Trauma Department, Hannover Medical School, Hannover, Germany.
Department of Orthopaedic Surgery, Brigham and Women's Hospital, Boston, MA, USA.
J Shoulder Elbow Surg. 2022 Oct;31(10):2203-2210. doi: 10.1016/j.jse.2022.05.019. Epub 2022 Jun 22.
Potential conflicts of interest (COIs) are common among physicians and may bias physician-reported outcome assessment in orthopedic research. It is unclear whether patients have COIs and whether these COIs could affect patient-reported outcome measures (PROMs). The purposes of this study were to investigate (1) the existence of COIs among patients and (2) the potential of these COIs to bias PROMs with a pseudonymized survey among consecutive shoulder and elbow patients.
Between February and May 2021, 144 shoulder and elbow patients who underwent consultation at our outpatient clinic were included in the survey study. Of these patients, 79.2% (n = 114) completed the 11-item questionnaire. Variables including sex, existence of chronic diseases, level of education, and economic status were also assessed to investigate any association between these variables and patients' perceptions of COIs.
Whereas 33.3% of respondents (n = 38) believe that COIs exist among patients and 28.1% (n = 32) believe that COIs could bias PROMs in general, fewer patients admit to personal COIs (24.6%, n = 28) and COIs biasing their self-assessment (23.7%, n = 27). Patients more frequently suggest COIs in their personal environment, such as among family members or friends (27.2%, n = 31), than in their own medical treatment. Financial factors such as sick pay (34.2%, n = 39) are thought to be the most likely reason for having COIs, followed by interpersonal reasons such as maintaining medical affection or bonds (29.8%, n = 34). Of respondents, 42.1% (n = 48) believe that sole usage of PROMs poses risks in treatment evaluation and only 21% (n = 24) consider PROMs reliable. In addition, 43% of respondents (n = 49) believe that patients should disclose COIs routinely in medical treatment. Multinomial logistic regression analysis revealed that wealthier patients are more likely to believe COIs could bias PROMs (odds ratio for poor vs. middle class, 0.23 [95% confidence interval, 0.053-0.963]; odds ratio for lower-middle class vs. middle class, 0.19 [95% confidence interval, 0.052-0.677]).
Although the majority of shoulder and elbow patients deny having self-experienced COIs and deny biased PROMs due to COIs in their own medical treatment, a considerable number of patients admit to having experienced both. Further studies might be justified to investigate the actual clinical relevance of patients' COIs and their impact on value-based health care.
潜在的利益冲突（COI）在医生中很常见，可能会影响骨科研究中医生报告的结果评估。目前尚不清楚患者是否存在 COI，以及这些 COI 是否会影响患者报告的结果测量（PROM）。本研究的目的是调查（1）患者中 COI 的存在情况，以及（2）通过对连续肩肘患者进行匿名调查，这些 COI 对 PROM 产生潜在偏差的可能性。
2021 年 2 月至 5 月，对在我院门诊就诊的 144 例肩肘患者进行了调查研究。其中，79.2%（n=114）完成了 11 项问卷调查。还评估了性别、慢性病存在情况、教育程度和经济状况等变量，以调查这些变量与患者对 COI 的看法之间是否存在关联。
虽然 33.3%（n=38）的受访者认为患者中存在 COI，28.1%（n=32）认为 COI 可能会普遍影响 PROM，但只有 24.6%（n=28）的患者承认存在个人 COI，23.7%（n=27）的患者承认 COI 会影响他们的自我评估。患者更频繁地认为 COI 存在于他们的个人环境中，例如在家庭成员或朋友中（27.2%，n=31），而不是在他们自己的医疗中。经济因素，如病假工资（34.2%，n=39），被认为是产生 COI 的最可能原因，其次是人际关系原因，如保持医疗感情或联系（29.8%，n=34）。42.1%（n=48）的受访者认为仅使用 PROMs 进行治疗评估存在风险，只有 21%（n=24）认为 PROMs 可靠。此外，43%的受访者（n=49）认为患者在医疗过程中应常规披露 COI。多项逻辑回归分析显示，较富裕的患者更有可能认为 COI 会影响 PROM（贫困与中产阶级相比，比值比为 0.23[95%置信区间，0.053-0.963]；中下阶层与中产阶级相比，比值比为 0.19[95%置信区间，0.052-0.677]）。
尽管大多数肩肘患者否认自己经历过 COI，也否认由于自己的医疗治疗而导致 PROM 存在偏差，但相当一部分患者承认自己经历过这两种情况。可能有必要进一步研究以调查患者 COI 的实际临床相关性及其对基于价值的医疗保健的影响。
