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Background Consumers, clinicians, policymakers and researchers require high quality evidence to guide decision-making in child health. Though Cochrane systematic reviews (SRs) are a well-established source of evidence, little is known about the characteristics of non-Cochrane child-relevant SRs. To complement published descriptions of Cochrane SRs, we aimed to characterize the epidemiologic, methodological, and reporting qualities of non-Cochrane child-relevant SRs published in 2014. Methods English-language child-relevant SRs of quantitative primary research published outside the Cochrane Library in 2014 were eligible for this descriptive analysis. A research librarian searched MEDLINE, CINAHL, Web of Science, and PubMed in August 2015. A single reviewer screened articles for inclusion; a second verified the excluded studies. Reviewers extracted: general characteristics of the review; included study characteristics; methodological approaches. We performed univariate analyses and presented the findings narratively. Results We identified 1598 child-relevant SRs containing a median (IQR) 19 (11, 33) studies. These originated primarily from high-income countries (n = 1247, 78.0%) and spanned 47 of the 53 Cochrane Review Groups. Most synthesized therapeutic (n = 753, 47.1%) or epidemiologic (n = 701, 43.8%) evidence. Though 39.3% (n = 628) of SRs included evidence related to children only, few were published in pediatric-specific journals (n = 283, 17.7%). Reporting quality seemed poor based on the items we assessed; few reviews mentioned an a-priori protocol (n = 246, 15.4%) or registration (n = 111, 6.9%), and only 23.4% (n = 374) specified a primary outcome. Many SRs relied solely on evidence from non-RCTs (n = 796, 49.8%). Less than two-thirds (n = 953, 59.6%) appraised the quality of included studies and assessments of the certainty of the body of evidence were rare (n = 102, 6.4%). Conclusions Child-relevant Cochrane SRs are a known source of high quality evidence in pediatrics. There exists, however, an abundance of evidence from non-Cochrane SRs that may be complementary. Our findings show that high-quality non-Cochrane SRs may not be practical nor easy for knowledge users to find. Improvements are needed to ensure that evidence syntheses published outside of the Cochrane Library adhere to the high standard of conduct and reporting characteristic of Cochrane SRs. Electronic supplementary material The online version of this article (10.1186/s12874-018-0562-2) contains supplementary material, which is available to authorized users.

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.

© Michele P Dyson, Amanda S Newton, Kassi Shave, Robin M Featherstone, Denise Thomson, Aireen Wingert, Ricardo M Fernandes, Lisa Hartling. Originally published in the Journal of Medical Internet Research (http://www.jmir.org), 01.09.2017. This is an open-access article distributed under the terms of the Creative Commons Attribution License (https://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work, first published in the Journal of Medical Internet Research, is properly cited. The complete bibliographic information, a link to the original publication on http://www.jmir.org/, as well as this copyright and license information must be included., Background: Health care providers value ready access to reliable synthesized information to support point-of-care decision making. Web-based communities, facilitated by the adoption of social media tools such as Facebook, Twitter, and YouTube, are increasingly being used for knowledge dissemination, bridging the gap between knowledge generation and synthesis and knowledge implementation. Objective: Our objective was to implement and evaluate a structured social media strategy, using multiple platforms, to disseminate Cochrane Child Health evidence to health care providers caring for children. Methods: Our social media strategy had three components: daily "tweets" using the Cochrane Child Health Twitter account, weekly WordPress blog posts, and a monthly journal club on Twitter ("tweet chat"). Each tweet, blog, and journal club shared Cochrane evidence on a child health topic. We evaluated the strategy through (1) Twitter and blog site analytics, (2) traceable link (Bitly) statistics, (3) Altmetric.com scores for promoted evidence, and (4) participant feedback. We also tracked the resources required to write the blog, tweet content, and manage the strategy. Results: The 22-week social media strategy ran between November 2014 and April 2015. We created 25 blog posts, sent 585 tweets, and hosted 3 tweet chats. Monthly blog visits and views and Twitter account followers increased over time. During the study period, the blog received 2555 visitors and 3967 page views from a geographically diverse audience of health care providers, academics, and health care organizations. In total, 183 traceable Bitly links received 3463 clicks, and the Twitter account gained 469 new followers. The most visited and viewed blog posts included gastrointestinal topics (lactose avoidance), research on respiratory conditions (honey for cough and treatments for asthma), and maternal newborn care (skin-to-skin contact). On Twitter, popular topics were related to public health (vaccination) and pain management. We collected Altmetric.com scores for 61 studies promoted during the study period and recorded an average increase of 11 points. Research staff (n=3) contributed approximately 433 hours to promotion activities and planning (6.5 hours each per week) to implement the social media strategy, and study investigators reviewed all content (blog posts and tweets). Conclusions: This study provides empirical evidence on the use of a coordinated social media strategy for the dissemination of evidence to professionals providing health services to children and youth. The results and lessons learned from our study provide guidance for future knowledge dissemination activities using social media tools., This work was supported by Alberta Innovates—Health Solutions, grant number 201300653. LH and ASN are supported, in part, by Canadian Institutes of Health Research New Investigator Awards.

