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Sökning: onr:"swepub:oai:DiVA.org:oru-77762" > Introducing the CON...

Introducing the CONsolidated Standards of Reporting Trials (CONSORT) statement for randomised controlled trials (RCTs) using cohorts and routinely collected health data

Juszczak, Edmund (författare)
National Perinatal Epidemiology Unit, Nuffield Department of Population Health, University of Oxford, Oxford, United Kingdom
Kwakkenbos, Linda (författare)
Behavioural Science Institute, Clinical Psychology, Radboud University, Nijmegen, The Netherlands
McCall, Stephen (författare)
National Perinatal Epidemiology Unit, Nuffield Department of Population Health, University of Oxford, Oxford, United Kingdom
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Imran, Mahrukh (författare)
Lady Davis Institue for Medical Research, Jewish General Hospital, Montreal, Canada
Hemkens, Lars G. (författare)
Basel Institute for Clinical Epidemiology and Biostatistics, Department of Clinical Research, University Hospital Basel, University of Basel, Basel, Switzerland
Zwarenstein, Merrick (författare)
Depts of Family Medicine and Epidemiology/Biostatistics, Western University, London, Canada
Fröbert, Ole, 1964- (författare)
Örebro universitet,Institutionen för medicinska vetenskaper
Relton, Clare (författare)
Pragmatic Clinical Trials Unit, Queen Mary University of London, London, United Kingdom
Sampson, Margaret (författare)
CHEO, Ottawa, Canada
Thabane, Chair Lehana (författare)
Biostatistics Unit (St Joseph's Healthcare)/FSORC, Hamilton, Canada
Benchimol, Eric I. (författare)
Department of Pediatrics and School of Epidemiology and Public Health, University of Ottawa, Ottawa, Canada
Campbell, Marion K. (författare)
University of Aberdeen, Aberdeen, United Kingdom
Torgerson, David J. (författare)
University of York, York, United Kingdom
Erlinge, David (författare)
Department of Cardiology, Lund University, Skane University Hospital, Lund, Sweden
Rice, Danielle B. (författare)
McGill University, Montreal, Canada
Langan, Sinead (författare)
London School of Hygiene and Tropical Medicine, London, United Kingdom
Mc Cord, Kimberly A. (författare)
Basel Institute for Clinical Epidemiology and Biostatistics, Department of Clinical Research, University Hospital Basel, University of Basel, Basel, Switzerland
van Staa, Tjeerd P. (författare)
University of Manchester, Manchester, United Kingdom
Moher, David (författare)
Centre for Journalology, Clinical Epidemiology Program, Ottawa Hospital Research Institute, Ottawa, Canada
Verkooijen, Helena M. (författare)
University Medical Center Utrecht, Utrecht, the Netherlands
Uher, Rudolf (författare)
Dalhousie Unversity, Department of Psychiatry, Halifax, Canada
Worron-Sauve, Maureen B. (författare)
Scleroderma Canada, Hamilton, Canada
Boutron, Isabelle (författare)
Université de Paris, Paris, France
Ravaud, Philippe (författare)
Centre de Recherche Épidémiologie et Statistique Sorbonne Paris Cité (CRESS-UMR1153), Paris, France
Thombs, Brett D. (författare)
Lady Davis Institue for Medical Research, Jewish General Hospital, Montreal, Canada
Gale, Chris (författare)
Imperial College London, London, United Kingdom
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 (creator_code:org_t)
BMC, 2019
2019
Engelska.
Ingår i: Trials. - : BMC. - 1745-6215. ; 20:Suppl. 1, s. 131-131
Relaterad länk:
https://urn.kb.se/re...
  • Tidskriftsartikel (övrigt vetenskapligt/konstnärligt)
Abstract Ämnesord
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  • Background: Randomised controlled trials (RCTs) are increasingly being conducted using existing sources of data, such as cohorts, administrative databases, disease registries and electronic health records. RCTs conducted using existing data sources require additional information to be reported. This reporting guideline is an extension of the 2010 version of the Consolidated Standards of Reporting Trials (CONSORT) Statement for RCTs using cohorts and routinely collected health data.Methods: A long-list of potential items for the checklist was identified through two methods: firstly, modifications to the current CONSORT checklist were generated using existing reporting guidelines, including the Reporting of Observational Studies in Epidemiology (STROBE) and REporting of studies Conducted using Observational Routinely-collected health Data (RECORD) statements. Secondly, ascoping review of RCTs conducted in the last decade using cohorts and routinely collected health data facilitated the modification and identification of other potential items. Using the long-list, a three-stage Delphi exercise was conducted to assess the importance of each item for inclusion in the final extension checklist, which was finalised at a face-to-face meeting of experts.Results: A long-list of 27 items was created and 125 experts registered for the three-round Delphi exercise (92, 77 and 62 experts participated in each round respectively). Consensus was reached on 21 out of 27 items. The results of the Delphi exercise informed a face-to-face consensus meeting in May 2019; core items to be included in the extension checklist were finalised at this meeting. Corresponding explanations of extensions and new items with examples of good reporting were developed subsequently.Conclusion: The guideline checklist can facilitate transparent reporting of RCTs using cohorts and routinely collected health data, to assist evaluations of rigour and reproducibility, enhance understanding of the methodology, and make the results more useful for clinicians, journal editors, reviewers, guideline authors, and funders.

Ämnesord

MEDICIN OCH HÄLSOVETENSKAP  -- Hälsovetenskap -- Hälso- och sjukvårdsorganisation, hälsopolitik och hälsoekonomi (hsv//swe)
MEDICAL AND HEALTH SCIENCES  -- Health Sciences -- Health Care Service and Management, Health Policy and Services and Health Economy (hsv//eng)

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