How to improve clinical practice on forced medication in psychiatric practice: Suggestions from the EUNOMIA European multicentre study.

BACKGROUND: The decision to adopt forced medication in psychiatric care is particularly relevant from a clinical and ethical viewpoint. The European Commission has funded the EUNOMIA study in order to develop European recommendations for good clinical practice on coercive measures, including forced medication. METHODS: The recommendations on forced medication have been developed in 11 countries with the involvement of national clinical leaders, key-professionals and stakeholders' representatives. The national recommendations have been subsequently summarized into a European shared document. RESULTS: Several cross-national differences exist in the use of forced medication. These differences are mainly due to legal and policy making aspects, rather than to clinical situations. In fact, countries agreed that forced medication can be allowed only if the following criteria are present: 1) a therapeutic intervention is urgently needed; 2) the voluntary intake of medications is consistently rejected; 3) the patient is not aware of his/her condition. Patients' dignity, privacy and safety shall be preserved at all times. CONCLUSION: The results of our study show the need of developing guidelines on the use of forced medication in psychiatric practice, that should be considered as the last resort and only when other therapeutic option have failed.

Do patient and ward-related characteristics influence the use of coercive measures? Results from the EUNOMIA international study.

PURPOSE: This study aims to identify whether selected patient and ward-related factors are associated with the use of coercive measures. Data were collected as part of the EUNOMIA international collaborative study on the use of coercive measures in ten European countries. METHODS: Involuntarily admitted patients (N = 2,027) were divided into two groups. The first group (N = 770) included patients that had been subject to at least one of these coercive measures during hospitalization: restraint, and/or seclusion, and/or forced medication; the other group (N = 1,257) included patients who had not received any coercive measure during hospitalization. To identify predictors of use of coercive measures, both patients' sociodemographic and clinical characteristics and centre-related characteristics were tested in a multivariate logistic regression model, controlled for countries' effect. RESULTS: The frequency of the use of coercive measures varied significantly across countries, being higher in Poland, Italy and Greece. Patients who received coercive measures were more frequently male and with a diagnosis of psychotic disorder (F20-F29). According to the regression model, patients with higher levels of psychotic and hostility symptoms, and of perceived coercion had a higher risk to be coerced at admission. Controlling for countries' effect, the risk of being coerced was higher in Poland. Patients' sociodemographic characteristics and ward-related factors were not identifying as possible predictors because they did not enter the model. CONCLUSIONS: The use of coercive measures varied significantly in the participating countries. Clinical factors, such as high levels of psychotic symptoms and high levels of perceived coercion at admission were associated with the use of coercive measures, when controlling for countries' effect. These factors should be taken into consideration by programs aimed at reducing the use of coercive measures in psychiatric wards.

Gender differences in coerced patients with schizophrenia.

BACKGROUND: Despite the recent increase of research interest in involuntary treatment and the use of coercive measures, gender differences among coerced schizophrenia patients still remain understudied. It is well recognized that there are gender differences both in biological correlates and clinical presentations in schizophrenia, which is one of the most common diagnoses among patients who are treated against their will. The extent to which these differences may result in a difference in the use of coercive measures for men and women during the acute phase of the disease has not been studied. METHODS: 291 male and 231 female coerced patients with schizophrenia were included in this study, which utilized data gathered by the EUNOMIA project (European Evaluation of Coercion in Psychiatry and Harmonization of Best Clinical Practice) and was carried out as a multi-centre prospective cohort study at 13 centers in 12 European countries. Sociodemographic and clinical characteristics, social functioning and aggressive behavior in patients who received any form of coercive measure (seclusion and/or forced medication and/or physical restraint) during their hospital stay were assessed. RESULTS: When compared to the non-coerced inpatient population, there was no difference in sociodemographic or clinical characteristics across either gender. However coerced female patients did show a worse social functioning than their coerced male counterparts, a finding which contrasts with the non-coerced inpatient population. Moreover, patterns of aggressive behavior were different between men and women, such that women exhibited aggressive behavior more frequently, but men committed severe aggressive acts more frequently. Staff used forced medication in women more frequently and physical restraint and seclusion more frequently with men. CONCLUSIONS: Results of this study point towards a higher threshold of aggressive behavior the treatment of women with coercive measures. This may be because less serious aggressive actions trigger the application of coercive measures in men. Moreover coerced women showed diminished social functioning, and more importantly more severe symptoms from the "excitement/hostile" cluster in contrast to coerced men. National and international recommendation on coercive treatment practices should include appropriate consideration of the evidence of gender differences in clinical presentation and aggressive behaviors found in inpatient populations.

