Real-world evidence: new opportunities for osteoporosis research. Recommendations from a Working Group from the European Society for Clinical and Economic Aspects of Osteoporosis, Osteoarthritis and Musculoskeletal Diseases (ESCEO) Osteoporosis International
Abstract Summary This narrative review summarises the recommendations of a Working Group of the European Society for Clinical and Economic Aspects of Osteoporosis, Osteoarthritis and Musculoskeletal Diseases (ESCEO) for the conduct and reporting of real-world evidence studies with a focus on osteoporosis research. Purpose Vast amounts of data are routinely generated at every healthcare contact and activity, and there is increasing recognition that these real-world data can be analysed to generate scientific evidence. Real-world evidence (RWE) is increasingly used to delineate the natural history of disease, assess real-life drug effectiveness, understand adverse events and in health economic analysis. The aim of this work was to understand the benefits and limitations of this type of data and outline approaches to ensure that transparent and high-quality evidence is generated. Methods A ESCEO Working Group was convened in December 2022 to discuss the applicability of RWE to osteoporosis research and approaches to best practice. Results This narrative review summarises the agreed recommendations for the conduct and reporting of RWE studies with a focus on osteoporosis research. Conclusions It is imperative that research using real-world data is conducted to the highest standards with close attention to limitations and biases of these data, and with transparency at all stages of study design, data acquisition and curation, analysis and reporting to increase the trustworthiness of RWE study findings. Keywords: Drug effectiveness, Fracture, Osteoporosis, Real-world evidence, Epidemiology, Registry
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Rebecca J Moon, Jean-Yves Reginster, Nasser M Al-Daghri et al.. Real-world evidence: new opportunities for osteoporosis research. Recommendations from a Working Group from the European Society for Clinical and Economic Aspects of Osteoporosis, Osteoarthritis and Musculoskeletal Diseases (ESCEO). Osteoporosis International. (2023). https://doi.org/10.1007/s00198-023-06827-2 Rebecca J Moon, Jean-Yves Reginster, Nasser M Al-Daghri, Jotheeswaran A Thiyagarajan, Charlotte Beaudart, Olivier Bruyère, Nansa Burlet, Manju Chandran, Mario Coelho da Silva, Philip G Conaghan, Willard H Dere, Adolfo Diez-Perez, Peyman Hadji, Philippe Halbout, Mickaël Hiligsmann, John A Kanis, Eugene V McCloskey, Sif Ormarsdottir, Daniel Prieto-Alhambra, Régis P Radermecker, René Rizzoli, Yousef Al-Saleh, Stuart L Silverman, Lee S Simon, Friederike Thomasius, Tjeerd van Staa, Andrea Laslop, Cyrus Cooper, Nicholas C Harvey
1MRC Lifecourse Epidemiology Centre, University of Southampton, Southampton, SO16 6YD UK 2Paediatric Endocrinology, University Hospital Southampton NHS Foundation Trust, Southampton, UK 3WHO Collaborating Center for Epidemiology of Musculoskeletal Health and Ageing, Liège, Belgium 4Division of Epidemiology, Public Health and Health Economics, University of Liège, Liège, Belgium 5Biochemistry Department, College of Science, King Saud University, Riyadh, Saudi Arabia 6Ageing and Health Unit, World Health Organisation, Geneva, Switzerland 7Osteoporosis and Bone Metabolism Unit, Department of Endocrinology, Singapore General Hospital, Singapore, Singapore 8Laboratory of Clinical and Therapeutical Pharmacology, Lisbon, Portugal 9Leeds Institute of Rheumatic and Musculoskeletal Medicine, University of Leeds, Leeds, UK 10NIHR Leeds Musculoskeletal Biomedical Research Unit, Leeds, UK 11Department of Internal Medicine, Utah Center for Clinical and Translational Science, University of Utah School of Medicine, Salt Lake City, UT USA 12Department of Internal Medicine, Hospital del Mar-IMIM, Autonomous University of Barcelona and CIBERFES, Instituto Carlos III, Barcelona, Spain 13Frankfurt Centre for Bone Health, Frankfurt, Germany 14Philipps University of Marburg, Hesse, Germany 15International Osteoporosis Foundation, Nyon, Switzerland 16Department of Health Services Research, CAPHRI Care and Public Health Research Institute, Maastricht University, Maastricht, the Netherlands 17Mary McKillop Institute for Health Research, Australian Catholic University, Melbourne, Australia 18Centre for Metabolic Bone Diseases, University of Sheffield, Sheffield, UK 19MRC Versus Arthritis Centre for Integrated Research in Musculoskeletal Ageing, University of Sheffield, Sheffield, UK 20Mellanby Centre for Musculoskeletal Research, Department of Oncology & Metabolism, University of Sheffield, Sheffield, UK 21Icelandic Medicines Agency, Reykjavik, Iceland 22Pharmaco- and Device Epidemiology, Centre for Statistics in Medicine, Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences (NDORMS), University of Oxford, Oxford, UK 23Department of Clinical Pharmacology, Diabetes, Nutrition and Metabolic Disorders, CHU Liege, Liege, Belgium 24Geneva University Hospitals and Faculty of Medicine, Geneva, Switzerland 25College of Medicine, King Saud Bin Abdulaziz University for Health Sciences, Riyadh, Saudi Arabia 26King Abdullah International Medical Research Center, Riyadh, Saudi Arabia 27Department of Medicine, King Abdulaziz Medical City, Riyadh, Ministry of National Guard-Health Affairs, Riyadh, Saudi Arabia 28Cedars Sinai Medical Center, Los Angeles, USA 29SDG LLC, Cambridge, MA USA 30Centre for Health Informatics, University of Manchester, Manchester, UK 31Scientific Office, Austrian Medicines and Medical Devices Agency, Vienna, Austria 32NIHR Southampton Biomedical Research Centre, University of Southampton and University Hospital Southampton NHS Foundation Trust, Southampton, UK 33National Institute for Health Research (NIHR) Musculoskeletal Biomedical Research Centre, University of Oxford, Oxford, UK 