domingo, 31 de marzo de 2024

The Supreme Court and the Abortion Pill EPISODE 340 MARCH 28, 2024

Overdosing on Chemo: A Common Gene Test Could Save Hundreds of Lives Each Year By Arthur Allen MARCH 26, 2024

The Burden of Getting Medical Care Can Exhaust Older Patients By Judith Graham MARCH 27, 2024

At Stake in Mifepristone Case: Abortion, FDA’s Authority, and Return to 1873 Obscenity Law By Sarah Varney MARCH 25, 2024

More Women Are Drinking Themselves Sick. The Biden Administration Is Concerned. By Lauren Sausser MARCH 28, 2024

A Physician Travels to South Asia Seeking Enduring Lessons From the Eradication of Smallpox By Céline Gounder MARCH 29, 2024

A Paramedic Was Skeptical About This Rx for Stopping Repeat Opioid Overdoses. Then He Saw It Help. By Lauren Peace, Tampa Bay Times MARCH 25, 2024

After Appalachian Hospitals Merged Into a Monopoly, Their ERs Slowed to a Crawl By Brett Kelman and Samantha Liss MARCH 25, 2024

WHO calls for urgent action on rising neurological conditions worldwide

WHO and IPU renew partnership to promote and protect the health, well-being of all people

As AI Eye Exams Prove Their Worth, Lessons for Future Tech Emerge By Hannah Norman MARCH 27, 2024 As AI Eye Exams Prove Their Worth, Lessons for Future Tech Emerge By Hannah Norman With artificial intelligence in health care on the rise, eye screenings for diabetic retinopathy are emerging as one of the first proven use cases of AI-based diagnostics in a clinical setting.

Some Medicaid Providers Borrow or Go Into Debt Amid ‘Unwinding’ Payment Disruptions By Katheryn Houghton MARCH 27, 2024

Some Medicaid Providers Borrow or Go Into Debt Amid ‘Unwinding’ Payment Disruptions By Katheryn Houghton Used to operating with scarce resources, Montana Medicaid providers say gaps in state payments have left them struggling further.

California Is Expanding Insurance Access for Teenagers Seeking Therapy on Their Own By April Dembosky, KQED MARCH 28, 2024 California Is Expanding Insurance Access for Teenagers Seeking Therapy on Their Own By April Dembosky, KQED A California law that takes effect this summer will grant minors on public insurance the ability to get mental health treatment without their parents’ consent, a privilege that their peers with private insurance have had for years. But the law has become a flashpoint in the state’s culture wars.

Your Doctor or Your Insurer? Little-Known Rules May Ease the Choice in Medicare Advantage By Susan Jaffe MARCH 29, 2024 Your Doctor or Your Insurer? Little-Known Rules May Ease the Choice in Medicare Advantage By Susan Jaffe Disputes between hospitals and Medicare Advantage plans are leading to entire hospital systems suddenly leaving insurance networks. Patients are left stuck in the middle, choosing between their doctors and their insurance plan. There’s a way out.v

A Mom’s $97,000 Question: How Was Her Baby’s Air-Ambulance Ride Not Medically Necessary? By Molly Castle Work MARCH 25, 2024 Bill of the Month This crowdsourced investigation by KFF Health News and NPR dissects and explains your medical bills every month in order to shed light on U.S. health care prices and to help patients learn how to be more active in managing costs. Do you have a medical bill that you’d like us to see and scrutinize? Submit it here and tell us the story behind it.

sábado, 30 de marzo de 2024

SUD Treatment in Medicaid: Variation by Service Type, Demographics, States and Spending Heather Saunders, Rhiannon Euhus, Alice Burns, and Robin Rudowitz Published: Mar 28, 2024

Washington wants to avert another Change Healthcare-like fiasco. Here’s what could be coming Mohana Ravindranath By Mohana Ravindranath March 29, 2024

Washington wants to avert another Change Healthcare-like fiasco. Here’s what could be coming Mohana Ravindranath By Mohana Ravindranath March 29, 2024 The recent ransomware attack on a billing company called Change Healthcare brought pharmacy and hospital payments across the country to a halt. Policy makers and industry lobbyists are demanding tougher strategies to prevent future attacks, but what that picture will look like is still murky. Some early ideas: A White House budget request would set aside $800 million to help financially struggling hospitals cover the cost of meeting minimum federal cybersecurity standards. The Homeland Security Department’s Cybersecurity and Infrastructure Security Agency proposed a rule setting a deadline for reporting cyber attacks and payments. Sen. Mark Warner (D-Va.) introduced a bill that would allow advance Medicare payments to providers who suffer a cybersecurity incident as long as they and their vendors meet minimum security requirements. STAT’s Mohana Ravindranath gets reaction to these trial balloons.

Gut bacteria could play role in kidney autoimmune disease, study shows Theresa Gaffney By Theresa Gaffney March 27, 2024 Gut bacteria may play a role in a kidney disease We’re accustomed to the idea that a whole universe of microbes lives within us. But what are they doing? A new study implicates certain bacteria in the development of an autoimmune disease in the kidney. Writing in Science Translational Medicine, the researchers describe how these bacteria change antibodies inside us so much that the immune system thinks they are enemies. Then friendly fire leads to IgA nephropathy, an autoimmune disease of the kidneys, they conclude. The rare disease causes inflammation, blood in the urine, and potential kidney failure. The new research traces the bacterially modified antibody from the gut to the intestines, the bloodstream, and then the kidney. “We need to stop thinking about this passive, indirect effect of the microbiota on human disease and autoimmunity,” study author James Gleeson said. “And more start looking for the direct ways that bacteria could be modifying molecules in the human body.” STAT’s Theresa Gaffney has more.

Multiple sclerosis has distinct subtypes, study finds, pointing to different treatments Isabella Cueto By Isabella Cueto March 27, 2024 Study discerns different MS subtypes As chronic conditions go, multiple sclerosis is a difficult one to live with and to treat. Thought to be more common in women, it causes vision problems, fatigue, and weakness or spasms in the arms and legs, among many other symptoms. But the neurological condition doesn’t always look the same. That spurred a team of scientists across Germany to look for clues in its earliest stages. A new study published yesterday in Science Translational Medicine sheds light on three specific subgroups of the disease they found in 500 patients, corresponding with differences in immunological activation early in their disease and sustained over the study’s four years. This could suggest the disease arises through multiple immune system pathways, the researchers say. And because the groups responded differently to treatments over time, that might help inform their care and future drug development. STAT’s Isabella Cueto has more.

The Food is Medicine movement originators are trying to standardize medically tailored meals Nicholas Florko By Nicholas Florko March 27, 2024 Food as medicine makes intuitive sense. Eating better can help treat certain medical conditions, including HIV and heart failure. The trick is how to define what constitutes a medically tailored meal. To fill that gap, the Food is Medicine Coalition, a group of community-based nonprofit food providers, released its accreditation standard yesterday, sharing it first with STAT’s Nicholas Florko. Some requirements: Organizations must have one accredited full-time dietitian on staff for every 1,000 clients they serve. No foods with artificial sweeteners, preservatives, or anything “ultra-processed.” Foods must be cooked in a way that “preserves the nutrient value of the food,” such as “baking, braising, and sautéing rather than frying.” The new standards were crafted to head off dilution of its goal — by commercial meal providers, among others — to become as much a part of health care as drugs and medical devices. Nick has more, including some pushback.

