Methodological challenges in randomized clinical trials in physical education: the design of non-inferiority

Opinion - e235604 - Published 2024, Oct 5

Abstract

The Physical Education professional, like any health professional, needs to make decisions during the exercise of his professional activity. These decisions must be prudent, aiming for the greatest benefit for your client. In this context, randomized clinical trials (RCTs) are considered the gold standard to guide decision making. In this context, randomized clinical trials (RCTs) are considered the gold standard to guide decisions. However, mistaken judgments can occur when interpreting the results of clinical superiority studies, because they assume that two interventions are identical due to the absence of statistical difference, however, the lack of statistical significance does not support the conclusion of equality; that is, the absence of evidence is not evidence of absence. In this scenario, an elegant alternative is equivalence and non-inferiority studies, which should be used whenever a new intervention has a substantial practical advantage compared to the old, already established one. According to the methodological strategy, a tolerance margin for non-inferiority is established using the limits of the confidence interval. In this way, once non-inferiority has been demonstrated, we become more convinced that the intervention will bring the expected benefit to our client. Therefore, our proposal was to draw attention to this methodological technique that can be of great use in our area and that needs to be further explored.