Transparency in surgical randomized clinical trials: cross-sectional observational study

Abstract

Background: RCTs provide the scientific basis upon which treatment decisions are made. To facilitate critical review, it is important that methods and results are reported transparently. The aim of this study was to explore transparency in surgical RCTs with respect to trial registration, disclosure of funding sources, declarations of investigator conflicts and data-sharing. Methods: This was a cross-sectional review of published surgical RCTs. Ten high-impact journals were searched systematically for RCTs published in years 2009, 2012, 2015 and 2018. Four domains of transparency were explored: trial registration, disclosure of funding, disclosure of investigator conflicts, and a statement relating to data-sharing. Results: Of 611 RCTs, 475 were eligible for analysis. Some 397 RCTs (83.6 per cent) were registered on a trial database, of which 190 (47⋅9 per cent) had been registered prospectively. Prospective registration increased over time (26 per cent in 2009, 33⋅0 per cent in 2012, 54 per cent in 2015, and 72⋅7 per cent in 2018). Funding disclosure was present in 55⋅0, 65⋅0, 69⋅4 and 75⋅4 per cent of manuscripts respectively. Conflict of interest disclosure was present in 49⋅5, 89⋅1, 94⋅6 and 98⋅3 per cent of manuscripts across the same time periods. Data-sharing statements were present in only 15 RCTs (3⋅2 per cent), 11 of which were published in 2018. Conclusion: Trial registration, disclosure of funding and disclosure of investigator conflicts in surgical RCTs have improved markedly over the past 10 years. Disclosure of data-sharing plans is exceptionally low. This may contribute to research waste and represents a target for improvement.

Data Sharing and Reanalyses Among Randomized Clinical Trials Published in Surgical Journals Before and After Adoption of a Data Availability and Reproducibility Policy

“…The role of journals in the promotion of transparency by way of strong policies should not be underestimated in improving value and reducing waste in research. 7 , 23 New indicators that valorize research transparency are being developed to incentivize journals to develop and adequately implement these optimal policies. For instance, the “TOP factor” 24 is being developed by the Center of Open Science to assess journals for transparency and openness.…”

“…Even data on transparency and on data sharing practices or the promotion of data sharing in the surgical community are scarce. 7 , 27 , 28 …”

“…Although transparency has improved over the past 10 years in surgical journals, data sharing statements are an exception, reaching approximately 3% of published RCTs, mostly in 2018 just after the ICMJE policy was issued. 7 …”

Transparency of COVID-19-Related Research in Dental Journals

“…However, evidence indicates that many journals require funding disclosure too [ 31 ]. Whilst there are reports of higher proportions for funding disclosure for randomized controlled trials [ 32 , 33 ], most COVID-19-related research articles have been observational studies, editorials, letters, and reviews, and thus it is logical that most research did not receive funding which would have affected the content of the articles. However, we should bear in mind that even if external funding was not received, it should be stated in order to increase transparency in science.…”

Trial registration and selective outcome reporting in Endodontic Research: Evidence over a 5‐year period

“…The picture in dentistry remains considerably bleaker than within biomedical research. A cross‐section of RCTs from the surgical literature, across 10 years and since 2009, has revealed that registration was evident in 84% of the studies overall, whilst prospective registration practices have been identified as increasing increments across the years, from 26% in 2009 to 73% in 2018 (Helliwell et al, 2020).…”