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Synopsis of 2024 VA Long COVID Clinical Guidance for U.S. Veterans: Part 1, Nervous System-Related Symptoms
No full textDESCRIPTION: Long COVID is common and includes nervous system-related symptoms (e.g., autonomic dysfunction, cognitive impairment, fatigue, and pain). We sought to develop just-in-time evidence-informed guidance for nervous system-related Long COVID, a condition for which mature evidence is limited. METHODS: The U.S. Veterans Affairs (VA) Veterans Health Administration (VHA) Long COVID Field Advisory Board commissioned an expert panel that worked with a GRADE methodologist to develop an evidence-to-decision framework for emergent conditions by applying core elements of the Standards for Developing Trustworthy Clinical Practice Guidelines and those of GRADE. We also convened a multidisciplinary writing group that identified a list of clinically relevant questions and commissioned an independent review and synthesis of existing evidence. The writing group conducted structured discussions and used this evidence base to make recommendations for evaluation and treatment ( Evidence-informed Recommendations ). For history-taking, physical exam, and commonly used, noninvasive diagnostic tests, statements were based on consensus determinations of useful and safe care ( Good Practice Statements ). We used a Whole Health Systems approach to support the development of guidance that was patient-centered, culturally appropriate, and available regardless of literacy or disability. Feedback was solicited from Veterans and other stakeholders. Where the published literature was insufficient, we used evidence from treatment of similar conditions. RECOMMENDATIONS: We drafted 30 Evidence-informed Recommendations and 41 Good Practice Statements for nervous system-related Long COVID in Veterans and disseminated them VA-wide, targeting specialty care providers. More research on the effectiveness of diagnostic and therapeutic interventions is needed. In particular, evidence borrowed from other conditions and populations should be replaced or supplemented by evidence in Long COVID. Clinical guidance should be updated as this evidence becomes available. KEY POINTS: QUESTION: How can clinicians provide evidence-informed care for nervous system-related Long COVID (e.g., autonomic dysfunction, cognitive impairment, fatigue, and pain)? FINDINGS: We commissioned an independent rapid evidence review which found that evidence supporting the care of nervous system-related Long COVID symptoms was limited. Using available evidence and other considerations (e.g., costs, equity, and applicability to Veterans experiencing Long COVID), we drafted 30 Evidence-informed Recommendations and 41 Good Practice Statements for nervous system-related Long COVID. MEANING: Although mature evidence was limited, this guidance can provide a framework for clinicians caring for patients with nervous system-related Long COVID. More research on the effectiveness of diagnostic and therapeutic interventions in Long COVID is needed
Emergency department-initiated palliative care screening among older adults: a systematic review and meta-analysis protocol
No full textINTRODUCTION: The rapidly growing population of older adults (individuals aged 65 years and older) presents a new set of challenges for healthcare providers in the emergency department (ED), given the prevalence of severe and life-threatening conditions among this group, such as chronic cancer, Alzheimer\u27s disease/dementia and congestive heart failure. ED encounters often represent a critical point in an older patient\u27s trajectory of care and can thus be an important opportunity for various interventions such as palliative care consultation. Therefore, identifying those who will benefit most from palliative care is of high importance, especially in determining the course of future treatment. Thus, we aim to conduct a systematic review assessing the efficacy of palliative care screening in the ED by assessing inpatient length of stay as the primary outcome and quality of life, percentage of hospitalisation and cost of care as secondary outcomes. METHODS: This study will use Ovid MEDLINE, Embase, EBSCO CINAHL, Web of Science and Cochrane as databases. The study population comprises adults aged 60 years and older, with no focus on any specific clinical specialty or disease. Patients who have not received palliative care screening will serve as the comparator. Only studies with an applicable comparator will be considered. Studies published from 1 January 2000 to 1 July 2025 will be included.All articles will be reviewed independently and in duplicate, and every author will participate in the review, data abstraction and conflict resolution process. ETHICS AND DISSEMINATION: Ethical approval is not required as it is a protocol for a systematic review. Findings will be disseminated through peer-reviewed publications and conference presentations. PROSPERO REGISTRATION NUMBER: CRD42024562389
Knowledge and Recommendations of Stakeholders regarding Ethical Oversight of Data Science Health Research: A qualitative study protocol
