GEM/cochrane-simplification huggingface dataset:
Abstract: We included four studies involving 644 pregnant women. Three studies were randomised controlled trials and one trial was a quasi-randomised study. A higher dose of oxytocin was associated with a significant reduction in length of labour reported from one trial (mean difference (MD) -3.50 hours; 95% confidence interval (CI) -6.38 to -0.62; one trial, 40 women). There was a decrease in the rate of caesarean section (risk ratio (RR) 0.62; 95% CI 0.44 to 0.86 four trials, 644 women) and an increase in the rate of spontaneous vaginal birth in the high-dose group (RR 1.35; 95% CI 1.13 to 1.62, three trials, 444 women), although for both of these outcomes there were inconsistencies between studies in the size of effect. When we carried out sensitivity analysis (temporarily removing a study at high risk of bias) the differences between groups were no longer statistically significant There were no significant differences between high- and low-dose regimens for instrumental vaginal birth, epidural analgesia, hyperstimulation, postpartum haemorrhage, chorioamnionitis or women's perceptions of experiences. For neonatal outcomes, there was no significant difference between groups for Apgar scores, umbilical cord pH, admission to special care baby unit, or neonatal mortality. The following outcomes were not evaluated in the included studies: perinatal mortality, uterine rupture, abnormal cardiotocography, women's pyrexia, dystocia and neonatal neurological morbidity. Higher-dose regimens of oxytocin (4 mU per minute or more) were associated with a reduction in the length of labour and in caesarean section, and an increase in spontaneous vaginal birth. However, there is insufficient evidence to recommend that high-dose regimens are advised routinely for women with delay in the first stage of labour. Further research should evaluate the effect of high-dose regimens of oxytocin for women delayed in labour and should include maternal and neonatal outcomes as well as the effects on women.

Plain-language summary: From the four randomised controlled trials involving 644 pregnant women that we included in this review, results indicate that a higher dose of oxytocin (4-7 mU per minute, compared with 1-2 mU per minute) reduced the length of labour and the rate of caesarean sections with increased spontaneous vaginal births, but the studies did not provide enough evidence on possible differences between the high- and low-dose regimens on adverse events including hyperstimulation of the uterus, and outcomes for the newborn infant. Only one trial reported on the possible effect on women. The overall quality of the included trials was mixed, but this might reflect how clinical trials were reported in the past. While the current evidence is promising and suggests that the high-dose regimens reduce the length of labour and the rate of caesarean sections, this evidence is not strong enough to recommend that high-dose regimens are used routinely for women delayed in labour. We recommend that further research is carried out.
Abstract: Despite extensive searching we found no randomised trials suitable for inclusion. Based on the available evidence a meaningful conclusion cannot be reached. The term "single brain metastasis" is used to describe a brain metastasis found in patients presenting with an inoperable lung cancer or from an uncontrolled primary tumour some time after diagnosis, and the term "solitary brain metastasis" is used when the brain metastasis is diagnosed some time after radical, potentially curative treatment. In the evaluated studies, we found that the criteria for the definition of solitary brain metastasis were not consistent. Some series combined patients with single and solitary brain metastasis. Some of the single arm or cohort studies came from single institutions where the availability of both techniques (radiosurgery and surgery) was not described. Therefore, it is possible that the most accessible technique might be used preferentially, reinforced by a general belief that the techniques are equivalent. This has prevented an appropriate treatment comparison, which should be made through a well designed phase III clinical trial.

Plain-language summary: This review set out to compare both techniques. Our literature search has shown that a well-designed randomised trial comparing surgery and radiosurgery for patients with solitary brain metastasis has never been performed. Therefore, this review has been unable to show any advantage of one treatment over the other for this group of patients.
Abstract: We included five studies with 1601 children in the review. Pooled analysis demonstrated that the following outcomes were comparable between the two groups: clinical cure at the end of therapy (RR 1.03, 95% CI 0.99 to 1.07); during therapy (RR 1.06, 95% CI 0.85 to 1.33) and at follow-up (RR 1.02, 95% CI 0.95 to 1.09); recurrent AOM (RR 1.21, 95% CI 0.52 to 2.81); compliance rate (RR 1.04, 95% CI 0.98 to 1.10) and overall adverse events (RR 0.92, 95% CI 0.52 to 1.63). When we performed subgroup analysis separately for trials with amoxicillin only and amoxicillin/clavulanate only, it showed that all important outcomes were comparable between once or twice daily groups and the three times daily group. The risk of bias amongst the five included studies was as follows: for random sequence generation we graded two studies as low and three unclear risk of bias; for allocation concealment all studies were at unclear risk of bias; for blinding (performance and detection bias) we graded four as high and one as unclear risk of bias; for incomplete outcome data (attrition bias) we graded two low, two high and one as unclear risk of bias; for reporting bias four were at low and one at high risk; and for ‘other’ bias four were at low and one at unclear risk of bias. This review showed that the results of using once or twice daily doses of amoxicillin, with or without clavulanate, were comparable with three doses for the treatment of AOM.

