Optimizing Indocyanine Green Dosage for Near-Infrared Fluorescence Perfusion Assessment in Bowel Anastomosis: A Prospective, Systematic Dose-Ranging Study.

BACKGROUND: Indocyanine green (ICG) near-infrared fluorescence (NIRF) has emerged as a promising technique for visualizing tissue perfusion. However, within the wide range of dosages and imaging conditions currently being applied, the optimal dosage of ICG remains unclear. This study aimed to investigate the feasibility and implications of implementing lower dosages of ICG than commonly used for visual and quantitative perfusion assessment in a standardized setting. METHODS: A prospective single-center cohort study was conducted on patients undergoing ileostomy reversal by hand-sewn anastomosis. ICG-NIRF visualization was performed before (T1) and after (T2) anastomosis with one of four different dosages of ICG (5 mg, 2.5 mg, 1.25 mg, or 0.625 mg) and recorded. Postoperatively, each visualization was evaluated for signal strength, completeness, and homogeneity of fluorescence. Additionally, perfusion graphs were generated by a software-based quantitative perfusion assessment, allowing an analysis of perfusion parameters. Statistical analysis comparing the effect of the investigated dosages on these parameters was performed. RESULTS: In total, 40 patients were investigated. Visual evaluation demonstrated strong, complete, and homogeneous fluorescence signals across all dosages. Perfusion graph assessment revealed a consistent shape for all dosages (ingress followed by egress phase). While the average signal intensity decreased with dosage, it was sufficient to enable perfusion assessment even at the lowest dosages of 1.25 mg and 0.625 mg of ICG. The baseline intensity at T2 (the second intraoperative visualization) significantly decreased with dosage. The slope of the egress phase steepened with decreasing dosage. CONCLUSIONS: Lower dosages of ICG were sufficient for intraoperative perfusion assessment, while causing lower residual fluorescence and quicker egress in subsequent visualizations.

Venous Access: National Guideline and Registry Development (VANGUARD): Advancing Patient-Centered Venous Access Care Through the Development of a National Coordinated Registry Network.

There are over 8 million central venous access devices inserted each year, many in patients with chronic conditions who rely on central access for life-preserving therapies. Central venous access device-related complications can be life-threatening and add tens of billions of dollars to health care costs, while their incidence is most likely grossly mis- or underreported by medical institutions. In this communication, we review the challenges that impair retention, exchange, and analysis of data necessary for a meaningful understanding of critical events and outcomes in this clinical domain. The difficulty is not only with data extraction and harmonization from electronic health records, national surveillance systems, or other health information repositories where data might be stored. The problem is that reliable and appropriate data are not recorded, or falsely recorded, at least in part because policy, payment, penalties, proprietary concerns, and workflow burdens discourage completeness and accuracy. We provide a roadmap for the development of health care information systems and infrastructure that address these challenges, framed within the context of research studies that build a framework of standardized terminology, decision support, data capture, and information exchange necessary for the task. This roadmap is embedded in a broader Coordinated Registry Network Learning Community, and facilitated by the Medical Device Epidemiology Network, a Public-Private Partnership sponsored by the US Food and Drug Administration, with the scope of advancing methods, national and international infrastructure, and partnerships needed for the evaluation of medical devices throughout their total life cycle.

Reducing ventriculoperitoneal shunt infection with intraoperative glove removal.

BACKGROUND: Contamination of ventriculoperitoneal shunts (VPS) by cutaneous flora, particularly coagulase-negative staphylococci, is a common cause of shunt infection and failure, leading to prolonged hospital stay, higher costs of care, and poor outcomes. Glove contamination may occur during VPS insertion, increasing risk of such infections. METHODS: We performed a systematic search of the PubMed database for studies published January 1, 1970, through August 31, 2021 that documented VPS infection rates before and after implementing a practice of double gloving with change or removal of the outer glove immediately prior to shunt insertion. RESULTS: Among 272 reports screened, 4 were eligible for review based on our inclusion criteria. The incidence of VPS infection was reduced in all 4 quasi-experimental studies with an aggregate incidence of VPS infection of 11.8% before the change in intraoperative protocol and 4.9% after protocol change. One study documented reduced hospital stay with this change in protocol. CONCLUSION: The risk of VPS infection is reduced by removal or replacement of the outer surgical gloves immediately prior to intraoperative insertion of a VPS as part of an infection control bundle.

