Care must always be taken to minimize missing responses and to continue to follow up those who withdraw from treatment. Also, it minimizes type I error due to cautious approach and allows for the greatest generalizability.Ī better application of the ITT approach is possible if complete outcome data are available for all randomized subjects. #PRINCIPLE SYNONYM TRIAL#ITT analysis limits inferences based on arbitrary or ad hoc subgroups of patients in the trial and emphasizes greater accountability for all patients enrolled in the study. ITT analysis preserves the sample size because if noncompliant subjects and dropouts are excluded from the final analysis, it might significantly reduce the sample size, leading to reduced statistical power. Moreover, subjects may be noncompliant or may drop out from the study due to their response of treatment. If noncompliant subjects and dropouts are excluded from the final analysis, it might create important prognostic differences among treatment groups. It gives an unbiased estimate of treatment effect. ITT analysis maintains prognostic balance generated from the original random treatment allocation. ITT analysis reflects the practical clinical scenario because it admits noncompliance and protocol deviations. The CONSORT statement for improving the quality of reports of RCTs states that number of participants in each group should be analyzed by “intention-to-treat” principle. #PRINCIPLE SYNONYM FULL#Full reporting of any deviations from random allocation and missing response is essential in the assessment of the necessity and appropriateness of an ITT approach, as emphasized in the Consolidated Standards of Reporting Trials (CONSORT) guidelines on the reporting of RCTs. ITT is better regarded as a complete trial strategy for design, conduct and analysis rather than as an approach to analysis alone. One potential solution to this problem is a statistical concept called ITT analysis. Hence, RCTs often suffer from two major complications, i.e., noncompliance and missing outcomes. Moreover, in some studies, drop out of the subjects is a problem. But unfortunately, one practical problem that investigators usually come across in RCT is that subjects do not always follow instructions. In an ideal scenario, every subject enrolled in RCT would follow instructions and complete their allocated treatment as described in the protocol and thus contribute data which were complete in all respects. The purpose of the RCT is to ensure that the groups differ only with respect to the interventions being compared. Randomization in clinical trials reduces bias. In an RCT, the study subjects is randomly allocated to receive one of the treatments under study after assessment of eligibility but before the intervention is administered. RCTs are the ideal design in assessing the efficacy and safety of medicine.
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