GEM/cochrane-simplification huggingface dataset:
Abstract: We identified one RCT that involved 40 participants, and addressed the timing of surgery for people with recently symptomatic carotid artery stenosis. It compared very early surgery with surgery performed after 14 days of the last symptomatic event. The overall quality of the evidence was very low, due to the small number of participants from only one trial, and missing outcome data. We found no statistically significant difference between the effects of very early or delayed surgery in reducing the combined risk of stroke and death within 30 days of surgery (risk ratio (RR) 3.32; confidence interval (CI) 0.38 to 29.23; very low-quality evidence), or the combined risk of perioperative death and stroke (RR 0.47; CI 0.14 to 1.58; very low-quality evidence). To date, no results are available to confirm the optimal timing for surgery. There is currently no high-quality evidence available to support either very early or delayed cerebral revascularization after a recent ischemic stroke. Hence, further randomized trials to identify which patients should undergo very urgent revascularization are needed. Future studies should stratify participants by age group, sex, grade of ischemia, and degree of stenosis. Currently, there is one ongoing RCT that is examining the timing of cerebral revascularization.

Plain-language summary: The searches are up-to-date to 26 January 2016. We found only one randomized trial that assessed the effect of the timing of surgery. It included a total of 40 participants, ranging in age from 47 to 84 years. From the limited evidence available, we cannot tell if the timing of surgery is an important factor in determining the outcome for individuals with recent symptoms from carotid artery narrowing. There is not enough evidence on the best time for surgical treatment for people with recent symptoms from carotid artery narrowing. The overall quality of the evidence was very low, due to the small number of participants from only one trial and missing outcome data. Further studies with a larger number of patients are needed.
Abstract: We included 13 studies with a total of 721 participants in the review. The studies were observational, 12 studies had only one relevant treatment arm and no control and for the one study with a control arm, very few details were given. The risk of bias was high and the certainty of evidence was graded as very low for all outcomes. Due to heterogeneity of data, meta-analysis was not performed and therefore the data were synthesised via a narrative summary. The evidence for benefit derived from PN was very low for survival and quality of life. All the studies measured overall survival and 636 (88%) of participants were deceased at the end of the study. However there were varying definitions of overall survival that yielded median survival intervals between 15 to 155 days (range three to 1278 days). Three studies used validated measures of quality of life. The results from assessment of quality of life were equivocal; one study reported improvements up until three months and two studies reported approximately similar numbers of participants with improvements and deterioration. Different quality of life scales were used in each of the studies and quality of life was measured at different time points. Due to the very low certainty of the evidence, we are very uncertain about the adverse events related to PN use. Adverse events were measured by nine studies and data for individual participants could be extracted from eight studies. This revealed that 32 of 260 (12%) patients developed a central venous catheter infection or were hospitalised because of complications related to PN. We are very uncertain whether HPN improves survival or quality of life in people with MBO as the certainty of evidence was very low for both outcomes. As the evidence base is limited and at high risk of bias, further higher-quality prospective studies are required.

Plain-language summary: The benefits of PN are uncertain as the evidence is of very low certainty, provided mainly by studies that only looked at people who received PN rather than comparing patients who received PN with those who did not. As we found no randomised controlled trials, we have included the results from 13 observational studies with a total of 721 participants. For 12 of the studies, there was only one relevant treatment group and no control group. Therefore, the results are only for people receiving PN and we have no information about those not receiving it. The average survival time for people on PN varied from three to 1278 days. Only three studies measured quality of life using a recognised measure. One study found quality of life improved and two studies found similar numbers of people both improved and deteriorated. However, the three studies monitored quality of life at different points in time and measured it in different ways. Side effects occurred in 12% of people in the eight studies that measured them. Further research is needed to find out if PN is of benefit to people with an inoperable blockage of the bowel caused by advanced cancer.
Abstract: We included 25 RCTs involving 4788 participants. Six of twelve trials showed that written information significantly improved knowledge about a medicine, compared with no written information. The inability to combine results means we cannot conclude whether written information was effective for increasing knowledge. The results for attitudinal and behavioural outcomes were mixed. No studies showed an adverse effect of medicines information. The combined evidence was not strong enough to say whether written medicines information is effective in changing knowledge, attitudes and behaviours related to medicine taking. There is some evidence that written information can improve knowledge. The trials were generally of poor quality, which reduces confidence in the results. Trials examining the effects of written information need to be better designed and use consistent and validated outcome measures. Trials should evaluate internet-based medicines information. It is imperative that written medicines information be based on best practice for its information design and content, which could improve its effectiveness in helping people to use medicines appropriately.