Background Systematic reviews support health systems and clinical decision-making by identifying and summarizing all existing studies on a particular topic. In 2009, a comprehensive description of child-relevant systematic reviews published in the Cochrane Database of Systematic Reviews was compiled. This study aims to provide an update, and to describe these systematic reviews according to their content and methodological approaches. Methods All child-relevant systematic reviews published by the Cochrane Collaboration in the Cochrane Database of Systematic Reviews (CDSR) as of March, 2013 were identified and described in relation to their content and methodological approaches. This step equated to an update of the Child Health Field Review Register (CHFRR). The content of the updated CHFRR was compared to the published 2009 CHFRR description regarding clinical and methodological characteristics, using bivariate analyses. As the Cochrane Collaboration has recognized that disease burden should guide research prioritization, we extracted data from the Global and National Burden of Diseases and Injuries Among Children and Adolescents Between 1990 and 2013 study in order to map the distribution of the burden of disease in child health to the distribution of evidence across Review Groups in the CHFRR. Results Of the 5,520 potential Cochrane systematic reviews identified, 1,293 (23.4%) were child-relevant (an increase of 24% since 2009). Overall, these reviews included 16,738 primary studies. The most commonly represented Review Groups were Airways (11.5%), Cystic Fibrosis and Genetic Diseases (7.9%), Acute Respiratory Infections (7.8%), Developmental, Psychological and Learning Problems (6.7%), and Infectious Diseases (6.2%). Corresponding authors were most often from Europe (51%), North America (15%), and Australia (15%). The majority of systematic reviews examined pharmacological interventions alone (52% compared to 59% in 2009). Out of 611 reviews that were assessed as up-to-date, GRADE was used in 204 (35%) reviews to assess the overall quality of the evidence, which was often moderate (35.6%) or low (37.8%) for primary outcomes. Ninety percent of reviews that were assessed as up to date used the Cochrane Risk of Bias tool, or a modified version, to assess methodological quality. Most reviews conducted one or more meta-analyses (73%). Among the 25 leading causes of death globally, the Review Groups associated with the largest number of causes were: 1) Infectious Diseases, 2) Anaesthesia, Critical, and Emergency Care, 3) Injuries, 4) Pregnancy and Childbirth (PC), and 5) Neonatal. There were large discrepancies between the number of causes of mortality that each Review Group was associated with and the total amount of evidence each Review Group contributed to the CHFRR. Ninety-eight percent of the causes of mortality in 2013 were from developing nations, but only 224 (17.3%) reviews had corresponding authors from developing countries. Conclusion The content and methodological characteristics of child-relevant systematic reviews in the Cochrane CHFRR have been described in detail. There were modest advances in methods between 2009 and 2013. Systematic reviews contained in the CDSR offer an important resource for researcher’s, clinicians and policy makers by synthesizing an extensive body of primary research. Further content analysis will allow the identification of clinical topics of greatest priority for future systematic reviews in child health. Electronic supplementary material The online version of this article (doi:10.1186/s12887-017-0908-7) contains supplementary material, which is available to authorized users.

