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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).
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This chapter describes the incidents that occur because of deviations from the design intention, as expressed in the process flow diagrams.
This chapter explains the essential features of a HAZOP study including the need for a conceptual model and the process of generating and examining possible deviations from the design intention.
Since missing data can constitute deviations from the intention-to-treat principle, clinical trial analyses require the use of imputation (19).
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.
Of the 475 trials, 192 (40%) reported one type of deviation from the intention to treat approach, 189 (40%) reported two, 67 (14%) reported three, five (1%) reported four, and 22 (5%) did not report any type.
The acronym CASCADA describes a partial order of intermediate outcomes through conscious knowledge, attitudes, subjective norms and positive deviation from these, the intention to change, the agency (individual and collective) to make change, discussion of possible action and finally action to change (Andersson, 2011; Andersson & Ledogar, 2008).
Since exclusions seem to be the direct consequence of the modified intention to treat description, we tested the hypothesis that the number of deviations from intention to treat was positively associated with the proportion of occurrences of exclusions after randomisation.
We retrieved the types and number of deviations from a true intention to treat analysis that occurred in analyses reported as modified intention to treat and accordingly classified the trials into six categories (box).
Deviations from the original definition of ITT are referred to as modified intention-to-treat (mITT).
We also documented how deviations from the treatment protocol were handled in terms of both the stated type of analysis (such as intention to treat) and any additional text description (box 1).
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CEO of Professional Science Editing for Scientists @ prosciediting.com