Effectiveness and Feasibility of a Remote Lifestyle Intervention by Dietitians for Overweight and Obese Adults: Pilot Study

BACKGROUND To tackle the problem of obesity and related diseases in Switzerland, cost-efficient, effective, and innovative primary health care interventions for weight management are required. In this context, Oviva has developed a scalable technology for registered dietitians to counsel overweight and obese patients via a mobile phone app. OBJECTIVE The aim of this study was to evaluate the effectiveness and feasibility of weight loss counseling by dietitians using a mobile phone app for patients with overweight and obesity. METHODS In this pre- and posttest pilot study, overweight and obese adults participated in a 1-year behavioral intervention to lose weight through remote counseling by dietitians in the German-speaking part of Switzerland. The study started in April 2016 and finished in May 2018. Participants received individual counseling through the app and the exchange with the dietitian focused on regular feedback on photo-based food log, motivation, and education. The contents were tailored to the individual lifestyle goal set. The predefined intensity of remote counseling decreased during the year. Group chat could be used. The outcomes examined were changes in weight (primary outcome), hemoglobin A1c, fasting glucose, fasting insulin, triglyceride, high-density lipoprotein cholesterol, blood pressure (BP), body mass index (BMI), waist circumference, body fat, and responses to a self-administered questionnaire with questions regarding participants' physical activity, dietary assessment, and health-related quality of life. Changes were tested at baseline, after 3 months, and after 12 months, as well as between the third and the 12th month. RESULTS In total, 36 women and 7 men, with a mean age of 40.6 years, participated and 36 participants completed the study. Median weight change after the first 12 weeks was -3.8 kg (range: -15 to 2.4 and P<.001), between week 12 and week 52 it was -1.1 kg (range: -9.7 to 7 and P=.08), and the median change during the entire period of intervention was -4.9 kg (range: -21.9 to 7.5 and P<.001). Furthermore, changes in BMI, waist circumference, body fat, and BP between baseline and 12 weeks and between baseline and 52 weeks were also significant. Significant changes in certain eating habits were also demonstrated (higher frequency of vegetable, fruit, and breakfast consumption and lower frequency of alcohol, sweet, and fat consumption). CONCLUSIONS In addition to the professional skills of a dietitian, a profession-specific app such as Oviva can provide effective support that meets the needs of dietitians and clients on the long path of behavioral change and sustainable weight reduction. TRIAL REGISTRATION ClinicalTrials.gov NCT02694614; https://clinicaltrials.gov/ct2/show/NCT02694614 (Archived by WebCite at http://www.webcitation.org/76gYkGOIc)

Prescription Patterns, Recurrence, and Toxicity Rates of Adjuvant Treatment for Stage III/IV Melanoma-A Real World Single-Center Analysis.

Approved adjuvant treatment options for stage III melanoma are the immune checkpoint inhibitors (ICI) pembrolizumab and nivolumab, and in presence of a BRAF V600E/K mutation additionally dabrafenib in combination with trametinib (BRAFi/MEKi). This study aims to describe prescription patterns and recurrence and toxicity rates of adjuvant-treated melanoma patients from the Cancer Center of the University Hospital Bern, Switzerland. One hundred and nine patients with an indication for adjuvant treatment were identified. Five (4.6%) had contraindications and, as such, were not proposed any adjuvant treatment, while 10 patients (9.2%) declined treatment. BRAF status was known for 91 (83.5%) patients. Of 40 (36.7%) patients with BRAF V600E/K melanoma, pembrolizumab was prescribed to 18 (45.0%), nivolumab to 16 (40.0%), and dabrafenib/trametinib to three (7.5%) patients. Grade 3-4 toxicity was reported in 18.9% and 16.7% of all the patients treated with pembrolizumab and nivolumab, respectively. No toxicities were observed for dabrafenib/trametinib. Thirty-eight percent of the patients treated with pembrolizumab and 40.0% of those treated with nivolumab relapsed. No relapses were reported for dabrafenib/trametinib. Prescription patterns indicate a clear preference for adjuvant ICI treatment

Validation of salt intake measurements: comparisons of a food record checklist and spot-urine collection to 24-hour-urine collection.

OBJECTIVE Monitoring population salt intake is operationally and economically challenging. We explored whether a questionnaire assessment and a prediction of Na intake from spot-urine could replace or complement the recommended measurement of Na in 24-hour urine (24hU). DESIGN Compare the agreement of a Na-specific food record checklist (FRCL) and a late afternoon spot-urine measurement (PM-spot) with 24hU measurement in estimating Na intake at group level. Each participant's use of these methods extended over three days. Agreement was assessed using mean (95% CI) differences, linear regression models, and Bland-Altman plots. SETTING The validation study was part of a one-year workplace intervention trial to lower salt intake in Switzerland. PARTICIPANTS 70 women and 71 men, 21-61 years, completed three FRCLs, and acceptable PM-spot and 24hU samples at baseline (April-October 2015). RESULTS Mean Na intake estimates varied slightly across methods (3.5-3.9 g/d). Mean Na intake differences from 24hU were 0.2 (95% CI 0, 0.5) g/d for FRCL, and 0.4 (95% CI 0.2, 0.6) g/d for PM-spot. Linear regression models and Bland-Altmann plots more clearly depicted differences by sex and discretionary salt use. CONCLUSIONS Although 24hU remains the best reference method for monitoring Na intake at the population level, PM-spot and FRCL might be more practical instruments for frequent, periodic Na intake assessments. Population specific prediction models to estimate 24hU could be developed and evaluated

secondary results of a randomized phase III trial (SAKK 10/94)

