Article type
Year
Abstract
Background: Increasingly, members of the scientific community and stakeholders expect transparency in the conduct and reporting of randomized controlled trials (RCTs). Measures have been implemented to attempt to increase the accessibility and availability of trial data. The individual participant data meta-analysis (IPDMA) is a type of study design which relies on the sharing of data to synthesize raw data from primary studies. In practice, data sharing is largely left at the discretion of study authors.
Objectives: Objectives were to determine the proportion of RCTs that contributed data to IPDMAs and explore factors associated with data sharing.
Methods: IPDMAs with ≥10 eligible RCTs, a documented systematic review of the literature, published references for all eligible RCTs indicating which provided data were identified by searching MEDLINE, EMBASE, CINAHL and Cochrane May 1, 2015 to February 13, 2017. From each IPDMA, we ascertained if there was a published protocol or a PROSPERO registration, country of the corresponding, participant population medical condition, and type of intervention assessed. For all eligible RCTs within each IPDMA, we ascertained if the RCT had contributed data, 2015 Thomson Reuters impact factor of the journal where the RCT was published, RCT publication year, RCT funding source and presence of author financial conflict of interest, and the number of participants from the RCT included in the IPDMA. Mixed effect logistic regression was used to identify factors associated with data contribution at the IPDMA and at the trial level.
Results: Of 774 eligible RCTs from 35 included IPDMAs, 517 (67%, 95% confidence interval [CI] 63-70%) contributed data. Compared to RCTs from journals with low impact factors (0-2.4), RCTs from journals with higher impact factors were more likely to contribute data: impact factor 5.0-9.9, odds ratio [OR] 2.6, 95% CI 1.37-4.86; impact factor 10.0-19.9, OR 5.7, 95% CI 3.0-10.8; impact factor >20.0, OR 4.6, 95% CI 1.9- 11.4. RCTs from the United Kingdom were more likely to contribute data than those from the United States (reference; OR 2.4, 95% CI, 1.3-4.6). There was an increase in OR per publication year (OR 1.05, 95% CI 1.02-1.09).
Conclusions: Country where RCTs are conducted, impact factor of the journal where RCTs are published, and RCT publication year were associated with data contribution in IPDMAs with ≥10 eligible RCTs.
Patient or healthcare consumer involvement: Data sharing promotes transparent verification and replication of trial results, ensures that important trial findings are reported, reduces waste in research by avoiding unnecessary repetition of efforts, guides the planning of future trials, and may serve to reduce the frequency and impact of non-publication and selective reporting of trial results. This study provides insight into potential factors associated with data sharing that may guide future interventions and practices to increase open data sharing.
Objectives: Objectives were to determine the proportion of RCTs that contributed data to IPDMAs and explore factors associated with data sharing.
Methods: IPDMAs with ≥10 eligible RCTs, a documented systematic review of the literature, published references for all eligible RCTs indicating which provided data were identified by searching MEDLINE, EMBASE, CINAHL and Cochrane May 1, 2015 to February 13, 2017. From each IPDMA, we ascertained if there was a published protocol or a PROSPERO registration, country of the corresponding, participant population medical condition, and type of intervention assessed. For all eligible RCTs within each IPDMA, we ascertained if the RCT had contributed data, 2015 Thomson Reuters impact factor of the journal where the RCT was published, RCT publication year, RCT funding source and presence of author financial conflict of interest, and the number of participants from the RCT included in the IPDMA. Mixed effect logistic regression was used to identify factors associated with data contribution at the IPDMA and at the trial level.
Results: Of 774 eligible RCTs from 35 included IPDMAs, 517 (67%, 95% confidence interval [CI] 63-70%) contributed data. Compared to RCTs from journals with low impact factors (0-2.4), RCTs from journals with higher impact factors were more likely to contribute data: impact factor 5.0-9.9, odds ratio [OR] 2.6, 95% CI 1.37-4.86; impact factor 10.0-19.9, OR 5.7, 95% CI 3.0-10.8; impact factor >20.0, OR 4.6, 95% CI 1.9- 11.4. RCTs from the United Kingdom were more likely to contribute data than those from the United States (reference; OR 2.4, 95% CI, 1.3-4.6). There was an increase in OR per publication year (OR 1.05, 95% CI 1.02-1.09).
Conclusions: Country where RCTs are conducted, impact factor of the journal where RCTs are published, and RCT publication year were associated with data contribution in IPDMAs with ≥10 eligible RCTs.
Patient or healthcare consumer involvement: Data sharing promotes transparent verification and replication of trial results, ensures that important trial findings are reported, reduces waste in research by avoiding unnecessary repetition of efforts, guides the planning of future trials, and may serve to reduce the frequency and impact of non-publication and selective reporting of trial results. This study provides insight into potential factors associated with data sharing that may guide future interventions and practices to increase open data sharing.