Objectives To evaluate the risk of bias tool, introduced by the Cochrane Collaboration for assessing the internal validity of randomised trials, for inter-rater agreement, concurrent validity compared with the Jadad scale and Schulz approach to allocation concealment, and the relation between risk of bias and effect estimates. Design Cross sectional study. Study sample 163 trials in children. Main outcome measures Inter-rater agreement between reviewers assessing trials using the risk of bias tool (weighted κ), time to apply the risk of bias tool compared with other approaches to quality assessment (paired t test), degree of correlation for overall risk compared with overall quality scores (Kendall's τ statistic), and magnitude of effect estimates for studies classified as being at high, unclear, or low risk of bias (metaregression). Results Inter-rater agreement on individual domains of the risk of bias tool ranged from slight (κ=0.13) to substantial (κ=0.74). The mean time to complete the risk of bias tool was significantly longer than for the Jadad scale and Schulz approach, individually or combined (8. 8 minutes (SD 2.2) per study v 2.0 (SD 0.8), P<0.001). There was low correlation between risk of bias overall compared with the Jadad scores (P=0.395) and Schulz approach (P=0.064). Effect sizes differed between studies assessed as being at high or unclear risk of bias (0.52) compared with those at low risk (0.23). Conclusions Inter-rater agreement varied across domains of the risk of bias tool. Generally, agreement was poorer for those items that required more judgment. There was low correlation between assessments of overall risk of bias and two common approaches to quality assessment: the Jadad scale and Schulz approach to allocation concealment. Overall risk of bias as assessed by the risk of bias tool differentiated effect estimates, with more conservative estimates for studies at low risk.

BACKGROUND:Hypnotics have a role in the management of acute insomnia; however, the efficacy and safety of pharmacological interventions in the management of chronic insomnia is unclear. OBJECTIVE:The objective of this paper is to conduct a systematic review of the efficacy and safety of drug treatments for chronic insomnia in adults.DATA SOURCES: Twenty-one electronic databases were searched, up to July 2006.STUDY SELECTION: Randomized double-blind, placebocontrolled trials were eligible. Quality was assessed using the Jadad scale. Data were pooled using the random effects model. DATA SYNTHESIS:One hundred and five studies were included in the review. Sleep onset latency, as measured by polysomnography, was significantly decreased for benzodiazepines (BDZ), (weighted mean difference: −10.0 minutes; 95% CI: −16.6, −3.4), non-benzodiazepines (non-BDZ) (−12.8 minutes; 95% CI: −16.9, −8.8) and antidepressants (ADP) (−7.0 minutes; 95% CI: −10.7, −3.3). Sleep onset latency assessed by sleep diaries was also improved (BDZ: −19.6 minutes; 95% CI: −23.9, −15.3; non-BDZ: −17.0 minutes; 95% CI: −20.0, −14.0; ADP: −12.2 minutes; 95% CI: −22.3, −2.2). Indirect comparisons between drug categories suggest BDZ and non-BDZ have a similar effect. All drug groups had a statistically significant higher risk of harm compared to placebo (BDZ: risk difference [RD]: 0.15; non-BDZ RD: 0.07; and ADP RD: 0.09), although the most commonly reported adverse events were minor. Indirect comparisons suggest that non-BDZ are safer than BDZ.CONCLUSIONS: Benzodiazepines and non-benzodiazepines are effective treatments in the management of chronic insomnia, although they pose a risk of harm. There is also some evidence that antidepressants are effective and that they pose a risk of harm.

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BackgroundMuch controversy exists regarding the clinical efficacy of behavioural and developmental interventions for improving the core symptoms of autism spectrum disorders (ASD). We conducted a systematic review to summarize the evidence on the effectiveness of behavioural and developmental interventions for ASD.Methods and FindingsComprehensive searches were conducted in 22 electronic databases through May 2007. Further information was obtained through hand searching journals, searching reference lists, databases of theses and dissertations, and contacting experts in the field. Experimental and observational analytic studies were included if they were written in English and reported the efficacy of any behavioural or developmental intervention for individuals with ASD. Two independent reviewers made the final study selection, extracted data, and reached consensus on study quality. Results were summarized descriptively and, where possible, meta-analyses of the study results were conducted. One-hundred-and-one studies at predominantly high risk of bias that reported inconsistent results across various interventions were included in the review. Meta-analyses of three controlled clinical trials showed that Lovaas treatment was superior to special education on measures of adaptive behaviour, communication and interaction, comprehensive language, daily living skills, expressive language, overall intellectual functioning and socialization. High-intensity Lovaas was superior to low-intensity Lovaas on measures of intellectual functioning in two retrospective cohort studies. Pooling the results of two randomized controlled trials favoured developmental approaches based on initiative interaction compared to contingency interaction in the amount of time spent in stereotyped behaviours and distal social behaviour, but the effect sizes were not clinically significant. No statistically significant differences were found for: Lovaas versus special education for non-verbal intellectual functioning; Lovaas versus Developmental Individual-difference relationship-based intervention for communication skills; computer assisted instruction versus no treatment for facial expression recognition; and TEACCH versus standard care for imitation skills and eye-hand integration.ConclusionsWhile this review suggests that Lovaas may improve some core symptoms of ASD compared to special education, these findings are based on pooling of a few, methodologically weak studies with few participants and relatively short-term follow-up. As no definitive behavioural or developmental intervention improves all symptoms for all individuals with ASD, it is recommended that clinical management be guided by individual needs and availability of resources.

