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Observational research, mainly prospective cohort studies (PCS), has represented a long-standing challenge for those attempting to draw up consistent policy recommendations in the area of diet and health. This has been due to the inherent limitations in ascribing causality from observed associations due to problems of confounding of the findings and publication and citation bias. Developments in nutritional epidemiology research over the past 20–30 years have enabled causal criteria to be derived from observational studies and the totality of the primary literature to be reviewed objectively, reducing previous focus on narrative accounts of individual studies. The gold standard approach to assessing causal relationships is via randomised controlled trials (RCT), but neither RCT nor PCS provide direct evidence for biological plausibility, which is a key criterion for assessing causality. Although extensive mechanistic data are available in the literature, a systematic approach to select and assess quality and relevance of published studies has not been available. This limits their use in the development of diet and health policy. Recent studies have investigated a proposed two-step framework and novel methodologies for integrating heterogeneous data from cell, animal and human studies. Pilot and feasibility studies have shown this to be a useful novel approach to studies of diet and cancer, but further refinements are required, including development of appropriate quality criteria which are less dependent on RCT designs. Future studies are needed to fully verify the approach and its potential for use in other diet–disease relationships.
The regulation of health claims for foods by the Nutrition and Health Claims Regulation is intended, primarily, to protect consumers from unscrupulous claims by ensuring claims are accurate and substantiated with high quality scientific evidence. In this position paper, the Academy of Nutrition Sciences uniquely recognises the strengths of the transparent, rigorous scientific assessment by independent scientists of the evidence underpinning claims in Europe, an approach now independently adopted in UK. Further strengths are the separation of risk assessment from risk management, and the extensive guidance for those submitting claims. Nevertheless, four main challenges in assessing the scientific evidence and context remain: (i) defining a healthy population, (ii) undertaking efficacy trials for foods, (iii) developing clearly defined biomarkers for some trial outcomes and (iv) ensuring the composition of a food bearing a health claim is consistent with generally accepted nutrition principles. Although the Regulation aims to protect the consumer from harm, we identify some challenges from consumer research: (i) making the wording of some health claims more easily understood and (ii) understanding the implications of the misperceptions around products bearing nutrition or health claims. Recommendations are made to overcome these challenges. Further, the Academy recommends that a dialogue is developed with the relevant national bodies about Article 12(c) in the Regulation. This should further clarify the GB Guidance to avoid the current non-level playing field between health professionals and untrained ‘influencers’ who are not covered by this Article about the communication of authorised claims within commercial communications.
A national survey characterized training and career development for translational researchers through Clinical and Translational Science Award (CTSA) T32/TL1 programs. This report summarizes program goals, trainee characteristics, and mentorship practices.
A web link to a voluntary survey was emailed to 51 active TL1 program directors and administrators. Descriptive analyses were performed on aggregate data. Qualitative data analysis used open coding of text followed by an axial coding strategy based on the grounded theory approach.
Fifty out of 51 (98%) invited CTSA hubs responded. Training program goals were aligned with the CTSA mission. The trainee population consisted of predoctoral students (50%), postdoctoral fellows (30%), and health professional students in short-term (11%) or year-out (9%) research training. Forty percent of TL1 programs support both predoctoral and postdoctoral trainees. Trainees are diverse by academic affiliation, mostly from medicine, engineering, public health, non-health sciences, pharmacy, and nursing. Mentor training is offered by most programs, but mandatory at less than one-third of them. Most mentoring teams consist of two or more mentors.
CTSA TL1 programs are distinct from other NIH-funded training programs in their focus on clinical and translational research, cross-disciplinary approaches, emphasis on team science, and integration of multiple trainee types. Trainees in nearly all TL1 programs were engaged in all phases of translational research (preclinical, clinical, implementation, public health), suggesting that the CTSA TL1 program is meeting the mandate of NCATS to provide training to develop the clinical and translational research workforce.
Clarifying the relationship between depression symptoms and cardiometabolic and related health could clarify risk factors and treatment targets. The objective of this study was to assess whether depression symptoms in midlife are associated with the subsequent onset of cardiometabolic health problems.
