[Nutrition in palliative care: guidelines from the Working Group on Bioethics, Spanish Society of Clinical Nutrition and Metabolism (SENPE)]. / Nutrición en cuidados paliativos: resumen de recomendaciones del Grupo de Trabajo de Ética de la SENPE.

Introduction: Palliative care provides a holistic approach and care for patients with a terminal illness and their families. In palliative care physical complaints as well as emotional, social and spiritual aspects are considered. Nutritional care should be also considered within palliative support. For those working in the nutritional support field, to withhold or withdraw nutritional support may be an ethical dilemma in this scenario. The controversy starts when considering nutrition and hydration as basic care or a treatment. The goals of nutrition support in palliative care patients differ from common ones, aiming to improve quality of life, survival or both. The decision should be based on a consideration of prognosis (length of survival), quality of life, and risks-benefits ratio. Regarding oral nutrition (with or without oral supplements) the idea prevails of "comfort feeding", based on providing oral feeding till discomfort or avoidance develop. There is no evidence on the benefit of specific nutrients, despite the fact that omega-3 FAs may have some positive effects in patients with cancer. Regarding nutritional support (enteral or parenteral), no scientific evidence is present, so the decision needs to be agreed according to the desires and beliefs of the patient and their family, and based on a consensus with the interdisciplinary team on the aims of this support.

Introducción: Los cuidados paliativos proporcionan una atención integral que tiene en cuenta los aspectos físicos, emocionales, sociales y espirituales del paciente con enfermedad terminal y su entorno familiar. El tratamiento nutricional debe formar parte activa de los equipos de cuidados paliativos. La necesidad de iniciar o no un tratamiento nutricional sigue siendo, desde hace décadas, uno de los principales problemas éticos a los que se enfrentan los profesionales dedicados a la nutrición clínica. El origen de tal controversia radica, fundamentalmente, en cómo se consideran la nutrición y la hidratación: cuidado/soporte o tratamiento médico. Los objetivos fundamentales del tratamiento nutricional en los pacientes en cuidados paliativos deben ser otros: la mejoría de la calidad de vida, de la supervivencia o de ambas. La decisión de indicar o no el tratamiento nutricional en cuidados paliativos debe tomarse tras considerar el pronóstico, la calidad de vida y la relación "riesgo/beneficio". En relación a la alimentación por vía oral (con o sin suplementos orales), prevalece la idea de la "alimentación de confort", que se basa en intentos de alimentación oral hasta que se produzcan la incomodidad y/o el rechazo del paciente. No existen evidencias que justifiquen el uso de nutrientes específicos, aunque desde hace años se señala la posibilidad de lograr beneficios cuando se utilizan ácidos grasos omega-3 en los pacientes con cáncer. En cuanto al tratamiento nutricional (enteral o parenteral), en ausencia de evidencia, las decisiones sobre si iniciar una nutrición artificial en un paciente paliativo deben tomarse teniendo en cuenta los deseos y creencias del paciente y sus familiares, y basarse en el consenso del equipo interdisciplinar sobre los objetivos que se persiguen al iniciarla.

Diagnosis and treatment of thyroid cancer in adult patients - Recommendations of Polish Scientific Societies and the National Oncological Strategy. 2022 Update [Diagnostyka i leczenie raka tarczycy u chorych doroslych - Rekomendacje Polskich Towarzystw Naukowych oraz Narodowej Strategii Onkologicznej. Aktualizacja na rok 2022].

The guidelines Thyroid Cancer 2022 are prepared based on previous Polish recommendations updated in 2018. They consider international guidelines - American Thyroid Association (ATA) 2015 and National Comprehensive Cancer Network (NCCN); however, they are adapted according to the ADAPTE process. The strength of the recommendations and the quality of the scientific evidence are assessed according to the GRADE system and the ATA 2015 and NCCN recommendations. The core of the changes made in the Polish recommendations is the inclusion of international guidelines and the results of those scientific studies that have already proven themselves prospectively. These extensions allow de-escalation of the therapeutic management in low-risk thyroid carcinoma, i.e., enabling active surveillance in papillary microcarcinoma to be chosen alternatively to minimally invasive techniques after agreeing on such management with the patient. Further extensions allow the use of thyroid lobectomy with the isthmus (hemithyroidectomy) in low-risk cancer up to 2 cm in diameter, modification of the indications for postoperative radioiodine treatment toward personalized approach, and clarification of the criteria used during postoperative L-thyroxine treatment. At the same time, the criteria for the preoperative differential diagnosis of nodular goiter in terms of ultrasonography and fine-needle aspiration biopsy have been clarified, and the rules for the histopathological examination of postoperative thyroid material have been updated. New, updated rules for monitoring patients after treatment are also presented. The updated recommendations focus on ensuring the best possible quality of life after thyroid cancer treatment while maintaining the good efficacy of this treatment.

