 RCTs, n = 1532, RR 1.00 CI 0.88 to 1.14, moderate quality evidence). There was no significant difference between fluphenazine and low-potency antipsychotics for numbers experiencing at least one adverse effect (fluphenazine 70%, low-potency antipsychotics 88%, 1 RCT, n = 65, RR 0.79 CI 0.58 to 1.07, moderate quality evidence). However, at least one movement disorder occurred significantly more frequently in the fluphenazine group (fluphenazine 15%, low-potency antipsychotics 10%, 3 RCTs, n = 971, RR 2.11 CI 1.41 to 3.15, low quality of evidence). In contrast, low-potency antipsychotics produced significantly more sedation (fluphenazine 20%, low-potency antipsychotics 64%, 1 RCT, n = 65, RR 0.31 CI 0.13 to 0.77, high quality evidence). No data were available for the outcomes of death and quality of life. The results of the primary outcome were robust in a number of subgroup and sensitivity analyses. Adverse effects such as akathisia (fluphenazine 15%, low-potency antipsychotics 6%, 5 RCTs, n = 1209, RR 2.28 CI 1.58 to 3.28); dystonia (fluphenazine 5%, low-potency antipsychotics 2%, 4 RCTs, n = 1309, RR 2.66 CI 1.25 to 5.64); loss of associated movement (fluphenazine 20%, low-potency antipsychotics 2%, 1 RCT, n = 338, RR 11.15 CI 3.95 to 31.47); rigor (fluphenazine 27%, low-potency antipsychotics 12%, 2 RCTs, n = 403, RR 2.18 CI 1.20 to 3.97); and tremor (fluphenazine 15%, low-potency antipsychotics 6%, 2 RCTs, n = 403, RR 2.53 CI 1.37 to 4.68) occurred significantly more frequently in the fluphenazine group. For other adverse effects such as dizziness (fluphenazine 8%, low-potency antipsychotics 17%, 4 RCTs, n = 1051, RR 0.49 CI 0.32 to 0.73); drowsiness (fluphenazine 18%, low-potency antipsychotics 25%, 3 RCTs, n = 986, RR 0.67 CI 0.53 to 0.86); dry mouth (fluphenazine 11%, low-potency antipsychotics 18%, 4 RCTs, n = 1051, RR 0.63 CI 0.45 to 0.89); nausea (fluphenazine 4%, low-potency antipsychotics 15%, 3 RCTs, n = 986, RR 0.25 CI 0.14 to 0.45); and vomiting (fluphenazine 3%, low-potency antipsychotics 8%, 3 RCTs, n = 986, RR 0.36 CI 0.18 to 0.72) results favoured fluphenazine with significantly more events occurring in the low-potency antipsychotic group for these outcomes. The results do not show a clear difference in efficacy between fluphenazine and low-potency antipsychotics. The number of included studies was low and their quality moderate. Therefore, further studies would be needed to draw firm conclusions about the relative effects of fluphenazine and low-potency antipsychotics. Output:

This review examined the effects of the high-potency antipsychotic fluphenazine compared with those of low-potency antipsychotics. A search for randomised trials comparing these types of drugs was carried out in 2010. The review includes seven studies with 1567 participants. Pooled data from two of these trials did not show a clear difference in effectiveness between fluphenazine and low-potency antipsychotics. However, evidence showed fluphenazine produced more movement disorders than low-potency antipsychotics, whereas the low-potency drugs were more likely to cause dizziness, drowsiness and sedation, a dry mouth, nausea and sometimes even vomiting. The number of included studies was low and the quality of evidence provided was moderate. Therefore, further good quality studies would be needed to draw firm conclusions about the relative effectiveness of fluphenazine compared to low-potency antipsychotics. Important information on service use, going into hospital again (rehospitalisation), costs and quality of life was missing and not reported. This plain language summary was written by a consumer Ben Gray from RETHINK mental illness.

CochranePLS763

***TASK*** the task is to simplify the input abstract of a biomedical literature ***INPUT*** the input is the abstract of a biomedical literature ***OUTPUT*** the output is the simplified abstract for the input abstract of a biomedical literature ***DOCUMENTATION*** ***EXAMPLES*** Input: Three studies (93 participants) that assessed cannabis in people with active CD met the inclusion criteria. One ongoing study was also identified. Participants in two of the studies were adults with active Crohn's disease who had failed at least one medical treatment. The inclusion criteria for the third study were unclear. No studies that assessed cannabis therapy in quiescent CD were identified. The studies were not pooled due to differences in the interventional drug. One small study (N = 21) compared eight weeks of treatment with cannabis cigarettes containing 115 mg of D9-tetrahydrocannabinol (THC) to placebo cigarettes containing cannabis with the THC removed in participants with active CD. This study was rated as high risk of bias for blinding and other bias (cannabis participants were older than placebo). The effects of cannabis on clinical remission were unclear. Forty-five per cent (5/11) of the cannabis group achieved clinical remission compared with 10% (1/10) of the placebo group (RR 4.55, 95% CI 0.63 to 32.56; very low certainty evidence). A difference was observed in clinical response (decrease in CDAI score of >100 points) rates. Ninety-one per cent (10/11) of the cannabis group achieved a clinical response compared to 40% (4/10) of the placebo group (RR 2.27, 95% CI 1.04 to 4.97; very low certainty evidence). More AEs were observed in the cannabis cigarette group compared to placebo (RR 4.09, 95% CI 1.15 to 14.57; very low certainty evidence). These AEs were considered to be mild in nature and included sleepiness, nausea, difficulty with concentration, memory loss, confusion and dizziness. This study did not report on serious AEs or withdrawal due to AEs. One small study (N = 22) compared cannabis oil (5% cannabidiol) to placebo oil in people with active CD. This study was rated as high risk of bias for other bias (cannabis participants were more likely than placebo participants to be smokers). There was no difference in clinical remission rates. Forty per cent (4/10) of cannabis oil participants achieved remission at 8 weeks compared to 33% (3/9) of the placebo participants (RR 1.20, 95% CI 0.36 to 3.97; very low certainty evidence). There was no difference in the proportion of participants who had a serious adverse event. Ten per cent (1/10) of participants in the cannabis oil group had a serious adverse event compared to 11% (1/9) of placebo participants (RR 0.90, 95% CI 0.07 to 12.38, very low certainty evidence). Both serious AEs were worsening Crohn's disease that required rescue intervention. This study did not report on clinical response, CRP, quality of life or withdrawal due to AEs. One small study (N= 50) compared cannabis oil (15% cannabidiol and 4% THC) to placebo in participants with active CD. This study was rated as low risk of bias. Differences in CDAI and quality of life scores measured by the SF-36 instrument were observed. The mean quality of life score after 8 weeks of treatment was 96.3 in the cannabis oil group compared to 79.9 in the placebo group (MD 16.40, 95% CI 5.72 to 27.08, low certainty evidence). After 8 weeks of treatment, the mean CDAI score was118.6 in the cannabis oil group compared to 212.6 in the placebo group (MD -94.00, 95%CI -148.86 to -39.14, low certainty evidence). This study did not report on clinical remission, clinical response, CRP or AEs. The effects of cannabis and cannabis oil on Crohn's disease are uncertain. Thus no firm conclusions regarding the efficacy and safety of cannabis and cannabis oil in adults with active Crohn's disease can be drawn. The effects of cannabis or cannabis oil in quiescent Crohn's disease have not been investigated. Further studies with larger numbers of participants are required to assess the potential benefits and harms of cannabis in Crohn's disease. Future studies should assess the effects of cannabis in people with active and quiescent Crohn's disease. Different doses of cannabis and delivery modalities should be investigated. Output:

The researchers extensively searched the literature up to 17 October 2018 and found three studies (93 participants) that met the inclusion criteria. One ongoing study was also identified. All of the studies were small in size and had some quality issues. One small study (21 participants) compared eight weeks of treatment with cannabis cigarettes containing 115 mg of D9-tetrahydrocannabinol (THC) to placebo cigarettes containing cannabis with the THC removed in participants with active Crohn's disease who had failed at least one medical treatment. Although no difference in clinical remission rates was observed, more participants in the cannabis group had improvement in their Crohn's disease symptoms than participants in the placebo group. More side effects were observed in the cannabis cigarette group compared to placebo. These side effects were considered to be mild in nature and included sleepiness, nausea, difficulty with concentration, memory loss, confusion and dizziness. Participants in the cannabis cigarette group reported improvements in pain, appetite and satisfaction with treatment. One small study (22 participants) compared cannabis oil (10 mg of cannabidiol twice daily) to placebo oil (i.e. olive oil) in participants with active Crohn's disease who had failed at least one medical treatment. No difference in clinical remission rates was observed. There was no difference in serious side effects. Serious side effects included worsening Crohn's disease in one participant in each group. One small study (50 participants) compared cannabis oil (composed of 15% cannabidiol and 4% THC) to placebo oil in participants with active Crohn's disease. Positive differences in quality of life and the Crohn's disease activity index were observed. The effects of cannabis and cannabis oil on Crohn's disease are uncertain. No firm conclusions regarding the benefits and harms (e.g. side effects) of cannabis and cannabis oil in adults with Crohn's disease can be drawn. The effects of cannabis and cannabis oil in people with Crohn's disease in remission have not been investigated. Further studies with larger numbers of participants are required to assess the potential benefits and harms of cannabis in Crohn's disease. Future studies should assess the effects of cannabis in people with active and inactive Crohn's disease. Different doses of cannabis and formulations (e.g. cannabis oil or pills) should be investigated.

CochranePLS764

***TASK*** the task is to simplify the input abstract of a biomedical literature ***INPUT*** the input is the abstract of a biomedical literature ***OUTPUT*** the output is the simplified abstract for the input abstract of a biomedical literature ***DOCUMENTATION*** ***EXAMPLES*** Input: We included two trials involving 312 infants. No data were available for correction of hypoglycaemia for each hypoglycaemic event. We found no evidence of a difference between dextrose gel and placebo gel for major neurosensory disability at two-year follow-up (risk ratio (RR) 6.27, 95% confidence interval (CI) 0.77 to 51.03; one trial, n = 184; quality of evidence very low). Dextrose gel compared with placebo gel or no gel did not alter the need for intravenous treatment for hypoglycaemia (typical RR 0.78, 95% CI 0.46 to 1.32; two trials, 312 infants; quality of evidence very low). Infants treated with dextrose gel were less likely to be separated from their mothers for treatment of hypoglycaemia (RR 0.54, 95% CI 0.31 to 0.93; one trial, 237 infants; quality of evidence moderate) and were more likely to be exclusively breast fed after discharge (RR 1.10, 95% CI 1.01 to 1.18; one trial, 237 infants; quality of evidence moderate). Estimated rise in blood glucose concentration following dextrose gel was 0.4 mmol/L (95% CI -0.14 to 0.94; one trial, 75 infants). Investigators in one trial reported no adverse outcomes (n = 237 infants). Treatment of infants with neonatal hypoglycaemia with 40% dextrose gel reduces the incidence of mother-infant separation for treatment and increases the likelihood of full breast feeding after discharge compared with placebo gel. No evidence suggests occurrence of adverse effects during the neonatal period or at two years' corrected age. Oral dextrose gel should be considered first-line treatment for infants with neonatal hypoglycaemia. Output:

Two trials to date have assessed use of dextrose gel to reverse low blood glucose levels while the baby remains in the mother's care; these studies included a total of 312 infants. Investigators rubbed dextrose gel into the inside of the infant's cheek; they provided a normal feed for 157 of these infants and placebo gel plus a normal feed, or a normal feed alone, for 155 infants.Key results:Results suggest that dextrose gel is effective in keeping mothers and infants together and improving the rate of full breast feeding after discharge from hospital. Researchers reported no adverse effects when dextrose gel was given to infants and no effects on development at two years of age. The review is limited by lack of data for the important outcomes of effectiveness of treatment for individual episodes of low blood glucose levels and effects on brain injury. Further research is required to address these important questions. Dextrose gel applied to the inside of the cheek is a simple and safe treatment for initial care of infants with low blood glucose levels. Overall the quality of the evidence was moderate to very low. Reasons for downgrading the quality of evidence included imprecision (variation in data), publication bias (evidence based on data from a single trial; one publication in abstract format only), insufficient detail to allow a judgement about risk of bias and/or high levels of disagreement for a particular outcome.

CochranePLS765

***TASK*** the task is to simplify the input abstract of a biomedical literature ***INPUT*** the input is the abstract of a biomedical literature ***OUTPUT*** the output is the simplified abstract for the input abstract of a biomedical literature ***DOCUMENTATION*** ***EXAMPLES*** Input: Of 3500 titles retrieved from the literature, 24 papers reporting on 23 studies could be included in the review. The studies were published between 1970 and 1997 and together included 1026 participants. Most were cross-over studies. Few studies provided sufficient information to judge the concealment of allocation. Four studies provided results for the percentage of symptom-free days. Pooling the results did not reveal a statistically significant difference between sodium cromoglycate and placebo. For the other pooled outcomes, most of the symptom-related outcomes and bronchodilator use showed statistically significant results, but treatment effects were small. Considering the confidence intervals of the outcome measures, a clinically relevant effect of sodium cromoglycate cannot be excluded. The funnel plot showed an under-representation of small studies with negative results, suggesting publication bias. There is insufficient evidence to be sure about the efficacy of sodium cromoglycate over placebo. Publication bias is likely to have overestimated the beneficial effects of sodium cromoglycate as maintenance therapy in childhood asthma. Output:

In this review we aimed to determine whether there is evidence for the effectiveness of inhaled sodium cromoglycate as maintenance treatment in children with chronic asthma. Most of the studies were carried out in small groups of patients. Furthermore, we suspect that not all studies undertaken have been published. The results show that there is insufficient evidence to be sure about the beneficial effect of sodium cromoglycate compared to placebo. However, for several outcome measures the results favoured sodium cromoglycate.

CochranePLS766

***TASK*** the task is to simplify the input abstract of a biomedical literature ***INPUT*** the input is the abstract of a biomedical literature ***OUTPUT*** the output is the simplified abstract for the input abstract of a biomedical literature ***DOCUMENTATION*** ***EXAMPLES*** Input: We found only three RCTs, in which a total of 230 postpartum women participated. Most of our analyses were based on relatively small numbers of patients and studies. Overall, the certainty of evidence regarding the effectiveness of interventions was low, due to risk of bias and imprecision. We found very low-certainty evidence regarding the safety of interventions because of risk of bias and imprecision. Two studies had unclear risk of selection bias. One study had unclear risk of reporting bias and a high risk of other bias associated with the study protocol. Women who received an intraperitoneal instillation of lidocaine experienced lower intensity intraperitoneal pain than those given a placebo (pooled MD -3.34, 95% CI -4.19 to -2.49, three studies, 190 participants, low-certainty evidence), or an intramuscular injection of morphine (MD -4.8, 95% CI -6.43 to -3.17, one study, 40 participants, low-certainty evidence). We found no clear difference in intraperitoneal pain between women who had an intramuscular injection of morphine added to an intraperitoneal instillation of lidocaine and those who had an intraperitoneal instillation of lidocaine alone (MD -0.40, 95% CI -1.52 to 0.72, one study, 40 participants, low-certainty evidence). An intramuscular injection of morphine alone was not effective for intraperitoneal pain relief compared to placebo (MD 0.50, 95% CI -1.33 to 2.33, one study, 40 women, low-certainty evidence). None of the studies reported any serious adverse events but the evidence was very low-certainty. Intraperitoneal instillation of lidocaine may reduce the number of women requiring additional pain control when compared to placebo (RR 0.27, 95% CI 0.17 to 0.44, three studies, 190 women, low-certainty evidence). An intraperitoneal instillation of lidocaine during postpartum mini-laparotomy tubal ligation before fallopian tubes were tied may offer better intraperitoneal pain control, although the evidence regarding adverse effects is uncertain. We found no clear difference in intraperitoneal pain between women who received a combination of an injection of morphine, and intraperitoneal instillation of lidocaine and those who received an intraperitoneal instillation of lidocaine alone. These results must be interpreted with caution, since the evidence overall was low to very low-certainty. Output:

We included three randomised controlled trials involving a total of 230 women. These studies compared lidocaine poured into the abdominal cavity with a placebo, or other treatments, such as an injection of morphine (also known as an opioid) into the muscle, or combination of lidocaine and morphine. All studies took place in Thailand. The evidence described here are from studies published before 31 July, 2017. Pouring lidocaine into the abdominal cavity during a mini-laparotomy tubal ligation before fallopian tubes were tied after delivery may offer better pain control than a placebo or morphine injection, although the evidence regarding adverse effects is uncertain. Women who received a combination of morphine injection and lidocaine poured into the abdominal cavity showed no clear difference in pain with those who received lidocaine alone. An injection of morphine into the muscle alone did not reduce pain more than a placebo. The certainty of evidence regarding the effectiveness of these interventions was low due to risk of bias and imprecision of results. The certainty of evidence regarding the safety of the interventions was very low because of risk of bias and imprecision.

