Development And Application Of Patient-Reported Outcomes Instrument For Unstable Angina And Estimation Of MCID

Objective:This study is based on the making principles and processes of PRO according to US Food and Drug Administration,to develop a patient-feeling centered unstable angina PRO scale that suits our own culture.Method:In accordance with the international PRO measurement tool development norms and procedures,the scale collects and extracts professional information and relevant psychological and sociological knowledge about UA through literature review,interviews with patients and consultation with relevant experts,forming a theoretical framework and item pool.Combined with the suggestions of experts and patients,the items were modified to form the initial scale.Four different levels of medical institutions and two communities in Shanxi Province were selected for preliminary investigation.The preliminary scale was formed by using the combination of Classical Test Theory and Item Response Theory to screen items and adjust dimensions.Formal survey was conducted in the same six places with the preliminary scale.After the scale was recovered,the same method was used to screen again to form the final scale.Finally,the reliability and validity of the final selection scale were assessed,and a clinical PRO scale for unstable angina pectoris was developed.Minimum clinically important difference(MCID)in each field of PRO scale was calculated to facilitate clinical workers to explain the significance of the change of PRO score.Based on the developed PRO scale,Structural Equation Model is made in relevant fields to explain and verify the causal relationship among the dimensions,and to evaluate the fitting effect of the model.Results:A PRO scale for unstable angina was developed,which included 38 items,12 dimensions and 4 domains.There are 14 items in the physical domain,including three dimensions of physical symptoms,independence and cognition;9 items in the psychological domain,including three dimensions of anxiety,depression and worry;10items in the social domain,including three dimensions of social support,social adaptationand support utilization;and 6 items in the treatment domain,including three dimensions of satisfaction,compliance and drug side effects.The reliability and validity of the scale were assessed.Reliability analysis: The Cronbach a coefficient of the total table is 0.787.Validity analysis: Structural validity of various domains and multiple fitted index indicators show that the multi-dimensional measurement in the scale meets the professional expectation structure.The MCID in the physical,psychological,social and therapeutic domains are 3.94,2.78,3.21 and 2.32.Poor somatic symptoms can lead to a negative psychological state of anxiety and concern in patients;patients with poor independence are more likely to be depressed and concerned;and reduced cognitive attainment can lead to bad moods such as anxiety,depression,and concern.The higher the social support,the better the patient's compliance,and the higher the degree of support,the lower the patient's compliance.Conclusion:The report outcome scale for patients with unstable angina developed in this paper has good reliability,validity and feasibility,and can be used as a tool for evaluating the clinical efficacy of the disease.MCID in various fields can help clinicians to explain the significance of PRO score changes.Structural equation model can better verify the relationship between the dimensions.