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针灸师对担任临床试验从业者的看法。

Acupuncturist perceptions of serving as a clinical trial practitioner.

机构信息

School of Nursing, University of Virginia, Charlottesville, VA, USA.

出版信息

Complement Ther Med. 2012 Aug;20(4):183-9. doi: 10.1016/j.ctim.2012.01.002. Epub 2012 Feb 10.

Abstract

OBJECTIVE

This article describes the experience of four acupuncturists in terms of what it meant for them to be a practitioner in a recently completed sham-controlled acupuncture randomized control trial (RCT) with a standardized protocol.

DESIGN

At the completion of the RCT for women with ovarian dysfunction, study acupuncturists (2 male MD/acupuncturists and 2 female professional acupuncturists) were queried about their perceptions of participating in the RCT using both written responses to 5 open-ended questions and a focus group interview. Data was analyzed to categorize responses and identify themes.

SETTING

Virginia, USA.

RESULTS

The acupuncturists' experience of participating in a RCT was generally very positive, including: usual practitioner/participant relationships, collegial sharing, and increased patient volume and diversity. There was angst expressed about the unknown RCT results. While there were concerns about standardizing the acupuncture session ("dilutes the power of acupuncture therapeutics"), the acupuncturists' were supportive of the pre-established protocol. The acupuncturists overall did not have concerns with a sham intervention arm because the sham recipients did not know their treatment arm and felt as satisfied with study participation as the true acupuncture recipients.

CONCLUSIONS

Despite initial misgivings about both a standardized protocol and a sham arm, all practitioners discovered positive aspects of being a study acupuncturist. The analysis highlights the need for communication before, during and after a clinical trial between the study investigators and the intervention practitioners. As stake holders in the perception of CAM therapies with the public and with conventional medicine practitioners, it would benefit future research on CAM to similarly assess experiences of being a CAM study practitioner in order to enhance provider recruitment and reduce provider drop-out.

摘要

目的

本文描述了四位针灸师在最近完成的一项假针对照随机对照试验(RCT)中作为从业者的经验,该试验采用了标准化方案。

设计

在卵巢功能障碍女性的 RCT 完成后,研究针灸师(2 名男性 MD/针灸师和 2 名女性专业针灸师)被询问他们对参与 RCT 的看法,使用对 5 个开放式问题的书面回答和焦点小组访谈。对数据进行分析以对回答进行分类并确定主题。

地点

美国弗吉尼亚州。

结果

针灸师参与 RCT 的经验总体上非常积极,包括:通常的从业者/参与者关系、同事之间的分享以及患者数量和多样性的增加。他们对未知的 RCT 结果表示焦虑。尽管对标准化针灸疗程存在担忧(“削弱了针灸治疗的效果”),但针灸师还是支持预先确定的方案。针灸师总体上不担心假干预组,因为假接受者不知道他们的治疗组,并且对研究参与感到与真正的针灸接受者一样满意。

结论

尽管最初对标准化方案和假针组都有疑虑,但所有从业者都发现了作为研究针灸师的积极方面。分析强调了在临床试验之前、期间和之后,研究调查人员和干预从业者之间需要进行沟通。作为公众和常规医学从业者对 CAM 疗法的看法的利益相关者,同样评估 CAM 研究从业者的经验将有助于未来的 CAM 研究,以增加提供者招募并减少提供者流失。

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