Adverse effects of antipsychotics as outcome measures.
BACKGROUND
Antipsychotic drugs are associated with adverse effects that can lead to poor medication adherence, stigma, distress and impaired quality of life.


OBJECTIVE
To review the use of adverse effects of antipsychotic drugs as outcome measures, with a particular emphasis on methodological issues.


METHODS
Review of data on adverse effects from sources including randomised controlled trials (RCTs), post-marketing surveillance and naturalistic studies.


RESULTS
All have advantages and disadvantages and the best overview comes from considering all sources of data together. Adverse effects are inconsistently reported, hampering cross-study comparisons. Many outcome measures lack clinical meaning. In both naturalistic studies and RCTs adverse effects often account for less treatment discontinuation than lack of efficacy.


CONCLUSIONS
Standardisation in the reporting of adverse effects is needed. Patients' subjective experience of medication should be given more consideration. Total discontinuation rates provide a useful global outcome measure that incorporates tolerability and efficacy as well as patient and clinician viewpoints. Patients should be informed of common side-effects prior to treatment and monitored for their occurrence during treatment.
Hamer
Samantha
S
Bolton, Salford and Trafford Mental Health NHS Trust, UK.
Haddad
Peter M
PM
D014150:Antipsychotic Agents / Q000009:adverse effects*; D004305:Dose-Response Relationship, Drug; D005260:Female; D006801:Humans; D008297:Male; D017063:Outcome Assessment, Health Care; D011788:Quality of Life / Q000523:psychology*; D016032:Randomized Controlled Trials as Topic; D012559:Schizophrenia / Q000150:complications / Q000188:drug therapy*; D016896:Treatment Outcome
D014150:Antipsychotic Agents