Evidence map›Paper›PMID 31179389›Full record

ArticleBMJ open ophthalmology2019

Patient-reported outcomes in the RELIGHT clinical trial of ranibizumab in diabetic macular oedema.

Usha Chakravarthy, Ian Pearce, Sanjiv Banerjee, Benjamin J L Burton, Louise Downey, Richard Gale, Jignesh Patel, Sudeshna Patra, Sobha Sivaprasad, Michael Stevenson and 1 more

Abstract read
In one paragraph

Article in BMJ open ophthalmology, 2019. 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
–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

3 citing papers in PubMed.

  1. Review
  2. Review
  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

11 authors.

Usha ChakravarthyDepartmentof Ophthalmology, Queens University, Belfast, UK.ORCID 0000-0002-2606-3734
Ian PearceSt Paul's Eye Unit, Royal Liverpool and Broadgreen University Hospitals NHS Trust, Liverpool, UK.
Sanjiv BanerjeeUniversity Hospital of Wales, Cardiff, UK.
Benjamin J L BurtonDepartmentof Ophthalmology, James Paget University Hospital, Great Yarmouth, UK.
Louise DowneyDepartment of Ophthalmology, Hull Royal Infirmary, Hull, UK.
Richard GaleDepartmentof Ophthalmology, The York Hospital UK, York, UK.
Jignesh PatelEssex County Hospital, Colchester, UK.
Sudeshna PatraWhipps Cross University Hospital, London, UK.
Sobha SivaprasadNIHR Moorfields Biomedical Research Centre, London, UK.
Michael StevensonMedical Education, Queens University of Belfast, Belfast, UK.
Susanne LuptonDepartmentof Ophthalmology, Novartis Pharma UK, Frimley, UK.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

BACKGROUND/

aimsThe RELIGHT clinical trial used an individualised treatment regimen of ranibizumab to treat diabetic macular oedema (DMO). We report findings from two patient-reported outcome instruments.

methodsThe National Eye Institute Visual Function Questionnaire (NEI-VFQ) was administered before starting treatment (M0) and at M6, 12 and 18. The Macular Disease Society Treatment Satisfaction Questionnaire (MacTSQ) was administered 1 month after treatment start (M1) and at M6, 12 and 18. Relationships between best-corrected visual acuity (BCVA) in the study eye (SE) and the status of the eye at baseline (as better or worse eye by BCVA) and the two instrument measures were investigated.

resultsBCVA in the SE correlated strongly with the NEI-VFQ composite scores and the majority of the subscales but not with the MacTSQ subscales. Statistically significant improvements were observed in the majority of the subscales of the NEI-VFQ at M6, 12 and 18. For the MacTSQ, improvements between baseline M6, 12 and 18 were seen for subscale 1 but only reached statistical significance at M12. In subscale 2, the changes in mean scores were statistically significant at all timepoints.

conclusionsAlthough ranibizumab treatment in DMO over an 18-month period resulted in improvements in visual functioning and patient satisfaction, no correlation was found between the instruments used to measure these outcomes. Our finding of a lack of correlation between BCVA and the MacTSQ suggests the presence of psychophysical factors not measured by traditional means.

Indexed as

clinical trialdrugsmacularetinavision

Identifiers

PMID31179389
PMCPMC6528749

What OpenQuestion holds

Textmetadata
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.