The Yale University-Mayo Clinic Center of Excellence in Regulatory Science and Innovation (CERSI),  a joint effort between Yale University, Mayo Clinic and the Food and Drug Administration (FDA) to conduct research and develop tools to support regulatory decision-making, has received renewed FDA funding to advance its efforts to improve public health.

The renewed funding — spanning 5 years and up to $50 million —will support a wide range of research projects focused on areas such as the development of innovative scientific approaches, improved regulatory decision-making and better patient outcomes.

The continued collaboration will enable both institutions to advance their efforts to improve the safety and availability of medical products and treatments.

"The CERSI grant supports research that addresses the FDA’s highest priority questions in regulatory science," says Molly M. Jeffery, Ph.D., scientific director at Mayo Clinic for Emergency Medicine Research and the co-Principal Investigator for Yale-Mayo Clinic CERSI. “The work we do in collaboration with the FDA results in immediate impact both for scientists and policymakers and for the public.”

The Yale-Mayo Clinic CERSI is one of a few cooperative agreements that work to support the FDA strategic plan for regulatory science. The CERSIs’ work includes promoting innovation in clinical evaluations and personalized medicine, harnessing diverse health data through information sciences and strengthening social and behavioral science to help consumers and professionals make informed decisions about regulated products.

Dr. Jeffery notes that the grant renewal highlights the importance of continued efforts to support research that protects and advances public health.

"One of the best things about the CERSI is that the work we do directly influences policy and practice," says Dr. Jeffery. "The FDA works with the CERSIs to promote projects that answer their most pressing questions."

The CERSI program is led by the FDA's Office of Regulatory Science and Innovation (ORSI), in collaboration with FDA scientific experts and funding offices.

Mayo Clinic's program is coordinated through the Mayo Clinic Robert D. and Patricia E. Kern Center for the Science of Health Care Delivery and the Mayo Clinic Knowledge and Evaluation Research Unit. It also leverages another of the Kern Center's collaborative relationships by using data available through the OptumLabs Data Warehouse.

More information about CERSI programs is available on the FDA website 

The post Yale University-Mayo Clinic CERSI Receive up to $50 Million FDA Grant to Advance Medical Research appeared first on Mayo Clinic News Network.

ROCHESTER, Minn. — A study published in the Journal of the American College of Surgeons reveals that performing a minor surgical procedure on patients newly diagnosed with pancreatic cancer helps to identify cancer spread early and determine the stage of cancer. The researchers add that the surgery ideally should be performed before the patient begins chemotherapy.

"This is an important study because it supports that staging laparoscopy may help with determining a patient's prognosis and better inform treatment so that patients avoid unhelpful or potentially harmful surgical therapy," says Mark Truty, M.D., surgical oncologist at the Mayo Clinic Comprehensive Cancer Center, who led this research. "Pancreatic cancer is the least survivable of all cancers, and it spreads fast. So, to have this information if cancer has spread will benefit patients and help clinicians determine the right treatment for the patient as soon as possible."

The minimally invasive surgical procedure is called a staging laparoscopy and is when a surgeon inserts a light and a camera (laparoscope) into the abdomen through small, thin slits to visually see if cancer has spread within the abdominal cavity. The surgeon also may combine this with peritoneal washings, where fluid is inserted into the abdominal cavity and then removed and evaluated under a microscope for cancer cells.

During the five-year study, the authors evaluated data from more than 1,000 patients, and the research showed that 1 in 5 patients who underwent a staging laparoscopy for pancreatic cancer had cancer that spread in the liver or the lining of the abdomen (peritoneum). 

In addition, the researchers found a variety of factors that identified which patients were more likely to have cancer spread. These factors included the patient's age, the location of the tumor and tumor markers (CA 19-9) in the blood. The researchers say that the more risk factors that are present, the higher the risk of finding cancer spread.

"Based on these results, we recommend that staging laparoscopy be performed before starting chemotherapy in the majority of patients who have pancreatic cancer and are being considered for surgery," says first author Hallbera Gudmundsdottir, M.D., general surgery resident and Mayo Clinic Robert D. and Patricia E. Kern Center for the Science of Health Care Delivery Scholar. The findings on staging laparoscopy can help guide what treatment will be the best option for each patient, such as surgical removal or chemotherapy.

