Browsing by Subject "policy"
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Item Open Access A Decade On: Systematic Review of ClinicalTrials.gov Infectious Disease Trials, 2007-2017.(Open forum infectious diseases, 2019-06) Jaffe, Ian S; Chiswell, Karen; Tsalik, Ephraim LBackground:Registration of interventional trials of Food and Drug Administration-regulated drug and biological products and devices became a legal requirement in 2007; the vast majority of these trials are registered in ClinicalTrials.gov. An analysis of ClinicalTrials.gov offers an opportunity to define the clinical research landscape; here we analyze 10 years of infectious disease (ID) clinical trial research. Methods:Beginning with 166 415 interventional trials registered in ClinicalTrials.gov from 2007-2017, ID trials were selected by study conditions and interventions. Relevance to ID was confirmed through manual review, resulting in 13 707 ID trials and 152 708 non-ID trials. Results:ID-related trials represented 6.9%-9.9% of all trials with no significant trend over time. ID trials tended to be more focused on treatment and prevention, with a focus on testing drugs, biologics, and vaccines. ID trials tended to be large, randomized, and nonblinded with a greater degree of international enrollment. Industry was the primary funding source for 45.2% of ID trials. Compared with the global burden of disease, human immunodeficiency virus/AIDS and hepatitis C trials were overrepresented, and lower respiratory tract infection trials were underrepresented. Hepatitis C trials fluctuated, keeping with a wave of new drug development. Influenza vaccine trials peaked during the 2009 H1N1 swine influenza outbreak. Conclusions:This study presents the most comprehensive characterization of ID clinical trials over the past decade. These results help define how clinical research aligns with clinical need. Temporal trends reflect changes in disease epidemiology and the impact of scientific discovery and market forces. Periodic review of ID clinical trials can help identify gaps and serve as a mechanism to realign resources.Item Open Access Annual Trends in Plastics Policy: A Brief(2022-02-23) Karasik, Rachel; Bering, Janet; Griffin, Madison; Diana, Zoie; Laspada, Christian; Schachter, Jonathan; Wang, Yifan; Pickle, Amy; Virdin, JohnIn 2020, the Plastics Policy Inventory and accompanying report, 20 Years of Government Responses to the Global Plastic Pollution Problem, were published, providing a baseline for the trends in government responses to the plastic pollution problem, as well as highlighting some gaps. Since that time, momentum has grown toward negotiation of an international agreement as a collective response to the problem, even as governments and resources have been strained by the ongoing coronavirus pandemic. This first brief builds upon the 2020 report and baseline by adding new data on national policy responses to plastic pollution from 2020 and 2021. Assessment of the more up-to-date policy inventory suggests that the twenty-year trend of an increase in the number of national policies introduced to reduce plastic pollution has stalled. While additional data on national policies may subsequently become available to revise these estimates, if confirmed they would suggest a pause in government responses to the problem, coinciding with the pandemic (though we cannot show causality). Our goal is for this brief to be the first in a regular series of annual updates on the trends in government responses to the global plastic pollution problem.Item Open Access Economic Structure and Performance(1986) Kuran, TimurThis festschrift, featuring 26 papers by 36 authors, is a fitting tribute to Hollis Chenery who, for over three decades, has been one of the luminaries of development economics. Most of the issues he brought into focus, the methodologies he helped develop, and the styl- ized facts he hammered into the consciousness of the profession receive detailed attention. The contributors include numerous influential scholars, many of whom are his distinguished students and colleagues from Harvard, Stan- ford, and the World Bank. Although a few of the papers lack originality, sophistication, or polish, the overall quality of the volume is high...Item Open Access Energetic Opportunities and Chemical Risks in Urban and Forested Stream Ecosystems(2024) Behrens, Jonathan RichardUrban watersheds are dynamic ecological systems shaped by social, chemical, physical, and ecological forces. Urban stressor and disturbance regimes alter the availability and incorporation of energetic resources and chemical risks into stream ecosystems, and their ultimate transport and fate to downstream or paired terrestrial ecosystems. In this dissertation, I investigate how human-driven stressors (land-use, organic and inorganic chemical contaminants, heat, and hydrologic "flashiness") alter the energetic and chemical regimes of each system. Study systems include stream ecosystems that drain urban (Ellerbe Creek) and forested (New Hope Creek) watersheds in the Piedmont of North Carolina. In Chapter 1, I quantified the concentrations of chemical indicators in a novel approach to characterize the timing and spatial distribution of three common mixtures of contaminants (and their chemical indicator) in our urban