Background: Two large randomized trials of regular salmeterol monotherapy in adults with asthma found an increased risk of asthma-related mortality for salmeterol versus placebo or regular salbutamol. There are no similar large trials in children, and the safety of monotherapy with salmeterol or other long-acting beta2-agonists in children with asthma is unclear. Current guidelines recommend that regular long-acting beta2-agonist therapy should be given only in combination with regular inhaled corticosteroids. However, the safety of combination therapy in children with asthma is also unclear. Objectives: We used the paediatric trial results from Cochrane systematic reviews to assess the safety of regular long-acting beta2-agonist therapy, either as monotherapy or as combination therapy with inhaled corticosteroids, in children with asthma. Methods: We searched the Cochrane Database of Systematic Reviews in May 2012 for Cochrane reviews relating to the safety of regular formoterol and salmeterol, and ran updated searches for trials for each of the Cochrane reviews. We used odds ratios (ORs) to summarize the direct randomized evidence on safety from trials comparing regular formoterol or regular salmeterol as monotherapy versus placebo and then as combination therapy with inhaled corticosteroids versus the same dose of inhaled corticosteroids. We indirectly compared the safety of monotherapy and combination therapy by testing for differences between the pooled ORs for monotherapy and for combination therapy. We used ORs to summarize the direct randomized evidence on safety from trials comparing regular formoterol with regular salmeterol. We also compared the safety of regular formoterol and regular salmeterol indirectly by calculating an OR for the pooled results of trials assessing formoterol and the pooled results of trials assessing salmeterol, and then combined the direct and indirect evidence by calculating an overall OR for this comparison. Results: We identified four Cochrane reviews examining the safety of regular formoterol or salmeterol as either monotherapy or combination therapy. The reviews included 19 trials in children and we found two additional studies on salmeterol combination therapy, for a total of 21 trials in 7318 children. We identified two Cochrane reviews comparing the safety of formoterol with salmeterol, which included a single trial in 156 children. We found a statistically significant increase in the odds of suffering a nonfatal serious adverse event in children on formoterol monotherapy [OR = 2.48; 95% confidence interval (CI) = 1.27–4.83, I2 = 0%, five trials, N = 1335] and smaller nonsignificant increases in odds for salmeterol monotherapy (OR = 1.30; 95% CI = 0.82–2.05, I2 = 17%, five trials, N = 1333), formoterol combination therapy (OR = 1.60; 95% CI = 0.80–3.28, I2 = 32%, seven trials, N = 2788) and salmeterol combination therapy (OR = 1.20; 95% CI = 0.37–2.91, I2 = 0%, five trials, N = 1862). There was no significant difference between the pooled ORs of a serious adverse event on monotherapy (OR = 1.60; 95% CI = 1.10–2.33, 10 trials, N = 2668) and combination therapy (OR = 1.50; 95% CI = 0.82–2.75, 12 trials, N = 4650). However, there was an absolute increase of 21 children (95% CI = 4–45) suffering a severe adverse event of any cause for every thousand children treated over six months on monotherapy, compared with an absolute increase of three (95% CI = 1 fewer to 12 more) per 1000 children over three months on combination therapy. The evidence comparing the safety of regular salmeterol to regular formoterol was limited, and even when direct and indirect evidence were combined, the CI around the effect on serious adverse events was too wide to tell whether there was a difference in the comparative safety of formoterol and salmeterol (OR = 1.26; 95% CI = 0.37–4.32). Only one child died across all the trials, so the impact on mortality could not be assessed. Authors' conclusions: Although regular combination therapy is likely to be safer than monotherapy in children with asthma, the safety of regular combination therapy with formoterol or salmeterol in children remains uncertain, particularly in terms of mortality. The relative safety of formoterol and salmeterol is also unclear. There are currently large ongoing surveillance studies that may clarify the risks of combination therapy in children and adolescents with asthma. Copyright © 2012 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd. The Cochrane Collaboration

