Strategies for improving diversity, equity, and inclusion in cardiovascular research

a primer

  • Prichard, Roslyn
  • Maneze, Della
  • Straiton, Nicola
  • Inglis, Sally C
  • McDonagh, Julee

  • Faculty of Health, University of the Sunshine Coast, 90 Sippy Downs Drive, Sippy Downs, 4556 Queensland, Australia

    School of Nursing, Faculty of Science, Medicine, and Health, University of Wollongong, Wollongong, New South Wales, Australia

    St Vincent’s Health Network, Nursing Research Institute, Australian Catholic University, Sydney, New South Wales, Australia

    IMPACCT, Faculty of Health, University of Technology Sydney, Sydney, New South Wales, Australia

    School of Nursing, Faculty of Science, Medicine, and Health, University of Wollongong, Wollongong, New South Wales, Australia

    Centre for Chronic and Complex Care Research, Blacktown Hospital, Blacktown, New South Wales, Australia

Corresponding author. Tel: +61 7 54594527, Email: [email protected]

Conflict of interest: none declared.

Received December 30, 2023

Accepted January 02, 2024

Revised January 19, 2024

This is an Open Access article distributed under the terms of the Creative Commons Attribution License (https://creativecommons.org/licenses/by/4.0/), which permits unrestricted reuse, distribution, and reproduction in any medium, provided the original work is properly cited.

European Journal of Cardiovascular Nursing 23(3):p 313-322, April 2024. | DOI: 10.1093/eurjcn/zvae002

Learning objectives

  • Understand diversity, equity, and inclusion (DE&I) in the context of cardiovascular (CV) research and its impact on research findings, translation, and patient outcomes.

  • Identify strategies that have demonstrated effectiveness in improving the participation of underrepresented population in CV disease research.

  • Develop greater confidence to advocate for the application of strategies and practices presented in the paper to improve DE&I in CV research.

The problem

Cardiovascular disease (CVD) is a prominent contributor to global mortality and morbidity, impacting people across diverse demographics. Nevertheless, cardiovascular (CV) research, including clinical trials, has traditionally fallen short in demonstrating inclusive practices for diversity, equity, and inclusion (DE&I), notably apparent in the unrepresentative enrolment and poorly sustained engagement of underrepresented groups, including women and culturally and linguistically diverse populations. Poor DE&I in clinical trials has been well-documented since the early 1990s, and despite many leading research funding bodies developing guidelines and policies mandating the inclusion of women and culturally and linguistically diverse populations in government-funded research, representation of both groups in CV trials remains worse than other specialties., A recently published review of 153 landmark CV randomized controlled trials (RCTs) from 1986 to 2019 (including over 1.1 million participants) revealed that only 56% of RCTs reported information about participant race. The review also found that no significant improvement in inclusion of underrepresented racial and ethnic groups has occurred over time. Race can have significant pathophysiological implications in CVD therapy as evidenced in the landmark African–American Heart Failure Trial (A-HeFT), which demonstrated a different response to standard heart failure therapy in African–American populations.,

An audit of five clinical trials listed on the American College of Cardiology Top Clinical Trials for 2022 underscores the persistency of the problem in that the majority of participants was Caucasian males, none of the trials clearly reported gender data, and some trials failed to report participant race (see Supplementary material online, Table S1). Although the proportion of transgendered or gender-diverse individuals (i.e. non-binary or genderqueer), is thought to be small (0.3–0.5% of the world’s population), there is a growing need to understand how sex, gender, and gender dysphoria influence CV traits, ischaemic heart disease, and heart failure mechanisms. How we choose to collect this data will influence how well we can identify and elucidate these links. Factors underpinning the continued deficit with regard to female participation include persistent historical and systemic bias in attitudes around the female hormonal profile and reproductive risk and the concurrent contradictory belief that women would have similar responses to drugs as men. In addition, women make up only 10% of CV clinical trials leadership teams or are listed as first or last authors on clinical trial publications.

