New race-free creatinine- and cystatin C-based equations for the estimation of glomerular filtration rate and association with cardiovascular mortality in the AtheroGene study.

Renal function is associated with cardiovascular outcomes and mortality. Among equations used to eGFR, CKD-EPI equations show more accurate association with cardiovascular risk and mortality than MDRD. Recently, new CKD-EPI equations were proposed which do not include race and would be considered sufficiently accurate to estimate eGFR in clinical practice. It is unknown if these new race-free equations are comparably well associated with cardiovascular outcomes in high-risk individuals. The analysis was performed in the AtheroGene Study cohort including patients at high cardiovascular risk. eGFR was determined using the established as well as the recently developed formulas which are calculated without the otherwise existing coefficient for black race. The outcome was cardiovascular death. Analyses included Cox-proportional hazard regression and area-under-the-curve calculation. The analysis included 2089 patients followed up for a median of 3.8 years with a maximum of 6.9 years, corresponding to an overall period of 7701 patient-years. Cardiovascular death occurred in 93 (4.45%), corresponding to an annualized rate of 1.2/100 person-years. In all Cox regression analyses, the estimated adjusted GFR was an independent predictor of cardiovascular death. The equations which included cystatin C showed higher C-index compared to those which did not include cystatin C (0.75-0.76 vs. 0.71, respectively). The equations for the estimation of eGFR which include cystatin C are better associated with cardiovascular death compared to the race-free equations which include only creatinine. This finding adds on the related literature which supports the elimination of race in GFR-estimating equations, and promotion of the use of cystatin C.

Deep learning-based NT-proBNP prediction from the ECG for risk assessment in the community.

OBJECTIVES: The biomarker N-terminal pro B-type natriuretic peptide (NT-proBNP) has predictive value for identifying individuals at risk for cardiovascular disease (CVD). However, it is not widely used for screening in the general population, potentially due to financial and operational reasons. This study aims to develop a deep-learning model as an efficient means to reliably identify individuals at risk for CVD by predicting serum levels of NT-proBNP from the ECG. METHODS: A deep convolutional neural network was developed using the population-based cohort study Hamburg City Health Study (HCHS, n=8,253, 50.9 % women). External validation was performed in two independent population-based cohorts (SHIP-START, n=3,002, 52.1 % women, and SHIP-TREND, n=3,819, 51.2 % women). Assessment of model performance was conducted using Pearson correlation (R) and area under the receiver operating characteristics curve (AUROC). RESULTS: NT-proBNP was predictable from the ECG (R, 0.566 [HCHS], 0.642 [SHIP-START-0], 0.655 [SHIP-TREND-0]). Across cohorts, predicted NT-proBNP (pNT-proBNP) showed good discriminatory ability for prevalent and incident heart failure (HF) (baseline: AUROC 0.795 [HCHS], 0.816 [SHIP-START-0], 0.783 [SHIP-TREND-0]; first follow-up: 0.669 [SHIP-START-1, 5 years], 0.689 [SHIP-TREND-1, 7.3 years]), comparable to the discriminatory value of measured NT-proBNP. pNT-proBNP also demonstrated comparable results for other incident CVD, including atrial fibrillation, stroke, myocardial infarction, and cardiovascular death. CONCLUSIONS: Deep learning ECG algorithms can predict NT-proBNP concentrations with high diagnostic and predictive value for HF and other major CVD and may be used in the community to identify individuals at risk. Long-standing experience with NT-proBNP can increase acceptance of such deep learning models in clinical practice.

Global Burden of Atrial Fibrillation and Flutter by National Income: Results From the Global Burden of Disease 2019 Database.

Background Atrial fibrillation (AF) and atrial flutter (AFL) are common conditions that can lead to significant morbidity and death. We aimed to understand the distribution and disparities of the global burden of AF/AFL as well as the underlying risk factors. Methods and Results Data on the AF/AFL burden from the Global Burden of Disease data set were analyzed for the years 1990 to 2019, with countries grouped into low, lower-middle, upper-middle, and high national income classes according to World Bank categories. Data were supplemented with World Health Organization and World Bank information. The prevalence of AF/AFL has more than doubled (+120.7%) since 1990 in all income groups, though with a larger increment in middle-income countries (+146.6% in lower-middle- and +145.2% in upper-middle-income countries). In absolute numbers, 63.4% of AF/AFL cases originate from upper-middle-income countries, although the relative prevalence is highest in high-income countries. Prevalence of AF/AFL appears to be correlated with medical doctor rate and life expectancy. The most relevant AF/AFL risk factors are unevenly distributed among income classes, with elevated blood pressure as the only risk factor that becomes less common with increasing income. The development of these risk factors differed over time. Conclusions The global burden of AF/AFL is increasing in all income groups and is more pronounced in middle-income countries, with further growth to be expected. Underdiagnosis of AF/AFL in low- and middle-income countries may contribute to lower reported prevalence. The risk factor distribution varies between income groups.