Plain-language summary: We identified five randomised clinical studies with 1601 children comparing two dosing schedules. Participants were aged 12 years or younger with AOM. The primary outcome was clinical cure rate in terms of resolution of otalgia and fever at the end of antibiotic therapy (days seven to 15). The secondary outcomes were clinical cure rate in terms of middle ear effusion during therapy, clinical cure rate post-treatment (one to three months) in terms of resolution of middle ear infection, AOM complications and adverse events to medication. The results showed that treating acute middle ear infection with either once/twice daily or three times daily amoxicillin, with or without clavulanate, has the same results using our outcome measures, including adverse events such as diarrhoea and skin reactions. The evidence is current to March 2013.
Abstract: Five studies met the criteria for inclusion in the review. Two of these were multi-intervention studies where the dietary intervention was one component of a wider programme of prevention, but where data on dietary behaviour change were reported. One of the single intervention studies was concerned with dental caries prevention. The other two concerned general health outcomes. There were no studies concerned with dietary change aimed at preventing tooth erosion. In four out of the five included studies a significant change in dietary behaviour was found for at least one of the primary outcome variables. There is some evidence that one-to-one dietary interventions in the dental setting can change behaviour, although the evidence is greater for interventions aiming to change fruit/vegetable and alcohol consumption than for those aiming to change dietary sugar consumption. There is a need for more studies, particularly in the dental practice setting, as well as greater methodological rigour in the design, statistical analysis and reporting of such studies.

Plain-language summary: We identified five studies. Two of these were concerned with diet advice given concerning general health (one was about alcohol and one was about fruit and vegetable consumption). In both these studies there was a change to healthier behaviour following the advice. We also identified three studies which attempted to change sugar consumption habits in order to reduce dental decay. However, in two out of these three studies there were also other types and forms of advice given at the same time, for example about toothbrushing. It was therefore impossible to say whether changes in diet came about because of the diet advice given or because they were subtly influenced by the other messages. For example: advice on toothbrushing might make patients more aware of their oral health resulting in changes to their diet. Most of the studies concerning sugar consumption are of relatively weak quality. The evidence for dietary advice aiming to change sugar consumption is poor. Further studies in this area should be considered.
Abstract: Eleven suitable trials that tested vigabatrin doses between 1000 mg and 6000 mg were identified and included in the analysis. There were 982 observations on 747 patients in the primary ITT analysis of treatment efficacy. Patients treated with vigabatrin were significantly more likely to obtain a 50% or greater reduction in seizure frequency compared with those treated with placebo (RR 2.58, 95% CI 1.87 to 3.57). Those treated with vigabatrin were also significantly more likely to have treatment withdrawn (RR 2.49, 95% CI 1.05 to 5.88), and were more likely to experience a number of side effects, significantly so for fatigue or drowsiness. There was some evidence of small study effect bias, with smaller studies tending to report greater estimates of RR than larger studies. It is possible, therefore, that the actual RR of obtaining 50% reduction in seizure frequency is less than that obtained by a meta-analysis of fully published studies. This review of randomised controlled trials showed that vigabatrin can reduce seizure frequency in people with drug-resistant partial epilepsy. Short-term follow-up of patients showed that some side effects were associated with its use. Further analysis of longer-term observational studies is required to evaluate how likely patients are to develop visual field defects and whether such side effects are associated with dose and duration of drug use.

Plain-language summary: These results were obtained from short-term randomised controlled trials. However, it should be noted that information that is not reported in this review, from longer-term follow-up studies of people using vigabatrin, has shown that its use is frequently associated with visual field defects which may go undetected.
Abstract: Ten studies (440 subfertile couples) were included. Results of the meta-analysis demonstrated no difference in outcome measures and adverse events in the routine use of adjuvant growth hormone in in-vitro fertilisation protocols. However, meta-analysis demonstrated a statistically significant difference in both live birth rates and pregnancy rates favouring the use of adjuvant growth hormone in in-vitro fertilisation protocols in women who are considered poor responders without increasing adverse events, OR 5.39, 95% CI 1.89 to 15.35 and OR 3.28, 95% CI 1.74 to 6.20 respectively. Although the use of growth hormone in poor responders has been found to show a significant improvement in live birth rates, we were unable to identify which sub-group of poor responders would benefit the most from adjuvant growth hormone. The result needs to be interpreted with caution, the included trials were few in number and small sample size. Therefore, before recommending growth hormone adjuvant in in-vitro fertilisation further research is necessary to fully define its role.