Coerced hospital admission and symptom change--a prospective observational multi-centre study.

INTRODUCTION: Coerced admission to psychiatric hospitals, defined by legal status or patient's subjective experience, is common. Evidence on clinical outcomes however is limited. This study aimed to assess symptom change over a three month period following coerced admission and identify patient characteristics associated with outcomes. METHOD: At study sites in 11 European countries consecutive legally involuntary patients and patients with a legally voluntary admission who however felt coerced, were recruited and assessed by independent researchers within the first week after admission. Symptoms were assessed on the Brief Psychiatric Rating Scale. Patients were re-assessed after one and three months. RESULTS: The total sample consisted of 2326 legally coerced patients and 764 patients with a legally voluntary admission who felt coerced. Symptom levels significantly improved over time. In a multivariable analysis, higher baseline symptoms, being unemployed, living alone, repeated hospitalisation, being legally a voluntary patient but feeling coerced, and being initially less satisfied with treatment were all associated with less symptom improvement after one month and, other than initial treatment satisfaction, also after three months. The diagnostic group was not linked with outcomes. DISCUSSION: On average patients show significant but limited symptom improvements after coerced hospital admission, possibly reflecting the severity of the underlying illnesses. Social factors, but not the psychiatric diagnosis, appear important predictors of outcomes. Legally voluntary patients who feel coerced may have a poorer prognosis than legally involuntary patients and deserve attention in research and clinical practice.

Acute psychopathology as a predictor of global functioning in patients with ICD-10 non-affective psychosis: a prospective study in 11 European countries.

This prospective analysis aimed to study the influence of psychopathological dimensions on the global functioning of persons suffering from psychotic disorders, taking into account the role of a broad range of potential confounders. A large international cohort (n=1888) with ICD-10 non-affective psychosis was evaluated both at baseline during a hospital admission and three months after discharge. Trained interviewers administered a global functioning scale (GAF) and a psychopathological scale (BPRS) at baseline and follow-up). Baseline BPRS psychopathological dimensions were extracted using Principal Component Analysis. Results of multiple linear regression analyses demonstrated that affective symptoms (depressive or manic) prospectively predict a better global functioning, whilst agitation/cognitive symptoms determined poorer global functioning. Other predictors showing an independent effect on better global functioning were medication compliance, country of residence, female gender, married or coupled status, younger age and having a diagnosis of schizoaffective disorder rather than schizophrenia or other ICD-10 psychosis. A predicting model for global functioning in patients with psychosis is provided, showing that assessment of affective and agitation/cognitive symptoms should be emphasised during admission as they can be more informative than positive/negative symptoms in prospectively planning follow-up care that is geared towards a better functional recovery.

Use of coercive measures during involuntary hospitalization: findings from ten European countries.

OBJECTIVE: Involuntary treatment in mental health care is a sensitive but rarely studied issue. This study was part of the European Evaluation of Coercion in Psychiatry and Harmonization of Best Clinical Practice (EUNOMIA) project. It assessed and compared the use of coercive measures in psychiatric inpatient facilities in ten European countries. METHODS: The sample included 2,030 involuntarily admitted patients. Data were obtained on coercive measures (physical restraint, seclusion, and forced medication). RESULTS: In total, 1,462 coercive measures were used with 770 patients (38%). The percentage of patients receiving coercive measures in each country varied between 21% and 59%. The most frequent reason for prescribing coercive measures was patient aggression against others. In eight of the countries, the most frequent measure used was forced medication, and in two of the countries mechanical restraint was the most frequent measure used. Seclusion was rarely administered and was reported in only six countries. A diagnosis of schizophrenia and more severe symptoms were associated with a higher probability of receiving coercive measures. CONCLUSIONS: Coercive measures were used in a substantial group of involuntarily admitted patients across Europe. Their use appeared to depend on diagnosis and the severity of illness, but use was also heavily influenced by the individual country. Variation across countries may reflect differences in societal attitudes and clinical traditions.

