The development and initial validation of the PROMIS®+HF-27 and PROMIS+HF-10 profiles

Abstract

Aims: Heart failure (HF) is a common and morbid condition impacting multiple health domains. We previously reported the development of the PROMIS®-Plus-HF (PROMIS+HF) profile measure, including universal and HF-specific items. To facilitate use, we developed shorter, PROMIS+HF profiles intended for research and clinical use.

Methods and results: Candidate items were selected based on psychometric properties and symptom range coverage. HF clinicians (n = 43) rated item importance and clinical actionability. Based on these results, we developed the PROMIS+HF-27 and PROMIS+HF-10 profiles with summary scores (0-100) for overall, physical, mental, and social health. In a cross-sectional sample (n = 600), we measured internal consistency reliability (Cronbach's alpha and Spearman-Brown), test-retest reliability (intraclass coefficient; n = 100), known-groups validity via New York Heart Association (NYHA) class, and convergent validity with Kansas City Cardiomyopathy Questionnaire (KCCQ) scores. In a longitudinal sample (n = 75), we evaluated responsiveness of baseline/follow-up scores by calculating mean differences and Cohen's d and comparing with paired t-tests. Internal consistency was good to excellent (α 0.82-0.94) for all PROMIS+HF-27 scores and acceptable to good (α/Spearman-Brown 0.60-0.85) for PROMIS+HF-10 scores. Test-retest intraclass coefficients were acceptable to excellent (0.75-0.97). Both profiles demonstrated known-groups validity for the overall and physical health summary scores based on NYHA class, and convergent validity for nearly all scores compared with KCCQ scores. In the longitudinal sample, we demonstrated responsiveness for PROMIS+HF-27 and PROMIS+HF-10 overall and physical summary scores. For the PROMIS+HF overall summary scores, a group-based increase of 7.6-8.3 points represented a small to medium change (Cohen's d = 0.40-0.42). For the PROMIS+HF physical summary scores, a group-based increase of 5.0-5.9 points represented a small to medium change (Cohen's d = 0.29-0.35).

Conclusions: The PROMIS+HF-27 and PROMIS+HF-10 profiles demonstrated good psychometric characteristics with evidence of responsiveness for overall and physical health. These new measures can facilitate patient-centred research and clinical care, such as improving care quality through symptom monitoring, facilitating shared decision-making, evaluating quality of care, assessing new interventions, and monitoring during the initiation and titration of guideline-directed medical therapy.

Keywords: Health status; Heart failure; Outcomes research; Patient-reported outcomes; Quality of life.

Figure 1

Comparison of domains covered in each of the PROMIS+HF profiles. This figure compares the domains covered in the long‐form PROMIS+HF, PROMIS+HF‐27, and PROMIS+HF‐10 profiles. All domains in the PROMIS+HF‐10 (in blue) are also in the PROMIS+HF‐27 and long‐form PROMIS+HF profiles. All domains in the PROMIS+HF‐27 (in green) are on the long‐form PROMIS+HF profile. The long‐form PROMIS+HF profile has five domains (in black) not included in the abbreviated profiles. The number of items in each domain varies by profile as detailed in the Supporting Information.

Figure 2

Box plot for known‐groups validity for PROMIS+HF‐27 profile by New York Heart Association (NYHA) class. With each increase in self‐reported NYHA class, there was a significant graded increase in mean PROMIS+HF‐27 overall (A) and physical health (B) summary scores (F‐value <0.001). The solid line represents median score, and the circle represents mean score. The box represents the inter‐quartile range of scores and whiskers the min and max values observed within each class. HF, heart failure; P+HF, PROMIS+HF; PROMIS, Patient‐Reported Outcomes Measurement Information System.

Figure 3

Box plot for known‐groups validity for PROMIS+HF‐10 profile by New York Heart Association (NYHA) class. With each increase in self‐reported NYHA class, there was a significant graded increase in mean PROMIS+HF‐10 overall (A) and physical health (B) summary scores (F‐value <0.001). The solid line represents median score, and the circle represents mean score. The box represents the inter‐quartile range of scores and whiskers the min and max values observed within each class. HF, heart failure; P+HF, PROMIS+HF; PROMIS, Patient‐Reported Outcomes Measurement Information System.