Teamwork and Nurse Care Coordination in Home Healthcare.

Home healthcare agencies provide interdisciplinary care to millions of individuals annually. Care is typically led by registered nurses who often determine additional disciplines need to be included in the plan of care. We found that, although persons living with dementia represent about 30% of the home healthcare population, data from our home healthcare system showed that over a 1-year period with 36,443 home care episodes, only 29.6% had one or more social worker visits. Recognizing Alzheimer's disease-related dementia as a terminal condition and shifting toward a palliative care approach can be a challenge in home healthcare where care is focused on restorative care or rehabilitative goals with a primary focus on improvement in condition. The goal of this article is to present insights into nurse-led care coordination and teamwork and provide implications for practice.

Insulin-like growth factor binding protein-7 concentrations in chronic heart failure: Results from the EMPEROR programme.

AIMS: Insulin-like growth factor binding protein-7 (IGFBP7) is a biomarker of tissue senescence with a role in cardio-renal pathophysiology. The role of IGFBP7 as a prognostic biomarker across the full ejection fraction (EF) spectrum of heart failure (HF) remains less well understood. We examined associations between IGFBP7 and risk of cardio-renal outcomes regardless of EF and the effect of empagliflozin treatment on IGFBP7 concentrations among individuals with HF. METHODS AND RESULTS: IGFBP7 was measured in 1125 study participants from the EMPEROR-Reduced and EMPEROR-Preserved trials. Cox regression was used to study associations with outcomes. Study participants with IGFBP7 levels in the highest tertile had a higher-risk clinical profile. In Cox proportional hazards models adjusted for clinical variables, N-terminal pro-B-type natriuretic peptide and high-sensitivity cardiac troponin T, baseline IGFBP7 values in the highest tertile predicted an increased risk of HF hospitalization or cardiovascular death (hazard ratio [HR] 2.00, 95% confidence interval [CI] 1.28-3.10, p = 0.002, p for trend <0.001) and higher risk of the renal composite endpoint (HR 4.66, 95% CI 1.61-13.53, p = 0.005, p for trend = 0.001), regardless of EF. Empagliflozin reduced risk for cardiovascular death/HF hospitalization irrespective of baseline IGFBP7 (p for trend across IGFBP7 tertiles = 0.26). Empagliflozin treatment was not associated with meaningful change in IGFBP7 at 12 or 52 weeks. CONCLUSION: Across the entire left ventricular EF spectrum in the EMPEROR Programme, concentrations of the senescence-associated biomarker IGFBP7 were associated with higher risk clinical status and predicted adverse cardio-renal outcomes even in models adjusted for conventional biomarkers. Empagliflozin did not significantly affect IGFBP7 levels over time.

Carbohydrate antigen 125 concentrations across the ejection fraction spectrum in chronic heart failure: The EMPEROR programme.

AIM: Vascular congestion may lead to an increase of carbohydrate antigen 125 (CA-125). The role of CA-125 as a biomarker of congestion or for prognosis across the full ejection fraction (EF) spectrum of chronic heart failure (HF) remains unknown. METHODS AND RESULTS: Serum CA-125 was measured in 1111 study participants from the EMPEROR-Reduced and EMPEROR-Preserved trials. Congestive signs and symptoms were evaluated across CA-125 tertiles. Cox regression was used to study the association with outcomes. The primary outcome was a composite of first HF hospitalization or cardiovascular (CV) death. No significant association was present between baseline CA-125 levels and congestive signs or symptoms. In the overall population, higher CA-125 levels were not associated with an increased risk of primary outcome (tertile 3 vs. tertile 1: hazard ratio [HR] 1.34; 95% confidence interval [CI] 0.91-1.96; p-trend = 0.11). However, higher CA-125 levels were associated with an increased risk of primary outcome in patients with HF and reduced EF (HFrEF; tertile 3 vs. tertile 1: HR 2.25 [95% CI 1.30-3.89]), but not among patients with preserved EF (HFpEF; tertile 3 vs. tertile 1: HR 0.68 [95% CI 0.38-1.21]); interaction-p = 0.02). Patients in the upper CA-125 tertile also showed the steepest estimated glomerular filtration rate decline over time (p-trend = 0.03). The effect of empagliflozin to reduce the risk of CV death or HF hospitalization appeared to be attenuated in those with lower baseline CA-125 levels (interaction-p-trend = 0.09). CONCLUSION: Across the range of EF in patients with chronic HF enrolled in the EMPEROR trials, the majority of whom did not have clinical evidence of congestion, CA-125 concentrations were not significantly associated with congestive signs or symptoms. CA-125 concentrations may predict HF hospitalization/CV death in patients with HFrEF, but not those with HFpEF. CLINICAL TRIAL REGISTRATION: EMPEROR-Reduced (NCT03057977), EMPEROR-Preserved (NCT03057951).

