Conflicts of interest in randomised controlled surgical trials: systematic review and qualitative and quantitative analysis

Abstract

Conflicts of interest may lead to biased trial designs and unbalanced interpretation of study results. We aimed to evaluate the reporting of potential conflicts of interest in full publications of surgical randomised controlled trials (RCTs). A systematic literature search was performed in CENTRAL, MEDLINE and EMBASE (1985–2014) to find all surgical RCTs of medical devices and perioperative pharmacological or nutritional interventions. The information on conflicts of interest was evaluated both quantitatively and qualitatively, and the development of stated conflicts over time was studied. Of 7934 articles, 444 met the inclusion criteria. In 93 of 444 trials (20.9%), conflicts of interest were disclosed. In half of the cases, the information provided was insufficient to permit conclusions regarding possible influence on the trials. Information about conflicts of interest has increased continuously during the last decades (1985–1994: 0%, 1995–2004: 2.8% and 2005–2014: 33.0%; p<0.001). Among the 115 industry-funded trials, industry participation was considered as a potential conflict of interest in 24 cases (20.9%). Over the past three decades, only every 10th trial has provided appropriate information on conflicts of interest. However, transparency is crucial for the reliability of evidence-based medicine. There is an urgent need for the full disclosure of all conflicts of interest in surgical publishing and for transparency regarding cooperation between academia and industry.

Critical analysis of the reporting quality of randomized trials within Endodontics using the Preferred Reporting Items for RAndomized Trials in Endodontics (PRIRATE) 2020 quality standard checklist

“…A conflict of interest is present when a researcher or clinician involved in the trial has a personal interest that could bias the conduct or reporting of trial (Probst et al . 2016). Hence, a conflict of interest statement must be reported or, if none exists, the authors should explicitly state this fact in the manuscript.…”

Innovative Surgical Sciences: more than just another new open access journal

“…Although 144 years old, the GSS is a young and modern surgical society focusing on the interests of its members and the purposes of modern surgery for the best available surgical care. In this respect, the GSS supports the claim for transparency, which is also crucial for randomized controlled surgical trials, as it is reported in the first article submitted to and published in Innovative Surgical Sciences [7]. We are sure that open access will ultimately change the current approach of scientific evaluation [8], [9], [10].…”

Glossary for randomized clinical trials

“…The presence of a conflicting interest, financial or otherwise, is likely to affect the validity of the trial and should be disclosed for the end‐user to understand that a conflict exists and make their own decision on its relevance (Probst et al . 2016). For example, a person who developed a new instrument, will inevitably be biased in favour of their own instrument when evaluating its effectiveness. Confounding bias ‐ The presence of various factors not considered as independent factors in a trial, but which may have an impact on the outcome of the trial.…”