Exploration of the Utility of Linguistic Validation Cognitive Debriefing Interviews in Generating Evidence for Adding or Modifying Source COA Content
Author(s)
Tim Poepsel, MS, PhD1, Chryso Hadjidemetriou, PhD2, Rebecca Israel, MS3, Rachael Emily Browning, BA4.
1Survey Research Analyst Team Lead, RWS Life Sciences, East Hartford, CT, USA, 2RWS, Croydon, United Kingdom, 3RWS, East Hartford, CT, USA, 4RWS, Bloxham, United Kingdom.
1Survey Research Analyst Team Lead, RWS Life Sciences, East Hartford, CT, USA, 2RWS, Croydon, United Kingdom, 3RWS, East Hartford, CT, USA, 4RWS, Bloxham, United Kingdom.
OBJECTIVES: An often overlooked but vital role of linguistic validation (LV) is continuous evaluation of COAs for completeness and relevance to the patient experience. FDA notes that sponsors may consider modifications to improve a COA’s ability to reflect the concept of interest, and importantly, that patient input can both identify which aspects of a concept are most impactful for patients, and be used to develop or modify COAs accordingly. The cognitive debriefing (CD) component of the LV process is well-positioned to evaluate and update COAs in this way. Namely, LV may occur frequently post-instrument development and pre-trial, engaging participants from a range of cultural, socioeconomic, and health literacy backgrounds who provide feedback on COA content periodically as understandings of conditions and treatments evolve.
METHODS: This pilot tested a novel probe assessing completeness / appropriateness of COA content, in a study involving CD of one 200-word chronic lung condition PRO in 21 languages.
RESULTS: Upon CD interview completion, patients were asked to identify any significant missing instrument elements (e.g., questions, topics, response options). Positive feedback was received in 10/21 (48%) CD samples, identifying 14 potentially missing symptom / QoL categories (most frequent: sleep effects; ADL impact; wheezing). Overall, 24/105 (23%) patients offered feedback to the novel probe.
CONCLUSIONS: Rigorous instrument validation methods and pre-testing produce robust and clinically relevant COAs, but COA completeness and patient-acceptability may degrade across time with evolving language use and clinical practices. Pilot testing of a novel probe assessing instrument completeness was well-received by patients, demonstrating effectiveness in contributing novel CD data useful for improving or updating COAs. We propose its addition as a standard probe in LV CD interviews, to strengthen their ability to contribute to the development of fully patient-centered and maximally relevant COAs in a usage-context marked by constant change in technology, language and culture, and health literacy.
METHODS: This pilot tested a novel probe assessing completeness / appropriateness of COA content, in a study involving CD of one 200-word chronic lung condition PRO in 21 languages.
RESULTS: Upon CD interview completion, patients were asked to identify any significant missing instrument elements (e.g., questions, topics, response options). Positive feedback was received in 10/21 (48%) CD samples, identifying 14 potentially missing symptom / QoL categories (most frequent: sleep effects; ADL impact; wheezing). Overall, 24/105 (23%) patients offered feedback to the novel probe.
CONCLUSIONS: Rigorous instrument validation methods and pre-testing produce robust and clinically relevant COAs, but COA completeness and patient-acceptability may degrade across time with evolving language use and clinical practices. Pilot testing of a novel probe assessing instrument completeness was well-received by patients, demonstrating effectiveness in contributing novel CD data useful for improving or updating COAs. We propose its addition as a standard probe in LV CD interviews, to strengthen their ability to contribute to the development of fully patient-centered and maximally relevant COAs in a usage-context marked by constant change in technology, language and culture, and health literacy.
Conference/Value in Health Info
2025-11, ISPOR Europe 2025, Glasgow, Scotland
Value in Health, Volume 28, Issue S2
Code
PCR89
Topic
Clinical Outcomes, Methodological & Statistical Research, Patient-Centered Research
Topic Subcategory
Instrument Development, Validation, & Translation, Patient-reported Outcomes & Quality of Life Outcomes
Disease
No Additional Disease & Conditions/Specialized Treatment Areas, Respiratory-Related Disorders (Allergy, Asthma, Smoking, Other Respiratory)