EORTC QLQ-C30 normative data for the United Kingdom: Results of a cross-sectional survey of the general population.

OBJECTIVE: The cancer-specific health-related quality of life (HRQoL) questionnaire of the European Organisation for Research and Treatment of Cancer (EORTC), the EORTC QLQ-C30, is a frequently applied questionnaire to assess cancer patients' self-reported health used as part of research and clinical practice. Normative data obtained from the general population can facilitate the interpretation of these data. Despite its frequent application, no detailed EORTC QLQ-C30 normative data have yet been published for the United Kingdom (UK). This study presents detailed EORTC QLQ-C30 normative data for the United Kingdom overall and by sex and age. METHODS: The data are drawn from a larger published, international, cross-sectional online survey. For the recruitment, the sample was stratified by sex (males, females) and age in five age groups with a sample size of n = 100 per subgroup. RESULTS: A total of N = 1026 UK respondents completed the survey (n = 517 females, n = 509 males). There were no clear subgroup patterns by sex or age; however, older patients tended to show higher (i.e., better) scores in emotional and social functioning; they also reported some of the lowest (i.e., best) scores for symptoms, such as insomnia, appetite loss, diarrhoea, nausea/vomiting or financial difficulties. CONCLUSION: This paper provides EORTC QLQ-C30 general population normative data for the UK, further stratified by sex and age. These data will greatly support the interpretation of EORTC QLQ-C30 scale scores obtained from UK cancer patients, and also enable comparison with other detailed national normative datasets collected in the same project, across several other European countries and the US.

Lipid parameters and depression in patients with chronic tinnitus: A cross-sectional observation.

BACKGROUND: Pathophysiological theories assume importance of metabolic abnormalities in patients with major depression - and possibly chronic tinnitus. Although chronic tinnitus frequently correlates with depression, links between high-density lipoprotein (HDL) and depression are uninvestigated. METHODS: Two-hundred patients with chronic tinnitus (Mage = 55; 51% female) were examined. Serum levels of total cholesterol (TC), triglycerides (TGs), HDL, low-density lipoprotein cholesterol (LDL), non-HDL, as well as LDL/HDL and TC/HDL ratios were analysed. Questionnaires included depression subscales of the ICD-10 Symptom Rating, the Hospital Anxiety and Depression Scale (HADS_D), and the Berlin Mood Questionnaire (BSF). Multivariate analyses of covariance and linear regression models - which controlled age, tinnitus-related distress and perceived stress - investigated between-subgroup differences (p < 0.05) and linear associations between HDL indices and depression (p < 0.01). RESULTS: HDL levels did not differ for tinnitus-symptom durations, smoking and alcohol use levels, statin or antihypertensive drug use, and body-mass indices. Relative to non-to-mildly depressed patients with chronic tinnitus, patients with moderate-to-severe depression (n = 45; 23%) had significantly lower HDL levels (d = -0.35) and higher LDL/HDL (d = 0.39) and TC/HDL ratios (d = 0.40). Across participants, HDL-levels were negatively associated with depression as measured by the HADS_D and BSF_indifference scales. CONCLUSIONS: In keeping with general depression research, low serum HDL levels correlate with depressive symptomatology in patients with chronic tinnitus. This association may be influenced by proximal (e.g. modulations of HPA-axis activity) or distal factors (e.g. maladaptive coping behaviours) - both of which should be conceptualized within psychological stimulus-processing frameworks.

Psychobehavioral B-Criteria of Somatic Symptom Disorder Are Associated with Somatic Symptom Reporting in a Large Sample of Psychosomatic Outpatients.