###

About Mayo Clinic
Mayo Clinic is a nonprofit organization committed to innovation in clinical practice, education and research, and providing compassion, expertise and answers to everyone who needs healing. Visit the Mayo Clinic News Network for additional Mayo Clinic news.

Media contact:

• Kelley Luckstein, Mayo Clinic Communications, newsbureau@mayo.edu

The post Staging pancreatic cancer early with minimally invasive surgery shows positive results in patient prognosis, Mayo Clinic study finds appeared first on Mayo Clinic News Network.

AcademyHealth's 2023 Annual Research Meeting at the Seattle Convention Center on June 24–27 will bring together experts in health services research and healthcare delivery.

Attendees can learn about how Mayo Clinic is helping to shape the future of healthcare, by visiting the booth of the Mayo Clinic Robert D. and Patricia E. Kern Center for the Science of Health Care Delivery.

Participants can speak directly with Mayo scientists at "Meet the Mayo Clinic Researcher" sessions, learn about opportunities to work at Mayo Clinic, and connect with peers to hear about the latest research and methods in the field.

The annual meeting will focus on learning, constructive feedback and networking. To learn more about the annual meeting and join the conversation on social media, follow Mayo Clinic's participation on Twitter @AcademyHealth and use the conference hashtag #ARM23.

Mayo Clinic presenters

Many of the Mayo Clinic researchers who will present at the meeting are staff or faculty members in the  Kern Center for the Science of Health Care Delivery. Center staff, scholars and internally affiliated researchers come from Mayo Clinic's campuses in Phoenix, Scottsdale, Jacksonville and Rochester, MN. Healthcare delivery research is also actively represented within Mayo Clinic Health System.

Ben Pollock, Ph.D., Kern Center for the Science of Health Care Delivery, will chair a session:

"The Science of Quality Measurement: Stakeholder Perspectives and Future Themes."

Molly Jeffery, Ph.D., Health Care Policy & Research, will chair two sessions:

"Rising Stars in Health Economics Interest Group: Showcasing New Research from 3 Health Economists in the Early Stages of Their Careers"

"Impact of Care Coordination on Outcomes for High-Cost, High-Need Populations"

In addition, the following Mayo Clinic staff will present abstracts and posters at the meeting:

"Artificial Intelligence-Guided Targeted Screening for Atrial Fibrillation: A Pragmatic, Digital-Enabled, Decentralized Trial"
Xiaoxi Yao, Ph.D., Cardiovascular Medicine

"National Trends in Emergency Conditions through the Omicron Wave of the COVID-19 Pandemic"
Maria Stevens, Health Care Policy and Research

Racial and Ethnic Disparities in Opioid Overdose Emergency Department Visits During and After the Early COVID-19 Pandemic
Maria Stevens, Health Care Policy and Research 

"Investigating the Relation of Social Vulnerability Factors to Heart-Related Cause of Deaths in the US: A Machine Learning Approach"
Alexander Keigley, Admission and Transfer Center

"Averting the Impending Storm: Health System Transformation and Aging Well"
Victor Montori, M.D., Endocrinology, Diabetes and Metabolism

"Hospital COVID-19 Preparedness: Are (Were) We Ready?"
Aaron Spaulding, Ph.D., Health Care Delivery Research

"Investigating the Relation of Social Vulnerability Factors to Heart Related Cause of Deaths in the U.S.: A Machine Learning Approach"
Alexander Keigley, Admission and Transfer Center

"Excess 30-Day Mortality Among Non-COVID Medicare Inpatient Encounters during the Early Pandemic"
Ben Pollock, Ph.D., Kern Center for the Science of Health Care Delivery

"Social Determinants and Social Needs Medication Management Support for Individuals with Limited English Proficiency: An Online Review of Patient Language Resources and Survey of Pharmacies"
Claire Arnold, M.D., Internal Medicine

"Evaluation of Patient Experiences as Part of the Pragmatic Non-Pharmacologic Options in Post-Operative Hospital-Based and Rehabilitation Pain Management (NOHARM) Trial"
Sarah Minteer, Ph.D., Kern Center for the Science of Health Care Delivery

