Telehealth Research and Innovation for Veterans with Cancer: the THRIVE Center.

BACKGROUND: In recent years the US health-care system has witnessed a substantial increase in telehealth use. Telehealth enhances health-care access and quality and may reduce costs. However, there is a concern that the shift from in-person to telehealth care delivery may differentially improve cancer care access and quality in certain clinical settings and for specific patient populations while potentially exacerbating disparities in care for others. Our National Cancer Institute-funded center, called Telehealth Research and Innovation for Veterans with Cancer (THRIVE), is focused on health equity for telehealth-delivered cancer care. We seek to understand how social determinants of telehealth-particularly race and ethnicity, poverty, and rurality-affect the use of telehealth. METHODS: THRIVE draws from the Health Disparities Research Framework and the Consolidated Framework for Implementation Research. THRIVE consists of multiple cores that work synergistically to assess and understand health equity for telehealth-delivered cancer care. These include the Administrative Core, Research and Methods Core, Clinical Practice Network, and Pragmatic Trial. RESULTS: As of October 2023, we identified and trained 5 THRIVE scholars, who are junior faculty beginning a research career. We have reviewed 20 potential pilot studies, funding 6. Additionally, in communication with our funders and advisory boards, we have adjusted our study design and analytic approach, ensuring feasibility while addressing our operational partners' needs. CONCLUSIONS: THRIVE has several key strengths. First, the Veterans Health Administration's health-care system is large and diverse regarding health-care setting type and patient population. Second, we have access to longitudinal data, predating the COVID-19 pandemic, about telehealth use. Finally, equitable access to high-quality care for all veterans is a major tenet of the Veterans Health Administration health-care mission. As a result of these advantages, THRIVE can focus on isolating and evaluating the impact of social determinants of telehealth on equity in cancer care.

Primary care nurse practitioner management of adolescent behavioral health.

OBJECTIVES: To determine the personnel costs and revenue generated by embedding a behavioral health nurse practitioner (BHNP) in primary care clinics to evaluate and manage adolescent behavioral health needs. STUDY DESIGN: We estimated personnel costs and revenue from a quality improvement project undertaken at 4 clinic sites between August 1, 2016, and July 31, 2018, at a large multispecialty medical group in northern California. METHODS: Costs were estimated by identifying the actual hours spent by the BHNP and for medical assistant (MA) support and using Bureau of Labor Statistics national data on wages and benefits. Revenue was estimated by analyzing Current Procedural Terminology (CPT) codes for BHNP visits from the Epic electronic health record and corresponding relative value units (RVUs), based on 135% of 2018 nationally unadjusted Medicare rates. RESULTS: We estimate 2-year revenue of $144,449 and personnel costs (salary + benefits) of $90,431. The BHNP work totaled 1083 hours, and MA support totaled 312 hours. Using a nurse practitioner wage of $53.70/hour and an MA wage of $16.95/hour, total salary costs were $63,451; we then added benefits costs. Using the CPT codes assigned to the 768 encounters with 207 unique patients, we estimated generation of 1640 RVUs and total revenue of $144,449. CONCLUSIONS: This analysis found that personnel costs ($90,514) of a primary care-embedded BHNP are 63% of the potential revenue generated ($144,449). This analysis suggests that a primary care BHNP could be a cost-saving and patient-centered way to reduce the burden on primary care providers while meeting the growing needs of adolescents with behavioral health needs.

Primary care provider utilization and satisfaction with a health system navigation program for adolescents with behavioral health needs.