CochranePLS767

***TASK*** the task is to simplify the input abstract of a biomedical literature ***INPUT*** the input is the abstract of a biomedical literature ***OUTPUT*** the output is the simplified abstract for the input abstract of a biomedical literature ***DOCUMENTATION*** ***EXAMPLES*** Input: Two studies with a total of 185 participants met the selection criteria. These trials studied all the absorbent product designs included in this review. One trial took place in nursing homes, the other in people's own homes. Gender was found to be a significant variable in both trials, and accordingly the results were analysed in gender groups. Data were presented on all included outcomes, except for quality of life. The results show that there is no single best design (i.e. one design that is significantly better than all other designs and for all users). Of the disposable designs, the more expensive pull-up and T-shaped diaper designs were not better overall than the diaper for men, but the diaper was better than the insert (the cheapest), making the diaper the most cost-effective disposable design for men both day and night. For women, disposable pull-ups were better overall than the other designs (except for those living in nursing homes when disposable diapers are better when used at night), but they are expensive. Unlike men, women in the community did not favour diapers (or T-shape diapers) and insert pads are therefore the most cost-effective alternative. Washable diapers are the least expensive design but are unacceptable to most women at any time. However, some people (particularly men living at home) prefer them at night and for them they are a cost-effective design. No firm conclusions could be drawn about the performance of designs for faecal incontinence and there was no firm evidence that there are differences in skin health between designs. Although data were available from only two eligible trials the data were sufficiently robust to make some recommendations for practice. There is evidence that different designs are better for men and women. Diapers are the most cost-effective disposable design for men. Disposable pull-ups are most preferred for women but are expensive: disposable inserts are a cheaper alternative (except in nursing homes where diapers are preferred to inserts at night). Washable diapers are the cheapest design but have limited acceptability, confined mainly to some men at night. There were not enough people in the trials to draw any conclusions about which designs are best for faecal incontinence and no particular design seemed to be better or worse for skin health. People have different preferences for absorbent product designs and using a combination (different designs for day/night, going out/staying in) may be more effective and less expensive than using one design all the time. Output:

This review found only two eligible clinical trials which had been carried out in the last 10 years and both were of bodyworn absorbent products. These trials included all the product designs and took place in nursing homes and in the community (i.e. involving people living in their own homes); both were carried out in the UK. There is evidence that different designs are better for men and women. Of the disposable designs diapers are the most cost-effective for men for both day and night. Women prefer disposable pull-ups, but they are expensive and disposable inserts are a cost-effective alternative (except for women at night in nursing homes where disposable diapers are better). Washable diapers are inexpensive but have limited acceptability, confined mainly to some men at night. There were not enough people in the trials to draw any conclusions about which designs are best for faecal incontinence or about which particular design was better or worse for skin health. Using combinations of designs (different designs for day/night or for staying in/going out) may be more effective and less expensive than using one design all the time.

CochranePLS768

***TASK*** the task is to simplify the input abstract of a biomedical literature ***INPUT*** the input is the abstract of a biomedical literature ***OUTPUT*** the output is the simplified abstract for the input abstract of a biomedical literature ***DOCUMENTATION*** ***EXAMPLES*** Input: We screened 1290 records and found only three trials involving 154 female participants, all of whom were aged above 65 years and had had hip fracture surgery. All studies had methodological shortcomings that placed them at high or unclear risk of bias. Because of this high risk of bias, imprecise results and likelihood of publication bias, we judged the quality of the evidence for all primary outcomes to be very low. These trials tested two comparisons. One trial had three groups and contributed data to both comparisons. None of the trials reported on patient acceptability of the intervention. Two very different trials compared anabolic steroid versus control (no anabolic steroid or placebo). One trial compared anabolic steroid injections (given weekly until discharge from hospital or four weeks, whichever came first) versus placebo injections in 29 "frail elderly females". This found very low quality evidence of little difference between the two groups in the numbers discharged to a higher level of care or dead (one person in the control group died) (8/15 versus 10/14; risk ratio (RR) 0.75, 95% confidence interval (CI) 0.42 to 1.33; P = 0.32), time to independent mobilisation or individual adverse events. The second trial compared anabolic steroid injections (every three weeks for six months) and daily protein supplementation versus daily protein supplementation alone in 40 "lean elderly women" who were followed up for one year after surgery. This trial provided very low quality evidence that anabolic steroid may result in less dependency, assessed in terms of being either dependent in at least two functions or dead (one person in the control group died) at six and 12 months, but the result was also compatible with no difference or an increase in dependency (dependent in at least two levels of function or dead at 12 months: 1/17 versus 5/19; RR 0.22, 95% CI 0.03 to 1.73; P = 0.15). The trial found no evidence of between-group differences in individual adverse events. Two trials compared anabolic steroids combined with another nutritional intervention ('steroid plus') versus control (no 'steroid plus'). One trial compared anabolic steroid injections every three weeks for 12 months in combination with daily supplement of vitamin D and calcium versus calcium only in 63 women who were living independently at home. The other trial compared anabolic steroid injections every three weeks for six months and daily protein supplementation versus control in 40 "lean elderly women". Both trials found some evidence of better function in the steroid plus group. One trial reported greater independence, higher Harris hip scores and gait speeds in the steroid plus group at 12 months. The second trial found fewer participants in the anabolic steroid group were either dependent in at least two functions, including bathing, or dead at six and 12 months (one person in the control group died) (1/17 versus 7/18; RR 0.15, 95% CI 0.02 to 1.10; P = 0.06). Pooled mortality data (2/51 versus 3/51) from the two trials showed no evidence of a difference between the two groups at one year. Similarly, there was no evidence of between-group differences in individual adverse events. Three participants in the steroid group of one trial reported side effects of hoarseness and increased facial hair. The other trial reported better quality of life in the steroid plus group. The available evidence is insufficient to draw conclusions on the effects, primarily in terms of functional outcome and adverse events, of anabolic steroids, either separately or in combination with nutritional supplements, after surgical treatment of hip fracture in older people. Given that the available data points to the potential for more promising outcomes with a combined anabolic steroid and nutritional supplement intervention, we suggest that future research should focus on evaluating this combination. Output:

There were only three studies available and all three were small and at high risk of bias. We therefore judged the quality of the evidence to be very low, which means that we are uncertain how reliable the evidence is. Two very different studies compared anabolic steroid versus control (no anabolic steroid or placebo). One study conducted in the hospital ward compared weekly anabolic steroid injections versus placebo injections in 29 "frail elderly females". This study found no evidence that anabolic steroid resulted in better function, as measured by numbers discharged to a higher level of care or dead, or the time to mobilisation. The second study compared steroid injections given every three weeks for six months plus daily protein supplementation versus daily protein supplementation alone in 40 "lean elderly women". This study provided some evidence that anabolic steroids may result in better function, but they may also make no difference or result in worse function. Neither study found a difference in the incidence of individual adverse events in the two groups. Two studies compared anabolic steroids combined with another nutritional intervention ('steroid plus') versus control (no 'steroid plus'). One study compared anabolic steroid injections every three weeks for 12 months in combination with daily supplement of vitamin D and calcium versus calcium only in 63 women who were living independently at home. The other study compared anabolic steroid injections every three weeks for six months and daily protein supplementation versus control in 40 "lean elderly women". Both studies found some evidence of better function in the steroid plus group. Pooled mortality data from the two studies showed no difference between the two groups at one year. Similarly, there was no evidence of between-group differences in individual adverse events. Three participants in the steroid group of one study reported side effects of hoarseness and increased facial hair. The other study reported better quality of life in the steroid plus group. None of the studies reported on patient acceptability of the intervention. 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 if anabolic steroids, either separately or in combination with nutritional supplements, improve recovery after hip fracture surgery in older people. Given that the results available point to the potential for more promising outcomes with a combined anabolic steroid and nutritional supplement intervention, we suggest that future research should focus on evaluating this combination.

CochranePLS769

***TASK*** the task is to simplify the input abstract of a biomedical literature ***INPUT*** the input is the abstract of a biomedical literature ***OUTPUT*** the output is the simplified abstract for the input abstract of a biomedical literature ***DOCUMENTATION*** ***EXAMPLES*** Input: We included 83 SRs; 70 had outcome data. Below we highlight key results from a subset of 36 SRs of interventions intended to prevent PTB. Outcome: preterm birth Clear evidence of benefit Four SRs reported clear evidence of benefit to prevent specific populations of pregnant women from giving birth early, including midwife-led continuity models of care versus other models of care for all women; screening for lower genital tract infections for pregnant women less than 37 weeks' gestation and without signs of labour, bleeding or infection; and zinc supplementation for pregnant women without systemic illness. Cervical cerclage showed clear benefit for women with singleton pregnancy and high risk of PTB only. Clear evidence of harm No included SR reported clear evidence of harm. No effect or equivalence For pregnant women at high risk of PTB, bedrest for women with singleton pregnancy and antibiotic prophylaxis during the second and third trimester were of no effect or equivalent to a comparator. Possible benefit Four SRs found possible benefit in: group antenatal care for all pregnant women; antibiotics for pregnant women with asymptomatic bacteriuria; pharmacological interventions for smoking cessation for pregnant women who smoke; and vitamin D supplements alone for women without pre-existing conditions such as diabetes. Possible harm One SR reported possible harm (increased risk of PTB) with intramuscular progesterone, but this finding is only relevant to women with multiple pregnancy and high risk of PTB. Another review found possible harm with vitamin D, calcium and other minerals for pregnant women without pre-existing conditions. Outcome: perinatal death Clear evidence of benefit Two SRs reported clear evidence of benefit to reduce pregnant women's risk of perinatal death: midwife-led continuity models of care for all pregnant women; and fetal and umbilical Doppler for high-risk pregnant women. Clear evidence of harm No included SR reported clear evidence of harm. No effect or equivalence For pregnant women at high risk of PTB, antibiotic prophylaxis during the second and third trimester was of no effect or equivalent to a comparator. Possible benefit One SR reported possible benefit with cervical cerclage for women with singleton pregnancy and high risk of PTB. Possible harm One SR reported possible harm associated with a reduced schedule of antenatal visits for pregnant women at low risk of pregnancy complications; importantly, these women already received antenatal care in settings with limited resources. Outcomes: preterm birth and perinatal death Unknown benefit or harm For pregnant women at high risk of PTB for any reason including multiple pregnancy, home uterine monitoring was of unknown benefit or harm. For pregnant women at high risk due to multiple pregnancy: bedrest, prophylactic oral betamimetics, vaginal progesterone and cervical cerclage were all of unknown benefit or harm. Implications for practice The overview serves as a map and guide to all current evidence relevant to PTB prevention published in the Cochrane Library. Of 70 SRs with outcome data, we identified 36 reviews of interventions with the aim of preventing PTB. Just four of these SRs had evidence of clear benefit to women, with an additional four SRs reporting possible benefit. No SR reported clear harm, which is an important finding for women and health providers alike. The overview summarises no evidence for the clinically important interventions of cervical pessary, cervical length assessment and vaginal progesterone because these Cochrane Reviews were not current. These are active areas for PTB research. The graphic icons we assigned to SR effect estimates do not constitute clinical guidance or an endorsement of specific interventions for pregnant women. It remains critical for pregnant women and their healthcare providers to carefully consider whether specific strategies to prevent PTB will be of benefit for individual women, or for specific populations of women. Implications for research Formal consensus work is needed to establish standard language for overviews of reviews and to define the limits of their interpretation. Clinicians, researchers and funders must address the lack of evidence for interventions relevant to women at high risk of PTB due to multiple pregnancy. Output:

We included 83 systematic reviews with evidence about whether or not the intervention was able to reduce pregnant women's chance of having a preterm birth or a baby death. Seventy of these reviews had information about preterm birth. We categorised the evidence we found as: clear benefit or harm; no effect; possible benefit or harm; or unknown effect. Clear benefit We were confident that the following interventions were able to help specific populations of pregnant women avoid giving birth early: midwife-led continuity models of care versus other models of care for all women; screening for lower genital tract infections; and zinc supplementation for pregnant women without systemic illness. Cervical stitch (cerclage) was of benefit only for women at high risk of preterm birth and with singleton pregnancy. Clear harm We found no treatment that increased women’s chance of giving birth preterm. Possible benefit The following interventions may have helped some groups of pregnant women avoid preterm birth, but we have less confidence in these results: group antenatal care for all pregnant women; antibiotics for pregnant women with asymptomatic bacteriuria; pharmacological interventions for smoking cessation; and vitamin D supplements alone for women without health problems. Possible harm We found two interventions that may have made things worse for some pregnant women: intramuscular progesterone for women at high risk of preterm birth with multiple pregnancy; and taking vitamin D supplements, calcium and other minerals for pregnant women without health problems. Clear benefit We were confident in evidence for midwife-led continuity models of care for all pregnant women; and for fetal and umbilical Doppler for high-risk pregnant women; these interventions appeared to reduce women's chance of experiencing baby death. Clear harm We found no intervention that increased women’s risk of baby death. Possible benefit We found a possible benefit with cervical stitch (cerclage) for women with singleton pregnancy and high risk of preterm birth. Possible harm One review reported possible harm associated with having fewer antenatal visits, even for pregnant women at low risk of pregnancy problems. The pregnant women in this review already received limited antenatal care. Unknown benefit or harm For pregnant women at high risk of preterm birth for any reason including multiple pregnancy, home uterine monitoring was of unknown benefit or harm. For high-risk pregnant women with multiple pregnancy: bedrest, prophylactic oral betamimetics, vaginal progesterone and cervical cerclage were all of unknown benefit or harm. There is valuable information in the Cochrane Library relevant to women, doctors, midwives and researchers interested in preventing early birth. We have summarised the results of systematic reviews to describe how well different strategies work to prevent early birth and baby death. We organised our information in clear figures with graphic icons to represent how confident we were in the results and to point readers toward promising treatments for specific groups of pregnant women. Our overview found no up-to-date information in the Cochrane Library for the important treatments of cervical pessary, vaginal progesterone or cervical assessment with ultrasound. We found no high-quality evidence relevant to women at high risk of preterm birth due to multiple pregnancy. It remains important for pregnant women and their healthcare providers to carefully consider whether specific strategies to prevent preterm birth will be of benefit for individual women, or for specific populations of women.