Plain-language summary: The review of trials found no evidence that growth hormone helps improve birth rates in women who are undergoing ovulation induction prior to in-vitro fertilisation. However there is some evidence of increased pregnancy and birth rates in women who are considered 'poor responders' to in-vitro fertilisation. More research is needed.
Abstract: We included six RCTs, with a total of 449 patients. In four studies (267 patients) the CL intervention resulted in reduced medical costs (in two studies the outcomes could be pooled: MD -352.55 US Dollars (95% CI -522.32 to -182.78)) and improved physical functioning (three studies, MD 5.71 (95% CI 4.11 to 7.31)). In two studies (182 patients) the intervention was a joint consultation with a psychiatrist in presence of the physician, and resulted in reduced severity of somatization symptoms, reduced medical consumption and improved social functioning. There is limited evidence that a CL is effective in terms of medical costs and improvement of physical functioning for patients with MUPS in primary care. The results are even less pronounced in patients with clinically less severe, but more meaningful, forms of MUPS and the results vary for other patient-related outcomes. All studies, except one, were performed in the United States and therefore the results can not be generalized directly to countries with other healthcare systems. Furthermore all studies were small and of only moderate quality. There is very limited evidence that a joint consultation with the patient by a psychiatrist in the presence of the physician, together with the provision of a CL, reduces severity of somatization symptoms and medical consumption.

Plain-language summary: In our review we found six studies, with a total of 449 patients, in which one of two interventions were applied. One intervention (four studies, 267 patients) was a CL following a consultation between the patient and the psychiatrist; the other (two studies, 182 patients) was a CL following a joint consultation between patient, psychiatrist and primary care physician. In each case comparison was against care as usual, provided by the primary care physician. The first intervention resulted in reduced medical costs (three studies) and improved physical functioning (three studies). We found evidence for a slight reduction in the severity of the MUPS, reduced medical consumption and improved social functioning following the second intervention, although in only one of two studies assessed. There are serious limitations in generalizability of the results to modern healthcare: most trials reported doctor-related outcomes with patient-related outcomes varying in results; the intervention appears to be far more effective for the most serious but rare disorders, and less so in the more common forms of MUPS; five of the six studies were performed in the United States and four studies before 1995. Furthermore the studied populations were small and five of the six studies were of moderate quality. Our final conclusion is that CLs may be helpful for physicians who treat patients with MUPS (based on the provider-related outcomes). However, until further studies are conducted to find out if the intervention results in improved patient-related outcomes, the overall effectiveness of CLs cannot be demonstrated.
Abstract: We included 14 trials with 1863 participants. Evidence from six studies showed that self management programmes improved quality of life in people with stroke (standardised mean difference (SMD) random effects 0.20, 95% confidence interval (CI) 0.00 to 0.41, P = 0.05; low quality evidence) and improved self efficacy (SMD, random effects 0.33, 95% CI 0.04 to 0.61, P = 0.03; low quality evidence) compared with usual care. Individual studies reported benefits for health-related behaviours such as reduced use of health services, smoking, and alcohol intake, as well as improved diet and attitude. However, there was no superior effect for such programmes in the domains of locus of control, activities of daily living, medication adherence, participation, or mood. Statistical heterogeneity was mostly low; however, there was much variation in the types and delivery of programmes. Risk of bias was relatively low for complex intervention clinical trials where participants and personnel could not be blinded. The current evidence indicates that self management programmes may benefit people with stroke who are living in the community. The benefits of such programmes lie in improved quality of life and self efficacy. These are all well-recognised goals for people after stroke. There is evidence for many modes of delivery and examples of tailoring content to the target group. Leaders were usually professionals but peers (stroke survivors and carers) were also reported - the commonality is being trained and expert in stroke and its consequences. It would be beneficial for further research to be focused on identifying key features of effective self management programmes and assessing their cost-effectiveness.

Plain-language summary: We found 14 studies up to April 2016 involving 1863 participants that looked at the benefits of these programmes for people with stroke. They were conducted in a variety of countries in a variety of formats - sometimes in groups, sometimes individually, and for varying time periods. We found that such programmes may improve the quality of life after stroke. People with stroke reported improvements in their ability to live the way they wanted and that they felt more empowered to take charge of their lives, rather than be dependent on other people for their happiness and satisfaction with life. There were no reports of any risks or negative effects. The majority of the studies were well conducted and represent credible evidence that self management programmes may benefit people with stroke who are living in the community.
Abstract: Eleven studies met the criteria for inclusion in this review, all were randomised clinical trials, two were double-blind. There were a total number of 1969 participants. The sequence generation was inadequate in one study, adequate in five studies and unclear in the remaining studies. The allocation of concealment was adequate in three studies and unclear in the remaining studies. Methadone appeared statistically significantly more effective than non-pharmacological approaches in retaining patients in treatment and in the suppression of heroin use as measured by self report and urine/hair analysis (6 RCTs, RR = 0.66 95% CI 0.56-0.78), but not statistically different in criminal activity (3 RCTs, RR=0.39; 95%CI: 0.12-1.25) or mortality (4 RCTs, RR=0.48; 95%CI: 0.10-2.39). Methadone is an effective maintenance therapy intervention for the treatment of heroin dependence as it retains patients in treatment and decreases heroin use better than treatments that do not utilise opioid replacement therapy. It does not show a statistically significant superior effect on criminal activity or mortality.

