GEM/cochrane-simplification huggingface dataset:
Abstract: We included seven trials involving 800 women. The comparisons revealed a very high clinical heterogeneity. As a result of the heterogeneity in the randomisation unit, we did not combine trials but reported the individual trial results in the ‘Data and analysis’ section and in the text. Half of trials have unclear or high risk of bias in several domains. We did not find any trial reporting data about maternal mortality. In terms of postoperative pain, PCB does not improve the control of postoperative pain when it is compared against sedation/analgesia or versus no anaesthesia/no analgesia. In the comparison of PCB with lidocaine versus PCB with saline solution, significant differences favouring the group with lidocaine were found in one trial (moderate or severe postoperative pain) (risk ratio (RR) 0.32; 95% confidence interval (CI) 0.18 to 0.59). When opioids were used, postoperative nausea and vomiting was more frequent in two trials comparing those versus PCB. In terms of requirement of blood transfusion, two trials showed conflicting results. Particular considerations that influence the choice of anaesthesia for this procedure such as availability, effectiveness, safety, side effects, practitioner's choice, costs and woman's preferences of each technique should continue to be used until more evidence supporting the use of one technique or another.

Plain-language summary: We included seven trials involving 800 women. None of the included studies reported any maternal mortality. We did not combine the results of the trials because the trials were very different in the clinical interventions used and how the outcomes were assessed. One study reported higher maternal satisfaction with the use of general anaesthesia than sedation and analgesia. Paracervical block did not improve the control of postoperative pain when compared against sedation and analgesia. More nausea and vomiting were reported when opioid drugs were used. Currently, the levels of postoperative pain experienced by women undergoing surgical evacuation of incomplete miscarriage are not completely relieved. Further studies in this context should be conducted to address this question. Key factors that influence the choice of anaesthesia include availability, effectiveness, safety, side effects, and costs. Other factors include patient preference, practitioner choice, facility resources and medical indications.
Abstract: We included 55 trials (3121 patients). Thirty-seven trials assessed physical methods, including 26 trials employing mattress encasings. Ten trials involved chemical methods and eight trials involved a combination of chemical and physical methods. Despite the fact that many trials were of poor quality and would be expected to exaggerate the reported effect, we did not find an effect of the interventions. For the most frequently reported outcome, peak flow in the morning (1665 patients), the standardised mean difference (SMD) was 0.01 (95% confidence interval (CI) -0.08 to 0.11). There were no statistically significant differences either in number of patients improved (risk ratio 1.01, 95% CI 0.80 to 1.27), asthma symptom scores (SMD -0.06, 95% CI -0.16 to 0.05), or in medication usage (SMD -0.05, 95% CI -0.17 to 0.07). Chemical and physical methods aimed at reducing exposure to house dust mite allergens cannot be recommended. It is doubtful whether further studies, similar to the ones in our review, are worthwhile. If other types of studies are considered, they should be methodologically rigorous and use other methods than those used so far, with careful monitoring of mite exposure and relevant clinical outcomes.

Plain-language summary: We included 55 randomised trials on 3121 people with asthma. There are both chemical (10 trials) and physical methods such as mattress encasings (37 trials) of reducing mite allergen levels and we included both types in this review. There were also eight trials that used both physical and chemical methods. Many trials were of poor quality and would therefore be expected to exaggerate the reported effect, but we did not find an effect of the interventions. There was no difference in peak flow (a measure of lung function), asthma symptoms and medication scores, or the number of patients reporting an improvement in their asthma symptoms. While reducing exposure to house dust mites is recommended in guidelines, we did not find an effect of control measures to reduce the exposure to mites or their products. .
Abstract: Four RCTs involving 3925 women were identified and included in this review. All were high quality with minimal risk of bias. Three trials compared the addition of RT to BCS. One trial was a two by two factorial design comparing the use of RT and tamoxifen, each separately or together, in which participants were randomised in at least one arm. Analysis confirmed a statistically significant benefit from the addition of radiotherapy on all ipsilateral breast events (hazards ratio (HR) 0.49; 95% CI 0.41 to 0.58, P < 0.00001), ipsilateral invasive recurrence (HR 0.50; 95% CI 0.32 to 0.76, p=0.001) and ipsilateral DCIS recurrence (HR 0.61; 95% CI 0.39 to 0.95, P = 0.03). All the subgroups analysed benefited from addition of radiotherapy. No significant long-term toxicity from radiotherapy was found. No information about short-term toxicity from radiotherapy or quality of life data were reported. This review confirms the benefit of adding radiotherapy to breast conserving surgery for the treatment of all women diagnosed with DCIS. No long-term toxicity from use of radiotherapy was identified.

