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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.
The Minnesota Center for Twin and Family Research (MCTFR) comprises multiple longitudinal, community-representative investigations of twin and adoptive families that focus on psychological adjustment, personality, cognitive ability and brain function, with a special emphasis on substance use and related psychopathology. The MCTFR includes the Minnesota Twin Registry (MTR), a cohort of twins who have completed assessments in middle and older adulthood; the Minnesota Twin Family Study (MTFS) of twins assessed from childhood and adolescence into middle adulthood; the Enrichment Study (ES) of twins oversampled for high risk for substance-use disorders assessed from childhood into young adulthood; the Adolescent Brain (AdBrain) study, a neuroimaging study of adolescent twins; and the Siblings Interaction and Behavior Study (SIBS), a study of adoptive and nonadoptive families assessed from adolescence into young adulthood. Here we provide a brief overview of key features of these established studies and describe new MCTFR investigations that follow up and expand upon existing studies or recruit and assess new samples, including the MTR Study of Relationships, Personality, and Health (MTR-RPH); the Colorado-Minnesota (COMN) Marijuana Study; the Adolescent Brain Cognitive Development (ABCD) study; the Colorado Online Twins (CoTwins) study and the Children of Twins (CoT) study.
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.
TwinsUK is the largest cohort of community-dwelling adult twins in the UK. The registry comprises over 14,000 volunteer twins (14,838 including mixed, single and triplets); it is predominantly female (82%) and middle-aged (mean age 59). In addition, over 1800 parents and siblings of twins are registered volunteers. During the last 27 years, TwinsUK has collected numerous questionnaire responses, physical/cognitive measures and biological measures on over 8500 subjects. Data were collected alongside four comprehensive phenotyping clinical visits to the Department of Twin Research and Genetic Epidemiology, King’s College London. Such collection methods have resulted in very detailed longitudinal clinical, biochemical, behavioral, dietary and socioeconomic cohort characterization; it provides a multidisciplinary platform for the study of complex disease during the adult life course, including the process of healthy aging. The major strength of TwinsUK is the availability of several ‘omic’ technologies for a range of sample types from participants, which includes genomewide scans of single-nucleotide variants, next-generation sequencing, metabolomic profiles, microbiomics, exome sequencing, epigenetic markers, gene expression arrays, RNA sequencing and telomere length measures. TwinsUK facilitates and actively encourages sharing the ‘TwinsUK’ resource with the scientific community — interested researchers may request data via the TwinsUK website (http://twinsuk.ac.uk/resources-for-researchers/access-our-data/) for their own use or future collaboration with the study team. In addition, further cohort data collection is planned via the Wellcome Open Research gateway (https://wellcomeopenresearch.org/gateways). The current article presents an up-to-date report on the application of technological advances, new study procedures in the cohort and future direction of TwinsUK.
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.
We investigated the physiology of two closely related albatross species relative to their breeding strategy: black-browed albatrosses (Thalassarche melanophris) breed annually, while grey-headed albatrosses (T. chrysostoma) breed biennially. From observations of breeding fate and blood samples collected at the end of breeding in one season and feather corticosterone levels (fCort) sampled at the beginning of the next breeding season, we found that in both species some post-breeding physiological parameters differed according to breeding outcome (successful, failed, deferred). Correlations between post-breeding physiology and fCort, and links to future breeding decisions, were examined. In black-browed albatrosses, post-breeding physiology and fCort were not significantly correlated, but fCort independently predicted breeding decision the next year, which we interpret as a possible migratory carry-over effect. In grey-headed albatrosses, post-breeding triglyceride levels were negatively correlated with fCort, but only in females, which we interpret as a potential cost of reproduction. However, this potential cost did not carry-over to future breeding in the grey-headed albatrosses. None of the variables predicted future breeding decisions. We suggest that biennial breeding in the grey-headed albatrosses may have evolved as a strategy to buffer against the apparent susceptibility of females to negative physiological costs of reproduction. Future studies are needed to confirm this.
