TY - JOUR
T1 - Heterogeneity and Gaps in Reporting Primary Outcomes From Neonatal Trials
AU - Baba, Ami
AU - Webbe, James
AU - Butcher, Nancy J.
AU - Rodrigues, Craig
AU - Stallwood, Emma
AU - Goren, Katherine
AU - Monsour, Andrea
AU - Chang, Alvin S. M.
AU - Trivedi, Amit
AU - Manley, Brett J.
AU - McCall, Emma
AU - Bogossian, Fiona
AU - Namba, Fumihiko
AU - Schmölzer, Georg M.
AU - Harding, Jane
AU - Nguyen, Kim An
AU - Doyle, Lex W.
AU - Jardine, Luke
AU - Rysavy, Matthew A.
AU - Konstantinidis, Menelaos
AU - Meyer, Michael
AU - Helmi, Muhd Alwi Muhd
AU - Lai, Nai Ming
AU - Hay, Susanne
AU - Onland, Wes
AU - Choo, Yao Mun
AU - Gale, Chris
AU - Soll, Roger F.
AU - Core Outcome Reporting in Neonatal Trials Study Group
AU - Offringa, Martin
N1 - Publisher Copyright: Copyright © 2023 by the American Academy of Pediatrics.
PY - 2023/9/1
Y1 - 2023/9/1
N2 - OBJECTIVES: Clear outcome reporting in clinical trials facilitates accurate interpretation and application of findings and improves evidence-informed decision-making. Standardized core outcomes for reporting neonatal trials have been developed, but little is known about how primary outcomes are reported in neonatal trials. Our aim was to identify strengths and weaknesses of primary outcome reporting in recent neonatal trials. METHODS: Neonatal trials including ≥100 participants/arm published between 2015 and 2020 with at least 1 primary outcome from a neonatal core outcome set were eligible. Raters recruited from Cochrane Neonatal were trained to evaluate the trials' primary outcome reporting completeness using relevant items from Consolidated Standards of Reporting Trials 2010 and Consolidated Standards of Reporting Trials-Outcomes 2022 pertaining to the reporting of the definition, selection, measurement, analysis, and interpretation of primary trial outcomes. All trial reports were assessed by 3 raters. Assessments and discrepancies between raters were analyzed. RESULTS: Outcome-reporting evaluations were completed for 36 included neonatal trials by 39 raters. Levels of outcome reporting completeness were highly variable. All trials fully reported the primary outcome measurement domain, statistical methods used to compare treatment groups, and participant flow. Yet, only 28% of trials fully reported on minimal important difference, 24% on outcome data missingness, 66% on blinding of the outcome assessor, and 42% on handling of outcome multiplicity. CONCLUSIONS: Primary outcome reporting in neonatal trials often lacks key information needed for interpretability of results, knowledge synthesis, and evidence-informed decision-making in neonatology. Use of existing outcome-reporting guidelines by trialists, journals, and peer reviewers will enhance transparent reporting of neonatal trials.
AB - OBJECTIVES: Clear outcome reporting in clinical trials facilitates accurate interpretation and application of findings and improves evidence-informed decision-making. Standardized core outcomes for reporting neonatal trials have been developed, but little is known about how primary outcomes are reported in neonatal trials. Our aim was to identify strengths and weaknesses of primary outcome reporting in recent neonatal trials. METHODS: Neonatal trials including ≥100 participants/arm published between 2015 and 2020 with at least 1 primary outcome from a neonatal core outcome set were eligible. Raters recruited from Cochrane Neonatal were trained to evaluate the trials' primary outcome reporting completeness using relevant items from Consolidated Standards of Reporting Trials 2010 and Consolidated Standards of Reporting Trials-Outcomes 2022 pertaining to the reporting of the definition, selection, measurement, analysis, and interpretation of primary trial outcomes. All trial reports were assessed by 3 raters. Assessments and discrepancies between raters were analyzed. RESULTS: Outcome-reporting evaluations were completed for 36 included neonatal trials by 39 raters. Levels of outcome reporting completeness were highly variable. All trials fully reported the primary outcome measurement domain, statistical methods used to compare treatment groups, and participant flow. Yet, only 28% of trials fully reported on minimal important difference, 24% on outcome data missingness, 66% on blinding of the outcome assessor, and 42% on handling of outcome multiplicity. CONCLUSIONS: Primary outcome reporting in neonatal trials often lacks key information needed for interpretability of results, knowledge synthesis, and evidence-informed decision-making in neonatology. Use of existing outcome-reporting guidelines by trialists, journals, and peer reviewers will enhance transparent reporting of neonatal trials.
UR - http://www.scopus.com/inward/record.url?scp=85169504498&partnerID=8YFLogxK
U2 - https://doi.org/10.1542/peds.2022-060751
DO - https://doi.org/10.1542/peds.2022-060751
M3 - Article
C2 - 37641881
SN - 0031-4005
VL - 152
JO - Pediatrics
JF - Pediatrics
IS - 3
M1 - e2022060751
ER -