Interventions addressing health-related social needs among patients with cancer.

Health-related social needs are prevalent among cancer patients; associated with substantial negative health consequences; and drive pervasive inequities in cancer incidence, severity, treatment choices and decisions, and outcomes. To address the lack of clinical trial evidence to guide health-related social needs interventions among cancer patients, the National Cancer Institute Cancer Care Delivery Research Steering Committee convened experts to participate in a clinical trials planning meeting with the goal of designing studies to screen for and address health-related social needs among cancer patients. In this commentary, we discuss the rationale for, and challenges of, designing and testing health-related social needs interventions in alignment with the National Academy of Sciences, Engineering, and Medicine 5As framework. Evidence for food, housing, utilities, interpersonal safety, and transportation health-related social needs interventions is analyzed. Evidence regarding health-related social needs and delivery of health-related social needs interventions differs in maturity and applicability to cancer context, with transportation problems having the most maturity and interpersonal safety the least. We offer practical recommendations for health-related social needs interventions among cancer patients and the caregivers, families, and friends who support their health-related social needs. Cross-cutting (ie, health-related social needs agnostic) recommendations include leveraging navigation (eg, people, technology) to identify, refer, and deliver health-related social needs interventions; addressing health-related social needs through multilevel interventions; and recognizing that health-related social needs are states, not traits, that fluctuate over time. Health-related social needs-specific interventions are recommended, and pros and cons of addressing more than one health-related social needs concurrently are characterized. Considerations for collaborating with community partners are highlighted. The need for careful planning, strong partners, and funding is stressed. Finally, we outline a future research agenda to address evidence gaps.

Longitudinal Assessment of Alkali Injury on Mouse Cornea Using Anterior Segment Optical Coherence Tomography.

Purpose: Chemical burns due to alkalis cause extensive damage to the ocular surface leading to blindness. Assessment of ocular burn could be challenging due to severe opacity, inflammation, and angiogenesis. Anterior segment optical coherence tomography (AS-OCT) and OCT angiography (OCTA) may provide fast, non-invasive deep tissue visualization of pathology with high sensitivity in conjunction with slit-lamp analysis. Methods: C57-BL/6J mice were anesthetized with ketamine/dexmedetomidine, and corneal alkali burn was induced (n = 6) by placing filter paper soaked in 1-M sodium hydroxide for 30 seconds on the right eye while the left eye was kept as control. Longitudinal imaging was done with AS-OCT/OCTA and fluorescein angiography at various time intervals for 14 days. Results: AS-OCT showed characteristic pathological changes in alkali-burned eyes with high sensitivity. Although OCT/OCTA showed three-dimensional and cross-sectional views of the anterior chamber and angiogenesis, fluorescein angiography showed nascent vessels with active leakage. Corneal swelling progressively increased by 125.26% on day 12 with a high prevalence of epithelial bullae, stromal cysts, stromal splitting, and Descemet's membrane detachment. Neovascularization was noted as early as day 4 in the burned eyes by both methods. Severe corneal opacity and anterior chamber inflammation were also detected by AS-OCT/OCTA. Conclusions: AS-OCT/OCTA is a promising, noninvasive, high-resolution imaging modality that can provide both qualitative and quantitative information regarding deep tissue pathology at a structural level. Translational Relevance: Noninvasive AS-OCT/OCTA and fluorescein methods show promise in clinical pathology evaluation for ocular injury management and prognostic indications, as the early presence of Descemet's membrane detachment and corneal swelling appears to be correlated with the severity and localization of corneal neovascularization.

Is Real-World Evidence Used in P&T Monographs and Therapeutic Class Reviews?

