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Modified versus standard intention-to-treat reporting: are there differences in methodological quality, sponsorship,

Alessandro Montedori1, Maria Isabella Bonacini, Giovanni Casazza

  • 1Regional Health Authority of Umbria, Perugia, Italy. amontedori@regione.umbria.it

Trials
|March 2, 2011
PubMed
Abstract

Insights

Modified intention-to-treat (mITT) trials show more post-randomization exclusions and are linked to industry funding and author conflicts of interest. Standard intention-to-treat (ITT) trials did not show these associations.

Area of Science:

  • Clinical Trial Methodology
  • Biostatistics
  • Medical Research Ethics

Background:

  • Randomized controlled trials (RCTs) increasingly utilize the modified intention-to-treat (mITT) approach.
  • Concerns exist regarding potential biases in mITT trials, including post-randomization exclusions, industry sponsorship, and favorable findings.
  • Limited data compares mITT trials to standard intention-to-treat (ITT) trials regarding these potential biases.

Purpose of the Study:

  • To compare methodological quality, sponsorship, author conflicts of interest, and findings between mITT and standard ITT trials.
  • To identify differences in reporting practices, specifically post-randomization exclusions, between mITT and ITT approaches.

Main Methods:

  • Cross-sectional study of RCTs published in 2006 across general and specialty medical journals.
  • Trials categorized as standard intention-to-treat (ITT), modified intention-to-treat (mITT), or no ITT.
  • Data extraction by two independent reviewers on reporting quality, methodological rigor, funding, and outcomes; Odds Ratios (OR) calculated.

Main Results:

  • Of 367 RCTs, 197 were ITT, 56 mITT, and 114 no ITT.
  • mITT trials showed similar reporting and methodological quality to ITT trials but were more likely to have post-randomization exclusions (aOR 3.43).
  • mITT trials were strongly associated with for-profit sponsorship (aOR 7.41) and author conflicts of interest (aOR 5.14); industry sponsorship linked to favorable results (aOR 2.30).

Conclusions:

  • Modified intention-to-treat (mITT) trials exhibit a higher likelihood of post-randomization exclusions.
  • mITT trials demonstrate a strong association with industry funding and authors' conflicts of interest.
  • While mITT itself wasn't linked to favorable results, for-profit sponsorship generally correlated with positive outcomes.

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