1,421 results match your criteria: "Philip R Lee Institute for Health Policy Studies[Affiliation]"

Modernizing Medical Device Regulation: Challenges and Opportunities for the 510(k) Clearance Process.

Ann Intern Med

November 2024

Center for Outcomes Research and Evaluation, Yale New Haven Hospital, Section of Cardiovascular Medicine, Department of Internal Medicine, Yale School of Medicine, and Department of Health Policy and Management, Yale School of Public Health, New Haven, Connecticut (H.M.K.).

Article Synopsis
  • Nearly all medical devices in the U.S. are authorized through the FDA's 510(k) clearance process, which compares new devices to existing ones without requiring extensive safety evidence.
  • Supporters argue this process fosters innovation and quick access to market, while critics raise concerns about patient safety.
  • In September 2023, the FDA released guidance documents aimed at reforming this process, focusing on improving predicate selection, clinical testing standards, and regulations for implantable devices to enhance transparency and safety.
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Wildfire smoke exposure leads to poorer health among those with pre-existing conditions such as asthma. Particulate matter in wildfire smoke can worsen asthma control, cause acute exacerbations, and increase health resource utilization (HRU) and costs. Research to date has been retrospective with few opportunities to project changes in underlying asthma control and HRU given exposure to wildfire smoke.

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Recreational cannabis outlets may influence rates of interpersonal violence, but research has yielded inconsistent findings. Modification by alcohol outlet density may help explain inconsistencies. We estimated the impacts of recreational cannabis outlets on neighborhood-level assault injury rates in California and evaluated whether alcohol outlet density moderated these associations.

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Adaptations to family-based treatment for Medicaid-insured adolescents with anorexia nervosa.

Front Psychol

September 2024

Department of Psychiatry and Behavioral Sciences, Philip R. Lee Institute for Health Policy Studies, University of California, San Francisco, San Francisco, San Francisco, CA, United States.

Article Synopsis
  • Family-based treatment (FBT) is the primary method for addressing anorexia nervosa in adolescents, but lacks research on its use in low-income and racially diverse groups.
  • Interviews with ten FBT clinicians highlighted various challenges and adaptations related to implementing FBT in publicly-funded environments.
  • Key themes such as cultural considerations, socioeconomic factors, and logistical challenges provide valuable insights for refining FBT to better serve diverse populations facing systemic barriers.
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Background: Education is strongly associated with cognitive outcomes at older ages, yet the extent to which these associations reflect causal effects remains uncertain due to potential confounding.

Methods: Leveraging changes in historical measures of state-level education policies as natural experiments, we estimated the effects of educational attainment on cognitive performance over 10 years in 20,248 non-Hispanic Black and non-Hispanic White participants, aged 45+ in the Reasons for Geographic and Racial Disparities in Stroke cohort (2003-2020) by (1) using state- and year-specific compulsory schooling laws, school-term length, attendance rate, and student-teacher ratio policies to predict educational attainment for US Census microsample data from 1980 and 1990, and (2) applying policy-predicted years of education (PPYEd) to predict memory, verbal fluency, and a cognitive composite. We estimated overall and race- and sex-specific effects of PPYEd on level and change in each cognitive outcome using random intercept and slope models, adjusting for age, year of first cognitive assessment, and indicators for state of residence at age 6.

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Objectives: The COVID-19 pandemic and subsequent policy response to mitigate disease spread had far-reaching impacts on health and social well-being. In response, the Supplemental Nutrition Assistance Program (SNAP) underwent several pandemic-era modifications, including a 15 % monthly benefit increase on January 1, 2021. Research documenting the health effects of these SNAP modifications among low-income households and minoritized groups who were most impacted by the economic fallout during the first years of the pandemic is lacking.

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Introduction: Interhospital transfer is an important mechanism for improving access to specialized neurologic care but there are large gaps in our understanding of interhospital transfer for the management of non-stroke-related neurologic disease.

Methods: This observational study included consecutive patients admitted to an adult academic general neurology service via interhospital transfer from July 1, 2015 to July 1, 2017. Characteristics of the referring hospital and transferred patients were obtained through the American Hospital Association Directory, a hospital transfer database maintained by the accepting hospital, and the electronic medical record.