Does decaf coffee contain a harmful additive? Advocates want to ban a certain chemical in the brew Nicholas Florko By Nicholas Florko March 28, 2024 Could the FDA ban decaf? If consumer health advocates get their way, the FDA will ban a key chemical used to decaffeinate coffee beans that is almost but not entirely removed during the process. Methylene chloride, a since-banned paint stripper, is used by major coffee U.S. companies including Starbucks, Dunkin Donuts, and Folgers. In its petition the Environmental Defense Fund says a 66-year-old federal law requires the agency to ban the additive because it has been proven to cause cancer in rodents. The FDA estimated in 1985 that the risk of cancer for decaf drinkers was one in a million. “There’s more methylene chloride in the water that you brew your decaf with than came with the decaf roasted beans,” said James Coughlin, a food toxicology consultant to the coffee industry. “It’s not as if there’s no good substitute,” said Maria Doa, of the Environmental Defense Fund. STAT’s Nicholas Florko has the details and the history.

Covid’s gift: A window into the human immune response — in real time Immunologists would never deny Covid-19’s worldwide devastation, but if you look through their eyes back to 2020, when the disease still had no name but was spreading across the world, you’ll see a silver lining. For a window of time that has now closed, they could watch what happened when 8 billion people were exposed to a novel coronavirus. They had a front-row seat to witness how we developed immunity to the virus — and its variants — at a cellular level. Pandemics have emerged before, but this time scientists had the tools to study how the immune system awakens to a new threat and develops defenses against it. “You see textbook immunology happening in real time,” said Marc Veldhoen, a professor of immunology at the University of Lisbon. “You couldn't have designed a better experiment,” said Stephen Deeks, an HIV researcher at the University of California, San Francisco. STAT’s Helen Branswell tells us what they did with this opportunity — and what they learned.

REGISTER FOR FREE CE/CMEs | April 04, 2024 DHA, CCSS, “Evidence-Based and Promising Practices in Pediatric Care for Military Children and Youth" Live Event | 6.5 FREE CE/CME Credits

Greetings, Registration is OPEN for the upcoming Clinical Communities Speaker Series (CCSS), "Evidence-Based and Promising Practices in Pediatric Care for Military Children and Youth” occurring on April 4th, 2024, 8:55 a.m. - 5:30 p.m. (ET). This live event offers up to 6.5 Continuing Education/Continuing Medical Education (CE/CME) credits. Register here: Purpose The Defense Health Agency (DHA), J-7, Continuing Education Program Office (CEPO) Clinical Communities Speaker Series (CCSS) events are designed to address the professional practice gaps of our learners to improve the care that our health care professionals deliver. This continuing education (CE)/continuing medical education (CME) event is conducted to achieve results that reflect a change in skills, competence, and performance of the health care team, and patient outcomes. Collaboration occurs with the Department of Defense, several government agencies, and other civilian experts for recruitment of academic subject matter experts (SMEs), clinicians, and researchers to present on current promising, evidence-based research and best practices, thus enhancing the overall educational experience. Participants are expected to apply what they learned in providing patient care individually and collaboratively as a team towards improved patient outcomes. Target Audience This activity is designed to meet the educational needs of Physicians, Nurses, Pharmacists, Pharmacy Technicians, Physician Assistants, Optometrists, Social Workers, Audiologists, Speech Language Pathologists, Psychologists, Dentists, Dental Hygienists, Dental Technicians, Registered Dieticians, Dietetic Technicians, Athletic Trainers, Case Managers, Certified Counselors, Occupational Therapists, Occupational Therapist Assistants, Physical Therapists/Physical Therapist Assistants, Kinesiotherapists, and Healthcare Executives. This activity is also approved for physicians who are board certified with the American Board of Pediatrics and other health care professionals who support/care for U.S. active-duty service members, reservists, Coast Guard, Public Health Service, National Guardsmen, military veterans, and their families. Program Overview This event will explore the evidence-based practices in the care of the pediatric patient through educational content created by military and civilian Subject Matter Experts specializing in bioethics, research, healthcare, and academia. Each session is designed to refine the quality of care, achieve the best outcomes, and improve population health in children and youth. Attending this continuing education opportunity will advance the practice, skills, and knowledge of the pediatric care provider in service to children and youth engaged in the military and civilian healthcare and education system. Program Agenda 8:55 - 9:00 a.m. (ET) - Welcome Remarks Lolita T. O’Donnell, Ph.D., M.S.N., R.N. Division Chief Leadership Education Analysis Development Sustainment (LEADS) Division Academic Superintendent, Continuing Education Program Office (CEPO), Education and Training (E&T) Directorate, J-7 Defense Health Agency (DHA) Falls Church, Va. 9:00 – 9:10 a.m. (ET) - Opening Remarks Gregory Leskin, Ph.D. Director, The National Child Traumatic Stress Network Military and Veteran Families and Children & Academy on Child Traumatic Stress University of California, Los Angeles/Duke University, National Center for Child Traumatic Stress Los Angeles, Ca. Moderator Army Col. Joseph May, M.D., M.P.H., F.A.A.P., F.A.C.C. Chief, Department of Pediatrics Walter Reed National Military Medical Center Associate Professor of Pediatrics Uniform Services University of the Health Sciences Bethesda, Md. 09:10 –10:10 a.m. (ET) - S01: "Overdiagnosis or Underdiagnosis? Considerations for Diagnosing and Treating ADHD and Autism" Jennifer A. Ulbricht, Ph.D. Behavioral Health Clinical Management Team Medical Affairs DHA Falls Church, Va. 10:20 – 11:20 a.m. (ET) - S02: “Or At Least Do No Harm: The Complexities of Pediatric Healthcare Ethics” Theophil A. Stokes, M.D. Medical Director, Neonatology, Howard University Hospital Associate Chief, Division of Regional Hospital Based Specialties Children's National Hospital Associate Professor of Pediatrics, The George Washington University School of Medicine, and Health Sciences Washington, DC 11:30 a.m. - 1:00 p.m. (ET) - S03: “Pediatric Immunizations: Current and Future Considerations” Cecilia Mikita, M.D., M.P.H., F.A.A.A.A.I. Medical Director North Atlantic Region Vaccine Safety Hub DHA Public Health (DHA-PH) Immunization Healthcare Division Bethesda, Md. Lakshmi Panagiotakopoulos, M.D., M.P.H. Medical Officer Center for Disease Control and Prevention Division of Coronaviruses and Other Respiratory Viruses Division Atlanta, Ga. 2:00 p.m. – 3:00 p.m. (ET) - S04: "Mental Health Needs Amongst Military Children and Youth: Strategies to Improve Access and Outcomes” Mary Acri, Ph.D. Chief, Child and Adolescent Services Research Program and Clinical Epidemiology Branch Division of Services and Intervention Research National Institute of Mental Health Bethesda, Md. 3:10 – 4:10 p.m. (ET) - S05: "The Millennium Cohort Program: Understanding Risk and Context in the Life Course of the Military Child” Hope Seib McMaster, Ph.D. Principal Investigator, Millennium Cohort Family Study and Study of Adolescent Resilience Naval Health Research Center San Diego, Ca. Sabrina Richardson, Ph.D. Research Psychologist for the Millennium Cohort Program NHRC San Diego, Ca. 4:20 – 5:20 p.m. (ET) - S06: "Addressing Problematic Technology Use in Children and Youth” Navy Lt. Cmdr. Nathan R. Moon, Psy.D., A.B.P.P. Clinical Child Psychologist Educational and Developmental Services Navy Medicine Readiness and Training Center Okinawa Okinawa, Japan 5:20 – 5:30 p.m. (ET) - Closing Remarks Army Col. Maria Molina, M.D., F.A.C.O.G., F.A.C.S., C.H.S.E. Acting Director, J-7, Education and Training Defense Health Agency Falls Church, Va. This agenda is subject to change. Please visit the following website to register: Continuing Education This CE/CME activity is provided through the DHA J-7 CEPO and is approved for a total of 6.5 CE/CMEs. Commercial Support No commercial support was provided for this activity. Participation Costs There is no cost to participate in this activity. CE/CME Inquiries For all CE/CME related inquiries, please contact us at: V/r, DHA, J-7, CEPO

