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Modified intention to treat reporting in randomised controlled trials: systematic review
Iosief Abraha1, Alessandro Montedori
1Regional Health Authority of Umbria, via Mario Angeloni 61, 06123 Perugia, Italy. iosief_a@yahoo.it
BMJ (Clinical Research Ed.)
|June 16, 2010
Summary
Modified intention to treat analyses in randomized controlled trials are increasing. However, their descriptions are often ambiguous, leading to potential misinterpretation of trial results.
Area of Science:
- Clinical Trials
- Biostatistics
- Medical Research Methodology
Background:
- The intention to treat principle is a cornerstone of randomized controlled trials (RCTs) to minimize bias.
- Modified intention to treat (mITT) analyses are increasingly reported, but their application and description vary.
- Understanding the reporting and characteristics of mITT is crucial for accurate interpretation of trial outcomes.
Purpose of the Study:
- To assess the incidence of RCTs reporting the use of modified intention to treat.
- To characterize how the modified intention to treat approach is described in published literature.
- To evaluate the types and frequency of deviations from the standard intention to treat approach.
Main Methods:
- Systematic review of RCTs.
- Searched multiple databases (PubMed, Embase, Cochrane, etc.) from inception to December 2006.
- Analyzed the incidence and description of modified intention to treat reporting, classifying deviations.
Main Results:
- 475 RCTs reported modified intention to treat; incidence increased significantly from 1982-2006.
- 55% of trials reported two or more types of deviations from intention to treat.
- Deviations commonly related to treatment received (56%) or post-baseline assessments (41%); 80% involved post-randomisation exclusions.
- A high proportion of superiority (77%) and equivalence/non-inferiority (100%) trials reported favorable results.
Conclusions:
- The reporting of modified intention to treat in RCTs is rising.
- Descriptions of modified intention to treat are often ambiguous, encompassing various exclusions like missing data or protocol deviations.
- Clearer reporting of post-randomisation exclusions is recommended over ambiguous modified intention to treat terminology.
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