Distress, anxiety, and depression in persons with hereditary cancer syndromes: Results from a nationwide cross-sectional study in Germany.

BACKGROUND: Persons with hereditary cancer syndromes (carriers) have a higher risk of developing cancer early. They are confronted with decisions regarding prophylactic surgeries, communication within their families, and childbearing. The present study aims to assess distress, anxiety, and depression in adult carriers and identify risk groups and predictors; clinicians can use to screen for particularly distressed persons. METHODS: N = 223 participants (n = 200 women, n = 23 men) with different hereditary cancer syndromes affected and unaffected by cancer answered questionnaires measuring their distress, anxiety, and depression levels. The sample was compared to the general population using one-sample t-tests. The n = 200 women with (n = 111) and without cancer (n = 89) were then compared and predictors for increased levels of anxiety and depression were identified using stepwise linear regression analyses. RESULTS: 66% reported clinical relevant distress, 47% reported clinical relevant anxiety, and 37% reported clinical relevant depression. Compared to the general population, carriers experienced increased distress, anxiety, and depression. Additionally, women with cancer suffered from more depressive symptoms than those without cancer. Past psychotherapy for a mental disorder and high distress were identified as predictors for increased anxiety and depression in female carriers. CONCLUSIONS: The results suggest that the psychosocial consequences of hereditary cancer syndromes are serious. Clinicians could regularly screen carriers regarding anxiety and depression. The NCCN Distress Thermometer can be combined with questions about past psychotherapy to identify especially vulnerable persons. Further studies are needed to develop psychosocial interventions.

Exploring the incremental utility of circulating biomarkers for robust risk prediction of incident atrial fibrillation in European cohorts using regressions and modern machine learning methods.

AIMS: To identify robust circulating predictors for incident atrial fibrillation (AF) using classical regressions and machine learning (ML) techniques within a broad spectrum of candidate variables. METHODS AND RESULTS: In pooled European community cohorts (n = 42 280 individuals), 14 routinely available biomarkers mirroring distinct pathophysiological pathways including lipids, inflammation, renal, and myocardium-specific markers (N-terminal pro B-type natriuretic peptide [NT-proBNP], high-sensitivity troponin I [hsTnI]) were examined in relation to incident AF using Cox regressions and distinct ML methods. Of 42 280 individuals (21 843 women [51.7%]; median [interquartile range, IQR] age, 52.2 [42.7, 62.0] years), 1496 (3.5%) developed AF during a median follow-up time of 5.7 years. In multivariable-adjusted Cox-regression analysis, NT-proBNP was the strongest circulating predictor of incident AF [hazard ratio (HR) per standard deviation (SD), 1.93 (95% CI, 1.82-2.04); P < 0.001]. Further, hsTnI [HR per SD, 1.18 (95% CI, 1.13-1.22); P < 0.001], cystatin C [HR per SD, 1.16 (95% CI, 1.10-1.23); P < 0.001], and C-reactive protein [HR per SD, 1.08 (95% CI, 1.02-1.14); P = 0.012] correlated positively with incident AF. Applying various ML techniques, a high inter-method consistency of selected candidate variables was observed. NT-proBNP was identified as the blood-based marker with the highest predictive value for incident AF. Relevant clinical predictors were age, the use of antihypertensive medication, and body mass index. CONCLUSION: Using different variable selection procedures including ML methods, NT-proBNP consistently remained the strongest blood-based predictor of incident AF and ranked before classical cardiovascular risk factors. The clinical benefit of these findings for identifying at-risk individuals for targeted AF screening needs to be elucidated and tested prospectively.

The Relationship Between Vitamin D and Postoperative Atrial Fibrillation: A Prospective Cohort Study.

