Assessing selective outcome reporting in sleep disorder trials: A registry-publication comparison study
- 1Office of Medical Student Research, Oklahoma State University Center for Health Sciences, Tulsa, OK, USA; Corresponding author. Oklahoma State University Center for Health Sciences, 1111 W 17th St., Tulsa, OK, 74107, USA.
- 2Office of Medical Student Research, Oklahoma State University Center for Health Sciences, Tulsa, OK, USA
- 3Office of Medical Student Research, Oklahoma State University Center for Health Sciences, Tulsa, OK, USA; Department of Psychiatry and Behavioral Sciences, Oklahoma State University Center for Health Sciences, Tulsa, OK, USA
Abstract
Background: Prespecified outcomes form the foundation of clinical trial validity. Despite federal registration requirements under the FDAAA Final Rule, discrepancies between registered and published outcomes remain common across medical fields. The extent of outcome modifications in interventional sleep disorder trials has not been systematically examined using registry version histories. Methods: We conducted a cross-sectional registry-publication comparison of 54 interventional sleep disorder trials registered on ClinicalTrials.gov between January 2017 and December 2024. Using the platform's “History of Changes” tool, we compared earliest and most recent registry versions to identify outcome modifications. Changes were classified as high, moderate, or low impact. Corresponding publications were reviewed to assess disclosure. Predictors of modification were evaluated using Firth penalized logistic regression. Results: Substantive outcome modifications were present in 94.4% of trials, with a median of five modifications per trial. High-impact modifications affecting primary outcomes occurred in 48.1% of trials. Changes most frequently involved clarification or increased specification (61.1%), outcome additions (57.4%), and removals (40.7%). The majority of modifications occurred after primary completion (60.8%) or publication (37.3%). Disclosure was rare: 3.9% of trials acknowledged modifications in the registry and 5.9% in the corresponding publication. Industry funding was associated with lower odds of high-impact modification (OR 0.2, 95% CI 0.0-0.7; p = 0.01) Conclusions: Outcome modifications are nearly universal in sleep disorder trials and are rarely disclosed. Strengthening preregistration practices, editorial oversight, and registry transparency may improve the reliability of the sleep medicine evidence base.
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BibTeX
@article{forbes2026assessing,
title = {{Assessing selective outcome reporting in sleep disorder trials: A registry-publication comparison study}},
author = {Caden Forbes and Makalie Lackey and Logan Corwin and Tag Harris and Daniel Archer and Rachel Hazlitt and Ahmed Elghzali and Alicia Ito Ford and Matt Vassar},
journal = {Sleep Medicine: X},
year = {2026},
month = oct,
doi = {10.1016/j.sleepx.2026.100204},
url = {https://doi.org/10.1016/j.sleepx.2026.100204},
note = {CC BY},
}
RIS
TY - JOUR
TI - Assessing selective outcome reporting in sleep disorder trials: A registry-publication comparison study
AU - Caden Forbes
AU - Makalie Lackey
AU - Logan Corwin
AU - Tag Harris
AU - Daniel Archer
AU - Rachel Hazlitt
AU - Ahmed Elghzali
AU - Alicia Ito Ford
AU - Matt Vassar
PY - 2026
DA - 2026/10/21
JO - Sleep Medicine: X
DO - 10.1016/j.sleepx.2026.100204
UR - https://doi.org/10.1016/j.sleepx.2026.100204
AB - Background: Prespecified outcomes form the foundation of clinical trial validity. Despite federal registration requirements under the FDAAA Final Rule, discrepancies between registered and published outcomes remain common across medical fields. The extent of outcome modifications in interventional sleep disorder trials has not been systematically examined using registry version histories. Methods: We conducted a cross-sectional registry-publication comparison of 54 interventional sleep disorder trials registered on ClinicalTrials.gov between January 2017 and December 2024. Using the platform's “History of Changes” tool, we compared earliest and most recent registry versions to identify outcome modifications. Changes were classified as high, moderate, or low impact. Corresponding publications were reviewed to assess disclosure. Predictors of modification were evaluated using Firth penalized logistic regression. Results: Substantive outcome modifications were present in 94.4% of trials, with a median of five modifications per trial. High-impact modifications affecting primary outcomes occurred in 48.1% of trials. Changes most frequently involved clarification or increased specification (61.1%), outcome additions (57.4%), and removals (40.7%). The majority of modifications occurred after primary completion (60.8%) or publication (37.3%). Disclosure was rare: 3.9% of trials acknowledged modifications in the registry and 5.9% in the corresponding publication. Industry funding was associated with lower odds of high-impact modification (OR 0.2, 95% CI 0.0-0.7; p = 0.01) Conclusions: Outcome modifications are nearly universal in sleep disorder trials and are rarely disclosed. Strengthening preregistration practices, editorial oversight, and registry transparency may improve the reliability of the sleep medicine evidence base.
SN - 2590-1427
ER -