Background Cochrane Child Health maintains a register of child-relevant Cochrane systematic reviews (SRs) to provide a comprehensive source of high-quality evidence. However, a large number of SRs are published outside of The Cochrane Collaboration (Cochrane), impacting the comprehensiveness of the Cochrane Database of Systematic Reviews (CDSR). We surveyed authors who published child-relevant SRs with Cochrane and elsewhere in the medical literature to (1) understand their experiences in preparing and publishing SRs and (2) identify factors influencing choice of publication venue. Methods We identified SRs published in the CDSR for the most recent complete year prior to our study (2013; n = 145). We searched the medical literature and randomly selected the same number of SRs published the same year. We developed an internet-based survey and contacted the corresponding author of each review via email. Data were analyzed descriptively. Qualitative analysis elicited common themes from open-ended questions. Results Seventy-six (26 %) responded: 41 % Cochrane, 42 % non-Cochrane, and 17 % published in both venues. Among respondents who published their SR in both venues (n = 13), 46 % found it easier to publish in a non-Cochrane journal, 15 % easier with Cochrane, and 31 % similar. Main reasons for conducting SRs with Cochrane (n = 44) were Cochrane’s positive reputation (82 %) and good impact factor (66 %). Among respondents who published their SR in a non-Cochrane journal (n = 32), most frequent reasons for not conducting their SR with Cochrane were time required to follow Cochrane processes (25 %), lack of knowledge about how to conduct an SR with Cochrane (19 %), administrative processes (16 %), and perception that non-Cochrane journals yielded more interest (16 %). Among respondents who published their SR in a non-Cochrane journal (n = 32), 78 % did not register their review and 22 % did not prepare a protocol. Conclusions Key reasons for publishing in Cochrane are its positive reputation and impact factor. Reasons for publishing in non-Cochrane sources include lack of familiarity or challenges with the Cochrane processes and desire to publish in a source more directly relevant to the topic of interest. End users looking for evidence in the form of SRs need to be aware that there is a vast number of SRs published across the medical literature. Efforts to optimize the identification of SRs in non-Cochrane sources (e.g., through effective labeling or protocol/review registration) and their content will help end users find the necessary synthesized evidence to support clinical practice. Electronic supplementary material The online version of this article (doi:10.1186/s13643-016-0276-7) contains supplementary material, which is available to authorized users.

* Abbreviations: RCT — : randomized controlled trial SSRI — : selective serotonin reuptake inhibitor It has long been an axiom in clinical pediatrics that “children are not just little adults.” It has also been recognized that there are many changes from birth through childhood and the adolescent years. However, the full implications of pediatric age groupings for health care and research are still not adequately understood. There is still much to be discovered about children’s biological and psychological development and how these processes affect the effectiveness and efficacy of interventions. Trial design that accounts for age differences and promotes consistency in reporting of age-related data is essential to ensure the validity and clinical usefulness of pediatric trial data. A recent study highlighted variable treatment efficacy in children versus adults. In this study, 128 meta-analyses from Cochrane reviews, containing data on at least 1 adult and 1 pediatric randomized controlled trial (RCT) with a binary primary efficacy outcome, were reviewed.1 The authors found that in all except 1 case, the 95% confidence intervals could not exclude a relative difference in treatment efficacy between adults and children of >20%; in two-thirds of these cases, the relative difference in observed point estimates was >50%. The study also highlighted the paucity of RCTs in pediatrics; the median number of children per meta-analysis was 2.5 times smaller than the number of adults. Children and adults seem to have distinctive responses to treatments. For example, administration of phenobarbitones is useful for adults with cerebral malaria and is associated with decreased convulsions. However, in children, this drug is associated with increased 6-month mortality. Similarly, corticosteroids may offer survival benefit for adults with bacterial meningitis but not for children with the same condition. In acute traumatic brain injury, corticosteroids did not decrease mortality in adults, but there was a trend for increased mortality in children.1 In asthma, long-acting β2-agonists decreased … Address correspondence to Martin Offringa, MD, PhD, Senior Scientist and Program Head, Child Health Evaluative Sciences, Research Institute, The Hospital for Sick Children, 555 University Ave, Toronto, Ontario, Canada M5G 1X8. E-mail: martin.offringa{at}sickkids.ca

