Development Of A Life Quality Evaluation Scale Based On Traditional Chinese Medicine Theor

BackgroundAs an important indicator of health outcomes evaluation,quality of life(QOL)is increasingly adopted by clinical research and pharmacoeconomic evaluation.As a unique medical and health resource in China,Chinese medicine(CM)is an important part of contemporary medicine of China and an outstanding representative of traditional medicine in the world.It is an original,applied,inherited,and developed medical system for Chinese national medicine scholars in understanding nature,life,disease prevention,and health care activities.It is of great significance to enrich the world’s medical undertakings and promote life science research.Therefore,the objective expression of CM intervention in health outcomes is particularly important.At present,the evaluation indicators of CM intervention health outcomes mainly include laboratory indicators,efficacy indicators,endpoint indicators,and CM syndrome indicators.These indicators were insufficient for the patient-reported outcomes(PROs)of CM.The health outcomes of CM intervention based on patient reports were underestimated.The concept of QOL was consistent with the holistic view of CM.In the QOL evaluation process of CM,although the existing international generic QOL scale was widely used in China,the scale items could not fully reflect the health outcomes of CM.The domestic CM generic QOL scales were developed from the perspective of CM syndromes and symptoms.The syndrome terms used in the scale items were professional,and patients could not make good judgments on their own.Therefore,the purpose of this study was to develop a QOL scale based on CM theory,which could objectively evaluate the PROs of CM.And the research was guided by CM theory and CM health concept.ObjectiveThis research was guided by the holistic view and health concept of Chinese medicine,and developed a QOL assessment scale based on CM theory.It provided an objective evaluation tool for the health outcomes generated by CM intervention,and solved the problem of underestimation of PROs with CM intervention.It improved the comparability of health outcomes of different intervention measures of CM,and provided a scientific evaluation scale for the evaluation of health outcomes of CM intervention and the evaluation of health technology of CM.MethodsLiterature research:This study built a theoretical framework for the scale based on CM theory and literatures.The related-QOL indicators in literatures of clinical effects evaluation of CM intervention were sorted out,and this study selected indicators by the guidance of CM theory.It combed the indicators of the foreign generic QOL scale and the generic scale of CM.In this study,it researched CM syndromes,sorted out indicators that reflected the QOL evaluation of CM intervention.A pool of scale indicators was initially formed.Patient Interview:According to the results of the literature research,a patient interview questionnaire was formed,and the patients receiving CM treatment were interviewed to collect the QOL of patients after CM intervention and the QOL they were most looking forward to.It preliminarily optimized the scale indicators based on interview results.Expert Consultation:It hold expert demonstrative meetings and expert consultation meetings to confirm the theoretical framework and indicators of the scale.Questionnaire Survey:(1)The importance score of patients for the indicators:The importance score was used to screen and optimize the scale indicators through the boundary value method.(2)The indicators were further selected through the patient questionnaire survey:A questionnaire survey was conducted on patients who had received CM treatment within the past 7 days.According to the results of the questionnaire survey,the discrete trend,Cronbach’s alpha coefficient,stepwise regression analysis,factor analysis,and critical ration were used to further screen the scale indicators to form the final scale.(3)Performance evaluation:The feasibility,reliability and validity of the scale were evaluated according to the results of the patient questionnaire survey.ResultsThis study was based on CM theory and health concept.It established an indicator pool of QOL assessment scale based on CM theory through literature research and patient interview.This study combined the expert consultation method and questionnaire survey method to select the indicators pool of scale,and finally formed the QOL assessment scale based on CM theory(CM-QOL).It contained 3 dimensions including the Physical Dimension of Physical and Spiritual Unity(PSU-PD)(10 items),the Spiritual Dimension of Physical and Spiritual Unity(PSU-SD)(4 items),and the Human and Society Unity Dimension(HSUD)(3 items).And it had 17 items and a VAS ruler.Results of Performance Evaluation of CM-QOL:The scale feasibility evaluation results showed that the scale had a good acceptance rate,a high completion rate,and a moderate completion time.The reliability evaluation results of the scale showed that the overall Cronbach’s α of the scale was 0.890,the Cronbach’s α of PSU-PD was 0.842,the Cronbach’sα of PSU-SD was 0.824,and the Cronbach’s α of HSUD was 0.615.The internal consistency of the scale was better.The total split-half reliability coefficient was 0.896,the split-half reliability coefficient of PSU-PD was 0.810,the split-half reliability coefficient of PSU-SD was 0.772,and the split-half reliability coefficient of HSUD was 0.691.The scale had better splithalf reliability.The validity evaluation results of the scale showed that the I-CVI ranged from 0.80 to 1.00,and the S-CVI/Ave was 0.90.The correlation coefficients between total score and scores of each dimension were 0.976,0.894,0.407.The content validity of the scale was better.In the factor analysis of structural validity,the KMO was 0.863,and Bartlett’s sphericity test was χ2=831.442,P<0.05.The factor with characteristic root>1 was selected for factor analysis.A total of 4 common factors were extracted,and the cumulative variance contribution of the factors was 63.724%.The items in the four common factors had an inherent logical relationship with the scale itself.The scale had structural validity.In the standard correlation validity,EQ-5D-5L was selected as the standard scale,and the correlation coefficient between the CM-QOL and the standard scale was 0.651.The correlation was higher and the standard validity was better.ConclusionIn this study,an international scale development program was used to develop the CMQOL.The feasibility,reliability and validity of the scale were evaluated,and the evaluation results showed that the scale had better feasibility,reliability and validity.It could be used as a scientific and quantitative tool for the evaluation of PROs by the intervention of CM,and provide basis and help for clinical decision-making of CM.