Evidence map›Paper›PMID 26245756›Full record

Trial reportAnnals of the rheumatic diseases2016

A psychometric analysis of outcome measures in peripheral spondyloarthritis.

Maureen C Turina, Sofia Ramiro, Dominique L Baeten, Philip Mease, Jacqueline E Paramarta, In-Ho Song, Aileen L Pangan, Robert Landewé

Registry-linked trialOpen access · hybridAbstract readRandomized Controlled Trial
In one paragraph

Trial report in Annals of the rheumatic diseases, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01064856 (A Multicenter Study of the Efficacy and Safety of the Human Anti-TNF Monoclonal Antibody Adalimumab in Subjects With Peripheral Spondyloarthritis), which is not on this map. Cited by 12 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
12citing papers in PubMed, 1 pooled it
1.6field-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.

NCT01064856 phase3completednot on this map

A Multicenter Study of the Efficacy and Safety of the Human Anti-TNF Monoclonal Antibody Adalimumab in Subjects With Peripheral Spondyloarthritis

TypeinterventionalSponsorAbbVie (prior sponsor, Abbott)Ran2010 to 2014Enrolled165ConditionsPeripheral SpondyloarthritisArmsAdalimumab, Placebo
3 · Its place in the literature

Who cites it

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

  1. Pooled it
  2. Trial
  3. Trial
  4. Article
  5. Article
  6. Article
  7. Article
  8. Review
  9. Review
  10. Review
  11. Article
  12. 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

8 authors at 3 institutions in 2 countries.

Maureen C TurinaDepartment of Clinical Immunology and Rheumatology, Amsterdam Rheumatology and immunology Center, Academic Medical Center/University of Amsterdam, Amsterdam, The Netherlands.
Sofia RamiroDepartment of Clinical Immunology and Rheumatology, Amsterdam Rheumatology and immunology Center, Academic Medical Center/University of Amsterdam, Amsterdam, The Netherlands.ORCID http://orcid.org/0000-0002-8899-9087
Dominique L BaetenDepartment of Clinical Immunology and Rheumatology, Amsterdam Rheumatology and immunology Center, Academic Medical Center/University of Amsterdam, Amsterdam, The Netherlands.
Philip MeaseSwedish Medical Center & University of Washington, Seattle, Washington, USA.
Jacqueline E ParamartaDepartment of Clinical Immunology and Rheumatology, Amsterdam Rheumatology and immunology Center, Academic Medical Center/University of Amsterdam, Amsterdam, The Netherlands.
In-Ho SongAbbVie Inc., North Chicago, Illinois, USA.
Aileen L PanganAbbVie Inc., North Chicago, Illinois, USA.
Robert LandewéDepartment of Clinical Immunology and Rheumatology, Amsterdam Rheumatology and immunology Center, Academic Medical Center/University of Amsterdam, Amsterdam, The Netherlands.
Amsterdam UMC Location University of Amsterdam · NLAbbVie (United States) · USUniversity of Washington · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectivesTo assess the discriminatory capacity of various outcome measures and response criteria in patients with peripheral spondyloarthritis (pSpA).

methodsData originated from two randomised controlled trials, ABILITY-2 and Tnf Inhibition in PEripheral SpondyloArthritis (TIPES). Continuous outcome measures included patient's global assessment (PGA)/physician's global assessment of disease (PhGA), C-reactive protein (CRP), tender joint counts (TJC)/swollen joint counts (SJC), Bath Ankylosing Spondylitis Disease Activity Index (BASDAI), and the Ankylosing Spondylitis Disease Activity Score (ASDAS). Dichotomous response criteria included Peripheral SpondyloArthritis Response Criteria (PSpARC), American College of Rheumatology (ACR), ASDAS and BASDAI response criteria. The capacity to discriminate between adalimumab and placebo groups was assessed by standardised mean differences (SMD) for continuous variables, and Pearson's χ(2) for dichotomous response criteria.

resultsWithin each trial, the composite indices for axial SpA assessment, ASDAS-CRP (SMD: -0.63 and -0.89 in ABILITY-2 and the TIPES trial, respectively) and BASDAI (SMD: -0.50 and -0.73), and the single-item measures PGA (SMD: -0.47 and -1.12) and PhGA (SMD: -0.64 and -0.87) performed better than other single-item measures, such as CRP (SMD: -0.18 and -0.53), SJC or TJC. In general, the PSpARC and ACR response criteria discriminated better than ASDAS and BASDAI response criteria.

conclusionsThe axial SpA-specific ASDAS-CRP and BASDAI, but also PGA and PhGA, demonstrated good discriminatory ability in patients with pSpA. The pSpA-specific pSpARC response criteria and the rheumatoid arthritis-specific ACR response criteria also discriminated well. To fully capture typical pSpA manifestations, it may be worth developing new pSpA-specific indices with better performance and face validity. TRIAL REGISTRATION NUMBERS: ABILITY-2: NCT01064856; TIPES: EUDRACT 2008-006885-27.

Indexed as

Severity of Illness IndexAdalimumabAdultAntirheumatic AgentsArthritis, RheumatoidDouble-Blind MethodFemaleHumansMaleOutcome Assessment, Health CarePsychometricsSpondylitis, AnkylosingAdalimumabAntirheumatic AgentsAnti-TNFDisease ActivityOutcomes researchPatient perspectiveSpondyloarthritis

Identifiers

PMID26245756
PMCPMC4941177
OpenAlexW1955996295

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
Read underepoch 390

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.