[Associations between Personality Structure, Psychodynamic Conflicts and Defense Styles in Adolescents with Mental Health Problems]. / Die Zusammenhänge von psychischer Struktur, psychodynamischen Konflikten und Abwehrstilen bei Adoleszenten mit psychischen Beschwerden.

OBJECTIVES: An exploration of the interrelationships between central psychodynamic constructs in adolescents with mental health problems was conducted. METHODS: 230 adolescents (Mage=18.0±1.9) were assessed using the Structure and the Conflict Questionnaire of the Operationalized Psychodynamic Diagnosis System in Childhood and Adolescence and the Defense Style Questionnaire for Adolescents. RESULTS: Controlling for the influence of gender, age, and socioeconomic status, low to moderate associations were revealed between increased psychodynamic conflict levels and immature defense styles (r=0.20 to 0.39, p<0.05 to 0.001) as wells as deficits in the personality structure and increased psychodynamic conflict levels (r=0.15 to 0.55, p<0.05 to p<0.001) or immature defense styles (r=0.30 to 0.69, p<0.001). Psychodynamic conflicts as well as defense styles could be predicted by the structural dimensions as well as age and sex (R2=0 .04 to 0.49, p<0.05 to 0.001). CONCLUSIONS: Theory-compliant correlations were demonstrated. The findings are particularly relevant against the background of the revision of the classification of personality functioning (ICD-11) in childhood and adolescence.

Operationalized Psychodynamic Diagnostic of Adolescents in Light of the New ICD-11 Model of Personality Functioning: Personality Structure, Psychodynamic Conflicts, and Mental Health Problems.

The International Classification of Diseases and Related Health Problems, 11th Revision introduced a fully dimensional approach to personality disorders which conceptionally converges with the long-standing psychodynamic understanding of psychopathology through underlying intra- and interpersonal impairments. In this study, the diagnostic contributions of the two psychodynamic concepts of personality structure and psychodynamic conflicts were investigated through the comparison of self-report data of 189 adolescents with mental health problems and 321 mentally healthy controls. The study results reveal that adolescents with mental health problems show significantly higher impairments in all four domains of personality structure and significantly higher levels of several psychodynamic conflicts. Further, adolescents with different mental health problems significantly differ regarding the impairments in the personality structure domains and several levels of psychodynamic conflicts. While higher structural impairments are shown in adolescents with eating and anxiety disorders, higher levels of the passive self-worth conflict persist in adolescents with depressive disorders, and higher levels of the passive identity conflict are affecting adolescents with eating disorders. The findings suggest that a standardized diagnostic assessment of personality structure and psychodynamic conflicts in adolescent patients could contribute to a deeper understanding of mental health problems and appropriate treatment planning through the detection of underlying intra- and interpersonal impairments.

Differences and similarities in personality functioning across different types of eating disorders.

Objective: The classification of anorexia nervosa (AN) into subtypes is relevant due to their different symptomatology. However, subtypes (restricting type: AN-R; purging type: AN-P) differ also in terms of their personality functioning. Knowledge about these differences would allow for better treatment stratification. A pilot study indicated differences in structural abilities that can be assessed by the operationalized psychodynamic diagnosis (OPD) system. The aim of this study was therefore to systematically explore differences in personality functioning and personality between the two AN subtypes and bulimia nervosa (BN) using three personality (functioning) constructs. Methods: A total of N = 110 inpatients with AN-R (n = 28), AN-P (n = 40), or BN (n = 42) were recruited in three clinics for psychosomatic medicine. Assignment to the three groups was performed using a comprehensive questionnaire validated for diagnostic purposes (Munich-ED-Quest). Personality functioning was examined using OPD Structure Questionnaire (OPD-SQ), personality by using the Personality Inventory for DSM-5-Brief Form and Big Five Inventory-10. (M)ANOVAs were used to examine differences across eating disorder groups. In addition, correlation and regression analyses were conducted. Results: We observed differences on several sub- and main scales of the OPD-SQ. Whereas patients with BN showed the lowest levels, AN-R patients displayed the highest levels of personality functioning. On some sub- and main scales, such as "affect tolerance," the subtypes of AN differed from BN, whereas on the scale "affect differentiation," AN-R, differed from the other two groups. The total eating disorder pathology score of the Munich-ED-Quest best predicted overall personality structure [stand. ß = 0.650; t(104) = 6.666; p < 0.001] and self-regulation [stand. ß = 0.449; t(104) = 3.628; p < 0.001]. Discussion: Our findings confirm most of the results of the pilot study. These findings can facilitate the development of stratified treatment approaches for eating disorders.

