This prospective qualitative thematic analysis of patients’ perceptions of the KCCQ-12 in an integrated, urban safety-net health system demonstrated that while items on the KCCQ-12 were relevant to their symptoms, they did not adequately capture all the factors that affect daily life with HF, such as diet, sexual activity, or key SDOH such as mental health and social relationships (Additional file 2). However, for patients to successfully manage their heart disease, all three components of the COM-B system (capability, opportunity, motivation) are important. Importantly, HF patients participating in these interviews did not draw categorical distinctions between symptoms, such as the extent of their shortness of breath, and their self-management, such as their dietary restrictions. Opportunity domains, such as one’s built environment and social factors like the quality of patient-provider communication, may influence a patient’s opportunity to engage in self-management behaviors. Mental health, resiliency, and social support are patient-important factors that were not captured on the KCCQ-12 but may influence a patient’s motivation to manage their heart disease. This is particularly relevant in this diverse, publicly insured population who face increased medical and social complexity in everyday life . Inclusion of a broader range of factors into HF PROMs may increase their relevance for diverse populations.
In our exploratory analysis, patients preferred an adapted version of the KCCQ-12, which reflected a lower literacy level, consistent with prior studies comparing higher vs. lower literacy patient-facing materials . Modifying the KCCQ-12 literacy level for diverse and low-income populations may improve its performance in predicting HF outcomes. Before the literacy-adapted version of the KCCQ-12 can be used, further testing in diverse populations with HF will need to be performed.
The KCCQ-12, a novel and well-validated health-related quality of life assessment tool for patients with HF, is comprised of distinct domains: physical limitations, symptoms (frequency, severity, and change over time), self-efficacy and knowledge, social interference, and quality of life [8, 18]. The subjective perception of dyspnea varies greatly and impacts the quality of life , and the KCCQ-12 captures this. The KCCQ-12 does not, however, capture patients’ SDOH, which has also been shown to impact risk . It has been shown that correlating physical and psychological symptom profiles are predictive of survival . The multiple factors that impact these, from mental health to housing to food insecurity, are acknowledged but seldom incorporated into patient assessments and shared-decision making . The current study further supports the imperative to prioritize and directly assess the broader SDOHs that impact patient experience, disease management, and ultimately survival.
Social determinants of health deeply impact patient experience and outcomes and are disproportionately present in patients with HF as compared to the general population. For example, depression is more common in patients with HF and portends a worse prognosis [22, 23]. Similar trends are seen with other SDOHs such as socioeconomic position , food insecurity , and unemployment . Non-White patients tend to experience these SDOHs more commonly than white patients, are underrepresented in clinical trials, and have poorer outcomes [2, 3, 10, 27]. This study of almost exclusively non-White patients brings to the surface these multiple factors that impact the burden of living with heart failure, from polypharmacy to dietary recommendations to social support to sex. Assessing and understanding how an individual patient navigates HF management with the competing demands of life, health, and work is paramount to providing thoughtful, personalized, and appropriate care.
Using the COM-B framework , we identified several key issues for the self-management of heart failure congruent with prior research [28, 29]. The KCCQ-12 most heavily captures capability, particularly physical issues, and patients’ feedback in this domain primarily focused on its psychological components. Most notably, patients in this study articulated the underrepresentation of the opportunity and motivation domains. They do not separate their HF symptoms from either external factors or conscious and unconscious processes that prompt and guide behavior. Patient perspectives on the overlap between the opportunity and motivation domains highlight the critical influence that SDOH has on HF self-management. Attributes in the opportunity and motivation domains weigh heavily on those facing medical and social complexity and have not been fully explored to date. This finding highlights a challenge in the use of PROMs across settings. Well-validated tools such as the PHQ-9 unfortunately do not fully capture those additional social determinants of health beyond mental health that impact their heart failure experience. Thus, inclusion of such an assessment in conjunction with the KCCQ-12 still leaves gaps in SDOH assessment. For medical product performance, PROMs need only include the target symptoms for the device or drug. However, for clinical care, patients experience their illness in the context of their social vulnerabilities. PROMs developed for regulatory purposes may be insufficient to inform clinical decision-making without consideration of SDOH.
Several limitations exist in the current study. We conducted interviews in a single safety-net health system hospital limiting external generalizability. However, this study touches on key demographic groups not typically represented in clinical studies. Only English-speaking patients were included, which unfortunately excluded non-English speaking patients in the SFHN, most commonly Spanish and Cantonese. This is an area of ongoing study. We employed the KCCQ-12 rather than the original 23-item KCCQ, which does have an item on depression and an item on sexual function. Based on our patients’ feedback, though, inclusion of these items would not have sufficiently addressed those SDOH deficiencies described above. Finally, the COVID-19 pandemic necessitated that the final 6 months of the study be conducted remotely via telephone or video conferencing. Given the socioeconomic makeup of our patient population, this likely impacted who was able to participate. Shelter-in-place requirements increased patient isolation and impacted patients’ feedback of the KCCQ-12. COVID-19 has exaggerated health disparities [30,31,32], and the impact of PROM and SDOH can be further explored.