When is a randomised controlled trial health equity relevant? Development and validation of a conceptual framework
BackgroundRandomised 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 repo...
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| creator | Jull, J Whitehead, M Petticrew, M Kristjansson, E Gough, D Petkovic, J Volmink, J Weijer, C Taljaard, M Edwards, S Mbuagbaw, L Cookson, R McGowan, J Lyddiatt, A Boyer, Y Cuervo, L G Armstrong, R White, H Yoganathan, M Pantoja, T Shea, B Pottie, K Norheim, O Baird, S Robberstad, B Sommerfelt, H Asada, Y Wells, G Tugwell, P Welch, V |
| description | BackgroundRandomised 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.MethodsAn 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.ResultsA 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.ConclusionThe 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. |
| doi_str_mv | 10.1136/bmjopen-2016-015815 |
| format | Article |
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Development and validation of a conceptual framework</title><source>BMJ Open Access Journals</source><source>MEDLINE</source><source>DOAJ Directory of Open Access Journals</source><source>PubMed Central Open Access</source><source>EZB-FREE-00999 freely available EZB journals</source><source>PubMed Central</source><creator>Jull, J ; Whitehead, M ; Petticrew, M ; Kristjansson, E ; Gough, D ; Petkovic, J ; Volmink, J ; Weijer, C ; Taljaard, M ; Edwards, S ; Mbuagbaw, L ; Cookson, R ; McGowan, J ; Lyddiatt, A ; Boyer, Y ; Cuervo, L G ; Armstrong, R ; White, H ; Yoganathan, M ; Pantoja, T ; Shea, B ; Pottie, K ; Norheim, O ; Baird, S ; Robberstad, B ; Sommerfelt, H ; Asada, Y ; Wells, G ; Tugwell, P ; Welch, V</creator><creatorcontrib>Jull, J ; Whitehead, M ; Petticrew, M ; Kristjansson, E ; Gough, D ; Petkovic, J ; Volmink, J ; Weijer, C ; Taljaard, M ; Edwards, S ; Mbuagbaw, L ; Cookson, R ; McGowan, J ; Lyddiatt, A ; Boyer, Y ; Cuervo, L G ; Armstrong, R ; White, H ; Yoganathan, M ; Pantoja, T ; Shea, B ; Pottie, K ; Norheim, O ; Baird, S ; Robberstad, B ; Sommerfelt, H ; Asada, Y ; Wells, G ; Tugwell, P ; Welch, V</creatorcontrib><description>BackgroundRandomised 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.MethodsAn 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.ResultsA 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.ConclusionThe 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.</description><identifier>ISSN: 2044-6055</identifier><identifier>EISSN: 2044-6055</identifier><identifier>DOI: 10.1136/bmjopen-2016-015815</identifier><identifier>PMID: 28951402</identifier><language>eng</language><publisher>England: BMJ Publishing Group LTD</publisher><subject>Clinical trials ; Consensus ; Evidence-based medicine ; Health disparities ; Health Equity ; Health Status Disparities ; Humans ; Intervention ; Life expectancy ; Low income groups ; Patient-Centred Medicine ; Public health ; Randomized Controlled Trials as Topic - methods ; Research Design ; Social Justice ; Society ; Socioeconomic Factors</subject><ispartof>BMJ open, 2017-09, Vol.7 (9), p.e015815</ispartof><rights>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.</rights><rights>2017 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/ Notwithstanding the ProQuest Terms and Conditions, you may use this content in accordance with the terms of the License.</rights><rights>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. 2017</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-b472t-40eb4c30e0edd11311df9f6640097398a98308f416a06e1478a44e03f49ef6cb3</citedby><cites>FETCH-LOGICAL-b472t-40eb4c30e0edd11311df9f6640097398a98308f416a06e1478a44e03f49ef6cb3</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktopdf>$$Uhttp://bmjopen.bmj.com/content/7/9/e015815.full.pdf$$EPDF$$P50$$Gbmj$$Hfree_for_read</linktopdf><linktohtml>$$Uhttp://bmjopen.bmj.com/content/7/9/e015815.full$$EHTML$$P50$$Gbmj$$Hfree_for_read</linktohtml><link.rule.ids>230,315,729,782,786,866,887,27558,27559,27933,27934,53800,53802,77611,77642</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/28951402$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Jull, J</creatorcontrib><creatorcontrib>Whitehead, M</creatorcontrib><creatorcontrib>Petticrew, M</creatorcontrib><creatorcontrib>Kristjansson, E</creatorcontrib><creatorcontrib>Gough, D</creatorcontrib><creatorcontrib>Petkovic, J</creatorcontrib><creatorcontrib>Volmink, J</creatorcontrib><creatorcontrib>Weijer, C</creatorcontrib><creatorcontrib>Taljaard, M</creatorcontrib><creatorcontrib>Edwards, S</creatorcontrib><creatorcontrib>Mbuagbaw, L</creatorcontrib><creatorcontrib>Cookson, R</creatorcontrib><creatorcontrib>McGowan, J</creatorcontrib><creatorcontrib>Lyddiatt, A</creatorcontrib><creatorcontrib>Boyer, Y</creatorcontrib><creatorcontrib>Cuervo, L