Development And Evaluation Of The Chronic Constipation Pro Rating Scale (cc-pro)

[Background]The incidence rate of chronic constipation is high, which is too heavy on mental and economy for patient. TCM has the preponderance over western medicine on preventing and treating constipation with low cost. But the current curative effect evaluation is varied, which could not reflect the valid point of action of TCM.In the wake of alteration of medical model, PRO (Patient-Reported Outcome) is the hot spot, which evaluate subjective feeling, functional status and quality of life of the patient synthetically. PRO is suitable for chronic constipation. Domestic rating scales of PRO and QOL on chronic constipation is absence while overseas rating scales depend on culture, which need to be translating, examining and adjusting.So it is necessary to research Patient-Reported Outcome of Chronic Constipation questionnaire, which is in line with Chinese culture, reflecting the valid point of action of TCM and paying close attention to QOL.[Purpose]Researching the Patient-Reported Outcome of Chronic Constipation rating scale, examining the reliability, validity and responsibility, approaching the methodology of curative effect evaluation of chronic constipation on TCM.[Method]Focusing on patient, follow the guideline of PRO of FDA, establishing the synthetic index system combining symptom with syndrome under the guidance of TCM theory.●Establishing theoretical mode of the questionnaire, including 4 domains:physiology (specific symptom of chronic constipation and effect index of syndrome), psychological, society and satisfaction;●Through literature and interview, collecting typical feeling of patients of chronic constipation, which include 96 items, establishing first draft of item pool;●Screening the items for the first time through the first expert and patient questionnaire, remaining 63 items;●Combining, deleting and revising the items according to the setting request of the questionnaire, optimizing the item pool;●Establishing the item pool (45 items), including physiology domain (29 items), psychological domain (9 items), society domain (3 items) and satisfaction domain (4 items), and accomplishing quantification of the item.●Modifying the presentation and quantification of the item through the second expert questionnaire, remaining 43 items;●Accomplishing language adjusting and consummating the important element of the questionnaire, establishing the first draft of the questionnaire.●Carrying out the pre-investigation, screening the items for the second time on item distributing, dispersion degree, coefficient correlation, factor analysis, discriminant analysis and Cronbachα;●Determining scoring method of the questionnaire;●Establishing the Patient-Reported Outcome of Chronic Constipation rating scale;●Examining the reliability, validity and responsibility of the questionnaire;●Determining the score meaning of the rating scale.[Result]●Establishing the Patient-Reported Outcome of Chronic Constipation rating scale①Quality:Using for patients of chronic constipation, reflecting the health condition and QOL, the clinic outcome is reported by patient himself.②Structure:The questionnaire includes 32 items, which is consist of 4 domains and 7 aspects. The 4 domains include:physiology domain (19 items), psychological domain (9 items), society domain (2 items) and satisfaction domain (2 items). Physiology domain contains specific symptom of chronic constipation and effect index of syndrome; psychological domain contains adjusting of disease and mental state; satisfaction domain contains self-evaluation of health and satisfaction of treatment.●Examining the reliability, validity and responsibility of the questionnaire①The receptance is 92.1%, the accomplishing rate is 97.4%,the accomplishing time is (12.14±7.79)min;(2)Internal reliability:Besides split-half reliability coefficient of satisfaction, the other domains and the total score of the questionnaire are all over 0.7;③Remeasure reliability:4 domains and the total score of the questionnaire are all over 0.7;④Content validity: The coefficient correlation of domain and total score, item and total score, item and domain are all over 0.7;⑤Construct validity:Accumulative offer rate of variance is 72.245% in factor analysis, the construction of the questionnaire is in line with the theory scheme;⑥Responsibility:Statistical significance exists between patients of chronic constipation and normal on score of item, domain and general concept (P<0.05). ●Determining the score meaningThe questionnaire is used to evaluate the quality of life of patients of chronic constipation, the score meaning including:①Normal:total score≤88;②Slightly poor:88<total score≤121;③Poor:121<total score≤160;④Very poor:160<total score≤199;④Quiet poor:total score>199.[Conclusion]Focusing on patient, follow the guideline of PRO of FDA, establishing the synthetic index system combining symptom with syndrome under the guidance of TCM theory, Patient-Reported Outcome of Chronic Constipation questionnaire is quite suitable to evaluate the curative effect of chronic constipation on TCM with better reliability, validity and responsibility, which is worth spreading and applying.