No full textBACKGROUND: Data science health research (DSHR) employs novel computational methods and high-performance computing to analyze big data from conventional and non-conventional health and related sources to generate novel insights and communications. DSHR creates valuable assets but generates substantial ethical, legal, and social (ELS) challenges. Key gaps in current ethical oversight of DSHR include blurred boundaries between research and non-research data use, inadequate protection of data donors, power imbalances that risk extractive research practices, algorithmic biases, and regulatory inadequacies. Nigeria, a typical LMIC with rapidly expanding DSHR exemplifies this environment and concerns. OBJECTIVE: This study will elicit the knowledge and recommendations of Nigerian DSHR stakeholders and contribute to improved knowledge of the ELSI of DSHR and the development of novel ethical oversight frameworks. METHODS: Between October 2024 and January 2025, we conducted Key Informant Interviews (KII) with 65 stakeholders out of 87 individuals who were approached. The KII guide comprised 12 construct-based question domains addressing awareness of policies and laws, ethical oversight processes, ELSI considerations in policy development, experiences addressing DSHR challenges, organizational and procedural frameworks, ideal oversight components, stakeholder roles, research impact on ethics and policy, regulatory influences on research practices, equity-enhancing policies, and balanced regulations. The interviews lasted 60-90 minutes and were transcribed. We analyzed the transcripts using a hybrid deductive-inductive approach. A priori codes derived from research objectives provided the analytical framework while allowing for identification of emergent concepts. The iterative three-level coding process involved initial code generation, evaluation, and refinement, with codes grouped into thematic families and semantic networks representing hierarchical concept relationships. Query tools and Boolean operators were used to interrogate the codes to extract findings. RESULTS: Of 87 invited individuals, 22 (25%) were unable to participate. The 65 participants (mean (SD) age = 47.9 (7.9) years; 77% male) included data science health researchers (39%), biomedical researchers (26%), HREC members (19%), and policy makers (17%). Most held doctoral degrees (57%), were affiliated with academic institutions (69%) and government organizations (40%) and had received general research ethics training (77%). However, only 12% had received predominantly short-duration ethics-specific DSHR training, while 92% acknowledged the need for specialized DSHR ethics education. As of January 2025, the interview transcripts have been generated and checking completed, with qualitative analysis scheduled for completion by March 2025 and completion of primary manuscripts by the end of 2025. CONCLUSIONS: This study will generate stakeholder-informed recommendations for ethical oversight of DSHR that addresses issues relating to broad consent, ELSI, data ownership, benefit-sharing, and donor protection in resource-limited settings. Our findings will inform the global DSHR and research ethics communities on the development of contextually appropriate oversight mechanisms that promote equitable partnerships, co-ownership, and tiered data governance
EndoCompass project: research roadmap for growth disorders
No full textBACKGROUND: Endocrine science remains underrepresented in European Union research programs despite the fundamental role of hormone health in human wellbeing. Analysis of the CORDIS database reveals a persistent gap between the societal impact of endocrine disorders and their research prioritization. At the national funding level, endocrine societies report limited or little attention of national research funding toward endocrinology. The EndoCompass project-a joint initiative between the European Society of Endocrinology and the European Society of Pediatric Endocrinology, aimed to identify and promote strategic research priorities in endocrine science to address critical hormone-related health challenges. METHODS: Research priorities were established through comprehensive analysis of the EU CORDIS database covering the Horizon 2020 framework period (2014-2020). Expert consultation in growth disorders was conducted to identify key research priorities, followed by broader stakeholder engagement, including society members and patient advocacy groups. RESULTS: Research priorities encompass genetic diagnosis of growth disorders; growth plate-targeted therapies; molecular mechanisms of Silver-Russell syndrome and imprinting disorders; hypothalamic dysfunction in Prader-Willi syndrome; and characterization of Noonan syndrome and tall stature conditions. Emphasis is placed on creating disease registries to facilitate outcome studies and developing precision therapeutics based on growth regulation pathways. CONCLUSIONS: This component of the EndoCompass project provides an evidence-based roadmap for strategic research investment. This framework identifies crucial investigation areas into growth disorder pathophysiology, prevention, and treatment strategies, ultimately aimed at reducing the burden of these disorders on individuals and society. The findings support the broader EndoCompass objective of aligning research funding with areas of highest potential impact in endocrine health
