Development of a Traditional Chinese Medicine Syndrome‐Specific Scale for Ulcerative Colitis: The Large Intestine Dampness‐Heat Syndrome Questionnaire

Abstract

The aim of this study was to develop and validate the large intestine dampness-heat syndrome questionnaire (LIDHSQ) for patients with ulcerative colitis (UC). The domains and items of the LIDHSQ were developed according to standard procedures, namely, construct definition, item generation, language testing, content validity, pilot study, and validation study. At first, a total of 20 items in 3 domains were generated based on literature review and expert consultation. After the item selection, the LIDHSQ contains 11 items in three domains: disease-related domain (diarrhoea, abdominal pain, bloody purulent stool, and mucus stool), heat domain (fever, dry mouth, red tongue, yellow fur, and anal burning), and dampness domain (greasy fur and defecation disorder). The Cronbach's alphas of all domains were greater than 0.6. All of the intraclass correlation coefficients were greater than 0.8. The LIDHSQ and domain scores of the patients with LIDHS were higher than those of the patients with other syndromes (P < 0.001). The area under the receiver operating characteristic curve of the LIDHSQ was 0.900, with a 95% confidence interval of 0.872–0.928. When the cut-off value of the LIDHSQ was ≥ 7, the sensitivity and specificity were 0.867 and 0.854, respectively. The LIDHSQ is valid and reliable for measuring LIDHS in UC patients with good diagnostic efficacy. We recommend the use of the LIDHSQ in Chinese UC patients.

Development of a Diagnostic Questionnaire for Damp Phlegm Pattern and Blood Stasis Pattern in Coronary Heart Disease Patients (CHD-DPBSPQ)

“…Internal consistency reliability, split-half reliability, and test-retest reliability were all evaluated [16,43]. e internal consistency reliability was estimated using Cronbach's α.…”

“…e method of determining content validity was not suitable, as content validity should be determined according to the CVI [45], but none of the three questionnaires used the CVI [13][14][15]. e method of construct validity was also not suitable, as Evidence-Based Complementary and Alternative Medicine construct validity should be determined via CFA rather than EFA [16]. e 15 items on the CHD-DPBSPQ were empirically selected by four methods using a sample population from a Guizhou tertiary grade A hospital.…”

“…Meanwhile, structural equation modelling is a valid method for testing TCM syndromes, as described in other studies [23,29]. Up to now, other researchers have formulated and exerted similar methods to explore TCM syndromes [16,24]. For example, Chen et al developed the LIDHS questionnaire and evaluated its reliability and validity as a "TCM Syndrome Questionnaire of Ulcerative Colitis" [16].…”

“…Up to now, other researchers have formulated and exerted similar methods to explore TCM syndromes [16,24]. For example, Chen et al developed the LIDHS questionnaire and evaluated its reliability and validity as a "TCM Syndrome Questionnaire of Ulcerative Colitis" [16]. e CHD-DPBSPQ, as an effective and reliable pattern of TCM questionnaire, can also be used to diagnose CHD-DPBSP in patients.…”

“…First, the process of developing these scales is not standardized. e method of determining construct validity is not suitable, as construct validity should be determined through confirmatory factor analysis (CFA) rather than exploratory factor analysis (EFA) [16]. Second, the items contained in these questionnaires are largely divergent; thus, the diagnosis of CHD is not systematic or consistent.…”