Article Text
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).
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Data availability statement
Data are available upon reasonable request. Data are available on reasonable request to the corresponding author (RSD).
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.
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