Clinical Care Research Research Articles

Classification of Documented Goals of Care Among Hospitalized Patients with High Mortality Risk: a Mixed-Methods Feasibility Study

BackgroundThe ability to classify patients’ goals of care (GOC) from clinical documentation would facilitate serious illness communication quality improvement efforts and pragmatic measurement of goal-concordant care. Feasibility of this approach remains unknown.ObjectiveTo evaluate the feasibility of classifying patients’ GOC from clinical documentation in the electronic health record (EHR), describe the frequency and patterns of changes in patients’ goals over time, and identify barriers to reliable goal classification.DesignRetrospective, mixed-methods chart review study.ParticipantsAdults with high (50–74%) and very high (≥ 75%) 6-month mortality risk admitted to three urban hospitals.Main MeasuresTwo physician coders independently reviewed EHR notes from 6 months before through 6 months after admission to identify documented GOC discussions and classify GOC. GOC were classified into one of four prespecified categories: (1) comfort-focused, (2) maintain or improve function, (3) life extension, or (4) unclear. Coder interrater reliability was assessed using kappa statistics. Barriers to classifying GOC were assessed using qualitative content analysis.Key ResultsAmong 85 of 109 (78%) patients, 338 GOC discussions were documented. Inter-rater reliability was substantial (75% interrater agreement; Cohen’s kappa = 0.67; 95% CI, 0.60–0.73). Patients’ initial documented goal was most frequently “life extension” (N = 37, 44%), followed by “maintain or improve function” (N = 28, 33%), “unclear” (N = 17, 20%), and “comfort-focused” (N = 3, 4%). Among the 66 patients whose goals’ classification changed over time, most changed to “comfort-focused” goals (N = 49, 74%). Primary reasons for unclear goals were the observation of concurrently held or conditional goals, patient and family uncertainty, and limited documentation.ConclusionsClinical notes in the EHR can be used to reliably classify patients’ GOC into discrete, clinically germane categories. This work motivates future research to use natural language models to promote scalability of the approach in clinical care and serious illness research.

Low-dose naltrexone for post-COVID fatigue syndrome: a study protocol for a double-blind, randomised trial in British Columbia

IntroductionA significant proportion of individuals suffering from post COVID-19 condition (PCC, also known as long COVID) can present with persistent, disabling fatigue similar to myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS) and...

A Conceptual Thematic Framework of Psychological Adjustment in Caregivers of Children with Craniofacial Microsomia.

Children with craniofacial microsomia (CFM) have complex healthcare needs, resulting in evaluations and interventions from infancy onward. Yet, little is understood about families' treatment experiences or the impact of CFM on caregivers' well-being. To address this gap, the NIH-funded 'Craniofacial microsomia: Accelerating Research and Education (CARE)' program sought to develop a conceptual thematic framework of caregiver adjustment to CFM. Caregivers reported on their child's medical and surgical history. Narrative interviews were conducted with US caregivers (n = 62) of children aged 3-17 years with CFM. Transcripts were inductively coded and final themes and subthemes were identified. Components of the framework included: 1) Diagnostic Experiences, including pregnancy and birth, initial emotional responses, communication about the diagnosis by healthcare providers, and information-seeking behaviors; 2) Child Health and Healthcare Experiences, including feeding, the child's physical health, burden of care, medical decision-making, surgical experiences, and the perceived quality of care; 3) Child Development, including cognition and behavior, educational provision, social experiences, and emotional well-being; and 4) Family Functioning, including parental well-being, relationships, coping strategies, and personal growth. Participants also identified a series of "high" and "low" points throughout their journey and shared their priorities for future research. Narrative interviews provided rich insight into caregivers' experiences of having a child with CFM and enabled the development of a conceptual thematic framework to guide clinical care and future research. Information gathered from this study demonstrates the need to incorporate evidence-based psychological support for families into the CFM pathway from birth onward.