Summary of the clinical practice guideline for the treatment of depression across three age cohorts.

The American Psychological Association (APA) developed this clinical practice guideline to provide recommendations for the treatment of depressive disorders, including major depression, subsyndromal depression, and persistent depressive disorder. It addresses three developmental cohorts: adolescents, general adults, and older adults (ages 60 and over). Ten systematic reviews and meta-analyses, along with other literature and observations from practitioners and patients, served as the basis for the guideline. The guideline development panel consisted of health professionals from psychology, psychiatry, and family medicine as well as community members who self-identified as having had depression. The panel examined the efficacy of psychological treatments and of complementary and alternative medicine treatments. It also examined comparative effectiveness among psychological treatments, by themselves and in combination with pharmacotherapy, and comparative effectiveness of psychological treatments in relation to pharmacotherapy and to complementary and alternative treatments. The panel made recommendations for treatment of depression in adolescents, adults, and older adults but did not make treatment recommendations specific to children. These recommendations, presented in detail in the guideline, are summarized here. The target audience for the guideline includes clinicians, researchers, patients, family members, and policymakers. (PsycInfo Database Record (c) 2022 APA, all rights reserved).

Brighton Collaboration Viral Vector Vaccines Safety Working Group (V3SWG) standardized template for collection of key information for benefit-risk assessment of live-attenuated viral vaccines.

Several live-attenuated viral vaccine candidates are among the COVID-19 vaccines in development. The Brighton Collaboration Viral Vector Vaccines Safety Working Group (V3SWG) has prepared a standardized template to describe the key considerations for the benefit-risk assessment of live-attenuated viral vaccines. This will help key stakeholders assess potential safety issues and understand the benefit-risk of such vaccines. The standardized and structured assessment provided by the template would also help to contribute to improved communication and support public acceptance of licensed live-attenuated viral vaccines.

Financial conflicts of interest among National Comprehensive Cancer Network clinical practice guideline panelists in 2019.

BACKGROUND: Clinical practice guidelines (CPGs) are evidence-based guidelines that serve as a standard of care in oncology practice, reimbursements, and quality improvement initiatives. To our knowledge, the extent of financial conflicts of interest (FCOIs) in National Comprehensive Cancer Network (NCCN) guidelines have not been systemically evaluated. The current study evaluated the extent of FCOIs in the NCCN CPGs for the most common malignancies in the United States. METHODS: The authors examined the latest 2019 versions of the NCCN CPGs for the 10 most common cancers by incidence in the United States. Using disclosure lists, they catalogued the FCOIs for the panelists under various categories outlined in the CPG. The authors also tabulated the companies and institutions involved in each panel disclosure. An "episode" describes 1 instance of participation of a panelist in 1 company in 1 category of each guideline. "Affiliation" describes an industrial, commercial, or institutional affiliation reported by a panelist in each episode. RESULTS: Of the 491 panelists on the CPG panel, 483 (98.3%) completed FCOI disclosures. A total of 224 (46.4%) reported at least 1 FCOI episode. A total of 1103 episodes were disclosed with an average of 4.9 episodes reported per panelist with FCOIs. Acting as part of scientific advisory boards, as a consultant, or as an expert witness was the most common FCOI category (19.9%). A total of 191 companies were associated with 1103 episodes of FCOI. The top companies were Bristol-Myers Squibb, Merck, Genentech, and AstraZeneca. Among cancers, the prevalence of FCOIs was highest for lung cancer (56%), bladder cancer (52%), pancreatic cancer (52%), non-Hodgkin lymphoma (50%), kidney cancer (49%), colorectal cancer (43%), breast cancer (42%), melanoma (40%), prostate cancer (38%), and uterine cancer (32%). Among the panelists with FCOIs, 26%, 17%, and 57%, respectively, reported 1, 2, and >3 episodes. There were 127 episodes noted among the CPG chairs and/or vice chairs who reported FCOIs (mean, 6.4 episodes). The chairs and/or vice chairs of CPGs for uterine cancer, pancreatic cancer, melanoma, and prostate cancer were not found to have any FCOIs. CONCLUSIONS: FCOIs are very prevalent among NCCN CPG panelists. In nearly one-half of the CPGs, the majority of the panelists had at least 1 FCOI. Greater than one-half of the CPG chairs and/or vice chairs reported multiple FCOIs. Further research studies are necessary to determine the impact of these FCOIs.

