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Open Access 28-05-2020

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

Auteurs: Olga Moshkovich, Katy Benjamin, Katie Hall, Ryan Murphy, Robyn von Maltzahn, Boris Gorsh, Vanja Sikirica, Rajnish Saini, Dennis Sprecher

Gepubliceerd in: Quality of Life Research | Uitgave 10/2020

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.

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Titel: Development of a conceptual model and patient-reported outcome measures for assessing symptoms and functioning in patients with heart failure
Auteurs: Olga Moshkovich
Katy Benjamin
Katie Hall
Ryan Murphy
Robyn von Maltzahn
Boris Gorsh
Vanja Sikirica
Rajnish Saini
Dennis Sprecher
Publicatiedatum: 28-05-2020
Uitgeverij: Springer International Publishing
Gepubliceerd in: Quality of Life Research / Uitgave 10/2020
Print ISSN: 0962-9343
Elektronisch ISSN: 1573-2649
DOI: https://doi.org/10.1007/s11136-020-02537-y

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Abstract

Purpose

Methods

Results

Conclusions

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