The reporting of observational studies of drug effectiveness and safety: recommendations to extend existing guidelines.

Autor:	Cragg JJ; Faculty of Pharmaceutical Sciences, University of British Columbia , Vancouver, BC, Canada.; International Collaboration on Repair Discoveries (ICORD), University of British Columbia , Vancouver, BC, Canada., Azoulay L; Department of Epidemiology, Biostatistics, and Occupational Health, McGill University , Montreal, QC, Canada., Collins G; Centre for Statistics in Medicine, University of Oxford , Oxford, United Kingdom & EQUATOR., De Vera MA; Faculty of Pharmaceutical Sciences, University of British Columbia , Vancouver, BC, Canada., Etminan M; Departments of Ophthalmology and Medicine, Faculty of Medicine, University of British Columbia , Vancouver, BC, Canada., Lalji F; Faculty of Pharmaceutical Sciences, University of British Columbia , Vancouver, BC, Canada., Gershon AS; Department of Medicine, University of Toronto , Toronto, Ontario., Guyatt G; Department of Health Research Methods, Evidence & Impact, McMaster University , Hamilton, Ontario, Canada., Harrison M; Faculty of Pharmaceutical Sciences, University of British Columbia , Vancouver, BC, Canada.; Center for Health Evaluation and Outcome Sciences (CHEOS), St. Paul's Hospital , Vancouver, BC, Canada., Jutzeler C; Department of Biosystems Science & Engineering, ETH Zurich , Zurich, Switzerland., Kassam R; School of Population and Public Health, University of British Columbia , Vancouver, BC, Canada., Kendzerska T; Department of Medicine, University of Ottawa , Ottawa, Ontario, Canada., Lynd L; Faculty of Pharmaceutical Sciences, University of British Columbia , Vancouver, BC, Canada., Mansournia MA; Department of Epidemiology and Biostatistics, School of Public Health, Tehran University of Medical Sciences , Tehran, Iran., Sadatsafavi M; Faculty of Pharmaceutical Sciences, University of British Columbia , Vancouver, BC, Canada., Tong B; International Collaboration on Repair Discoveries (ICORD), University of British Columbia , Vancouver, BC, Canada., Warner FM; Faculty of Pharmaceutical Sciences, University of British Columbia , Vancouver, BC, Canada., Tremlett H; Division of Neurology, Department of Medicine, University of British Columbia , Vancouver, BC, Canada.
Jazyk:	angličtina
Zdroj:	Expert opinion on drug safety [Expert Opin Drug Saf] 2021 Jan; Vol. 20 (1), pp. 1-8. Date of Electronic Publication: 2020 Dec 21.
DOI:	10.1080/14740338.2021.1849134
Abstrakt:	Introduction: The use of observational data to assess drug effectiveness and safety can provide relevant information, much of which may not be feasible to obtain through randomized clinical trials. Because observational studies provide critical drug safety and effectiveness information that influences drug policy and prescribing practices, transparent, consistent, and accurate reporting of these studies is critical. Areas Covered: We provide recommendations to extend existing reporting guidelines, covering the main components of primary research studies (methods, results, discussion). Expert Opinion: Our recommendations include extending drug safety and effectiveness guidelines to include explicit checklist items on: study registration, causal diagrams, rationale for measures of effect, comprehensive assessment of bias, comprehensive data cleaning steps, drug equivalents, subject-level drug data visualization, sex and gender-based analyses and results, patient-oriented outcomes, and patient involvement in research.
Databáze:	MEDLINE
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