Substantial discrepancies exist between registered protocol and published manuscript in trials on exercise interventions for chronic low back pain: a metaresearch

Silvia Bargeri, Giacomo Basso, Ignazio Geraci, Greta Castellini, Alessandro Chiarotto, Silvia Gianola, Raymond Ostelo, Marco Testa, Tiziano Innocenti*

*Corresponding author for this work

Research output: Contribution to journalArticleAcademicpeer-review

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Abstract

Objectives: Reporting bias, prevalent in biomedical fields, can undermine evidence credibility. Our objective was to evaluate the proportion of discrepancies between registered protocols and published manuscripts in randomized controlled trials (RCTs) on exercise interventions for patients with chronic low back pain (CLBP). Study Design and Setting: We conducted a cross-sectional meta-research study, starting from the 2021 “Exercise therapy for CLBP” Cochrane Review. We selected all RCTs reporting a protocol registration on a primary register of the World Health Organization (WHO) International Clinical Trials Registry Platform (ICTRP) or in ClinicalTrials.gov. We extracted data from both registered protocol and published manuscript of RCTs, collecting recruitment and administrative information (eg, record dates) and details of trial characteristics (eg, outcomes, arms, statistical analysis plan details [SAPs]). Independent pairs of reviewers assessed discrepancies between registered protocol and published manuscript for the reporting of primary and secondary outcomes domains, measurement instruments, time-points, number of arms and SAPs(if attached). Outcome discrepancies were characterized as addition, omission, upgrade or downgrade. Results: We included 116 RCTs reporting an available protocol registration. Overall, 100 RCTs (86.2%) distinguished between primary and secondary outcomes. Of these, 39 RCTs (39.0%) reported one or more discrepancies in primary outcomes, and 78 RCTs (78.0%) reported one or more discrepancies in secondary outcomes. Focusing on discrepancies for the primary outcome, 64.5% of added, upgraded or downgraded outcomes favored statistically significant effects. Few RCTs (n = 6) reported discrepancies in the number of arms. SAPs were poorly reported in the registered protocols (n = 3) for being compared to the publications. Conclusion: We found substantial outcome discrepancies comparing registered protocols and published manuscripts in RCTs assessing exercise interventions for patients with CLBP, with some impacting the statistical significance of the effects. Readers are encouraged to approach RCTs results in this field with caution.

Original languageEnglish
Article number111465
JournalJournal of Clinical Epidemiology
Volume173
DOIs
Publication statusPublished - Sept 2024

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Publisher Copyright: © 2024 The Author(s)

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