Decentralised, collaborative, and privacy-preserving machine learning for multi-hospital data

The Lancet Voice A new vaccine in the fight against malaria

Can the 2024 UK election change the child health trajectory? The Lancet Child & Adolescent Health

A global call for adolescent intimate partner violence prevention Savannah L Johnson,Jennifer Mootz,Bernadine Waller,Palmira Fortunato dos Santos,Florence Jaguga,Ali Giusto

The Lancet Countdown on Health and Climate Change: 2023 Global Launch Event

The Lancet Psychiatry Commission on Transforming Mental Health Implementation Research Published: March 26, 2024

The Lancet Psychiatry Commission on Transforming Mental Health Implementation Research Published: March 26, 2024 Effective approaches exist to prevent and treat mental illness and to promote mental health but most people who could benefit from evidence-based interventions (policies, programmes, and individual-level practices or services) do not receive them. Too often, research produces interventions and implementation strategies that are difficult to scale owing to misalignment with the political, cultural, policy, system, community, provider, and individual realities of real-world settings. This Commission considers strategies for transforming how research is done to produce more actionable evidence. It examines how to integrate research and real-world implementation; centre equity in mental health intervention and implementation research; apply a complexity science lens to mental health research; expand designs beyond the randomised clinical trial; and value transdisciplinarity across endeavours. Most mental health implementation research has been done in high-income countries but the Commission’s recommendations incorporate research from low-income and middle-income countries and call for strategies to expand mental health implementation research globally.

Streamlining Drug Development and Improving Public Health through Quantitative Medicine: An Introduction to the CDER Quantitative Medicine Center of Excellence APRIL 25, 2024Streamlining Drug Development and Improving Public Health through Quantitative Medicine: An Introduction to the CDER Quantitative Medicine Center of Excellence APRIL 25, 2024

viernes, 29 de marzo de 2024

Effective Health Care Program Nominate Topics To Be Addressed by Upcoming AHRQ Evidence-based Practice Center Program Evidence Reviews: Deadline March 30, 2024

Fiber Intake and Laxation Outcomes

Fiber Intake and Laxation Outcomes: This review is intended to provide a summary of evidence to serve as a foundation for the National Academies of Sciences, Engineering, and Medicine (NASEM) to review the DRI values for dietary fiber. This effort is part of a joint Working Group initiative between the United States and Canada Federal to review and update DRIs values.

Pharmacologic and Nonpharmacologic Treatments for Posttraumatic Stress Disorder: 2024 Update of the Evidence Base for the PTSD Trials Standardized Data Repository

Pharmacologic and Nonpharmacologic Treatments for Posttraumatic Stress Disorder: 2024 Update of the Evidence Base for the PTSD Trials Standardized Data Repository: PTSD is a disorder that results from being exposed to a traumatic event. People with PTSD have symptoms such as flashbacks, avoidance of trauma-related stimuli, negative beliefs about themselves and/or others, and hypervigilance. These symptoms reduce quality of life and function. The purpose of this report is to update the previous AHRQ report by identifying and abstracting data from newly published RCTs examining treatment for PTSD and comorbid PTSD/SUD: this project builds upon our previous work.

Failure To Rescue – Rapid Response Systems

Failure To Rescue – Rapid Response Systems: The Agency for Healthcare Research and Quality (AHRQ) Making Healthcare Safer (MHS) reports consolidate information for healthcare providers, health system administrators, researchers, and government agencies about practices that can improve patient safety across the healthcare system—from hospitals to primary care practices, long-term care facilities, and other healthcare settings. In spring 2023, AHRQ launched its fourth iteration of the MHS Report (MHS IV).

ADHD Diagnosis and Treatment in Children and Adolescents Systematic Review Mar 25, 2024 Attention Deficit Hyperactivity Disorder: Diagnosis and Treatment in Children and Adolescents The systematic review assessed evidence on the diagnosis, treatment, and monitoring of attention deficit hyperactivity disorder in children and adolescents to inform a planned update of the American Academy of Pediatrics guidelines.

Cybersecurity and How to Maintain Patient Safety Barbara Pelletreau, RN; John Riggi; Bryan M. Gale, MA; Sarah E. Mossburg, RN, PhD | March 27, 2024

Communication During Transitions of Care Ayse P. Gurses; Sarah Mossburg; Zoe Sousane | March 27, 2024

Equity in Patient Safety Angela D. Thomas, DrPH, MPH, MBA; Merton Lee, PhD, PharmD; Sarah Mossburg, RN, PhD | March 27, 2024

RaDonda Vaught says some system practices contributed to fatal mistake. March 27, 2024

Safety and Human Performance in the Operating Room and Other Extreme Environments. March 27, 2024

Use of computerized physician order entry with clinical decision support to prevent dose errors in pediatric medication orders: a systematic review. March 27, 2024

The impact of digital hospitals on patient and clinician experience: systematic review and qualitative evidence synthesis. March 27, 2024

Scoping review of the second victim syndrome among surgeons: understanding the impact, responses, and support systems. March 27, 2024

Risk management and patient safety in the artificial intelligence era: a systematic review. March 27, 2024

Describing the evidence linking interprofessional education interventions to improving the delivery of safe and effective patient care: a scoping review. March 27, 2024

The limits of clinician vigilance as an AI safety bulwark. March 27, 2024

Patients' and doctors' views and experiences of the patient safety trajectory of breast cancer care. March 27, 2024

Patient safety indicators during the initial COVID-19 pandemic surge in the United States. March 27, 2024 The COVID-19 pandemic led to dramatic changes in healthcare delivery and presented new challenges to safe patient care. Among patients ages 18 years and older admitted to the hospital between January 2019 and June 2020, this study found that the first surge of the COVID-19 pandemic was not associated with an increase in patient safety events (measured using the AHRQ patient safety indicators) among patients without COVID-19. Among the individual PSIs, only in-hospital falls with hip fractures were significantly higher during the first surge of the pandemic.

