Development of a Novel Adult Congenital Heart Disease–Specific Patient‐Reported Outcome Metric
| Autor: | Jeffrey R. Vittengl, Ari M. Cedars, John A. Spertus, Ada C. Stefanescu-Schmidt, Robin B. Jarrett, Anitha S. John, Jong Mi Ko, Shelby Kutty |
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| Rok vydání: | 2020 |
| Předmět: |
Adult
Heart Defects Congenital Male medicine.medical_specialty Adolescent Psychometrics Heart disease Walk Test Outcome (game theory) Young Adult Quality of life (healthcare) Predictive Value of Tests Patient experience adult congenital heart disease medicine Health Status Indicators Humans Patient Reported Outcome Measures Prospective Studies Intensive care medicine Original Research Quality and Outcomes business.industry Congenital Heart Disease Age Factors Reproducibility of Results Middle Aged medicine.disease Texas Clinical Practice Clinical trial Mental Health quality of life District of Columbia patient‐reported health status Female Patient-reported outcome patient‐reported outcome metric Metric (unit) Symptom Assessment Cardiology and Cardiovascular Medicine business |
| Zdroj: | Journal of the American Heart Association: Cardiovascular and Cerebrovascular Disease |
| ISSN: | 2047-9980 |
| DOI: | 10.1161/jaha.119.015730 |
| Popis: | Background Patient‐reported outcome metrics ( PRO s) quantify important outcomes in clinical trials and can be sensitive measures of patient experience in clinical practice. Currently, there is no validated disease‐specific PRO for adults with congenital heart disease ( ACHD ). Methods and Results We conducted a preliminary psychometric validation of a novel ACHD PRO . ACHD patients were recruited prospectively from 2 institutions and completed a series of questionnaires, a physician health assessment, and a 6‐minute walk test. Participants returned to complete the same questionnaires and assessment 3 months±2 weeks later. We tested the internal consistency and test–retest reliability by comparing responses among clinically stable patients at the 2 study visits. We assessed convergent and divergent validity by comparison of ACHD PRO responses to existing validated questionnaires. We assessed responsiveness by comparison with patient‐reported clinical change. One hundred three patients completed 1 study visit and 81 completed both. The ACHD PRO demonstrated good internal consistency in each of its 5 domains (Cronbach's α: 0.87; 0.74; 0.74; 0.90; and 0.89, respectively) and in the overall summary score (0.92). Test–retest reliability was good with an intraclass correlation ≥0.73 for all domains and 0.78 for the Summary Score. The ACHD PRO accurately assessed domain concepts based on comparison with validated standards. Preliminary estimates of responsiveness suggest sensitivity to clinical status. Conclusions These studies provide initial support for the validity and reliability of the ACHD PRO . Further studies are needed to assess its sensitivity to changes in clinical status. |
| Databáze: | OpenAIRE |
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