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).

Autor: Moon RJ; MRC Lifecourse Epidemiology Centre, University of Southampton, Southampton, SO16 6YD, UK.; Paediatric Endocrinology, University Hospital Southampton NHS Foundation Trust, Southampton, UK., Reginster JY; WHO Collaborating Center for Epidemiology of Musculoskeletal Health and Ageing, Liège, Belgium.; Division of Epidemiology, Public Health and Health Economics, University of Liège, Liège, Belgium., Al-Daghri NM; Biochemistry Department, College of Science, King Saud University, Riyadh, Saudi Arabia., Thiyagarajan JA; Ageing and Health Unit, World Health Organisation, Geneva, Switzerland., Beaudart C; WHO Collaborating Center for Epidemiology of Musculoskeletal Health and Ageing, Liège, Belgium.; Division of Epidemiology, Public Health and Health Economics, University of Liège, Liège, Belgium., Bruyère O; WHO Collaborating Center for Epidemiology of Musculoskeletal Health and Ageing, Liège, Belgium.; Division of Epidemiology, Public Health and Health Economics, University of Liège, Liège, Belgium., Burlet N; Division of Epidemiology, Public Health and Health Economics, University of Liège, Liège, Belgium., Chandran M; Osteoporosis and Bone Metabolism Unit, Department of Endocrinology, Singapore General Hospital, Singapore, Singapore., da Silva MC; Laboratory of Clinical and Therapeutical Pharmacology, Lisbon, Portugal., Conaghan PG; Leeds Institute of Rheumatic and Musculoskeletal Medicine, University of Leeds, Leeds, UK.; NIHR Leeds Musculoskeletal Biomedical Research Unit, Leeds, UK., Dere WH; Department of Internal Medicine, Utah Center for Clinical and Translational Science, University of Utah School of Medicine, Salt Lake City, UT, USA., Diez-Perez A; Department of Internal Medicine, Hospital del Mar-IMIM, Autonomous University of Barcelona and CIBERFES, Instituto Carlos III, Barcelona, Spain., Hadji P; Frankfurt Centre for Bone Health, Frankfurt, Germany.; Philipps University of Marburg, Hesse, Germany., Halbout P; International Osteoporosis Foundation, Nyon, Switzerland., Hiligsmann M; Department of Health Services Research, CAPHRI Care and Public Health Research Institute, Maastricht University, Maastricht, the Netherlands., Kanis JA; Mary McKillop Institute for Health Research, Australian Catholic University, Melbourne, Australia.; Centre for Metabolic Bone Diseases, University of Sheffield, Sheffield, UK., McCloskey EV; MRC Versus Arthritis Centre for Integrated Research in Musculoskeletal Ageing, University of Sheffield, Sheffield, UK.; Mellanby Centre for Musculoskeletal Research, Department of Oncology & Metabolism, University of Sheffield, Sheffield, UK., Ormarsdottir S; Icelandic Medicines Agency, Reykjavik, Iceland., Prieto-Alhambra D; Pharmaco- and Device Epidemiology, Centre for Statistics in Medicine, Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences (NDORMS), University of Oxford, Oxford, UK., Radermecker RP; Department of Clinical Pharmacology, Diabetes, Nutrition and Metabolic Disorders, CHU Liege, Liege, Belgium., Rizzoli R; Geneva University Hospitals and Faculty of Medicine, Geneva, Switzerland., Al-Saleh Y; College of Medicine, King Saud Bin Abdulaziz University for Health Sciences, Riyadh, Saudi Arabia.; King Abdullah International Medical Research Center, Riyadh, Saudi Arabia.; Department of Medicine, King Abdulaziz Medical City, Riyadh, Ministry of National Guard-Health Affairs, Riyadh, Saudi Arabia., Silverman SL; Cedars Sinai Medical Center, Los Angeles, USA., Simon LS; SDG LLC, Cambridge, MA, USA., Thomasius F; Frankfurt Centre for Bone Health, Frankfurt, Germany., van Staa T; Centre for Health Informatics, University of Manchester, Manchester, UK., Laslop A; Scientific Office, Austrian Medicines and Medical Devices Agency, Vienna, Austria., Cooper C; MRC Lifecourse Epidemiology Centre, University of Southampton, Southampton, SO16 6YD, UK.; NIHR Southampton Biomedical Research Centre, University of Southampton and University Hospital Southampton NHS Foundation Trust, Southampton, UK.; National Institute for Health Research (NIHR) Musculoskeletal Biomedical Research Centre, University of Oxford, Oxford, UK., Harvey NC; MRC Lifecourse Epidemiology Centre, University of Southampton, Southampton, SO16 6YD, UK. nch@mrc.soton.ac.uk.; NIHR Southampton Biomedical Research Centre, University of Southampton and University Hospital Southampton NHS Foundation Trust, Southampton, UK. nch@mrc.soton.ac.uk.
Jazyk: angličtina
Zdroj: Osteoporosis international : a journal established as result of cooperation between the European Foundation for Osteoporosis and the National Osteoporosis Foundation of the USA [Osteoporos Int] 2023 Aug; Vol. 34 (8), pp. 1283-1299. Date of Electronic Publication: 2023 Jun 23.
DOI: 10.1007/s00198-023-06827-2
Abstrakt: 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.
(© 2023. The Author(s).)
Databáze: MEDLINE
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