Plain-language summary: The review identified four large randomised controlled trials (3925 women) that compared treatment with breast conserving surgery alone and breast conserving surgery with the addition of RT. The addition of RT reduced the risk of a recurrence of either DCIS or invasive cancer in the treated breast by 51%. Older trials of breast conserving surgery followed by RT for invasive breast cancer have shown long-term toxicity from the addition of RT. We found no evidence of increased toxicity from the use of RT although some trials did not report on the causes of non-breast cancer deaths (deaths which potentially could be related to side effects). The number of non-breast cancer deaths reported were similar in both radiotherapy and control groups. Changes in delivery of RT between older and more recent trials and a subsequent decrease in exposure of normal tissue may account for this finding. Longer follow up of trial participants is required before a definite conclusion can be drawn, however radiotherapy techniques are continuing to improve and future patients are likely to experience a further decrease in exposure of nearby normal tissues. Overall survival was high and similar between each group whether radiotherapy was used or not. There were no reports of short-term toxicity from use of radiotherapy, or quality of life data.
Abstract: Four trials, involving a total of 149 participants, compared the effectiveness of oral corticosteroids against placebo. All the trials were small and of low methodological quality. Although there was an overall significant effect of corticosteroids compared with placebo medication on complete caloric recovery at one month (risk ratio (RR) of 2.81; 95% confidence interval (CI) 1.32 to 6.00, P = 0.007), no significant effect was seen on complete caloric recovery at 12 months (RR 1.58; 95% CI 0.45 to 5.62, P = 0.48), or on the extent of caloric recovery at either one month (mean difference (MD) 9.60%; 95% CI -20.66 to 39.86, P = 0.53) or at 12 months (MD 6.83%; 95% CI -27.69 to 41.36, P = 0.70). In addition, there was no significant difference between corticosteroids and placebo medication in the symptomatic recovery of vestibular function following idiopathic acute vestibular dysfunction with respect to vertigo at 24 hours (RR 0.39; 95% CI 0.04 to 3.57, P = 0.40) and use of the Dizziness Handicap Inventory score at one, three, six and 12 months. Overall, there is currently insufficient evidence from these trials to support the administration of corticosteroids to patients with idiopathic acute vestibular dysfunction. We found no trials with a low risk of methodological bias that used the highest level of diagnostic criteria and outcome measures. We recommend that future studies should include health-related quality of life and symptom-based outcome measures, in addition to objective measures of vestibular improvement, such as caloric testing and electronystagmography.

