Development And Evaluation Of The Scale For Syndrome Related Health Impairment In The Patient With The Stroke

ObjectiveTo develop the Scale for Syndrome Related Health Impairment in the patient with the Stroke, evaluate its reliability, validity and responsibility, and explore the methodology of curative effect evaluation of stroke on TCM.MethodTo develop the Scale of Syndrome Related Health Impairment under the guidance of TCM theory and through starting from the stroke patients’ self-feeling symptoms, following the guidelines of PRO research issued by the U.S. FDA.· Establishing the working group, and making the concept clear that the scale measures as stroke patients reported outcomes;· Under the guidance of traditional Chinese medicine theory, constructing the theoretical structure framework of the scale;· Literature study, expert consultation, focus group discussing, patients interviews, caregivers interviews and clinical record review, were comprehensive used to develop items, which were screened and optimized from the perspective of language and logic, and classified and reorganized according to the scale’s expected structure framework to establish the primary item pool;· Screening the items according to the difficulty, reaction of answering and the meaning, to achieve the optimized effect of the item pool;· Accomplishing language adjustment and consummating the important element of the scale, determining the form of alternative answers, designing the scale format, The draft scale was formed;· Conducting small-scale draft scale cognitive tests, according to the test results to make changes on the draft scales, and finally form the pre-test questionnaire; · Carrying out a field survey with the pre-test questionnaire, analyzing the importance and representativeness of the items through patient assessment, combining, deleting and revising the items according to the setting request of the questionnaire, optimizing the structure;· Establishing the Scale for Syndrome Related Health Impairment in the patient with the Stroke;· Evaluating the reliability, validity and responsibility of the scale.Result· The Scale of Syndrome Related Health Impairment in the patient with the Stroke was established.①Quality:Using for the stoke patients, reflecting the syndrome related health impairment and QOL, the clinical outcome is reported by patient himself (herself).②Structure:The scale includes71items, which is consist of3domains and13aspects. The3domains include:coordinated domain of the body’s own (48items), coordinated domain of human and social environment (17items), coordinated domain of human and natural environment (5items), and the last item is total evaluation of health condition. Coordinated domain of the body’s own contains symptoms of wind syndrome, symptoms of fire syndrome, symptoms of phlegm syndrome, symptoms of blood stasis syndrome, symptoms of qi deficiency syndrome, symptoms of hyperactivity of yang due to yin deficiency syndrome and local symptoms; coordinated domain of human and social environment contains social relations, vigilance behavior, communion, burden of family; coordinated domain of human and natural environment contains dressing (climatic environment), habitancy (local environment).· The scientific appraisal of the scale has been completed.①The acceptance rate is95%, the accomplishing rate is100%, and the accomplishing time is (22.45±10.18) min;②Reliability:The split-half reliability coefficient of the whole scale is0.828,while the two half part of the scale are0.905,0.912;③Content validity:The coefficient correlation of domain and total score, facet and total score are all over0.6; the coefficient correlation of items and total score are all over0.3,except the items that the eyeballs move around, dry eyes, cold diet restricted and impaired concentration; The correlation coefficients of the scale’s all items and their domains were greater than those of items and domains which were not theirs, except for a very small part.④Construct validity:Accumulative offer rate of variance is65.896%in factor analysis, the construction of the scale is basically in line with the theory scheme, however, not perfect;⑤Responsibility:The result of one-way ANOVA shows that the mean comparisons between patients of acute stage, decubation and chronic stage are all of statistical significance in each domain and the total scale score (P<0.05).ConclusionFollowing the guidelines of PRO research issued by the U.S. FDA, establishing the evaluation system of syndrome related health impairment, the Scale of Syndrome Related Health Impairment in the patient with the Stroke was established under the guidance of TCM theory, which is used for evaluating the health impairment and quality of life of the stroke patients. The Scale has passed the preliminary assessment with better feasibility, reliability, and responsibility, however, the validity was not perfect. However, it could be suitable to evaluate the curative effect of stroke on TCM after appropriate modification and adjustment.