Diversity, equity, and inclusion deficits in CVD research can also impact guideline development, with guidelines inevitably based on the extrapolation of results obtained in unrepresentative patient populations, potentially exacerbating pre-existing health disparities and hindering the development of effective prevention and treatment strategies for all those affected by CVD.,,, In turn, the makeup of CVD guideline authorship teams reflects disparity in the inclusion of women as chairs or members of guideline development committees. The evidence points to the fact that where women do lead in research teams and in translation, DE&I in participant recruitment and retention, as well as participation in guideline development, improve.,

The persistent DE&I deficit in CVD research requires a ‘root and branch’ approach with leadership required at every level of the research ecosystem from trial governance to guideline development. This methods paper is aimed at clinician–researchers who may find themselves involved at various points in the CVD research cycle and collates evidence and strategies to improve DE&I, applicable at each stage.

Moving towards a solution: strategies to improve diversity, equity, and inclusion in cardiovascular disease research

As clinician–researchers, we are uniquely placed to advocate for and have an ethical and moral responsibility to design, conduct, and implement research that ensures evidence-based CV care is representative and accessible. Diversity, equity, and inclusion principles need to be incorporated throughout the research cycle, from conceptualization through to translation and knowledge exchange. To do this, it is important to become familiar with existing evidence-based strategies that focus on DE&I across the various phases of the research cycle (Box 1).

Box 1Definition of key DE&I terms in the context of cardiovascular disease research

Diversity is the representation of a wide range of people with different backgrounds, identities, and perspectives in a particular group—in this case, cardiovascular disease (CVD) research participants, research teams, and those involved in research translation. Dimensions may include race, ethnicity, gender, sexual orientation, age, disability, religion, and socioeconomic status.

Equity is about, justice, and equal opportunities. It is the recognition that different people may require different resources, support, or accommodations to achieve equitable CVD outcomes, ensuring that their identities do not dictate their access to opportunities in research participation.

Inclusion refers to the behaviours and practices that ensure all individuals and groups are valued. It is about making sure participants are representative of the population the treatment or intervention is intended for and that the study results are meaningful and applicable to the target population.

Underrepresentation happens when groups or individuals are not adequately or proportionately represented within a particular research setting. It often highlights the need for increased attention to the enhanced opportunities these groups may need to address imbalances and promote equitable participation.,

Co-design is a collaborative approach to cardiovascular research that involves including diverse stakeholders, and people affected by cardiovascular conditions, in designing the proposed research-based solutions. It can be used to address potential barriers that hinder effective research translation across underrepresented groups.

Culturally tailored communication involves adapting messages, materials, or strategies to effectively reach and resonate with specific groups. It involves recognizing the cultural norms, values, beliefs, and linguistic preferences of the target audience to ensure that research communication is culturally appropriate, sensitive, and relatable.

Decentralized clinical trials (DCTs) leverage remote data collection, allowing participants to complete study requirements from home while still being closely monitored. They can potentially address barriers to diversity, patient participation, and accessibility in the clinical trial recruitment and retention.

Targeted recruitment research refers to the deliberate and strategic efforts made to identify and enrol participants from specific demographic or population groups into research studies.

Community engagement involves proactive and ongoing collaboration with the communities being served throughout all phases of the research cycle. It requires bidirectional communication, with researchers listening to and learning with the community.

Pre-planning and study design

Ensuring meaningful and relevant research for underrepresented communities necessitates early involvement of diverse patients, community members, and stakeholders in formulating research questions. One effective approach to achieve this is through research co-design processes. Co-design emphasizes collaboration with the community and makes use of existing strengths and resources, fostering a sense of ownership. Various frameworks and examples have been published that focus on different aspects of the participatory process. By adopting a co-design framework, the community is actively engaged in the creation and development of new, innovative, and culturally tailored strategies that address identified problems. Working within an identified co-design conceptual framework that fits the aims of the study is important. For example, Nesbitt and colleagues utilized the user experience design framework (UX design) in the development of a web-based portal for cardiac rehabilitation. In a narrative review of previously published frameworks intended to facilitate lay participation in research, Greenhalgh and colleagues identified a total of 56 resources. Their conclusion is that a universal framework that applies across the board may be less valuable than customizing a variety of resources that can be merged and tailored to the specific research context.

Incorporating patient and community members as part of the research team yields numerous benefits. Firstly, it provides a valuable source of social support, allowing individuals to feel empowered and to actively participate in shaping the research agenda. Additionally, involving community members helps to build trust and establish rapport between researchers and the community, facilitating culturally sensitive engagement throughout the research process. The Australian Consumer Involvement and Engagement Toolkit, a recently published resource, offers practical guidance on authentic partnership with patients and community members in clinical research.