Plain-language summary: The findings of this review were inconclusive for a number of reasons. First, because the included trials measured different outcomes in different ways, we were unable to combine their results. Second, these trials presented the written information for patients in different ways, and most did not design the leaflets in a way that made them easy to read. Third, in many cases trials were not clearly reported, so we do not know if they were carried out correctly. Despite these limitations several trials, while using different types of information and different measures, found written information improved knowledge. This is encouraging for people who want to learn about their medicines from leaflets. None of the studies showed that written information was harmful. Future research needs to use improved methods, and needs to examine the same measures on many occasions. It is important that medicines information be well written and designed to maximise the possibility of improving knowledge. Consumers are increasingly seeking out health information, including information about medicines, on the internet, but we found no trials examining whether internet-based medicines information changed people's knowledge, attitudes, or behaviour.
Abstract: Of 1777 potential studies evaluated, only two Randomized Control Trials (123 patients) were included. ß-interferon treatment compared to placebo did not show differences regarding the proportion of patients with progression of the disease (RR 0.89, 95% CI 0.55 to1.43), and it was associated with a greater frequency of treatment-related adverse events (RR 1.90, 95% CI 1.45-2.48). One of the trials evaluated the MRI secondary outcome pre-specified in the protocol. This trial showed that at two years the numbers of active lesions on brain MRI scan in ß-interferon arm were significantly lower than in placebo arm (weighted mean difference -1.3, 95% CI -2.15 to -0.45, P = 0.003); also, the number of participants with active lesions was significantly higher in placebo arm vs. ß-interferon arm at two years (RR 0.43, 95% CI 0.22 to 0.86, P = 0.02). Limited data on the effect of ß-interferon treatment on PPMS exists. Only two single-centre placebo controlled trials of interferon beta have been done. Based on this review, the included studies showed that ß-interferon treatment was not associated with reduced disability progression in PPMS patients. However, the trial population was too small to allow definitive conclusions on the efficacy of ß-interferon therapy in PPMS patients. Larger research studies need to be done in patients with PPMS in order to clarify whether ß-interferon is effective in this population.

Plain-language summary: Among the pertinent medical literature only  two studies, comprising  a total of 123 participants,  met the criteria of the methodological quality necessary for their inclusion in this review. Taking into account  the disability progression, the analysis of the data showed that INF beta treatment in  patients with PPMS was  not associated with a reduction of  this parameter during the first two years of therapy. Adverse effects, mainly flu-like symptoms and injection site reactions, occurred frequently and were the same as  reported by the many studies on   IFN beta treatments in MS patients with different types of the disease. It is worth nothing that the patients’ population analysed was too small to allow a definitive conclusion on the efficacy of IFN beta therapy  in PPMS.
Abstract: Twenty-two eligible randomised trials were identified, of which 11 were crossover trials. The trials included 1099 women with 673 receiving an adrenergic drug (phenylpropanolamine in 11 trials, midodrine in two, norepinephrine in three, clenbuterol in another three, terbutaline in one, eskornade in one and Ro 115-1240 in one). No trials included men. The limited evidence suggested that an adrenergic agonist drug is better than placebo in reducing the number of pad changes and incontinence episodes, as well as improving subjective symptoms. In two small trials, the drugs also appeared to be better than pelvic floor muscle training, possibly reflecting relative acceptability of the treatments to women but perhaps due to differential withdrawal of women from the trial groups. There was not enough evidence to evaluate the use of higher compared to lower doses of adrenergic agonists nor the relative merits of an adrenergic agonist drug compared with oestrogen, whether used alone or in combination. Over a quarter of women reported adverse effects. There were similar numbers of adverse effects with adrenergics, placebo or alternative drug treatment. However, when these were due to recognised adrenergic stimulation (insomnia, restlessness and vasomotor stimulation) they were only severe enough to stop treatment in 4% of women. There was weak evidence to suggest that use of an adrenergic agonist was better than placebo treatment. There was not enough evidence to assess the effects of adrenergic agonists when compared to or combined with other treatments. Further larger trials are needed to identify when adrenergics may be useful. Patients using adrenergic agonists may suffer from minor side effects, which sometimes cause them to stop treatment. Rare but serious side effects, such as cardiac arrhythmias and hypertension, have been reported.

