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  • Kwakkenbos, LindaBehavioural Science Institute, Clinical Psychology, Radboud University, Nijmegen, Netherlands (author)

CONSORT extension for the reporting of randomised controlled trials conducted using cohorts and routinely collected data (CONSORT-ROUTINE) : checklist with explanation and elaboration

  • Article/chapterEnglish2021

Publisher, publication year, extent ...

  • 2021-04-29
  • BMJ Publishing Group Ltd,2021
  • printrdacarrier

Numbers

  • LIBRIS-ID:oai:DiVA.org:oru-91686
  • https://urn.kb.se/resolve?urn=urn:nbn:se:oru:diva-91686URI
  • https://doi.org/10.1136/bmj.n857DOI
  • https://lup.lub.lu.se/record/27d9aeba-b7bb-457a-9688-06989e745070URI

Supplementary language notes

  • Language:English
  • Summary in:English

Part of subdatabase

Classification

  • Subject category:ref swepub-contenttype
  • Subject category:art swepub-publicationtype

Notes

  • Funding agencies:Canadian Institutes of Health Research (CIHR) PJT-156172 PCS-161863  United Kingdom National Institute of Health Research (NIHR) Clinical TrialsUnit Support FundingCanadian Institutes of Health Research (CIHR)Wellcome Senior Clinical Fellowship in Science 205039/Z/16/Z
  • Randomised controlled trials are increasingly conducted as embedded, nested, or using cohorts or routinely collected data, including registries, electronic health records, and administrative databases, to assess if participants are eligible for the trial and to facilitate recruitment, to deliver an embedded intervention, to collect trial outcome data, or a combination of these purposes. This report presents the Consolidated Standards of Reporting Trials (CONSORT) extension for randomised controlled trials conducted using cohorts and routinely collected data (CONSORT-ROUTINE). The extension was developed to look at the unique characteristics of trials conducted with these types of data with the goal of improving reporting quality in the long term by setting standards early in the process of uptake of these trial designs. The extension was developed with a sequential approach, including a Delphi survey, a consensus meeting, and piloting of the checklist. The checklist was informed by the CONSORT 2010 statement and two reporting guidelines for observational studies, the Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) statement and the REporting of studies Conducted using Observational Routinely collected Data (RECORD) statement. The extension includes eight items modified from the CONSORT 2010 statement and five new items. Reporting items with explanations and examples are provided, including key aspects of trials conducted using cohorts or routinely collected data that require specific reporting considerations.

Subject headings and genre

Added entries (persons, corporate bodies, meetings, titles ...)

