Lloyd-Williams Ffion, Mair Frances, Shiels Christopher, Hanratty Barbara, Goldstein Pauline, Beaton Susan, Capewell Simon, Lye Michael, Mcdonald Ruth, Roberts Christopher, Connelly Derek
Department of Primary Care, University of Liverpool, Whelan Building, 2nd Floor, Quadrangle Borwnlow Hill, L69 3DG, Liverpool, UK.
J Clin Epidemiol. 2003 Dec;56(12):1157-62. doi: 10.1016/s0895-4356(03)00205-1.
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.
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.
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.
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.
背景/目的：循证研究因与社区患者护理的现实世界无关而受到批评，主要原因是研究参与者与日常实践中常见的参与者不同。本文探讨了招募困难，并确定了心力衰竭患者拒绝参与研究试验的主要原因。
在招募时对潜在试验参与者（n = 667）进行邮寄调查。分析（1）调查的应答者和无应答者以及随机对照试验的拒绝者和同意者的临床和社会人口统计学特征。
在社会人口统计学或临床变量方面，应答者和无应答者之间未发现显著差异。男性（OR = 1.58，CI = 1.04 - 2.41）、年轻患者（OR = 1.05，CI = 1.03 - 1.08）以及开具了血管紧张素转换酶（ACE）抑制剂的患者（OR = 1.68，CI = 1.10 - 2.57）同意参与的可能性显著更高。不参与的主要原因是认为自己年龄太大、身体太差或太忙。
研究目的的解释需要消除参与者的顾虑，并在身体不适时阐明参与干预研究的利弊。研究设计应认识到许多老年患者生活忙碌且有护理责任。应考虑为参与提供经济支持。
