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The 2019 ESPEN Arvid Wretlind lecture perioperative nutritional and metabolic care: Patient-tailored or organ-specific approach?
Gianotti, L, Sandini, M
Clinical nutrition (Edinburgh, Scotland). 2020;(8):2347-2357
Abstract
BACKGROUND & AIM: The perioperative severe changes in the nutritional and metabolic homeostasis are, by some means, proportional to the extent of tissue injury and magnitude of operative trauma. An adequate qualitative and quantitative replacement of nutritional substrates are of utmost importance to facilitate proper tissue healing and recovery and maintenance of organ function after surgery. METHODS The present manuscript has been planned to put the most recent research of the Milano-Bicocca University surgical working group in the context of a more personalized nutritional therapy and metabolic care for surgical patients. Particular prominence has been given to major pancreatic resections because these surgeries are among the most complex and challenging operations for the degree of parenchyma resection and tissue dissection, the consequent overall injury, and the fairly high rate of major complications resulting in a catabolic response. RESULTS Anthropometric parameters and particularly sarcopenia, visceral obesity - and their relative proportion -, are strongly associated with poor outcome after pancreatic surgery. Adequate perioperative nutritional therapy is of utmost importance in affecting morbidity. Long-term nutritional and metabolic sequelae, caused by exocrine pancreatic insufficiency, need to be promptly recognized and treated with an adequate enzyme supplementation. CONCLUSIONS There is strong evidence sustaining the necessity of proper perioperative metabolic and nutritional care into the management of patients undergoing major pancreatic surgery.
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Personalized Web-Based Weight Loss Behavior Change Program With and Without Dietitian Online Coaching for Adults With Overweight and Obesity: Randomized Controlled Trial.
Beleigoli, A, Andrade, AQ, Diniz, MF, Ribeiro, AL
Journal of medical Internet research. 2020;(11):e17494
Abstract
BACKGROUND The effect of computer- or human-delivered personalized feedback on the effectivess of web-based behavior change platforms for weight loss is unclear. OBJECTIVE We aimed to compare the effectiveness of a web-based behavior change intervention personalized through either computerized or human-delivered feedback with a nonpersonalized intervention in promoting weight loss in community-based adults with overweight or obesity. METHODS This pragmatic, 3-group, parallel-arm, randomized trial recruited students and staff in a Brazilian public university who were aged 18 to 60 years, had a BMI of ≥25 kg/m2, and were not pregnant. Participants were allocated to one of 3 groups: platform only (24-week behavior change program delivered using a web platform with personalized computer-delivered feedback), platform plus coaching (same 24-week web-based behavior change program plus 12 weeks of personalized feedback delivered online by a dietitian), or waiting list (nonpersonalized dietary and physical activity recommendations delivered through an e-booklet and videos). Self-reported weight at 24 weeks was the primary outcome. Changes in dietary and physical activity habits within 24 weeks were secondary outcomes. RESULTS Among the 1298 participants, 375 (28.89%) were lost to follow-up. In the intention-to-treat analysis, the platform-only and platform plus coaching groups had greater mean weight loss than the waiting-list group at 24 weeks (-1.08 kg, 95% CI -1.41 to -0.75 vs -1.57 kg, 95% CI -1.92 to -1.22 vs -0.66 kg, 95% CI -0.98 to -0.34, respectively). The platform-only and platform plus coaching groups, compared with the waiting list group, had a greater increase in the consumption of vegetables (3%, 95% CI 1% to 6% vs 5%, 95% CI 2% to 8% vs -3%, 95% CI -5% to 0%) and fruits (9%, 95% CI 6% to 12% vs 6%, 95% CI 2% to 9% vs 2%, 95% CI 0% to 6%) and a larger reduction in ultraprocessed food intake (-18%, 95% CI -23% to -13% vs -25%, 95% CI -30% to -20% vs -12%, 95% CI -16% to -8%). Changes in physical activity did not differ across the groups. Engagement was higher in the platform plus coaching group than in the platform-only group (7.6 vs 5.2 completed sessions; P=.007). Longer usage of the platform was associated with clinically meaningful (≥5%) weight loss (odds ratio 1.02, 95% CI 1.01 to 1.04). CONCLUSIONS The web-based behavior change programs with computer- and human-delivered personalized feedback led to greater, albeit small-magnitude, weight loss within 24 weeks. Improvement in multiple dietary habits, but not physical activity, were also greater in the personalized programs compared with the nonpersonalized one. The human-delivered personalized feedback by the online dietitian coach increased user engagement with the program and was associated with a significantly higher chance of clinically meaningful weight loss. TRIAL REGISTRATION ClinicalTrials.gov NCT03435445; https://clinicaltrials.gov/ct2/show/NCT03435445. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): RR2-10.2196/10.1186/s12889-018-5882-y.
