Considerations and guidance in designing equity-relevant clinical trials

International Journal for Equity in Health

Commentary

Manosila Yoganathan¹  Vivian Welch²  Monica Taljaard³  Theresa Aves⁴  Lawrence Mbuagbaw⁵  Regina Greer-Smith⁶  Beverley Shea⁷  George Wells⁸  Peter Tugwell⁹  Janet Jull^1,10 

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

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

DOI  :  10.1186/s12939-017-0591-1

 received in 2017-02-13, accepted in 2017-05-26,  发布年份 2017

来源: Springer

【 摘 要 】

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.

【 授权许可】

CC BY   
© The Author(s). 2017