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1.
J Public Health Manag Pract ; 28(5): 478-485, 2022.
Article in English | MEDLINE | ID: covidwho-2029155

ABSTRACT

CONTEXT: It is well established that rural communities face geographic and socioeconomic challenges linked to higher rates of health disparities across the United States, though the coronavirus disease 2019 (COVID-19) impact on rural communities is less certain. OBJECTIVE: To understand the COVID-19 pandemic's impact on rural communities in Tennessee, investigate differences in rural-urban mortality rates after controlling for confounding variables, and inform state pandemic response policy. DESIGN: A cross-sectional analysis of cumulative COVID-19 morality rates. SETTING/PARTICIPANTS: Tennessee county-level COVID-19 mortality data from March 1, 2020, to January 31, 2021, were matched with county-level sociodemographic and health data from public datasets: Agency for Healthcare Research and Quality Social Determinants of Health, PLACES: Local Data for Better Health County Data, and the US Census Bureau. County status was defined using the 2013 National Center for Health Statistics Urban-Rural Classification. MAIN OUTCOME MEASURES: A negative binomial regression model estimated adjusted incidence rate ratio and 95% confidence intervals (CI) for rural compared with urban mortality. Unadjusted rate ratios and rate differences for COVID-19 mortality in rural versus urban counties were compared with those for influenza and pneumonia and all-cause mortality over the past 5 years. RESULTS: During the study period, 9650 COVID-19 deaths occurred across 42 urban and 53 rural counties. Controlling for county-level sociodemographic characteristics, health care access, and comorbidities, incidence rate ratio was 1.13 (95% CI, 1.00-1.28, P < .05) for rural as compared with urban deaths. Unadjusted COVID-19 mortality risk difference between rural and urban counties was greater (61.85, 95% CI, 54.31-69.31) than 5-year influenza and pneumonia rural-urban risk difference (12.57, 95% CI, 11.16-13.00) during 2015-2019. CONCLUSIONS: COVID-19 mortality rates were greater for populations living in Tennessee's rural as compared with urban counties during the study period. This differential impact must be considered in public health decision making to mitigate COVID-19.


Subject(s)
COVID-19 , Influenza, Human , COVID-19/epidemiology , Cross-Sectional Studies , Health Policy , Health Status Disparities , Humans , Pandemics , Rural Population , United States/epidemiology , Urban Population
2.
Prof Case Manag ; 27(5): 223-228, 2022.
Article in English | MEDLINE | ID: covidwho-2029149

ABSTRACT

PURPOSE/OBJECTIVES: In June 2019, a Case Management Society of America (CMSA) task force published "The Practice of Hospital Case Management: A White Paper." This was an important first step to outline the value of hospital case managers (HCMs) and to put forward recommendations for how to operationalize a major change in most hospitals for how case managers can practice.The SARS-CoV2 (COVID-19) pandemic drastically changed the practice of all interdisciplinary work within hospitals. The White Paper recommended that HCMs follow a select patient population through the hospital. Hospital case manager leaders realized that HCMs can work remotely and communicate with patients because meeting them in person was not an option. Hospital case managers are still resistant to leaving the hospital unit-based model, even after they experienced the value of this concept during the height of the pandemic. PRIMARY PRACTICE SETTING: Acute care hospitals. FINDINGS/CONCLUSIONS: The White Paper recommended separating HCMs from utilization management. One unintended consequence is the loss of necessary knowledge and competencies. These are related to compliance with the Centers for Medicare & Medicaid Services Conditions of Participation and regulatory mandates that can affect patient care and financial well-being. Hospital case manager leaders must stay current with these government requirements for hospitals and for all levels of care and keep the case managers informed, proficient, and fluent when coordinating the care of patients. IMPLICATIONS FOR CASE MANAGEMENT PRACTICE: Hospital case manager practice is evolving; change is the single constant in health care. This review of the CMSA Hospital Case Management Whitepaper demonstrates that in just three short years, the landscape of health care can change dramatically.Today's HCM leader must proactively address a multigenerational workforce, lack of title protection, and the COVID-19-induced "Great Resignation." The value of the HCM has never been more apparent as during the pandemic as the need to "empty beds" is critical, and the HCM is the professional who has the skill to provide efficient and patient-centered care coordination. The HCM leader practices positive leadership techniques that benefit the leader, the HCM, and most importantly the patient.


