| Background:Heart failure is a progressive,continuous progression of end-stage disease,the patient’s physical,psychological and social health are seriously affected.Comprehensive and accurate collection of health-related information of patients with heart failure and identification of patients’ health troubles are the primary task to improve the treatment and nursing quality of patients with heart failure at present.However,clinical information biased to the subjective feelings of patients,such as pain,dyspnea and anxiety,cannot be obtained solely by objective measurement.Patient-reported Outcomes(PROs)are often used for assessment.The success of PROs apps depends largely on the measurement tools chosen and what they measure.Our PROs measuring tools have developed for many years,but there are still two big problems in application:the lack of unified standardized tools and the excessive burden of patient response.Patient-reported Outcomes Measurement Information System(PROMIS)is a global collection of standardized measurement tools,PROMIS+HF is developed for patients with heart failure.The tool includes two versions of PROMIS+HF-27 and PROMIS+HF-10.Compared with other tools,PROMIS+HF improves the specificity of patients with heart failure.The crosspopulation comparability is retained and the number of items is simplified,which provides an opportunity to break the tool application barrier of patient report outcome in the field of heart failure.Therefore,the purpose of this study is to introduce PROMIS+HF to provide a new global standardized measurement tool for health evaluation of patients with heart failure.Objectives:Translation of PROMIS+HF into Chinese and cultural adaptation.On this basis,the psychometric characteristics of PROMIS+HF in Chinese patients with heart failure were further verified.Methods:This study consists of two parts.In the first part,Functional Assessment of Chronic Illness Therapy Trans(FACIT-trans)was used to translate PROMIS+HF into Chinese.Five patients diagnosed with heart failure admitted to a Class Ⅲ cardiovascular hospital in Beijing were recruited for cognitive interview,and cultural debugging of the tool was completed.In the second part,patients were recruited from the hospital by convenience sampling method.A cross-sectional survey was conducted using PROMIS+HF,Kansas City Cardiomyopathy Questionnaire,and Minnesota Heart Failure Quality of Life Scale to verify its structural validity,criterion association validity,aggregate validity,known group validity,and internal consistency.Then,patients were recruited from cross-sectional survey subjects to fill in PROMIS+HF again 7 days after cross-sectional survey and 30 days after discharge for retest reliability and response analysis.Results:1.Translation and Cognitive interview resultsThe items of PROMIS+HF were translated by the Chinese research team in strict accordance with the FACIT-trans step of the official PROMIS requirements.The cognitive interview showed that most items of the tool were clear and easy to understand.The research team contacted the PROMIS Center and the original authors to modify this statement to "usual activities.All translation processes and results of the final two versions of PROMIS+HF were approved by the PROMIS Center in the United States.2.PROMIS+HF psychometric validation resultsA total of 446 cross-sectional data were collected and 26 invalid data were excluded.Finally,420 cross-sectional data,50 test-retest reliability data and 75 responsiveness data were included for analysis.The results showed that the adjusted 3-factor models of the two versions of PROMIS+HF confirmatory factor analysis fitted well,the main fitting indicators met the requirements,and had good construct validity.The PROMIS+HF-27 and PROMIS+HF-10 physical health scores had good criterion correlation validity with the 6-minute walk test distance(r=0.653,P<0.01;r=0.628,P<0.01);The physical,mental,and global health scores of the two versions of PROMIS+HF had expected good correlations with the clinical summary,quality of life,and global summary scores of the Kansas City Cardiomyopathy Questionnaire(all r>0.7).The social health domain scores were slightly less correlated,but the r was also greater than 0.6.There was a very good correlation between MLHFQ and physical dimension,emotional dimension and total score(r>0.7),which had good convergent validity.Patients were divided into four groups according to New York Heart Association(NYHA)class.As NYHA class increased,both versions of PROMIS+HF physical and global health mean scores decreased significantly(F<0.001).The known group validity was good.The Cronbach’s a of PROMIS+HF-27 for physical,psychological,social,and global health scores ranged from 0.87 to 0.95.The Cronbach’s a of PROMIS+HF-10 for physical and global health scores ranged from 0.71 to 0.88.The internal consistency coefficient of the two versions of PROMIS+HF ranged from 0.89 to 0.98,which showed excellent internal consistency and test-retest reliability.There were significant differences between the two versions of PROMIS+HF scores on admission and 1 month after discharge.The Cohen’s d of PROMIS+HF-27 ranged from 0.41 to 0.66,and the Cohen’s d of PROMIS+HF-27 ranged from 0.26 to 0.48,which had a good response.Conclusion:The two Chinese versions of PROMIS+HF have been proved to have excellent content validity,construct validity,criterion-related validity,convergent validity,known group validity,internal consistency,test-retest reliability and responsiveness,and have good applicability in the Chinese population.Compared with the two versions of PROMIS+HF,PROMIS+HF-27 has more comprehensive content and is suitable for academic research and more detailed clinical investigation,while PROMIS+HF-10 has fewer items and reduces the burden on patients while retaining the important content of PROMIS+HF-27,which is more suitable for practical clinical application.However,the overall PROMIS+HF-10 is not as accurate as PROMIS+HF-27,and users can choose the appropriate tool according to their specific application scenarios and needs. |
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