Agreement between self-reports and statutory health insurance claims data on healthcare utilization in patients with mental disorders.

BACKGROUND: Data on resource use are frequently required for healthcare assessments. Studies on healthcare utilization (HCU) in individuals with mental disorders have analyzed both self-reports and administrative data. Source of data may affect the quality of analysis and compromise the accuracy of results. We sought to ascertain the degree of agreement between self-reports and statutory health insurance (SHI) fund claims data from patients with mental disorders. METHODS: Claims data from six German SHI and self-reports were obtained along with a cost-effectiveness analysis performed as a part of a controlled prospective multicenter cohort study conducted in 18 psychiatric hospitals in Germany (PsychCare), including patients with pre-defined psychiatric disorders. Self-reports were collected using the German adaption of the Client Sociodemographic and Service Receipt Inventory (CSSRI) questionnaire with a 6-month recall period. Data linkage was performed using a unique pseudonymized identifier. Missing responses were coded as non-use for all analyses. HCU was calculated for inpatient and outpatient care, day-care services, home treatment, and pharmaceuticals. Concordance was measured using Cohen's Kappa (κ) and intraclass correlation coefficient (ICC). Regression approaches were used to investigate the effect of independent variables on the agreements. RESULTS: In total 274 participants (mean age 47.8 [SD = 14.2] years; 47.08% women) were included in the analysis. No significant differences were observed between the linked and unlinked patients in terms of baseline characteristics. Total agreements values were 63.9% (κ = 0.03; PABAK = 0.28) for outpatient contacts, 69.3% (κ = 0.25; PABAK = 0.39) for medication use, 81.0% (κ = 0.56; PABAK = 0.62) for inpatient days and 86.1% (κ = 0.67; PABAK = 0.72) for day-care services. There was varied quantitative agreement between data sources, with the poorest agreement for outpatient care (ICC [95% CI] = 0.22 [0.10-0.33]) and the best for psychiatric day-care services (ICC [95% CI] = 0.72 [0.66-0.78]). Marital status and time since first treatment positively affected the chance of agreement on utilization of outpatient services. CONCLUSIONS: Although there were high levels of absolute agreement, the measures of concordance between administrative records and self-reports were generally minimal to moderate. Healthcare investigations should consider using linked or at least different data sources to estimate HCU for specific utilization areas, where unbiased information can be expected. TRIAL REGISTRATION: This study was part of the multi-center controlled PsychCare trial (German Clinical Trials Register No. DRKS00022535; Date of registration: 2020-10-02).

[Evidence-based inpatient psychotherapy of bipolar disorders]. / Evidenzbasierte stationäre Psychotherapie bipolarer Störungen.

BACKGROUND: Although psychotherapy is an important pillar in the treatment of bipolar disorders, alongside pharmacotherapy, non-drug and complementary procedures, there is no up to date evidence synthesis for inpatient psychotherapeutic treatment and work with caregivers. OBJECTIVE: To review and evaluate the current study situation on evidence-based inpatient psychotherapy for bipolar disorders. MATERIAL AND METHODS: 1.Summary of the evidence for inpatient psychotherapy in adolescents and adults with bipolar disorders from current review articles and guidelines (German S3 guidelines, Australian, Canadian, and British NICE guidelines). 2. Systematic literature search (PRISMA) in Cochrane trials and Medline (via PubMed). 2a. Identification of original articles using the following search term: "bipolar fft" OR "bipolar ipsrt" OR "bipolar cbt" OR "bipolar cognitive remediation" OR "bipolar psychotherapy inpatient". 2b. Screening of n = 942 publications on the following inclusion criteria: randomized controlled efficacy trials, inpatient treatment/recruitment in the inpatient setting, adolescent or adult patients with bipolar disorder or caregivers. RESULTS: The guidelines recommend a combination of pharmacotherapy and psychotherapy for the treatment of patients with bipolar disorders (so far no evidence-based presentation of inpatient psychotherapy). The results from reviews and original papers are heterogeneous. Recently described evidence-based psychotherapeutic approaches for inpatient treatment are family focused therapy (FFT), interpersonal and social rhythm therapy (IPSRT) and psychoeducation. CONCLUSION: Although the current evidence is heterogeneous and further systematic studies are necessary, the results indicate that psychotherapy should be started or initiated in the inpatient setting with inclusion of caregivers.

