miércoles, 31 de enero de 2024
Medical Devices; Quality System Regulation Amendments
https://www.federalregister.gov/public-inspection/2024-01709/medical-devices-quality-system-regulation-amendments?utm_medium=email&utm_source=govdelivery
FDA Issues Quality Management System Regulation: Final Rule Amending the Quality System Regulation
To ensure medical devices on the market are safe, effective, and of good quality, the U.S. Food and Drug Administration (FDA) issued the Quality Management System Regulation (QMSR) Final Rule.
The QMSR rule emphasizes risk management activities and risk-based decision making and aims to reduce regulatory burdens on device manufacturers and importers by harmonizing domestic and international requirements.
The rule amends the current good manufacturing practice requirements of the Quality System regulation in 21 CFR 820.
“This final rule is the latest action taken by the FDA to promote global harmonization in device regulation to help assure that patients and providers have timely and continued access to safe, effective, and high-quality medical devices both at home and abroad,” said Jeff Shuren, M.D., J.D., director of the FDA's Center for Devices and Radiological Health. “By harmonizing key areas of a medical device manufacturer’s quality management system with the international standard, the FDA is streamlining actions device manufacturers must take to meet requirements by multiple regulatory authorities.”
Device manufacturers and importers will have two years to modify their Quality Systems to meet the requirements of the QMSR rule by February 2, 2026. Until then, manufacturers are required to comply with the existing Quality System regulation.
Integrating Patient-Reported Outcomes into Practice: Benefits, Challenges, and Recommendations for Action Event Date: February 27, 2024 | 3:00pm – 4:30pm ET
Integrating Patient-Reported Outcomes into Practice: Benefits, Challenges, and Recommendations for Action
Event Date: February 27, 2024 | 3:00pm – 4:30pm ET
https://digital.ahrq.gov/national-webinars/integrating-patient-reported-outcomes-practice-benefits-challenges-recommendations
Register Now for Feb. 27 Webinar on Integrating Patient-Reported Outcomes Into Practice
Registration is open for a webinar on Feb. 27 from 3 to 4:30 p.m. ET on strategies to expand the use of patient-reported outcomes (PROs) in health systems despite challenges. Speakers will highlight recent research projects that provided insights into how PROs may be used to enhance care for patients with varying health conditions. Examples will include how to implement patient-reported outcomes across rheumatology practices; understanding the benefits and challenges of using a mobile application to collect PRO data on medication adherence in pharmacies; and how patient preferences may influence how PRO measures are used and may enhance shared decision-making in orthopedic care. The webinar will be sponsored by AHRQ’s Digital Healthcare Research Program.
https://digital.ahrq.gov/
AHRQ Papers on Diagnostic Safety Topics
AHRQ Papers on Diagnostic Safety Topics: Diagnostic errors occur in all settings of care, contribute to about 10 percent of patient deaths, and are the primary reason for medical liability claims. AHRQ is the lead Federal agency investing in research to improve diagnostic safety and reduce diagnostic error. AHRQ is currently developing a series of papers on different diagnostic safety issues, which will be released over the next year.
Current State of Diagnostic Safety: Implications for Research, Practice, and Policy
Current State of Diagnostic Safety: Implications for Research, Practice, and Policy: This brief identifies major themes related to the current state of diagnostic safety and highlight key gaps in knowledge.
Diagnostic errors have emerged as a major patient safety concern. A new issue brief—Current State of Diagnostic Safety: Implications for Research, Practice, and Policy—presents the results of a rapid narrative review and expert interviews to determine the current state of diagnostic safety and highlights key gaps in knowledge. The brief covers the past decade of progress in the field and identifies the current state of science and gaps in diagnostic safety work within 10 domains. Access the issue brief and other AHRQ publications related to diagnostic safety.
Using Digital Health Tools to Improve Patient Safety during Acute Care
Using Digital Health Tools to Improve Patient Safety during Acute Care: Grantee Profile
Anuj Dalal, M.D., associate physician at Brigham and Women's Hospital and associate professor of medicine at Harvard Medical School in Boston, is helping to reduce adverse events during care transitions with digital health interventions that improve patient safety and outcomes. With funding from AHRQ, Dr. Dalal has designed, developed and implemented digital health tools that promote patient engagement, facilitate effective patient-clinician communication and automate workflow tasks by leveraging the electronic health record and patient-generated health data.
Opioids in Older Adults Compendium: New Tool Helps Manage Opioid Use in Older Adults
Opioids in Older Adults Compendium
A new online tool developed by AHRQ supports efforts by primary care practices and healthcare systems to improve opioid medication management and prevent opioid misuse and opioid use disorder in older adults. The Opioids in Older Adults Compendium allows users to explore potential “high-level changes” that may improve opioid management, including tracking data to provide insights into patients’ opioid use, developing workflows to promote team-based care, using shared decision making to provide individualized care, and increasing referrals to nonpharmacologic chronic pain management. Case studies and key activities with tools and resources are provided to support improved care. Access the compendium.
AHRQ Stats: Racial/Ethnic Differences in Insurance
AHRQ Stats: Racial/Ethnic Differences in Insurance
In 2021, 95 percent of non-Hispanic Asian people had some form of health insurance, the most of any group, followed by 93.4 percent of White people, 92.5 percent of multiracial people, 80 percent of Black people and 78.2 percent of Hispanic people. (Source: AHRQ 2023 National Healthcare Quality and Disparities Report.)
https://www.ahrq.gov/sites/default/files/wysiwyg/research/findings/nhqrdr/2023-nhqdr.pdf#page=50
SOPS Hospital Database
SOPS Hospital Database: The Hospital SOPS Database is a central repository for survey data from hospitals that administered the AHRQ patient safety culture survey.
Now Available: Additional results for the AHRQ SOPS® Hospital Workplace Safety Supplemental Item Set
A new appendix for AHRQ’s 2022 Surveys on Patient Safety Culture® (SOPS®) Hospital Workplace Safety Supplemental Item Set provides composite measure and item scores by job satisfaction, intent to leave, tenure in unit/work area, and interaction with patients.
