AI Article Synopsis
- The text emphasizes the importance of researchers in clinical trials to carefully evaluate when to use intention-to-treat (ITT) analysis versus per protocol analysis for accurate outcomes.
- It highlights that while ITT analysis is generally recommended for assessing treatment adherence, it can be misused due to inappropriate questions being posed, misunderstanding noncompletion of treatment, and random assignment violations.
- The authors suggest that future clinical trial designs, especially in child and adolescent research, will likely incorporate hybrid trial elements, merging efficacy, effectiveness, and implementation research, where both ITT and per protocol analyses will be utilized correctly.
Article Abstract
We call for clinical trials researchers to carefully consider questions about use of intention-to-treat (ITT) analysis and per protocol analysis. We discuss how questions about are appropriately answered through the application of per protocol analysis. ITT analysis is well-suited and appropriate for addressing questions related to treatment , typically adherence to the treatment with respect to an outcome. While guided by admirable intentions, ITT analysis is often not guided by the right questions, leading to ITT misapplication. We address additional misconceptions that often lead to ITT misapplication, including issues relating to treatment noncompletion and violation of random assignment. We further highlight future directions and implications, particularly that future clinical child and adolescent research trial designs will be increasingly characterized by hybrid trials that combine elements of efficacy, effectiveness, and implementation research, where ITT and per protocol analysis will be appropriately applied to answer the right questions.
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| http://dx.doi.org/10.1080/15374416.2024.2384035 | DOI Listing |
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