Utility of Patient-Reported Outcomes in Heart Failure
- Kelkar AA, Spertus J, Pang P, et al.
- Utility of Patient-Reported Outcome Instruments in Heart Failure. JACC Heart Fail 2016;Feb 10:[Epub ahead of print].
The following are 10 points to remember about the utility of patient-reported outcome instruments in heart failure:
- Patient-reported outcomes (PRO) are defined as reports coming directly from patients about how they feel or function in relation to a health condition and its therapy.
- PRO have shown to be more reproducible than other clinical trial measures such as assessments of left ventricular ejection fraction or valve gradients.
- Although PRO have been increasingly included as endpoints in clinical trials, they have not been utilized in routine clinical practice.
- The study authors used databases to identify PRO instruments, and the measurement properties identified include reliability (test/retest or intra-/interviewer reliability, internal consistency), validity (content and construct validity), responsiveness (ability to detect change), diversity in performance, feasibility, interpretability, and prognostic value.
- The authors found that 9 of the 31 instruments developed for heart failure fit the inclusion criteria of this study including Chronic Heart Failure Questionnaire (CHFQ), Kansas City Cardiomyopathy Questionnaire (KCCQ), Minnesota Living with Heart Failure Questionnaire (MLHFQ), Chronic Heart Failure Assessment Tool (CHAT), San Diego Heart Failure Questionnaire (SDHFQ), Quality of Life Questionnaire for Severe Heart Failure (QLQ-SHF), Left Ventricular Dysfunction Questionnaire (LVD-36), and Memorial Symptom Assessment Scale—Heart Failure (MSAS-HF).
- They found that two instruments best fit all of the evaluation criteria and meet the most symptom endpoints: KCCQ and MLHFQ.
- Both the MLHFQ and KCCQ have prognostic significance, which may aid in clinical interpretation and decision making based on risk stratification. A 5-point change in KCCQ score is associated with a fully adjusted 10% change in mortality or hospitalization risk. MLHFQ scores have also correlated with changes in functional classes, but they were limited in detecting differences among patients with more advanced HF (i.e., between New York Heart Association functional classes III and IV).
- However, even MLHFQ and KCCQ have a limited focus on emotional and relationship aspects (KCCQ and MLHFQ meet five of nine emotional endpoints).
- The authors recommended that more research should be conducted to better define how to present cross-sectional and longitudinal changes in PRO scores and that more education is required as to what calculated PRO scores means to aid their overall interpretability and usefulness in clinical care.
- The study authors opined that it is time to conduct a cluster-randomized clinical trial where some practices routinely incorporate PRO into their care and are compared with usual care that does not use these measures in practice.
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