title: OARSI Clinical Trials Recommendations: Key analytic considerations in design, analysis, and reporting of randomized controlled trials in osteoarthritis.
abstract: To highlight methodologic challenges pertinent to design, analysis, and reporting of results of randomized clinical trials in OA and offer practical suggestions to overcome these challenges. The topics covered in this paper include subject selection, randomization, approaches to handling missing data, subgroup analysis, sample size, and issues related to changing design mid-way through the study. Special attention is given to standardizing the reporting of results and economic analyses. Key findings include the importance of blinding and concealment, the distinction between superiority and non-inferiority trials, the need to minimize missing data, and appropriate analysis and interpretation of subgroup effects. Investigators may use the findings and recommendations advanced in this paper to guide design and conduct of randomized controlled trials of interventions for osteoarthritis.
authors.affiliation: Orthopedic and Arthritis Center for Outcomes Research, Department of Orthopedic Surgery, Brigham and Women's Hospital, Boston, MA, USA; Harvard Medical School, Boston, MA, USA; Department of Biostatistics, Boston University School of Public Health, Boston, MA, USA. Electronic address: elosina@partners.org.
authors.forename: E
authors.initials: E
authors.lastname: Losina
authors.affiliation: Department of Clinical Sciences, Orthopedics, Lund University, and Skane University Hospital, Lund, Sweden. Electronic address: jonas.ranstam@gmail.com.
authors.forename: J
authors.initials: J
authors.lastname: Ranstam
authors.affiliation: Orthopedic and Arthritis Center for Outcomes Research, Department of Orthopedic Surgery, Brigham and Women's Hospital, Boston, MA, USA; Harvard Medical School, Boston, MA, USA. Electronic address: jcollins13@partners.org.
authors.forename: J E
authors.initials: JE
authors.lastname: Collins
authors.affiliation: Northwestern University School of Medicine, USA. Electronic address: tjs@northwestern.edu.
authors.forename: T J
authors.initials: TJ
authors.lastname: Schnitzer
authors.affiliation: Orthopedic and Arthritis Center for Outcomes Research, Department of Orthopedic Surgery, Brigham and Women's Hospital, Boston, MA, USA; Harvard Medical School, Boston, MA, USA. Electronic address: jnkatz@partners.org.
authors.forename: J N
authors.initials: JN
authors.lastname: Katz
mesh_terms: D006801:Humans; D010003:Osteoarthritis / Q000628:therapy*; D017410:Practice Guidelines as Topic / Q000592:standards*; D016032:Randomized Controlled Trials as Topic / Q000706:statistics & numerical data*; D058028:Research Report / Q000592:standards*
keywords: Design; Economic evaluation; Missing data; Outcomes; Randomized controlled trials; Reporting