Measuring PROMIS pain interference in German patients with chronic conditions: calibration, validation, and cross-cultural use of item parameters.

PURPOSE: To calibrate the item parameters of the German PROMIS® Pain interference (PROMIS PI) items using an item-response theory (IRT) model and investigate psychometric properties of the item bank. METHODS: Forty items of the PROMIS PI item bank were collected in a convenience sample of 660 patients, which were recruited during inpatient rheumatological treatment or outpatient psychosomatic medicine visits in Germany. Unidimensionality, monotonicity, and local independence were tested as required for IRT analyses. Unidimensionality was examined using confirmatory factor analyses (CFA) and exploratory factor analysis (EFA). Unidimensional and bifactor graded-response IRT models were fitted to the data. Bifactor indices were used to investigate whether multidimensionality would lead to biased scores. To evaluate convergent and discriminant validity, the item bank was correlated with legacy pain instruments. Potential differential item functioning (DIF) was examined for gender, age, and subsample. To investigate whether U.S. item parameters may be used to derive T-scores in German patients, T-scores based on previously published U.S. and newly estimated German item parameters were compared with each other after adjusting for sample specific differences. RESULTS: All items were sufficiently unidimensional, locally independent, and monotonic. Whereas the fit of the unidimensional IRT model was not acceptable, a bifactor IRT model demonstrated acceptable fit. Explained common variance and Omega hierarchical suggested that using the unidimensional model would not lead to biased scores. One item demonstrated DIF between subsamples. High correlations with legacy pain instruments supported construct validity of the item bank. T-scores based on U.S. and German item parameters were similar suggesting that U.S. parameters could be used in German samples. CONCLUSION: The German PROMIS PI item bank proved to be a clinically valid and precise instrument for assessing pain interference in patients with chronic conditions.

Are OMERACT recommendations followed in clinical trials on fibromyalgia? A systematic review of patient-reported outcomes and their measures.

PURPOSE: Patient-Reported Outcomes (PROs) and its measures (PROMs) are key to outcome assessment in Fibromyalgia (FM) trials. The aim of this review was to investigate which domains and instruments were assessed in recent FM trials and to compare them to recommendations by the Outcome Measures in Rheumatology (OMERACT) initiative. In addition, we investigated the overlap with a generic health assessment approach, i.e. eight domains suggested by the Patient-Reported Outcome Measurement Information System® (PROMIS®). METHODS: In compliance with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines, a systematic literature search in scientific databases including PubMed, PsycInfo, and Embase was conducted to identify studies that assessed at least two dimensions of health-related quality of life (HRQoL) from 2015 to June 2022. Non-randomized and randomized controlled trials were included in the analysis. We extracted PROs and PROMs used in each study. RESULTS: From 1845 identified records, 107 records out of 105 studies met the inclusion criteria. Studies investigated 50 PROs using 126 different PROMs. Most frequently assessed domains were pain, depression, fatigue, and anxiety (> 95% of the studies). The disease-specific FIQ was the most frequently applied PROM (82%). Overall, only 9% of the studies covered all domains deemed mandatory by OMERACT. Very few studies covered all eight generic health domains suggested by PROMIS. CONCLUSION: The majority of trials covered most OMERACT domains or generic PROMIS health domains. There was, however, great variability in the instruments used to assess the domains, which points at a limited degree of standardization in the field.

Frequently Used Patient-Reported Outcome Measures of General Physical Function Were Highly Correlated With a Multitask Performance Outcome Test Battery.

