Evidence map›Paper›PMID 36063293›Full record

ReviewJournal of ophthalmic inflammation and infection2022

Evaluating patient-reported outcome measures (PROMs) for clinical trials and clinical practice in adult patients with uveitis or scleritis: a systematic review.

Charles O'Donovan, Jesse Panthagani, Olalekan Lee Aiyegbusi, Xiaoxuan Liu, Susan Bayliss, Melanie Calvert, Konrad Pesudovs, Alastair Denniston, David Moore, Tasanee Braithwaite

Open access · goldAbstract readReview
In one paragraph

Review in Journal of ophthalmic inflammation and infection, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 4 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
4citing papers in PubMed, 2 pooled it
1.4field-weighted citation impact, top 20% 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, 2 syntheses or guidelines pooled it, 8 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Article
  4. 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

10 authors at 6 institutions in 2 countries.

Charles O'Donovan *School of Immunology and Microbiology, King's College London, London, England. charles.odonovan@kcl.ac.uk.
Jesse Panthagani *University Hospitals Birmingham, Birmingham, England.
Olalekan Lee AiyegbusiCentre for Patient Reported Outcomes Research (CPROR), Institute of Applied Health Research, Birmingham Health Partners for Regulatory Science and Innovation, and NIHR, Birmingham Biomedical Research Centre, University of Birmingham, Birmingham, B15 2TT, UK.
Xiaoxuan LiuInstitute of Inflammation and Ageing, University of Birmingham, University Hospitals Birmingham, Birmingham, England.
Susan BaylissInstitute of Applied Health Research, University of Birmingham, Birmingham, England.
Melanie CalvertCentre for Patient Reported Outcomes Research (CPROR), Institute of Applied Health Research, Birmingham Health Partners for Regulatory Science and Innovation, NIHR, Birmingham Biomedical Research Centre, NIHR Surgical Reconstruction and Microbiology Centre and NIHR Applied Research Collaboration West Midlands, University of Birmingham, Birmingham, B15 2TT, UK.
Konrad PesudovsUniversity of New South Wales, Kensington, Australia.
Alastair DennistonInstitute of Inflammation and Ageing, University of Birmingham, University Hospitals Birmingham, Birmingham, England.
David Moore *Institute of Applied Health Research, University of Birmingham, Birmingham, England.
Tasanee Braithwaite *School of Immunology and Microbiology, King's College London, London, England.
University of Birmingham · GBNIHR Birmingham Biomedical Research Centre · GBAnglia Ruskin University · GBHealth Data Research UK · GBKing's College School · GBNIHR Surgical Reconstruction and Microbiology Research Centre · GB

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Patient reported outcome measures (PROMs) capture impact of disease and treatment on quality of life, and have an emerging role in clinical trial outcome measurement. This study included a systematic review and quality appraisal of PROMs developed or validated for use in adults with uveitis or scleritis. We searched MEDLINE, EMBASE, PsycINFO, CINAHL and grey literature sources, to 5 November 2021. We used established quality criteria to grade each PROM instrument in multiple domains from A (high quality) to C (low quality), and assessed content development, validity, reliability and responsiveness. For instruments developed using classic test theory-based psychometric approaches, we assessed acceptability, item targeting and internal consistency. For instruments developed using Item Response Theory (IRT) (e.g. Rasch analysis), we assessed response categories, dimensionality, measurement precision, item fit statistics, differential item functioning and targeting. We identified and appraised four instruments applicable to certain uveitis types, but none for scleritis. Specifically, the National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ), a 3-part PROM for Birdshot retinochoroiditis (Birdshot Disease & Medication Symptoms Questionnaire [BD&MSQ], the quality of life (QoL) impact of Birdshot Chorioretinopathy [QoL BCR], and the QoL impact of BCR medication [QoL Meds], the Kings Sarcoidosis Questionnaire (KSQ), and a PROM for cytomegalovirus retinitis. These instruments had limited coverage for these heterogeneous conditions, with a focus on very rare subtypes. Psychometric appraisal revealed considerable variability between instruments, limited content development, and only one developed using Item Response Theory. In conclusion, there are few validated PROMs for patients with uveitis and none for scleritis, and existing instruments have suboptimal psychometric performance. We articulate why we do not recommend their inclusion as clinical trial outcome measures for drug licensing purposes, and highlight an unmet need for PROMs applicable to uveitis and scleritis.

Identifiers

PMID36063293
PMCPMC9443634
OpenAlexW4294666594

What OpenQuestion holds

Textmetadata
LicenceCC BY
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.