Introduction: Somatic symptom disorder (SSD) as introduced by the DSM-5 is characterized by chronic somatic symptoms not fully explained by underlying pathology and accompanied by psychological factors, the diagnostic B-criteria. These cognitive, affective, and behavioral disturbances are related to increased attention to somatic symptoms. However, there is a lack of empirical evidence regarding the association between the B-criteria and high symptom reporting in clinical settings. Methods: This 12-year retrospective, cross-sectional, observational study examined 6,491 patients from a German psychosomatic outpatient center. The somatoform subscale of HEALTH-49 was used to evaluate somatic symptom reporting. Excessive health concerns and other potential criteria associated with symptom reporting were determined using the ICD-10-Symptom Rating and other HEALTH-49 subscales. Results: Regression analysis revealed that the established B-criteria for SSD were the strongest factors associated with somatic symptom reporting, with a standardized beta-coefficient of ß = 0.31 (R2 = 0.428, df = 24, F = 187.886). Other psychobehavioral factors were clearly less associated with somatic symptom reporting, such as depressive symptoms with ß = 0.15 and impaired activity and participation with ß = 0.12. Sociodemographic factors, such as age (ß = 0.16) and gender (ß = 0.12), were also independently associated with somatic symptom reporting. Conclusion: This study provides evidence for the concept of SSD related to specific B-criteria associated with somatic symptom reporting, based on a large patient sample. These results point to an important role of psychological symptomatology in patients with somatic symptoms. The findings also suggest that additional factors contribute to the reporting of somatic symptoms. Our results may inform future diagnostic criteria for SSD.

This scientific study examines the association between psychobehavioral factors and somatic symptom reporting in a large sample of psychosomatic outpatients. We investigated the association of established and possible additional psychobehavioral criteria for somatic symptom disorder (SSD) as defined in the DSM-V. The study included 6,491 patients from a psychosomatic outpatient center over a 12-year period. The participants completed self-report questionnaires to assess somatic symptom reporting and psychobehavioral factors. The results showed that the B-criteria of SSD were associated with somatic symptom reporting, indicating the validity of these criteria in clinical practice. Other psychobehavioral factors, such as depressive symptoms and impaired activity and participation, as well as sociodemographic factors such as age and gender were also associated with somatic symptom reporting but to a much lesser extent. This study has limitations, including its retrospective and cross-sectional design, reliance on self-report measures, and the need for further research using longitudinal data and clinician-rated assessments to complement self-report data. However, our research highlights the importance of psychological symptomatology in individuals who report somatic symptoms. These findings may inform future diagnostic criteria and treatment approaches for individuals with SSD and improve treatment and patient outcomes.

EORTC QLQ-C30 general population normative data for the United States.

OBJECTIVE: The European Organisation for Research and Treatment of Cancer (EORTC) QLQ-C30 is a frequently used cancer-specific health-related quality of life (HRQoL) questionnaire. To aid interpretation of data obtained via EORTC QLQ-C30, general population norm data have been published for many countries. However, despite its frequent use in the United States, no normative data by sex and age exist to date. Therefore, this study aimed to generate sex- and age-specific EORTC QLQ-C30 normative data for the United States. METHODS: Recruitment and data collection were carried out via online panels as part of a larger cross-sectional study. For the recruitment, the sample was stratified by sex and age (18-39, 40-49, 50-59, 60-69, ≥ 70 years) to achieve a balanced distribution, with n = 100 per subgroup. Descriptive statistics are presented by age and age/sex. RESULTS: A total of N = 1009 respondents completed the survey (n = 508 females, n = 501 males). More than two thirds of participants (72.5%) reported at least one health condition, e.g., arthritis (26%). Across EORTC QLQ-C30 scales, women and men 60 years and older reported generally better/higher functioning and better/lower symptom scores compared to the younger age groups. CONCLUSION: To date, no specific EORTC QLQ-C30 general population normative data have been published for the United States. This paper provides these important normative data, which will greatly support the interpretation of EORTC QLQ-C30 scale scores obtained from US cancer patients, and also enable comparison with European norms.

Role of Creative Therapies in Gynecological Oncology: Results of a Multigenerational Survey in Patients and Caregivers.

INTRODUCTION: Although creative therapies like painting, dancing, and writing are often used and encouraged to treat various diseases, including cancer, there are few systematic scientific studies on innovative therapies in medical care. METHODS: An anonymous survey was developed for female patients, their relatives, and female medical staff on the impact of creative therapies on optimizing clinical therapy management in exclusively female trials. RESULTS: Of 718 respondents, 358 were female patients, 69 were medical personnel, and 291 were in the control group. Overall, 91.2% of respondents had sought access to creative therapies, indicating strong self-motivated engagement in activities to improve health and well-being. This study also uncovered a significant preference for creative writing among patients. Furthermore, the data suggest that integrating innovative therapies into biopsychosocial anamnesis could offer valuable insights into patients' mobility, mood, and social behaviors. Despite a general hesitation to discuss leisure activities with medical professionals, many patients wanted to incorporate creative activities into their treatment plans. Moreover, group settings for innovative therapy were preferred, highlighting the need for more structured support in medical environments to facilitate these therapeutic interactions. CONCLUSIONS: This study suggests creative therapies can be valuable in medical care.

