Diagnostic delay stages and pre-diagnostic treatment in patients with suspected rheumatic diseases before special care consultation: results of a multicenter-based study.

Early and effective discrimination (triage) of patients with inflammatory rheumatic diseases (IRD) and other diseases (non-IRD) is essential for successful treatment and preventing damage. The aim of this study was to investigate diagnostic delays and pre-diagnosis treatment in patients newly presenting to rheumatology outpatient clinics. A total of 600 patients newly presenting to one university hospital and two non-academic centers were included. Time from onset of symptoms to rheumatology consultation "total delay" as well as medical treatment before consultation were recorded. Median time from symptom onset to rheumatologist appointment (total delay) was 30 weeks. Median time to online search, first physician appointment request and first physician appointment was 2, 4 and 5 weeks, respectively. Total delay was significantly shorter for IRD patients compared to non-IRD patients, 26 vs 35 weeks (p = 0.007). Only 17.7% of all patients and 22.9% of IRD patients had a delay of less than 12 weeks. Total delay was significantly lower in patients seen in non-academic centers compared to the university center, 20 vs 50 weeks (p < 0.0001). 32.2% of IRD patients received medical treatment that eased their symptoms prior to the rheumatology appointment. These findings highlight the persistent diagnostic delays in rheumatology; however, they also suggest that current triage strategies effectively lead to earlier appointments for IRD patients. Improvement of triage methods and pre-diagnosis treatment could decrease overall burden of disease in IRD patients.

[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.

[Implementation of New Flexible and Integrative Psychiatric Care Models (According to §64b SGB V) in Rural Northern Germany in Comparison to Federal Territory]. / Analyse von Implementierungsmerkmalen psychiatrischer Modellvorhaben (nach §64b SGB V) in Schleswig-Holstein im Vergleich zum Bundesgebiet.

AIM: New treatment models (according to §64b German Social Code) have been introduced in Germany to improve flexible and integrated forms of psychiatric care. The aim of this study was to analyse the specific conditions under which many of these models have been implemented in the federal state of Schleswig-Holstein (SH) in comparison to other federal regions. METHODS: A standardized survey reached 383 patients in seven psychiatric departments, among them three departments in SH. In addition, routine data and data evaluating the grade of implementation in these departments were analysed. RESULTS: Departments in SH showed more developed implementation processes, compared with departments in other regions. Implemented changes were perceived and evaluated as being better by patients in SH. CONCLUSIONS: Implementation processes of flexible and integrated forms of care according to §64b were particularly successful in SH. Extensive political support is discussed as a major reason, among others, for this development.

[Implementation and Stakeholders' Experiences with Home Treatment in Germany's Integrative and Flexible Psychiatric Care Models - A Mixed-Methods Study]. / Implementierungsstand und Erfahrungen der Stakeholder mit der Zuhause-Behandlung in psychiatrischen Modellvorhaben (nach §64b SGB V) ­ Eine Mixed-Methods Untersuchung.

OBJECTIVE: This paper seeks to illustrate current implementation of and the stakeholders' experiences with Home Treatment (=HT) according to §64b of the German Social Code Book V (=SGB V). METHODS: 381 Patients from 8 hospitals were questioned about their experiences and evaluation of HT using a standardized questionnaire (SEPICC-Scale). Further interviews and focus groups with 37 participants (including users, carers and employees) were thematically analysed. In addition, structural and performance data were collected from participating hospitals and HT teams. RESULTS: HT according to §64b SGB V is implemented quite heterogeneously, especially between rural and urban catchment areas. It provides a long-term, cross-sectoral care, which seems to strengthen the integration of patients' everyday life, treatment flexibility and continuity of care. After having experienced HT once, it is generally rated better. CONCLUSION: An important strength of HT (§64b SGB V) is its adaption to the users' needs and to regional distinctions. Implications for the implementation of outreach services on a larger scale in Germany can be drawn.

Hospital length of stay among older people treated with flexible and integrative psychiatric service models in Germany.