OBJECTIVES: This study aimed to determine the relationship between frequently used patient-reported outcome (PRO) measures and a multitask performance outcome (PerfO) measure of general physical function (PF) and to examine the association of these measures with depressive mood, pain, and age. METHODS: Frequently used PRO measures of general PF (Patient-Reported Outcomes Measurement Information System [PROMIS] PF item bank, PROMIS PF Short Form 20a, Short Form 36 Physical Function Scale) and a PerfO test battery, namely, the Physical Performance Test (PPT), were administered to 78 adult patients from 3 inpatient clinics (cardiology and angiology, rheumatology and clinical immunology, and psychosomatic medicine) at Charité - Universitätsmedizin Berlin. Pearson correlations were used to investigate the associations between PRO measures and the PPT. To explore the predictive value of age, depressive symptoms, and pain intensity, we conducted multiple linear regression analysis for each PF measure. RESULTS: We found strong linear relationships between PRO measures and PPT sum scores. Correlations between PPT sum scores and PROMIS PF T-scores were r > 0.75. For all PRO and PerfO measures, age was a predictor of general PF whereas depressive mood was not found to be a relevant predictor. Moreover, pain intensity was found to be a significant predictor of PRO measures but not for PPT sum scores. CONCLUSIONS: Our findings suggest that frequently used PRO measures and a multitask PerfO measure of general PF can be used to measure a common PF construct. Nevertheless, PF scores based on PRO measures should ideally be controlled for self-rated pain intensity.

Achieving reliable pain change scores for individuals in the postoperative phase: carefully choose sampling density, test length, and administration mode.

ABSTRACT: Despite tremendous efforts to increase the reliability of pain measures and other self-report instruments, improving or even evaluating the reliability of change scores has been largely neglected. In this study, we investigate the ability of 2 instruments from the Patient-Reported Outcomes Measurement Information System, pain interference (6 items) and pain behavior (7 items), to reliably detect individual changes in pain during the postsurgical period of a hernia repair in 98 patients who answered daily diaries over almost 3 weeks after surgery. To identify the most efficient strategy for obtaining sufficiently reliable estimates of change (reliability >0.9), the number of measurement occasions over the study period (sampling density), the number of items (test length), and the mode of administration (ie, static short form vs Computer adaptive testing) were manipulated in post-hoc simulations. Reliabilities for different strategies were estimated by comparing the observed change with the best approximation of "real" (ie, latent) change. We found (1) that near perfect reliability can be achieved if measures from all days over the whole study period, obtained with all pain interference or pain behavior items, were used to estimate the observed change, (2) that various combinations of the number of items and the number of measurement occasions could achieve acceptable reliability, and (3) that computer adaptive testings were superior to short forms in achieving sufficient reliability. We conclude that the specific strategy for assessing individual postoperative change in pain experience must be selected carefully.

A Modified Version of the Transactional Stress Concept According to Lazarus and Folkman Was Confirmed in a Psychosomatic Inpatient Sample.

BACKGROUND: Stress is a major risk factor for the impairment of psychological well-being. The present study aimed to evaluate the empirical evidence of the Transactional Stress Model proposed by Lazarus and Folkman in patients with psychosomatic health conditions. METHODS: A structural equation model was applied in two separate subsamples of inpatients from the Department of Psychosomatic Medicine (total n = 2,216) for consecutive model building (sample 1, n = 1,129) and confirmatory analyses (sample 2, n = 1,087) using self-reported health status information about perceived stress, personal resources, coping mechanisms, stress response, and psychological well-being. RESULTS: The initial model was created to reflect the theoretical assumptions by Lazarus and Folkman about their transactional stress concept. This model was modified until a sufficient model fit was reached (sample 1: CFI = 0.904, TLI = 0.898, RMSEA = 0.072 [0.071-0.074], SRMR = 0.061). The modified model was confirmed in a second sample (sample 2: CFI = 0.932, TLI = 0.928, RMSEA = 0.066 [0.065-0.068], SRMR = 0.052). Perceived external stressors and personal resources explained 91% of the variance of the stress response, which was closely related to symptoms of depression (63% variance explained). The attenuating effect of resources on stress response was higher (standardized ß = -0.73, p < 0.001) than the impact of perceived stressors on stress response (standardized ß = 0.34, p < 0.001). CONCLUSION: The empirical data largely confirmed the theoretical assumption of the Transactional Stress Model, which was first presented by Lazarus and Folkman, in patients with a wide range of psychosomatic conditions. However, data analyses were solely based on self-reported health status. Thus, proposed inner psychological mechanisms such as the appraisal process could not be included in this empirical validation. The operationalization and understanding of coping processes should be further improved.

Applying Item Response Theory to the OPD Structure Questionnaire: Identification of a Unidimensional Core Construct and Feasibility of Computer Adaptive Testing.