How Are Age, Gender, and Country Differences Associated With PROMIS Physical Function, Upper Extremity, and Pain Interference Scores?

BACKGROUND: The interpretation of patient-reported outcomes requires appropriate comparison data. Currently, no patient-specific reference data exist for the Patient-Reported Outcome Measurement Information System (PROMIS) Physical Function (PF), Upper Extremity (UE), and Pain Interference (PI) scales for individuals 50 years and older. QUESTIONS/PURPOSES: (1) Can all PROMIS PF, UE, and PI items be used for valid cross-country comparisons in these domains among the United States, the United Kingdom, and Germany? (2) How are age, gender, and country related to PROMIS PF, PROMIS UE, and PROMIS PI scores? (3) What is the relationship of age, gender, and country across individuals with PROMIS PF, PROMIS UE, and PROMIS PI scores ranging from very low to very high? METHODS: We conducted telephone interviews to collect custom PROMIS PF (22 items), UE (eight items), and PI (eight items) short forms, as well as sociodemographic data (age, gender, work status, and education level), with participants randomly selected from the general population older than 50 years in the United States (n = 900), United Kingdom (n = 905), and Germany (n = 921). We focused on these individuals because of their higher prevalence of surgeries and lower physical functioning. Although response rates varied across countries (14% for the United Kingdom, 22% for Germany, and 12% for the United States), we used existing normative data to ensure demographic alignment with the overall populations of these countries. This helped mitigate potential nonresponder bias and enhance the representativeness and validity of our findings. We investigated differential item functioning to determine whether all items can be used for valid crosscultural comparisons. To answer our second research question, we compared age groups, gender, and countries using median regressions. Using imputation of plausible values and quantile regression, we modeled age-, gender-, and country-specific distributions of PROMIS scores to obtain patient-specific reference values and answer our third research question. RESULTS: All items from the PROMIS PF, UE, and PI measures were valid for across-country comparisons. We found clinically meaningful associations of age, gender, and country with PROMIS PF, UE, and PI scores. With age, PROMIS PF scores decreased (age ß Median = -0.35 [95% CI -0.40 to -0.31]), and PROMIS UE scores followed a similar trend (age ß Median = -0.38 [95% CI -0.45 to -0.32]). This means that a 10-year increase in age corresponded to a decline in approximately 3.5 points for the PROMIS PF score-a value that is approximately the minimum clinically important difference (MCID). Concurrently, we observed a modest increase in PROMIS PI scores with age, reaching half the MCID after 20 years. Women in all countries scored higher than men on the PROMIS PI and 1 MCID lower on the PROMIS PF and UE. Additionally, there were higher T-scores for the United States than for the United Kingdom across all domains. The difference in scores ranged from 1.21 points for the PROMIS PF to a more pronounced 3.83 points for the PROMIS UE. Participants from the United States exhibited up to half an MCID lower T-scores than their German counterparts for the PROMIS PF and PROMIS PI. In individuals with high levels of physical function, with each 10-year increase in age, there could be a decrease of up to 4 points in PROMIS PF scores. Across all levels of upper extremity function, women reported lower PROMIS UE scores than men by an average of 5 points. CONCLUSION: Our study provides age-, gender-, and country-specific reference values for PROMIS PF, UE, and PI scores, which can be used by clinicians, researchers, and healthcare policymakers to better interpret patient-reported outcomes and provide more personalized care. These findings are particularly relevant for those collecting patient-reported outcomes in their clinical routine and researchers conducting multinational studies. We provide an internet application ( www.common-metrics.org/PROMIS_PF_and_PI_Reference_scores.php ) for user-friendly accessibility in order to perform age, gender, and country conversions of PROMIS scores. Population reference values can also serve as comparators to data collected with other PROMIS short forms or computerized adaptive tests. LEVEL OF EVIDENCE: Level II, diagnostic study.

Equipercentile equating of scores from common patient-reported outcome measures of physical function in patients with cancer.

