Development and Initial Validation of the PROMIS®-Plus-HF Profile Measure

Area of Science:

• Cardiology
• Health Outcomes Research
• Psychometrics

Background:

• Assessing patient-reported outcomes in heart failure (HF) is crucial for clinical care, shared decision-making, and research.
• Existing generic measures may not fully capture the complexities of HF patients' health status.
• A comprehensive, publicly available measure integrating generic and HF-specific items is needed.

Purpose of the Study:

• To develop and validate the PROMIS®-Plus-HF (Patient-Reported Outcomes Measurement Information System®-Plus-Heart Failure) profile measure.
• To create a HF-specific instrument based on the generic PROMIS framework.
• To assess the psychometric properties of the new measure for use in clinical practice and research.

Main Methods:

• A mixed-methods approach involving focus groups with 61 HF patients and interviews with 10 HF clinicians.
• Iterative development and testing of 86 items (64 existing, 22 new) across 18 domains.
• Reliability (internal consistency, test-retest) and validity (convergent, divergent) analyses in a 600-patient sample; responsiveness testing in 75 patients.

Main Results:

• The PROMIS-Plus-HF measure demonstrated good reliability, with internal consistency (Cronbach α) ≥0.70 in 12 of 17 domains and test-retest reliability (intraclass correlation) ≥0.90.
• Validity was supported by correlations with the Kansas City Cardiomyopathy Questionnaire, showing expected convergent and divergent patterns.
• Responsiveness testing indicated significant improvements in 10 of 18 domains in patients receiving interventions.

Conclusions:

• The PROMIS-Plus-HF profile measure exhibits favorable psychometric characteristics for assessing physical, mental, and social health in HF patients.
• This comprehensive tool can enhance patient-centered care, shared decision-making, and research in heart failure.
• Flexible use of subsets of domains and items is possible depending on specific clinical or research objectives.