[Challenges and current approaches in the development of psychiatric living guidelines in Germany]. / Herausforderungen und aktuelle Ansätze der Entwicklung psychiatrischer Living Guidelines in Deutschland.

Outdated guidelines can cause inadequate care. To counter this problem a dynamic updating process for guidelines is being internationally discussed (living guidelines). This process has specific challenges. The rhythm of updating has to be determined and a priori criteria have to be defined, which indicate that a substantial change of the medical practice is needed in order to then update individual recommendations. Digital tools have to be identified that can support a dynamic updating. Their (further) development has to be oriented to the specific requirements and needs of the trialogically composed guideline development teams. Recommendations have to be examined from the user perspective. The current guideline development methods that are still divergent, have to be harmonized and specific needs with respect to the cross-linking of guidelines have to be taken into account. The German Association for Psychiatry, Psychotherapy and Psychosomatics (DGPPN) supports and accompanies scientific projects dealing with the challenges of the dynamics of guideline development. From the first results of "Guide2Guide", a project funded by the Innovation Fund, it can be summarized that the development of living guidelines is a complex dynamic process that has only just started internationally and in Germany. It demands a special engagement of the guideline developers including representatives of patients and relatives, to responsibly work long term and flexibly. Digital tools can be useful in various process steps but at present they still have to be meaningfully linked into the process. Central elements of the development of S3 guidelines will continue to require substantial working time of the experts in the trialogue. In order for living guidelines to be actually used dissemination and implementation have to be integrated into the dynamic process.

[Concepts to support dynamic updating processes of guidelines and their practical implementation-Systematic literature review]. / Konzepte zur Unterstützung dynamischer Aktualisierungsprozesse von Leitlinien und ihre Implementierung in der Praxis ­ systematische Literaturrecherche.

BACKGROUND: Clinical practice guidelines (CPG), which are crucial for evidence-based healthcare, should be kept up to date, especially on topics where emerging evidence could modify one of the recommendations with implications for the healthcare service; however, an updating process, which is practicable for guideline developers as well as users represents a challenge. OBJECTIVE: This article provides an overview of the currently discussed methodological approaches for the dynamic updating of guidelines and systematic reviews. MATERIAL AND METHODS: As part of a scoping review, a literature search was conducted in the databases MEDLINE, EMBASE (via Ovid), Scopus, Epistemonikos, medRxiv, as well as in study and guideline registers. Concepts on the dynamic updating of guidelines and systematic reviews or dynamically updated guidelines and systematic reviews or their protocols published in English or German were included. RESULTS: The publications included most frequently described the following main processes that must be adapted in dynamic updating processes 1) the establishment of continuously working guideline groups, 2) networking between guidelines, 3) the formulation and application of prioritization criteria, 4) the adaptation of the systematic literature search and 5) the use of software tools for increased efficiency and digitalization of the guidelines. CONCLUSION: The transformation to living guidelines requires a change in the needs for temporal, personnel and structural resources. The digitalization of guidelines and the use of software to increase efficiency are necessary instruments, but alone do not guarantee the realization of living guidelines. A process in which dissemination and implementation must also be integrated is necessary. Standardized best practice recommendations on the updating process are still lacking.

[Expectations of guideline developers on living guidelines]. / Erwartungen der Leitlinienentwickler*innen an "living guidelines".

BACKGROUND: Guidelines are central pillars of high-quality care and care planning. The quality requirements for the development of guidelines and the associated effort are very high. Therefore, more efficient approaches are being forced. OBJECTIVE: The opportunities and challenges in the introduction of a dynamic updating concept within the framework of the digitalization of guidelines were explored from the perspective of guideline developers in the field of psychiatry. This perspective should be included in the implementation. MATERIAL AND METHODS: Between January and May 2022 a cross-sectional survey was conducted among guideline developers (N = 561, response 39%) based on a questionnaire developed and tested in advance. Data were analyzed descriptively. RESULTS: A total of 60% were familiar with the concept of living guidelines. A large proportion endorsed a dynamic updating (83%) and digitalization (88%) of guidelines; however, various challenges are associated with the concept of living guidelines: the risk of inflationary changes (34%), the need for continuity of all actors (53%), involvement of patient and family representatives (37%) and definition of criteria regarding the decision what to change (38%). The vast majority (85%) thought it necessary that guideline development should be followed by implementation projects. CONCLUSION: German guideline developers are very receptive regarding the implementation of living guidelines; however, they named numerous challenges, which need to be addressed in this approach.

