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OP0199 POINTS TO CONSIDER WHEN ANALYSING AND REPORTING COMPARATIVE EFFECTIVENESS RESEARCH WITH OBSERVATIONAL DATA IN RHEUMATOLOGY
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  1. D. Courvoisier1,
  2. K. Lauper1,
  3. S. A. Bergstra2,
  4. M. De Wit3,
  5. B. Fautrel4,
  6. T. Frisell5,
  7. K. Hyrich6,
  8. F. Iannone7,
  9. J. Kedra8,
  10. P. M. Machado9,
  11. L. Midtbøll Ørnbjerg10,
  12. Z. Rotar11,
  13. M. J. Santos12,
  14. T. Stamm13,
  15. S. Stones14,
  16. A. Strangfeld15,
  17. R. B. M. Landewé16,17,
  18. A. Finckh1
  1. 1Geneva University Hospitals, Geneva, Switzerland
  2. 2LUMC, Rheumatology, Leiden, Netherlands
  3. 3EULAR Patient Research Partner, Amsterdam, Netherlands
  4. 4Pitié-Salpêtrière Hospital, APHP, Rheumatology, Paris, France
  5. 5Karolinska Institutet, Clinical Epidemiology, Stockholm, Sweden
  6. 6University of Manchester, Centre for Epidemiology Versus Arthritis, Manchester, United Kingdom
  7. 7University Hospitals Bari, Rheumatology, Bari, Italy
  8. 8Institut Pierre-Louis d’épidémiologie et de Santé Publique, Paris, France
  9. 9University College London, Centre for Rheumatology & Department of Neuromuscular Diseases, London, United Kingdom
  10. 10Rigshospitalet, Center for Rheumatology and Spine Diseases, Copenhagen, Denmark
  11. 11University Medical Centre Ljubljana, Rheumatology, Ljubljana, Slovenia
  12. 12Faculdade Medicina de Lisboa, Rheumatology, Lisboa, Portugal
  13. 13Medical University Vienna, Centre for Medical Statistics, Informatics and Complex Systems, Vienna, Austria
  14. 14EULAR Patient Research Partner, London, United Kingdom
  15. 15Deutsches Rheuma-Forschungszentrum, Programme area Epidemiology, Berlin, Germany
  16. 16Zuyderland Medical Centre Heerlen, Rheumatology, Limburg, Netherlands
  17. 17Amsterdam University Medical Centres, Rheumatology, Amsterdam, Netherlands

Abstract

Background: Comparing drug effectiveness in observational settings is hampered by several major threats, among them confounding and attrition bias bias (patients who stop treatment no longer contribute information, which may overestimate true drug effectiveness).

Objectives: To present points to consider (PtC) when analysing and reporting comparative effectiveness with observational data in rheumatology (EULAR-funded taskforce).

Methods: The task force comprises 18 experts: epidemiologists, statisticians, rheumatologists, patients, and health professionals.

Results: A systematic literature review of methods currently used for comparative effectiveness research in rheumatology and a statistical simulation study were used to inform the PtC (table). Overarching principles focused on defining treatment effectiveness and promoting robust and transparent epidemiological and statistical methods increase the trustworthiness of the results.

Points to consider

Conclusion: The increased use of real-world comparative effectiveness studies makes it imperative to reduce divergent or contradictory results due to biases. Having clear recommendations for the analysis and reporting of these studies should promote agreement of observational studies, and improve studies’ trustworthiness, which may also facilitate meta-analysis of observational data.

Disclosure of Interests: Delphine Courvoisier: None declared, Kim Lauper: None declared, Sytske Anne Bergstra: None declared, Maarten de Wit Grant/research support from: Dr. de Wit reports personal fees from Ely Lilly, 2019, personal fees from Celgene, 2019, personal fees from Pfizer, 2019, personal fees from Janssen-Cilag, 2017, outside the submitted work., Consultant of: Dr. de Wit reports personal fees from Ely Lilly, 2019, personal fees from Celgene, 2019, personal fees from Pfizer, 2019, personal fees from Janssen-Cilag, 2017, outside the submitted work., Speakers bureau: Dr. de Wit reports personal fees from Ely Lilly, 2019, personal fees from Celgene, 2019, personal fees from Pfizer, 2019, personal fees from Janssen-Cilag, 2017, outside the submitted work., Bruno Fautrel Grant/research support from: AbbVie, Lilly, MSD, Pfizer, Consultant of: AbbVie, Biogen, BMS, Boehringer Ingelheim, Celgene, Lilly, Janssen, Medac MSD France, Nordic Pharma, Novartis, Pfizer, Roche, Sanofi Aventis, SOBI and UCB, Thomas Frisell: None declared, Kimme Hyrich Grant/research support from: Pfizer, UCB, BMS, Speakers bureau: Abbvie, Florenzo Iannone Consultant of: Speaker and consulting fees from AbbVie, Eli Lilly, Novartis, Pfizer, Roche, Sanofi, UCB, MSD, Speakers bureau: Speaker and consulting fees from AbbVie, Eli Lilly, Novartis, Pfizer, Roche, Sanofi, UCB, MSD, Joanna KEDRA: None declared, Pedro M Machado Consultant of: PMM: Abbvie, Celgene, Janssen, Lilly, MSD, Novartis, Pfizer, Roche and UCB, Speakers bureau: PMM: Abbvie, BMS, Lilly, MSD, Novartis, Pfizer, Roche and UCB, Lykke Midtbøll Ørnbjerg Grant/research support from: Novartis, Ziga Rotar Consultant of: Speaker and consulting fees from Abbvie, Amgen, Biogen, Eli Lilly, Medis, MSD, Novartis, Pfizer, Roche, Sanofi., Speakers bureau: Speaker and consulting fees from Abbvie, Amgen, Biogen, Eli Lilly, Medis, MSD, Novartis, Pfizer, Roche, Sanofi., Maria Jose Santos Speakers bureau: Novartis and Pfizer, Tanja Stamm Grant/research support from: AbbVie, Roche, Consultant of: AbbVie, Sanofi Genzyme, Speakers bureau: AbbVie, Roche, Sanofi, Simon Stones Consultant of: I have been a paid consultant for Envision Pharma Group and Parexel. This does not relate to this abstract., Speakers bureau: I have been a paid speaker for Actelion and Janssen. These do not relate to this abstract., Anja Strangfeld Speakers bureau: AbbVie, BMS, Pfizer, Roche, Sanofi-Aventis, Robert B.M. Landewé Consultant of: AbbVie; AstraZeneca; Bristol-Myers Squibb; Eli Lilly & Co.; Galapagos NV; Novartis; Pfizer; UCB Pharma, Axel Finckh Grant/research support from: Pfizer: Unrestricted research grant, Eli-Lilly: Unrestricted research grant, Consultant of: Sanofi, AB2BIO, Abbvie, Pfizer, MSD, Speakers bureau: Sanofi, Pfizer, Roche, Thermo Fisher Scientific

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