Article Text

Download PDFPDF
Hidden influence? Unmasking conflicts of interest from randomized clinical trials on spinal cord stimulation for chronic pain
  1. Ryan S D'Souza1,
  2. Johana Klasova1,
  3. Donald J Kleppel1,
  4. Larry Prokop2 and
  5. Nasir Hussain3
  1. 1Department of Anesthesiology and Perioperative Medicine, Mayo Clinic, Rochester, Minnesota, USA
  2. 2Mayo Clinic Libraries, Mayo Clinic Minnesota, Rochester, Minnesota, USA
  3. 3Department of Anesthesiology, The Ohio State University Wexner Medical Center, Columbus, Ohio, USA
  1. Correspondence to Dr Ryan S D'Souza; DSouza.Ryan{at}mayo.edu

Abstract

Background Randomized clinical trials (RCTs) are considered the gold standard for evaluating the efficacy of healthcare interventions. However, conflicts of interest (COIs) can compromise the scientific integrity in these trials. This study characterized COIs in RCTs on spinal cord stimulation for chronic pain, focusing on the prevalence, disclosure, and monetary value of COIs.

Methods This cross-sectional study analyzed RCTs published from January 1, 2013 to July 27, 2023. Primary outcomes included the presence, disclosure, and monetary value of COIs, while secondary outcomes assessed the presence of direct/indirect COIs, sponsor access to data, and associations between COIs and select variables, including journal impact factor, publication year, and study outcomes.

Results Of 38 RCTs, 30 (78.9%) reported COIs. On average, 35.6% of authors per RCT had at least one COI, with a mean of 0.7 COIs per author. The mean annual monetary value of COIs was US$41,157.83 per author per RCT. 29 RCTs (76.3%) had undisclosed COIs, with an average of 24.2% of authors per RCT having undisclosed COIs. Sponsor access to data was reported in 67.6% of RCTs. No associations were observed between the mean percentage of authors with COIs and the monetary value of COIs and select dependent variables (impact factor, publication year, and study outcomes).

Conclusions A substantial majority of RCTs reported COIs with many authors having undisclosed conflicts, highlighting the need for stringent COI disclosure guidelines to maintain research integrity. Expanding COI registry systems globally and increasing non-industry funding are crucial steps toward enhancing transparency and reducing biases in medical research.

  • Spinal Cord Stimulation
  • Analgesia
  • ETHICS

Data availability statement

Data are available upon reasonable request. Data are available on reasonable request to the corresponding author (RSD).

Statistics from Altmetric.com

Request Permissions

If you wish to reuse any or all of this article please use the link below which will take you to the Copyright Clearance Center’s RightsLink service. You will be able to get a quick price and instant permission to reuse the content in many different ways.

Data availability statement

Data are available upon reasonable request. Data are available on reasonable request to the corresponding author (RSD).

View Full Text

Footnotes

  • X @Ryan_S_DSouzaMD, @JohanaKlasova

  • Contributors RSD and NH devised the project, the main conceptual ideas and, proof outline. RSD, JK, LP, and DJK worked out all of the technical details. JK, DJK, and RSD worked on data collection. RSD and NH were involved in data validation and statistical analysis. RSD wrote the manuscript and all authors were involved in reviewing and revising the submitted manuscript. RSD is the guarantor of this manuscript.

  • Funding The authors have not declared a specific grant for this research from any funding agency in the public, commercial or not-for-profit sectors.

  • Competing interests RSD received investigator-initiated grant funding from Nevro and Saol Therapeutics paid to his institution.

  • Provenance and peer review Not commissioned; externally peer reviewed.

  • Supplemental material This content has been supplied by the author(s). It has not been vetted by BMJ Publishing Group Limited (BMJ) and may not have been peer-reviewed. Any opinions or recommendations discussed are solely those of the author(s) and are not endorsed by BMJ. BMJ disclaims all liability and responsibility arising from any reliance placed on the content. Where the content includes any translated material, BMJ does not warrant the accuracy and reliability of the translations (including but not limited to local regulations, clinical guidelines, terminology, drug names and drug dosages), and is not responsible for any error and/or omissions arising from translation and adaptation or otherwise.