[Flexible and integrative treatment in psychiatry: implementation of specific care components at model and standard care clinics in Germany (PsychCare study)]. / Settingübergreifende Behandlung in der Psychiatrie: Umsetzung spezifischer Versorgungsmerkmale an Kliniken der Modell- und Regelversorgung (PsychCare-Studie).

BACKGROUND: Since 2003 a new remuneration and care model has been implemented in currently 22 psychiatric clinics in Germany, which provides flexible and integrative treatment (FIT) across different settings of treatment, including assertive outreach care. The FIT is based on a global treatment budget covering costs for all psychiatric hospital services and is related to the number of patients treated per year. Previous research identified 11 program components that describe treatment structures and processes of FIT. The present analysis quantitatively compared FIT with standard care, aiming to validate these components. METHODS: As part of the PsychCare study, grading according to FIT-specific components was carried out and comparatively analyzed in nine hospitals that used FIT and seven hospitals of standard care. The FIT models were examined in depth in subgroups, which were divided according to the share of the FIT model in the total hospital budget. RESULTS: Of the 11 FIT program components 7 (flexible care management across settings, therapeutic group sessions across all settings, outreach home care, involvement of informal caregivers, accessibility of services, cooperation across sectors and expansion of professional expertise) showed a high statistical differentiation. These differences were even stronger in the subgroup of those hospitals that had a model contract with all health insurers. CONCLUSION: Specific components of FIT are suitable for evaluating the quality of implementation of intersectoral, flexible and outreach psychiatric care.

Social contacts, friends and satisfaction with friendships in patients with psychotic, mood and neurotic disorders 1 year after hospitalisation: data from five European countries.

BACKGROUND: People with severe mental illness often struggle with social relationships, but differences among diagnostic groups are unclear. We assessed and compared objective and subjective social relationship indicators among patients with psychotic, mood and neurotic disorders one year after hospitalisation in five European countries (Belgium, Germany, Italy, Poland and United Kingdom). METHODS: The number of social contacts, including family members and friends during the previous week (Social Network Schedule), and satisfaction with the number and quality of friendships (Manchester Short Assessment of Quality of Life Quality) were assessed by face-to-face interview. Linear regression models were used to analyse associations with diagnostic groups. RESULTS: Participants (n = 2155) reported on average 2.79 ± 2.37 social contacts overall in the previous week, among whom, a mean of 1.65 ± 1.83 (59.2 ± 38.7%) were friends. Satisfaction with friendships was moderate (mean 4.62, SD 1.77). In the univariable model, patients with psychotic disorders reported having less social contact with friends than those with either mood (p < 0.05) or neurotic disorders (p < 0.001), but this difference disappeared when adjusting for socioeconomic and clinical variables (ß = - 0.106, 95% CI - 0.273 to 0.061, p = 0.215). Satisfaction with friendships was similar across diagnostic groups in both univariable (ß = - 0.066, 95% CI - 0.222 to 0.090, p = 0.408) and multivariable models (ß = 0.067, 95% CI - 0.096 to 0.229, p = 0.421). The two indicators showed a weak correlation in the total sample (total social contacts, rs = 0.266; p < 0.001; friends, rs = 0.326, p < 0.001). CONCLUSION: While objective and subjective social relationship indicators appear to be weakly correlated concepts, there is no variation in either indicator across diagnostic groups when confounders are taken into account among patients with severe mental illness. Interventions specifically targeting social relationships are needed, but they do not necessitate diagnosis-specific adaptations.

Evaluation of a flexible and integrative psychiatric care model in a department of child and adolescent psychiatry in Tübingen, Germany: study protocol (EVA_TIBAS).