Role of Artificial Intelligence in Developing Hospital Information Management Systems

Hospital information management systems (HIMS) play significant roles in improving clients' health by applying developed technologies, one of which is artificial intelligence (AI). This study aims to explore the roles of AI in order to support the development of HIMS. We conducted a literature review by extracting the articles from PubMed, ProQuest, and Google Scholar in the past 5 years (January 2019-August 2023) using specific keywords. The full text of relevant articles then thematically synthesized and to be presented. Our findings revealed eight themes that represent the role of AI in supporting the hospital information management system and its implementation in healthcare settings. The themes identified include Diagnosis and Medical Imaging, Health Data Management, Risks Prediction and Disease Progression, Inventory and Procurement Management, Telemedicine and Remote Consultation, Patient Care Management, Drug Development and Clinical Research, and Hospital Data Security System. The AI implementation brings the potential to improve efficiency, accuracy, and quality of care in hospitals. However, it should be noted that the development and implementation of AI need to consider the ethical aspects and proper integration through existing health systems.

Using digital tools in clinical, health and social care research: a mixed-methods study of UK stakeholders

ObjectiveThe COVID-19 pandemic accelerated changes to clinical research methodology, with clinical studies being carried out via online/remote means. This mixed-methods study aimed to identify which digital tools are currently used...

The role of Europe in Global Psychiatry

AbstractThe burden of mental illness in Europe: High individual and societal burden, but only 2% spent on mental health. The tradition of European Psychiatry needs to be strengthened in care, research and teaching.Within the long-term Strategic Mental Health Plan of the EPA the improvement of clinical care research, the “mapping excellence” and “developing core treatment guidelines” require further action. Researching the influence of environmental stressors on the development and maintenance of mental illness and fostering stepped care approaches to improve resilience are none the less important. Furthermore, to improve the reliability and especially validity of diagnoses of mental disorders by introducing (bio)markers and defining dimensions of mental illnesses using big data and predictive sciences are just as important as an enforced research on reducing stigma and discrimination of mental disorders.Disclosure of InterestNone Declared

Sample size estimation for stratified cluster randomization trial with survival endpoint.

Cluster randomization trials with survival endpoint are predominantly used in drug development and clinical care research when drug treatments or interventions are delivered at a group level. Unlike conventional cluster randomization design, stratified cluster randomization design is generally considered more effective in reducing the impacts of imbalanced baseline prognostic factors and varying cluster sizes between groups when these stratification factors are adopted in the design. Failure to account for stratification and cluster size variability may lead to underpowered analysis and inaccurate sample size estimation. Apart from the sample size estimation in unstratified cluster randomization trials, there are no development of an explicit sample size formula for survival endpoint when a stratified cluster randomization design is employed. In this article, we present a closed-form sample size formula based on the stratified cluster log-rank statistics for stratified cluster randomization trials with survival endpoint. It provides an integrated solution for sample size estimation that account for cluster size variation, baseline hazard heterogeneity, and the estimated intracluster correlation coefficient based on the preliminary data. Simulation studies show that the proposed formula provides the appropriate sample size for achieving the desired statistical power under various parameter configurations. A real example of a stratified cluster randomization trial in the population with stable coronary heart disease is presented to illustrate our method.

Comprehensive proteomics of CSF, plasma, and urine identify DDC and other biomarkers of early Parkinson’s disease

