A pilot study to develop and validate a traditional Chinese medicine (TCM) questionnaire: a health status instrument for TCM assessment in patients with Osteoarthritis (OA) of the hip or knee
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Research suggests acupuncture is potentially an effective treatment for osteoarthritis (OA) of the hip or knee. Essential for the evaluation of Chinese acupuncture treatment is the availability of a reliable and valid measurement. However, currently there is no appropriate measurement instrument validated within traditional Chinese medicine (TCM) concepts and frameworks. Objective is to develop and validate a TCM questionnaire as a health status instrument for TCM assessment in patients with OA of the hip and knee. Methods The TCM questionnaire was developed from TCM theory and clinical experience. The questionnaire was examined by experts, for content and faces validity and pre-tested on a volunteer sample of three subjects. The developed questionnaire was validated on a convenience sample of ten subjects from six different clinical settings in Auckland region. The practitioner or receptionist from the selected clinical sites handed out the questionnaire package to their patients who fulfilled the study criteria. Each patient (subject) completed the questionnaire on their arrival and the re-testing questionnaire at a two-week interval. The reliability of the questionnaire was estimated by examining the internal consistency reliability (Cronbach's alpha statistic) and test-retest reliability (Intra-class correlation coefficients). The content validity of the questionnaire was examined by literature review, interviews with patients, and experts' judgement. The construct validity was estimated by the methods of known groups, correlations between scales, and correlations with the SF-36 health survey. The success of the grouping or scaling of the questionnaire was estimated by examining the item (i.e. question) internal consistency and item (i.e. question) discriminant validity. Results The TCM questionnaire scales corresponded to the "eight principal syndromes", "ten questions", and "eight patterns of OA" within TCM concepts and frameworks. Internal consistency reliability (Cronbach's alpha) was above .70 for all scales on both occasions of the first test and the second test. Test-retest reliability (intra-class correlation coefficient) for each scale was also above .70 for all scales, except the exterior (EXT) scale, which was .44. Moderate associations were found between the age of subjects and the scores of the interior (INT) scale and summary (SUM) scale. There was a significant difference between the groups of use and non-use of on-going medication in the EXT scale scores on the first test, p = .012. However, this significant difference was not found on the second test. As expected, strong or moderate associations were found between the TCM questionnaire and SF-36 comparable scales. Conclusions The TCM questionnaire was developed within TCM concepts and frameworks. The questionnaire contains 23 items with two main scales (the EXT scale and the INT scale) and one additional scale (the SUM scale). It takes approximately five minutes to complete and is entirely self-administered. Results from this pilot study indicate that this TCM questionnaire might have adequate reliability and validity. Therefore, the questionnaire has potential usage as an outcome measurement instrument for the assessment of TCM in the patients with OA of the hip or knee. For this application to be possible, the questionnaire needs further development and validation with a larger sample of patients who have a variety of OA conditions.