Randomized controlled trials in long-term care residents with dementia: a systematic review.

OBJECTIVE: To evaluate the quality of reporting of randomized controlled trials for pharmacologic interventions in long-term care residents with dementia.

DATA SOURCES: We performed electronic searches of AMED, CINAHL, E-PSYCHE, Cochrane Controlled Trials Register, and MEDLINE. We also searched the reference lists of included studies and bibliographies of relevant review articles.

STUDY SELECTION: All randomized controlled trials for pharmacologic interventions in patients with dementia residing in long-term care facilities.

DATA ABSTRACTION: We abstracted data independently, in duplicate, using a data abstraction sheet and a quality checklist.

DATA SYNTHESIS: Fifteen trials met inclusion criteria. Five trials lacked institutional ethical review, while two lacked informed consent. Eleven trials gave adequate description of withdrawals and 14 trials reported adverse events adequately. We found incomplete reporting of methods of randomization, allocation concealment, restriction, blinding, sample size estimation and intention-to-treat analysis. Sensitivity analysis indicated that reporting of allocation concealment was associated with increased quality of trial according to the quality scale (P = 0.007).

CONCLUSIONS: Clinicians and the public do not have high-quality information to guide pharmacologic decision making for long-term care residents with dementia. The reporting quality is highly variable in the trials reviewed, and concerns exist surrounding the conduct of several trials.