Approximately 49.5% of the adolescents report a mental health disorder; only about half of the children and adolescents with mental health disorders seek treatment from a mental health professional. Stigma and poor access to behavioral health providers are leading barriers to care. A large ambulatory health system implemented a BH navigation program to facilitate referrals from primary care physicians (PCPs), including pediatricians and family physicians, to BH providers. We studied PCP adoption of BH navigation services over a 4-year period, from July 2014 to June 2018. We retrieved operational data regarding service utilization, patient information from electronic health records and PCP information from administrative data, and surveyed PCPs for their appraisals of navigation services. Four thousand five hundred and fifty-five referrals were made for 3,912 patients from 290 PCPs (71% of PCPs in the health system). Depression (39%), anxiety (25%), and attention-deficit hyperactivity disorder (7%) were the most frequent reasons for referral. Referrals increased dramatically in the first half of the study period and decreased afterwards. Ninety-one percent of the PCPs agreed or strongly agreed that navigation enhanced their clinical care at 12-month survey. More than 90% of the PCPs rated the referral process, communication with navigation staff, and the overall experience as above average or excellent at 12 months. There was a decrease in these evaluation indicators after 2.5 years. The initial high referral volume reflects a need for BH navigation services. However, challenges remain to maintain positive PCP assessment in the face of such demand.

Impact of socioeconomic status on survival for patients with anal cancer.

BACKGROUND: Although outcomes for patients with squamous cell carcinoma of the anus (SCCA) have improved, the gains in benefit may not be shared uniformly among patients of disparate socioeconomic status. In the current study, the authors investigated whether area-based median household income (MHI) is predictive of survival among patients with SCCA. METHODS: Patients diagnosed with SCCA from 2004 through 2013 in the Surveillance, Epidemiology, and End Results registry were included. Socioeconomic status was defined by census-tract MHI level and divided into quintiles. Multivariable Cox proportional hazards models and logistic regression were used to study predictors of survival and radiotherapy receipt. RESULTS: A total of 9550 cases of SCCA were included. The median age of the patients was 58 years, 63% were female, 85% were white, and 38% were married. In multivariable analyses, patients living in areas with lower MHI were found to have worse overall survival and cancer-specific survival (CSS) compared with those in the highest income areas. Mortality hazard ratios for lowest to highest income were 1.32 (95% confidence interval [95% CI], 1.18-1.49), 1.31 (95% CI, 1.16-1.48), 1.19 (95% CI, 1.06-1.34), and 1.16 (95% CI, 1.03-1.30). The hazard ratios for CSS similarly ranged from 1.34 to 1.22 for lowest to highest income. Older age, black race, male sex, unmarried marital status, an earlier year of diagnosis, higher tumor grade, and later American Joint Committee on Cancer stage of disease also were associated with worse CSS. Income was not found to be associated with the odds of initiating radiotherapy in multivariable analysis (odds ratio of 0.87 for lowest to highest income level; 95% CI, 0.63-1.20). CONCLUSIONS: MHI appears to independently predict CSS and overall survival in patients with SCCA. Black race was found to remain a predictor of SCCA survival despite controlling for income. Further study is needed to understand the mechanisms by which socioeconomic inequalities affect cancer care and outcomes. Cancer 2018;124:1791-7. © 2018 American Cancer Society.

Underutilization and disparities in access to EGFR testing among Medicare patients with lung cancer from 2010 - 2013.

BACKGROUND: Tumor testing for mutations in the epidermal growth factor receptor (EGFR) gene is indicated for all newly diagnosed, metastatic lung cancer patients, who may be candidates for first-line treatment with an EGFR tyrosine kinase inhibitor. Few studies have analyzed population-level testing. METHODS: We identified clinical, demographic, and regional predictors of EGFR & KRAS testing among Medicare beneficiaries with a new diagnosis of lung cancer in 2011-2013 claims. The outcome variable was whether the patient underwent molecular, EGFR and KRAS testing. Independent variables included: patient demographics, Medicaid status, clinical characteristics, and region where the patient lived. We performed multivariate logistic regression to identify factors that predicted testing. RESULTS: From 2011 to 2013, there was a 19.7% increase in the rate of EGFR testing. Patient zip code had the greatest impact on odds to undergo testing; for example, patients who lived in the Boston, Massachusetts hospital referral region were the most likely to be tested (odds ratio (OR) of 4.94, with a 95% confidence interval (CI) of 1.67-14.62). Patient demographics also impacted odds to be tested. Asian/Pacific Islanders were most likely to be tested (OR 1.63, CI 1.53-1.79). Minorities and Medicaid patients were less likely to be tested. Medicaid recipients had an OR of 0.74 (CI 0.72-0.77). Hispanics and Blacks were also less likely to be tested (OR 0.97, CI 0.78-0.99 and 0.95, CI 0.92-0.99), respectively. Clinical procedures were also correlated with testing. Patients who underwent transcatheter biopsies were 2.54 times more likely to be tested (CI 2.49-2.60) than those who did not undergo this type of biopsy. CONCLUSIONS: Despite an overall increase in EGFR testing, there is widespread underutilization of guideline-recommended testing. We observed racial, income, and regional disparities in testing. Precision medicine has increased the complexity of cancer diagnosis and treatment. Targeted interventions and clinical decision support tools are needed to ensure that all patients are benefitting from advances in precision medicine. Without such interventions, precision medicine may exacerbate racial disparities in cancer care and health outcomes.