One highlight of the appendix shows that 72% of providers and staff who were dissatisfied with their job reported symptoms of burnout compared with only 23% of those who were satisfied with their job.
The SOPS Workplace Safety Supplemental Item Set for hospitals was designed for use with the core SOPS Hospital Survey to help hospitals assess the extent to which their organization’s culture supports workplace safety for providers and staff.
For more information, please email DatabasesOnSafetyCulture@westat.com or call the helpline at 1-888-324-9790.
martes, 30 de enero de 2024
Why Be a Fellow @ DCEG: Launching Your Future
Career Paths of our Alumni: Q&A with Former Fellows
https://dceg.cancer.gov/fellowship-training/fellowship-experience/former-fellows-qa
The People’s Voice Survey on Health System Performance
https://www.thelancet.com/series/peoples-voice-survey?dgcid=hubspot_update_feature_langlopeoplesvoice23&utm_campaign=update-langlo&utm_medium=email&_hsmi=291852180&_hsenc=p2ANqtz-9OUIDDx4tbPyjBxyacoJX9k_Fz_ICI9hfncOeHOABo_Hnx1mcTfpQEmIU6Jn_n-N4jzN6RBPe75Qcgd3HR4GM-_PVeEQ&utm_content=291846406&utm_source=hs_email
Understanding how health systems perform is key to improving health service delivery and health outcomes. Like any other service sector, health systems need to learn from the populations who use and fund them. Currently, there are few rapid and comparable approaches that incorporate population views when tracking health system performance. The People’s Voice Survey is a new survey that is rapid, low-cost, and population-representative. With proper adaptation, it is applicable to any country, regardless of national income, health expenditure, or health system structure.
The six papers in this Series highlight the innovative measures featured in the People’s Voice Survey, including confidence in public primary care, system competence in preventive care, and user activation. They examine quality and confidence in health systems as well as people’s experience with several prominent health system initiatives, such as universal health coverage, primary care, and vaccination drives. Given the manifest inequities in health quality and effective coverage, they also examine wealth, location, and gender equity in key aspects of health system performance.
lunes, 29 de enero de 2024
CAHPS Home and Community-Based Services (HCBS) Survey Database
CAHPS Home and Community-Based Services (HCBS) Survey Database: The Home and Community-Based Services (HCBS) Survey Database is a repository for survey results that have been voluntarily submitted by State Medicaid agencies and the managed care entities with which they contract. This database became operational in early 2020.
Dana-Farber expands studies to be retracted to 6, plus 31 to be corrected over mishandled data Angus Chen Jonathan Wosen By Angus Chen and Jonathan Wosen Jan. 22, 2024
https://www.statnews.com/2024/01/22/dana-farber-research-retractions-corrections/?utm_campaign=morning_rounds&utm_medium=email&_hsmi=291721681&_hsenc=p2ANqtz-8SKpML8sNTHQV53f0lQXZtZeOAHy_efqta7y1ekNgkaONdsYlMWJZgnOUicVHPotmgyUOGhqqv-9BqO3_ie3FvwSkNzw&utm_content=291721681&utm_source=hs_email
The sleuth behind research allegations against Dana-Farber
Sholto David spends his time poring over other people’s research papers looking for images with clues that they’ve been manipulated in some way — duplicated, misleadingly cropped, or partially obscured. In the past three years, David, a scientist with a doctorate in cellular molecular biology, has flagged issues on more than 2,000 papers. Often, his comments go ignored, but earlier this month he wrote a blog post that shook leadership at the Dana-Farber Cancer Institute, one of the world’s preeminent cancer research centers, and led the institute to announce six planned retractions and 31 corrections.
Some people may view the work as noble, or important, but David doesn’t necessarily like that idea. He does it because he enjoys it. The sleuthing is like a puzzle — can you look at this scan of two dozen mice and spot which, if any, of the animals have been duplicated? “I’m the sort of person who writes 2,000 comments on some obscure website just for doing it,” he said. “I like a little bit of engagement, but I would do it anyway.” Read more from STAT’s Andrew Joseph.
From a small town in Wales, a scientific sleuth has shaken Dana-Farber — and elevated the issue of research integrity
Andrew Joseph
By Andrew Joseph
https://www.statnews.com/2024/01/27/sholto-david-profile-dana-farber-retractions/?utm_campaign=morning_rounds&utm_medium=email&_hsmi=291721681&_hsenc=p2ANqtz--V4Z7wjJ8bZCl6WVvmp7ICE9Zje-Sj6P6q3122J6arWqRvFqFraXjxGizAASnP0QNeYgAZZzJK0aQhKhMFskkh89LqXw&utm_content=291721681&utm_source=hs_email
Information Session: NIMH Intramural Research Program Training Opportunities (March) March 28, 2024 1:00–3:00 p.m. ET
Information Session: NIMH Intramural Research Program Training Opportunities (March)
March 28, 2024
1:00–3:00 p.m. ET
https://www.nimh.nih.gov/news/events/information-session-nimh-intramural-research-program-training-opportunities-march
The National Institute of Mental Health (NIMH) Office of Fellowship Training is bringing back their popular series of virtual information sessions about the NIMH Intramural Research Program (IRP). The first session takes place March 28, 2024 from 1:00–3:00 p.m. ET.
These information sessions are open to undergraduates, graduate students, medical students, postdoctoral fellows, and anyone else interested in learning more about opportunities with the NIMH Intramural Research Program.
The sessions will provide information about a variety of National Institutes of Health (NIH) training programs, exciting research being done in NIMH IRP laboratories, and give attendees a chance to chat with current NIMH staff and trainees.
