The 2nd Affiliated Hospital of Guangzhou University of Chinese Medicine, Guangzhou, China.
Health Qual Life Outcomes. 2013 Dec 21;11:212. doi: 10.1186/1477-7525-11-212.
Zheng 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.
We 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.
ZRADSQ 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, x2=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.
The 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.
中医的“证”是中医治疗理论的基本单位和关键概念，它基于中医的生理和病理。特应性皮炎（AD）的所有结局测量均与“证”无关。如果没有与“证”相关的症状特异性仪器，可能会低估中医的疗效。本研究旨在开发一种用于测量 AD 患者“证”相关症状特异性状态的仪器。
我们遵循标准方法开发仪器，包括项目生成和选择、项目缩减和呈现以及预测试，并招募了 188 名参与六中心随机对照试验（ChiCTR-TRC-08000156）的 AD 患者对问卷进行验证。我们进行了结构有效性、可靠性和响应性分析。使用标准化效应量（SES）和标准化反应均值（SRM）来计算附加项目和评分项目总分的响应性。
ZRADSQ 有 15 个项目，其中 12 个评分项目和 3 个附加项目。这 12 个评分项目分为三个领域：AD 症状（n=6 个项目）；热（n=4 个项目）和情绪（n=2 个项目）。验证性因子分析为三因素模型提供了良好的支持（自由度=51，x2=97.11，RMSEA=0.07，CFI=0.96），ZRADSQ 与特应性皮炎严重程度评分（SCORAD）之间的皮尔逊相关系数为 0.40（P<0.001）。可靠性也很好，ZRADSQ 的 Cronbach's alpha 值为 0.84，半分系数为 0.75，测试-重测信度系数为 0.98。标准化效应量和标准化反应均值接近或大于 1，表明具有中度至良好的反应性。
ZRADSQ 具有良好的可靠性、有效性和响应性。它可用于确定是否使用特定于“证”或特定于症状的治疗来缓解患者最困扰的症状。
