CONSORT-Equity 2017 extension and elaboration for better reporting of health equity in randomised trials
We outline CONSORT-Equity 2017 reporting standards, an extension to the CONSORT (Consolidated Standards of Reporting Trials) statement that aims to improve the reporting of intervention effects in randomised trials where health equity is relevant. Health inequities are unfair differences in health t...
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| Vydané v: | BMJ (Online) Ročník 359; s. j5085 |
|---|---|
| Hlavní autori: | , , , , , |
| Médium: | Journal Article |
| Jazyk: | English |
| Vydavateľské údaje: |
England
British Medical Journal Publishing Group
23.11.2017
BMJ Publishing Group LTD |
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| ISSN: | 0959-8138, 1756-1833, 1756-1833 |
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| Abstract | We outline CONSORT-Equity 2017 reporting standards, an extension to the CONSORT (Consolidated Standards of Reporting Trials) statement that aims to improve the reporting of intervention effects in randomised trials where health equity is relevant. Health inequities are unfair differences in health that can be avoided by reasonable action. We defined a randomised trial where health equity is relevant as one that assesses effects on health equity by evaluating an intervention focused on people experiencing social disadvantage or by exploring the difference in the effect of the intervention between two groups (or as a gradient across more than two groups) experiencing different levels of social disadvantage, or both. We held a consensus meeting with diverse potential users from high, middle, and low income countries, including knowledge users such as patients and methodologists. We discussed evidence for each proposed extension item from empirical studies, reviews, key informant interviews, and an online survey, aiming to improve clarity of reporting without imposing undue burden on authors. The new guidance contains equity extensions to 16 items from CONSORT 2010 plus one new item on research ethics reporting, with examples of good practice and a brief explanation and elaboration for each. Widespread uptake of this guidance for the reporting of trials where health equity is relevant will make it easier for decision makers to find and use evidence from randomised trials to reduce unfair inequalities in health. |
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| AbstractList | We outline CONSORT-Equity 2017 reporting standards, an extension to the CONSORT (Consolidated Standards of Reporting Trials) statement that aims to improve the reporting of intervention effects in randomised trials where health equity is relevant. Health inequities are unfair differences in health that can be avoided by reasonable action. We defined a randomised trial where health equity is relevant as one that assesses effects on health equity by evaluating an intervention focused on people experiencing social disadvantage or by exploring the difference in the effect of the intervention between two groups (or as a gradient across more than two groups) experiencing different levels of social disadvantage, or both. We held a consensus meeting with diverse potential users from high, middle, and low income countries, including knowledge users such as patients and methodologists. We discussed evidence for each proposed extension item from empirical studies, reviews, key informant interviews, and an online survey, aiming to improve clarity of reporting without imposing undue burden on authors. The new guidance contains equity extensions to 16 items from CONSORT 2010 plus one new item on research ethics reporting, with examples of good practice and a brief explanation and elaboration for each. Widespread uptake of this guidance for the reporting of trials where health equity is relevant will make it easier for decision makers to find and use evidence from randomised trials to reduce unfair inequalities in health. |
| Author | Jull, Janet Tugwell, Peter Norheim, Ole F Sommerfelt, Halvor Cookson, Richard Welch, Vivian A |
| Author_xml | – sequence: 1 givenname: Vivian A surname: Welch fullname: Welch, Vivian A email: vwelch@campbellcollaboration.org organization: School of Epidemiology, Public Health and Preventive Medicine, University of Ottawa – sequence: 2 givenname: Ole F surname: Norheim fullname: Norheim, Ole F organization: Department of Global Health and Population, Harvard TH Chan School of Public Health, Bergen, Norway – sequence: 3 givenname: Janet surname: Jull fullname: Jull, Janet organization: Ottawa Hospital Research Institute, University of Ottawa – sequence: 4 givenname: Richard surname: Cookson fullname: Cookson, Richard organization: Centre for Health Economics, University of York, York YO10 5DD, UK – sequence: 5 givenname: Halvor surname: Sommerfelt fullname: Sommerfelt, Halvor organization: Norwegian Institute of Public Health, Oslo, Norway – sequence: 6 givenname: Peter surname: Tugwell fullname: Tugwell, Peter organization: Department of Medicine, University of Ottawa |
