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. 2010 Jun 14:340:c2697.
doi: 10.1136/bmj.c2697.

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

Iosief Abraha  1 , Alessandro Montedori
Affiliations

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

Iosief Abraha et al. BMJ. .

Abstract

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.

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Conflict of interest statement

Competing interests: All authors have completed the Unified Competing Interest form at www.icmje.org/coi_disclosure.pdf (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.

Figures

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Fig 1 Study screening process
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Fig 2 Number (percentage) of four most common types of deviations from intention to treat. Each type of deviation overlapped with at least one other type
See this image and copyright information in PMC

References

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