Development and initial validation of a traditional Chinese medicine symptom-specific outcome measure: a Zheng-related atopic dermatitis symptom questionnaire ZRADSQReportar como inadecuado

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Health and Quality of Life Outcomes

, 11:212

First Online: 21 December 2013Received: 29 May 2013Accepted: 17 December 2013


BackgroundZheng represents pattern differentiation in Traditional Chinese Medicine TCM, as the basic unit and a key concept in TCM therapeutic theory, is based on the physiology and pathology of TCM. None of the outcome measurements of atopic dermatitis AD are Zheng-specific. The effectiveness of TCM is likely to be underestimated without a Zheng-related symptom-specific instrument. The aim of this study was to develop an instrument for measuring the Zheng-related symptom-specific status of patients with AD.

MethodsWe followed standard methodology to develop the instrument, including item generation and selection, item reduction and presentation, and pretesting, and recruited 188 patients with AD involved in a six-center randomized-controlled trial ChiCTR-TRC-08000156 to validate the questionnaire. We conducted construct validity, reliability, and responsiveness analysis. The standardized effect size SES and standardized response mean SRM were used to calculate the responsiveness of additional items and the total score for the rating items.

ResultsZRADSQ has 15 items, with 12 rating items and 3 additional items. The 12 rating items fall within three domains: AD symptoms n = 6 items; Heat n = 4 items and Mood n = 2 items. Confirmatory factor analysis provided good support for a three-factor model d.f. = 51, x=97.11, RMSEA = 0.07, CFI = 0.96, and the Pearson’s correlation coefficient between ZRADSQ and Severity Scoring of Atopic Dermatitis SCORAD was 0.40 P < 0.001. The reliability was also good, with a Cronbach’s alpha value for ZRADSQ of 0.84, a split-half coefficient of 0.75, and a test-retest reliability coefficient of 0.98. The standardized effect size and standardized response mean were close to or larger than 1, which indicated moderate to good responsiveness.

ConclusionsThe ZRADSQ demonstrates promising reliability, validity, and responsiveness. It can be used to determine whether Zheng-specific or symptom-specific treatments relieve the symptom that is most bothersome the patient.

KeywordsAtopic dermatitis Development Questionnaire Traditional Chinese medicine Validation Symptom AbbreviationsZRADSQZheng-related atopic dermatitis symptom questionnaire

TCMTraditional Chinese medicine

ADAtopic dermatitis

CAMComplementary or alternative medicine

SCORADSeverity scoring of atopic dermatitis

EASIEczema area and severity index

POEMPatient-oriented eczema measure

CFAConfirmatory factor analysis

RMSEARoot mean square error of approximation

SESStandardized effect size

SRMStandardized response mean

CFIComparative fit index

VASVisual analogue scale.

Electronic supplementary materialThe online version of this article doi:10.1186-1477-7525-11-212 contains supplementary material, which is available to authorized users.

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Autor: Darong Wu - Chujun Huang - Xiumei Mo - Junfeng Liu - Jianxiong Cai - Chi Liu - Haili Zhu - Hongyi Li - Dacan Chen


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