Following the introduction of donepezil into clinical practice a protocol for prescribing it was developed in Leicestershire. A prospective clinical audit was undertaken to monitor compliance with the protocol, which also provided an opportunity to evaluate the outcome of therapy in routine clinical practice.
Overall there was close adherence to the protocol by the clinicians and clinical factors, as well as organisational and resource-related factors, were important in determining who received treatment. The principal outcome measures (Mini-Mental State Examination, Barthel ADL Index and Clinical Dementia Rating Scale) did not demonstrate any significant treatment effect.
This study demonstrates the feasibility and acceptability of using a protocol-based approach to manage the introduction of new drug treatments in psychiatry.
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