| Objective : To preliminarily develop A Patient Reported Syndrome Scale: Phlegm Syndrome(PRS-PS), and to evaluate its feasibility, reliability and validity. Though this study, a specific module(SM) of traditional Chinese medicine(TCM) syndrome was provided for disease-syndrome combination module, and a new convenient and quantifiable instrument was established for patients of phlegm syndrome to evaluate clinical efficacy by themselves.Methods:According to the international guidance of scale development, and referring to related research, an item pool was generated based on the information extracted from criteria collection,teaching material sorting out, literature review and patient interview. The items with the property of efficacy evaluation were selected by experts discussion to entry final item pool. Based on the theoretical framework, the item pool was classified and sorted to compile questions. Likert five classification methods were used for the question options. The initial scale was formed after adjustments of semanteme by the patient’s cognitive interview. A clinical study was conducted to screen items by a variety of statistical methods and then the final scale was established. A clinical investigation was conducted to evaluated its feasibility, reliability and validity. Finally, the scale was used to assess the efficacy of phlegm turbidity syndrome in patients with coronary heart disease and angina pectoris.Results:The scale were preliminarily established and three dimensions including 11 items were covered. 61 subjects were asked to complete the scale. The scale results were comprehensively analyzed from semanteme, option settings, variability, internal consistency, representation, independence and sensitivity. If the item was not selected by three kinds or above methods, the item would be deleted. With the experts discussion, two items of full of taste and sticky greasy coating were deleted and the final scale was developed. 201 subjects were asked to complete the scale. The rate of recovery and completion of the scale were 96.63% and 100%, respectively. The median completion time of the scale was 2min. The retest reliability of total scale was 0.896, and the retest reliability of all items were greater than 0.7(0.739-0.920). Cronbach’ s α of the scale was 0. 643, and Cronbach’ s α of other items reduced(0.600-0.631) after deleting one item. The correlation coefficient of the dimensions or items and the total scores were both greater than 0.4(0.409-0.722). Three common factors extracted by the scale had a certain difference with the theoretical framework, and the cumulative contribution rate was 54.463%. Combined with experts discussion, the structure of the scale was adjusted further. The total scores were not significantly correlated with TC, TG, HDL-C and LDL-C. The scale can be used to distinguish the healthy population and different diseases. After treatment, the scores of each item and the total score of the patients with angina pectoris of coronary heart disease and angina pectoris were significantly decreased.Conclusion: 1. PRS-PS included three dimensions( distention and fullness, sticky feeling and heaviness) and nine items(abdominal distension, less capacity for eating, poor appetite, greasy mouth, expectoration, sticky stool, dizziness, heaviness in the body and daytime somnolence). 2. PRS-PS has good feasibility, retest reliability, internal consistency reliability, content validity, construct validity, sensitivity and function of efficacy evaluation, so it can be preliminary used in clinical study. What’s more, deficiency was also existed to be improved for the scale. |
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