Global approaches to integrated care: Best practices and ongoing innovation.

The integration of behavioral health in primary care is critical for addressing worldwide concerns for access to, and quality of, health care services for physical and mental health promotion, prevention, and disease management. Clearly, promoting knowledge exchange internationally is critical to progress. In late 2015, the American Psychological Association convened an interdisciplinary summit on global approaches to integrated health care, bringing together 82 health care professionals (nurses, primary care physicians, psychologists, psychiatrists, and social workers) and scholars from diverse disciplines in medicine, psychology, economics, health policy, public health, and demography; participants came from 10 countries. The Global Summit provided an opportunity to share best practices and innovation in patient-centered integrated health care internationally. In this article, Global Summit participants from different countries reflect on the recommendations for future interprofessional endeavors across the following themes: build international interprofessional communities for change; advocate for, and promote social equity with, a population health and patient focus; advance research and program evaluation in integrated care; advance interprofessional training and education in integrated care; and develop financially sustainable models for integrated primary care. Building upon these recommendations and reflecting on current advancement in health care policy and integrated care research, new directions are suggested for clinicians, researchers, administrators, and policymakers working toward the advancement of integrated care to improve health care services globally. (PsycInfo Database Record (c) 2020 APA, all rights reserved).

New Author Guidelines for Displaying Data and Reporting Data Analysis and Statistical Methods in Experimental Biology.

The American Society for Pharmacology and Experimental Therapeutics has revised the Instructions to Authors for Drug Metabolism and Disposition, Journal of Pharmacology and Experimental Therapeutics, and Molecular Pharmacology These revisions relate to data analysis (including statistical analysis) and reporting but do not tell investigators how to design and perform their experiments. Their overall focus is on greater granularity in the description of what has been done and found. Key recommendations include the need to differentiate between preplanned, hypothesis-testing, and exploratory experiments or studies; explanations of whether key elements of study design, such as sample size and choice of specific statistical tests, had been specified before any data were obtained or adapted thereafter; and explanations of whether any outliers (data points or entire experiments) were eliminated and when the rules for doing so had been defined. Variability should be described by S.D. or interquartile range, and precision should be described by confidence intervals; S.E. should not be used. P values should be used sparingly; in most cases, reporting differences or ratios (effect sizes) with their confidence intervals will be preferred. Depiction of data in figures should provide as much granularity as possible, e.g., by replacing bar graphs with scatter plots wherever feasible and violin or box-and-whisker plots when not. This editorial explains the revisions and the underlying scientific rationale. We believe that these revised guidelines will lead to a less biased and more transparent reporting of research findings.

Nationwide Actions Against Heart Failure Pandemic in Japan　- What Should We Do From Academia?

Heart failure pandemic is rapidly approaching in Japan, requiring nationwide actions. In particular, the Japanese Circulation Society and related societies launched the Stroke and Cardiovascular Disease Control Act, which was passed by the National Diet, as the first ever legislative policy measure against stroke and cardiovascular disease. In association with this, actions against heart failure pandemic from the scientific field are also important. Because heart failure pandemic is a critical problem not only in Japan but also in many developed countries, we believe the nationwide approach, as summarized here, will greatly contribute to the development of cardiovascular medicine, particularly the management and treatment of heart failure worldwide.

Clinical Nutrition in Critical Care Medicine - Guideline of the German Society for Nutritional Medicine (DGEM).