Objectives: Frequent emergency department (ED) users are high-risk and high-resource-utilizing patients. This systematic review evaluates effectiveness of interventions targeting adult frequent ED users in reducing visit frequency and improving patient outcomes.Methods: An a priori protocol was published in PROSPERO. Two independent reviewers screened, selected, rated quality, and extracted data. Third-party adjudication resolved disagreements. Rate ratios of post-versus pre-intervention ED visits were calculated. Data sources were from a comprehensive search that included seven databases and the gray literature. Eligibility criteria for selecting studies included experimental studies assessing the effect of interventions on frequent users' ED visits and patient-oriented outcomes.Results: A total of 6,865 citations were identified and 31 studies included. Designs were noncontrolled (n = 21) and controlled (n = 4) before-after studies and randomized controlled trials (n = 6). Frequent user definitions varied considerably and risk of bias was moderate to high. Studies examined general frequent users or those with psychiatric comorbidities, chronic disease, or low socioeconomic status or the elderly. Interventions included case management (n = 18), care plans (n = 8), diversion strategies (n = 3), printout case notes (n = 1), and social work visits (n = 1). Post-versus pre-intervention rate ratios were calculated for 25 studies and indicated a significant visit decrease in 21 (84%) of these studies. The median rate ratio was 0.63 (interquartile range = 0.41 to 0.71), indicating that the general effect of the interventions described was to decrease ED visits post-intervention. Significant visit decreases were found for a majority of studies in subgroup analyses based on 6-or 12-month follow-up, definition thresholds, clinical frequent user subgroups, and intervention types. Studies reporting homelessness found consistent improvements in stable housing. Overall, interstudy heterogeneity was high. The authors have no potential conflicts to disclose. PROSPERO registration number CRD42014015058. Study group authorship: Jessica Moe conceptualized and drafted the protocol, screened abstracts and articles for inclusion, extracted data, analyzed data, and wrote the manuscript; Scott Kirkland helped to draft the protocol, screened abstracts and articles for inclusion, analyzed data, assessed study quality, and wrote sections of the manuscript; Erin Rawe drafted the protocol and extracted data; Maria Ospina helped to draft the protocol, assessed study quality, and provided third-party adjudication for inclusion screening and quality assessment; Ben Vandermeer helped to plan and perform the statistical analysis; Sandy Campbell developed and ran the search strategy; Brian H. Rowe conceptualized the protocol, provided third-party adjudication for inclusion screening and quality assessment, analyzed data, and wrote a section of the manuscript. All authors reviewed, edited, and approved the final manuscript. Existing evide...

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Background Adverse outcomes in adolescent pregnancies have been attributed to both biological immaturity and social determinants of health (SDOH). The present systematic review evaluated the evidence on the association between SDOH and adverse maternal and birth outcomes in adolescent mothers. Methods Comprehensive literature searches were conducted to identify observational studies evaluating the relationship between SDOH and adverse adolescent pregnancy outcomes. Study selection, risk of bias appraisal, and data extraction of study characteristics were independently performed by two reviewers. Pooled odds ratios (pOR) with 95% confidence intervals (95% CI) were calculated to assess the association between SDOH and adverse birth outcomes. Results Thirty‐one studies met the inclusion criteria. The most frequently evaluated SDOH was race while the most commonly reported maternal and birth outcomes were caesarean section and preterm birth (PTB), respectively. The risk of bias of included studies was fair on the Newcastle‐Ottawa Scale. Meta‐analyses of retrospective cohort studies showed that, compared to White adolescent mothers, African American teens had increased odds of PTB (pOR 1.67; 95% CI 1.59, 1.75) and low birthweight (pOR 1.53; 95% CI 1.45, 1.62). Rural residence was consistently linked with PTB while low maternal socio‐economic (SES) and illiteracy were found to increase the risk of adolescent maternal mortality and LBW infants. Conclusion Social determinants of health contribute to the risk of adverse pregnancy outcomes in adolescent mothers. African American race, rural residence, inadequate education, and low SES are markers for poor pregnancy outcomes in adolescent mothers. Further research needs to be done to understand the underlying causal pathways to inequalities in adolescent pregnancy outcomes.

Most clinical trials on meditation practices are generally characterized by poor methodological quality with significant threats to validity in every major quality domain assessed. Despite a statistically significant improvement in the methodological quality over time, it is imperative that future trials on meditation be rigorous in design, execution, analysis, and the reporting of results.