59 Subversion of allocation in a randomised controlled trial

Important outcome predictors showed greater baseline heterogeneity than age in two systematic reviews

“…We would recommend that age and another relevant prognostic factor are investigated simultaneously if possible when exploring baseline heterogeneity within systematic reviews. Age is known to be a variable on which allocation within RCTs have been subverted [20]. If there is a lack of available data to perform an analysis on a prognostic factor specific to the review, then age can be considered.…”

Is restricted randomisation necessary?

“…Most examples of known subversion relate to situations where allocation sequences are public knowledge or the concealment of the allocation is inadequate, such as using sealed envelopes that can be tampered with 3 4. However, this type of subversion is not specific to restricted randomisation.…”

Randomised controlled trial of total compared with subtotal hysterectomy with one-year follow up results

“…No description regarding these components was given by Lalos and Bjerle 18 . Thakar et al's 11 allocation sequence was computer-generated random numbers and the concealment of allocation was performed using sealed envelopes, which one knows can be broken 31,32 . Further, Thakar et al…”