Organizational learning in the morbidity and mortality conference. March 27, 2024

7 New Clinical Practice Guidelines: What’s New New Clinical Practice Guidelines are published monthly after evaluation of guidelines recently released in the United States and internationally by major medical groups and organizations. Following systematic review, evidence-based recommendations are provided in an abbreviated format, with particular attention paid to specific areas of patient care such as workup, diagnosis, and treatment. For more extensive information and to review the recommendations in their entirety, see the reference(s) provided for each Clinical Practice Guideline and the resource(s) contained within. Management of Osteoarthritis of the Hip Clinical Practice Guidelines (AAOS, 2023) 2023 guidelines on the management of osteoarthritis of the hip from the American Academy of Orthopaedic Surgeons (AAOS) Mar 3, 2024 Clinical Practice Guidelines on Heart Failure-Related Cardiogenic Shock (ISHLT, 2024) 2024 clinical practice guidelines on heart failure-related cardiogenic shock published by the International Society for Heart and Lung Transplantation in Journal of Heart and Lung Transplantation. Feb 27, 2024 Anaphylaxis Clinical Practice Guidelines (JTFPP, 2023) 2023 guidelines from the Allergy Immunology Joint Task Force on Practice Parameters (JTFPP) for anaphylaxis, published in the Annals of Allergy, Asthma & Immunology Feb 26, 2024 Clinical Practice Guidelines for Early Breast Cancer (ESMO, 2024) 2024 update of guidelines on early breast cancer by the European Society for Medical Oncology. Feb 25, 2024 Antiplatelet Therapy Clinical Practice Guidelines (CCS/CAIC, 2023) 2023 Clinical practice guidelines focused updates on the use of antiplatelet therapy from the Canadian Cardiovascular Society and Canadian Association of Interventional Cardiology, published in the journal Canadian Journal of Cardiology. Feb 25, 2024 Clinical Practice Guidelines for the Management of Inherited Adenomatous Polyposis Syndromes (ASCRS, 2024) 2024 clinical practice guidelines on the management of inherited adenomatous polyposis syndromes, published in Diseases of the Colon and Rectum. Feb 22, 2024 Clinical Practice Guidelines on Pediatric Acute Bacterial Arthritis (PIDS/IDSA, 2023) 2023 Guidelines on acute bacterial arthritis in children from the Pediatric Infectious Diseases Society and the Infectious Diseases Society of America, published in Journal of the Pediatric Infectious Diseases Society. Feb 22, 2024

Development and evaluation of I-PASS-to-PICU: a standard electronic template to improve referral communication for inter-facility transfers to the pediatric intensive care unit. March 27, 2024 The I-PASS tool is a commonly-used tool to improve handoff quality. This study evaluated the usability of the I-PASS-to-PICU (Pediatric Intensive Care Unit) tool, which is designed to support handoffs between referring clinicians and receiving PICU physicians. Testing with a small group of PICU physicians using simulated and actual handoff calls indicated good feasibility.

Organisational conditions for safety management practice in homecare and nursing homes, pre-pandemic and in pandemic. March 27, 2024 Organisational conditions for safety management practice in homecare and nursing homes, pre-pandemic and in pandemic. Dellve L, Skagert K. Safety Sci. 2024;174:106488. Rates of transmission of COVID-19 were high in nursing homes for both residents and staff with wide variation in implementing infection control measures. This study describes the gaps between infection control work-as-imagined and work-as-done in nursing homes and home health before and during the pandemic. Gaps included instructions for personal protective equipment created for hospitals that were not practical for providing care inside a recipient's homecare or nursing home.

Analysis of intervention employability in pharmacy-related medication safety reports at a tertiary medical center. March 27, 2024 Analysis of intervention employability in pharmacy-related medication safety reports at a tertiary medical center. Crozier N, Robinson E, Murtagh NC, et al. Hosp Pharm. 2024;59(2):210-216. The Institute for Safe Medication Practices (ISMP) hierarchy of effectiveness of risk-reduction strategies ranks interventions from the least to most effective. Using 665 pharmacy-related medication safety reports at one hospital, researchers evaluated the actionability of the reports on the ISMP hierarchy. Three-quarters of the reports were only actionable at the least effective levels (e.g., suggestions to "be more careful", educational programs). The researchers suggest events that lent themselves to more effective levels of intervention were acted upon and, therefore, recurred less frequently.

Transfusion-related errors and associated adverse reactions and blood product wastage as reported to the National Healthcare Safety Network Hemovigilance Module, 2014-2022. March 27, 2024 Transfusion-related errors and associated adverse reactions and blood product wastage as reported to the National Healthcare Safety Network Hemovigilance Module, 2014-2022. Chavez Ortiz JL, Griffin I, Kazakova SV, et al. Transfusion. 2024;Epub Mar 12. Blood transfusion errors, while rare, can be severe and potentially fatal. This study used eight years of transfusion-related errors reported to the National Healthcare Safety Network (NHSN) Hemovigilance Module to quantify errors, adverse events, and blood wastage. Most reported errors were near misses and occurred during sample collection, sample handling, and product administration. Error reporting declined significantly during the study period; the researchers state efforts are underway to decrease reporting burden and increase participation in the NHSN Hemovigilance Module.

CDRHNew - News and Updates

jueves, 28 de marzo de 2024

Training Institute for Dissemination and Implementation Research in Genomics and Precision Public Health (TIDR-GPPH) UNC Precision Public Health Network, March 2024 (Posted Mar 20, 2024 7AM)

Guidance on Use of Race, Ethnicity, and Geographic Origin as Proxies for Genetic Ancestry Groups in Biomedical Publications G Feero et al, JAMA, March 12, 2024 (Posted Mar 12, 2024 0PM)

Cost-Effectiveness of Population-Based Multigene Testing for Breast and Ovarian Cancer Prevention. Fangjian Guo et al. JAMA Netw Open 2024 2 (2) e2356078 (Posted Feb 15, 2024 9AM)

Prediction of pyrazinamide resistance in Mycobacterium tuberculosis using structure-based machine-learning approaches

The development of a prediction model based on deep learning for prognosis prediction of gastrointestinal stromal tumor: a SEER-based study. Junjie Zeng et al. Sci Rep 2024 14(1) 6609

A treaty to prepare the world for the next pandemic hangs in the balance Cohen J. Science, Mar 15, 2024.

Human Genetics Society of Australasia Position Statement: Predictive and Presymptomatic Genetic Testing in Adults and Children. Danya F Vears et al. Twin Res Hum Genet 2024 1-8

The effectiveness of psychiatric genetic counseling training: An analysis of 13 international workshops. Tiera Mack et al. Am J Med Genet B Neuropsychiatr Genet 2024 e32978

Facilitating Generic Drug Product Development through Product-Specific Guidances APRIL 25, 2024

Defense Health Agency Launches New Digital Health Care Tools at Five Military Hospitals

What’s New for Biologics

Animal Studies for Dental Bone Grafting Material Devices - Premarket Notification (510(k)) Submissions Draft Guidance for Industry and Food and Drug Administration Staff MARCH 2024

Evaluation of Automatic Class III Designation (De Novo) Summaries - Invitae Common Hereditary Cancers Panel (DEN210011)

Accreditation Scheme for Conformity Assessment (ASCA) Center for Devices and Radiological Health's (CDRH)

Genetics providers' perspectives on the use of digital tools in clinical practice. Whiwon Lee et al. Genet Med 2024 101122

miércoles, 27 de marzo de 2024

Notice of Funding Opportunities

Notice of Funding Opportunities: Grant announcements from AHRQ for supporting research to improve the quality, effectiveness, accessibility, and cost effectiveness of health care

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.