"Mental Health and Substance Use National Trends in Synthetic and Other Opioid Overdose Mortalities Inside and Outside of the Hospital, 2018–2021"
Molly Jeffery, Ph.D., Health Care Policy & Research

"Hospital Characteristics Associated with the Hospital Consumer Assessment of Healthcare Providers and Systems (HCAHPS) Summary Star Rating"
Ugochukwu Ugwuowo, M.D., Kern Center for the Science of Health Care Delivery

"Evaluation of the Predictive Value of Routinely Collected Social Determinants of Health Measures"
Sam Savitz, Ph.D., Kern Center for the Science of Health Care Delivery

"Evaluation of Care Models for High-Need, Vulnerable Populations"
Molly Jeffery, Ph.D., Health Care Policy & Research

"The Science of Quality Measurement: Stakeholder Perspectives and Future Themes"
Ben Pollock, Ph.D., Kern Center for the Science of Health Care Delivery

"'I Can Forgive, But I Don’t Forget': A Qualitative Study of the Impact of the Killing of Mr. George Floyd and the COVID-19 Pandemic on the Cardiovascular Health of Black Minnesotans"
LaPrincess Brewer, M.D., Cardiovascular Medicine

"National Trends in the Prescribing of Buprenorphine for Opioid Use Disorder in Commercial and Medicare Advantage Enrollees, 2019–22"
Sam Savitz, Ph.D., Kern Center for the Science of Health Care Delivery

Learn more

Visit the AcademyHealth website.

The post Mayo Clinic to showcase advancements in science and healthcare delivery at AcademyHealth’s Annual Research Meeting appeared first on Mayo Clinic News Network.

An estimated 41.2% of Indigenous North Americans smoke, which is the highest rate of any race or ethnicity in the U.S., according to the Centers for Disease Control. The high prevalence of smoking among these diverse tribal communities has been linked to disparities in cancer, cardiovascular disease and cancer rates.

"These findings have important implications for public health efforts to lower smoking prevalence among Indigenous populations, help bridge the gap in health disparities and promote health equity," says Annie Rusk, M.D., a pulmonary disease specialist at Mayo Clinic.

Dr. Rusk, a member of a tribal nation herself, notes that many Native people have not been offered standard-of-care, evidence-based interventions.

In their review, the researchers analyzed 608 studies of smoking cessation interventions completed between 2010 and 2021. They found only 10 that examined standard-of-care interventions in Indigenous North Americans.

Among those studies, they identified five categories of smoking cessation therapies that may help improve smoking cessation outcomes: phone or web-based tools, culturally tailored interventions, the inclusion of Indigenous study personnel, behavioral intervention aids and medications.

Their review found that the two most effective approaches were providing individualized counseling sessions or offering access to validated smoking cessation tools, including medications. Involving tribal or community input in planning the studies also was found to be helpful.

They noted an overall favorable smoking cessation rate of 21.8% among Indigenous North Americans, with 67% of participants using medications. Within that group, 52% of participants received varenicline, 42% accessed nicotine replacement therapy and 6% were given bupropion.

In addition to finding that medications were the most beneficial smoking cessation aid, researchers found that the most effective single intervention included individualized counseling sessions tailored to the tribe or community.

"Many people have tried to make interventions culturally tailored or to acknowledge the role of tobacco because there is a spiritual element to tobacco use for many tribes, particularly in the Northwest," says Dr. Rusk. "Each tribal nation is so different and has different practices and beliefs that you can't have a blanket intervention for every tribe because it's going to be different in terms of beliefs and practices you're walking into."

There are over five million Indigenous North Americans in the U.S., represented by 574 federally recognized tribal communities, with roughly 54% of the population residing in rural areas. Among the various communities, examples of culturally tailored cessation interventions include acknowledging the traditional role of tobacco, hiring Indigenous study staff and collaborating with Indigenous communities.

The researchers further underscored that culturally tailored collaborative efforts with tribal communities in planning and implementing interventions aided in improving smoking cessation outcomes. Identifying the economic and social conditions that influence a person, differences in health status and tobacco's role in specific communities provided additional background and understanding within the study.