Equity, diversity, and inclusion landscape in Canadian postgraduate medical education for ophthalmology.

OBJECTIVE: To collect information on the current equity, diversity, and inclusion (EDI) landscape at Canadian ophthalmology academic centres. DESIGN: Cross-sectional survey. PARTICIPANTS: Faculty representatives from 15 accredited Canadian ophthalmology postgraduate training programs and 57 ophthalmology resident survey respondents. METHOD: A three-phase virtual EDI initiative was conducted by the Association of Canadian University Professors of Ophthalmology in 2021. A qualitative survey of Canadian academic ophthalmology programs and an anonymous survey of Canadian ophthalmology residents were completed. RESULTS: All Canadian ophthalmology programs provided information on their current EDI strategies, yielding a response rate of 100%. The majority (73%) of Canadian academic ophthalmology centres identified as being in the beginning stages of building an EDI framework. Of the 57 responding resident physicians, 44% identified as a woman and 51% as a visible minority. There were no respondents who identified as Indigenous. Three respondents identified as having a disability per the Accessible Canada Act. Most respondents either agreed or strongly agreed that their programs are equal opportunity providers (80%), trustworthy (72%), respectful (74%), and of diverse opinions and ideas (71%). There were no statistically significant associations between responses to EDI questions and gender across population groups. CONCLUSIONS: Most Canadian ophthalmology academic centres are in the beginning stages of implementing EDI initiatives. Multiple priorities have been identified as areas for improvement, such as increasing EDI education for patients, learners, and physicians, and implementing EDI policies in selection and recruitment.

Defining the Impact of Social Drivers on Health Outcomes for People with Inherited Bleeding Disorders.

The ways in which the social drivers of health, also known as the social determinants of health (SDOH), affect health outcomes for people with inherited bleeding disorders (PwIBDs) is unclear. This systematic review of the published literature examines the impact of SDOH on health outcomes in PwIBDs. Articles that included the following parameters in PubMed informed this study: published in English between 2011-2021; available in free full text; study population diagnosed with an inherited bleeding disorder; and study measured at least one of the clinical/non-clinical outcome measures: bleeding frequency, chronic pain, mortality, quality of life (QOL), and/or cost. The main findings from the 13 included articles emphasized the unmet need for reducing the economic burden with sustainable population health strategies and treatment options for PwIBDs. Rural location was also a significant contributor to both delayed diagnosis and decreased access to care. Furthermore, the need for a multidisciplinary comprehensive care team to address physical, psychosocial, and emotional needs of PwIBDs was raised as a priority target in the desire for equitable and optimal health. This systematic literature review suggests that the SDOH are associated with inferior health outcomes and may influence the clinical progression of inherited bleeding disorders.

Feasibility of Novel Software-Based Perfusion Indicators for the Ileal J-Pouch-On the Path towards Objective and Quantifiable Intraoperative Perfusion Assessment with Indocyanine Green Near-Infrared Fluorescence.

