[Psychosocial therapy in psychiatry : Update of the DGPPN-S3 guidelines "Psychosocial therapies for severe mental illnesses"]. / Psychosoziale Therapien in der Psychiatrie : Update der DGPPN-S3-Leitlinie "Psychosoziale Therapien bei schweren psychischen Erkrankungen".

BACKGROUND: Severe mental illnesses are often associated with substantial impairments of psychosocial functioning and a high risk of social exclusion. Along with somatic and psychotherapeutic treatment approaches, psychosocial interventions are an integral component of treatment. Psychosocial therapies aim to improve participation and enable patients to live self-determined lives as far as possible. OBJECTIVE: This paper provides an overview of the structure and recommendations of the German S3 guidelines "Psychosocial therapies for severe mental illnesses" of the German Association for Psychiatry, Psychotherapy and Psychosomatics (DGPPN). MATERIAL AND METHODS: In the DGPPN S3 guidelines psychosocial therapies are systematically described for the first time and recommendations are formulated on the basis of a systematic processing of scientific evidence and a formalized consensus process. RESULTS: The evidence-based and consensus-based guidelines formulate a total of 33 recommendations and 12 statements. For many psychosocial interventions there is a broad evidence base. In the field of individual interventions psychoeducation, social skills training and health-promoting interventions have been given the highest recommendation strength (A). In the field of system level interventions, team-based, multiprofessional community psychiatric approaches, supported employment and self-determined housing with mobile support (supported housing) are given A level recommendations. For other interventions, the current evidence base is less robust. CONCLUSION: The successful implementation of guidelines depends not only on the quality but also on the dissemination. Therefore, in addition to the treatment guidelines a short version, a patient version and a waiting room version were developed.

[Frontal brain volume reduction due to antipsychotic drugs?]. / Frontale Hirnvolumenminderung durch Antipsychotika?

This article reviews the results of longitudinal studies on frontal brain volume reduction in patients with schizophrenia spectrum disorders and focuses on the relationship with antipsychotic treatment. Based on a systematic literature search all studies were included in which results on changes of brain volumes over a longer period of time were correlated with antipsychotic treatment dose and disease severity. The findings indicate that there is evidence for grey and white matter volume changes of the frontal brain, which cannot be explained by the severity of the disease alone but are also very likely a manifestation of long-term effects of antipsychotics. Whether second generation antipsychotics have an advantage compared to first generation antipsychotics is currently unclear. Considering the contribution of antipsychotics to the changes in brain structure, which seem to depend on cumulative dosage and can exert adverse effects on neurocognition, negative and positive symptoms and psychosocial functioning, the guidelines for antipsychotic long-term drug treatment should be reconsidered. This is the reason why we and others recommend prescribing the lowest dose necessary to control symptoms. In non-schizophrenic psychiatric disorders, antipsychotics should be used only with great caution after a careful risk-benefit assessment. Moreover, treatment approaches which can help to minimize antipsychotic medication or even administer them only selectively are of increasing importance.

[Cost evaluation of a model for integrated care of seriously mentally ill patients]. / Kostenevaluation eines Modells der Integrierten Versorgung für schwer psychisch Kranke.