The Folkloric Practices of Dominican Women in Managing Bacterial Vaginosis.

Bacterial vaginosis (BV) is characterized by changes in the vaginal flora caused by an elevated pH, resulting in symptoms of vaginal discharge, odor, and irritation. BV affects all women, including Dominican women who have specific cultural beliefs regarding vaginal health hygiene. Due to the prevalence of this condition and cultural norms that may influence how women respond to the diagnosis of BV, it is important to understand the factors that may promote the development of BV and that may influence women's choices of treatment options. Amsel's criteria are the most commonly used clinical approach for the diagnosis of BV. Recurrent BV is common and affects women's lives to varying degrees. Discussion about cultural norms and hygienic practices may provide information that may decrease the recurrence of BV. Nurses can provide support and evidence-based information in a culturally sensitive manner to help Dominican women manage BV.

Growth differentiation factor-15 and the effect of empagliflozin in heart failure: Findings from the EMPEROR program.

AIMS: Growth differentiation factor-15 (GDF-15) is upregulated in part in response to cardiomyocyte stretch and stress, and it exerts a protective role that is mediated by its action to suppress signalling through insulin-like growth factor (IGF) and enhance signalling through adenosine monophosphate-activated protein kinase (AMPK). Sodium-glucose cotransporter 2 (SGLT2) inhibitors improve outcomes in heart failure, which has been experimentally linked to AMPK. This study aimed at evaluating the associations of GDF-15 with baseline characteristics, the prognostic significance of GDF-15, and the effect of empagliflozin on GDF-15 in patients with heart failure with a reduced and preserved ejection fraction. METHODS AND RESULTS: Growth differentiation factor-15 was determined in serum samples from the EMPEROR-Reduced and EMPEROR-Preserved trials. Cox regression and mixed models for repeated measures were used to study the association with outcomes and the effect of empagliflozin on GDF-15, respectively. We studied 1124 patients (560 placebo and 564 empagliflozin) with median GDF-15 levels at baseline of 2442 (interquartile range 1603-3780) pg/ml. Patients with higher GDF-15 levels were typically older men with more severe symptoms, higher N-terminal pro-B-type natriuretic peptide levels, worse kidney function and who were prescribed metformin. Baseline levels of GDF-15 were well correlated with levels of IGF-binding protein 7 (rho = 0.64). Higher levels of GDF-15 were independently associated with an increased risk of cardiovascular death, heart failure hospitalizations, and worse kidney outcomes. When considered as a continuous variable, for each doubling in GDF-15, the adjusted hazard ratio for cardiovascular death or heart failure hospitalization was 1.40 (95% confidence interval 1.15-1.71; p < 0.001). The relative effect of empagliflozin on cardiovascular death and hospitalization for heart failure was most pronounced in patients with higher baseline levels of GDF-15 (interaction p-trend = 0.031). At week 52, when compared with placebo, empagliflozin increased GDF-15 by an additional 8% (p = 0.020), an effect that was primarily seen in patients not receiving metformin, a known AMPK activator. CONCLUSIONS: Growth differentiation factor-15 is a marker of worse heart failure severity, is an independent predictor of major heart failure outcomes and may be associated with more pronounced benefits of empagliflozin. GDF-15 is increased among metformin users, and empagliflozin was associated with an increase in GDF-15 levels, primarily in patients not receiving metformin.

mRNA-based SARS-CoV-2 Comirnaty vaccine elicits weak and short specific memory B cell response in individuals with no previous infection.