Exploration of the ASCO and ESMO Value Frameworks for Antineoplastic Drugs.

PURPOSE: In 2015, both ASCO and the European Society for Medical Oncology (ESMO) proposed frameworks to quantify the benefit of antineoplastic drugs in the face of rising costs. We applied these frameworks to drugs approved by the US Food and Drug Administration over the past 12 years and examined relationships between costs and benefits. METHODS: We searched FDA.gov for drugs that received initial approval for solid tumors from 2004 to 2015 and calculated the ASCO Net Health Benefit version 2016 (NHB16) and 2015 (NHB15) and the ESMO Magnitude of Clinical Benefit Scale scores for each drug. We calculated descriptive statistics and explored correlations and associations among benefit scores, cost, and independent variables. RESULTS: We identified 55 drug approvals supported by phase II (18.2%) and III (81.8%) trials, with primary outcomes of overall survival (36.4%), progression-free survival (43.6%), or response rate (20.0%). No significant association was found between NHB16 and year of approval ( P = .81), organ system ( P = .20), or trial comparator arm ( P = .17), but trials with progression-free survival outcomes were associated with higher scores ( P = .007). Both NHB15 and Magnitude of Clinical Benefit Scale scores were approximately normally distributed, but only a moderate correlation existed between them ( r = 0.40, P = .006). No correlation between benefit score and cost (NHB16, r = 0.19; ESMO, r = -0.07) was found. Before 2010, two (15.3%) of 13 approved drugs exceeded $500/NHB point × month compared with 10 (25.0%) of 40 drugs subsequently approved. CONCLUSION: Our analysis of the ASCO and ESMO value frameworks illuminates the heterogeneous benefit of new medications and highlights challenges in constructing a unified concept of drug value. Drug benefit does not correlate with cost, and the number of high cost/benefit outliers has increased.

Y90 radioembolization of colorectal cancer liver metastases: response assessment by contrast-enhanced computed tomography with or without PET-CT guidance.

PURPOSE: To compare various computed tomography (CT) parameters to the positron emission tomography with computed tomography (PET-CT) response, with or without PET guidance for the response assessment of colorectal cancer (CRC) metastases treated by Y90 radioembolization. METHODS: Thirty-six CRC metastases were retrospectively evaluated on 18F-Fluoro-Deoxy-Glucose PET-CT and contrast-enhanced computed tomography (CECT) performed at baseline and 2-3 months after Y90 radioembolization. RESULTS: Median SUVmax values decreased from 11.39 to 6.71 after radioembolization (P<.001), and 23/36 (64%) metastases were categorized metabolic responses according to European Organisation for Research and Treatment of Cancer criteria. Only a decrease of the mean attenuation in the structural (P<.001) and metabolic active volume (P<.001) was observed. The change in these criteria was correlated with the change of SUVmax.

The epidemiology of childhood and adolescent traumatic spinal cord injury in the United States: 2007-2010.

