title: Hand-related physical function in rheumatic hand conditions: a protocol for developing a patient-reported outcome measurement instrument.
abstract: There is no consensus about what constitutes the most appropriate patient-reported outcome measurement (PROM) instrument for measuring physical function in patients with rheumatic hand conditions. Existing instruments lack psychometric testing and vary in feasibility and their psychometric qualities. We aim to develop a PROM instrument to assess hand-related physical function in rheumatic hand conditions.
  
  
  
  We will perform a systematic search to identify existing PROMs to rheumatic hand conditions, and select items relevant for hand-related physical function as well as those items from the Patient Reported Outcomes Measurement Information System (PROMIS) Physical Function (PF) item bank that are relevant to patients with rheumatic hand conditions. Selection will be based on consensus among reviewers. Content validity of selected items will be established through the use of focus groups. If patients deem necessary, we will develop new items based on the patients' input. We will examine whether it is valid to score all selected and developed items on the same scale as the original items from the PROMIS PF item bank. Our analyses will follow the methods used for calibrating the original PROMIS PF item bank in US samples, which were largely based on the general PROMIS approach.
  
  
  
  This study will be carried out in accordance with the Helsinki Declaration. Ethics approvals will be obtained where necessary, and signed informed consent will be obtained from all participants. We aim to disseminate the results of the study through publication in international peer-reviewed journals and at international conferences.
authors.affiliation: The Parker Institute, Bispebjerg & Frederiksberg Hospital, Copenhagen, Denmark.
authors.forename: Louise
authors.initials: L
authors.lastname: Klokker
authors.affiliation: Department of Epidemiology and Biostatistics, VU University Medical Center, Amsterdam, The Netherlands.|The EMGO Institute for Health and Care Research, VU University Medical Center, Amsterdam, The Netherlands.
authors.forename: Caroline B
authors.initials: CB
authors.lastname: Terwee
authors.affiliation: The Parker Institute, Bispebjerg & Frederiksberg Hospital, Copenhagen, Denmark.|Department of Public Health, University of Southern Denmark, Odense, Denmark.
authors.forename: Eva Ejlersen
authors.initials: EE
authors.lastname: Wæhrens
authors.affiliation: The Parker Institute, Bispebjerg & Frederiksberg Hospital, Copenhagen, Denmark.|Department of Physical and Occupational Therapy, Copenhagen University Hospital Bispebjerg Frederiksberg, Copenhagen, Denmark.
authors.forename: Marius
authors.initials: M
authors.lastname: Henriksen
authors.affiliation: Department of Psychosomatic Medicine, Center of Internal Medicine and Dermatology, Charité-Universitätsmedizin Berlin, Berlin, Germany.|Department of Public Health Innovation, Population Health Strategic Research Centre, School of Health and Social Development, Deakin University, Burwood, Victoria, Australia.
authors.forename: Sandra
authors.initials: S
authors.lastname: Nolte
authors.affiliation: Department of Psychosomatic Medicine, Center of Internal Medicine and Dermatology, Charité-Universitätsmedizin Berlin, Berlin, Germany.
authors.forename: Gregor
authors.initials: G
authors.lastname: Liegl
authors.affiliation: Department of Rheumatology, Leiden University Medical Center, Leiden, The Netherlands.|Department of Clinical Epidemiology, Leiden University Medical Center, Leiden, The Netherlands.
authors.forename: Margreet
authors.initials: M
authors.lastname: Kloppenburg
authors.affiliation: Department of Development and Regeneration KU Leuven, Rheumatology, Skeletal Biology and Engineering Research Center, University Hospitals Leuven, Leuven, Belgium.
authors.forename: Rene
authors.initials: R
authors.lastname: Westhoven
authors.affiliation: Department of Rheumatology, Ghent University Hospital, Ghent, Belgium.
authors.forename: Ruth
authors.initials: R
authors.lastname: Wittoek
authors.affiliation: National Advisory Unit on Rehabilitation in Rheumatology, Department of Rheumatology, Diakonhjemmet Hospital, Oslo, Norway.
authors.forename: Ingvild
authors.initials: I
authors.lastname: Kjeken
authors.affiliation: Department of Rheumatology, Diakonhjemmet Hospital, Oslo, Norway.
authors.forename: Ida K
authors.initials: IK
authors.lastname: Haugen
authors.affiliation: Department of Medical Social Sciences, Feinberg School of Medicine, Northwestern University, Chicago, Illinois, USA.
authors.forename: Ben
authors.initials: B
authors.lastname: Schalet
authors.affiliation: Department of Medical Social Sciences, Feinberg School of Medicine, Northwestern University, Chicago, Illinois, USA.
authors.forename: Richard
authors.initials: R
authors.lastname: Gershon
authors.affiliation: The Parker Institute, Bispebjerg & Frederiksberg Hospital, Copenhagen, Denmark.
authors.forename: Henning
authors.initials: H
authors.lastname: Bliddal
authors.affiliation: The Parker Institute, Bispebjerg & Frederiksberg Hospital, Copenhagen, Denmark.
authors.forename: Robin
authors.identifier: 0000-0002-6600-0631
authors.initials: R
authors.lastname: Christensen
mesh_terms: D001172:Arthritis, Rheumatoid / Q000473:pathology; D032921:Consensus; D004185:Disability Evaluation; D017144:Focus Groups; D006225:Hand / Q000473:pathology; D006801:Humans; D010003:Osteoarthritis / Q000473:pathology; D000071066:Patient Reported Outcome Measures; D011594:Psychometrics; D012107:Research Design; D011795:Surveys and Questionnaires
keywords: Arthritis; Hand function; Outcome Measurement Instrument; PROMIS