Evidence map›Paper›PMID 34843092›Full record

ArticleRheumatology and therapy2022

Patient-Reported Nausea and Fatigue Related to Methotrexate: A Prospective, Self-Controlled Study in the ArthritisPower

W Benjamin Nowell, Elaine Karis, Kelly Gavigan, Laura Stradford, Hong Zhao, Lang Chen, Scott Stryker, Huifeng Yun, Shilpa Venkatachalam, Gregory Kricorian and 2 more

Open access · goldAbstract read
In one paragraph

Article in Rheumatology and therapy, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 9 papers.

0numbers the graph read from it
0cells of the map it votes in
9citing papers in PubMed
3.1field-weighted citation impact, top 8% 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

9 citing papers in PubMed, 21 citations in OpenAlex.

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  8. Examining the influence of inflammatory bowel disease medications on sleep quality.JGH open : an open access journal of gastroenterology and hepatology · 2023
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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

12 authors at 3 institutions in 1 country.

W Benjamin NowellPatient-Centered Research, Global Healthy Living Foundation, Upper Nyack, NY, USA.
Elaine KarisAmgen Inc., Thousand Oaks, CA, USA.
Kelly GaviganPatient-Centered Research, Global Healthy Living Foundation, Upper Nyack, NY, USA.
Laura StradfordPatient-Centered Research, Global Healthy Living Foundation, Upper Nyack, NY, USA.
Hong ZhaoDivision of Clinical Immunology and Rheumatology, University of Alabama at Birmingham, Faculty Office Tower, 510 20th Street South #834, Birmingham, AL, 35294, USA.
Lang ChenDivision of Clinical Immunology and Rheumatology, University of Alabama at Birmingham, Faculty Office Tower, 510 20th Street South #834, Birmingham, AL, 35294, USA.
Scott StrykerAmgen Inc., Thousand Oaks, CA, USA.
Huifeng YunDivision of Clinical Immunology and Rheumatology, University of Alabama at Birmingham, Faculty Office Tower, 510 20th Street South #834, Birmingham, AL, 35294, USA.
Shilpa VenkatachalamPatient-Centered Research, Global Healthy Living Foundation, Upper Nyack, NY, USA.
Gregory KricorianAmgen Inc., Thousand Oaks, CA, USA.
Fenglong XieDivision of Clinical Immunology and Rheumatology, University of Alabama at Birmingham, Faculty Office Tower, 510 20th Street South #834, Birmingham, AL, 35294, USA.
Jeffrey R CurtisDivision of Clinical Immunology and Rheumatology, University of Alabama at Birmingham, Faculty Office Tower, 510 20th Street South #834, Birmingham, AL, 35294, USA. jrcurtis@uabmc.edu.
University of Alabama at Birmingham · USGlobal Healthy Living Foundation · USAmgen (United States) · US

Funding

Methods and Health Informatics CoreP30AR072583 · NIAMS · UNIVERSITY OF ALABAMA AT BIRMINGHAM · PI JEFFREY R. CURTIS · 2020 to 2026
$5.7M
NIAMS NIH HHS NIAMS P30AR072583NIAMS NIH HHS P30 AR072583Patient-Centered Outcomes Research Institute PPRN-1306-04811
6 · The paper itself

Abstract

introductionThe magnitude and frequency of temporally related methotrexate (MTX)-associated side effects in rheumatoid arthritis (RA) or psoriatic arthritis (PsA) patients are difficult to quantify using traditional research methods. As proof of concept designed in part to implement digital data collection for remote patient monitoring, we conducted a study implementing self-controlled case series analytic methods to understand MTX-related symptoms in RA or PsA.

methodsIn study phase 1, adults with RA or PsA from the ArthritisPower

resultsThe baseline survey was completed by 671 participants (mean age: 54 years, 88% female, 92% white, 79% with RA). Among current MTX users (353/671 [53%]), most reported MTX-associated side effects (216/353 [61%]), most frequently fatigue (161/353 [46%]). Among phase 2 participants with (n = 39) and without (n = 84) baseline nausea, mean increase in PROMIS nausea was 5.1 units (P < 0.0001) and 0.7 units (P = 0.135), respectively; among those with (n = 51) and without (n = 72) baseline fatigue, mean increase in PROMIS fatigue was 3.9 units (P = 0.0003) and 0.4 units (P = 0.554), respectively.

conclusionsDigital remote patient monitoring presents an opportunity to detect and address medication tolerability in real time. Using a novel study design to control for between-person confounding, the magnitude of nausea and fatigue experienced by participants with RA and PsA temporally related to weekly MTX use was substantial.

Indexed as

Adverse eventsFatigueMethotrexateNauseaPatient-reported outcome measures

Identifiers

PMID34843092
PMCPMC8628141
OpenAlexW3214796003

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.