THE HERCULES STUDY: METHODS AND RATIONALE OF ASSESSING THE HEALTH-RELATED QUALITY OF LIFE (HRQOL) IN PATIENTS LIVING WITH EARLY-STAGE CHRONIC KIDNEY DISEASE AND THEIR CARERS IN THE US
Author(s)
Villum Wittrup-Jensen, PhD1, John F. Bridges, PhD2, Jason Hyman, PhD3, Brandon Foster, PhD3, Sean Delaney, MA3, Nicole Puetz, PhD1, Silvia Scalabrini, PhD1, Nathan Johnson, BS, MPH3, Kevin F. Erickson, MD4;
1Boehringer Ingelheim International GmbH, Ingelheim, Germany, 2Ohio State University College of Medicine, Columbus, OH, USA, 3Lumanity, Boston, MA, USA, 4Baylor College of Medicine, Houston, TX, USA
1Boehringer Ingelheim International GmbH, Ingelheim, Germany, 2Ohio State University College of Medicine, Columbus, OH, USA, 3Lumanity, Boston, MA, USA, 4Baylor College of Medicine, Houston, TX, USA
OBJECTIVES: Late-stage chronic kidney disease (CKD) substantially affects the health-related quality of life (HRQoL) of both patients and their caregivers. In contrast, less is known about the experiences of individuals with early-stage CKD, particularly those living with multiple comorbid conditions such as diabetes, cardiovascular disease, and hypertension.
METHODS: A cross-sectional survey will be administered to patients in the United States, with CKD, building on a patient-centered analytic framework of self-reported patient-reported outcomes (PROs) using validated instruments, including the 36-Item Short Form Survey (SF-36), Kidney Disease Quality of Life (KDQoL), EQ-5D-5L, Overactive Bladder-Bladder Assessment Tool (OAB-BAT), and the Kansas City Cardio-myopathy Questionnaire (KCCQ), with feedback from approximately 360 U.S.-based diagnosed CKD patients. A subset of caregivers (n = 60), to the enrolled CKD patients, will also complete the Adult Carer Quality of Life (AC-QoL) questionnaire and the Work Productivity and Activity Impairment questionnaire (WPAI). Latent class analysis will be used to identify and characterize latent subgroups based on shared patterns of self-reported responses. Results will be summarized using descriptive statistics and total and subscale scores calculated according to instrument scoring algorithms. Linear regression models will be applied, with adjustment for potential confounders, to support identification of clinically meaningful CKD sub-groups.
RESULTS: The HERCULES CKD program is a patient-centered research initiative designed to characterize patient and caregiver characteristics, HRQoL outcomes, and associated utility scores across early- and late-stage CKD. Analyses will use a structured, multistakeholder-informed analytical framework, which will support identification of clinically meaningful CKD subgroups based on patterns of symptom experience and HRQoL impact.
CONCLUSIONS: The HERCULES CKD program will provide contemporary HRQoL insights to inform clinical practice and strengthen understanding of how early-stage CKD impacts patients and their caregivers, as well as offer data-driven segmentation of the CKD population into subgroups that may exhibit distinct HRQoL experiences.
METHODS: A cross-sectional survey will be administered to patients in the United States, with CKD, building on a patient-centered analytic framework of self-reported patient-reported outcomes (PROs) using validated instruments, including the 36-Item Short Form Survey (SF-36), Kidney Disease Quality of Life (KDQoL), EQ-5D-5L, Overactive Bladder-Bladder Assessment Tool (OAB-BAT), and the Kansas City Cardio-myopathy Questionnaire (KCCQ), with feedback from approximately 360 U.S.-based diagnosed CKD patients. A subset of caregivers (n = 60), to the enrolled CKD patients, will also complete the Adult Carer Quality of Life (AC-QoL) questionnaire and the Work Productivity and Activity Impairment questionnaire (WPAI). Latent class analysis will be used to identify and characterize latent subgroups based on shared patterns of self-reported responses. Results will be summarized using descriptive statistics and total and subscale scores calculated according to instrument scoring algorithms. Linear regression models will be applied, with adjustment for potential confounders, to support identification of clinically meaningful CKD sub-groups.
RESULTS: The HERCULES CKD program is a patient-centered research initiative designed to characterize patient and caregiver characteristics, HRQoL outcomes, and associated utility scores across early- and late-stage CKD. Analyses will use a structured, multistakeholder-informed analytical framework, which will support identification of clinically meaningful CKD subgroups based on patterns of symptom experience and HRQoL impact.
CONCLUSIONS: The HERCULES CKD program will provide contemporary HRQoL insights to inform clinical practice and strengthen understanding of how early-stage CKD impacts patients and their caregivers, as well as offer data-driven segmentation of the CKD population into subgroups that may exhibit distinct HRQoL experiences.
Conference/Value in Health Info
2026-05, ISPOR 2026, Philadelphia, PA, USA
Value in Health, Volume 29, Issue S6
Code
PCR153
Topic
Patient-Centered Research
Topic Subcategory
Patient-reported Outcomes & Quality of Life Outcomes
Disease
No Additional Disease & Conditions/Specialized Treatment Areas, SDC: Urinary/Kidney Disorders