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Small molecules under development for psoriasis: on the road to the individualized therapies.
Claudia, CD, María-Elena, VH, Josué, VE, María-Carmen, BC, Alain-Raimundo, RO, Martha-Estrella, GP
Archives of dermatological research. 2020;(9):611-627
Abstract
Psoriasis is an incurable cutaneous illness characterized by the presence of well-delimited reddish plaques and silvery-white dry scales. So far, there is a limited understanding of its pathogenesis, though recent discoveries on the immunological, genetic and molecular aspects of this disease have significantly contributed to the identification of new targets and the development of novel drugs. Despite these advances, many patients are still dissatisfied, so to improve patient satisfaction, reliability, and clinical outcomes, the individualization of the treatments for this disease becomes a necessity. This review summarizes recent findings related to psoriasis pathogenesis and describes new small molecules and targets recently identified as promising for treatments. Additionally, the current status, challenges and the future directions for achieving individualized therapy for this disease and the need for more collaborative studies are discussed. The individualization of treatments for psoriasis, rather than a goal, is analyzed as a process where a dynamic integration between the needs and characteristics of the patients, the pharmacological progress, and the clinical decisions takes place.
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A Systematic Review and Meta-Analysis Comparing Heterogeneity in Body Mass Responses Between Low-Carbohydrate and Low-Fat Diets.
Smith, ES, Smith, HA, Betts, JA, Gonzalez, JT, Atkinson, G
Obesity (Silver Spring, Md.). 2020;(10):1833-1842
Abstract
OBJECTIVE An important notion in personalized medicine is that there is clinically relevant treatment response heterogeneity. Low-carbohydrate (CHO) and low-fat diets are widely adopted to reduce body mass. To compare individual differences in responses between two dietary interventions, a formal statistical comparison of response variances between study arms in a randomized controlled trial (RCT) is crucial. METHODS The change in variances in RCTs for the body mass responses to low-CHO dietary interventions versus change variances for the low-fat groups (typically considered as the comparator intervention) were compared. A literature search identified relevant RCTs (n = 25; 3,340 participants). The means and SDs of body mass change in low-CHO and low-fat study arms were extracted to calculate the variances of individual responses. These were meta-analyzed in a random-effects model and converted to the SD for individual responses. RESULTS The pooled SD for individual responses for body mass was 1.4 kg (95% CI: -1.1 to 2.3) with a wide 95% prediction interval of -6.3 to 10.4 kg. CONCLUSIONS Evidence is insufficient to suggest the response heterogeneity to low-CHO diets differs from that observed with low-fat diets.
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Innovations in Infant Feeding: Future Challenges and Opportunities in Obesity and Cardiometabolic Disease.
Alvarez-Pitti, J, de Blas, A, Lurbe, E
Nutrients. 2020;(11)
Abstract
The field of nutrition in early life, as an effective tool to prevent and treat chronic diseases, has attracted a large amount of interest over recent years. The vital roles of food products and nutrients on the body's molecular mechanisms have been demonstrated. The knowledge of the mechanisms and the possibility of controlling them via what we eat has opened up the field of precision nutrition, which aims to set dietary strategies in order to improve health with the greatest effectiveness. However, this objective is achieved only if the genetic profile of individuals and their living conditions are also considered. The relevance of this topic is strengthened considering the importance of nutrition during childhood and the impact on the development of obesity. In fact, the prevalence of global childhood obesity has increased substantially from 1990 and has now reached epidemic proportions. The current narrative review presents recent research on precision nutrition and its role on the prevention and treatment of obesity during pediatric years, a novel and promising area of research.