CochranePLS770

***TASK*** the task is to simplify the input abstract of a biomedical literature ***INPUT*** the input is the abstract of a biomedical literature ***OUTPUT*** the output is the simplified abstract for the input abstract of a biomedical literature ***DOCUMENTATION*** ***EXAMPLES*** Input: Three studies (866 participants) compared rectally administered sumatriptan with placebo or an active comparator. Most of the data were for the 12.5 mg and 25 mg doses. For the majority of efficacy outcomes, sumatriptan surpassed placebo. For sumatriptan 12.5 mg versus placebo the NNTs were 5.2 and 3.2 for headache relief at one and two hours, respectively. Results for the 25 mg dose were similar to the 12.5 mg dose, and there were no significant differences between the two doses for any of the outcomes analysed. The NNTs for sumatriptan 25 mg versus placebo were 4.2, 3.2, and 2.4 for pain-free at two hours, headache relief at one hour, and headache relief at two hours, respectively. Relief of functional disability was greater with sumatriptan than with placebo, with NNTs of 8.0 and 4.0 for the 12.5 mg and 25 mg doses, respectively. For the most part, adverse events were transient and mild and were more common with sumatriptan than with placebo, but there were insufficient data to perform any analyses. Direct comparison of sumatriptan with active treatments was limited to one study comparing sumatriptan 25 mg with ergotamine tartrate 2 mg + caffeine 100 mg. Based on limited amounts of data, sumatriptan 25 mg, administered rectally, is an effective treatment for acute migraine attacks, with participants in these studies experiencing a significant reduction in headache pain and functional disability within two hours of treatment. The lack of data on relief of headache-associated symptoms or incidence of adverse events limits any conclusions that can be drawn. Output:

This review found that a single dose administered rectally was effective in relieving migraine headache pain and functional disability. Pain was reduced from moderate or severe to no pain by two hours in approximately 2 in 5 people (41%) taking sumatriptan 25 mg, compared with about 1 in 6 (17%) taking placebo. Pain was reduced from moderate or severe to no worse than mild pain by two hours in roughly 2 in 3 people (71%) taking sumatriptan 25 mg, compared with approximately 1 in 3 (30%) taking placebo. In addition to relieving headache pain, sumatriptan 25 mg also relieved functional disability by two hours in about 2 in 5 people (41%), compared with about 1 in 6 (16%) taking placebo. There was not enough evidence to draw any conclusions about the incidence of adverse events or to compare rectal sumatriptan directly with any other active comparators.

CochranePLS771

***TASK*** the task is to simplify the input abstract of a biomedical literature ***INPUT*** the input is the abstract of a biomedical literature ***OUTPUT*** the output is the simplified abstract for the input abstract of a biomedical literature ***DOCUMENTATION*** ***EXAMPLES*** Input: Six studies involving 1001 women were included. Three trials compared one counselling session with no counselling. There was no significant difference in psychological well being including anxiety, grief, depression avoidance and self-blame. One trial compared three one-hour counselling sessions with no counselling at four and 12 months. Some subscales showed statistical significance in favour of counselling and some in favour of no counselling. The results for two trials were given in narrative form as data were unavailable for meta-analyses. One trial compared multiple interventions. The other trial compared two counselling sessions with no counselling. Neither study favoured counselling. Evidence is insufficient to demonstrate that psychological support such as counselling is effective post-miscarriage. Further trials should be good quality, adequately-powered using standardised interventions and outcome measures at specific time points. The economic implications and women's satisfaction with psychological follow-up should also be explored in any future study. Output:

Miscarriage is the premature, or loss of a fetus, up to 23 weeks of pregnancy. Some women suffer from anxiety and depression after miscarriage which may be part of their grief following the loss. Psychological follow-up might detect those women who are at risk of psychological complications following miscarriage. This review of six studies, involving 1001 women, found that there is insufficient evidence from randomised controlled trials to recommend any method of psychological follow-up. Timing of the counselling interventions varied from one week following miscarriage up to 11 weeks. In all studies the interventions were delivered by different professional groups including a midwife, psychologists and nurses. Measurements of the outcomes were made from one month to 12 months after miscarriage in the different studies, which highlights the uncertainty surrounding the rate of psychological recovery following miscarriage. The two larger studies included a complex combination of interventions and outcome measures so that any potentially significant effects may have been diluted. Further robust research is needed to determine if any recognised psychological follow-up is effective is hastening psychological recovery following miscarriage.

CochranePLS772

***TASK*** the task is to simplify the input abstract of a biomedical literature ***INPUT*** the input is the abstract of a biomedical literature ***OUTPUT*** the output is the simplified abstract for the input abstract of a biomedical literature ***DOCUMENTATION*** ***EXAMPLES*** Input: In this review, we included a total of five studies comparing supervised walking exercise and alternative modes of exercise. The alternative modes of exercise therapy included cycling, strength training, and upper-arm ergometry. The studies represented a sample size of 135 participants with a low risk of bias. Overall, there was no clear evidence of a difference between supervised walking exercise and alternative modes of exercise in maximum walking distance (8.15 METs, 95% confidence interval (CI) -2.63 to 18.94, P = 0.14, equivalent of an increase of 173 metres, 95% CI -56 to 401) on a treadmill with no incline and an average speed of 3.2 km/h, which is comparable with walking in daily life. Similarly, there was no clear evidence of a difference between supervised walking exercise and alternative modes of exercise in pain-free walking distance (6.42 METs, 95% CI -1.52 to 14.36, P = 0.11, equivalent of an increase of 136 metres, 95% CI -32 to 304). Sensitivity analysis did not alter the results significantly. Quality of life measures showed significant improvements in both groups; however, because of skewed data and the very small sample size of the studies, we did not perform a meta-analysis for health-related quality of life and functional impairment. There was no clear evidence of differences between supervised walking exercise and alternative exercise modes in improving the maximum and pain-free walking distance of patients with intermittent claudication. More studies with larger sample sizes are needed to make meaningful comparisons between each alternative exercise mode and the current standard of supervised treadmill walking. The results indicate that alternative exercise modes may be useful when supervised walking exercise is not an option for the patient. Output:

The present review shows that there are few studies comparing alternative modes of exercise training to the standard of supervised walking exercise. The review authors identified five studies that randomised a total of 135 participants. The alternative modes of exercise therapy included cycling, strength training, and upper-arm ergometry. Comparing these alternative modes of exercise with supervised walking exercise showed no clear evidence of a difference in maximum or pain-free walking distance between the groups. Quality of life measures showed significant improvements in both groups; however, we could not make a direct comparison because of limited data. This review shows that alternative modes of exercise therapy seem to yield similar results to supervised walking therapy. Therefore, they may be considered useful when supervised walking exercise is not an option for the patient. However, more randomised controlled trials are needed to make a meaningful comparison between the different modes of exercise therapy.

CochranePLS773

***TASK*** the task is to simplify the input abstract of a biomedical literature ***INPUT*** the input is the abstract of a biomedical literature ***OUTPUT*** the output is the simplified abstract for the input abstract of a biomedical literature ***DOCUMENTATION*** ***EXAMPLES*** Input: Thirteen trials (n=1154) investigated external beam radiotherapy with dosages ranging from 7.5 to 24 Gy; one additional trial (n=88) used plaque brachytherapy (15Gy at 1.75mm for 54 minutes/12.6 Gy at 4mm for 11 minutes). Most studies found effects (not always significant) that favoured treatment. Overall there was a small statistically significant reduction in risk of visual acuity loss in the treatment group. There was considerable inconsistency between trials and the trials were considered to be at risk of bias, in particular because of the lack of masking of treatment group. Subgroup analyses did not reveal any significant interactions, however, there were small numbers of trials in each subgroup (range three to five). There was some indication that trials with no sham irradiation in the control group reported a greater effect of treatment. The incidence of adverse events was low in all trials; there were no reported cases of radiation retinopathy, optic neuropathy or malignancy. Three trials found non-significant higher rates of cataract progression in the treatment group. This review currently does not provide convincing evidence that radiotherapy is an effective treatment for neovascular AMD. If further trials are to be considered to evaluate radiotherapy in AMD then adequate masking of the control group must be considered. Output:

This review identified 14 randomised controlled trials of radiotherapy for wet AMD. Most of these trials showed effects (not always significant) that favoured treatment with radiotherapy to prevent vision loss. However, overall this review does not provide convincing evidence that radiotherapy is an effective treatment for wet AMD, in part because the results of different trials were inconsistent, but also because it is possible that the treatment effects could be explained by the fact that it was not possible to mask the participants, and people measuring outcome, to the treatment group. The incidence of adverse effects reported in these trials was low - nobody developed any radiation-specific side effects although in three trials higher rates of cataract were reported in the radiotherapy group.

CochranePLS774

***TASK*** the task is to simplify the input abstract of a biomedical literature ***INPUT*** the input is the abstract of a biomedical literature ***OUTPUT*** the output is the simplified abstract for the input abstract of a biomedical literature ***DOCUMENTATION*** ***EXAMPLES*** Input: We included 69 trials that randomly assigned 7863 participants. Twenty-two trials compared the same beta lactam in both study arms, while the remaining trials compared different beta lactams using a broader-spectrum beta lactam in the monotherapy arm. In trials comparing the same beta lactam, we observed no difference between study groups with regard to all-cause mortality (RR 0.97, 95% CI 0.73 to 1.30) and clinical failure (RR 1.11, 95% CI 0.95 to 1.29). In studies comparing different beta lactams, we observed a trend for benefit with monotherapy for all-cause mortality (RR 0.85, 95% CI 0.71 to 1.01) and a significant advantage for clinical failure (RR 0.75, 95% CI 0.67 to 0.84). No significant disparities emerged from subgroup and sensitivity analyses, including assessment of participants with Gram-negative infection. The subgroup of Pseudomonas aeruginosa infections was underpowered to examine effects. Results for mortality were classified as low quality of evidence mainly as the result of imprecision. Results for failure were classified as very low quality of evidence because of indirectness of the outcome and possible detection bias in non-blinded trials. We detected no differences in the rate of development of resistance. Nephrotoxicity was significantly less frequent with monotherapy (RR 0.30, 95% CI 0.23 to 0.39). We found no heterogeneity for all these comparisons. We included a small subset of studies addressing participants with Gram-positive infection, mainly endocarditis. We identified no difference between monotherapy and combination therapy in these studies. The addition of an aminoglycoside to beta lactams for sepsis should be discouraged. All-cause mortality rates are unchanged. Combination treatment carries a significant risk of nephrotoxicity. Output:

We searched the literature until November 2013. We included in the review 69 trials that randomly assigned 7863 participants . Participants were hospitalized with urinary tract, intra-abdominal, skin and soft tissue infections, pneumonia and infections of unknown source. One set of studies compared a broad-spectrum beta lactam versus a different, generally narrower-spectrum beta lactam combined with an aminoglycoside (47 studies). No clear difference in all-cause deaths was observed, but treatment failures were fewer with single beta lactam antibiotic treatment. A significant survival advantage was seen with single therapy in studies that involved infections of unknown source. The other studies compared one beta lactam versus the same beta lactam combined with an aminoglycoside antibiotic (22 studies). In these trials, no differences between single and combination antibiotic treatments were seen. Overall, adverse event rates did not differ between the study groups, but renal damage was more frequent with the combination therapy. Combination therapy did not prevent the development of secondary infection. The review authors concluded that beta lactam-aminoglycoside combination therapy does not provide an advantage over beta lactams alone. Furthermore, combination therapy was associated with an increased risk of renal damage. The limited number of trials comparing the same beta lactam in both study arms and the fact that more than a third of the studies did not report on all-cause deaths may limit these conclusions. The subgroup of Pseudomonas aeruginosa infections was underpowered to examine effects.

CochranePLS775

***TASK*** the task is to simplify the input abstract of a biomedical literature ***INPUT*** the input is the abstract of a biomedical literature ***OUTPUT*** the output is the simplified abstract for the input abstract of a biomedical literature ***DOCUMENTATION*** ***EXAMPLES*** Input: We included four studies with a total of 746 participants. All studies included adult patients undergoing surgery for primary tumour resection. Two studies enrolled male and female participants undergoing major abdominal surgery for cancer. One study enrolled male participants undergoing surgery for prostate cancer, and one study male participants undergoing surgery for colon cancer. Follow-up time ranged from nine to 17 years. All four studies compared general anaesthesia alone versus general anaesthesia combined with epidural anaesthesia and analgesia. All four studies are secondary data analyses of previously conducted prospective randomized controlled trials. Of the four included studies, only three contributed to the outcome of overall survival, and two each to the outcomes of progression-free survival and time to tumour progression. In our meta-analysis, we could not find an advantage for either study group for the outcomes of overall survival (hazard ratio (HR) 1.03, 95% confidence interval (CI) 0.86 to 1.24) and progression-free survival (HR 0.88, 95% CI 0.56 to 1.38). For progression-free survival, the level of inconsistency was high. Pooled data for time to tumour progression showed a slightly favourable outcome for the control group (general anaesthesia alone) compared with the intervention group (epidural and general anaesthesia) (HR 1.50, 95% CI 1.00 to 2.25). Quality of evidence was graded low for overall survival and very low for progression-free survival and time to tumour progression. The outcome of overall survival was downgraded for serious imprecision and serious indirectness. The outcomes of progression-free survival and time to tumour progression were also downgraded for serious inconsistency and serious risk of bias, respectively. Reporting of adverse events was sparse, and data could not be analysed. Currently, evidence for the benefit of regional anaesthesia techniques on tumour recurrence is inadequate. An encouraging number of prospective randomized controlled trials are ongoing, and it is hoped that their results, when reported, will add evidence for this topic in the near future. Output:

We found four studies with a total of 746 adult men and women undergoing abdominal surgery for removal of cancer. All studies were reanalyses of previously conducted trials, which means that none of the included studies was actually designed to investigate tumour recurrence. All patients underwent primary cancer surgery, which means that surgery on cancer metastases was not included. A total of 354 participants received general anaesthesia and 392 participants received a general anaesthesia along with an epidural anaesthesia. Epidural anaesthesia is a certain type of regional anaesthesia by which a numbing medication is injected continuously via a catheter into the epidural space. The epidural space serves as the outermost surrounding of the spinal cord. Numbing medication injected into the epidural space causes certain parts of the belly area to go numb and be insensitive to pain. Study participants were followed for at least 7.8 years after they had undergone cancer surgery. We did not find a benefit for either study group on cancer recurrence or survival. Because of incomplete reporting and the low number of reported adverse events, we cannot estimate possible differences in adverse effects between the different anaesthesia techniques used. The quality of the evidence for outcomes was graded low for overall survival and very low for progression-free survival and time to tumour progression. The main limitations of the evidence we identified were that the results could have been influenced by the background treatments given to people who participated in the trials.