What AHRQ Learned While Working to Transform Primary Care

Advancing Heart Health: Commentary Summarizes Lessons Learned in AHRQ Effort to Transform Primary Care

Advancing Heart Health AHRQ’s EvidenceNOW: Advancing Heart Health initiative showed that efforts to transform primary care must be responsive to changes, focus on personal relationships and remain flexible to accommodate practices’ most pressing needs rather than be tied to a specific disease or initiative, according to a commentary in the Annals of Family Medicine. The EvidenceNOW initiative provided external quality improvement support to help small- and medium-sized primary care practices implement the latest evidence to improve their delivery of cardiovascular care. Access the commentary.

A Nationally Representative Summary of 2020 Changes in the Use of Health Care in the United States

Statistical Brief 556: Concentration of Healthcare Expenditures and Selected Characteristics of Persons With High Expenses, United States Civilian Noninstitutionalized Population, 2018-2021. This Statistical Brief uses data from the 2021 Medical Expenditure Panel Survey-Household Component (MEPS-HC) to explore the concentration of healthcare expenditures and other selected characteristics of persons with high expenses.

Association Between Facility and Clinician Characteristics and Family Planning Services Provided During U.S. Outpatient Care Visits

Medicare meets the cloud: the development of a secure platform for the storage and analysis of claims data

AHRQ Grantee Profiles

AHRQ Grantee Profiles: These profiles highlight AHRQ research training grantees whose work has led to significant changes in health care policy and notably influenced research and practice. AHRQ supports a range of research training and career development grant programs that help emerging health services researchers better understand, improve, and share knowledge about how health care is delivered in the United States.

Tailoring Digital Technologies To Improve Outcomes Among Minorities With Chronic Conditions

Tailoring Digital Technologies To Improve Outcomes Among Minorities With Chronic Conditions: Grantee profile

The role of hospital-based vascular access teams and implications for patient safety: A multi-methods study

What's going well: a qualitative analysis of positive patient and family feedback in the context of the diagnostic process

Tools for the Diagnosis of ADHD in Children and Adolescents: A Systematic Review

Evidence-based Practice Center (EPC) Reports

Evidence-based Practice Center (EPC) Reports: The Agency for Healthcare Research and Quality (AHRQ), through its EPCs, sponsors the development of various reports to assist public- and private-sector organizations in their efforts to improve the quality of healthcare in the United States. These reports provide comprehensive, science-based information on common, costly medical conditions and new healthcare technologies and strategies. The EPCs review all relevant scientific literature on a wide spectrum of clinical and health services topics. EPCs also produce technical reports on methodological topics and other types of evidence synthesis-related reports. These reports may be used for informing and developing coverage decisions, quality measures, educational materials and tools, clinical practice guidelines, and research agendas. The EPCs also conduct research on methodology of evidence synthesis.

ADHD Diagnosis and Treatment in Children and Adolescents Systematic Review Mar 25, 2024ADHD Diagnosis and Treatment in Children and Adolescents Systematic Review Mar 25, 2024

Treatments for ADHD in Children and Adolescents: A Systematic Review

Comparison of evaluation methods for improving the usability of a Spanish mHealth tool

Family Support Services and Reported Parent Coping Among Caregivers of Children with Emotional, Behavioral, or Developmental Disorders

Postpartum Hospital Discharge: Birthing Parent Perspectives on Supportive Practices and Areas for Improvement

NEW! Earn 13.25 CEs: SBIA | Generic Drugs Forum 2024: Regulatory Considerations to Enhance Generic Drug Access Day One: Wed, April 10 | 8:30 AM - 5:00 PM ET Day Two: Thu, April 11 | 8:30 AM - 5:00 PM ET Day One: Wed, April 10 | 8:30 AM - 5:00 PM ET Day Two: Thu, April 11 | 8:30 AM - 5:00 PM ET

Short-Stay Units vs Routine Admission From the Emergency Department in Patients With Acute Heart Failure: The SSU-AHF Randomized Clinical Trial

Dental Utilization and Expenditures, U.S. Civilian Noninstitutionalized Population Aged 2 and Older, 2019-2021 Statistical Brief #555 | March 2024 | R. Henry Olaisen, PhD, MPH, PMP and Richard J Manski, DDS, MBA, PhD

FTC Continues to Rage Against Device Patent Listings in the Orange Book By Sara W. Koblitz —

Guidance Recap Podcast | Clinical Pharmacology Considerations for Antibody-Drug Conjugates

China urges hospitals to establish rapid response mechanism for patient complaints Xinhua | Updated: 2024-03-27 09:44

martes, 26 de marzo de 2024

Hair-Straightening Products Entail Acute Kidney Failure Risk Vincent Richeux March 26, 2024

Study Shows Elimination of Cervical Cancer With Vaccination; Oncologist Highlights the Importance Maurie Markman, MD

Handling and Retention of Bioavailability BA and Bioequivalence BE Testing Samples Guidance for Industry MARCH 2024

Register Today! Natural History Studies and Registries in the Development of Rare Disease Treatments Workshop

Natural History Studies and Registries in the Development of Rare Disease Treatments MAY 13, 2024

NCTR Research Highlights: Women in Cancer Research | FDA Presentation on Sequencing NCTR Researcher Serves as Chair for Women in Cancer Research During its 25th Year

More exposure to artificial, bright, outdoor nighttime light linked to higher stroke risk Air pollution and nighttime outdoor light each were associated with harmful effects on brain health, finds new study in the journal Stroke Another form of pollution is tied to stroke risk: outdoor light at night We know people exposed to air pollution may be more susceptible to strokes because the particulate matter they breathe in can lead to blood vessel inflammation. Outdoor light pollution at night is also suspected in stroke risk because it may interfere with melatonin production and the sound sleep it induces. A new study in the journal Stroke followed 28,000 people in China who lived in a large industrial city whose light exposure was tracked by satellite imaging. Researchers found greater stroke risk with each kind of pollution acting independently of the other. After six years of follow up, 1,278 of the study participants had suffered strokes. People with the highest exposure to light at night had a 43% greater risk of stroke, while people who had the highest exposure to air pollution also had a greater risk of stroke, from burning fuel (41%), dust and smoke (50%), and vehicle exhaust (31%). Those who had strokes tended to have lower income, as well as greater exposure to both air and light pollution. Outdoor light at night may be an emerging risk factor for stroke, the authors conclude.

