[Methodological Standard for the Development of Quality Indicators within Clinical Practice Guidelines - Results of a structured consensus process]. / Methodischer Standard für die Entwicklung von Qualitätsindikatoren im Rahmen von S3-Leitlinien ­ Ergebnisse einer strukturierten Konsensfindung.

BACKGROUND: Recommendations of evidence- and formally consensus-based clinical practice guidelines (CPGs) represent a valuable source of quality indicators (QIs). Nevertheless, a standardized methodological procedure for developing QIs in the context of CPGs does not yet exist in Germany for all CPGs. For this reason, a methodological standard for the guideline-based development of QIs (QI Standard) was developed based on a structured consensus process involving multiple key stakeholders. METHODS: The proposed content of the QI Standard was derived from evidence, drawing upon results of reviews and qualitative studies, and considered German manuals for guideline-based QI development of two guideline programs. A multi-perspective consensus panel, broadly representing key stakeholders from the German healthcare system with expertise in CPGs and/or quality management, was nominated to vote on recommendations for guideline-based development of QIs. The iterative, structured consensus process included a two-stage online survey based on the Delphi method ("preliminary voting") and a moderated final stakeholder conference where all those recommendations were definitely included in the QI Standard that received approval of more than 75 % (consensus criterion) of the consensus panel. RESULTS: Based on the agreed QI Standard, the QI development process starts with a criteria-based selection of "potential" QIs which - in case of adoption - are published in CPGs as "preliminary" QIs and can achieve the status "final" after successful testing. The QI Standard is composed of a total of 30 recommendations, which are allocated to six areas: A) preparatory work steps for the guideline-based recommendation of QIs, B) QI development group and cooperation with the CPG group, C) development of potential QIs, D) critical appraisal of potential QIs, E) formal adoption and publication as well as F) piloting/testing of preliminary QIs and conversion into final QIs. DISCUSSION: Before the QI Standard can be recommended for implementation in future CPGs, it should have been successfully tested in selected German CPG projects. In addition to methodological requirements for the QI development, it must be ensured that guideline groups have adequate resources for the implementation of the QI Standard. CONCLUSION: By using the QI Standard, scientifically sound and healthcare-relevant QIs can be expected.

Dissociative symptoms in patients with schizophrenia: relationships with childhood trauma and psychotic symptoms.

OBJECTIVE: This study sought to examine the stability of dissociative symptoms in patients with schizophrenia spectrum disorders as well as relationships between psychotic symptoms, childhood trauma, and dissociation. METHOD: One hundred forty-five patients with schizophrenia spectrum disorders (72% schizophrenia, 67% men) were examined at admission to inpatient treatment and 3 weeks later using the Positive and Negative Syndrome Scale, the Childhood Trauma Questionnaire, and the Dissociative Experiences Scale. RESULTS: Dissociative symptoms significantly decreased over time (mean, 19.2 vs 14.1; P < .001). The best predictor of dissociative symptoms at admission was the Positive and Negative Syndrome Scale positive subscale (F(inc)(3,64) = 3.66, P = .017), whereas childhood sexual abuse best predicted dissociation when patients were stabilized (F(inc)(10,80) = 2.00, P = .044). CONCLUSION: Dissociative symptoms in patients with schizophrenia spectrum disorders are related to childhood trauma. Dissociation seems to be state dependent in this diagnostic group. Moreover, diagnostic interviews, in addition to the Dissociative Experiences Scale, should be considered to avoid measurement artifacts.

The validity of the German version of the Health of the Nation Outcome Scales (HoNOS-D): a clinician-rating for the differential assessment of the severity of mental disorders.

The Health of the Nation Outcome Scales (HoNOS) is an internationally-established clinician-rating instrument for the differential assessment of the severity of patients with mental disorders. The aim of this study was to examine the validity of the German version of the HoNOS (HoNOS-D). Evaluation of validity, including factor validity, convergent and discriminant validity and sensitivity to change, was conducted on a large, virtually representative, clinical sample of patients with mental disorders in inpatient psychotherapy (Study 1, N = 3169). Additional assessment of criterion-based validity was completed using another clinical sample of patients with mental disorders (Study 2, N = 55). Although factor validity of the HoNOS-D and its total score could not be confirmed as expected, the majority of single items of the HoNOS-D proved to be valid in terms of convergent validity, criterion-based validity and sensitivity to change. Hence, single items, rather than the total score of the HoNOS-D, can be recommended for obtaining a picture of the impairment of patients with mental disorders in the clinical setting.

[Evidence-based treatment of depression: what does the new S3- and national healthcare guideline Unipolar Depression really recommend?]. / Evidenzbasierte Behandlung bei depressiven Erkrankungen--was empfiehlt die neue S3-/Nationale Versorgungsleitlinie "Unipolare Depression" wirklich?

