Protocol for a scoping review to support development of a CONSORT extension for randomised controlled trials using cohorts and routinely collected health data

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Protocol for a scoping review to support development of a CONSORT extension for randomised controlled trials using cohorts and routinely collected health data

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

Imran, Mahrukh (author): Lady Davis Institute for Medical Research, Jewish General Hospital, Montréal QC, Canada

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

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

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

Gale, Chris (author): Section of Neonatal Medicine, Department of Medicine, Imperial College London, London, United Kingdom

Hemkens, Lars G. (author): Basel Institute for Clinical Epidemiology and Biostatistics, Department of Clinical Research, University Hospital Basel, University of Basel, Basel, Switzerland

Langan, Sinead M. (author): Faculty of Epidemiology and Population Health, London School of Hygiene and Tropical Medicine, London, United Kingdom

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

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

Zwarenstein, Merrick (author): Department of Family Medicine, Western University, London, United Kingdom; Institute for Clinical Evaluative Sciences, Toronto ON, Canada,Institute for Clinical Evaluative Sciences (ICES),University of Western Ontario

Benchimol, Eric I. (author): Department of Pediatrics and School of Epidemiology and Public Health, University of Ottawa, Ottawa ON, Canada; Institute for Clinical Evaluative Sciences, Ottawa ON, Canada; Division of Gastroenterology, Hepatology and Nutrition, Children's Hospital of Eastern Ontario, Ottawa ON, Canada,Institute for Clinical Evaluative Sciences (ICES)

Boutron, Isabelle (author): Sorbonne Paris Cité Epidemiology and Statistics Research Center, INSERM, UMR1153, 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,Centre of Epidemiology And Biostatistics Sorbonne Paris Cité Center (CRESS)

Campbell, Marion K. (author): Health Services Research Unit, University of Aberdeen, Aberdeen, United Kingdom

Erlinge, David (author): 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

Jawad, Sena (author): Section of Neonatal Medicine, Department of Medicine, Imperial College London, London, United Kingdom

Ravaud, Philippe (author): Sorbonne Paris Cité Epidemiology and Statistics Research Center, INSERM, UMR1153, 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,Centre of Epidemiology And Biostatistics Sorbonne Paris Cité Center (CRESS)

Rice, Danielle B. (author): Lady Davis Institute for Medical Research, Jewish General Hospital, Montréal QC, Canada; Department of Psychology, McGill University, Montréal QC, Canada

Sauve, Maureen (author): Scleroderma Society of Ontario, Hamilton, ON, Canada; Scleroderma Canada, Hamilton ON, Canada

van Staa, Tjeerd P. (author): Health E-Research Centre, School of Health Sciences, Faculty of Biology, Medicine and Health, University of Manchester, Manchester, United Kingdom; Division of Pharmacoepidemiology and Clinical Pharmacology, Faculty of Science, Utrecht University, Utrecht, Netherlands

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

Uher, Rudolf (author): Department of Psychiatry, Dalhousie University, Halifax NS, Canada

Verkooijen, Helena M. (author): Department of Epidemiology, University Medical Center Utrecht, Utrecht, Netherlands; Department of Epidemiology, University of Utrecht, Utrecht, Netherlands

Juszczak, Edmund (author): NPEU Clinical Trials Unit, National Perinatal Epidemiology Unit, Nuffield Department of Population Health, University of Oxford, Oxford, United Kingdom

Thombs, Brett D. (author): Lady Davis Institute for Medical Research, Jewish General Hospital, Montréal QC, Canada; Department of Psychology, McGill University, Montréal QC, Canada; Department of Psychiatry, McGill University, Montreal QC, Canada; Departments of Epidemiology, Biostatistics and Occupational Health, McGill University, Montreal QC, Canada; Department of Medicine, McGill University, Montreal QC, Canada; Departments of Educational and Counselling Psychology, McGill University, Montreal QC, Canada

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(creator_code:org_t)

2018-08-05
2018
English.
In: BMJ Open. - : BMJ Publishing Group Ltd. - 2044-6055. ; 8:8

Related links:: https://doi.org/10.1...; show more...; https://bmjopen.bmj....; http://dx.doi.org/10... (free); https://urn.kb.se/re...; https://doi.org/10.1...; https://lup.lub.lu.s...; show less...

Research review (peer-reviewed)

Abstract Subject headings

Introduction: Randomised controlled trials (RCTs) conducted using cohorts and routinely collected health data, including registries, electronic health records and administrative databases, are increasingly used in healthcare intervention research. The development of an extension of the CONsolidated Standards of Reporting Trials (CONSORT) statement for RCTs using cohorts and routinely collected health data is being undertaken with the goal of improving reporting quality by setting standards early in the process of uptake of these designs. To develop this extension to the CONSORT statement, a scoping review will be conducted to identify potential modifications or clarifications of existing reporting guideline items, as well as additional items needed for reporting RCTs using cohorts and routinely collected health data.Methods and analysis: In separate searches, we will seek publications on methods or reporting or that describe protocols or results from RCTs using cohorts, registries, electronic health records and administrative databases. Data sources will include Medline and the Cochrane Methodology Register. For each of the four main types of RCTs using cohorts and routinely collected health data, separately, two investigators will independently review included publications to extract potential checklist items. A potential item will either modify an existing CONSORT 2010, Strengthening the Reporting of Observational Studies in Epidemiology or REporting of studies Conducted using Observational Routinely collected health Data item or will be proposed as a new item. Additionally, we will identify examples of good reporting in RCTs using cohorts and routinely collected health data.Ethics and dissemination: The proposed scoping review will help guide the development of the CONSORT extension statement for RCTs conducted using cohorts and routinely collected health data.

Subject headings

MEDICIN OCH HÄLSOVETENSKAP -- Klinisk medicin -- Allmänmedicin (hsv//swe)
MEDICAL AND HEALTH SCIENCES -- Clinical Medicine -- General Practice (hsv//eng)
MEDICIN OCH HÄLSOVETENSKAP -- Klinisk medicin -- Annan klinisk medicin (hsv//swe)
MEDICAL AND HEALTH SCIENCES -- Clinical Medicine -- Other Clinical Medicine (hsv//eng)

Keyword

cohort
consort
randomized controlled trials
reporting guideline
routinely collected health data
rcts
cohort
consort
randomized controlled trials
rcts
reporting guideline
routinely collected health data

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MEDICAL AND HEALTH SCIENCES: MEDICAL AND HEAL ...; and Clinical Medicin ...; and General Practice

MEDICAL AND HEALTH SCIENCES: MEDICAL AND HEAL ...; and Clinical Medicin ...; and Other Clinical M ...

Articles in the publication: BMJ Open

By the university: Örebro University; Lund University

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