CochranePLS776

***TASK*** the task is to simplify the input abstract of a biomedical literature ***INPUT*** the input is the abstract of a biomedical literature ***OUTPUT*** the output is the simplified abstract for the input abstract of a biomedical literature ***DOCUMENTATION*** ***EXAMPLES*** Input: We found no RCTs on this topic. We included in this review 12 non-randomised studies that compared laparoscopic versus open distal pancreatectomy (1576 participants: 394 underwent laparoscopic distal pancreatectomy and 1182 underwent open distal pancreatectomy); 11 studies (1506 participants: 353 undergoing laparoscopic distal pancreatectomy and 1153 undergoing open distal pancreatectomy) provided information for one or more outcomes. All of these studies were retrospective cohort-like studies or case-control studies. Most were at unclear or high risk of bias, and the overall quality of evidence was very low for all reported outcomes. Differences in short-term mortality (laparoscopic group: 1/329 (adjusted proportion based on meta-analysis estimate: 0.5%) vs open group: 11/1122 (1%); OR 0.48, 95% CI 0.11 to 2.17; 1451 participants; nine studies; I2 = 0%), long-term mortality (HR 0.96, 95% CI 0.82 to 1.12; 277 participants; three studies; I2 = 0%), proportion of people with serious adverse events (laparoscopic group: 7/89 (adjusted proportion: 8.8%) vs open group: 6/117 (5.1%); OR 1.79, 95% CI 0.53 to 6.06; 206 participants; three studies; I2 = 0%), proportion of people with a clinically significant pancreatic fistula (laparoscopic group: 9/109 (adjusted proportion: 7.7%) vs open group: 9/137 (6.6%); OR 1.19, 95% CI 0.47 to 3.02; 246 participants; four studies; I2 = 61%) were imprecise. Differences in recurrence at maximal follow-up (laparoscopic group: 37/81 (adjusted proportion based on meta-analysis estimate: 36.3%) vs open group: 59/103 (49.5%); OR 0.58, 95% CI 0.32 to 1.05; 184 participants; two studies; I2 = 13%), adverse events of any severity (laparoscopic group: 33/109 (adjusted proportion: 31.7%) vs open group: 45/137 (32.8%); OR 0.95, 95% CI 0.54 to 1.66; 246 participants; four studies; I2 = 18%) and proportion of participants with positive resection margins (laparoscopic group: 49/333 (adjusted proportion based on meta-analysis estimate: 14.3%) vs open group: 208/1133 (18.4%); OR 0.74, 95% CI 0.49 to 1.10; 1466 participants; 10 studies; I2 = 6%) were also imprecise. Mean length of hospital stay was shorter by 2.43 days in the laparoscopic group than in the open group (MD -2.43 days, 95% CI -3.13 to -1.73; 1068 participants; five studies; I2 = 0%). None of the included studies reported quality of life at any point in time, recurrence within six months, time to return to normal activity and time to return to work or blood transfusion requirements. Currently, no randomised controlled trials have compared laparoscopic distal pancreatectomy versus open distal pancreatectomy for patients with pancreatic cancers. In observational studies, laparoscopic distal pancreatectomy has been associated with shorter hospital stay as compared with open distal pancreatectomy. Currently, no information is available to determine a causal association in the differences between laparoscopic versus open distal pancreatectomy. Observed differences may be a result of confounding due to laparoscopic operation on less extensive cancer and open surgery on more extensive cancer. In addition, differences in length of hospital stay are relevant only if laparoscopic and open surgery procedures are equivalent oncologically. This information is not available currently. Thus, randomised controlled trials are needed to compare laparoscopic distal pancreatectomy versus open distal pancreatectomy with at least two to three years of follow-up. Such studies should include patient-oriented outcomes such as short-term mortality and long-term mortality (at least two to three years); health-related quality of life; complications and the sequelae of complications; resection margins; measures of earlier postoperative recovery such as length of hospital stay, time to return to normal activity and time to return to work (in those who are employed); and recurrence of cancer. Output:

No randomised controlled trials have examined this topic. Randomised controlled trials are the best studies for finding out whether one treatment is better or worse than another because they ensure that similar types of people are receiving the treatments being assessed. In the absence of randomised controlled trials, we sought information from non-randomised studies. We identified 12 non-randomised studies that compared laparoscopic versus open distal pancreatectomy in a total of 1576 patients. One of these studies did not provide results in a useable way. Thus, we included 11 studies in which a total of 1506 patients underwent distal pancreatectomy. Some 353 patients underwent laparoscopic distal pancreatectomy, and 1153 patients underwent open distal pancreatectomy. In all studies, historical information was collected from hospital records (retrospective studies). In general, historical information is less reliable than newly collected (prospective) information and findings of randomised controlled trials. Differences in short-term deaths, long-term deaths, percentage of people with major complications, percentage of people with a pancreatic fistula (abnormal communication between the pancreas and other organs or the skin), recurrence of cancer at final time of follow-up of participants, percentage of people with any complications and percentage of patients in whom cancer was not completely removed were imprecise. Average length of hospital stay was shorter in the laparoscopic group than in the open group by about two days. However, this is not relevant until we can be sure that cancer cures are similar between laparoscopic surgery and open surgery. No studies have reported quality of life at any point in time, short-term recurrence of cancer, time to return to normal activity, time to return to work or blood transfusion requirements. The quality of the evidence was very low, mainly because it was not clear whether similar types of participants received laparoscopic and open distal pancreatectomy. In many studies, people with less extensive cancer received laparoscopic surgery, and those with more extensive cancer received open surgery. This makes study findings unreliable. Well-designed randomised controlled trials are necessary if we are to obtain good quality evidence on this topic.

CochranePLS777

***TASK*** the task is to simplify the input abstract of a biomedical literature ***INPUT*** the input is the abstract of a biomedical literature ***OUTPUT*** the output is the simplified abstract for the input abstract of a biomedical literature ***DOCUMENTATION*** ***EXAMPLES*** Input: Seven heterogeneous English language RCTs with reasonable quality were included. Three small studies (168 people) separately showed statistically significant but clinically unimportant pain relief for LLLT versus sham therapy for sub-acute and chronic low-back pain at short-term and intermediate-term follow-up (up to six months). One study (56 people) showed that LLLT was more effective than sham at reducing disability in the short term. Three studies (102 people) reported that LLLT plus exercise were not better than exercise, with or without sham in the short-term in reducing pain or disability. Two studies (90 people) reported that LLLT was not more effective than exercise, with or without sham in reducing pain or disability in the short term. Two small trials (151 people) independently found that the relapse rate in the LLLT group was significantly lower than in the control group at the six-month follow-up. No side effects were reported. Based on the heterogeneity of the populations, interventions and comparison groups, we conclude that there are insufficient data to draw firm conclusions on the clinical effect of LLLT for low-back pain. There is a need for further methodologically rigorous RCTs to evaluate the effects of LLLT compared to other treatments, different lengths of treatment, wavelengths and dosages. Output:

We included seven small studies with a total of 384 people with non-specific LBP of varying durations. Three studies (168 people) separately showed that LLLT was more effective at reducing pain in the short-term (less than three months), and intermediate-term (six months) than sham (fake) laser. However, the strength and number of treatments were varied and the amount of the pain reduction was small. Three studies (102 people) separately reported that LLLT with exercise was not better than exercise alone or exercise plus sham in short-term pain reduction. One study (56 people) showed that LLLT was more effective than sham at reducing disability in the short term. Three studies (102 people) compared LLLT plus exercise with exercise plus sham or exercise alone and did not show significant reduction in disability. Two studies (90 people) separately reported that LLLT was not more effective at reducing disability than exercise alone or exercise plus sham in the short-term. Based on these small trials, with different populations, LLLT doses and comparison groups, there are insufficient data to either support or refute the effectiveness of LLLT for the treatment of LBP. We were unable to determine optimal dose, application techniques or length of treatment with the available evidence. Larger trials that look specifically at these questions are required.

CochranePLS778

***TASK*** the task is to simplify the input abstract of a biomedical literature ***INPUT*** the input is the abstract of a biomedical literature ***OUTPUT*** the output is the simplified abstract for the input abstract of a biomedical literature ***DOCUMENTATION*** ***EXAMPLES*** Input: In this update we did not identify any new trials for inclusion. We included five RCTs with 208 participants in the review and meta-analysis. We also identified 17 non-RCTs comparing different types of antibiotic prophylaxis with placebo or no intervention in patients with basilar skull fractures. Most trials presented insufficient methodological detail. All studies included meningitis in their primary outcome. When we evaluated the five included RCTs, there were no significant differences between antibiotic prophylaxis groups and control groups in terms of reduction of the frequency of meningitis, all-cause mortality, meningitis-related mortality and need for surgical correction in patients with CSF leakage. There were no reported adverse effects of antibiotic administration, although one of the five RCTs reported an induced change in the posterior nasopharyngeal flora towards potentially more pathogenic organisms resistant to the antibiotic regimen used in prophylaxis. We performed a subgroup analysis to evaluate the primary outcome in patients with and without CSF leakage. We also completed a meta-analysis of all the identified controlled non-RCTs (enrolling a total of 2168 patients), which produced results consistent with the randomised data from the included studies. Using the GRADE approach, we assessed the quality of trials as moderate. Currently available evidence from RCTs does not support prophylactic antibiotic use in patients with basilar skull fractures, whether there is evidence of CSF leakage or not. Until more research is available, the effectiveness of antibiotics in patients with basilar skull fractures cannot be determined because studies published to date are flawed by biases. Large, appropriately designed RCTs are needed. Output:

This review examined five randomised controlled trials, comprising a total of 208 participants with basilar skull fracture, which compared those who received preventive antibiotic therapy with those who did not receive antibiotics, to establish how many participants developed meningitis. The evidence is current to June 2014. The available data did not support the use of prophylactic antibiotics, as there is no proven benefit of such therapy. There was a possible adverse effect of increased susceptibility to infection with more pathogenic (disease-causing) organisms. We suggest that research is needed to address this question, as there are too few studies available on this subject and they have overall design shortcomings and small combined numbers of participants studied. We ranked the evidence as being of moderate quality because it is based on randomised data, although with some methodological limitations in design that caused us to downgrade the quality of the trials.

CochranePLS779

***TASK*** the task is to simplify the input abstract of a biomedical literature ***INPUT*** the input is the abstract of a biomedical literature ***OUTPUT*** the output is the simplified abstract for the input abstract of a biomedical literature ***DOCUMENTATION*** ***EXAMPLES*** Input: Since the original version of this review we have identified 11 new studies in women. The one study identified in the earlier version of this review was excluded in this update as it did not meet our narrower inclusion criteria to include only interventions for the treatment, not prevention, of sexual dysfunction. In total 1509 female participants were randomised across 11 trials. All trials explored interventions following treatment either for gynaecological or breast cancer. Eight trials evaluated a psychotherapeutic or psycho-educational intervention. Two trials evaluated a pharmaceutical intervention and one pelvic floor exercises. All involved heterosexual women. Eight studies were at a high risk of bias as they involved a sample of fewer than 50 participants per trial arm. The trials varied not only in intervention content but in outcome measurements, thereby restricting combined analysis. In the trials evaluating a psychotherapeutic intervention the effect on sexual dysfunction was mixed; in three trials benefit was found for some measures of sexual function and in five trials no benefit was found. Evidence from the other three trials, two on different pharmaceutical applications and one on exercise, differed and was limited by small sample sizes. Only the trial of a pH-balanced vaginal gel found significant improvements in sexual function. The trials of pharmaceutical interventions measured harm: neither reported any. Only one psychological intervention trial reported that no harm occurred because of the intervention; the other trials of psychological support did not measure harm. Since the last version of this review, the new studies do not provide clear information on the impact of interventions for sexual dysfunction following treatments for cancer in women. The sexual dysfunction interventions in this review are not representative of the range that is available for women, or of the wider range of cancers in which treatments are known to increase the risk of sexual problems. Further evaluations are needed. Output:

We identified 11 new trials on interventions for women in September 2015. We excluded one trial that was included in the earlier version of this review because it assessed treatment for preventing sexual dysfunction and was no longer relevant to this review. Interventions differed in their content and how the researchers measured benefit. Eight of the interventions involved psychological support such as counselling on sexual matters, or peer support. One of the others was of a testosterone cream, another tested a vaginal pH-balanced gel and the other was of pelvic floor exercise. The findings from six of the trials are weak because they involved small numbers of women. Across the trials the impact on sexual function was different. This makes it difficult to derive clear conclusions. For instance, in those that evaluated a psychological support treatment, four studies found that it improved some measures of sexual function but not others, but five found that it did not improve sexual function according to any of the measures used. For the other interventions tested, only the trial of the vaginal gel found improvements in sexual function and no side effects were reported. Only one of the psychological interventions reported that no harm occurred because of the intervention. The other trials of psychological support did not assess harm. This is an important gap as some women may find it distressing to discuss personal sexual problems as part of their treatment. Further evaluations are needed for all interventions. Current studies have only explored effectiveness in women with gynaecological and breast cancers, but there is a risk of sexual problems after treatments for other cancers. New evaluations need to involve larger numbers of participants.

CochranePLS780

***TASK*** the task is to simplify the input abstract of a biomedical literature ***INPUT*** the input is the abstract of a biomedical literature ***OUTPUT*** the output is the simplified abstract for the input abstract of a biomedical literature ***DOCUMENTATION*** ***EXAMPLES*** Input: We found four RCTs eligible for inclusion in this review (248 eyes of 151 participants between the ages of 6 months to 22 years). All trials were assessed as having unclear risk of bias overall due to insufficient reporting of study methods. One trial was conducted in Canada and compared anteriorization of the inferior oblique muscle with resection versus anteriorization of the inferior oblique muscle alone; one in the USA compared superior rectus recession with posterior fixation suture versus superior rectus recession alone; and two in the Czech Republic compared anteriorization of the inferior oblique muscle versus myectomy of the inferior oblique muscle. Only one trial reported data that allowed analysis of the primary outcome for this review, the proportion of participants with treatment success. The difference between inferior oblique anteriorization plus resection versus inferior oblique anteriorization alone was uncertain when measured at least four months postoperatively (risk ratio 1.13, 95% confidence interval 0.60 to 2.11, 30 participants, very low-quality evidence). Three trials measured the magnitude of hyperdeviation, but did not provide sufficient data for analysis. All four trials reported a relatively low rate of adverse events; hypotropia, limited elevation, and need for repeat surgery were reported as adverse events associated with some of the surgical interventions. No trials reported any other secondary outcome specified for our review. The four trials included in this review assessed the effectiveness of five different surgical procedures for the treatment of DVD. Nevertheless, insufficient reporting of study methods and data led to methodological concerns that undermine the conclusions of all studies. There is a pressing need for carefully executed RCTs of treatment for DVD in order to improve the evidence for the optimal management of this condition. Output:

We conducted the search for studies on 3 August 2015. We found four randomized controlled trials (RCTs) of surgical treatment for DVD. We found no studies evaluating non-surgical treatments. One trial was conducted in Canada and compared a surgical repositioning procedure (anteriorization of the inferior oblique muscle) with or without resection; one in the USA compared surgical weakening of an eye muscle (superior rectus recession) with or without augmentation with a fixation suture; and two in the Czech Republic compared anteriorization of the inferior oblique muscle versus removal of a piece of the inferior oblique muscle (myectomy). Only one of the RCTs examined what we wanted to know: the proportion of participants who had surgical success. There was insufficient information available to determine the differences between any of the surgical procedures with respect to surgical success or any other outcome relevant to our review. The most common adverse events from the surgical procedures were downward drifting of the eye after surgery (hypotropia), limited upward movement of the eye, and need for repeat surgery. All four of the included studies had flaws in design, execution, or both that weaken their conclusions. There is a need for well-designed, rigorously conducted RCTs of treatments for DVD to provide more reliable evidence for the management of this condition.