The study sample comprised 787 male twin veterans with polygenic risk score data who participated in the Harvard Twin Study of Substance Abuse (‘baseline’) and the longitudinal Vietnam Era Twin Study of Aging (‘follow-up’). Depression symptoms were assessed at baseline [mean age 41.42 years (s.d. = 2.34)] using the Diagnostic Interview Schedule, Version III, Revised. The onset of eight cardiometabolic conditions (atrial fibrillation, diabetes, erectile dysfunction, hypercholesterolemia, hypertension, myocardial infarction, sleep apnea, and stroke) was assessed via self-reported doctor diagnosis at follow-up [mean age 67.59 years (s.d. = 2.41)].
Total depression symptoms were longitudinally associated with incident diabetes (OR 1.29, 95% CI 1.07–1.57), erectile dysfunction (OR 1.32, 95% CI 1.10–1.59), hypercholesterolemia (OR 1.26, 95% CI 1.04–1.53), and sleep apnea (OR 1.40, 95% CI 1.13–1.74) over 27 years after controlling for age, alcohol consumption, smoking, body mass index, C-reactive protein, and polygenic risk for specific health conditions. In sensitivity analyses that excluded somatic depression symptoms, only the association with sleep apnea remained significant (OR 1.32, 95% CI 1.09–1.60).
A history of depression symptoms by early midlife is associated with an elevated risk for subsequent development of several self-reported health conditions. When isolated, non-somatic depression symptoms are associated with incident self-reported sleep apnea. Depression symptom history may be a predictor or marker of cardiometabolic risk over decades.
This Position Paper from the Academy of Nutrition Sciences is the first in a series which describe the nature of the scientific evidence and frameworks that underpin nutrition recommendations for health. This first paper focuses on evidence which underpins dietary recommendations for prevention of non-communicable diseases. It considers methodological advances made in nutritional epidemiology and frameworks used by expert groups to support objective, rigorous and transparent translation of the evidence into dietary recommendations. The flexibility of these processes allows updating of recommendations as new evidence becomes available. For CVD and some cancers, the paper has highlighted the long-term consistency of a number of recommendations. The innate challenges in this complex area of science include those relating to dietary assessment, misreporting and the confounding of dietary associations due to changes in exposures over time. A large body of experimental data is available that has the potential to support epidemiological findings, but many of the studies have not been designed to allow their extrapolation to dietary recommendations for humans. Systematic criteria that would allow objective selection of these data based on rigour and relevance to human nutrition would significantly add to the translational value of this area of nutrition science. The Academy makes three recommendations: (i) the development of methodologies and criteria for selection of relevant experimental data, (ii) further development of innovative approaches for measuring human dietary intake and reducing confounding in long-term cohort studies and (iii) retention of national nutrition surveillance programmes needed for extrapolating global research findings to UK populations.
Sports medicine clinicians face conflicts of interest in providing medical care to athletes. Using a survey of college football players, this study evaluates whether athletes are aware of these conflicts of interest, whether these conflicts affect athlete trust in their health care providers, or whether conflicts or athletes' trust in stakeholders are associated with athletes' injury reporting behaviors.
Scientific quality and feasibility are part of ethics review by Institutional Review Boards (IRBs). Scientific Review Committees (SRCs) were proposed to facilitate this assessment by the Clinical and Translational Science Award (CTSA) SRC Consensus Group. This study assessed SRC feasibility and impact at CTSA-affiliated academic health centers (AHCs).
SRC implementation at 10 AHCs was assessed pre/post-intervention using quantitative and qualitative methods. Pre-intervention, four AHCs had no SRC, and six had at least one SRC needing modifications to better align with Consensus Group recommendations.
Facilitators of successful SRC implementation included broad-based communication, an external motivator, senior-level support, and committed SRC reviewers. Barriers included limited resources and staffing, variable local mandates, limited SRC authority, lack of anticipated benefit, and operational challenges. Research protocol quality did not differ significantly between study periods, but respondents suggested positive effects. During intervention, median total review duration did not lengthen for the 40% of protocols approved within 3 weeks. For the 60% under review after 3 weeks, review was lengthened primarily due to longer IRB review for SRC-reviewed protocols. Site interviews recommended designing locally effective SRC processes, building buy-in by communication or by mandate, allowing time for planning and sharing best practices, and connecting SRC and IRB procedures.