Dr. Rusk emphasizes the importance of approaching every patient with evidence-based treatments.

"When it comes to health care disparities, there is this preconceived notion that a certain population isn't interested in receiving the same treatments," says Dr. Rusk. "If you don't know something, just ask. If you're asking from a place that's sincere, that's the first way to start a dialogue with patients who are not like yourself," says Dr. Rusk.

The Mayo Clinic Robert D. and Patricia E. Kern Center for the Science of Health Care Delivery supported the research. Review the study for a complete list of authors, disclosures and funding.

The post Medications, counseling help Indigenous North Americans quit smoking appeared first on Mayo Clinic News Network.

ROCHESTER, Minn. — According to a new study published by Mayo Clinic researchers, the COVID-19 pandemic was linked to a 17% increase in the death rate in Minnesota during the first year of the pandemic compared to the two previous years.

Deaths were driven by both COVID-19 and other causes linked with preventable "deaths of despair," such as overdose, alcohol use and malnutrition.

The study analyzed Minnesota death certificate data available through the Rochester Epidemiology Project for 89,910 deaths in 2018–2019 and 52,030 deaths in 2020 to examine the effects of the pandemic on deaths across the state. This study represents the first analysis of complete population-level data in Minnesota on COVID-19, analyzing all-cause and cause-specific mortality in 2020.

Older adults and racial and ethnic minority populations, especially Native Americans, were disproportionately affected, according to the study. Authors say the study's findings revealed disparities in certain populations due to a lack of access to medical care.

Researchers identified a 68% increase in assault by firearms, a 49% increase in accidental poisonings, a 48% increase in malnutrition and a 25% increase in liver disease. 

Lead author, Rozalina McCoy, M.D., an endocrinologist and primary care physician, noted that COVID-19 caused or contributed to almost 10% of all Minnesota deaths in 2020. Social isolation was a major cause of these deaths, especially among older people in rural areas.

"We were expecting to see heart disease, cancer, stroke, all those things where people delay care, and we didn't see any of that," says Dr. McCoy.

The study’s findings serve as a reminder of the need for continued vigilance in the face of COVID-19 and the importance of supporting communities and populations affected by the pandemic.

The research team plans to continue to assess the pandemic's long-term effect on Minnesota death rates and identify practical solutions to mitigate the effects. They also call for continued monitoring of excess mortality over time.

The Mayo Clinic Robert D. and Patricia E. Kern Center for the Science of Health Care Delivery provided methodologic expertise throughout the study. The Mayo Clinic Department of Emergency Medicine supported the research. Review the study for a complete list of authors, disclosures and funding.

### 

About Mayo Clinic 
Mayo Clinic is a nonprofit organization committed to innovation in clinical practice, education and research, and providing compassion, expertise and answers to everyone who needs healing. Visit the Mayo Clinic News Network for additional Mayo Clinic news.

Media contact: 

• Vincent Jacobbi, Mayo Clinic Communications, newsbureau@mayo.edu 

The post ‘Deaths of Despair’ contribute to 17% rise in Minnesota’s death rate during COVID-19 pandemic appeared first on Mayo Clinic News Network.

Prescription opioid use could have a negative effect on cognitive function in older adults, according to a recent Mayo Clinic study published in the Journal of the American Geriatrics Society. The population-based observational study used data from the Mayo Clinic Study of Aging, a research initiative examining the cognitive decline in older people for nearly 20 years. 

Findings

The study found that 70% of participants received at least one opioid prescription over an average of 7.5 years. Each prescription was linked to declines in cognitive performance, particularly in memory, language and attention. Those receiving opioids also had a 20% higher chance of developing mild cognitive impairment, a state of cognitive decline that exceeds normal aging.

“This information is important to include in shared decision-making between patients and their health care professionals regarding optimal pain management strategies,” says Nafisseh Warner, M.D., an anesthesiologist and pain medicine physician.

Apart from her clinical duties, Dr. Warner also is heavily engaged in clinical research, which is supported by the National Institute on Aging, and was a Kern Health Care Delivery Scholar at the Mayo Clinic Robert D. and Patricia E. Kern Center for the Science of Health Care Delivery. The Kern Health Care Delivery Scholars Program trains doctoral-level fellows and junior faculty in health services research.

