Figure 1 presents the analytic framework for the update of this Comparative Effectiveness Review, with the five key questions depicted. This figure is described further on page nine as follows. “By reviewing utilization data, surveys on prescribing patterns, and general information about the leading off-label uses, new off-label uses and trends in utilization in the target populations are summarized. Next, by using data from clinical trials and large cohort studies, evidence of benefits and harms in treating the mental health conditions is documented. The evidence of benefits – efficacy and comparative effectiveness (versus placebo, versus other atypicals, or versus conventional therapy) for the off-label indications – is evaluated separately for each of the atypical antipsychotics within condition (dementia, OCD, PTSD, depression, etc.) via the examination of selected outcome measures, mainly symptom response rates measured by recognized psychometric tools. Where available, benefits and harms for specific subpopulations (by gender, age, and race/ethnicity) or other important factors (setting, severity of condition, length of use, and dosage) are documented. Special attention is given to identify the efficacious dose and time limit for off-label indications. The evidence of risks – adverse events associated with off-label indications – is summarized, first within individual drugs across condition, and then compared within the class and with other drugs used for the conditions.“

Figure 1Analytic framework for comparative effectiveness review: off-label uses of atypical antipsychotics

From: Methods

Cover of Off-Label Use of Atypical Antipsychotics: An Update
Off-Label Use of Atypical Antipsychotics: An Update [Internet].
Comparative Effectiveness Reviews, No. 43.
Maglione M, Maher AR, Hu J, et al.

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