title: Why are patients in clinical trials of heart failure not like those we see in everyday practice?
abstract: OBJECTIVE
  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.
authors.affiliation: Department of Primary Care, University of Liverpool, Whelan Building, 2nd Floor, Quadrangle Borwnlow Hill, L69 3DG, Liverpool, UK. ffionlw@liv.ac.uk
authors.forename: Ffion
authors.initials: F
authors.lastname: Lloyd-Williams
authors.forename: Frances
authors.initials: F
authors.lastname: Mair
authors.forename: Christopher
authors.initials: C
authors.lastname: Shiels
authors.forename: Barbara
authors.initials: B
authors.lastname: Hanratty
authors.forename: Pauline
authors.initials: P
authors.lastname: Goldstein
authors.forename: Susan
authors.initials: S
authors.lastname: Beaton
authors.forename: Simon
authors.initials: S
authors.lastname: Capewell
authors.forename: Michael
authors.initials: M
authors.lastname: Lye
authors.forename: Ruth
authors.initials: R
authors.lastname: Mcdonald
authors.forename: Christopher
authors.initials: C
authors.lastname: Roberts
authors.forename: Derek
authors.initials: D
authors.lastname: Connelly
mesh_terms: D000368:Aged; D002986:Clinical Trials as Topic; D006304:Health Status; D006333:Heart Failure / Q000628:therapy*; D006801:Humans; D010358:Patient Participation; D018579:Patient Selection; D016312:Treatment Refusal