OBJECTIVE: To provide equipercentile equating of physical function (PF) scores from frequently used patient-reported outcome measures (PROMs) in cancer patients to facilitate data pooling and comparisons. STUDY DESIGN AND SETTING: Adult cancer patients from five European countries completed the European Organization for Research and Treatment of Cancer (EORTC) computer adaptive test (CAT) Core, EORTC Quality of Life Questionnaire Version 3.0 (QLQ-C30), Functional Assessment of Cancer Therapy - General (FACT-G), 36-item Short Form Health Survey (SF-36), and the Patient-Reported Outcomes Measurement Information System (PROMIS) Physical Function 20a short form. The R package "equate" was used to establish conversion tables of PF scores on those measures with a bivariate rank correlation of at least 0.75. RESULTS: In total, 953 patients with cancer (mean age 58.9 years, 54.7% men) participated. Bivariate rank correlations between PF scores from the EORTC CAT Core, EORTC QLQ-C30, SF-36, and PROMIS were all above 0.85, but below 0.69 for the FACT-G. Conversion tables were established for all measures but the FACT-G. These tables indicate which score from one PROM best matches the score from another PROM and provide standard errors of converted scores. CONCLUSION: Our analysis indicates that linking of PF scores from both EORTC measures (CAT and QLQ-C30) with PROMIS and SF-36 is possible, whereas the physical domain of the FACT-G seems to be different. The established conversion tables may be used for comparing results or pooling data from clinical studies using different PROMs.

[Psychosocial Care in the Intensive Care Unit]. / Psychosoziale Betreuung auf der Intensivstation.

The improvement of intensive care treatment options leads to an increasing number of patients being treated in this setting. For the majority of those affected and their relatives, this treatment is associated with tremendous stress, but also subsequent physical, psychological and cognitive impairments, the post-intensive care syndrome. The aim of psychosocial support in the intensive care unit is to stabilise and minimise the acute stress. This is done through care services oriented towards trauma therapy interventions and emergency psychology. Equally central are the needs of the patient's relatives and ways to stabilise and relieve them. The third pillar of psychosocial work in the intensive care unit is the support of the treatment team. Finally, an outlook is given for the specialised aftercare of these complex patients in PICS outpatient clinics.

Scale agreement, ceiling and floor effects, construct validity, and relative efficiency of the PROPr and EQ-5D-3L in low back pain patients.

BACKGROUND: The PROMIS Preference score (PROPr) is a new health state utility (HSU) score that aims to comprehensively incorporate the biopsychosocial model of health and apply favorable psychometric properties from the descriptive PROMIS system to HSU measurements. However, minimal evidence concerning comparisons to the EQ-5D-3L and the PROPr's capability to differentiate clinical severity are available. Therefore, the aim of this study was to compare the PROPr to the EQ-5D-3L in terms of scale agreement, ceiling/floor effects, distribution, construct validity, discriminatory power, and relative efficiency (RE) in terms of the Oswestry Disability Index (ODI) for patients with low back pain (LBP). METHODS: We used intra-class correlation coefficients (ICC) and Bland-Altman plots to compare the PROPr and EQ-5D-3L with regared to scale agreement in a cross-sectional routine sample of LBP patients. For distribution, we used the Pearson's coefficient for skewness and for ceiling/floor effects, a 15%-top/bottom threshold. For convergent validity, we used Pearson's correlation coefficients. For known-groups validity, we applied a linear regression with interaction terms (predictors sex, age, and ODI level) and an analysis of variance (ANOVA). For discriminatory power, we calculated the effect size (ES) using Cohen's d and the ratio of the area under the receiver-operating characteristics curves (AUROC-ratio = AUROCPROPr/AUROCEQ-5D-3L). RE was measured using the ratio of F-values (RE = FPROPr/FEQ-5D-3L). RESULTS: Of 218 LBP patients, 50.0% were female and the mean age was 61.8 years. The mean PROPr (0.20, 95%CI: 0.18; 0.22) and EQ-5D-3L scores (0.55, 95%CI: 0.51; 0.58) showed low agreement (d = 0.35, p < 0.001; ICC 0.27, 95%CI: -0.09; 0.59). The PROPr's distribution was positively skewed, whereas the EQ-5D-3L's was negative. Neither tool showed ceiling/floor effects, but all EQ-5D-3L dimensions did. Pearson correlation was r = 0.66 (95%CI: 0.58; 0.73). Differences were invariant to sex and age but not to ODI severity: ESEQ-5D-3L > ESPROPr and RE < 1 in higher ODI severity; ESEQ-5D-3L < ESPROPr and RE > 1 in lower ODI severity. AUROC-ratios did not show significant differences in terms of ODI severity. CONCLUSIONS: All PROPr and EQ-5D-3L biopsychosocial dimensions of health showed impairment in LPB patients. The capability of EQ-5D-3L and PROPr to differentiate ODI levels depends on ODI severity. Joint application of both tools may provide additional information.