Background To analyze the impact of weight loss before and during chemoradiation on survival outcomes in patients with locally advanced head and neck cancer. Methods From 07/1994-07/2000 a total of 224 patients with squamous cell carcinoma of the head and neck were randomized to either hyperfractionated radiation therapy alone or the same radiation therapy combined with two cycles of concomitant cisplatin. The primary endpoint was time to any treatment failure (TTF); secondary endpoints were locoregional recurrence-free survival (LRRFS), distant metastasis-free survival (DMFS) and overall survival (OS). Patient weight was measured 6 months before treatment, at treatment start and treatment end. Results The proportion of patients with >5% weight loss was 32% before, and 51% during treatment, and the proportion of patients with >10% weight loss was 12% before, and 17% during treatment. After a median follow-up of 9.5 years (range, 0.1 – 15.4 years) weight loss before treatment was associated with decreased TTF, LRRFS, DMFS, cancer specific survival and OS in a multivariable analysis. However, weight loss during treatment was not associated with survival outcomes. Conclusions Weight loss before and during chemoradiation was commonly observed. Weight loss before but not during treatment was associated with worse survival

Prediction of Biochemical Recurrence Based on Molecular Detection of Lymph Node Metastasis After Radical Prostatectomy.

Background Molecular detection of lymph node (LN) micrometastases by analyzing mRNA expression of epithelial markers in prostate cancer (PC) patients provides higher sensitivity than histopathological examination. Objective To investigate which type of marker to use and whether molecular detection of micrometastases in LNs was predictive of biochemical recurrence. Design setting and participants LN samples from PC patients undergoing radical prostatectomy with extended LN dissection between 2009 and 2011 were examined for the presence of micrometastases by both routine histopathology and molecular analyses. Outcome measurements and statistical analysis The mRNA expression of a panel of markers of prostate epithelial cells, prostate stem cell-like cells, epithelial-to-mesenchymal transition, and stromal activation, was performed by quantitative real-time polymerase chain reaction. The expression levels of these markers in LN metastases from three PC patients were compared with the expression levels in LN from five control patients without PC in order to identify the panel of markers best suited for the molecular detection of LN metastases. The predictive value of the molecular detection of micrometastases for biochemical recurrence was assessed after a follow-up of 10 yr. Results and limitations Prostate epithelial markers are better suited for the detection of occult LN metastases than molecular markers of stemness, epithelial-to-mesenchymal transition, or reactive stroma. An analysis of 1023 LNs from 60 PC patients for the expression of prostate epithelial cell markers has revealed different expression levels and patterns between patients and between LNs of the same patient. The positive predictive value of molecular detection of occult LN metastasis for biochemical recurrence is 66.7% and the negative predictive value is 62.5%. Limitations are sample size and the hypothesis-driven selection of markers. Conclusions Molecular detection of epithelial cell markers increases the number of positive LNs and predicts tumor recurrence already at surgery. Patient summary We show that a panel of epithelial prostate markers rather than single genes is preferred for the molecular detection of lymph node micrometastases not visible at histopathological examination

RE-AIM evaluation of a one-year trial of a combined educational and environmental workplace intervention to lower salt intake in Switzerland

Reducing excessive dietary sodium may reduce cardiovascular disease risk. Environmental and behavioral interventions in workplaces may reduce salt consumption, but information on the effectiveness of workplace nutrition interventions is sparse. We used the RE-AIM framework to evaluate a one-year trial in 2015–2016 of an educational and environmental intervention to lower salt intake of employees in organizations with catering facilities in Switzerland. Five educational workshops for employees and assessments that included 24-hour urine collection were combined with five coaching sessions and food analyses in catering operations. We studied the adoption, reach, implementation, effectiveness, and maintenance of the intervention. Eight of 389 candidate organizations participated in the trial in which 145 (50% men) out of 5794 potentially eligible employees consented to participate, and 138 completed the trial with 13 in the control group. The overall mean change of daily salt intake was −0.6 g from 8.7 g to 8.1 g (6.9%). Though the mean daily salt intake of women was unaltered from 7 g, the mean intake of men declined by −1.2 g from 10.4 g to 9.2 g. Baseline salt intake, sex, and waist-to-height ratio were significant predictors of salt reduction. The analysis also highlighted pivotal determinants of low adoption and reach, and program implementation in catering operations. We conclude that a workplace program of nutrition intervention for employees and catering staff is feasible. The acceptance, effectiveness, and maintenance of nutrition interventions in the workplace require strong employer support. In a supportive food environment, interventions tailored to sex, age, and CVD risk inter alia could be successful

