Qualitative Research to Understand the Patient Experience and Evaluate Content Validity of the Chronic Ocular Pain Questionnaire (COP-Q)

Paul M Karpecki; Amy Findley; Brigitte J Sloesen; Nicola Hodson; Sarah Bentley; Rob Arbuckle; Paul O'Brien; Michela Montecchi-Palmer; Christel Naujoks; Pedram Hamrah

doi:10.1007/s40123-023-00860-4

Qualitative Research to Understand the Patient Experience and Evaluate Content Validity of the Chronic Ocular Pain Questionnaire (COP-Q)

Ophthalmol Ther. 2024 Feb;13(2):615-633. doi: 10.1007/s40123-023-00860-4. Epub 2024 Jan 6.

Authors

Paul M Karpecki^{1

2}, Amy Findley^{3

4}, Brigitte J Sloesen⁵, Nicola Hodson⁶, Sarah Bentley³, Rob Arbuckle³, Paul O'Brien^{7

8}, Michela Montecchi-Palmer^{9

10}, Christel Naujoks⁵, Pedram Hamrah¹¹

Affiliations

¹ University of Pikeville Kentucky College of Optometry, Pikeville, KY, USA.
² Kentucky Eye Institute, Lexington, KY, USA.
³ Patient-Centered Outcomes, Adelphi Values Ltd., Bollington, Cheshire, UK.
⁴ Novo Norisk, Copenhagen, Denmark.
⁵ Novartis Pharma AG, Basel, Switzerland.
⁶ Patient-Centered Outcomes, Adelphi Values Ltd., Bollington, Cheshire, UK. nicola.hodson@adelphivalues.com.
⁷ Novartis Ireland Ltd., Dublin, Ireland.
⁸ ViiV Healthcare, London, UK.
⁹ Novartis Pharma AG, Fort Worth, TX, USA.
¹⁰ Alcon, Fort Worth, TX, USA.
¹¹ Department of Ophthalmology, New England Eye Center and Tufts Medical Center, Tufts University School of Medicine, Boston, MA, USA.

Abstract

Introduction: Chronic ocular surface pain (COSP) is described as a persistent, moderate-to-severe pain at the ocular surface lasting more than 3 months. Symptoms of COSP have a significant impact on patients' vision-dependent activities of daily living (ADL) and distal health-related quality of life (HRQoL). To adequately capture patient perspectives in clinical trials, patient-reported outcome (PRO) measures must demonstrate sufficient evidence of content validity in the target population. This study aimed to explore the patient experience of living with COSP and evaluate content validity of the newly developed Chronic Ocular Pain Questionnaire (COP-Q) for use in COSP clinical trials.

Methods: Qualitative, combined concept elicitation (CE) and cognitive debriefing (CD) interviews were conducted with 24 patients experiencing COSP symptoms in the USA. Interviews were supplemented with real-time data collection via a daily diary app task in a subset of patients (n = 15) to explore the day-to-day patient experience. Three healthcare professionals (HCPs) from the USA, Canada, and France were also interviewed to provide a clinical perspective. CE results were used to further inform development of a conceptual model and to refine PRO items/response options. CD interviews assessed relevance and understanding of the COP-Q. Interviews were conducted across multiple rounds to allow item modifications and subsequent testing.

Results: Eye pain, eye itch, burning sensation, eye dryness, eye irritation, foreign body sensation, eye fatigue, and eye grittiness were the most frequently reported symptoms impacting vision-dependent ADL (e.g., reading, using digital devices, driving) and wider HRQoL (e.g., emotional wellbeing, social functioning, work). COP-Q instructions, items, and response scales were understood, and concepts were considered relevant. Feedback supported modifications to instruction/item wording and confirmed the most appropriate recall periods.

Conclusions: Findings support content validity of the COP-Q for use in COSP populations. Ongoing research to evaluate psychometric validity of the COP-Q will support future use of the instrument in clinical trial efficacy endpoints.

Keywords: Chronic ocular surface pain; Cognitive debriefing; Concept elicitation; Content validity; Health-related quality of life; Patient experience; Qualitative interviews.