Abstract

Intention to Treat Analysis: Are We Really Doing It?: Reply

Highlights

  • This reply addresses a response to an article my colleagues and I wrote on the subject of the principle of intentionto-treat (ITT), which has become widely accepted for the analysis of controlled clinical trials [1]

  • 210 consenting female patients considered for total thyroidectomy were randomly assigned to two groups equal in size (n = 105): visual inspection of the external branch of the superior laryngeal nerve (EBSLN) and recurrent laryngeal nerve (RLN) versus this visual inspection plus EBSLN and RLN neural monitoring

  • The secondary outcomes included anatomical variability of the EBSLN according to the Cernea classification, and changes in postoperative voice performance during a six-month follow-up

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Summary

Introduction

This reply addresses a response to an article my colleagues and I wrote on the subject of the principle of intentionto-treat (ITT), which has become widely accepted for the analysis of controlled clinical trials [1]. A few missing outcomes do not cause a problem, if the power of the trial is not lost by a reduced total sample size, and if loss to follow-up is not related to a patient’s response to treatment.

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