BACKGROUND: Payers are faced with making coverage and reimbursement decisions based on the best available evidence. Often these decisions apply to patient populations, provider networks, and care settings not typically studied in clinical trials. Treatment effectiveness evidence is increasingly available from electronic health records, registries, and administrative claims. However, little is known about when and what types of real-world evidence (RWE) studies inform pharmacy and therapeutic (P&T) committee decisions. OBJECTIVE: To evaluate evidence sources cited in P&T committee monographs and therapeutic class reviews and assess the design features and quality of cited RWE studies. METHODS: A convenience sample of representatives from pharmacy benefit management, health system, and health plan organizations provided recent P&T monographs and therapeutic class reviews (or references from such documents). Two investigators examined and grouped references into major categories (published studies, unpublished studies, and other/unknown) and multiple subcategories (e.g., product label, clinical trials, RWE, systematic reviews). Cited comparative RWE was reviewed to assess design features (e.g., population, data source, comparators) and quality using the Good ReseArch for Comparative Effectiveness (GRACE) Checklist. RESULTS: Investigators evaluated 565 references cited in 27 monographs/therapeutic class reviews from 6 managed care organizations. Therapeutic class reviews mostly cited published clinical trials (35.3%, 155/439), while single-product monographs relied most on manufacturer-supplied information (42.1%, 53/126). Published RWE comprised 4.8% (21/439) of therapeutic class review references, and none (0/126) of the monograph references. Of the 21 RWE studies, 12 were comparative and assessed patient care settings and outcomes typically not included in clinical trials (community ambulatory settings [10], long-term safety [8]). RWE studies most frequently were based on registry data (6), conducted in the United States (6), and funded by the pharmaceutical industry (5). GRACE Checklist ratings suggested the data and methods of these comparative RWE studies were of high quality. CONCLUSIONS: RWE was infrequently cited in P&T materials, even among therapeutic class reviews where RWE is more readily available. Although few P&T materials cited RWE, the comparative RWE studies were generally high quality. More research is needed to understand when and what types of real-world studies can more routinely inform coverage and reimbursement decisions. DISCLOSURES: This project was funded by the National Pharmaceutical Council. Hurwitz, Brown, Peters, and Malone have nothing to disclose. Graff is employed by the National Pharmaceutical Council Part of this study was presented as a poster presentation at the AMCP Managed Care & Specialty Pharmacy 2016 Annual Meeting; April 19-22, 2016; San Francisco, CA. Study concept and design were primarily contributed by Malone and Graff, along with Hurwitz and Brown. All authors participated in data collection, and data interpretation was performed by Malone, Hurwitz, and Graff, with assistance from Brown and Peters. The manuscript was written primarily by Hurwitz and Malone, along with Graff, Brown, and Peters, and revised by Malone, Brown, Peters, Hurwitz, and Graff.

Addressing Crime, Violence, and Other Determinants of Health through Community-Based Participatory Research and Implementation Science.

In this paper, we describe the assessment and planning phase of the Thrive community-based initiative to reduce violence and address other determinants of health in a community in the Southwestern United States. Using community-based participatory research (CBPR) and an implementation science framework, we engaged residents and other key stakeholders as equal partners in the assessment and planning process. The Thrive assessment and planning phase involved collaboration among researchers, residents, law enforcement, nonprofit agencies, public health, local government, and other cross-sector partners. We used implementation science in order to examine the barriers and facilitators to addressing community health and safety, to assess the nature and scope of health and safety issues, to review existing solutions, to assess the acceptability and necessary adaptations of selected interventions, and to assess feasibility and sustainability of the initiative. Through interviews, focus groups, analysis of crime incident data, geomapping, and direct observations, our findings highlighted the presence of an open-air drug market, the high-stress nature of the community, concern for the lack of opportunities for youth, the lack of trust between residents and law enforcement, and a need to address the built environment to promote safety and well-being.

Consensus Organizing and Community-Based Participatory Research to Address Social-Structural Disparities and Promote Health Equity: The Hope Zone Case Study.

This case study illustrates the process of integrating community-based participatory research and consensus organizing in an effort to deconstruct social-structural risk factors and markers of health disparities, and build positive relationships between members of the criminal justice system and the community. Community residents, law enforcement, and other cross-sector partners engaged in an extensive planning initiative to address crime and social-structural risk factors in a majority African American community. Community-based participatory research and consensus organizing can be integrated as an effective approach to engaging and empowering communities to take action to dismantle social-structural disparities and promote a culture of health and well-being.

The 3G Multigenerational Cohort of Nova Scotian women and their mothers and offspring.

