Center for Early Childhood Health and Development, Department of Population Health, NYU School of Medicine, 227 E. 30th Str., New York, NY 10036, USA.
Institute for Excellence in Health Equity, Department of Population Health, NYU School of Medicine, 180 Madison Ave, New York, NY 10016, USA.
Int J Environ Res Public Health. 2022 Jul 16;19(14):8660. doi: 10.3390/ijerph19148660.
Patient health literacy is vital to clinical trial engagement. Knowledge and beliefs about clinical trials may contribute to patient literacy of clinical trials, influencing engagement, enrollment and retention. We developed and assessed a survey that measures clinical trial health knowledge and beliefs, known as the Clinical trial HEalth Knowledge and belief Scale (CHEKS). The 31 survey items in CHEKS represent knowledge and beliefs about clinical trial research (n = 409) in 2017. We examined item-scale correlations for the 31 items, eliminated items with item-scale correlations less than 0.30, and then estimated internal consistency reliability for the remaining 25 items. We used the comparative fit index (CFI) and the root mean squared error of approximation (RMSEA) to evaluate model fit. The average age of the sample was 34 (SD = 15.7) and 48% female. We identified 6 of the 31 items that had item-scale correlations (corrected for overlap) lower than 0.30. Coefficient alpha for the remaining 25 items was 0.93 A one-factor categorical confirmatory factor analytic model with 16 correlated errors was not statistically significant (chi-square = 10011.994, df = 300, p < 0.001) but fit the data well (CFI = 0.95 and RMSEA = 0.07). CHEKS can assess clinical trial knowledge and beliefs.
患者健康素养对于临床试验的参与至关重要。对临床试验的了解和信念可能会影响患者对临床试验的了解程度，进而影响参与度、入组率和保留率。我们开发并评估了一种衡量临床试验健康知识和信念的量表，称为临床试验健康知识和信念量表（CHEKS）。CHEKS 中的 31 个调查项目代表了 2017 年临床试验研究的知识和信念（n=409）。我们检验了 31 个项目的项目-量表相关性，剔除了项目-量表相关性小于 0.30 的项目，然后估计了剩余 25 个项目的内部一致性信度。我们使用比较拟合指数（CFI）和近似均方根误差（RMSEA）来评估模型拟合度。样本的平均年龄为 34 岁（标准差=15.7），女性占 48%。我们发现 31 个项目中有 6 个项目的项目-量表相关性（校正重叠后）低于 0.30。剩余 25 个项目的系数α为 0.93。一个具有 16 个相关误差的单因素分类验证性因子分析模型在统计学上并不显著（卡方=10011.994，df=300，p<0.001），但很好地拟合了数据（CFI=0.95，RMSEA=0.07）。CHEKS 可以评估临床试验的知识和信念。
