Comparison of reporting of ethnicity in US and European randomised controlled trials
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《英国医生杂志》
1 GP Section, Division of Community Health Sciences, University of Edinburgh, Edinburgh EH8 9DX, 2 Division of Primary Care and Population Health Sciences, Imperial College, London, 3 Division of Primary Care, University of Nottingham, Nottingham
Correspondence to: A Sheikh aziz.sheikh@ed.ac.uk
Introduction
American studies are five times more likely than European trials to report information on the ethnicity of participants. The random selection procedures adopted and the standardised and independent extraction of data with an initially agreed approach to handle disagreements should have minimised the risk of selection bias or information bias accounting for these findings.
Our results seem likely to reflect active policies in the United States. For example, all federally supported programmes with sufficient sample size are required to report statistics according to race or ethnicity.3 None the less, it is still concerning that only two fifths of recently published trials from the United States report on the ethnicity of participants. Possible explanations include known difficulties in identifying, enrolling, and following up minority ethnic populations in trials. Another possible factor is the argument that ethnicity reporting is only important in specific disease areas with known ethnic disparities. Relevant here are recent data showing that in the study of such conditions 59% of US trials report on the ethnicity of participants.4
Mechanisms to facilitate inclusion and standards to ensure reporting of minority ethnic communities in studies are needed. These reporting standards are absent in current CONSORT requirements and we suggest that the merits of insisting on presentation of such data, where appropriate, should be debated.5 In particular, European governments should consider the US model for promoting inclusion of ethnic minority participants in research.
This article was posted on bmj.com on 11 May 2004: http://bmj.com/cgi/doi/10.1136/bmj.38061.593935.F7
Contributors: AS conceived this study, formulated the study protocol, and led the writing of the manuscript. GN and SSP extracted data. GN analysed the data. JK interpreted the results and wrote the paper. AS is guarantor.
Funding: None.
Competing interests: None declared.
Ethical approval: Not needed.
References
National Institutes of Health. Monitoring adherence to the NIH policy on the inclusion of women and minorities as subjects in clinical research. Bethesda: NIH, 2001. www4.od.nih.gov/orwh/salmonrpt.pdf (accessed 15 Mar 2004).
Mulrow CD, Oxman AD, eds. Cochrane Collaboration handbook. In: Cochrane Library. Issue 4. Oxford: Update Software, 1997.
Office of Management and Budget. Recommendations from the interagency committee for the review of the racial and ethnic standards to the Office of Management and Budget concerning changes to the standards for the classification of federal data on race and ethnicity. Washington, DC: OoMaB, 1997. (Directive number 15.) www.whitehouse.gov/omb/fedreg/directive_15.html (accessed 15 Mar 2004).
Corbie-Smith G, St George DMM, Moody-Ayers S, Ransohoff DF. Adequacy of reporting race/ethnicity in clinical trials in areas of health disparities. J Clin Epidemiol 2003;56: 416-20.
Revised consort statement. www.consort-statement.org (accessed 15 Mar 2004).(Aziz Sheikh, professor of)
Correspondence to: A Sheikh aziz.sheikh@ed.ac.uk
Introduction
American studies are five times more likely than European trials to report information on the ethnicity of participants. The random selection procedures adopted and the standardised and independent extraction of data with an initially agreed approach to handle disagreements should have minimised the risk of selection bias or information bias accounting for these findings.
Our results seem likely to reflect active policies in the United States. For example, all federally supported programmes with sufficient sample size are required to report statistics according to race or ethnicity.3 None the less, it is still concerning that only two fifths of recently published trials from the United States report on the ethnicity of participants. Possible explanations include known difficulties in identifying, enrolling, and following up minority ethnic populations in trials. Another possible factor is the argument that ethnicity reporting is only important in specific disease areas with known ethnic disparities. Relevant here are recent data showing that in the study of such conditions 59% of US trials report on the ethnicity of participants.4
Mechanisms to facilitate inclusion and standards to ensure reporting of minority ethnic communities in studies are needed. These reporting standards are absent in current CONSORT requirements and we suggest that the merits of insisting on presentation of such data, where appropriate, should be debated.5 In particular, European governments should consider the US model for promoting inclusion of ethnic minority participants in research.
This article was posted on bmj.com on 11 May 2004: http://bmj.com/cgi/doi/10.1136/bmj.38061.593935.F7
Contributors: AS conceived this study, formulated the study protocol, and led the writing of the manuscript. GN and SSP extracted data. GN analysed the data. JK interpreted the results and wrote the paper. AS is guarantor.
Funding: None.
Competing interests: None declared.
Ethical approval: Not needed.
References
National Institutes of Health. Monitoring adherence to the NIH policy on the inclusion of women and minorities as subjects in clinical research. Bethesda: NIH, 2001. www4.od.nih.gov/orwh/salmonrpt.pdf (accessed 15 Mar 2004).
Mulrow CD, Oxman AD, eds. Cochrane Collaboration handbook. In: Cochrane Library. Issue 4. Oxford: Update Software, 1997.
Office of Management and Budget. Recommendations from the interagency committee for the review of the racial and ethnic standards to the Office of Management and Budget concerning changes to the standards for the classification of federal data on race and ethnicity. Washington, DC: OoMaB, 1997. (Directive number 15.) www.whitehouse.gov/omb/fedreg/directive_15.html (accessed 15 Mar 2004).
Corbie-Smith G, St George DMM, Moody-Ayers S, Ransohoff DF. Adequacy of reporting race/ethnicity in clinical trials in areas of health disparities. J Clin Epidemiol 2003;56: 416-20.
Revised consort statement. www.consort-statement.org (accessed 15 Mar 2004).(Aziz Sheikh, professor of)