Schnyer, RN, Conboy L, McKnight P, Jacobson E, Goddard T, Moscatelli F, Legedza A, Kerr C, Kaptchuk T, Wayne P.

Development of a Chinese medicine assessment measure: an interdisciplinary approach using the Delphi method.

Osher Instiute, Harvard Medical School, New England School of Acupuncture, 259 Spiers Rd, Newton, MA 02459. Rosa_Schnyer@hms.harvard.edu

BACKGROUND: 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; appropriate assessment and outcome instrumentation is an important step in this direction.

PURPOSE: As part of a larger study aimed at assessing the validity and increase the inter-rater reliability of the Chinese medicine diagnostic process, we systematically developed a structured assessment instrument for use in clinical trials of acupuncture and other Chinese medicine systems.

METHODS: In order to foster collaboration and maximize resources and information, we assembled an interdisciplinary advisory team consisting of Chinese medicine experts, a measurement methodologist, a sociologist, a medical anthropologist, a biostatistician, and clinical researchers. 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), two group process facilitators, convened a panel of TCM expert clinicians and organized their responses using the Delphi process, an iterative, anonymous, consensus building process.

RESULTS: An aggregate rating measure was obtained by taking the mean of mean ratings for each question across all 10 experts. Over 3 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 standard deviation. 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's health issues; 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 is currently underway.

 

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