Institutional conflicts of interest in studies investigating the volume-outcome relationship of clinical procedures

Article type
Authors
Kugler C1, Goossen K2, Akl E3, Pieper D1
1Brandenburg Medical School Theodor Fontane, Rüdersdorf bei Berlin, Germany; Brandenburg Medical School Theodor Fontane, Center for Health Services Research Brandenburg, Rüdersdorf bei Berlin, Germany
2Witten/Herdecke University, Institute for Research in Operative Medicine, Cologne, Germany
3American University of Beirut, Department of Internal Medicine, Beirut, Lebanon
Abstract
Background: Published evidence of relationships between hospital volume and outcomes for clinical procedures has led to policies aimed at centralising the provision of some of those procedures. Authors of primary studies may have an interest to influence health policy decisions by preferentially publishing research results that favour the volume category of the hospital with which they are affiliated. This can be considered a form of institutional conflict of interest (COI). Institutional COIs may compromise patient care by biasing health policy decisions.

Objective: This study aimed to explore the existence of institutional COIs in volume-outcome studies.

Methods: We used a sample of studies included in a systematic review on the hospital volume-outcome relationship in total knee arthroplasty. For studies in which at least one of the authors was affiliated with a hospital, we contacted the study authors by e-mail to obtain their institutional volume and to survey them about their opinion on institutional COIs. We categorised the study’s conclusions (positive vs. non-positive) and author’s hospital volume (high, intermediate, low). We compared conclusions for high vs. intermediate/low hospital volume categories. The survey results were analysed descriptively.

Results: Fifty-three studies were eligible. Of 29 hospital-affiliated authors contacted, 20 replied. Results suggest that studies by authors from high-volume institutions more often concluded a hospital volume-outcome relationship existed compared to studies by authors from intermediate- or low-volume institutions (odds ratio, OR: 2.0; 95% confidence interval, CI: 0.21; 18.7). As for the authors’ opinions, 6/17 (35%) believed that institutional factors such as the case volume were (very) likely to influence the study design, analysis, or conclusions of research in the field of volume-outcome studies; 4/17 (24%) were neutral; and 7/17 (41%) believed that this was (very) unlikely.

Conclusions: To the best of our knowledge, this is the first explorative study investigating institutional COIs. Overall, findings suggest the possibility that institutional COIs may influence the results of volume-outcome studies, although the results are inconclusive. Surveyed authors had divergent opinions on whether institutional factors are likely to influence on the study design, analysis, or conclusions. Further research is needed to investigate institutional COIs.