Background and Aims: The relationship between postoperative atrial fibrillation (POAF) and 25-hydroxyvitamin D [25(OH)D] concentration as well as vitamin D supplementation has been discussed controversially. The relation of pre-operative vitamin D status and POAF remains unclear. Methods and Results: We analysed the risk of POAF in a prospective, observational cohort study of n = 201 patients undergoing coronary artery bypass graft surgery (CABG) with 25(OH)D concentration. The median age was 66.6 years, 15.4% were women. The median (25th/75th percentile) vitamin D concentration at baseline was 17.7 (12.6/23.7) ng/ml. During follow-up we observed 48 cases of POAF. In age, sex, and creatinine-adjusted analyses, 25(OH)D was associated with an increased risk of POAF, though with borderline statistical significance [odds ratio (OR) 1.85, 95% confidence interval (CI) 0.87-3.92, p-value 0.107], in further risk factor-adjusted analyses the results remained stable (OR 1.99, 95% CI 0.90-4.39, p-value 0.087). The subgroup with vitamin D supplementation at baseline showed an increased risk of POAF (OR 5.03, 95% CI 1.13-22.33, p-value 0.034). Conclusion: In our contemporary mid-European cohort, higher 25(OH)D concentration did not show a benefit for POAF in CABG patients and may even be harmful, though with borderline statistical significance. Our data are in line with a recent randomised study in community-based adults and call for further research to determine both, the clinical impact of elevated 25(OH)D concentration and vitamin D supplementation as well as the possible underlying pathophysiological mechanisms.

Psychometric Properties of the Questionnaire on Stress in Partners of Cancer Patients.

A cancer disease can be associated with psychological stress for both patients and partners. To date, no psychometrically tested measuring instrument has been available for the assessment of cancer-specific distress in partners of cancer patients. The Questionnaire on Stress in Partners of Cancer Patients (QSC-P) was developed to close this gap. This study validates the QSC-P in two subsamples of n1 = 227 and n2 = 297 partners of cancer patients by application of exploratory factor analysis methods in n1 and confirmatory factor analysis methods in n2. Additionally, correlations with common measures of anxiety, depression, and quality of life were calculated. A cut-off for high distress was determined. A three-factor structure with 23 items that was generated in n1 could be replicated in n2. Reliability and validity analyses resulted in good to very good characteristic values of the resulting QSC-P (α = .84- .93). A cut-off of 68.5 with good sensitivity and specificity was calculated. The QSC-P proved to be a valid and reliable measuring instrument for psychological distress of partners of cancer patients and a helpful tool for clinical care and research. Future directions include development of a short-form and detailed comparison of the sexes.

Body image in patients with different types of cancer.

BACKGROUND: Cancer can cause physical changes and affect satisfaction with a persons' physical appearance, which in turn can affect overall quality of life. Previous studies have primarily focused on women with breast cancer and few is known about body image in patients with other cancers and especially men. The present study compares satisfaction with body image of patients with different types of cancer with the general population and across sexes and identifies risk factors for diminished body image. Additionally, patients that were diagnosed within the last year and those living with cancer for longer are compared. METHODS: In this cross-sectional study, N = 531 cancer patients answered the German Self-Image Scale to assess body image. One sample t-tests are utilized to compare the body image of cancer patients with the general population. Stepwise regression analyses were used to identify factors associated with body image and ANOVAs with posthoc tests as well as t-tests were used to examine group differences. RESULTS: Cancer patients showed diminished body image compared to the general population. For men, higher relationship satisfaction and lower cancer-specific distress were associated with more positive body self-acceptance (SA), whereas younger age, higher relationship satisfaction, and lower cancer-specific distress resulted in better perceived partner-acceptance of one's body (PA). In women, higher education, lower anxiety and cancer-specific distress were associated with more positive SA. Female cancer patients with breast/gynecological cancer reported better SA than those with visceral cancers. Higher relationship satisfaction and lower cancer-specific distress were found to be associated with more satisfactory PA in females. Time since diagnosis did not affect body image in this study. CONCLUSIONS: Results indicate that cancer patients regardless of sex tend to have decreased body image satisfaction. Future research directions include examination of additional entities of cancer, deeper research in men and the role of time since diagnosis.

[The Pathological Buying Screener: Validation in a Clinical Sample]. / Der Pathological Buying Screener: Validierung in einer klinischen Stichprobe.

