The management of bipolar mania: a national survey of baseline data from the EMBLEM study in Italy

<p>Abstract</p> <p>Background</p> <p>Although a number of studies have assessed the management of mania in routine clinical practice, no studies have so far evaluated the short- and long-term management and outcome of patients affected by bipolar mania in different European countries.</p> <p>The objective of the study is to present, in the context of a large multicenter survey (EMBLEM study), an overview of the baseline data on the acute management of a representative sample of manic bipolar patients treated in the Italian psychiatric hospital and community settings. EMBLEM is a 2-year observational longitudinal study that evaluates across 14 European countries the patterns of the drug prescribed in patients with bipolar mania, their socio-demographic and clinical features and the outcomes of the treatment.</p> <p>Methods</p> <p>The study consists of a 12-week acute phase and a ≤ 24-month maintenance phase. Bipolar patients were included into the study as in- or out-patients, if they initiated or changed, according to the decision of their psychiatrist, oral antipsychotics, anticonvulsants and/or lithium for the treatment of an episode of mania.</p> <p>Data concerning socio-demographic characteristics, psychiatric and medical history, severity of mania, prescribed medications, functional status and quality of life were collected at baseline and during the follow-up period.</p> <p>Results</p> <p>In Italy, 563 patients were recruited in 56 sites: 376 were outpatients and 187 inpatients. The mean age was 45.8 years. The mean CGI-BP was 4.4 (± 0.9) for overall score and mania, 1.9 (± 1.2) for depression and 2.6 (± 1.6) for hallucinations/delusions. The YMRS showed that 14.4% had a total score < 12, 25.1% ≥ 12 and < 20, and 60.5% ≥ 20. At entry, 75 patients (13.7%) were treatment-naïve, 186 (34.1%) were receiving a monotherapy (of which haloperidol [24.2%], valproate [16.7%] and lithium [14.5%] were the most frequently prescribed) while 285 (52.2%) a combined therapy (of which 8.0% were represented by haloperidol/lithium combinations). After a switch to an oral medication, 137 patients (24.8%) were prescribed a monotherapy while the rest (415, 75.2%) received a combination of drugs.</p> <p>Conclusion</p> <p>Data collected at baseline in the Italian cohort of the EMBLEM study represent a relevant source of information to start addressing the short and long-term therapeutic strategies for improving the clinical as well as the socio-economic outcomes of patients affected by bipolar mania. Although it's not an epidemiological investigation and has some limitations, the results show several interesting findings as a relatively late age of onset of bipolar disorder, a low rate of past suicide attempts, a low lifetime rate of alcohol abuse and drug addiction.</p

The Factors Influencing Depression Endpoints Research (FINDER) study: final results of Italian patients with depression