BACKGROUND: Model projects for flexible and integrated treatment (FIT) in Germany aim at advancing the quality of care for people with mental disorders. A new FIT model project was established in 2017 at the Department of child and adolescent psychiatry (KJP) of the University Hospital Tübingen (Universitätsklinikum Tübingen, UKT). The study design of EVA_TIBAS presented here describes the evaluation of the FIT model project at the KJP of the UKT. This evaluation aims at quantifying the anticipated FIT model project changes, which are to improve patients' cross-sectoral care at the same maximum cost as standard care. METHODS: EVA_TIBAS is a controlled cohort study using a mix of quantitative and qualitative methods. The FIT evaluation consists of three modules. In Module A, anonymized claims data of a statutory health insurance fund will be used to compare outcomes (duration of inpatient and day care psychiatric treatment, inpatient and day care psychiatric length of stay, outpatient psychiatric treatment in hospital, inpatient hospital readmission, emergency admission rate, direct medical costs) of patients treated in the model hospital with patients treated in structurally comparable control hospitals (estimated sample size = ca. 600 patients). In Module B, patient-reported outcomes (health related quality of life, symptom burden, return to psychosocial relationships (e.g. school, friends, hobbies), treatment satisfaction, societal costs) will be assessed quantitatively using validated questionnaires for the model and two control hospitals (estimated sample size = ca. 300 patients). A subsequent health economic evaluation will be based on cost-effectiveness analyses from both the insurance fund's and the societal perspective. In Module C, about 30 semi-structured interviews will examine the quality of offer, effects and benefits of the service offered by the social service of the AOK Baden-Württemberg (for stabilizing the overall situation of care in the family) in the model hospital. A focus group discussion will address the quality of cooperation between employees of the university hospital and the social services. DISCUSSION: The results of this evaluation will be used to inform policy makers whether this FIT model project or aspects of it should be implemented into standard care. TRIAL REGISTRATION: This study was registered at ClinicalTrials.gov PRS (ID: NCT04727359 , date: 27 January 2021).

Melatonin suppression by melanopsin-weighted light in patients with bipolar I disorder compared to healthy controls

Background: Multiple lines of evidence suggest that the onset and course of bipolar disorder is influenced by environmental light conditions. Increased suppression of melatonin by light (supersensitivity) in patients with bipolar disorder has been postulated as an endophenotype by several studies. However, due to methodological shortcomings, the results of these studies remain inconclusive. This study investigated melatonin suppression in euthymic patients with bipolar I disorder using evening blue light specifically targeting the melanopsin system. Methods: Melatonin suppression was assessed in euthymic patients with bipolar I disorder and healthy controls by exposure to monochromatic blue light (λmax = 475 nm; photon density = 1.6 × 1013 photons/cm2/s) for 30 minutes at 2300 h, administered via a ganzfeld dome for highly uniform light exposure. Serum melatonin concentrations were determined from serial blood sampling via radioimmunoassay. All participants received mydriatic eye drops and were genotyped for the PER3 VNTR polymorphism to avoid or adjust for potential confounding. As secondary outcomes, serum melatonin concentrations during dark conditions and after monochromatic red light exposure (λmax = 624 nm; photon density = 1.6 × 1013 photons/cm2/s) were also investigated. Changes in subjective alertness were investigated for all 3 lighting conditions. Results: A total of 90 participants (57 controls, 33 bipolar I disorder) completed the study. Melatonin suppression by monochromatic blue light did not differ between groups (F1,80 = 0.56; p = 0.46). Moreover, there were no differences in melatonin suppression by monochromatic red light (F1,82 = 1.80; p = 0.18) or differences in melatonin concentrations during dark conditions (F1,74 = 1.16; p = 0.29). Healthy controls displayed a stronger increase in subjective alertness during exposure to blue light than patients with bipolar I disorder (t85 = 2.28; p = 0.027). Limitations: Large interindividual differences in melatonin kinetics may have masked a true difference. Conclusion: Despite using a large cohort and highly controlled laboratory conditions, we found no differences in melatonin suppression between euthymic patients with bipolar I disorder and healthy controls. These findings do not support the notion that supersensitivity is a valid endophenotype in bipolar I disorder.

Personal continuity versus specialisation of care approaches in mental healthcare: experiences of patients and clinicians-results of the qualitative study in five European countries.

