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Off-Label Use of Atypical Antipsychotics: An Update

Slide: 14 of 47

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:

Population: Adults

  • 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