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When is a randomised controlled trial health equity relevant? Development and validation of a conceptual framework
  1. J Jull1,
  2. M Whitehead2,
  3. M Petticrew3,
  4. E Kristjansson4,
  5. D Gough5,
  6. J Petkovic6,
  7. J Volmink7,8,
  8. C Weijer9,
  9. M Taljaard10,11,
  10. S Edwards12,
  11. L Mbuagbaw13,14,
  12. R Cookson15,
  13. J McGowan16,
  14. A Lyddiatt17,
  15. Y Boyer18,
  16. L G Cuervo19,
  17. R Armstrong20,
  18. H White21,
  19. M Yoganathan6,
  20. T Pantoja22,
  21. B Shea6,
  22. K Pottie,
  23. O Norheim23,24,
  24. S Baird25,
  25. B Robberstad23,26,
  26. H Sommerfelt23,26,33,
  27. Y Asada27,
  28. G Wells28,29,
  29. P Tugwell6,
  30. V Welch6
  1. 1 Ottawa Hospital Research Institute, University of Ottawa, Ottawa, Ontario, Canada
  2. 2 Department of Public Health and Policy, University of Liverpool, Liverpool, UK
  3. 3 Department of Social and Environmental Health Research, Faculty of Public Health and Policy, London School of Hygiene and Tropical Medicine, London, UK
  4. 4 Centre for Research on Educational and Community Services, School of Psychology, University of Ottawa, Ottawa, Ontario, Canada
  5. 5 Department of Social Science, Evidence for Policy and Practice Information and Co-ordinating Centre, Social Science Research Unit, University College London, London, UK
  6. 6 Bruyère Continuing Care, Bruyère Research Institute, Elisabeth Bruyere Research Institute, University of Ottawa, Ottawa, Ontario, Canada
  7. 7 The South African Cochrane Center, South African Medical Research Council, Cape Town, South Africa
  8. 8 Faculty of Medicine and Health Sciences, Stellenbosch University, Stellenbosch, South Africa
  9. 9 Rotman Institute of Philosophy, University of Western Ontario, Ontario, Canada
  10. 10 Clinical Epidemiology Program, Ottawa Hospital Research Institute, Ottawa, Ontario, Canada
  11. 11 School of Epidemiology, Public Health and Preventive Medicine, University of Ottawa, Ottawa, Ontario, Canada
  12. 12 Research Ethics and Governance, University College London, London, UK
  13. 13 Department of Clinical Epidemiology and Biostatistics, McMaster University, Hamilton, Ontario, Canada
  14. 14 Biostatistics Unit, Father Sean O’Sullivan Research Centre, St Joseph’s Healthcare, Hamilton, Ontario, Canada
  15. 15 Centre for Health Economics, University of York, York, UK
  16. 16 Department of Medicine, University of Ottawa, Ottawa, Ontario, Canada
  17. 17 Cochrane Musculoskeletal Group, Ontario, Canada
  18. 18 Brandon University, Brandon, Manitoba, Canada
  19. 19 Office of Knowledge Management, Bioethics and Research, Pan American Health Organization/World Health Organization, Washington, District of Columbia, USA
  20. 20 Melbourne School of Population and Global Health, The University of Melbourne, Melbourne, Victoria, Australia
  21. 21 Campbell Collaboration, New Delhi, India
  22. 22 Department of Family Medicine, Pontificia Universidad Catolica de Chile, Santiago, Chile
  23. 23 Centre for Intervention Science in Matnernal and Child Health (CISMAC), University of Bergen, Bergen, Norway
  24. 24 Department of Global Public Health and Primary Health Care, University of Bergen, Bergen, Norway
  25. 25 Department of Global Health, Milken Institute School of Public Health, George Washington University, Washington, District of Columbia, USA
  26. 26 Centre for International Health, University of Bergen, Bergen, Norway
  27. 27 Department of Community Health and Epidemiology, Faculty of Medicine, Dalhousie University, Halifax, Nova Scotia, Canada
  28. 28 Department of Epidemiology and Community Medicine, University of Ottawa, Ottawa, Ontario, Canada
  29. 29 Ottawa Heart Institute, University of Ottawa, Ottawa, Ontario, Canada
  30. 33 Norwegian Institute of Public Health, Oslo, Norway
  1. Correspondence to J Jull; jjull013{at}


Background Randomised controlled trials can provide evidence relevant to assessing the equity impact of an intervention, but such information is often poorly reported. We describe a conceptual framework to identify health equity-relevant randomised trials with the aim of improving the design and reporting of such trials.

Methods An interdisciplinary and international research team engaged in an iterative consensus building process to develop and refine the conceptual framework via face-to-face meetings, teleconferences and email correspondence, including findings from a validation exercise whereby two independent reviewers used the emerging framework to classify a sample of randomised trials.

Results A randomised trial can usefully be classified as ‘health equity relevant’ if it assesses the effects of an intervention on the health or its determinants of either individuals or a population who experience ill health due to disadvantage defined across one or more social determinants of health. Health equity-relevant randomised trials can either exclusively focus on a single population or collect data potentially useful for assessing differential effects of the intervention across multiple populations experiencing different levels or types of social disadvantage. Trials that are not classified as ‘health equity relevant’ may nevertheless provide information that is indirectly relevant to assessing equity impact, including information about individual level variation unrelated to social disadvantage and potentially useful in secondary modelling studies.

Conclusion The conceptual framework may be used to design and report randomised trials. The framework could also be used for other study designs to contribute to the evidence base for improved health equity.

  • health
  • equity
  • randomized controlled trials
  • framework

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  • Contributors JJ and VW conceived and led the design of the work described in the manuscript and were responsible for the first and final drafts of this manuscript. All authors participated in and provided substantial contributions to the analysis and interpretation during development of the work described in the manuscript. All authors made contributions to drafts of this manuscript and have reviewed and revised it for important intellectual content and approved the final version.

  • Competing interests None declared.

  • Provenance and peer review Not commissioned; externally peer reviewed.

  • Data sharing statement No additional data available.