G</creatorcontrib><creatorcontrib>Armstrong, R</creatorcontrib><creatorcontrib>White, H</creatorcontrib><creatorcontrib>Yoganathan, M</creatorcontrib><creatorcontrib>Pantoja, T</creatorcontrib><creatorcontrib>Shea, B</creatorcontrib><creatorcontrib>Pottie, K</creatorcontrib><creatorcontrib>Norheim, O</creatorcontrib><creatorcontrib>Baird, S</creatorcontrib><creatorcontrib>Robberstad, B</creatorcontrib><creatorcontrib>Sommerfelt, H</creatorcontrib><creatorcontrib>Asada, Y</creatorcontrib><creatorcontrib>Wells, G</creatorcontrib><creatorcontrib>Tugwell, P</creatorcontrib><creatorcontrib>Welch, V</creatorcontrib><title>When is a randomised controlled trial health equity relevant? Development and validation of a conceptual framework</title><title>BMJ open</title><addtitle>BMJ Open</addtitle><description>BackgroundRandomised 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.MethodsAn 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.ResultsA 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.ConclusionThe 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.</description><subject>Clinical trials</subject><subject>Consensus</subject><subject>Evidence-based medicine</subject><subject>Health disparities</subject><subject>Health Equity</subject><subject>Health Status Disparities</subject><subject>Humans</subject><subject>Intervention</subject><subject>Life expectancy</subject><subject>Low income groups</subject><subject>Patient-Centred Medicine</subject><subject>Public health</subject><subject>Randomized Controlled Trials as Topic - methods</subject><subject>Research Design</subject><subject>Social Justice</subject><subject>Society</subject><subject>Socioeconomic Factors</subject><issn>2044-6055</issn><issn>2044-6055</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2017</creationdate><recordtype>article</recordtype><sourceid>9YT</sourceid><sourceid>ACMMV</sourceid><sourceid>EIF</sourceid><sourceid>ABUWG</sourceid><sourceid>AFKRA</sourceid><sourceid>AZQEC</sourceid><sourceid>BENPR</sourceid><sourceid>CCPQU</sourceid><sourceid>DWQXO</sourceid><sourceid>GNUQQ</sourceid><recordid>eNqNkU9rFTEUxYNYbGn7CQQJuHEzNf9fZqNI1VYouFFchszMjS_PTDLNZF7ptzeP9yy1q2aTC_mdc-_NQeg1JReUcvW-GzdpgtgwQlVDqNRUvkAnjAjRKCLly0f1MTqf5w2pR8hWSvYKHTPdSioIO0H51xoi9jO2ONs4pNHPMOA-xZJTCLUs2duA12BDWWO4XXy5xxkCbG0sH_Fn2EJI0wix4CrHWxv8YItPESdXPatRD1NZqoXLdoS7lP-coSNnwwznh_sU_fz65cfldXPz_erb5aebphMrVhpBoBM9J0BgGOrOlA6udUoJQtoVb7VtNSfaCaosUUDFSlshgHAnWnCq7_gp-rD3nZZuhKGvM2YbzJT9aPO9Sdab_1-iX5vfaWukYlwyWg3eHQxyul1gLqb-Tg8h2AhpmQ1tBVe1v5YVffsE3aQlx7rejmJCc6lZpfie6nOa5wzuYRhKzC5Wc4jV7GI1-1ir6s3jPR40_0KswMUeqOpnOf4Ff7CwBw</recordid><startdate>20170901</startdate><enddate>20170901</enddate><creator>Jull, J</creator><creator>Whitehead, M</creator><creator>Petticrew, M</creator><creator>Kristjansson, E</creator><creator>Gough, D</creator><creator>Petkovic, J</creator><creator>Volmink, J</creator><creator>Weijer, C</creator><creator>Taljaard, M</creator><creator>Edwards, S</creator><creator>Mbuagbaw, L</creator><creator>Cookson, R</creator><creator>McGowan, J</creator><creator>Lyddiatt, A</creator><creator>Boyer, Y</creator><creator>Cuervo, L G</creator><creator>Armstrong, R</creator><creator>White, H</creator><creator>Yoganathan, M</creator><creator>Pantoja, T</creator><creator>Shea, B</creator><creator>Pottie, K</creator><creator>Norheim, O</creator><creator>Baird, S</creator><creator>Robberstad, B</creator><creator>Sommerfelt, H</creator><creator>Asada, Y</creator><creator>Wells, G</creator><creator>Tugwell, P</creator><creator>Welch, V</creator><general>BMJ Publishing Group LTD</general><general>BMJ Publishing Group</general><scope>9YT</scope><scope>ACMMV</scope><scope>CGR</scope><scope>CUY</scope><scope>CVF</scope><scope>ECM</scope><scope>EIF</scope><scope>NPM</scope><scope>AAYXX</scope><scope>CITATION</scope><scope>3V.