Evidence map›Paper›PMID 27209012›Full record

Trial reportArthritis research & therapy2016

Discordance between patient and physician assessments of global disease activity in rheumatoid arthritis and association with work productivity.

Josef S Smolen, Vibeke Strand, Andrew S Koenig, Annette Szumski, Sameer Kotak, Thomas V Jones

Registry-linked trialOpen access · goldAbstract readClinical TrialMulticenter Study
In one paragraph

Trial report in Arthritis research & therapy, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00565409 (A Randomized, Double-Blind Study Comparing the Safety & Efficacy of Once-Weekly Etanercept 50 mg, Etanercept 25 mg, & Placebo in Combination With Methotrexate in Subjects With Active Rheumatoid Arthritis), which is not on this map. Cited by 30 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
30citing papers in PubMed, 1 pooled it
8.1field-weighted citation impact, top 2% 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.

NCT00565409 phase4completednot on this map

A Randomized, Double-Blind Study Comparing the Safety & Efficacy of Once-Weekly Etanercept 50 mg, Etanercept 25 mg, & Placebo in Combination With Methotrexate in Subjects With Active Rheumatoid Arthritis

TypeinterventionalSponsorPfizerRan2008 to 2011Enrolled834ConditionsArthritis, RheumatoidArmsEtanercept, Methotrexate, Placebo
3 · Its place in the literature

Who cites it

30 citing papers in PubMed, 1 synthesis or guideline pooled it, 65 citations in OpenAlex.

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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

6 authors at 4 institutions in 2 countries.

Josef S SmolenDivision of Rheumatology, Medical University of Vienna and Hietzing Hospital, Vienna, Austria. josef.smolen@wienkav.at.
Vibeke StrandDivision of Immunology/Rheumatology, Stanford University School of Medicine, Palo Alto, CA, USA.
Andrew S KoenigPfizer, Collegeville, PA, USA.
Annette SzumskiinVentiv Health, Princeton, NJ, USA.
Sameer KotakPfizer, New York, NY, USA.
Thomas V JonesPfizer, Collegeville, PA, USA.
Pfizer (United States) · USMedical University of Vienna · ATPrinceton University · USStanford University · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundDiscordance between patient and physician ratings of rheumatoid arthritis (RA) severity occurs in clinical practice and correlates with pain scores and measurements of joint disease. However, information is lacking on whether discordance impacts patients' ability to work. We evaluated the discordance between patient and physician ratings of RA disease activity before and after treatment with etanercept and investigated the associations between discordance, clinical outcomes, and work productivity.

methodsIn the PRESERVE clinical trial, patients with moderate RA received open-label etanercept 50 mg once weekly plus methotrexate for 36 weeks. Baseline and week-36 disease characteristics and clinical and work productivity outcomes were categorized according to week-36 concordance category, defined as positive discordance (patient global assessment - physician global assessment ≥2), negative discordance (patient global assessment - physician global assessment ≤ -2), and concordance (absolute difference between the two disease activity assessments = 0 or 1). Correlations between discordance, clinical outcomes, and predictors of discordance were determined.

resultsAt baseline, 520/762 (68.2 %) patient and physician global assessment scores were concordant, 194 (25.5 %) were positively discordant, and 48 (6.3 %) were negatively discordant. After 36 weeks of therapy, 556/763 (72.9 %) scores were concordant, 189 (24.8 %) were positively discordant, and 18 (2.4 %) were negatively discordant. Patients with week-36 concordance had the best 36-week clinical and patient-reported outcomes, and overall, the greatest improvement between baseline and week 36. Baseline pain, swollen joint count, duration of morning stiffness, fatigue, and patient general health significantly correlated with week-36 discordance, p < 0.0001 to p < 0.05. Additionally, baseline pain, patient general health, and C-reactive protein were predictors of week-36 discordance (odds ratios 1.22, 1.02, and 0.98, respectively). For the employed patients, percent impairment while working and percent overall work impairment were highest (greatest impairment) at baseline and 36 weeks in the group with positive discordance.

conclusionsThe percentage of patients with concordance increased after 36 weeks of treatment with etanercept, with concordant patients demonstrating the greatest improvement in clinical and patient-reported outcomes. Discordance correlated with several measures of disease activity and was associated with decreased work productivity.

trial registrationClinicalTrials.gov identifier: NCT00565409 . Registered 28/11/2007.

Indexed as

PhysiciansWork PerformanceAdultAgedAntirheumatic AgentsArthritis, RheumatoidDisability EvaluationEfficiencyEtanerceptFemaleHumansMaleMethotrexateMiddle AgedSeverity of Illness IndexAntirheumatic AgentsEtanerceptMethotrexateDiscordanceEtanerceptPRESERVERheumatoid arthritisWork productivity

Identifiers

PMID27209012
PMCPMC4875609
OpenAlexW2403707357

What OpenQuestion holds

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LicenceCC BY
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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.