Frequently Asked Questions

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You state that adaptive interventions are protocolized, but then you stated that clinical judgment can be part of an adaptive intervention. How can this be?

Within an adaptive intervention, do the intervention options at any given decision point need to be similar in their dosage (i.e., frequency, duration, or intensity)?

Why are there repeated randomizations in an MRT?

When should I use a SMART design?

When should I conduct a Pilot SMART?

What types of intervention components would only be randomized at baseline and not repeatedly?

What types of intervention components would not be investigated with an MRT?

What types of intervention components might be investigated via an MRT?

What is the role of the observations of an individual’s current context?

What is the role of the distal outcome in an MRT?

What is the role of carry-over effects in an MRT?

What is the relationship between the proximal and distal outcomes in an MRT?

What is the difference between a SMART and an adaptive intervention?

What is an “embedded tailoring variable”?

What happens if the tailoring variable that is needed to inform the next intervention could not be collected, or its value is missing, for a specific patient?

What does it mean for an adaptive intervention to be “embedded” in a SMART?

The statistician on our research team has explained that missing data is best handled using a “multiple imputation” approach.

Should I consider a SMART if my goal is to evaluate the effectiveness of an already developed adaptive intervention?

Must I use a SMART to develop an optimized adaptive intervention?

Must an adaptive intervention recommend a single intervention component at each decision point?

Is randomization part of an adaptive intervention?

Is it the case that SMARTs never include a reference group or “usual care treatment”?

Is it the case that Adaptive Interventions seek to replace clinical judgment?

Is it difficult to calculate the sample size for a SMART?

Is it a requirement that all SMARTs include an embedded tailoring variable?

Is a SMART an adaptive trial design?

In an adaptive intervention, can the tailoring variable differ depending on which intervention was provided in a previous stage?

How do I address non-adherence in the design of an adaptive intervention?

How are MRTs related to N-of-1 trials?

Do all aspects of an adaptive intervention have to be randomized/studied in a SMART?

Can an adaptive intervention tailor the intervention at baseline?

Can a SMART include just one randomization stage?

At what stage would you run a SMART optimization study versus a confirmatory RCT?

Are SMARTs factorial designs?

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