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Journal of Pediatrics, The

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The Conduct and Reporting of Child Health Research: An Analysis of Randomized Controlled Trials Published in 2012 and Evaluation of Change over 5 Years - 31/01/18

Doi : 10.1016/j.jpeds.2017.09.014 
Allison Gates, PhD 1, Lisa Hartling, PhD 1, Ben Vandermeer, MSc 1, Patrina Caldwell, PhD 2, Despina G. Contopoulos-Ioannidis, MD 3, Sarah Curtis, MD 4, Ricardo M. Fernandes, MD, PhD 5, 6, Terry P. Klassen, MD 7, Katrina Williams, PhD 8, Michele P. Dyson, PhD 1, *
1 Department of Pediatrics and the Alberta Research Centre for Health Evidence (ARCHE), University of Alberta, Edmonton, Alberta, Canada 
2 Center for Kidney Research and Discipline of Pediatrics and Child Health, University of Sydney, Sydney, New South Wales, Australia 
3 Department of Pediatrics, Division of Infectious Diseases, Stanford University School of Medicine and Meta Research Innovation Center at Stanford (METRICS), Stanford, CA 
4 Department of Pediatrics and Emergency Medicine, Women and Children's Health Research Institute, University of Alberta, Edmonton, Alberta, Canada 
5 Instituto de Medicina Molecular, Faculdade de Medicina, Universidade de Lisboa, Lisbon, Portugal 
6 Department of Pediatrics, Hospital de Santa Maria, Centro Hospitalar Lisboa Norte, Lisbon, Portugal 
7 Children's Hospital Research Institute of Manitoba, University of Manitoba, Winnipeg, Manitoba, Canada 
8 Department of Pediatrics, Royal Children's Hospital and Murdoch Childrens Research Institute, University of Melbourne, Victoria, Australia 

*Reprint requests: Michele P. Dyson, PhD, University of Alberta, ECHA 4-474, 11405-87 Ave NW, Edmonton, AB, T6G 1C9, Canada.University of AlbertaECHA 4-474, 11405-87 Ave NWEdmontonABT6G 1C9Canada

Abstract

Objectives

For child health randomized controlled trials (RCTs) published in 2012, we aimed to describe design and reporting characteristics and evaluate changes since 2007; assess the association between trial design and registration and risk of bias (RoB); and assess the association between RoB and effect size.

Study design

For 300 RCTs, we extracted design and reporting characteristics and assessed RoB. We assessed 5-year changes in design and reporting (based on 300 RCTs we had previously analyzed) using the Fisher exact test. We tested for associations between design and reporting characteristics and overall RoB and registration using the Fisher exact, Cochran-Armitage, Kruskal-Wallis, and Jonckheere-Terpstra tests. We pooled effect sizes and tested for differences by RoB using the χ2 test for subgroups in meta-analysis.

Results

The 2012 and 2007 RCTs differed with respect to many design and reporting characteristics. From 2007 to 2012, RoB did not change for random sequence generation and improved for allocation concealment (P < .001). Fewer 2012 RCTs were rated high overall RoB and more were rated unclear (P = .03). Only 7.3% of 2012 RCTs were rated low overall RoB. Trial registration doubled from 2007 to 2012 (23% to 46%) (P < .001) and was associated with lower RoB (P = .009). Effect size did not differ by RoB (P = .43)

Conclusions

Random sequence generation and allocation concealment were not often reported, and selective reporting was prevalent. Measures to increase trialists' awareness and application of existing reporting guidance, and the prospective registration of RCTs is needed to improve the trustworthiness of findings from this field.

Le texte complet de cet article est disponible en PDF.

Keywords : pediatrics, medicine, clinical studies, research design, bias

Abbreviations : CONSORT, DMC, RCTs, RoB, SMD


Plan


 Funded by the Canadian Institutes of Health Research (#KRS 140989). The authors declare no conflicts of interest.


© 2017  The Author(s). Publié par Elsevier Masson SAS. Tous droits réservés.
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Vol 193

P. 237 - février 2018 Retour au numéro
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