Why are patients in clinical trials of heart failure not like those we see in everyday practice?

BACKGROUND/OBJECTIVES: Evidence-based research has been criticized for not being relevant to the real world of patient care in the community, mainly because participants in research studies are dissimilar to those typically seen in every day practice. This article examines recruitment difficulties, and identifies the main reasons why patients with heart failure declined to participate in a research trial.

METHODS

Postal survey of potential trial participants (n=667), at time of recruitment. Analysis of (1) clinical and sociodemographic characteristics of respondents and nonrespondents to survey, and decliners and consenters to participation in a randomized controlled trial.

RESULTS

No significant differences were found between respondents and nonrespondents in respect to sociodemographic or clinical variables. Males (OR=1.58, CI=1.04-2.41), younger patients (OR=1.05, CI=1.03-1.08), and those prescribed an angiotensin converting enzyme (ACE) inhibitor (OR=1.68, CI=1.10-2.57) were significantly more likely to consent to participate. Main reasons for nonparticipation were perceptions of being too old, too unwell, or too busy.

CONCLUSIONS

Explanations of the purpose of research need to counter against perceptions among participants and clarify the benefits and disadvantages of participating in an intervention study when unwell. Study design should recognize that many elderly patients have busy lives and caring responsibilities. Financial support for participation should be considered.