Intention-to-Treat Analysis: To Modify or Not to Modify

Data analysis is the crucial final stage of Randomized Controlled Trials (RCTs) and requires strict adherence to the intention-to-treat principle(ITT), in which all subjects are included in the final analysis and analyzed in the groups which they were originally randomized.  Trials with conditions that deviate from the standard intention-to-treat definition are classified as modified intention-to-treat (mITT).  RCTs that use the mITT approach are increasingly being published but descriptions of mITT analyses vary greatly from trial to trial.  Although the primary factor that characterizes the mITT analysis appear to be post-randomization exclusion, it has been found that mITT trials were strongly associated with industry funding and authors’ conflicts of interest and reported results that favored the therapy under investigation.   The updated version of the CONSORT statement warned that authors need to adhere to the standard intention-to-treat principle.
Fewer than half of the RCTs published in top medical journals analyzed all participants as they were initially randomized and described the ITT principle inappropriately. The major aim of this speech will be to make awareness of ITT principle. There may be a possibility of a never cited problem; lack of knowledge of ITT principle before the paper was admitted for publication. The speech will also aim to report types of deviation from a true intention-to- treat analysis and report the possible explanations for the emergence of use of a modified intention-to-treat approach that reflect the difficulty that investigators face when managing missing data or deviations from protocol.