[Analysis of items on the short forms of the tinnitus questionnaire: Mini-TQ-12 and Mini-TQ-15]. / Itemanalyse der Kurzformen des Tinnitusfragebogens: Mini-TF-12 und Mini-TF-15.

BACKGROUND: A brief but reliable measurement of tinnitus-related distress is crucial for understanding and treatment options for this often very limiting symptom. Several self-report questionnaires are used in German-speaking countries and several short versions exist for the German translation of the Tinnitus Questionnaire (TQ). OBJECTIVE: In the present work, the frequently used Mini-TQ-12 questionnaire and the newly developed Mini-TQ-15 questionnaire will be investigated with regard to reliability, item difficulty, sensitivity (discriminatory power), and predictive power of the items in order to facilitate a decision for one or the other questionnaire in different examination contexts. METHODS: Data from 1409 patients with chronic tinnitus who completed the German 52-item version of the TQ and additional psychological tests (ADS­L, BSF, PHQ, ACSA and SWOP) at the Tinnitus Centre of the Charité Universitaetsmedizin Berlin, Germany, were retrospectively analyzed. We performed external validation of items from different versions of the TQ (original version, Mini-TQ-12, and Mini-TQ-15). RESULTS: The items of the Mini-TQ-12 and the Mini-TQ-15 predicted specifically the total score. Both short questionnaires are of comparable quality in terms of reliability and item construction (difficulty, discriminatory power). CONCLUSION: Both questionnaires have a very good item quality and are clinically more efficient to use than the long-form TQ. If a similarity of the factor structure to the original questionnaire is required for research questions, the use of the Mini-TQ-15 is recommended.

[Chronic tinnitus: An interplay between somatic and psychological factors]. / Chronischer Tinnitus im Wechselspiel somatischer und psychischer Faktoren.

Chronic tinnitus is a common, sometimes highly distressing phenomenon that can be triggered and maintained by an interplay of physical and psychological factors. Partnering with clinical psychology and psychosomatic medicine, modern otolaryngology integrates both medical (e.g., hearing loss) and psychological influences (e.g., interactions between biographical experiences, personality traits, subjective evaluation of intrapsychic and interpersonal stimuli, emotional states, and intrapsychic or interpersonal emotion regulation strategies). Both groups of variables can influence the intensity and course of chronic tinnitus symptomatology both directly and indirectly, whereby the quality and relative degrees of psychological and physical components in a person's self-experience can fluctuate. With this in mind, the present article distinguishes between chronic tinnitus symptomatology with or without hearing loss-and strongly advocates for an integrated understanding of the symptomatology within a holistic psychological frame of reference. After a brief introduction to the principles of psychosomatic medicine and psychotherapy, the article discusses psychological case conceptualization using a vulnerability-stress-coping (VSC) model as an example, outlines clinical aspects and diagnostics of chronic tinnitus symptomatology, and concludes with a conceptualization of chronic tinnitus-related distress as a function of person-centered VSC interactions.

The multicenter effectiveness study of inpatient and day hospital treatment in departments of psychosomatic medicine and psychotherapy in Germany.

Background: Reliable outcome data of psychosomatic inpatient and day hospital treatment with a focus on psychotherapy are important to strengthen ecological validity by assessing the reality of mental health care in the field. This study aims to evaluate the effectiveness of inpatient and day hospital treatment in German university departments of Psychosomatic Medicine and Psychotherapy in a prospective, naturalistic, multicenter design including structured assessments. Methods: Structured interviews were used to diagnose mental disorders according to ICD-10 and DSM-IV at baseline. Depression, anxiety, somatization, eating disorder and posttraumatic stress disorder (PTSD) symptoms, as well as personality functioning were assessed by means of questionnaires on admission and at discharge. Results: 2,094 patients recruited by 19 participating university hospitals consented to participation in the study. Effect sizes for each of the outcome criteria were calculated for 4-5 sub-groups per outcome domain with differing severity at baseline. Pre-post effect sizes for patients with moderate and high symptom severity at baseline ranged from d = 0.78 to d = 3.61 with symptoms of PTSD, depression, and anxiety showing the largest and somatization as well as personality functioning showing somewhat smaller effects. Conclusions: Inpatient and day hospital treatment in German university departments of Psychosomatic Medicine and Psychotherapy is effective under field conditions. Clinical trial registration: https://drks.de/search/de/trial/DRKS00016412, identifier: DRKS00016412.

