The target trial framework proceeds in two steps. The first step requires that the investigators specify the components of the (hypothetical) target trial that would answer the research question. The second step is to emulate each protocol component using the observational data. Which of the following components of the protocol of the target trial includes randomization to assign treatment strategies to individual study participants that occurs in randomized trials?

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The question asks which component of the target trial protocol includes randomization to assign treatment strategies to individual study participants, a feature characteristic of randomized trials.
Option A: Eligibility criteria. These specify who is eligible to participate but do not involve randomization or allocation of treatments. They set inclusion and exclusion rules rather than the mechanism of assignment. So this is incorrect.
Option B: Treatment strategies. This defines which interventions or plans could be assigned but does not specify how assignment occurs. While it is about what could be given, it doesn’t address the randomization process. Therefore this option is not about randomization and is incorrect.
Option C: Treatment assignment. This is precisely the component that describes how participants are allocated to different treatment strategies, including the randomized allocation mechanism (e.g., randomization scheme, allocation ratios). This embodies the randomization aspect of a trial protocol and correctly answers the question. This option is correct.
Option D: Outcomes. This specifies what will be measured to determine results, not how participants are randomized. It does not involve randomization itself, so it is incorrect.
In summary, the distinguishing feature of randomization is captured by the treatment assignment component, which governs how participants receive one treatment strategy versus another, ensuring comparability between groups. The other components (eligibility criteria, treatment strategies, and outcomes) relate to who is studied, what could be given, and what is measured, but not to the mechanism of random allocation.

EPI 202 Week 7: Self Assessment: Misclassification AND Target Trials

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