PURPOSE: Enteral and parenteral nutrition of adult critically ill patients varies in terms of the route of nutrient delivery, the amount and composition of macro- and micronutrients, and the choice of specific, immune-modulating substrates. Variations of clinical nutrition may affect clinical outcomes. The present guideline provides clinicians with updated consensus-based recommendations for clinical nutrition in adult critically ill patients who suffer from at least one acute organ dysfunction requiring specific drug therapy and/or a mechanical support device (e.g., mechanical ventilation) to maintain organ function. METHODS: The former guidelines of the German Society for Nutritional Medicine (DGEM) were updated according to the current instructions of the Association of the Scientific Medical Societies in Germany (AWMF) valid for a S2k-guideline. According to the S2k-guideline classification, no systematic review of the available evidence was required to make recommendations, which, therefore, do not state evidence- or recommendation grades. Nevertheless, we considered and commented the evidence from randomized-controlled trials, meta-analyses and observational studies with adequate sample size and high methodological quality (until May 2018) as well as from currently valid guidelines of other societies. The liability of each recommendation was described linguistically. Each recommendation was finally validated and consented through a Delphi process. RESULTS: In the introduction the guideline describes a) the pathophysiological consequences of critical illness possibly affecting metabolism and nutrition of critically ill patients, b) potential definitions for different disease phases during the course of illness, and c) methodological shortcomings of clinical trials on nutrition. Then, we make 69 consented recommendations for essential, practice-relevant elements of clinical nutrition in critically ill patients. Among others, recommendations include the assessment of nutrition status, the indication for clinical nutrition, the timing and route of nutrient delivery, and the amount and composition of substrates (macro- and micronutrients); furthermore, we discuss distinctive aspects of nutrition therapy in obese critically ill patients and those treated with extracorporeal support devices. CONCLUSION: The current guideline provides clinicians with up-to-date recommendations for enteral and parenteral nutrition of adult critically ill patients who suffer from at least one acute organ dysfunction requiring specific drug therapy and/or a mechanical support device (e.g., mechanical ventilation) to maintain organ function. The period of validity of the guideline is approximately fixed at five years (2018-2023).

Summary of the clinical practice guideline for the treatment of posttraumatic stress disorder (PTSD) in adults.

The American Psychological Association (APA) developed a clinical practice guideline (CPG) to provide recommendations on psychological and pharmacological treatments for posttraumatic stress disorder (PTSD) in adults. This paper is a summary of the CPG, including the development process. Members of the guideline development panel (GDP) used a comprehensive systematic review conducted by the Research Triangle Institute-University of North Carolina Evidence-based Practice Center (RTI-UNC EPC) as its primary evidence base (Jonas et al., 2013). The GDP consisted of health professionals from psychology, psychiatry, social work, and family medicine as well as community members who self-identified as having had PTSD. PTSD symptom reduction and serious harms were selected by the GDP as critical outcomes for making recommendations. The GDP strongly recommends use of the following psychotherapies/interventions (in alphabetical order) for adults with PTSD: cognitive-behavioral therapy, cognitive processing therapy, cognitive therapy, and prolonged exposure therapy. The GDP conditionally recommends the use of brief eclectic psychotherapy, eye movement desensitization and reprocessing (EMDR), and narrative exposure therapy (NET). For medications, the GDP conditionally recommends the following (in alphabetical order): fluoxetine, paroxetine, sertraline, and venlafaxine. There is insufficient evidence to recommend for or against offering Seeking Safety, relaxation, risperidone, and topiramate. A subgroup of the GDP reviewed studies published after the systematic review for those treatments that received substantive recommendations; the GDP concluded that future systematic reviews that incorporated those new studies could change the recommendations for EMDR and NET from conditional to strong. For all other treatments, results of the update indicated that recommendations were unlikely to change or that there were no new trials for comparison. The target audience for this CPG includes clinicians, researchers, patients, and policymakers. (PsycINFO Database Record (c) 2019 APA, all rights reserved).

Ethnopharmacology - A journal, a definition and a society.

ETHNOPHARMACOLOGICAL RELEVANCE: Historical development of the Journal of Ethnopharmacology, the International Society of Ethnopharmacology, and the first definition of ethnopharmacology. AIM OF THE STUDY: To present the background to, and the people involved, in the foundation of the journal and the society. MATERIALS AND METHODS: Personal recollections, archival documents and photographs. RESULTS: A concise review of the early years of the JEP and the ISE, and the development of the first definition of ethnopharmacology. CONCLUSIONS: The definition of ethnopharmacology as an interdisciplinary science, and its establishment as a journal and a society was timely, filled a need, and opened up publication and meeting possibilities for scientists from various academic fields. Most important has been, and continues to be, the bridges created between people from all cultures and all countries.

Microsampling for quantitative bioanalysis, an industry update: output from an AAPS/EBF survey.

There is continuing interest in the development and application of various microsampling technologies for drug development. The AAPS bioanalytical community microsampling subgroup and the European Bioanalysis Forum conducted a survey of their members (39 individual organizations). This gives a snapshot of current practices and demonstrates that implementation of microsampling approaches is becoming increasingly commonplace, but not universal. Greater adoption was observed for nonclinical studies, particularly nonregulatory. A number of respondents reported that they have included microsampling data in regulatory submissions. Another important observation was that where microsampling is employed for clinical studies, dried blood approaches predominate, reflecting the interest in their use where they enable sample collection which is not feasible with standard approaches or to derive richer data sets.

