Considerations and guidance in designing equity-relevant clinical trials

Lawrence Mbuagbaw^{1

2}, Theresa Aves³, Beverley Shea⁴, Janet Jull⁵, Vivian Welch^{6

7

8}, Monica Taljaard^{9

10}, Manosila Yoganathan¹¹, Regina Greer-Smith¹², George Wells^{7

13

14}, Peter Tugwell^{7

8

14

15}

Affiliations

¹ Department of Health Research Methods, Evidence and Impact, McMaster University, Hamilton, ON, Canada. mbuagblc@mcmaster.ca.
² Biostatistics Unit, Father Sean O'Sullivan's Research Centre, St Joseph's Healthcare Hamilton, 50 Charlton Avenue East, 3rd Floor Martha Wing, Room H321, Hamilton, ON, L8N 4A6, Canada. mbuagblc@mcmaster.ca.
³ Department of Health Research Methods, Evidence and Impact, McMaster University, Hamilton, ON, Canada.
⁴ Ottawa Hospital Research Institute, Center for Practice Changing Research and School of Epidemiology, Public Health and Preventive Medicine, Faculty of Medicine, University of Ottawa, Ottawa, ON, K1H 8M5, Canada.
⁵ University of Ottawa and Ottawa Hospital Research Institute, 501 Smyth Road, Ottawa, ON, K1H 8M2, Canada.
⁶ Bruyère Research Institute, Ottawa, Canada.
⁷ School of Epidemiology, Public Health and Preventive Medicine, University of Ottawa, Ottawa, Canada.
⁸ Ottawa Hospital Research Institute, Ottawa, Canada.
⁹ Clinical Epidemiology Program, Ottawa Hospital Research Institute, Ottawa, ON, Canada.
¹⁰ Department of Epidemiology and Community Medicine, University of Ottawa, Ottawa, ON, Canada.
¹¹ Bruyère Research Institute, Bruyère Continuing Care and University of Ottawa, 85 Primrose, Ottawa, ON, Canada.
¹² Healthcare Research Associates, 2700 Concord Place, Hazel Crest, IL, USA.
¹³ Cardiovascular Research Methods Centre, University of Ottawa Heart Institute, Ottawa, ON, K1Y4W7, Canada.
¹⁴ Department of Medicine Faculty of Medicine, University of Ottawa, Ottawa, Canada.
¹⁵ WHO Collaborating Centre for Knowledge Translation and Health Technology Assessment in Health Equity, Bruyère Research Institute, Ottawa, Canada.

PMID: 28583125
PMCID: PMC5460332
DOI: 10.1186/s12939-017-0591-1

Considerations and guidance in designing equity-relevant clinical trials

Lawrence Mbuagbaw et al. Int J Equity Health. 2017.

. 2017 Jun 5;16(1):93.

doi: 10.1186/s12939-017-0591-1.

Authors

Affiliations

¹ Department of Health Research Methods, Evidence and Impact, McMaster University, Hamilton, ON, Canada. mbuagblc@mcmaster.ca.
² Biostatistics Unit, Father Sean O'Sullivan's Research Centre, St Joseph's Healthcare Hamilton, 50 Charlton Avenue East, 3rd Floor Martha Wing, Room H321, Hamilton, ON, L8N 4A6, Canada. mbuagblc@mcmaster.ca.
³ Department of Health Research Methods, Evidence and Impact, McMaster University, Hamilton, ON, Canada.
⁴ Ottawa Hospital Research Institute, Center for Practice Changing Research and School of Epidemiology, Public Health and Preventive Medicine, Faculty of Medicine, University of Ottawa, Ottawa, ON, K1H 8M5, Canada.
⁵ University of Ottawa and Ottawa Hospital Research Institute, 501 Smyth Road, Ottawa, ON, K1H 8M2, Canada.
⁶ Bruyère Research Institute, Ottawa, Canada.
⁷ School of Epidemiology, Public Health and Preventive Medicine, University of Ottawa, Ottawa, Canada.
⁸ Ottawa Hospital Research Institute, Ottawa, Canada.
⁹ Clinical Epidemiology Program, Ottawa Hospital Research Institute, Ottawa, ON, Canada.
¹⁰ Department of Epidemiology and Community Medicine, University of Ottawa, Ottawa, ON, Canada.
¹¹ Bruyère Research Institute, Bruyère Continuing Care and University of Ottawa, 85 Primrose, Ottawa, ON, Canada.
¹² Healthcare Research Associates, 2700 Concord Place, Hazel Crest, IL, USA.
¹³ Cardiovascular Research Methods Centre, University of Ottawa Heart Institute, Ottawa, ON, K1Y4W7, Canada.
¹⁴ Department of Medicine Faculty of Medicine, University of Ottawa, Ottawa, Canada.
¹⁵ WHO Collaborating Centre for Knowledge Translation and Health Technology Assessment in Health Equity, Bruyère Research Institute, Ottawa, Canada.

PMID: 28583125
PMCID: PMC5460332
DOI: 10.1186/s12939-017-0591-1

Abstract

Health research has documented disparities in health and health outcomes within and between populations. When these disparities are unfair and avoidable they may be referred to as health inequities. Few trials attend to factors related to health inequities, and there is limited understanding about how to build consideration of health inequities into trials. Due consideration of health inequities is important to inform the design, conduct and reporting of trials so that research can build evidence to more effectively address health inequities and importantly, ensure that inequities are not aggravated. In this paper, we discuss approaches to integrating health equity-considerations in randomized trials by using the PROGRESS Plus framework (Place of residence, Race/ethnicity/culture/language, Occupation, Gender, Religion, Education, Socio-economic status, Social capital and "Plus" that includes other context specific factors) and cover: (i) formulation of research questions, (ii) two specific scenarios relevant to trials about health equity and (iii) describe how the PROGRESS Plus characteristics may influence trial design, conduct and analyses. This guidance is intended to support trialists designing equity-relevant trials and lead to better design, conduct, analyses and reporting, by addressing two main issues: how to avoid aggravating inequity among research participants and how to produce information that is useful to decision-makers who are concerned with health inequities.

Keywords: Design; Education; Ethnicity; Gender; Health equity; PROGRESS plus; Randomized trial; Religion; Socio-economic.

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Figures

**Fig. 1**
Mixed (scenario A) and homogenous population groups (scenario B—defined by age, gender and ethnicity). Courtesy of www.sweetclipart.com

See this image and copyright information in PMC

References

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Considerations and guidance in designing equity-relevant clinical trials

Affiliations

Considerations and guidance in designing equity-relevant clinical trials

Authors

Affiliations

Abstract

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References

MeSH terms

LinkOut - more resources

Full Text Sources

Other Literature Sources

Medical