Pain is considered common in older adults, with more than half of those 65 or older experiencing pain on most days. Study authors suggest that when considering the use of prescription opioids in older adults, treatment should be tailored to each patient through assessment of risks and benefits and close clinical follow-up.

The researchers believe that the results of their study could lead to the development of more effective treatment strategies for older adults and help to mitigate the negative impact of prescription opioids on cognitive function.

They note that the mechanisms by which opioids may lead to cognitive decline are not fully understood. The key question is whether observed associations between prescription opioids and cognitive decline show causal relationships, or whether prescription opioids are a marker for other conditions associated with cognitive dysfunction.

“This data, while compelling, does not establish a causal link between prescription opioids and cognitive decline," says Dr. Warner. "However, a clear association exists between opioids and long-term cognitive decline, which should spark conversation when considering whether to start an older adult on a prescription opioid.”

Dr. Warner further states that any treatment decision should be made by considering what matters most to the patient, including the patient's health, life goals and care preferences.   

“When we decide to proceed with opioid therapy, it’s important to optimize other factors that may be protective against cognitive declines, such as sleep, exercise and socialization, “says Dr. Warner.

What's next?

As trends in opioid prescribing for U.S. adults have changed considerably in recent years, future longitudinal studies are necessary to assess the broader view of the study’s findings, evaluate geographic and socioeconomic disparities in prescription opioid availability, and investigate the mechanisms underlying the association between opioid availability and long-term cognitive function in older adults.

The researchers note that this study is a reminder of the need for continued research on the effect of prescription opioids on older adults and the importance of considering the potential consequences of opioid use in this population. They plan to continue their work to understand the long-term effect of prescription opioids on cognitive function in older adults and to develop practical solutions to address this issue.

The National Institute on Aging (NIA) and the Mayo Clinic Robert D. and Patricia E. Kern Center for the Science of Health Care Delivery supported the research. Review the study for a complete list of authors, disclosures and funding.

The post Do prescription opioids impact cognitive function in older adults? appeared first on Mayo Clinic News Network.

ROCHESTER, Minn. — Artificial intelligence can improve diagnosis and treatment for patients, but first the AI-enabled clinical tools have to be easily available and used.

New research from Mayo Clinic finds that clinicians who were high adopters of an AI-enabled clinical decision support tool were twice as likely to diagnose low left ventricular ejection fraction as low adopters of the tool. The study, published in Mayo Clinic Proceedings, found wide variation in the rate of adoption of AI recommendations. Clinicians who were high adopters tended to be less experienced in dealing with patients with complex health issues, but age, gender, years of experience and number of patients cared for were not significant factors.

"It was surprising to see the significant difference in the rate of diagnosis between high adopters and low adopters," says David Rushlow, M.D., a Mayo Clinic physician and chair of Family Medicine for Mayo Clinic in the Midwest. "The tool is extremely helpful, but we did not expect to see a full doubling of the diagnosis rate of low ejection fraction as compared to low adopters."

Ejection fraction measures the percentage of blood that leaves the heart each time it contracts. Low ejection fraction can be caused by heart muscle weakness, such as cardiomyopathy, as well as heart valve problems, uncontrolled high blood pressure or damage caused by a heart attack.

Early diagnosis and treatment in patients with low ejection fraction is critical to reduce the risk of symptomatic heart failure, hospitalization and mortality. "AI decision support tools have the potential to be very effective in aiding the diagnosis of serious health conditions before the onset of usual clinical symptoms, and may outperform traditional diagnostic approaches," Dr. Rushlow says.

Clinicians at 48 Mayo Clinic primary care practices in Minnesota and Wisconsin participated in the randomized controlled trial, which involved 358 physicians, nurse practitioners and physician assistants, of which 165 clinicians were randomized to the AI arm and were included in the current adoption analysis. The AI algorithm was run on 22,641 patients who had an electrocardiogram (ECG) performed between Aug. 5, 2019, and March 31, 2020. The clinicians who were randomized to the intervention group had access to the screening report, which displayed the AI-ECG screening as positive or negative; the clinicians who were randomized to usual care did not have access.