  • Imran, MahrukhLady Davis Institute for Medical Research, Jewish General Hospital, Montreal, Canada (author)
  • McCall, Stephen J.National Perinatal Epidemiology Unit Clinical Trials Unit, Nuffield Department of Population Health, University of Oxford, Oxford, UK; Center for Research on Population and Health, Faculty of Health Sciences, American University of Beirut, Ras Beirut, Lebanon (author)
  • McCord, Kimberly A.Basel Institute for Clinical Epidemiology and Biostatistics, Department of Clinical Research, University Hospital Basel, University of Basel, Basel, Switzerland (author)
  • Fröbert, Ole,1964-Örebro University,Örebro universitet,Institutionen för medicinska vetenskaper,Department of Cardiology(Swepub:oru)oft (author)
  • Hemkens, Lars G.Basel Institute for Clinical Epidemiology and Biostatistics, Department of Clinical Research, University Hospital Basel, University of Basel, Basel, Switzerland; Meta-Research Innovation Center at Stanford (METRICS), Stanford University, Palo Alto, USA; Meta-Research Innovation Centre Berlin (METRIC-B), Berlin Institute of Health, Berlin, Germany (author)
  • Zwarenstein, MerrickDepartment of Family Medicine, Western University, London, Canada; ICES, Toronto, Canada,University of Western Ontario,Institute for Clinical Evaluative Sciences (ICES) (author)
  • Relton, ClareCentre for Clinical Trials and Methodology, Barts Institute of Population Health Science, Queen Mary University, London, UK (author)
  • Rice, Danielle B.Lady Davis Institute for Medical Research, Jewish General Hospital, Montreal, Canada; Department of Psychology, McGill University, Montréal, Québec, Canada (author)
  • Langan, Sinéad M.Faculty of Epidemiology and Population Health, London School of Hygiene and Tropical Medicine, London, UK (author)
  • Benchimol, Eric I.ICES, Toronto, Canada; Department of Paediatrics, University of Toronto, Toronto, Canada; Division of Gastroenterology, Hepatology, and Nutrition and Child Health Evaluative Sciences, SickKids Research Institute, The Hospital for Sick Children, Toronto, Canada,Institute for Clinical Evaluative Sciences (ICES) (author)
  • Thabane, LehanaDepartment of Health Research Methods, Evidence, and Impact, McMaster University, Hamilton, Canada (author)
  • Campbell, Marion K.Health Services Research Unit, University of Aberdeen, Aberdeen, UK (author)
  • Sampson, MargaretLibrary Services, Children's Hospital of Eastern Ontario, Ottawa, Canada (author)
  • Erlinge, DavidLund University,Lunds universitet,Kardiologi,Sektion II,Institutionen för kliniska vetenskaper, Lund,Medicinska fakulteten,Molekylär kardiologi,Forskargrupper vid Lunds universitet,Cardiology,Section II,Department of Clinical Sciences, Lund,Faculty of Medicine,Molecular Cardiology,Lund University Research Groups(Swepub:lu)kard-der (author)
  • Verkooijen, Helena M.University Medical Centre Utrecht, Utrecht, Netherlands; University of Utrecht, Utrecht, Netherlands (author)
  • Moher, DavidCentre for Journalology, Clinical Epidemiology Program, Ottawa Hospital Research Institute, Ottawa, Canada (author)
  • Boutron, IsabelleUniversité de Paris, Centre of Research Epidemiology and Statistics (CRESS), Inserm, INRA, Paris, France; Centre d'Épidémiologie Clinique, Assistance Publique-Hôpitaux de Paris (AP-HP), Hôpital Hôtel Dieu, Paris, France,Centre of Epidemiology And Biostatistics Sorbonne Paris Cité Center (CRESS) (author)
  • Ravaud, PhilippeUniversité de Paris, Centre of Research Epidemiology and Statistics (CRESS), Inserm, INRA, Paris, France; Centre d'Épidémiologie Clinique, Assistance Publique-Hôpitaux de Paris (AP-HP), Hôpital Hôtel Dieu, Paris, France,Centre of Epidemiology And Biostatistics Sorbonne Paris Cité Center (CRESS) (author)
  • Nicholl, JonSchool of Health and Related Research, University of Sheffield, Sheffield, UK (author)
  • Uher, RudolfDepartment of Psychiatry, Dalhousie University, Halifax, Canada (author)
  • Sauvé, MaureenScleroderma Society of Ontario, Hamilton, Canada; Scleroderma Canada, Hamilton, Canada (author)
  • Fletcher, JohnThe BMJ,British Medical Journal (author)
  • Torgerson, DavidYork Trials Unit, Department of Health Sciences, University of York, York, UK (author)
  • Gale, ChrisNeonatal Medicine, School of Public Health, Faculty of Medicine, Imperial College London, Chelsea and Westminster campus, London, UK (author)
  • Juszczak, EdmundNational Perinatal Epidemiology Unit Clinical Trials Unit, Nuffield Department of Population Health, University of Oxford, Oxford, UK; Nottingham Clinical Trials Unit, University of Nottingham, University Park, Nottingham, UK (author)
  • Thombs, Brett D.Lady Davis Institute for Medical Research, Jewish General Hospital, Montreal, Canada; Departments of Psychiatry, Epidemiology, Biostatistics, and Occupational Health Medicine and Educational and Counselling Psychology and Biomedical Ethics Unit, McGill University, Montreal, Canada (author)
  • Behavioural Science Institute, Clinical Psychology, Radboud University, Nijmegen, NetherlandsLady Davis Institute for Medical Research, Jewish General Hospital, Montreal, Canada (creator_code:org_t)

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  • In:The BMJ: BMJ Publishing Group Ltd3731756-18330959-8146

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