Parkinson’s disease (PD) starts at the molecular and cellular level long before motor symptoms appear, yet there are no early-stage molecular biomarkers for diagnosis, prognosis prediction, or monitoring therapeutic response. This lack of biomarkers greatly impedes patient care and translational research—l-DOPA remains the standard of care more than 50 years after its introduction. Here, we performed a large-scale, multi-tissue, and multi-platform proteomics study to identify new biomarkers for early diagnosis and disease monitoring in PD. We analyzed 4877 cerebrospinal fluid, blood plasma, and urine samples from participants across seven cohorts using three orthogonal proteomics methods: Olink proximity extension assay, SomaScan aptamer precipitation assay, and liquid chromatography–mass spectrometry proteomics. We discovered that hundreds of proteins were upregulated in the CSF, blood, or urine of PD patients, prodromal PD patients with DAT deficit and REM sleep behavior disorder or anosmia, and non-manifesting genetic carriers of LRRK2 and GBA mutations. We nominate multiple novel hits across our analyses as promising markers of early PD, including DOPA decarboxylase (DDC), also known as l-aromatic acid decarboxylase (AADC), sulfatase-modifying factor 1 (SUMF1), dipeptidyl peptidase 2/7 (DPP7), glutamyl aminopeptidase (ENPEP), WAP four-disulfide core domain 2 (WFDC2), and others. DDC, which catalyzes the final step in dopamine synthesis, particularly stands out as a novel hit with a compelling mechanistic link to PD pathogenesis. DDC is consistently upregulated in the CSF and urine of treatment-naïve PD, prodromal PD, and GBA or LRRK2 carrier participants by all three proteomics methods. We show that CSF DDC levels correlate with clinical symptom severity in treatment-naïve PD patients and can be used to accurately diagnose PD and prodromal PD. This suggests that urine and CSF DDC could be a promising diagnostic and prognostic marker with utility in both clinical care and translational research.

Training pathologists to assess stromal tumour-infiltrating lymphocytes in breast cancer synergises efforts in clinical care and scientific research.

A growing body of research supports stromal tumour-infiltrating lymphocyte (TIL) density in breastcancer to be a robust prognostic and predicive biomarker. The gold standard for stromal TIL densityquantitation in breast cancer is pathologist visual assessment using haematoxylin and eosin-stained slides. Artificial intelligence/machine-learning algorithms are in development to automate the stromal TIL scoring process, and must be validated against a reference standard such as pathologist visual assessment. Visual TIL assessment may suffer from significant interobserver variability. To improve interobserver agreement, regulatory science experts at the US Food and Drug Administration partnered with academic pathologists internationally to create a freely available online continuing medical education (CME) course to train pathologists in assessing breast cancer stromal TILs using an interactive format with expert commentary. Here we describe and provide a user guide to this CME course, whose content was designed to improve pathologist accuracy in scoring breast cancer TILs. We also suggest subsequent steps to translate knowledge into clinical practice with proficiency testing.

Designing an accessible and equitable conference and the evaluation of the barriers to research inclusion for rare disease communities

Introduction: The United Kingdom Rare Diseases Framework, published in 2021, addresses the lack of diversity in rare disease research, particularly in clinical trials, due to intersecting issues related to rare disease symptoms and health inequalities. The framework outlines the government's commitment to improving the lives of the 3.5 million people living with rare conditions in the United Kingdom.Objective: The primary objective is to advance equality, diversity, and inclusion in research by developing innovative methods to engage with communities, establish trust, and enhance the participation and voices of underrepresented and underserved communities.Methods: The conference was held in May 2023, bringing together voices with lived experiences from rare and diverse communities to meet and discuss with established researchers, policy influencers and advocates. The evaluation design was developed using the Program Logic Model and utilised a conference evaluation form on barriers to inclusion.Results: The Rare Disease Community identifies disability as the primary obstacle to inclusion. Social Care and Public Health Communities and Clinical Research Communities identified a need for more cultural competency. The Diverse Community selected psychosocial issues, and the Academic Community identified funding as the most significant barrier.Conclusions: The Community of Practice workshops showed the variety of lived experiences and potential barriers people confront for inclusion in research. Listening to individual viewpoints was crucial to creating or repairing community trust. The Academic Community felt that research funders and ethics review boards must adapt their institutional practices to include financial resources for outreach and participation in research design.

The Top 100 Most Cited Journal Articles on Hydrocephalus.

