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Recommendations and evidence for reporting items in pediatric clinical trial protocols and reports: two systematic reviews.

作者信息

Clyburne-Sherin April V P, Thurairajah Pravheen, Kapadia Mufiza Z, Sampson Margaret, Chan Winnie W Y, Offringa Martin

机构信息

The Hospital for Sick Children, Peter Gilgan Centre for Research and Learning, SickKids Research Institute, Child Health Evaluative Sciences, 686 Bay Street, Toronto, ON, M5G 0A4, Canada.

Children's Hospital of Eastern Ontario, 401 Smyth Road, Ottawa, ON, K1H 8L1, Canada.

出版信息

Trials. 2015 Sep 18;16:417. doi: 10.1186/s13063-015-0954-0.


DOI:10.1186/s13063-015-0954-0
PMID:26385379
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC4574457/
Abstract

BACKGROUND: Complete 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. METHOD: MEDLINE, 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. RESULTS: For 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. CONCLUSION: These 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.

摘要
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/3986/4574457/2a4640a338af/13063_2015_954_Fig2_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/3986/4574457/380a772b3f34/13063_2015_954_Fig1_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/3986/4574457/2a4640a338af/13063_2015_954_Fig2_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/3986/4574457/380a772b3f34/13063_2015_954_Fig1_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/3986/4574457/2a4640a338af/13063_2015_954_Fig2_HTML.jpg

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Recommendations and evidence for reporting items in pediatric clinical trial protocols and reports: two systematic reviews.

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[4]
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.

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[5]
Guidance for reporting outcomes in clinical trials: scoping review protocol.

BMJ Open. 2019-2-19

[6]
Consent and recruitment: the reporting of paediatric trials published in 2012.

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[7]
Primary outcomes reporting in trials of paediatric type 1 diabetes mellitus: a systematic review.

BMJ Open. 2017-12-19

[8]
Trends in the number and the quality of trial protocols involving children submitted to a French Institutional Review Board.

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[9]
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[10]
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本文引用的文献

[1]
Methodological issues and research recommendations for prognosis after mild traumatic brain injury: results of the International Collaboration on Mild Traumatic Brain Injury Prognosis.

Arch Phys Med Rehabil. 2014-3

[2]
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J Natl Cancer Inst. 2013-9-18

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Trials. 2013-4-19

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Dev World Bioeth. 2013-5-31

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