Evidence map›Paper›PMID 41448679›Full record

Observational studyBMJ open2025

Assessing uptake of the macular degeneration core outcome set in clinical trials: a cross-sectional study.

Eli Oldham, R Hunter Hall, Garrett Jones, Jay Modi, Shaelyn Ward, Trevor Magee, Kyle Fitzgerald, Kimberly Magana, Griffin Hughes, Alicia Ito Ford and 1 more

Abstract readObservational Study
In one paragraph

Observational study in BMJ open, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
–field-weighted citation impact
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

1 citing paper in PubMed.

  1. Review
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

11 authors.

Eli OldhamOklahoma State University Center for Health Sciences, Tulsa, USA eli.oldham@okstate.edu.ORCID http://orcid.org/0000-0002-8177-9153
R Hunter HallOklahoma State University Center for Health Sciences, Tulsa, USA.
Garrett JonesOklahoma State University Center for Health Sciences, Tulsa, USA.
Jay ModiOklahoma State University Center for Health Sciences, Tulsa, USA.
Shaelyn WardOklahoma State University Center for Health Sciences, Tulsa, USA.
Trevor MageeOklahoma State University Center for Health Sciences, Tulsa, USA.
Kyle FitzgeraldOklahoma State University Center for Health Sciences, Tulsa, USA.
Kimberly MaganaOklahoma State University Center for Health Sciences, Tulsa, USA.
Griffin HughesOklahoma State University Center for Health Sciences, Tulsa, USA.
Alicia Ito FordOklahoma State University Center for Health Sciences, Tulsa, USA.
Matthew VassarOklahoma State University Center for Health Sciences, Tulsa, USA.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

purposeEstablishing comparability between measured outcomes in clinical trials poses a significant obstacle for systematic reviewers. Core outcome sets (COSs) were developed to address this issue. The macular degeneration (MD) COS is designed to standardise outcome measurement across clinical trials for MD. This study investigates the uptake of the MD COS in standardising outcome measurement across clinical trials.

designCross-sectional analysis

methodsWe conducted a search on ClinicalTrials.gov to locate MD clinical trials that were registered 5 years prior to COS publication through the search date of 26 June 2023 and obtained a pool of 2152 registered studies. After applying various inclusion and exclusion criteria, we analysed 159 trials. We then analysed the COS uptake using an interrupted time series analysis (ITSA) and performed performed analyses of variance (ANOVAs) and Pearson correlations to evaluate associations between trial characteristics and outcome measurement.

resultsITSA showed no significant change in uptake following the MD COS (2016): mean percentage of completion of the COS increased by 0.24% per month before publication (p=0.27) and by 0.07% per month after publication (p=0.62), indicating no meaningful post-publication slope change in COS use. For context, visual acuity was most commonly measured, while several patient-reported and disutility domains were infrequently captured.

conclusionNo discernible patterns in COS usage for MD trials were observed. We recommend further collaboration between regulators and COS developers to help with COS uptake. Additionally, we suggest that further studies analyse adherence to COSs in respect to regulatory recommendations.

Indexed as

Clinical Trials as TopicMacular DegenerationOutcome Assessment, Health CareCross-Sectional StudiesHumansClinical TrialClinical trialsCross-Sectional StudiesOPHTHALMOLOGYPatient Reported Outcome MeasuresTreatment Outcome

Identifiers

PMID41448679
PMCPMC12742102

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.