Subject(s)
COVID-19 , Aged , Case Management , Hospitals , Humans , Medicare , RNA, Viral , SARS-CoV-2 , United States
3.
J Med Internet Res ; 24(8): e39094, 2022 08 01.
Article in English | MEDLINE | ID: covidwho-2022409

ABSTRACT

BACKGROUND: Efficacious mental health interventions for sexual and gender minority youth have had limited reach, given their delivery as time-intensive, in-person sessions. Internet-based interventions may facilitate reach to sexual and gender minority youth; however, there is little research examining their efficacy. OBJECTIVE: This study aims to describe the results of a pilot randomized controlled trial of imi, a web application designed to improve mental health by supporting lesbian, gay, bisexual, transgender, queer, and other sexual and gender minority identity affirmation, coping self-efficacy, and coping skill practice. METHODS: Sexual and gender minority youth (N=270) aged 13 to 19 (mean 16.5, SD 1.5) years and living in the United States were recruited through Instagram advertisements. Approximately 78% (210/270) of the sample identified as racial or ethnic minorities. Participants were randomized in a 1:1 fashion to the full imi intervention web application (treatment; 135/270, 50%) or a resource page-only version of the imi site (control; 135/270, 50%). The imi application covered four topical areas: gender identity; lesbian, gay, bisexual, transgender, queer, and other sexual and gender minority identity; stress and coping; and internalized homophobia and transphobia. Participants explored these areas by engaging with informational resources, exercises, and peer stories at a self-guided pace. Both arms were assessed via web-based surveys at baseline and 4-week follow-up for intervention satisfaction, stress appraisals (ie, challenge, threat, and resource), coping skills (ie, instrumental support, positive reframing, and planning), and mental health symptoms among other outcomes. Main intent-to-treat analyses compared the arms at week 4, controlling for baseline values on each outcome. RESULTS: Survey retention was 90.4% (244/270) at week 4. Participants in the treatment arm reported greater satisfaction with the intervention than participants in the control arm (t241=-2.98; P=.003). The treatment arm showed significantly greater improvement in challenge appraisals (ie, belief in one's coping abilities) than the control (Cohen d=0.26; P=.008). There were no differences between the arms for threat (d=0.10; P=.37) or resource (d=0.15; P=.14) appraisals. The treatment arm showed greater increases in coping skills than the control arm (instrumental support: d=0.24, P=.005; positive reframing: d=0.27, P=.02; planning: d=0.26, P=.02). Mental health symptoms improved across both the treatment and control arms; however, there were no differences between arms. Within the treatment arm, higher engagement with imi (≥5 sessions, >10 minutes, or >10 pages) predicted greater improvement in stress appraisals (all P values <.05). CONCLUSIONS: The results provide initial evidence that asynchronous psychosocial interventions delivered via a web application to sexual and gender minority youth can support their ability to cope with minority stress. Further research is needed to examine the long-term effects of the imi application. TRIAL REGISTRATION: ClinicalTrials.gov NCT05061966; https://clinicaltrials.gov/ct2/show/NCT05061966.


Subject(s)
Gender Identity , Sexual and Gender Minorities , Adaptation, Psychological , Adolescent , Female , Humans , Male , Pilot Projects , Sexual Behavior/psychology , United States
4.
JMIR Public Health Surveill ; 8(8): e37039, 2022 Aug 09.
Article in English | MEDLINE | ID: covidwho-2022361