BACKGROUND: The negative impact of exposures such as maternal obesity, excessive gestational weight gain, and hypertension in pregnancy on the health of the next generation has been well studied. Evidence from animal studies suggests that the effects of in utero exposures may persist into the second generation, but the epidemiological literature on the influence of pregnancy-related exposures across three generations in humans is sparse. OBJECTIVES: This cohort was established to investigate associations between antenatal and perinatal exposures and health outcomes in women and their offspring. POPULATION: The cohort includes women who were born and subsequently had their own pregnancies in the Canadian province of Nova Scotia from 1980 onward. DESIGN: Intergenerational linkage of data in the Nova Scotia Atlee Perinatal Database was used to establish a population-based dynamic retrospective cohort. METHODS: The cohort has prospectively collected information on sociodemographics, maternal health and health behaviours, pregnancy health and complications, and obstetrical and neonatal outcomes for two generations of women and their offspring. PRELIMINARY RESULTS: As of October 2018, the 3G cohort included 14 978 grandmothers (born 1939-1986), 16 766 mothers or cohort women (born 1981-2003), and 28 638 children (born 1996-2018). The cohort women were generally younger than Nova Scotian women born after 1980, and as a result, characteristics associated with pregnancy at a younger age were more frequently seen in the cohort women; sampling weights will be created to account for this design effect. The cohort will be updated annually to capture future deliveries to women who are already in the cohort and women who become eligible for inclusion when they deliver their first child. CONCLUSIONS: The 3G Multigenerational Cohort is a population-based cohort of women and their mothers and offspring, spanning a time period of 38 years, and provides the opportunity to study inter- and transgenerational associations across the maternal line.

Hazards of Our Helping Profession: A Practical Self-Care Model for Community Practice.

The social work profession is a helping profession; social workers provide services with the intent to improve life opportunities in pursuit of social justice for individuals, groups, communities, and society as a whole. Social workers are called to work on behalf of the most vulnerable people in our society, and as such, the hazards of our helping profession are abundant. Though the literature offers numerous frameworks that can be used by social workers in a variety of settings, many issues that are unique to community practice settings can lead to professional burnout and compassion fatigue for social workers. At present there are no comprehensive models for self-care that attend specifically to the unique needs of the community practitioner. This article presents the iM-PAACT model, a four-part conceptual framework that helps to fill this gap in the literature. This practical self-care model has been designed specifically for social workers engaged primarily in community practice settings, including the community activist, community organizer, and community-engaged scholar.

Training in the Management of Psychobehavioral Conditions: A Needs Assessment Survey of Emergency Medicine Residents.

OBJECTIVE: Mental health-related ED visits are increasing. Despite this trend, most emergency medicine (EM) residency programs devote little time to psychiatry education. This study aimed to identify EM residents' perceptions of training needs in emergency psychiatry and self-confidence in managing patients with psychobehavioral conditions. METHODS: A needs assessment survey was distributed to residents at 15 Accreditation Council for Graduate Medical Education-accredited EM programs spanning the U.S. Survey items addressed amount and type of training in psychiatry during residency, perceived training needs in psychiatry, and self-confidence performing various clinical skills related to emergency psychiatric care. Residents used a 5-point scale (1 = nothing; 5 = very large amount) to rate their learning needs in a variety of topic areas related to behavioral emergencies (e.g., medically clearing patients, substance use disorders). Using a scale from 0 to 100, residents rated their confidence in their ability to independently perform various clinical skills related to emergency psychiatric care (e.g., differentiating a psychiatric presentation from delirium). RESULTS: Of the 632 residents invited to participate, 396 (63%) responded. Twelve percent of respondents reported completing a psychiatry rotation during EM residency. One of the 15 participating programs had a required psychiatry rotation. Residents reported that their program used lectures (56%) and/or supervised training in the ED (35%) to teach residents about psychiatric emergencies. Most residents reported minimal involvement in the treatment of patients with psychiatric concerns. The majority of residents (59%) believed that their program should offer more education on managing psychiatric emergencies. Only 14% of residents felt "quite" or "extremely" prepared to treat psychiatric patients. Overall, residents reported the lowest levels of confidence and highest need for more training related to counseling suicidal patients and treating psychiatric issues in special populations (e.g., pregnant women, elderly, and children). CONCLUSIONS: Most EM residents desire more training in managing psychiatric emergencies than is currently provided.

Cesarean Delivery and Healthcare Utilization and Costs in the Offspring: A Retrospective Cohort Study.