OBJECTIVE: Since 2012, a new law (§64b, Book V of the Social Security Code [SGB V]) regulates the implementation of flexible and integrative psychiatric treatment projects (FIT64b) in Germany. FIT64b allows rapid discharge of patients from inpatient to outpatient settings and cost reductions of hospital stays. Several psychiatric centres exclusively provide FIT64b; others provide FIT64b alongside with standard health care. The aim of the study was to assess the average hospital length of stay (AHLS) of older patients with mental illness included in FIT64b projects. METHODS: A secondary data analysis was conducted using administrative data from eight German mental health centres providing FIT64b. The effects of gender, age, type of centre, and main diagnosis on AHLS were calculated for all older patients with age 65 years or older (n = 3495) treated in FIT64b in the year 2016. Data were analysed with descriptive statistics and robust multiway procedures. RESULTS: The AHLS of older people with mental illness was 4.8 (SD = 11.5) days. The AHLS was shorter in centres exclusively providing FIT64b than in centres providing FIT64b alongside with standard health care: 3.2 (SD = 6.4) vs 8.4 (SD = 17.8) days, P = .001. This difference was particularly marked among patients with schizophrenia spectrum disorders, mood disorders, and neurotic, stress-related, and somatoform disorders. CONCLUSIONS: FIT64b relates to very short AHLS even among older people. Centres using FIT64b alongside with standard health care usually provide standard care to most patients, which could lead to lower fidelity in the implementation of FIT64b.

The Underlying Structure of Comorbid Mental Health and Substance Use Disorders in Prison Populations.

BACKGROUND: High rates of mental disorders have been reported for prison populations. Understanding patterns of comorbidity may be essential for the development of adequate treatment interventions. The present study aimed to assess the underlying structure of comorbidity between mental health and substance use disorders in prison populations. METHODS: Current mental disorders were assessed using the Mini-International Neuropsychiatric Interview in a cross-sectional observational study of 427 individuals consecutively committed to prison facilities in Santiago, Chile. Five alternative structural models were tested using confirmatory factor analysis (CFA). Latent class analysis of comorbid mental health and substance use disorders was carried out. RESULTS: CFA indicated the best fit for a bifactor model with a general psychopathology P factor and specific internalizing and externalizing factors. Borderline personality disorder loaded highest on the P factor (0.85). The latent comorbidity structure showed a four-class solution representing one class without relevant comorbidities (48% prevalence) and three classes representing the following comorbidities: (1) externalizing disorders including substance use and antisocial personality disorder (31%), (2) internalizing disorders including anxiety disorders (10%), and (3) all types of disorders co-occurring (11%). Major depression and borderline personality disorder were present across all three latent classes of comorbidity. CONCLUSIONS: Prison mental health services need to serve a highly comorbid population. Specific approaches may be useful for an externalizing and an internalizing spectrum of disorders. An important group of individuals with all types of mental disorders co-occurring may need new approaches in treatment development.

Associations between childhood abuse, mental health problems, and suicide risk among male prison populations in Spain.

BACKGROUND: There are few studies exploring associations between different types of childhood abuse and mental health problems among adult prisoners. AIMS: To explore associations between history of childhood abuse, depression or anxiety, and near-lethal suicide attempts among adult prisoners, and test the hypothesis that post-traumatic stress disorder (PTSD) may be a mediator between childhood abuse and adult disorder among prisoners. METHOD: We enrolled 943 men from three prisons in Spain. Childhood abuse was assessed with the Childhood Trauma Questionnaire at interview and current symptoms were assessed using the 21-item Depression Anxiety and Stress Scale (DASS-21). Self-reported histories of near-lethal suicide attempts were recorded. RESULTS: Overall, 360 (40%) of the men reported at least one type of childhood abuse; 231 (24.5%) described exposure to emotional abuse, 236 (25%) to physical abuse, and 97 (10%) to sexual abuse. Survivors of all types of childhood abuse had over twice the prevalence of severe depression, anxiety, stress disorder, and near-lethal suicide attempts than men who had not been exposed. Survivors of sexual and emotional violence during childhood had more symptoms of PTSD than survivors of physical abuse. Statistically, PTSD had a mediating effect, but it was very small. CONCLUSIONS: Although other studies have shown high rates of childhood abuse histories among prisoners, this is the first to link such a history to near-lethal suicide attempts in this population.

