Vidant Health

Abstract INTRODUCTION Local control remains a major challenge in the surgical management of recurrent glioblastomas. Brachytherapy, such as Gammatile, offers a promising solution by delivering targeted radiation to the surgical bed. Here, we report the outcome of 60 consecutive recurrent glioblastoma patients who underwent resection/GT-implant. METHODS Clinical information was collected for consecutive, recurrent glioblastoma (isocitrate dehydrogenase wild-type) patients treated at the University of Minnesota, Honor Health, Robert Wood Johnson, Emory, Allegheny Health, East Carolina University, and Inova. Median progression-free and overall survival (mPFS and mOS) were calculated from the time of GT implant and stratified by methyl-guanine-methyl transferase (MGMT) status. RESULTS The study cohort comprised 47 male and 13 female subjects, with 1-3 previous glioblastoma recurrences. Karnofsky Performance Score (KPS) decreased post-resection/GT implant in 24 patients (41.2%); all experienced functional recovery, but to variable extents. Surgical/GT morbidities (6%) included hemorrhage, wound infection, and radiation necrosis (each at 1/60 or 2%). The median hospital stay was 2 days (range: 1- 21 days). 16.7% of the cohort required 30-day readmission, comparable to the expected readmission rate for craniotomy alone. There was no instance of rapid early recurrence, defined as tumor regrowth in the first MRI following surgical resection. Actuarial local control at one year was 92% and 80% for MGMT-methylated and -unmethylated patients, respectively (p=0.17). MGMT-methylated patients showed improved OS (mOS=14.7 mo) compared to unmethylated patients (mOS=7.9 mo, p=0.01). These results compare favorably to historical survival for these patient cohorts. Patients who showed a KPS decline after resection/GT-implant showed reduced OS relative to those with stable/improved KPS (mOS of 388 and 218 days, respectively, p=0.03). The number of tumor recurrences or prior bevacizumab did not prognosticate survival. CONCLUSION This multi-institutional experience supports the safety and efficacy of GT brachytherapy and provides a basis for selecting patients who would most benefit from this treatment.

Osteoporosis leads to bone fragility, increasing the risk of fractures in the elderly population, with associated morbidity and mortality. Screening is conducted using the Fracture Risk Assessment Tool (FRAX®). This study aims to evaluate the application of FRAX®and implement strategies to improve osteoporosis screening and diagnosis in a primary health care center (USF) in Portugal. This is an intervention study with evaluations at 0, 3, and 6 months. Representative samples of patients aged ≥50 years (N=5200, 95% CI, ME 5%) who had had a consultation in the previous month were selected, with 364 patients included. Patients who were bedridden, already diagnosed with osteoporosis, had requested bone densitometry, or were undergoing osteoporosis treatment were excluded. The documenting of the utilization of FRAX®was assessed in the programme SClinico®. Intervention included training sessions for the medical team on osteoporosis, development of a Protocol, and periodic reminders. To assess the impact of intervention, the following goals were defined: <25% of FRAX®records as insufficient, between 25% and 50% as sufficient, and over 50% as desirable. Prior to intervention, 0.8% (n=3) of the patient sample had FRAX®recorded in SClinico®. At the 3-month interim assessment, 4.7% (n=17) had FRAX®applied, with 20.6% (n=75) of the patient sample having a record of FRAX®being utilized at 6 months. The results show a significant improvement in the application of FRAX®compared to the baseline, although still below the established goals. This study highlights the need for continuous efforts to improve adherence to osteoporosis screening.