Recent developments in the dimensional assessment of personality functioning have made the implementation of latent measurement models increasingly attractive. In this study, we applied item response theory (IRT) to a well-established personality functioning instrument (the OPD Structure Questionnaire) to identify a unidimensional latent trait and to evaluate the feasibility of computer adaptive testing (CAT). We hypothesized that the use of IRT could reduce the test burden - compared to a fixed short form - while maintaining high precision over a wide range of the latent trait. The OPD-SQ was collected from 1235 patients in a psychosomatic clinic. IRT assumptions were fulfilled. A 9-factor model yielded sufficient fit and unidimensionality in exploratory factor analysis with bifactor rotation. Items were iteratively reduced, and a graded-response IRT model was fitted to the data. Simulations showed that a CAT with approximately 7 items was able to capture an OPD-SQ global severity score with an accuracy similar to that of a fixed 12-item short form. The final item bank and CAT yielded satisfactory content validity. Strong correlations with depression and anxiety replicated previous results on the OPD-SQ. We concluded that IRT applications could be useful to reduce the test burden of personality functioning instruments.

A combination of pain indices based on momentary assessments can predict placebo response in patients with fibromyalgia syndrome.

ABSTRACT: Many factors are known to affect assay sensitivity; however, limited attention has been devoted to understanding whether characteristics of patients' baseline pain impact assay sensitivity. In this study, we tested whether a combination of 3 baseline pain indices based on ecological momentary assessments (EMA) could detect patients with enhanced responses to placebo. The analysis was conducted with secondary data from 2 clinical trials in fibromyalgia patients (N = 2084). For each patient, pain intensity, pain variability (individual SD), and pain consistency (first-order autocorrelation) were computed from baseline EMA. A latent profile analysis identified 3 subgroups of patients based on these indices. Group 1 (n = 857, 41.3%) showed the lowest pain intensity levels, coupled with the highest consistency and greatest variability of pain. Group 3 (n = 110, 5.3%) showed the opposite pattern, and group 2 (n = 1109, 53.4%) showed intermediate levels on all pain indices. It was then tested whether the subgroups moderated treatment effects (changes in pain for active treatment vs placebo) using repeated-measures analysis of variance. Treatment effects varied significantly between subgroups. Patients in group 3 demonstrated greater reduction in pain in response to placebo then those in groups 1 and 2. Further analysis showed that the removal of patients in class 3 would significantly enhance the observed treatment effect by 8% to 15%. In conclusion, profiles of pain characteristics derived from baseline EMA may be useful for detecting patient subgroups with enhanced placebo responses that can diminish assay sensitivity in pain clinical trials.

Using subdomain-specific item sets affected PROMIS physical function scores differently in cardiology and rheumatology patients.

OBJECTIVES: The Patient-Reported Outcomes Measurement Information System (PROMIS) physical function (PF) item bank has been developed to standardize patient-reported PF across medical fields. However, evidence of scoring equivalence across cardiology and rheumatology patients is still missing. Therefore, this study aims to investigate both (1) the extent of disease-related differential item functioning (DIF) and (2) the impact of the disease group on using subdomain-specific item sets for generating PROMIS PF scores in cardiology and rheumatology patients. STUDY DESIGN AND SETTING: Ordinal regression was used to evaluate DIF between cardiology (n = 201) and rheumatology (n = 200) inpatients. To explore the disease-specific impact of PF subdomains on scoring, we compared scores derived from the full item bank with scores derived from subdomain-specific item sets for each disease group. RESULTS: DIF was detected in 18 items, predominately from the upper extremity subdomain. When upper extremity items were used, cardiology patients reached systematically higher scores than using the full item bank. Rheumatology patients scored substantially higher when mobility items were used. CONCLUSION: Applying the PROMIS PF metric to disease-specific item sets including items from differing subdomains may lead to biased comparisons of PF levels across disease groups. Disease-specific item parameters should be provided for items showing DIF, and subdomain-related content balancing is recommended for scoring the generic PROMIS PF construct.

A Step Towards a Better Understanding of Pain Phenotypes: Latent Class Analysis in Chronic Pain Patients Receiving Multimodal Inpatient Treatment.

