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Made available in DSpace on 2022-04-28T19:29:02Z (GMT). No. of bitstreams: 0 Previous issue date: 2020-07-01 Medical Research Council Canada National Institute for Health Research Objectives: To develop consensus definitions for the core outcome set for pre-eclampsia. Study design: Potential definitions for individual core outcomes were identified across four formal definition development initiatives, nine national and international guidelines, 12 Cochrane systematic reviews, and 79 randomised trials. Eighty-six definitions were entered into the consensus development meeting. Ten healthcare professionals and three researchers, including six participants who had experience of conducting research in low- and middle-income countries, participated in the consensus development process. The final core outcome set was approved by an international steering group. Results: Consensus definitions were developed for all core outcomes. When considering stroke, pulmonary oedema, acute kidney injury, raised liver enzymes, low platelets, birth weight, and neonatal seizures, consensus definitions were developed specifically for low- and middle-income countries because of the limited availability of diagnostic interventions including computerised tomography, chest x-ray, laboratory tests, equipment, and electroencephalogram monitoring. Conclusions: Consensus on measurements for the pre-eclampsia core outcome set will help to ensure consistency across future randomised trials and systematic reviews. Such standardization should make research evidence more accessible and facilitate the translation of research into clinical practice. Video abstract can be available at: www.dropbox.com/s/ftrgvrfu0u9glqd/6.%20Standardising%20definitions%20in%20teh%20pre-eclampsia%20core%20outcome%20set%3A%20a%20consensus%20development%20study.mp4?dl=0. Nuffield Department of Primary Care Health Sciences University of Oxford Institute for Women’s Health University College London Department of Women and Children’s Health School of Life Course Sciences King’s College London Department of Obstetrics and Gynecology Amsterdam UMC Academic Medical Center Academic Neonatal Medicine Imperial College London Department of Renal Medicine St George Hospital and University of New South Wales Department of Obstetrics and Gynaecology Feinberg School of Medicine Northwestern University Health Services Research Unit Nuffield Department of Population Health University of Oxford Cedars-Sinai Medical Center London North West University Healthcare NHS Trust Women’s Health Care Research Group Department of Obstetrics and Gynaecology Monash University Department of Obstetrics and Gynaecology University of Adelaide Women’s Health Research Unit Barts and The London School of Medicine and Dentistry School of Health and Related Research University of Sheffield MRC North West Hub for Trials Methodology Research Department of Biostatistics University of Liverpool Centro Rosarino de Estudios Perinatales Chelsea and Westminster Hospital NHS Foundation Trust Babcock University Ailem Academic Counselling KU Leuven Universidad Nacional de Colombia Northwell Health University of Oxford Université de Montréal University of Montreal Hospital Centre Ondokuz Mayıs University Prince Sultan Military Medical City Postgraduate Institute of Medical Education and Research King's Fertility Fetal Medicine Research Institute University Hospital Limerick Drexel University University of Aberdeen University of Groningen University of Auckland Haaglanden Medisch Centrum Nottingham University Medical School Utrecht University King Edward Memorial Hospital for Women Imperial College Healthcare NHS Trust Jean-Verdier Hospital Downland Practice University of Campinas Université Lyon University of North Carolina School of Medicine South Ural State Medical University Stellenbosch University Irish Neonatal Health Alliance University of Rzeszow Royal Brisbane and Women’s Hospital Nottingham University Hospitals NHS Trust University Hospitals of Leicester North Bristol NHS Trust University of Nottingham Soroka University Medical Center Ben Gurion University of the Negev St George’s University Hospitals NHS Foundation Trust Hospitalsenhed Midt University of Glasgow Amsterdam Universitair Medische Centra All India Institute of Medical Sciences Patna Luton and Dunstable University Hospital Khyber Medical University Institution of Medical Sciences Midwife Mid Essex Hospitals NHS Trust University of Oulu University of Michigan Bastyr University Irish Nurses and Midwives Organisation University of Toronto Barts Health NHS Trust University Hospitals Plymouth NHS Trust Burnet Institute Aga Khan University Medical University of Graz Homerton University Hospital NHS Foundation Trust Mount Royal University Université de Paris Royal Surrey County Hospital University Hospital Southampton NHS Foundation Trust University of Washington School of Nursing Evelina London Children's Hospital Neonatal Unit University of Sydney University of Leicester Academic Hospital of Udine NHS Borders Weill Cornell Medical College University of Dundee University of Edinburgh South Australian Health and Medical Research Institute University of Sheffield Monash University and Monash Health United Lincolnshire Hospitals NHS Trust University of Kwa Zulu-Natal Beatrix Hospital Keele University Government Medical College Institut Catala de la Salut. IdiapJgol University College London National Center for Child Health and Development Basavatarakam Indo-American Cancer Hospital and Research Institute Axon Anaesthesia Associates Pennine Acute Hospitals NHS Trust St George's University of London Norfolk and Norwich University Hospital Jichi Medical University School of Medicine São Paulo State University National Institute of Public Health University of Kyrenia King Edward Memorial Hospital Amsterdam University Centres University of British Columbia Chulalongkorn University University of Brescia University Of British Columbia University of Montreal Women's Clinic of Tartu University Hospital Universidade Federal de São Paulo Université de Sherbrooke University Hospital of Wales University of Iowa King's College London Westmead Hospital Princess Royal Maternity Leipzig University Centre Hospitalier Public du Cotentin Lewisham and Greenwich NHS Trust Juntendo University Faculty of Medicine Western Sydney University National Institute of Health Research University of Washington Baylor College of Medicine Capelle aan den Ijssel Sanatorio Anchorena Oxford University Hospitals NHS Foundation Trust University of Leeds Institute of Medical Sciences UPMC Magee Womens Hospital Penn Medicine Princeton Health University of North Carolina at Chapel Hill São Paulo State University

Rationale and background: The global rapid spread of COVID-19 caused by the SARS-CoV-2 triggered the need for developing vaccines to control for this pandemic. This study aimed to generate background incidence rates of adverse events of special interest (AESI) that may be used to monitor benefit-risk profile of COVID-19 vaccines. Data sources: This study included 10 data sources from 7 European countries (Denmark, Germany, France, Italy, Netherlands, Spain, United Kingdom). Data sources contain health insurance data (GePaRD, SNDS), hospitalisation record linkage data (PHARMO, Danish registries (DCE-AU), SIDIAP, ARS) or data from general practitioners (CPRD, PEDIANET, BIFAP, FISABIO). For this final report data from 9 data sources were included. Study size: The study population for the total study comprised approximately 141.6 million individuals. In this final report, a total number of 45 million individuals were included. An update including French data is expected later this year Results This report comprises background rate data on AESI from 6 countries (UK, ES, IT, DK, NL, DE) and 9 data sources(BIFAP, Pedianet (children only), CPRD, ARS, Danish registries, FISABIO, SIDIAP, PHARMO, GeParD). Data from France (SNDS) could not be generated in a timely manner due to administrative constraints in data release. Data sources included different subpopulations based on the availability of numerator data of the observed persontime (Hosp= hospital based, PC= primary care, HOSP-PC= overlap between hospitalization and primary care). This entry also includes the results in excel format and also the links to the codes and event definitions, This protocol has been accepted by EMA as a deliverable of the framework contract No EMA/2018/28/PE. The protocol expresses the expertise of the authors and the ACCESS consortium as well as feedback received from EMA. It may not be understood or quoted as being made on beh behalf, or reflecting the position of the European Medicines Agency or one of its Committees or Working Parties. For questions please contact: m.c.j.sturkenboom@umcutrecht.nl