Objectives: The dynamics of the memory B cell (MBC) repertoire after SARS-CoV-2 vaccination is crucial for assessing long-term immunity. We compare spike-specific MBC responses between SARS-CoV-2 unexposed and recovered individuals, and their impact on breakthrough infections during follow-up. Methods: Spike-specific MBC and T cells were quantified at inclusion and after two doses of mRNA vaccine in a longitudinal cohort of 85 naïve and 64 recovered participants (47 with positive serology and 17 with negative serology after infection). Results: At inclusion, there was minimal spike-specific MBC in naïve SARS-CoV-2 individuals. After the second vaccine dose, MBCs were significantly boosted in naïve individuals, but reached a significantly lower level than that observed even in unvaccinated SARS-CoV-2 convalescents (p<0.001). Furthermore, while the secondary memory B cell (MBC) population consisted of 100%, 33%, and 76% IgG+, IgM+, and IgA+ expressing cells, respectively, in the unexposed group, the MBC response showed a significant decrease across all isotypes. Similarly, although secondary specific IgG+, IgM+, and IgA+-MBC isotypes were found in 100%, 39%, and 76% of the unexposed participants, respectively, the magnitude of the MBC levels was significantly lower for all the isotypes compared to convalescents. Interestingly, convalescents without an initial serological response had a lower MBC response, like what found in unexposed subjects. There was an inverse correlation between specific MBCs (r=-0.307; p=0.027), especially for isotype IgA+ (r=-0.279, p=0.045), and the time since the second vaccination dose. Furthermore, during a median follow-up of 434 days (IQR, 339-495), 49 out of 149 individuals (33%) became infected, 29 in naïve and 20 in convalescent individuals, showing a significant correlation between spike-specific MBC magnitude after vaccination and the time for SARS-CoV-2 infection, especially for IgA+/IgG+ MBC isotypes. Conclusions: MBCs were primed by mRNA-based vaccination in most cases, but SARS-CoV-2 naïve individuals had a blunted specific MBC response, and this was associated with a shorter time to breakthrough SARS-CoV-2 infection.

Buffy coat signatures of breast cancer risk in a prospective cohort study.

BACKGROUND: Epigenetic alterations are a near-universal feature of human malignancy and have been detected in malignant cells as well as in easily accessible specimens such as blood and urine. These findings offer promising applications in cancer detection, subtyping, and treatment monitoring. However, much of the current evidence is based on findings in retrospective studies and may reflect epigenetic patterns that have already been influenced by the onset of the disease. METHODS: Studying breast cancer, we established genome-scale DNA methylation profiles of prospectively collected buffy coat samples (n = 702) from a case-control study nested within the EPIC-Heidelberg cohort using reduced representation bisulphite sequencing (RRBS). RESULTS: We observed cancer-specific DNA methylation events in buffy coat samples. Increased DNA methylation in genomic regions associated with SURF6 and REXO1/CTB31O20.3 was linked to the length of time to diagnosis in the prospectively collected buffy coat DNA from individuals who subsequently developed breast cancer. Using machine learning methods, we piloted a DNA methylation-based classifier that predicted case-control status in a held-out validation set with 76.5% accuracy, in some cases up to 15 years before clinical diagnosis of the disease. CONCLUSIONS: Taken together, our findings suggest a model of gradual accumulation of cancer-associated DNA methylation patterns in peripheral blood, which may be detected long before clinical manifestation of cancer. Such changes may provide useful markers for risk stratification and, ultimately, personalized cancer prevention.