BACKGROUND: In restorative proctocolectomy with ileal J-pouch, perfusion assessment is vital to prevent complications such as anastomotic leak (AL). Indocyanine green near-infrared fluorescence (ICG-NIRF) is gaining popularity, while its interpretation and relevance remain subjective. This study aimed to evaluate a standardized ICG-NIRF imaging protocol combined with a novel, software-based assessment to detect areas of impaired perfusion and a possible correlation with AL of the pouch. METHODS: In this prospective study, patients undergoing ileal J-pouch for ulcerative colitis at an inflammatory bowel disease (IBD) referral center were included. Intraoperatively, strictly standardized ICG-NIRF visualization was performed and video-recorded. Postoperatively, a specific software was utilized to determine the change in fluorescence intensity per second (i/s) for systematic regions of interest, generating perfusion-time curves and a pixel-to-pixel map. These were analysed in detail and correlated with clinical outcome (primary end point: AL within 30 days; clearly defined and screened for by pouchoscopy). RESULTS: Four out of 18 included patients developed AL of the ileal pouch-anal anastomosis (IPAA). In the AL group, the perfusion curves on the area adjacent to the IPAA (pouch apex) displayed considerably lower ingress/inflow (median = 1.7; range = 8.5; interquartile-range = 3.8 i/s) and egress/outflow (median = -0.1; range = 0.7; interquartile-range = 0.5 i/s) values than in the non-AL group (ingress: median = 4.3; range = 10.3; interquartile-range = 4.0 i/s); egress: median = (-1.1); range = 3.9; interquartile range = 1.0 i/s). This was confirmed by further novel parameters of pouch perfusion (maximum ingress; maximum egress) and pixel-to-pixel analysis. CONCLUSIONS: This study presents the feasibility of a novel methodology to precisely assess pouch perfusion with ICG-NIRF, identifying comparable, quantifiable, and objective parameters to potentially detect perfusion-associated complications in surgery in real-time.

Current state of unhealthy living characteristics in White, African American and Latinx populations.

The United States (US) is similar to most industrialized countries in that it falls short on many of the basic metrics related to cardiovascular and overall health. These metrics include nutritional patterns, levels of physical activity (PA), cardiorespiratory fitness (CRF), and prevalence of overweight and obesity. These issues are even more apparent in underserved communities, among whom unhealthy living characteristics cluster and contribute to a disproportionate chronic disease burden. The reasons for these inequities are complex and include social and economic factors as well as reduced access to health care. CRF has been demonstrated to be a critically important risk factor that tends to be lower in disadvantaged groups. In this article we discuss the current state of health & lifestyle characteristics in the US, the impact of social inequality on health, and the particular role that CRF and PA patterns play in the current state of unhealthy living characteristics as they relate to underserved populations.

A quantitative approach to the spread of variance in translational research using Monte Carlo simulation.

The translation of promising preclinical research into successful trials often fails. One contributing factor is the "Princess and the Pea" problem, which refers to how an initially significant effect size dissipates as research transitions to more complex systems. This work aimed to quantify the effects of spreading variability on sample size requirements. Sample size estimates were performed by Monte Carlo simulation. To simulate the process of progressing from preclinical to clinical studies, nested sigmoidal dose-response transformations with modifiable input parameter variability were used. The results demonstrated that adding variabilty to the dose-response parameters substantially increases sample size requirements compared to standared calculations. Increasing the number of consecutive studies further increases the sample size. These results quantitatively demonstrate how the spread of variability in translational research, which is not typically accounted for, can result in drastic increases in the sample size required to maintain a desired study power.

Whole Person Health: The Role of Advocacy.

The U.S. healthcare system is naturally evolving toward integrative, whole-person health. Optimal health is not just absence of disease-it is holistic in nature (physical, mental, emotional, and spiritual) including a person's sense of purpose and meaning in their lives. Through the efforts of groups such as the Integrative Health Policy Consortium (www.ihpc.org ) and several others, Congress and many other stakeholder groups became aware that we need to focus on all aspects of health including environmental considerations. Currently, the U.S. healthcare system is in the process of embracing whole-person health with its focus on wellness and well-being in addition to the treatment of clinical disorders. The Veterans Administration Whole Health Program is one such example, where they are shifting the healthcare paradigm from "What's the matter with you?" to "What matters to you?" On the Hill, we are seeing growth in the Congressional Caucus on Integrative Health and Wellness as well as the Social Determinants of Health Caucus.

Objective Perfusion Assessment in Gracilis Muscle Interposition-A Novel Software-Based Approach to Indocyanine Green Derived Near-Infrared Fluorescence in Reconstructive Surgery.

