The Enhancing Recovery in Coronary Heart Disease Trial (ENRICHD): strategies and techniques for enhancing retention of patients with acute myocardial infarction and depression or social isolation.
The Enhancing Recovery in Coronary Heart Disease Trial (ENRICHD): strategies and techniques for enhancing retention of patients with acute myocardial infarction and depression or social isolation.
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DOI：
10.1097/00008483-200307000-00004
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发表时间：
2003-07-01
期刊：
影响因子：
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通讯作者：
Wadley, Virginia
中科院分区：
文献类型：
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作者：
Froelicher, Erika Sivarajan;Miller, Nancy Houston;Wadley, Virginia
本报告旨在回顾文献并描述临床研究中用于保留患者的方法。增强冠心病恢复（ENRICHD）试验是一项多中心、随机临床试验，旨在评价心理社会干预对心血管发病率和死亡率的影响。共有2481名患者符合心肌梗死后抑郁、社会支持不足或两者兼而有之的标准，需要进行随访。随访评价包括入组后3、9、12、24、36和48个月的电话访视以及计划在6、18、30、42和54个月进行的诊所访视。创造性的策略，用于实现最佳保留这个复杂的患者人群在一个较长的随访期。在整个试验过程中提高依从性的策略需要对患者进行充分跟踪，以确保最低的脱落率，通过多种联系方法优化随访评价，以保证数据收集的完整性;并制定程序，以满足有脱落风险的患者的需求。完成研究的患者平均参与了28.3个月，而那些失去随访评估的患者平均参与了19个月。保留没有实质性的差异，性别或少数民族地位。该项目的结果可以帮助研究者规划需要患者随访评估的研究，并可以为临床医生提供最大限度地提高保留治疗建议的具体策略。由于本报告中描述的保留策略，93.02%的患者完成了研究参与或死亡。考虑到研究样本、方案的复杂性和随访评价所需的持续时间，这是一个非常高的留存率。
The report aims to review the literature and describe the methods used for retention of patients in a clinical study. The Enhanced Recovery in Coronary Heart Disease (ENRICHD) trial was a multicenter, randomized clinical trial designed to evaluate the effects of a psychosocial intervention on cardiovascular morbidity and mortality. A total of 2481 patients met the criteria for depression, low social support, or both after a myocardial infarction and needed to be followed. Follow-up evaluation consisted of telephone interviews 3, 9, 12, 24, 36, and 48 months after enrollment and clinic visits scheduled at 6, 18, 30, 42, and 54 months. Creative strategies used to achieve optimum retention of this complex patient population over a long follow-up period are presented. Strategies to enhance adherence throughout the course of the trial required adequate tracking of patients to ensure minimum dropout, follow-up evaluation optimized through multiple methods of contact to guarantee completeness of data collection; and development of procedures to address the needs of patients at risk for dropout. Patients in the group that completed the study participated for a mean of 28.3 months, and those lost to follow-up evaluation participated for a mean of 19 months. Retention was not substantially different by gender or minority status. The results of this project can assist investigators in planning studies that require patient follow-up evaluation, and can provide clinicians with specific strategies for maximizing retention-to-treatment recommendations. As a result of the retention strategies described in this report, 93.02% of the patients completed their study participation or died. This is a very high retention rate given the complexity of the study sample, protocol, and required duration of follow-up evaluation.