Risk of harm in synthetic and biological intervention trials in patients with inflammatory arthritis: protocol for a metaepidemiological study focusing on contextual factors

• Lars Erik Kristensen,
• Daniel Furst,
• Torkell Ellingsen,
• Sabrina Mai Nielsen,
• Simon Tarp,
• Esben Malm,
• Johannes Berg,
• John P. A. Ioannidis,
• Josef S. Smolen,
• Peter C. Taylor

Affiliations

Lars Erik Kristensen

Section for Biostatistics and Evidence-Based Research, the Parker Institute, Bispebjerg and Frederiksberg Hospital, Copenhagen, Denmark

Daniel Furst

Division of Rheumatology, Department of Medicine, University of California at Los Angeles, LA, CA, USA

Torkell Ellingsen

Research Unit of Rheumatology, Department of Clinical Research, University of Southern Denmark, Odense University Hospital, Odense, Denmark

Sabrina Mai Nielsen

Section for Biostatistics and Evidence-Based Research, the Parker Institute, Bispebjerg and Frederiksberg Hospital, Copenhagen, Denmark

Simon Tarp

Section for Biostatistics and Evidence-Based Research, the Parker Institute, Bispebjerg and Frederiksberg Hospital, Copenhagen, Denmark

Esben Malm

Section for Biostatistics and Evidence-Based Research, the Parker Institute, Bispebjerg and Frederiksberg Hospital, Copenhagen, Denmark

Johannes Berg

Section for Biostatistics and Evidence-Based Research, the Parker Institute, Bispebjerg and Frederiksberg Hospital, Copenhagen, Denmark

John P. A. Ioannidis

Department of Medicine, Department of Epidemiology and Population Health, Department of Biomedical Data Science, Department of Statistics, and Meta-Research Innovation Center at Stanford (METRICS), Stanford University, Stanford, CA, USA

Josef S. Smolen

Division of Rheumatology, Department of Medicine, Medical University of Vienna, Vienna, Austria

Peter C. Taylor

Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, Oxford, UK