Section 12
Chapter 11,384

Special intervention reduces CVD mortality for adherent participants in the multiple risk factor intervention trial

Gump, B.B.; Matthews, K.A.

Annals of Behavioral Medicine a Publication of the Society of Behavioral Medicine 26(1): 61-68


ISSN/ISBN: 0883-6612
PMID: 12867355
DOI: 10.1207/s15324796abm2601_08
Accession: 011383027

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Background: Patient adherence affects treatment efficacy, and surprisingly, adherence is frequently associated with reductions in mortality for those receiving placebo. Methods: 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. Results: A significant AdherenceXGroup 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. Conclusions: 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.

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