. 2017 Sep 25;7(9):e015815.

doi: 10.1136/bmjopen-2016-015815.

When is a randomised controlled trial health equity relevant? Development and validation of a conceptual framework

J Jull¹, M Whitehead², M Petticrew³, E Kristjansson⁴, D Gough⁵, J Petkovic⁶, J Volmink^{7

8}, C Weijer⁹, M Taljaard^{10

11}, S Edwards¹², L Mbuagbaw^{13

14}, R Cookson¹⁵, J McGowan¹⁶, A Lyddiatt¹⁷, Y Boyer¹⁸, L G Cuervo¹⁹, R Armstrong²⁰, H White²¹, M Yoganathan⁶, T Pantoja²², B Shea⁶, K Pottie, O Norheim^{23

24}, S Baird²⁵, B Robberstad^{23

26}, H Sommerfelt^{23

26

27}, Y Asada²⁸, G Wells^{29

30}, P Tugwell⁶, V Welch⁶

Affiliations

¹ Ottawa Hospital Research Institute, University of Ottawa, Ottawa, Ontario, Canada.
² Department of Public Health and Policy, University of Liverpool, Liverpool, UK.
³ Department of Social and Environmental Health Research, Faculty of Public Health and Policy, London School of Hygiene and Tropical Medicine, London, UK.
⁴ Centre for Research on Educational and Community Services, School of Psychology, University of Ottawa, Ottawa, Ontario, Canada.
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 Bruyère Continuing Care, Bruyère Research Institute, Elisabeth Bruyere Research Institute, University of Ottawa, Ottawa, Ontario, Canada.
⁷ The South African Cochrane Center, South African Medical Research Council, Cape Town, South Africa.
⁸ Faculty of Medicine and Health Sciences, Stellenbosch University, Stellenbosch, South Africa.
⁹ Rotman Institute of Philosophy, University of Western Ontario, Ontario, Canada.
¹⁰ Clinical Epidemiology Program, Ottawa Hospital Research Institute, Ottawa, Ontario, Canada.
¹¹ School of Epidemiology, Public Health and Preventive Medicine, University of Ottawa, Ottawa, Ontario, Canada.
¹² Research Ethics and Governance, University College London, London, UK.
¹³ Department of Clinical Epidemiology and Biostatistics, McMaster University, Hamilton, Ontario, Canada.
¹⁴ Biostatistics Unit, Father Sean O'Sullivan Research Centre, St Joseph's Healthcare, Hamilton, Ontario, Canada.
¹⁵ Centre for Health Economics, University of York, York, UK.
¹⁶ Department of Medicine, University of Ottawa, Ottawa, Ontario, Canada.
¹⁷ Cochrane Musculoskeletal Group, Ontario, Canada.
¹⁸ Brandon University, Brandon, Manitoba, Canada.
¹⁹ Office of Knowledge Management, Bioethics and Research, Pan American Health Organization/World Health Organization, Washington, District of Columbia, USA.
²⁰ Melbourne School of Population and Global Health, The University of Melbourne, Melbourne, Victoria, Australia.
²¹ Campbell Collaboration, New Delhi, India.
²² Department of Family Medicine, Pontificia Universidad Catolica de Chile, Santiago, Chile.
²³ Centre for Intervention Science in Matnernal and Child Health (CISMAC), University of Bergen, Bergen, Norway.
²⁴ Department of Global Public Health and Primary Health Care, University of Bergen, Bergen, Norway.
²⁵ Department of Global Health, Milken Institute School of Public Health, George Washington University, Washington, District of Columbia, USA.
²⁶ Centre for International Health, University of Bergen, Bergen, Norway.
²⁷ Norwegian Institute of Public Health, Oslo, Norway.
²⁸ Department of Community Health and Epidemiology, Faculty of Medicine, Dalhousie University, Halifax, Nova Scotia, Canada.
²⁹ Department of Epidemiology and Community Medicine, University of Ottawa, Ottawa, Ontario, Canada.
³⁰ Ottawa Heart Institute, University of Ottawa, Ottawa, Ontario, Canada.

PMID: 28951402
PMCID: PMC5623521
DOI: 10.1136/bmjopen-2016-015815

When is a randomised controlled trial health equity relevant? Development and validation of a conceptual framework

J Jull et al. BMJ Open. 2017.

. 2017 Sep 25;7(9):e015815.

doi: 10.1136/bmjopen-2016-015815.

