Evidence map›Paper›PMID 31958274›Full record

Trial reportRMD open2020

Fatigue numeric rating scale validity, discrimination and responder definition in patients with psoriatic arthritis.

Dafna Gladman, Peter Nash, Hitoshi Goto, Julie A Birt, Chen-Yen Lin, Ana-Maria Orbai, Tore K Kvien

3 registry-linked trialsAbstract readClinical Trial, Phase IIIMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in RMD open, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 3 registered trials, which are not on this map. Cited by 33 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
33citing papers in PubMed, 2 pooled it
–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.

NCT05487430 nacompletednot on this map

The Effect of Self-Affirmation on Anxiety and Perceived Discomfort in Patients Who Underwent Open-Heart Surgery. A Randomized Controlled Trial

TypeinterventionalSponsorUniversity of Vic - Central University of CataloniaRan2019 to 2020Enrolled61ConditionsSurgery, Cardiac DiseaseArmsPositive Self-Affirmation
NCT07654738 not yet recruitingnot on this mapstarted 2026, after this paper: background citation

Investigation of the Relationship Between Core Stability, Functional Capacity, Balance, Lower Extremity Strength, and Fatigue in Pediatric Demyelinating Diseases

TypeobservationalSponsorIstanbul University - CerrahpasaRan2026 to 2028Enrolled32ConditionsDemyelinating Diseases of the Central Nervous System, Child, Core Stability, BalanceArmsNo ADT
NCT07778836 phase3recruitingnot on this mapstarted 2026, after this paper: background citation

A Phase 3 Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate the Efficacy and Safety of Subcutaneous Nomlabofusp in Subjects With Friedreich's Ataxia

TypeinterventionalSponsorLarimar Therapeutics, Inc.Ran2026 to 2029Enrolled150ConditionsFriedreich Ataxia, Friedreich's AtaxiaArmsNomlabofusp, Placebo
3 · Its place in the literature

Who cites it

33 citing papers in PubMed, 2 syntheses or guidelines pooled it.

  1. Pooled it
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  3. Determining minimal clinically important differences in ecological momentary assessment measures of fatigue in people with multiple sclerosis.Quality of life research : an international journal of quality of life aspects of treatment, care and rehabilitation · 2025
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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

7 authors.

Dafna GladmanMedicine/Rheumatology, Krembil Research Institute, Toronto, Ontario, Canada dafna.gladman@utoronto.ca.ORCID 0000-0002-9074-0592
Peter NashDepartment of Medicine, Griffith University, Brisbane, Queensland, Australia.
Hitoshi GotoOsaka City University Hospital, Osaka, Japan.
Julie A BirtEli Lilly and Company, Indianapolis, Indiana, USA.
Chen-Yen LinEli Lilly and Company, Indianapolis, Indiana, USA.
Ana-Maria OrbaiMedicine Rheumatology, Johns Hopkisn University, Baltimore, Maryland, USA.ORCID 0000-0001-8644-8567
Tore K KvienRheumatology, Diak Hospital, Oslo, Norway.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectivesThis study assessed the psychometric properties of the fatigue numeric rating scale (NRS) and sought to establish values for clinically meaningful change (responder definition).

methodsUsing disease-specific clinician-reported and patient-reported data from two randomised clinical trials of patients with psoriatic arthritis (PsA), the fatigue NRS was evaluated for test-retest reliability, construct validity and responsiveness. A responder definition was also explored using anchor-based and distribution-based methods.

resultsTest-retest reliability analyses supported the reproducibility of the fatigue NRS in patients with PsA (intraclass correlation coefficient=0.829). Mean (SD) values at baseline and week 2 were 5.7 (2.2) and 5.7 (2.4), respectively. Supporting construct validity of the fatigue NRS, moderate-to-large correlations with other assessments measuring similar concepts as measured by Sackett's conventions were demonstrated. Fatigue severity was reduced when the underlying disease activity was improved and reductions remained consistent at week 12 and 24. A 3-point improvement was identified as being optimal for demonstrating a level of clinically meaningful improvement in fatigue NRS after 12-24 weeks of treatment.

conclusionsFatigue NRS is a valid and responsive patient-reported outcome instrument for use in patients with PsA. The established psychometric properties from this study support the use of fatigue NRS in clinical trials and in routine clinical practice. Robust validation of reliability for use in routine clinical practice in treating patients with active PsA in less active disease states and other more diverse ethnic groups is needed.

Indexed as

Severity of Illness IndexAdultArthritis, PsoriaticFatigueFemaleHumansMaleMiddle AgedPain MeasurementPatient Reported Outcome MeasuresPsychometricsQuality of LifeReproducibility of ResultsSurveys and QuestionnairesTumor Necrosis Factor InhibitorsTumor Necrosis Factor Inhibitorsoutcomes researchpatient perspectivepsoriatic arthritis

Identifiers

PMID31958274
PMCPMC7046948

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.