Early planning and budgeting are required to resource the development of inclusive study materials and build partnerships with external community organisations. This aspect of the research planning phase can be daunting for clinician–researchers, and it is useful to access tools and guidance such as the Consumer Involvement Cost Calculator provided by the Australian Clinical Trials Alliance. Clinician–researchers need to be able to advocate for sufficient funding to enable deployment of DE&I strategies and translation of findings back to target groups.

Table 1 provides DE&I strategies and evidenced-based examples for the pre-planning and study design phases.

Study conduct: recruitment and retention

To ensure that underrepresented populations have an equal opportunity to participate in clinical research, researchers must carefully consider the eligibility criteria. Subjective eligibility criteria that rely on clinician judgement (e.g. a participant’s perceived ability to provide informed consent or comply with study procedures) that is likely to disproportionately affect people from underrepresented groups should be avoided. Instead, the use of objective assessments, such as diagnostic tests or biomarker measurements to determine eligibility, may be more appropriate in some circumstances. Cognitive ability can be objectively assessed using an appropriate tool, or a diagnosis of major cognitive impairment may be found in the medical record. But every exclusion criterion need to be scientifically justified and those included as participants should reflect the larger group of all those affected by the researched disease or condition. For example, cognitive impairment is highly prevalent in heart failure, yet many studies still exclude these patients., Including underrepresented groups may require concerted efforts from the research team to successfully recruit and safely retain representative cohorts.

Targeted recruitment strategies, such as partnering with community organisations or using social media platforms to reach underrepresented populations, have been successfully deployed in several studies., Ensuring culturally tailored communication strategies includes making sure that the language and visual materials developed in information documents and in interventions are culturally appropriate and relevant., Researchers can then use materials that are relevant and resonant with underrepresented populations to communicate the goals, procedures, and potential benefits and risks of the study. Approaching potential participants in places in which they are already active, particularly in settings that are familiar and comfortable to them, and providing incentives relevant to them and their community have also been found to encourage participation. Decentralized clinical trial methods that leverage digital technologies to reduce the need for participants to travel back to the study centre frequently could also be used to address barriers faced by some underrepresented groups.

Cultural sensitivity during recruitment could include considering the role of family. In Western culture, privacy and patient confidentiality often require that healthcare professionals (HCPs) talk with the patient alone, but in many cultures, the family is part of the decision-making processes. Asking consent for potential participant to take part in a research programme may be a ‘family business’ rather than a lone decision to be made by the potential participant. You will more often be directed to ‘ask my wife or my partner or my son or my daughter’ for consent. Some cultures are collectivist in orientation, and potential participants may be more receptive when the benefits of the research are not only for the individual but also for the family and the community at large. For example, some Asian people view self as an extension of significant others and as such they are all included in the discussion about important matters such as participating in a clinical trial.

Table 2 provides DE&I strategies and evidenced-based examples for the study recruitment and retention phases.

Data collection, analysis, and reporting

Ensuring participant safety and comfort during data collection is crucial. This involves providing DE&I and cultural awareness training to research staff and maintaining engagement with community members to build ongoing trust and mutual respect. Special attention is needed for populations with historical grievances, such as First Nations. Community voices and Indigenous knowledge should be prioritized and meaningful partnerships established., Using a framework such as community-based participatory research can be used to support knowledge sharing that prioritizes lived experience and places community voices at the centre of the partnership. Where appropriate, and under the leadership of community and/or First Nations research partners and elders, the incorporation of Indigenous research methodologies, such as Two-Eyed Seeing, Yarning, or Storytelling, can be considered for data collection.,

When working with culturally and linguistically diverse populations, translating study materials requires careful consideration. Colloquialisms and English terminologies may lack equivalence in other languages, emphasizing the need for briefings with translation experts and consultations with culturally congruent community members to ensure accurate interpretation during data analysis.

For quantitative data analysis, researchers should employ statistical techniques, including weighting methods to address sample biases and should include analysis of disaggregated data, to help identify disparities and patterns across subgroups. Considering the impact of multiple intersecting identities on health outcomes can require sophisticated statistical approaches to account for complex interactions between social identities and health outcomes. These might include multiple main effects, statistical interactions, and multilevel modelling, to explore the additive, multiplicative, and multilevel effects of intersecting identities on CV outcomes. This is particularly relevant when considering sex-specific and gender-based disparities in outcomes where intersecting social determinants may be particularly impactful. Embedding these methods early in the study design phase is also crucial.

