Evidence map›Paper›PMID 29391382›Full record

Observational studyBMJ open2018

Identification of new biomarkers to promote personalised treatment of patients with inflammatory rheumatic disease: protocol for an open cohort study.

Tina Marie Kringelbach, Bente Glintborg, Estrid V Hogdall, Julia Sidenius Johansen, Merete Lund Hetland, Biomarker Protocol Study Group

Registry-linked trialOpen access · goldAbstract readObservational Study
In one paragraph

Observational study in BMJ open, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03214263 (Identification of New Biomarkers to Improve Diagnostics or Predict Treatment Responses, Adverse Events or Prognosis in Patients With Inflammatory Rheumatic Disease Followed in the Danish Nationwide Quality Registry, DANBIO), which is not on this map. Cited by 16 papers.

0numbers the graph read from it
0cells of the map it votes in
16citing papers in PubMed
1.0field-weighted citation impact, top 24% 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.

NCT03214263 unknown statusnot on this map

Identification of New Biomarkers to Improve Diagnostics or Predict Treatment Responses, Adverse Events or Prognosis in Patients With Inflammatory Rheumatic Disease Followed in the Danish Nationwide Quality Registry, DANBIO

Typeobservational_patient_registrySponsorRigshospitalet, DenmarkRan2015 to 2024Enrolled20,000ConditionsArthritis, Rheumatoid, Psoriatic Arthritis, Axial Spondyloarthritis, Connective Tissue Diseases
3 · Its place in the literature

Who cites it

16 citing papers in PubMed, 24 citations in OpenAlex.

  1. Trial
  2. Article
  3. Review
  4. Article
  5. Article
  6. Review
  7. RMD open · 2024
    Article
  8. Article
  9. Article
  10. Article
  11. Review
  12. Article
  13. Article
  14. Article
  15. Review
  16. 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

6 authors at 5 institutions in 2 countries.

Tina Marie KringelbachThe Danish Rheumatologic Biobank, Capital Region, Denmark.
Bente GlintborgThe Danish Rheumatologic Biobank, Capital Region, Denmark.
Estrid V HogdallThe Danish Rheumatologic Biobank, Capital Region, Denmark.
Julia Sidenius JohansenThe Danish Rheumatologic Biobank, Capital Region, Denmark.
Merete Lund HetlandThe Danish Rheumatologic Biobank, Capital Region, Denmark.
Biomarker Protocol Study Group
Copenhagen University Hospital · DKGigtforeningen · DKGlostrup Hospital · DKHerlev Hospital · DKUniversity of Copenhagen · DK

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionThe introduction of biological disease-modifying antirheumatic drugs (bDMARDs) has improved the treatment of inflammatory rheumatic diseases dramatically. However, bDMARD treatment failure occurs in 30%-40% of patients due to lack of effect or adverse events, and the tools to predict treatment outcomes in individual patients are currently limited. The objective of the present study is to identify diagnostic, prognostic and predictive biomarkers, which can be used to (1) diagnose inflammatory rheumatic diseases early in the disease course with high sensitivity and specificity, (2) improve prognostication or (3) predict and monitor treatment effectiveness and tolerability for the individual patient. METHODS AND ANALYSIS: The present study is an observational and translational open cohort study with prospective collection of clinical data and biological materials (primarily blood) in patients with inflammatory rheumatic diseases treated in routine care. Patients contribute with one cross-sectional blood sample and/or are enrolled for longitudinal follow-up on initiation of a new DMARD (blood sampling after 0, 3, 6, 12, 24, 36, 48, 60 months of treatment). Other biological materials will be collected when accessible and relevant. Demographics, disease characteristics, comorbidities and lifestyle factors are registered at inclusion; DMARD treatment and outcomes are collected repeatedly during follow-up. Currently (July 2017), >5000 samples from approximately 3000 patients have been collected. Data will be analysed using appropriate statistical analyses. ETHICS AND DISSEMINATION: The protocol is approved by the Danish Ethics Committee and the Danish Data Protection Agency. Participants give written and oral informed consent. Biomarkers will be evaluated and published according to the Reporting Recommendations for Tumour Marker (REMARK) prognostic studies, Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) and the Standards for Reporting of Diagnostic Accuracy (STARD) guidelines. Results will be published in peer-reviewed scientific journals and presented at international conferences. TRIAL REGISTRATION NUMBER: NCT03214263.

Indexed as

Precision MedicineAdultAntirheumatic AgentsCross-Sectional StudiesDenmarkDisease ProgressionFemaleHumansInflammationMalePredictive Value of TestsPrognosisProspective StudiesRheumatic DiseasesSensitivity and SpecificityTranslational Research, BiomedicalAntirheumatic Agentsbiomarkersdanish rheumatologic biobankinflammatory rheumatic diseasepersonalised treatmentrheumatology

Identifiers

PMID29391382
PMCPMC5829933
OpenAlexW2791426643

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.