BACKGROUND: The model for integrated care (IC) of those seriously mentally ill patients insured with the DAK-Gesundheit health insurance and various Betriebskrankenkassen (members of the VAG Mitte) from the regions Berlin, Brandenburg, Lower Saxony and Bremen allows a complex treatment in the outpatient setting which consists of psychiatrists, general practitioners and clinicians, psychiatric nursing, sociotherapy (only in Berlin), internal medicine quality circles, orientation on treatment guidelines and conceptual consensus with the relevant care clinics. The aim of the evaluation is to illustrate the health economic effects of IC. METHODS: In the period from 2006 to 2010 insured members of the DAK-Gesundheit and other involved health insurance companies with a serious mental illness, a significant impairment of social functioning and the need to be treated to avoid or substitute an in-hospital stay were included in the integrated care. The cost perspective was that of the statutory health insurance companies. For the health economic evaluation, the utilisation of continuous IC over 18 months was compared to the last 18 months prior to the inclusion in IC. The clinical findings were gathered quarterly during the IC using CGI (Clinical Global Impressions) and GAF (Global Assessment of Functioning Scale). RESULTS: A total of 1 364 patients receiving IC in 66 doctor's practices were documented (of those, 286 had diagnoses of ICD-10 F2, 724 ICD-10 F32-F39). The median age was 48.8 years, 69% were female. 24% had their own source of income, 40% were on the pension, and the rest of the patients were receiving transfer benefits in some form. In 54% of the cases IC was used to avoid an in-hospital stay, in 46% of the cases to substitute an in-hospital stay. The degree of the CGI was 5.5 on average at the time of inclusion and the GAF score was 36.5 on average. The 226 patients with continuous documentation over 18 months were included in the health economic analysis. The number of days spent in hospital was lower during the IC period as compared to the 18 months prior to IV (11.8 vs. 28.6 days, p<0.001), the inpatient costs were lower (5 929 ± 13 837 Euro vs. 2 458 ± 6 940 Euro, p<0.001), the total was not significantly changed (7 777 ± 14 263 Euro vs. 7 321 ± 7 910 Euro, p=0.65). The substantial reduction of inpatient costs was compensated by the additional costs for medication and the costs of the complex outpatient care. Results were comparable for the 2 subgroups of schizophrenic/schizoaffective (n=66, 40.9 vs. 17.9 days, p=0.03; inpatient cost 9 009 ± 15 677 Euro vs. 3 650 ± 8 486 Euro, p=0.02; total expenditures 11 789 ± 15 975 Euro vs. 9 623 ± 9 262 Euro, p=0.33) and unipolar depressive patients (n=90, 29.8 vs. 9.8 days, p=0.006; inpatient cost 5 664 ± 14 921 Euro vs. 1 967 ± 5 276 Euro, p=0.02; total expenditures 7 146 ± 15 164 Euro vs. 6 234 ± 6 292 Euro, p=0.57). CONCLUSION: The IC was able to considerably reduce the utilisation of inpatient treatment through offering a complex range of services in the outpatient setting and allowed for a weight-shift in a low-threshold comprehensive care structure without an increase in costs from the statutory health insurance companies' perspective. For a detailed description of clinical effects further studies are required.

Safety of zoster vaccine in adults from a large managed-care cohort: a Vaccine Safety Datalink study.

OBJECTIVES: The aim of this study was to examine a large cohort of adults who received the zoster vaccine for evidence of an increased risk of prespecified adverse events requiring medical attention. DESIGN: Two self-comparison approaches, including a case-centred approach and a self-controlled case series (SCCS) analysis were used. SETTING: Eight managed-care organizations participating in the Vaccine Safety Datalink project in the United States. SUBJECTS: A total of 193 083 adults aged 50 and older receiving a zoster vaccine from 1 January 2007 to 31 December 2008 were included. MAIN OUTCOME MEASURES: Prespecified adverse events were identified by aggregated International Classification of Diseases, Ninth Revision (ICD-9) codes in automated health plan datasets. RESULTS: The risk of allergic reaction was significantly increased within 1-7 days of vaccination [relative risk = 2.13, 95% confidence interval (CI): 1.87-2.40 by case-centred method and relative rate = 2.32, 95% CI: 1.85-2.91 by SCCS]. No increased risk was found for the following adverse event groupings: cerebrovascular events; cardiovascular events; meningitis; encephalitis; and encephalopathy; and Ramsay-Hunt syndrome and Bell's palsy. CONCLUSIONS: The results of this study support the findings from the prelicensure clinical trials, providing reassurance that the zoster vaccine is generally safe and well-tolerated with a small increased risk of allergic reactions in 1-7 days after vaccination.

