Kim Jennifer Y, Botto Emily, Ford Ruby Madison
Tufts School of Medicine, Boston, Massachusetts.
Tufts Center for the Study of Drug Development, Tufts School of Medicine, Boston, Massachusetts.
JAMA Netw Open. 2025 May 1;8(5):e259481. doi: 10.1001/jamanetworkopen.2025.9481.
Patient-staff interactions in clinical trials may influence future enrollment decisions among racial and ethnic minority patients, who remain underrepresented in clinical research. A scale that measures common patient-staff interactions encountered by racial and ethnic minority patients in clinical trials may help improve patient experience and enrollment outcomes.
To develop and validate a scale that measures common interactions encountered by racial and ethnic minority patients in clinical trials.
DESIGN, SETTING, AND PARTICIPANTS: This mixed-methods survey study involved interviews and online surveys for data collection between April 1, 2023, and June 30, 2024. Adult (aged ≥18 years) racial and ethnic minority patients were interviewed to identify common interactions with research staff. The survey was validated across potential clinical trial participants and among former clinical trial participants.
Fit statistics for exploratory factor analysis and confirmatory factor analysis were used to confirm the validity of the scale. Structural equation modeling coefficients were used to assess the validity of the scale for measuring patients' trust toward the research staff and willingness to participate in future studies.
The sample include 1113 participants. The scale item derivation cohort comprised 16 racial and ethnic minority participants with clinical trial experience (mean [SD] age, 44.9 [12.9] years; 10 female [62.5%]; 3 identifying as Asian or Pacific Islander [18.8%], 9 as Black [56.3%], 3 as Latino [18.8%], and 1 as multiracial [6.3%]). The scale structure validation cohort of potential clinical trial participants comprised 479 survey respondents (mean [SD] age, 35.5 [11.9] years; 219 women [45.7%]; 1 identifying as American Indian [0.2%], 59 as Asian or Pacific Islander [12.3%], 266 as Black [55.5%], 59 as Latino [12.3%], and 86 as multiracial [19.7%]). The concurrent validation cohort included 618 participants (mean [SD] age, 45.3 [16.3] years; 53% male; 63 identifying as Asian or Pacific Islander [10.2%], 228 as Black [36.9%], 75 as Latino [12.1%], 223 as White [36.1%], and 29 as multiracial [4.7%]). The 22-item Clinical Research Interaction Scale had high reliability (α = 0.96) and validity (comparative fit index, 0.92; Tucker-Lewis index, 0.91; root mean square error of approximation, 0.08). Patient experience of frequent low-quality interactions was significantly associated with lowered trust toward research staff (β, -0.56; 95% CI, -0.74 to -0.37), which in turn significantly lowered patients' willingness to return to the site for future studies (β, 0.80; 95% CI, 0.70-0.90).
These findings suggest that low-quality interactions with research staff may reduce racial and ethnic minority patients' willingness to return for future studies, mediated by lowered trust toward the staff. The Clinical Research Interaction Scale may be a useful tool to improve the experience and enrollment outcomes for racial and ethnic minorities in clinical trials.
临床试验中的患者与工作人员互动可能会影响种族和少数族裔患者未来的入组决策，而这些患者在临床研究中的代表性仍然不足。一个衡量种族和少数族裔患者在临床试验中常见的患者与工作人员互动的量表，可能有助于改善患者体验和入组结果。
开发并验证一个衡量种族和少数族裔患者在临床试验中常见互动的量表。
设计、背景和参与者：这项混合方法的调查研究包括在2023年4月1日至2024年6月30日期间进行的访谈和在线调查以收集数据。对成年（年龄≥18岁）的种族和少数族裔患者进行访谈，以确定与研究人员的常见互动。该调查在潜在的临床试验参与者和以前的临床试验参与者中进行了验证。
使用探索性因素分析和验证性因素分析的拟合统计量来确认量表的有效性。结构方程建模系数用于评估该量表在测量患者对研究人员的信任以及参与未来研究的意愿方面的有效性。
样本包括1113名参与者。量表项目推导队列包括16名有临床试验经验的种族和少数族裔参与者（平均[标准差]年龄，44.9[12.9]岁；10名女性[62.5%]；3名被认定为亚裔或太平洋岛民[18.8%]，9名黑人[56.3%]，3名拉丁裔[18.8%]，1名多种族[6.3%]）。潜在临床试验参与者的量表结构验证队列包括479名调查受访者（平均[标准差]年龄，35.5[11.9]岁；219名女性[45.7%]；1名被认定为美洲印第安人[0.2%]，59名亚裔或太平洋岛民[12.3%]，266名黑人[55.5%]，59名拉丁裔[12.3%]，86名多种族[19.7%]）。同时验证队列包括618名参与者（平均[标准差]年龄，45.3[16.3]岁；53%为男性；63名被认定为亚裔或太平洋岛民[10.2%]，228名黑人[36.9%]，75名拉丁裔[12.1%]，223名白人[36.1%]，29名多种族[4.7%]）。22项的临床研究互动量表具有高信度（α = 0.96）和效度（比较拟合指数，0.92；塔克-刘易斯指数，0.91；近似误差均方根，0.08）。频繁经历低质量互动的患者体验与对研究人员的信任降低显著相关（β，-0.56；95%置信区间，-0.74至-0.37），这反过来又显著降低了患者返回该机构参加未来研究的意愿（β，0.80；95%置信区间，0.70 - 0.90）。
这些发现表明，与研究人员的低质量互动可能会降低种族和少数族裔患者返回参加未来研究的意愿，这是由对工作人员的信任降低所介导的。临床研究互动量表可能是一个有用的工具，可改善临床试验中种族和少数族裔的体验和入组结果。
