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智力残疾女性参与健康促进干预随机对照试验的招募和同意。

Recruitment and consent of women with intellectual disabilities in a randomised control trial of a health promotion intervention.

机构信息

School of Social Work, UNC Chapel Hill, Chapel Hill, NC, USA.

出版信息

J Intellect Disabil Res. 2011 May;55(5):474-83. doi: 10.1111/j.1365-2788.2011.01399.x. Epub 2011 Mar 8.

Abstract

BACKGROUND

The need for evidence-based health promotion interventions for women with intellectual and developmental disabilities is critical. However, significant barriers impede them from participating in research, including those related to recruitment and obtaining informed consent.

METHODS

This study describes a procedure for the recruitment and consent of women with intellectual disabilities into a community-based, multi-site randomised controlled trial.

RESULTS

Of 269 women who participated in information sessions, 203 (75%) enrolled in the study. While women with and without legal guardians consented at the same approximate rates (83% and 85%, respectively), those with legal guardians enrolled at significantly lower rates (61%) because of lower rates (74%) of guardian consent.

CONCLUSIONS

It is possible to recruit community-dwelling women with intellectual disabilities into randomised controlled trials at relatively high participation rates. Recruiting women who have guardians poses additional challenges for researchers.

摘要

背景

为智力和发育障碍的女性提供循证健康促进干预措施的需求至关重要。然而,包括招募和获得知情同意在内的各种障碍严重阻碍了她们参与研究。

方法

本研究描述了一种将智力障碍女性招募并纳入基于社区的多地点随机对照试验的程序。

结果

在参加信息会议的 269 名女性中,有 203 名(75%)入组研究。虽然有和没有法定监护人的女性同意参与研究的比例大致相同(分别为 83%和 85%),但有法定监护人的女性入组率明显较低(61%),因为监护人同意的比例较低(74%)。

结论

有可能以较高的参与率招募到智力障碍的社区居住女性参与随机对照试验。招募有监护人的女性对研究人员来说提出了额外的挑战。

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