Authors

Affiliations

¹ Ottawa Hospital Research Institute, University of Ottawa, Ottawa, Ontario, Canada.
² Department of Public Health and Policy, University of Liverpool, Liverpool, UK.
³ Department of Social and Environmental Health Research, Faculty of Public Health and Policy, London School of Hygiene and Tropical Medicine, London, UK.
⁴ Centre for Research on Educational and Community Services, School of Psychology, University of Ottawa, Ottawa, Ontario, Canada.
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 Bruyère Continuing Care, Bruyère Research Institute, Elisabeth Bruyere Research Institute, University of Ottawa, Ottawa, Ontario, Canada.
⁷ The South African Cochrane Center, South African Medical Research Council, Cape Town, South Africa.
⁸ Faculty of Medicine and Health Sciences, Stellenbosch University, Stellenbosch, South Africa.
⁹ Rotman Institute of Philosophy, University of Western Ontario, Ontario, Canada.
¹⁰ Clinical Epidemiology Program, Ottawa Hospital Research Institute, Ottawa, Ontario, Canada.
¹¹ School of Epidemiology, Public Health and Preventive Medicine, University of Ottawa, Ottawa, Ontario, Canada.
¹² Research Ethics and Governance, University College London, London, UK.
¹³ Department of Clinical Epidemiology and Biostatistics, McMaster University, Hamilton, Ontario, Canada.
¹⁴ Biostatistics Unit, Father Sean O'Sullivan Research Centre, St Joseph's Healthcare, Hamilton, Ontario, Canada.
¹⁵ Centre for Health Economics, University of York, York, UK.
¹⁶ Department of Medicine, University of Ottawa, Ottawa, Ontario, Canada.
¹⁷ Cochrane Musculoskeletal Group, Ontario, Canada.
¹⁸ Brandon University, Brandon, Manitoba, Canada.
¹⁹ Office of Knowledge Management, Bioethics and Research, Pan American Health Organization/World Health Organization, Washington, District of Columbia, USA.
²⁰ Melbourne School of Population and Global Health, The University of Melbourne, Melbourne, Victoria, Australia.
²¹ Campbell Collaboration, New Delhi, India.
²² Department of Family Medicine, Pontificia Universidad Catolica de Chile, Santiago, Chile.
²³ Centre for Intervention Science in Matnernal and Child Health (CISMAC), University of Bergen, Bergen, Norway.
²⁴ Department of Global Public Health and Primary Health Care, University of Bergen, Bergen, Norway.
²⁵ Department of Global Health, Milken Institute School of Public Health, George Washington University, Washington, District of Columbia, USA.
²⁶ Centre for International Health, University of Bergen, Bergen, Norway.
²⁷ Norwegian Institute of Public Health, Oslo, Norway.
²⁸ Department of Community Health and Epidemiology, Faculty of Medicine, Dalhousie University, Halifax, Nova Scotia, Canada.
²⁹ Department of Epidemiology and Community Medicine, University of Ottawa, Ottawa, Ontario, Canada.
³⁰ Ottawa Heart Institute, University of Ottawa, Ottawa, Ontario, Canada.

PMID: 28951402
PMCID: PMC5623521
DOI: 10.1136/bmjopen-2016-015815

Abstract

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.

Keywords: equity; framework; health; randomized controlled trials.

PubMed Disclaimer

Conflict of interest statement

Competing interests: None declared.

Figures

**Figure 1**
Description of the conceptual framework development process.

See this image and copyright information in PMC

References

1. World Health Organization. Rio political declaration on social determinants of health . Geneva (CH): World Health Organization, 2011. http://www.who.int/sdhconference/declaration/en/ (accessed 10 Dec 2016).
1. Statistics Canada. Life Expectancy. 2015. http://www.statcan.gc.ca/pub/89-645-x/2010001/life-expectancy-esperance-... (accessed 10 Dec 2016).
1. Whitehead M. The concepts and principles of equity and health. Int J Health Serv 1992;22:429–45. 10.2190/986L-LHQ6-2VTE-YRRN - DOI - PubMed
1. Eyal N. Inequalities in health: concepts, measures, and ethics: Oxford University Press, 2013.
1. Tsuchiya A, Williams A. A “fair innings” between the sexes: are men being treated inequitably? Soc Sci Med 2005;60:277–86. 10.1016/j.socscimed.2004.04.035 - DOI - PubMed

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When is a randomised controlled trial health equity relevant? Development and validation of a conceptual framework

Affiliations

When is a randomised controlled trial health equity relevant? Development and validation of a conceptual framework

Authors

Affiliations

Abstract

Conflict of interest statement

Figures

References

Publication types

MeSH terms

Grants and funding

LinkOut - more resources

Full Text Sources

Other Literature Sources