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Background: Approximately 1 in 6 cannabis users develop a cannabis use disorder (CUD) and the odds increase to 1 in 2 for daily users.

Objective: The Dual use of Cannabis and Tobacco Monitoreing through a Gamified Web app (DuCATA_GAM-CaT) project aims to identify cannabis-tobacco patterns of use and withdrawal symptoms among individuals with CUD who are attending substance abuse programs.

Methods: The project uses a mixed methods approach consisting of 3 studies.

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If We Measure, We Can Improve.

J Am Coll Cardiol

September 2024

Cardiology Section, Medical Service, San Francisco Veterans Affairs Health Care System, San Francisco, California, USA; Department of Medicine, University of California, San Francisco School of Medicine, San Francisco, California, USA; Philip R. Lee Institute for Health Policy Studies, University of California, San Francisco, California, USA. Electronic address:

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Article Synopsis
  • * Some patients leave hospice care before death, a situation known as live discharge, which can be difficult for patients, caregivers, and healthcare providers.
  • * The paper addresses the challenges of live discharge and offers practical strategies for clinicians to improve support for patients and families, alongside recommendations for systemic change in hospice practices.
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Background: Cataract surgery is one of the most common surgical procedures performed in older adults in the United States and is generally considered to be extremely low-risk. As of 2019, routine preoperative evaluation within 30 days of surgery is no longer mandated by the United States of America (USA) Centers for Medicare & Medicaid Services (CMS) for ambulatory surgery centers, but it is unclear how primary care providers perceive this change.

Methods: We performed a qualitative analysis of semi-structured interviews with six primary care providers to explore primary care providers' perspectives on routine preoperative assessment for cataract surgery.

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Background: Cardiovascular devices account for one third of all Class I recalls, the U.S. Food and Drug Administration's (FDA) most severe designation, indicating a reasonable probability of "serious adverse health consequences or death.

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Geographic Access to High-Volume Mechanical Thrombectomy Centers in Florida, 2019.

Neurol Clin Pract

December 2024

UCSF Weill Institute for Neurosciences, Department of Neurology (LS, ELG, ASK), Department of Emergency Medicine (RYH); Philip R. Lee Institute for Health Policy Studies (RYH, ELG), University of California, San Francisco; Naval Postgraduate School (Y-CS), Monterey, CA; National Bureau of Economic Research (Y-CS), Cambridge, MA; and Department of Neurology (JCC), School of Medicine, Jeju National University, Korea.

Background And Objectives: Mechanical thrombectomy (MT) improves outcomes for acute ischemic stroke (AIS) due to large vessel occlusion, but is time sensitive and requires specialized infrastructure. Professional organizations and certification bodies have promulgated minimum procedural volume standards for centers and for individual proceduralists but it is unclear whether enforcing these requirements would decrease geographic access to MT. Therefore, we sought to evaluate the potential impact of applying a minimum procedural volume threshold on geographic access to MT.

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Evaluating the feasibility of prehospital point-of-care EEG: The prehospital implementation of rapid EEG (PHIRE) study.

J Am Coll Emerg Physicians Open

October 2024

Emergency Medical Services, City of Alameda Fire Department Alameda California USA.

Background: Point-of-care electroencephalography (EEG) devices can be rapidly applied and do not require specialized technologists, creating new opportunities to use EEG during prehospital care. We evaluated the feasibility of point-of-care EEG during ambulance transport for 911 calls.

Methods: This mixed-methods study was conducted between May 28, 2022 and October 28, 2023.

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[From evidence to practice: The Disemination and Implementation Science in primary care].

Aten Primaria

January 2025

Unidad de Control del Tabaco, Programa de Prevención y Control del Cáncer, Institut Català d'Oncologia, L'Hospitalet de Llobregat, Barcelona, España; Grupo de Prevención y Control del Cáncer, Institut d'Investigació Biomèdica de Bellvitge-IDIBELL, L'Hospitalet de Llobregat, Barcelona, España; CIBER en Enfermedades Respiratorias (CIBERES), Madrid, España; Departamento de Ciencias Clínicas, Facultad de Medicina, Universitat de Barcelona, L'Hospitalet de Llobregat, Barcelona, España.

