Confronting diversity in the production of clinical evidence goes beyond merely including under-represented groups in clinical trials

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Abstract

There is increasing evidence that outcomes of health care differ by patient characteristics, such as gender and ethnicity. If evidence-based medicine is to improve quality of care for all patients, it is essential to take this diversity into account when designing clinical studies. So far, this notion has mainly been translated into recommendations for including minority populations in trials. We argue that a more comprehensive view of the production of diversity-sensitive clinical evidence is needed, one that takes heterogeneity as a starting point in research. We call for a mix of methodological approaches aimed at identifying diversity issues that matter and analysing the impact of these diversities on clinical outcomes. Institutional changes are necessary to support this methodological reform.

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Most cited references 30

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Pathogenesis of bone fragility in women and men.

Ego Seeman (2002)

There is no one cause of bone fragility; genetic and environmental factors play a part in development of smaller bones, fewer or thinner trabeculae, and thin cortices, all of which result in low peak bone density. Material and structural strength is maintained in early adulthood by remodelling; the focal replacement of old with new bone. However, as age advances less new bone is formed than resorbed in each site remodelled, producing bone loss and structural damage. In women, menopause-related oestrogen deficiency increases remodelling, and at each remodelled site more bone is resorbed and less is formed, accelerating bone loss and causing trabecular thinning and disconnection, cortical thinning and porosity. There is no equivalent midlife event in men, though reduced bone formation and subsequent trabecular and cortical thinning do result in bone loss. Hypogonadism contributes to bone loss in 20-30% of elderly men, and in both sexes hyperparathyroidism secondary to calcium malabsorption increases remodelling, worsening the cortical thinning and porosity and predisposing to hip fractures. Concurrent bone formation on the outer (periosteal) cortical bone surface during ageing partly compensates for bone loss and is greater in men than in women, so internal bone loss is better offset in men. More women than men sustain fractures because their smaller skeleton incurs greater architectural damage and adapts less effectively by periosteal bone formation. The structural basis of bone fragility is determined before birth, takes root during growth, and gains full expression during ageing in both sexes.

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Unravelling the impact of ethnicity on health in Europe: the HELIUS study

Karien Stronks, Marieke Snijder, Ron JG Peters … (2013)

Background Populations in Europe are becoming increasingly ethnically diverse, and health risks differ between ethnic groups. The aim of the HELIUS (HEalthy LIfe in an Urban Setting) study is to unravel the mechanisms underlying the impact of ethnicity on communicable and non-communicable diseases. Methods/design HELIUS is a large-scale prospective cohort study being carried out in Amsterdam, the Netherlands. The sample is made up of Amsterdam residents of Surinamese (with Afro-Caribbean Surinamese and South Asian-Surinamese as the main ethnic groups), Turkish, Moroccan, Ghanaian, and ethnic Dutch origin. HELIUS focuses on three disease categories: cardiovascular disease (including diabetes), mental health (depressive disorders and substance use disorders), and infectious diseases. The explanatory mechanisms being studied include genetic profile, culture, migration history, ethnic identity, socio-economic factors and discrimination. These might affect disease risks through specific risk factors including health-related behaviour and living and working conditions. Every five years, participants complete a standardized questionnaire and undergo a medical examination. Biological samples are obtained for diagnostic tests and storage. Participants’ data are linked to morbidity and mortality registries. The aim is to recruit a minimum of 5,000 respondents per ethnic group, to a total of 30,000 participants. Discussion This paper describes the rationale, conceptual framework, and design and methods of the HELIUS study. HELIUS will contribute to an understanding of inequalities in health between ethnic groups and the mechanisms that link ethnicity to health in Europe.

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Causal inference in public health.

Steven N Goodman, Miguel A. Hernán, Jonathan M. Samet … (2013)

Causal inference has a central role in public health; the determination that an association is causal indicates the possibility for intervention. We review and comment on the long-used guidelines for interpreting evidence as supporting a causal association and contrast them with the potential outcomes framework that encourages thinking in terms of causes that are interventions. We argue that in public health this framework is more suitable, providing an estimate of an action's consequences rather than the less precise notion of a risk factor's causal effect. A variety of modern statistical methods adopt this approach. When an intervention cannot be specified, causal relations can still exist, but how to intervene to change the outcome will be unclear. In application, the often-complex structure of causal processes needs to be acknowledged and appropriate data collected to study them. These newer approaches need to be brought to bear on the increasingly complex public health challenges of our globalized world.

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Journal

Journal ID (nlm-ta): Trials

Journal ID (iso-abbrev): Trials

Title: Trials

Publisher: BioMed Central

ISSN (Electronic): 1745-6215

Publication date Collection: 2013

Publication date (Electronic): 15 June 2013

Volume: 14

Page: 177

Affiliations

[1 ]Department of Public Health, Academic Medical Center, University of Amsterdam, Amsterdam, The Netherlands

[2 ]Communication Department, University Medical Center Groningen, University of Groningen, Groningen, The Netherlands

[3 ]Amsterdam Institute for Social Science Research, University of Amsterdam, Amsterdam, The Netherlands

Article

Publisher ID: 1745-6215-14-177

DOI: 10.1186/1745-6215-14-177

PMC ID: 3689626

PubMed ID: 23768231

SO-VID: 9aa05837-0588-4fd1-b33b-242f8c776c52

License:

This is an Open Access article distributed under the terms of the Creative Commons Attribution License ( http://creativecommons.org/licenses/by/2.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.

Confronting diversity in the production of clinical evidence goes beyond merely including under-represented groups in clinical trials

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Most cited references 30

Pathogenesis of bone fragility in women and men.

Unravelling the impact of ethnicity on health in Europe: the HELIUS study

Causal inference in public health.

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