OBJECTIVE: To examine the association between cesarean delivery and healthcare utilization and costs in offspring from birth until age 7 years. STUDY DESIGN: A retrospective cohort study of singleton term births in the Canadian province of Nova Scotia between 2003 and 2007 followed until age 7 years was conducted using data from the Nova Scotia Atlee Perinatal Database and administrative health data. The main exposure was mode of delivery (cesarean delivery vs vaginal birth); the outcome was healthcare utilization and costs during the first 7 years of life. Associations were modeled using multiple regression adjusting for maternal prepregnancy weight and sociodemographic factors. RESULTS: In total, 32 464 births were included in the analysis. Compared with children born by vaginal birth, children born by cesarean delivery had more physician visits (incidence rate ratio 1.06, 95% CI 1.05-1.08) and longer hospital stays (incidence rate ratio 1.12, 95% CI 1.03-1.21) and were more likely to be high utilizers of physician visits (OR 1.23, 95% CI 1.10-1.37). Physician and hospital costs were $775 higher for children born by cesarean delivery compared with vaginal birth. CONCLUSIONS: Cesarean delivery compared with vaginal birth is associated with small but statistically significant increases in healthcare utilization and costs during the first 7 years of life.

Assessment of Child Lead Exposure in a Philadelphia Community, 2014.

INTRODUCTION: Several urban neighborhoods in Philadelphia, Pennsylvania, have a history of soil, household lead paint, and potential lead-emitting industry contamination. OBJECTIVES: To (1) describe blood lead levels (BLLs) in target neighborhoods, (2) identify risk factors and sources of lead exposure, (3) describe household environmental lead levels, and (4) compare results with existing data. METHODS: A simple, random, cross-sectional sampling strategy was used to enroll children 8 years or younger living in selected Philadelphia neighborhoods with a history of lead-emitting industry during July 2014. Geometric mean of child BLLs and prevalence of BLLs of 5 µg/dL or more were calculated. Linear and logistic regression analyses were used to ascertain risk factors for elevated BLLs. RESULTS: Among 104 children tested for blood lead, 13 (12.4%; 95% confidence interval [CI], 7.5-20.2) had BLLs of 5 µg/dL or more. The geometric mean BLL was 2.0 µg/dL (95% CI, 1.7-2.3 µg/dL). Higher geometric mean BLLs were significantly associated with front door entryway dust lead content, residence built prior to 1900, and a child currently or ever receiving Medicaid. Seventy-one percent of households exceeded the screening level for soil, 25% had an elevated front door floor dust lead level, 28% had an elevated child play area floor dust lead level, and 14% had an elevated interior window dust lead level. Children in households with 2 to 3 elevated environmental lead samples were more likely to have BLLs of 5 µg/dL or more. A spatial relationship between household proximity to historic lead-emitting facilities and child BLL was not identified. CONCLUSION: Entryway floor dust lead levels were strongly associated with blood lead levels in participants. Results underscore the importance to make housing lead safe by addressing all lead hazards in and around the home. Reduction of child lead exposure is crucial, and continued blood lead surveillance, testing, and inspection of homes of children with BLLs of 5 µg/dL or more to identify and control lead sources are recommended. Pediatric health care providers can be especially vigilant screening Medicaid-eligible/enrolled children and children living in very old housing.

Maternal pre-pregnancy obesity and health care utilization and costs in the offspring.

BACKGROUND/OBJECTIVE: The association between maternal pre-pregnancy obesity and adverse child health outcomes is well described, but there are few data on the relationship with offspring health service use. We examined the influence of maternal pre-pregnancy obesity on offspring health care utilization and costs over the first 18 years of life. METHODS: This was a population-based retrospective cohort study of children (n = 35,090) born between 1989 and 1993 and their mothers, who were identified using the Nova Scotia Atlee Perinatal Database and linked to provincial administrative health data from birth through 2014. The primary outcome was health care utilization as determined by the number and cost of physician visits, hospital admissions and days, and high utilizer status (>95th percentile of physician visits). The secondary outcome was health care utilization by ICD chapter. Maternal pre-pregnancy weight was categorized as normal weight, overweight, or obese. Multivariable-adjusted regression models were used to examine the association between maternal weight status and offspring health care use. RESULTS: Children of mothers with pre-pregnancy obesity had more physician visits (10%), hospital admissions (16%), and hospital days (10%) than children from mothers of normal weight over the first 18 years of life. Offspring of mothers with obesity had C$356 higher physician costs and C$1415 hospital costs over 18 years than offspring of normal weight mothers. Children of mothers with obesity were 1.74 times more likely to be a high utilizer of health care and had higher rates of physician visits and hospital stays for nervous system and sense organ disorders, respiratory disorders, and gastrointestinal disorders compared to children of normal weight mothers. CONCLUSION: Our findings suggest that maternal pre-pregnancy overweight and obesity are associated with slightly higher offspring health care utilization and costs in the first 18 years of life.