BACKGROUND: The current debate on organisation of the mental health care raises a question whether to prioritise specialisation of clinical teams or personal continuity of care. The article explores the experiences of patients and clinicians regarding specialisation (SC) and personal continuity (PCC) of care in five European countries. METHODS: Data were obtained via in-depth, semi-structured interviews with patients (N = 188) suffering from mental disorders (F20-49) and with clinicians (N = 63). A maximum variation sampling was applied to assume representation of patients and of clinicians with different characteristics. The qualitative data from each country were transcribed verbatim, coded and analysed through a thematic analysis method. RESULTS: Many positive experiences of patients and clinicians with the PCC approach relate to the high quality of therapeutic relationship and the smooth transition between hospital and community care. Many positive experiences of patients and clinicians with the SC approach relate to concepts of autonomy and choice and the higher adequacy of diagnosis and treatment. Clinicians stressed system aspects of providing mental health care: more effective management structure and higher professionalization of care within SC approach and the lower risk of disengagement from treatment and reduced need for coercion, restraint, forced medication or involuntary admission within PCC. CONCLUSIONS: Neither the PCC, nor the SC approach meets the needs and expectations of all patients (and clinicians). Therefore, future reforms of mental health services should offer a free choice of either approach, considering that there is no evidence of differences in patient outcomes between PCC and SC approaches.

[How Successful is the Participation of People with Mental Illness and Family Members in the Development of Evidence- and Consensus-Based Clinical Practice Guidelines? Results of a Survey in Psychiatry]. / Wie gelingt die Einbindung von Betroffenen- und Angehörigenvertreter:innen in die Entwicklung von evidenz- und konsensbasierten Behandlungsleitlinien? Ergebnisse einer Umfrage im Fachbereich Psychiatrie.

OBJECTIVE: The study examines how successful the participation of people with mental illness and family members is currently in the development of psychiatric guidelines. METHODS: Survey results of N=561 (Response 37%) guideline developers are analyzed. RESULTS: Involvement of affected individuals succeeds more often than that of family members (61% vs. 55%). 68% felt that this participation was central to successful guideline development. 51% perceived discrepancies between empirical evidence and experience perspective. 33-36% perceived a lack of appreciation of experience expertise, 37% an insufficient representation and 46% an inequality in consensus building. 45% did not see barriers effectively removed. CONCLUSION: There remain challenges in the participation of people with mental illness and family members. There is an increasing awareness that their participation is central.

Health-related quality of life among patients with treated alcohol use disorders, schizophreniform disorders or affective disorders and the influence of flexible and integrative psychiatric care models in Germany (PsychCare).

Introduction: Flexible and integrated treatment options (FIT) have been established in German psychiatric hospitals to enhance continuous and patient-centered treatment for patients with mental disorders. We hypothesized that patients with experience in FIT treatment showed higher health-related quality of life (HRQoL) and comparable symptom severity compared with patients treated as usual (TAU). Further, we expected that some sub-dimensions of HRQoL determined HRQoL results clearer than others, while certain factors influenced HRQoL and symptom severity stronger in the FIT compared to the TAU group. In addition, we hypothesized that HRQoL is correlated with symptom severity. Methods: We undertook a controlled, prospective, multicenter cohort study (PsychCare) conducted in 18 psychiatric hospitals in Germany, using the questionnaires Quality of Well Being Self-Administered (QWB-SA) (HRQoL) and Symptom-Checklist-K-9 (SCL-K-9) (symptom severity) at recruitment (measurement I) and 15 months later (measurement II). We assessed overall HRQoL (measured in health utility weights (HUW) and symptom severity score for patients from FIT and TAU treatment. We investigated the QWB-SA dimensions and separated the results by diagnosis. We used beta regressions to estimate the effect of multiple co-variates on both outcomes. To investigate the correlation between HRQoL and symptom severity, we used Pearson correlation. Results: During measurement I, 1,150 patients were recruited; while 359 patients participated during measurement II. FIT patients reported higher HUWs at measurement I compared to TAU patients (0.530 vs. 0.481, p = 0.003) and comparable HUWs at measurement II (0.581 vs. 0.586, p = 0.584). Symptom severity was comparable between both groups (I: 21.4 vs. 21.1, p = 0.936; II: 18.8 vs. 19.8, p = 0.122). We found lowest HRQoL and highest symptom severity in participants with affective disorders. HRQoL increased and symptom severity decreased over time in both groups. The QWB-SA dimension acute and chronic symptoms was associated with highest detriments in HRQoL. We identified risk/protective factors that were associated with lower quality of life and higher symptom severity in both groups. We confirmed that HRQoL was negatively associated with symptom severity. Discussion: Health-related quality of life (during hospital treatment) was higher among patients treated in FIT hospitals compared to patients in routine care, while symptom severity was comparable between both groups.