The CTSA SRC Consensus Group recommendations appear feasible. Although not conclusive in this relatively short initial implementation, sites perceived positive impact by SRCs on study quality. Optimal benefit will require local or federal mandate for implementation, adapting processes to local contexts, and employing SRC stipulations.
A new fossil site in a previously unexplored part of western Madagascar (the Beanka Protected Area) has yielded remains of many recently extinct vertebrates, including giant lemurs (Babakotia radofilai, Palaeopropithecus kelyus, Pachylemur sp., and Archaeolemur edwardsi), carnivores (Cryptoprocta spelea), the aardvark-like Plesiorycteropus sp., and giant ground cuckoos (Coua). Many of these represent considerable range extensions. Extant species that were extirpated from the region (e.g., Prolemur simus) are also present. Calibrated radiocarbon ages for 10 bones from extinct primates span the last three millennia. The largely undisturbed taphonomy of bone deposits supports the interpretation that many specimens fell in from a rock ledge above the entrance. Some primates and other mammals may have been prey items of avian predators, but human predation is also evident. Strontium isotope ratios (87Sr/86Sr) suggest that fossils were local to the area. Pottery sherds and bones of extinct and extant vertebrates with cut and chop marks indicate human activity in previous centuries. Scarcity of charcoal and human artifacts suggests only occasional visitation to the site by humans. The fossil assemblage from this site is unusual in that, while it contains many sloth lemurs, it lacks ratites, hippopotami, and crocodiles typical of nearly all other Holocene subfossil sites on Madagascar.
As urbanization increases in low- and middle-income countries (LMICs), urban populations will be increasingly exposed to a range of environmental risk factors for non-communicable diseases. Inadequate living conditions in urban settings may influence mechanisms that regulate gene expression, leading to the development of non-communicable respiratory diseases. We conducted a systematic review of the literature to assess the relationship between respiratory health and epigenetic factors to urban environmental exposures observed in LMICs using MEDLINE, PubMed, EMBASE, and Google Scholar searching a combination of the terms: epigenetics, chronic respiratory diseases (CRDs), lung development, chronic obstructive airway disease, and asthma. A total of 2835 articles were obtained, and 48 articles were included in this review. We found that environmental factors during early development are related to epigenetic effects that may be associated with a higher risk of CRDs. Epigenetic dysregulation of gene expression of the histone deacetylase (HDAC) and histone acetyltransferase gene families was likely involved in lung health of slum dwellers. Respiratory-related environmental exposures influence HDAC function and deoxyribonucleic acid methylation and are important risk factors in the development of CRD. Additional epigenetic research is needed to improve our understanding of associations between environmental exposures and non-communicable respiratory diseases.
A pilot study was designed to evaluate the potential of zircon geochronology as a provenance indicator of till from the Lake Michigan, Saginaw, and Huron-Erie Lobes of the Laurentide Ice Sheet. Based on existing ice flow-path models, we hypothesized that till from each lobe would have different zircon age population distributions because the lobes originated from regions of the Canadian Shield with different bedrock ages. After correcting for zircon fertility, the majority of grains in all till samples are 1600–950 Ma, with ~30 % of ages >2500 Ma. This similarity means that till from the three lobes cannot be clearly differentiated based on their zircon populations. The dominant ages found and the homogeneity of distributions in the till indicates a non-Shield source and, instead, reflect an origin from some combination of underlying till and sedimentary bedrock in the Great Lakes region. Even though the datasets are small, the tills have similarities to zircon distributions in Michigan Basin rocks. This implies that a substantial fraction of zircon in till was not transported long distances from the Canadian Shield. Although zircon ages are not distinct between tills, the method provides a novel application to understand Laurentide Ice Sheet glacial erosion and transport.