Recent technological advances allowed an exponential expansion of biological sequence data, and the extraction of meaningful information through Machine Learning (ML) algorithms. This knowledge improved the understanding of the mechanisms related to several fatal diseases, e.g., Cancer and COVID-19, helping to develop innovative solutions, such as CRISPR-based gene editing, coronavirus vaccine, and precision medicine. These advances benefit our society and economy, directly impacting peoples lives in various areas, such as health care, drug discovery, forensic analysis, and food analysis. Nevertheless, ML approaches applied to biological data require representative, quantitative, and informative features. Necessarily, as many ML algorithms can handle only numerical data, sequences need to be translated into a feature vector. This process, known as feature extraction, is a fundamental step for the elaboration of high-quality ML-based models in bioinformatics, by allowing the feature engineering stage, with the design and selection of suitable features. Feature engineering, ML algorithm selection, and hyperparameter tuning are often manual and time-consuming processes, requiring extensive domain knowledge, and performed manually by a human expert. To deal with this problem, we developed a new package, BioAutoML, which automatically runs an end-to-end ML pipeline. BioAutoML extracts numerical and informative features from biological sequence databases, automating feature selection, recommendation of ML algorithm(s), and tuning of hyperparameters, using Automated ML (AutoML). BioAutoML has two components, divided into four modules, (1) automated feature engineering (feature extraction and selection modules) and (2) Metalearning (algorithm recommendation and hyperparameter tuning modules). Our experimental results, assessing the relevance of our proposal, indicate robust results for different problem domains, such as SARS-CoV-2, anticancer peptides, HIV sequences, and non-coding RNAs. According to our systematic review, our proposal is innovative compared to available studies in the literature, being the first study to propose automated feature engineering and metalearning for biological sequences. BioAutoML has a high potential to significantly reduce the expertise required to use ML pipelines, aiding researchers in combating diseases, particularly in low- and middle-income countries. This initiative can provide biologists, physicians, epidemiologists, and other stakeholders with an opportunity for widespread use of these techniques to enhance the health and well-being of their communities.

Abstract Background: Adherence is increasingly understood as a complex concept and is affected by many factors. Among rural patients with cancer, adherence behavior can be affected by increased psychosocial and physical distress as well as economic burden. This study explored facilitators and barriers to medication adherence to oral chemotherapeutic agents (OCAs) from the perspective of both rural patients with cancer and their cancer care providers. Methods: This study was conducted in a regional Cancer Center in North Carolina. Data for the cancer care providers (N = 10) were collected (January-February 2016), and data for the patients with cancer (N = 25) were collected (March-June 2016). Qualitative interviews were conducted with patients with cancer currently taking OCAs, and interviews/focus groups were conducted with cancer care providers. Data analysis was conducted using the immersion crystallization approach. Results: The results of this qualitative study provide valuable insights into the attitudes of both cancer care providers and patients with cancer and their perceptions of adherence barriers and facilitators. The main barriers to adherence were costs associated with treatment, side effect management, comorbidities and concomitant treatments, limited health literacy, lack of social support, and patient-provider communication. Facilitators to adherence include education and follow-up, social support networks, and adherence strategies. Conclusion: Better communication, education/information, and social support were identified as facilitators of adherence in this study. It is critical to develop tailored strategies such as self-management behaviors, adherence strategies, and effective communication that can improve medication adherence and empower patients and their caregivers in their treatment management.

Introduction: Clinically significant weight loss is associated with health benefits for overweight and obese adults. Participation in adequate amounts of physical activity is critical for weight maintenance. However, few studies in the literature have evaluated the amount of physical activity needed to promote weight maintenance in a supervised exercise training study with corresponding data on cardiovascular risk factors. Methods: Overweight and obese adults (N=39) completed a 10-week OPTIFAST ® weight loss program with supervised aerobic exercise training with the goal of achieving clinically significant weight loss (≥7%). Participants who met the weight loss goal were randomized to levels of aerobic training consistent with physical activity recommendations (PA-REC) (~550 MET minutes per week) or weight maintenance recommendations (WM-REC) (~970 MET minutes per week) for 18 additional weeks. Weight, body composition, and blood measures (e.g., fasting glucose, insulin, and lipids) were measured at baseline, after weight loss (10 weeks), and at follow-up (28 weeks). Results: Thirty-three of the 39 participants achieved clinically significant weight loss (~85%). There were reductions in weight (-8.8 kg), body fat (-2.1%), visceral fat (-120.4 g), along with other health indicators (systolic blood pressure [-6.8 mmHg], diastolic blood pressure [-5.9 mmHg], HOMA-IR [-2.4] and lipids) after the weight loss phase (all p’s< 0.05). Full data for the weight maintenance phase were available in 21 participants due to the COVID pandemic (PA-REC: 12, WM-REC:9). Larger improvements in cardiorespiratory fitness (as assessed by estimated METs [1.7 vs. 0 METs, p=0.01] and relative VO 2 peak [2.3 vs.0.5 ml/kg/min, p=0.04]) were observed in the WM-REC group compared to the PA-REC group, while changes in waist circumference (-2.4 vs. 0.5 cm, p=0.06), visceral fat (-45.7 vs. 8.2 g, p=0.06), and absolute VO 2 (0.1 vs. 0.2 L/min, p=0.09) approached significance. No significant changes were observed between groups for changes in weight, blood pressure, glucose metabolism, or lipid parameters during the maintenance phase (all ps>0.05). Discussion: Clinically significant weight loss combined with aerobic exercise resulted in improvements in cardiometabolic parameters. Exercise at levels associated with the weight maintenance guidelines resulted in greater improvements in cardiorespiratory fitness and may have the potential to improve measures of central adiposity to a greater extent than the minimum physical activity recommendations following weight loss. Future studies should evaluate the impact of different levels of aerobic exercise after clinically significant weight loss in long term interventions.

