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颅面疾病患者参与补充和替代医学临床试验的意愿。

Willingness to participate in complementary and alternative medicine clinical trials among patients with craniofacial disorders.

作者信息

Schneider Jennifer, Vuckovic Nancy, DeBar Lynn

机构信息

Center for Health Research, Kaiser Permanente Northwest, Oregon Center for Complementary and Alternative Medicine in Craniofacial Disorders, Portland, OR, USA.

出版信息

J Altern Complement Med. 2003 Jun;9(3):389-401. doi: 10.1089/107555303765551615.

DOI:10.1089/107555303765551615
PMID:12816627
Abstract

OBJECTIVES

The Oregon Center for Complementary and Alternative Medicine (OCCAM) conducted focus groups with participants to determine willingness to join a complementary and alternative medicine (CAM) research study, and to aid in the design of three clinical randomized controlled trials (RCTs) of CAM and craniofacial disorders.

SETTING/LOCATION: Center for Health Research, Kaiser Permanente, in Portland, Oregon.

SUBJECTS

Kaiser Permanente health plan members meeting RCT inclusion criteria.

DESIGN

Twelve (12) focus groups were conducted with a total of 85 participants. Six (6) of the focus groups were with members who self-identified as users of CAM therapies. Focus groups explored participants' experiences of CAM for temporomandibular disorder (TMD) and periodontal disease, and their reactions to proposed aspects of the trials. Trained facilitators led the focus groups, which lasted approximately 2 hours and were audiotaped for future transcription. Researchers then coded the transcripts to identify responses to specific questions and to capture emergent themes.

RESULTS

Acupuncture, chiropractic, and massage were most frequently accessed and reported as helpful by participants. Participants who had not used CAM treatments for their condition expressed interest and openness to experiencing CAM treatments through a research study. In general, participants expressed willingness to be randomly assigned to (rather than choose) a CAM treatment arm. Travel to practitioners' offices and frequent (> 1 per week) visits were acceptable to most participants, if there was flexibility in appointment scheduling.

CONCLUSIONS

Findings indicate considerable willingness to engage in CAM trials, even among individuals who have not used CAM. Participants' willingness to engage in CAM studies was influenced by the nature of their condition, their prior experiences with conventional and CAM treatments, and the possibility of experiencing CAM "for free" through participation in the trial. Their acceptance also was tempered by concerns about particular modalities and the possibility of having to give up aspects of their current health routine. Researchers engaging in CAM studies should take these factors into consideration as they design studies.

摘要

目的

俄勒冈补充与替代医学中心(OCCAM)与参与者进行了焦点小组讨论,以确定他们参与补充与替代医学(CAM)研究的意愿,并协助设计三项关于CAM与颅面疾病的临床随机对照试验(RCT)。

地点

俄勒冈州波特兰市凯撒医疗机构的健康研究中心。

研究对象

符合RCT纳入标准的凯撒医疗机构健康计划成员。

设计

共进行了12个焦点小组讨论,共有85名参与者。其中6个焦点小组的成员自认为是CAM疗法的使用者。焦点小组探讨了参与者使用CAM治疗颞下颌关节紊乱(TMD)和牙周疾病的经历,以及他们对试验拟议方面的反应。由经过培训的主持人主持焦点小组讨论,讨论持续约2小时,并进行录音以便日后转录。研究人员随后对转录内容进行编码,以确定对特定问题的回答并捕捉新出现的主题。

结果

针灸、整脊疗法和按摩是参与者最常使用且认为有帮助的疗法。未使用CAM治疗其病症的参与者表示有兴趣并愿意通过研究体验CAM治疗。总体而言,参与者表示愿意被随机分配到(而不是选择)CAM治疗组。如果预约安排灵活,大多数参与者可以接受前往从业者办公室就诊以及频繁(每周超过1次)就诊。

结论

研究结果表明,即使在未使用过CAM的个体中,也有相当大的意愿参与CAM试验。参与者参与CAM研究的意愿受到其病情性质、以往使用传统和CAM治疗的经历以及通过参与试验“免费”体验CAM的可能性的影响。他们的接受程度也受到对特定疗法的担忧以及可能不得不放弃当前健康习惯某些方面的影响。从事CAM研究的人员在设计研究时应考虑这些因素。

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