Comparing Modified and Standard Intention-to-Treat Reporting in Trials
Author Information
Author(s): Alessandro Montedori, Maria Isabella Bonacini, Giovanni Casazza, Maria Laura Luchetta, Piergiorgio Duca, Francesco Cozzolino, Iosief Abraha
Primary Institution: Regional Health Authority of Umbria, Perugia, Italy
Hypothesis
Are there differences in methodological quality, sponsorship, and findings in randomized trials using modified versus standard intention-to-treat reporting?
Conclusion
The study found that modified intention-to-treat trials were more likely to perform post-randomization exclusions and were strongly associated with industry funding and authors' conflicts of interest.
Supporting Evidence
- Of the 367 RCTs included, 197 were classified as ITT, 56 as mITT, and 114 as 'no ITT' trials.
- mITT trials were more likely to report post-randomization exclusions.
- mITT trials had a strong association with for-profit agency sponsorship.
- There was no association between mITT reporting and favourable results.
Takeaway
This study looked at different ways of reporting trial results and found that some methods are linked to more exclusions and industry funding.
Methodology
A cross-sectional study of randomized controlled trials published in 2006 in selected medical journals, comparing different types of intention-to-treat reporting.
Potential Biases
The study highlights potential biases due to industry sponsorship and conflicts of interest.
Limitations
The results may not be generalizable to trials published in other journals.
Statistical Information
P-Value
p<0.001
Confidence Interval
95% CI, 1.70 to 6.95
Statistical Significance
p<0.001
Digital Object Identifier (DOI)
Want to read the original?
Access the complete publication on the publisher's website