Session dates:
March 28, 2024, 1:00–3:00 p.m. ET
June 5, 2024, 3:00–5:00 p.m. ET
August 30, 2024, 12:00–2:00 p.m. ET
December 3, 2024, 2:00–4:00 p.m. ET
domingo, 28 de enero de 2024
Understanding Liability Risk from Using Health Care Artificial Intelligence Tools. Michelle M Mello et al. N Engl J Med 2024 1 (3) 271-278
https://phgkb.cdc.gov/PHGKB/phgHome.action?action=archive&date=01/20/2024
From the article: "Optimism about the explosive potential of artificial intelligence (AI) to transform medicine is tempered by worry about what it may mean for the clinicians being “augmented.” One question is especially problematic because it may chill adoption: when AI contributes to patient injury, who will be held responsible? Some attorneys counsel health care organizations with dire warnings about liability1 and dauntingly long lists of legal concerns.2 Unfortunately, liability concern can lead to overly conservative decisions,3 including reluctance to try new things. "
We need to stand together on the shoulders of giants: consolidating effective approaches for translating genomics into practice with implementation science. Stephanie Best et al. Public Health Genomics 2023 12
https://phgkb.cdc.gov/PHGKB/phgHome.action?action=archive&date=01/22/2024
From the article: "Adopting a genomics learning implementation system approach would provide opportunities to bring together clinical and implementation data from observational studies and clinical trials, providing real-world evidence. These findings could be housed in the Digital Implementation Toolshed (DIT), an online bi-directional platform for resources generated from implementation science activity in genomics. The highly curated DIT (Fig. 1) would augment the Centers for Disease Control and Prevention Genomics and Precision Health Weekly Update. " "
Genetics Adviser: The development and usability testing of a new patient digital health application to support clinical genomic testing. M CLausen et al, Genetics in Med Open, January 24, 2024
https://phgkb.cdc.gov/PHGKB/phgHome.action?action=archive&date=01/23/2024
From the abstract: " Increasing demand for genomic testing coupled with genetics workforce shortages has placed unsustainable pressure on standard models of care. Digital tools can offer improved access, efficiency, and cost savings. We created a patient-facing digital health application to support genomic testing. We developed the digital application through user-centered design, guided by an advisory board. We tested its usability and acceptability with patients, practitioners and members of the general public using mixed methods."
Prospective study design and data analysis in UK Biobank. Naomi E Allen et al. Sci Transl Med 2024 1 (729) eadf4428
https://phgkb.cdc.gov/PHGKB/phgHome.action?action=archive&date=01/25/2024
From the abstract: " Population-based prospective studies, such as UK Biobank, are valuable for generating and testing hypotheses about the potential causes of human disease. We describe how UK Biobank’s study design, data access policies, and approaches to statistical analysis can help to minimize error and improve the interpretability of research findings, with implications for other population-based prospective studies being established worldwide."
Precision Medicine Has a Data Equity Problem TM Gordon, NPQ, January 21, 2024
https://phgkb.cdc.gov/PHGKB/phgHome.action?action=all%20hot%20topics
From the article: " The ability to deepen our understanding of disease susceptibility, diagnose diseases with greater accuracy, and develop tailored treatments that promote wellbeing and prolong people’s lives presents an opportunity to rectify longstanding healthcare inefficiencies and disparities. However, due to disparities in genomic data, the advent of genetically informed, personalized, or “precise” medicine may perpetuate—rather than alleviate—complex inequalities in care. "
Population Screening for Hereditary Hemochromatosis More than a Quarter Century After Gene Discovery – Current Status and the Path Forward February 15, 2024, 1:00 pm – 2:00 pm ET
https://www.cdc.gov/genomics/events/pop_screen_hereditary_hemochromatosis_2024.htm
Current data suggest that 1 in 300 non-Hispanic White individuals in the United States carry a genetic variation in the HFE gene (C282Y homozygosity) that accounts for most cases of hereditary hemochromatosis (HH). This variation can lead to iron overload and life-threatening complications, such as severe liver disease. However, complications are preventable with early diagnosis and periodic phlebotomies to remove excess iron from the body. At present, Tier 1 evidence-based guidelines support family-based genetic testing for HH. However, uncertainty remains concerning the best strategy for pre-symptomatic case identification and the suitability of HFE-associated HH as a target for population screening or ancestry-targeted screening using either measures of iron status or direct genetic testing. To devise optimal preventive strategies for HH, we must consider existing evidence about HH genetics, penetrance, and prevalence and the acceptability, cost, and effectiveness of potential screening strategies. In this webinar, our speakers will discuss how knowledge about HH has evolved since the discovery of the HFE gene in 1997, current opportunities for clinical and public health action to prevent disease, and future research priorities to advance case detection and reduce clinical complications from HH.
sábado, 27 de enero de 2024
Making Healthcare Safer IV: Opioid Stewardship
Making Healthcare Safer IV: Opioid Stewardship: Making Healthcare Safer IV: Opioid Stewardship
Reducing Adverse Drug Events Related to Anticoagulant Use in Adults
Reducing Adverse Drug Events Related to Anticoagulant Use in Adults: This rapid response summarizes the most relevant and recent literature on two PSPs: interventions to support safe care transitions and continuation of anticoagulants post-discharge (PSP 1), and anticoagulation management services in ambulatory settings (PSP 2). Both had been covered in the 2020 MHS III report (which only included literature before 2019), and this report summarizes more recent literature (published in 2019 or later)
viernes, 26 de enero de 2024
Interprofessional learning in multidisciplinary healthcare teams is associated with reduced patient mortality: a quantitative systematic review and meta-analysis.
https://psnet.ahrq.gov/issue/interprofessional-learning-multidisciplinary-healthcare-teams-associated-reduced-patient
Interprofessional learning in multidisciplinary healthcare teams is associated with reduced patient mortality: a quantitative systematic review and meta-analysis.
Webster CS, Coomber T, Liu S, et al. J Patient Saf. 2024;20(1):57-65.
Interprofessional learning (IPL) is a common strategy to improve patient safety. This systematic review of quantitative evidence found that healthcare provider participation in interventions including IPL led to significant reductions in adverse events and mortality compared to conventional patient care.