Risk Factors and Treatment Outcomes of 1,375 Patients with Testicular Leydig Cell Tumors: Analysis of Published Case Series Data

AIMS Leydig cell tumors (LCTs) are rare but the most common non-germ cell testicular tumors. Only limited evidence exists for reliably differentiating between benign and malignant LCTs and for optimally managing the different types and stages of this rare disease. This review aims to synthesize the available evidence regarding the clinical presentation and clinicopathological characteristics associated with LCT malignancy and management. METHODS We analyzed published case series with LCTs patients. The association between clinicopathological variables and the presence of metastatic disease was assessed using regression analyses. RESULTS We included 357 reports, reviewing available data from 1,375 patients (median age: 34y). Testis-sparing surgery (TSS) was performed in 463 patients. Local recurrence after TSS occurred in 8 of 121 (7%) patients with available follow-up information. Metastases were found in 101 patients and were most often located in the retroperitoneal lymph nodes (60%), lungs (38%), and/or liver (29%). The multivariable models with or without multiple imputation predicting metastatic disease included older age, larger tumor size, the presence of any adverse factor (larger tumor diameter, necrosis, angiolymphatic invasion, pleomorphism, high mitotic index, atypia), and any protective factor (Reinke crystals, lipofuscin pigments, gynecomastia) with model AUCs of 0.93. Durable remission after resection of metastases or platinum-based chemotherapy was rarely seen. CONCLUSION Our risk tables using clinicopathological parameters can help identify patients harboring malignant tumors. These patients should undergo staging and either be followed or receive further treatment. In metastatic disease surgical and systemic treatment might result in disease control in in some patients

The role of immune checkpoint inhibitors in clinical practice: an analysis of the treatment patterns, survival and toxicity rates by sex.

PURPOSE Our aim is to describe the role of immune checkpoint inhibitors (ICI) in clinical practice by providing the patient and tumor characteristics as well as survival and toxicity rates by sex. METHODS We used electronic health records to identify patients treated at the Cancer Center of the University Hospital Bern, Switzerland between January 1, 2017 and June 16, 2021. RESULTS We identified 5109 patients, 689 of whom (13.5%) received at least one dose of ICI. The fraction of patients who were prescribed ICI increased from 8.6% in 2017 to 22.9% in 2021. ICI represented 13.2% of the anticancer treatments in 2017 and increased to 28.2% in 2021. The majority of patients were male (68.7%), who were older than the female patients (median age 67 vs. 61 years). Over time, adjuvant and first line treatments increased for both sexes. Lung cancer and melanoma were the most common cancer types in males and females. The incidence of irAEs was higher among females (38.4% vs. 28.1%) and lead more often to treatment discontination in females than in males (21.1% vs. 16.8%). Independent of sex, the occurrence of irAEs was associated with greater median overall survival (OS, not reached vs. 1.1 years). Female patients had a longer median OS than males (1.9 vs. 1.5 years). CONCLUSIONS ICI play an increasingly important role in oncology. irAEs are more frequent in female patients and are associated with a longer OS. More research is needed to understand the association between patient sex and toxicity and survival

Integration of Baseline Metabolic Parameters and Mutational Profiles Predicts Long-Term Response to First-Line Therapy in DLBCL Patients: A Post Hoc Analysis of the SAKK38/07 Study.

Accurate estimation of the progression risk after first-line therapy represents an unmet clinical need in diffuse large B-cell lymphoma (DLBCL). Baseline (18)F-fluorodeoxyglucose positron emission tomography/computed tomography (PET/CT) parameters, together with genetic analysis of lymphoma cells, could refine the prediction of treatment failure. We evaluated the combined impact of mutation profiling and baseline PET/CT functional parameters on the outcome of DLBCL patients treated with the R-CHOP14 regimen in the SAKK38/07 clinical trial (NCT00544219). The concomitant presence of mutated SOCS1 with wild-type CREBBP and EP300 defined a group of patients with a favorable prognosis and 2-year progression-free survival (PFS) of 100%. Using an unsupervised recursive partitioning approach, we generated a classification-tree algorithm that predicts treatment outcomes. Patients with elevated metabolic tumor volume (MTV) and high metabolic heterogeneity (MH) (15%) had the highest risk of relapse. Patients with low MTV and favorable mutational profile (9%) had the lowest risk, while the remaining patients constituted the intermediate-risk group (76%). The resulting model stratified patients among three groups with 2-year PFS of 100%, 82%, and 42%, respectively (p < 0.001)