GEM/cochrane-simplification huggingface dataset:
Abstract: This review includes a total of 5142 participants (mostly inpatients) from 44 trials conducted between 1988 and 2009 (median study duration ˜ 12 weeks, risk of bias - moderate). We found that incidences of non-compliance were lower in the psychoeducation group in the short term (n = 1400, RR 0.52 CI 0.40 to 0.67, NNT 11 CI 9 to 16). This finding holds for the medium and long term. Relapse appeared to be lower in psychoeducation group (n = 1214, RR 0.70 CI 0.61 to 0.81, NNT 9 CI 7 to 14) and this also applied to readmission (n = 206, RR 0.71 CI 0.56 to 0.89, NNT 5 CI 4 to 13). Scale-derived data also suggested that psychoeducation promotes better social and global functioning. In the medium term, treating four people with schizophrenia with psychoeducation instead of standard care resulted in one additional person showing a clinical improvement. Evidence suggests that participants receiving psychoeducation are more likely to be satisfied with mental health services (n = 236, RR 0.24 CI 0.12 to 0.50, NNT 5 CI 5 to 8) and have improved quality of life. Psychoeducation does seem to reduce relapse, readmission and encourage medication compliance, as well as reduce the length of hospital stay in these hospital-based studies of limited quality. The true size of effect is likely to be less than demonstrated in this review - but, nevertheless, some sort of psychoeducation could be clinically effective and potentially cost beneficial. It is not difficult to justify better, more applicable, research in this area aimed at fully investigating the effects of this promising approach. Note: the 27 new citations in the awaiting classification section of the review may alter the conclusions of the review once assessed.

Plain-language summary: This review compares the efficacy of psychoeducation added to standard care as a means of helping severely mentally ill people with that of standard care alone. The evidence shows a significant reduction of relapse or readmission rates. There seems to be some suggestion that psychoeducation may improve compliance with medication, but the extent of improvement remains unclear. The findings show a possibility that psychoeducation has a positive effect on a person's well being and promotes better social function. In the medium term, treating four people with schizophrenia with psychoeducation instead of standard care resulted in one additional person showing a clinical improvement. The scarcity of studies made the comparison between the efficacy of different formats (programmes of 10 sessions or less or 11 or more, individual or group sessions) weak.
Abstract: We included six studies involving 119 participants. We combined studies that evaluated MP in addition to another treatment versus the other treatment alone. Mental practice in combination with other treatment appears more effective in improving upper extremity function than the other treatment alone (Z = 3.48, P = 0.0005; standardised mean difference (SMD) 1.37; 95% confidence interval (CI) 0.60 to 2.15). We attempted subgroup analyses, based on time since stroke and dosage of MP; however, numbers in each group were small. We evaluated the quality of the evidence with the PEDro scale, ranging from 6 to 9 out of 10; we determined the GRADE score to be moderate. There is limited evidence to suggest that MP in combination with other rehabilitation treatment appears to be beneficial in improving upper extremity function after stroke, as compared with other rehabilitation treatment without MP. Evidence regarding improvement in motor recovery and quality of movement is less clear. There is no clear pattern regarding the ideal dosage of MP required to improve outcomes. Further studies are required to evaluate the effect of MP on time post stroke, volume of MP that is required to affect the outcomes and whether improvement is maintained long-term. Numerous large ongoing studies will soon improve the evidence base.