Clinical deterioration as a nurse sensitive indicator in the out-of-hospital context: a scoping review.
https://psnet.ahrq.gov/issue/clinical-deterioration-nurse-sensitive-indicator-out-hospital-context-scoping-review
Clinical deterioration as a nurse sensitive indicator in the out-of-hospital context: a scoping review.
Mccullough K, Baker M, Bloxsome D, et al. J Clin Nurs. 2023;Epub Nov 12.
Clearly defined and tracked outcome measures are necessary for evaluation of health services. In the hospital setting, clinical deterioration as a nurse-sensitive outcome (NSO) measure is widely recognized and clearly defined, yet there is a lack of clarity around NSO in out-of-hospital settings. This review identified 34 studies and reviews of clinical deterioration in community settings, such as ambulatory or home care. Contributing factors were similar to those identified in hospitals, including workload, staff mix, and education.
Characteristics and patient impact of boarding in the pediatric emergency department, 2018-2022.
https://psnet.ahrq.gov/issue/characteristics-and-patient-impact-boarding-pediatric-emergency-department-2018-2022
Characteristics and patient impact of boarding in the pediatric emergency department, 2018-2022.
Kappy B, Berkowitz D, Isbey S, et al. Am J Emerg Med. 2023;77:139-146.
Patient boarding (i.e., time from admission order to transfer to inpatient unit) in adult emergency departments (ED) has been associated with poorer patient outcomes. This study assessed the impact of boarding times in one pediatric emergency department (PED) from 2018 to 2022. Increased boarding time was associated with increased length of overall hospital stay for patients admitted to hospital wards, but not for patients admitted to the intensive care unit.
2023 NIMH James S. Jackson Memorial Award Lecture: The Critical Health E...
2023 NIMH James S. Jackson Memorial Award Lecture: The Critical Health Equity Imperative: Five Insights About Reducing Health Inequities From My Research With U.S. Black LGB People and Heterosexual Men
https://www.nimh.nih.gov/news/media/2023/2023-nimh-james-s-jackson-memorial-award-lecture-the-critical-health-equity-imperative-five-insights-about-reducing-health-inequities-from-my-research
Voluntary Quality Management Maturity Prototype Assessment Protocol Evaluation Program
https://www.federalregister.gov/documents/2024/01/25/2024-01423/voluntary-quality-management-maturity-prototype-assessment-protocol-evaluation-program?utm_medium=email&utm_source=govdelivery
Today, the U.S. Food and Drug Administration is announcing an opportunity for drug manufacturers to participate in the next phase of the development of the Center for Drug Evaluation and Research’s Quality Manufacturing Maturity (QMM) Program.
FDA is launching a voluntary QMM Prototype Assessment Protocol Evaluation Program, which involves the use of a prototype assessment protocol, to evaluate an establishment’s QMM. QMM is the extent to which drug manufacturing establishments prioritize patients, drive continual improvement, and enhance supply chain reliability through the strategic integration of business decisions and manufacturing operations with quality practices and technological advancements. The QMM program aims to encourage drug manufacturers to implement quality management practices that go beyond current good manufacturing practice (CGMP) requirements.
FDA has developed a prototype assessment protocol to evaluate an establishment’s level of QMM and is seeking the participation of nine firms to evaluate the protocol’s effectiveness. The prototype assessment protocol includes a series of questions in five practice areas: leadership, business continuity, technical excellence, advanced pharmaceutical quality system, and employee empowerment and engagement. The program will allow drug establishments to gain experience with the prototype assessment protocol and allow FDA to evaluate whether use of the protocol, as designed, will enable a meaningful assessment of the establishment’s quality management practices while providing useful feedback for the establishment. The outcomes from this program will help to inform the development of the protocol to be used in the eventual QMM program.
Please review the notice for the types of establishments FDA is seeking for participation and the process for submitting a request to participate in the program.
Register for FDA OMHHE's Technical Session for the Health Equity Innovation Award Funding Opportunity 1 feb 2024 03:00 p. m.
https://us06web.zoom.us/webinar/register/WN_-vwcly3LQzyEDtnOoK3Auw?utm_medium=email&utm_source=govdelivery#/registration
he FDA Office of Minority Health and Health Equity (OMHHE) serves to promote and protect the health of diverse populations through research and communication strategies that address health disparities.
As part of OMHHE’s Enhance EQUITY Initiative, OMHHE announced a new Health Equity Innovation Award: Enhance Equity Funding Opportunity. The purpose of this funding opportunity announcement (FOA) is to support innovative research that will strengthen and advance health outcomes for diverse communities.
The FDA OMHHE will host a technical session on Thursday, February 1, 2024, from 1 PM - 2 PM EST for the Health Equity Innovation Award Funding Opportunity. The technical session will be hosted on Zoom. Click on the "Register on Zoom" button, below, to register for the event.
Achieving health equity requires commitment and dedication from stakeholders from all corners of the public health and research community. Together, we can continue to make a difference. You can learn more about the funding opportunity by visiting OMHHE’s website.
jueves, 25 de enero de 2024
Supporting Older Adult Populations within the Criminal Justice System — Webinar January 30, 2024, 12:30 p.m. ET
https://us06web.zoom.us/webinar/register/WN_S4-9mOYxSxaz5BmHAgsW8g?utm_source=SAMHSA&utm_campaign=ddb96bc6ef-EMAIL_CAMPAIGN_2024_01_16_08_33&utm_medium=email&utm_term=0_-ddb96bc6ef-%5BLIST_EMAIL_ID%5D&utm_source=SAMHSA&utm_campaign=fba89cf0db-EMAIL_CAMPAIGN_2024_01_23_07_09&utm_medium=email&utm_term=0_-fba89cf0db-%5BLIST_EMAIL_ID%5D#/registration
This SAMHSA-funded GAINS Center for Behavioral Health and Justice Transformation webinar will focus on supporting older adults who have criminal justice involvement. Speakers will discuss considerations related to the medical and social care needs of older adults and ways to support this population and improve outcomes. Strategies to address the challenges faced by this demographic prior to, and following, contact with the criminal justice system will be discussed. A reentry program that is specifically designed to support the older adult population following incarceration will also be featured.
