title: Harmonising data collection from osteoarthritis studies to enable stratification: recommendations on core data collection from an Arthritis Research UK clinical studies group.
abstract: Treatment of OA by stratifying for commonly used and novel therapies will likely improve the range of effective therapy options and their rational deployment in this undertreated, chronic disease. In order to develop appropriate datasets for conducting post hoc analyses to inform approaches to stratification for OA, our aim was to develop recommendations on the minimum data that should be recorded at baseline in all future OA interventional and observational studies.
  
  
  
  An Arthritis Research UK study group comprised of 32 experts used a Delphi-style approach supported by a literature review of systematic reviews to come to a consensus on core data collection for OA studies.
  
  
  
  Thirty-five systematic reviews were used as the basis for the consensus group discussion. For studies with a primary structural endpoint, core domains for collection were defined as BMI, age, gender, racial origin, comorbidities, baseline OA pain, pain in other joints and occupation. In addition to the items generalizable to all anatomical sites, joint-specific domains included radiographic measures, surgical history and anatomical factors, including alignment. To demonstrate clinical relevance for symptom studies, the collection of mental health score, self-efficacy and depression scales were advised in addition to the above.
  
  
  
  Currently it is not possible to stratify patients with OA into therapeutic groups. A list of core and optional data to be collected in all OA interventional and observational studies was developed, providing a basis for future analyses to identify predictors of progression or response to treatment.
authors.affiliation: Institute of Rheumatic and Musculoskeletal Medicine and NIHR Leeds Musculoskeletal Biomedical Research Unit, University of Leeds, Leeds s.r.kingsbury@leeds.ac.uk.
authors.forename: Sarah R
authors.initials: SR
authors.lastname: Kingsbury
authors.affiliation: Arthritis Research UK Primary Care Centre, Research Institute for Primary Care and Health Sciences, Keele University, Keele.
authors.forename: Nadia
authors.initials: N
authors.lastname: Corp
authors.affiliation: Arthritis Research UK Centre for Osteoarthritis Pathogenesis, Kennedy Institute of Rheumatology, Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, Oxford.
authors.forename: Fiona E
authors.initials: FE
authors.lastname: Watt
authors.affiliation: Arthritis Research UK Epidemiology Unit, University of Manchester, Manchester, UK Clinical Epidemiology Unit, Boston University School of Medicine, Boston, MA, USA.
authors.forename: David T
authors.initials: DT
authors.lastname: Felson
authors.affiliation: Arthritis Research UK Epidemiology Unit, University of Manchester, Manchester, UK.
authors.forename: Terence W
authors.initials: TW
authors.lastname: O'Neill
authors.affiliation: School of Engineering, Cardiff University, Wales.
authors.forename: Cathy A
authors.initials: CA
authors.lastname: Holt
authors.affiliation: School of Health Sciences, University of Salford, Manchester.
authors.forename: Richard K
authors.initials: RK
authors.lastname: Jones
authors.affiliation: Institute of Rheumatic and Musculoskeletal Medicine and NIHR Leeds Musculoskeletal Biomedical Research Unit, University of Leeds, Leeds.
authors.forename: Philip G
authors.initials: PG
authors.lastname: Conaghan
authors.affiliation: Arthritis Research UK Centre for Sport, Exercise and Osteoarthritis, University of Oxford MRC Lifecourse Epidemiology Unit, University of Southampton, Southampton, UK.
authors.forename: Nigel K
authors.initials: NK
authors.lastname: Arden
mesh_terms: D002986:Clinical Trials as Topic; D032921:Consensus; D003625:Data Collection / Q000379:methods*; D018450:Disease Progression; D005260:Female; D006801:Humans; D008297:Male; D059352:Musculoskeletal Pain / Q000453:epidemiology / Q000503:physiopathology; D064887:Observational Studies as Topic; D010003:Osteoarthritis / Q000453:epidemiology / Q000503:physiopathology*; D012196:Review Literature as Topic; D006113:United Kingdom / Q000453:epidemiology
keywords: clinical trials; osteoarthritis; personalized medicine; prognosis; stratification