Evidence map›Paper›PMID 38183618›Full record

ArticleOphthalmology and therapy2024

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

Open access · goldAbstract read
In one paragraph

Article in Ophthalmology and therapy, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 4 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
4citing papers in PubMed, 1 pooled it
3.3field-weighted citation impact, top 9% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

4 citing papers in PubMed, 1 synthesis or guideline pooled it, 6 citations in OpenAlex.

  1. Pooled it
  2. Article
  3. Article
  4. Observational
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

10 authors at 6 institutions in 4 countries.

Paul M KarpeckiUniversity of Pikeville Kentucky College of Optometry, Pikeville, KY, USA.
Amy FindleyPatient-Centered Outcomes, Adelphi Values Ltd., Bollington, Cheshire, UK.ORCID http://orcid.org/0000-0001-9887-6956
Brigitte J SloesenNovartis Pharma AG, Basel, Switzerland.
Nicola HodsonPatient-Centered Outcomes, Adelphi Values Ltd., Bollington, Cheshire, UK. nicola.hodson@adelphivalues.com.ORCID http://orcid.org/0009-0004-5975-8032
Sarah BentleyPatient-Centered Outcomes, Adelphi Values Ltd., Bollington, Cheshire, UK.ORCID http://orcid.org/0000-0001-9914-8934
Rob ArbucklePatient-Centered Outcomes, Adelphi Values Ltd., Bollington, Cheshire, UK.ORCID http://orcid.org/0000-0003-0345-2523
Paul O'BrienNovartis Ireland Ltd., Dublin, Ireland.
Michela Montecchi-PalmerNovartis Pharma AG, Fort Worth, TX, USA.
Christel NaujoksNovartis Pharma AG, Basel, Switzerland.ORCID http://orcid.org/0000-0002-3799-6521
Pedram HamrahDepartment of Ophthalmology, New England Eye Center and Tufts Medical Center, Tufts University School of Medicine, Boston, MA, USA.
Adelphi Group (United Kingdom) · GBNovartis (Switzerland) · CHAlcon (United States) · USTufts University · USUniversity of Pikeville · USViiV Healthcare (United Kingdom) · GB

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionChronic 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.

methodsQualitative, 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.

resultsEye 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.

conclusionsFindings 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.

Indexed as

Chronic ocular surface painCognitive debriefingConcept elicitationContent validityHealth-related quality of lifePatient experienceQualitative interviews

Identifiers

PMID38183618
PMCPMC10787728
OpenAlexW4390638431

What OpenQuestion holds

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LicenceCC BY-NC
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Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.