Organizational Wellness: A Strategy for Rural Behavioral Health Workforce Recruitment and Retention — Webinar Thursday, February 8, 2024 2 p.m. ET
https://mhttcnetwork.org/centers/mountain-plains-mhttc/event/organizational-wellness-strategy-rural-behavioral-health?utm_source=SAMHSA&utm_campaign=fba89cf0db-EMAIL_CAMPAIGN_2024_01_23_07_09&utm_medium=email&utm_term=0_-fba89cf0db-%5BLIST_EMAIL_ID%5D
Join us to learn how focusing on organizational wellness can bolster both the recruitment and retention of rural behavioral health providers. While this webinar will briefly discuss the reasons for high provider turnover, it will emphasize why workers stay in their jobs. We will then focus on practical suggestions for creating a workplace climate of wellness focused on care, respect, compassion, shared values as well as sustaining such a climate that benefits all healthcare providers and staff alike.
Integrating Behavioral Therapy with Pharmacotherapy in Treating Patients with Substance Use Disorders — Webinar Wednesday, February 7, 2024 12 p.m. ET
https://opioidresponsenetwork.org/events/?utm_source=SAMHSA&utm_campaign=fba89cf0db-EMAIL_CAMPAIGN_2024_01_23_07_09&utm_medium=email&utm_term=0_-fba89cf0db-%5BLIST_EMAIL_ID%5D#event=77227782;instance=20240207120000?popup=1
In this webinar, the speaker will talk about the role of behavioral therapy in the context of pharmacotherapy for substance use disorders. He will speak about the goals of behavioral therapy when combined with medication (including medication adherence). He will also review studies of combined pharmacotherapy and behavioral therapy with different medications and different behavioral interventions.
HIV, Harm Reduction, and Youth Engagement — Webinar Friday, February 2, 2024 12 p.m. ET
https://opioidresponsenetwork.org/events/?utm_source=SAMHSA&utm_campaign=fba89cf0db-EMAIL_CAMPAIGN_2024_01_23_07_09&utm_medium=email&utm_term=0_-fba89cf0db-%5BLIST_EMAIL_ID%5D#event=77180625;instance=20240202000000?popup=1
This training will provide an updated lens on the current state of HIV and substance use in the United States. We will discuss rates of HIV amongst people who use drugs (PWUD) and what unique factors impact health outcomes for them. Guidelines for prevention and meaningful engagement surrounding risk reduction for PWUD will be discussed as well as a focus on engaging youth who are living with HIV and youth engaging in substance use.
Join SAMHSA’s Webinar on Medicaid Coverage of Medications to Reverse Opioid Overdose and Treat Alcohol and Opioid Use Disorders Wednesday, January 31, 1:30 p.m. ET
https://westat.zoomgov.com/webinar/register/WN_XiyXZ_fLSJ2Xn1hdfuQRMw?utm_source=SAMHSA&utm_campaign=b64ecef227-EMAIL_CAMPAIGN_2024_01_11_03_47&utm_medium=email&utm_term=0_-b64ecef227-%5BLIST_EMAIL_ID%5D&utm_source=SAMHSA&utm_campaign=fba89cf0db-EMAIL_CAMPAIGN_2024_01_23_07_09&utm_medium=email&utm_term=0_-fba89cf0db-%5BLIST_EMAIL_ID%5D#/registration
On January 31, SAMHSA will host a webinar to improve behavioral health care by understanding the financing of behavioral health care to identify opportunities and challenges to service delivery and access to care. This webinar will coincide with the release of an upcoming report Medicaid Coverage of Medications to Reverse Opioid Overdose and Treat Alcohol and Opioid Use Disorders.
Embedding Equity in 988 Crisis Systems — Webinar Wednesday, January 31, 2024 1 p.m. ET
https://us06web.zoom.us/webinar/register/WN_ZUKP38pNSFa3Jr706TEX4A?utm_source=SAMHSA&utm_campaign=a70075912e-EMAIL_CAMPAIGN_2024_01_16_06_24&utm_medium=email&utm_term=0_-a70075912e-%5BLIST_EMAIL_ID%5D&utm_source=SAMHSA&utm_campaign=fba89cf0db-EMAIL_CAMPAIGN_2024_01_23_07_09&utm_medium=email&utm_term=0_-fba89cf0db-%5BLIST_EMAIL_ID%5D#/registration
With 988, we have the opportunity to build equitable behavioral health crisis response systems from the ground up. This webinar will provide participants with the context and rationale for equity, as well as a vision for equity at all system levels – community, state/territory, tribal, and federal. After the presentation, participants are invited to stay logged into the webinar for a 30-minute Office Hour session with the National Crisis Systems Response Training and Technical Assistance Center to engage in deeper discussion on considerations to make to ensure equity is embedded in their behavioral health crisis response systems.
Stimulants 101 — Webinar Wednesday, January 31, 2024 12 p.m. ET
https://opioidresponsenetwork.org/events/?utm_source=SAMHSA&utm_campaign=fba89cf0db-EMAIL_CAMPAIGN_2024_01_23_07_09&utm_medium=email&utm_term=0_-fba89cf0db-%5BLIST_EMAIL_ID%5D#event=77266348;instance=20240131120000?popup=1
This one-hour training is intended to provide an overview of stimulant use disorders. Topics include stigma, pharmacology, and physiology of methamphetamines and cocaine, identifying stimulant overdose (overamping), managing acute stimulant intoxication, de-escalation techniques, and evidence-based treatment for people with stimulant use disorders.