Plain-language summary: Our review of six studies involving 119 participants provided limited evidence that mental practice, when added to traditional physical rehabilitation treatment, produced improved outcomes compared with the use of traditional rehabilitation treatment alone. The evidence to date shows the improvements are limited to measures of performance of real-life tasks appropriate to the upper limb (e.g. drinking from a cup, manipulating a door knob). It is not clear if mental practice added to physical practice produces improvements in the motor capacity of the upper limb (i.e. the ability to perform selected movements of the upper limb with strength, speed and/or co-ordination). Finally, there is no evidence available detailing either the components of the mental practice (e.g. How long should the mental practice sessions be? How many mental practice sessions are necessary?, etc) or the qualities of the survivor of a stroke (How long since onset of stroke? How much recovery is required?, etc) that are required to obtain a positive outcome. However, there is reason for optimism that some of the questions will be answered as there are several large trials currently ongoing.
Abstract: Five trials were identified and included in the meta-analysis. From one of the included trials only preliminary data are reported. The addition of chemotherapy to preoperative RT significantly increased grade III and IV acute toxicity (OR 1.68-10, P = 0.002) and marginally affected postoperative overall morbidity (OR 0.67-1.00, P = 0.05) while no differences were observed in postoperative mortality or anastomotic leak rate. Compared to preoperative RT alone, preoperative CRT significantly increased the rate of complete pathological response (OR 2.12-5.84, P < 0.00001) although this did not translate into a higher sphincter preservation rate (OR 0.92-1.30, P = 0.32). The incidence of local recurrence at five years was significantly lower in the CRT group compared to RT alone (OR 0.39-0.72, P < 0.001). No statistically significant differences were observed in DFS (OR 0.92-1.34, P = 0.27) or OS (OR 0.79-1.14, P = 0.58) at five years. Compared to preoperative RT alone, preoperative CRT enhances pathological response and improves local control in resectable stage II and III rectal cancer, but does not benefit disease free or overall survival. The effects of preoperative CRT on functional outcome and quality of life are incompletely understood and should be addressed in future trials.

Plain-language summary: It has been proven in clinical studies that this 'preoperative' radiotherapy improves the outcome in rectal cancer patients. Recently, several studies have investigated the combination of radiotherapy with chemotherapy (CRT) before surgery. In theory, adding chemotherapy enhances the antitumour activity of radiotherapy. This meta-analysis has summarized the results of five studies that compared preoperative RT alone with preoperative CRT in rectal cancer patients. All of these studies were randomized, which means that the decision to administer either RT or CRT was determined by chance (ballot draw). The results of the meta-analysis may be summarized as follows. Compared to RT alone, preoperative CRT leads to increased side effects during treatment. Also, postoperative complications are somewhat increased, although the risk of dying from postoperative complications is similar. Preoperative CRT is more effective in causing tumour shrinkage (downstaging), and in preventing local recurrence of the disease. However, addition of chemotherapy did not result in more sphincter preserving surgeries, and did not affect the overall survival in rectal cancer patients.
Abstract: Twenty-two trials (3142 episodes in 2372 patients) were included in the analyses. The mortality rate was similar when comparing oral to intravenous antibiotic treatment (RR 0.95, 95% CI 0.54 to 1.68, 9 trials, 1392 patients, median mortality 0, range 0% to 8.8%). Treatment failure rates were also similar (RR 0.96, 95% CI 0.86 to 1.06, all trials). No significant heterogeneity was shown for all comparisons but adverse events. The effect was stable in a wide range of patients. Quinolones alone or combined with another antibiotic were used with comparable results. Adverse reactions, mostly gastrointestinal, were more common with oral antibiotics. Based on the present data, oral treatment is an acceptable alternative to intravenous antibiotic treatment in febrile neutropenic cancer patients (excluding patients with acute leukaemia) who are haemodynamically stable, without organ failure, and do not have pneumonia, infection of a central line or a severe soft-tissue infection. The wide CI for mortality allows the present use of oral treatment in groups of patients with an expected low risk for mortality, and further research should be aimed at clarifying the definition of low risk patients.

