Qualitative Research to Understand the Patient Experience and Evaluate Content Validity of the Chronic Ocular Pain Questionnaire (COP-Q)
Bibliographic record
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.
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How this classification was reachedexpand
Full frame machine prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. The Gemma side is a direct model label for every work in the frame, read from the title-only record. The Codex side is a classifier learned from the 10,348 direct Codex labels and calibrated to design-weighted sample rates; fields without enough sample support carry no Codex call. Candidate is the union of the two sides; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels.
Distilled classifier scores by category (both heads)
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.039 | 0.048 |
| Meta-epidemiology (narrow) | 0.000 | 0.000 |
| Meta-epidemiology (broad) | 0.001 | 0.000 |
| Bibliometrics | 0.002 | 0.002 |
| Science and technology studies | 0.004 | 0.005 |
| Scholarly communication | 0.003 | 0.003 |
| Open science | 0.001 | 0.004 |
| Research integrity | 0.001 | 0.002 |
| Insufficient payload (model declined to judge) | 0.004 | 0.001 |
Machine scores (provisional)
The two teacher heads of the student model, read on this work. A score orders the frame for review; it never asserts a category, and the validation status ships verbatim with every row.
Baseline scores from an immature model (maturity gate not passed, 7 training rounds). Scores rank; they never assert a category.
score_only:v0-immature-baseline · verbatim from the scoring run: score_only means the number may rank works, and no category label ships from itClassification
machine, unvalidatedMachine predicted; a candidate call from one source (direct Gemma or distilled Codex), not a consensus.
How this classification was reached, model by model and score by score, is at the end of the page under "How this classification was reached".