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

Brooks B Gump1, Karen A Matthews

  • 1State University of New York, Oswego, USA.

Annals of Behavioral Medicine : a Publication of the Society of Behavioral Medicine
|July 18, 2003
PubMed

Insights

Patient adherence to the Special Intervention (SI) in the Multiple Risk Factor Intervention Trial (MRFIT) reduced cardiovascular disease (CVD) mortality. Poor adherence, however, increased CVD mortality risk compared to Usual Care (UC).

Area of Science:

  • Clinical Trials
  • Cardiovascular Disease Epidemiology
  • Health Behavior Research

Background:

  • Patient adherence significantly impacts treatment efficacy.
  • Adherence is paradoxically linked to reduced mortality in placebo groups.
  • Understanding adherence is crucial for interpreting clinical trial results.

Purpose of the Study:

  • To investigate the role of patient adherence in the Multiple Risk Factor Intervention Trial (MRFIT).
  • To determine the impact of adherence on cardiovascular disease (CVD) mortality in participants randomized to Special Intervention (SI) or Usual Care (UC).

Main Methods:

  • Analysis of data from 12,338 men in the prospective MRFIT study with a 9-year follow-up.
  • Annual visit attendance rates served as the primary measure of participant adherence.
  • Statistical analysis examined the interaction between adherence and group assignment on CVD mortality.

Main Results:

  • A significant interaction between adherence and group assignment (p =.002) was observed.
  • Special Intervention (SI) reduced CVD mortality for highly adherent participants (RR =.91) but increased it for poorly adherent participants (RR = 1.28) versus Usual Care (UC).
  • These findings persisted after controlling for baseline characteristics, illness, or nonfatal CVD events.

Conclusions:

  • Special Intervention (SI) demonstrated reduced CVD mortality risk solely among adherent participants in the MRFIT.
  • Positive changes in CVD risk factors, such as reduced smoking and blood pressure, accounted for the benefits in adherent individuals.
  • The study suggests evaluating treatment efficacy by considering patient response subgroups, like adherence to study visits.
Abstract

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