Plain-language summary: This review of randomised controlled trials showed comparable death and failure rates for oral and intravenous antibiotics for low risk patients, those with solid tumours or chronic leukaemia or lymphoma, and independent of age, source of infection and severity of the neutropenia.
Abstract: Seven trials assessing 4556 women were identified. Three trials included women with stage one disease only, whereas four included women with more advanced disease. Meta-analysis of four trials showed that there was no significant difference in the risk of death at five years between adjuvant progestagen therapy and no further treatment (RR = 1.00, 95% CI 0.85 to 1.18). This conclusion is also robust to single trial analyses at 4 and 7 years and in one trial across all points in time using a hazard ratio (HR). There was also no significant difference between progestagen therapy and control in terms of the risk of death from endometrial cancer, cardiovascular disease and intercurrent disease. Relapse of disease appeared to be reduced by progestagen therapy in one trial (HR = 0.71, 95% CI 0.52 to 0.97 and 5 year RR = 0.74, 95% CI 0.58 to 0.96), but there was no evidence of a difference in disease recurrence in another trial at 7 years (RR = 1.34, 95% CI 0.79 to 2.27). There is no evidence to support the use of adjuvant progestagen therapy in the primary treatment of endometrial cancer. There have now been several RCTs which have failed to establish a role for adjuvant progestagen therapy after primary treatment for endometrial cancer and therefore, further trials in this field are probably not justified.

Plain-language summary: Endometrial (womb) cancer is the most common genital tract cancer in developed countries. Progestagen (a hormone) therapy is sometimes used following initial surgery to reduce the risk of recurrence. However, progestagens have been found to reduce one of the protective factors against heart disease and may also make tumours more resistant to radiotherapy. This review found no evidence to support the use of progestagen as an addition to surgery for newly diagnosed endometrial cancer. Progestagen can, however, prevent or delay recurrence of cancer in some patients.
Abstract: Eleven reports (relating to five possible trials) were found. We included one study (six trial reports) involving 256 women. Four other studies are ongoing. The included trial consisted of three treatment arms: probiotic with dietary intervention, placebo and dietary intervention, and dietary intervention alone; it was at a low risk of bias. The study reported primary outcomes of a reduction in the rate of gestational diabetes mellitus (risk ratio (RR) 0.38, 95% confidence interval (CI) 0.20 to 0.70), with no statistical difference in the rates of miscarriage/intrauterine fetal death (IUFD)/stillbirth/neonatal death (RR 2.00, 95% CI 0.35 to 11.35). Secondary outcomes reported were a reduction in infant birthweight (mean difference (MD) -127.71 g, 95% CI -251.37 to -4.06) in the probiotic group and no clear evidence of increased risk of preterm delivery (RR 3.27, 95% CI 0.44 to 24.43), or caesarean section rate (RR 1.23, 95% CI 0.65 to 2.32). The primary infant outcomes of rates of macrosomia and large-for-gestational age infants were not reported. The following secondary outcomes were not reported: maternal gestational weight gain, pre-eclampsia, and the long-term diagnosis of diabetes mellitus; infant body composition, shoulder dystocia, admission to neonatal intensive care, jaundice, hypoglycaemia and long-term rates of obesity and diabetes mellitus. One trial has shown a reduction in the rate of GDM when women are randomised to probiotics early in pregnancy but more uncertain evidence of any effect on miscarriage/IUFD/stillbirth/neonatal death. There are no data on macrosomia. At this time, there are insufficient studies to perform a quantitative meta-analysis. Further results are awaited from four ongoing studies.

Plain-language summary: This review was designed to look at whether there is evidence to show if this is true or not. At the moment there is only one randomised controlled study, which involved 256 women. This study does show a lower rate of gestational diabetes mellitus in women who took probiotics from early pregnancy, with the rate of diagnosis of gestational diabetes mellitus being reduced by two-thirds and their babies on average weighed 127 g less at birth. This study did not find differences in the rates of miscarriage, intrauterine or neonatal death or stillbirth. There was no clear evidence of a change in the proportion of women delivered by caesarean section or in the risk of preterm delivery. The study did not report on how much weight the mothers gained during pregnancy or how many babies were large-for-gestational age or that weighed more than 4000 g at birth or on the body composition of the babies. One study is not enough to draw any definite conclusions at the moment. There are other studies underway.
Abstract: Six trials involving 321 infants in three different settings were included. Compared with beta2-agonist alone, the combination of ipratropium bromide and beta2-agonist was associated with a reduced need for additional treatment, but no difference was seen in treatment response, respiratory rate or oxygen saturation improvement in the emergency department. There was no significant difference in length of hospital stay between ipratropium bromide and placebo; or between ipratropium bromide and beta2-agonist combined compared with beta2-agonist alone. However, combined ipratropium bromide and beta2-agonist compared to placebo showed significantly improved clinical scores at 24 hours. Parents preferred ipratropium bromide over nebulised water or placebo for relief of their children's symptoms at home. A further updated search conducted in June 2005 did not yield any new studies. There is not enough evidence to support the uncritical use of anti-cholinergic therapy for wheezing infants, although parents using it at home were able to identify benefits.