Plain-language summary: This review of 22 trials involving 673 women and seven different adrenergic drugs found weak evidence that adrenergic agonists may help stress urinary incontinence. Side effects do occur but are usually minor. Rarely, more serious adverse effects such as high blood pressure can occur. More evidence is needed to compare adrenergic drugs with other drugs for stress incontinence and also with pelvic floor muscle exercises.
Abstract: Of the 2077 references identified, 24 trials were included in this review. For electrostimulation compared with no treatment this review found that electrostimulation improved some aspects of functional motor ability and some aspects of motor impairment and normality of movement. In addition, there was a significant difference in favour of no treatment compared with electrostimulation for an aspect of functional motor ability. For electrostimulation compared with placebo this review found that electrostimulation improved an aspect of functional motor ability. For electrostimulation compared with conventional physical therapy this review found that electrostimulation improved an aspect of motor impairment. There were no statistically significant differences between electrostimulation and control treatment for all other outcomes. However, these results need to be interpreted with reference to the following: (1) the majority of analyses only contained one trial; (2) variation was found between included trials in time after stroke, level of functional deficit, and dose of electrostimulation; and (3) the possibility of selection and detection bias in the majority of included trials. At present, there are insufficient robust data to inform clinical use of electrostimulation for neuromuscular re-training. Research is needed to address specific questions about the type of electrostimulation that might be most effective, in what dose and at what time after stroke.

Plain-language summary: Electrostimulation is a potential treatment to improve recovery of movement control and functional ability after stroke but the results of this review are inconclusive. After stroke many people are unable to use their affected limbs in everyday activities such as walking, ascending/descending stairs, washing hair or opening a coffee jar. One way to improve recovery might be to train affected muscles by using electrostimulation. This review examined the findings of 24 randomised controlled trials of electrostimulation provided to improve the ability to voluntarily move the affected limb and/or use the affected limb in everyday activities. The available evidence suggests that when electrostimulation is compared to no treatment then there might be a small effect on some aspects of function in favour of electrostimulation. However, the majority of findings in favour of electrostimulation were found when it was compared to a group of stroke patients who were not receiving any treatment and for all but two of the outcomes examined there were no differences between either electrostimulation and placebo or between electrostimulation and another type of physical therapy. This review also found that there were many differences between randomised controlled trials in the types of stroke patients who were included, the doses of electrostimulation and the outcome measures used. This meant that many of the comparisons made in the review related to one randomised trial rather than two or more. In addition, the numbers of participants in trials were relatively small. The results of this review therefore need to be interpreted with caution.
Abstract: Two trials with a total of 529 patients met the inclusion criteria. Patients fulfilling the American Rheumatism Association 1987 RA diagnostic criteria were randomized to receive either infliximab 1mg/kg (with and without MTX), 3mg/kg(with and without MTX) , 10mg/kg of infliximab (with and without MTX) or placebo infusion plus MTX. Infusions were given every 4 or 8 weeks. After 6 months ACR 20, ACR 50 and ACR 70 response rates were significantly improved in all infliximab doses compared to control. The number needed to treat with infliximab to achieve an ACR 20, 50 or 70 response in patients with refractory RA under specialist care ranged from 2.94-3.33 for ACR 20, 3.57-4.76 for ACR 50 and 5.88 -12.5 for ACR 70 depending on the dose (3mg/kg or 10mg/kg given either every 4 or 8 weeks). Total withdrawals and withdrawals due to lack of efficacy were lower for all doses of infliximab versus controls. Withdrawals for adverse events and withdrawals for other reasons were not statistically significantly different for those receiving infliximab from control. Treatment with infliximab for 6 and 12 months significantly reduces RA disease activity and appeared to have an acceptable safety profile in these trials. Total radiographic scores improved, fewer patients showed radiographic progression, and more patients showed radiographic improvement with infliximab treatment at 12 months compared to controls. However, only 2 trials met the inclusion criteria, and these results are largely driven by the largest trial. The available efficacy and toxicity data is relatively short-term (6-12 months). In order to detect rare events that may be associated with infliximab, larger and longer term studies are required.

