Gump Brooks B, Matthews Karen A
State University of New York, Oswego, USA.
Ann Behav Med. 2003 Aug;26(1):61-8. doi: 10.1207/S15324796ABM2601_08.
Patient adherence affects treatment efficacy, and surprisingly, adherence is frequently associated with reductions in mortality for those receiving placebo.
This study considers the role of trial adherence for men (N = 12,338) in the Multiple Risk Factor Intervention Trial (MRFIT), a prospective study of 9-year follow-up mortality following randomization to Special Intervention (SI) or Usual Care (UC). Annual visit attendance rates were used as a measure of adherence.
A significant Adherence x Group Assignment interaction (p =.002) revealed that SI significantly reduced cardiovascular disease (CVD) mortality for highly adherent participants, RR =.91 (95% confidence interval [CI] =.84-.99) but significantly increased CVD mortality for poorly adherent participants, RR = 1.28 (95% CI = 1.05-1.57) when compared to UC. These associations remained after controlling for baseline characteristics (e.g., income), reported illness, or occurrence of a nonfatal CVD event during the trial. The beneficial effect of SI among the adherent participants was partly due to reduced smoking and diastolic blood pressure levels during the trial.
SI significantly reduced the risk of CVD mortality for participants adherent with the MRFIT, and this effect was accounted for by positive changes in CVD risk factors. These findings suggest a method for evaluating treatment efficacy in subgroups determined by patient responses (e.g., adherence to annual assessment visits) to the treatment program after randomization.
患者的依从性会影响治疗效果，令人惊讶的是，对于接受安慰剂治疗的患者，依从性常常与死亡率降低相关。
本研究探讨了在多重危险因素干预试验（MRFIT）中男性（N = 12338）的试验依从性所起的作用，该试验是一项前瞻性研究，对随机分配至特殊干预（SI）或常规护理（UC）的患者进行9年随访死亡率观察。年度就诊率被用作依从性的衡量指标。
显著的依从性×分组分配交互作用（p =.002）表明，与UC相比，SI显著降低了高依从性参与者的心血管疾病（CVD）死亡率，相对危险度（RR） =.91（95%置信区间[CI] =.84 -.99），但显著增加了低依从性参与者的CVD死亡率，RR = 1.28（95% CI = 1.05 - 1.57）。在控制了基线特征（如收入）、报告的疾病或试验期间非致命CVD事件的发生情况后，这些关联依然存在。SI在依从性参与者中的有益效果部分归因于试验期间吸烟和舒张压水平的降低。
SI显著降低了MRFIT依从性参与者的CVD死亡风险，这种效果是由CVD危险因素的积极变化所导致的。这些发现提示了一种在随机分组后根据患者对治疗方案的反应（如对年度评估就诊依从性）所确定的亚组中评估治疗效果的方法。
