Protocol for the development of a CONSORT-equity guideline to improve reporting of health equity in randomized trials.
BACKGROUND
Health equity concerns the absence of avoidable and unfair differences in health. Randomized controlled trials (RCTs) can provide evidence about the impact of an intervention on health equity for specific disadvantaged populations or in general populations; this is important for equity-focused decision-making. Previous work has identified a lack of adequate reporting guidelines for assessing health equity in RCTs. The objective of this study is to develop guidelines to improve the reporting of health equity considerations in RCTs, as an extension of the Consolidated Standards of Reporting Trials (CONSORT).


METHODS
A six-phase study using integrated knowledge translation governed by a study executive and advisory board will assemble empirical evidence to inform the CONSORT-equity extension. To create the guideline, the following steps are proposed: (1) develop a conceptual framework for identifying "equity-relevant trials," (2) assess empirical evidence regarding reporting of equity-relevant trials, (3) consult with global methods and content experts on how to improve reporting of health equity in RCTs, (4) collect broad feedback and prioritize items needed to improve reporting of health equity in RCTs, (5) establish consensus on the CONSORT-equity extension: the guideline for equity-relevant trials, and (6) broadly disseminate and implement the CONSORT-equity extension.


CONCLUSIONS
This work will be relevant to a broad range of RCTs addressing questions of effectiveness for strategies to improve practice and policy in the areas of social determinants of health, clinical care, health systems, public health, and international development, where health and/or access to health care is a primary outcome. The outcomes include a reporting guideline (CONSORT-equity extension) for equity-relevant RCTs and a knowledge translation strategy to broadly encourage its uptake and use by journal editors, authors, and funding agencies.
Bruyère Research Institute, Bruyère Continuing Care and University of Ottawa, 85 Primrose, Ottawa, Ontario, Canada. vivian.welch@uottawa.ca.
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Welch
Bruyère Research Institute, Bruyère Continuing Care and University of Ottawa, 85 Primrose, Ottawa, Ontario, Canada. jjull013@uottawa.ca.
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Jull
Bruyère Research Institute, Bruyère Continuing Care and University of Ottawa, 85 Primrose, Ottawa, Ontario, Canada. jennnifer.petkovic@uottawa.ca.
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Petkovic
Centre for Health Equity, Melbourne School of Population and Global Health, University of Melbourne, 5/207 Bouverie St Carlton 3010, Victoria, Australia. armr@unimelb.edu.au.
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Armstrong
Canada Research Chair in Aboriginal Health and Wellness, Brandon University, Manitoba, Canada. yboyer@gmail.com.
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Boyer
Research Promotion and Development Office of Knowledge Management, Bioethics and Research Pan American Health Organization, World Health Organization, Washington, DC, USA. CuervoLu@PAHO.org.
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Cuervo
Research Ethics and Governance, University College London, London, England. sarah.edwards@ucl.ac.uk.
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Edwards
Cochrane Musculoskeletal Group, London, Ontario, Canada. alydiatt@primus.ca.
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Lydiatt
Department of Social Science, University College London, London, UK. D.Gough@ioe.ac.uk.
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Gough
Ottawa Hospital Research Institute, Medicine University of Ottawa, Ottawa, Canada. jgrimshaw@ohri.ca.
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Grimshaw
School of Psychology, Institute of Population Health, University of Ottawa, Ottawa, Ontario, Canada. kristjan@uottawa.ca.
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Kristjansson
Department of Clinical Epidemiology and Biostatistics, McMaster University, Hamilton, ON, Canada. mbuagblc@mcmaster.ca.|Biostatistics Unit, Father Sean O'Sullivan Research Centre, St Joseph's Healthcare, Hamilton, ON, Canada. mbuagblc@mcmaster.ca.|Centre for the Development of Best Practices in Health (CDBPH), Yaoundé Central Hospital, Avenue Henri Dunant, Messa, Yaoundé, Cameroon. mbuagblc@mcmaster.ca.
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Mbuagbaw
Department of Medicine, University of Ottawa, Ontario, Canada. jmcgowan@uottawa.ca.
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McGowan
Ottawa Hospital Research Institute; School of Epidemiology, Public Health and Preventive Medicine, Faculty of Medicine, University of Ottawa, Ottawa, Canada. dmoher@ohri.ca.
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Moher
Department of Family Medicine, Pontificia Universidad Católica de Chile, Centro Médico San Joaquín Vicuña Mackenna 4686, Macul, Santiago, Chile. tpantoja@med.puc.cl.
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Pantoja
Department of Social and Environmental Health Research, Public Health Evaluation, Faculty of Public Health and Policy, London School of Hygiene and Tropical Medicine, London, England. Mark.Petticrew@lshtm.ac.uk.
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Petticrew
Departments of Family Medicine and Epidemiology and Community Medicine Primary Care Research Group and Equity Methods Group, Bruyere Research Institute; School of Epidemiology, Public Health and Preventive Medicine, University of Ottawa, Ottawa, Canada. kpottie@uottawa.ca.
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Pottie
Canadian Agency for Drugs and Technology in Health, 865 Carling Ave Ottawa, Ontario, Canada. tamarar@cadth.ca.
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Rader
Bruyère Research Institute, Bruyère Continuing Care and University of Ottawa, 85 Primrose, Ottawa, Ontario, Canada. bevshea35@gmail.com.
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Shea
Clinical Epidemiology Program, Ottawa Hospital Research Institute; School of Epidemiology, Public Health and Preventive Medicine, University of Ottawa, Ontario, Canada. mtaljaard@ohri.ca.
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Taljaard
Public Health Insight, Melbourne School of Population and Global Health, University of Melbourne, 5/207 Bouverie St Carlton 3010, Victoria, Australia. ewaters@unimelb.edu.au.
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Waters
Rotman Institute of Philosophy, Western University, 1151 Richmond Street, London, Ontario, Canada. cweijer@uwo.ca.
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Weijer
Department of Epidemiology and Community Medicine, University of Ottawa, Ottawa, Ontario, Canada. gawells@ottawaheart.ca.
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Wells
Alfred Deakin University, Geelong, Victoria, Australia. howardwhite@c2admin.org.
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White
Department of Public Health and Policy, University of Liverpool, Liverpool, UK. mmw@liverpool.ac.uk.
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Whitehead
Bruyère Research Institute, Bruyère Continuing Care and University of Ottawa, 85 Primrose, Ottawa, Ontario, Canada. ptugwell@uottawa.ca.
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Tugwell
D000367:Age Factors; D003469:Culture; D017408:Guidelines as Topic; D000069576:Health Equity / Q000592:standards*; D006801:Humans; D016032:Randomized Controlled Trials as Topic / Q000592:standards*; D012107:Research Design; D012737:Sex Factors; D012959:Socioeconomic Factors