Evaluation of new flexible and integrative psychiatric treatment models in Germany- assessment and preliminary validation of specific program components.

BACKGROUND: Flexible and integrative treatment (FIT) models are rather novel in German mental health care. This study aimed at identifying and evaluating empirically based, practicable, and quantifiable program components that describe the specific treatment structures and processes of German FIT models. METHODS: A multi-step, iterative research process, based on Grounded Theory Methodology (GTM), was used to identify and operationalise components. A complex algorithm and expert-interviews were applied to quantify the relative weight of each component and to develop a sum score. Face and content validity were examined and internal consistency was tested by Cronbach's α coefficient. RESULTS: Ten of eleven FIT components could be operationalised, quantified and united in the total score. All operationalised components showed sufficient face and content validity and eight components had a good reliability. CONCLUSIONS: The components are a first step in the process of operationally defining German FIT models. They considerably overlap with various critical ingredients of international FIT models and may serve as a theoretical basis for constructing fidelity tools and research guides to enable process and outcome evaluation of German FIT models.

Social characteristics of psychological distress in a disadvantaged urban area of Kazakhstan.

The present study aimed to systematically assess the association of socio-economic characteristics and psychological distress in a disadvantaged urban area of a post-Soviet Republic. Psychological distress was assessed in a random sample of 200 persons, aged 18-57, living in a disadvantaged urban area of Kazakhstan using the General Health Questionnaire with 28 items (GHQ-28). Bivariate and multivariate analyses were used to examine the association of social characteristics and psychological distress. Female gender (P < 0.05), living without a partner (P < 0.01), higher age (P < 0.01), unemployment (P < 0.01), and low perceived income (P < 0.05) were associated with psychological distress in multivariate analyses. Non-Kazakh ethnicity (P < 0.05) was linked with psychological distress in bivariate analyses. The educational level was not significantly associated with psychological distress. Women, aged 38-57, living without partner and with low access to financial resources, were at a very high risk of psychological distress. Possibly due to social drift or status inconsistency, higher educational levels were not associated with lower levels of psychological distress in the disadvantaged area.

Montreal Cognitive Assessment (MoCA) as a screening tool for cognitive impairment in early stages of psychosis.

Background: Cognitive alterations have been reported in early stages of psychosis including people with First Episode Psychosis (FEP), Clinical High-Risk Mental State (CHR), and Psychotic-Like Experience (PLE). This study aimed to compare the cognitive function in early stages of psychosis using the Montreal Cognitive Assessment (MoCA), a low-cost and brief assessment tool of cognitive functions. Methods: A total of 154 individuals, including 35 with FEP, 38 CHR, 44 PLE, and 37 healthy controls (HC), were evaluated with the MoCA in Santiago, Chile. We calculated the mean total score of the MoCA and the standard deviation of the mean. Groups were assessed for a trend to lower scores in a pre-determined sequence (HC > PLE > CHR > FEP) using the Jonckheere-Terpstra test (TJT). Results: The mean total MoCA scores were 24.8 ± 3.3 in FEP, 26.4 ± 2.4 in CHR, 26.4 ± 2.3 in PLE, and 27.2 ± 1.8 in HC. The analyses revealed a significant trend (p < 0.05) toward lower MoCA individual domain scores and MoCA total scores in the following order: HC > PLE > CHR > FEP. The mean total scores of all groups were above the cut-off for cognitive impairment (22 points). Conclusions: The MoCA describes lower scores in cognition across early stages of psychosis and may be a useful low-cost assessment instrument in early intervention centers of poorly resourced settings.

