Off-Label Use of Atypical Antipsychotics: An Update
Summary of Study Characteristics Evaluated in the Effectiveness Review: PICOTS Framework
Development of clinical studies of effectiveness of medical interventions is guided by the PICOTS framework. These items are critical elements that will help to answer important clinical questions. In the comparative effectiveness review, the clinical study literature was reviewed and summarized by using the PICOTS framework as summarized below. The evidence concerning the outcomes identified here was examined in:
- All indications for which the intervention does not have formal approval
Interventions: Atypical antipsychotics
- All formulations, administration routes, and doses
Comparators: Other antipsychotics, other active interventions, placebo, or no active intervention
- Symptom response and remission, general health and quality of life
- Key adverse effects: mortality, weight gain, endocrine disturbance/diabetes, cardiovascular events, extrapyramidal symptoms, and sedation
Timing: Any time point, ranging from less than 6 weeks to months/years
Setting: All settings, including community-dwelling, nursing home, inpatient, Veterans Administration, and outpatient
Keywords: adverse events | atypical antipsychotics | cardiovascular events | diabetes | elderly | endocrine | extrapyramidal symptoms | mortality | off-label | second generation | sedation | weight | antipsychotics
- Maglione M, Ruelaz Maher A, Hu J, et al. Off-Label Use of Atypical Antipsychotics: An Update. Comparative Effectiveness Review No. 43 (Prepared by the Southern California RAND Evidence-based Practice Center under Contract No. HHSA 290-2007-10062-I). Rockville, MD: Agency for Healthcare Research and Quality; September 2011. AHRQ Publication No. 11(12)-EHC087-EF. Available at www.effectivehealthcare.ahrq.gov/offlabelantipsych.cfm.
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