Circulating Neuronatin Levels Are Positively Associated with BMI and Body Fat Mass but Not with Psychological Parameters.

Human genetic studies have associated Neuronatin gene variants with anorexia nervosa (AN) and obesity. Studies on the expression of the Neuronatin gene product, a proteolipid, are lacking. We investigated the relationship between circulating Neuronatin, body mass index (BMI), body composition (BC), physical activity (PA), and psychometric outcomes in patients with AN, normal weight, and obesity. Plasma Neuronatin was measured by ELISA in (1) 79 subjects of five BMI categories (AN/BMI < 17.5 kg/m2; normal weight/BMI 18.5-25 kg/m2; obesity/BMI 30-40 kg/m2; obesity/BMI 40-50 kg/m2; obesity/BMI > 50 kg/m2) with assessment of BC (bioimpedance analysis; BIA); (2) 49 women with AN (BMI 14.5 ± 1.8 kg/m2) with measurements of BC (BIA) and PA (accelerometry); (3) 79 women with obesity (BMI 48.8 ± 7.8 kg/m2) with measurements of anxiety (GAD-7), stress (PSQ-20), depression (PHQ-9) and eating behavior (EDI-2). Overall, a positive correlation was found between Neuronatin and BMI (p = 0.006) as well as total fat mass (FM; p = 0.036). In AN, Neuronatin did not correlate with BMI, FM, or PA (p > 0.05); no correlations were found between Neuronatin and psychometric outcomes in obesity (p > 0.05). The findings suggest an FM-dependent peripheral Neuronatin expression. The decreased Neuronatin expression in AN provides evidence that Neuronatin is implicated in the pathogenesis of eating disorders.

The statistical analysis plan for the unification of treatments and interventions for tinnitus patients randomized clinical trial (UNITI-RCT).

BACKGROUND: Tinnitus is a leading cause of disease burden globally. Several therapeutic strategies are recommended in guidelines for the reduction of tinnitus distress; however, little is known about the potentially increased effectiveness of a combination of treatments and personalized treatments for each tinnitus patient. METHODS: Within the Unification of Treatments and Interventions for Tinnitus Patients project, a multicenter, randomized clinical trial is conducted with the aim to compare the effectiveness of single treatments and combined treatments on tinnitus distress (UNITI-RCT). Five different tinnitus centers across Europe aim to treat chronic tinnitus patients with either cognitive behavioral therapy, sound therapy, structured counseling, or hearing aids alone, or with a combination of two of these treatments, resulting in four treatment arms with single treatment and six treatment arms with combinational treatment. This statistical analysis plan describes the statistical methods to be deployed in the UNITI-RCT. DISCUSSION: The UNITI-RCT trial will provide important evidence about whether a combination of treatments is superior to a single treatment alone in the management of chronic tinnitus patients. This pre-specified statistical analysis plan details the methodology for the analysis of the UNITI trial results. TRIAL REGISTRATION: ClinicalTrials.gov NCT04663828 . The trial is ongoing. Date of registration: December 11, 2020. All patients that finished their treatment before 19 December 2022 are included in the main RCT analysis.

Limited Link of Common Blood Parameters with Tinnitus.

