A SMART is unique from other clinical trials as it uses multiple randomizations and a tailoring variable to customize treatment to meet individuals’ needs, while still maintaining its research integrity.
To the State of Mind community,
In my absence from state of mind for the last several months, I spent my days implementing, managing and coordinating a newly developed clinical trial research methodology. The clinical trial that I have been working on is named a sequential multiple assignment randomized trial or SMART.
A SMART is unique from other clinical trials as it uses multiple randomizations and a tailoring variable to customize treatment to meet individuals’ needs, while still maintaining its research integrity.
A SMART is able to do this through structured treatment sequencing and the timed application of a tailoring variable. Ultimately, in contrast to the standard randomized control trial (RCT), which compares the effectiveness of two treatment types, SMART compares two-treatment types as well as four embedded treatment strategies.
The development of a SMART begins much like an RCT. Investigators decide on two initial structured treatment types that they wish to compare the effectiveness of. A third treatment type is also included. This third treatment type plays an essential role in the trial, but will not be utilized until later in treatment. Investigators then decide upon the timing of treatment and the measures used to assess their participants progress.
There are three essential measurement points in a SMART. Like an RCT, there is a baseline assessment and a follow up assessment. In theory, these assessments measure participants’ initial symptoms and their symptoms at completion of the trial. The third assessment point that is unique to the SMART is called the tailoring variable. The three treatments and tailoring variable, sums the essential content of a SMART.
The best way to explain a SMART is to walk readers through the methodology.
An individual is recruited for the study based on predetermined criteria. The individual is then assessed using a battery of questionnaires to determine their eligibility (baseline assessment). If they are deemed eligible, they are then randomized into one of two forms of treatment. Individuals will then continue their assigned treatment for a predetermined period of time. After this time is finished, individuals are assessed again using a battery of questionnaires. This battery assessment makes up the tailoring variable. Depending on the individuals’ scores on this assessment, one of two things can happy. They can continue treatment (if they are progressing well).
The second option is that they can be re-randomized (if their scores are lower than the pre-determined cut-off scores). If an individual is re-randomized, they can either be placed into a new form of treatment entirely or continue their original treatment alternated or combined the third form of treatment (typically medication). Individuals will then continue in their predetermined course of treatment while being assessed periodically. Once treatment is completed, individuals will complete their follow up assessment.
The successful completion of a SMART results in the comparison of multiple treatment pathways. This includes the comparison of two treatment types, as you would in a standard RCT, as well as the sequence of multiple treatment types. This is truly a novel way of examining not only the effectiveness of individual treatment, but treatment sequences as well.
I’m happy to answer any questions about SMART methodology.