Influence of Emotional Skills on Attitudes towards Communication: Nursing Students vs. Nurses.

Communication in nursing is essential to the quality of care and patients' satisfaction, and personal variables such as empathy and emotional intelligence (EI) can improve it; however, no studies have to date analyzed these competencies and their relations among nursing students compared with nurses. The aims of this study are, therefore, to analyze the differences between nursing students and nurses in the means for empathy, EI and attitudes towards communication in order to assess the impact of empathy and EI on nurses' and nursing students' attitudes towards communication, and their influence on the behavioral dimension of attitude. A cross-sectional descriptive study was performed on a convenience sample of 961 nursing students and 460 nurses from the Valencian Community, Spain. T-test and hierarchical regression models (HRM) were used. The data was collected in the selected universities in the 2018/2019 academic year. The results showed high levels in all the variables analyzed (i.e., empathy, EI, and attitudes towards communication) in both samples. The HRM results suggested that empathy was a better predictor than EI of the attitudes towards patient communication among both the nursing students and nurses. In the behavioral dimension of the attitude, the cognitive and affective dimensions had greater weight than the emotional component (i.e., empathy and EI). Developing empathy and the cognitive dimension of the attitude in nursing students and nurses could, therefore, help improve EI and attitudes towards communication. These findings are important for developing intervention programs adjusted to real needs.

Lower T cell response against SARS-CoV-2 variants of concern after mRNA vaccine and risk of breakthrough infections in people with HIV.

OBJECTIVES: We evaluated T-cell immune responses against SARS-CoV-2 variants of concern (VOC) after vaccination in people with HIV (PWH), and their impact on the incidence of disease. METHODS: A prospective cohort study. Peripheral blood mononuclear cells (PBMCs) were collected a median of 53 days after second dose of mRNA vaccine. Humoral response and T cell responses against the spike (S) glycoprotein of wild-type SARS-CoV-2 (ancestral Wuhan variant) and mutated S-protein regions found in the Delta and Omicron variants were assessed by flow cytometry analysis. RESULTS: In 142 PWH without preceding SARS-CoV-2 infection, bivariate correlations showed a close association between T-cell responses to the different variants. However, despite at least 70% of PWH having a cellular immune response to any variant, CD4 + and CD8 + T cell responses against VOC were lower in frequency and magnitude (-3% and -20% for Delta, -33% and -28% for Omicron variant) compared with that observed against the Wuhan strain. A higher magnitude of SARS-CoV-2 spike-specific CD8 + T cell responses against all the variants was observed in those PWH with greater immune reconstitution. Notably, 27 symptomatic breakthrough infections (19%) in the setting of Delta and Omicron transmission were observed during follow-up, associated with a significant lower humoral and T-cell response to ancestral strain and VOC. On the contrary, only one PWH with COVID-19 (4%) required hospitalization. CONCLUSION: A blunted T-cell response against Delta and Omicron variant is observed in PWH who received two doses of mRNA vaccine. This lower immune response is associated with breakthrough SARS-CoV-2 infections.

Langerhans cell histiocytosis in the glenoid neck with rare mutation: A case report.

Langerhans cell histiocytosis (LCH) is a rare disease that occurs mainly in children. It has several forms of clinical presentation. Early diagnosis is important for better results. A 17-year-old male patient presented with right sharp shoulder pain for 2 months. Magnetic resonance image (MRI) of the shoulder showed an expansile osseous lesion in the anterosuperior spine of the right scapula with significant edema that causes compression of the subscapular neurovascular bundle. A CT scan and X-rays were also performed. Overall, all the images suggested a lesion compatible with chondroblastoma; however, the pathology images documented a Langerhans cell histiocytosis with a mutation in the V600E/E2/D in the 15 exon of the BRAF gene. LCH is a difficult diagnosis, especially in cases where clinical presentation is not the most common. This case is unique as the lesion developed not only in the scapula which has a 3% prevalence in LCH, but also had radiographic and MRI characteristics of a chondroblastoma more than the typical LCH lesion. Additionally, it was accompanied by a BRAF V600E mutation which is uncommon in LCHs bone cases.