In this work the quantitative and qualitative ability of a kinetic-theory-based two-fluid model (KT-TFM) is assessed in a state of fully periodic sedimentation (fluidization), with a focus on statistically steady, unstable (clustered) states. The accuracy of KT-TFM predictions is evaluated via direct comparison to direct numerical simulation (DNS) data. The KT-TFM and DNS results span a rather wide parameter space: mean-flow Reynolds numbers on the order of 1 and 10, mean solid volume fractions from 0.1 to 0.4, solid-to-fluid density ratios from 10 to 1000 and elastic and moderately inelastic (restitution coefficient of 0.9) conditions. Data from both KT-TFM and DNS display a rich variety of statistically steady yet unstable structures (clusters). Instantaneous snapshots of KT-TFM and DNS demonstrate remarkable qualitative agreement. This qualitative agreement is quantified by calculating the critical density ratio at which the structure transitions from a chaotic, dynamic state to a regular, plug-flow state, with good overall comparisons. Further quantitative assessments of mean and fluctuating velocities show good agreement at high density ratios but weaker agreement at intermediate to low density ratios depending on the mean-flow Reynolds numbers and solid fractions. Deviations of the KT-TFM results from the DNS data were traced to a breakdown in one of the underlying assumptions of the kinetic theory derivation: high thermal Stokes number. Surprisingly, however, even though the low Knudsen number assumption, also associated with the kinetic theory derivation, is violated throughout most of the parameter space, it does not seem to affect the good quantitative accuracy of KT-TFM simulations.
Persistent pain is common and inadequately treated in cancer patients. Behavioral pain interventions are a recommended part of multimodal pain treatments, but they are underused in clinical care due to barriers such as a lack of the resources needed to deliver them in person and difficulties coordinating their use with clinical care. Pain coping skills training (PCST) is an evidence-based behavioral pain intervention traditionally delivered in person. Delivering this training via the web would increase access to it by addressing barriers that currently limit its use. We conducted a patient pilot study of an 8-week web-based PCST program to determine the acceptability of this approach to patients and the program features needed to meet their needs. Focus groups with healthcare providers identified strategies for coordinating the use of web-based PCST in clinical care.
Participants included 7 adults with bone pain due to multiple myeloma or metastasized breast or prostate cancer and 12 healthcare providers (4 physicians and 8 advanced practice providers) who treat cancer-related bone pain. Patients completed web-based PCST at home and then took part in an in-depth qualitative interview. Providers attended focus groups led by a trained moderator. Qualitative analyses identified themes in the patient and provider data.
Patients reported strongly favorable responses to web-based PCST and described emotional and physical benefits. They offered suggestions for adapting the approach to better fit their needs and to overcome barriers to completion. Focus groups indicated a need to familiarize healthcare providers with PCST and to address concerns about overburdening patients. Providers would recommend the program to patients they felt could benefit. They suggested applying a broad definition of cancer pain and having various types of providers help coordinate program its use with clinical care.
Significance of results:
Web-based PCST was acceptable to patients and providers. Our findings suggest that patients could benefit from this approach, especially if patient and provider barriers are addressed.
Skin is the parchment upon which identity is written; class, race, ethnicity, and gender are all legible upon the human surface. Removing skin tears away identity, and leaves a blank slate upon whichlaw, punishment, sanctity, or monstrosity can be inscribed; whether as an act of penal brutality, as a comic device, or as a sign of spiritual sacrifice, it leaves a lasting impression about the qualities and nature of humanity. Flaying often functioned as an imaginative resource for medieval and early modern artists and writers, even though it seems to have been rarely practiced in reality. From images of Saint Bartholomew holding his skin in his arms, to scenes of execution in Havelok the Dane, to laws that prescribed it as a punishment for treason, this volume explores the ideaand the reality of skin removal - flaying - in the Middle Ages. It interrogates the connection between reality and imagination in depictions of literal skin removal, rather than figurative or theoretical interpretations of flaying, and offers a multilayered view of medieval and early modern perceptions of flaying and its representations in European culture. Its two parts consider practice and representation, capturing the evolution of flaying as both an idea and a practice in the premodern world.
Larissa Tracy is Associate Professor, Longwood University.
Contributors: Frederika Bain, Peter Dent, Kelly DeVries, Valerie Gramling, Perry Neil Harrison, Jack Hartnell, Emily Leverett, Michael Livingston, Sherry C.M. Lindquist, Asa Mittman, Mary Rambaran-Olm, William Sayers, Christina Sciacca, Susan Small, Larissa Tracy, Renée Ward