Background Acute otitis media (AOM) is one of the most common clinical problems in childhood with peak incidence occurring in the first 2 years of life. Objectives To critically evaluate the available evidence in The Cochrane Library regarding the treatment of AOM. Methods The Cochrane Library was searched using the terms ‘otitis media’ and ‘ear infection’. Reviews focusing on the treatment of AOM in children were included. Data on patient relevant outcomes (pain, treatment failure, AOM recurrence and adverse events) were extracted by two authors. Main results Six reviews were included in this overview. The first review compared antibiotics with placebo. Antibiotics reduced pain on days 2–7 [odds ratio (OR): 0.61; 95% confidence interval (CI): 0.49–0.75; Number needed to treat (NNT) = 14] but increased overall adverse events (OR: 2.35; 95% CI: 1.14–4.84; NNT = 7). Antibiotics also reduced the number of children with treatment failure (persistence of signs and symptoms at the end of therapy) (OR: 0.40; 95% CI: 0.27–0.60; NNT = 8), and this effect was larger in two recent randomized controlled trials which used stringent diagnostic criteria and were restricted to young children (OR: 0.24; 95% CI: 0.16–0.34; NNT = 4). The second review addressing the length of antibiotic treatment showed that shorter courses of oral antibiotics resulted in a slightly increased likelihood of treatment failure (OR: 1.34; 95% CI: 1.16, 1.55), although trial quality was limited. In the third review, no significant differences were noted between once- or twice-daily versus three times-daily administration of amoxicillin-based antibiotic treatment; however, the quality of the original data on which the review was based was less than optimal. The fourth review compared delayed antibiotics to immediate therapy or to no antibiotics for AOM, with no differences in pain between groups. In the fifth review, decongestants and/or antihistamines were compared with placebo. Decongestants and antihistamines provided no appreciable benefit and were associated with significant adverse events (OR: 3.74; 95% CI: 1.53, 9.16). In the sixth review, topical analgesic drops and placebo were compared. Use of analgesic drops was associated with a significant increase in pain reduction (OR: 3.07; 95% CI: 1.33, 7.05). Authors' conclusions Current evidence suggests that antibiotic treatment may be justified in young children with stringently diagnosed AOM. Copyright © 2012 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd. The Cochrane Collaboration

Background Chronic cough is a universal condition of childhood that affects approximately one in ten children. Chronic cough can be either specific (‘wet’ cough or other symptoms concurrently present) or nonspecific (‘dry’ cough in the absence of other symptoms). Compared to adults, specific and non-specific chronic cough in children differs in terms of both aetiology and treatment, and the methods used to treat chronic cough in adults may actually be harmful for children. Objective This overview of reviews synthesizes the evidence currently in the Cochrane Library Database of Systematic Reviews (CDSR) in order to answer the following question: in the treatment of childhood specific and non-specific chronic cough, which pharmacologic or non-pharmacologic treatments improve cough symptoms and decrease adverse events? Methods The Cochrane Database of Systematic Reviews was searched using the terms ‘specific cough’, ‘non-specific cough’, ‘moist cough’ and ‘chronic cough’ in the record title for all systematic reviews examining pharmacologic or non-pharmacologic interventions for the treatment of chronic cough in children. Data were extracted, complied into tables, and synthesized using qualitative and quantitative methods. Main Results Six reviews (five on non-specific cough and one on specific cough) were indentified for inclusion. For non-specific cough, one review found that very high-dose inhaled corticosteroids were effective in reducing non-specific cough (RR: 2.04; 95% CI: 1.10, 3.77), but this treatment was not advocated. To date, there is no evidence that anti-histamines, β2 agonists, gastro-oesophageal reflux treatments or leukotriene receptor antagonists are efficacious for the treatment of non-specific chronic cough. For specific cough related to isolated wet cough, there was significant clinical improvement when children were treated with antibiotics (RR: 2.42; 95% CI: 1.65, 3.53). Limited data were available for adverse events associated with any of the treatment options. Authors' Conclusions The paucity of RCT evidence in the management of children with chronic cough is striking. Five systematic reviews on interventions for non-specific cough do not support an empirical treatment approach. One systematic review on interventions for specific cough found some support for the use of antibiotics. Copyright © 2010 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd. The Cochrane Collaboration