ABSTRACT

BACKGROUND: Obesity is a global epidemic causing at least 2.8 million deaths per year. This complex disease is associated with significant socioeconomic burden, reduced work productivity, unemployment, and other social determinants of health (SDOH) disparities. OBJECTIVE: The objective of this study was to investigate the effects of SDOH on obesity prevalence among adults in Shelby County, Tennessee, the United States, using a geospatial machine learning approach. METHODS: Obesity prevalence was obtained from the publicly available 500 Cities database of Centers for Disease Control and Prevention, and SDOH indicators were extracted from the US census and the US Department of Agriculture. We examined the geographic distributions of obesity prevalence patterns, using Getis-Ord Gi* statistics and calibrated multiple models to study the association between SDOH and adult obesity. Unsupervised machine learning was used to conduct grouping analysis to investigate the distribution of obesity prevalence and associated SDOH indicators. RESULTS: Results depicted a high percentage of neighborhoods experiencing high adult obesity prevalence within Shelby County. In the census tract, the median household income, as well as the percentage of individuals who were Black, home renters, living below the poverty level, 55 years or older, unmarried, and uninsured, had a significant association with adult obesity prevalence. The grouping analysis revealed disparities in obesity prevalence among disadvantaged neighborhoods. CONCLUSIONS: More research is needed to examine links between geographical location, SDOH, and chronic diseases. The findings of this study, which depict a significantly higher prevalence of obesity within disadvantaged neighborhoods, and other geospatial information can be leveraged to offer valuable insights, informing health decision-making and interventions that mitigate risk factors of increasing obesity prevalence.


Subject(s)
Obesity , Residence Characteristics , Adult , Humans , Machine Learning , Obesity/epidemiology , Socioeconomic Factors , Tennessee/epidemiology , United States
5.
Am J Public Health ; 112(9): 1253-1256, 2022 Sep.
Article in English | MEDLINE | ID: covidwho-2022191

ABSTRACT

Tailored public health messaging encouraging COVID-19 vaccination may help increase vaccination rates and decrease the burden of COVID-19. We conducted a three-part COVID-19 vaccine uptake public health campaign disseminated on Facebook between April and June 2021. Our first campaign focused on reaching Black and Latinx communities; our second campaign focused on addressing vaccine access and scheduling in Latinx communities; and our third campaign focused on religious communities. Overall, we reached 25 million individuals with 171 million views across the United States. (Am J Public Health. 2022;112(9):1253-1256. https://doi.org/10.2105/AJPH.2022.306934).


Subject(s)
COVID-19 , Social Media , COVID-19/epidemiology , COVID-19/prevention & control , COVID-19 Vaccines , Health Promotion , Humans , Public Health , United States/epidemiology , Vaccination
6.
PLoS One ; 17(6): e0269442, 2022.
Article in English | MEDLINE | ID: covidwho-2021785

ABSTRACT

Using polynomial distributed lag (PDL) models, the impacts of macroeconomic factors relating to economic, financial, and sociological stress and designed to be short-run predictors of U.S. economic performance are identified and assessed concerning participation in key food assistance programs (SNAP, WIC, and NSLP). The econometric analysis covers the period October 1999 to September 2020. The impact of COVID-19 on participation in these programs also is quantified. Based on the parameter estimates obtained from the econometric PDL models, ex-ante forecasts of participation in the SNAP, WIC, and NSLP subsequently are made and evaluated over the period October 2020 to August 2021. The empirical results show that different sets of macroeconomic drivers affect participation levels across the respective food assistance programs. No macroeconomic factor is common across SNAP, WIC, and NSLP participation. Changes in macroeconomic conditions which influence SNAP, WIC and NSLP participation are not just contemporaneous but also affect participation levels anywhere from 1 month to 12 months later. Importantly, this research allows not only the determination of the macroeconomic factors which affect program participation but also allows the determination of the ability of the respective models to forecast program participation. As such, the Food and Nutrition Service will be in better position to assess program needs as well as to forecast program participation levels to minimize errors in the budgetary process.


Subject(s)
COVID-19 , Food Assistance , COVID-19/epidemiology , Humans , Nutritional Status , United States
7.
Anesth Analg ; 135(2S Suppl 1): S62-S67, 2022 08 01.
Article in English | MEDLINE | ID: covidwho-2021406

ABSTRACT

The founding of Anesthesia & Analgesia (A&A) in 1922 was roughly contemporaneous with the creation of the first intensive care unit (ICU) in the United States at Johns Hopkins in 1923. Throughout the next 100 years, the pages of A&A have mirrored the development of critical care as its own distinct specialty. Although primarily a journal focused on intraoperative anesthesia, A&A has maintained a small but steady presence in critical care research. This review highlights the history and development of critical care publications in the pages of A&A from early observations on the physiology of critical illness (1922-1949) to the groundbreaking work of Peter Safar and others on cardiopulmonary resuscitation (1950-1970), the growth of modern critical care (1970-2010), and the 2020 to 2022 coronavirus disease 2019 (COVID-19) era.


