Research transparency promotion by surgical journals publishing randomised controlled trials: a survey

N Lombard (1) , A Gasmi (1) , L Sulpice (1, 2, 3) , K Boudjema (1, 2, 3) , Florian Naudet (3) , D Bergeat (1, 2)

1 Centre Hospitalier Universitaire de Rennes [CHU Rennes] = Rennes University Hospital [Ponchaillou]
2 NuMeCan - Nutrition, Métabolismes et Cancer
3 CIC - Centre d'Investigation Clinique [Rennes]

Objective - To describe surgical journals' position statements on data-sharing policies (primary objective) and to describe key features of their research transparency promotion. Methods - Only "SURGICAL" journals with an impact factor higher than 2 (Web of Science) were eligible for the study. They were included, if there were explicit instructions for clinical trial publication in the official instructions for authors (OIA) or if they had published randomised controlled trial (RCT) between 1 January 2016 and 31 December 2018. The primary outcome was the existence of a data-sharing policy included in the instructions for authors. Data-sharing policies were grouped into 3 categories, inclusion of data-sharing policy mandatory, optional, or not available. Details on research transparency promotion were also collected, namely the existence of a "prospective registration of clinical trials requirement policy", a conflict of interests (COIs) disclosure requirement, and a specific reference to reporting guidelines, such as CONSORT for RCT. Results - Among the 87 surgical journals identified, 82 were included in the study: 67 (82%) had explicit instructions for RCT and the remaining 15 (18%) had published at least one RCT. The median impact factor was 2.98 [IQR = 2.48-3.77], and in 2016 and 2017, the journals published a median of 11.5 RCT [IQR = 5-20.75]. The OIA of four journals (5%) stated that the inclusion of a data-sharing statement was mandatory, optional in 45% (n = 37), and not included in 50% (n = 41). No association was found between journal characteristics and the existence of data-sharing policies (mandatory or optional). A "prospective registration of clinical trials requirement" was associated with International Committee of Medical Journal Editors (ICMJE) allusion or affiliation and higher impact factors. Journals with specific RCT instructions in their OIA and journals referenced on the ICMJE website more frequently mandated the use of CONSORT guidelines. Conclusion - Research transparency promotion is still limited in surgical journals. Standardisation of journal requirements according to ICMJE guidelines could be a first step forward for research transparency promotion in surgery.

Mots clés: Randomised controlled trial; Data sharing; Conflict of interest; CONSORT statement

Domaines: Sciences du Vivant [q-bio]

N Lombard, A Gasmi, L Sulpice, K Boudjema, Florian Naudet, et al.. Research transparency promotion by surgical journals publishing randomised controlled trials: a survey. Trials, 2020, 21 (1), pp.824. ⟨10.1186/s13063-020-04756-7⟩. ⟨hal-02972769⟩