Literature DB >> 14680665

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

Ffion Lloyd-Williams1, Frances Mair, Christopher Shiels, Barbara Hanratty, Pauline Goldstein, Susan Beaton, Simon Capewell, Michael Lye, Ruth Mcdonald, Christopher Roberts, Derek Connelly.   

Abstract

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.

Entities:  

Mesh:

Year:  2003        PMID: 14680665     DOI: 10.1016/s0895-4356(03)00205-1

Source DB:  PubMed          Journal:  J Clin Epidemiol        ISSN: 0895-4356            Impact factor:   6.437


  20 in total

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Authors:  Kate Jolly; Rod S Taylor; Gregory Y H Lip; Mick Davies; Russell Davis; Jonathan Mant; Sally Singh; Sheila Greenfield; Jackie Ingram; Jane Stubley; Stirling Bryan; Andrew Stevens
Journal:  Eur J Heart Fail       Date:  2009-02       Impact factor: 15.534

9.  Age- and gender-specific risk of death after first hospitalization for heart failure.

Authors:  I Vaartjes; A W Hoes; J B Reitsma; A de Bruin; D E Grobbee; A Mosterd; M I Bots
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10.  Identifying strategies to maximise recruitment and retention of practices and patients in a multicentre randomised controlled trial of an intervention to optimise secondary prevention for coronary heart disease in primary care.

Authors:  Claire S Leathem; Margaret E Cupples; Mary C Byrne; Mary O'Malley; Ailish Houlihan; Andrew W Murphy; Susan M Smith
Journal:  BMC Med Res Methodol       Date:  2009-06-19       Impact factor: 4.615

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