Reporting results explicitly so that the demographic characteristics of your study participants are clearly outlined and variations in study outcomes across different demographic groups are highlighted is important. This should include recognition of intersecting identities (e.g. race, gender, and sexual orientation) and their influence on study outcomes where possible.

Table 3 provides DE&I strategies and evidenced-based examples data collection and analysis phases.

Translation and impact

The translation and implementation of research into practice is a critical part of the research process with the persistent 17-year gap between research and translation further entrenching DE&I deficits in CVD outcomes., To address this, a flexible research dissemination plan might include developing tailored presentations to participating community groups, establishing a point person to serve as a community liaison, and a continuing dialogue with community members after the study. The principles of co-design and community participation discussed earlier can accelerate community uptake of research findings through feedback and consultation processes. Communicating research findings back to key participants and community leaders helps builds trust, accelerates uptake of evidence-based research findings, and sets the scene for future collaborations. Fostering this dialogue, particularly with populations that are historically mistrustful of research, aids in both developing culturally relevant interventions and improving uptake of relevant research findings.

Table 4 provides DE&I strategies and evidenced-based examples for the reporting, translation, and impact phases.

Research team and research environment

A key driver of diverse, equitable, and inclusive research is the makeup of the investigator team. Recent findings from a systematic bibliometric review highlight that trials led by women are more likely to enrol diverse participants and report race and ethnicity. But tackling the DE&I climate within a research team or institution requires an active stance from senior leadership and mentoring of staff from underrepresented groups, along with the promotion of ally behaviours amongst existing staff., As clinician–researchers, practical steps to promote diversity and inclusion in our workplaces include engaging in DE&I training, staying informed about research on organizational diversity and discrimination, endorsing ally behaviours (such as advocating for and attending DE&I events), reflecting on personal biases, and cultivating diverse social support.

Table 5 provides DE&I strategies and evidenced-based examples regarding the research team and environment.

Additional resources

Table 6 provides a summary of available resources from international peak bodies and organisations that support a greater understanding and adoption of DE&I strategies in research. Box 2 provides a practical checklist researchers can use when designing and delivering inclusive research.

Box 2.Adapted from the National Institute for Health and Care Research, Guidance from the INCLUDE project (2020).

Checklist to Guide Research Teams in Designing and Delivering Inclusive Research:

  1. What are the characteristics/demographics of the population which your research looks to serve?

  2. How will your inclusion/exclusion criteria enable your trial population to match the population that you aim to serve?

  3. Can you justify any difference between your projected trial population and the population you aim to serve?

  4. How will your recruitment and retention methods engage with underrepresented groups?

  5. What evidence have you that your intervention is feasible and accessible to a broad range of patients in the populations that your research seeks to serve?

  6. Are your outcomes validated and relevant to a broad range of patients in the populations that your research seeks to serve?

  7. Who are the underrepresented groups within your study catchment area? (e.g., geographical areas that the delivery team operates in)

  8. What are the barriers to including these groups in research in our area?

  9. What actions can we take to overcome those local barriers?

  10. What tools, training and resources does your team need to implement these actions successfully?

Conclusion

Addressing persistent deficiencies in DE&I in CV research requires action across the entire research continuum, from the inception of study concepts to the dissemination of findings. In the pre-planning and study design phase, early engagement with patients and community stakeholders helps to ensure research objectives are aligned with real-world healthcare needs. During the execution of studies, meticulous attention to eligibility criteria, the inclusivity of study materials, and the implementation of targeted recruitment strategies, such as forging partnerships with community organizations and employing culturally tailored communication approaches, becomes pivotal. Finally, advocating for sufficient resources to implement DE&I practices, prioritizing funding for research initiatives explicitly dedicated to DE&I, and improving diversity in journal peer review processes and editorial boards will enhance the translation and impact of research outcomes. Underpinning success is also the cultivation of diverse and inclusive research teams and environments to support the effective recruitment and retention of underrepresented participants. In summary, the advancement of DE&I principles at every stage of the research cycle is a responsibility shared by researchers, institutions, and funding entities alike. This collective commitment is essential for substantial progress towards achieving equitable CVD health outcomes.

Acknowledgements

S.C.I. receives funding through a Heart Foundation Future Leader Fellowship by the Heart Foundation of Australia (Ref: 102821).

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