Hydrocephalus represents a significant burden of disease, with more than 383,000 new cases annually worldwide. When the magnitude of this condition is considered, a centralized archive of pertinent literature is of great clinical value. From a neurosurgical standpoint, hydrocephalus is one of the most frequently treated conditions in the field. The focus of this study was to identify the top 100 journal articles specific to hydrocephalus using bibliometric analysis. Using the Journal of Citation Report database, 10 journals were identified. The Web of Science Core Collection was then searched using each journal name and the search term "hydrocephalus." The results were ordered by "Times Cited" and searched by the number of citations. The database contained journal articles from 1976 to 2021, and the following variables were collected for analysis: journal, article type, year of publication, and the number of citations. Journal articles were excluded if they had no relation to hydrocephalus, mostly involved basic science research, or included animal studies. Ten journals were identified using the above criteria, and a catalog of the 100 most cited publications in the hydrocephalus literature was created. Articles were arranged from highest to lowest citation number, with further classification by journal, article type, and publication year. Of the 100 articles referenced, 38 were review articles, 24 were original articles, 15 were comparative studies, 11 were clinical trials, six were multi-center studies, three were cross-sectional, and three were case reports with reviews. Articles were also sorted by study type and further stratified by etiology. If the etiology was not specified, studies were instead subcategorized by treatment type. Etiologies such as aqueductal stenosis, tumors, and other obstructive causes of hydrocephalus were classified as obstructive (n=6). Communicating (n=15) included idiopathic, normal pressure hydrocephalus, and other non-obstructive etiologies. The category "other" (n=3) was assigned to studies that included etiologies, populations, and/or treatments that did not fit into the classifications previously outlined. Through our analysis of highly cited journal articles focusing on different etiologies and the surgical or medical management of hydrocephalus, we hope to elucidate important trends. By establishing the 100 most cited hydrocephalus articles, we contribute one source, stratified for efficient referencing, to facilitate clinical care and future research on hydrocephalus.

Publics' knowledge of, attitude to and motivation towards health-related genomics: a scoping review.

The use of genomic data in research and genomic information in clinical care is increasing as technologies advance and sequencing costs decrease. Using Rogers' Diffusion of Innovation (DOI) theory as a framework we reviewed recent literature examining publics' current knowledge of, attitude to, and motivation towards health-related genomics in clinical and research settings. The population of interest was described as 'publics' to denote the heterogeneity of 'the public'. Eligible studies were published in English between 2016-2022. We retrieved 1657 records, with 278 full-text reviewed against the eligibility criteria and concept definitions. In total, 99 articles were included in the review and descriptive numerical summaries were collated. Knowledge literature was categorized using deductive thematic analysis. For attitude and motivation, literature was coded using an analytic framework developed by the authors. There was wide variability in concept definition and measurement across studies. Overall, there was general positivity about genomics, with high awareness but little familiarity or factual knowledge. Publics had high expectations of genomics and perceived that it could provide them with information for their future. Only a few key attitudes were found to be important as motivators or barriers for participation in genomics; these were related to personal and clinical utility of the information. Context was often missing from studies, decreasing the utility of findings for implementation or public engagement. Future research would benefit by using theory-driven approaches to assess relevant publics' knowledge and attitudes of specific contexts or applications to support genomic implementation and informed decision-making.

The Pain Intervention & Digital Research Program: an operational report on combining digital research with outpatient chronic disease management.

Chronic pain affects up to 28% of U.S. adults, costing ∼$560 billion each year. Chronic pain is an instantiation of the perennial complexity of how to best assess and treat chronic diseases over time, especially in populations where age, medical comorbidities, and socioeconomic barriers may limit access to care. Chronic disease management poses a particular challenge for the healthcare system's transition from fee-for-service to value and risk-based reimbursement models. Remote, passive real-time data from smartphones could enable more timely interventions and simultaneously manage risk and promote better patient outcomes through predicting and preventing costly adverse outcomes; however, there is limited evidence whether remote monitoring is feasible, especially in the case of older patients with chronic pain. Here, we introduce the Pain Intervention and Digital Research (Pain-IDR) Program as a pilot initiative launched in 2022 that combines outpatient clinical care and digital health research. The Pain-IDR seeks to test whether functional status can be assessed passively, through a smartphone application, in older patients with chronic pain. We discuss two perspectives-a narrative approach that describes the clinical settings and rationale behind changes to the operational design, and a quantitative approach that measures patient recruitment, patient experience, and HERMES data characteristics. Since launch, we have had 77 participants with a mean age of 55.52, of which n = 38 have fully completed the 6 months of data collection necessitated to be considered in the study, with an active data collection rate of 51% and passive data rate of 78%. We further present preliminary operational strategies that we have adopted as we have learned to adapt the Pain-IDR to a productive clinical service. Overall, the Pain-IDR has successfully engaged older patients with chronic pain and presents useful insights for others seeking to implement digital phenotyping in other chronic disease settings.