When the report was negative, no further testing was recommended, but when it was positive, the recommendation was "to consider ordering an echocardiogram." The clinicians also received an email alert when the AI-ECG screening was positive, indicating patients had a high likelihood of previously unrecognized low ejection fraction.

"Clinicians who were most likely to follow through with the recommendations of the AI decision aid tended to be less experienced in dealing with complex patients," says Dr. Rushlow. "This demonstrates the importance of AI systems that integrate seamlessly into the workflows of clinicians. Given the technical nature of AI in health care, it often is initiated and developed in academic specialty practices. To maximize AI's benefits, more collaboration is needed between specialty practices and primary care."

Mayo Clinic holds a patent for the AI technology and may receive financial benefits from it, but it will not benefit financially from its use in the care of patients at Mayo Clinic. Co-authors Itzhak Attia, Ph.D., Paul Friedman, M.D., and Francisco Lopez-Jimenez, M.D., also may receive financial benefits from this agreement. The remaining co-authors report no competing interests.

The study was supported in part by Mayo Clinic Robert D. and Patricia E. Kern Center for the Science of Health Care Delivery.

###

About Mayo Clinic Proceedings
Mayo Clinic Proceedings is a monthly peer-reviewed journal that publishes original articles and reviews on clinical and laboratory medicine, clinical research, basic science research, and clinical epidemiology. The journal, sponsored by the Mayo Foundation for Medical Education and Research as part of its commitment to physician education, has been published for 95 years and has a circulation of 127,000.

About Mayo Clinic
Mayo Clinic is a nonprofit organization committed to innovation in clinical practice, education and research, and providing compassion, expertise and answers to everyone who needs healing. Visit the Mayo Clinic News Network for additional Mayo Clinic news.

Media contact:

• Jay Furst, Mayo Clinic Education Communications, newsbureau@mayo.edu

The post High adopters of AI-enabled screening tool are more likely to diagnose left ventricular dysfunction than low adopters, Mayo Clinic study finds appeared first on Mayo Clinic News Network.

ROCHESTER, Minn. — Mayo Clinic researchers have found that using artificial intelligence (AI) algorithms to analyze patterns of changes in women who are in labor can help identify whether a successful vaginal delivery will occur with good outcomes for mom and baby. The findings were published in PLOS ONE.

"This is the first step to using algorithms in providing powerful guidance to physicians and midwives as they make critical decisions during the labor process," says Abimbola Famuyide, M.D., a Mayo Clinic OB-GYN and senior author of the study. "Once validated with further research, we believe the algorithm will work in real time, meaning every input of new data during an expectant woman's labor automatically recalculate the risk of adverse outcome. This may help reduce the rate of cesarean delivery, and maternal and neonatal complications."

Women in labor understand the importance of periodic cervical examinations to gauge the progress of labor. This is an essential step, as it helps obstetricians predict the likelihood of a vaginal delivery in a specified period of time. The problem is that cervical dilation in labor varies from person to person, and many important factors can determine the course of labor.

In the study, researchers used data from the Eunice Kennedy Shriver National Institute of Child Health and Human Development's multicenter Consortium on Safe Labor database to create the prediction model. They examined more than 700 clinical and obstetric factors in 66,586 deliveries from the time of admission and during labor progression.

The risk-prediction model consisted of data known at the time of admission in labor, including patient baseline characteristics, the patient's most recent clinical assessment, as well as cumulative labor progress from admission. The researchers explain that the models may provide an alternative to conventional labor charts and promote individualization of clinical decisions using baseline and labor characteristics of each patient.

"It is very individualized to the person in labor," says Dr. Famuyide. He adds that this will be a powerful tool for midwives and physicians remotely as it will allow time for transfers of patients to occur from rural or remote settings to the appropriate level of care.

"The AI algorithm’s ability to predict individualized risks during the labor process will not only help reduce adverse birth outcomes but it can also reduce healthcare costs associated with maternal morbidity in the U.S., which has been estimated to be over $30 billion," adds Bijan Borah, Ph.D., Robert D. and Patricia E. Kern Scientific Director for Health Services and Outcomes Research.

Validation studies are ongoing to assess the outcomes of these models after they were implemented in labor units.