The prevalence of diabetes remains high, with traditional lifestyle interventions demonstrating limited success in improving diabetes-related outcomes, particularly among individuals with diabetes-related mental health comorbidities. Digital health interventions provide the ability to ease the sustained and rigorous self-management needs associated with diabetes care and treatment. Current interventions though, are plagued by small sample sizes, underpowered pilot studies, and immense heterogeneity in program intervention, duration, and measured outcomes. Therefore, this work aimed to evaluate the effectiveness of a mobile health diabetes management program on measures of glycemic control in a high-risk population with type 2 diabetes (hemoglobin A1c [HbA1c] ≥8.0%), utilizing a sample of 1128 participants who provided baseline and follow-up data. The sustainability of this change in glycemic control was examined in a subset of participants (n=455) at 6 months and 1 year following program enrollment. A secondary analysis examined changes in glycemic control among a subset of participants with self-reported mild-to-moderate depression at baseline. This study utilized a single-arm, retrospective design. Participants were enrolled in the Vida Health Diabetes Management Program. This app-based intervention utilized one-on-one remote sessions with a health coach, registered dietitian nutritionist, and/or a certified diabetes care and education specialist and structured lessons and tools related to diabetes management and self-care. Participants provided baseline (-365 to 21 days of program enrollment) as well as follow-up (at least 90 days following program enrollment) HbA1c values. Paired t tests were used to evaluate changes in HbA1c between baseline and follow-up time points. The 8-item Patient Health Questionnaire and the 7-item Generalized Anxiety Disorder Scale were utilized to assess self-reported depressive and anxiety symptoms, respectively. Paired t tests and linear regression modeling accounting for pertinent covariates were used to evaluate changes in mental health symptom acuity and their relationship with changes in glycemic control. We observed a significant decrease in HbA1c of -1.35 points between baseline (mean 9.84, SD 1.64) and follow-up (mean 8.48, SD 1.77; t=22.56, P<.001) among this large, high-risk sample. This decrease was sustained up to 1 year following program enrollment. Additionally, a significant relationship between improvements in depressive symptom acuity and improvements in HbA1c was observed (β=-0.74, P=.03). This study demonstrates clinically meaningful improvements in glycemic control among participants enrolled in the Vida Health Diabetes Management Program. Additionally, this work presents one of the largest studied samples of participants enrolled in a digital health diabetes management program to date.

Patients with cancer are at heightened risk of experiencing financial hardship. Financial navigation (FN) is an evidence-based approach for identifying and addressing patient and caregiver financial needs. In preparation for the implementation of a multisite FN intervention, we describe existing processes (ie, events and actions) and mechanisms (ie, how events work together) connecting patients to financial assistance, comparing rural and nonrural practices. We conducted in-depth, semistructured interviews with stakeholders (ie, administrators, providers, and staff) at each of the 10 oncology care sites across a single state (five rural and five nonrural practices). We developed process maps for each site and analyzed stakeholder perspectives using thematic analysis. After reporting findings back to stakeholders, we synthesized themes and process maps across rural and nonrural sites separately. Eighty-three stakeholders were interviewed. We identified six core elements of existing financial assistance processes across all sites: distress screening (including financial concerns), referrals, resource connection points, and pharmaceutical, insurance, and community/foundation resources. Processes differed by rurality; however, facilitators and barriers to identifying and addressing patient financial needs were consistent. Open communication between staff, providers, patients, and caregivers was a primary facilitator. Barriers included insufficient staff resources, challenges in routinely identifying needs, inadequate preparation of patients for anticipated medical costs, and limited tracking of resource availability and eligibility. This study identified a clear need for systematic implementation of oncology FN to equitably address patient and caregiver financial hardship. Results have informed our current efforts to implement a multisite FN intervention, which involves comprehensive financial toxicity screening and systematization of intake and referrals.