Impact of SARS-CoV-2-specific memory B cells on the immune response after mRNA-based Comirnaty vaccine in seronegative health care workers.

Purpose: To analyze the impact of SARS-COV-2-specific memory B cells (MBC) on the immune response after two doses of mRNA-based Comirnaty COVID-19 vaccine in seronegative health care workers. This study is seeking a rationale for boosting vaccines. Methods: Longitudinal study including 31 seronegative health care workers with undetectable specific MBCs (IgG-MBC- group), 24 seronegative with detectable specific MBCs (IgG-MBC+ group), and 24 seropositive with detectable specific MBCs (IgG+MBC+ group). The level of antibodies that inhibit ACE2-RBD interaction, and anti-Spike IgG, IgA, and IgM antibodies was quantified by ELISA. In addition, specific memory B and T cells were quantified by flow cytometry. Results: The level of specific MBCs, and isotypes, in the IgG-MBC- group was lower compared to that found in IgG-MBC+ (p = 0.0001) and IgG+MBC+ (p < 0.0001) groups, respectively. ACE2-RBD neutralizing antibodies and anti-S IgG antibodies were at lower levels in the IgG-MBC-group after the vaccine. Specific MBCs directly correlated with specific CD4+ T cells (although not significant, p = 0.065), while no correlation was found with specific CD8+ T cells (p = 0.156) after the vaccine. In parallel, ACE2-RBD neutralizing antibodies only positively correlated with specific CD4+ T cells (p = 0.034). Conclusion: IgG-MBC- individuals showed the worst humoral and cellular responses, both in frequency and magnitude, after vaccination. Individuals whose antibodies wane and become undetectable after a given period of time post vaccination and show no specific MBCs are less protected and hence are good candidates for boosting vaccine. On the other hand, seronegative individuals with specific MBC showed faster and higher responses compared to the IgG-MBC- group.

Situaciones estresantes y estrategias de afrontamiento en comunidad LGB / Stressful situations and coping strategies in the LGB community / Situações stressantes e Estratégias de Cópia na Comunidade LGB

Resumen Introducción: El estrés en la comunidad LGB está asociada a su orientación sexual, violencia o discriminación, eventos estresantes los cuales son distintos a los reportados por personas heterosexuales. La literatura reporta relación del nivel de estrés con problemáticas de salud mental, de mayor intensidad y frecuencia en la población LGB. Objetivo: El propósito fue identificar las situaciones estresantes, estrategias de afrontamiento y emociones asociadas en la comunidad LGB. Método: Se realizó un estudio descriptivo con un diseño no experimental de tipo transversal, mediante un muestreo no probabilístico; participaron 272 hombres y mujeres de 14 a 56 años. Se empleó el Cuestionario de Emociones, Estrés y Afrontamiento de Vega et al. (2012). Resultados: Los participantes homosexuales, bisexuales y lesbianas coinciden en reportar en primer lugar situaciones de comunicar su orientación sexual, las situaciones restantes son escolares, laborales y de discriminación por pertenecer a la comunidad LGB. Los participantes usan estrategias de afrontamiento centradas en la acción y en la emoción en proporciones similares (48 %50 %). Las emociones asociadas a situaciones estresantes son ansiedad, temor, vergüenza, culpa. En situaciones placenteras reportan también emociones negativas. Conclusiones: El tipo de situaciones estresantes son distintas en estas poblaciones, debido a que enfrentan con mayor frecuencia eventos relacionados con discriminación o confrontación por su orientación sexual. Se aporta información sobre qué y cómo se afrontan las situaciones que generan estrés en población LGB. Se sugiere generar intervenciones cognitivoconductuales de regulación emocional y afrontamiento efectivo.

