SynthesisBMC pediatrics2010
A descriptive analysis of a representative sample of pediatric randomized controlled trials published in 2007.
Synthesis in BMC pediatrics, 2010. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 34 papers, 7 of them syntheses that pooled it.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
34 citing papers in PubMed, 7 syntheses or guidelines pooled it, 74 citations in OpenAlex.
- Randomized controlled trials in patients with COVID-19: a systematic review and critical appraisal.International journal of infectious diseases : IJID : official publication of the International Society for Infectious Diseases · 2022Pooled it
- Registration of published randomized trials: a systematic review and meta-analysis.BMC medicine · 2018Pooled it
- Randomized controlled trials in children's heart surgery in the 21st century: a systematic review.European journal of cardio-thoracic surgery : official journal of the European Association for Cardio-thoracic Surgery · 2018Pooled it
- EAP viewpoint on unpublished data from paediatric clinical trials.European journal of pediatrics · 2018Guideline
- Systematic review and meta-analysis of distraction and hypnosis for needle-related pain and distress in children and adolescents.Journal of pediatric psychology · 2014Pooled it
- Quantifying bias in randomized controlled trials in child health: a meta-epidemiological study.PloS one · 2014Pooled it
- Pooled it
- Supporting study registration to reduce research waste.Nature ecology & evolution · 2024Review
- Article
- Changes to design and analysis elements of research plans during randomised controlled trials in Australia.The Medical journal of Australia · 2022Article
- Methodological Quality and Risk of Bias Assessment of Cardiovascular Disease Research: Analysis of Randomized Controlled Trials Published in 2017.Frontiers in cardiovascular medicine · 2022Article
- Creating efficiencies in the extraction of data from randomized trials: a prospective evaluation of a machine learning and text mining tool.BMC medical research methodology · 2021Article
- P value and Bayesian analysis in randomized-controlled trials in child health research published over 10 years, 2007 to 2017: a methodological review protocol.Systematic reviews · 2021Article
- Publication Trends of Pediatric and Adult Randomized Controlled Trials in General Medical Journals, 2005-2018: A Citation Analysis.Children (Basel, Switzerland) · 2020Article
- Reporting of data monitoring committees and adverse events in paediatric trials: a descriptive analysis.BMJ paediatrics open · 2019Article
- Reporting of interventions and "standard of care" control arms in pediatric clinical trials: a quantitative analysis.Pediatric research · 2018Article
- Critical components for designing and implementing randomized controlled trials.Pediatric investigation · 2018Article
- Article
- Consent and recruitment: the reporting of paediatric trials published in 2012.BMJ paediatrics open · 2018Article
- Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
8 authors at 2 institutions in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundRandomized 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.
methodsWe 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.
resultsMost 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.
conclusionsMore 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.
Indexed as
Identifiers
What OpenQuestion holds
Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.