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Modified intention to treat reporting in randomised controlled trials: systematic review

BMJ 2010; 340 doi: (Published 14 June 2010) Cite this as: BMJ 2010;340:c2697
  1. Iosief Abraha, researcher,
  2. Alessandro Montedori, researcher
  1. 1Regional Health Authority of Umbria, via Mario Angeloni 61, 06123 Perugia, Italy
  1. Correspondence to: I Abraha iosief_a{at}
  • Accepted 12 March 2010


Objectives To determine the incidence and characteristics of randomised controlled trials that report using the modified intention to treat approach, and how the approach is described.

Design Systematic review.

Data sources PubMed, Embase, Cochrane central register of controlled trials, ISI Web of Knowledge, Ovid, HighWire Press, Science-Direct, Ingenta, Medscape, BioMed Central, Springer, and Wiley, from inception to December 2006.

Main outcome measures Incidence of trials in which use of modified intention to treat was reported, and how the approach was described (classified according to the type and number of deviations from the intention to treat approach).

Results 475 randomised controlled trials reported use of a modified intention to treat analysis. Of these, 76 (16%) were published in five highly cited general medical journals. The incidence of all trials that reported use of modified intention to treat published in journals indexed in Medline increased from 0.006% in 1982-6 to 0.5% in 2002-6 (P<0.001 for linear trend). When the description of the modified intention to treat was examined in each trial, 192 (40%) reported one type of deviation from the intention to treat approach, 261 (55%) reported two or more types, and 22 (5%) did not describe any type. In 266 (56%) of the trials the deviation was related to the treatment received, in 196 (41%) to a post baseline assessment, in 118 (25%) to a baseline assessment, in 108 (23%) to a target condition, and in 23 (5%) to follow-up. Post-randomisation exclusions occurred in 380 (80%) trials. The results reported by 270 of the 352 (77%) superiority trials favoured the drug under investigation. All of the 123 trials using equivalence or non-inferiority methods to investigate interventions reported results that favoured their assumptions.

Conclusions Randomised controlled trials that report using a modified intention to treat are increasingly being published in the medical literature. The descriptions of such an approach were ambiguous, and may cover any type of descriptions for exclusion, such as missing data and deviation from protocol. Explicit statements about post-randomisation exclusions should replace the ambiguous terminology of modified intention to treat.


  • We thank Carlo Romagnoli, Marcello Catanelli, and Mariangela Rossi for their support, Holger Schunemann for his suggestions; IA is indebted to the missionaries and teachers at the Italian school in Asmara for their help in his formative years.

  • Contributors: IA conceived the study. Both authors collected the data, did the analysis, drafted and critically revised the manuscript for important intellectual content, and approved the final version. IA and AM are the guarantors.

  • Funding: None.

  • Competing interests: All authors have completed the Unified Competing Interest form at (available on request from the corresponding author) and declare that (1) none of the authors have support from any company for the submitted work; (2) none of the authors have relationships with any companies that might have an interest in the submitted work in the previous 3 years; (3) none of their spouses, partners, or children have financial relationships that may be relevant to the submitted work; and (4) none of the authors have no non-financial interests that may be relevant to the submitted work.

  • Ethical approval: Not required.

  • Data sharing: No additional data available.

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