Subject(s)
Analgesia , Anesthesia , COVID-19 , Anesthesia/adverse effects , Critical Care , Humans , Intensive Care Units , United States
8.
Am J Med Qual ; 37(1): 22-31, 2022.
Article in English | MEDLINE | ID: covidwho-2018177

ABSTRACT

Recently published national data demonstrate inadequate and worsening control of high blood pressure (HBP) in the United States, outcomes that likely have been made even worse by the coronavirus disease 2019 (COVID-19) pandemic. This major public health crisis exposes shortcomings of the US health care delivery system and creates an urgent opportunity to reduce mortality, major cardiovascular events, and costs for 115 million Americans. Ending this crisis will require a more coherent and systemic change to traditional patterns of care. The authors present an evidence-based Blueprint for Change for comprehensive health delivery system redesign based on current national clinical practice guidelines and quality measures. This innovative model includes a systems-based approach to ensuring proper BP measurement, assessment of cardiovascular risk, effective patient-centered team-based care, addressing social determinants of health, and shared decision-making. The authors also propose building on current national quality improvement initiatives designed to better control HBP.


Subject(s)
COVID-19 , Hypertension , Humans , Hypertension/prevention & control , Pandemics , Patient-Centered Care , SARS-CoV-2 , United States
10.
J Am Med Dir Assoc ; 23(8): 1418-1423.e7, 2022 Aug.
Article in English | MEDLINE | ID: covidwho-2015550

ABSTRACT

OBJECTIVES: Quantify the relationship between increasing influenza and respiratory syncytial virus (RSV) community viral activity and cardiorespiratory rehospitalizations among older adults discharged to skilled nursing facilities (SNFs). DESIGN: Retrospective cohort. SETTING AND PARTICIPANTS: Adults aged ≥65 years who were hospitalized and then discharged to a US SNF between 2012 and 2015. METHODS: We linked Medicare Provider Analysis and Review claims to Minimum Data Set version 3.0 assessments, PRISM Climate Group data, and the Centers for Disease Control and Prevention viral testing data. All data were aggregated to US Department of Health and Human Services regions. Negative binomial regression models quantified the relationship between increasing viral activity for RSV and 3 influenza strains (H1N1pdm09, H3N2, and B) and cardiorespiratory rehospitalizations from SNFs. Incidence rate ratios described the relationship between a 5% increase in circulating virus and the rates of rehospitalization for cardiorespiratory outcomes. Analyses were repeated using the same model, but influenza and RSV were considered "in season" or "out of season" based on a 10% positive testing threshold. RESULTS: Cardiorespiratory rehospitalization rates increased by approximately 1% for every 5% increase in circulating influenza A(H3N2), influenza B, and RSV, but decreased by 1% for every 5% increase in circulating influenza A(H1N1pdm09). When respiratory viruses were in season (vs out of season), cardiorespiratory rehospitalization rates increased by approximately 6% for influenza A(H3N2), 3% for influenza B, and 5% for RSV, but decreased by 6% for influenza A(H1N1pdm09). CONCLUSIONS AND IMPLICATIONS: The respiratory season is a particularly important period to implement interventions that reduce cardiorespiratory hospitalizations among SNF residents. Decreasing viral transmission in SNFs through practices such as influenza vaccination for residents and staff, use of personal protective equipment, improved environmental cleaning measures, screening and testing of residents and staff, surveillance of viral activity, and quarantining infected individuals may be potential strategies to limit viral infections and associated cardiorespiratory rehospitalizations.