Phase 3 Trial of Sotatercept for Treatment of Pulmonary Arterial Hypertension List of authors. Marius M. Hoeper, M.D., David B. Badesch, M.D., H. Ardeschir Ghofrani, M.D., J. Simon R. Gibbs, M.D., Mardi Gomberg-Maitland, M.D., Vallerie V. McLaughlin, M.D., Ioana R. Preston, M.D., Rogerio Souza, M.D., Ph.D., Aaron B. Waxman, M.D., Ph.D., Ekkehard Grünig, M.D., Grzegorz Kopeć, M.D., Ph.D., Gisela Meyer, M.D., et al., for the STELLAR Trial Investigators* For people with a rare and deadly lung disorder called pulmonary arterial hypertension, treatment has meant measures to relax their blood vessels so it's easier for their hearts to pump blood into their lungs. Now the FDA is expected to approve a new drug from Merck that more directly targets the illness by blocking proteins known as activins that are involved in the growth of cells within the blood vessels. Today’s decision follows a large trial published in the New England Journal of Medicine last year showing that the drug, called sotatercept, exceeded expectations in significantly increasing the distance that patients could walk and cutting their risk of death, worsening disease, and needing new treatments. The drug, given by injection every three weeks, does have a risk of bleeding so might be best suited at first for people at highest risk while longer-term data come in. STAT’s Elaine Chen has more. With a potent new medicine, Merck marks a return to cardiology Matthew Herper By Matthew Herper March 6, 2023 Merck drug for rare, deadly lung condition appears set for approval in U.S. Elaine Chen By Elaine Chen March 26, 2024

Disparities in donor acceptance rates point to need for more equitable heart transplant care Deborah Balthazar By Deborah Balthazar March 25, 2024 Acceptance rates by transplant teams for donated hearts varied by race and gender, study finds Researcher Khadijah Breathett calls the JAMA findings “really bizarre.” While access to donor hearts has improved in recent years, disparities persist in who gets a heart transplant. Breathett, an advanced heart failure transplant cardiologist at Indiana University Health, led a team that discovered both white and Black women were more likely to have an offered heart accepted by their transplant team, but Black men had the longest wait as transplant centers repeatedly rejected offers. The number of matched offers until an accepted offer was much lower for women, especially white women, and greatest for Black men. For every offer made, the odds were significantly lower for Black individuals than white individuals that one would be accepted. Breathett suspects bias, but in a companion editorial, Paul Heidenreich writes, “I don’t think we’ve proven that African Americans are getting worse care … But we do see concerning disparities.” STAT’s Deborah Balthazar has more.

THE WAR ON RECOVERY STAT is examining how the U.S. denies lifesaving medications — methadone and buprenorphine — to people with opioid addiction. Barely one-fifth of the roughly 2.5 million Americans with opioid use disorder receive treatment, and tens of thousands of l…

How expanded methadone access helped Switzerland defuse its drug crisis Lev Facher By Lev Facher March 26, 2024 Photography by Djamila Grossman for STAT At a leading Swiss addiction clinic in Zurich, all patients who need addiction care gain instant access to weeks’ worth of medication. They are not required to participate in counseling, or subjected to drug tests, or punished if they relapse and use any kind of illicit substances. American methadone clinics would say that approach leads to disaster. European experts disagree, saying that’s the continent’s key to success. They have a point in Switzerland, where the opioid death rate is now roughly one-twentieth the U.S. rate. In a dozen other wealthy, developed nations where methadone is far more accessible than in the U.S., public health outcomes are far better, with lower rates of opioid overdose, infectious disease transmission, and death. American doctors, lawmakers, and public health officials are beginning to speak out for liberalizing access to methadone as the best tool available to address the crisis. Those who take it are 59% less likely to die of opioid overdose. But American methadone clinics counter that argument, saying that the current restrictions are necessary safety precautions. That doesn’t go over in Europe. “There’s just no evidence for it,” said Philip Bruggmann, a Swiss doctor and medical director of the Arud Centre for Addiction Medicine, told STAT’s Lev Facher. “It really helps people to reintegrate, to stabilize, and I’m not aware of a single case of a person who became opioid-dependent because of this treatment. If you leave it to the black market, people disappear and you can’t reach them, and I think the risk is much bigger.”

National plans and awareness campaigns as priorities for achieving global brain health

No health without brain health The Lancet Global Health

GPS-derived environmental exposures during pregnancy and early postpartum - Evidence from the madres cohort

GPS-derived environmental exposures during pregnancy and early postpartum - Evidence from the madres cohort The built and natural environment factors (e.g., greenspace, walkability) are associated with maternal and infant health during and after pregnancy. Most pregnancy studies assess exposures to environmental factors via static methods (i.e., residential location at a single point in time, usually 3rd trimester). These do not capture dynamic exposures encountered in activity spaces (e.g., locations one visits and paths one travels) and their changes over time. In this study, researchers aimed to compare daily environmental exposure estimates using residential and global positioning systems (GPS)-measured activity space approaches and evaluated potential for exposure measurement error in the former. Author: Li Yi, Yan Xu, Sydney O'Connor, Jane Cabison, Marisela Rosales, Daniel Chu, Thomas A. Chavez, Mark Johnson, Tyler B. Mason, Sandrah P. Eckel, Theresa M. Bastain, Carrie V. Breton, John P. Wilson, Genevieve F. Dunton, Rima Habre Journal: The Science of the Total Environment, February 8

Maternal Dietary Patterns During Pregnancy Are Linked to Hypertensive Disorders of Pregnancy Among a Predominantly Low-Income US Hispanic/Latina Pregnancy Cohort

Maternal dietary patterns during pregnancy are linked to hypertensive disorders of pregnancy among a predominantly low-income US Hispanic/Latina pregnancy cohort Using the MADRES (Maternal and Developmental Risks from Environmental and Social stressors) study, researchers evaluated the association between diet during pregnancy and hypertensive disorders that disproportionally burdens Hispanic/Latina women. MADRES is a prospective pregnancy cohort of predominantly low-income Hispanic/Latina women in Los Angeles, California, who completed up to 2 staff-administered 24-hour dietary recalls in the third trimester of pregnancy. Author: Luis E Maldonado, Theresa M. Bastain, Claudia M. Toledo-Corral, Genevieve F. Dunton, Rima Habre, Sandrah P. Eckel, Tingyu Yang, Brendan H. Grubbs, Thomas Chavez, Laila A Al-Marayati, Carrie V. Breton, Shohreh F. Farzan Journal: Journal of the American Heart Association, February 27

Community based participatory research as a promising practice for addressing vaccine hesitancy, rebuilding trust and addressing health disparities among racial and ethnic minority communities

Community based participatory research as a promising practice for addressing vaccine hesitancy, rebuilding trust and addressing health disparities among racial and ethnic minority communities Building on the principles of community based participatory research (CBPR) and with the support of the National Institutes of Health (NIH), Project 2VIDA! was born. It is a multidisciplinary collaborative of academic researchers, community members, and clinicians whose aim is to foster sustainable partnerships to reduce the burden of COVID-19 in Hispanic and Black communities across Southern California. This article explores how this CBPR model has been well received by community members. Future health interventions focused on reducing health disparities should prioritize the role of the community, leverage the voices of key community partners, and be grounded in equitable power sharing. Author: Sophie E. O'Bryan, Fatima Muñoz, David Smith, Adriana Bearse, Blanca Melendrez, Biren Kamdar, Cynthia James-Price, Daniel Ramirez, Argentina E. Servin Journal: Human Vaccines & Immunotherapeutics, March 18

The PhenX Toolkit: Recommended Measurement Protocols for Social Determinants of Health Research

The PhenX Toolkit: recommended measurement protocols for social determinants of health research This article describes a basic protocol for using the PhenX (consensus measures for Phenotypes and eXposures) Toolkit to select and implement Social Determinants of Health SDoH measurement protocols for use in research studies. The availability of recommended measurement protocols for SDoH will enable investigators to consistently collect data for SDoH constructs. Author: Cataia L. Ives, Michelle C. Krzyzanowski, Vanessa J. Marshall*, Keith Norris, Myles Cockburn, Keisha Bentley-Edwards, Dinushika Mohottige, Keshia M. Pollack Porter, Denise Dillard, Yochai Eisenberg, Monik C. Jiménez, Eliseo J. Pérez-Stable*, Nancy L. Jones*, Jyoti Dayal, Deborah R. Maiese, David Williams, Tabitha P. Hendershot, Carol M. Hamilton Journal: Current Protocols, March 5

Influence of biopsychosocial factors on self-reported anxiety/depression symptoms among first-generation immigrant population in the U.S.

