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

Abstract

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) and or if they had published randomized controlled trial (RCT) between 1st January 2016 and 31st 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.

Quality of randomized controlled trials and systematic reviews in pediatric surgery: A cross‐sectional meta‐research study

“…Studies whose primary topic related to noninvasive procedures (e.g., casting, shockwave lithotripsy, bracing, molding), postoperative therapies (e.g., tranexamic acid for postoperative bleeding, opioids and nerve blocks for postoperative pain, radiation as neoadjuvant therapy post tumor resection), fetal surgery, anesthetics, intensive care, dentistry, nursing or meta-research were not included. 3 The study was published in full in 2021. Study protocols and studies written as replies, letters to the editor or secondary analyses were not included because their risk of bias and reporting quality could not be adequately assessed.…”

“…Similarly, a systematic review of studies in pediatric surgery published in 1998 and 2013 found that only 1.8% and 1.9%, respectively, were RCTs [2]. These figures are even poorer than those for adult surgery: a review of 87 surgical journals by Lombard et al (2020) found that only 18% of surgical journals had published an RCT between 2016 and 2018 [3]. This is a long-standing trend.…”