Subject(s)
Influenza, Human , Aged , Hospitalization , Humans , Influenza A Virus, H3N2 Subtype , Influenza, Human/epidemiology , Influenza, Human/prevention & control , Medicare , Retrospective Studies , Subacute Care , United States/epidemiology
11.
J Am Board Fam Med ; 34(6): 1265-1266, 2021.
Article in English | MEDLINE | ID: covidwho-1565129
12.
Med Care ; 60(9): 680-690, 2022 Sep 01.
Article in English | MEDLINE | ID: covidwho-2008676

ABSTRACT

BACKGROUND: In the US, Medicaid covers over 80 million Americans. Comparing access, quality, and costs across Medicaid programs can provide policymakers with much-needed information. As each Medicaid agency collects its member data, multiple barriers prevent sharing Medicaid data between states. To address this gap, the Medicaid Outcomes Distributed Research Network (MODRN) developed a research network of states to conduct rapid multi-state analyses without sharing individual-level data across states. OBJECTIVE: To describe goals, design, implementation, and evolution of MODRN to inform other research networks. METHODS: MODRN implemented a distributed research network using a common data model, with each state analyzing its own data; developed standardized measure specifications and statistical software code to conduct analyses; and disseminated findings to state and federal Medicaid policymakers. Based on feedback on Medicaid agency priorities, MODRN first sought to inform Medicaid policy to improve opioid use disorder treatment, particularly medication treatment. RESULTS: Since its 2017 inception, MODRN created 21 opioid use disorder quality measures in 13 states. MODRN modified its common data model over time to include additional elements. Initial barriers included harmonizing utilization data from Medicaid billing codes across states and adapting statistical methods to combine state-level results. The network demonstrated its utility and addressed barriers to conducting multi-state analyses of Medicaid administrative data. CONCLUSIONS: MODRN created a new, scalable, successful model for conducting policy research while complying with federal and state regulations to protect beneficiary health information. Platforms like MODRN may prove useful for emerging health challenges to facilitate evidence-based policymaking in Medicaid programs.


Subject(s)
Medicaid , Opioid-Related Disorders , Costs and Cost Analysis , Humans , United States
13.
Medicine (Baltimore) ; 101(31): e29931, 2022 Aug 05.
Article in English | MEDLINE | ID: covidwho-2008660

ABSTRACT

BACKGROUND: The diagnosis and treatment rate of Parkinson disease (PD) with depression has a low diagnostic rate, and there is no consensus on the choice of treatment mode. This study evaluates the global research trends of scientific outputs related to depression in PD from multiple perspectives, using a bibliometric analysis and visualization tool to scientifically analyze the knowledge from the literature. METHODS: Literature related to depression in PD published from 2012 to 2021 was included and selected from the Web of Science Core Collection database in October 2021. CiteSpace software was used to visualize and analyze co-occurrence analyses for countries, institutions, authors, and keywords. RESULTS: A total of 4533 articles from the Web of Science database were included. The United States made the largest contribution with the majority of publications (1215; 29.40%). Toronto University was the most productive institution. PD, depression, quality of life, dementia, nonmotor symptom, prevalence, anxiety, Alzheimer disease, symptom, and disorder would be significantly correlated with depression in PD. The current hot spots in this field focus on the following: risk factors for depression in PD, assessment scale of depression in PD, and rehabilitation of depression in PD. CONCLUSIONS: This analysis not only reveals the current research trends and hotspots but also provides some instructive suggestions on the development of depression in PD.


Subject(s)
Parkinson Disease , Bibliometrics , Depression/epidemiology , Depression/etiology , Humans , Parkinson Disease/complications , Parkinson Disease/epidemiology , Parkinson Disease/therapy , Publications , Quality of Life , United States
14.
Obstet Gynecol ; 140(2): 143-145, 2022 Aug 01.
Article in English | MEDLINE | ID: covidwho-2008647
15.
Int J Environ Res Public Health ; 19(15)2022 Jul 25.
Article in English | MEDLINE | ID: covidwho-2005993

ABSTRACT

This paper aims to summarize the publishing trends, current status, research topics, and frontier evolution trends of health technology between 1990 and 2020 through various bibliometric analysis methods. In total, 6663 articles retrieved from the Web of Science core database were analyzed by Vosviewer and CiteSpace software. This paper found that: (1) The number of publications in the field of health technology increased exponentially; (2) there is no stable core group of authors in this research field, and the influence of the publishing institutions and journals in China is insufficient compared with those in Europe and the United States; (3) there are 21 core research topics in the field of health technology research, and these research topics can be divided into four classes: hot spots, potential hot spots, margin topics, and mature topics. C21 (COVID-19 prevention) and C10 (digital health technology) are currently two emerging research topics. (4) The number of research frontiers has increased in the past five years (2016-2020), and the research directions have become more diverse; rehabilitation, pregnancy, e-health, m-health, machine learning, and patient engagement are the six latest research frontiers.


