| Objective:To develop a scale that can evaluate the comprehensive function of active period of rheumatoid arthritis(RA)patients according to the standardized scale preparation process and conduct preliminary clinical verification.Methods:Resting on the framework system of the International Classification of Functioning,Disability and Health(ICF),the comprehensive functional assessment scale of RA in active stage was constructed through the following four stages:(1)item pool establishment: the first draft of the entry pool was constructed through literature review and semi-structured interview with patients.(2)Item pool optimization: through the discussion of the research group,medical survey and two rounds of expert consultation,the items were screened layer by layer to form a pre-survey scale.Then,a small sample of active RA patients were pre-investigated for the understandability,acceptability and evaluation time of the scale content;(3)Preliminary clinical validation: Through the assessment of the scale in clinically active RA patients,item analysis,exploratory factor analysis,confirmatory factor analysis and reliability analysis were carried out to verify the scale.Results:1.Establishment of the entry poolThe item pool was established with 94 items based on the ICF core set of RA,79 literature studies were selected,existing diagnostic criteria,maturity scale and 20 clinical semi-structured interviews were referred.Finally,the first draft of the scale item pool with 42 items was formed,including 6 dimensions of sensory function,disease activity,motor function,activities of daily living,social participation ability and psychological function.2.Item pool optimizationAfter the discussion of the research group,the investigation of 53 medical staff and two rounds of consultation with 15 experts,the patient pre-investigation scale was finally screened and formed,including 6 dimensions of clinical laboratory indicators,sensory function,motor function,psychological function,activities of daily living and social participation ability,and the patient pre-investigation scale with 37 items.After the pre-investigation of 30 active RA patients,the items of the scale were easy to understand,and the frequency words in the response items of all items were re-clarified according to the feedback of patients,the 6 dimensional,37-item test version of scale was formed.3.Preliminary clinical validation A total of 300 scales were collected in the clinical validation stage,and the mean age of patients was 57.19(SD=12.62).In terms of validity,two exploratory factor analyses of 300 samples showed that the five common factors ranged from 0.457 to 0.917,and the variance contribution rate was 67.135%.Criterion association validity: The criterion association validity analysis of 80 samples showed that the scale was moderately correlated with DAS28 and HAQ-DI(r=0.618;0.407).The confirmatory factor analysis of 300 samples showed that the 5-factor model structure of 27 items had good fit and fit.Reliability: Cronabach’s α was 0.900,and the correlation coefficient of broken half reliability was 0.934,indicating that the scale had good reliability and validity.Conclusion:1.A formal scale with 5 dimensions and 27 items was finally formed: The five dimensions of sensory function(5 items),motor function(5 items),activities of daily living(6 items),social participation(2 items)and psychological function(9 items)can reflect the three frameworks of physical function,activity and participation in the ICF construct,and also conform to the content scope of the ICF core set of RA.2.The Comprehensive Functional Rating Scale for Active Period of RA based on the ICF core set is reliable and effective,with good reliability and validity.It is expected to be a new preferred tool for clinical medical staff to evaluate the functional status of active period of RA. |
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