Using a Natural Language Processing Approach to Support Rapid Knowledge Acquisition.

Implementing artificial intelligence to extract insights from large, real-world clinical data sets can supplement and enhance knowledge management efforts for health sciences research and clinical care. At Vanderbilt University Medical Center (VUMC), the in-house developed Word Cloud natural language processing system extracts coded concepts from patient records in VUMC's electronic health record repository using the Unified Medical Language System terminology. Through this process, the Word Cloud extracts the most prominent concepts found in the clinical documentation of a specific patient or population. The Word Cloud provides added value for clinical care decision-making and research. This viewpoint paper describes a use case for how the VUMC Center for Knowledge Management leverages the condition-disease associations represented by the Word Cloud to aid in the knowledge generation needed to inform the interpretation of phenome-wide association studies.

Quantitative Skeletal Imaging and Image-Based Modeling in Pediatric Orthopaedics.

Musculoskeletal imaging serves a critical role in clinical care and orthopaedic research. Image-based modeling is also gaining traction as a useful tool in understanding skeletal morphology and mechanics. However, there are fewer studies on advanced imaging and modeling in pediatric populations. The purpose of this review is to provide an overview of recent literature on skeletal imaging modalities and modeling techniques with a special emphasis on current and future uses in pediatric research and clinical care. While many principles of imaging and 3D modeling are relevant across the lifespan, there are special considerations for pediatric musculoskeletal imaging and fewer studies of 3D skeletal modeling in pediatric populations. Improved understanding of bone morphology and growth during childhood in healthy and pathologic patients may provide new insight into the pathophysiology of pediatric-onset skeletal diseases and the biomechanics of bone development. Clinical translation of 3D modeling tools developed in orthopaedic research is limited by the requirement for manual image segmentation and the resources needed for segmentation, modeling, and analysis. This paper highlights the current and future uses of common musculoskeletal imaging modalities and 3D modeling techniques in pediatric orthopaedic clinical care and research.

Overcoming Mission Competition in Departments of Family Medicine.

Departments of family medicine are centered around the tripartite mission of education, research, and clinical care. Historically, these three missions have been balanced and interdependent; however, changes in the funding and structures of health systems have resulted in shrinking education and research missions and an increased emphasis on clinical care. In the wake of waning state and federal contributions to primary care research, many departments of family medicine have adopted a private practice approach. This approach is centered on generating revenue for the institution, incentivizing physicians to remain clinically focused through productivity and intense attention to volume targets. As a department's focus shifts to the clinical care mission, education and research are increasingly neglected and underresourced. Meanwhile, the administrative burden of electronic health records (EHRs) has further encroached on time previously allocated to research, with the EHR burden disproportionately affecting the primary care workforce. To counteract mission competition in departments of family medicine and to recover the vital missions of education and scholarship, devising a clear plan for reclaiming and sustaining a tripartite mission is important. Advocating for increased primary care research funding, enhancing EHRs, balancing clinical and education metrics, and supporting primary care research, especially for groups underrepresented in medicine, are interventions to help fully support education and research missions and to recover and sustain mission balance in departments of family medicine.