Newly Approved Weekly and Monthly Buprenorphine: A Primer for Clinicians — Virtual Roundtable Wednesday, January 31, 2024 12 p.m. ET
https://pcssnow.org/event/newly-approved-weekly-and-monthly-buprenorphine-a-primer-for-clinicians/?utm_source=SAMHSA&utm_campaign=fba89cf0db-EMAIL_CAMPAIGN_2024_01_23_07_09&utm_medium=email&utm_term=0_-fba89cf0db-%5BLIST_EMAIL_ID%5D
This activity was developed to meet the needs of physicians, nurses and interprofessional healthcare providers. Discussion is designed to promote interactivity through an informal “round table” conversation. Attendees will be given the opportunity to speak directly with the presenter to ask questions and discuss issues.
Youth Anxiety, Stress, and Worry: What is typical? — Webinar Tuesday, January 30, 2024 3 p.m. ET
https://mhttcnetwork.org/centers/mountain-plains-mhttc/event/youth-anxiety-stress-and-worry-what-typical?utm_source=SAMHSA&utm_campaign=fba89cf0db-EMAIL_CAMPAIGN_2024_01_23_07_09&utm_medium=email&utm_term=0_-fba89cf0db-%5BLIST_EMAIL_ID%5D&utm_source=SAMHSA&utm_campaign=fba89cf0db-EMAIL_CAMPAIGN_2024_01_23_07_09&utm_medium=email&utm_term=0_-fba89cf0db-%5BLIST_EMAIL_ID%5D
It is estimated that one in five youth will suffer from some type of mental health disorder by age 18. There are modular youth treatments that build youth skills to address these concerns. This training will provide resources to mental health and school professionals on identifying anxiety in youth and understanding different symptoms as they relate to typical developmental trajectory. The training will also provide strategies to address worry in youth, especially youth of color, with free resources to help in the identification and treatment of anxiety disorders.
Global launch of The Lancet Gastroenterology & Hepatology Commission on viral hepatitis Thursday, February 15, 2024 1:00 PM Greenwich Mean Time 1 hour, 30 minutes
Global launch of The Lancet Gastroenterology & Hepatology Commission on viral hepatitis
Thursday, February 15, 2024
1:00 PM Greenwich Mean Time
1 hour, 30 minutes
https://event.on24.com/wcc/r/4449673/08D38FC8543A295C4603FC13120CF571?partnerref=hubspot_email_langasviralhepatitis24_registration1&utm_campaign=langasviralhepatitis24&utm_medium=email&_hsenc=p2ANqtz-_2QPacdlo9_Mb2th5Rc8TxZU108wRGg7xcCTegMn1aAiWrAXpwSGkzwU1jqNe3_J1auBPjFOa6o_uODyYNDBk5U85uvQ&_hsmi=291305580&utm_content=290153532&utm_source=hs_email&hsCtaTracking=61e79908-f472-4333-ace4-a58e7c002d7e%7C88fe4561-1512-4cde-85bf-633df19ad9a8
We are pleased to invite you to the Lancet Webinar for the global launch of The Lancet Gastroenterology & Hepatology Commission on viral hepatitis on Feb 15, 2024, at 13:00 GMT/08:00 EST. Attendance is free with registration and you can register for the webinar here.
Globally, more than 300 million individuals are living with hepatitis B or C. Deaths and disability caused by the long-term complications of these chronic infections represent a major public health challenge, comparable in scale to other major communicable diseases, such as tuberculosis and malaria. In 2016, the WHO set ambitious goals to eliminate viral hepatitis as a public health threat by 2030.
Thurs, Feb 15, 2024
13:00 GMT / 08:00 EST
‘The response defies belief’: Year of inaction leaves children at risk from bad cancer drugs By Rosa Furneaux and Laura Margottini — TBIJJan. 25, 2024
https://www.statnews.com/2024/01/25/chemotherapy-asparaginase-cancer-drug-investigation/?utm_campaign=morning_rounds&utm_medium=email&_hsmi=291354684&_hsenc=p2ANqtz--0LYKT6mE0JnvJS7W1h9L35E47l0pzaUvmrnW_KKhX33UY_lhY6FCEl071LRoSWumFO5jjwJJnjQFyoLDEaO_VVHLWQA&utm_content=291354684&utm_source=hs_email
Last January, the Bureau of Investigative Journalism, in partnership with STAT, revealed that at least a dozen brands of asparaginase, a key childhood chemotherapy drug, had failed quality tests, putting an estimated 70,000 children in more than 90 countries at risk. Update: A year later, almost nothing has changed. The WHO has issued no alert about the problematic cancer drug and national drug regulators around the world have not taken meaningful action, with both sides claiming communication breakdowns and a lack of evidence.
Researchers in the U.S. and Africa have begun developing cheap, simple tests allowing doctors to check the quality of asparaginase. “This issue is something that needs to be addressed urgently,” said Gregory Reaman, a scientific director at the U.S. National Cancer Institute. “These are children who are already sick, and have the potential for being cured. And yet they are given substandard drugs.” Read more.
https://www.thebureauinvestigates.com/stories/2023-01-25/the-drug-was-meant-to-save-childrens-lives-instead-theyre-dying?utm_campaign=morning_rounds&utm_medium=email&_hsmi=291354684&_hsenc=p2ANqtz--2Qguqe9YxeKYTXWBE3p60oaiDjEM88YDwrK_tigm1OUl_vVRGSgvTcF49RUJ6TFTXzMuC--OZsxymRY82QsL2lNjXRg&utm_content=291354684&utm_source=hs_email
miércoles, 24 de enero de 2024
Public Engagement Partnership Meeting Series: Upcoming Event - USPTO’s new Public Engagement Partnership meeting series
The United States Patent and Trademark Office (USPTO) is hosting a series of Public Engagement Partnership meetings. USPTO wants to connect with individuals, advocacy groups, public interest focused nonprofits, and academics in order to exchange ideas, experiences, and insights related to patent policies and procedures. These meetings may be of interest to patients, caregivers and patient advocates.