Environmental Assessment and Blood Lead Levels of Children in Owino Uhuru and Bangladesh Settlements in Kenya.

BACKGROUND: Lead exposure is linked to intellectual disability and anemia in children. The United States Centers for Disease Control and Prevention (CDC) recommends biomonitoring of blood lead levels (BLLs) in children with BLL ≥5 µg/dL and chelation therapy for those with BLL ≥45 µg/dL. OBJECTIVES: This study aimed to determine blood and environmental lead levels and risk factors associated with elevated BLL among children from Owino Uhuru and Bangladesh settlements in Mombasa County, Kenya. METHODS: The present study is a population-based, cross-sectional study of children aged 12-59 months randomly selected from households in two neighboring settlements, Owino Uhuru, which has a lead smelter, and Bangladesh settlement (no smelter). Structured questionnaires were administered to parents and 1-3 ml venous blood drawn from each child was tested for lead using a LeadCare ® II portable analyzer. Environmental samples collected from half of the sampled households were tested for lead using graphite furnace atomic absorption spectroscopy. RESULTS: We enrolled 130 children, 65 from each settlement. Fifty-nine (45%) were males and the median age was 39 months (interquartile range (IQR): 30-52 months). BLLs ranged from 1 µg/dL to 31 µg/dL, with 45 (69%) children from Owino Uhuru and 18 (28%) children from Bangladesh settlement with BLLs >5 µg/dL. For Owino Uhuru, the geometric mean BLL in children was 7.4 µg/dL (geometric standard deviation (GSD); 1.9) compared to 3.7 µg/dL (GSD: 1.9) in Bangladesh settlement (p<0.05). The geometric mean lead concentration of soil samples from Owino Uhuru was 146.5 mg/Kg (GSD: 5.2) and 11.5 mg/Kg (GSD: 3.9) (p<0.001) in Bangladesh settlement. Children who resided <200 m from the lead smelter were more likely to have a BLL ≥5 µg/dL than children residing ≥200 m from the lead smelter (adjusted odds ratio (aOR): 33.6 (95% confidence interval (CI): 7.4-153.3). Males were also more likely than females to have a BLL ≥5 µg/dL (39, 62%) compared to a BLL<5 µg/dL [aOR: 2.4 (95% CI: 1.0-5.5)]. CONCLUSIONS: Children in Owino Uhuru had significantly higher BLLs compared with children in Bangladesh settlement. Interventions to diminish continued exposure to lead in the settlement should be undertaken. Continued monitoring of levels in children with detectable levels can evaluate whether interventions to reduce exposure are effective. PARTICIPANT CONSENT: Obtained. ETHICS APPROVAL: Scientific approval for the study was obtained from the Ministry of Health, lead poisoning technical working group. Since this investigation was considered a public health response of immediate concern, expedited ethical approval was obtained from the Kenya Medical Research Institute and further approval from the Mombasa County Department of Health Services. The investigation was considered a non-research public health response activity by the CDC. COMPETING INTERESTS: The authors declare no competing financial interests.

Barriers and facilitators to knowledge transfer and exchange in palliative care research.

In order to ensure the effective transfer of research knowledge to those who can effect positive changes in practice, models of knowledge transfer and exchange (KTE) are required. Limited evidence exists as to how palliative care researchers use existing models to support their practice and to what extent they are perceived as effective. We set out to identify factors that influence KTE planning and implementation through semistructured interviews with experienced palliative care researchers in Ireland. Issues around KTE were drawn out through thematic analysis. Nine interviews were held with investigators on eight research projects. Ten themes were identified and categorised as either barriers or facilitators to KTE. Perceived barriers included inadequate time and funding, limited institutional capacity, competing priorities, weak communication channels and negative perceptions of palliative care. Perceived facilitators included dedicated time and resources, aligned priorities, strong professional networks, multipronged approach and KTE experience. In order to improve the quality, acceptability and reach of palliative research, it is vital that researchers improve their understanding of KTE within the context of palliative care, moving beyond academic dissemination to achieve research-informed practice by overcoming barriers to KTE through facilitated action. This study provides an overview of factors that influence KTE planning and implementation among palliative care researchers.

A checklist for clinical trials in rare disease: obstacles and anticipatory actions-lessons learned from the FOR-DMD trial.