Dissemination and Implementation Science focuses on bridging the gap between scientific research and its practical application in the real world. By identifying and promoting effective strategies, the Science of Dissemination and Implementation disseminates and implements evidence-based interventions in healthcare settings, taking into account the needs, barriers, context, resources, and end users. This special article introduces and debates the most recent advances in this field, highlighting key approaches, theoretical frameworks, as well as specific challenges and opportunities applied to primary and community care.

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Importance: The widowhood effect, in which mortality increases and function decreases in the period following spousal death, may be heightened in older adults with functional impairment and serious illnesses, such as cancer, dementia, or organ failure, who are highly reliant on others, particularly spouses, for support. Yet there are limited data on widowhood among people with these conditions.

Objective: To determine the association of widowhood with function and mortality among older adults with dementia, cancer, or organ failure.

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State Biomarker Testing Insurance Coverage Laws-Reply.

JAMA

September 2024

Center for Translational and Policy Research on Precision Medicine (TRANSPERS), University of California, San Francisco.

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Background: The COVID-19 pandemic underscored the challenge of swiftly disseminating research findings to a global audience. Language barriers further exacerbated disparities in access to timely scientific information, particularly for non-English speaking communities. The majority of COVID-19 research was published in English, limiting accessibility for Spanish-speaking populations.

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Interventions to Increase Affordable Care Act Marketplace Enrollment: A Systematic Review and Meta-Analysis.

Popul Health Manag

June 2024

Office of Evaluation Sciences, U.S. General Services Administration, Washington, District of Columbia, USA.

Over 10 million uninsured individuals are eligible for subsidized health insurance coverage through the Affordable Care Act (ACA) marketplaces, and millions more were projected to become eligible with the end of the federal COVID-19 Public Health Emergency in 2023. Individual studies on behaviorally informed interventions designed to encourage enrollment suggest that some are more effective than others. This study summarizes evidence on the efficacy of these interventions and suggests which administrative burdens might be most relevant for potential enrollees.

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Attitudes Towards Dementia Among a Diverse Group of Refugees Resettled in the United States.

J Geriatr Psychiatry Neurol

September 2024

Herbert Wertheim School of Public Health & Human Longevity Science, University of California San Diego, La Jolla, CA, USA.

Background: Forced migration results in exposure to trauma, interrupted access to healthcare, and loss of social support and may increase dementia risk. Literature on refugees' knowledge of dementia and its risk factors is scant. This study investigates refugee perspectives on dementia and their access to cognitive healthcare in the United States (US).

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Individuals within the criminal justice system are at greater risk of substance use-related morbidity and mortality and have substantial healthcare needs. In this quasi-experimental study, we assessed utilization patterns of Massachusetts Medicaid Program (MassHealth) services and associated expenditures among drug court probationers compared to a propensity score-matched sample of traditional court probationers. Risk of reoffending, employment status, age, and living arrangement data were used to calculate propensity scores and match probationers between the two court types, producing a final sample of 271 in each court (N=542).

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Critical feminist research addresses social inequities, encourages equitable partnerships between researchers and participants, and acknowledges that research can be inherently political. Building upon critical feminist research practices, community-based participatory research, and social and structural epidemiology, we propose the approach of critical feminist epidemiology. A critical feminist epidemiology approach can study community and population health inequities with an eye towards identifying interventions that reduce inequities, through research processes that center the lived experiences of people from minoritized genders.

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Designing and optimizing clinical trials for long COVID.

Life Sci

October 2024

Patient-Led Research Collaborative, United States of America; University of California San Francisco, Department of Epidemiology & Biostatistics and Philip R. Lee Institute for Health Policy Studies, 550 16th street, 2nd floor, San Francisco, CA 94158, United States of America.

Long COVID is a debilitating, multisystemic illness following a SARS-CoV-2 infection whose duration may be indefinite. Over four years into the pandemic, little knowledge has been generated from clinical trials. We analyzed the information available on ClinicalTrials.

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