ArticleTrials2015
Recommendations and evidence for reporting items in pediatric clinical trial protocols and reports: two systematic reviews.
Article in Trials, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 15 papers, 2 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
15 citing papers in PubMed, 2 syntheses or guidelines pooled it.
- Primary outcomes reporting in trials of paediatric type 1 diabetes mellitus: a systematic review.BMJ open · 2017Pooled it
- Pooled it
- An Image-Recognition Dietary Assessment App for Adolescents With Obesity: Pilot Randomized Controlled Trial.JMIR formative research · 2024Trial
- Trial
- Experiences, impact, and enablers of involving young people and family caregivers in developing reporting guidelines for paediatric randomised trials: a case study.Research involvement and engagement · 2025Article
- Article
- Transparent reporting of recruitment and informed consent approaches in clinical trials recruiting children with minor parents in sub-Saharan Africa: a secondary analysis based on a systematic review.BMC public health · 2021Article
- When research goes wrong: the importance of clinical trials methodology.Pediatric research · 2020Article
- Article
- Consent and recruitment: the reporting of paediatric trials published in 2012.BMJ paediatrics open · 2018Article
- Trends in the number and the quality of trial protocols involving children submitted to a French Institutional Review Board.BMC medical research methodology · 2017Article
- Using reporting guidelines to publish paediatric research.Archives of disease in childhood · 2017Article
- Are child-centric aspects in newborn and child health systematic review and meta-analysis protocols and reports adequately reported?-two systematic reviews.Systematic reviews · 2017Article
- Article
- 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
6 authors.
Funding
Abstract
backgroundComplete and transparent reporting of clinical trial protocols and reports ensures that these documents are useful to all stakeholders, that bias is minimized, and that the research is not wasted. However, current studies repeatedly conclude that pediatric trial protocols and reports are not appropriately reported. Guidelines like SPIRIT (Standard Protocol Items: Recommendations for Interventional Trials) and CONSORT (Consolidated Standards of Reporting Trials) may improve reporting, but do not offer guidance on issues unique to pediatric trials. This paper reports two systematic reviews conducted to build the evidence base for the development of pediatric reporting guideline extensions: 1) SPIRIT-Children (SPIRIT-C) for pediatric trial protocols, and 2) CONSORT-Children (CONSORT-C) for pediatric trial reports.
methodMEDLINE, the Cochrane Methodology Register, and reference lists of included studies were searched. Publications of any type were eligible if they included explicit recommendations or empirical evidence for the reporting of potential items in a pediatric protocol (SPIRIT-C systematic review) or trial report (CONSORT-C systematic review). Study characteristics, recommendations and evidence for pediatric extension items were extracted. Recurrent themes in the recommendations and evidence were identified and synthesized. All steps were conducted by two reviewers.
resultsFor the SPIRIT-C and CONSORT-C systematic reviews 366 and 429 publications were included, respectively. Recommendations were identified for 48 of 50 original reporting items and sub-items from SPIRIT, 15 of 20 potential SPIRIT-C reporting items, all 37 original CONSORT items and sub-items, and 16 of 22 potential CONSORT-C reporting items. The following overarching themes of evidence to support or refute the utility of reporting items were identified: transparency; reproducibility; interpretability; usefulness; internal validity; external validity; reporting bias; publication bias; accountability; scientific soundness; and research ethics.
conclusionThese systematic reviews are the first to systematically gather evidence and recommendations for the reporting of specific items in pediatric protocols and trials. They provide useful and translatable evidence on which to build pediatric extensions to the SPIRIT and CONSORT reporting guidelines. The resulting SPIRIT-C and CONSORT-C will provide guidance to the authors of pediatric protocols and reports, respectively, helping to alleviate concerns of inappropriate and inconsistent reporting, and reduce research waste.
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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.