The burden of acute traumatic spinal cord injury (TSCI) among U. S. children and adolescents was last described over a decade ago using inpatient data. We describe cumulative incidence, mortality, discharge disposition, and inflation-adjusted charges of childhood and adolescent TSCI in the U.S. using emergency department (ED) data from the Nationwide Emergency Department Sample (2007-2010). Patients ages 17 years and younger with a diagnosis of acute TSCI were identified using the International Classification of Diseases, Ninth Revision (ICD-9) diagnosis codes 806.* and 952.* (N = 6132). The cumulative incidence of childhood and adolescent TSCI averaged 17.5 per million population per year. The median age at presentation was 15 years (interquartile range [IQR] = 12-16) and the majority of patients were male (72.5%). The overall median new injury severity score (NISS) was 16 (IQR = 9-27), remaining unchanged during the study duration (p=0.703). Children 5 years and younger were more likely to be injured from a road traffic accident (RTA; 50.9%), sustain C1-C4 injuries (47.4%), have more severe injury (median NISS = 22; IQR = 13-29), and concurrent brain injury (24%) compared to older children and adolescents, p<0.001. Firearms were implicated in 8.3% of injuries, of which 94.7% were among adolescents ages 13-17 years. Of the 35 TSCI-related ED deaths, 40% occurred among children ages 5 years and younger. 62.4% of patients required inpatient admission. Despite stable cumulative incidence and overall injury severity, ED treatment charge per visit increased on average $1394 from $3495 in 2007 to $4889 in 2010 (p=0.008). RTA-related TSCI disproportionately affects young children, while firearm-related TSCI is most common among adolescents. These findings inform TSCI prevention strategies. Prevention may be key in mitigating rising healthcare cost.

The burden of acute traumatic spinal cord injury among adults in the united states: an update.

The current incidence estimate of 40 traumatic spinal cord injuries (TSCI) per million population/year in the United States (U.S.) is based on data from the 1990s. We sought to update the incidence and epidemiology of TSCI in U.S adults by using the Nationwide Emergency Department Sample (NEDS), the largest all-payer emergency department (ED) database in the United States. Adult ED visits between 2007 and 2009 with a principal diagnosis of TSCI were identified using International Classification of Diseases (ICD)-9 codes (806.0-806.9 and 952.0-952.9). We describe TSCI cumulative incidence, mortality, discharge disposition, and hospital charges weighted to the U.S. population. The estimated 3-year cumulative incidence of TSCI was 56.4 per million adults. Cumulative incidence of TSCI in older adults increased from 79.4 per million older adults in 2007 to 87.7 by the end of 2009, but remained steady among younger adults. Overall, falls were the leading cause of TSCI (41.5%). ED charges rose by 20% over the study period, and death occurred in 5.7% of patients. Compared with younger adults, older adults demonstrated higher adjusted odds of mortality in the ED (adjusted odds ratio [AOR]=4.4; 95% confidence interval [CI]: 1.1-16.6), mortality during hospitalization (AOR=5.9; 95% CI: 4.7-7.4), and being discharged to chronic care (AOR=3.7; 95% CI: 3.0-4.5). The incidence of TSCI is higher than previously reported with a progressive increase among older adults who also experience worse outcomes compared with younger adults. ED-related TSCI charges are also increasing. These updated national estimates support the development of customized prevention strategies based on age-specific risk factors.

Impact of oncology drug shortages on patient therapy: unplanned treatment changes.