Assessment of Knowledge, Attitude, and Practices on Genetic Research Data Reuse for Future Research: Clinical Trial Investigators Perspectives

ABSTRACT Introduction: According to the principle of good clinical practice, it is imperative that the personnel involved in the pharmaceutical or genetic research possess an educational background and comprehensive training. The clinical trial investigator must ensure the safeguard the privacy and confidentiality and prevent inadvertent reuse of research results of study participants. Aim: The objective of the current research is to assess the knowledge, attitude, and practices of clinical trial investigators concerning the reuse of genetic research data. Settings and Design: As a cross-sectional study, there was only one-time collection of knowledge, attitude, and practice on genetics and its data for future research from clinical trial investigators from the Tertiary Care Hospital and Clinical Research Centers in Belagavi Karnataka, India. Subjects and Methods: A study was conducted using validated knowledge, attitude, and practices questionnaire on the clinical trial investigators. Statistical Analysis Used: Data were analyzed using the SPSS software version 21one-way analysis of variance. Results: The present study was comprised n = 50 clinical trial investigators calculated by using the general formula for the calculation of sample size with a confidence of interval limit, of whom 64% exhibited awareness of genetic data reuse in clinical trials. Seventy-four percent of clinical trial investigators expressed concerns about confidentiality issues related to the reuse of genomic data. Conclusions: The lack of synchronized international conference on harmonization of technical requirements for pharmaceuticals for human use (ICH) guidelines directives concerning genomic sampling and data management in health-care research presents a formidable obstacle for pharmaceutical sponsors in achieving consistent and standardized genomic research samples and its data execution in pharmaceutical research on a global scale.

Validating evidence for the knowledge, management and involvement of dentists in a dental approach to sickle-cell disease.

This study validated the content of an instrument designed to assess the knowledge, involvement (attitudes) and management (practice) of dentists relative to sickle-cell disease (KAPD-SCD). The instrument consisted of five domains composed of a total of thirteen items: I. Dentist's self-assessment relative to sickle-cell disease; II. Dentist's knowledge of the repercussions of sickle-cell disease on the stomatognathic system; III. Dentist's knowledge of the complications of sickle-cell disease in the stomatognathic system; IV. Dentist's knowledge concerning the dental management of sickle-cell disease patients; and V. Dentist's involvement in an approach to sickle-cell disease. Twelve experts assigned scores to each item of the instrument. The criteria were clarity, understanding and appropriateness, leaving open fields for comments. Descriptive and content analyses of the data were made. Each expert analyzed 39 assessment units. The percentages considered for agreement were high (>80%), medium (70%-80%), or low (<70%), and each item was maintained or revised according to the percentage observed. There was high consensus in 74% of the assessment units (the corresponding items were maintained), medium consensus in 24% of them (the corresponding items were revised), and disagreement in 2% of them, namely as regards the "appropriateness" of item 5 ("Are there oral complications in sickle-cell disease?"), which was revised. The final version of the instrument had 16 items for different applications such as in the clinical care program, teaching program, or research program, with different cut-off scores for each application. In conclusion, the level of agreement among experts showed evidence of the content validity of the instrument.

Bibliometric Analysis of Psychological Distress in Stroke: Research Trends, Hot Spots, and Prospects- An Emphasis on China.

Currently, the psychological problems of stroke patients are of great concern. It is a hot topic of clinical care research to analyze and discuss the current status and hot spots, frontiers and development trends of research on psychological distress of stroke patients, and to develop and implement psycho-social care programs to improve the quality of life of patients.However, there is an absence of visual overviews to assess the published literature systematically. The Web of Science (WOS) database was used to search the relevant literature in this field, spanning the period 2009-2023, and the countries, institutions, and research keywords in this field were visualized and analyzed by CiteSpace analysis software. An analysis of 416 papers found that the overall trend of psychological distress in stroke patients was increasing, and the research hotspots were mainly focusing on the relationship between different risk factors and psychological distress in stroke patients, psychological distress in stroke caregivers, positive psychology in stroke patients, and interventions on psychological distress in stroke patients. In the future, the research population may gradually shift to stroke caregivers, and the research focus will be on developing and studying scales. Visual analysis of psychological distress studies in stroke patients can provide strategies for clinical interventions and broaden thinking about clinical care.