CochranePLS781

***TASK*** the task is to simplify the input abstract of a biomedical literature ***INPUT*** the input is the abstract of a biomedical literature ***OUTPUT*** the output is the simplified abstract for the input abstract of a biomedical literature ***DOCUMENTATION*** ***EXAMPLES*** Input: Two RCTs including 85 participants met our inclusion criteria. One study included people with single untreated brain metastasis (n = 64), and the other included people with solitary brain metastasis (22 consented to randomisation and 21 were analysed). We identified a third trial reported as completed and pending results this may be included in future updates of this review. The two included studies were prematurely closed due to poor participant accrual. One study compared surgery plus whole brain radiotherapy (WBRT) versus stereotactic radiosurgery alone, and the second study compared surgery plus WBRT versus stereotactic radiosurgery plus WBRT. Meta-analysis was not possible due to clinical heterogeneity between trial interventions. The overall certainty of evidence was low or very low for all outcomes due to high risk of bias and imprecision. We found no difference in overall survival in either of the two comparisons. For the comparison of surgery plus WBRT versus stereotactic radiosurgery alone: HR 0.92, 95% CI 0.48 to 1.77; 64 participants, very low-certainty evidence. We downgraded the certainty of the evidence to very low due to risk of bias and imprecision. For the comparison of surgery plus WBRT versus stereotactic radiosurgery plus WBRT: HR 0.53, 95% CI 0.20 to 1.42; 21 participants, low-certainty evidence. We downgraded the certainty of the evidence to low due to imprecision. Adverse events were reported in both trial groups in the two studies, showing no differences for surgery plus WBRT versus stereotactic radiosurgery alone (RR 0.31, 95% CI 0.07 to 1.44; 64 participants) and for surgery plus WBRT versus stereotactic radiosurgery plus WBRT (RR 0.37, 95% CI 0.05 to 2.98; 21 participants). Most of the adverse events were related to radiation toxicities. We considered the certainty of the evidence from the two comparisons to be very low due to risk of bias and imprecision. There was no difference in progression-free survival in the study comparing surgery plus WBRT versus stereotactic radiosurgery plus WBRT (HR 0.55, 95% CI 0.22 to 1.38; 21 participants, low-certainty evidence). We downgraded the evidence to low certainty due to imprecision. This outcome was not clearly reported for the other comparison. In general, there were no differences in quality of life between the two studies. The study comparing surgery plus WBRT versus stereotactic radiosurgery plus WBRT found no differences after two months using the QLQ-C30 global scale (MD -10.80, 95% CI -44.67 to 23.07; 14 participants, very low-certainty evidence). We downgraded the certainty of evidence to very low due to risk of bias and imprecision. Currently, there is no definitive evidence regarding the effectiveness and safety of surgery versus stereotactic radiotherapy on overall survival, adverse events, progression-free survival and quality of life in people with single or solitary brain metastasis, and benefits must be decided on a case-by-case basis until well powered and designed trials are available. Given the difficulties in participant accrual, an international multicentred approach should be considered for future studies. Output:

We searched relevant databases up to 25 March 2018. We found two clinical trials with a total of 85 participants with either single or solitary brain metastasis. One trial included 64 participants with a single brain metastasis, and the other included participants with a solitary brain metastasis (22 of these consented to randomisation and 21 were analysed). Both studies were prematurely closed due to difficulties in finding participants meeting the inclusion criteria or agreeing to participate. One trial compared surgery plus whole brain radiotherapy (WBRT) versus stereotactic radiosurgery alone, and the second trial compared surgery plus WBRT versus stereotactic radiosurgery plus WBRT. Due to the small number of people included in the studies, neither study had sufficient power to detect differences in the effects of surgery versus stereotactic radiotherapy on overall survival, adverse events, progression-free survival or quality of life in participants with single or solitary brain metastasis. The certainty of the evidence was low or very low mainly because of imprecision and risk of bias since the number of people in each trial was very small and participants and researchers were aware of the trial intervention (not blinded studies), so this could have affected how the participants evaluated outcomes, such as some adverse events and quality of life. Even though blinding of participants is difficult due to the nature of the intervention, study authors did not mention other ways of reducing the risk of bias, such as blinding during data analysis.

CochranePLS782

***TASK*** the task is to simplify the input abstract of a biomedical literature ***INPUT*** the input is the abstract of a biomedical literature ***OUTPUT*** the output is the simplified abstract for the input abstract of a biomedical literature ***DOCUMENTATION*** ***EXAMPLES*** Input: Nineteen studies randomising a total of 2863 women were included in this review. There were three main comparison groups: 15 studies compared non-opioid drugs with placebo or no treatment (2133 women); three studies compared non-opioid drugs with opioids (563 women); and three studies compared one type of non-opioid drug with a different type or dose of non-opioid drug (590 women). Some of the studies included three or more groups and so have been put in more than one comparison. Overall, there was little difference between groups for most of the comparisons. Any differences observed for outcomes were mainly limited to one or two studies. Non-opioid drugs (sedatives) were found to offer better pain relief (mean difference (MD) -22.00; 95% confidence interval (CI) -35.86 to -8.14, one trial, 50 women), better satisfaction with pain relief (sedatives and antihistamines) (risk ratio (RR) 1.59; 95% CI 1.15 to 2.21, two trials, 204 women; RR 1.80; 95% CI 1.16 to 2.79, one trial, 223 women) and better satisfaction with the childbirth experience (RR 2.16; 95% CI 1.34 to 3.47, one trial, 40 women) when compared with placebo or no treatment. However, women having non-opioid drugs (NSAIDs or antihistamines) were less likely to be satisfied with pain relief compared with women having opioids (RR 0.50; 95% CI 0.27 to 0.94, one trial, 76 women; RR 0.73; 95% CI 0.54 to 0.98, one trial, 223 women). Women receiving the antihistamine hydroxyzine were more likely to express satisfaction with pain relief compared with the antihistamine promethazine (RR 1.21; 95% CI 1.02 to 1.43, one trial, 289 women). Women receiving sedatives were more likely to express satisfaction with pain relief compared with antihistamines (RR 1.52; 95% CI 1.06 to 2.17, one study, 157 women). The majority of studies were conducted over 30 years ago. The studies were at unclear risk of bias for most of the quality domains. Opioids appear to be superior to non-opioids in satisfaction with pain relief, while non-opioids appear to be superior to placebo for pain relief and satisfaction with the childbirth experience. There were little data and no evidence of a significant difference for any of the comparisons of non-opioids for safety outcomes. Overall, the findings of this review demonstrated insufficient evidence to support a role for non-opioid drugs on their own to manage pain during labour. Output:

There was little evidence on the effectiveness and safety of most non-opioid drugs. However, evidence from single trials or at most two trials, suggests that some non-opioid drugs may work in providing pain relief. Non-opioid drugs were found to offer better pain relief (sedatives: one trial, 50 women), better satisfaction with pain relief (sedatives and antihistamines: two trials, 204 women; one trial, 223 women respectively) and better satisfaction with the childbirth experience (sedatives: one trial, 40 women) when compared with placebo. Women taking non-opioid drugs (NSAIDs or antihistamines) were less likely to be satisfied with pain relief when compared with women receiving opioids (one trial, 76 women; one trial 223 women). Women having the antihistamine hydroxyzine were more satisfied with their pain relief than those taking the antihistamine promethazine (one trial, 289 women) and women having sedatives were more satisfied with their pain relief than those having antihistamines. There were little data and no evidence of a significant difference for any of the comparisons of non-opioids for safety outcomes. The majority of studies were conducted over 30 years ago and the quality of all studies was questionable. No study used paracetamol.

CochranePLS783

***TASK*** the task is to simplify the input abstract of a biomedical literature ***INPUT*** the input is the abstract of a biomedical literature ***OUTPUT*** the output is the simplified abstract for the input abstract of a biomedical literature ***DOCUMENTATION*** ***EXAMPLES*** Input: Eight trials met the inclusion criteria of this review, enrolling a total of 1612 participants. Three trials evaluated the effect of providing antihelminthics to all adults with HIV without knowledge of their helminth infection status, and five trials evaluated the effects of providing deworming drugs to HIV-positive individuals with confirmed helminth infections. Seven trials were conducted in sub-Saharan Africa and one in Thailand. Antihelminthics for people with unknown helminth infection status Providing antihelminthics (albendazole and praziquantel together or separately) to HIV-positive adults with unknown helminth infection status may have a small suppressive effect on mean viral load at six weeks but the 95% CI includes the possibility of no effect (difference in mean change −0.14 log10 viral RNA/mL, 95% CI −0.35 to 0.07, P = 0.19; one trial, 166 participants, low quality evidence). Repeated dosing with deworming drugs over two years (albendazole every three months plus annual praziquantel), probably has little or no effect on mean viral load (difference in mean change 0.01 log10 viral RNA, 95% CI: −0.03 to −0.05; one trial, 917 participants, moderate quality evidence), and little or no effect on mean CD4+ count (difference in mean change 2.60 CD4+ cells/µL, 95% CI −10.15 to 15.35; P = 0.7; one trial, 917 participants, low quality evidence). Antihelminthics for people with confirmed helminth infections Treating confirmed helminth infections in HIV-positive adults may have a small suppressive effect on mean viral load at six to 12 weeks following deworming (difference in mean change −0.13 log10 viral RNA, 95% CI −0.26 to −0.00; P = 0.04; four trials, 445 participants, low quality evidence). However, this finding is strongly influenced by a single study of praziquantel treatment for schistosomiasis. There may also be a small favourable effect on mean CD4+ cell count at 12 weeks after deworming in HIV-positive populations with confirmed helminth infections (difference in mean change 37.86 CD4+ cells/µL, 95% CI 7.36 to 68.35; P = 0.01; three trials, 358 participants, low quality evidence). Adverse events and mortality There is no indication that antihelminthic drugs impart additional risks in HIV-positive populations. However, adverse events were not well reported (very low quality evidence) and trials were underpowered to evaluate effects on mortality (low quality evidence). There is low quality evidence that treating confirmed helminth infections in HIV-positive adults may have small, short-term favourable effects on markers of HIV disease progression. Further studies are required to confirm this finding. Current evidence suggests that deworming with antihelminthics is not harmful, and this is reassuring for the routine treatment of confirmed or suspected helminth infections in people living with HIV in co-endemic areas. Further long-term studies are required to make confident conclusions regarding the impact of presumptively deworming all HIV-positive individuals irrespective of helminth infection status, as the only long-term trial to date did not demonstrate an effect. Output:

This Cochrane Review summarizes trials that evaluated the benefits and potential risks of providing deworming drugs (antihelminthics) to people infected with human immunodeficiency virus (HIV). After we searched for relevant trials up to 29 September 2015 we included eight trials that enrolled 1612 participants. What are deworming drugs and why might they delay HIV disease progression Deworming drugs are used to treat a variety of human helminth infections, such as soil-transmitted helminths, schistosomiasis, onchocerciasis, and lymphatic filariasis. In areas where these infections are common, the World Health Organization currently recommends that targeted populations are routinely treated every six to 12 months without prior confirmation of an individual's infection status. The use of empiric therapy, or treating all at-risk populations presumptively, is preferred to test-and-treat strategies because deworming drugs are inexpensive and well tolerated. Additionally, a strategy of testing before treatment is considered less cost-effective given that available diagnostic tests are relatively expensive and can exhibit poor sensitivity. Helminth infections are known to affect the human immune system. In people with HIV, some studies have suggested that helminth infections may reduce the number of CD4+ cells (which are a critical part of the immune response to HIV) and compromise a person's ability to control HIV viral replication. Thus, treatment of helminth infections could have important benefits for people living with HIV beyond the benefits observed in the general population as a result of deworming. What the evidence in this review suggests Treating all HIV-positive adults with deworming drugs without knowledge of their helminth infection status may have a small suppressive effect on viral load at six weeks (low quality evidence), but repeated dosing over two years appears to have little or no effect on either viral load (moderate quality evidence) or CD4+ cell count (low quality evidence). These findings are based on two included studies. Providing deworming drugs to HIV-positive adults with diagnosed helminth infection may result in a small suppressive effect on mean viral load at six to 12 weeks (low quality evidence) and a small favourable effect on mean CD4+ cell count at 12 weeks (low quality evidence). However, these findings are based on small studies and are strongly influenced by a single study of praziquantel for schistosomiasis. Further studies from different settings and populations are needed for confirmation. Adverse events were not well reported (very low quality evidence), and trials were too small to evaluate the effects on mortality (low quality evidence). However there is no suggestion that deworming drugs are harmful for HIV-positive individuals.

CochranePLS784

***TASK*** the task is to simplify the input abstract of a biomedical literature ***INPUT*** the input is the abstract of a biomedical literature ***OUTPUT*** the output is the simplified abstract for the input abstract of a biomedical literature ***DOCUMENTATION*** ***EXAMPLES*** Input: Sixteen studies (n = 1787) met inclusion criteria for the comparison systemic corticosteroid versus placebo and 13 studies contributed data (n = 1620). Four studies (n = 298) met inclusion criteria for the comparison oral corticosteroid versus parenteral corticosteroid and three studies contributed data (n = 239). The mean age of participants with COPD was 68 years, median proportion of males 82% and mean forced expiratory volume in one second (FEV1) per cent predicted at study admission was 40% (6 studies; n = 633). We judged risk of selection, detection, attrition and reporting bias as low or unclear in all studies. We judged risk of performance bias high in one study comparing systemic corticosteroid with control and in two studies comparing intravenous corticosteroid versus oral corticosteroid. Systemic corticosteroids reduced the risk of treatment failure by over half compared with placebo in nine studies (n = 917) with median treatment duration 14 days, odds ratio (OR) 0.48 (95% confidence interval (CI) 0.35 to 0.67). The evidence was graded as high quality and it would have been necessary to treat nine people (95% CI 7 to 14) with systemic corticosteroids to avoid one treatment failure. There was moderate-quality evidence for a lower rate of relapse by one month for treatment with systemic corticosteroid in two studies (n = 415) (hazard ratio (HR) 0.78; 95% CI 0.63 to 0.97). Mortality up to 30 days was not reduced by treatment with systemic corticosteroid compared with control in 12 studies (n = 1319; OR 1.00; 95% CI 0.60 to 1.66). FEV1, measured up to 72 hours, showed significant treatment benefits (7 studies; n = 649; mean difference (MD) 140 mL; 95% CI 90 to 200); however, this benefit was not observed at later time points. The likelihood of adverse events increased with corticosteroid treatment (OR 2.33; 95% CI 1.59 to 3.43). Overall, one extra adverse effect occurred for every six people treated (95% CI 4 to 10). The risk of hyperglycaemia was significantly increased (OR 2.79; 95% CI 1.86 to 4.19). For general inpatient treatment, duration of hospitalisation was significantly shorter with corticosteroid treatment (MD -1.22 days; 95% CI -2.26 to -0.18), with no difference in length of stay the intensive care unit (ICU) setting. Comparison of parenteral versus oral treatment showed no significant difference in the primary outcomes of treatment failure, relapse or mortality or for any secondary outcomes. There was a significantly increased rate of hyperglycaemia in one study (OR 4.89; 95% CI 1.20 to 19.94). There is high-quality evidence to support treatment of exacerbations of COPD with systemic corticosteroid by the oral or parenteral route in reducing the likelihood of treatment failure and relapse by one month, shortening length of stay in hospital inpatients not requiring assisted ventilation in ICU and giving earlier improvement in lung function and symptoms. There is no evidence of benefit for parenteral treatment compared with oral treatment with corticosteroid on treatment failure, relapse or mortality. There is an increase in adverse drug effects with corticosteroid treatment, which is greater with parenteral administration compared with oral treatment. Output:

We found 16 studies including over 1700 people with COPD who experienced a flare-up that required additional medical treatment that compared corticosteroid given by injections or tablets with dummy treatment. Four studies with nearly 300 people compared corticosteroid injections with corticosteroid tablets. More men than women took part in the studies and they were usually in their late 60s, with moderately severe symptoms of COPD. Most studies took place in hospitals, two in intensive care units with people who needed breathing support, and three studies involved people who were treated at home. The last search for studies to include in the review was done in May 2014. There were three studies where people knew which treatment they were getting, but otherwise studies were generally well designed. People treated with either corticosteroid injections or tablets compared with dummy treatment were less likely to experience treatment failure, 122 fewer people per 1000 treated, with a lower rate of relapse by one month. They had shorter stays in hospital if they did not require assisted ventilation in an intensive care unit, and their lung function and breathlessness improved more quickly during treatment. However, they had more adverse events while taking treatment, especially a temporary increase in glucose levels in blood. Corticosteroid treatment did not reduce the number of people who died within one month of their flare-up. In studies comparing two ways of giving corticosteroid, either by injections or tablets, there were no differences in treatment failure, the time in hospital or number of deaths after discharge; however, a temporary increase in glucose levels in blood was more likely with injections than tablets. There is high-quality evidence that is unlikely to be changed by future research that people who experience flare-ups of COPD benefit from treatment with corticosteroid given by injections or tablets with the increased risk of some temporary side effects.