Patients' views of involuntary hospital admission after 1 and 3 months: prospective study in 11 European countries.

BACKGROUND: Legislation and practice of involuntary hospital admission vary substantially among European countries, but differences in outcomes have not been studied. AIMS: To explore patients' views following involuntary hospitalisation in different European countries. METHOD: In a prospective study in 11 countries, 2326 consecutive involuntary patients admitted to psychiatric hospital departments were interviewed within 1 week of admission; 1809 were followed up 1 month and 1613 3 months later. Patients' views as to whether the admission was right were the outcome criterion. RESULTS: In the different countries, between 39 and 71% felt the admission was right after 1 month, and between 46 and 86% after 3 months. Females, those living alone and those with a diagnosis of schizophrenia had more negative views. Adjusting for confounding factors, differences between countries were significant. CONCLUSIONS: International differences in legislation and practice may be relevant to outcomes and inform improvements in policies, particularly in countries with poorer outcomes.

A meta-analysis of heart rate and QT interval alteration in anorexia nervosa.

OBJECTIVE: Reports have suggested association between sudden death and QT prolongation in AN patients. Incidence and clinical consequences of cardiac abnormalities remain controversial. As the course of AN disease is long-lasting it remains unclear how often psychiatrists should send AN patients for somatic and especially cardiological investigation. The objective of the study was to aggregate the published data on HR and QT alteration and to perform a meta-analysis of the HR and QT alteration in patients with anorexia nervosa. METHODS: A Medline search of all English language studies from 1994 to 2005 was performed. The inclusion criteria were confirmed diagnosis of AN, measurement of QTc and mean heart rate. Data from 10 studies were analyzed using weighted linear regression model. RESULTS: Analysis showed that bradycardia and relationship between HR and BMI decreases as the disease continues. QTc interval in AN patients was within normal range although significantly longer than in controls. CONCLUSION: Further investigations of sudden death in patients with AN due to cardiac arrest are needed and a model of clinical monitoring of cardiovascular system should be elaborated. If QTc prolongation is detected even in the normal range further cardiological examination for risk assessment and systematic clinical surveillance of the cardiovascular system should be considered.

[Practice recommendation for administering mechanical restraint during acute psychiatric hospitalization]. / Eine Empfehlung zur Durchführungspraxis von Fixierungen im Rahmen der stationären psychiatrischen Akutbehandlung.

OBJECTIVE: One aim of the multi-site EUNOMIA-project was to establish a European recommendation for the best clinical practice of administering coercive measures. This article reports the results on mechanical restraint. METHODS: Local expert groups in 11 countries worked out their recommendations mostly in semi-structured group discussions. By use of a system of categories developed with a content-analytical method, these national documents were comparatively assessed, and integrated into a common clinical recommendation. RESULTS: Legal and clinical pre-conditions for the use of mechanical restraint, specific instructions for the clinical behaviour of different professional groups, ethical issues, and procedural aspects of quality assurance are reported in detail. CONCLUSIONS: Compared with established clinical guidelines, similarities concerning basic principles of clinical use appear to be higher than similarities concerning practical details. Future development of guidelines for the best practice of coercive measures urgently needs the use of advanced methodology.

[Professor Juozas Blazys--psychiatrist, academic and public figure]. / Profesorius Juozas Blazys--psichiatras, mokslininkas, visuomenes veikejas.