<p>Abstract</p> <p>Background</p> <p>Factors Influencing Depression Endpoints Research (FINDER) is a 6-month, prospective, observational study carried out in 12 European countries aimed at investigating health-related quality of life (HRQoL) in outpatients receiving treatment for a first or new depressive episode. The Italian HRQoL data at 6 months is described in this report, and the factors associated with HRQoL changes were determined.</p> <p>Methods</p> <p>Data were collected at baseline, 3 and 6 months of treatment. HRQoL was measured using components of the 36-item Short Form Health Survey (SF-36; mental component summary (MCS), physical component summary (PCS)) and the European Quality of Life-5 Dimensions (EQ-5D; visual analogue scale (VAS) and health status index (HSI)). The Hospital Anxiety and Depression Scale (HADS) was adopted to evaluate depressive symptoms, while somatic and painful physical symptoms were assessed by using the 28-item Somatic Symptom Inventory (SSI-28) and a VAS.</p> <p>Results</p> <p>Of the initial 513 patients, 472 completed the 3-month observation and 466 the 6-month observation. The SF-36 and EQ-5D mean (± SD) scores showed HRQoL improvements at 3 months and a further smaller improvement at 6 months, with the most positive effects for SF-36 MCS (baseline 22.0 ± 9.2, 3 months 34.6 ± 10.0; 6 months 39.3 ± 9.5) and EQ-5D HSI (baseline 0.4 ± 0.3; 3 months 0.7 ± 0.3; 6 months 0.7 ± 0.2). Depression and anxiety symptoms (HADS-D mean at baseline 13.3 ± 4.2; HADS-A mean at baseline 12.2 ± 3.9) consistently decreased during the first 3 months (8.7 ± 4.3; 7.5 ± 3.6) and showed a further positive change at 6 months (6.9 ± 4.3; 5.8 ± 3.4). Somatic and painful symptoms (SSI and VAS) significantly decreased, with the most positive changes in the SSI-28 somatic item (mean at baseline 2.4 ± 0.7; mean change at 3 months: -0.5; 95% CI -0.6 to -0.5; mean change at 6 months: -0.7; 95% CI -0.8 to -0.7); in 'interference of overall pain with daily activities' (mean at baseline 45.2 ± 30.7; mean change at 3 months -17.4; 95% CI -20.0 to -14.8; mean change at 6 months -24.4; 95% CI -27.3 to -21.6) and in 'having pain while awake' (mean at baseline 41.1 ± 29.0; mean change at 3 months -13.7; 95% CI -15.9 to -11.5; mean change at 6 months -20.2; 95% CI -22.8 to -17.5) domains. The results from linear regression analyses showed that the antidepressant switch within classes was consistently associated with a worsening in SF-36 MCS, EQ-5D VAS and HSI compared to non-switching treatment. Furthermore, between-group antidepressants (AD) switch was associated with a worse SF-36 MCS and EQ-5D HSI. MCS (<it>P </it>= 0.028), PCS (<it>P </it>= 0.036) and HSI (<it>P </it>= 0.002) were inversely related to the number of each previous additional depressive episode. PCS (<it>P </it>= 0.009) and HSI (<it>P </it>= 0.005) were also less improved in patients suffering from a chronic medical condition. Moreover, PCS (<it>P </it>= 0.044) and EQ-5D VAS (<it>P </it>< 0.0001) worsening was consistently associated with the presence of a psychiatric illness in the 24 months before baseline. For every additional point on the SSI-somatic score and on the overall pain VAS score at baseline, HSI score were on average 0.062 (<it>P </it>< 0.001) and 0.001 (<it>P </it>= 0.005) smaller, respectively.</p> <p>Conclusions</p> <p>After starting AD treatment, HRQoL improvements at 3 and 6 months were observed. However, several factors can negatively influence HRQoL, such as the presence of somatic and painful symptoms, the presence of any chronic medical condition or previous psychiatric illness.</p

Development of a health care systems curriculum

Zachary Pruitt,1 Rahul Mhaskar,2 Bryan G Kane,3 Robert D Barraco,4 Deborah J DeWaay,2 Alex M Rosenau,3 Kristin A Bresnan,5 Marna Rayl Greenberg3 1Department of Health Policy and Management, College of Public Health, Morsani College of Medicine, University of South Florida, Tampa, FL, 2Department of Internal Medicine, Morsani College of Medicine, University of South Florida, Tampa, FL, 3Department of Emergency Medicine, Morsani College of Medicine, University of South Florida, Lehigh Valley Campus, Allentown, PA, 4Department of Surgery, Morsani College of Medicine, University of South Florida, Lehigh Valley Campus, Allentown, PA, 5Department of Family Medicine, Morsani College of Medicine, University of South Florida, Lehigh Valley Campus, Allentown, PA,&nbsp;USA Background: There is currently no gold standard for delivery of systems-based practice in medical education, and it is challenging to incorporate into medical education. Health systems competence requires physicians to understand patient care within the broader health care system and is vital to improving the quality of care clinicians provide. We describe a health systems curriculum that utilizes problem-based learning across 4 years of systems-based practice medical education at a single institution.Methods: This case study describes the application of a problem-based learning approach to system-based practice medical education. A series of behavioral statements, called entrustable professional activities, was created to assess student health system competence. Student evaluation of course curriculum design, delivery, and assessment was provided through web-based surveys.Results: To meet competency standards for system-based practice, a health systems curriculum was developed and delivered across 4 years of medical school training. Each of the health system lectures and problem-based learning activities are described herein. The majority of first and second year medical students stated they gained working knowledge of health systems by engaging in these sessions. The majority of the 2016 graduating students (88.24%) felt that the course content, overall, prepared them for their career.Conclusion: A health systems curriculum in undergraduate medical education using a problem-based learning approach is feasible. The majority of students learning health systems curriculum through this format reported being prepared to improve individual patient care and optimize the health system&rsquo;s value (better care and health for lower cost). Keywords: health systems, undergraduate medical, educatio

Trauma in Pregnancy

The general principles of trauma management remain the same in a pregnant patient, with the additional challenge of a living fetus. Trauma is the leading cause of nonobstetric death in pregnancy. Motor vehicle accident and domestic violence account for the majority of maternal trauma. Although the principles of management are similar, the secondary survey includes elements of obstetrical history. This chapter will clarify the different aspects of the initial evaluation and management of a pregnant patient with major trauma