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向研究参与者集体展示研究结果的初步经验。

Initial experience with a group presentation of study results to research participants.

作者信息

Avins Andrew L, Bent Stephen, Padula Amy, Staccone Suzanne, Badua Evelyn, Goldberg Harley

机构信息

Division of Research, Northern California Kaiser Permanente, Oakland, California, USA.

出版信息

Trials. 2008 Mar 21;9:16. doi: 10.1186/1745-6215-9-16.

Abstract

BACKGROUND

Despite ethical imperatives, informing research participants about the results of the studies in which they take part is not often performed. This is due, in part, to the costs and burdens of communicating with each participant after publication of the results.

METHODS

Following the closeout and publication of a randomized clinical trial of saw palmetto for treatment of symptoms of benign prostatic hyperplasia, patients were invited back to the research center to participate in a group presentation of the study results.

RESULTS

Approximately 10% of participants attended one of two presentation sessions. Reaction to the experience of the group presentation was very positive among the attendees.

CONCLUSION

A group presentation to research participants is an efficient method of communicating study results to those who desire to be informed and was highly valued by those who attended. Prospectively planning for such presentations and greater scheduling flexibility may result in higher attendance rates.

TRIAL REGISTRATION NUMBER

Clinicaltrials.gov #NCT00037154.

摘要

背景

尽管存在伦理要求,但向参与研究的受试者告知其参与研究的结果这一做法并不常见。部分原因在于研究结果发表后与每位受试者进行沟通的成本和负担。

方法

在一项关于锯叶棕治疗良性前列腺增生症状的随机临床试验结束并发表后,邀请患者回到研究中心参加研究结果的小组汇报会。

结果

约10%的受试者参加了两场汇报会中的一场。与会者对小组汇报会的体验反应非常积极。

结论

向研究受试者进行小组汇报是向希望了解情况者传达研究结果的一种有效方法,且受到与会者的高度重视。对此类汇报进行前瞻性规划并提高日程安排的灵活性可能会提高出席率。

试验注册号

Clinicaltrials.gov #NCT00037154

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本文引用的文献

1
Proven and unproven therapy for benign prostatic hyperplasia.
N Engl J Med. 2006 Feb 9;354(6):632-4. doi: 10.1056/NEJMe058301.
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Saw palmetto for benign prostatic hyperplasia.
N Engl J Med. 2006 Feb 9;354(6):557-66. doi: 10.1056/NEJMoa053085.
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Offering results to research participants.
BMJ. 2006 Jan 28;332(7535):188-9. doi: 10.1136/bmj.332.7535.188.
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Receiving a summary of the results of a trial: qualitative study of participants' views.
BMJ. 2006 Jan 28;332(7535):206-10. doi: 10.1136/bmj.38675.677963.3A. Epub 2006 Jan 9.
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Reactions to treatment debriefing among the participants of a placebo controlled trial.
BMC Health Serv Res. 2005 Apr 22;5(1):30. doi: 10.1186/1472-6963-5-30.
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Considerations and costs of disclosing study findings to research participants.
CMAJ. 2004 Apr 27;170(9):1417-9. doi: 10.1503/cmaj.1031668.

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