Critical Appraisal informs us that:
Data extrapolated from small study samples are especially prone to error and bias.
Clinical trial researchers have a duty to recruit a sample of volunteers that closely represent the population under study to ensure its results are generalisable.
Minoritised ethnic populations are repeatedly underrepresented in research studies and trials.
Minoritised ethnic populations are disproportionately impacted by various conditions and illnesses.
How Underrepresentation impacts study validity:
Impact to generalisability - participants differ systematically from population under study
Missing racial categories - can not be applied to reader’s population
Too-small sample sizes of minoritised ethnic populations can impact reliability as it leads to higher variability which may lead to bias
Evidence generated from small sample sizes is especially prone to error (false negatives/positives)
Examples of Underrepresentation in research:
Loree et al., 2019: Review of trials which led to FDA cancer drug approvals found Black population significantly underrepresented (22% of expected proportion). Race was only reported in 63% of trials
Murphy et al., 2016: Review of 209 US studies regarding mood and anxiety disorders. At least 38% no African Americans, 42% no race reported, 4% appropriate representation
Ding et al., 2021: Review of pivotal trials for dermatology drugs. Despite the varying population demographics of different countries and continents, where a study was conducted seemed to have minimal influence on the central tendency to predominantly enroll White participants.
Akincigil, A., Olfson, M., Siegel, M., Zurlo, K. A., Walkup, J. T., & Crystal, S. (2012). Racial and ethnic disparities in depression care in community-dwelling elderly in the United States. American Journal of Public Health, 102(2), 319-328.
American Lung Association. (2001). Urban air pollution and health inequities: a workshop report. Environmental Health Perspectives, 109(suppl 3), 357-374.
Armitage, R. (2022). Addressing the under-representation of ethnic minority groups in COVID-19 vaccine trials. Perspect Public Health, 142(1), 13-14.
Artiga, S., Hill, L., Orgera, K., & Damico, A. (2021). Health coverage by race and Ethnicity, 2010–2019. Kaiser Family Foundation,
Azar, K. M., Shen, Z., Romanelli, R. J., Lockhart, S. H., Smits, K., Robinson, S., Brown, S., & Pressman, A. R. (2020). Disparities In Outcomes Among COVID-19 Patients In A Large Health Care System In California: Study estimates the COVID-19 infection fatality rate at the US county level. Health Affairs, 39(7), 1253-1262.
Bonham, V. L., Warshauer-Baker, E., & Collins, F. S. (2005). Race and ethnicity in the genome era: the complexity of the constructs. American Psychological Association.
Borrell, L. N., Elhawary, J. R., Fuentes-Afflick, E., Witonsky, J., Bhakta, N., Wu, A. H., Bibbins-Domingo, K., Rodríguez-Santana, J. R., Lenoir, M. A., & Gavin III, J. R. (2021). Race and genetic ancestry in medicine—a time for reckoning with racism. New England Journal of Medicine, 384(5), 474-480.
British Heart Foundation, [. (2021). How your ethnic background affects your risk of heart and circulatory diseases. bhf.org.uk. https://www.bhf.org.uk/what-we-do/our-research/research-successes/ethnicity-and-heart-disease
Burls, A. (2014). What is critical appraisal? Citeseer.
Burns, P. B., Rohrich, R. J., & Chung, K. C. (2011). The levels of evidence and their role in evidence-based medicine. Plastic and Reconstructive Surgery, 128(1), 305-310.
Cardemil, E. V., Nelson, T., & Keefe, K. (2015). Racial and ethnic disparities in depression treatment. Current Opinion in Psychology, 4, 37-42.
Chen, J., Barron, C., Lin, K., & Chung, H. (2002). Prescribing medication for Asians with mental disorders. Western Journal of Medicine, 176(4), 271.
Chen, P. Y., Wang, S. C., Poland, R. E., & Lin, K. M. (2009). Biological variations in depression and anxiety between East and West. CNS neuroscience & therapeutics, 15(3), 283–294
Collins, P. (2008). Black Feminist Thought. London: Routledge.