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Study design of Dal-GenE, a pharmacogenetic trial targeting reduction of cardiovascular events with dalcetrapib.
Tardif, JC, Dubé, MP, Pfeffer, MA, Waters, DD, Koenig, W, Maggioni, AP, McMurray, JJV, Mooser, V, White, HD, Heinonen, T, et al
American heart journal. 2020;:157-165
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Abstract
The objectives of precision medicine are to better match patient characteristics with the therapeutic intervention to optimize the chances of beneficial actions while reducing the exposure to unneeded adverse drug experiences. In a retrospective genome-wide association study of the overall neutral placebo-controlled dal-Outcomes trial, the effect of the cholesteryl ester transfer protein (CETP) modulator dalcetrapib on the composite of cardiovascular death, myocardial infarction or stroke was found to be influenced by a polymorphism in the adenylate cyclase type 9 (ADCY9) gene. Whereas patients with the AA genotype at position rs1967309 experienced fewer cardiovascular events with dalcetrapib, those with the GG genotype had an increased rate and the heterozygous AG genotype exhibited no difference from placebo. Measurements of cholesterol efflux and C-reactive protein (CRP) offered directionally supportive genotype-specific findings. In a separate, smaller, placebo-controlled trial, regression of ultrasonography-determined carotid intimal-medial thickness was only observed in dalcetrapib-treated patients with the AA genotype. Collectively, these observations led to the hypothesis that the cardiovascular effects of dalcetrapib may be pharmacogenetically determined, with a favorable benefit-risk ratio only for patients with this specific genotype. We describe below the design of dal-GenE, a precision medicine, placebo-controlled clinical outcome trial of dalcetrapib in patients with a recent acute myocardial infarction with the unique feature of selecting only those with the AA genotype at rs1967309 in the ADCY9 gene.
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Brief Acceptance and Commitment Therapy for Fibromyalgia: Feasibility and Effectiveness of a Replicated Single-Case Design.
Gómez-Pérez, MC, García-Palacios, A, Castilla, D, Zaragozá, I, Suso-Ribera, C
Pain research & management. 2020;:7897268
Abstract
OBJECTIVE Overall, the literature on the effectiveness of psychological treatments in general and those for fibromyalgia in particular has been dominated by research designs that focus on large groups and explore changes on average, so the treatment impact at the individual level remains unclear. In this quasi-experimental, replicated single-case design, we will test the feasibility and effectiveness of a brief acceptance and committed therapy intervention using ecological momentary assessment supported by technology. METHODS The sample comprised 7 patients (3 in the individual condition and 4 in the group condition) who received a brief, 5-week psychological treatment. Patient evolution was assessed one week prior to treatment onset and during the whole study with a smartphone app. Because ecological momentary assessment and the use of an app are not frequent practices in routine care, we also evaluated the feasibility of this assessment methodology (i.e., compliance with the app). Change was investigated with a nonoverlap of all pairs index. Outcomes were pain interference with sleep and social activities, fatigue, sadness, and pain intensity. RESULTS Patient change was not uniform across outcomes. Four patients (two in each condition) showed relatively moderate levels of change (approximately 60% nonoverlap in several outcomes). The remaining patients showed more modest improvements which affected a reduced number of outcomes. Based on nonoverlapping indices, there was no clear evidence in favor of any treatment format. CONCLUSIONS An alternative design to large-scale trials, one that focuses on the individual change, exists and it can be implemented in pain research. The use of technology (e.g., smartphones) simplifies such designs by facilitating ecological momentary assessment. Based on our findings showing that changes were not homogeneous across patients or outcomes, more single-case designs and patient-centered analyses (e.g., responder and moderation analyses) are required.
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Eosinophilic Esophagitis: Existing and Upcoming Therapies in an Age of Emerging Molecular and Personalized Medicine.
