Development of a conceptual model and patient-reported outcome measures for assessing symptoms and functioning in patients with heart failure

Abstract

Purpose Heart failure (HF) is a common condition that places considerable burden on patients. We aimed to develop a patient-reported outcome (PRO) measure to assess the symptoms and impacts of HF. Methods Phase 1: a targeted literature review, expert interviews, and concept elicitation (CE) interviews with patients with HF (n = 26) were used to develop a conceptual model of the core symptoms and impacts of HF. To capture these concepts, three new fit-for-purpose PRO questionnaires were constructed in accordance with US Food and Drug Administration PRO guidance. Phase 2: three ‘waves’ of cognitive interviews were conducted with patients with HF (n = 28) to validate and refine the questionnaires. Results Three key symptoms—shortness of breath, oedema, and fatigue—were identified across the literature review, expert interviews and CE interviews. Several additional symptoms, cognitive changes and impacts of HF were reported in the CE interviews and included in the conceptual model. A 10-item symptom questionnaire (Heart Failure-Daily Symptom Diary) was constructed; cognitive testing showed that the final PRO measure was easy to understand/complete and relevant to patients with HF, confirming content validity. Two HF impact questionnaires were developed (Assessing Dyspnoea’s Impact on Mobility and Sleep and Heart Failure-Functional Status Assessment), but required refinement to ensure patient understanding. Conclusions Patient input contributed to the development of a PRO instrument for assessing physical and cognitive symptoms important to patients with HF using novel measurement strategies. Inclusion of daily metrics offers differentiation from other qualified instruments and may provide clinical insight for improving lifestyles. Additionally, two draft PRO measures may, after further validation, be useful to assess the impacts of HF.

Living with heart failure: patient experiences and implications for physical activity and daily living

“…While many studies have previously found that HF limits physical activity in these patients, the primary focus of these interview studies has been on symptoms. 8,13 This study, however, focused on physical activity and provides an in-depth understanding of the different important aspects to physical limitations experienced by patients to a degree of detail that has not previously been reported. The current study included oneon-one interviews with patients to identify the core mobility impairments that patients experience, how these are related to symptoms, and how they impact broader limitations in day-to-day functioning.…”

“…For example, HF patient interview studies consistently identify dyspnoea, fatigue, and peripheral oedema as key symptoms experienced by patients. 8,13 The studies have also identified broad areas of physical activity, such as walking, climbing stairs, and lifting and carrying items, as relevant for HF patients. However, they were not designed to specifically focus on physical activity limitations and, therefore, do not provide detailed descriptions of the limitations that HF patients face in their day-to-day lives.…”

Nurses have the key to your heart

“…Heart failure in the US is expected to affect 8.5 million individuals by 2030, with a high percentage of deaths related to mismanagement of the disease 1. Hospital admission due to CHF symptom exacerbation contributes to the highest frequency of 30-day readmissions.…”

“…mismanagement of the disease. 1 Hospital admission due to CHF symptom exacerbation contributes to the highest frequency of 30-day readmissions. This lowers insurance reimbursement rates and requires hospitals to monitor the discharge process to prevent reoccurrence by evaluating the intensity of treatment and assessing the discharge status of those readmitted.…”

“…Heart failure affects 2.5% of the population in the US and is expected to increase to an estimated 9 million individuals by 2030. 1 As it becomes one of the most common diagnoses, it amplifies demand on the already burdened healthcare system. Nurses, daunted by the responsibility of providing education to their patients, struggle with gaps in their own knowledge and balancing the demands of their jobs, which may impact patient care.…”