PURPOSE: The number of non-responders to treatment among patients with chronic pain (CP) is high, although intensive multimodal treatment is broadly accessible. One reason is the large variability in manifestations of CP. To facilitate the development of tailored treatment approaches, phenotypes of CP must be identified. In this study, we aim to identify subgroups in patients with CP based on several aspects of self-reported health. PATIENTS AND METHODS: A latent class analysis (LCA) was carried out in retrospective data from 411 patients with CP of different origins. All patients experienced severe physical and psychosocial consequences and were therefore undergoing multimodal inpatient pain treatment. Self-reported measures of pain (visual analogue scales for pain intensity, frequency, and impairment; Pain Perception Scale), emotional distress (Patient Health Questionnaire, PHQ-9; Generalized Anxiety Disorder Scale, GAD-7) and physical health (Short Form Health Survey; SF-8) were collected immediately after admission and before discharge. Instruments assessed at admission were used as input to the LCA. Resulting classes were compared in terms of patient characteristics and treatment outcome. RESULTS: A model with four latent classes demonstrated the best model fit and interpretability. Classes 1 to 4 included patients with high (54.7%), extreme (17.0%), moderate (15.6%), and low (12.7%) pain burden, respectively. Patients in class 4 showed high levels of emotional distress, whereas emotional distress in the other classes corresponded to the levels of pain burden. While pain as well as physical and mental health improved in class 1, only the levels of depression and anxiety improved in patients in the other groups during multimodal treatment. CONCLUSION: The specific needs of these subgroups should be taken into account when developing individualized treatment programs. However, the retrospective design limits the significance of the results and replication in prospective studies is desirable.

Measurement of Personality Structure by the OPD Structure Questionnaire Can Help to Discriminate Between Subtypes of Eating-Disorders.

BACKGROUND: Differentiation between purging type (AN-P) and restricting type (AN-R) is common in anorexia nervosa (AN) and relevant for clinical practice. However, differences of personality pathology in eating disorders (ED) and their subtypes, which can be captured by the operationalized psychodynamic diagnosis (OPD) system, have not been systematically investigated to date. OBJECTIVES: The aim of this study was to explore differences in personality structure between the subtypes of AN and bulimia nervosa (BN) using the OPD structure questionnaire (OPD-SQ). In addition, the ability of the instrument to support the classification of eating disorders was examined. MATERIALS AND METHODS: We conducted a retrospective, exploratory study in a subset sample of a larger validation study. The OPD-SQ had been collected from n = 60 patients with AN or BN. Patients were assigned to the ED groups by clinical assessment. Statistical analyses included multivariate analysis of variance (MANOVA) and discriminant analysis. RESULTS: Differences between ED groups were observed on 5 OPD-SQ main scales and 9 subscales, as well as on the global scale. AN-P patients demonstrated the lowest personality structure on most of the main scales and subscales, whereas AN-R patients showed a higher personality structure level as compared to both BN and AN-P patients. The OPD-SQ scales with the largest differences include self-perception, object perception, and attachment to internal objects. Discriminant analysis resulted in satisfactory assignment to ED groups by OPD-SQ subscales. CONCLUSIONS: Personality structure was found to be less developed in patients with BN and AN-P as compared to patients with AN-R. Although the results have to be proven in larger prospective studies, these results suggest that the OPD-SQ may be used to support the clinical assessment and classification in patients with EDs.

[Evaluation of Factor Structure and Construct Validity of the 12-Item Short Version of the OPD Structure Questionnaire (OPD-SQS) in Psychosomatic Patients]. / Evaluation der Faktorenstruktur und Konstruktvalidität der 12-Item Kurzversion des OPD-Strukturfragebogens (OPD-SFK) an psychosomatischen Patienten.

BACKGROUND: Screening for personality dysfunction is regarded as increasingly important for treatment planning in clinical settings as this allows to determine specific clinical pathways in an early stage. Recently, the 12-item OPD Structure Questionnaire (OPD-SQS) was developed for this purpose and initial results of the factor structure and validity have been published. This study aimed to investigate and validate the OPD-SQS in further patient samples beyond the team of developers and to provide reference values. METHODS: Data was assessed in psychosomatic outpatients (N=565) and inpatients (N=670) at Charité - Universitätsmedizin Berlin between 2012 and 2016. To examine the factor structure of the OPD-SQS confirmatory factor analyses (CFA) were applied in both samples. To evaluate construct validity, a SKID-II-Interview was performed in N=105 patients and narcissism inventory (NI-90) was completed by N=160 patients. In addition, a range of instruments reflecting emotional, social and physical health were assessed. Bivariate correlations were performed to analyze relations between these instruments and the OPD-SQS. RESULTS: CFAs indicated a good to satisfying fit for the proposed model including 3 factors. A Bifactormodel resulted in very good modelfit. Analyses of construct validity resulted in high positive correlations of OPD-SQS with dimensional SCID-II scores, SKID-II interviews, and NI-90 confirming convergent validity. Results for discriminant validity were heterogeneous. Medium to high correlations were found with a range of instruments including D-CAT (depression), A-CAT (anxiety), S-CAT (stress), and PHQ-15 (somatic symptoms). Subsequent analyses revealed, that the factor self-perception is potentially being influenced by current depression and anxiety. Analyses showed only minor differences of correlations between OPD-SQS subscales and other instruments. CONCLUSIONS: The OPD-SQS seems to be appropriate for screening of personality dysfunction. However, other aspects of psychopathology are gathered in addition. Therefore, further investigation of the patients' personality structure such as an OPD interview may be added in clinical settings.