Plain-language summary: Infliximab is a relatively new disease modifying anti-rheumatic drug that inhibits tumour necrosis factor alpha. Short term (six to twelve month) studies suggest infliximab is well tolerated, and in combination with methotrexate, decreases disease activity in RA. Infliximab 3mg/kg or 10mg/kg, in combination with methotrexate, taken every 4 or 8 weeks for either 6 or 12 months, significantly improved disease activity as measured by tender and swollen joints and ACR response rates. Pain and physical function also improved compared to those taking methotrexate alone. Infliximab significantly reduced radiographic progression at 12 months.
Abstract: We included two separate German studies involving a total of 518 participants. One study was undertaken in the inpatient treatment of schizophrenia and the other in the treatment of people newly diagnosed with depression in primary care. Regarding the primary outcomes, one study reported statistically significant increases in patient satisfaction, the other study did not. There was no evidence of effect on clinical outcomes or hospital readmission rates in either study. Regarding secondary outcomes, there was an indication that interventions to increase shared decision making increased doctor facilitation of patient involvement in decision making, and did not increase consultation times. Nor did the interventions increase patient compliance with treatment plans. Neither study reported any harms of the intervention. Definite conclusions cannot be drawn, however, on the basis of these two studies. No firm conclusions can be drawn at present about the effects of shared decision making interventions for people with mental health conditions. There is no evidence of harm, but there is an urgent need for further research in this area.

Plain-language summary: We conducted thorough searches for randomised controlled trials (RCTs), quasi-randomised controlled trials (q-RCTs), controlled before-and-after studies (CBAs); and interrupted time series (ITS) studies of interventions to increase shared decision making in people with mental health conditions. We found two studies that met the inclusion criteria. Both studies were of good quality and made attempts to reduce potential sources of bias. We examined whether interventions to increase shared decision making affected patient satisfaction with treatment or care, led to better health outcomes or to patients being less likely to be readmitted to hospital. One of the studies indicated that the intervention increased patient satisfaction in the short term. One study indicated that doctor facilitation of consumer involvement in decision making was increased by the intervention, but no effects were found on the clinical or health service outcomes in either study. Neither study reported that shared decision making for people with mental health conditions is harmful. However, no firm conclusions can be drawn from these two studies on any of the outcomes measured and further research is needed.
Abstract: As a group, NSAIDs were more effective than placebo at reducing HMB but less effective than tranexamic acid, danazol or the levonorgestrel-releasing intrauterine system (LNG IUS). Treatment with danazol caused a shorter duration of menstruation and more adverse events than NSAIDs, but this did not appear to affect the acceptability of treatment, based on trials from 1980 to 1990. However, currently danazol is not a usual or recommended treatment for HMB. There was no clear evidence of difference between NSAIDs and the other treatments (oral luteal progestogen, ethamsylate, an older progesterone-releasing intrauterine system and the oral contraceptive pill (OCP), but most studies were underpowered. There was no evidence of a difference between the individual NSAIDs (naproxen and mefenamic acid) in reducing HMB. The evidence quality ranged from low to moderate, the main limitations being risk of bias and imprecision. NSAIDs reduce HMB when compared with placebo, but are less effective than tranexamic acid, danazol or LNG IUS. However, adverse events are more severe with danazol therapy. In the limited number of small studies suitable for evaluation, there was no clear evidence of a difference in efficacy between NSAIDs and other medical treatments such as oral luteal progestogen, ethamsylate, OCP or the older progesterone-releasing intrauterine system.

Plain-language summary: Authors search medical databases and identified 19 randomised controlled trials (RCTs; clinical studies where people are randomly put into one of two or more treatment groups) with 759 women that could be included in the review, but data from only nine trials were suitable for analyses. Women sought help for HMB when it affected their quality of life. Levels of prostaglandin (a naturally occurring hormone) are higher in women with HMB and are reduced by NSAIDs. The review of trials found that NSAIDs were modestly effective in reducing HMB, but other medicines, such as danazol, tranexamic acid and levonorgestrel-releasing intrauterine system (LNG IUS), are more effective. These results were based on a small number of low- to moderate-quality trials. The evidence quality ranged from low to moderate, the main limitations being poor reporting of study methods and imprecision resulting from small study numbers.