Efficacy and safety of aripiprazole in the treatment of bipolar disorder: a systematic review

Abstract BACKGROUND: The current article is a systematic review concerning the efficacy and safety of aripiprazole in the treatment of bipolar disorder. METHODS: A systematic Medline and repositories search concerning the usefulness of aripiprazole in bipolar disorder was performed, with the combination of the words 'aripiprazole' and 'bipolar'. RESULTS: The search returned 184 articles and was last updated on 15 April 2009. An additional search included repositories of clinical trials and previous systematic reviews specifically in order to trace unpublished trials. There were seven placebo-controlled randomised controlled trials (RCTs), six with comparator studies and one with add-on studies. They assessed the usefulness of aripiprazole in acute mania, acute bipolar depression and during the maintenance phase in comparison to placebo, lithium or haloperidol. CONCLUSION: Aripiprazole appears effective for the treatment and prophylaxis against mania. The data on bipolar depression are so far negative, however there is a need for further study at lower dosages. The most frequent adverse effects are extrapyramidal signs and symptoms, especially akathisia, without any significant weight gain, hyperprolactinaemia or laboratory test changes

The effect of adapting Hospital at Home to facilitate implementation and sustainment on program drift or voltage drop

Abstract Background Translating evidence-based interventions from study conditions to actual practice necessarily requires adaptation. We implemented an evidence-based Hospital at Home (HaH) intervention and evaluated whether adaptations could avoid diminished benefit from “voltage drop” (decreased benefit when interventions are applied under more heterogeneous conditions than existing in studies) or “program drift.” (decreased benefit arising from deviations from study protocols). Methods Patients were enrolled in HaH over a 6-month pilot period followed by nine quarters of implementation activity. The program retained core components of the original evidence-based HaH model, but adaptations were made at inception and throughout the implementation. These adaptations were coded as to who made them, what was modified, for whom the adaptations were made, and the nature of the adaptations. We collected information on length of stay (LOS), 30-day readmissions and emergency department (ED) visits, escalations to the hospital, and patient ratings of care. Outcomes were assessed by quarter of admission. Selected outcomes were tracked and fed back to the program leadership. We used logistic or linear regression with an independent variable included for the numerical quarter of enrollment after the initial 6-month pilot phase. Models controlled for season and for patient characteristics. Results Adaptations were made throughout the implementation period. The nature of adaptations was most commonly to add or to substitute new program elements. HaH services substituting for a hospital stay were received by 295 patients (a mean of 33, range 11–44, per quarter). A small effect of quarter from program inception was seen for escalations (OR 1.09, 95% CI 1.01 to 1.18, p = 0.03), but no effect was observed for LOS (− 0.007 days/quarter; SE 0.02, p = 0.75), 30 day ED visit (OR 0.93, 95% CI 0.86 to 1.01, p = 0.09), 30-day readmission (OR 1.00, 95% CI 0.93 to 1.08, p = 0.99), or patient rating of overall hospital care (OR for highest overall rating 0.99, 95% CI 0.93 to 1.05, p = 0.66). Conclusions We made adaptations to HaH at inception and over the course of implementation. Our findings indicate that adaptations to evidence-based programs may avoid diminished benefits due to potential ‘program drift’ or ‘voltage drop.’ Trial registration Not applicable. This study is not a clinical trial by the International Committee of Medical Journal Editors (ICMJE) definition because it is an observational study “in which the assignment of the medical intervention is not at the discretion of the investigator.