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Sara Fernandes,1 Guillaume Fond,1 Xavier Yves Zendjidjian,1 Karine Baumstarck,1 Christophe Lançon,1 Fabrice Berna,2 Franck Schurhoff,2 Bruno Aouizerate,2 Chantal Henry,2 Bruno Etain,2 Ludovic Samalin,2 Marion Leboyer,2 Pierre-Michel Llorca,2 Magali Coldefy,3 Pascal Auquier,1 Laurent Boyer1 On behalf of the French PREMIUM Group1Aix-Marseille University, School of Medicine - La Timone Medical Campus, EA 3279: CEReSS - Health Service Research and Quality of Life Center, Marseille, France; 2FondaMental Foundation, Créteil, France; 3Institute for Research and Information in Health Economics (IRDES), Paris, FranceCorrespondence: Sara FernandesAix-Marseille University, School of Medicine - La Timone Medical Campus, EA 3279: CEReSS - Health Service Research and Quality of Life Center, Marseille, FranceTel +33-660185077Email sfernandes.sara@gmail.comBackground: There is growing concern about measuring patient experience with mental health care. There are currently numerous patient-reported experience measures (PREMs) available for mental health care, but there is little guidance for selecting the most suitable instruments. The objective of this systematic review was to provide an overview of the psychometric properties and the content of available PREMs.Methods: A comprehensive review following the preferred reporting items for systematic reviews and meta-analysis (PRISMA) guidelines was conducted using the MEDLINE database with no date restrictions. The content of PREMs was analyzed using an inductive qualitative approach, and the methodological quality was assessed according to Pesudovs quality criteria.Results: A total of 86 articles examining 75 PREMs and totaling 1932 items were included. Only four PREMs used statistical methods from item response theory (IRT). The 1932 items covered seven key mental health care domains: interpersonal relationships (22.6%), followed by respect and dignity (19.3%), access and care coordination (14.9%), drug therapy (14.1%), information (9.6%), psychological care (6.8%) and care environment (6.1%). Additionally, a few items focused on patient satisfaction (6.7%) rather than patient experience. No instrument covered the latent trait continuum of patient experience, as defined by the inductive qualitative approach, and the psychometric properties of the instruments were heterogeneous.Conclusion: This work is a critical step in the creation of an item library to measure mental health care patient-reported experience that will be used in France to develop, validate, and standardize item banks and computerized adaptive testing (CAT) based on IRT. It will also provide internationally replicable measures that will allow direct comparisons of mental health care systems.Trial Registration: NCT02491866.Keywords: patient-reported experience measures, patient experience, patient satisfaction, health services research, schizophrenia, bipolar disorder, major depression, systematic review

Sara Fernandes,1 Guillaume Fond,1 Xavier Zendjidjian,1 Pierre Michel,1 Karine Baumstarck,1 Christophe Lancon,1 Fabrice Berna,2 Franck Schurhoff,2 Bruno Aouizerate,2 Chantal Henry,2 Bruno Etain,2 Ludovic Samalin,2 Marion Leboyer,2 Pierre-Michel Llorca,2 Magali Coldefy,3 Pascal Auquier,1 Laurent Boyer1 On behalf of the French PREMIUM Group 1Aix-Marseille University, School of Medicine, CEReSS – Health Service Research and Quality of Life Center – EA 3279 Research Unit, Marseille, France; 2FondaMental Foundation, Créteil, France; 3Institute for Research and Information in Health Economics (IRDES), Paris, France Background: Measuring the quality and performance of health care is a major challenge in improving the efficiency of a health system. Patient experience is one important measure of the quality of health care, and the use of patient-reported experience measures (PREMs) is recommended. The aims of this project are 1) to develop item banks of PREMs that assess the quality of health care for adult patients with psychiatric disorders (schizophrenia, bipolar disorder, and depression) and to validate computerized adaptive testing (CAT) to support the routine use of PREMs; and 2) to analyze the implementation and acceptability of the CAT among patients, professionals, and health authorities.Methods: This multicenter and cross-sectional study is based on a mixed method approach, integrating qualitative and quantitative methodologies in two main phases: 1) item bank and CAT development based on a standardized procedure, including conceptual work and definition of the domain mapping, item selection, calibration of the item bank and CAT simulations to elaborate the administration algorithm, and CAT validation; and 2) a qualitative study exploring the implementation and acceptability of the CAT among patients, professionals, and health authorities.Discussion: The development of a set of PREMs on quality of care in mental health that overcomes the limitations of previous works (ie, allowing national comparisons regardless of the characteristics of patients and care and based on modern testing using item banks and CAT) could help health care professionals and health system policymakers to identify strategies to improve the quality and efficiency of mental health care.Trial registration: NCT02491866. Keywords: patient-reported experience measures, quality of care, item bank, computerized adaptive testing, psychiatry