Abstract Introduction: Stress in the LGB community is associated with their sexual orientation, violence or discrimination, stressful events which are different from those reported by heterosexual people. The literature reports a relationship between the level of stress and mental health problems, of greater intensity and frequency in the LGB population. Objective: The purpose was to identify stressful situations, coping strategies and associated emotions in the LGB community. Method: A descriptive study was carried out with a non-experimental cross-sectional design, through non-probabilistic sampling, with the participation of 272 men and women aged 14 to 56 years. The Questionnaire of Emotions, Stress and Coping of Vega et al. (2012). Results: Homosexual, bisexual and lesbian participants agree in first reporting situations of communicating their sexual orientation, the remaining situations are school, work and discrimination for belonging to the LGB community. Participants use action-focused and emotion-focused coping strategies in similar proportions (48 % 50 %). Emotions associated with stressful situations are anxiety, fear, shame, guilt. In pleasant situations they also report negative emotions. Conclusions: The type of stressful situations are different in these populations because they more frequently face events related to discrimination or confrontation due to their sexual orientation. Information is provided on what and how situations that generate stress in the LGB population are coped with. It is suggested to generate cognitive behavioral interventions for emotional regulation and effective coping.

Resumo Introdução: O estresse na comunidade LGB está associado à sua orientação sexual, violência ou discriminação, eventos estressantes diferentes dos relatados por pessoas heterossexuais. A literatura relata uma relação entre o nível de estresse e problemas de saúde mental, de maior intensidade e frequência na população LGB. Objetivo: O objetivo foi identificar situações estressantes, estratégias de enfrentamento e emoções associadas na comunidade LGB. Método: Foi realizado um estudo descritivo com delineamento transversal não experimental, utilizando amostragem não probabilística, com a participação de 272 homens e mulheres com idades entre 14 e 56 anos. O Questionário de Emoções, Estresse e Enfrentamento de Vega et al. (2012). Resultados: Os participantes homossexuais, bissexuais e lésbicas concordam no primeiro relato de situações de comunicação de sua orientação sexual, as demais situações são escola, trabalho e discriminação por pertencer à comunidade LGB. Os participantes usam estratégias de enfrentamento focadas na ação e na emoção em proporções semelhantes (48 % 50 %). As emoções associadas a situações estressantes são ansiedade, medo, vergonha, culpa. Em situações agradáveis também relatam emoções negativas. Conclusões: Os tipos de situações estressantes são diferentes nestas populações, pois enfrentam mais frequentemente eventos relacionados à discriminação ou confronto devido à sua orientação sexual. São fornecidas informações sobre o que e como as situações geradoras de estresse na população LGB são enfrentadas. Sugere-se gerar intervenções cognitivo-comportamentais para regulação emocional e enfrentamento eficaz.

Adaptation and Validation of the Spanish Version of the Instrument to Evaluate Nurses' Attitudes Toward Communication With the Patient for Nursing Students.

Communication is essential to the quality of care and patient satisfaction. It has been linked to positive patient outcomes, increased engagement, improved health outcomes, and safe practices. Given these benefits and the association between attitudes and behaviors, as behaviors can be predicted by studying attitudes, assessing attitudes of nursing students toward patient communication is critical for future nursing professionals. For this purpose, the main aim of this study was to adapt and validate an instrument to measure nurses' attitudes toward communication (ACO) for nursing students. The ACO with patients was analyzed. Then, differences in the dimensions of the instrument (ACO) for nursing students according to an academic course and the correlations were calculated. A cross-sectional study was carried out in a convenience sample of 1,417 nursing students from five universities in the Valencian Community (Spain) during the 2018/2019 academic year and 83.8% (1,187) were women. The reliability was analyzed by using Cronbach's alpha and composite reliability (CR). Analysis of construct validity was performed with exploratory factor analysis (EFA) and confirmatory factor analysis (CFA). The instrument adapted from nurses to nursing students was composed of 25 items grouped in three dimensions: affective, cognitive, and behavioral. The psychometric properties suggested that the instrument ACO for nursing students was reliable and valid. The ACO of nursing students was positive with high levels in cognitive and behavioral dimensions, while scores were worst in the affective component. The second-year nursing students showed more positive attitudes in the affective dimension, while in the cognitive and behavioral dimensions, the most positive attitudes were found in the first year. In the correlations, the behavioral and cognitive dimensions showed a significant, positive, and very high correlation. These findings should be considered in developing academic plans to improve the effectiveness of the communication education process of the students to increase the quality of patient care and well-being of nursing students.

