Telephone-based assessments to minimize missing data in longitudinal depression trials: a project IMPACTS study report.

PURPOSE: Missing data in clinical efficacy and effectiveness trials continue to be a major threat to the validity of study findings. The purpose of this report is to describe methods developed to ensure completion of outcome assessments with public mental health sector subjects participating in a longitudinal, repeated measures study for the treatment of major depressive disorder. We developed longitudinal assessment procedures that included telephone-based clinician interviews in order to minimize missing data commonly encountered with face-to-face assessment procedures. METHODS: A pre-planned, multi-step strategy was developed to ensure completeness of data collection. The procedure included obtaining multiple pieces of patient contact information at baseline, careful education of both staff and patients concerning the purpose of assessments, establishing good patient rapport, and finally being flexible and persistent with phone appointments to ensure the completion of telephone-based follow-up assessments. A well-developed administrative and organizational structure was also put in place prior to study implementation. RESULTS: The assessment completion rate for the primary outcome for 310 of 504 subjects who enrolled and completed 52 weeks (at the time of manuscript) of telephone-based follow-up assessments was 96.8%. CONCLUSION: By utilizing telephone-based follow-up procedures and adapting our easy-to-use pre-defined multi-step approach, researchers can maximize patient data retention in longitudinal studies.

Managing depressive disorders in patients with epilepsy.

Patients with epilepsy are more likely to suffer from psychiatric illnesses, and more specifically depressive disorders (9% to 22%), than the general population. Depression in epilepsy is often described by the temporal correlation to a seizure, with interictal depression being the most commonly described. Furthermore, epileptic patients with depression often report a poorer quality of life on global assessments and are at an increased risk of suicide as compared to the general population, 11.5 percent versus 1.2 percent, respectively. Despite the clinical significance of depression, it often goes unrecognized and hence untreated in this population. Recently, more efforts at screening epilepsy patients for coexisting depression have been undertaken, yielding fair results. However, some epilepsy patients express a certain constellation of symptoms, including an explosive or irritable mood, somatic pains, anxiety and fear, and periods of brief euphoria, which are not captured by common depression screening tools. Fears of antidepressants lowering seizure thresholds coupled with potential pharmacokinetic interactions between antiepileptic and antidepressant medications have strongly contributed to the undertreatment of this population. Finally, the treatment of depressive disorders in epilepsy is understudied and the few existing research studies have yet to display an effective treatment. Depressive disorders in patients with epilepsy pose significant and specific problems with regard to recognition, diagnosis, and treatment that require careful and thorough management.