Of the consensus-based rheumatology recommendations published between 2000 and 2020, approximately one-third were sponsored by the pharmaceutical industry, and compared with recommendations authored or endorsed by major societies, industry-sponsored recommendations generally ranked lower on measures of methodologic quality. Findings from this systematic review were published in Lancet Rheumatology.
Consensus-based recommendations are typically used to establish standard-of-care and educate practitioners in the field. In rheumatology, medical societies like the American College of Rheumatology (ACR) and the European Alliance of Associations for Rheumatology (EULAR) often participate in recommendation development. The pharmaceutical industry is another common sponsor in guideline authorship. While industry-sponsored recommendations can provide substantial value to the literature, concerns have been raised about their objectivity.
To assess the role and impact of industry sponsorship on guideline quality, authors conducted a systematic review of online research databases from inception through April 2020.
Eligible projects provided consensus-based recommendations or guidelines for any adult rheumatic condition. Studies published before 2000 or in a language other than English were excluded from the analysis. Data about project characteristics, including industry sponsorship or pharmaceutical-funder involvement, were collected. Guideline quality was assessed using the validated Appraisal of Guidelines for Research and Evaluation (AGREE) II instrument. Guidelines were considered to be “high quality” if the AGREE II rigor of development domain score was 60% and higher and “low quality” if the rigor of development domain score was lower than 60%.
Descriptive statistics and linear regression were used to compare overall guideline quality by consensus technique, disease category, endorsement category, and the presence of an industry sponsor.
A total of 234 articles were included in analysis. The most common consensus-based methods were Delphi processes (38%) and consensus conferences (31%). Projects were conducted in Europe (52%), North America (14%), and Asia Pacific (10%). The mean number of authors per article was 18.4±11.3. The most common diseases studied were rheumatoid arthritis (26%), spondyloarthritis (13%), osteoarthritis (9%), crystal arthritis (7%), psoriatic arthritis (7%), and vasculitis (6%).
Overall, 74 projects (32%) were industry-sponsored. An additional 51 (22%) were endorsed by a major society, including the ACR (6%) and EULAR (16%). Industry sponsorship was observed in 8% of projects endorsed by EULAR, 23% of projects endorsed by other professional societies, and 72% of projects not endorsed by any society. None of the projects sponsored by the ACR or government entities had an industry sponsor. Of 74 sponsored projects, 44 (59%) had at least 1 author declare conflicts of interest with an industry sponsor, including 25 (34%) first authors.
Compared with projects endorsed by major societies, industry-sponsored guidelines were less likely to be considered high quality, according to the rigor of development AGREE II domain score (24% vs 84%; P <.0001). On average, industry-sponsored projects scored lower than society-endorsed projects on 4 of the 6 AGREE II domains: stakeholder involvement (50% vs 68%; P <.0001); rigor of development (44% vs 69%; P <.0001); clarity of presentation (69% vs 91%; P <.0001); and applicability (14% vs 21%; P =.025).
Results from the systematic review suggested that industry sponsorship is common in the development of clinical guidelines. On average, industry-sponsored guidelines were of lower quality than guidelines endorsed by major professional societies.
Study limitations included the fact that industry involvement may have been undeclared in a number of projects. Further, the current review was limited to the field of rheumatology and thus may not provide insight into other clinical areas.
“[T]his study suggests that industry sponsorship of consensus-based guidelines in rheumatology is common among projects that do not receive ACR or EULAR endorsement,” the authors noted. “[T]o maintain the actual and perceived integrity of these projects, medical journals should take steps to encourage greater [rigor] of development and to limit undue influence by industry sponsors.”
Disclosure: Some study authors declared affiliations with biotech, pharmaceutical, and/or device companies. Please see the original reference for a full list of disclosures.
Feterman Jimenez D, Duron G, Hendin J, et al. Industry involvement in rheumatology consensus-based recommendations: a systematic review. Lancet Rheumatol. Published online December 17, 2021. doi:10.1016/S2665-9913(21)00332-5