BACKGROUND: Trials in rare diseases have many challenges, among which are the need to set up multiple sites in different countries to achieve recruitment targets and the divergent landscape of clinical trial regulations in those countries. Over the past years, there have been initiatives to facilitate the process of international study set-up, but the fruits of these deliberations require time to be operationally in place. FOR-DMD (Finding the Optimum Steroid Regimen for Duchenne Muscular Dystrophy) is an academic-led clinical trial which aims to find the optimum steroid regimen for Duchenne muscular dystrophy, funded by the National Institutes of Health (NIH) for 5 years (July 2010 to June 2015), anticipating that all sites (40 across the USA, Canada, the UK, Germany and Italy) would be open to recruitment from July 2011. However, study start-up was significantly delayed and recruitment did not start until January 2013. METHOD: The FOR-DMD study is used as an example to identify systematic problems in the set-up of international, multi-centre clinical trials. The full timeline of the FOR-DMD study, from funding approval to site activation, was collated and reviewed. Systematic issues were identified and grouped into (1) study set-up, e.g. drug procurement; (2) country set-up, e.g. competent authority applications; and (3) site set-up, e.g. contracts, to identify the main causes of delay and suggest areas where anticipatory action could overcome these obstacles in future studies. RESULTS: Time from the first contact to site activation across countries ranged from 6 to 24 months. Reasons of delay were universal (sponsor agreement, drug procurement, budgetary constraints), country specific (complexity and diversity of regulatory processes, indemnity requirements) and site specific (contracting and approvals). The main identified obstacles included (1) issues related to drug supply, (2) NIH requirements regarding contracting with non-US sites, (3) differing regulatory requirements in the five participating countries, (4) lack of national harmonisation with contracting and the requirement to negotiate terms and contract individually with each site and (5) diversity of languages needed for study materials. Additionally, as with many academic-led studies, the FOR-DMD study did not have access to the infrastructure and expertise that a contracted research organisation could provide, organisations often employed in pharmaceutical-sponsored studies. This delay impacted recruitment, challenged the clinical relevance of the study outcomes and potentially delayed the delivery of the best treatment to patients. CONCLUSION: Based on the FOR-DMD experience, and as an interim solution, we have devised a checklist of steps to not only anticipate and minimise delays in academic international trial initiation but also identify obstacles that will require a concerted effort on the part of many stakeholders to mitigate.

Real-World Evidence: Useful in the Real World of US Payer Decision Making? How? When? And What Studies?

OBJECTIVES: To examine how real-world evidence (RWE) is currently perceived and used in managed care environments, especially to inform pharmacy and therapeutic (P&T) committee decisions, to assess which study factors (e.g., data, design, and funding source) contribute to RWE utility in decisions, and to identify barriers to consideration of RWE studies in P&T decision making. METHODS: We conducted focus groups/telephone-based interviews and surveys to understand perceptions of RWE and assess awareness, quality, and relevance of two high-profile examples of published RWE studies. A purposive sample comprised 4 physicians, 15 pharmacists, and 1 researcher representing 18 US health plans and health system organizations. RESULTS: Participants reported that RWE was generally used, or useful, to inform safety monitoring, utilization management, and cost analysis, but less so to guide P&T decisions. Participants were not aware of the two sample RWE studies but considered both studies to be valuable. Relevant research questions and outcomes, transparent methods, study quality, and timely results contribute to the utility of published RWE. Perceived organizational barriers to the use of published RWE included lack of skill, training, and timely study results. CONCLUSIONS: Payers recognize the value of RWE, but use of such studies to inform P&T decisions varies from organization to organization and is limited. Relevance to payers, timeliness, and transparent methods were key concerns with RWE. Participants recognized the need for continuing education on evaluating and using RWE to better understand the study methods, findings, and applicability to their organizations.

The Contribution of the International Pain Policy Fellowship in Improving Opioid Availability in Georgia.