Plain-language summary: Six trials involving 321 infants in three different settings were reviewed. The review was unable to identify clear benefits in outcomes such as duration of hospitalisation or improvement in oxygenation though there were suggestions that some patients may benefit particularly in recurrently wheezy infants treated at home. Well designed studies are required to clarify the role of these agents in young children with wheeze.
Abstract: We identified one randomized controlled trial of high quality, involving 300 patients , comparing SmartCare™ to a written protocol. In this trial, SmartCare™ had no effect on discontinuation time. While SmartCare™ significantly reduced the time to the first SBT (mean difference (MD) -0.34 days, 95% CI -0.60 to -0.08; P = 0.01) it did not reduce the time to the first successful SBT (MD -0.25 days, 95% CI -0.55 to 0.05; P = 0.10) and other clinically important outcomes. SmartCare™ did not demonstrate beneficial effects on most clinically important outcomes including time to successful extubation, total duration of mechanical ventilation, ICU and hospital lengths of stay, and the requirement for tracheostomy. Moreover, SmartCare™ did not favourably impact reintubation, mortality, self-extubation, and the proportion of patients undergoing protracted mechanical ventilation, with a small numbers of events in this single trial. There is a paucity of evidence from randomized controlled trials to support or refute use of automated weaning and SBT systems in discontinuing invasive mechanical ventilation in adult postoperative patients. In a single large trial of high methodologic quality, while the use of SmartCare™ to adjust ventilator settings and conduct SBTs shortened the time to undergoing the first SBT, it did not reduce the time to the first successful SBT or the rate of tracheostomy compared to a written protocol implemented by physicians. SmartCare™ did not demonstrate beneficial effects on clinically important outcomes including time to mechanical ventilation discontinuation, time to successful discontinuation, total duration of mechanical ventilation, and ICU and hospital lengths of stay. Additional well-designed, adequately powered randomized controlled trials are needed to clarify the role for SmartCare™ on important outcomes in patients who predominantly require short term ventilation and in specific postoperative patient populations.

Plain-language summary: In a single large trial of high methodologic quality that involved 300 patients, use of a system (SmartCare™) that automatically adjusted ventilator settings and conducted tests of patients' ability to breathe spontaneously there was no clear benefit of SmartCare™. While it reduced the time to undergo the first test of spontaneous breathing, it did not reduce the time to the first successful spontaneous breathing test compared to a written weaning protocol applied by physicians. There was no clear benefit of SmartCare™ on other clinically important outcomes including the time to successful discontinuation of artificial ventilation , the total duration of mechanical ventilation, the time spent in the intensive care unit and hospital, and the requirement for tracheostomy (an airway inserted into the trachea). Further studies are needed to clarify the role of SmartCare™ in the postoperative setting, in general, and in specific patient populations.
Abstract: We identified four RCTs with 148 participants in total. In the first one, of 14 participants with moderate or severe myasthenia gravis, improvement after one month was not significantly greater for participants treated with plasma exchange and prednisone than for those treated with prednisone alone. A randomised controlled cross-over trial of 12 participants with moderate to severe myasthenia gravis found no statistically significant difference in the efficacy of plasma exchange or intravenous immunoglobulins after four weeks. A trial including 87 participants with myasthenia gravis exacerbation found no statistically significant difference between plasma exchange and immunoglobulin after two weeks. The fourth RCT, with 35 participants, showed a statistically significant difference in favour of plasma exchange before thymectomy. However these trials, except the third, are at high risk of bias and have a weak statistical power. No adequate RCTs have been performed to determine whether plasma exchange improves the short- or long-term outcome for chronic myasthenia gravis or myasthenia gravis exacerbation. However, many studies with case series report short-term benefit from plasma exchange in myasthenia gravis, especially in myasthenic crisis. In severe exacerbations of myasthenia gravis one RCT did not show a significant difference between plasma exchange and intravenous immunoglobulin. Further research is need to compare plasma exchange with alternative short-term treatments for myasthenic crisis or before thymectomy and to determine the value of long-term plasma exchange for treating myasthenia gravis.