</scope><scope>7RV</scope><scope>7X7</scope><scope>7XB</scope><scope>88E</scope><scope>88G</scope><scope>8FI</scope><scope>8FJ</scope><scope>8FK</scope><scope>ABUWG</scope><scope>AFKRA</scope><scope>AZQEC</scope><scope>BENPR</scope><scope>BTHHO</scope><scope>CCPQU</scope><scope>DWQXO</scope><scope>FYUFA</scope><scope>GHDGH</scope><scope>GNUQQ</scope><scope>K9-</scope><scope>K9.</scope><scope>KB0</scope><scope>M0R</scope><scope>M0S</scope><scope>M1P</scope><scope>M2M</scope><scope>NAPCQ</scope><scope>PIMPY</scope><scope>PQEST</scope><scope>PQQKQ</scope><scope>PQUKI</scope><scope>PRINS</scope><scope>PSYQQ</scope><scope>Q9U</scope><scope>7X8</scope><scope>5PM</scope></search><sort><creationdate>20170901</creationdate><title>When is a randomised controlled trial health equity relevant? Development and validation of a conceptual framework</title><author>Jull, J ; Whitehead, M ; Petticrew, M ; Kristjansson, E ; Gough, D ; Petkovic, J ; Volmink, J ; Weijer, C ; Taljaard, M ; Edwards, S ; Mbuagbaw, L ; Cookson, R ; McGowan, J ; Lyddiatt, A ; Boyer, Y ; Cuervo, L G ; Armstrong, R ; White, H ; Yoganathan, M ; Pantoja, T ; Shea, B ; Pottie, K ; Norheim, O ; Baird, S ; Robberstad, B ; Sommerfelt, H ; Asada, Y ; Wells, G ; Tugwell, P ; Welch, V</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-b472t-40eb4c30e0edd11311df9f6640097398a98308f416a06e1478a44e03f49ef6cb3</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2017</creationdate><topic>Clinical trials</topic><topic>Consensus</topic><topic>Evidence-based medicine</topic><topic>Health disparities</topic><topic>Health Equity</topic><topic>Health Status Disparities</topic><topic>Humans</topic><topic>Intervention</topic><topic>Life expectancy</topic><topic>Low income groups</topic><topic>Patient-Centred Medicine</topic><topic>Public health</topic><topic>Randomized Controlled Trials as Topic - 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Academic</collection><collection>PubMed Central (Full Participant titles)</collection><jtitle>BMJ open</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Jull, J</au><au>Whitehead, M</au><au>Petticrew, M</au><au>Kristjansson, E</au><au>Gough, D</au><au>Petkovic, J</au><au>Volmink, J</au><au>Weijer, C</au><au>Taljaard, M</au><au>Edwards, S</au><au>Mbuagbaw, L</au><au>Cookson, R</au><au>McGowan, J</au><au>Lyddiatt, A</au><au>Boyer, Y</au><au>Cuervo, L G</au><au>Armstrong, R</au><au>White, H</au><au>Yoganathan, M</au><au>Pantoja, T</au><au>Shea, B</au><au>Pottie, K</au><au>Norheim, O</au><au>Baird, S</au><au>Robberstad, B</au><au>Sommerfelt, H</au><au>Asada, Y</au><au>Wells, G</au><au>Tugwell, P</au><au>Welch, V</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>When is a randomised controlled trial health equity relevant? Development and validation of a conceptual framework</atitle><jtitle>BMJ open</jtitle><addtitle>BMJ Open</addtitle><date>2017-09-01</date><risdate>2017</risdate><volume>7</volume><issue>9</issue><spage>e015815</spage><pages>e015815-</pages><issn>2044-6055</issn><eissn>2044-6055</eissn><abstract>BackgroundRandomised 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.MethodsAn 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.ResultsA 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.ConclusionThe 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.</abstract><cop>England</cop><pub>BMJ Publishing Group LTD</pub><pmid>28951402</pmid><doi>10.1136/bmjopen-2016-015815</doi><oa>free_for_read</oa></addata></record> |
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| source | BMJ Open Access Journals; MEDLINE; DOAJ Directory of Open Access Journals; PubMed Central Open Access; EZB-FREE-00999 freely available EZB journals; PubMed Central |
| subjects | Clinical trials Consensus Evidence-based medicine Health disparities Health Equity Health Status Disparities Humans Intervention Life expectancy Low income groups Patient-Centred Medicine Public health Randomized Controlled Trials as Topic - methods Research Design Social Justice Society Socioeconomic Factors |
| title | When is a randomised controlled trial health equity relevant? Development and validation of a conceptual framework |
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