Ludovic Samalin, Marion Garnier, Pierre-Michel LlorcaCentre Hospitalier Universitaire, Clermont-Ferrand, FranceAbstract: Lurasidone is a new second-generation antipsychotic approved in October 2010 by the Food and Drug Administration for the treatment of schizophrenia. Like other second-generation antipsychotics, lurasidone is a powerful antagonist of D2 dopamine and 5HT2A serotonin receptors, but differs from the other second-generation antipsychotics in its action profile for certain receptors. Lurasidone is the second-generation antipsychotic with the greatest affinity for 5HT7 receptors and has a high affinity for 5HT1A serotonin receptors, compatible with favorable effects on cognitive function and an antidepressant action. By contrast, lurasidone has a low affinity for α1 and α2C-adrenergic and 5HT2C serotonin receptors, and no affinity for histaminergic H1 or muscarinic M1 receptors, suggesting a better tolerability profile than the other second-generation antipsychotics. Lurasidone has demonstrated its efficacy in several short-term trials in acute schizophrenia, promptly and significantly reducing total Positive and Negative Syndrome Scale and Brief Psychiatric Rating Scale scores compared with placebo. Several long-term studies are in progress to assess its efficacy in the maintenance treatment of schizophrenic patients. The efficacy of lurasidone with regard to cognitive functions and depressive symptoms seems good, but requires further work. Lurasidone differs from the other second-generation antipsychotics by having a good tolerability profile, in particular for cardiometabolic tolerability. However, it seems to have a significant although moderate link with the occurrence of akathisia, extrapyramidal symptoms, and hyperprolactinemia at the start of treatment. This tolerance profile greatly broadens the scope of second-generation antipsychotics and so supports the view of some authors that the term “second-generation antipsychotic” is now outdated. Other therapeutic perspectives of lurasidone are assessed here, in particular bipolar depression.Keywords: lurasidone, second-generation antipsychotic, schizophrenia, efficacy, safety

Introduction: Metabolic syndrome (MetS) is a cluster of components including abdominal obesity, hyperglycemia, hypertension, and dyslipidemia. MetS is highly prevalent in individuals with bipolar disorders (BD) with an estimated global rate of 32.6%. Longitudinal data on incident MetS in BD are scarce and based on small sample size. The objectives of this study were to estimate the incidence of MetS in a large longitudinal cohort of 1521 individuals with BD and to identify clinical and biological predictors of incident MetS. Methods: Participants were recruited from the FondaMental Advanced Center of Expertise for Bipolar Disorder (FACE‐BD) cohort and followed‐up for 3 years. MetS was defined according to the International Diabetes Federation criteria. Individuals without MetS at baseline but with MetS during follow‐up were considered as having incident MetS. A logistic regression model was performed to estimate the adjusted odds ratio and its corresponding 95% confidence interval (CI) for an association between each factor and incident MetS during follow‐up. We applied inverse probability‐of‐censoring weighting method to minimize selection bias due to loss during follow‐up. Results: Among individuals without MetS at baseline (n = 1521), 19.3% developed MetS during follow‐up. Multivariable analyses showed that incident MetS during follow‐up was significantly associated with male sex (OR = 2.2, 95% CI = 1.7–3.0, p < 0.0001), older age (OR = 2.14, 95% CI = 1.40–3.25, p = 0.0004), presence of a mood recurrence during follow‐up (OR = 1.91, 95% CI = 1.22–3.00, p = 0.0049), prolonged exposure to second‐generation antipsychotics (OR = 1.56, 95% CI = 0.99, 2.45, p = 0.0534), smoking status at baseline (OR = 1.30, 95% CI = 1.00–1.68), lifetime alcohol use disorders (OR = 1.33, 95% CI = 0.98–1.79), and baseline sleep disturbances (OR = 1.04, 95% CI = 1.00–1.08), independently of the associations observed for baseline MetS components. Conclusion: We observed a high incidence of MetS during a 3 years follow‐up (19.3%) in individuals with BD. Identification of predictive factors should help the development of early interventions to prevent or treat early MetS. [ABSTRACT FROM AUTHOR]