Plain-language summary: However the review found that people have withdrawn from trials when they are assigned to a drug-free program. Consequently, there are no trials comparing methadone maintenance treatment with drug-free methods other than methadone placebo trials, or comparing methadone maintenance with methadone for detoxification only. These trials show that methadone can reduce the use of heroin in dependent people, and keep them in treatment programs.
Abstract: We included eight RCTs (746 participants) in the review. The risk of bias in the studies was generally low. Five studies did not demonstrate any advantage in using a topical treatment prior to endoscopy. One study suggested that a vasoconstrictor alone should be used to reduce the general level of unpleasantness. Two studies did not compare treatment against placebo or no treatment, so it was not possible to draw meaningful conclusions from them. There may be some unpleasant side effects from the use of topical preparations, such as unpleasant taste. There was variation in the format of the outcome data and a lack of complete data; none of the included studies reported their results in a way that would allow pooling and we could not therefore perform meta-analysis. The included studies do not demonstrate any evidence to support the use of topical treatments prior to the use of a fibre-optic nasal endoscope. Some go as far as to suggest that these agents should not be used due to cost and unpleasant side effects. Five studies did not demonstrate any advantage in terms of reducing pain or discomfort when using a topical treatment prior to endoscopy. The absence of demonstrable effect may be due to relatively small patient groups. It is therefore possible that there is a small effect of using these sprays. Further research using standardised reporting methods is needed.

Plain-language summary: We looked for randomised controlled trials comparing any of these topical treatments with placebo, no treatment or another topical treatment in adult patients undergoing nasal pharyngolaryngoscopy (NPL). We included eight studies in the review (with a total of 746 patients). It was not possible to combine data from any of the studies, therefore we assessed the individual study results. Five of the studies did not demonstrate any advantage, in terms of reducing pain or discomfort, of using a topical treatment prior to endoscopy. One of these suggested that a vasoconstrictor (xylometazoline) alone reduced the level of "general unpleasantness". Two studies did not compare the treatment against placebo or no treatment. A final study actually suggested an increase in pain with the use of topical agents. There may be some unpleasant side effects from the use of topical preparations, such as unpleasant taste. Further standardised research is required.
Abstract: Five RCTs (295 participants) were included in this review. All were identified during the original review. The overall risk of bias was high for two RCTs and unclear for three. One RCT compared different proprietary alginate dressings (20 participants), three compared alginate and hydrocolloid dressings (215 participants), and one compared alginate and plain non-adherent dressings (60 participants). Follow-up periods were six weeks in three RCTs and 12 weeks in two. No statistically significant between-group differences were detected for any comparison, for any healing outcome. Meta-analysis was feasible for one comparison (alginate and hydrocolloid dressings), with data from two RCTs (84 participants) pooled for complete healing at six weeks: risk ratio 0.42 (95% confidence interval 0.14 to 1.21). Adverse event profiles were generally similar between groups (not assessed for alginate versus plain non-adherent dressings). The current evidence base does not suggest that alginate dressings are more or less effective in the healing of venous leg ulcers than hydrocolloid or plain non-adherent dressings, and there is no evidence to indicate a difference between different proprietary alginate dressings. However, the RCTs in this area are considered to be of low or unclear methodological quality. Further, good quality evidence is required from well designed and rigorously conducted RCTs that employ - and clearly report on - methods to minimise bias, prior to any definitive conclusions being made regarding the efficacy of alginate dressings in the management of venous leg ulcers.

Plain-language summary: We evaluated the evidence from five randomised controlled trials that compared either different brands of alginate dressings, or alginate dressings with other types of dressings. In terms of wound healing, we found no good evidence to suggest that there is any difference between different brands of alginate dressings, nor between alginate dressings and hydrocolloid or plain non-adherent dressings. Adverse events were generally similar between treatment groups (but not assessed for alginate versus plain non-adherent dressings). Overall, the current evidence is of low quality. Further, good quality evidence is required before any definitive conclusions can be made regarding the use of alginate dressings in the management of venous leg ulcers.