Development of a Preliminary Conceptual Model to Capture the Adult Patient Experience of Follicular Lymphoma
Author(s)
Louise Newton, MSc1, Sally Mannix, BA2, Chris Marshall, MSc3, Natalie Aldhouse, MA3, Sonya Dubiner, MA4, Yadvinder Gill, PhD1, Francesc Garcia Pallarols, PhD5, Ricardo Espinola, PhD5, Jason Ward, BSc1, Greg Davis, MSc3, Shannon Cummings, MSc3, Helen Kitchen, MSc3.
1AstraZeneca, Cambridge, United Kingdom, 2AstraZeneca, Gaithersburg, MD, USA, 3Clarivate, London, United Kingdom, 4AstraZeneca, Wilmington, DE, USA, 5AstraZeneca, Barcelona, Spain.
1AstraZeneca, Cambridge, United Kingdom, 2AstraZeneca, Gaithersburg, MD, USA, 3Clarivate, London, United Kingdom, 4AstraZeneca, Wilmington, DE, USA, 5AstraZeneca, Barcelona, Spain.
OBJECTIVES: Follicular lymphoma (FL) is the second most common lymphoma diagnosed in the US and Western Europe, comprising ~35% of all non-Hodgkin lymphoma cases. Disease and treatment symptoms can significantly impair patients’ functioning and quality of life. This study involved a literature review and clinical insights to develop a preliminary conceptual model of the FL patient experience to support selection of patient-reported outcome (PRO) strategies.
METHODS: Using pre-specified search terms, a targeted review identified studies describing FL signs/symptoms/impacts through electronic databases, regulatory websites, FDA-approved product labels, and reference lists. Publications were screened against pre-defined eligibility criteria (e.g. studies involving FL adults, reporting patient experience data, published in English from 2014). Concepts were extracted using content analysis methods. Feedback from N=2 FL clinical experts (N=1 US, N=1 Europe) explored clinical validity of concepts and symptom attribution.
RESULTS: Twenty-three FL-related signs/symptoms were identified from 6 full-text publications and 4 conference abstracts. Signs/symptoms were grouped into conceptually-related domains to create the preliminary model. The most frequently reported disease-related symptoms included fatigue, pain, nausea/vomiting, and diarrhea. Nine impact domains were identified: physical functioning (PF), work/role functioning, emotional well-being, cognition, social functioning, finances, and general HRQoL. Clinicians confirmed the relevance of these concepts/domains; they highlighted 2 potential new concepts of ‘sexual activity’ and ‘night sweats’.
CONCLUSIONS: This preliminary conceptual model is a first step to capture the experience of FL from a patient’s perspective. In upcoming qualitative interviews, we will collect direct feedback from patients on the relevance of the model, where we will also confirm the importance of additional concepts noted by clinicians. These interviews will allow us to explore the most salient and bothersome concepts to patients, and deep-dive into their impacts. The goal is to continue model iteration such that it provides a basis to inform future PRO and digital health strategies in FL clinical trials.
METHODS: Using pre-specified search terms, a targeted review identified studies describing FL signs/symptoms/impacts through electronic databases, regulatory websites, FDA-approved product labels, and reference lists. Publications were screened against pre-defined eligibility criteria (e.g. studies involving FL adults, reporting patient experience data, published in English from 2014). Concepts were extracted using content analysis methods. Feedback from N=2 FL clinical experts (N=1 US, N=1 Europe) explored clinical validity of concepts and symptom attribution.
RESULTS: Twenty-three FL-related signs/symptoms were identified from 6 full-text publications and 4 conference abstracts. Signs/symptoms were grouped into conceptually-related domains to create the preliminary model. The most frequently reported disease-related symptoms included fatigue, pain, nausea/vomiting, and diarrhea. Nine impact domains were identified: physical functioning (PF), work/role functioning, emotional well-being, cognition, social functioning, finances, and general HRQoL. Clinicians confirmed the relevance of these concepts/domains; they highlighted 2 potential new concepts of ‘sexual activity’ and ‘night sweats’.
CONCLUSIONS: This preliminary conceptual model is a first step to capture the experience of FL from a patient’s perspective. In upcoming qualitative interviews, we will collect direct feedback from patients on the relevance of the model, where we will also confirm the importance of additional concepts noted by clinicians. These interviews will allow us to explore the most salient and bothersome concepts to patients, and deep-dive into their impacts. The goal is to continue model iteration such that it provides a basis to inform future PRO and digital health strategies in FL clinical trials.
Conference/Value in Health Info
2025-11, ISPOR Europe 2025, Glasgow, Scotland
Value in Health, Volume 28, Issue S2
Code
CO72
Topic
Clinical Outcomes, Methodological & Statistical Research, Patient-Centered Research
Topic Subcategory
Clinical Outcomes Assessment
Disease
Oncology