Equity-relevant trials
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Equity-relevant trials
Equity-relevant trials are designed to address health disparities and ensure that the benefits of health research extend to disadvantaged and underrepresented populations. These trials prioritize fairness and social justice by embedding equity considerations into every phase—from planning and implementation to evaluation and dissemination. By doing so, they provide evidence to inform policies and interventions that improve outcomes for historically marginalized groups.
Defining the Equity Focus
An equity-relevant trial begins with a clear statement of how the study will address health equity. This often involves focusing on populations that experience disproportionate health burdens, such as low-income individuals, racial and ethnic minorities, rural residents, or Indigenous communities. The outcomes selected should reflect areas of disparity—such as access to care, quality of life, or social determinants of health. The intervention itself should be accessible, affordable, and culturally appropriate for the target group. For example, a trial might evaluate whether a culturally tailored diabetes prevention program improves outcomes among low-income and Indigenous populations compared to standard care.
Choosing an Appropriate Study Design
Several trial designs are particularly well-suited for equity-relevant research. A stratified randomized controlled trial (RCT) can ensure balanced representation across equity-relevant characteristics like socioeconomic status or race/ethnicity. Cluster randomized trials (CRTs), which randomize entire communities or clinics, can address population-level disparities. Stepped-wedge designs are useful in resource-constrained settings where it's important that all sites eventually receive the intervention. Adaptive trial designs allow for modifications based on interim results, which can be especially helpful in dynamically addressing emerging equity gaps.
Engaging Stakeholders Early
Community engagement is essential for ensuring that equity-relevant trials are acceptable, meaningful, and feasible. Researchers should involve community organizations, patients, and policymakers early in the process through co-design approaches. This helps tailor the intervention to the population’s needs and builds trust. For example, collaborating with community leaders can help adapt mental health services for immigrant or refugee communities.
Selecting Equity-Relevant Outcomes
Trials should measure both clinical and equity-specific outcomes. Standard health outcomes may include mortality, disease biomarkers, or quality of life. Equity-specific outcomes might address access to care (e.g., appointment availability or wait times), social determinants of health (e.g., education or income levels), and patient-reported outcomes like satisfaction or perceived cultural relevance. Researchers should disaggregate data by relevant factors—such as gender, income, or race—to assess differential impacts.
Ensuring Inclusive Recruitment
Inclusive recruitment strategies are key to representing diverse populations. Researchers should proactively address barriers such as language, transportation, and health literacy. Methods may include using multilingual materials, working with trusted community networks, and providing support like transportation vouchers. These strategies ensure that underrepresented populations can participate meaningfully in the trial.
Adapting the Intervention for Equity
Interventions should be tailored to the needs, preferences, and circumstances of the target population. Cultural adaptation involves ensuring that materials and procedures align with participants’ values, languages, and norms. Financial barriers should be considered by offering the intervention at no cost or with subsidies to improve accessibility and uptake.
Monitoring and Evaluating Equity Impact
Researchers should use equity frameworks such as PROGRESS-Plus (Place of residence, Race/ethnicity, Occupation, Gender, Religion, Education, Socioeconomic status, Social capital, and other characteristics) to guide data collection and analysis. Process evaluations can help identify which implementation factors facilitate or hinder equity, and whether different subgroups experience the intervention differently. For example, a trial may evaluate the differential impact of a telehealth program in rural versus urban settings.
Analyzing for Differential Effects
Equity-relevant trials should include subgroup analyses to examine how different groups respond to the intervention. Researchers should report both overall and group-specific outcomes, and use interaction analyses to determine whether the effects vary significantly by equity-relevant characteristics. This helps identify for whom the intervention works best and highlights potential unintended consequences.
Ethical Considerations
Ethics is especially important in equity-relevant research. Informed consent processes should be accessible and understandable to all participants, including those with limited literacy or language skills. Researchers must avoid exploiting or stigmatizing vulnerable populations and should plan for long-term sustainability to ensure that beneficial interventions are not withdrawn after the trial ends.
Disseminating Findings with Equity in Mind
Dissemination strategies should ensure that trial findings reach the communities involved. This includes sharing results through community meetings, multilingual reports, or accessible digital platforms. Researchers should also target decision-makers and policymakers to encourage implementation of findings into practice and policy. Equity-focused dissemination ensures that the research contributes to real-world improvements in health outcomes.
Example Framework
An example of an equity-relevant trial might ask: Does a mobile health app improve medication adherence and reduce hospitalizations in low-income individuals with chronic disease? The design could be a pragmatic RCT with stratification by socioeconomic status. Primary outcomes might include medication adherence and hospitalization rates, with data disaggregated by income level and geographic region to assess differential effects.
Bibliography
- Welch V, Petticrew M, Petkovic J, et al. Extending the CONSORT statement to equity-relevant trials (CONSORT-Equity 2017): explanation and elaboration. BMJ. 2017;359:j5085.
- Tugwell P, Petticrew M, Kristjansson E, et al. Equity and systematic reviews: overcoming barriers to inclusion of relevant studies. Journal of Clinical Epidemiology. 2010;63(8):764–772.
- O’Neill J, Tabish H, Welch V, et al. Applying an equity lens to interventions: using PROGRESS ensures consideration of socially stratifying factors to illuminate inequities in health. Journal of Clinical Epidemiology. 2014;67(1):56–64.
- White H, Saran A, Kemmer L. A guidance note for researchers on assessing equity in systematic reviews. Campbell Collaboration; 2020. Available from: https://www.campbellcollaboration.org
- Kapiriri L, Norheim OF, Martin DK. Priority setting at the micro-, meso- and macro-levels in Canada, Norway and Uganda. Health Policy. 2007;82(3):321–336. Discusses ethnicity and other equity-relevant factors in health policy decisions.
- Ahmed S, Shahid RK. Disparity in cancer care: a Canadian perspective. Current Oncology. 2012;19(6):e376–e382. Explores ethnic disparities in access and outcomes.
Adapted for educational use. Please cite relevant trial methodology sources when using this material in research or teaching.