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. Author manuscript; available in PMC: 2019 Feb 19.
Published in final edited form as: J Am Geriatr Soc. 2019 Jan 29;67(2):211–217. doi: 10.1111/jgs.15784

Table 4.

Educational Needs of Investigators and Study Staff on Inclusion Plans that can be Addressed by Geriatrics Researchers

Topic Learning objectives
Evidence-based practices for participant recruitment, consent/assent
  1. Use of purposeful recruitment, and working with stakeholders to understand potential barriers to recruitment and retention

  2. Use of proactive recruitment strategies including engaging the communities

  3. Assessing capacity to provide informed consent, inclusion of legally authorized representatives

Study design
  1. Strategies to remove logistical barriers (transportation, mobility, sensory impairment)

  2. Minimize acceptable criteria to balance scientific justification vs generalizability

  3. 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

Data collection, analysis, and reporting
  1. Multivariable risk-based analytic methods needed to address heterogeneity

  2. Choosing analytic strategies to maximize the potential knowledge gained from preplanned subgroups or stratified recruitment