CochranePLS785

***TASK*** the task is to simplify the input abstract of a biomedical literature ***INPUT*** the input is the abstract of a biomedical literature ***OUTPUT*** the output is the simplified abstract for the input abstract of a biomedical literature ***DOCUMENTATION*** ***EXAMPLES*** Input: We included three RCTs, one from New Zealand, one from Japan and one from China, published between 2015 and 2019. Together, these trials enrolled 114 adults (228 eyes). Two studies used a paired-eye (inter-eye comparison) design to evaluate the effects of a sham (control) IPL treatment relative to an actual IPL treatment. One study randomised individuals to either an IPL intervention combined with meibomian gland expression (MGX), or MGX alone (standard therapy). The study follow-up periods ranged from 45 days to nine months. None of the trials were at low risk of bias in all seven domains. The first authors of two included studies were in receipt of funding from patents or the manufacturers of IPL devices. The funding sources and declaration of interests were not given in the report of the third included trial. All three trials evaluated the effect of IPL on dry eye symptoms, quantified using the Standard Patient Evaluation of Eye Dryness (SPEED) questionnaire. Pooling data from two trials that used a paired-eye design, the summary estimate for these studies indicated little to no reduction in dry eye symptoms with IPL relative to a sham intervention (mean difference (MD) –0.33 units, 95% confidence interval (CI) –2.56 to 1.89; I² = 0%; 2 studies, 144 eyes). The other study was not pooled as it had a unit-of-analysis error, but reported a reduction in symptoms in favour of IPL (MD –4.60, 95% CI –6.72 to –2.48; 84 eyes). The body of evidence for this outcome was of very low certainty, so we are uncertain about the effect of IPL on dry eye symptoms. There were no relevant combinable data for any of the other secondary outcomes, thus the effect of IPL on clinical parameters relevant to dry eye disease are currently unclear. For sodium fluorescein TBUT, two studies indicated that there may be an improvement in favour of IPL (MD 2.02 seconds, 95% CI 0.87 to 3.17; MD 2.40 seconds, 95% CI 2.27 to 2.53; 172 eyes total; low-certainty evidence). We are uncertain of the effect of IPL on non-invasive tear break-up time (MD 5.51 seconds, 95% CI 0.79 to 10.23; MD 3.20, 95% CI 3.09 to 3.31 seconds; two studies; 140 eyes total; very low-certainty evidence). For tear osmolarity, one study indicated that there may be an improvement in favour of IPL (MD –7.00 mOsmol/L, 95% –12.97 to –1.03; 56 eyes; low-certainty evidence). We are uncertain of the effect of IPL on meibomian gland orifice plugging (MD –1.20 clinical units, 95% CI –1.24 to –1.16; 84 eyes; very low-certainty evidence). We are uncertain of the effect of IPL on corneal sodium fluorescein staining. One study reported no evidence of a difference between the IPL and sham intervention arms at three months of follow-up (P = 0.409), and a second study reported data favouring IPL (MD –1.00 units, 95% CI –1.07 to –0.93 units; 172 eyes in total; very low-certainty evidence). We considered the incidence of adverse events at the study endpoint, as a measure of safety. As most trials did not specifically report adverse events, the safety of IPL as a treatment for MGD could also not be determined with any certainty. Very low-certainty results from individual studies suggest some adverse effects that may be experienced by participants, include mild pain and burning, and the potential for partially losing eyelashes (due to clinician error). This systematic review finds a scarcity of RCT evidence relating to the effectiveness and safety of IPL as a treatment for MGD. Whether IPL is of value for modifying the symptoms or signs of evaporative dry eye disease is currently uncertain. Due to a lack of comprehensive reporting of adverse events, the safety profile of IPL in this patient population is also unclear. The current limitations in the evidence base should be considered by clinicians using this intervention to treat MGD, and outlined to individuals potentially undergoing this procedure with the intent of treating dry eye disease. The results of the 14 RCTs currently in progress will be of major importance for establishing a more definitive answer regarding the effectiveness and safety of IPL for treating MGD. We intend to update this review when results from these trials become available. Output:

we searched for studies that had been published up to 1 August 2019. We identified three randomised controlled trials (RCTs; clinical studies where people are randomly put into one of two or more treatment groups) involving 114 adults (228 eyes) from three countries (New Zealand, Japan and China) that had been published between 2015 and 2019. The maximum time that people in the studies were followed up for after the treatment was nine months. because of very low-quality evidence, we are unclear about the effect of IPL on dry eye symptoms. IPL may be helpful to improve some of the clinical signs of MGD (such as tear stability and tear composition - both signs of how healthy the tears produced by the eye are). We are uncertain about the effect of IPL on meibomian gland blockage or corneal sodium fluorescein staining. As most studies did not report side effects, we are uncertain about the safety of IPL as a treatment for MGD. Very low-quality results from individual studies suggest there may be some side effects, including mild eye pain and burning, and partially losing eyelashes (due to mistakes when using the IPL device). the evidence for how effective and safe IPL is for treating MGD was of low or very low quality. due to limited information in the clinical trials, we could not determine with certainty whether IPL treatment for MGD is effective or safe. The review findings indicate that more research is needed. It is important that eye care clinicians, and people considering having IPL as a dry eye treatment, are aware that there is limited high-quality research to understand whether the procedure is effective or safe.

CochranePLS786

***TASK*** the task is to simplify the input abstract of a biomedical literature ***INPUT*** the input is the abstract of a biomedical literature ***OUTPUT*** the output is the simplified abstract for the input abstract of a biomedical literature ***DOCUMENTATION*** ***EXAMPLES*** Input: Three placebo-controlled RCTs (714 adult participants) were included. The participants had moderate to severely active CD (CDAI 220 to 450). Two studies were rated as at low risk of bias and one study was rated as at unclear risk of bias. Seventy-six per cent (342/451) of adalimumab participants failed to achieve clinical remission at four weeks compared to 91% (240/263) of placebo participants (RR 0.85, 95% CI 0.79 to 0.90; high-certainty evidence). Forty-four per cent (197/451) of adalimumab participants compared to 66% (173/263) of placebo participants failed to achieve a 70-point clinical response at four weeks (RR 0.68, 95% CI 0.59 to 0.79; high-certainty evidence). At four weeks, 57% (257/451) of adalimumab participants failed to achieve a 100-point clinical response compared to 76% (199/263) of placebo participants (RR 0.77, 95% CI 0.69 to 0.86; high-certainty evidence). Sixty-two per cent (165/268) of adalimumab participants experienced an AE compared to 72% (188/263) of participants in the placebo group (RR 0.90, 95% CI 0.74 to 1.09; moderate-certainty evidence). Two percent (6/268) of adalimumab participants experienced a SAE compared to 5% (13/263) of participants in the placebo group (RR 0.44, 95% CI 0.17 to 1.15; low-certainty evidence). Lastly, 1% (3/268) of adalimumab participants withdrew due to AEs compared to 3% (8/268) of participants in the placebo group (RR 0.38, 95% CI 0.11 to 1.30; low-certainty evidence). Commonly reported adverse events included injection site reactions, abdominal pain, fatigue, worsening CD and nausea. Quality of life data did not allow for meta-analysis. Three studies reported better quality of life at four weeks with adalimumab (measured with either Inflammatory Bowel Disease Questionnaire or Short-Form 36; moderate-certainty evidence). Endoscopic remission and response, histologic remission and response, and steroid withdrawal were not reported in the included studies. High-certainty evidence suggests that adalimumab is superior to placebo for induction of clinical remission and clinical response in people with moderate to severely active CD. Although the rates of AEs, SAEs and withdrawals due to AEs were lower in adalimumab participants compared to placebo, we are uncertain about the effect of adalimumab on AEs due to the low number of events. Therefore, no firm conclusions can be drawn regarding the safety of adalimumab in CD. Futher studies are required to look at the long-term effectiveness and safety of using adalimumab in participants with CD. Output:

The researchers found three studies with a total of 714 adult (> 18 years) participants. These participants all had moderate to severely active Crohn's disease. A total of 451 participants were treated with adalimumab and 268 were treated with a placebo (a fake medication). More participants who were treated with adalimumab achieved remission or improvement of their symptoms than those who were treated with placebo. The rates of side effects (adalimumab: 62%, placebo: 72%), serious side effects (adalimumab: 2%, placebo: 5%) and study withdrawal due to side effects (adalimumab: 1%, placebo: 3%) were lower in adalimumab participants than placebo participants. Commonly reported side effects included injection site reactions, abdominal pain, fatigue, worsening Crohn's disease and nausea. High-certainty evidence suggests that treating participants with adalimumab is better than treating them with placebo for inducing remission and improving symptoms in people with moderate to severely active Crohn's disease. Side effects were lower in adalimumab participants compared to placebo. However, we are uncertain about the effect of adalimumab on side effects due to the low number of events, therefore, no firm conclusions can be drawn regarding the harms (side effects) of adalimumab in Crohn's disease. Futher studies are required to look at the long-term benefits and harms of using adalimumab in people with Crohn's disease.

CochranePLS787

***TASK*** the task is to simplify the input abstract of a biomedical literature ***INPUT*** the input is the abstract of a biomedical literature ***OUTPUT*** the output is the simplified abstract for the input abstract of a biomedical literature ***DOCUMENTATION*** ***EXAMPLES*** Input: Eight trials randomised 384 patients with chronic hepatitis C to glucocorticosteroids plus interferon versus interferon plus placebo/no intervention, glucocorticosteroids versus interferon, or glucocorticosteroids versus placebo. Glucocorticosteroids treatment given as short pre-treatment followed by interferon or as long-term parallel treatment combined with interferon versus interferon monotherapy had no significant effect on mortality (no deaths occurred; 342 patients), virological response at six months follow-up (RR 0.85; 95% CI 0.52 to 1.38; 38 patients), or biochemical response at six months follow-up (RR 0.95; 95% CI 0.84 to 1.06; 307 patients). There was no significant difference in serious adverse events between combination therapy versus interferon monotherapy (RR 4.76; 95% CI 0.24 to 93.19; 342 patients). Glucocorticosteroids versus interferon had no significant effect on mortality (RR 2.33; 95% CI 0.27 to 17.80; 13 patients) or virological response at follow-up (RR 1.17; 95% CI 0.86 to 1.58; 13 patients). We found no trials on glucocorticosteroids for acute hepatitis C. There is insufficient evidence neither to confirm nor exclude both beneficial and harmful effects of glucocorticosteroids for chronic hepatitis C with or without autoimmune disorders. This Review is not able to rule out potential serious adverse effects of glucocorticosteroids. Therefore, this Review cannot establish whether glucocorticosteroids treatment can be safely administrated for indications requiring glucocorticosteroids without analysing for hepatitis C virus. The effect of glucocorticosteroids for acute hepatitis C has not been examined in randomised trials. Output:

This review found no significant effect of glucocorticosteroids on chronic hepatitis, but the amount of data is sparse. Accordingly there is insufficient evidence to neither confirm nor exclude beneficial and harmful effects of glucocorticosteroids for hepatitis C. Further, the evidence is unclear as to whether glucocorticosteroids treatment can be safely administered for other diseases in patients with concomitant hepatitis C. The authors were unable to identify randomised clinical trials on glucocorticosteroids for acute hepatitis C.

CochranePLS788

***TASK*** the task is to simplify the input abstract of a biomedical literature ***INPUT*** the input is the abstract of a biomedical literature ***OUTPUT*** the output is the simplified abstract for the input abstract of a biomedical literature ***DOCUMENTATION*** ***EXAMPLES*** Input: We identified no trials comparing RFA versus placebo, no intervention, or liver transplantation. We identified and included 11 randomised clinical trials with 1819 participants that included four comparisons: RFA versus hepatic resection (three trials, 578 participants); RFA versus percutaneous ethanol injection (six trials, 1088 participants) including one three-armed trial that also investigated RFA versus acetic acid injection; RFA versus microwave ablation (one trial, 72 participants); and RFA versus laser ablation (one trial, 81 participants). Ten of the eleven included trials reported on the primary outcome of this review, overall survival. Rates of major complications or procedure-related deaths were reported in 10 trials. The overall risk of bias was considered low in five trials and high in six trials. For a subgroup analysis, we included only low risk of bias trials. Regarding the comparison RFA versus hepatic resection, there was moderate-quality evidence from two low risk of bias trials that hepatic resection seems more effective than RFA regarding overall survival (HR 0.56; 95% CI 0.40 to 0.78) and two-year survival (HR 0.38; 95% CI 0.17 to 0.84). However, if we included a third trial with high risk of bias, the difference became insignificant (overall survival: HR 0.71; 95% CI 0.44 to 1.15). With regards to the outcomes event-free survival and local progression, hepatic resection also yielded better results than RFA. However, the number of complications was higher in surgically treated participants (odds ratio (OR) 8.24; 95% CI 2.12 to 31.95). RFA seemed superior to percutaneous ethanol or acetic acid injection regarding overall survival (HR 1.64; 95% CI 1.31 to 2.07). The RR for mortality was also in favour of RFA, but did not reach statistical significance (150/490 (30.6%) people in the percutaneous ethanol or acetic acid group versus 119/496 (24.0%) people in the RFA group; RR 1.76; 95% CI 0.97 to 3.22). The proportion of adverse events did not differ significantly between RFA and percutaneous ethanol or acetic acid injection (HR 0.70; 95% CI 0.33 to 1.48). Trial sequential analyses revealed that the number of participants in the included trials was insufficient and that more trials are needed to assess the effects of RFA versus other interventions. The effects of RFA versus no intervention, chemotherapeutic treatment, or liver transplantation are unknown. We found moderate-quality evidence that hepatic resection is superior to RFA regarding survival. However, RFA might be associated with fewer complications and a shorter hospital stay than hepatic resection. We found moderate-quality evidence showing that RFA seems superior to percutaneous ethanol injection regarding survival. There were too sparse data to recommend or refute ablation achieved by techniques other than RFA. More randomised clinical trials with low risk of bias and low risks of random errors assessing the effect of RFA are needed. Output:

The review authors searched the medical literature in order to clarify the role of RFA for the treatment of hepatocellular carcinoma and to compare its benefits and harms with no treatment, placebo (a pretend treatment), or other treatments (such as hepatic resection, percutaneous ethanol injection (PEI), percutaneous acetic acid injection (PAI), laser or microwave ablation, and liver transplantation). We looked for randomised clinical trials (where people were allocated at random to one of two or more treatments groups) of people with hepatocellular carcinoma who were able to receive RFA. Evidence is current to September 2013. We found no trials comparing RFA versus no intervention, placebo, chemotherapy, or liver transplantation. The review authors found moderate-quality evidence from two trials with low risk of bias (where there was a low risk of a flaw in study design, method of collecting or interpreting results) randomising 578 patients suggesting that hepatic resection yielded better results regarding overall survival (the length of time that the patient remains alive), event-free survival (time that the person remains free of cancer or a certain symptom relating to cancer), and progression (time that the patient lives with cancer without it getting worse) compared with RFA. However, as resection is a more invasive procedure, resection has an eight times higher risk of major complications compared with RFA. Resected patients stayed twice as long in the hospital as the RFA patients. Moderate-quality evidence suggested that RFA prolongs survival and decreases recurrences (where the cancer returns) compared with PEI or PAI. This conclusion was based on data from six randomised clinical trials with 1088 participants. Some patients developed side effects such as fever, rash, and pain. These occurred at the same frequency in both treatment groups. We calculated the number of patients that would be required to judge a relative risk reduction (relative risk is a comparison of the risk of an event happening for one treatment group compared with another treatment group) for survival of 20%. The review authors found that for both comparisons, that is RFA versus PEI or PAI, and RFA versus resection, the number of patients in the included trials was too low to reach valid conclusions. No firm conclusion can be drawn from the comparison of RFA against other interventional techniques or combination approaches. The information provided by the single trials was limited. More randomised clinical trials with low risks of bias (that is low risks of systematic errors, leading to overestimation of benefits and underestimation of harms) and low risk of play of chance (that is random errors, leading to overestimation or underestimation of benefits and harms) are required.