IntroductionThe undertreatment of pediatric pain is a significant concern among families, clinicians, and researchers. Although some have examined prehospital pain management, the deterrents to pediatric analgesia administration by Emergency Medical Services (EMS) have not yet been examined in Canada.ProblemThis study describes EMS pain-management practices and prehospital provider comfort treating pediatric pain. It highlights differences in pain management between adults and children and assesses the potential barriers, misconceptions, difficulties, and needs related to provision of pediatric analgesia.MethodsA study-specific survey tool was created and distributed to all Primary Care Paramedics (PCPs) and Advanced Care Paramedics (ACPs) over four mandatory educational seminars in the city of Edmonton (Alberta, Canada) from September through December 2008.ResultsNinety-four percent (191/202) of EMS personnel for the city of Edmonton completed the survey. The majority of respondents were male (73%, 139/191), aged 26-35 (42%, 80/191), and had been in practice less than 10 years (53%, 101/191). Seventy-four percent (141/191) of those surveyed were ACPs, while 26% (50/191) were PCPs. Although the majority of respondents reported using both pain scales and clinical judgement to assess pain for adults (85%, 162/191) and adolescents (86%, 165/191), children were six times more likely than adults (31%, 59/191 vs 5%, 10/191) to be assessed by clinical judgement alone. Emergency Medical Services personnel felt more comfortable treating adults than children (P< .001), and they were less likely to treat children even if they were experiencing identical types and intensities of pain as adults (allPvalues Pvalues < .05). Twenty-five percent of providers (37/147) assumed pediatric patients required less analgesia due to immature nervous systems. Three major barriers to treating children's pain included limited clinical experience (34%, 37/110), difficulty in communication (24%, 26/110) and inability to assess children's pain accurately (21%, 23/110).ConclusionEmergency Medical Services personnel self-report that children's pain is less rigorously measured and treated than adults’ pain. Educational initiatives aimed at increasing clinical exposure to children, as well as further education regarding simple pain measurement tools for use in the field, may help to address identified barriers and discomfort with assessing and treating children.RahmanA,CurtisS,DeBruyneB,SookramS,ThomsonD,LutzS,AliS.Emergency Medical Services provider comfort with prehospital analgesia administration to children.Prehosp Disaster Med.2015;30(1):1-6.

BACKGROUND: An important step toward improvement of the conduct of pediatric clinical research is the standardization of the ages of children to be included in pediatric trials and the optimal age-subgroups to be analyzed. METHODS: We set out to evaluate empirically the age ranges of children, and age-subgroup analyses thereof, reported in recent pediatric randomized clinical trials (RCTs) and meta-analyses. First, we screened 24 RCTs published in Pediatrics during the first 6 months of 2011; second, we screened 188 pediatric RCTs published in 2007 in the Cochrane Central Register of Controlled Trials; third, we screened 48 pediatric meta-analyses published in the Cochrane Database of Systematic Reviews in 2011. We extracted information on age ranges and age-subgroups considered and age-subgroup differences reported. RESULTS: The age range of children in RCTs published in Pediatrics varied from 0.1 to 17.5 years (median age: 5; interquartile range: 1.8–10.2) and only 25% of those presented age-subgroup analyses. Large variability was also detected for age ranges in 188 RCTs from the Cochrane Central Register of Controlled Trials, and only 28 of those analyzed age-subgroups. Moreover, only 11 of 48 meta-analyses had age-subgroup analyses, and in 6 of those, only different studies were included. Furthermore, most of these observed differences were not beyond chance. CONCLUSIONS: We observed large variability in the age ranges and age-subgroups of children included in recent pediatric trials and meta-analyses. Despite the limited available data, some age-subgroup differences were noted. The rationale for the selection of particular age-subgroups deserves further study.

Background Overviews of systematic reviews compile data from multiple systematic reviews (SRs) and are a new method of evidence synthesis. Objectives To describe the methodological approaches in overviews of interventions. Design Descriptive study. Methods 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. Results 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. Conclusions 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.

Background 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. Methodology/Principal Findings 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