Methods and results used in the development of a consensus-driven extension to the Consolidated Standards of Reporting Trials (CONSORT) statement for trials conducted using cohorts and routinely collected data (CONSORT-ROUTINE)

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Methods and results used in the development of a consensus-driven extension to the Consolidated Standards of Reporting Trials (CONSORT) statement for trials conducted using cohorts and routinely collected data (CONSORT-ROUTINE)

Imran, Mahrukh (författare): Lady Davis Institute for Medical Research, Jewish General Hospital, Montreal, Québec, Canada

Kwakkenbos, Linda (författare): Behavioural Science Institute, Clinical Psychology, Radboud University, Nijmegen, Netherlands

McCall, Stephen J. (författare): 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; Institute of Applied Health Sciences, School of Medicine, Medical Sciences and Nutrition, University of Aberdeen, Aberdeen, UK

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McCord, Kimberly A. (författare): Basel Institute for Clinical Epidemiology and Biostatistics, Department of Clinical Research, University Hospital Basel, University of Basel, Basel, Switzerland

Fröbert, Ole, 1964- (författare): Örebro University,Örebro universitet,Institutionen för medicinska vetenskaper,Department of Cardiology

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): Department of Family Medicine, Western University, London, Ontario, Canada; IC/ES Western, London, Ontario, Canada

Relton, Clare (författare): Centre for Clinical Trials and Methodology, Barts Institute of Population Health Science, Queen Mary University, London, UK

Rice, Danielle B. (författare): Lady Davis Institute for Medical Research, Jewish General Hospital, Montreal, Québec, Canada; Department of Psychology, McGill University, Montreal, Quebec, Canada

Langan, Sinéad M. (författare): Faculty of Epidemiology and Population Health, London School of Hygiene and Tropical Medicine, London, UK

Benchimol, Eric I. (författare): Department of Pediatrics and School of Epidemiology and Public Health, University of Ottawa, Ottawa, Ontario, Canada; ICES uOttawa, Ottawa, Ontario, Canada; Children's Hospital of Eastern Ontario Research Institute, Ottawa, Ontario, Canada

Thabane, Lehana (författare): Department of Health Research Methods, Evidence, and Impact, McMaster University, Hamilton, Ontario, Canada

Campbell, Marion K. (författare): Health Services Research Unit, University of Aberdeen, Aberdeen, UK

Sampson, Margaret (författare): Library Services, Children's Hospital of Eastern Ontario, Ontario, Ottawa, Canada

Erlinge, David (författare): Lund 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

Verkooijen, Helena M. (författare): University Medical Center Utrecht, Utrecht, Netherlands; University of Utrecht, Utrecht, Netherlands

Moher, David (författare): Centre for Journalology, Clinical Epidemiology Program, Ottawa Hospital Research Institute, Ottawa, Ontario, Canada

Boutron, Isabelle (författare): INSERM, Paris, France; Centre d'Épidémiologie Clinique, Hôpital Hôtel Dieu, Assistance Publique-Hôpitaux de Paris, Paris, France; Faculté de Médecine, Université Paris Descartes, Sorbonne Paris Cité, Paris, France,Paris Diderot University,Institut Gustave Roussy

Ravaud, Philippe (författare): INSERM, Paris, France; Centre d'Épidémiologie Clinique, Hôpital Hôtel Dieu, Assistance Publique-Hôpitaux de Paris, Paris, France; Faculté de Médecine, Université Paris Descartes, Sorbonne Paris Cité, Paris, France,Paris Diderot University,Institut Gustave Roussy

Nicholl, Jon (författare): School of Health and Related Research, University of Sheffield, Sheffield, UK

Uher, Rudolf (författare): Department of Psychiatry, Dalhousie University, Halifax, Nova Scotia, Canada

Sauvé, Maureen (författare): Scleroderma Society of Ontario, Hamilton, Ontario, Canada; Scleroderma Canada, Hamilton, Ontario, Canada

Fletcher, John (författare): British Medical Journal, London, UK

Torgerson, David (författare): York Trials Unit, Department of Health Sciences, University of York, York, UK

Gale, Chris (författare): Neonatal Medicine, School of Public Health, Faculty of Medicine, Imperial College London, London, UK

Juszczak, Edmund (författare): National Perinatal Epidemiology Unit Clinical Trials Unit, Nuffield Department of Population Health, University of Oxford, Oxford, UK; Nottingham Clinical Trials Unit, University of Nottingham, Nottingham, UK

Thombs, Brett D. (författare): Lady Davis Institute for Medical Research, Jewish General Hospital, Montreal, Québec, Canada; Departments of Psychiatry, Epidemiology, Biostatistics and Occupational Health, Medicine and Educational and Counselling Psychology and Biomedical Ethics Unit, McGill University, Montreal, Quebec, Canada

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2021-04-29
2021
Engelska.
Ingår i: BMJ Open. - : BMJ Publishing Group Ltd. - 2044-6055. ; 11:4

Relaterad länk:: https://doi.org/10.1...; visa fler...; https://bmjopen.bmj....; http://dx.doi.org/10... (free); https://urn.kb.se/re...; https://doi.org/10.1...; https://lup.lub.lu.s...; visa färre...

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OBJECTIVES: Randomised controlled trials conducted using cohorts and routinely collected data, including registries, electronic health records and administrative databases, are increasingly used in healthcare intervention research. A Consolidated Standards of Reporting Trials (CONSORT) statement extension for trials conducted using cohorts and routinely collected data (CONSORT-ROUTINE) has been developed with the goal of improving reporting quality. This article describes the processes and methods used to develop the extension and decisions made to arrive at the final checklist.METHODS: The development process involved five stages: (1) identification of the need for a reporting guideline and project launch; (2) conduct of a scoping review to identify possible modifications to CONSORT 2010 checklist items and possible new extension items; (3) a three-round modified Delphi study involving key stakeholders to gather feedback on the checklist; (4) a consensus meeting to finalise items to be included in the extension, followed by stakeholder piloting of the checklist; and (5) publication, dissemination and implementation of the final checklist.RESULTS: 27 items were initially developed and rated in Delphi round 1, 13 items were rated in round 2 and 11 items were rated in round 3. Response rates for the Delphi study were 92 of 125 (74%) invited participants in round 1, 77 of 92 (84%) round 1 completers in round 2 and 62 of 77 (81%) round 2 completers in round 3. Twenty-seven members of the project team representing a variety of stakeholder groups attended the in-person consensus meeting. The final checklist includes five new items and eight modified items. The extension Explanation & Elaboration document further clarifies aspects that are important to report.CONCLUSION: Uptake of CONSORT-ROUTINE and accompanying Explanation & Elaboration document will improve conduct of trials, as well as the transparency and completeness of reporting of trials conducted using cohorts and routinely collected data.

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Methods and results used in the development of a consensus-driven extension to the Consolidated Standards of Reporting Trials (CONSORT) statement for trials conducted using cohorts and routinely collected data (CONSORT-ROUTINE)

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