PURPOSE: Cancer drug shortages have increased considerably over the past 5 years, but quantitative analyses of the scope and effects are limited. We assessed the effects of drug shortages on outpatient medication use in a single New York City university hospital. METHODS: We examined pharmacy records for drug shortages, as defined by the American Society of Health-System Pharmacists. We assessed outpatient records for all patients with cancer treated with infusional antineoplastic medications from April 2010 to September 2010 and April 2011 to September 2011. RESULTS: Twelve medications were in shortage in 2010 and 22 in 2011. Drugs in shortage were used for 170 patients (50.8%) in 2010 and 241 patients (63.6%) in 2011 (P < .001). Of 235 patients treated in August-September 2011, there were 23(9.8%) documented therapy changes due to shortages, compared with zero changes in August-September 2010 (P < .001). Among patients treated in August-September 2010, 24 (11.4%) received paclitaxel and 19 (9.0%) received docetaxel. Among patients treated in August-September 2011, 11 (4.7%) received paclitaxel and 38 (16.2%) received docetaxel, a 69% decrease for paclitaxel and 80% increase for docetaxel from 1 year prior (P = .009, and P = .024, respectively). The estimated cost of a single treatment with paclitaxel for one patient with body-surface area 1.75 was $47.59 versus $858.39 for docetaxel, a 1,704% increase. Surveyed physicians frequently reported lower level evidence (30.4%) and increased risk of toxicity (34.8%) with alternative therapy in drug shortage cases. CONCLUSION: Oncology drug shortages affected the majority of patients in our center and increased at an alarming rate. Drug shortages have substantial economic costs and mandate treatment changes that may affect efficacy and toxicity.

Rights, knowledge, and governance for improved health equity in urban settings.

All three of the interacting aspects of daily urban life (physical environment, social conditions, and the added pressure of climate change) that affect health inequities are nested within the concept of urban governance, which has the task of understanding and managing the interactions among these different factors so that all three can be improved together and coherently. Governance is defined as: "the process of collective decision making and processes by which decisions are implemented or not implemented": it is concerned with the distribution, exercise, and consequences of power. Although there appears to be general agreement that the quality of governance is important for development, much less agreement appears to exist on what the concept really implies and how it should be used. Our review of the literature confirmed significant variation in meaning as well as in the practice of urban governance arrangements. The review found that the linkage between governance practices and health equity is under-researched and/or has been neglected. Reconnecting the fields of urban planning, social sciences, and public health are essential "not only for improving local governance, but also for understanding and addressing global political change" for enhanced urban health equity. Social mobilization, empowering governance, and improved knowledge for sustainable and equitable development in urban settings is urgently needed. A set of strategic research questions are suggested.

Judicial developments in the US Hatch-Waxman infringement safe harbor.

Life science companies often seek guidance on whether certain current or proposed activities fall within the Hatch-Waxman safe harbor, which exempts from infringement the making, using, offering to sell or sale within the US, or the importation into the US, of "a patented invention ... solely for uses reasonably related to the development and submission of information under a Federal law which regulates the manufacture, use, or sale of drugs ...". In 2005, the US Supreme Court provided some clarity as to the scope of this safe harbor. In Merck KGaA v. Integra Lifesciences I, Ltd, the Court held that the exemption from infringement can reach certain preclinical experiments, outlining one test by which such preclinical experiments can be shown to be sufficiently 'reasonably related' to FDA submission as to qualify for the safe harbor. On remand of the case from the Supreme Court, the Court of Appeals added further explanatory detail. In late 2008, however, much of that hard-won clarity was lost when the Court of Appeals, in Proveris Scientific Corp. v. Innovasystems, Inc., addressed the 'patented invention' language of the statutory exemption, and articulated a two part test that is, in the opinion of the authors, unnecessary, unwarranted and unworkable.

Network of healthy communities of Rio de Janeiro--Brazil.

Poor communities in Rio de Janeiro, which are known as favelas, suffer from various problems related to poor housing, poverty, unemployment, violence and organized crime, and lack of access to basic services, such as health care and education. In order to tackle these determinants, and inspired by WHO's international Healthy Communities/Cities movement, the etwork of Healthy Communities of Rio de Janeiro was formed in 2004. The Network is coordinated by the Center for Health Promotion (CEDAPS) and now includes more than 100 community groups and organizations in the state of Rio de Janeiro. Their aim is to promote health, community development and equity through community empowerment, participation, capacity building and advocacy. The paper describes the work that has been done since the Network's inception and the challenges which they face to reach their goals in the context of a country like Brazil. The Network represents an important landmark of how poor populations can organize themselves in a collective, participatory and constructive way to influence public policy and strive for better conditions of life in disadvantaged settings, like the favelas.

Website for rhinoplasty and facial plastic surgery.

