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临床试验参与者满意度:老年收缩期高血压计划(SHEP)入组者调查。SHEP合作研究小组。老年收缩期高血压计划。

Clinical trial participant satisfaction: survey of SHEP enrollees. SHEP Cooperative Research Group. Systolic Hypertension in the Elderly Program.

作者信息

Schron E B, Wassertheil-Smoller S, Pressel S

机构信息

National Heart, Lung, and Blood Institute, NIH, Bethesda, MD 20892-7936, USA.

出版信息

J Am Geriatr Soc. 1997 Aug;45(8):934-8. doi: 10.1111/j.1532-5415.1997.tb02962.x.

DOI:10.1111/j.1532-5415.1997.tb02962.x
PMID:9256844
Abstract

OBJECTIVE

The purpose of this study was to determine older persons' reasons for joining a clinical trial, and to provide data that could be useful in planning and carrying out clinical trials in older and minority populations.

DESIGN

A survey.

PARTICIPANTS

The sample included 4281 men and women 60 years of age or older who were randomized to the Systolic Hypertension in the Elderly Program (SHEP).

MEASUREMENTS

A 10-item satisfaction/attitude questionnaire was designed to evaluate (1) what personal benefits people expect from participation in this trial, (2) motivation for joining, and (3) satisfaction with clinic staff and operations. Each question had a response category asking for a measure of agreement, satisfaction, or importance.

RESULTS

The most important reasons for joining the clinical trial were to contribute to science (96%), improve the health of others (96%), and improve their own health (93%). Free medical care and social aspects were less important reasons to join. There were no differences by treatment assignment, but differences in reasons for joining SHEP by age, race, gender, and education were observed.

CONCLUSION

Older adults were enthusiastic about clinical trial participation. Recruitment, participant management strategies, and allocation of resources should consider the needs of specific patient groups.

摘要

目的

本研究旨在确定老年人参与临床试验的原因,并提供有助于针对老年人群体和少数族裔群体规划和开展临床试验的数据。

设计

一项调查。

参与者

样本包括4281名60岁及以上的男性和女性,他们被随机分配到老年收缩期高血压计划(SHEP)中。

测量

设计了一份包含10个项目的满意度/态度问卷,以评估(1)人们期望从参与该试验中获得哪些个人益处,(2)参与动机,以及(3)对诊所工作人员和运营的满意度。每个问题都有一个要求衡量同意程度、满意度或重要性的回答类别。

结果

参与临床试验最重要的原因是为科学做贡献(96%)、改善他人健康(96%)以及改善自身健康(93%)。免费医疗和社交方面是参与的次要原因。按治疗分配无差异,但观察到按年龄、种族、性别和教育程度划分的参与SHEP的原因存在差异。

结论

老年人热衷于参与临床试验。招募、参与者管理策略和资源分配应考虑特定患者群体的需求。

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