Human Genetics Branch, Intramural Research Program, National Institute of Mental Health, NIH, USDHHS, Bethesda, MD.
Depress Anxiety. 2013 Nov;30(11):1137-44. doi: 10.1002/da.22134. Epub 2013 May 30.
High attrition rates among African-Americans (AA) volunteers are a persistent problem that makes clinical trials less representative and complicates estimation of treatment outcomes. Many studies contrast AA with other ethnic/racial groups, but few compare the AA volunteers who remain in treatment with those who leave. Here, in addition to comparing patterns of attrition between African Americans and Whites, we identify predictors of overall and early attrition among African Americans.
Sample comprised non-Hispanic African-American (n = 673) and White (n = 2,549) participants in the Sequenced Treatment Alternatives to Relieve Depression (STAR*D) study. Chi-square tests were used to examine racial group differences in reasons for exit. Multivariate logistic regression was used to examine predictors of overall attrition, early attrition (by level 2) and top reasons cited for attrition among African Americans.
Both African-American and White dropouts most commonly cited noncompliance reasons for attrition during the earlier phases of the study, while citing reasons related to efficacy and medication side effects later in the study. Satisfaction with treatment strongly predicted overall attrition among African Americans independent of socioeconomic, clinical, medical or psychosocial factors. Early attrition among African American dropouts was associated with less psychiatric comorbidity, and higher perceived physical functioning but greater severity of clinician-rated depression.
Compliance, efficacy, and side effects are important factors that vary in relative importance during the course of a clinical trial. For African Americans in such trials, retention strategies should be broadened to emphasize patient engagement and satisfaction during the critical periods immediately following enrollment and treatment initiation.
非裔美国人（AA）志愿者的高流失率是一个持续存在的问题，这使得临床试验的代表性降低，并使治疗效果的估计变得复杂。许多研究将 AA 与其他族裔/种族群体进行对比，但很少将仍在治疗中的 AA 志愿者与那些离开的志愿者进行比较。在这里，除了比较非裔美国人和白人之间的流失模式外，我们还确定了非裔美国人总体和早期流失的预测因素。
样本包括非西班牙裔非裔美国人（n = 673）和白人（n = 2549），他们参加了缓解抑郁的序贯治疗替代方案（STAR*D）研究。卡方检验用于检查退出原因的种族群体差异。多变量逻辑回归用于检查非裔美国人总体流失、早期流失（第 2 级）和流失的主要原因的预测因素。
非裔美国人和白人的辍学者在研究的早期阶段最常因不遵守规定而退出，而在研究后期则因与疗效和药物副作用相关的原因而退出。治疗满意度强烈预测了非裔美国人的总体流失，独立于社会经济、临床、医疗或心理社会因素。非裔美国辍学者的早期流失与较少的精神共病、较高的感知身体功能以及更严重的临床医生评定的抑郁有关。
依从性、疗效和副作用是临床试验过程中重要的、相对重要的因素。对于参加此类试验的非裔美国人，保留策略应扩大，以强调在招募和治疗开始后关键时期的患者参与和满意度。
