Background: Heart failure with preserved ejection fraction (HFpEF) is a heterogenous clinical syndrome. Individuals living with HFpEF and obesity display a distinct phenotype that places considerable burden on their health-related quality of life. This study explored signs, symptoms, and impacts most relevant to individuals living with HFpEF and obesity. Clinician interviews provided a clinical perspective on the patient experience. Methodology: Qualitative interviews were conducted virtually with adults in the US diagnosed with HFpEF and obesity (body mass index ≥ 30.0 kg/m2). Clinicians in the US, China, and Germany with ≥ 3 years of experience treating HFpEF were also interviewed. Patient interviews were conducted until conceptual saturation was achieved. Content analysis was conducted using Atlas.ti v9.0 software. A conceptual model (CM) of the lived experience of HFpEF and obesity based on patient and clinician feedback was developed. Results: Twenty-two patients and 6 clinicians participated. The CM demonstrated that living with HFpEF impacts many facets of life, with patient and clinician participants reporting impacts on their (or their patients’) physical functioning (e.g., walking), activities of daily living (e.g., household chores) and work. Impacts on emotional well-being (e.g., feeling anxious or worried), social lives, relationships, and sleep were also reported. Shortness of breath and fatigue were spontaneously noted as salient and bothersome symptoms by most patient participants with edema noted by most on probing; this was further corroborated by clinicians who also considered these symptoms as the most bothersome symptoms of HFpEF. Conclusions: This study highlighted the substantial burden of living with HFpEF and obesity. The resultant conceptual model highlights the key concepts that should be considered in patient-focused drug development.

Background and objective: Typical endpoints in cancer clinical trials focus on standardized efficacy endpoints, such as overall survival. Pain is not always assessed, although it is a highly prevalent and distressing aspect of patients’ cancer experience and plays a critical role in health-related quality of life. To inform future pain measurement strategies in oncology, this targeted literature review of pain-related qualitative publications in oncology aimed to characterize and explore the patient experience of pain, and its impact on how patients feel and function. Methods: A review of publications in MEDLINE, Embase and PsycINFO from 2018 to 2023 was conducted. Patient quotes or author descriptions/interpretations were extracted and analyzed with directed content analysis techniques, using ATLAS.ti v9. Data were synthesized to inform the development of a conceptual model. Results: Twenty-eight publications, with data from 534 patients across different oncology indications and geographies, were reviewed. Pain was triggered by disease symptoms and treatment, including surgical procedures, chemotherapy, and radiation. Pain was most often daily, severe, and chronic in nature. Characterizations of pain varied, but most often “sharp”/“stabbing”/“shooting” pain was described across different treatment stages. Pain had an extensive impact on emotional wellbeing, activities of daily living, physical, physiological and social functioning, sleep and work. Unmet needs included difficulty communicating pain needs to healthcare practitioners and fear/distrust of opioid pain medication. Conclusions: This research provides a patient-centric model conceptualizing the patient experience of cancer-related pain. The findings highlight the burden and all-encompassing impact of cancer-related pain, demonstrating the importance of assessing pain in oncology clinical trials.