Clonal Hematopoiesis and Inflammation in the Vasculature (CHIVE), a Prospective, Longitudinal Clonal Hematopoiesis Cohort and Biorepository

Introduction Clonal hematopoiesis (CH), the expansion of a clonal population of hematopoietic cells, is an age-associated phenomenon leading to increased risk of both hematologic malignancy and non-malignant organ dysfunction. There have been significant advances in our understanding of the underlying pathophysiology of CH in recent years. However, additional studies are needed to better understand clinical trajectories and optimal care of patients with CH. To address this gap, the prospective, longitudinal CHIVE (Clonal Hematopoiesis and Inflammation in the VasculaturE) registry and biorepository was created to support multidisciplinary CH clinics. Methods Adults without active hematological malignancy who were clinically identified to have CH or who were at risk for CH were sequentially enrolled utilizing a multidisciplinary referral approach between October 2020 to April 2023 at Vanderbilt University Medical Center (VUMC). Research samples were procured at the time of routine clinical blood draws or bone marrow biopsies and stored in a newly established biorepository, equipped to store DNA, plasma, and viably cryopreserved cells to enable a spectrum of downstream applications. Specimens were sequenced on a highly cost efficient (~$6/sample) targeted next generation sequencing capture panel that identified mutations residing in the 24 most frequently mutated CHIP genes.The VUMC CH clinic, which serves as a referral pool, were included in Arm A of CHIVE (n=57). We also sought out a population at risk for CH which included patients over 18 years of age with a history of solid tumor, cardiovascular disease, renal disease, rheumatologic disease, or diabetes, who were included in Arm B (n=122). Patients from Arm A or B were included in the CH-positive (CH+) group if they met criteria for CH on the research assay at any time during their enrollment in the study. All other genotyped patients who were not found to have CH by the research assay, regardless of their clinical CH status at study enrollment, were included in the CH-negative (CH-) group.Anthropometric data and clinical assessments, including laboratories and cardiovascular studies obtained in the course of routine clinical care were extracted from the electronic health record, and recorded and maintained in the CHIVE database. Results 261 patients were approached for consent to enroll in CHIVE and 179 were ultimately enrolled. More than one half (54%) of all participants had a CH mutation (CH+) and of those, 49.5% were female. Median age of CH+ patients was 71.9 (IQR 64.0-77.5). DNMT3A (n=44) and TET2 (n=39) were the most commonly mutated genes, while variant allele fractions (VAF) ranged from 2.1 - 79.8% (Figure 1). 246 samples were serial samples collected from 89 patients at regular intervals. Significantly more CH+ patients had a diagnosis of coronary artery disease compared to CH- patients (55.7% vs 32.9%, p=0.004). CH+ patients also had increased rates of hypertension and heart failure compared to the CH- group (p&amp;lt;0.001, 0.035, respectively). Laboratory evaluation showed CH+ patients to have a lower median white blood cell count, hemoglobin, and platelets, and elevated blood urea nitrogen values compared to CH- patients, differences that did not meet statistical significance. 8.2% of the CH+ patients progressed to frank hematologic malignancy over the course of the 2.5-year study (Table 1). Eight of the 97 CH+ and 2 of the 82 CH- patients died over the course of the study period resulting in a trend toward decreased survival in CH+ patients (p=0.112). Conclusions We demonstrate the feasibility of a prospective, observational study of CH patients utilizing a robust referral network to support both clinical care and translational research. A well-genotyped and phenotyped cohort of CH patients will be critical to future translational research efforts and clinical trials - a key function of our study design. Early clinical findings from our cohort recapitulate large scale retrospective datasets where CH patients are at an increased risk of development of hematologic malignancy, end organ damage, and all-cause mortality. Scaling this resource in collaboration with other centers is underway and will ultimately enable the development of clinical guidelines and treatment strategies for this increasingly recognized patient population.