| BackLink | https://www.ncbi.nlm.nih.gov/pubmed/29170161$$D View this record in MEDLINE/PubMed |
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| ContentType | Journal Article |
| Contributor | Petticrew, Mark McGowan, Jessie Mbuagbaw, Lawrence Taljaard, Monica Wells, George A Boyer, Yvonne Gough, David Pantoja, Tomas Wester, Gry Weijer, Charles Whitehead, Margaret White, Howard Shea, Beverley Pottie, Kevin Edwards, Sarah JL Lyddiatt, Anne Moher, David Volmink, Jimmy Armstrong, Rebecca Yoganathan, Manosila Nyamai Kisia, Caroline Cuervo, Luis Gabriel Asada, Yukiko Bhutta, Zulfiqar A Kristjansson, Elizabeth Johansson, Kjell Arne Bærøe, Kristine Grimshaw, Jeremy M Loder, Elizabeth Verguet, Stéphane Petkovic, Jennifer Baird, Sarah Greer-Smith, Regina Robberstad, Bjarne |
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| Copyright | Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to Copyright: 2017 Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions |
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Evidence from systematic reviews publication-title: J Epidemiol Community Health – volume: 17 start-page: 1 year: 2013 article-title: A cluster randomised controlled trial and economic evaluation of a structured training programme for caregivers of inpatients after stroke: the TRACS trial publication-title: Health Technol Assess – volume: 379 start-page: 1320 year: 2012 article-title: Effect of a cash transfer programme for schooling on prevalence of HIV and herpes simplex type 2 in Malawi: a cluster randomised trial publication-title: Lancet – volume: 177 start-page: 870 year: 2013 article-title: Can changes in the distributions of and associations between education and income bias temporal comparisons of health disparities? An exploration with causal graphs and simulations publication-title: Am J Epidemiol – volume: 9 start-page: e1001346 year: 2012 article-title: The Ottawa statement on the ethical design and conduct of cluster randomized trials publication-title: PLoS Med – volume: 18 start-page: 726 year: 2014 article-title: Outcomes of a behavioral intervention to reduce HIV risk among drug-involved female sex workers publication-title: AIDS Behav – volume: 30 start-page: 190 year: 2004 article-title: The standard of care debate: the Declaration of Helsinki versus the international consensus opinion publication-title: J Med Ethics – volume: 94 start-page: 923 year: 2004 article-title: The standard of care debate: can research in developing countries be both ethical and responsive to those countries’ health needs? publication-title: Am J Public Health – volume: 8 start-page: 24584 year: 2015 article-title: Effect of the Uganda Newborn Study on care-seeking and care practices: a cluster-randomised controlled trial publication-title: Glob Health Action – volume: 348 start-page: g3804 year: 2014 article-title: Relation of completeness of reporting of health research to journals’ endorsement of reporting guidelines: systematic review publication-title: BMJ – volume: 19 start-page: 636 year: 2014 article-title: Pilot study of a brief intervention based on the theory of planned behaviour and self-identity to increase chlamydia testing among young people living in deprived areas publication-title: Br J Health Psychol – volume: 11 start-page: 46 year: 2014 article-title: The effect of active video games by ethnicity, sex and fitness: subgroup analysis from a randomised controlled trial publication-title: Int J Behav Nutr Phys Act – volume: 115 start-page: 1063 year: 2010 article-title: CONSORT 2010 statement: updated guidelines for reporting parallel group randomized trials publication-title: Obstet Gynecol – volume: 7 start-page: e1000217 year: 2010 article-title: Guidance for developers of health research reporting guidelines publication-title: PLoS Med – volume: 379 start-page: 181 year: 2012 article-title: Building of the global movement for health equity: from Santiago to Rio and beyond publication-title: Lancet – volume: 373 start-page: 1447 year: 2009 article-title: Public policy for the poor? A randomised assessment of the Mexican universal health insurance programme publication-title: Lancet – volume: 353 start-page: 773 year: 1999 article-title: Short-course zidovudine for perinatal HIV-1 transmission in Bangkok, Thailand: a randomised controlled trial publication-title: Lancet – volume: 10 start-page: 146 year: 2015 article-title: Protocol for the development of a CONSORT-equity guideline to improve reporting of health equity in randomized trials publication-title: Implement Sci – year: 1997 article-title: Randomized experiments for planning and evaluation: A practical guide, vol. 44 publication-title: Sage – volume: 1 start-page: 60 year: 2012 article-title: Does use of the CONSORT Statement impact the completeness of reporting of randomised controlled trials published in medical journals? A Cochrane