Subject(s)
COVID-19 , Publications , Bibliometrics , Biomedical Technology , COVID-19/epidemiology , Humans , Imidazoles , Sulfonamides , Thiophenes , United States
16.
Nicotine Tob Res ; 24(8): 1273-1280, 2022 07 13.
Article in English | MEDLINE | ID: covidwho-2004997

ABSTRACT

PURPOSE: Heated tobacco products (HTP) heat-processed tobacco leaf into an aerosol inhaled by the user. This study assessed prevalence and correlates of HTP awareness, ever use, and current use among US middle and high school students. METHODS: Data came from the 2019 and 2020 National Youth Tobacco Survey, a cross-sectional survey of US public and private, middle and high school students. HTP awareness, ever use, and current (past 30-day) use were assessed. Weighted prevalence estimates and adjusted prevalence ratios (aPR) were assessed overall and by sex, school level, race/ethnicity, and current other tobacco product use. RESULTS: In 2019, 12.8% (3.44 million) of all students reported HTP awareness, increasing to 19.3% (5.29 million) in 2020 (p < .01). Ever [2019: 2.6% (630 000); 2020: 2.4% (620 000)] and current [2019: 1.6% (420 000); 2020: 1.4% (370 000)] HTP use did not significantly change from 2019 to 2020. Current e-cigarette users were more likely to report ever (2020 aPR = 1.79, 95% CI:1.23, 2.62) or current HTP use (2019 aPR = 5.16, 95% CI: 3.48, 7.67; 2020 aPR = 3.39, 95% CI: 2.10, 5.47) than nonusers. In both years, ever and current HTP use was more likely among current combustible (aPR range = 3.59-8.17) and smokeless tobacco product (aPR range = 2.99-4.09) users than nonusers. CONCLUSIONS: HTP awareness increased 51% among US students during 2019-2020; however, HTP use did not significantly change during this period. Students who used other tobacco products were more likely to currently use HTPs. Estimates of HTP awareness and use provided serve as a baseline as future monitoring of these products is warranted. IMPLICATIONS: Awareness of heated tobacco products (HTPs) increased among US youth from 2019 to 2020; however, HTP use did not change. These estimates of HTP awareness and use serve as a baseline for future surveillance of these products as their availability in the US increases.


Subject(s)
Electronic Nicotine Delivery Systems , Tobacco Products , Adolescent , Cross-Sectional Studies , Humans , Prevalence , Students , Tobacco Use , United States/epidemiology
17.
Arch Phys Med Rehabil ; 103(7): 1379-1386, 2022 07.
Article in English | MEDLINE | ID: covidwho-2003864

ABSTRACT

OBJECTIVE: The current study examined health care disruptions and use of telehealth services among people with multiple sclerosis (pwMS) during the COVID-19 pandemic. DESIGN: Cross-sectional survey. SETTING: General community. PARTICIPANTS: Participants (N=163) included 70 pwMS and 93 healthy controls (HCs). The majority of respondents were from the United States (88%). INTERVENTIONS: Not applicable. MAIN OUTCOME MEASURES: Rates of health care disruptions (eg, missing/canceling appointments, experiencing delays) and telehealth use for MS and non-MS medical care and mental health care. RESULTS: In this U.S. majority, predominantly White, and high socioeconomic status sample, 38% to 50% of pwMS reported experiencing disruptions in their MS and non-MS medical care and 20% to 33% reported disruptions in their mental health care; this was significantly lower than the rates observed among HCs. Compared with HCs, pwMS were more likely to use telehealth than in-person services, especially for mental health care. The majority of pwMS and HCs reported being satisfied with telehealth services. Individuals with higher degrees of functional limitation experienced more health care disruptions and were more likely to use telehealth services than individuals with lower degrees of functional limitation. CONCLUSIONS: Despite high health care disruption rates, pwMS frequently used and were highly satisfied with telehealth services during the COVID-19 pandemic. Due to physical limitations commonly observed in the MS population that may preclude travel, telehealth services should be continued even after resolution of the pandemic to expand access and reduce health care disparities.