Landscape analysis of oncology nutrition research among patients being treated for cancer
No full textRecent efforts by numerous organizations and societies have found limited scientific evidence to support oncology nutrition guideline development. This project was undertaken to describe oncology nutrition studies that are underway or recently completed and to evaluate factors related to the completion and publication of study findings. Searches of ClinicalTrials.gov and the Australian New Zealand Clinical Trials Registry were performed in January 2025 using combinations of the terms: cancer, nutrition, diet, and oncology. Search results were merged and duplicates were removed using R/RStudio, and then, each entry was manually reviewed for eligibility in REDCap. Eligibility criteria were as follows: a study start date between January 2015 and December 2024, participants who were actively receiving cancer treatment, and a measure of diet/nutritional status and/or a nutrition intervention. Descriptive statistics, including stratified analyses, were conducted in R/RStudio. The database searches identified 1866 unique study listings. After exclusion criteria were applied, 444 studies met the inclusion criteria. Most studies (n = 352, 79.3%) were intervention studies. The vast majority of studies (n = 380, 85.6%) were funded by sources other than government (n = 48, 10.8%) or industry (n = 16, 3.6%) grants. Nine broad categories of study topics were identified, with the most common being intake of specific nutrients/supplements (n = 173), prehabilitation/perioperative nutrition (n = 153), quality of life, symptom/toxicity management (n = 136), and nutrition assessment, counseling, and education (n = 100). Median target enrollment for the included studies was 80 participants (range: 1-10,000). Less than a third of completed studies had published findings as of January 1, 2025. Larger, rigorously designed trials are needed for inclusion in future evidence-based guideline development efforts
Shared and distinct metabolomics profiles associated with microvascular complications in the Diabetes Prevention Program Outcomes Study
No full textAIMS/HYPOTHESIS: The aim of this study was to identify shared and distinct metabolite profiles prospectively associated with nephropathy, retinopathy and neuropathy at 15 years\u27 follow-up among 1947 participants in the Diabetes Prevention Program Outcomes Study, the long-term follow-up of the Diabetes Prevention Program (DPP). METHODS: We applied bootstrapped LASSO to 353 annotated metabolites to identify metabolites associated with one or more complication. For these metabolite hits, we tested for an interaction with DPP treatment arm, and ran multivariable models for the pooled sample or within treatment group as appropriate. RESULTS: At follow-up, 572 participants had one or more complication (n=277 nephropathy, n=194 retinopathy, n=212 neuropathy). Of 105 metabolites that predicted any complication, 74 predicted one, 27 predicted two, and four predicted all three. In a pooled analysis of 69 metabolites without treatment arm interactions, histidine predicted lower odds of nephropathy (OR 0.75; 95% CI 0.69, 0.88), and serine predicted lower odds of nephropathy (OR 0.69; 95% CI 0.58, 0.82) and neuropathy (OR 0.68; 95% CI 0.56, 0.84). Of 36 metabolites that interacted with treatment arm, higher N-carbamoyl-β-alanine predicted greater odds of nephropathy (OR 1.99; 95% CI 1.38, 2.99) and C22:0-sphingomyelin predicted lower odds of neuropathy (OR 0.54; 95% CI 0.37, 0.77) in the metformin arm. In the lifestyle intervention arm, quinolinic acid predicted greater odds of neuropathy (OR 1.64; 95% CI 1.24, 2.19). These estimates accounted for sex, race, baseline age, BMI and smoking, and time elapsed during follow-up. Further adjustment for HbA during follow-up, incident diabetes and eGFR did not change the results. CONCLUSIONS/INTERPRETATION: The existence of distinct metabolite profiles associated with single microvascular complications highlights the importance of characterising pathophysiological mechanisms specific to each complication, in addition to studying shared mechanisms across multiple complications
Implementation of a Healthcare Implicit Bias Training across Three Oncology Care Settings
No full textThe purpose of this study was to describe evaluation outcomes, including reach, satisfaction with training, and strategies to increase uptake of implicit bias training across three cancer centers in Washington, DC. From October 25, 2022, to March 29, 2023, oncology clinicians and staff were asked to complete an implicit bias training and post-training survey. Strategies used to increase training reach included identifying and preparing champions, identifying facilitators and barriers, promoting adaptation, and mandating completion. We quantitatively assessed satisfaction with training and self-reported learning outcomes and qualitatively explored impact of the training and how implementation strategies affected uptake. We reviewed open-text responses for feedback and insights from learners. At the suggestion of our champions, we pivoted from a five-hour training to a one-hour training to adapt to clinical team availability. The most successful strategies for increasing training uptake included reducing training length and personalized follow-up from institutional champions. One hundred eight of the 163 (66%) invited learners completed the training. Over 94% of learners agreed or strongly agreed that they met the training\u27s three learning objectives: describing implicit bias, providing examples of implicit bias in healthcare settings, and reflecting on one\u27s own biases. Learners\u27 open-ended responses described how training reaffirmed viewpoints for some learners while others became more aware of their biases. Implementing an implicit bias training across multiple care settings was successful in reaching our goal of 100 learners; however, reach varied by setting due to competing priorities and less champion influence at one institution