Validation of multivariable lung cancer risk prediction models for the personalized assignment of optimal screening frequency: a retrospective analysis of data from the German Lung Cancer Screening Intervention Trial (LUSI).

BACKGROUND: Current guidelines for lung cancer screening via low-dose computed tomography recommend annual screening for all candidates meeting basic eligibility criteria. However, lung cancer risk of eligible screening participants can vary widely, and further risk stratification could be used to individually optimize screening intervals in view of expected benefits, possible harms and financial costs. To this effect, models have been developed in the US National Lung Screening Trial based on self-reported lung cancer risk factors and imaging data. We evaluated these models using data from an independent screening trial in Germany. METHODS: We examined the Polynomial model by Schreuder et al., the Lung Cancer Risk Assessment Tool extended by CT characteristics (LCRAT + CT) by Robbins et al., and a criterion of presence vs. absence of pulmonary nodules ≥4 mm (Patz et al.), applied to sub-sets of screening participants according to eligibility criteria. Discrimination was evaluated via the receiver operating characteristic curve. Delayed diagnoses and false positive results were calculated at various thresholds of predicted risk. Model calibration was assessed by comparing mean predicted risk versus observed incidence. RESULTS: One thousand five hundred and six participants were eligible for the validation of the LCRAT + CT model, and 1,889 for the validation of the Polynomial model and Patz criterion, yielding areas under the receiver operating characteristic curve of 0.73 (95% CI: 0.63, 0.82), 0.75 (0.67, 0.83), and 0.56 (0.53, 0.72) respectively. Skipping 50% annual screenings (participants within the 5 lowest risk deciles by LCRAT + CT in any round or by the Polynomial model; baseline screening round), would have avoided 75% (21.9%, 98.7%) and 40% (21.8%, 61.1%) false positive screen tests and delayed 10% (1.8%, 33.1%) or no (0%, 32.1%) diagnoses, respectively. Using the Patz criterion, referring 63.2% (61.0% to 65.4%) of participants to biennial screening would have avoided 4% (0.2% to 22.3%) of false positive screen tests but delayed 55% (24.6% to 81.9%) diagnoses. CONCLUSIONS: In this German trial, the LCRAT + CT and Polynomial models showed useful discrimination of screening participants for one-year lung cancer risk following CT examination. Our results illustrate the remaining heterogeneity in risk within screening-eligible subjects and the trade-off between a low-frequency screening approach and delayed detection.

Adherence and Dietary Composition during Intermittent vs. Continuous Calorie Restriction: Follow-Up Data from a Randomized Controlled Trial in Adults with Overweight or Obesity.

Although intermittent calorie restriction (ICR) has become popular as an alternative weight loss strategy to continuous calorie restriction (CCR), there is insufficient evidence on diet quality during ICR and on its feasibility over longer time periods. Thus, we compared dietary composition and adherence between ICR and CCR in a follow-up analysis of a randomized trial. A total of 98 participants with overweight or obesity [BMI (kg/m2) 25-39.9, 35-65 years, 49% females] were randomly assigned to ICR, operationalized as a "5:2 diet" (energy intake: ~100% on five non-restricted (NR) days, ~25% on two restricted (R) days), or CCR (daily energy intake: ~80%). The trial included a 12-week (wk) intervention phase, and follow-up assessments at wk24, wk50 and wk102. Apart from a higher proportion of energy intake from protein with ICR vs. CCR during the intervention (wk2: p < 0.001; wk12: p = 0.002), there were no significant differences with respect to changes in dietary composition over time between the groups, while overall adherence to the interventions appeared to be good. No significant difference between ICR and CCR regarding weight change at wk102 was observed (p = 0.63). However, self-reported adherence was worse for ICR than CCR, with 71.1% vs. 32.5% of the participants reporting not to or only rarely have followed the regimen to which they were assigned between wk50 and wk102. These results indicate that within a weight management setting, ICR and CCR were equivalent in achieving modest weight loss over two years while affecting dietary composition in a comparable manner.

