430 likes | 659 Views
Study design Data collection Data analysis. Study design Data collection Data analysis. Study design: Key inclusion criteria. Inflammatory back pain (Berlin or Calin criteria). Probability of spondylarthropathy > 50% based on the physician’s assessment. Age > 18, < 50.
E N D
Study design • Data collection • Data analysis
Study design • Data collection • Data analysis
Study design: Key inclusion criteria • Inflammatory back pain (Berlin or Calin criteria) • Probability of spondylarthropathy >50% based on the physician’s assessment • Age >18, <50 • Symptoms duration >3 months, <3years • Referral from rheumatologists, GP, … patients
Study design: Data collected Calendar
Study design: Data collected Outcome measures
Study design: Data collected *only centers from Paris area **only centers with DEXA and/or ultrasonographs
Study design: Data collected *only centers from Paris area **only centers with DEXA and/or ultrasonographs
Study design • Data collection • Data analysis
Data collection • Who? • How?
Data collection: Who? Paris area: 11 centers Lille Amiens Nancy Besançon Dijon Nice Marseille Brest Le Mans Tours Clermont-Ferrand Bordeaux Toulouse Montpellier
Data collection: How? • Clinical database • Radiological database • Biological database
Data collection: How? • Clinical database • Radiological database • Biological database
Clinical database (questionnaires, physical examination, local imaging reading, BMD, US) • Data collection (investigators/paper CRF) • Data entry (CRO: ClinInfo) • Data quality control (Nîmes [Pr Daurès]) • Data queries (Paris Clinical Research Unit) • Database storage (Nîmes [Pr Daurès])
Data collection: How? • Clinical database • Radiological database • Biological database
Radiological database (Pelvic X-rays, Spine X-rays, MRI) • Data collection (investigators / CD) • Data entry (Paris Clinical Research Unit) • Data storage (Paris, …)
Data collection: How? • Clinical database • Radiological database • Biological database
Biological database (Serum, urines, DNA, RNA) • Data collection (investigators / specific material) • Data storage (Biologic Ressource Center / Bichat Hospital [Paris])
Study design • Data collection • Data analysis
Data analysis • Organization • Preliminary results
Data analysis • Organization • Preliminary results
Data analysis: organization • When? • How? • Who?
Data analysis: organization • When? • How? • Who?
Data analysis: When? after the database has been locked • after the last patient has completed the last visit (clinical trial) • every year for all patients (cohorts) • every year for the visits for which data are available for all patients
Data analysis: When? after the database has been locked • after the last patient has completed the last visit (clinical trial) • every year for all patients (cohorts) • every year for the visits for which data are available for all patients
Data analysis: When? • M0: June 2010 • M0 + M12: June 2011 • M0 M24: June 2012 • M0 M36: June 2013 • M0 M48: June 2014 • M0 M60: June 2015
Data analysis: organization • When? • How? • Who?
Data analysis: How? • RFP: Request For Proposal of a research question (twice a year) • Specifif format for application • Scientific committee: Fautrel Bruno, Richette Pascal, Miceli-Richard Corinne, Benessiano Joëlle, Berenbaum Francis, Breban Maxime, Claudepierre Pascal, Combe Bernard, Cotten Anne, d’Agostino Maria-Antonietta, Dargent Patricia, Daurès Jean-Pierre, Dougados Maxime, Goupille Philippe, Logeart Isabelle, Pham Thao, Roux Christian, Rudwaleit Martin, Saraux Alain, van der Heijde Désirée, Wendling Daniel • Review of the applications by the reviewers (within and outside the scientific committee) • Decision by the scientific committee • If OK, the database is provided to the applicant
Data analysis: organization • When? • How? • Who?
Data analysis: Who? • Embargo period: 2 years after the date a specific database has been locked • During the embargo period: • Investigators • Scientific committee members • After the embargo period: • Any researcher
Data analysis • Organization • Preliminary results
Data analysis • Description of the database • Presentation / publication
Data analysis • Description of the database • Presentation / publication
Description of the database • Age: n = 708 m = 33.7 SD = 8.6 Range = [18 – 60.6] • Sex: Male n = 327 (46 %) • B27 positive: n = 410 (57.9 %) • Radiologic sacroiliitis: n = 182 (25.7 %)
Description of the database Percentage of patients with recent inflammatory rachialgia and past history of….
Data analysis • Description of the database • Presentation / publication
Presentations during congress (1/2) Smokers in early axial spondyloarthritis have an earlier disease onset, more inflammation and damage: results from the DESIR cohort. Oral presentation Do HLA-B27 positive patients differ from HLA-B27 negtive patients in clinical presentation and imaging? Results from the DESIR cohort on patients with recent onset in ……… arthritis. Poster Psoriasis influences the phenotype of patients with early inflammatory back pain: data from the DESIR cohort. Oral presentation Past history or present symptoms of extra-spinal manifestations are frequent in patients presenting with recent inflammatory back pain: data from the DESIR cohort. Poster Comparison of axial spondyloarthropathy (ASPA) and non ASPA patients rheumatologist diagnosis among a recent inflammatory back pain patients cohorts – the DESIR cohort. Oral presentation
Presentations during congress (2/2) Impact of uveitis on the phenotype of patients with recent inflammatory back pain. Poster Smokers in early axial spondyloarthritis have an earlier disease onset, more inflammation and damage: results from the DEvenir des Spondyloarthropathies Indifférenciées Récentes cohort. Oral presentation Association between axial pain site and site of MRI inflammatory lesions or structural change in patietns with early inflammatory back pain. The DESIR cohort study. Oral presentation Differences between women and men with recent onset axial spondyloarthritis: results from the DESIR cohort. Poster Three phenotype profiles are revealed by cluster analysis in early inflammatory back pain suggestive of spondyloarthritis (SpA). Results from the Devenir des Spondyloarthropathies Indifférenciées Récentes (DESIR) cohort. Poster
Publications • The DESIR cohort: A 10-year follow-up of early inflammatory back pain in France: Study design and baseline characteristics of the 708 recruited patients.Dougados M, d’Agostino MA, Benessiano J, Berenbaum F, Breban M, Claudepierre P, Combe B, Dargent-Molina P, Daurès JP, Fautrel B, Feydy A, Goupille P, Leblanc V, Logeart I, Pham T, Richette P, Roux C, Rudwaleit M, Saraux A, Treluyer JM, van der Heijde D, Wendling M.Joint Bone Spine 2011 Mar 30 [Epub ahead of print] • HLA-B27 positive patients differ from HLA-B27 negative patietns in clinical presentation and imaging: Results from the DESIR cohort of patients with recent onsel axial spondyloarthritis.Chung HY, Machado P, vander Heijde D, Dougados M.Ann Rheum Dis 2011;in press
Conclusions • Potential interest of the collected data • Burden of the disease • Treatment effect in daily practice • Physiopathology • YOU ARE WELCOME TO SUBMIT A RESEARCH PROJECT!!!www.lacohortedesir.fr