BACKGROUND: Gracilis muscle interposition (GMI) is an established treatment option for complex perineal fistulas and reconstruction. The outcome is limited by complications such as necrosis, impaired wound healing and fistula persistence or recurrence. Quantifiable methods of assessing muscle flap perfusion intraoperatively are lacking. This study evaluates a novel and objective software-based assessment of indocyanine green near-infrared fluorescence (ICG-NIRF) in GMI. METHODS: Intraoperative ICG-NIRF visualization data of five patients with inflammatory bowel disease (IBD) undergoing GMI for perineal fistula and reconstruction were analyzed retrospectively. A new software was utilized to generate perfusion curves for the specific regions of interest (ROIs) of each GMI by depicting the fluorescence intensity over time. Additionally, a pixel-to-pixel and perfusion zone analysis were performed. The findings were correlated with the clinical outcome. RESULTS: Four patients underwent GMI without postoperative complications within 3 months. The novel perfusion indicators identified here (shape of the perfusion curve, maximum slope value, distribution and range) indicated adequate perfusion. In one patient, GMI failed. In this case, the perfusion indicators suggested impaired perfusion. CONCLUSIONS: We present a novel, software-based approach for ICG-NIRF perfusion assessment, identifying previously unknown objective indicators of muscle flap perfusion. Ready for intraoperative real-time use, this method has considerable potential to optimize GMI surgery in the future.

The impact of surgical site infection-a cost analysis.

PURPOSE: Surgical site infection (SSI) occurs in up to 25% of patients after elective laparotomy. We aimed to determine the effect of SSI on healthcare costs and patients' quality of life. METHODS: In this post hoc analysis based on the RECIPE trial, we studied a 30-day postoperative outcome of SSI in a single-center, prospective randomized controlled trial comparing subcutaneous wound irrigation with 0.04% polyhexanide to 0.9% saline after elective laparotomy. Total medical costs were analyzed accurately per patient with the tool of our corporate controlling team which is based on diagnosis-related groups in Germany. RESULTS: Between November 2015 and May 2018, 456 patients were recruited. The overall rate of SSI was 28.2%. Overall costs of inpatient treatment were higher in the group with SSI: median 16.685 €; 19.703 USD (IQR 21.638 €; 25.552 USD) vs. median 11.235 €; 13.276 USD (IQR 11.564 €; 13.656 USD); p < 0.001. There was a difference in surgery costs (median 6.664 €; 7.870 USD with SSI vs. median 5.040 €; 5.952 USD without SSI; p = 0.001) and costs on the surgical ward (median 8.404 €; 9.924 USD with SSI vs. median 4.690 €; 5.538 USD without SSI; p < 0.001). Patients with SSI were less satisfied with the cosmetic result (4.3% vs. 16.2%; p < 0.001). Overall costs for patients who were irrigated with saline were median 12.056 €; 14.237 USD vs. median 12.793 €; 15.107 USD in the polyhexanide group (p = 0.52). CONCLUSION: SSI after elective laparotomy increased hospital costs substantially. This is an additional reason why the prevention of SSI is important. Overall costs for intraoperative wound irrigation with saline were comparable with polyhexanide.

The potential impact of post-COVID symptoms in the healthcare sector.

BACKGROUND: The phenomenon of post-COVID syndrome (PCS) is evolving from an abstract array of non-specific symptoms to an identifiable clinical entity of variable severity. Its frequency and persistence have implications for service delivery and workforce planning. AIMS: This study was aimed to assess the prevalence of symptoms consistent with PCS and the subjective degree of recovery in a cohort of healthcare workers, focusing on those who have returned to work. METHODS: A study population of 1176 was surveyed when attending for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) antibody testing. Two sub-groups were identified: those with known (i.e. diagnosed on PCR testing) and assumed (i.e. antibody evidence of previous infection) SARs-CoV-2 infection, at least 12 weeks prior to the study. Each group was asked about their subjective degree of recovery and the nature of their persistent symptoms. Results were analysed via excel and SPSS. RESULTS: In total, 144 employees showed PCR evidence of previous infection, with 139 of these being infected at least 12 weeks prior to the study. Of these 139, only 19% (n = 26) reported feeling 100% recovered, and 71% reported persistent symptoms. Of those with assumed SARS-CoV-2 infection (n = 78), 32 (41%) were truly asymptomatic since the commencement of the pandemic, while 46 (59%) described symptoms suggestive of possible infection at least 12 weeks prior to the study. Of this latter group, 23% (n = 18) also reported residual symptoms. CONCLUSIONS: PCS is prevalent among this group, including those not previously diagnosed with COVID-19. Its' frequency and duration present challenges to employers with regards to the management of work availability and performance.