Coulter, A., & Collins, A. (2011). Making shared decision-making a reality: No decision about me, without me. https://www.kingsfund.org.uk/publications/making-shared-decision-making-reality
Critical Appraisal Skills Programme [CASP] (2020). CASP Randomised Controlled Trial Checklist. https://casp-uk.net/casp-tools-checklists/
Cwalina, T. B., Jella, T. K., Manyak, G. A., Kuo, A., & Kamath, A. F. (2021). Is Our Science Representative? A Systematic Review of Racial and Ethnic Diversity in Orthopaedic Clinical Trials from 2000 to 2020. Clinical Orthopaedics and Related Research
Etti, M., Fofie, H., Razai, M., Crawshaw, A. F., Hargreaves, S., & Goldsmith, L. P. (2021). Ethnic minority and migrant underrepresentation in Covid-19 research: Causes and solutions. eClinicalMedicine, 36
Flanagin, A., Frey, T., Christiansen, S. L., & Bauchner, H. (2021). The Reporting of Race and Ethnicity in Medical and Science Journals: Comments Invited. Jama, 325(11), 1049-1052.
Fuentes, A., Ackermann, R. R., Athreya, S., Bolnick, D., Lasisi, T., Lee, S., McLean, S., & Nelson, R. (2019). AAPA statement on race and racism. American Journal of Physical Anthropology, 169(3), 400-402.
Gibiino, S., Marsano, A., & Serretti, A. (2014). Specificity profile of venlafaxine and sertraline in major depression: metaregression of double-blind, randomized clinical trials. International Journal of Neuropsychopharmacology, 17(1), 1-8.
Glasziou, P. P., Irwig, L., Bain, C. J., & Colditz, G. A. (2000). How to review the evidence: systematic identification and review of the scientific literature. Canberra, Australia: National Health and Medical Research Council.
GOV.UK. (2020). Population of England and Wales. Gov.UK. https://www.ethnicity-facts-figures.service.gov.uk/uk-population-by-ethnicity/national-and-regional-populations/population-of-england-and-wales/latest#by-ethnicity
Greenhalgh, T. (2019). How to read a paper: the basics of evidence-based medicine (6th ed.). John Wiley & Sons.
Hamel, L. M., Penner, L. A., Albrecht, T. L., Heath, E., Gwede, C. K., & Eggly, S. (2016). Barriers to Clinical Trial Enrollment in Racial and Ethnic Minority Patients With Cancer. Cancer Control : Journal of the Moffitt Cancer Center, 23(4), 327-337.
Harding, K., Mersha, T. B., Pham, P., Waterman, A. D., Webb, F. A., Vassalotti, J. A., & Nicholas, S. B. (2017). Health Disparities in Kidney Transplantation for African Americans. American Journal of Nephrology, 46(2), 165-175.
Higgins, J., Savović, J., Page, M. J., Elbers, R. G., & Sterne, J. (2022). Chapter 8: Assessing risk of bias in a randomized trial. In J. Higgins, J. Thomas, J. Chandler, M. Cumpston, T. Li, M. J. Page & V. A. Welch (Eds.), Cochrane Handbook for Systematic Reviews of Interventions.
Hoberman, J. (2012). Black and Blue: The Origins and Consequences of Medical Racism. Berkley: University of California Press.
Hoffman, K. M., Trawalter, S., Axt, J. R., & Oliver, M. N. (2016). Racial bias in pain assessment and treatment recommendations, and false beliefs about biological differences between blacks and whites. Proceedings of the National Academy of Sciences of the United States of America, 113(16), 4296-4301.
Lagomasino, I. T., Stockdale, S. E., & Miranda, J. (2011). Racial-ethnic composition of provider practices and disparities in treatment of depression and anxiety, 2003-2007. Psychiatric Services (Washington, D.C.), 62(9), 1019-1025.
Lin, K. (2001). Biological differences in depression and anxiety across races and ethnic groups. Journal of Clinical Psychiatry, 62, 13-21.