Plain-language summary: This review identified four randomised controlled trials including 149 adult patients with idiopathic acute vestibular dysfunction (vestibular neuritis) treated with either corticosteroids or placebo. The studies were varied in that they used different drugs and different treatment regimens. On the basis of these studies, there is currently insufficient evidence in favour of corticosteroids over placebo medication in the symptomatic recovery and objective testing of vestibular function, both in the short-term and long-term. Further studies of higher quality are needed to test the effectiveness of corticosteroids in patients with the condition.
Abstract: A total of 10 studies recruiting 6292 apparently healthy adults met the inclusion criteria. All of the studies took place in high-income countries. The effect of interventions on self-reported PA at one year (eight studies; 6725 participants) was positive and moderate with significant heterogeneity (I² = 74%) (SMD 0.19; 95% CI 0.06 to 0.31; moderate quality evidence) but not sustained in three studies at 24 months (4235 participants) (SMD 0.18; 95% CI -0.10 to 0.46). The effect of interventions on cardiovascular fitness at one year (two studies; 349 participants) was positive and moderate with no significant heterogeneity in the observed effects (SMD 0.50; 95% CI 0.28 to 0.71; moderate quality evidence). Three studies (3277 participants) reported a positive effect on increasing PA levels when assessed as a dichotomous measure at 12 months, but this was not statistically significant (OR 1.52; 95% CI 0.88 to 2.61; high quality evidence). Although there were limited data, there was no evidence of an increased risk of adverse events (one study; 149 participants). Risk of bias was assessed as low (four studies; 4822 participants) or moderate (six studies; 1543 participants). Any conclusions drawn from this review require some caution given the significant heterogeneity in the observed effects. Despite this, there was some indication that the most effective interventions were those that offered both individual and group support for changing PA levels using a tailored approach. The long term impact, cost effectiveness and rates of adverse events for these interventions was not established because the majority of studies stopped after 12 months. Although we found evidence to support the effectiveness of face-to-face interventions for promoting PA, at least at 12 months, the effectiveness of these interventions was not supported by high quality studies. Due to the clinical and statistical heterogeneity of the studies, only limited conclusions can be drawn about the effectiveness of individual components of the interventions. Future studies should provide greater detail of the components of interventions, and assess impact on quality of life, adverse events and economic data.

Plain-language summary: We included a total of 10 studies recruiting 6292 apparently healthy adults in this review. The findings of the review indicate that interventions can successfully support adults' attempts to become active and fitter, for example with personal counselling and advice, feedback and offering choices of exercise, and supervision. Outcomes are improved if the intervention comprises a specified type of physical activity and is supervised by a non-health professional using a combination of group and individual approaches. New physical activity can be maintained for up to at least one year and does not increase the risk of falls or exercise related injuries. More research is needed to establish which methods of exercise promotion work best in the long term to encourage specific groups of people to be more physically active.
Abstract: Only one study met our inclusion criteria, involving 1106 adult patients with relapsing-remitting MS (RRMS) and an entry Expanded Disability Status Scale (EDSS) score of ≤ 5.5 and an entry disease duration of ≥ 6 months. Five hundred and fifty patients treated with laquinimod at a dose of 0.6 mg orally administered once daily in a capsule were compared with 556 patients treated with a matching placebo capsule. The study had a high risk for attrition bias (21.9%). Laquinimod had potential benefits in reducing relapse rates and was safe for most patients with RRMS in the short term. The most common adverse events included headache, back pain, arthralgia, diarrhoea, cough, urinary tract infection, elevated alanine aminotransferase, insomnia, nausea, abdominal pain and sinusitis. One ongoing trial was identified. We found low-level evidence for the use of laquinimod as a disease-modifying therapy for MS because only one study with limited quality (high risk of attrition bias) was included. The published study suggests that laquinimod at a dose of 0.6 mg orally administered once daily may be safe and have potential benefits for most patients with RRMS in the short term. We are waiting for the publication of ongoing trials.