Experiencing (Shared) Decision Making: Results from a Qualitative Study of People with Mental Illness and Their Family Members.

(1) Background: There is a fundamental shift in healthcare toward shared decision making (SDM). This study explores SDM from the perspective of individuals affected by mental illness and their family members and investigates factors which promote and hinder the process. (2) Methods: We conducted N = 15 telephone interviews (n = 4 adults affected by mental illness, n = 5 family members, n = 6 both applicable, the majority reporting experiences with affective and anxiety disorders). Data were recorded, transcribed, and analyzed according to procedures established by Mayring. (3) Results: Individuals affected by mental illness and their family members have a strong desire to be involved in treatment decisions and to participate in finding a diagnosis. Often these stakeholders are denied the opportunity to participate; sometimes enabling behaviors impede participation. The stigmatization of mental illnesses is a major barrier. There are also structural barriers to SDM within the healthcare system. Peer support, self-help associations, and psychosocial counseling services are important to empowering individuals and promoting SDM. (4) Conclusions: SDM has the potential to improve the quality of mental healthcare. Barriers can be mitigated and new approaches for interventions in the psychiatric sector have been identified. This study has also shown the importance of understanding SDM as a process that should begin at the diagnostic phase.

[Implementing a Global Treatment Budget for Psychiatric Hospital Services - What are Incentives, Requirements, and Challenges?] / Implementierung eines globalen Behandlungsbudgets in der Psychiatrie ­ Welche Anreize, Voraussetzungen und Herausforderungen gibt es?

OBJECTIVE: Since 2013, flexible and integrative psychiatric treatment models (FIT64b) have been set up in 22 German hospitals. FIT64b is based on a global treatment budget (GTB) covering costs for all psychiatric hospital services and is related to the number of patients treated. As part of the "PsychCare"-study we are examining incentives, requirements and challenges which relate to the introduction of FIT64b. METHODS: Expert interviews and focus groups (n = 29) were led with management and controlling staff from 7 FIT64b adopting hospitals and 3 statutory health insurance funds (SHI). A thematic analysis was conducted. RESULTS: A central component for the introduction of a GTB is a cooperative relation based on mutual trust between hospitals and SHI. Challenging are, above all, performance documentation and performance control of cross-sectoral treatment as well as the parallel structure of FIT64b and standard care. CONCLUSION: Apart from several surmountable obstacles to implementation, the GTB seems to be a strong driver for the future-oriented transformation of psychiatric hospital services in Germany. In the further development of GTB, the obligation to contract with all SHI should be considered.

Demands on Health Information and Clinical Practice Guidelines for Patients from the Perspective of Adults with Mental Illness and Family Members: A Qualitative Study with In-Depth Interviews.

(1) Background: "Patient health information" promote health literacy. "Patient guidelines" as a sub group reflect the current evidence about illnesses and treatment options adapted to the needs of laypersons. Little is known about factors promoting and hindering their use by people affected by mental illness and their relatives. (2) Methods: Telephone interviews (N = 15; n = 4 adults affected by mental illness, n = 5 relatives, n = 6 both applicable) were conducted according to the Sørensen model of health literacy. Data were recorded, transcribed and content-analyzed following Mayring. (3) Results: Health information is used regularly by individuals affected by mental illness and their relatives, but "patient guidelines" are largely unknown. Yet, there is a great willingness to use them. Main barriers are a lack of statistical knowledge, the complexity of health-related topics and cognitive impairment sometimes accompanying mental illnesses. Target group-oriented adaptation as well as transparent and even-handed presentation of (dis-)advantages of treatment options can increase trust. (4) Conclusions: Health information and guidelines can help affected persons and relatives to make treatment decisions by conveying unbiased, up-to-date knowledge. Target group-specific adaptations should be made for psychiatric illnesses and features specific to mental illnesses compared to physical illnesses should be included. Clinical practice guidelines must be distributed more widely to increase their impact.

Needs and Experiences in Psychiatric Treatment (NEPT)- Piloting a Collaboratively Generated, Initial Research Tool to Evaluate Cross-Sectoral Mental Health Services.

