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Validation study of a remote electronic monitoring system for patients with bipolar disorder

Abstract

Background. Despite the availability of effective pharmacological and psychosocial treatments, the course of bipolar disorder (BD) is characterised by a high rate
of relapse. This has prompted the rapid development of digital mental state monitoring, which relies on mobile and web technologies for regular self-assessment of
symptoms in the patient’s natural environment.

This study aimed to evaluate the validity and sensitivity of an electronic monitoring system (EMS) for patients with BD by comparing self-assessment scores with
clinician-rated psychometric assessment.

Materials and methods. The final analysis included 77 patients followed for at least one month, who were assessed monthly by a clinician using the HDRS (Hamilton
Depression Rating Scale) and the YMRS (Young Mania Rating Scale). Women predominated in the sample, 53 (68.8 %); the median age was 26.0 [23.0–34.0] years.
BD type II was diagnosed in 47 patients (61.0 %) and type I in 30 (39.0 %). Depression was defined as a score ≥ 8 on the HDRS-17 with a YMRS score < 12, and
hypomania/mania as a YMRS score ≥ 12. The validity analysis included 402 clinical assessment visits, of which 244 (60.7 %) met the criteria for remission, 116
(28.9 %) for depression and 42 (10.4 %) for hypomania/mania.

Results. A significant correlation was found between lowered self-rated mood and the severity of depressive symptoms on the HDRS both for the week preceding the
clinical assessment and for two weeks before it (p < 0.001 and p = 0.005, respectively). Hypomanic symptoms were captured considerably less often by the subjective mood tracker scale, and a moderate, statistically significant association with YMRS severity was found only for the current week of assessment (p = 0.042). ROC
analysis showed that the mood tracker score for the week preceding the psychometric assessment had good diagnostic accuracy for both depressive and hypomanic/
manic episodes (AUC = 0.826 and 0.805, respectively). The final cut-offs adopted were a score of −2 or lower for depression and 2 or higher for hypomania/mania,
which provided the highest agreement with clinical assessment (κ = 0.552 and 0.621, respectively) together with high specificity (89.2 and 96.9 %). The high negative predictive values (86.1 and 95.6 %) support the use of the EMS as a tool that reliably rules out an affective episode, while the comparable positive predictive
values (70.8 and 70.3 %) indicate that it can reasonably be used to flag the need for additional clinical assessment by the physician. Sleep duration was one of the
most sensitive markers of affective instability in BD. Compared with remission, during the week preceding the clinical assessment a significant shortening of sleep was
observed in hypomanic/manic states (p = 0.03), whereas an increase in sleep duration was more frequent in depression (p = 0.011).

Conclusions. The developed EMS for patients with BD demonstrated adequate sensitivity and validity in capturing affective symptoms and can be recommended as
an additional tool for the dynamic assessment of patient status and the early detection of relapse.

Keywords

remote electronic monitoring system, bipolar disorder, validation study, mood tracker, sleep duration tracker

PDF (Русский)

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