Intention to treat keeps all participants, treatment on treat only includes participants who adhered to the treatment protocol
#researchlandscape
| Intention-to-treat (ITT) Analysis | Treatment-on-treat (TOT) Analysis | |
|---|---|---|
| Definition | Includes all participants in the final analysis, regardless of whether they completed the intervention or adhered to the protocol. | Includes only participants who completed the treatment as per the original allocation. |
| Advantage | Reflects effectiveness under real-world conditions; maintains baseline comparability between groups; preserves randomization. | Reflects efficacy under ideal conditions; provides information on how effective a treatment can be when fully adhered to. |
| Disadvantage | Can dilute the effect of treatment due to inclusion of non-compliant subjects and those who drop out from study. | Susceptible to high bias; results may not be generalizable due to exclusion of patients who did not comply or dropped out from study; potential loss of randomization. |
| Ideal Use | When a conservative analysis is desired that accounts for all randomized patients, including those who did not complete or adhere to intervention. | When details about efficacy of treatment under ideal circumstances are required, where there is full adherence to protocol. |