Background: The objective of this study was to develop a conceptual framework to define a domain map describing the experience of patients with severe mental illnesses (SMIs) on the quality of mental health care. Methods: This study used an exploratory qualitative approach to examine the subjective experience of adult patients (18–65 years old) with SMIs, including schizophrenia (SZ), bipolar disorder (BD) and major depressive disorder (MDD). Participants were selected using a purposeful sampling method. Semistructured interviews were conducted with 37 psychiatric inpatients and outpatients recruited from the largest public hospital in southeastern France. Transcripts were subjected to an inductive analysis by using two complementary approaches (thematic analysis and computerized text analysis) to identify themes and subthemes. Results: Our analysis generated a conceptual model composed of 7 main themes, ranked from most important to least important as follows: interpersonal relationships, care environment, drug therapy, access and care coordination, respect and dignity, information and psychological care. The interpersonal relationships theme was divided into 3 subthemes: patient-staff relationships, relations with other patients and involvement of family and friends. All themes were spontaneously raised by respondents. Conclusion: This work provides a conceptual framework that will inform the subsequent development of a patient-reported experience measure to monitor and improve the performance of the mental health care system in France. The findings showed that patients with SMIs place an emphasis on the interpersonal component, which is one of the important predictors of therapeutic alliance. Trial registration: NCT02491866 [ABSTRACT FROM AUTHOR]

Sleep alterations are frequent occurrence in Bipolar Disorder (BD), both in acute and interepisodic phases. Sleep alterations have been also described both long before BD onset, as aspecific risk syndromes, or as immediate prodromes of BD onset. The aim of the present study is to systematically review the relationship between sleep alterations anticipating for the full-blown onset of BD, both in general and according to specific polarities of onset. A systematic literature research according to PRISMA statement and considering: 1. prospective studies about BD patients' offspring with sleep alterations who later developed BD. 2. prospective studies assessing patients with sleep disorders who later developed BD. 3. retrospective studies on BD patients where sleep alterations before BD onset of the disease were reported. A total of 16 studies were included in this review. Sleep disturbances may frequently appear 1 year before the onset of BD or more, often during childhood or adolescence. A decreased need for sleep may precede the onset of the illness, specially a manic episode, while insomnia appears to anticipate either a manic or a depressive episode. Hypersomnia seems to precede bipolar depressive episodes. Sleep alterations frequently appear long before the onset of BD, and appear to be related specifically to the polarity of the index episode. The detection and treatment of sleep alterations in special high risk populations may help achieving an earlier detection of the illness. [ABSTRACT FROM AUTHOR]