Background: Tinnitus severity is generally assessed by psychometric and audiological instruments. However, no objective measure exists to evaluate the subjective discomfort and suffering caused by this hearing phenomenon. The objective of this work was to determine the possible blood parameters for diagnostics and therapy. Methods: We measured tinnitus distress by using the Tinnitus Questionnaire (TQ) and collected tinnitus-related audiological measures, namely the hearing threshold (HT), tinnitus loudness (TL), and sensation level (SL, i.e., the tinnitus loudness/hearing threshold at a tinnitus frequency). Blood samples were taken from 200 outpatients of the Tinnitus Centre of the Charité, and 46 routine blood count parameters were examined. The possible interactions were determined by (robust) linear models. Results: Tinnitus distress and audiological measurements were largely uncorrelated but could partly be predicted by selected blood parameters. First, the erythrocyte counts predicted tinnitus distress to a small extent. Second, the levels of vitamin D3 explained about 6% of tinnitus loudness and, age-dependently, the hearing threshold variability. Last, the levels of uric acid explained about 5% of the sensation level variability. Conclusions: Tinnitus is a multidimensional phenomenon. The marginal influences of blood markers suggest the possible roles of inflammation and oxidative stress produced by psychological or somatic burdens. Clinically, a vitamin D substitution (in older patients) might have a hearing-protective effect.

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.

Effect of Hemodiafiltration or Hemodialysis on Mortality in Kidney Failure.

BACKGROUND: Several studies have suggested that patients with kidney failure may benefit from high-dose hemodiafiltration as compared with standard hemodialysis. However, given the limitations of the various published studies, additional data are needed. METHODS: We conducted a pragmatic, multinational, randomized, controlled trial involving patients with kidney failure who had received high-flux hemodialysis for at least 3 months. All the patients were deemed to be candidates for a convection volume of at least 23 liters per session (as required for high-dose hemodiafiltration) and were able to complete patient-reported outcome assessments. The patients were assigned to receive high-dose hemodiafiltration or continuation of conventional high-flux hemodialysis. The primary outcome was death from any cause. Key secondary outcomes were cause-specific death, a composite of fatal or nonfatal cardiovascular events, kidney transplantation, and recurrent all-cause or infection-related hospitalizations. RESULTS: A total of 1360 patients underwent randomization: 683 to receive high-dose hemodiafiltration and 677 to receive high-flux hemodialysis. The median follow-up was 30 months (interquartile range, 27 to 38). The mean convection volume during the trial in the hemodiafiltration group was 25.3 liters per session. Death from any cause occurred in 118 patients (17.3%) in the hemodiafiltration group and in 148 patients (21.9%) in the hemodialysis group (hazard ratio, 0.77; 95% confidence interval, 0.65 to 0.93). CONCLUSIONS: In patients with kidney failure resulting in kidney-replacement therapy, the use of high-dose hemodiafiltration resulted in a lower risk of death from any cause than conventional high-flux hemodialysis. (Funded by the European Commission Research and Innovation; CONVINCE Dutch Trial Register number, NTR7138.).

NUCB2/nesfatin-1 in the acute stress response of obese women with high and low anxiety.

NUCB2/nesfatin-1 is an anorexigenic peptide hormone first known for its effects on energy homeostasis. More recently, a growing evidence suggests a role of NUCB2/nesfatin-1 in emotion regulation, particularly in the modulation of anxiety, depression and emotional stress response. Since stress-related mood disorders are often comorbid with obesity, we investigated the effect of acute psychosocial stress on circulating NUCB2/nesfatin-1 in obese women and normal-weight controls and its association with symptoms of anxiety. Forty women, 20 obese and 20 normal-weight controls, (aged between 27 and 46 years) were exposed to the Trier Social Stress Test (TSST). We assessed changes of plasma NUCB2/nesfatin-1, salivary cortisol, heart rate and subjective emotional state. Symptoms of anxiety (GAD-7), depressiveness (PHQ-9), perceived stress (PSQ-20), disordered eating (EDE-Q, EDI-2) and health-related quality of life (SF-8) were measured psychometrically. Obese women were further subdivided in a high and low anxiety group. Women with obesity displayed higher psychopathology compared to normal-weight controls. The TSST induced a biological and psychological stress response in both groups (p < 0.001). In normal-weight controls NUCB2/nesfatin-1 increased in response to stress (p = 0.011) and decreased during recovery (p < 0.050), while in obese women only the decrease during recovery was significant (p = 0.002). Obese women with high anxiety displayed higher NUCB2/nesfatin-1 levels than those in the low anxiety group (TSST: +34 %, p = 0.008; control condition: +52 %, p = 0.013). Our data substantiate the involvement of NUCB2/nesfatin-1 in the modulation of stress and anxiety. It remains unclear whether the attenuated stress response in obese subjects is due to metabolic changes or mental comorbidity.

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.