[Empirical Assessment of Patient-Reported Outcomes and Exemplary Introduction to Health-Related Quality of Life]. / Empirische Erfassung subjektiver Gesundheitsmerkmale am Beispiel der gesundheitsbezogenen Lebensqualität.

Health-related quality of life (HRQoL) acquires increased importance as a target parameter for different stakeholders in healthcare, e. g. to assess treatment outcome in chronically ill patients. In this educational article, we explain the levels of the health-related quality of life construct and associated main dimensions including physical, mental and social health. State-of-the-art approaches for assessment of patient-reported outcomes (PROs) are introduced on the basis of the HRQoL model. Furthermore, modern test-theoretical approaches and their applications are presented, which are aimed at standardizing and improving the assessment of PROs (e. g., computer-adaptive testing). Finally, we present 2 major international PRO initiatives (PROMIS® and EORTC Quality of Life Group) that have been influential in advancing the assessment of patient outcomes over the last few years.

A 67-item stress resilience item bank showing high content validity was developed in a psychosomatic sample.

OBJECTIVES: To develop the first item bank to measure stress resilience (SR) in clinical populations. STUDY DESIGN AND SETTING: Qualitative item development resulted in an initial pool of 131 items covering a broad theoretical SR concept. These items were tested in n = 521 patients at a psychosomatic outpatient clinic. Exploratory and confirmatory factor analysis, as well as other state-of-the-art item analyses and item response theory were used for item evaluation and calibration of the final item bank. RESULTS: Of the initial item pool of 131 items, we excluded 64 items (54 factor loading <0.5, four residual correlations >0.3, two nondiscriminative item response curves, and four differential item functioning). The final set of 67 items indicated sufficient model fit in confirmatory factor analysis and item response theory analyses. In addition, a 10-item short form with high measurement precision (SE ≤ 0.32 in a theta range between -1.8 and +1.5) was derived. Both the SR item bank and the SR short form were highly correlated with an existing static legacy tool (Connor-Davidson Resilience Scale). CONCLUSION: The final SR item bank and 10-item short form showed good psychometric properties. When further validated, they will be ready to be used within a framework of computer-adaptive tests for a comprehensive assessment of the stress construct.

An initial psychometric evaluation of the German PROMIS v1.2 Physical Function item bank in patients with a wide range of health conditions.

OBJECTIVES: To translate the PROMIS Physical Function (PF) item bank version 1.2 into German and to investigate psychometric properties of resulting full bank and seven derived short forms. DESIGN: Cross-sectional psychometric study. SETTING: Inpatient and outpatient clinics of the Department of Psychosomatic Medicine at Charité-Universitätsmedizin Berlin, Germany. SUBJECTS: A total of 10 adult patients with various chronic diseases participated in cognitive debriefing interviews. The final item bank was administered to n = 266 adult patients with a broad range of medical conditions. INTERVENTIONS: Patient-reported outcome assessment as part of routine care. MAIN MEASURES: PROMIS v1.2 PF bank; MOS SF-36 PF scale (PF-10). RESULTS: Cross-cultural adaptation of the item bank followed established guidelines. For the final German translation, the corrected item-total correlations ranged from 0.44 to 0.84. Cronbach's alpha was high for each PROMIS PF short form ( α = 0.88-0.96). The full PROMIS PF bank and most short forms correlated highly with the SF-36 PF-10 ( r = 0.85-0.90), with the exception of PROMIS Upper Extremity ( r = 0.64). PROMIS Upper Extremity showed ceiling effects and lower agreement with the full bank than other short forms. Unidimensionality was supported for all PROMIS PF measures using traditional factor analysis and nonparametric item response theory. CONCLUSION: The German PROMIS PF bank was found to be conceptually equivalent to the English version and fulfilled the psychometric requirements for use of short forms in clinical practice. Future studies should pay particular attention to samples with upper extremity functional limitations to further investigate the dimensional structure of PF as conceptualized according to PROMIS.

