Schnyer Rosa N, Conboy Lisa A, Jacobson Eric, McKnight Patrick, Goddard Thomas, Moscatelli Francesca, Legedza Anna T R, Kerr Catherine, Kaptchuk Ted J, Wayne Peter M
New England School of Acupuncture, Watertown, MA 02215, USA.
J Altern Complement Med. 2005 Dec;11(6):1005-13. doi: 10.1089/acm.2005.11.1005.
The diagnostic framework and clinical reasoning process in Chinese medicine emphasizes the contextual and qualitative nature of a patient's illness. Chinese medicine assessment data may help interpret clinical outcomes.
As part of a study aimed at assessing the validity and improving the inter-rater reliability of the Chinese diagnostic process, a structured assessment instrument was developed for use in clinical trials of acupuncture and other Chinese medical therapies.
To foster collaboration and maximize resources and information, an interdisciplinary advisory team was assembled. Under the guidance of two group process facilitators, and in order to establish whether the assessment instrument was consistent with accepted Chinese medicine diagnostic categories (face validity) and included the full range of each concept's meaning (content validity), a panel of Traditional Chinese Medicine (TCM) expert clinicians was convened and their responses were organized using the Delphi process, an iterative, anonymous, idea-generating and consensus-building process. An aggregate rating measure was obtained by taking the mean of mean ratings for each question across all 10 experts.
Over three rounds, the overall rating increased from 7.4 (SD = 1.3) in Round 1 to 9.1 (SD = 0.5) in Round 3. The level of agreement among clinicians was measured by a decrease in SD.
The final instrument TEAMSI-TCM (Traditional East Asian Medicine Structured Interview, TCM version) uses the pattern differentiation model characteristic of TCM. This modular, dynamic version was specifically designed to assess women, with a focus on gynecologic conditions; with modifications it can be adapted for use with other populations and conditions. TEAMSI-TCM is a prescriptive instrument that guides clinicians to use the proper indicators, combine them in a systematic manner, and generate conclusions. In conjunction with treatment manualization and training it may serve to increase inter-rater reliability and inter-trial reproducibility in Chinese medicine clinical trials. Testing of the validity and reliability of this instrument currently is underway.
中医的诊断框架和临床推理过程强调患者疾病的背景和定性特征。中医评估数据可能有助于解释临床结果。
作为一项旨在评估中医诊断过程的有效性并提高评分者间信度的研究的一部分，开发了一种结构化评估工具，用于针灸和其他中医疗法的临床试验。
为促进合作并最大限度地利用资源和信息，组建了一个跨学科咨询团队。在两名小组流程促进者的指导下，为确定评估工具是否与公认的中医诊断类别一致（表面效度）以及是否涵盖每个概念的全部含义（内容效度），召集了一组中医专家临床医生，并使用德尔菲法整理他们的回答，这是一个迭代、匿名、产生想法和达成共识的过程。通过计算所有10位专家对每个问题的平均评分的平均值来获得综合评分指标。
经过三轮，总体评分从第一轮的7.4（标准差=1.3）提高到第三轮的9.1（标准差=0.5）。通过标准差的降低来衡量临床医生之间的一致程度。
最终工具TEAMSI - TCM（传统东亚医学结构化访谈，中医版本）采用了中医特有的辨证模型。这个模块化、动态的版本专门设计用于评估女性，重点关注妇科疾病；经过修改后可适用于其他人群和疾病。TEAMSI - TCM是一种规范性工具，指导临床医生使用适当的指标，以系统的方式将它们结合起来，并得出结论。结合治疗手册化和培训，它可能有助于提高中医临床试验中评分者间的信度和试验间的可重复性。目前正在对该工具的有效性和信度进行测试。
