Evidence map›Paper›PMID 33675850›Full record

Trial reportOphthalmology2021

Health- and Vision-Related Quality of Life in a Randomized Controlled Trial Comparing Methotrexate and Mycophenolate Mofetil for Uveitis.

Nicole K Kelly, Aheli Chattopadhyay, S R Rathinam, John A Gonzales, Radhika Thundikandy, Anuradha Kanakath, S Bala Murugan, R Vedhanayaki, Dean Cugley, Lyndell L Lim and 7 more

Registry-linked trialOpen access · greenAbstract readComparative StudyMulticenter StudyRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Ophthalmology, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01829295 (First-line Antimetabolites as Steroid-sparing Treatment), which is not on this map. Cited by 5 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
5citing papers in PubMed, 1 pooled it
1.7field-weighted citation impact, top 18% 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.

NCT01829295 phase3completednot on this map

First-line Antimetabolites as Steroid-sparing Treatment (FAST) Uveitis Trial

TypeinterventionalSponsorUniversity of California, San FranciscoRan2013 to 2018Enrolled216ConditionsUveitisArmsMycophenolate mofetil, Methotrexate, Prednisone
3 · Its place in the literature

Who cites it

5 citing papers in PubMed, 1 synthesis or guideline pooled it, 11 citations in OpenAlex.

  1. Pooled it
  2. Trial
  3. Article
  4. Article
  5. 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

17 authors at 5 institutions in 4 countries.

Nicole K KellyF. I. Proctor Foundation, University of California, San Francisco, San Francisco, California.
Aheli ChattopadhyayF. I. Proctor Foundation, University of California, San Francisco, San Francisco, California.
S R RathinamUvea Services, Aravind Eye Hospitals and Postgraduate Institute of Ophthalmology, Madurai, India.
John A GonzalesF. I. Proctor Foundation, University of California, San Francisco, San Francisco, California; Department of Ophthalmology, University of California, San Francisco, San Francisco, California.
Radhika ThundikandyUvea Services, Aravind Eye Hospitals and Postgraduate Institute of Ophthalmology, Madurai, India.
Anuradha KanakathUvea Services, Aravind Eye Hospitals and Postgraduate Institute of Ophthalmology, Coimbatore, India.
S Bala MuruganUvea Services, Aravind Eye Hospitals and Postgraduate Institute of Ophthalmology, Pondicherry, India.
R VedhanayakiUvea Services, Aravind Eye Hospitals and Postgraduate Institute of Ophthalmology, Madurai, India.
Dean CugleyCentre for Eye Research Australia, Royal Victorian Eye and Ear Hospital, East Melbourne, Australia.
Lyndell L LimCentre for Eye Research Australia, Royal Victorian Eye and Ear Hospital, East Melbourne, Australia.
Eric B SuhlerCasey Eye Institute, Oregon Health and Science University, OHSU-PSU School of Public Health, and Portland Veterans' Affairs Health Care System, Portland, Oregon.
Hassan A Al-DhibiDivision of Vitreoretinal Surgery and Uveitis, King Khaled Eye Specialist Hospital, Riyadh, Kingdom of Saudi Arabia.
Caleb D EbertF. I. Proctor Foundation, University of California, San Francisco, San Francisco, California.
Elyse J BerlinbergF. I. Proctor Foundation, University of California, San Francisco, San Francisco, California.
Travis C PorcoF. I. Proctor Foundation, University of California, San Francisco, San Francisco, California; Department of Ophthalmology, University of California, San Francisco, San Francisco, California; Department of Epidemiology and Biostatistics, University of California, San Francisco, San Francisco, California.
Nisha R AcharyaF. I. Proctor Foundation, University of California, San Francisco, San Francisco, California; Department of Ophthalmology, University of California, San Francisco, San Francisco, California; Department of Epidemiology and Biostatistics, University of California, San Francisco, San Francisco, California. Electronic address: nisha.acharya@ucsf.edu.
FAST Research Group
University of California, San Francisco · USAravind Eye Hospital · INCentre for Eye Research Australia · AUKing Khaled Eye Specialist Hospital · SAOregon Health & Science University · US

Funding

First-line Antimetabolites as Steroid-sparing Treatment (FAST) Uveitis TrialU10EY021125 · NEI · UNIVERSITY OF CALIFORNIA, SAN FRANCISCO · PI ACHARYA, NISHA · 2012 to 2016
$4.6M
NEI NIH HHS U10 EY021125
6 · The paper itself

Abstract

purposeTo evaluate changes in health-related and vision-related quality of life (VRQoL) among patients with noninfectious uveitis who were treated with antimetabolites.

designSecondary analysis of a randomized controlled trial.

participantsPatients with noninfectious uveitis from India, the United States, Australia, Saudi Arabia, and Mexico.

methodsFrom 2013 through 2017, 216 participants were randomized to receive 25 mg weekly oral methotrexate or 1.5 g twice daily oral mycophenolate mofetil. Median changes in quality of life (QoL) were measured using Wilcoxon signed-rank tests, and differences between treatment groups were measured using linear mixed models, adjusting for baseline QoL score, age, gender, and site. Among Indian patients, VRQoL scores from a general scale (the National Eye Institute Visual Function Questionnaire [NEI-VFQ]) and a culturally specific scale (the Indian Visual Function Questionnaire [IND-VFQ]) were compared using Pearson correlation tests.

main outcome measuresVision-related QoL (NEI-VFQ and IND-VFQ) and health-related QoL (HRQoL; physical component score [PCS] and mental component score [MCS] of the Medical Outcomes Study 36-Item Short Form Survey [SF-36v2]) were measured at baseline, the primary end point (6 months or treatment failure before 6 months), and the secondary end point (12 months or treatment failure between 6 and 12 months).

resultsAmong 193 participants who reached the primary end point, VRQoL increased from baseline by a median of 12.0 points (interquartile range [IQR], 1.0-26.1, NEI-VFQ scale), physical HRQoL increased by a median of 3.6 points (IQR, -1.4 to 14.9, PCS SF-36v2), and mental HRQoL increased by a median of 3.0 points (IQR, -3.7 to 11.9, MCS SF-36v2). These improvements in NEI-VFQ, SF-36v2 PCS, and SF-36v2 MCS scores all were significant (P < 0.01). The linear mixed models showed that QoL did not differ between treatment groups for each QoL assessment (NEI-VFQ, IND-VFQ, PCS SF-36v2, and MCS SF-36v2; P > 0.05 for all). The NEI-VFQ and IND-VFQ scores for Indian participants were correlated highly at baseline and the primary and secondary end points (correlation coefficients, 0.87, 0.80, and 0.90, respectively).

conclusionsAmong patients treated with methotrexate or mycophenolate mofetil for uveitis, VRQoL and HRQoL improved significantly over the course of 1 year and did not differ by treatment allocation. These findings suggest that antimetabolites could improve overall patient well-being and daily functioning.

Indexed as

Administration, OralAdultAgedEnzyme InhibitorsFemaleHealthHealth StatusHumansImmunosuppressive AgentsMaleMethotrexateMiddle AgedMycophenolic AcidProspective StudiesQuality of LifeSickness Impact ProfileEnzyme InhibitorsImmunosuppressive AgentsMethotrexateMycophenolic AcidAntimetabolitesQuality of lifeuveitis

Identifiers

PMID33675850
PMCPMC8384645
OpenAlexW3134853783

What OpenQuestion holds

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Registered trials

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.