Overviews of systematic reviews compile data from multiple systematic reviews (SRs) and are a new method of evidence synthesis. To describe the methodological approaches in overviews of interventions. Descriptive study. We searched 4 databases from 2000 to July 2011; we handsearched Evidence-based Child Health: A Cochrane Review Journal. We defined an overview as a study that: stated a clear objective; examined an intervention; used explicit methods to identify SRs; collected and synthesized outcome data from the SRs; and intended to include only SRs. We did not restrict inclusion by population characteristics (e.g., adult or children only). Two researchers independently screened studies and applied eligibility criteria. One researcher extracted data with verification by a second. We conducted a descriptive analysis. From 2,245 citations, 75 overviews were included. The number of overviews increased from 1 in 2000 to 14 in 2010. The interventions were pharmacological (n = 20, 26.7%), non-pharmacological (n = 26, 34.7%), or both (n = 29, 38.7%). Inclusion criteria were clearly stated in 65 overviews. Thirty-three (44%) overviews searched at least 2 databases. The majority reported the years and databases searched (n = 46, 61%), and provided key words (n = 58, 77%). Thirty-nine (52%) overviews included Cochrane SRs only. Two reviewers independently screened and completed full text review in 29 overviews (39%). Methods of data extraction were reported in 45 (60%). Information on quality of individual studies was extracted from the original SRs in 27 (36%) overviews. Quality assessment of the SRs was performed in 28 (37%) overviews; at least 9 different tools were used. Quality of the body of evidence was assessed in 13 (17%) overviews. Most overviews provided a narrative or descriptive analysis of the included SRs. One overview conducted indirect analyses and the other conducted mixed treatment comparisons. Publication bias was discussed in 18 (24%) overviews. This study shows considerable variation in the methods used for overviews. There is a need for methodological rigor and consistency in overviews, as well as empirical evidence to support the methods employed.

Background: Randomized controlled trials (RCTs) are the gold standard for trials assessing the effects of therapeutic interventions; therefore it is important to understand how they are conducted. Our objectives were to provide an overview of a representative sample of pediatric RCTs published in 2007 and assess the validity of their results. Methods: We searched Cochrane Central Register of Controlled Trials using a pediatric filter and randomly selected 300 RCTs published in 2007. We extracted data on trial characteristics; outcomes; methodological quality; reporting; and registration and protocol characteristics. Trial registration and protocol availability were determined for each study based on the publication, an Internet search and an author survey. Results: Most studies (83%) were efficacy trials, 40% evaluated drugs, and 30% were placebo-controlled. Primary outcomes were specified in 41%; 43% reported on adverse events. At least one statistically significant outcome was reported in 77% of trials; 63% favored the treatment group. Trial registration was declared in 12% of publications and 23% were found through an Internet search. Risk of bias (ROB) was high in 59% of trials, unclear in 33%, and low in 8%. Registered trials were more likely to have low ROB than non-registered trials (16% vs. 5%; p = 0.008). Effect sizes tended to be larger for trials at high vs. low ROB (0.28, 95% CI 0.21,0.35 vs. 0.16, 95% CI 0.07,0.25). Among survey respondents (50% response rate), the most common reason for trial registration was a publication requirement and for non-registration, a lack of familiarity with the process. Conclusions: More than half of this random sample of pediatric RCTs published in 2007 was at high ROB and three quarters of trials were not registered. There is an urgent need to improve the design, conduct, and reporting of child health research.

The objective of this study was to describe randomized controlled trials (RCTs) and controlled clinical trials (CCTs) in child health published between 1948 and 2006, in terms of quantity, methodological quality, and publication and trial characteristics. We used the Trials Register of the Cochrane Child Health Field for overall trends and a sample from this to explore trial characteristics in more detail. We extracted descriptive data on a random sample of 578 trials. Ninety-six percent of the trials were published in English; the percentage of child-only trials was 90.5%. The most frequent diagnostic categories were infectious diseases (13.2%), behavioural and psychiatric disorders (11.6%), neonatal critical care (11.4%), respiratory disorders (8.9%), non-critical neonatology (7.9%), and anaesthesia (6.5%). There were significantly fewer child-only studies (i.e., more mixed child and adult studies) over time (P = 0.0460). The proportion of RCTs to CCTs increased significantly over time (P<0.0001), as did the proportion of multicentre trials (P = 0.002). Significant increases over time were found in methodological quality (Jadad score) (P<0.0001), the proportion of double-blind studies (P<0.0001), and studies with adequate allocation concealment (P<0.0001). Additionally, we found an improvement in reporting over time: adequate description of withdrawals and losses to follow-up (P<0.0001), sample size calculations (P<0.0001), and intention-to-treat analysis (P<0.0001). However, many trials still do not describe their level of blinding, and allocation concealment was inadequately reported in the majority of studies across the entire time period. The proportion of studies with industry funding decreased slightly over time (P = 0.003), and these studies were more likely to report positive conclusions (P = 0.028). The quantity and quality of pediatric controlled trials has increased over time; however, much work remains to be done, particularly in improving methodological issues around conduct and reporting of trials.

Journal of Medical Internet Research - International Scientific Journal for Medical Research, Information and Communication on the Internet

Children are particularly vulnerable to patient safety concerns due to pediatric-specific and general health care challenges. This scoping review identifies and describes the vulnerabilities of those aged 0 to 18 years to iatrogenic harm in various health care settings. Six databases were searched from 1991 to 2012. Primary studies were categorized using predetermined groupings. Categories were tallied and descriptive statistics were employed. A total of 388 primary studies exploring interventions that improved patient safety, deficiencies, or errors leading to safety concerns were included. The most common issues were medication (189 studies, 48.7%) and general medical (81 studies, 20.9%) errors. Sixty studies (15.5%) evaluated or described patient safety interventions, 206 studies (53.1%) addressed health care systems and technologies, 17 studies (4.4%) addressed caregiver perspectives and 20 studies (5.2%) discussed analytic models for patient safety. Further work is needed to ensure consistency of definitions in patient safety research to facilitate comparison and collation of results.