title: Achieving consensus on minimum data items (including core outcome domains) for a longitudinal observational cohort study in rheumatoid arthritis.
abstract: To obtain consensus on the minimum data items for an observational cohort study in RA in the UK and to make available the process for similar studies and other rheumatic conditions.
  
  
  
  Individuals with a diverse range of expertise and backgrounds were invited to participate in a process of proposing a minimum core dataset (MCD) for research studies, commissioned by Arthritis Research UK as part of the larger INBANK project. The group included patients and representatives from clinical and academic rheumatology, outcomes science, stratified medicine, health economics, and national professional and academic bodies/committees. A process was devised based on OMERACT principles for reviewing aims/objectives, defining the scope, identifying the important research questions and selecting key domains.
  
  
  
  Following the initial multistakeholder meeting, subsequent teleconferences and email communications: consensus was obtained on the most important and relevant research questions; agreement on how the OMERACT Core Areas (life impact, pathophysiological manifestations, resource use and death) could form the basis of a MCD; and consensus on 22 items for inclusion into a MCD. Workshops were undertaken for two essential items that required further exploration: work/social participation and co-morbidity.
  
  
  
  Reaching a consensus for the proposed minimal data items for long-term observational cohort studies of RA in the UK posed novel challenges and opportunities, and was largely successful. Further work is needed for selecting instruments for two important items and for achieving compatibility with other UK national initiatives, and more widely across Europe.
authors.affiliation: Rheumatology Department, Whittington Hospital, London.
authors.forename: Elena
authors.initials: E
authors.lastname: Nikiphorou
authors.affiliation: Rheumatology, NIHR-Leeds Musculoskeletal Biomedical Research Unit, Leeds Teaching Hospitals NHS Trust.|Leeds Institute of Rheumatic and Musculoskeletal Medicine, School of Medicine, University of Leeds, Leeds.
authors.forename: Sarah L
authors.initials: SL
authors.lastname: Mackie
authors.affiliation: Academic Rheumatology Unit, Bristol Royal Infirmary, University of Bristol, Bristol, UK.
authors.forename: John
authors.initials: J
authors.lastname: Kirwan
authors.affiliation: Department of Epidemiology and Biostatistics, VU University Medical Center, Amersfoort, Netherlands.
authors.forename: Martin
authors.initials: M
authors.lastname: Boers
authors.affiliation: Musculoskeletal Group, Newcastle University, Newcastle-upon-Tyne.
authors.forename: John
authors.initials: J
authors.lastname: Isaacs
authors.affiliation: Rheumatology, NIHR-Leeds Musculoskeletal Biomedical Research Unit, Leeds Teaching Hospitals NHS Trust.|Leeds Institute of Rheumatic and Musculoskeletal Medicine, School of Medicine, University of Leeds, Leeds.
authors.forename: Ann W
authors.initials: AW
authors.lastname: Morgan
authors.affiliation: Rheumatology Department, St Albans City Hospital, St. Albans, UK.
authors.forename: Adam
authors.initials: A
authors.lastname: Young
mesh_terms: D000328:Adult; D001172:Arthritis, Rheumatoid; D035843:Biomedical Research / Q000379:methods*; D032921:Consensus; D003625:Data Collection / Q000379:methods*; D006801:Humans; D064887:Observational Studies as Topic / Q000379:methods*; D006113:United Kingdom
keywords: co-morbidity; long-term observational studies; mortality; outcome measures; rheumatoid arthritis