This study was conducted in collaboration with scientists from the Mayo Clinic Robert D. and Patricia E. Kern Center for the Science of Health Care Delivery. The authors have declared no competing or potential conflicts of interest.

###

About Mayo Clinic
Mayo Clinic is a nonprofit organization committed to innovation in clinical practice, education and research, and providing compassion, expertise and answers to everyone who needs healing. Visit the Mayo Clinic News Network for additional Mayo Clinic news.

Media contact:

• Kelley Luckstein, Mayo Clinic Communications, newsbureau@mayo.edu

The post Mayo Clinic study shows successful labor outcomes in expectant mothers using AI appeared first on Mayo Clinic News Network.

ROCHESTER, Minn. — Buprenorphine is a prescription approved by the Food and Drug Administration (FDA) that effectively treats opioid dependence or addiction. But women, as well as Black and Hispanic populations, do not have equal access to this potentially lifesaving medication, new Mayo Clinic research finds. The study published Friday, June 3, in JAMA Network Open.

The research team used the OptumLabs Data Warehouse to examine 3,110 filled prescriptions of buprenorphine from 72,055 emergency department visits across the U.S. from 2014 to 2020. While access to the medication increased over time for all groups studied, it was consistently lower for people 41 and older, women, and Black and Hispanic people. These disparities remained relatively steady over the years studied.

"The persistence of the disparities is frustrating. This is a truly lifesaving treatment. But it does appear that all groups are gaining access over time, which is what we want to see," says Molly Jeffery, Ph.D., scientific director for Mayo Clinic's Division of Emergency Medicine Research and the study's senior author.

The researchers note that people with socioeconomic advantages — white, male or younger — were more likely to receive buprenorphine. "These findings are not surprising, given that patient- and system-level barriers for accessing buprenorphine often disproportionately impact vulnerable populations," they write. They say that obstacles to receiving the drug include systemic racism, mistrust of health care professionals and the health care system, not enough clinicians able and prepared to prescribe buprenorphine in the emergency department, regulatory requirements, reimbursement issues, and addiction and mental health stigmas.

"The laws that currently limit access to buprenorphine are a legacy of an earlier opioid epidemic from literally 100 years ago. Those laws are based in mistrust of physicians and patients and a fundamental misunderstanding about substance use disorders," Dr. Jeffery says. "Making it easy to access safe and effective treatment is the best way to fight the epidemic of opioid overdoses, which has gotten worse during the COVID-19 pandemic."

The FDA approved buprenorphine to treat opioid use disorder in 2002. Since then, the National Institutes of Health points to several studies showing its efficacy in treating opioid addiction and thereby reducing opioid overdose deaths. A 2014 meta-analysis study showed that patients receiving buprenorphine were 1.82 times more likely to stay in treatment than those who received a placebo.

To Dr. Jeffery and her Mayo colleagues, the solution is simple: Get more physicians to prescribe buprenorphine.

"We know exactly what to do to close the gap: Get more health care providers, particularly primary care providers, involved in prescribing buprenorphine," Dr. Jeffery says. "Mayo Clinic recognizes the importance of primary care access to buprenorphine, and our clinicians are addressing the disparity gap by prescribing buprenorphine whenever appropriate and providing it through a primary care program and an addiction clinic."

Dr. Jeffery said another way to close the gap is to remove policy barriers, such as additional requirements for clinicians to prescribe buprenorphine beyond what's needed for an opioid prescription. Policies like that "needlessly limit access to a safe and effective treatment and increase stigma," she adds.

These findings also will be presented at the AcademyHealth Annual Research Meeting on Sunday, June 5, in Washington, D.C., by lead author Maria Stevens, a Mayo Clinic researcher and a Ph.D. candidate in Health Policy and Management at the University of North Carolina at Chapel Hill in the Gillings School of Global Public Health.

The research is supported by the Mayo Clinic Robert D. and Patricia E. Kern Center for the Science of Health Care Delivery. The center works within the medical practice, gathering and analyzing data with the goal of making broad-based quality and efficiency improvements in patient care at Mayo and beyond.

Dr. Jeffery is a health care practice and policy researcher in the Mayo Clinic Kern Center for the Science of Health Care Delivery. Stevens is also a researcher in the center.