CochranePLS789

***TASK*** the task is to simplify the input abstract of a biomedical literature ***INPUT*** the input is the abstract of a biomedical literature ***OUTPUT*** the output is the simplified abstract for the input abstract of a biomedical literature ***DOCUMENTATION*** ***EXAMPLES*** Input: We included eight RCTs, with 1083 participants. All studies compared a form of probiotic (Lactobacillus casei rhamnosus; Lactobacillus plantarum; Synbiotic 2000FORTE; Ergyphilus; combination Bifidobacterium longum + Lactobacillus bulgaricus + Streptococcus thermophilus) versus a control group (placebo; glutamine; fermentable fibre; peptide; chlorhexidine). The analysis of all RCTs showed that the use of probiotics decreased the incidence of VAP (odds ratio (OR) 0.70, 95% confidence interval (CI) 0.52 to 0.95, low quality evidence). However, the aggregated results were uncertain for ICU mortality (OR 0.84, 95% CI 0.58 to 1.22 very low quality evidence), in-hospital mortality (OR 0.78, 95% CI 0.54 to 1.14, very low quality evidence), incidence of diarrhoea (OR 0.72, 95% CI 0.47 to 1.09, very low quality evidence), length of ICU stay (mean difference (MD) -1.60, 95% CI -6.53 to 3.33, very low quality evidence), duration of mechanical ventilation (MD -6.15, 95% CI -18.77 to 6.47, very low quality evidence) and antibiotic use (OR 1.23, 95% CI 0.51 to 2.96, low quality evidence). Antibiotics for VAP were used for a shorter duration (in days) when participants received probiotics in one small study (MD -3.00, 95% CI -6.04 to 0.04). However, the CI of the estimated effect was too wide to exclude no difference with probiotics. There were no reported events of nosocomial probiotic infections in any included study. The overall methodological quality of the included studies, based on our 'Risk of bias' assessments, was moderate with half of the included studies rated as a 'low' risk of bias; however, we rated four included studies as a 'high' risk of bias across one or more of the domains. The study limitations, differences in probiotics administered and participants, and small sample sizes across the included studies mean that the power to detect a trend of overall effect may be limited and chance findings cannot be excluded. To explore the influence of some potential confounding factors in the studies, we conducted an intention-to-treat (ITT) analysis, which did not change the inference of per-protocol analysis. However, our sensitivity analysis did not indicate a significant difference between groups for instances of VAP. Evidence suggests that use of probiotics is associated with a reduction in the incidence of VAP. However, the quality of the evidence is low and the exclusion of the one study that did not provide a robust definition of VAP increased the uncertainty in this finding. The available evidence is not clear regarding a decrease in ICU or hospital mortality with probiotic use. Three trials reported on the incidence of diarrhoea and the pooled results indicate no clear evidence of a difference. The results of this meta-analysis do not provide sufficient evidence to draw conclusions on the efficacy and safety of probiotics for the prevention of VAP in ICU patients. Output:

We identified eight studies with 1083 participants comparing probiotics versus placebo for preventing VAP. The studies were conducted between 2006 and 2011 in China, France, Greece, Slovenia, Sweden, the UK and the USA, with funding from various sources including hospital/National Health Service, pharmaceuticals and the National Institutes of Health. In the studies that stated the gender ratios, there were 611 males and 378 females. The evidence is current to September 2014. The results from these trials show that probiotics are associated with a reduction in instances of VAP. However, the quality of the evidence is low and the exclusion of the one study that did not provide a robust definition of VAP increased the uncertainty in this finding. Results for all remaining reported outcomes (including mortality, incidence of diarrhoea, length of ICU stay, duration of mechanical ventilation and general antibiotic use) were uncertain between groups receiving either probiotics or placebo or standard treatment. Incidence of diarrhoea was reported in half of the included studies, which demonstrated no clear evidence of a difference between probiotics over standard care or placebo. The quality of the evidence was generally low to very low between studies. Due to the contradictions in the results from previously published systematic reviews and the uncertainty of these results, there is need for larger, well-designed and robustly reported studies.

CochranePLS790

***TASK*** the task is to simplify the input abstract of a biomedical literature ***INPUT*** the input is the abstract of a biomedical literature ***OUTPUT*** the output is the simplified abstract for the input abstract of a biomedical literature ***DOCUMENTATION*** ***EXAMPLES*** Input: Six studies involving 126 participants who completed the study protocols were included. Most studies recruited participants with severe to very severe COPD (mean forced expiratory volume in one second (FEV1) ranged from 26% to 48% predicted). There was an increase in percentage change peak and endurance exercise capacity with NIV during training (mean difference in peak exercise capacity 17%, 95% confidence interval (CI) 7% to 27%, 60 participants, low-quality evidence; mean difference in endurance exercise capacity 59%, 95% CI 4% to 114%, 48 participants, low-quality evidence). However, there was no clear evidence of a difference between interventions for all other measures of exercise capacity. The results for HRQL assessed using the St George's Respiratory Questionnaire do not rule out an effect of NIV (total score mean 2.5 points, 95% CI -2.3 to 7.2, 48 participants, moderate-quality evidence). Physical activity was not assessed in any study. There was an increase in training intensity with NIV during training of 13% (95% CI 1% to 27%, 67 participants, moderate-quality evidence), and isoload lactate was lower with NIV (mean difference -0.97 mmol/L, 95% CI -1.58mmol/L to -0.36 mmol/L, 37 participants, moderate-quality evidence). The effect of NIV on dyspnoea or the number of dropouts between interventions was uncertain, although again results were imprecise. No adverse events and no information regarding cost were reported. Only one study blinded participants, whereas three studies used blinded assessors. Adequate allocation concealment was reported in four studies. The small number of included studies with small numbers of participants, as well as the high risk of bias within some of the included studies, limited our ability to draw strong evidence-based conclusions. Although NIV during lower limb exercise training may allow people with COPD to exercise at a higher training intensity and to achieve a greater physiological training effect compared with exercise training alone or exercise training with sham NIV, the effect on exercise capacity is unclear. Some evidence suggests that NIV during exercise training improves the percentage change in peak and endurance exercise capacity; however, these findings are not consistent across other measures of exercise capacity. There is no clear evidence that HRQL is better or worse with NIV during training. It is currently unknown whether the demonstrated benefits of NIV during exercise training are clinically worthwhile or cost-effective. Output:

The evidence is current to November 2013. We included six studies involving 126 participants who completed the study protocols. Most studies recruited participants with severe to very severe COPD. The average age of participants ranged from 63 to 71 years. Cycling or treadmill exercise training was performed in the studies. The duration of exercise training programmes ranged from six to twelve weeks. The percentage change in peak exercise capacity increased by an average of 17% in three studies, and the percentage change in endurance exercise capacity by an average of 59% in two studies that provided NIV during training compared with training without NIV or training with sham NIV. However, these improvements in exercise capacity were not consistent findings as there was no clear evidence that NIV improved all other measures of exercise capacity. The results for quality of life were uncertain and our analysis did not exclude there being an effect with NIV during exercise training in two studies. Physical activity was not assessed in any of the studies. Non-invasive ventilation allowed participants to exercise at a higher training intensity (average of 13% higher) in three studies, and evidence of a greater training effect on the muscles was found in two studies, as a marker in the blood (isoload blood lactate) was significantly lower by an average of 0.97 mmol/L. No information regarding adverse events or cost was reported. It is currently unknown whether demonstrated benefits of NIV during exercise training are clinically worthwhile or cost-effective. This review was generally limited by the small number of included studies and the small numbers of participants within the included studies. The quality of the evidence was low for exercise capacity outcomes, largely because of issues with study design. Consequently, the effect of NIV during exercise training on exercise capacity is uncertain. The quality of the evidence for quality of life, training intensity and isoload blood lactate was moderate, and these findings can be interpreted with a greater degree of confidence.

CochranePLS791

***TASK*** the task is to simplify the input abstract of a biomedical literature ***INPUT*** the input is the abstract of a biomedical literature ***OUTPUT*** the output is the simplified abstract for the input abstract of a biomedical literature ***DOCUMENTATION*** ***EXAMPLES*** Input: Two studies were eligible for inclusion. In one study only one of our primary outcomes was available: the duration of cannula patency for the first cannula used per infant was slightly longer in the continuous infusion group, but not significantly so, with a mean difference of -4.3 hours (95% CI -18.2 to 9.7). In the second study, only one of our primary outcomes was available: the mean (SD) number cannulas used per infant in the first 48 hours was less in the intermittent flush group with a mean difference of -0.76 cannulas (95% CI -1.37 to -0.15). No results were available for any of our other primary outcomes: in the published report, results were reported per catheter rather than per infant, a number of infants received more than one intravenous catheter (39 infants received an unknown number of catheters). The overall duration of cannula patency was significantly longer in the intermittent flush group with a mean duration of patency in the intermittent flush group of 2.1 days (SD 1.0) compared with the continuous infusion group where the mean duration of patency was 1.0 days (SD 0.5) - Student's t test P value 0.0003. It is difficult to draw reliable conclusions given the way the data were analysed and reported in the two included studies. The reliability of the results is uncertain. However, given the caution in interpreting these data, it should also be noted that the use of intermittent flushes was not associated in either study with a decreased cannula life or any other disadvantages, thus lending some support for the use of intermittent flushing of cannulas in a selected population in neonatal nurseries. Output:

We aimed to find out which was the better way to keep a newborn baby's intravenous line open and working -- either running a continuous amount of intravenous fluid through it (continuous infusion) or giving a small amount of fluid through it every few hours (intermittent flush) only. One study showed no difference between the two approaches for keeping a baby's intravenous line open and working and one study showed an advantage for intermittent flushes. The studies, however, had some problems in how the data were analysed and reported. Therefore, we are uncertain as to how reliable the results are and further research should be undertaken.

CochranePLS792

***TASK*** the task is to simplify the input abstract of a biomedical literature ***INPUT*** the input is the abstract of a biomedical literature ***OUTPUT*** the output is the simplified abstract for the input abstract of a biomedical literature ***DOCUMENTATION*** ***EXAMPLES*** Input: Our primary objective was to assess effects of INO on mortality. We found no statistically significant effects of INO on longest follow-up mortality: 250/654 deaths (38.2%) in the INO group compared with 221/589 deaths (37.5%) in the control group (RR 1.04, 95% CI 0.9 to 1.19; I² statistic = 0%; moderate quality of evidence). We found no statistically significant effects of INO on mortality at 28 days: 202/587 deaths (34.4%) in the INO group compared with 166/518 deaths (32.0%) in the control group (RR 1.08, 95% CI 0.92 to 1.27; I² statistic = 0%; moderate quality of evidence). In children, there was no statistically significant effects of INO on mortality: 25/89 deaths (28.1%) in the INO group compared with 34/96 deaths (35.4%) in the control group (RR 0.78, 95% CI 0.51 to 1.18; I² statistic = 22%; moderate quality of evidence). Our secondary objective was to assess the benefits and harms of INO. For partial pressure of oxygen in arterial blood (PaO2)/fraction of inspired oxygen (FiO2), we found significant improvement at 24 hours (mean difference (MD) 15.91, 95% CI 8.25 to 23.56; I² statistic = 25%; 11 trials, 614 participants; moderate quality of evidence). For the oxygenation index, we noted significant improvement at 24 hours (MD -2.31, 95% CI -2.73 to -1.89; I² statistic = 0%; five trials, 368 participants; moderate quality of evidence). For ventilator-free days, the difference was not statistically significant (MD -0.57, 95% CI -1.82 to 0.69; I² statistic = 0%; five trials, 804 participants; high quality of evidence). There was a statistically significant increase in renal failure in the INO groups (RR 1.59, 95% CI 1.17 to 2.16; I² statistic = 0%; high quality of evidence). Evidence is insufficient to support INO in any category of critically ill patients with AHRF. Inhaled nitric oxide results in a transient improvement in oxygenation but does not reduce mortality and may be harmful, as it seems to increase renal impairment. Output:

We included in this updated review 14 trials with 1275 participants. We found the overall quality of trials to be moderate, with little information provided on how experiments were carried out. Results were limited, and most included trials were small. In most trials, we identified risk of misleading information. Thus, results must be interpreted with caution. The evidence is up-to-date to 18 November 2015. No strong evidence is available to support the use of INO to improve survival of adults and children with acute respiratory failure and low blood oxygen levels. In the present systematic review, we set out to assess the benefits and harms of its use in adults and children with acute respiratory failure. We identified 14 randomized trials comparing INO versus placebo or no intervention. We found no beneficial effects: despite signs of oxygenation and initial improvement, INO does not appear to improve survival and might be hazardous, as it may cause kidney function impairment.

CochranePLS793

***TASK*** the task is to simplify the input abstract of a biomedical literature ***INPUT*** the input is the abstract of a biomedical literature ***OUTPUT*** the output is the simplified abstract for the input abstract of a biomedical literature ***DOCUMENTATION*** ***EXAMPLES*** Input: Predominantly older people with trochanteric fractures were treated in the 11 included trials. One trial (65 participants undergoing fixation with a fixed nail-plate) found no statistically significant differences between osteotomy versus anatomical reduction. Four trials, involving 465 participants undergoing fixation with a sliding hip screw (SHS), compared osteotomy versus anatomical reduction. Osteotomy was associated with an increased operative blood loss and length of surgery. There were no statistically significant differences for mortality, morbidity or measures of anatomical deformity. Two trials (138 participants) compared SHS fixation of a trochanteric hip fracture augmented with cement against a standard fixation. There were no reoperations even for the four cases of fixation failure in the cement group. The cement group had significantly better quality of life scores at six months. One trial (200 participants) comparing compression versus no compression of a trochanteric fracture in conjunction with SHS fixation found no significant differences between the two groups. One trial (120 participants) found a tendency to improved outcomes with a hydroxyapatite coated lag screw, but none reached statistical significance. One trial (19 participants) reported reduced temperatures when using a modified reaming method. Another trial (50 participants) found reduced bone marrow intravascular embolism, detected by oesophageal ultrasound, when a Gamma nail was inserted with a distal pressure venting hole in the femur. There is inadequate evidence to support the use of osteotomy for internal fixation of a trochanteric hip fracture. Similarly, there is insufficient evidence to support the use of the other techniques examined in the trials included in this review. Output:

This review included 11 randomised or quasi-randomised trials. The majority of the participants were female, usually aged around 80 years. There were seven comparisons but the evidence for each of these was insufficient to draw conclusions. Thus, the review found that there was too little evidence from randomised trials to show which, if any, specific surgical techniques used during operations for extracapsular proximal femoral fractures are better.

CochranePLS794

***TASK*** the task is to simplify the input abstract of a biomedical literature ***INPUT*** the input is the abstract of a biomedical literature ***OUTPUT*** the output is the simplified abstract for the input abstract of a biomedical literature ***DOCUMENTATION*** ***EXAMPLES*** Input: One trial met the inclusion criteria; a placebo-controlled trial of 17,826 children and adults living in rural villages in Ghana and Tanzania (Africa) and Bangladesh (Asia). Villagers with no previous medical training were trained to recognize the symptoms of severe malaria, administer rectal artesunate and refer patients to hospital. The trained villagers were supervised during the trial period. In the African sites only children aged 6 to 72 months were enrolled, whereas in Bangladesh, older children and adults were also enrolled. In young children (aged 6 to 72 months) there were fewer deaths following rectal artesunate than with placebo (RR 0.74; 95% CI 0.59 to 0.93; one trial; 8050 participants; moderate quality evidence), while in older children and adults there were more deaths in those given rectal artesunate (RR 2.21; 95% CI 1.18 to 4.15; one trial; 4018 participants; low quality evidence). In Africa, only 56% of participants reached a secondary healthcare facility within six hours compared to over 90% in Asia. There were no differences between the intervention and control groups in the proportion of participants reaching a healthcare facility within six hours (RR 0.99; 95% CI 0.98 to 1.01; 12,068 participants), or in the proportion with parasitaemia (RR 1.00; 95% CI 0.98 to 1.02; 17,826 participants), or with coma or convulsions on arrival (RR 1.01; 95% CI 0.90 to 1.14; 12,068 participants). There are no existing trials that compare rectal versus intramuscular artesunate. In rural areas without access to injectable antimalarials rectal artesunate provided before transfer to a referral facility probably reduces mortality in severely ill young children compared to referral without treatment. However, the unexpected finding of possible higher mortality in older children and adults has to be taken into account in forming any national or local policies about pre-referral rectal artesunate. Output:

Only one trial evaluated rectal artesunate as pre-referral treatment. In the African sites only, children aged 6 to 72 months were included in the trial; while in the Asian trial site, older children and adults were included. Young children in the African and Asian trial sites (aged 6 to 72 months) had fewer deaths with rectal artesunate than with placebo (moderate quality evidence). However, in Asia among older children and adults, there were more deaths in those that received rectal artesunate (low quality evidence). In the African sites, 56% of children took longer than six hours to reach hospital whereas over 90% of people in the Asian site reached hospital within six hours. The unexpected finding of more deaths with rectal artesunate in older children and adults should be taken into account when forming national and local policies about pre-referral treatment.