[Transition from Child and Adolescent to Adult Psychiatry in a German Metropolitan Region: An Explorative Cross-Sectional Study]. / Transition von der Kinder- und Jugend- hin zur Erwachsenenpsychiatrie in einer deutschen Metropolenregion: Eine explorative Querschnittstudie.

CONCERN: In psychiatry, the transition phase presents a particular challenge. The study aims to investigate gaps in care during the transition to adult psychiatry. METHODOLOGY: After a qualitative preliminary study, 100 patients with previous child and adolescent psychiatric treatment were interviewed in a standardised way about the utilisation behaviour, the need for help and the experience during, before and after the transition phase. The data were analysed descriptively and using interval estimation (probability of coverage). RESULTS: A treatment gap of more than 3 months was documented in 75% of the patients*. The study showed that treatment interruption was experienced as a risk for further crises and that there was often a lack of information on further treatment options. CONCLUSION: The transition from child and adolescent to adult psychiatric treatment is not seamless and requires professional support.

[Experience-based items of quality in psychiatric treatment: A first multivariate construct]. / Erlebensbezogene Qualitätsmerkmale für die psychiatrische Behandlung: Vorstellung eines vorläufigen multivariaten Konstrukts.

In the context of psychiatric care, user-generated measurement instruments may contribute to quality development and assurance. An explorative construct of experience-related quality components was developed in participative-collaborative cooperation that grasps the users' experiences of psychiatric care. After developing the components using a grounded theory methodology, they were quantified, and their interrelations were investigated using a multidimensional scaling method to explore their internal cohesion. The construct makes it possible to separate structural from interpersonal requirements of the quality components. It further indicated which components are more feasible for the home treatment setting, and which ones for an institutional setting. The components and the construct may be perceived as first steps towards the development of user-generated quality indicators; however, further validation steps are necessary.

Psychometric properties of a Russian version of the General Health Questionnaire-28.

BACKGROUND: The 28-item General Health Questionnaire (GHQ-28) is a scaled version of the General Health Questionnaire that has been used internationally to screen for mental disorders in nonpsychiatric populations. There is great need to validate international screening instruments in the Russian language for their use in post-Soviet countries. METHODS: 200 persons were surveyed in a deprived area of Almaty, Kazakhstan using the Russian version of the GHQ-28 and socioeconomic measures (income level, employment situation and education). We calculated the median and the mean GHQ-28 scores for different socioeconomic subgroups. The internal reliability was tested using Cronbach's α coefficient and intersubscale correlations. We conducted an exploratory factor analysis using varimax rotation. RESULTS: The median score of the GHQ-28 was 2 (mean = 3.56; SD = 5.09) for the total sample. Higher age, unemployment and female gender were significantly associated with high mean GHQ-28 scores. Cronbach's α coefficient was 0.92 for the total scale. Exploratory factor analysis revealed four factors explaining 50.07% of the variance. The factor Anxiety/Insomnia accounted for 14.87%, Severe Depression for 13.74%, Social Dysfunction for 13.47% and Somatic Symptoms for 8.81% of the variance. CONCLUSIONS: The test showed good internal consistency. The median GHQ-28 score was relatively low compared to other countries. The subscale Severe Depression including items on suicidal ideation may have a lower acceptance than the other subscales Somatic Symptoms, Anxiety/Insomnia and Social Dysfunction.

Random sampling for a mental health survey in a deprived multi-ethnic area of Berlin.

The aim of the study was to assess the response to random sampling for a mental health survey in a deprived multi-ethnic area of Berlin, Germany, with a large Turkish-speaking population. A random list from the registration office with 1,000 persons stratified by age and gender was retrieved from the population registry and these persons were contacted using a three-stage design including written information, telephone calls and personal contact at home. A female bilingual interviewer contacted persons with Turkish names. Of the persons on the list, 202 were not living in the area, one was deceased, 502 did not respond. Of the 295 responders, 152 explicitly refused(51.5%) to participate. We retained a sample of 143 participants(48.5%) representing the rate of multi-ethnicity in the area (52.1% migrants in the sample vs. 53.5% in the population). Turkish migrants were over-represented(28.9% in the sample vs. 18.6% in the population). Polish migrants (2.1 vs. 5.3% in the population) and persons from the former Yugoslavia (1.4 vs. 4.8% in the population)were under-represented. Bilingual contact procedures can improve the response rates of the most common migrant populations to random sampling if migrants of the same origin gate the contact. High non-contact and non-response rates for migrant and non-migrant populations in deprived urban areas remain a challenge for obtaining representative random samples.