review publication-title: Syst Rev – volume: 104 start-page: e106 year: 2014 article-title: Effectiveness of circle of life, an HIV-preventive intervention for American Indian middle school youths: a group randomized trial in a Northern Plains tribe publication-title: Am J Public Health – volume: 11 start-page: e0153190 year: 2016 article-title: Cluster randomized controlled trial evaluation of a gender equity and family planning intervention for married men and couples in rural India publication-title: PLoS One – article-title: GRADE Equity series: Why health equity and guidelines? publication-title: J Clin Epidemiol – volume: 1 start-page: 2 year: 2016 article-title: Sex and gender equity in research: rationale for the SAGER guidelines and recommended use publication-title: Res Integr Peer Rev. – volume: 9 start-page: 86 year: 2014 article-title: Looking inside the black box: results of a theory-based process evaluation exploring the results of a randomized controlled trial of printed educational messages to increase primary care physicians’ diabetic retinopathy referrals [Trial registration number ISRCTN72772651] publication-title: Implement Sci – volume: 11 start-page: 14 year: 2012 article-title: Participant demographics reported in “Table 1” of randomised controlled trials: a case of “inverse evidence”? publication-title: Int J Equity Health – volume: 340 start-page: c2138 year: 2010 article-title: Impact of an informed choice invitation on uptake of screening for diabetes in primary care (DICISION): randomised trial publication-title: BMJ – volume: 221 start-page: 957 year: 2016 article-title: Effectiveness of person-centred care after acute coronary syndrome in relation to educational level: Subgroup analysis of a two-armed randomised controlled trial publication-title: Int J Cardiol – volume: 14 start-page: 199 year: 2016 article-title: Impact of a web-based tool (WebCONSORT) to improve the reporting of randomised trials: results of a randomised controlled trial publication-title: BMC Med – volume: 9 start-page: 30578 year: 2016 article-title: Impact of a peer-counseling intervention on breastfeeding practices in different socioeconomic strata: results from the equity analysis of the PROMISE-EBF trial in Uganda publication-title: Glob Health Action – volume: 387 start-page: 2145 year: 2016 article-title: The world report on ageing and health: a policy framework for healthy ageing publication-title: Lancet – volume: 372 start-page: 1661 year: 2008 article-title: Closing the gap in a generation: health equity through action on the social determinants of health publication-title: Lancet – volume: 11 start-page: e0152423 year: 2016 article-title: London education and inclusion project (LEIP): exploring negative and null effects of a cluster-randomised school-intervention to reduce school exclusion—findings from protocol-based subgroup analyses publication-title: PLoS One – volume: 7 start-page: e31360 year: 2012 article-title: Does consideration and assessment of effects on health equity affect the conclusions of systematic reviews? A methodology study publication-title: PLoS One – volume: 32 start-page: 623 year: 2014 article-title: Impact of maternal education about complementary feeding on their infants’ nutritional outcomes in low- and middle-income households: a community-based randomized interventional study in Karachi, Pakistan publication-title: J Health Popul Nutr – volume: 61 start-page: 243 year: 2013 article-title: Collaborative care management reduces disparities in dementia care quality for caregivers with less education publication-title: J Am Geriatr Soc – volume: 9 start-page: 186 year: 2010 article-title: Effect of incentives on insecticide-treated bed net use in sub-Saharan Africa: a cluster randomized trial in Madagascar publication-title: Malar J – volume: 59 start-page: 1125 year: 2006 article-title: Why are so few randomized trials useful, and what can we do about it? publication-title: J Clin Epidemiol – volume: 337 start-page: a1655 year: 2008 article-title: Developing and evaluating complex interventions: the new Medical Research Council guidance publication-title: BMJ – volume: 42 start-page: 2448 year: 2015 article-title: Toward ensuring health equity: readability and cultural equivalence of OMERACT patient-reported outcome measures publication-title: J Rheumatol – volume: 73 start-page: 924 year: 2013 article-title: Naltrexone reduction of long-term smoking cessation weight gain in women but not men: a randomized controlled trial publication-title: Biol Psychiatry – volume: 111 start-page: 1630 year: 2016 article-title: Financial incentives for promoting colorectal cancer screening: a randomized, comparative effectiveness trial publication-title: Am J Gastroenterol |
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| Title | CONSORT-Equity 2017 extension and elaboration for better reporting of health equity in randomised trials |
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