CochranePLS795

***TASK*** the task is to simplify the input abstract of a biomedical literature ***INPUT*** the input is the abstract of a biomedical literature ***OUTPUT*** the output is the simplified abstract for the input abstract of a biomedical literature ***DOCUMENTATION*** ***EXAMPLES*** Input: Forty three trials involving 3957 women were included. There were 11 comparisons in this review. Pregnancy rates are reported here since results of live birth rates were lacking. Seven studies (n = 556) were pooled comparing gonadotrophins with anti-oestrogens showing significant higher pregnancy rates with gonadotrophins (OR 1.8, 95% CI 1.2 to 2.7). Five studies (n = 313) compared anti-oestrogens with aromatase inhibitors reporting no significant difference (OR 1.2 95% CI 0.64 to 2.1). The same could be concluded comparing different types of gonadotrophins (9 studies included, n = 576). Four studies (n = 415) reported that gonadotrophins alone are more effective than with the addition of a GnRH agonist (OR 1.8 95% CI 1.1 to 3.0). Data of three studies (n = 299) showed no convincing evidence of adding a GnRH antagonist to gonadotrophins (OR 1.5 95% CI 0.83 to 2.8). The results of two studies (n = 297) reported no evidence of benefit in doubling the dose of gonadotrophins (OR 1.2 95% 0.67 to 1.9) although the multiple pregnancy rates and OHSS rates were increased. For the remaining five comparisons only one or none studies were included. Robust evidence is lacking but based on the available results gonadotrophins might be the most effective drugs when IUI is combined with ovarian hyperstimulation. When gonadotrophins are applied it might be done on a daily basis. When gonadotrophins are used for ovarian stimulation low dose protocols are advised since pregnancy rates do not differ from pregnancy rates which result from high dose regimen, whereas the chances to encounter negative effects from ovarian stimulation such as multiples and OHSS are limited with low dose gonadotrophins. Further research is needed for each comparison made. Output:

Forty three trials involving 3957 women were included. The review compared different drugs for ovarian hyperstimulation showing that injections result in higher pregnancy rates compared with oral medication. However, the evidence for this result is not very strong. Furthermore, it showed that if stimulation is used it might be done with low dose injections, since multiple pregnancy rates were increased with high dose injections, without resulting in more pregnancies. This review does not show which injection should be used, since there is no convincing evidence of a difference. Finally, this review does not answer the question whether the addition of GnRH agonist or antagonist is useful.

CochranePLS796

***TASK*** the task is to simplify the input abstract of a biomedical literature ***INPUT*** the input is the abstract of a biomedical literature ***OUTPUT*** the output is the simplified abstract for the input abstract of a biomedical literature ***DOCUMENTATION*** ***EXAMPLES*** Input: The searches found 130 citations, from which we could identify 22 possibly relevant studies. From these, we could only include one study. This study had a relatively small sample size of 17 participants who received lorazepam or oxazepam and were drug free for one week before the trial started. The only usable data reported by this study were clinically important change in symptoms of catatonia measured as 50% improvement on the Visual Analogue Scale (VAS). There was no difference in the numbers of participants showing a clinically important change in their catatonic symptoms (RR 0.95, 95% CI 0.42 to 2.16; participants = 17; studies = 1; very low quality evidence). No data were reported for other important outcomes of hospital stay, clinically important change in satisfaction with care, global state, adverse effects or general functioning We did find a few studies meeting our inclusion criteria but they reported no usable data. We had to exclude these. Although poorly reported, these studies do illustrate that relevant studies have been undertaken — they are not impossible to design and conduct. Analysis of the results from this review, which was a head-to-head comparison of two benzodiazepine monotherapies, does not show a clear difference in effect. No data were available for benzodiazepines compared to placebo or standard care. The lack of usable data and very low quality of data available makes it impossible to draw firm conclusions and further studies with a high-quality methodology and reporting are required in order to determine more definitively the outcomes associated with benzodiazepine use in the clinical management of catatonia in persons with schizophrenia and other SMI. Output:

The Information Specialist from Cochrane Schizophrenia ran electronic searches of the group's specialised register (the most recent in February 2019) for trials that randomised people with catatonia occurring in conjunction with schizophrenia or other similar serious mental illnesses to receive either benzodiazepines or any of the following: other drugs, placebo, or electroconvulsive therapy. One hundred and thirty records were found and checked by the review authors. One trial was found in the search which met the review requirements and provided limited, very low quality usable data for one outcome only. This trial compared two benzodiazepines (lorazepam vs oxazepam) and found no clear difference between these two treatments for improvement in the symptoms of catatonia for people who have catatonia and schizophrenia or similar serious mental illness. There is insufficient high quality evidence available to answer the review question. More high quality research is needed.

CochranePLS797

***TASK*** the task is to simplify the input abstract of a biomedical literature ***INPUT*** the input is the abstract of a biomedical literature ***OUTPUT*** the output is the simplified abstract for the input abstract of a biomedical literature ***DOCUMENTATION*** ***EXAMPLES*** Input: We included 19 trials (5839 randomised participants); seven compared penicillin with cephalosporins, six compared penicillin with macrolides, three compared penicillin with carbacephem, one trial compared penicillin with sulphonamides, one trial compared clindamycin with ampicillin, and one trial compared azithromycin with amoxicillin in children. All included trials reported clinical outcomes. Reporting of randomisation, allocation concealment, and blinding was poor in all trials. The overall quality of the evidence assessed using the GRADE tool was low for the outcome 'resolution of symptoms' in the intention-to-treat (ITT) analysis and very low for the outcomes 'resolution of symptoms' of evaluable participants and for adverse events. We downgraded the quality of evidence mainly due to lack of (or poor reporting of) randomisation or blinding, or both, heterogeneity, and wide confidence intervals (CIs). There was a difference in symptom resolution in favour of cephalosporins compared with penicillin (evaluable patients analysis odds ratio (OR) for absence of resolution of symptoms 0.51, 95% CI 0.27 to 0.97; number needed to treat to benefit (NNTB) 20, N = 5, n = 1660; very low quality evidence). However, this was not statistically significant in the ITT analysis (OR 0.79, 95% CI 0.55 to 1.12; N = 5, n = 2018; low quality evidence). Clinical relapse was lower for cephalosporins compared with penicillin (OR 0.55, 95% CI 0.30 to 0.99; NNTB 50, N = 4, n = 1386; low quality evidence), but this was found only in adults (OR 0.42, 95% CI 0.20 to 0.88; NNTB 33, N = 2, n = 770). There were no differences between macrolides and penicillin for any of the outcomes. One unpublished trial in children found a better cure rate for azithromycin in a single dose compared to amoxicillin for 10 days (OR 0.29, 95% CI 0.11 to 0.73; NNTB 18, N = 1, n = 482), but there was no difference between the groups in ITT analysis (OR 0.76, 95% CI 0.55 to 1.05; N = 1, n = 673) or at long-term follow-up (evaluable patients analysis OR 0.88, 95% CI 0.43 to 1.82; N = 1, n = 422). Children experienced more adverse events with azithromycin compared to amoxicillin (OR 2.67, 95% CI 1.78 to 3.99; N = 1, n = 673). Compared with penicillin carbacephem showed better symptom resolution post-treatment in adults and children combined (ITT analysis OR 0.70, 95% CI 0.49 to 0.99; NNTB 14, N = 3, n = 795), and in the subgroup analysis of children (OR 0.57, 95% CI 0.33 to 0.99; NNTB 8, N = 1, n = 233), but not in the subgroup analysis of adults (OR 0.75, 95% CI 0.46 to 1.22, N = 2, n = 562). Children experienced more adverse events with macrolides compared with penicillin (OR 2.33, 95% CI 1.06 to 5.15; N = 1, n = 489). Studies did not report on long-term complications so it was unclear if any class of antibiotics was better in preventing serious but rare complications. There were no clinically relevant differences in symptom resolution when comparing cephalosporins and macrolides with penicillin in the treatment of GABHS tonsillopharyngitis. Limited evidence in adults suggests cephalosporins are more effective than penicillin for relapse, but the NNTB is high. Limited evidence in children suggests carbacephem is more effective than penicillin for symptom resolution. Data on complications are too scarce to draw conclusions. Based on these results and considering the low cost and absence of resistance, penicillin can still be regarded as a first choice treatment for both adults and children. All studies were in high-income countries with low risk of streptococcal complications, so there is need for trials in low-income countries and Aboriginal communities where risk of complications remains high. Output:

We included 19 trials (18 publications) that involved 5835 people. Trials studied different antibiotics for people with sore throat who tested positive for GABHS, and were aged from one month to 80 years. Nine trials included only children; and nine included people aged 12 years or older. Most studies were published over 15 years ago; all but one reported on clinical outcomes. Thirteen trials were supported by drug study funding - some received grants - others included people employed by drug companies. Five studies did not report funding. Antibiotic effects were similar, and all caused side effects (such as nausea and vomiting, rash), but there was no strong evidence to show meaningful differences between antibiotics. Studies did not report on long-term complications so it was unclear if any class of antibiotics was better in preventing serious but rare complications. All studies were in high-income countries with low risk of streptococcal complications, so there is a need for trials in low-income countries and Aboriginal communities where risk remains high. Our review supports the use of penicillin as a first choice antibiotic in patients with throat infections caused by GABHS. Evidence quality was low or very low for all outcomes when macrolides or cephalosporins were compared with penicillin. Evidence quality was downgraded because of concerns about randomisation and blinding, wide confidence intervals (estimates were not very precise) and statistical differences among studies that may impact on the validity of the estimate. Most study authors did not report enough information about methods to be sure there was no bias.

CochranePLS798

***TASK*** the task is to simplify the input abstract of a biomedical literature ***INPUT*** the input is the abstract of a biomedical literature ***OUTPUT*** the output is the simplified abstract for the input abstract of a biomedical literature ***DOCUMENTATION*** ***EXAMPLES*** Input: Two short-term studies involving 753 participants met the inclusion criteria. Only one study investigated the effects of pregabalin compared with lamotrigine in patients with newly diagnosed partial seizures, and the other study investigated the effects of pregabalin compared with gabapentin in hospitalised patients with refractory partial epilepsy. There were no studies on generalised-onset tonic-clonic seizures (with or without other generalised seizure types). We found that pregabalin was inferior in comparison to lamotrigine when measuring time to withdrawal due to inadequate seizure control after dose stabilisation from randomisation: hazard ratio (HR) 4.52; 95% confidence interval (CI) 1.93 to 10.60; time to achieve six-month remission after dose stabilisation from randomisation: HR 0.56; 95% CI 0.41 to 0.76; the proportion of participants who remained seizure-free for six or more continuous months: RR 0.76, 95% CI 0.67 to 0.87 (Europe: 0.83, 95% CI 0.69 to 0.99; Asia: RR 0.70, 95% CI 0.57 to 0.86; the Americas: RR 0.62, 95% CI 0.33 to 1.19); and time to first seizure after dose stabilisation from randomisation: HR 1.74; 95% CI 1.26 to 2.39. There was no significant difference in safety-related outcomes between pregabalin and lamotrigine, but more participants in the pregabalin group developed somnolence, weight increase and convulsion. Pregabalin was better than gabapentin when measuring time to withdrawal due to all reasons after randomisation: HR 0.25; 95% CI 0.11 to 0.57; and time to withdrawal due to inadequate seizure control after randomisation: HR 0.41; 95% CI 0.18 to 0.92. No significant difference was found in safety-related outcomes between pregabalin and gabapentin. But we found some limitations in the study design which may have had an influence on the results. Pregabalin seems to have similar tolerability but inferior efficacy in comparison to lamotrigine for newly diagnosed partial seizures. However, considering the limitations in the study design (such as the short-term follow-up and the low initial target dose selection), the results should be interpreted with caution. The available data were too limited to draw any conclusions between pregabalin and gabapentin. The result indicated that the treatment effects were influenced by the study regions. The clinical disadvantage of pregabalin was more prominent in Asia when compared with lamotrigine. We should determine whether pregabalin has ethnic differences in the treatment of epilepsy in the future. This review does not inform any treatment policy for patients with generalized onset tonic-clonic seizures. Further long-term trials are needed to investigate the genuine effectiveness of pregabalin as monotherapy. Output:

This systematic review evaluated the efficacy and tolerability of pregabalin in people with epilepsy. The review authors only included two, short-term randomised controlled trials involving 753 participants treated with pregabalin monotherapy for epilepsy. Studies included in this review suggested that pregabalin was inferior to lamotrigine but was better than gabapentin, but we found some limitations in the study design which may have had a great influence on the results. There is no strong evidence to support its monotherapy as a treatment for epilepsy. Long-term trials and high quality randomised clinical trials are needed to evaluate the efficacy and safety of pregabalin monotherapy for treating epilepsy.

CochranePLS799

***TASK*** the task is to simplify the input abstract of a biomedical literature ***INPUT*** the input is the abstract of a biomedical literature ***OUTPUT*** the output is the simplified abstract for the input abstract of a biomedical literature ***DOCUMENTATION*** ***EXAMPLES*** Input: We included 14 trials (17 comparisons) in the review; three trials involved multiple comparisons. Six trials, two of which had three comparison arms, (972 participants) compared hair removal (shaving, clipping, or depilatory cream) with no hair removal and found no statistically significant difference in SSI rates however the comparison is underpowered. Three trials (1343 participants) that compared shaving with clipping showed significantly more SSIs associated with shaving (RR 2.09, 95% CI 1.15 to 3.80). Seven trials (1213 participants) found no significant difference in SSI rates when hair removal by shaving was compared with depilatory cream (RR 1.53, 95% CI 0.73 to 3.21), however this comparison is also underpowered. One trial compared two groups that shaved or clipped hair on the day of surgery compared with the day before surgery; there was no statistically significant difference in the number of SSIs between groups however this comparison was also underpowered. We identified no trials that compared clipping with depilatory cream; or investigated application of depilatory cream at different pre-operative time points, or hair removal in different settings (e.g. ward, anaesthetic room). Whilst this review found no statistically significant effect on SSI rates of hair removal insufficient numbers of people have been involved in this research to allow confidence in a conclusion. When it is necessary to remove hair, the existing evidence suggests that clippers are associated with fewer SSIs than razors. There was no significant difference in SSI rates between depilatory creams and shaving, or between shaving or clipping the day before surgery or on the day of surgery however studies were small and more research is needed. Output:

Existing research studies are too small and methodologically flawed to allow us to draw strong conclusions; on the basis of existing evidence it is not clear whether hair removal pre-operatively affects rates of surgical site infections. However if hair has to be removed to facilitate surgery or the application of adhesive dressings, clipping rather than shaving appears to result in fewer surgical site infections.