Allison Gates1, Lisa Hartling1, Ben Vandermeer1, Patrina Caldwell2, Despina G Contopoulos-Ioannidis3, Sarah Curtis4, Ricardo M Fernandes5, Terry P Klassen6, Katrina Williams7, Michele P Dyson8. 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; Department of Pediatrics, Hospital de Santa Maria, Centro Hospitalar Lisboa Norte, Lisbon, Portugal. 6. Children's Hospital Research Institute of Manitoba, University of Manitoba, Winnipeg, Manitoba, Canada. 7. Department of Pediatrics, Royal Children's Hospital and Murdoch Childrens Research Institute, University of Melbourne, Victoria, Australia. 8. Department of Pediatrics and the Alberta Research Centre for Health Evidence (ARCHE), University of Alberta, Edmonton, Alberta, Canada. Electronic address: mdyson@ualberta.ca.
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.
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.
Authors: Pamela R Buckley; Charles R Ebersole; Christine M Steeger; Laura E Michaelson; Karl G Hill; Frances Gardner Journal: Prev Sci Date: 2021-05-13
Authors: Allison Gates; Patrina Caldwell; Sarah Curtis; Leonila Dans; Ricardo M Fernandes; Lisa Hartling; Lauren E Kelly; Katrina Williams; Kerry Woolfall; Michele P Dyson Journal: BMJ Paediatr Open Date: 2018-11-26
Authors: Allison Gates; Patrina Caldwell; Sarah Curtis; Leonila Dans; Ricardo M Fernandes; Lisa Hartling; Lauren E Kelly; Ben Vandermeer; Katrina Williams; Kerry Woolfall; Michele P Dyson Journal: BMJ Paediatr Open Date: 2019-03-20
Authors: Alex Aregbesola; Allison Gates; Amanda Coyle; Shannon Sim; Ben Vandermeer; Megan Skakum; Despina Contopoulos-Ioannidis; Anna Heath; Lisa Hartling; Terry P Klassen Journal: Syst Rev Date: 2021-03-10