Can autoantibody tests enhance lung cancer screening?-an evaluation of EarlyCDT®-Lung in context of the German Lung Cancer Screening Intervention Trial (LUSI).

BACKGROUND: Tumor-associated autoantibodies are considered promising markers for early lung cancer detection; so far, however, their capacity to detect cancer has been tested mostly in a clinical context, but not in population screening settings. This study evaluates the early detection accuracy, in terms of sensitivity and specificity, of EarlyCDT®-Lung-a test panel of seven tumor-associated autoantibodies optimized for lung cancer detection-using blood samples originally collected as part of the German Lung Cancer Screening Intervention Trial. METHODS: The EarlyCDT®-Lung test was performed for all participants with lung cancer detected via low-dose computed tomography and with available blood samples taken at detection, and for 180 retrospectively selected cancer-free participants at the end of follow-up: 90 randomly selected from among all cancer-free participants (baseline controls) and 90 randomly selected from among cancer-free participants with suspicious imaging findings (suspicious nodules controls). Sensitivity and specificity of lung cancer detection were estimated in the case group and the two control groups, respectively. RESULTS: In the case group, the test panel showed a sensitivity of only 13.0% (95% CI: 4.9-26.3%). Specificity was estimated at 88.9% (95% CI: 80.5-94.5%) in the baseline control group, and 91.1% (95% CI: 83.2-96.1%) among controls presenting CT-detected nodules. CONCLUSIONS: The test panel showed insufficient sensitivity for detecting lung cancer at an equally early stage as with low-dose computed tomography screening.

Overdiagnosis in lung cancer screening: Estimates from the German Lung Cancer Screening Intervention Trial.

Overdiagnosis is a major potential harm of lung cancer screening; knowing its potential magnitude helps to optimize screening eligibility criteria. The German Lung Screening Intervention Trial ("LUSI") is a randomized trial among 4052 long-term smokers (2622 men), 50.3 to 71.9 years of age from the general population around Heidelberg, Germany, comparing five annual rounds of low-dose computed tomography (n = 2029) with a control arm without intervention (n = 2023). After a median follow-up of 9.77 years postrandomization and 5.73 years since last screening, 74 participants were diagnosed with lung cancer in the control arm and 90 in the screening arm: 69 during the active screening period; of which 63 screen-detected and 6 interval cancers. The excess cumulative incidence in the screening arm (N = 16) represented 25.4% (95% confidence interval: -11.3, 64.3] of screen-detected cancer cases (N = 63). Analyzed by histologic subtype, excess incidence in the screening arm appeared largely driven by adenocarcinomas. Statistical modeling yielded an estimated mean preclinical sojourn time (MPST) of 5.38 (4.76, 5.88) years and a screen-test sensitivity of 81.6 (74.4%, 88.8%) for lung cancer overall, all histologic subtypes combined. Based on modeling, we further estimated that about 48% (47.5% [43.2%, 50.7%]) of screen-detected tumors have a lead time ≥4 years, whereas about 33% (32.8% [28.4%, 36.1%]) have a lead time ≥6 years, 23% (22.6% [18.6%, 25.7%]) ≥8 years, 16% (15.6% [12.2%, 18.3%]) ≥10 years and 11% (10.7% [8.0%, 13.0%]) ≥12 years. The high proportions of tumors with relatively long lead times suggest a major risk of overdiagnosis for individuals with comparatively short remaining life expectancies.