AIM: The aim of the study was to evaluate the psychometric properties of the 13-item Pathological Buying Screener (PBS, [1]) in a clinical sample. METHOD: The PBS was administered to a total sample of 413 treatment-seeking patients (buying-shopping disorder n=151, gambling disorder n=59, alcohol dependency n=60, other mental disorders [anxiety, depressive, eating, somatoform disorders] n=143). Factor structure was tested in the total sample using confirmatory factor analysis (CFA), reliability was determined by means of Cronbach's α. Group comparisons were used to determine to which degree the PBS discriminates between patients with BSD and other clinical groups. The BSD-group completed a battery of other measures to explore convergent and divergent validity. A subgroup (n=29) answered the PBS before and after psychotherapy to investigate sensitivity to change. A receiver operating characteristic (ROC) curve analysis with PBS data of patients with buying-shopping disorder and those from a previous community sample 1 was performed to define a cut-off point for buying-shopping disorder. RESULTS: The CFA showed a good model fit for both a one-factor and a two-factor structure with the subscales "loss of control/consequences" (10 items) and "excessive buying behavior" (3 items). The subscales were highly intercorrelated (r=0.92). A hierarchical regression analysis with another BSD measure as dependent variable did not indicate an own incremental validity of the subscale "excessive buying behavior". Good convergent, divergent and discriminative capacity was obtained for the PBS total score. At its recommended cut-off point of ≥29 the PBS has a sensitivity of 98% and a specificity of 94.7%. CONCLUSION: The findings indicate good psychometric properties of the PBS and suggest that the PBS total score can be used in clinical settings.

Psychological Distress in a Sample of Inpatients With Mixed Cancer-A Cross-Sectional Study of Routine Clinical Data.

BACKGROUND: The diagnosis and treatment of cancer are associated with psychological distress that often leads to a significant reduction in emotional and physical well-being and quality of life. Early detection of psychological distress is therefore important. This study aims to assess the psychological distress of inpatient cancer patients using routine clinical data. Furthermore, variables and problems most strongly associated with psychological distress should be identified. MATERIALS AND METHODS: N = 1,869 inpatients were investigated (mean age = 60.89 years; 35.94% female) using the National Comprehensive Cancer Network Distress Thermometer and problem checklist to assess distress as well as multiple possible problem areas. Visceral oncological cancer (31.6%) was the most common tumor diagnosis, followed by skin cancer (26.2%) and urological cancer (21.7%). RESULTS: 65.9% of the sample experienced high levels of distress (Distress Thermometer ≥ 5). Female sex, stage 4 of disease, and visceral and head and neck cancer emerged as risk factors for high distress. A younger age (<65 years) was significantly correlated with higher distress. The most frequently self-reported problems were fears (50.1%), worry (49.9%), and fatigue (49.1%). Patients with all 3 of these problems had 24 times higher risk [odds ratio (OR) = 23.9] for high levels of distress than patients without these problems. Women reported significantly more practical, emotional, and physical problems than men. Younger (<50 years) and middle-aged patients (50-64 years) reported increased levels of practical, family, and emotional problems compared with older patients (≥65 years). DISCUSSION: Almost two-thirds of the sample reported high levels of distress. The most frequently reported problem areas were emotional and physical problems. These results can help to identify patients with high risk for psychological distress and, therefore, be used to optimize psychosocial and psycho-oncological care for patients with cancer.

Psychometric properties of the German version of the Self Image Scale (SIS-D) in a sample of cancer patients.

BACKGROUND: A cancer disease can affect the satisfaction with the physical appearance, so that the standardized assessment of the body image is important in cancer patients. The German version of the Self-Image Scale is a self-report measure that uses two subscales to assess appearance satisfaction (self-acceptance) and perceptions of partners' acceptance of their appearance (partner-acceptance). The present study aimed to validate the Self-Image Scale's two-factor structure in a sample of cancer patients with a variety of different diagnoses to further increase its utility. METHODS: Confirmatory factor analysis methods were used to examine the two-factor model in a sample of cancer patients (N = 278). Scale reliability and validity were then assessed through internal consistency measures and correlations with external criteria such as depressiveness, anxiety, distress, and relationship satisfaction. RESULTS: The proposed factor structure was supported by the results and the internal consistencies were good with α = .83 for the self-acceptance scale and α = .88 for the partner-acceptance scale while additional correlations with external criteria were observed as expected. CONCLUSIONS: The results support the use of the German version of the Self-Image Scale in cancer patients in general. Future research directions include validation across further entities of cancer, the in-depth investigation of sex differences, and research in other diseases that might impact body image.

Factor Analyses and Validity of the Transplant Evaluation Rating Scale (TERS) in a Large Sample of Lung Transplant Candidates.

