The Development And Evaluation Of Of Menopause Rating Scale Of TCM

Backgroud: People attach more importance to the improvement of softindex when treated menopause syndrome. Scale was approved universally asthe the instrument to assess soft index quantificationally andobjectively in medical field. And several scales were frequently used toevaluate the curative effect of menopause syndrome. But those scales havedeficiency as themselves, and because of the difference of culture andsociety background and conception between fremdness and home, anddifferent opinion about disease or health was exist between west medicineand traditional Chinese medicine(TCM), so those scales can't assesscurative effect of TCM objectively. As the deficiency of proper appraisiveindexes to assess the curative effect for menopause syndrome using TCMat present, the application of TCM was affected. It was believed that thoseindexes should be selected when assess the curative effect of TCM whichhave the characteristic of TCM(diagnosis and treatment on the basis ofan overall analysis of the illness and the patient's condition forexample)and superiority of curative effect of TCM(especially theuncomfortable symptoms). The research is aimed at develop the menopauserating scale of TCM(MRSTCM) under the guidance of TCM theory and thedirection of different scientific research methods, such as psychometricsand clinical epidemiology and evidence based medicine(EBM).Objective:1. Developing MRSTCM, which should be based on TCM theory andbe proper to curative effect assessment of TCM; 2. Evaluation of thereliability and validity and responsibility of the scale, andmodification the scale.Hypothesis:1. MRSTCM, which is designed according to the definitionof menopause syndrome and is based on the TCM perspective, can reflectthe connotation of TCM. 2. MRSTCM is self-administered scale, should besimple, easy to understand and operate. 3. MRSTCM should be reliable andvalid, and sensitive to changes of therapeutic intervention.Design: Cross-sectional survey andSelf-control observation.Sample obtaining: convenience samplingParticipants: patient with menopause syndrome and women in menopausebut without menopause syndrome. The participants should meet thediagnostic criteria and inclusive criteria, and if meet the exclusive criteria, should be exclude.Setting: Guangzhou city; Tianjin city; Shanghai city; Wenzhou city;Nanjing city; Wuhan city; Chengdu city; Foshan city.Main measures to develop scale: 1. The MRSTCM was preliminary developed,based on a series of steps, for example, literature search, confirmingthe character of scale; forming operative definition of MRS, puttingforward the theoretic frame, collecting and selecting items, scaletesting; pilot survey, et al. 2.3343 convenience samples,which werecomposed of 2320 patients and 1023 menopause women, were surveyed in 8different settings. The participants were asked to complete the MRSTCM,the Kupperman Index, which were delivered in-order, and somesocioeconomic characteristics. 192 patient were interviewed again after7-10 days. hard and fast criterion were established during the survey,for example, the duty of investigator, the order of the scale, the qualitycontrol, et al. 3. 174 patient were treated with TCM. After 12 weekstherapy, the responsibility was evaluated. 4. Statistical content: itemselection statistical method include item distributing, t test,correlation analysis, differentiable coefficient, factorial analysis,Cronbach a et al. The characteristic of scale were evaluated fromreliability, validity and responsibility.Results: 1. MRSTCM is disease-specific, self-administered,evaluation scale. 2. The frame of MRSTCM is based on TCM and characteristicof menopause syndrome. MRSTCM is composed of three dimension: somadimension, psychology dimension and community dimension. Soma dimensionis composed of six facets, which are 'disease-specific symptoms,''kidney,' 'heart,' 'liver', 'spleen' and 'lung' facets.Psychology dimension is composed of 'anger', 'worry', 'miss''loneliness,' 'horror' and 'cognitive Function' facets. Communitydimension is composed of three facets, that is 'social support', 'socialduty and social ability,' 'social adaption and social communication.'3. After item selecting,35 items were hold. MRSTCM is composed of threedimensions, 35 items at present. The soma dimension, psychology dimensionand community dimension have 18,11,3 items respectively. And the lastthree items are general health evaluation item (1 item) and lie items(2items). 4. scale evaluation: (1)feasibility: The rate of recovery is100%. The response rate is 99.7%. the completion of the MRSTCM took 10.30minutes on average. (2)reliability: The Cronbach's alpha of MRSTCM, Thesoma dimension, psychology dimension and community dimension were 0.93,0.87, 0.89, 0.73 respectively, the correlation coefficient of split halfof MRSTCM, The soma dimension, psychology dimension and communitydimension were 0.92, 0.89, 0.86, 0.73 respectively, the test-retestcorrelation coefficient of MRSTCM, The soma dimension, psychologydimension and community dimension were 0.88,0.91,0.85,0.77 respectively.The above results indicate that the MRSTCM has a satisfactory reliability. (3)validity:â‘ content-relatedvalidity: MRSTCM was established on thebasis of connotation of menopause syndrome, and a series of steps wereadapt to modify the scale. MRSTCM is applicable for the patient withmenopause syndrome.â‘¡construct-related validity: The result ofexploratory factor analysis was accorded with the theory frame of MRSTCMby and large; The result of confirmatory factor analysis was as following:The CFI of MRSTCM, The soma dimension, psychology dimension and communitydimension were 0.92,0.92,0.95,0.99 respectively. The GFI of MRSTCM, Thesoma dimension, psychology dimension and community dimension were0.92,0.94,0.90,1.00 respectively. The RMR of MRSTCM, The soma dimension,psychology dimension and community dimension were 0.23,0.06,0.03,0.01respectively.â‘¢discriminant validity: The MRSTCM was able todiscriminate between groups of people with and without menopausalsyndrome; patient "require medical assistance" and "don't requiremedical assistance".â‘£criterion-related validity: The correlationbetween the MRSTCM and KI were 0.83. In conclusion, the MRSTCM has asatisfactory validity. (4) responsibility: The MRSTCM was measured basedon 174 patients with menopausal syndrome before and after TCM therapy.The result shows that the MRSTCM has the ability to measure the clinicallyimportant difference.Conclusion: The MRSTCM, which is developed based on the TCM theory,is suitable for outcome assessment of menopausal syndrome. The primaryresearch proved that the MRSTCM had good feasibility, reliability,validity and responsibility.