[Team-based community psychiatry: importance of context factors and transferability of evidence from studies]. / Teambasierte Gemeindepsychiatrie : Bedeutung von Kontextfaktoren und Übertragbarkeit der Studienevidenz.

The German Society for Psychiatry, Psychotherapy and Neurology (DGPPN) guidelines on psychosocial interventions for people with severe mental illness appraise the transferability of results of trials evaluating community-based mental health services to the German situation. This assessment has to draw on research results on factors determining effectiveness. This must be seen against the background of a lack of high-quality trials in Germany. The article discusses system, context and setting factors related to the transfer of evidence on community-based service models from other countries. These issues are discussed on the basis of evidence concerning the models of case management, assertive community treatment and community mental health teams. International differences in study findings are highlighted and the importance of treatment-as-usual in influencing study results is emphasized. The more control services including elements of community-based care there are and the less the pressure to reduce inpatient treatment (threshold to inpatient care admission), the smaller the relative effect sizes of innovative care models will be.In the absence of direct evidence, careful examination of transferability is required before introducing health care models. Research has revealed solid evidence for several factors influencing the effects of innovative community mental health care. Among key factors in the care of people with severe mental illness, home visits and joint team responsibility for both psychiatric and social care were identified. This evidence can facilitate the adaptation of successful mental health care models in Germany.

[Psychosocial interventions in severe mental illness: evidence and recommendations: psychoeducation, social skill training and exercise]. / Psychosoziale Interventionen bei schweren psychischen Störungen : Evidenz und Empfehlungen: Psychoedukation, Training sozialer Fertigkeiten, Sport und Bewegung.

This paper summarizes the results of a systematic literature search on three widely used psychosocial interventions for people with severe mental illness: psychoeducation for patients and relatives, social skill training and physical exercise. Based on this evidence, recommendations given in the S3 guidelines on psychosocial therapies in severe mental illness of the German Society for Psychiatry, Psychotherapy and Neurology (DGPPN) will be reported. Areas of future research are identified.

[Arts therapies in severe mental illness: are they effective?]. / Künstlerische Therapien bei schweren psychischen Störungen : Sind sie wirksam?

Arts therapies are widely used treatment strategies for people with severe mental illness. Generally, only a few randomized trials are available, however, the studies show that additional use of arts therapies reduces the appearance of negative symptoms among people with schizophrenia. The most significant evidence can be seen with music therapy. The treatment of severe depression has shown that additional music therapy improves depression. The S3 guidelines on psychosocial therapies in severe mental illness of the Germany Society for Psychiatry, Psychotherapy and Neurology (DGPPN) recommended arts therapies are with recommendation level B.

A systematic review of duloxetine and venlafaxine in major depression, including unpublished data.

OBJECTIVE: To determine the short-term antidepressant efficacy and tolerability of duloxetine and venlafaxine vs. each other, placebo, selective serotonin reuptake inhibitors (SSRIs), and tri- and tetracyclic antidepressants (TCAs) in adults with major depression. METHOD: Meta-analysis of randomised controlled trials identified through bibliographical databases and other sources, including unpublished manufacturer reports. RESULTS: Fifty-four studies including venlafaxine arms (n = 12,816), 14 including duloxetine arms (n = 4,528), and two direct comparisons (n = 836) were analysed. Twenty-three studies were previously unpublished. In the meta-analysis, both duloxetine and venlafaxine showed superior efficacy (higher remission and response rates) and inferior tolerability (higher discontinuation rates due to adverse events) to placebo. Venlafaxine had superior efficacy in response rates but inferior tolerability to SSRIs (OR = 1.20, 95% CI 1.07-1.35 and 1.38, 95% CI 1.15-1.66, respectively), and no differences in efficacy and tolerability to TCAs. Duloxetine did not show any advantages over other antidepressants and was less well tolerated than SSRIs and venlafaxine (OR = 1.53, 95% CI 1.10-2.13 and OR 1.79, 95% CI 1.16-2.78, respectively). CONCLUSION: Rather than being a first-line option, venlafaxine appears to be a valid alternative in patients who do not tolerate or respond to SSRIs or TCAs. Duloxetine does not seem to be indicated as a first-line treatment.