watershed (Ellerbe Creek): treated and untreated sewage (sucralose, artificial sweetener), lawncare runoff (DPG and 6PPD-Q, automobile tire additives), and road runoff (Glyphosate and AMPA, active ingredient of herbicide RoundUp® and its major degradation product). We demonstrate that the concentrations of these chemical indicators, and by extension the mixtures of contaminants they represent across the heterogenous urban watershed, are highly variable across the landscape, seasons, and discharge regimes. In Chapter 2, I measured rates of ecosystem metabolism (gross primary production and ecosystem respiration), macroinvertebrate secondary production, and aquatic insect emergence to assess the efficiency at which energy moves through two types of urban stream ecosystems (wastewater and stormwater dominated) in Ellerbe Creek and our forested watershed in New Hope Creek. Urban disturbance regimes alter the composition, magnitude, and timing of energy availability. In turn, the efficiency at which energetic inputs were converted into primary production did not readily predict macroinvertebrate secondary production and emergence in our urban sites. This is the first known investigation of primary and secondary production in an urbanized watershed, and it provides compelling evidence that energetic regimes in two common types of urban watersheds (wastewater and stormwater dominated) are notably distinct from one another. Finally, in Chapter 3, emergent insects collected for Chapter 2 were assessed for trace metals to investigate how distinct communities of emergent winged insects altered the timing, magnitude, and composition of metals flux. I demonstrated that the transport of positive (energy) and negative (trace metals) subsidies is driven by distinct communities of organisms, which are simplified and constrained in our wastewater and stormwater dominated sites, rather than total emergent biomass or metals loading alone. Families of aquatic insects were differentially efficient at moving metals (Zn, Cu, Se) out of the stream food web and into the terrestrial food web. The biological community dynamics—composition, diversity of traits, and timing—play an equally if not more important role in the magnitude, timing, and composition of metals flux relative to metals inputs alone. The availability, assimilation, and transformation of energetic and contaminant inputs in-stream will ultimately enable (or suppress) export into paired riparian and terrestrial ecosystems. In human impacted systems, such as urban watersheds, analysis requires methods, models, and concepts in ecosystem and community ecology, urban ecology, environmental chemistry, and biogeochemistry. By further exploring the heterogeneity of urban watersheds, as demonstrated in this dissertation, stakeholders can better manage these ecosystems to support wildlife communities and human societies.
Item Open Access Examining the Crack Epidemic and Subsequent Drug Policy through Identifying Trends in Outpatient Substance Abuse Treatment for Crack Use/Abuse: 1995-2005(Journal of Equity in Health, 2014-02) kim, M; Barrett, NJ; Gilbert, KL; Taylor, Y; Godley, P; Howard, DDisparities in the crack/cocaine discourse have changed drastically since its inception over 30 years ago. Since the late 1980s, research examining this particular abuse has become more complex as both nationally and globally crack use/abuse has been examined within various contexts. Crack use has often been framed as an African American problem in part resulting from the high volume of African Americans seeking treatment for illnesses associated with their crack-cocaine use, and more African Americans dying from crack-cocaine overdose. This logical fallacy persists despite evidence showing African Americans have lower substance use/abuse compared to Caucasians. Given the impact of the crack epidemic as well as its related drug policies on African American communities and their families, further examination of crack use/abuse is necessary. This study will discuss the crack epidemic historically and examine crack use among clients of a large sample of outpatient substance abuse treatment units over a decade period between 1995 and 2005.Item Open Access Medication adherence: process for implementation.(Patient preference and adherence, 2014-01) Mendys, Phil; Zullig, Leah L; Burkholder, Rebecca; Granger, Bradi B; Bosworth, Hayden BImproving medication adherence is a critically important, but often enigmatic objective of patients, providers, and the overall health care system. Increasing medication adherence has the potential to reduce health care costs while improving care quality, patient satisfaction and health outcomes. While there are a number of papers that describe the benefits of medication adherence in terms of cost, safety, outcomes, or quality of life, there are limited reviews that consider how best to seamlessly integrate tools and processes directed at improving medication adherence. We will address processes for implementing medication adherence interventions with the goal of better informing providers and health care systems regarding the safe and effective use of medications.Item Open Access State of the Coast: A Review of Coastal Management Policies for Six