Juozas Blazys (1890-1939)--the first chief of the Department of Nerve and Psychiatric Illnesses and Vice Rector of Lithuanian Vytautas Magnus University in the interwar period. In 2004 we commemorated the 65th anniversary of his death. He was a highly prominent personality of enormous erudition and productive scientist. He wrote a coursebook "Introduction to psychiatry", monograph-study "Tolerance, as a basis of culture", published around 100 articles in "Medicina" and various journals of that period. His ideas about psychiatry are relevant nowadays too. Professor was interested in the causes of psychosis origin, analyzed alcoholic, somatogenic psychosis, was interested and working in the fields of forensic psychiatry, military expertise, heredity and is contradictory evaluated in the field of eugenics till now. Juozas Blazys was born in Siauliai. In 1914 he graduated Petersburg Academy of Military Medicine, worked at the various hospitals of Russian military. In 1918 he returned to Lithuania and started to work at the psychiatric hospital in Taurage at first as a chief of department, and later as director, at the same time working as a physician of Taurage district. In 1920-1921 Juozas Blazys lectured the course of psychiatry at Higher Courses of Study in Kaunas. In 1924, after the establishment of the University of Kaunas, he was elected as a chief of the department of Nerve and Psychiatric Illnesses. In 1935 he was granted the degree of professor, in 1938--appointed as Vice Rector of Vytautas Magnus University. He had been developing educative activities: wrote articles on psycho hygiene, negative impact of alcohol, smoking and prostitution on heredity, cared about the improvement of Lithuanian genotype.

The EUNOMIA project on coercion in psychiatry: study design and preliminary data.

Previous national research has shown significant variation in several aspects of coercive treatment measures in psychiatry. The EUNOMIA project, an international study funded by the European Commission, aims to assess the clinical practice of these measures and their outcomes. Its naturalistic and epidemiological design is being implemented at 13 centres in 12 European countries. This article describes the design of the study and provides preliminary data on the catchment areas, staff, available facilities and modalities of care at the participating centres.

Efficacy and tolerability of olanzapine in patients with schizophrenia in lithuania: A 13-week, multicenter, open-label, nonrandomized study.

BACKGROUND: The atypical antipsychotic olanzapine has been approved for the treatment of schizophrenia in Europe since 1996 but has been used primarily as a second-line treatment to the less expensive typical agents. However, similar to other atypical antipsychotic drugs, olanzapine has a lower risk of inducing extrapyramidal symptoms, tardive dyskinesia, neuroleptic malignant syndrome, and sexual dysfunction compared with the typical antipsychotic drugs. OBJECTIVE: The aim of this study was to determine whether patients with schizophrenia who have a poor response to their present antipsychotic therapy would show improvement when switched to olanzapine. METHODS: This 13-week, multicenter, open-label, nonrandomized trial was conducted at 5 centers in Lithuania. Patients were started on oral olanzapine 10-mg tablets once daily, which could be adjusted by 5 mg/d in the dosing range of 5 to 20 mg/d. The primary efficacy measure was the total score on the Brief Psychiatric Rating Scale (BPRS), which was extracted from the Positive and Negative Syndrome Scale (PANSS). Efficacy response rate was defined a priori as the percentage of patients achieving ≥40% improvement in the BPRS total score. Secondary assessments included the PANSS total and BPRS and PANSS subscales and scores on the Clinical Global Impression-Severity of Illness (CGI-S), the CGI-Global Improvement (CGI-I), and the Patient Global Impression-Improvement (PGI-I) tests. Tolerability was primarily measured by assessing the incidence of treatment-emergent adverse events (AEs) according to the Udvalg fuer Kliniske Undersogelser (UKU) Side Effect Rating Scale and laboratory analyses. RESULTS: Twenty-four patients (13 men [54.2%]; mean [SD] age, 32.4 [8.1] years) entered the study. Twenty-three (95.8%) of the 24 patients completed the study. The mean (SD) daily dosage of olanzapine was 11.40 (2.18) mg/d. The total mean (SD) BPRS score improved significantly from 37.8 (7.9) to 19.5 (13.7) (P < 0.001). The response rate was 58.3% (14/24 patients). The mean positive and negative BPRS scores and the mean total and subscale PANSS scores all improved significantly from baseline (P < 0.001). The mean (SD) CGI-S score improved significantly from 4.8 (0.8) at baseline to 3.5 (1.1) at end point (P < 0.001). Twenty-two patients (91.7%) showed improvement on the CGM scale. Similar improvement was found on the PGM scale. Treatment-emergent AEs occurred in 7 patients (29.2%). Improvement was found on 31 of the 48 UKU scale items; no change was shown on 15 items; and slight worsening was shown on 2 items. No clinical abnormalities were detected during the study. CONCLUSION: In this study of Lithuanian patients with schizophrenia, significant improvement was shown in all efficacy measures. In addition, olanzapine was well tolerated in these patients.