title: OARSI Clinical Trials Recommendations: Design and conduct of implementation trials of interventions for osteoarthritis.
abstract: Rigorous implementation research is important for testing strategies to improve the delivery of effective osteoarthritis (OA) interventions. The objective of this manuscript is to describe principles of implementation research, including conceptual frameworks, study designs and methodology, with specific recommendations for randomized clinical trials of OA treatment and management. This manuscript includes a comprehensive review of prior research and recommendations for implementation trials. The review of literature included identification of seminal articles on implementation research methods, as well as examples of previous exemplar studies using these methods. In addition to a comprehensive summary of this literature, this manuscript provides key recommendations for OA implementation trials. This review concluded that to date there have been relatively few implementation trials of OA interventions, but this is an emerging area of research. Future OA clinical trials should routinely consider incorporation of implementation aims to enhance translation of findings.
authors.affiliation: Thurston Arthritis Research Center, University of North Carolina, Chapel Hill, NC, USA; Department of Medicine, University of North Carolina, Chapel Hill, NC, USA; Health Services Research and Development, Department of Veterans Affairs Medical Center, Durham, NC, USA. Electronic address: kdallen@email.unc.edu.
authors.forename: K D
authors.initials: KD
authors.lastname: Allen
authors.affiliation: Department of General Practice, Erasmus MC - University Medical Center Rotterdam, The Netherlands; Department of Orthopaedic Surgery, Erasmus MC - University Medical Center Rotterdam, The Netherlands. Electronic address: s.bierma-zeinstra@erasmusmc.nl.
authors.forename: S M A
authors.initials: SM
authors.lastname: Bierma-Zeinstra
authors.affiliation: Arthritis Research UK Primary Care Centre, Institute of Primary Care and Health Sciences, Keele University, Keele, UK. Electronic address: n.foster@keele.ac.uk.
authors.forename: N E
authors.initials: NE
authors.lastname: Foster
authors.affiliation: Thurston Arthritis Research Center, University of North Carolina, Chapel Hill, NC, USA; Department of Epidemiology, University of North Carolina, Chapel Hill, NC, USA. Electronic address: golight@email.unc.edu.
authors.forename: Y M
authors.initials: YM
authors.lastname: Golightly
authors.affiliation: Department of Medicine, University of Toronto, Canada; Women's College Research Institute, Women's College Hospital, University of Toronto, Canada. Electronic address: g.hawker@utoronto.ca.
authors.forename: G
authors.initials: G
authors.lastname: Hawker
mesh_terms: D002986:Clinical Trials as Topic / Q000592:standards*; D006284:Health Plan Implementation; D006801:Humans; D019637:Orthopedic Procedures / Q000592:standards*; D010003:Osteoarthritis / Q000628:therapy*; D017410:Practice Guidelines as Topic
keywords: Clinical trials; Implementation; Osteoarthritis