The paper reflects central recommendations and methodological issues of the new German guidelines for the treatment of depression, as discussed in the article New German Guidelines for the Treatment of Depression - The Central Role of Psychotherapy (Schauenburg et al. 2009). Members of the steering group for these guidelines disagree with the authors' description in several points, especially with reference to the efficacy of pharmacotherapy with antidepressants and psychotherapy, as well as the relationship between both strategies of therapy and their combination in diverse phases of treatment (acute/maintenance). Furthermore, we try to clarify some misunderstandings in matters of the guideline's methodology which arose in the paper cited.

[Psychometric analysis of a short form of the "Hamburg Modules for the Assessment of Psychosocial Health" (HEALTH-49)]. / Psychometrische Uberprüfung einer verkürzten Version der "Hamburger Module zur Erfassung allgemeiner Aspekte psychosozialer Gesundheit für die therapeutische Praxis" (HEALTH-49).

OBJECTIVES: The HEALTH questionnaire, which originally consisted of 79 items, aims to assess generic aspects of psychosocial health. METHODS: Based on large clinical and healthy samples (n = 1548 psychotherapy inpatients, n = 5630 primary-care patients), the questionnaire was shortened and psychometrically analyzed. RESULTS: The resulting 49-item questionnaire ("HEALTH-49") comprises six discrete modules with nine scales (somatoform complaints, depressiveness, phobic anxiety, psychological wellbeing, interactional problems, self-efficacy, activity and participation, social support, and social stress). It proves to be well accepted and feasible under routine conditions. Factor analyses confirm the intended dimensional configuration and the relative independence of modules. The scales reveal high reliability. Evidence of their validity and sensitivity to change are demonstrated. CONCLUSIONS: The HEALTH-49 is a self-rating instrument that allows for the comprehensive and economic assessment of generic aspects of psychosocial health. It is highly suitable for use in clinical practice. The questionnaire is available as a free download from http://www.hamburger-module.de/

Development and evaluation of a case group concept for inpatients with mental disorders in Germany: using self-report and expert-rated instruments.

The aim of this study was to evaluate a case-mix system to classify inpatients with mental disorders in Germany by means of self-report and expert-rated instruments. The use of case-mix systems enhances the transparency of performance and cost structure and can thus improve the quality of mental health care. We analysed a consecutive sample of 1677 inpatients with mental disorders from 11 hospitals using regression tree analysis. The model assigns patients to 17 groups, accounting for 17% of the variance for duration of stay. Patients with eating disorders had a longer duration of stay than patients with anxiety disorder, duration of mental illness of less than 3-5 years, lower levels of interpersonal problems and higher occupational position. The results showed that besides diagnosis, variables such as duration of illness and interpersonal problems are important for classifying inpatients with mental disorders. The results of the study should be critically reviewed regarding the empirical results of other studies and the appropriateness of case group concepts for inpatients with mental disorders.

Incentives increased return rates but did not influence partial nonresponse or treatment outcome in a randomized trial.

OBJECTIVE: Our aim was to analyze monetary incentives and shortening the questionnaire as means of increasing response rates in a mailed follow-up survey 1 year after inpatient psychotherapeutic treatment. Additionally, effects on partial nonresponse and the assessment of treatment outcome were examined. STUDY DESIGN AND SETTING: In a 2x2 factorial design, a sample of 3,825 patients was randomized to the two following interventions: (1) receiving a prepaid monetary incentive or none; and (2) getting a short or a long questionnaire. Treatment outcome was measured prospectively by a self-assessment instrument for psychopathology. RESULTS: When using incentives, the response rate significantly increased by 7.3% (95% confidence interval [CI] 2.6-11.9%). Receiving a short questionnaire led to an augmentation of the response rate of 3.7% (95% CI 0.9-8.3%), which was not significant. The corresponding odds ratios were significantly increased for monetary incentives (1.36; 95% CI 1.30-1.88), and when abridging the questionnaire (1.15; 95% CI 1.01-1.31). However, partial nonresponse and treatment outcome were independent of the two factors. CONCLUSION: Incentives and a shorter questionnaire led to higher return rates but did not affect partial nonresponse and self-report of treatment outcome in a randomized postal survey.

A Psychometric evaluation of the German version of the 'Health of the Nation Outcome Scales, HoNOS-D': on the feasibility and reliability of clinician-performed measurements of severity in patients with mental disorders.