Treatment of schizoaffective disorder - a challenge for evidence-based psychiatry.

OBJECTIVE: Schizoaffective disorder is a common diagnosis in mental health services. The aim of the present article was to review treatment studies for schizoaffective disorder and draw conclusions for clinical decision making. METHOD: We searched MEDLINE and Cochrane Library for relevant clinical trials and review articles up to the year 2008. RESULTS: Thirty-three studies using standardized diagnostic criteria, 14 of which were randomized controlled trials, could be identified. The comparability of studies is limited by the use of different diagnostic criteria. The studies reviewed do not permit consistent recommendations as to whether schizoaffective disorder should be treated primarily with antipsychotics, mood stabilizers or combinations of these drugs. The relevance of diverse subtypes of schizoaffective disorder for treatment recommendations is unclear. CONCLUSION: The pertinent empirical database is small and heterogeneous. The lack of conclusive recommendations is related to issues of nosological status, plurality of diagnostic criteria and validity of the concept of schizoaffective disorder.

Limits of meta-analysis: methylphenidate in the treatment of adult attention-deficit hyperactivity disorder.

Guidelines for the treatment of attention-deficit hyperactivity disorder (ADHD) in adults advocate methylphenidate as first-line treatment. The aim of this study was to review the effectiveness of methylphenidate treatment of adult ADHD and to examine the influence of methods on meta-analytic results. Electronic databases were searched to identify clinical trials comparing methylphenidate with placebo in the treatment of adult ADHD. Studies were summarised with meta-analytic methods. Subgroup analyses were conducted with respect to parallel group versus cross-over trials and self versus observer ratings. The relationship between dosage and effect size was explored by weighted regression analysis. The results were tested for publication bias, and several sensitivity analyses were performed. Findings and methods were compared with a previous meta-analysis. Eighteen studies met the inclusion criteria of which 16 were included in the meta-analysis. The overall effect size (d = 0.42) was significantly different from zero, but was only half the size expected on the basis of a previous meta-analysis. No significant differences could be observed in the subgroup analyses. The regression analysis showed no significant influence of mean daily dose on effect size. These results contradict findings of a previous meta-analysis and challenge guideline recommendations. Methodological issues in meta-analyses are discussed.

Quality assurance in psychiatry: quality indicators and guideline implementation.

In many occasions, routine mental health care does not correspond to the standards that the medical profession itself puts forward. Hope exists to improve the outcome of severe mental illness by improving the quality of mental health care and by implementing evidence-based consensus guidelines. Adherence to guideline recommendations should reduce costly complications and unnecessary procedures. To measure the quality of mental health care and disease outcome reliably and validly, quality indicators have to be available. These indicators of process and outcome quality should be easily measurable with routine data, should have a strong evidence base, and should be able to describe quality aspects across all sectors over the whole disease course. Measurement-based quality improvement will not be successful when it results in overwhelming documentation reducing the time for clinicians for active treatment interventions. To overcome difficulties in the implementation guidelines and to reduce guideline non-adherence, guideline implementation and quality assurance should be embedded in a complex programme consisting of multifaceted interventions using specific psychological methods for implementation, consultation by experts, and reimbursement of documentation efforts. There are a number of challenges to select appropriate quality indicators in order to allow a fair comparison across different approaches of care. Carefully used, the use of quality indicators and improved guideline adherence can address suboptimal clinical outcomes, reduce practice variations, and narrow the gap between optimal and routine care.

[Innovative structuring in German care for schizophrenics]. / Innovative Versorgungsstrukturen in der Behandlung von Menschen mit Schizophrenie in Deutschland.