Plain-language summary: Four randomised controlled trials were identified. In the first one, of 14 participants with moderate or severe myasthenia gravis, the myasthenic muscular score after one month was not significantly different for participants treated with plasma exchange and prednisone than for those treated with prednisone alone but there can be only low statistical confidence in the results of this study because of its small size. A randomised controlled cross-over trial of only 12 participants reported the same efficacy, after four weeks, of plasma exchange or intravenous immunoglobulins for the treatment of moderate to severe myasthenia gravis, but because of bias and a very weak statistical power the data prevent any conclusion. The third, including 87 participants, showed the same efficacy, after two weeks, of plasma exchange or intravenous immunoglobulins for the treatment of myasthenia gravis exacerbation. The fourth randomised controlled trial involving 35 participants reported a benefit from plasma exchange before thymectomy but this trial was heavily biased. No trial addressed the new subtype with antibodies to a muscle specific kinase. Further research is needed to determine the value of long-term plasma exchange for treating myasthenia gravis and to compare plasma exchange with alternative short-term treatments for myasthenic crisis or before thymectomy in both types of autoimmune myasthenia.
Abstract: There were three randomized controlled trials that met our inclusion criteria recruited HIV-negative participants with chancroid (two trials with 143 participants) and primary syphilis (one trial with 30 participants). The syphilis study, carried out in the US between 1995 and 1997, randomized participants to receive a single 2.0 g oral dose of azithromycin (11 participants); two 2.0 g oral doses of azithromycin administered six to eight days apart (eight participants); or benzathine penicillin G administered as either 2.4 million units intramuscular injection once or twice seven days apart (11 participants). No participant in the trial seroconverted during 12 months of follow-up. The chancroid trials, conducted in Kenya by 1990, found no significant differences in HIV seroconversion rates during four to 12 weeks of follow-up between 400 and 200 mg single oral doses of fleroxacin (one trial, 45 participants; RR 3.00; 95% CI 0.29 to 30.69), or between 400 mg fleroxacin and 800 mg sulfamethoxazole plus 160 mg trimethoprim (one trial, 98 participants; RR 0.33; 95% CI 0.04 to 3.09). Adverse events reported were mild to moderate in severity, and included Jarisch-Herxheimer reactions and gastrointestinal symptoms. The differences between the treatment arms in the incidence of adverse events were not significant. The quality of this evidence on the effectiveness of genital ulcer disease treatment in reducing sexual acquisition of HIV, according to GRADE methodology, is of very low quality. At present, there is insufficient evidence to determine whether curative treatment of genital ulcer disease would reduce the risk of HIV acquisition. The very low quality of the evidence implies that the true effect of genital ulcer disease treatment on sexual acquisition of HIV may be substantially different from the effect estimated from currently available data. However, genital ulcer diseases are public health problems in their own right and patients with these conditions should be treated appropriately; whether the treatment reduces the risk of HIV infection or not.

Plain-language summary: This review assessed whether giving treatment for diseases that present with ulcers in the genital region would reduce sexual acquisition of HIV. Three studies were identified involving 173 HIV-negative patients with genital ulcers. These studies did not provide sufficient evidence that treatment of genital ulcer diseases reduces sexual acquisition of HIV infection. However, genital ulcer diseases are public health problems in their own right and patients with these conditions should be treated appropriately; whether the treatment reduces the risk of HIV infection or not.