Loree, J. M., Anand, S., Dasari, A., Unger, J. M., Gothwal, A., Ellis, L. M., Varadhachary, G., Kopetz, S., Overman, M. J., & Raghav, K. (2019). Disparity of Race Reporting and Representation in Clinical Trials Leading to Cancer Drug Approvals From 2008 to 2018. JAMA Oncology, 5(10), e191870.
Mhaskar, R., Emmanuel, P., Mishra, S., Patel, S., Naik, E., & Kumar, A. (2009). Critical appraisal skills are essential to informed decision-making. Indian Journal of Sexually Transmitted Diseases and AIDS, 30(2), 112.
Murphy, E. (2016). African-American representation in family and twin studies of mood and anxiety disorders: A systematic review. Journal of Affective Disorders, 205, 311-318.
National Institute for Health and Care Excellence, [NICE]. (2014). Developing NICE guidelines: the
manual . https://www.nice.org.uk/media/default/about/what-we-do/our-programmes/developing-nice-guidelines-the-manual.pdf
National Institute for Health Research, [NIHR]. (2020). Improving inclusion of under-served groups in clinical research: Guidance from INCLUDE project. https://www.nihr.ac.uk/documents/improving-inclusion-of-under-served-groups-in-clinical-research-guidance-from-include-project/25435
NHS Digital. (2021). Coronavirus vaccine studies volunteers dashboard. digital.nhs.uk. https://digital.nhs.uk/dashboards/coronavirus-covid-19-vaccine-studies-volunteers-dashboard-uk
Office for National Statistics, [ONS]. (2021). Ethnicity facts and figures. https://www.ethnicity-facts-figures.service.gov.uk/. https://www.ethnicity-facts-figures.service.gov.uk/
Oh, S. S., Galanter, J., Thakur, N., Pino-Yanes, M., Barcelo, N. E., White, M. J., de Bruin, D. M., Greenblatt, R. M., Bibbins-Domingo, K., & Wu, A. H. (2015). Diversity in clinical and biomedical research: a promise yet to be fulfilled. PLoS Medicine, 12(12), e1001918.
Paradies, Y., Ben, J., Denson, N., Elias, A., Priest, N., Pieterse, A., Gupta, A., Kelaher, M., & Gee, G. (2015). Racism as a determinant of health: a systematic review and meta-analysis. PloS One, 10(9), e0138511.
Parnham, M. J., & Kricker, J. A. (2022). Factors Determining Plasticity of Responses to Drugs. International Journal of Molecular Sciences, 23(4), 2068.
Priest, N., Paradies, Y., Trenerry, B., Truong, M., Karlsen, S., & Kelly, Y. (2013). A systematic review of studies examining the relationship between reported racism and health and wellbeing for children and young people. Social Science & Medicine, 95, 115-127.
Quiñones, A.,R., Thielke, S. M., Beaver, K. A., Trivedi, R. B., Williams, E. C., & Fan, V. S. (2014). Racial and ethnic differences in receipt of antidepressants and psychotherapy by veterans with chronic depression. Psychiatric Services (Washington, D.C.), 65(2), 193-200.
Rai, T., Dixon, S., & Ziebland, S. (2021). Shifting research culture to address the mismatch between where trials recruit and where populations with the most disease live: a qualitative study. BMC Medical Research Methodology, 21(1), 80.
Rai, T., Hinton, L., McManus, R. J., & Pope, C. (2022). What would it take to meaningfully attend to ethnicity and race in health research? Learning from a trial intervention development study. Sociology of Health & Illness.
Raleigh, V., & Homes, J. (2021). The health of people from ethnic minority groups in England. kingsfund.org.uk. https://www.kingsfund.org.uk/publications/health-people-ethnic-minority-groups-england#Cancer
Roberts, D. E. (2021). Abolish race correction. The Lancet, 397(10268), 17-18.
Ross, P. T., Hart-Johnson, T., Santen, S. A., & Zaidi, N. L. B. (2020). Considerations for using race and ethnicity as quantitative variables in medical education research. Perspectives on Medical Education, 9(5), 318-323.
Royal College of Psychiatrists. (2018). Racism and Mental Health. www.rcpsych.ac.uk
Saini, A. (2020). Superior: The Return of Race Science. London: 4th Estate.