Artificial Intelligence as a New Player in Dietary Management of Inflammatory Bowel Disease
No full textRethinking Resting Heart Rate Variability: No Evidence of Association With Self-Regulation and Psychopathology in a Cross-Sectional Study Among Adolescents in Colombia, Nepal, and South Africa
No full textResting-state heart rate variability (HRV) has been proposed by some researchers as a potential transdiagnostic measure of psychopathology. It is often found to be reduced across a range of mental health conditions and is thought to reflect self-regulatory processes, which are often impaired in these conditions. However, most existing evidence is derived from high-income countries with limited ethnic variation. This leaves a critical gap in understanding whether these associations generalize to low- and middle-income countries (LMICs) or to individuals from under-represented ethnic backgrounds. In this cross-sectional study, we examined the relationship between resting-state HRV, self-regulation, and psychopathology in a large, diverse sample of 1107 adolescents aged 13-15 years living in urban poverty across Colombia, Nepal, and South Africa. We tested seven pre-registered hypotheses across two domains: self-regulation (emotional regulation, inhibitory control, and delay discounting) and psychopathology (anxiety, depression, externalizing symptoms). We used linear mixed models for the confirmatory analyses and complemented them with exploratory equivalence testing. Contrary to our hypotheses based on the neurovisceral integration (NVI) model, HRV was not significantly associated with any outcomes, except for a small effect on externalizing behavior in the opposite direction of our hypothesis. Equivalence testing further indicated that the observed estimates were statistically equivalent, which suggests a meaningful effect is absent. These findings challenge the assumption that HRV-psychological associations are universal and point to the importance of considering contextual, cultural, developmental, and methodological factors in psychophysiological research. This study aims to contribute to a broader rethinking of HRV\u27s role in mental health research, especially in populations that have been under-represented in the literature
Donor human milk and structural brain development in very preterm infants
No full textBACKGROUND: We investigated the impact of donor milk on structural brain development, relative to maternal milk feeding, in very preterm infants at term-equivalent age (TEA). METHODS: Very preterm infants ( ≤32 weeks\u27 gestation) were enrolled in an observational study. Infants categorized as receiving primarily maternal milk (MOM), donor human milk (DHM), or preterm formula (PTF) based on cumulative feed volume underwent TEA brain magnetic resonance imaging for volumetric (coronal T2) and white matter (diffusion tensor imaging) development. RESULTS: In this cohort of 152 infants (67 MOM, 44 DHM, 41 PTF), there were no significant differences in brain volumes between MOM and DHM. PTF demonstrated lower deep gray matter (β = -1.2, p = 0.024), brainstem (β = -0.4, p = 0.002) and total brain volumes (β = -17.2, p = 0.016) than MOM. Relative to MOM, DHM showed decreased white matter mean diffusivity in the pons (right: β = -0.04, p = 0.008; left: β = -0.06, p \u3c 0.001); PTF had increased mean diffusivity in the corpus callosum (genu: β = 0.11, p = 0.007; splenium: β = 0.13, p = 0.007) and posterior limb of internal capsule (PLIC) (right: β = 0.06, p = 0.002; left: β = 0.06, p = 0.001) and decreased fractional anisotropy in the right PLIC (β = -0.02, p = 0.019). CONCLUSIONS: Brain volumes and overall white matter development were not significantly different between DHM and MOM, while PTF-fed infants demonstrated lower total and regional brain volumes and greater white matter microstructural alterations. IMPACT: Feeding very preterm infants maternal milk is associated with improved ex-utero third trimester brain development compared to formula, but the implications of donor milk for structural brain development remain unknown. We performed brain magnetic resonance imaging at term-equivalent age to compare structural brain development between very preterm infants primarily fed either maternal milk, donor milk, or preterm formula. Brain volumes and white matter microstructure in primarily donor milk-fed very preterm infants more closely resembled that of maternal-milk fed infants than did infants fed formula, suggesting donor milk offers a potential advantage for structural brain development when maternal milk is unavailable