BACKGROUND: Research tools to evaluate institutions or interventions in the field of mental health have rarely been constructed by researchers with personal experience of using the mental health system ("experiential expertise"). This paper presents a preliminary tool that has been developed within a participatory-collaborative process evaluation as part of a controlled, multi-center, prospective cohort study (PsychCare) to evaluate psychiatric flexible and integrative treatment, FIT for short, models in Germany. METHOD: The collaborative research team consisting of researchers with and without experiential expertise developed 12 experiential program components of FIT models by an iterative research process based on the Grounded Theory Methodology. These components were transformed into a preliminary research tool that was evaluated by a participatory expert panel, and during a pilot and validation study, the latter using a random sample of 327 users from 14 mental health departments. Internal consistency of the tool was tested using Cronbach's alpha. Construct validity was evaluated using a Principal Components Analysis (PCA) and a Jonckheere Terpstra test in relation to different implementation levels of the FIT model. Concurrent validity was tested against a German version of the Client Satisfaction Questionnaire (ZUF-8) using correlation analysis and a linear regression model. RESULTS: The evaluation of the expert panel reduced 29 initial items to 16 that were further reduced to 11 items during the pilot study, resulting into a research tool (Needs and Experiences in Psychiatric Treatment-NEPT) that demonstrated good internal consistency (Cronbach's alpha of 0.89). PCA yielded a 1-component structure, which accounted for 49% of the total variance supporting the unidimensional structure of the tool. The total NEPT score increased alongside the increasing implementation of the FIT model (p < 0.05). There was evidence (p < 0.001) for convergent validity assessed against the ZUF-8 as criterion measure. CONCLUSIONS: The NEPT tool seems to be promising for further development to assess the experiences with and fulfillment of needs of psychiatric care models from the perspective of users. This paper demonstrates that it is possible to use a participatory-collaborative approach within the methodologically rigorous confines of a prospective, controlled research design.

Supersensitivity of Patients With Bipolar I Disorder to Light-Induced Phase Delay by Narrow Bandwidth Blue Light.

Background: Bipolar disorder is a severe chronic mental disorder. There is a bidirectional relationship between disease course and circadian phase. Significant circadian phase shifts occur during transitions between episodes, but episodes can also be elicited during euthymia by forced rapid changes in circadian phase. Although an instability of circadian phase has been described in multiple observational reports, no studies quantifying the propensity to phase shift following an experimental standardized stimulus have been published. This study therefore aimed to assess whether patients with bipolar I disorder (BDI) are more prone to phase delay following blue light exposure in the evening than healthy control subjects. Methods: Euthymic participants with BDI confirmed by Structured Clinical Interview for DSM-IV Axis I (n = 32) and healthy control subjects (n = 55) underwent a 3-day phase shift protocol involving exposure to a standardized dose of homogeneous, constant, narrow bandwidth blue light (478 nm, half bandwidth = 18 nm, photon flux = 1.29 × 1015 photons/cm2/s) for 2 hours at 9:00 pm via a ganzfeld dome on day 2. On days 1 and 3, serial serum melatonin assessments during total darkness were performed to determine the dim light melatonin onset. Results: Significant differences in the light-induced phase shift between BDI and healthy control subjects were detected (F 1,82 = 4.110; p = .046), with patients with bipolar disorder exhibiting an enhanced phase delay (η2 = 0.49). There were no significant associations between the magnitude of the phase shift and clinical parameters. Conclusions: Supersensitivity of patients with BDI to light-induced phase delay may contribute to the observed phase instability and vulnerability to forced phase shifts associated with the disorder.

Multiperspective and Multimethod Evaluation of Flexible and Integrative Psychiatric Care Models in Germany: Study Protocol of a Prospective, Controlled Multicenter Observational Study (PsychCare).