Influence of biopsychosocial factors on self-reported anxiety/depression symptoms among first-generation immigrant population in the U.S. Despite increasing studies on mental health among immigrants, there are limited studies using nationally representative samples to examine immigrants’ mental health and its potential biopsychosocial contributing factors, especially during the COVID-19 pandemic. This study explored and estimated the influence of life satisfaction, social/emotional support, and other biopsychosocial factors on self-reported anxiety/depression symptoms among a nationally representative sample of first-generation immigrants in the U.S. Author: David Adzrago*, Kiran Thapa, Janani Rajbhandari-Thapa, Saanie Sulley, Faustine Williams* Journal: BMC Public Health, March 15

A Scoping Review of Personalized, Interactive, Web-Based Clinical Decision Tools Available for Breast Cancer Prevention and Screening in the United States A Scoping review of personalized, interactive, web-based clinical decision tools available for breast cancer prevention and screening in the United States Personalized web-based clinical decision tools for breast cancer prevention and screening could address knowledge gaps, enhance patient autonomy in shared decision-making, and promote equitable care. The purpose of this review was to present evidence on the availability, usability, feasibility, acceptability, quality, and uptake of breast cancer prevention and screening tools to support their integration into clinical care. Author: Dalya Kamil*, Kaitlyn M Wojcik*, Laney Smith, Julia Zhang, Oliver W. A. Wilson*, Gisela Butera, Jinani Jayasekera* Journal: MDM Policy & Practice, March 17

CDER Establishes New Quantitative Medicine Center of Excellence

Streamlining Drug Development and Improving Public Health through Quantitative Medicine: An Introduction to the CDER Quantitative Medicine Center of Excellence APRIL 25, 2024

Prevalence of depressive symptoms among Hispanic/Latino ethnic subgroups during the COVID-19 pandemic Prevalence of depressive symptoms among Hispanic/Latino ethnic subgroups during the COVID-19 pandemic Hispanic/Latino populations experienced disproportionate exposure to depression risk factors during the COVID-19 pandemic. While aggregated data confirm the risks of depressive symptoms among Hispanic/Latino individuals, little research uses disaggregated data to investigate these risks based on ethnic subgroups. Using the "Understanding the Impact of the Novel Coronavirus (COVID-19) and Social Distancing on Physical and Psychosocial (Mental) Health and Chronic Diseases" survey, researchers in this study estimated the prevalence of depressive symptoms among Hispanic/Latino ethnic subgroups during the pandemic. Author: Maryam Elhabashy*, Jolyna Chiangong*, Kevin Villalobos*, Francisco A. Montiel Ishino, David Adzrago*, Faustine Williams* Journal: Scientific Reports, March 20

NCTR Science Insights—Looking Back at 2023 Accomplishments

FDA Approval of New Therapy, Duvyzat, for Duchenne Muscular Dystrophy Represents Several Meaningful Firsts By Charles G. Raver & James E. Valentine & Frank J. Sasinowski —

CDRHNew - News and Updates A comprehensive list of the latest CDRH updates.

Information Session: NIMH Intramural Research Program Training Opportunities (March) Date and Time March 28, 2024 1:00–3:00 p.m. ET Additional session dates 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 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.

lunes, 25 de marzo de 2024

Fiscal Year 2024 Generic Drug Science and Research Initiatives Public Workshop MAY 20 - 21, 2024 Fiscal Year 2024 Generic Drug Science and Research Initiatives Public Workshop May 20-21, 2024 FDA will provide an overview of the status of science and research initiatives for generic drugs and solicit public input. FDA uses this input from the generic drug industry, academia, patient advocates, professional societies, and other interested parties to develop an annual list of science and research initiatives specific to generic drugs.

Considerations and Potential Regulatory Applications for a Model Master File Workshop May 2-3, 2024 Considerations and Potential Regulatory Applications for a Model Master File Workshop May 2-3, 2024 FDA, model developers, and industry will discuss the concept, scope, and regulatory application of a Model Master File. FDA will illustrate how model master files can improve the efficiency with which evidence from modeling and simulation can facilitate drug product development. Additionally, presenters will explore how modeling and simulation can increase efficiency in application assessment and consistency in regulatory use and acceptance of established models.

Challenges and Opportunities for Modified Release Oral Drug Product Development Workshop April 18, 2024 Challenges and Opportunities for Modified Release Oral Drug Product Development Workshop April 18, 2024 Leaders and subject matter experts from regulatory agencies, industry, and academia will discuss current regulations around modified-release drug products for oral administration and identify areas of scientific need required to support efficient development and regulatory review of these products.

The Global Bioequivalence Harmonisation Initiative Workshop April 16-17, 2024 The Global Bioequivalence Harmonisation Initiative (GBHI) is intended to support the process of global harmonization via scientific discussion among international stakeholders. The GBHI Workshop allows scientists from the pharmaceutical industry and academia to exchange their experiences and views with the regulators and engage in active scientific discussions.

Generic Drugs Forum (GDF) 2024: Regulatory Considerations to Enhance Generic Drug Access APRIL 10 - 11, 2024 Generic Drugs Forum 2024: Regulatory Considerations to Enhance Generic Drug Access April 10-11, 2024 Experts from across FDA’s generic drug program will provide applicants with information on how to engage with the Agency and gain information about generic drug development and submitting high-quality abbreviated new drug applications (ANDAs) for assessment. Generic drug program leads will present resources, best practices, common deficiencies, policy updates, and opportunities to engage with the Agency from pre-ANDA to post-approval submissions.

Averting catastrophic tuberculosis costs in an Indian state: integration of Ayushman Bharat Arogya Karnataka with National Tuberculosis Elimination Program

Tuberculosis – eliminating the latent killer The Lancet Regional Health – Southeast Asia

CDER Establishes New Quantitative Medicine Center of Excellence

Dignity and support after cancer: we need to talk about palliative care The Lancet Regional Health – Americas


Factors associated with parental human papillomavirus vaccination intentions among adolescents from socioeconomically advantaged versus deprived households: a nationwide, cross-sectional survey

CRC: Next-Generation mt-sDNA Test Beats FIT for Sensitivity but Not Specificity Diana Swift March 25, 2024

AI's health misinformation challenge: Study calls for stronger safeguards and transparency

Navigating the minefield of AI in healthcare: Balancing innovation with accuracy

FDA Proposes New Ban of Electrical Stimulation Devices for Self-Injurious or Aggressive Behavior

Factors contributing to differences in cervical cancer screening in rural and urban community health centers A new study explains the rural-urban divide in cervical screening rates Despite the rate of women dying from cervical cancer being almost a third higher in rural areas than in urban ones, screening rates are actually lower in rural communities. A new study published in Cancer found that this disparity has persisted in the country’s community health centers, which serve marginalized populations regardless of their ability to pay. In rural CHCs, 38% of women were up to date on their cervical cancer screenings, compared to 43% in urban ones. Researchers found that the disparity could be mostly explained by increased use of CHCs in urban areas by patients who have limited English proficiency, and lower use in rural areas by those with Medicaid or no insurance. Other factors included the proportion of patients with incomes below the poverty line and broader community factors like the area’s level of unemployment and the density of primary care physicians. The analysis is based on data including all CHCs in the U.S. from 2014-2021.