Objective: This systematic review provided a critical synthesis and a comprehensive overview of guidelines on the treatment of mixed states. Method: The MEDLINE/PubMed and EMBASE databases were systematically searched from inception to March 21st, 2018. International guidelines covering the treatment of mixed episodes, manic/hypomanic, or depressive episodes with mixed features were considered for inclusion. A methodological quality assessment was conducted with the Appraisal of Guidelines for Research and Evaluation‐AGREE II. Results: The final selection yielded six articles. Despite their heterogeneity, all guidelines agreed in interrupting an antidepressant monotherapy or adding mood‐stabilizing medications. Olanzapine seemed to have the best evidence for acute mixed hypo/manic/depressive states and maintenance treatment. Aripiprazole and paliperidone were possible alternatives for acute hypo/manic mixed states. Lurasidone and ziprasidone were useful in acute mixed depression. Valproate was recommended for the prevention of new mixed episodes while lithium and quetiapine in preventing affective episodes of all polarities. Clozapine and electroconvulsive therapy were effective in refractory mixed episodes. The AGREE II overall assessment rate ranged between 42% and 92%, indicating different quality level of included guidelines. Conclusion: The unmet needs for the mixed symptoms treatment were associated with diagnostic issues and limitations of previous research, particularly for maintenance treatment. [ABSTRACT FROM AUTHOR]

Objective Although many studies showed the negative impact of residual symptoms on the course of bipolar disorder ( BD), there is a need to examine potential differences in residual symptoms according to the duration of euthymia in remitted BD patients. Method This was a large cross-sectional study of 525 euthymic BD out-patients. A multivariate analysis of covariance was conducted to compare depressive and manic residual symptoms, sleep disturbances and cognitive complaints among three patient groups on the basis of duration of euthymia (A. 6 months to <1 year; B. 1 year to <3 years; C. 3 years to ≤5 years). Results A significant difference between the three groups was found in residual symptoms [Pillai's Trace: F(8942) = 4.659, P < 0.001]. Tukey post hoc analysis indicated that patients from Group C presented lower residual depressive symptoms, higher sleep quality and better perceived cognitive performance compared with Group A. Group B also presented better sleep and cognitive outcomes than Group A. In addition, Group C showed the lowest incidence of functional impairment. Conclusion This study suggests that the intensity of residual symptoms and functional impairment in remitted BD patients is negatively related to the duration of euthymia. [ABSTRACT FROM AUTHOR]

The treatment modalities of bipolar disorder and adherence to international guidelines recommendations in France were investigated. We conducted an observational survey among 210 French psychiatrists concerning their prescribing practice in bipolar disorder, and whether they use guidelines or not. Simple mania is mainly treated with valproate, whereas second-generation antipsychotics are preferred for delusional mania. Lithium is mostly used as second-line treatment by 'young psychiatrists.' Personal experience appears in the foreground (41% of psychiatrists) in the choice of therapy. Young psychiatrists refer more to guidelines (32% of responders) as compared with other psychiatrists. The main reason for the lack of use of guidelines is because they refer mostly to an Anglo-Saxon medical practice, which is considered different from the French practice. Guidelines for treatment of bipolar disorder are not frequently used. French psychiatrists' age and practice type are the most important variables correlated to the level of use of guidelines. [ABSTRACT FROM AUTHOR]

Introduction Most studies selected euthymic patients with bipolar disorder in inter-episodic phase according to clinical remission criteria at least between 1 and 6 months. However, possible differences can exist in the course of clinical symptoms in bipolar patients related to the duration of clinical remission. Objectives The main aim of this study was to evaluate the clinical status of bipolar patients after 6 months of clinical remission. Methods We performed a cross-sectional study of bipolar outpatients in clinical remission for at least 6 months. Bipolar Depression Rating Scale (BDRS), Young Mania Rating scale, Pittsburgh Sleep Quality Index (PSQI) scale, Visual Analogic Scales (VAS) evaluated cognitive impairment were used to assess residual symptomatology of patients. Multivariate analysis (MANCOVA) was conducted for analysing possible differences between 3 groups of patients according to their duration of clinical remission (< 6 months–1 year, < 1 year–3 years, < 3 years–5 years). Results A total of 525 patients were included into the study. The multivariate analysis indicated a significant effect of the duration of clinical remission on the different residual symptoms (Pillai's trace: F 4.48, P < 0.001). The duration of clinical remission was associated with the significant improvement of the BDRS total score ( P = 0.013), the PSQI total score ( P < 0.001) and the cognitive VAS total score ( P < 0.001) Conclusion These results support a possible improvement of residual symptoms according to the duration of clinical remission in bipolar patients. Any definition of euthymia should specify the duration criteria. [ABSTRACT FROM AUTHOR]

