Development And Validation Of The Patient-reported Outcomes Scale For Patients With Differentiated Thyroid Cancer After ¹³¹I Treatment

Objective:In order to form a scale that can provide a scientific and effective tool for the evaluation of health-related clinical outcomes and treatment effectiveness of differentiated thyroid cancer patient after ¹³¹I treatment,the study was aimed to develop the patient-reported outcomes scale for patients with differentiated thyroid cancer after ¹³¹I treatment,and to test the reliability and validity of the scale according to the guidance of Patient-Reported Outcomes Measures conducted by Food and Drug and the Modern bio-psycho-social medicine model.Methods:1.Literature analysis:A large number of literature related to health status of patients with differentiated thyroid cancer after ¹³¹I treatment were searched from domestic and international databases,and a preliminary conceptual framework and item pool were constructed by referring to existing domestic and international patient-reported outcomes scales.2.Semi-structured interview method:12 patients with differentiated thyroid cancer after ¹³¹I treatment from the nuclear medicine department of a third grade A hospital in Shanxi were selected by the purpose sampling method for face-to-face interview,to understand their subjective experience and feelings after treatment,extract relevant items,and supplement and improve the scale item pool.3.Delphi expert consultation method:Thirty experts in the nuclear medicine field were invited to conduct two rounds of expert consultation,and the items were added,deleted,revised and sorted out according to the importance scores and opinions of the experts in each round.4.Pre-test method:20 patients with differentiated thyroid cancer after ¹³¹I treatment were selected for pre-test,and the item description and scoring format were evaluated,then the initial patient-reported outcomes scale of patients with differentiated thyroid cancer after ¹³¹I treatment was formed.5.Questionnaire method:280 patients with differentiated thyroid cancer after ¹³¹I treatment from the nuclear medicine department of a third grade A hospital in Shanxi were selected by the convenience sampling for the field survey.Critical ratio method,correlation coefficient method,Cronbach’sαcoefficient method were used to analyze the items of the scale,and the formal patient-reported outcomes scale of patients with differentiated thyroid cancer after ¹³¹I treatment was formed by reliability and validity test.Results:The formal scale includes 4 first-level items,9 second-level items,47 third-level items.The scale-content validity index（S-CVI）was 0.947,the item-content validity Index（I-CVI）ranged from 0.875 to 1.000.The exploratory factor analysis extracted 4 common factors,whose cumulative variance contribution rate was 61.455%.The correlation coefficients between each factor ranged from 0.524 to 0.649,and the correlation coefficients between each factor and the total scale ranged from 0.778 to 0.873.The Cronbach’sαcoefficient of total scale was 0.971,and the Cronbach’sαcoefficient of each factor ranged from 0.914 to 0.952;the split-half reliability of total scale was 0.839,and the split-half reliability of each factor ranged from 0.886 to 0.935;the test-retest reliability of total scale was 0.764,and the test-retest reliability of each factor ranged from 0.885 to0.984.Conclusion:In this study,the patient-reported outcomes scale for patients with differentiated thyroid cancer after ¹³¹I treatment was developed with good reliability and validity,which can be used as a tool to evaluate the health status of patients with differentiated thyroid cancer after ¹³¹I treatment.It can help medical professionals fully understand the problems and needs of patients with differentiated thyroid cancer after ¹³¹I treatment,and provide a reference for making clinical nursing decisions and improving the quality of care.