ARE SPONTANEOUSLY REPORTED SYMPTOMS THE MOST BOTHERSOME TO PATIENTS? EXPLORING AN UNDERLYING ASSUMPTION IN CLINICAL OUTCOMES ASSESSMENTS RESEARCH
Author(s)
Cindy Umanzor Figueroa, MPH1, Chloe Tolley, BSc2, Traci Helen Abraham, PhD1.
1Clinical Outcomes Solutions, Chicago, IL, USA, 2Clinical Outcomes Solutions, Folkestone, United Kingdom.
1Clinical Outcomes Solutions, Chicago, IL, USA, 2Clinical Outcomes Solutions, Folkestone, United Kingdom.
OBJECTIVES: Concept elicitation (CE) interviews aim to understand the patient’s experience of a given disease or condition and are a critical stage of evidence generation in clinical outcome assessment (COA) development. A common assumption is that the signs/symptoms mentioned spontaneously, or more frequently during CE represent those that are most bothersome to patients. This has direct implications on prioritization of concepts for measurement in COAs. This targeted literature review aimed to explore this assumption.
METHODS: A targeted literature review to identify publications in journals focused on quality-of-life research was conducted across MEDLINE, Embase, and APA PsycINFO. An additional hand search was also conducted. Inclusion criteria included: publication date 2022-2026 reporting 1) frequencies for concepts mentioned spontaneously and probed; 2) frequencies for most bothersome concepts. Frequency counts for spontaneously mentioned, probed and most bothersome signs/ symptoms were extracted by publication into Excel and reviewed by concept.
RESULTS: Of the 18 reviewed, 10 publications were included, collectively reporting data from 229 patients across 9 conditions. In 9/10 studies, the concept most frequently reported spontaneously and overall was also most frequently the most bothersome. However, in 5/10 studies, some of patients’ most bothersome symptoms were either among the concepts less frequently reported spontaneously or not reported during CE.
CONCLUSIONS: These findings suggest that the concepts that are reported as most bothersome do not always correspond with the most frequently reported spontaneously or overall in CE studies. Thus, it is essential to ask patients about their most bothersome signs, symptoms or impacts in CE interviews and to consider these alongside frequency of spontaneous or overall report when evaluating or deciding on concepts for inclusion in COA measures. This ensures that COAs reflect the most salient concepts from a patient perspective, where measurement is appropriate and feasible. Future research will expand the search to include most important signs/symptoms.
METHODS: A targeted literature review to identify publications in journals focused on quality-of-life research was conducted across MEDLINE, Embase, and APA PsycINFO. An additional hand search was also conducted. Inclusion criteria included: publication date 2022-2026 reporting 1) frequencies for concepts mentioned spontaneously and probed; 2) frequencies for most bothersome concepts. Frequency counts for spontaneously mentioned, probed and most bothersome signs/ symptoms were extracted by publication into Excel and reviewed by concept.
RESULTS: Of the 18 reviewed, 10 publications were included, collectively reporting data from 229 patients across 9 conditions. In 9/10 studies, the concept most frequently reported spontaneously and overall was also most frequently the most bothersome. However, in 5/10 studies, some of patients’ most bothersome symptoms were either among the concepts less frequently reported spontaneously or not reported during CE.
CONCLUSIONS: These findings suggest that the concepts that are reported as most bothersome do not always correspond with the most frequently reported spontaneously or overall in CE studies. Thus, it is essential to ask patients about their most bothersome signs, symptoms or impacts in CE interviews and to consider these alongside frequency of spontaneous or overall report when evaluating or deciding on concepts for inclusion in COA measures. This ensures that COAs reflect the most salient concepts from a patient perspective, where measurement is appropriate and feasible. Future research will expand the search to include most important signs/symptoms.
Conference/Value in Health Info
2026-11, ISPOR Europe 2026, Vienna, Austria
Value in Health, Volume 29, Issue 12S
Code
CO96
Topic
Clinical Outcomes, Methodological & Statistical Research, Patient-Centered Research
Topic Subcategory
Clinical Outcomes Assessment
Disease
No Additional Disease & Conditions/Specialized Treatment Areas