This article aims to construct a disease and syndrome combined evaluation scale for the dampness and turbidity syndrome in non-alcoholic fatty liver disease (NAFLD). Based on traditional Chinese medicine theory, combining classical measurement theory and item response theory, the study uses the Delphi method for multi-round expert consultation, screens and scientifically assigns scores to items, enhancing the objectivity and scientificity of the evaluation. The study first establishes an initial item pool through literature analysis, revised through clinical pre-survey and four rounds of expert questionnaires, and finally determines the scale structure: containing 9 core items (such as discomfort in the hypochondrium, abdominal distension, and heavy feeling in the head and body), with a total score of 123 points, where tongue and pulse signs are not included in the scoring but serve as attribute information. The innovation lies in the first time constructing a disease and syndrome combined quantitative evaluation tool with characteristics of traditional Chinese medicine for the specific TCM pattern of NAFLD - dampness and turbidity syndrome, filling the gap in the field lacking a standardized syndrome evaluation system, and enhancing the operability and scientificity of clinical differentiation. The scale has good reliability (Cronbach's alpha 0.790) and expert consensus (Kendall's coefficient reaches 0.848, with all coefficients of variation <0.5), and has the value of promotion and application.
The main significance of this study lies in constructing a specialized disease and syndrome combined evaluation scale for the dampness and turbidity syndrome in non-alcoholic fatty liver disease (NAFLD), filling the gap in the lack of unified efficacy evaluation standards for traditional Chinese medicine treatment of NAFLD. By mining literature, patient interviews, and clinical physician consultations to establish an item pool, and combining classical measurement theory and item response theory for objective selection, while using the Delphi method for multi-round expert consultation to ensure the scientificity and representativeness of the items. Finally, 9 primary items and 12 secondary items are determined, and the Analytic Hierarchy Process is introduced to assign weights to the items, enhancing the operability and clinical applicability of the scale. In addition, the study uses a scientific scoring model (such as formula S=W×Fdeg) to quantify the severity of each syndrome, enhancing the objectivity and sensitivity of the evaluation. The scale not only conforms to the characteristics of TCM syndrome differentiation and treatment but also achieves disease and syndrome combination, providing a standardized and quantifiable tool for traditional Chinese medicine efficacy evaluation, which helps to improve the homogeneity and scientific research value of clinical research. Its good feasibility (average completion time 5.3 minutes, 100% recovery rate) also guarantees the prospects for practical application.