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Background: Quality acupuncture influences the outcomes of clinical research, and issues associated with effective administration of acupuncture in randomized controlled trials need to be addressed when appraising studies. Objective: The study objective was to achieve consensus on domains and items for inclusion in a rating scale to assess quality acupuncture administered in clinical research. Study design and subjects: An active group of Australian acupuncture researchers initially identified a pool of items assessing quality. The Delphi consensus process was then used to select and reduce the number of items, and an additional expert panel of 42 researchers were invited to participate. Participants initially ranked items along a five-point scale for the first Delphi round, and indicated an agree or disagree response during the second round. For an item to be retained into the second round, an item had to attain greater than 80% agreement that the item described a dimension of quality acupuncture and related study design. Results: Thirty-two (32) experts agreed to participate in the study. After two rounds of the Delphi process, consensus was reached on 14 domains and 26 items relating to quality acupuncture. Domains, items, and minimum standards related to study design; rationale of the intervention; criteria relating to needling stimulation either manual or electrostimulation; duration and frequency of treatment; and practitioner training. Conclusions: Items for inclusion in an instrument to assess quality acupuncture in clinical research were identified. Further development of the instrument including relative weighting of items and reliability testing is under way. [ABSTRACT FROM AUTHOR]

Introduction: Traditional Chinese Medicine (TCM), a modern interpretation of Chinese medicine, developed in the 1950s. It differentiates biomedical diseases into patterns. Each pattern comprises symptom/signs that have their own unique treatment protocol. Most TCM research has used fixed formula treatments for Western-defined diseases with outcomes often measured using objective biomedical markers. More recently, a number of trials have attempted to accommodate TCM clinical practice within the framework of rigorous evidence-based medical research. The aim of this article is to describe a novel outcome measure based on TCM patterns that was used in a pilot study for people with hepatitis C virus (HCV). Methods: Sixteen (16) participants with HCV were enrolled in a randomized, controlled pilot study and allocated to a treatment or control group. TCM pattern diagnosis was obtained at baseline and used to guide acupuncture treatment for the treatment group. Each individual's primary, secondary, and tertiary TCM patterns were identified, which involved the systematic evaluation of the participant's information against the TCM patterns and conversion of the pattern to a percentage. Baseline and postintervention percentages for the three TCM patterns for the two groups were compared to assess change. Results: There was a significant mean percentage decrease in pattern expression at week 12 compared to baseline for the secondary and tertiary patterns of the treatment group (56.3% versus 47.5%; p = 0.045 and 48.1% versus 33.6%; p = 0.037, respectively). No significant change was found for the primary, secondary, or tertiary patterns for the control group or for the primary pattern associated with the treatment group. Conclusions: The quantification of TCM patterns in this study permitted statistical evaluation of TCM pattern change. Previously, TCM pattern identification had only been used as a basis for developing the treatment protocol in clinical trials. This is the first time it has been employed as a novel outcome measure. [ABSTRACT FROM AUTHOR]

Aim: To examine the reliability of Traditional Chinese Medicine (TCM) tongue inspection by evaluation of inter- and intrapractitioner agreement levels for specific tongue characteristics, achieved by a group of TCM practitioners. Method: Ten (10) realistic tongue slides and a set of questionnaires were used to examine the agreement levels among 30 TCM practitioners in two data collection sessions. Statistical analysis involved descriptive statistics, predominantly percentage frequency agreement with the agreement level of ≥80% set as the criterion for an acceptable level of reliability. Results: Overall, both inter- and intrapractitioner agreement levels were low. Only on 19 occasions (17.3%) in session 1 and 21 occasions (19.1%) in session 2 were interpractitioner (between a practitioner) agreement levels of ≥80% achieved. Moreover, virtually all (15 occasions in session 1 and 14 occasions in session 2) of these questions involved simple dichotomous response choices, and the practitioners achieved levels of ≥80% reliability in only 5% of occasions where more complex response choices were offered. In terms of intrapractitioner (within a practitioner) agreement, the highest agreement level was achieved for the dichotomous response choice questions on presence of coat and presence of crack, with the 29 and 20 practitioners achieving ≥80% intrapractitioner agreement, respectively. Only 2 subjects achieved higher than 80% intrapractitioner agreement level for all tongue slides on all questions, with the highest intrapractitioner agreement level being 88% followed by 82%. The findings showed that the TCM tongue inspection for specific characteristics examined was not a reliable diagnostic method, at least for the group of TCM practitioners involved in this study. Conclusions: The findings suggest that a major contribution to the low levels of inter- and intrapractitioner agreements stems from inadequate operational definitions of both the tongue characteristics studied and of the inspection regions of the tongue. [ABSTRACT FROM AUTHOR]

A response by Christine A. Berle and colleagues to a letter to the editor regarding their article "A novel approach to evaluate Traditional Chinese Medicine outcomes using pattern identification" in the 2010 issue is presented.