Supplementary material: COVID-19 clinical trials: who is likely to participate and why?

These are peer-reviewed supplementary materials for the article 'COVID-19 clinical trials: who is likely to participate and why?' published in the Journal of Comparative Effectiveness Research.Appendix 1: Research Participation SurveyAppendix 2: Statistical Analyses and ResultsSupplemental Table 1: Logistic Regression Models Predicting Intent to Participate in Hypothetical Research StudyAim: To identify factors associated with willingness to participate in a COVID-19 clinical trial and reasons for and against participating. Materials & methods: We surveyed Massachusetts (MA, USA) residents online using the Dynata survey platform and via phone using random digit dialing between October and November 2021. Respondents were asked to imagine they were hospitalized with COVID-19 and invited to participate in a treatment trial. We assessed willingness to participate by asking, “Which way are you leaning” and why. We used multivariate logistic regression to model factors associated with leaning toward participation. Open-ended responses were analyzed using conventional content analysis. Results: Of 1071 respondents, 65.6% leaned toward participating. Multivariable analyses revealed college education (OR: 1.59; 95% CI: 1.11, 2.27), trust in the healthcare system (OR: 1.32; 95% CI: 1.10, 1.58) and relying on doctors (OR: 1.77; 95% CI: 1.45, 2.17) and family or friends (OR: 1.31; 95% CI: 1.11, 1.54) to make health decisions were significantly associated with leaning toward participating. Respondents with lower health literacy (OR: 0.57; 95% CI: 0.36, 0.91) and who identify as Black (OR: 0.40; 95% CI: 0.24, 0.68), Hispanic (OR: 0.61; 95% CI: 0.38, 0.98), or republican (OR: 0.61; 95% CI: 0.38, 0.97) were significantly less likely to lean toward participating. Common reasons for participating included helping others, benefitting oneself and deeming the study low risk. Common reasons for leaning against were deeming the study high risk, disliking experimental treatments and not wanting to be a guinea pig. Conclusion: Our finding that vulnerable individuals and those with lower levels of trust in the healthcare system are less likely to be receptive to participating in a COVID-19 clinical trial highlights that work is needed to achieve a healthcare system that provides confidence to historically disadvantaged groups that their participation in research will benefit their community.

本数据集为发表在《比较疗效研究杂志》上的文章《COVID-19 临床试验：谁可能参与以及原因何在？》的同行评审补充材料。附录一：研究参与调查；附录二：统计分析与结果；补充表1：预测假设性研究参与意愿的逻辑回归模型。研究目的：旨在识别与愿意参与 COVID-19 临床试验的相关因素，以及参与与否的理由。研究方法：我们于 2021 年 10 月至 11 月间，利用 Dynata 调查平台在线以及通过随机数字拨号电话对马萨诸塞州（MA，美国）居民进行问卷调查。受访者被要求设想他们因 COVID-19 而住院，并被邀请参与一项治疗试验。我们通过询问“您倾向于哪一方”以及原因来评估参与意愿。我们采用多元逻辑回归模型来构建倾向于参与的因素模型。开放式回答通过传统内容分析进行。研究结果：在 1071 名受访者中，65.6% 倾向于参与。多变量分析显示，大学教育（OR：1.59；95% CI：1.11，2.27）、对医疗体系的信任（OR：1.32；95% CI：1.10，1.58）以及依赖医生（OR：1.77；95% CI：1.45，2.17）以及家人或朋友（OR：1.31；95% CI：1.11，1.54）做出健康决策与倾向于参与显著相关。健康状况素养较低（OR：0.57；95% CI：0.36，0.91）以及自认为是黑人（OR：0.40；95% CI：0.24，0.68）、西班牙裔（OR：0.61；95% CI：0.38，0.98）或共和党人（OR：0.61；95% CI：0.38，0.97）的受访者倾向于参与的可能性显著较低。参与的主要原因包括帮助他人、自我受益以及认为研究风险较低。反对参与的原因包括认为研究风险较高、不喜欢实验性治疗方案以及不愿意成为小白鼠。结论：我们发现在医疗体系信任度较低以及脆弱个体中，参与 COVID-19 临床试验的意愿较低，这一发现凸显了为了实现一个能够为历史上处于不利地位的群体提供参与研究将有益于其社区信心的医疗体系，尚需开展大量工作。