Plain-language summary: The authors of this review assessed the efficacy and safety of laquinimod in patients with MS. Concerning the outcomes, they considered relapse, disability progression, inflammatory lesion, and brain atrophy. Among the pertinent literature only one study met the inclusion criteria. The study involved a total of 1106 patients with relapsing-remitting MS and evaluated the efficacy and safety of laquinimod as unique therapy versus placebo. As far as safety was concerned, common adverse events included headache, back pain, arthralgia, diarrhoea, cough, urinary tract infection, elevated alanine aminotransferase, insomnia, nausea, abdominal pain and sinusitis. The authors were unable to give any clear recommendations for the use of laquinimod as a DMD for MS because the study was poor quality and was funded by a pharmaceutical company. Future studies with higher methodological quality are needed to assess the potential benefits and the safety in a longer period of administration.
Abstract: A total of 13 trials with 8,698 participants were included. Primary outcomes (HIV and STI prevalence and incidence) were reported in seven trials. Of these, HIV incidence was reported in only three trials. After a 6-month follow-up assessment, there was no evidence that social cognitive behavioral intervention was effective in reducing HIV incidence (RR 0.12, 95% CI 0.01 to 2.22). However, there was a reduction in HIV incidence at 3-month follow-up assessment of promotion of female and male condom (RR 0.07, 95% CI 0.00 to 1.38). Social cognitive interventions and promotion of female and male condom use were significantly reduced STIs incidence (RR 0.57, 95% CI 0.34 to 0.96) and (RR 0.63, 95% CI 0.45 to 0.88), respectively. Secondary outcomes were identified in 13 trials. Meta-analyses showed evidence that interventions to promote the use of female and male condoms do reduce non-condom use (RR 0.83, 95% CI 0.65 to 1.05) compared to promotion of male condoms alone, and that social cognitive interventions reduced drug use among sex workers (RR 0.65, 95% CI 0.36 to 1.16) compared to standard care. Available evidence nevertheless suggests that compared with standard care or no intervention, behavioral interventions are effective in reducing HIV and the incidence of STIs amongst female sex workers (FSWs). Given the benefits of social cognitive theory and the promotion of condom use in reducing HIV/STI and the public health need to control transmission amongst FSWs, there is a clear finding in favour of behavioral interventions. However, it should be recognized that there is a lack of information about most other outcomes and target populations, and that all of the trials were conducted in low- and middle-income countries.

Plain-language summary: The review found seven individual randomised controlled trials (RCTs), two cluster-RCTs and four quasi-RCTs involving 8,698 participants examining a variety of behavioral interventions to evaluate whether they reduced HIV/STIs rates or resulted in changed behavior among sex workers and their clients. Results showed that the interventions were effective in HIV/STI prevention, including reducing the incidence and prevalence of HIV and STIs. Furthermore, there were some differences in self-reported behavior including increased condom use and a reduction in the risk of drug use. However, these trials were small and generally had few participants. As a result, evidence for the effectiveness of social cognitive theory and promoting condom use in reducing HIV/STI incidence compared to other behavioral interventions was limited, because no RCTs examined the effects of these interventions on HIV prevalence or on sex workers other than FSWs. In future research and program agendas therefore it is important to assess other potentially more potent behavioral change strategies.
Abstract: One-hundred-and-two quasi-experimental studies, with 666,615 children are included in this review. The 'Risk of bias' analysis indicates that the evidence base contains studies with unclear risk for selection bias, performance bias, detection bias, reporting bias, and attrition bias, with the highest risk associated with selection bias and the lowest associated with reporting bias. The outcome data suggest that children in kinship foster care experience fewer behavioural problems (standardised mean difference effect size -0.33, 95% confidence interval (CI) -0.49 to -0.17), fewer mental health disorders (odds ratio (OR) 0.51, 95% CI 0.42 to 0.62), better well-being (OR 0.50, 95% CI 0.38 to 0.64), and less placement disruption (OR 0.52, 95% CI 0.40 to 0.69) than do children in non-kinship foster care. For permanency, there was no difference on reunification rates, although children in non-kinship foster care were more likely to be adopted (OR 2.52, 95% CI 1.42 to 4.49), while children in kinship foster care were more likely to be in guardianship (OR 0.26, 95% CI 0.17 to 0.40). Lastly, children in non-kinship foster care were more likely to utilise mental health services (OR 1.79, 95% CI 1.35 to 2.37). This review supports the practice of treating kinship care as a viable out-of-home placement option for children removed from the home for maltreatment. However, this conclusion is tempered by the pronounced methodological and design weaknesses of the included studies.