Standardization of health outcomes assessment for depression and anxiety: recommendations from the ICHOM Depression and Anxiety Working Group.

PURPOSE: National initiatives, such as the UK Improving Access to Psychological Therapies program (IAPT), demonstrate the feasibility of conducting empirical mental health assessments on a large scale, and similar initiatives exist in other countries. However, there is a lack of international consensus on which outcome domains are most salient to monitor treatment progress and how they should be measured. The aim of this project was to propose (1) an essential set of outcome domains relevant across countries and cultures, (2) a set of easily accessible patient-reported instruments, and (3) a psychometric approach to make scores from different instruments comparable. METHODS: Twenty-four experts, including ten health outcomes researchers, ten clinical experts from all continents, two patient advocates, and two ICHOM coordinators worked for seven months in a consensus building exercise to develop recommendations based on existing evidence using a structured consensus-driven modified Delphi technique. RESULTS: The group proposes to combine an assessment of potential outcome predictors at baseline (47 items: demographics, functional, clinical status, etc.), with repeated assessments of disease-specific symptoms during the treatment process (19 items: symptoms, side effects, etc.), and a comprehensive annual assessment of broader treatment outcomes (45 items: remission, absenteeism, etc.). Further, it is suggested reporting disease-specific symptoms for depression and anxiety on a standardized metric to increase comparability with other legacy instruments. All recommended instruments are provided online ( www.ichom.org ). CONCLUSION: An international standard of health outcomes assessment has the potential to improve clinical decision making, enhance health care for the benefit of patients, and facilitate scientific knowledge.

Alterations of circulating NUCB2/nesfatin-1 during short term therapeutic improvement of anxiety in obese inpatients.

In addition to its anorexigenic properties in the neuroendocrine regulation of hunger and satiety, mounting evidence indicates a role for NUCB2/nesfatin-1 in the regulation of emotional stress responses which seems to occur in a sex-specific way. In the present study, we investigated the association of NUCB2/nesfatin-1 plasma levels with anxiety, depressiveness and perceived stress in obese men and women and their alterations during inpatient treatment. We expected a decrease of NUCB2/nesfatin-1 levels in female and an increase in male patients reporting a relevant alleviation of anxiety. We analyzed 69 inpatients (44 female, 25 male; body mass index, mean: 50.2±9.5kg/m2, range: 31.8-76.5kg/m2; mean age: 45.0±12.4years) hospitalized due to morbid obesity with mental (not necessarily anxiety disorders) and somatic comorbidities. NUCB2/nesfatin-1 plasma levels were measured by ELISA. Anxiety (GAD-7), depressiveness (PHQ-9) and perceived stress (PSQ-20) were concurrently determined as patient-reported outcomes. All measurements were carried out at the initiation of and during inpatient treatment when a clinically meaningful improvement of anxiety was achieved (≥5 points on GAD-7) or missed (±1 point). NUCB2/nesfatin-1 was positively correlated with anxiety scores in women at the beginning of (r=0.411; p=0.006) and during (r=0.301; p=0.047) inpatient treatment. In men, a significant negative correlation was observed following treatment (r=-0.469; p=0.018), while at the outset of treatment only a trend was observed (r=-0.381; p=0.059). Unexpectedly, neither women (n=19; at beginning vs. during treatment; 0.49±1.00ng/ml vs. 0.38±0.72ng/ml; p=0.687) nor men (n=9; 0.17±0.31ng/ml vs. 0.19±0.36ng/ml; p=0.427) who improved in anxiety scores (p<0.001) displayed significant changes of NUCB2/nesfatin-1 plasma levels, although the direction of change was as expected with a decrease in women (-23.3%) and an increase in men (+12.4%). In addition, the change of NUCB2/nesfatin-1 was not explained by the course of anxiety (women: p=0.587; men: p=0.373). In conclusion, women and men showed an inverse association between NUCB2/nesfatin-1 and anxiety with a positive correlation in women and a negative correlation in men (although this correlation was not statistically significant in men at the beginning of treatment). However, no significant change of NUCB2/nesfatin-1 following improvement of anxiety has been observed. This might be due to the short observation interval, or due to too small anxiety improvements associated with too low baseline anxiety levels.