Background: New cross-sectoral mental health care models have been initiated in Germany to overcome the fragmentation of the German health care system. Starting in 2013, flexible and integrative psychiatric care model projects according to §64b SGB V German Social Law (FIT64b) have been implemented. The study "PsychCare" combines quantitative and qualitative primary data with routine health insurance data for the evaluation of these models. Effects, costs and cost-effectiveness from the perspectives of patients, relatives and care providers are compared with standard care. Additionally, quality indicators for a modern, flexible and integrated care are developed. This article describes the rationale, design and methods of the project. Methods: "PsychCare" is built on a multiperspective and multimethod design. A controlled prospective multicenter cohort study is conducted with three data collection points (baseline assessment, follow-up after 9 and 15 months). A total of 18 hospitals (10 FIT64b model and 8 matched control hospitals) have consecutively recruited in- and outpatients with pre-specified common and/or severe psychiatric disorders. Primary endpoints are differences in change of health-related quality of life and treatment satisfaction. Sociodemographic and service receipt data of the primary data collection are linked with routine health insurance data. A cost-effectiveness analysis, a mixed method, participatory process evaluation by means of qualitative surveys and the development of quality indicators are further elements of "PsychCare." Discussion and Practical Implications: The results based on data from different methodological approaches will provide essential conclusions for the improvement of hospital based mental health care in Germany. This should result in the identification of key FIT64b elements that can be efficiently implemented into standard care in Germany and re-structure the care strongly aligned to patient needs. Clinical Trial Registration: German Clinical Trial Register, identifier DRKS 00022535.

Flexible and Integrative Psychiatric Care Based on a Global Treatment Budget: Comparing the Implementation in Germany and Poland.

Background: The past decade has witnessed the establishment of flexible and integrative treatment (FIT) models in 55 German and Polish psychiatric catchment areas. FIT is based on a global treatment budget (GTB), which integrates funding of all acute psychiatric hospital services for a regional population. Prior research has identified 11 specific program components of FIT in Germany. In this paper we aim at assessing the applicability of these components to the Polish context and at comparatively analysing FIT implementation in Poland and Germany. Methods: Qualitative interviews about the applicability of the 11 FIT-specific components were conducted with the program managers of the Polish FIT models (n = 19). Semi-quantitative data on the FIT-specific components were then collected in 19 Polish and 10 German FIT models. We assessed the grading of each component, their overall degree of implementation and compared them between the two countries. In all study hospitals, structural and statistical parameters of service delivery were collected and compared. Results: The qualitative results showed that the German FIT-specific components are in principle applicable to the polish context. This allowed the comparative assessment of components grading and degree of implementation, which showed only subtle discrepancies between German and Polish FIT models. The little discrepancies point to specific aspects of care such as home treatment, peer support, and cooperation with non-clinical and social welfare institutions that should be further integrated in the components' definition. Conclusions: The specific program components of FIT as first defined from the German experience, serves as a powerful tool to measure, and evaluate implementation of integrated psychiatric care both within and between health systems.

Association of pro-inflammatory cytokines with clinical features in euthymic patients with Bipolar-I-Disorder.

BACKGROUND: A chronic low-grade inflammatory state appears to be a relevant mechanism in the pathophysiology of bipolar disorder. Pro-inflammatory cytokines may influence disease course and individual symptomatology; and biological markers correlating with illness features may be of utility in clinical decision making during euthymia. METHODS: 51 euthymic outpatients with Bipolar-I-Disorder (BD-I) and 93 healthy controls (HC) were investigated. Comparisons between groups, and correlations with clinical features were performed. Serum concentrations of interleukin-1ß (IL-1ß), tumor necrosis factor-α (TNF-α), and soluble interleukin-6 receptor (sIL-6R) were evaluated by ELISA under highly standardized conditions. Clinical features included duration of illness, number of previous suicide attempts and mood episodes (manic, hypomanic, depressive), scores of the Young Mania Rating Scale (YMRS), the Inventory of Depressive Symptoms (IDS-30), the Pittsburg Sleep Quality Index (PSQI), and the Global Assessment of Functioning (GAF). RESULTS: No significant difference in serum concentrations of IL-1ß, TNF-α, and sIL-6R between BD-I euthymic patients and HC could be identified. Among euthymic BD-I patients, a positive correlation of rs = 0.47 (p = 0.004) between levels of IL-1ß and IDS-30 score was identified. LIMITATIONS: The design was cross-sectional, most patients were receiving medication, only 3 cytokines were assessed, only euthymic BD-I patients were evaluated. CONCLUSIONS: The findings suggest that elevated pro-inflammatory cytokine concentrations are likely state rather than trait markers of BD-I. It also seems unlikely that cytokine concentrations are clinically informative interepisode. An inflammatory component might possibly be involved in the pathophysiology of subsyndromic depression in BD-I, and conceivably of bipolar depression per se.