[Biometric properties of QUALIFY: a tool for assessing quality indicators]. / Biometrische Eigenschaften des QUALIFY-Instruments zur Bewertung von Qualitätsindikatoren.

INTRODUCTION: Accurate health care evaluation using quality indicators (QIs) is of vital clinical importance for a quality-oriented health care system. The QUALIFY tool is the current research standard for assessing QIs of health care; however, its biometric properties in psychiatry have not yet been evaluated empirically. Our aim was to evaluate the internal consistency and structure of QUALIFY. METHODS: This study applies a literature-based post-hoc analytical design to a sample of 289 QIs of mental health care. First, the indicators were assessed on the basis of nineteen ordinal QUALIFY criteria as a single measuring tool. Second, using Cronbach's alpha the internal consistency of the measuring tool was evaluated and the structure of QUALIFY using an explorative principal component analysis was tested. RESULTS AND DISCUSSION: The tool showed an acceptable internal consistency (Cronbach's α=0.75), with three criteria (consideration of potential risks/side effects when using the indicator, implementation barriers taken into account, and the ability to influence the indicator) being inconsistent with the full scale. If these three criteria were not taken into account, the tool had a good internal consistency (Cronbach's α=0.81). The QUALIFY structural matrix comprises three components, one of which reflected six from eight original quality criteria of the scientific category. The other two components represent the semiotic structure of the QIs. CONCLUSION: QUALIFY is an internally inconsistent instrument, which may be useful to assess mental health care QIs. The information about the structure of QUALIFY can be applied for the purposes of research planning as well as the interpretation and development of QIs.

Physicians' Perspectives on the Implementation of the Second Opinion Directive in Germany-An Exploratory Sequential Mixed-Methods Study.

A new Second Opinion Directive (SOD) was introduced in Germany in December 2018 for hysterectomy, tonsillotomy, and tonsillectomy to support shared decision making and to avoid unnecessary surgeries. Owing to its recent implementation, evidence and insights regarding outcomes and challenges encountered with the SOD are lacking, notably from the physicians' perspective. To assess this, we undertook an exploratory sequential mixed-methods design with an initial qualitative phase followed by a quantitative evaluation. A qualitative analysis of 22 interviews with specialists in gynecology and otorhinolaryngology was followed by a statistical analysis of a survey of 136 physicians in those disciplines. The specialists expressed a generally positive opinion of the new SOD, emphasizing the aspects of patient orientation, support in decision making, and patient safety. However, they also highlighted the following structural problems regarding the SOD implementation: In addition to an increased organisational effort, the specialists criticised the SOD with regard to its implementation in rural regions with a low availability of specialists for referral. Barriers that impede the implementation of the current directive, such as the adaptation of the qualifying requirements for authorized second opinion physicians, as well as the inclusion of relevant indications, need focused consideration to obtain better alignment with everyday practice.

Mental and Physical Well-Being and Burden in Palliative Care Nursing: A Cross-Setting Mixed-Methods Study.

