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Per-protocol analysis
4%
3/82
Intention-to-treat analysis
18%
15/82
As-treated analysis
26%
21/82
Sub-group analysis
Non-inferiority analysis
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Intention-to-treat analysis is used to help preserve the benefits of randomization in superiority trials. In an ideal setting, all subjects enrolled in a research trial would complete the trial exactly as prescribed in the protocol. However, this ideal is rarely achieved, and thus trial design and data analysis must account for incomplete adherence and follow-up. Intention-to-treat analysis, in which subject results are analyzed according to the group that they were initially assigned to (not according to adherence) is one technique used to analyze outcome data and preserve randomization. In contrast, per-protocol analysis analyzes data based on actual adherence to the protocol. The American Academy of Family Physicians discussed the strength of recommendation taxonomy in the assessment of medical literature. For trials seeking to demonstrate the superiority of an intervention, results should be analyzed using an intention-to-treat analysis. Because participants may drop out because of adverse effects or may need to modify their treatment course for other unknown reasons, intention-to-treat analysis helps to maintain randomization and gives conservative results in superiority trials. Whenever possible, the highest standard for evidence of superiority should be a randomized controlled trial, with blinding and intention-to-treat analysis. Lewis discusses the E9 statistical principles for research trials. Intention-to-treat analysis maintains that all randomized subjects should be analyzed at the end of the trial. Ideal intention-to-treat analysis requires complete follow-up, which is unrealistic in most clinical trials. In non-inferiority trials, as opposed to superiority trials, intention-to-treat analysis is generally not conservative, and may not be the best choice for analysis. Incorrect Answers: Answer 1: Per-protocol analysis may overestimate the benefits in superiority trials, as patients that complete the protocol may be more likely to adhere because they are getting good results. Answer 3: As-treated analysis is similar to per-protocol analysis in that it may overestimate benefits in superiority trials. Answer 4: Sub-group analysis does not help to preserve the benefits of randomization. Answer 5: The trial in the stem was designed to show superiority, not to show non-inferiority.
4.8
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