MAR 1, 2024 - ALEXANDRIA, VA
Attend the Public Engagement Partnership meeting
Join USPTO March 1, 1-5 p.m. ET, virtually and in person at USPTO headquarters in Alexandria, Virginia, for the inaugural Public Engagement Partnership meeting.
Meetings will have their specific agendas providing opportunities to:
Learn about the patent system and the USPTO’s practices and policies
Participate in panel discussions
Learn how read a patent and its parts.
Learn how to submit third-party input on a patent application
Learn how to submit requests for reexamination of patents
Learn how to challenge patents after they are issued
https://www.uspto.gov/patents/initiatives/publicengagementpartnership?utm_medium=email&utm_source=govdelivery
“Using Artificial Intelligence & Machine Learning in the Development of Drug & Biological Products” +++
https://www.fda.gov/media/167973/download?utm_medium=email&utm_source=govdelivery
“Framework for the Use of Digital Health Technologies in Drug and Biological Product Development,”
https://www.fda.gov/media/166396/download?utm_medium=email&utm_source=govdelivery
Digital Health Technologies for Remote Data Acquisition in Clinical Investigations
DECEMBER 2023
https://www.fda.gov/regulatory-information/search-fda-guidance-documents/digital-health-technologies-remote-data-acquisition-clinical-investigations?utm_medium=email&utm_source=govdelivery
Practice Opportunity to Improve Antibiotic Use in Telemedicine
Is your practice interested in improving appropriate use of antibiotics in telemedicine? The Agency for Healthcare Research and Quality (AHRQ) is currently recruiting practices for a no-cost, 18-month program beginning in June 2024 to promote appropriate antibiotic use while maintaining patient satisfaction and reducing potential side effects in patients seen via telemedicine. Practices will receive training and one-on-one expert coaching to implement sustainable improvements in the diagnosis and treatment of infectious syndromes in the telemedicine environment. Practices will learn how to improve workflow efficiencies and participants will be eligible for continuing education units (CEUs), continuing medical education (CME) credits, and American Board of Internal Medicine maintenance of certification (MOC) points. Learn more and sign up for an informational webinar on the program website: safetyprogram4telemedicine.org.
https://safetyprogram4telemedicine.org/page/home
Register Now for Webinars on AHRQ’s Medical Expenditure Panel Survey
https://meps.ahrq.gov/mepsweb/about_meps/workshops_events.jsp
Registration is open for webinars on AHRQ’s Medical Expenditure Panel Survey (MEPS), the nation’s most complete source of data on the cost and use of healthcare and health insurance coverage. The webinars will offer a general overview plus hands-on sessions on addressing challenges that researchers face when linking the MEPS-Household Component Medical Conditions public use data file to the Prescribed Medicines public use data file. Attendees will be encouraged to ask questions pertaining to their research. Access more information, including how to register for one of the two-hour webinars, which are scheduled for 11:30 a.m. ET on Jan. 30, Jan. 31 and Feb. 1.
AHRQ Research Priorities and Compliance Guidance
AHRQ Research Priorities and Compliance Guidance: This page contains AHRQ policy information and guidance about procedures related to grants, including AHRQ research priorities.
AHRQ and PCORI Invest in Learning Health Systems Scientist Training
AHRQ and PCORI Invest in Learning Health Systems Scientist Training: Learn how AHRQ and PCORI are investing in learning health systems scientist training.
PCORI: Who We Are, What We Do and Why Our Work Is Important
https://www.pcori.org/
PCORI 2024 & Beyond Webinar
7 feb 2024 04:00 p. m. en
Descripción
Join Executive Director Nakela L. Cook, M.D., MPH, and other PCORI leaders for an information-rich webinar on Wednesday, Feb. 7, at 2 pm (ET) to learn what’s in store for 2024, including upcoming funding opportunities, and how you can get involved with PCORI.
During this 30-minute webinar, you will hear about funding announcements for patient-centered comparative clinical effectiveness research (CER) as well as engagement and dissemination and implementation projects. You’ll also learn about ways to share your experience and knowledge and make your voice heard through public input on reports and projects, advisory panels and other PCORI programs.
https://pcori-org.zoom.us/webinar/register/6017031924501/WN_gMJlyE6qSl2IzewGCksukg#/registration
2023 NATIONAL HEALTHCARE QUALITY AND DISPARITIES REPORT
AHRQ Stats: Life Expectancy Among Americans
In 2021, the average life expectancy in the United States decreased to 76.1 years, compared with an average of 77 years in 2020 and 78.8 years in 2019. Life expectancy in comparable countries improved to 82.4 years in 2021 from 82.1 years in 2020. (Source: AHRQ 2023 National Healthcare Quality and Disparities Report.)
https://www.ahrq.gov/sites/default/files/wysiwyg/research/findings/nhqrdr/2023-nhqdr.pdf#page=37
Preventable Hospitalizations Among Adult Medicaid Enrollees in 2019 Variation by Supplemental Security Income Eligibility Status, Race, and State
https://www.rwjf.org/en/insights/our-research/2024/01/preventable-hospitalizations-among-adult-medicaid-enrollees-in-2019.html
Not every hospital admission has to happen. They can often be prevented — in up to 3.5 million cases, one annual estimate says — if patients can find timely, high-quality outpatient care. A new analysis from the Urban Institute has found that Black people enrolled in Medicaid have higher rates of preventable hospitalizations than white people covered by Medicaid. Looking at 21 U.S. states, three previously diagnosed conditions were most likely to result in a hospital stay: asthma or chronic obstructive pulmonary disease, diabetes, and heart failure.
Hospitalization rates were higher for people insured by Medicaid through the Supplemental Security Income program, which is based on a qualifying disability, but for heart disease in particular, Black Medicaid enrollees were more likely to have a preventable hospitalization than white enrollees, with or without SSI, the report found. “These findings suggest a need to improve access to outpatient care to effectively manage chronic conditions,” the report concludes.
