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Increased study duration
5%
3/66
Posthoc analysis of primary outcome among patients who withdrew from study
15%
10/66
Randomization
14%
9/66
Retrial of primary outcome for clinical effectiveness instead of non-inferiority
21%
14/66
Increased sample size
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This question presents a controlled, non-inferiority trial for a medication that is deemed to be non-inferior to the control medication. This study's methodology can be improved by randomizing patients to reduce the possibility of confounders. A confounder is a factor that is either positively or negatively associated with both the exposure and outcome. Confounders are not in the causal pathway, but not adjusting the analysis for confounding can distort the true association and lead to false conclusions. In order for randomization to effectively balance out the effect of confounding factors, one assumes that the study sample size is large enough and that both the investigators and patients are blinded to the identity of the intervention. Incorrect Answers: Answer 1: Increased study duration would improve the trial's analysis for its primary outcome and improve its documentation of the drug's side effects, but it would not minimize the potential for confounding. A non-randomized study presents more concerns for interpreting the results. Answer 2: Posthoc analysis of the primary outcome among patients who withdrew from the study would be unnecessary because the analysis was already conducted as an intention-to-treat analysis. This means that patients who withdrew from the study are still counted in their original study group during the final analysis. Answer 4: Retrial of primary outcome for clinical effectiveness instead of non-inferiority may further strengthen these investigators' argument (and sales pitch) for salisartan but would be expensive and time-consuming. Furthermore, the secondary outcome of subjective improvement of symptoms was already inferior, decreasing the yield of a retrial under similar conditions. Answer 5: Increased sample size would strengthen the statistical precision of the trial analysis (i.e., p-value), but it would not decrease the potential for confounding. Given the large sample size, it is more important to randomize the participants then to recruit more. Bullet Summary: Confounding in prospective clinical research can be minimized by randomization.
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