Scientific and Regulatory Policy Committee Points to Consider*: Review of Scientific and Regulatory Policy Committee Points to Consider: Review of Current Practices for Ultrastructural Pathology Evaluations in Support of Nonclinical Toxicology Studies.

Anatomic pathology and clinical pathology end points are standard components of almost every nonclinical general toxicity study conducted during the risk assessment of novel pharmaceuticals and chemicals. On occasion, an ultrastructural pathology evaluation using transmission electron microscopy (TEM) may be included in nonclinical toxicity studies. Transmission electron microscopy is most commonly used when a light microscopic finding may require further characterization that could inform on the pathogenesis and/or mechanism of action. Regulatory guidance do not address the use of TEM in general study designs nor whether these assessments should be performed in laboratories conducted in compliance with Good Laboratory Practices. The Scientific and Regulatory Policy Committee of the Society of Toxicologic Pathology (STP) formed a Working Group to assess the current practices on the use of TEM in nonclinical toxicity studies. The Working Group constructed a survey sent to members of societies of toxicologic pathology in the United States, Europe, Britain, and Japan, and responses were collected through the STP for evaluation by the Working Group. The survey results and regulatory context are discussed, as are "points to consider" from the collective experience of the Working Group. This survey indicates that TEM remains an essential diagnostic option for complementing toxicologic pathology evaluations. *This Points to Consider article is a product of a Society of Toxicologic Pathology (STP) Working Group commissioned by the Scientific and Regulatory Policy Committee (SRPC) of the STP. It has been reviewed and approved by the SRPC and Executive Committee of the STP but it does not represent a formal Best Practice recommendation of the Society; rather, it is intended to provide key "points to consider" in designing nonclinical studies or interpreting data from toxicity and safety studies intended to support regulatory submissions. The points expressed in this document are those of the authors and do not reflect views or policies of the employing institutions. Readers of Toxicologic Pathology are encouraged to send their thoughts on these articles or ideas for new topics to the Editor.

Genome-wide analyses as part of the international FTLD-TDP whole-genome sequencing consortium reveals novel disease risk factors and increases support for immune dysfunction in FTLD.

Frontotemporal lobar degeneration with neuronal inclusions of the TAR DNA-binding protein 43 (FTLD-TDP) represents the most common pathological subtype of FTLD. We established the international FTLD-TDP whole-genome sequencing consortium to thoroughly characterize the known genetic causes of FTLD-TDP and identify novel genetic risk factors. Through the study of 1131 unrelated Caucasian patients, we estimated that C9orf72 repeat expansions and GRN loss-of-function mutations account for 25.5% and 13.9% of FTLD-TDP patients, respectively. Mutations in TBK1 (1.5%) and other known FTLD genes (1.4%) were rare, and the disease in 57.7% of FTLD-TDP patients was unexplained by the known FTLD genes. To unravel the contribution of common genetic factors to the FTLD-TDP etiology in these patients, we conducted a two-stage association study comprising the analysis of whole-genome sequencing data from 517 FTLD-TDP patients and 838 controls, followed by targeted genotyping of the most associated genomic loci in 119 additional FTLD-TDP patients and 1653 controls. We identified three genome-wide significant FTLD-TDP risk loci: one new locus at chromosome 7q36 within the DPP6 gene led by rs118113626 (p value = 4.82e - 08, OR = 2.12), and two known loci: UNC13A, led by rs1297319 (p value = 1.27e - 08, OR = 1.50) and HLA-DQA2 led by rs17219281 (p value = 3.22e - 08, OR = 1.98). While HLA represents a locus previously implicated in clinical FTLD and related neurodegenerative disorders, the association signal in our study is independent from previously reported associations. Through inspection of our whole-genome sequence data for genes with an excess of rare loss-of-function variants in FTLD-TDP patients (n ≥ 3) as compared to controls (n = 0), we further discovered a possible role for genes functioning within the TBK1-related immune pathway (e.g., DHX58, TRIM21, IRF7) in the genetic etiology of FTLD-TDP. Together, our study based on the largest cohort of unrelated FTLD-TDP patients assembled to date provides a comprehensive view of the genetic landscape of FTLD-TDP, nominates novel FTLD-TDP risk loci, and strongly implicates the immune pathway in FTLD-TDP pathogenesis.