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


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          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.


          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.


          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.


          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.

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          Most cited references40

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          The concepts and principles of equity and health.

          In 1984, the 32 member states of the World Health Organization European Region took a remarkable step forward in agreeing unanimously on 38 targets for a common health policy for the Region. Not only was equity the subject of the first of these targets, but it was also seen as a fundamental theme running right through the policy as a whole. However, equity can mean different things to different people. This article looks at the concepts and principles of equity as understood in the context of the World Health Organization's Health for All policy. After considering the possible causes of the differences in health observed in populations--some of them inevitable and some unnecessary and unfair--the author discusses equity in relation to health care, concentrating on issues of access to care, utilization, and quality. Lastly, seven principles for action are outlined, stemming from these concepts, to be borne in mind when designing or implementing policies, so that greater equity in health and health care can be promoted.
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            Applying an equity lens to interventions: using PROGRESS ensures consideration of socially stratifying factors to illuminate inequities in health.

            To assess the utility of an acronym, place of residence, race/ethnicity/culture/language, occupation, gender/sex, religion, education, socioeconomic status, and social capital ("PROGRESS"), in identifying factors that stratify health opportunities and outcomes. We explored the value of PROGRESS as an equity lens to assess effects of interventions on health equity.
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              What types of interventions generate inequalities? Evidence from systematic reviews.

              Some effective public health interventions may increase inequalities by disproportionately benefiting less disadvantaged groups ('intervention-generated inequalities' or IGIs). There is a need to understand which types of interventions are likely to produce IGIs, and which can reduce inequalities. We conducted a rapid overview of systematic reviews to identify evidence on IGIs by socioeconomic status. We included any review of non-healthcare interventions in high-income countries presenting data on differential intervention effects on any health status or health behaviour outcome. Results were synthesised narratively. The following intervention types show some evidence of increasing inequalities (IGIs) between socioeconomic status groups: media campaigns; and workplace smoking bans. However, for many intervention types, data on potential IGIs are lacking. By contrast, the following show some evidence of reducing health inequalities: structural workplace interventions; provision of resources; and fiscal interventions, such as tobacco pricing. Our findings are consistent with the idea that 'downstream' preventive interventions are more likely to increase health inequalities than 'upstream' interventions. More consistent reporting of differential intervention effectiveness is required to help build the evidence base on IGIs.

                Author and article information

                BMJ Open
                BMJ Open
                BMJ Open
                BMJ Publishing Group (BMA House, Tavistock Square, London, WC1H 9JR )
                25 September 2017
                : 7
                : 9
                : e015815
                [1 ] Ottawa Hospital Research Institute, University of Ottawa , Ottawa, Ontario, Canada
                [2 ] departmentDepartment of Public Health and Policy , University of Liverpool , Liverpool, UK
                [3 ] departmentDepartment of Social and Environmental Health Research, Faculty of Public Health and Policy , London School of Hygiene and Tropical Medicine , London, UK
                [4 ] departmentCentre for Research on Educational and Community Services , School of Psychology, University of Ottawa , Ottawa, Ontario, Canada
                [5 ] departmentDepartment of Social Science , Evidence for Policy and Practice Information and Co-ordinating Centre, Social Science Research Unit, University College London , London, UK
                [6 ] departmentBruyère Continuing Care , Bruyère Research Institute, Elisabeth Bruyere Research Institute, University of Ottawa , Ottawa, Ontario, Canada
                [7 ] departmentThe South African Cochrane Center , South African Medical Research Council , Cape Town, South Africa
                [8 ] departmentFaculty of Medicine and Health Sciences , Stellenbosch University , Stellenbosch, South Africa
                [9 ] departmentRotman Institute of Philosophy , University of Western Ontario , Ontario, Canada
                [10 ] departmentClinical Epidemiology Program , Ottawa Hospital Research Institute , Ottawa, Ontario, Canada
                [11 ] departmentSchool of Epidemiology, Public Health and Preventive Medicine , University of Ottawa , Ottawa, Ontario, Canada
                [12 ] departmentResearch Ethics and Governance , University College London , London, UK
                [13 ] departmentDepartment of Clinical Epidemiology and Biostatistics , McMaster University , Hamilton, Ontario, Canada
                [14 ] departmentBiostatistics 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 ] departmentDepartment of Medicine , University of Ottawa , Ottawa, Ontario, Canada
                [17 ] Cochrane Musculoskeletal Group , Ontario, Canada
                [18 ] Brandon University , Brandon, Manitoba, Canada
                [19 ] departmentOffice 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 ] departmentDepartment of Family Medicine , Pontificia Universidad Catolica de Chile , Santiago, Chile
                [23 ] departmentCentre for Intervention Science in Matnernal and Child Health (CISMAC) , University of Bergen , Bergen, Norway
                [24 ] departmentDepartment of Global Public Health and Primary Health Care , University of Bergen , Bergen, Norway
                [25 ] departmentDepartment 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 ] departmentDepartment of Community Health and Epidemiology, Faculty of Medicine , Dalhousie University , Halifax, Nova Scotia, Canada
                [28 ] departmentDepartment of Epidemiology and Community Medicine , University of Ottawa , Ottawa, Ontario, Canada
                [29 ] Ottawa Heart Institute, University of Ottawa , Ottawa, Ontario, Canada
                [33 ] Norwegian Institute of Public Health , Oslo, Norway
                Author notes
                [Correspondence to ] J Jull; jjull013@ 123456uottawa.ca
                © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2017. All rights reserved. No commercial use is permitted unless otherwise expressly granted.

                This is an Open Access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/

                : 03 January 2017
                : 07 July 2017
                : 31 July 2017
                Patient-Centred Medicine
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                health,equity,randomized controlled trials,framework
                health, equity, randomized controlled trials, framework


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