Plain-language summary: This review was designed to help find out if research studies could tell us which kind of placement is best. We found 102 studies with 666,615 children that met the methodological standards we considered acceptable. Wherever possible we combined the data from studies looking at the same outcome for children, in order to be more confident about what the research was telling us. Current best evidence suggests that children in kinship foster care may do better than children in traditional foster care in terms of their behavioural development, mental health functioning, and placement stability. Children in traditional foster care placements may do better with regard to achieving adoption and accessing services they may need. There were no negative effects experienced by children who were placed in kinship care. The major limitation of this systematic review is that the quality of research on kinship care is weakened by the poor methods of the included studies. Implications for practice and future research are discussed.
Abstract: Five RCTs involving 604 people were included. The pooled results revealed that the addition of corticosteroids reduces statistically significant the risk for acute GvHD grade I to IV (HR 0.58; 95% CI 0.45 to 0.76) and II to IV (HR 0.69; 95% CI 0.51 to 0.92). No evidence was found that it has any clinical relevance on overall survival (HR 0.99; 95% CI 0.79 to 1.25) or disease-free survival (HR 0.95; 95% CI 0.74 to 1.23). As well, no statistically significant influence was found for acute GvHD grade III to IV (HR 0.78; 95% CI 0.52 to 1.15), chronic GvHD (HR 1.21;95% CI 0.89 to 1.65]), relapse incidence (HR 0.82; 95% CI 0.57 to 1.18) or non-relapse mortality (HR 0.88;95% CI 0.61 to 1.26). No clear evidence was found that the rate of infectious complications (under the concomitant use of antiviral or antibacterial medication or both) increases with the addition of corticosteroids. With respect to the other outcomes no significant differences could be detected. The addition of corticosteroids reduces the incidences of acute GvHD grade I to IV and II to IV. This reduction, however, did not show any effect on overall survival and disease-free survival. Further randomised controlled studies are needed to evaluate if the timing of steroid administration has a significant influence on the outcome; data on quality of life should be assessed systematically.

Plain-language summary: Five RCTs involving 604 people were included in this review. Analyses of these studies showed that the incidence of moderate forms of GvHD can be reduced by prophylactic corticosteroid regimens. However, there is no evidence that the incidence of life-threatening forms or patient mortality can be reduced. Effects on quality of life could not be estimated because this information was not systematically collected during these studies. Further studies are needed to determine if the timing of steroid administration influences the outcomes of GvHD.
Abstract: Eleven randomised clinical trials involving 716 patients with primary biliary cirrhosis fulfilled the inclusion criteria. No significant differences were detected between colchicine and placebo/no intervention on the number of deaths (RR 1.21, 95% CI 0.71 to 2.06), the number of deaths and/or patients who underwent liver transplantation (RR 1.00, 95% CI 0.67 to 1.49), liver complications, liver biochemical variables, liver histological measurements, and adverse events. Trial methodology was generally low and some trials had high drop-out rate. A best-worst-case-scenario analysis showed no significant effect of colchicine on mortality (RR 0.59, 95%CI 0.30 to 1.15), while a worst-best-case-scenario analysis showed a significant detrimental effect of colchicine on mortality (RR 2.28, 95% CI 1.17 to 4.44). Colchicine significantly decreased the number of patients without improvement of pruritus (RR 0.75, 95% CI 0.65 to 0.87). However, this estimate was based on only 156 patients from three trials. The effect of the combined treatment with ursodeoxycholic acid was not significantly different from that of colchicine alone. We did not find evidence either to support or refute the use of colchicine for patients with primary biliary cirrhosis. As we are not able to exclude a detrimental effect of colchicine, we suggest that it is only used in randomised clinical trials.

Plain-language summary: Colchicine, a plant alkaloid, has been used to treat patients with primary biliary cirrhosis and was tested in randomised clinical trials. When all identified trials were combined, colchicine appeared to be not significantly different from placebo/no intervention in respect to mortality, mortality and/or patients who underwent liver transplantation, liver complications, liver biochemistry, liver histology, and the occurrences of adverse events. Colchicine may reduce pruritus, but this finding may be due to bias. The addition of ursodeoxycholic acid did not significantly influence the effect of colchicine.