OBJECTIVE: It is well known that the occurrence of mental disorders is more common in lung transplant candidates compared to the general population. After transplantation mental disorders may negatively affect quality of life, adherence to immunosuppressive medication, as well as overall survival. Therefore, the identification of patients at risk is of utmost importance and in Germany pre-transplant psychosocial evaluation of the patients is required. To ensure high quality and comparability of these assessments, the use of psychometrically sound instruments is recommended. We applied the Transplant Evaluation Rating Scale (TERS), a broadly used expert interview. Two research groups have detected a two-factor structure of the TERS in different transplant samples; however, with slightly different results. The present study investigated which of the models would fit best in our sample of lung transplant patients. Additionally, we assessed convergent and predictive validity of the best fitting model to evaluate its clinical usefulness. METHODS: Between 2016 and 2019, 390 lung transplant candidates were evaluated and included in the study. The median age was 53 years and 54% were male. TERS interviews were conducted by trained medical doctors and psychologists. The participants completed questionnaires assessing quality of life and levels of depression and anxiety. Transplant- and disease-specific variables (lung disease, listing date, oxygen use) were taken from the patient charts. Confirmatory factor analysis was used to test the two proposed TERS-models in the present sample. RESULTS: The two-factor structure of the TERS reported by Hoodin and Kalbfleisch fit our sample best, showing good psychometric properties. The factor "emotional sensitivity" was highly correlated with quality of life and measures of psychosocial health while the factor "defiance" correlated with obstructive lung disease and older age but not with quality of life. The two factors showed differential predictive validity with regard to time until listing and pulmonary-specific quality of life 1 year after transplantation. CONCLUSIONS: The two factors showed good psychometric properties, and differential convergent and predictive validity. However, further studies concentrating on the predictive value of the TERS and its factors regarding somatic outcomes (mortality, graft functioning) are required.

Psychometric properties of the German version of the Self-Image Scale (SIS-D).

BACKGROUND: The Self-Image Scale is a self-report measure originally developed for use in women with cancer. Two subscales assess appearance satisfaction (self-acceptance) and perceptions of partners' acceptance of their appearance (partner-acceptance). This study aimed to increase the Self-Image Scale's utility by 1) confirming the two-factor structure of the German version of the Self-Image Scale, 2) testing measurement invariance across sex and age groups and validity, and 3) gathering general population normative data. METHODS: Confirmatory factor analysis methods were used to examine the proposed two-factor model in a random sample of adults from the general German population (N = 1367). Measurement invariance, scale reliability, and validity were assessed. RESULTS: The original factor structure and measurement invariance across sexes and age groups were supported. Women showed significantly lower self-acceptance than men. Adolescent and young adult women showed higher self-acceptance than senior women. For both sexes, partner-acceptance lowered across successive age cohorts. Internal consistencies were good. CONCLUSIONS: Results support the use of the German version of the Self-Image Scale in research and clinical practice. Research directions include validation in further diseases, collecting normative data across countries, and dyadic research, particularly exploring partner-acceptance across the life span.

Psychometric Properties of the German Version of the Pulmonary-Specific Quality-of-Life Scale in Lung Transplant Patients.

The Pulmonary-Specific Quality-of-Life Scale (PQLS) is a validated self-report questionnaire assessing health-related quality of life (HRQoL) in patients with end-stage lung disease awaiting lung transplantation. The aim of our study was to evaluate the psychometric properties of the German version of the PQLS. One hundred and forty patients awaiting lung transplantation (55% men) with a median age of 53 years [Interquartile range (IQR) 13] answered the PQLS. A group of the participants (n = 43) was evaluated again 1 year later after transplantation. A confirmatory factor analysis (CFA) of the PQLS was conducted to test the three-factor structure of the PQLS. We examined the internal consistency of the scales using Cronbach's α. Convergent validity was explored through correlations with generic measures of HRQoL [Short-Form 8 Health Survey (SF-8), 10-item quality of life (QoL) scale], measures of depression (nine-item Patient Health Questionnaire-Depression Scale), anxiety (Generalized Anxiety Scale), and measures of lung disease severity (supplemental oxygen use, stairway steps). In the group of 43 patients assessed before and after transplantation, sensitivity to change was explored. The CFA confirmed the three-factor model with an acceptable fit. The PQLS total and the three subscale scores "task interference," "psychological," and "physical" showed acceptable internal consistency. The PQLS and its subscales showed a significant negative correlation with the 10-item QoL measure and the physical component score of the SF-8, whereas the mental component score of the SF-8 showed a significant negative correlation only with the PQLS subscale "psychological." Negative correlation was found due to the opposed alignment of the PQLS compared to the 10-item QoL and the SF-8. Symptoms of depression and anxiety were significantly and positively correlated with the subscale "psychological." Measures of lung disease severity also exhibited a significant positive correlation with the subscales "task interference" and "physical" but not "psychological." In patients 1 year after a successful transplantation, the PQLS scores were significantly reduced by 50%. The three-factor structure of the PQLS could be replicated using CFA. The results indicate good reliability, validity, and sensitivity to change of the German version of the PQLS.