Evidence map›Paper›PMID 36781630›Full record

ArticleOphthalmology and therapy2023

Content Validity and Cognitive Debriefing of a Patient-Reported Outcome Instrument Evaluating Symptoms and Disease Impact in Patients with Geographic Atrophy.

Antonia Morga, Christina X Chamberlain, Oren Meyers, Caroline Roberts, Luis Gaspar, Jun Su

Open access · goldAbstract read
In one paragraph

Article in Ophthalmology and therapy, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 3 papers.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed
0.8field-weighted citation impact, top 30% 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

3 citing papers in PubMed, 3 citations in OpenAlex.

  1. US Retina Specialists' Preferences for Geographic Atrophy Treatment.Clinical ophthalmology (Auckland, N.Z.) · 2026
    Article
  2. Article
  3. Article
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

6 authors at 4 institutions in 3 countries.

Antonia MorgaAstellas Pharma Europe Ltd, 300 Dashwood Lang Road, Bourne Business Park, Addlestone, Surrey, KT15 2NX, UK. antonia_morga@astellas.com.
Christina X ChamberlainAstellas Pharma US Inc., 1 Astellas Way, Northbrook, IL, USA.
Oren MeyersIQVIA, 300 Vesey St 13th floor, New York, USA.
Caroline RobertsIQVIA, 300 Vesey St 13th floor, New York, USA.
Luis GasparIQVIA, Reading, UK.
Jun SuAstellas Pharma US Inc., 9 Technology Drive, Westborough, MA, USA.
Astellas Pharma (United States) · USIQVIA (United States) · USAstellas Pharma (Netherlands) · NLIQVIA (United Kingdom) · GB

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionGeographic atrophy (GA) occurs in the later stages of dry age-related macular degeneration (AMD) and impairs visual acuity, eventually causing permanent blindness in some patients and impacting patient quality of life. Patient-reported outcome (PRO) measures that assess the experience of patients with visual impairment do not sufficiently capture all concepts salient to patients with GA. In this study the experience of patients with GA secondary to dry AMD was evaluated, and items from the novel 10-item Visual Impairment Symptom Severity Assessment (VISSA-10) PRO instrument were mapped to salient symptoms to assess its content validity, ease of use, and relevance.

methodsConcept elicitation interviews were conducted with patients with GA to determine salient symptoms and impacts of GA, and a conceptual model was developed to reflect these. The items in the VISSA-10 instrument were then mapped onto the salient symptoms included in this conceptual model. Cognitive debriefing interviews were also conducted with the same cohort to determine the comprehensiveness and comprehensibility of the instrument, and to qualitatively assess levels of change considered meaningful by patients.

resultsIn total, 25 symptoms and 36 impacts were reported by 19 patients with GA, with seven symptoms and 11 impacts identified as salient. Of these, 12 symptoms and 15 impacts reported were not included in a previously published conceptual model for patients with dry AMD. Overall, eight of the ten items from the VISSA-10 instrument mapped to salient symptoms reported by patients with GA. All patients reported that the instrument was clear and easy to understand.

conclusionsThe VISSA-10 instrument was shown to be content valid, clear, and comprehensible, with sufficient concept coverage to measure the experience of patients with GA. Although further quantitative validation is required, this instrument has demonstrated potential for implementation in future clinical trials to evaluate the efficacy of new treatments for GA.

Indexed as

Clinical outcomes assessmentCognitive debriefingContent validityGeographic atrophyPatient-reported outcomesVisionVisual acuity

Identifiers

PMID36781630
PMCPMC10011295
OpenAlexW4320483838

What OpenQuestion holds

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LicenceCC BY-NC
Read underepoch 390

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.