BACKGROUND:Based on 6-month data from the InVivo Study of Probable Benefit of the Neuro-Spinal Scaffold for Safety and Neurological Recovery in Patients with Complete Thoracic Spinal Cord Injury (INSPIRE) study (NCT02138110), acute implantation of an investigational bioresorbable polymer device (Neuro-Spinal Scaffold [NSS]) appeared to be safe in patients with complete thoracic spinal cord injury (SCI) and was associated with an ASIA Impairment Scale (AIS) conversion rate that exceeded historical controls.OBJECTIVE:To evaluate outcomes through 24 months postimplantation.METHODS:INSPIRE was a prospective, open-label, multicenter, single-arm study. Eligible patients had traumatic nonpenetrating SCI with a visible contusion on MRI, AIS A classification, neurological level of injury at T2-T12, and requirement for open spine surgery ≤96 hours postinjury.RESULTS:Nineteen patients underwent NSS implantation. Three patients had early death determined by investigators to be unrelated to the NSS or its implantation procedure. Seven of 16 evaluable patients (44%) had improvement of ≥1 AIS grade at 6 months (primary end point) to AIS B (n = 5) or AIS C (n = 2). Three patients with AIS B at 6 months had further neurological improvement to AIS C by 12 (n = 2) and 24 (n = 1) months, respectively; none have deteriorated per latest available follow-up. No unanticipated or serious adverse device effects were reported.CONCLUSIONIn this small group of patients with complete thoracic SCI, acute NSS implantation within the spinal cord appeared to be safe with no long-term neurological issues identified during the 24-month follow-up. Patients remain stable, with additional AIS conversions observed in some patients at 12 months and beyond. These data further support the safety and probable benefit of NSS implantation in this patient population.

IntroductionThe COVID-19 Community Research Partnership is a population-based longitudinal syndromic and sero-surveillance study. The study includes over 17,000 participants from six healthcare systems in North Carolina who submitted over 49,000 serology results. The purpose of this study is to use these serology data to estimate the cumulative proportion of the North Carolina population that has either been infected with SARS-CoV-2 or developed a measurable humoral response to vaccination.MethodsAdult community residents were invited to participate in the study between April 2020 and February 2021. Demographic information was collected and daily symptom screen was completed using a secure, HIPAA-compliant, online portal. A portion of participants were mailed kits containing a lateral flow assay to be used in-home to test for presence of anti-SARS-CoV-2 IgM or IgG antibodies. The cumulative proportion of participants who tested positive at least once during the study was estimated. A standard Cox proportional hazards model was constructed to illustrate the probability of seroconversion over time up to December 20, 2020 (before vaccines available). A separate analysis was performed to describe the influence of vaccines through February 15, 2021.Results17,688 participants contributed at least one serology result. 68.7% of the population were female, and 72.2% were between 18 and 59 years of age. The average number of serology results submitted per participant was 3.0 (±1.9). By December 20, 2020, the overall probability of seropositivity in the CCRP population was 32.6%. By February 15, 2021 the probability among healthcare workers and non-healthcare workers was 83% and 49%, respectively. An inflection upward in the probability of seropositivity was demonstrated around the end of December, suggesting an influence of vaccinations, especially for healthcare workers. Among healthcare workers, those in the oldest age category (60+ years) were 38% less likely to have seroconverted by February 15, 2021.ConclusionsResults of this study suggest more North Carolina residents may have been infected with SARS-CoV-2 than the number of documented cases as determined by positive RNA or antigen tests. The influence of vaccinations on seropositivity among North Carolina residents is also demonstrated. Additional research is needed to fully characterize the impact of seropositivity on immunity and the ultimate course of the pandemic.

Palliative care has become an integral part of today's health care system. Inclusion of palliative care has been shown to positively affect patient satisfaction and can also impact medical costs. One of the ways palliative care can have such influence is through the development of prognostic awareness or a patient's understanding of their likely illness trajectory. Although palliative care programs have multiplied in general, there are still notable discrepancies in program availability, particularly in smaller rural hospitals. Despite numerous health care thought leaders' recommendations regarding the "ideal" palliative care team, this is not always feasible due to resource allocation. This article aims to describe 1 rural hospital's development of and initial outcomes from a hospital-based palliative care program.