6 8 Briefly, this multicentre, rater-blinded, randomised controlled study (RCT) included 330 outpatients with mild AD, or dementia with Lewy bodies, and their 330 primary caregivers.
To address the methodological problems in some earlier research, we have designed our trial as a double blind, randomised controlled study with a one year follow up.
23 This double blind randomised controlled study aimed to investigate the effect of discontinuing maintenance treatment in a group of first episode patients who had completed at least one year of antipsychotic drug treatment with no relapses.
Of the 1407 unique publications obtained during the medical literature database search, 1256 were excluded because they were not double-blind, randomised, controlled studies, did not include the intervention of interest, did not include the population of interest, had less than 4 weeks of follow-up (n=4) or had a sample size of fewer than 25 patients.
Of these, 1388 abstracts were excluded because they did not provide sufficient information, had results that were subsequently published in the peer-reviewed literature and included in the medical literature database search, were not double-blind, randomised, controlled studies; or did not evaluate anti-TNFα agents in RA.
The study is a prospective, assessor blinded, randomised controlled clinical trial.
Design Multicentre observer blinded randomised controlled trial.
Design Multicentre, blinded, randomised controlled trial.
Single blinded randomised controlled clinical trial.
