Randomized controlled trials

Abstract

ROGERS, S.L. & FRIEDHOFF, L.T. (1996). The ef® cacy and safety of donepezil in patients with Alzheimer's Disease: results of a US multicentre, randomized, double-blind, placebo-controlled trial. Dementia, 7, 293± 303. This is a large multicentre trial of the ® rst drug to be licensed for use in the treatment of Alzheimer's Disease in the UK. It is an ef® cacy orscienti® c' study and the multiple exclusion criteria mean that the study population is very different from any clini- cal population so limiting the generalizability of the data to real-life clinical settings. However the design is relatively simple as is the intervention. The clini- cal relevance of the outcome measures used is un- clear. BANERJEE, S., SHAMASH, K., MACDONALD, A. & MANN, A. (1996). Randomized controlled trial of effect of intervention by psychogeriatric team on depression in frail elderly people at home. British Medical Journal , 313, 1058± 1061. This is a small scale pragmatic trial evaluating the effectiveness of team intervention for depression in the elderly. The small sample size and the arguably atypical nature of the team may limit generalizabil- ity, but there are very few exclusion criteria and a large effect size. The intervention is ablack box' consisting of what a multidisciplinary team sug- gested as a treatment package. Outcome measures are designed to be clinically relevant.