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招募绝经后妇女参加口服脱氢表雄酮随机、双盲、安慰剂对照试验的方法及挑战

Methodology and challenges to recruitment to a randomized, double-blind, placebo-controlled trial of oral DHEA in postmenopausal women.

作者信息

Panjari Mary, Bell Robin, Adams Jenny, Morrow Corallee, Papalia Mary-Anne, Astbury Jill, Davis Susan R

机构信息

NH&MRC Centre of Clinical Research Excellence in the Women's Health Program, Department of Medicine, Central and Eastern Clinical School, Monash University, Alfred Hospital, Prahran, Victoria, Australia.

出版信息

J Womens Health (Larchmt). 2008 Dec;17(10):1559-65. doi: 10.1089/jwh.2007.0732.

DOI:10.1089/jwh.2007.0732
PMID:19000028
Abstract

OBJECTIVE

To report on the issues encountered in the recruitment of healthy naturally menopausal women in the community to a randomized placebo-controlled trial of dehydroepiandrosterone (DHEA) therapy for treatment of loss of sexual desire.

METHODS

Recruitment of women was achieved by advertising and media publicity. We have reported on the method by which women initially contacted us and the reasons for nonparticipation.

RESULTS

Nine hundred and eighteen women contacted us about participating in the study; 706 of these were telephoned screened, and 93 of these (10%) women were randomized to therapy. The main determinants for nonparticipation included ineligibility on phone screening (58%), withdrawal of interest either before or after screening (55%), and preexisting pathology after attending for screening (8%).

CONCLUSIONS

Despite ongoing interest by women to participate in research for therapies to treat low libido, concerns about the use of any hormonal treatment and the time poverty experienced by many women at midlife present new barriers to recruitment and need to be considered in assessing the feasibility of studies in this field.

摘要

目的

报告在社区招募健康自然绝经女性参加一项关于脱氢表雄酮(DHEA)治疗性欲减退的随机安慰剂对照试验时遇到的问题。

方法

通过广告和媒体宣传招募女性。我们已经报告了女性最初与我们联系的方式以及不参与的原因。

结果

918名女性联系我们询问参与研究的事宜;其中706名接受了电话筛选,这些女性中有93名(10%)被随机分配接受治疗。不参与的主要决定因素包括电话筛选不合格(58%)、筛选前后兴趣减退(55%)以及筛选后发现已有病变(8%)。

结论

尽管女性对参与治疗性欲低下的研究仍有兴趣,但对任何激素治疗的担忧以及许多中年女性面临的时间匮乏问题为招募工作带来了新的障碍,在评估该领域研究的可行性时需要加以考虑。

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