Subject(s)
COVID-19 , Multiple Sclerosis , Telemedicine , COVID-19/epidemiology , Cross-Sectional Studies , Healthcare Disparities , Humans , Pandemics , United States
18.
Ther Innov Regul Sci ; 56(5): 698-703, 2022 Sep.
Article in English | MEDLINE | ID: covidwho-2003772

ABSTRACT

The accelerated approval pathway has been criticized recently for employing lower regulatory standards than traditional drug approval, undue delays in withdrawing approvals of drugs for which studies have not confirmed clinical benefit, and confirmatory trials not being pursued with due diligence. This article examines the status of confirmatory studies of drugs approved under the US Food and Drug Administration's (FDA's) accelerated approval program between December 1992 and December 2021. It includes background on the program and provides broader context about the program's performance to date over its 30-year history. Our analysis demonstrates that the accelerated approval program has been largely successful, with half of accelerated approvals converted to traditional approval in a median time of 3.2 years. Furthermore, recent FDA actions show that the agency is appropriately managing the program when a drug approved under accelerated approval fails to confirm a clinical benefit. Any proposed changes to the program should be based on cumulative experience with the program, rather than outliers.


Subject(s)
Drug Approval , Pharmaceutical Preparations , United States , United States Food and Drug Administration
19.
Western Pac Surveill Response J ; 13(2): 1-3, 2022.
Article in English | MEDLINE | ID: covidwho-2002629

ABSTRACT

Objective: This paper presents a rapid assessment of coronavirus disease 2019 (COVID-19) pandemic plans and explores the representation of culturally and linguistically diverse (CALD) communities in such plans. Four levels of pandemic plans were reviewed: regional, state, national and international. Methods: Discussions with representatives from four CALD communities informed the development of search and selection criteria for the COVID-19 plans, which were gathered and assessed using a CALD lens. Six COVID-19 pandemic plans that met the inclusion criteria were critically assessed. Results: The reviewed plans did not report any CALD community voices, views or consultations with community groups in the development phase, nor did they acknowledge the diversity of CALD populations. A few plans noted the vulnerability of CALD communities, but none discussed the challenges CALD communities face in accessing health information or health services during the pandemic, or other structural barriers (social determinants of health). Discussion: Our analysis revealed major gaps in all pandemic plans in terms of engaging with immigrant or CALD communities. Policies and plans that address and consider the complex needs and challenges of CALD communities are essential. Collaboration between public health services, multicultural services and policy-makers is vital for the inclusion of this higher-risk population.


Subject(s)
COVID-19 , COVID-19/epidemiology , Cultural Diversity , Humans , Pandemics , Policy , United States
20.
Am J Public Health ; 112(S5): S545-S554, 2022 06.
Article in English | MEDLINE | ID: covidwho-2002386

ABSTRACT

Objectives. To investigate trends in the use and quality of telehealth for contraceptive care during the COVID-19 pandemic in the United States. Methods. The 2021 Guttmacher Survey of Reproductive Health Experiences is a national online survey of 6211 people assigned female at birth, aged 18 to 49 years, and that ever had penile‒vaginal sex. We used weighted bivariable and multivariable logistic regressions to analyze the use of telehealth for contraceptive care and the quality of this care. Results. Of the respondents, 34% received a contraceptive service in the 6 months before the survey; of this group, 17% utilized telehealth. Respondents who were uninsured at some point in the 6 months before the survey had greater odds of using telehealth for this care. Respondents had lower odds of rating the person-centeredness of their care as "excellent" if they received services via telehealth compared with in person (25% vs 39%). Conclusions. Telehealth has helped bridge gaps in contraceptive care deepened by COVID-19. More work is needed to improve the quality of care and reduce access barriers to ensure telehealth can meet its full potential as part of a spectrum of care options. (Am J Public Health. 2022;112(S5):S545-S554. https://doi.org/10.2105/AJPH.2022.306886).


Subject(s)
COVID-19 , Telemedicine , COVID-19/epidemiology , Contraceptive Agents , Female , Humans , Infant, Newborn , Pandemics , Surveys and Questionnaires , United States/epidemiology
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