States(2023-01-17) Karasik, Rachel; Pickle, Amy; O’Shea, Maggie; Reilly, Kelly; Bruce, Molly; Earnhardt, Rachel; Ahmed, IqraThis analysis of coastal habitat policy in six US states—California, Florida, Massachusetts, North Carolina, Texas, and Washington—aims to identify promising policy approaches for improved protection and restoration of oyster reefs, mangroves, salt marshes, and seagrass. Coastal habitats provide critical environmental, economic, and recreational services valued at billions of dollars in the United States alone. However, the quantity and quality of most coastal habitats have been under decline for centuries due to a variety of threats. Coordinated policy responses across levels of government are required for protection and restoration of coastal habitats because they do not have discrete jurisdictional boundaries and are often harmed by distant anthropogenic activities. The analysis finds that state-level management is principally guided by federal coastal protection and management statutes, namely the Clean Water Act and Coastal Zone Management Act. State and federal policies are rarely habitat-specific and do not comprehensively address threats, which can result in a fragmented policy landscape that struggles to meet habitat protection and restoration goals. With limited long-term monitoring data and few effectiveness studies, our ability to understand which policy levers work and the extent to which they can be replicated in other states is limited. A successful path forward may be found through local initiatives tailored and designed for their local context that have effectively restored degraded habitats and employed innovative regulatory mechanisms intended to streamline the permitting process for restoration. Dedicated funding for sustained, long-term monitoring to best understand the effects and outcomes of habitat protection and restoration policy efforts will also be critical to identify enabling conditions and replicate effective measures in similar contexts. The Pew Charitable Trusts supported the development of this report. Pew is not responsible for any inaccuracies and does not necessarily endorse the findings.Item Open Access The Missed Opportunity of Patient-Centered Medical Homes to Thrive in an Asian Context.(International journal of environmental research and public health, 2021-02-13) Surendran, Shilpa; Foo, Chuan De; Tam, Chen Hee; Ho, Elaine Qiao Ying; Matchar, David Bruce; Car, Josip; Koh, Gerald Choon HuatIn recent years, there is growing interest internationally to implement patient-centered medical homes (PCMHs), and Singapore is no exception. However, studies understanding the influence of contextual policy factors on the implementation of PCMHs are limited. We conducted 10 semi-structured in-depth interviews with general practitioners working in seven out of the nine PCMHs. Audio recordings were transcribed and analyzed by two study team members in NVivo 12 Software using grounded theory techniques. Power dynamics between the stakeholders and lack of shared decision-making among them in selecting the locale of the PCMH and formulating the practice fee and pharmacy structure were the key factors which negatively affected the implementation of PCMHs on a larger scale. Over time, lack of funding to hire dedicated staff to transfer patients and misalignment of various stakeholders' interest to other right-siting programs also resulted in low number of patients with chronic conditions and revenue. Countries seeking to implement a successful PCMH may benefit from building trust and relationship between stakeholders, engaging in shared decision-making, ongoing cost-efficiency efforts, and formulating a clear delineation of responsibilities between stakeholders. For a healthcare delivery model to succeed in the primary care landscape, policies should be developed keeping mind the realities of primary care practice.Item Open Access The new landscape of medication adherence improvement: where population health science meets precision medicine.(Patient preference and adherence, 2018-01) Zullig, Leah L; Blalock, Dan V; Dougherty, Samantha; Henderson, Rochelle; Ha, Carolyn C; Oakes, Megan M; Bosworth, Hayden BDespite the known health and economic benefits of medications, nonadherence remains a significant, yet entirely preventable public health burden. Over decades, there have been numerous research studies evaluating health interventions and policy efforts aimed at improving adherence, yet no universal or consistently high impact solutions have been identified. At present, new challenges and opportunities in policy and the movement toward value-based care should foster an environment that appreciates adherence as a mechanism to improve health outcomes and control costs (eg, fewer hospitalizations, reduced health care utilization). Our objective was to provide a commentary on recent changes in the landscape of research and health policy directed toward improving adherence and an actionable agenda to achieve system level savings and improved health by harnessing the benefits of medications. Specifically, we address the complementary perspectives of precision medicine and population health management; integrating data sources to develop innovative measurement of adherence and target adherence interventions; and behavioral economics to determine appropriate incentives.