Background <p>Incarcerated people experience disproportionately poor health outcomes yet often remain excluded from clinical research due to ethical concerns of limited autonomy and coercion. As a result, traditional randomized controlled trials face significant challenges in carceral settings, driven by mistrust of the medical system, randomization limiting choice, and logistical barriers with blinding and masking. These challenges necessitate alternative methodologies that balance scientific rigor while empowering participant choice.</p> Main text <p>This commentary proposes partially randomized preference trials as a methodology to advance equity and inclusion in carceral health research. In these hybrid designs, participants with strong preferences choose their intervention, while those without strong preferences are randomized. This approach facilitates participant autonomy while maintaining causal inference capabilities. Further, the design allows researchers to quantify preference and selection effects, enhancing external validity (generalizability), and can increase patient recruitment and retention. We discuss practical considerations including sample size calculations and data analysis approaches that estimate treatment effects, selection bias, and preference bias.</p> Conclusions <p>Partially randomized preference trials are a way to generate rigorous evidence in carceral settings while respecting participant autonomy. They may also be useful for engaging other communities with limited autonomy. This approach should be considered as a tool for advancing health equity and inclusion in research.</p>

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Partially randomized preference trials in carceral health research: a methodology to advance equity and inclusion

  • Justin Berk,
  • Mike Gordon,
  • Margaret A. Handley,
  • Helen E. Jack

摘要

Background

Incarcerated people experience disproportionately poor health outcomes yet often remain excluded from clinical research due to ethical concerns of limited autonomy and coercion. As a result, traditional randomized controlled trials face significant challenges in carceral settings, driven by mistrust of the medical system, randomization limiting choice, and logistical barriers with blinding and masking. These challenges necessitate alternative methodologies that balance scientific rigor while empowering participant choice.

Main text

This commentary proposes partially randomized preference trials as a methodology to advance equity and inclusion in carceral health research. In these hybrid designs, participants with strong preferences choose their intervention, while those without strong preferences are randomized. This approach facilitates participant autonomy while maintaining causal inference capabilities. Further, the design allows researchers to quantify preference and selection effects, enhancing external validity (generalizability), and can increase patient recruitment and retention. We discuss practical considerations including sample size calculations and data analysis approaches that estimate treatment effects, selection bias, and preference bias.

Conclusions

Partially randomized preference trials are a way to generate rigorous evidence in carceral settings while respecting participant autonomy. They may also be useful for engaging other communities with limited autonomy. This approach should be considered as a tool for advancing health equity and inclusion in research.