What is the difference between ITT and mITT?
Trials reporting the use of ITT with descriptions or conditions different from the standard intention-to-treat definition were classified as mITT. Descriptions of mITT were retrieved to evaluate the type and deviation from a true intention-to-treat analysis according to our previous classification[5].
What is mITT analysis?
To address some of these issues, many clinical trials have excluded participants after the random assignment in their analysis, which is often referred to as modified intention-to-treat analysis or mITT. Trials employing mITT have been linked to industry sponsorship and conflicts of interest by the authors.
What is meant by intention-to-treat?
“Intention to treat” is a strategy for the analysis of randomised controlled trials that compares patients in the groups to which they were originally randomly assigned.
What is intention-to-treat vs AS treated?
The fundamental difference is that in intent- to-treat (ITT) analyses, the groups com- pared have been determined by a random- ization procedure, while in the as-treated analyses, the groups compared have been determined by an algorithm based on the way patients complied with the protocol during the trial.
What is the purpose of randomization during an RCT?
The main purpose of randomisation is to eliminate selection bias and balance known and unknown confounding factors in order to create a control group that is as similar as possible to the treatment group.
What does ITT stand for in clinical trial?
In a randomised trial, the set of all randomised patients is known as the ‘intention to treat population’, or the ITT population. This clinical trial study population is intended to represent suitable patients and to be reflective of what might be seen if the treatment was used in clinical practice.
Does intention-to-treat reduce attrition bias?
ITT prevents attrition bias when evaluating treatment assignment but may not provide a true estimate of treatment effect if some patients are non-adherent.
What bias does intention-to-treat reduce?
The intention-to-treat analysis preserves the prognostic balance afforded by randomization, thereby minimizing any risk of bias that may be introduced by comparing groups that differ in prognostic variables.
How can you minimize performance bias?
It can be minimized or eliminated by using blinding, which prevents the investigators from knowing who is in the control or treatment groups. If blinding is used, there still may be differences in care levels, but these are likely to be random, not systematic, which should not affect outcomes.
When to use modified intention to treat analysis?
As described in the Consolidated Standards of Reporting Trials statement, a modified intention-to-treat analysis 18, 19 was used to determine whether the trial would work in a group of adhering participants.
What are the different types of intention to treat reporting?
Trials were categorized based on the “type” of intention-to-treat reporting as follows: ITT, trials reporting the use of standard ITT approach; mITT, trials reporting the use of a “modified intention-to-treat” approach; and “no ITT”, trials not reporting the use of any intention-to-treat approach.
What is the purpose of intention to treat?
Background: Intention to treat (ITT) is an important approach used for the analysis of randomised controlled trials. It implies that subjects are included in a trial and analysed regardless of whether they satisfied the entry criteria, the treatment to which they were originally allocated and subsequent withdrawal or deviation from protocol.
How are patients included in an intention to treat analysis?
With strict intention-to-treat analysis (sITT), patients are included in the data analysis according to their original treatment allocation, regardless of whether they actually began the treatment, crossed over to another treatment group, or were lost to follow-up.