Résumé non reçu. [ABSTRACT FROM AUTHOR]

Background: The FACE-BD cohort is an observational cohort of individuals with bipolar disorders (BD) who benefited from a systematic evaluation with evidence-based treatment recommendations and who were followed-up every year for 3 years in France. The objectives were to describe the lifetime course of BD, associated psychiatric and somatic comorbidities, and cognition profile. This cohort aims to identify clinical/biological signatures of outcomes, trajectories of functioning and transition between clinical stages. This article summarizes 10 years of findings of the FACE-BD cohort.Method& Results: We included 4422 individuals, all having a baseline assessment, among which 61.2% had at least one follow-up visit at either one, two or three years. A subsample of 1200 individuals had at least one biological sample (serum, plasma, DNA). Assessments include family history of psychiatric disorders, psychiatric diagnosis, current mood symptoms, functioning, hospitalizations, suicidal attempts, physical health, routine blood tests, treatment history, psychological dimensions, medico-economic data and a cognitive assessment. Studies from this cohort illustrate that individuals with BD display multiple coexistent psychiatric associated conditions including sleep disturbances, anxiety disorders, substance use disorders and suicide attempts as well as a high prevalence of metabolic syndrome. During follow-up, we observed a 55% reduction of the number of days of hospitalization and a significant improvement in functioning.Conclusions: The FACE-BD cohort provides a strong research infrastructure for clinical research in BD and has a unique position among international cohorts because of its comprehensive clinical assessment and sustainable funding from the French Ministry of Health. [ABSTRACT FROM AUTHOR]

Background Deliberate self-harm (DSH) causes important concern in prison inmates as it worsens morbidity and increases the risk for suicide. The aim of the present study is to investigate the prevalence and correlates of DSH in a large sample of male prisoners. Methods A cross-sectional study evaluated male prisoners aged 18+ years. Current and lifetime psychiatric diagnoses were assessed with the Structured Clinical Interview for Diagnostic and Statistical Manual of Mental Disorders - DSM-IV Axis I and Axis II Disorders and with the Addiction Severity Index-Expanded Version. DSH was assessed with The Deliberate Self-Harm Inventory. Multivariable logistic regression models were used to identify independent correlates of lifetime DSH. Results Ninety-three of 526 inmates (17.7%) reported at least 1 lifetime DSH behavior, and 58/93 (62.4%) of those reported a DSH act while in prison. After multivariable adjustment (sensitivity 41.9%, specificity 96.1%, area under the curve = 0.854, 95% confidence interval CI = 0.811–0.897, P < 0.001), DSH was significantly associated with lifetime psychotic disorders (adjusted Odds Ratio aOR = 6.227, 95% CI = 2.183–17.762, P = 0.001), borderline personality disorder (aOR = 6.004, 95% CI = 3.305–10.907, P < 0.001), affective disorders (aOR = 2.856, 95% CI = 1.350–6.039, P = 0.006) and misuse of multiple substances (aOR = 2.024, 95% CI = 1.111–3.687, P = 0.021). Conclusions Borderline personality disorder and misuse of multiple substances are established risk factors of DSH, but psychotic and affective disorders were also associated with DSH in male prison inmates. This points to possible DSH-related clinical sub-groups, that bear specific treatment needs. [ABSTRACT FROM AUTHOR]

B Introduction: b Three-monthly palmitate paliperidone (PP3M) is a therapeutic option for schizophrenia approved based on randomized controlled trials (RCTs) data [1],[2]. B Objective b : The objectives of the study are to describe the characteristics of patients treated with PP3M in clinical practice: previous treatment prior to PP3M initiation, PP3M use characteristics, PP3M treatment persistence, and evolution of pharmacological co-treatments. PP3M treatment duration (persistence) was analyzed with the Kaplan Meier method, to estimate the proportion of patients still treated according to the time since the first dispensing. [Extracted from the article]