Bridging the gap in complementary and alternative medicine research: manualization as a means of promoting standardization and flexibility of treatment in clinical trials of acupuncture.
Bridging the gap in complementary and alternative medicine research: manualization as a means of promoting standardization and flexibility of treatment in clinical trials of acupuncture.
复制标题
弥合补充和替代医学研究的差距：手册化作为促进针灸临床试验治疗标准化和灵活性的手段。
DOI：
10.1089/107555302320825147
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发表时间：
2002
期刊：
影响因子：
--
通讯作者：
Allen,JohnJB
中科院分区：
文献类型：
--
作者：
Schnyer,RosaN;Allen,JohnJB
介绍：针灸临床研究中遇到的一个重要的方法学挑战涉及治疗方案的设计，有助于确保标准化和可复制性， 允许必要的灵活性来为每个个体定制治疗。针灸和其他基于传统的补充和替代临床试验中使用的协议手册 CAM系统促进了可复制和标准化的系统化治疗，但个体定制的治疗。目的：促进高质量的CAM针灸研究 通过概述一种基于治疗手册化概念的CAM临床试验中使用的方案的系统设计和实施方法。 是为了系统地阐明中医理论和临床框架，为给定的西方定义的疾病，以提高质量和治疗的一致性，并规范 议定书的技术方面。总共有三本手册是为美国国立卫生研究院（NIH）资助的针灸治疗抑郁症、脑瘫痉挛和 重复性应激损伤第一部分讨论了这些手册的基本原理和编写过程中遇到的挑战，并对其效用进行了定性评估。部分 II，一种方法来开发用于临床试验的治疗手册是详细的，并给出了例子。结论：治疗手册提供了一种精确的方式来培训和监督从业人员， 使符合性和能力的评价，促进培训过程，并提高能力，以确定针灸临床试验中的有效治疗成分。
Introduction:An important methodological challenge encountered in acupuncture clinical research involves the design of treatment protocols that help ensure standardization and replicability while allowing for the necessary flexibility to tailor treatments to each individual. Manualization of protocols used in clinical trials of acupuncture and other traditionally-based complementary and alternative medicine (CAM) systems facilitates the systematic delivery of replicable and standardized, yet individually-tailored treatments.Objectives:To facilitate high-quality CAM acupuncture research by outlining a method for the systematic design and implementation of protocols used in CAM clinical trials based on the concept of treatment manualization.Methods:A series of treatment manuals was developed to systematically articulate the Chinese medical theoretical and clinical framework for a given Western-defined illness, to increase the quality and consistency of treatment, and to standardize the technical aspects of the protocol. In all, three manuals were developed for National Institutes of Health (NIH)-funded clinical trials of acupuncture for depression, spasticity in cerebral palsy, and repetitive stress injury. In Part I, the rationale underlying these manuals and the challenges encountered in creating them are discussed, and qualitative assessments of their utility are provided. In Part II, a methodology to develop treatment manuals for use in clinical trials is detailed, and examples are given.Conclusions:A treatment manual provides a precise way to train and supervise practitioners, enable evaluation of conformity and competence, facilitate the training process, and increase the ability to identify the active therapeutic ingredients in clinical trials of acupuncture.