Slack, IF, Schwartz, JT, Mukkada, VA, Hottinger, S, Abonia, JP
Current allergy and asthma reports. 2020;(8):30
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Abstract
PURPOSE OF REVIEW Recent research efforts have spurred great progress in the diagnosis and management of eosinophilic esophagitis (EoE). Nonetheless, challenges remain in addressing disease burden and impairment in the growing EoE population. We highlight work from the Cincinnati Center for Eosinophilic Disorders, the Consortium of Eosinophilic Gastrointestinal Disease Researchers, and others that address these ongoing challenges. RECENT FINDINGS New tools for characterizing EoE disease activity include the EoE Histology Scoring System (EoEHSS), endoscopic alternatives, validated patient-reported outcome (PRO) questionnaires, and investigational biomarkers. These diagnostic and monitoring strategies have been complemented by advances in EoE therapy. Treatment modalities have refined the traditional approaches of dietary elimination, swallowed steroids, and proton pump inhibitors (PPI), and biologics offer promise for future treatment. This review summarizes EoE advances in disease management and newly defined EoE endotypes that may serve as the foundation for EoE-personalized medicine.
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Individualized treatment for allergic rhinitis based on key nasal clinical manifestations combined with histamine and leukotriene D4 levels.
Shen, C, Chen, F, Wang, H, Zhang, X, Li, G, Wen, Z
Brazilian journal of otorhinolaryngology. 2020;(1):63-73
Abstract
INTRODUCTION The types of allergic rhinitis are roughly classified based on the causative antigens, disease types, predilection time, and symptom severity. OBJECTIVE To examine the clinical typing and individualized treatment approach for allergic rhinitis and to determine the optimal treatment method for this disease using various drug combination therapies. METHODS A total of 108 participants with allergic rhinitis were divided into three groups based on symptoms. Subsequently, each group was further categorized into four subgroups based on the medications received. The efficacy of the treatments was evaluated using the visual analog scale VAS scores of the total and individual nasal symptoms, decline index of the symptom score, histamine and leukotriene levels, and mRNA and protein expression levels of histamine 1 and cysteinyl leukotriene 1 receptors. RESULTS Loratadine+mometasone furoate and loratadine+mometasone furoate+montelukast significantly improved the sneezing symptom and reduced the histamine levels compared with the other combination therapies (p<0.05). Meanwhile, montelukast+mometasone furoate and montelukast+mometasone furoate+loratadine considerably improved the nasal obstruction symptom and decreased the leukotriene D4 levels compared with the other combination therapies (p<0.05). CONCLUSION Clinical symptom evaluation combined with experimental detection of histamine and leukotriene levels can be an objective and accurate method to clinically classify the allergic rhinitis types. Furthermore, individualized treatment based on allergic rhinitis classification can result in a good treatment efficacy.
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A Phase Ib Trial of Personalized Neoantigen Therapy Plus Anti-PD-1 in Patients with Advanced Melanoma, Non-small Cell Lung Cancer, or Bladder Cancer.
Ott, PA, Hu-Lieskovan, S, Chmielowski, B, Govindan, R, Naing, A, Bhardwaj, N, Margolin, K, Awad, MM, Hellmann, MD, Lin, JJ, et al
Cell. 2020;(2):347-362.e24
Abstract
Neoantigens arise from mutations in cancer cells and are important targets of T cell-mediated anti-tumor immunity. Here, we report the first open-label, phase Ib clinical trial of a personalized neoantigen-based vaccine, NEO-PV-01, in combination with PD-1 blockade in patients with advanced melanoma, non-small cell lung cancer, or bladder cancer. This analysis of 82 patients demonstrated that the regimen was safe, with no treatment-related serious adverse events observed. De novo neoantigen-specific CD4+ and CD8+ T cell responses were observed post-vaccination in all of the patients. The vaccine-induced T cells had a cytotoxic phenotype and were capable of trafficking to the tumor and mediating cell killing. In addition, epitope spread to neoantigens not included in the vaccine was detected post-vaccination. These data support the safety and immunogenicity of this regimen in patients with advanced solid tumors (Clinicaltrials.gov: NCT02897765).