The working routines in palliative care nursing are associated with a variety of causes of stress with regional and setting-specific differences in Germany. This mixed-methods study aimed to investigate the mental and physical well-being among nurses in German palliative and hospice care and to gain a deeper understanding of procedural and structural aspects that may influence the mental and physical burden in palliative nursing care. The mixed-methods approach combined qualitative interviews, (n = 16) an online survey (n = 101), and subsequent data validation in a focus group (n = 6). Interview and focus group data were analysed using structured qualitative content analysis. Survey data were analysed using descriptive statistics and an explorative quantitative analysis. Moderate to very high levels of stress were reported across all settings, but were highest for nurses in specialized outpatient palliative care settings. Underlying causes of stress related to working conditions in the nursing profession across all palliative care settings were poor working hours, perceived inadequate remuneration, and high demands for documentation. To ensure sustainable high-quality palliative care, adaptations to working conditions that target causes of stress and burden in palliative care nurses are required.

Implementation of open dialogue in Germany: Efforts, challenges, and obstacles.

Purpose: The Open Dialogue (OD) approach has been implemented in different countries worldwide. OD not only depends on therapeutic principles but also requires a distinct set of structural changes that may impede its full implementation. In Germany, OD is currently practiced in different mental health care settings across the country. Yet, full implementation of OD principles is limited due to the extreme structural and financial fragmentation of the German mental health care system. With this as a background, the aim of this study was to investigate the efforts, challenges and obstacles of OD implementation in Germany. Methods: This article presents the German results from the international HOPEnDIALOGUE survey, supplemented with expert interview data. Thirty eight teams currently providing OD took part in the survey. Sixteen expert interviews were carried out with stakeholders from various care settings. Survey data were analyzed descriptively and the qualitative data were evaluated using a thematic analysis approach. Results: While having to adapt to the fragmented German health care system, OD has been mainly implemented from outpatient service providers and stand-alone services. About half of the teams implemented OD under the conditions of cross-sectoral model contracts and, thus, are considerably limited when it comes to OD implementation. Altogether, OD is not implemented to its full extent in each of the institutions surveyed. Similarly, the expert interviews revealed various challenges that mainly relate to the realization of OD's structural principles, whereas the implementation of its therapeutic benefits remains less affected. However, these challenges have managed to lead to great commitment by single teams and a certain level of implementation of OD-related concepts. Conclusion: OD in Germany can currently only be fully implemented under the cross-sectoral care model contract system that is often temporary, thus significantly hindering its continuous development. Any evaluation of OD's effectiveness in Germany thus needs to take into account the fragmented nature of the country's health care system and control for the multiple barriers that impede implementation. Reforms of the German health care system are also urgently needed to create more favorable conditions for the implementation of OD.

Unmet Information Needs of Patients with Rheumatic Diseases: Results of a Cross-Sectional Online Survey Study in Germany.

To effectively self-manage a chronic disease, patients require specific education. In clinical routines, rheumatologists and other healthcare professionals often cannot devote the necessary time to adequately educate their patients. Digital technologies such as mobile applications represent promising tools to overcome this problem. This study aims to identify unmet information needs of patients with rheumatic diseases to inform the conception of a mobile education application. An online national survey was developed together with rheumatic patients and rheumatologists and distributed between June and September 2021 via social media (Instagram, Facebook, Twitter), QR code and email. Self-reported rheumatic patients, rheumatologists, specialized rheumatology nurses (SRN) and self-reported relatives of rheumatic patients were eligible to participate in the survey. Three major topics were addressed: (1) How well do patients feel informed about disease-relevant topics; (2) how important do patients rate different disease-relevant topics; and (3) patient willingness to adopt digital education services. Responses of 254 patients and 53 SRN were analyzed. Most patients were female (91%; n = 231), the median age was 48 years and the most common disease was rheumatoid arthritis (23%; n = 59). Only 24% of patients perceived their disease education level as very good or good compared to an SRN estimate of 42%. The three information topics rated as most important (very/important) were: individual disease (98%), medication (94%) and coping techniques (91%). In total, 89% of patients asserted that they would very likely, likely or rather likely use digital education tools in the future to learn about their condition, and 82% of SRN would very likely, likely or rather likely recommend digital information services to their patients. These findings depict currently unmet patient information needs and a high willingness of patients and SRN to use digital education services. A mobile education application is currently adapted based on these results and will be evaluated in a multicenter study.

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.