BACKGROUND: The assessment of the severity of a mental illness is a central component in the treatment of patients with mental disorders in both the in- and outpatient settings. In Great Britain, the 'Health of the Nation Outcome Scales, HoNOS' were developed to assess the health and social functioning of patients with mental disorders. AIMS: To examine the psychometric properties, especially the feasibility and reliability, of a German version of the HoNOS (HoNOS-D) and to thus provide international data for the comparison of different mental health services. SAMPLING AND METHODS: The HoNOS was translated into German (HoNOS-D) in an extensive and multilayered consensus procedure. The HoNOS-D was then reviewed within the framework of a pilot study on quality assurance measures implemented by the German statutory health insurance institutes in 11 hospitals. Assessments were made of the psychometric qualities of feasibility and reliability using a representative sample of patients with mental and behavioral disorders. RESULTS: An analysis of the feasibility of the HoNOS-D showed a range of missing values between 1.3 and 4.5% for 11 of the 12 items. An item analysis showed that three items of the HoNOS-D are particularly positively skewed. In most instances, the individual items of the rating scale exhibited only slight correlations to each other. With regard to retest reliability, satisfactory intraclass correlations between 0.80 and 0.91 were seen for 9 of the 12 items. CONCLUSIONS: The authors of the original version of the HoNOS [Wing et al.:Br J Psychiatry 1998;172:11-18] primarily emphasized the feasibility of the instrument and the independence of the individual items and dimensions. The analysis of the missing values showed satisfactory results for feasibility. The intercorrelation matrix of the individual items also exhibited only few correlations >0.30. The retest reliability also proves to be satisfactory for the majority of the items. The narrow distribution of some of the items must be critically discussed in comparison to analyses of results in other countries (e.g. Great Britain) and other settings (e.g. inpatient psychiatric hospitals or outpatient psychotherapy).

Childhood trauma and dissociation in female patients with schizophrenia spectrum disorders: an exploratory study.

The few studies that have investigated the relationship between trauma and dissociative symptoms in patients with schizophrenia have not assessed the role of the severity of psychotic symptoms. The current study examined correlations among five domains of childhood trauma and dissociative symptoms in 30 female patients with schizophrenia spectrum disorders, using the Dissociative Experiences Scale and the Childhood Trauma Questionnaire. Psychotic symptoms were measured by the Positive and Negative Syndrome Scale. Consistent with previous studies, high levels of childhood traumatic experiences were found (Childhood Trauma Questionnaire total score M = 48.5, SD = 18.3). Physical neglect and emotional abuse showed significant correlations with dissociative symptoms at admission. When patients were stabilized, about a month after admission, emotional abuse still showed a significant correlation with dissociative symptoms. However, in contrast to previous findings, Dissociative Experiences Scale findings were not stable over time. Our results confirm the relevance of childhood trauma in schizophrenic patients but also demonstrate the need to develop appropriate methodologies for measuring dissociation in this population.

Psychometric properties of the EORTC Quality of Life Questionnaire in inpatient cancer rehabilitation in Germany.

OBJECTIVE: Recent years have shown an increase in the use of questionnaires measuring health-related quality of life to verify the quality of treatment in the field of oncology. An often used cancer-specific questionnaire is the "Quality of Life Core Questionnaire of the European Organization for the Research and Treatment of Cancer" (EORTC QLQ-C30). The purpose of this study is to analyze the psychometric properties of the EORTC QLQ-C30 (version 1) in order to determine the feasibility and appropriateness for its use in inpatient cancer rehabilitation in Germany with heterogeneous diagnoses. METHODS: The questionnaire was administrated to a sample of 972 cancer patients at the beginning of treatment and to 892 patients after treatment. Besides descriptive analysis, the statistical analyses include confirmatory analysis and the multitrait/multimethod approach to test the questionnaire's postulated scale structure (factorial validity) and its reliability (internal consistencies). The analysis also includes a comparison of responsiveness indices (effect size, reliable change index) to test the sensitivity of the instrument. RESULTS: The EORTC QLQ-C30 showed satisfactory levels of reliability and sensitivity, but the postulated scale structure could not be confirmed. The results illustrate that the varimax-rotated solution of a principal component analysis does not confirm the scale structure postulated by the authors. Correspondingly, the selected fit indices within the scope of the confirmatory factor analysis do not show satisfactory results either. SIGNIFICANCE OF RESULTS: We therefore consider version 1 of the EORTC QLQ-C30 to be only limitedly useful for the routine assessment of changes in the quality of life of cancer patients in inpatient rehabilitation in Germany, especially because of the instrument's length and possible redundancies. For this reason, a scoring procedure limited to a subset of items is suggested, revealing satisfactory to good psychometric indices. However, further psychometric tests are necessary, especially with regard to validity and sensitivity.

[Clinic comparisons as an instrument for quality assurance in the treatment of patients with mental disorders: the significance of risk adjustment]. / Klinikvergleiche als Instrument der Qualitäts- sicherung in der Rehabilitation von Patienten mit psychischen/psychosomatischen Störungen: Bedeutung von Risikoadjustierung.

It is becoming increasingly more relevant for health care providers to also participate in external quality assurance measures. A few systematic approaches that also integrate outcome quality and include a comparison of different clinics have only recently been developed for the area of the treatment of patients with mental disorders. In this context, a key issue is the appropriate consideration of confounders, i.e., of unevenly distributed patient characteristics that are causally related to the treatment results. Using a sample of consecutive patients from four psychotherapeutic clinics, we exemplarily examined the significance of the confounders for the comparison of the clinics with regard to short-term outcome. The results show that an adjustment is principally advisable and is generally associated with a reduction of the differences in treatment results. The discussion asserts that the use of regression weights, which were ascertained using an independent, representative sample, allows for a more valid risk adjustment. Finally, reference will be made to the relevance of giving consideration to varying resource usage in the assessment of the risk-adjusted clinic comparisons.