Gene × Environment interaction contributes to externalizing disorders in childhood and adolescence, but little is known about whether such effects are long lasting or present in adulthood. We examined gene–environment interplay in the concurrent and prospective associations between antisocial peer affiliation and externalizing disorders (antisocial behavior and substance use disorders) at ages 17, 20, 24, and 29. The sample included 1,382 same-sex twin pairs participating in the Minnesota Twin Family Study. We detected a Gene × Environment interaction at age 17, such that additive genetic influences on antisocial behavior and substance use disorders were greater in the context of greater antisocial peer affiliation. This Gene × Environment interaction was not present for antisocial behavior symptoms after age 17, but it was for substance use disorder symptoms through age 29 (though effect sizes were largest at age 17). The results suggest adolescence is a critical period for the development of externalizing disorders wherein exposure to greater environmental adversity is associated with a greater expression of genetic risk. This form of Gene × Environment interaction may persist through young adulthood for substance use disorders, but it appears to be limited to adolescence for antisocial behavior.
The importance of chronic low-grade inflammation in the pathology of numerous age-related chronic conditions is now clear. An unresolved inflammatory response is likely to be involved from the early stages of disease development. The present position paper is the most recent in a series produced by the International Life Sciences Institute's European Branch (ILSI Europe). It is co-authored by the speakers from a 2013 workshop led by the Obesity and Diabetes Task Force entitled ‘Low-grade inflammation, a high-grade challenge: biomarkers and modulation by dietary strategies’. The latest research in the areas of acute and chronic inflammation and cardiometabolic, gut and cognitive health is presented along with the cellular and molecular mechanisms underlying inflammation–health/disease associations. The evidence relating diet composition and early-life nutrition to inflammatory status is reviewed. Human epidemiological and intervention data are thus far heavily reliant on the measurement of inflammatory markers in the circulation, and in particular cytokines in the fasting state, which are recognised as an insensitive and highly variable index of tissue inflammation. Potential novel kinetic and integrated approaches to capture inflammatory status in humans are discussed. Such approaches are likely to provide a more discriminating means of quantifying inflammation–health/disease associations, and the ability of diet to positively modulate inflammation and provide the much needed evidence to develop research portfolios that will inform new product development and associated health claims.
People who undergo hematopoietic stem cell transplantation are highly dependent on their caregiver during their lengthy treatment and recovery. The effectiveness of their caregiver's social support can profoundly affect their day-to-day treatment experiences and, in turn, how they recall those experiences and are affected by them long after the treatment ends.
Our participants were 182 men and women who had undergone a transplant within the previous 9 months to 3 years. They completed baseline measures (including a measure of caregiver social support effectiveness) and then completed three writing assignments describing their transplant experiences. Linguistic analyses were conducted to investigate their use of words indicating negative emotions, cognitive processing (insight and causation), and practical problems with money and insurance. Theory-based hypotheses predicted associations between specific functional types of caregiver support (emotional, informational, and instrumental) and these word categories.
As hypothesized, the effectiveness of different functional types of support from a caregiver were uniquely associated with theoretically relevant categories of word use. Structural equation models indicated that more effective caregiver emotional support predicted lower use of negative emotion words; more effective caregiver informational support predicted lower use of causation words; and more effective caregiver instrumental support predicted lower use of words related to money and insurance.
Significance of results:
Our findings provide insights to guide research on the mechanisms through which caregiver support influences patient outcomes after stem cell transplantation. For instance, research suggests that these kinds of effects could have implications for survivors' current self-concept, psychosocial functioning, and meaning-making.
Survivors of hematopoietic stem cell transplant (HSCT) have experienced a life threatening and potentially traumatic illness and treatment that make them vulnerable to long lasting negative psychological outcomes, including anxiety and depression. Nevertheless, studies show that overcoming cancer and its treatment can present an opportunity for personal growth and psychological health (reduced symptoms of anxiety and depression and high levels of emotional well-being) through resilience. However, research has not yet clarified what differentiates HSCT survivors who experience psychological growth from those who do not. By analyzing recovery narratives, we examined whether HSCT survivors’ interpretation of their experiences helps explain differences in their post-treatment psychological health.
Guided by narrative psychology theory, we analyzed the narratives of 23 HSCT survivors writing about their experience of cancer treatment. Psychological health was measured by: (1) emotional well-being subscale part of the Functional Assessment of Cancer Therapy Bone Marrow Transplant (FACT-BMT), (2) depression, and (3) anxiety subscales of the Brief Symptom Inventory.
Findings revealed a positive relation between psychological health and a greater number of redemption episodes (going from an emotionally negative life event to an emotionally positive one) as well as fewer negative emotional expressions.
Significance of the results:
Theoretical and practical implications of these findings are discussed, showing how narratives can inform interventions to assist cancer survivors with their psychological recovery.