Satel, S. (2002). I Am a Racially Profiling Doctor. New York Times, 5, 56-58. https://www.nytimes.com/2002/05/05/magazine/i-am-a-racially-profiling-doctor.html
Scottish Intercollegiate Guidelines Network [SIGN]. (2012). Cohort Studies Checklist.
Seabury, S. A., Terp, S., & Boden, L. I. (2017). Racial And Ethnic Differences In The Frequency Of Workplace Injuries And Prevalence Of Work-Related Disability. Health Affairs, 36(2), 266-273.
Shah, R. R., & Gaedigk, A. (2018). Precision medicine: does ethnicity information complement genotype-based prescribing decisions? Therapeutic Advances in Drug Safety, 9(1), 45-62.
Sirugo, G., Tishkoff, S. A., & Williams, S. M. (2021). The quagmire of race, genetic ancestry, and health disparities. The Journal of Clinical Investigation, 131(11)
Skelly, A. C., Dettori, J. R., & Brodt, E. D. (2012). Assessing bias: the importance of considering confounding. Evidence-Based Spine-Care Journal, 3(1), 9-12.
Social Metric Commission. (2020). Measuring Poverty. socialmetricscommission.org.uk
Stafford, M., Boolaky, U., Elwell-Sutton, T., Asaria, M., & Nazroo, J. (2020). How to interpret research on ethnicity and COVID-19 risk and outcomes: five key questions.
Swartz, T. H., Palermo, A. S., Masur, S. K., & Aberg, J. A. (2019). The Science and Value of Diversity: Closing the Gaps in Our Understanding of Inclusion and Diversity. The Journal of Infectious Diseases, 220, S33-S41
Tchouankam, T., Estabrooks, P., Cloyd, A., Notice, M., Teel-Williams, M., Smolsky, A., Burnett, P., Alexis, G., Conley, T., Partridge, E. J., Hogan, P., Thorpe, R., & King, K. M. (2021). Recruiting Low-Income African American Men in Mental Health Research: A Community-Based Participatory Research Feasibility Study. American Journal of Men's Health, 15(3), 15579883211018418.
Tod, D., Booth, A., & Smith, B. (2021). Critical appraisal. Null, 1-21.
Treweek, S., Forouhi, N. G., Narayan, K. M. V., & Khunti, K. (2020). COVID-19 and ethnicity: who will research results apply to? Lancet (London, England), 395(10242), 1955-1957.
United States Census Bureau. (2021). Income and Poverty in the United States: 2020. United States Census Bureau. https://www.census.gov/library/publications/2021/demo/p60-273.html
United States Environmental Protection Agency, [US EPA]. (2019). Policy Assessment for the Review of the National Ambient Air Quality Standards for Particulate Matter.
US Renal Data System. (2013). USRDS 2013 annual data report: atlas of chronic kidney disease and end-stage renal disease in the United States. National Institutes of Health, National Institute of Diabetes and Digestive and Digestive and Kidney Diseases, Vol.2014,
Vyas, D. A., Eisenstein, L. G., & Jones, D. S. (2020). Hidden in Plain Sight — Reconsidering the Use of Race Correction in Clinical Algorithms. N Engl J Med, 383(9), 874-882.
Washington, H. (2006). Medical apartheid: the dark history of medical experimentation on Black Americans from colonial times to the present. New York: Doubleday.
Williamson, L. (2021). The link between structural racism, high blood pressure and Black people's health. American Heart Association.
Witherspoon, D. J., Wooding, S., Rogers, A. R., Marchani, E. E., Watkins, W. S., Batzer, M. A., & Jorde, L. B. (2007). Genetic similarities within and between human populations. Genetics, 176(1), 351-359.
Wright, N. (2020). BAME underrepresentation in clinical trials. British Journal of Cardiac Nursing, 15(9), 1-5.
Yu, N., Chen, F., Ota, S., Jorde, L. B., Pamilo, P., Patthy, L., Ramsay, M., Jenkins, T., Shyue, S., & Li, W. (2002). Larger Genetic Differences Within Africans Than Between Africans and Eurasians. Genetics, 161(1), 269-274.