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Tribal Deliberations about Precision Medicine Research: Addressing Diversity and Inequity in Democratic Deliberation Design and Evaluation.

ABSTRACT: Deliberative democratic engagement is used around the globe to gather informed public input on contentious collective questions. Yet, rarely has it been used to convene individuals exclusively from Indigenous communities. The relative novelty of using this approach to engage tribal communities and concerns about diversity and inequities raise important methodological questions. We describe the design and quality outcomes for a 2.5-day deliberation that elicited views of American Indian and Alaska Native (AIAN) leaders about the potential value and ethical conduct of precision medicine research (PMR), an emerging approach to research that investigates the health effects of individual genetic variation in tandem with variation in health-relevant practices, social determinants, and environmental exposures. The event met key goals, such as relationship and rapport formation, cross-site learning, equality of opportunity to participate, and respect among participants in the context of disagreement.

SUBMITTER: Blacksher E

PROVIDER: S-EPMC9173705 | biostudies-literature | 2022 Jul

REPOSITORIES: biostudies-literature

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Tribal Deliberations about Precision Medicine Research: Addressing Diversity and Inequity in Democratic Deliberation Design and Evaluation.

Blacksher Erika E Trinidad Susan Brown SB Woodbury R Brian RB Hopkins Scarlett E SE Woodahl Erica L EL Boyer Bert B BB Burke Wylie W Hiratsuka Vanessa V

Journal of empirical research on human research ethics : JERHRE 20220228 3

Deliberative democratic engagement is used around the globe to gather informed public input on contentious collective questions. Yet, rarely has it been used to convene individuals exclusively from Indigenous communities. The relative novelty of using this approach to engage tribal communities and concerns about diversity and inequities raise important methodological questions. We describe the design and quality outcomes for a 2.5-day deliberation that elicited views of American Indian and Alask ...[more]

PMID: 35225705

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Project description:BackgroundPrecision medicine seeks to better tailor medical care to the needs of individual patients, but there are challenges involved in communicating to patients, health care providers, and health system leaders about this novel and complex approach to research and clinical care. These challenges may be exacerbated for Alaska Native and American Indian (ANAI) people, whose experiences of unethical research practices have left some ANAI communities hesitant to engage in research that involves extensive data-sharing and diminished control over the terms of data management and who may have distinct, culturally-informed communication needs and preferences. There is need for communication research to support Tribal health organizations and ANAI people as they consider implementation of and participation in precision medicine. To address that need, this study characterizes the informational needs and communication preferences of patients, providers, and leaders at an Alaska Native Tribal health organization.MethodsWe conducted 46 individual, semi-structured interviews to explore perspectives on precision medicine and related communication needs among patients, providers, and leaders of a Tribal health organization. Analysis involved team-based coding to identify a priori and emergent themes, followed by identification and recoding of content relevant to precision medicine informational needs and communication preferences.ResultsPatients, providers, and leaders were described as both sources and recipients of information about precision medicine. Information deemed essential for making decisions about whether to participate in or implement a precision medicine program included information about the clinical and research applications of precision medicine, benefits and risks, health system costs and impacts, and data management practices. Preferred communication channels included digital and non-digital informational materials, as well as in-person learning opportunities for individuals and groups. Participants also describe contextual factors and barriers that influenced the acceptability and effectiveness of approaches to health communication.ConclusionResults can inform approaches to communicating information about precision medicine to stakeholders within Tribal and other health care systems considering implementation of precision medicine in clinical or research contexts.

Project description:ObjectiveTo compare theoretical strengths and limitations of common immortal time adjustment methods, propose a new approach using multiple imputation (MI), and provide practical guidance for using MI in precision medicine evaluations centered on a real-world case study.Study setting and designMethods comparison, guidance, and real-world case study based on previous literature. We compared landmark analysis, time-distribution matching, time-dependent analysis, and our proposed MI application. Guidance for MI spanned (1) selecting the imputation method; (2) specifying and applying the imputation model; and (3) conducting comparative analysis and pooling estimates. Our case study used a matched cohort design to evaluate overall survival benefits of whole-genome and transcriptome analysis, a precision medicine technology, compared to usual care for advanced cancers, and applied both time-distribution matching and MI. Bootstrap simulation characterized imputation sensitivity to varying data missingness and sample sizes.Data sources and analytic sampleCase study used population-based administrative data and single-arm precision medicine program data from British Columbia, Canada for the study period 2012 to 2015.Principal findingsWhile each method described can reduce immortal time bias, MI offers theoretical advantages. Compared to alternative approaches, MI minimizes information loss and better characterizes statistical uncertainty about the true length of the immortal time period, avoiding false precision. Additionally, MI explicitly considers the impacts of patient characteristics on immortal time distributions, with inclusion criteria and follow-up period definitions that do not inadvertently risk biasing evaluations. In the real-world case study, survival analysis results did not substantively differ across MI and time distribution matching, but standard errors based on MI were higher for all point estimates. Mean imputed immortal time was stable across simulations.ConclusionsPrecision medicine evaluations must employ immortal time adjustment methods for unbiased, decision-grade real-world evidence generation. MI is a promising solution to the challenge of immortal time bias.

Dataset Information

Tribal Deliberations about Precision Medicine Research: Addressing Diversity and Inequity in Democratic Deliberation Design and Evaluation.

Publications

Tribal Deliberations about Precision Medicine Research: Addressing Diversity and Inequity in Democratic Deliberation Design and Evaluation.

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