Individual versus Group Calibration of Machine Learning Models for Physical Activity Assessment Using Body-Worn Accelerometers.

PURPOSE: We sought to determine if individually calibrated machine learning models yielded higher accuracy than a group calibration approach for physical activity intensity assessment. METHODS: Participants (n = 48) wore accelerometers on the right hip and nondominant wrist while performing activities of daily living in a semistructured laboratory and/or free-living setting. Criterion measures of activity intensity (sedentary, light, moderate, vigorous) were determined using direct observation. Data were reintegrated into 30-s epochs, and eight random forest models were created to determine physical activity intensity by using all possible conditions of training data (individual vs group), protocol (laboratory vs free-living), and placement (hip vs wrist). A 2 × 2 × 2 repeated-measures analysis of variance was used to compare epoch-level accuracy statistics (% accuracy, kappa [κ]) of the models when used to determine activity intensity in an independent sample of free-living participants. RESULTS: Main effects were significant for the type of training data (group: accuracy = 80%, κ = 0.59; individual: accuracy = 74% [P = 0.02], κ = 0.50 [P = 0.01]) and protocol (free-living: accuracy = 81%, κ = 0.63; laboratory: accuracy = 74% [P = 0.04], κ = 0.47 [P < 0.01]). Main effects were not significant for placement (hip: accuracy = 79%, κ = 0.58; wrist: accuracy = 75% [P = 0.18]; κ = 0.52 [P = 0.18]). Point estimates for mean absolute error were generally lowest for the group training, free-living protocol, and hip placement. CONCLUSIONS: Contrary to expectations, individually calibrated machine learning models yielded poorer accuracy than a traditional group approach. In addition, models should be developed in free-living settings when possible to optimize predictive accuracy.

Patterns of Community Violence Exposure among African American Adolescents Living in Low-Resourced Urban Neighborhoods.

African American adolescents living in neighborhoods with concentrated economic disadvantage are disproportionately exposed to community violence. This study builds upon previous research and examines patterns, severity, and chronicity of violence exposure, within a sample of African American adolescents living in low-resourced, urban neighborhoods (n = 327). The influence of both individual- and contextual-level factors on community violence exposure (CVE) is examined. Data were collected across four time points at 6-month intervals. Latent transition analysis identified three patterns of CVE at each time point: low witnessing and low victimization (LW-LV), high witnessing and low victimization (HW-LV), and high witnessing and high victimization (HW-HV), as well as transitions between each class. Although a stable LW-LV class membership over time was the most prevalent pattern, most adolescents experienced some change in exposure. Nearly one-third of the participants were classified in the HW-HV group at some point in time. Analyses on individual- and contextual-level factors revealed that more depressive symptoms, community problems (e.g., drugs, graffiti, noise), or community resources (e.g., schools, parks, recreational facilities) were associated with an increased likelihood of experiencing high levels of violent victimization. Implications for intervention and prevention of CVE are discussed.

African American adolescent suicidal ideation and behavior: The role of racism and prevention.

Suicide is one of the most devastating, yet preventable, health disparities for African American adolescents. African American adolescent suicidal ideation and behavior may have different manifestations and risk factors relative to those of adolescents from other ethnic backgrounds that impact prevention efforts. For example, in addition to more common manifestations of suicidal ideation and behavior, African American youth may engage in violent or high-risk behaviors, use more lethal means, or report ideation at lower depression levels. The Adapted-Coping with Stress Course (A-CWS), an adaptation of Gregory Clarke and colleagues' Coping with Stress Course, was developed to address the cultural nuances of African American adolescents. The A-CWS is a 15-session cognitive-behavioral, group-based preventive intervention that aims to enhance adaptive coping skills and reduce suicidal ideation, by incorporating strategies that counter stressors associated with systemic racism that burden African American adolescents. This study evaluated the feasibility and acceptability of the A-CWS intervention, using a sample of predominantly African American ninth-grade students. Results indicated that the adolescents were very favorable and receptive to the A-CWS intervention and that the intervention could be conducted feasibly. The A-CWS intervention serves as a model to advance culturally-grounded, evidence-based preventive intervention, for an underserved sector of adolescents.