Understanding How Older Adults Use the U.S. Health Care System: From Measurement to Meaning
https://www.acpjournals.org/doi/10.7326/M23-3453?utm_campaign=morning_rounds&utm_medium=email&_hsmi=291183600&_hsenc=p2ANqtz-9Zw0EU90ZjOWslW28L-U9YNzBQsOYuUMXrN6U3h8t4DDaSPeYbTWIwK98eUOsFTJvcI7mKLMvwXFDyPTVOJM6l1Y5wHA&utm_content=291183600&utm_source=hs_email
Older patients spend three weeks a year getting health care away from home
Back in June 2020, I visited a cancer center with a patient participating in a clinical trial to treat her ovarian cancer. Because Covid-19 was fairly new and vaccines were still far away, great efforts were made to streamline visits so no patient was exposed longer than necessary to other people. That came to mind as I read a study in this week's Annals of Internal Medicine tracking just how much time older patients who still live independently spend getting health care outside their homes.
The average was three weeks a year in the cross-sectional study of more than 6,500 adults 65 and older (and 50 days for 11% of them). Here’s what made me recall the cancer story: About half of the older patients’ test days and imaging days were not on the same days as office visits, which doesn’t sound like streamlined care. But an editorial hints that could change: “Policymakers and health care systems are increasingly using measures that more fully capture what matters most to many older adults — the amount of time they spend outside of the health care system.”
https://www.statnews.com/2020/06/16/cancer-patients-doctors-carry-on-clinical-trials-during-covid-19/?utm_campaign=morning_rounds&utm_medium=email&_hsmi=291183600&_hsenc=p2ANqtz-_LisZ_r3cYX9tcrGnkGdX7oWUt6eofpj6VbBcct-Q5pNqQNeZoxLf9G2vI6RYk5qo4tbU4BD52bbqvhsUUHutxKbI8HA&utm_content=291183600&utm_source=hs_email
U.S. Health Care Workers Want Their Employers to Address Climate Change
https://www.commonwealthfund.org/publications/issue-briefs/2024/jan/us-health-care-workers-want-employers-address-climate-change?utm_campaign=morning_rounds&utm_medium=email&_hsmi=291183600&_hsenc=p2ANqtz-8wDHiR8RK9XXz1knRsJq6ApS2qI7qxudi7vKTq7TGvLOSe_JKTKS2G-BF8TWWrPGAMGthhhy_dCEazEsVKgBDfql7JBA&utm_content=291183600&utm_source=hs_email
Clinicians want health care to do better on climate
Health care workers on the front lines — nurses, physicians assistants, nurse practitioners, primary care physicians, and specialists — want their institutions to move the needle on climate change, a new Commonwealth Fund survey out today says. Hospitals and other health care services contribute 8.5% of greenhouse gas emissions, as the report notes and STAT’s Karen Pennar has described. Reducing that number could be significant, whether it’s achieved by lowering carbon dioxide output or tying executive compensation to progress toward a greener future, respondents said. Other findings:
Three in four clinicians say they themselves should act to reduce their environmental impact, at work and at home.
Respondents in leadership said most hospitals are reducing energy consumption (69%) and waste (76%) or setting emissions targets (35%).
About six in 10 said a prospective employer’s policies and actions on climate change would affect their decision to apply for a job.
‘If I were a hospital, I’d be reading the tea leaves’: Pressures grow on the health care industry to reduce its climate pollution
Karen Pennar
By Karen Pennar
https://www.statnews.com/2022/10/27/health-care-hospitals-climate-pollution/?utm_campaign=morning_rounds&utm_medium=email&_hsmi=291183600&_hsenc=p2ANqtz-_kbw7oEbLgWkSht8hWUIXkrrMklVjQN58mxp36NzlH-xGnZhYCEdWlnvBx56qbqExdDRZpq3AeHpKQBqgSTz37mESCOw&utm_content=291183600&utm_source=hs_email
ACI’s 42nd FDA Boot Camp – New York City Edition January 24, 2024
The American Conference Institute’s (“ACI’s”) popular “FDA Boot Camp”—now in its 42nd iteration—is scheduled to take place from March 13-14, 2024, at the SpringHill Suites NY Manhattan Times Square South, New York. The conference is billed as the premier event to provide folks with a roadmap to navigate the difficult terrain of FDA regulatory law.
https://www.thefdalawblog.com/2024/01/acis-42nd-fda-boot-camp-new-york-city-edition/?utm_source=rss&utm_medium=rss&utm_campaign=acis-42nd-fda-boot-camp-new-york-city-edition
Pragmatic solutions to reduce the global burden of stroke: a World Stroke Organization–Lancet Neurology Commission
https://www.thelancet.com/commissions/global-burden-stroke?dgcid=hubspot_email_conferencealerts_sccm24&utm_campaign=conferencealerts&utm_medium=email&_hsmi=290943338&_hsenc=p2ANqtz--YzxJubE0BB1wLFZhnUWaJO0Isjh4XpyXC7asr_OWdgZ8-MjYFWal0wQk06wvPDl7JonYPq66eUPFekEeF8QJvDzSLrA&utm_content=290943338&utm_source=hs_email
The burden of mortality and disability caused by stroke is rapidly increasing worldwide, particularly in countries where the resources to tackle this burden are scarce. However, the implementation of evidence-based interventions could reverse these epidemiological trajectories. A large proportion of strokes can be prevented and, for most patients who present to a stroke unit during the first few hours after the onset of symptoms, treatment can improve survival and functional outcomes. Furthermore, rehabilitation interventions can reduce disability in stroke survivors, improving quality of life for patients and carers.
In this Lancet Neurology Commission, the World Stroke Organization (WSO) draws up its roadmap to tackle the burden of stroke by 2030 and beyond, in line with the UN Sustainable Development Goal on health and wellbeing. If implemented by policy makers, in collaboration with stakeholders in every country, the WSO recommendations could lead to substantial improvements in prevention of stroke, acute treatment, and rehabilitation worldwide. The Commission also provides guidance on the epidemiological surveillance necessary to monitor progress.
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