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Selective reporting bias in randomised controlled trials from two network meta-analyses: comparison of clinical trial registrations and their respective publications
- Source :
- BMJ Open
- Publication Year :
- 2019
- Publisher :
- BMJ, 2019.
-
Abstract
- ObjectiveTo determine (i) the difference in the frequency of serious adverse events (SAEs) reported in trial registrations and their respective primary publications and (ii) the effect of adding SAE data from registries to a network meta-analysis (NMA) in changing the surface under the cumulative ranking (SUCRA) curve values of interventions.DesignSecondary analysis of primary publications from two NMAs.Eligibility criteria for selecting studiesWe included randomised trials published in English after 2005 that were included in two NMAs of pharmacological interventions for Alzheimer’s disease and chronic obstructive pulmonary disease.Data extractionTwo reviewers independently searched multiple international trial registries for registration status and abstracted data from the included study publications and ClinicalTrials.gov.ResultsOf the 203 randomised trials included, 140 (69.0%) were registered with a trial registry and 72 (35.5%) posted results in the registry. The proportion of registered trials increased over time (38.5% in 2005 vs 78.6% in 2014). Of the publications with results posted in a trial registry, 14 (19.4%) had inconsistent reporting of overall SAEs; 7 (10.4%) studies did not report SAEs in the publication but did in the registry. In the 134 randomised trials with a prespecified primary outcome in the registry, 19 studies (9.4%) had a change in the primary outcome in the publication. Adding SAEs reported in registries to the NMAs did not affect the ranking of interventions.ConclusionWe identified inconsistent reporting of SAEs in randomised trials that were included in two NMAs. Findings highlight the importance of including trial registries in the grey literature search and verifying safety data before incorporating it into NMAs.Study registrationosf.io/mk6dr.
- Subjects :
- selective reporting
medicine.medical_specialty
Drug-Related Side Effects and Adverse Reactions
Network Meta-Analysis
Psychological intervention
Pulmonary disease
030204 cardiovascular system & hematology
Pulmonary Disease, Chronic Obstructive
03 medical and health sciences
0302 clinical medicine
Alzheimer Disease
Research Methods
medicine
Humans
Registries
030212 general & internal medicine
Adverse effect
Selection Bias
Original Research
Randomized Controlled Trials as Topic
randomised trials
Publishing
business.industry
Publications
reporting bias
General Medicine
3. Good health
Clinical trial
Reporting bias
Data extraction
Network Meta-Analyses
Adverse events
Emergency medicine
clinical trial registries
business
Registration status
Subjects
Details
- ISSN :
- 20446055
- Volume :
- 9
- Database :
- OpenAIRE
- Journal :
- BMJ Open
- Accession number :
- edsair.doi.dedup.....eab003001cca8911d1fd942e8ad5ffb9