Intention-to-treat concept: A review.
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In this work, per-protocol population is defined as a subset of the ITT population who completed the study without any major protocol violations, and estimate of treatment effect is generally conservative.Abstract:
Randomized controlled trials often suffer from two major complications, ie, noncompliance and missing outcomes One potential solution to this problem is a statistical concept called intention-to-treat (ITT) analysis ITT analysis includes every subject who is randomized according to randomized treatment assignment It ignores noncompliance, protocol deviations, withdrawal, and anything that happens after randomization ITT analysis maintains prognostic balance generated from the original random treatment allocation In ITT analysis, estimate of treatment effect is generally conservative A better application of the ITT approach is possible if complete outcome data are available for all randomized subjects Per-protocol population is defined as a subset of the ITT population who completed the study without any major protocol violationsread more
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References
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Journal ArticleDOI
The CONSORT statement: revised recommendations for improving the quality of reports of parallel-group randomised trials
TL;DR: The revised CONSORT statement is intended to improve the reporting of an RCT, enabling readers to understand a trial's conduct and to assess the validity of its results.
Book
Epidemiology in Medicine
TL;DR: The core of the subject remains essentially simple, and a good epidemiological study should be capable of describing in such a way that all who are interested in the cause of disease can follow the argument and decide for themselves the validity of the conclusions as mentioned in this paper.
Journal ArticleDOI
The CONSORT statement: revised recommendations for improving the quality of reports of parallel group randomized trials
TL;DR: The revised CONSORT statement is intended to improve the reporting of an RCT, enabling readers to understand a trial's conduct and to assess the validity of its results.
Journal ArticleDOI
What is meant by intention to treat analysis? Survey of published randomised controlled trials
Sally Hollis,Fiona Campbell +1 more
TL;DR: Assessment of reports of randomised controlled trials published in 1997 found that intention to treat was used, but handling of deviations from randomised allocation varied widely and methods used to deal with this were generally inadequate, potentially leading to bias.
Journal ArticleDOI
Reporting of noninferiority and equivalence randomized trials: an extension of the CONSORT statement.
TL;DR: An updated extension of the CONSORT checklist for reporting noninferiority and equivalence trials is presented, based on the 2010 version of theconsORT Statement and the 2008 CONSORT Statement for the reporting of abstracts, and illustrative examples and explanations for those items that differ from the main 2010consORT checklist are provided.