The Internet has become an important avenue for facial plastic surgeons to make potential patients aware of their practice. It is important for the facial plastic surgeon to understand how the Internet is used by patients and how it can complement a physician's practice. The website unavoidably has a marketing aspect. Although there are no statistics available, certainly a substantial number of patients use the Internet as a primary source for both learning about cosmetic surgical procedures and also to locate a physician. A practice website can provide potential patients with important logistical information; it also provides an opportunity to educate the potential patient about the surgical procedures provided. A website can be an important aspect of the overall practice image. An increasing number of individuals visit the website of their physician or potential physician, so it is important that attention is given to this aspect of a practice.

Devastating injuries in healthcare workers: description of the crisis and legislative solution to the epidemic of back injury from patient lifting.

The purpose of this report is to describe a crisis in healthcare, disabling back injuries in US healthcare workers. In addition, outlined is the proven solution of safe, mechanized, patient lifting, which has been shown to prevent these injuries. A "Safe Patient Handling--No Manual Lift" policy must be immediately instituted throughout this country. Such a policy is essential to halt hazardous manual patient lifting, which promotes needless disability and loss of healthcare workers, pain and risk of severe injury to patients, and tremendous waste of financial resources to employers and workers' compensation insurance carriers. Healthcare workers consistently rank among top occupations with disabling back injuries, primarily from manually lifting patients. Back injury may be the single largest contributor to the nursing shortage. Reported injuries to certified nursing assistants are three to four times that of registered nurses. A national healthcare policy for "Safe Patient Handling--No Manual Lift" is urgently needed to address this crisis. Body mechanics training is ineffective in prevention of back injury with patient lifting. Mandated use of mechanical patient lift equipment has proven to prevent most back injury to nursing personnel and reduce pain and injury to patients associated with manual lifting. With the national epidemic of morbid obesity in our country, innovative devices are available for use in emergency medical systems and hospitals for patient lifting and transfer without injury to hospital personnel. The US healthcare industry has not voluntarily taken measures necessary to reduce patient handling injury by use of mechanical lift devices. US healthcare workers who suffer disabling work-related back injuries are limited to the fixed, and often inadequate, relief which they may obtain from workers' compensation. Under workers' compensation law, healthcare workers injured lifting patients may not sue their employer for not providing mechanical lift equipment. Discarding healthcare workers disabled by preventable back injuries is an abuse which legislators must remedy. In addition, Medicare reimbursement policies must also be updated to allow the disabled community to purchase electrically operated overhead ceiling lifts. The US lags far behind countries with legislated manual handling regulations and "No Lifting" nursing policies. England and Australia have had "No Lifting" nursing policies in place since 1996 and 1998, respectively. The National Occupational Research Agenda (NORA) recognized a model in 2003 for reduction of back injuries to nursing staff in US healthcare facilities. Also in 2003, the American Nurses Association called for elimination of manual patient handling because it is unsafe and causes musculoskeletal injuries to nurses. The first state legislation for safe patient handling passed both houses in California but was vetoed by the Governor in September 2004. California and other states are preparing to (re)introduce legislation in January 2005. A national, industry-specific policy is essential to quell the outflow of nursing personnel to disability from manual patient lifting.

An Internet otolaryngology referral center: a preliminary report.

BACKGROUND: The aim of this study was to review our early experience with the UPenn Otolaryngology Referral Center Website, ENTConsult.org. METHODS: ENTConsult.org is an interactive website that allows a referring physician to select a University of Pennsylvania Health System otolaryngologist and share clinical information, including uploaded pictures, radiographs, and other images via the Internet. Traditional methods of long-distance consultation involve mailing clinical information, which often is slow and unwieldy, thus discouraging consultation. ENTConsult.org seeks to take advantage of Internet functionality to facilitate efficient and timely consultation regardless of any of the participants' locations. RESULTS: In this report we reviewed our initial experience with ENTConsult.org, including an overview of the website functionality and a detailed review of critical logistical considerations. CONCLUSION: The UPenn Otolaryngology Referral Center Website ENTConsult.org offers considerable promise as an avenue for long-distance referral and consultation.