In a narrative literature review, innovative models of mental health care for people with schizophrenia are described. Structural aspects of mental health care such as the integration of services, new care paradigms, and innovative research questions are discussed. Key targets of innovative care include: improving continuity of care, introducing team-based community care, improving cooperation of all therapists, and integrating mental health, medical care, and social services. Models of current care for people with schizophrenia such as case management, crisis intervention, home treatment, and supported employment are described; and the evidence supporting these interventions is discussed. In the models of integrated care, there is an enhanced integration of psychosocial modules or service elements. One of the key challenges in mental health service systems is to consider the needs and aims of people with severe mental illness, to take into account biological vulnerability, symptoms of illness, and cognitive impairment of patients (whenever interventions are possible). One of the guiding principles is patient/user autonomy and a focus on user perspective. This implies that people suffering from schizophrenia should have the right to live in the least restrictive environment possible.

Re-evaluation of the efficacy and tolerability of venlafaxine vs SSRI: meta-analysis.

RATIONALE: A number of reviews have claimed that the selective serotonin and noradrenalin re-uptake inhibitor venlafaxine is more effective than selective serotonin re-uptake inhibitors (SSRIs) in achieving remission and symptom reduction in major depression. OBJECTIVES: The aim of this study was to systematically review studies on the efficacy of venlafaxine vs SSRI and to evaluate the influence of methodological issues on the effect sizes. MATERIALS AND METHODS: Following a systematic literature search, we pooled data on depression scores, response, remission and dropout rates. We also performed sub-group analyses. RESULTS: Seventeen studies were included. We found no significant superiority in remission rates (risk ratio [RR] = 1.07, 95% confidence intervals [95%CI] = 0.99 to 1.15, numbers needed to treat [NNT] = 34) and a small superiority in response rates (RR = 1.06, 95%CI = 1.01 to 1.12, NNT = 27) over SSRIs. There was a small advantage to venlafaxine in change scores (effect size = -0.09, 95%CI = -0.16 to -0.02, p = 0.013), which did not reach significance when post-treatment scores were used (effect size = -0.06, 95%CI = -0.13 to 0.00). Discontinuation rates due to adverse events were 45% higher in the venlafaxine group. The main reasons for the differences between this analysis and previous reviews were the exclusion of studies with methodological limitations, avoiding to pool selectively reported study results and exclusion of studies available as abstracts only. CONCLUSIONS: Our analysis does not support a clinically significant superiority of venlafaxine over SSRIs. Differences between our study and previous reviews were not accounted for by technical aspects of data synthesis, but rather by study selection and choice of outcome parameters.

Leisure-time physical activity and the risk of primary cardiac arrest.

BACKGROUND: Because the risks of sudden cardiac death and myocardial infarction are transiently increased during acute bouts of high-intensity activity, it is an important question from the public health perspective whether regular participation in moderate-intensity activity confers overall protection from sudden cardiac death. PARTICIPANTS AND METHODS: We used data from a population-based case-control study to assess the associations of regular high-intensity and moderate-intensity leisure-time physical activity with primary cardiac arrest. Cases were patients with primary cardiac arrest, aged 25 to 74 years, attended by paramedics between 1988 and 1994 in King County, Washington (n = 333). Controls were randomly identified from the same community (n = 503), matched for age and sex. All case patients and controls were free of prior clinical heart disease, major comorbidity, and self-reported poor health. Spouses of case patients and controls were interviewed to assess participation in 15 high-intensity and 6 moderate-intensity physical activities during the prior year. RESULTS: Compared with subjects who performed none of the activities, the odds ratio for primary cardiac arrest from matched analyses was 0.34 (95% confidence interval, 0.13-0.89) among subjects who performed only gardening activities for more than 60 minutes per week; 0.27 (95% confidence interval, 0.11-0.67) among subjects who walked for exercise for more than 60 minutes per week; and 0.34 (95% confidence interval, 0.16-0.75) among subjects who engaged in any high-intensity activities, after adjustment for age, smoking, education, diabetes, hypertension, and health status. CONCLUSIONS: The results suggest that regular participation in moderate-intensity activities, such as walking and gardening, are associated with a reduced risk of PCA and support current exercise recommendations.