During the pandemic, were great vaccines bad business? A company-by-company review Matthew Herper By Matthew Herper March 25, 2024 It’s been four years since Covid-19 emerged and I began to spend every day pacing the long hallway of my railroad apartment in Queens. A key factor in taming a pandemic that killed millions of people and brought the world to its knees was the creation of effective vaccines, which have saved millions of lives. You might assume developing these shots was an unmitigated financial win for companies. And, indeed, for Pfizer and its partner BioNTech, as well as for Moderna, the revenues generated were absolutely staggering. But investors have shrugged those sales off as gains that will not be repeated. STAT’s Matthew Herper offers an in-depth assessment of how each major pharmaceutical company fared in the vaccine race. Read more to see the real winners, the winning losers, the biggest loser, and more.

Nvidia says generative AI will revolutionize health care. So did IBM, with Dr. Watson Casey Ross By Casey Ross March 25, 2024 Will generative AI actually revolutionize health care? Health systems, drugmakers, and insurers are racing to build artificial intelligence technology into their operations, aligning themselves with corporate giants such as Microsoft, Google, and Nvidia, whose executives speak about each incremental advancement of AI as an earth-shattering event. “The generative AI revolution is here,” Jensen Huang, 61, Nvidia’s leather-jacket-clad CEO, declared during the company’s GTC conference in San Jose, Calif., last week. Maybe. The technology is undeniably getting more powerful and more beneficial to businesses in health care and beyond. But many physicians, chemists, and computer scientists also fear that the overheated rhetoric — and the thinly veiled profit motives behind it — will inevitably result in yet another letdown. And health care should have already learned this lesson a decade ago, STAT’s Casey Ross writes. IBM overhyped its Watson supercomputer during the deep learning run-up as a cancer cure, only to have its health care business collapse under the weight of its own exaggerations. So is it worth holding our breath on generative AI? Read more to find out.

Despite new Wegovy coverage, Medicare patients may face high drug costs and other hurdles Elaine Chen By Elaine Chen March 22, 2024 Medicare will cover Wegovy to prevent heart problems — but access could still be an issue Medicare confirmed last week that it will cover Novo Nordisk’s obesity drug Wegovy if prescribed to prevent heart problems. But policy experts say Medicare patients are still likely to encounter significant barriers getting access to the highly popular and expensive drug. The federal payer previously wasn’t reimbursing for Wegovy, since Medicare is legally barred from covering weight loss drugs. But the Food and Drug Administration this month approved Wegovy for preventing heart problems in people with obesity and heart disease, leading many to suspect that Medicare would start covering the drug for this usage. But there are still challenges ahead. “Even though Medicare is clarifying that they will reimburse for this indication, that does not necessarily mean that patients are going to have widespread access to the drug, at least not right away,” said Benedic Ippolito, an economist at the American Enterprise Institute. Read more from STAT’s Elaine Chen. Obesity drug Wegovy gets FDA approval to add cardiovascular benefits on its label Elaine Chen By Elaine Chen March 8, 2024 Medicare couldn’t cover Wegovy for weight loss. But now that it’s also a heart drug, the door is open Rachel Cohrs By Rachel Cohrs March 14, 2024

SCOTUS’ abortion pill mifepristone case is really about the FDA Sarah Owermohle By Sarah Owermohle March 25, 2024 Last week, the Texas Medical Board proposed draft guidance Friday in an attempt to clarify what constitutes emergency grounds for a legal abortion after pressure from the state Supreme Court and widespread uncertainty among physicians. The board’s language largely drew from existing state legislation, and its president, Sherif Zaafran, noted that physicians who deem an abortion to be medically necessary would be expected to document how the risk of death or major impairment was determined. The board would not issue a list of conditions that constitute a medical emergency, arguing that circumstances vary considerably and the same condition could be an emergency or not depending on context. Response to the guidance has been mixed — one woman who was denied an abortion as emergency medical care in Texas told the board she was “hopeful” but “skeptical” the proposal would help physicians. STAT’s Olivia Goldhill has more on the details of the guidance. Meanwhile, the U.S. Supreme Court will hear opening arguments tomorrow in an abortion medication case that pharmaceutical companies warn could upend the industry and paralyze drug development. Mifepristone was first approved by the Food and Drug Administration in 2000 for abortion up to seven weeks of pregnancy. That approval was later extended to 10 weeks, and eventually the in-person dispensing requirement was removed. Now, in the wake of the overturning of Roe v. Wade, both those later changes could be reversed after a Fifth Circuit Court of Appeals’ ruling. In addition to the clear ramifications for reproductive rights across the country, pharmaceutical companies and former health officials have argued that reversing the FDA’s decisions would upend and politicize otherwise routine regulatory review processes. “This is a dagger at the heart of the entire industry,” said Ovid Therapeutics CEO Jeremy Levin. Read more from STAT’s Sarah Owermohle about the far-reaching ramifications of the case.

Arkansas Law Prohibiting Manufacturer 340B Contract Pharmacy Restrictions Upheld by 8th Circuit By Faraz Siddiqui —

domingo, 24 de marzo de 2024

Systematic reanalysis of genomic data by diagnostic laboratories: a scoping review of ethical, economic, legal and (psycho)social implications. Marije A van der Geest et al. Eur J Hum Genet 2024 3 (Posted Mar 18, 2024 9AM) From the abstract: "In total, we identified nine ELSI aspects, such as (perceived) professional responsibilities, implications for consent and cost-effectiveness. The identified ELSI aspects brought forward necessary trade-offs for GHPs to consciously take into account when considering responsible implementation of systematic reanalysis of NGS data in routine diagnostics, balancing the various strains on their laboratories and personnel while creating optimal results for new and former patients. "

The Top Five: A Review of Post-Pandemic Patient Safety Priorities. March 20, 2024

Global Burden of Preventable Medication-related Harm in Health Care: A Systematic Review. March 20, 2024

All in Her Head. The Truth and Lies Early Medicine Taught Us About Women's Bodies and Why It Matters Today. March 20, 2024

2024 National Impact Assessment of the Centers for Medicare & Medicaid Services (CMS) Quality Measures Report. March 20, 2024

Question answering systems for health professionals at the point of care - a systematic review. March 20, 2024

Operating room organization and surgical performance: a systematic review. March 20, 2024

Medication errors in pediatric emergency departments: a systematic review and recommendations for enhancing medication safety. March 20, 2024

Systemic failures in health care oversight. March 20, 2024