Reducing health disparities among black individuals in the post-treatment environment.

An important step in reducing health disparities among racial and ethnic minorities with substance use disorders involves identifying interventions that lead to successful recovery outcomes for this population. The current study evaluated outcomes of a community-based recovery support program for those with substance use disorders. Participants included 632 residents of recovery homes in three states in the US. A multi-item recovery factor was found to increase over time for these residents. However, rates of improvement among Black individuals were higher than for other racial/ethnic groups. Black Americans perhaps place a higher value on communal relationships relative to all other racial/ethnic groups, and by adopting such a communitarian perspective, they might be even more receptive to living in a house that values participation and involvement. The implications of these findings for health disparities research are discussed.

An Empirically-based Theory of the Relationships Among Social Embeddedness, Economic Viability, Learned Recovery Skills and Perceived Quality of Life in Recovery Homes.

Key characteristics of recovery homes include governance style (which can play a central role in structuring recovery mechanisms), social embeddedness (e.g., social relationships within the home), economic viability (e.g., the individual's ability to be self-supporting), and learned recovery skills (such as coping with stress, avoiding putting one's self in risky situations, etc.). These domains can have important associations with perceived quality of life (measured across physical, psychological, social relationships, and environmental domains). The current study investigated relationships among these key "active ingredients" (Moos, 2007) of recovery homes. In addition, we present dynamic model consistent with these observed relationships, to illustrate how relevant mechanisms interact over time to and affect system evolution. Data were collected from recovery home residents in three states. Findings supported our overall hypotheses indicating that social embeddedness, stress, and self-efficacy were related to quality of life, and policy and treatment-design implications are further examined by simulating system dynamics.

Health Disparities Among People Infected With Influenza, Rhode Island, 2013-2018.

OBJECTIVES: Health disparities are associated with poor outcomes related to public health. The objective of this study was to assess health disparities associated with influenza infection based on median household income and educational attainment. METHODS: We geocoded people with documented confirmed influenza infection by home address to identify the US Census 2010 tract in which they lived during 4 influenza surveillance seasons (2013-2014, 2015-2016, 2016-2017, and 2017-2018) in Rhode Island. We dichotomized influenza as severe if the person with influenza infection was hospitalized (ie, inpatient) or as nonsevere if the person was not hospitalized (ie, outpatient). We examined 2 socioeconomic factors: median household income (defined as low, medium low, medium high, and high) and educational attainment (defined as a ratio among people who completed

Research update: The relation between ME/CFS disease burden and research funding in the USA.

BACKGROUND: Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS) is a debilitating, chronic, multisystem disease that affects an estimated 1 to 2.5 million Americans. It has no widely accepted biomarkers and no FDA-approved treatment. ME/CFS has traditionally been one of the lowest funded diseases by the United States National Institutes of Health (NIH). OBJECTIVES: We provide here an update to our 2016 article, which estimated the disease burden of ME/CFS in the United States in 2013 and its relation to NIH's 2015 analysis of research funding and disease burden. This update incorporates more recent burden data from 2015 and funding data from 2017. METHODS: We perform a regression analysis on funding versus disease burden to determine 2017 funding levels that would be commensurate with burden. Burden figures for 2017 are estimated using population-based extrapolations of earlier data. RESULTS: We find the disease burden of ME/CFS is double that of HIV/AIDS and over half that of breast cancer. We also find that ME/CFS is more underfunded with respect to burden than any disease in NIH's analysis of funding and disease burden, with ME/CFS receiving roughly 7% of that commensurate with disease burden. CONCLUSIONS: To be commensurate with disease burden, NIH funding would need to increase roughly 14-fold.