In the Republic of Georgia, the incidence and prevalence of cancer are increasing, signifying a growing need for palliative care and pain relief, including with controlled opioid medicines. As a signatory to the Single Convention, the Georgian government has a responsibility to ensure the adequate availability of controlled medicines for medical purposes; however, the consumption of morphine is very low, suggesting a high occurrence of unrelieved pain. In Georgia, palliative care development began in the 2000s including the adoption of a policy document in 2005, the creation of the National Palliative Care Coordinator in 2006, and important changes in Georgian legislation in 2007 and 2008, which served to lay a foundation for improving opioid availability. In 2008, a neurologist from the Sarajishvili Institute of Neurology and Neurosurgery in Tbilisi, and member of the Georgia National Association for Palliative Care, was selected to be an International Pain Policy Fellow to focus on improving opioid availability. Working with colleagues, government officials, and international experts, the Fellow contributed to several improvements to opioid availability, such as 1) positive changes to opioid prescribing legislation, 2) clarification of legislative terminology regarding dependence syndrome, 3) initiating the importation of both sustained-release and immediate-release oral morphine, and 4) improvements in the availability of sustained-release morphine. Despite these varied achievements, morphine consumption remains low in Georgia relative to the estimated amounts needed. The Fellow is continuing to study and understand the barriers that are impeding physician's prescription of opioids and patient's acceptance of them.

Is Real-World Evidence Used in P&T Monographs and Therapeutic Class Reviews?

BACKGROUND: Payers are faced with making coverage and reimbursement decisions based on the best available evidence. Often these decisions apply to patient populations, provider networks, and care settings not typically studied in clinical trials. Treatment effectiveness evidence is increasingly available from electronic health records, registries, and administrative claims. However, little is known about when and what types of real-world evidence (RWE) studies inform pharmacy and therapeutic (P&T) committee decisions. OBJECTIVE: To evaluate evidence sources cited in P&T committee monographs and therapeutic class reviews and assess the design features and quality of cited RWE studies. METHODS: A convenience sample of representatives from pharmacy benefit management, health system, and health plan organizations provided recent P&T monographs and therapeutic class reviews (or references from such documents). Two investigators examined and grouped references into major categories (published studies, unpublished studies, and other/unknown) and multiple subcategories (e.g., product label, clinical trials, RWE, systematic reviews). Cited comparative RWE was reviewed to assess design features (e.g., population, data source, comparators) and quality using the Good ReseArch for Comparative Effectiveness (GRACE) Checklist. RESULTS: Investigators evaluated 565 references cited in 27 monographs/therapeutic class reviews from 6 managed care organizations. Therapeutic class reviews mostly cited published clinical trials (35.3%, 155/439), while single-product monographs relied most on manufacturer-supplied information (42.1%, 53/126). Published RWE comprised 4.8% (21/439) of therapeutic class review references, and none (0/126) of the monograph references. Of the 21 RWE studies, 12 were comparative and assessed patient care settings and outcomes typically not included in clinical trials (community ambulatory settings [10], long-term safety [8]). RWE studies most frequently were based on registry data (6), conducted in the United States (6), and funded by the pharmaceutical industry (5). GRACE Checklist ratings suggested the data and methods of these comparative RWE studies were of high quality. CONCLUSIONS: RWE was infrequently cited in P&T materials, even among therapeutic class reviews where RWE is more readily available. Although few P&T materials cited RWE, the comparative RWE studies were generally high quality. More research is needed to understand when and what types of real-world studies can more routinely inform coverage and reimbursement decisions. DISCLOSURES: This project was funded by the National Pharmaceutical Council. Hurwitz, Brown, Peters, and Malone have nothing to disclose. Graff is employed by the National Pharmaceutical Council Part of this study was presented as a poster presentation at the AMCP Managed Care & Specialty Pharmacy 2016 Annual Meeting; April 19-22, 2016; San Francisco, CA. Study concept and design were primarily contributed by Malone and Graff, along with Hurwitz and Brown. All authors participated in data collection, and data interpretation was performed by Malone, Hurwitz, and Graff, with assistance from Brown and Peters. The manuscript was written primarily by Hurwitz and Malone, along with Graff, Brown, and Peters, and revised by Malone, Brown, Peters, Hurwitz, and Graff.

Species interactions and the effects of climate variability on a wetland amphibian metacommunity.