Dietary intake of long-chain n-3 polyunsaturated fatty acids and the risk of primary cardiac arrest.

Whether the dietary intake of long-chain n-3 polyunsaturated fatty acids (PUFAs) from seafood reduces the risk of ischemic heart disease remains a source of controversy, in part because studies have yielded inconsistent findings. Results from experimental studies in animals suggest that recent dietary intake of long-chain n-3 PUFAs, compared with saturated and monounsaturated fats, reduces vulnerability to ventricular fibrillation, a life-threatening cardiac arrhythmia that is a major cause of ischemic heart disease mortality. Until recently, whether a similar effect of long-chain n-3 PUFAs from seafood occurred in humans was unknown. We summarize the findings from a population-based case-control study that showed that the dietary intake of long-chain n-3 PUFAs from seafood, measured both directly with a questionnaire and indirectly with a biomarker, is associated with a reduced risk of primary cardiac arrest in humans. The findings also suggest that 1) compared with no seafood intake, modest dietary intake of long-chain n-3 PUFAs from seafood (equivalent to 1 fatty fish meal/wk) is associated with a reduction in the risk of primary cardiac arrest; 2) compared with modest intake, higher intakes of these fatty acids are not associated with a further reduction in such risk; and 3) the reduced risk of primary cardiac arrest may be mediated, at least in part, by the effect of dietary n-3 PUFA intake on cell membrane fatty acid composition. These findings also may help to explain the apparent inconsistencies in earlier studies of long-chain n-3 PUFA intake and ischemic heart disease.

Recruitment of American Indians and Alaska Natives into clinical trials.

Challenges in recruiting American Indians and Alaska Natives into cancer clinical trials are addressed in this article. Researchers, health care providers, and American Indian and Alaska Native patients face significant communication barriers when prevention or treatment trials are designed or implemented. For researchers, the challenges lie in understanding the cultural distinctiveness of individual tribes, coping with the family orientation of Indian subjects, dealing with the lack of standardized research measures, and defining the subject's pathway in seeking and obtaining healing and health care services. For providers, the challenges center on patient-provider communication, illness beliefs, transportation, and sociocultural barriers. This article explores these complex issues and offers recommendations for researchers and health care providers on conducting research in American Indian and Alaska Native populations.

Plasma thyroid hormone profiles immediately following out-of-hospital cardiac arrest.

Previous studies have shown abnormal thyroid hormone profiles during cardiac arrest. We explored this association further by characterizing plasma thyroid hormone profiles in 473 patients with out-of-hospital cardiac arrest and correlating them with clinical outcomes. Paramedics collected blood at the end of attempted resuscitation regardless of success. Bloods were collected and processed in a similar manner from 18 control subjects randomly selected from the community. Total thyroxine and total triiodothyronine were lower and reverse triiodothyronine and thyrotropin were higher in cardiac arrest patients than control subjects (all p < 0.001). Except for reverse triiodothyronine, findings were similar for a subgroup of cardiac arrest patients considered to be previously healthy (n = 30). Being discharged alive was associated with total thyroxine, total triiodothyronine and reverse triiodothyronine concentrations closer to the control range and thyrotropin concentrations farther from it, namely higher. In a multivariate stepwise model, only total triiodothyronine and thyrotropin were significantly associated with outcome. Whether these profoundly abnormal profiles represent a pre-existing state or a sudden change of thyroid hormone concentrations cannot be answered with this retrospective study. These observations suggest that thyroid hormones may play a role in the etiology of cardiac arrest, its prognosis, or both.