Patient recruitment to a randomized clinical trial of behavioral therapy for chronic heart failure.
Patient recruitment to a randomized clinical trial of behavioral therapy for chronic heart failure.
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DOI：
10.1186/1471-2288-4-8
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发表时间：
2004-04-17
影响因子：
4
通讯作者：
Locastro, Joseph S
中科院分区：
文献类型：
--
作者：
Chang, Bei-Hung;Hendricks, Ann M;Locastro, Joseph S
背景：患者招募是临床试验中最困难的方面之一，特别是对于涉及老年受试者的研究。在本文中，我们描述了我们在行为干预随机试验“慢性心力衰竭的放松反应干预（RRCHF）”中招募患者的经验。特别是，根据患者报告，我们确定了促进研究参与的因素。方法：RRCHF 是一项三组随机对照试验，旨在评估对患有慢性心力衰竭的退伍军人进行 15 周放松反应干预的疗效和成本。来自美国退伍军人事务部 (VA) 波士顿医疗系统的患者是通过诊所和电话招募的。在筛选过程中记录患者拒绝参与研究的原因。试验中的一项定性子研究包括对参与的患者进行电话采访，了解他们在研究中的经历。定性研究包括前 57 名完成干预和/或首次随访结果测量的患者。使用 t 检验或卡方检验确定了区分同意参与研究的患者与拒绝参与研究的患者的因素。研究参与的原因是从定性访谈中提取的。结果：我们在 27 个月内成功获得了 134 名患者的同意，略多于我们的目标数量。九十五名同意的患者参加了这项研究。通过诊所接触的患者登记率为 18%，通过电话招募的患者登记率为 6%。诊所招募的患者拒绝参加研究的最常见原因是“住得太远”；对于通过电话招募的患者，他们表示“对这项研究不感兴趣”。显着区分同意的患者与拒绝的患者的一个因素是他们的居住地与研究地点之间的距离（t 检验：p
BACKGROUND: Patient recruitment is one of the most difficult aspects of clinical trials, especially for research involving elderly subjects. In this paper, we describe our experience with patient recruitment for the behavioral intervention randomized trial, "The relaxation response intervention for chronic heart failure (RRCHF)." Particularly, we identify factors that, according to patient reports, motivated study participation.METHODS: The RRCHF was a three-armed, randomized controlled trial designed to evaluate the efficacy and cost of a 15-week relaxation response intervention on veterans with chronic heart failure. Patients from the Veterans Affairs (VA) Boston Healthcare System in the United States were recruited in the clinic and by telephone. Patients' reasons for rejecting the study participation were recorded during the screening. A qualitative sub-study in the trial consisted of telephone interviews of participating patients about their experiences in the study. The qualitative study included the first 57 patients who completed the intervention and/or the first follow-up outcome measures. Factors that distinguished patients who consented from those who refused study participation were identified using a t-test or a chi-square test. The reason for study participation was abstracted from the qualitative interview.RESULTS: We successfully consented 134 patients, slightly more than our target number, in 27 months. Ninety-five of the consented patients enrolled in the study. The enrollment rate among the patients approached was 18% through clinic and 6% through telephone recruitment. The most commonly cited reason for declining study participation given by patients recruited in the clinic was 'Lives Too Far Away'; for patients recruited by telephone it was 'Not Interested in the Study'. One factor that significantly distinguished patients who consented from patients who declined was the distance between their residence and the study site (t-test: p