Disentangling the role that multiple interacting factors have on species responses to shifting climate poses a significant challenge. However, our ability to do so is of utmost importance to predict the effects of climate change on species distributions. We examined how populations of three species of wetland-breeding amphibians, which varied in life history requirements, responded to a six-year period of extremely variable precipitation. This interval was punctuated by both extensive drought and heavy precipitation and flooding, providing a natural experiment to measure community responses to environmental perturbations. We estimated occurrence dynamics using a discrete hidden Markov modeling approach that incorporated information regarding habitat state and predator-prey interactions. This approach allowed us to measure how metapopulation dynamics of each amphibian species was affected by interactions among weather, wetland hydroperiod, and co-occurrence with fish predators. The pig frog, a generalist, proved most resistant to perturbations, with both colonization and persistence being unaffected by seasonal variation in precipitation or co-occurrence with fishes. The ornate chorus frog, an ephemeral wetland specialist, responded positively to periods of drought owing to increased persistence and colonization rates during periods of low-rainfall. Low probabilities of occurrence of the ornate chorus frog in long-duration wetlands were driven by interactions with predators due to low colonization rates when fishes were present. The mole salamander was most sensitive to shifts in water availability. In our study area, this species never occurred in short-duration wetlands and persistence probabilities decreased during periods of drought. At the same time, negative effects occurred with extreme precipitation because flooding facilitated colonization of fishes to isolated wetlands and mole salamanders did not colonize wetlands once fishes were present. We demonstrate that the effects of changes in water availability depend on interactions with predators and wetland type and are influenced by the life history of each of our species. The dynamic species occurrence modeling approach we used offers promise for other systems when the goal is to disentangle the complex interactions that determine species responses to environmental variability.

Community Health Workers as Support for Sickle Cell Care.

Community health workers are increasingly recognized as useful for improving health care and health outcomes for a variety of chronic conditions. Community health workers can provide social support, navigation of health systems and resources, and lay counseling. Social and cultural alignment of community health workers with the population they serve is an important aspect of community health worker intervention. Although community health worker interventions have been shown to improve patient-centered outcomes in underserved communities, these interventions have not been evaluated with sickle cell disease. Evidence from other disease areas suggests that community health worker intervention also would be effective for these patients. Sickle cell disease is complex, with a range of barriers to multifaceted care needs at the individual, family/friend, clinical organization, and community levels. Care delivery is complicated by disparities in health care: access, delivery, services, and cultural mismatches between providers and families. Current practices inadequately address or provide incomplete control of symptoms, especially pain, resulting in decreased quality of life and high medical expense. The authors propose that care and care outcomes for people with sickle cell disease could be improved through community health worker case management, social support, and health system navigation. This paper outlines implementation strategies in current use to test community health workers for sickle cell disease management in a variety of settings. National medical and advocacy efforts to develop the community health workforce for sickle cell disease management may enhance the progress and development of "best practices" for this area of community-based care.

The economic burden of exposure to secondhand smoke for child and adult never smokers residing in U.S. public housing.

OBJECTIVE: The World Health Organization (WHO) reports that nonsmokers experience disease and death due to secondhand smoke (SHS) exposure in the home. We estimated the total excess burden and costs to society due to SHS exposure in U.S. public housing. METHODS: We quantified the public health burden for outcomes causally related to SHS exposure for nationally representative never-smoking residents in U.S. public housing using (1) WHO-recommended health outcomes and methodology, (2) publicly available and other large databases, and (3) published estimates of morbidity and mortality rates. We used published estimates of direct medical and nonmedical care costs and the value of productivity losses to estimate SHS-related societal costs for disease and death. We estimated the public health and economic burden for two serum cotinine limits of detection (LODs): 0.05 nanograms per milliliter (ng/mL) and 0.015 ng/mL. RESULTS: In 2011, an estimated 37,791 never-smoking child and adult U.S. public housing residents experienced illness and death due to SHS exposure at home based on an LOD=0.05 ng/mL (50,967 residents at LOD=0.015 ng/mL). Costs incurred by society for these illnesses and deaths totaled $183 million (LOD=0.05 ng/mL) and $267 million (LOD=0.015 ng/mL) annually. Of the total costs, direct costs (medical and nonmedical) accounted for $128 million and $176 million for LOD=0.05 ng/mL and LOD=0.015 ng/mL, respectively. Medical care accounted for the majority of direct costs-$110 million at LOD=0.05 ng/mL and $153 million at LOD=0.015 ng/mL. Adverse respiratory health outcomes accounted for approximately one-half (56% at LOD=0.05 ng/mL and 52% at LOD=0.015 ng/mL) of total societal costs. CONCLUSION: Implementing smoke-free policies in all U.S. public housing could save lives and decrease SHS-related morbidity and mortality in never-smoking residents, resulting in annual societal savings of $183 million at LOD=0.05 ng/mL and $267 million at LOD=0.015 ng/mL.