Evidence-based practices for participant recruitment, consent/assent |
Use of purposeful recruitment, and working with stakeholders to understand potential barriers to recruitment and retention
Use of proactive recruitment strategies including engaging the communities
Assessing capacity to provide informed consent, inclusion of legally authorized representatives
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Study design |
Strategies to remove logistical barriers (transportation, mobility, sensory impairment)
Minimize acceptable criteria to balance scientific justification vs generalizability
Use of alternative study designs to allow for greater inclusion: adaptive trials (ie, sequential, multiple assignment, randomized trials); platform trials (flexible features, such as dropping treatments for futility, declaring one or more treatments superior, or adding new treatments to be tested during the course of a trial); preference designs; pragmatic trials
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Data collection, analysis, and reporting |
Multivariable risk-based analytic methods needed to address heterogeneity
Choosing analytic strategies to maximize the potential knowledge gained from preplanned subgroups or stratified recruitment
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