###

About OptumLabs
OptumLabs is a collaborative center for research and innovation co-founded by Optum Inc. and Mayo Clinic, and focused on improving patient care and patient value. The OptumLabs Data Warehouse contains de-identified data from a large U.S. health plan with claims from commercial and Medicare Advantage enrollees, as well as de-identified electronic health record data from a nationwide network of provider groups. The Mayo Clinic Robert D. and Patricia E. Kern Center for the Science of Health Care Delivery, which leads the relationship with OptumLabs for Mayo Clinic, has published a number of studies identifying areas for potential improvements in health care delivery using the OptumLabs Data Warehouse.

About Mayo Clinic
Mayo Clinic is a nonprofit organization committed to innovation in clinical practice, education and research, and providing compassion, expertise and answers to everyone who needs healing. Visit the Mayo Clinic News Network for additional Mayo Clinic news.

Media contact:

• Adam Harringa, Mayo Clinic Public Affairs, newsbureau@mayo.edu

The post Disparities in opioid treatment access remain for women, Black and Hispanic people appeared first on Mayo Clinic News Network.

ROCHESTER, Minn. — Atrial fibrillation, the most common cardiac rhythm abnormality, has been linked to one-third of ischemic strokes, the most common type of stroke. But atrial fibrillation is underdiagnosed, partly because many patients are asymptomatic.

Artificial intelligence-enabled electrocardiography (ECG) was recently shown to identify the presence of brief episodes of atrial fibrillation, and the ability of an AI-enabled ECG algorithm to predict atrial fibrillation up to 10 years before clinical diagnosis has been confirmed in a population-based study conducted by Mayo Clinic researchers.

A new population-based study from Mayo Clinic now offers evidence that the algorithm can help identify patients at greater risk of cognitive decline. AI-enabled ECG that shows high probability of atrial fibrillation also was associated with the presence of infarctions, or incidents of cerebral stroke, on MRI, according to the study.

The study is described in an article, "Artificial Intelligence-Enabled Electrocardiogram for Atrial Fibrillation Identifies Cognitive Decline Risk and Cerebral Infarcts," which is published in Mayo Clinic Proceedings.

Most of the infarctions observed were subcortical, meaning that they occurred in the region of the brain below the cortex. This suggests that AI-enabled ECG not only predicts atrial fibrillation, but also detects other cardiac disease markers and correlates with small vessel cerebrovascular disease and cognitive decline.

"This study finds that artificial intelligence-enabled electrocardiography acquired during normal sinus rhythm was associated with worse baseline cognition and gradual decline in global cognition and attention," says Jonathan Graff-Radford, M.D., a Mayo Clinic neurologist and the study's corresponding author. "The findings raise the question whether initiation of anticoagulation is an effective and safe preventive strategy in individuals with a high AI-ECG algorithm score for reducing the risk of stroke and cognitive decline."

Prospective controlled studies are needed to determine whether a high atrial fibrillation score on an AI-enabled electrocardiogram could be a biomarker to identify patients for anticoagulation or more aggressive stroke risk factor modification, Dr. Graff-Radford says.

The retrospective study reviewed sinus-rhythm ECG of 3,729 patients with a median age of 74 years who were enrolled in the Mayo Clinic Study of Aging between 2004 and 2020. Adjusting for demographic factors, the AI-enabled ECG atrial fibrillation score correlated with lower baseline and faster decline in global cognitive scores. About one-third of the patients who underwent ECG also had an MRI, and high atrial fibrillation probability in the ECG correlated with MRI-detected cerebral infarcts.

"Application of this AI-ECG algorithm may be another way to screen individuals not only to determine risk of atrial fibrillation, but also to identify future risk of cognitive decline and stroke," says Dr. Graff-Radford.

Research reported in the article was supported by grants from the National Institute on Aging and the National Institutes of Health. The study was made possible by the Rochester Epidemiology Project. Potential competing interests are identified in the article. Among the potential competing interests, Peter Noseworthy, M.D., a Mayo Clinic cardiologist, and Mayo Clinic have filed patents related to the application of AI to ECG for diagnosis and risk stratification.

Journalists: Video of Erika Weil, M.D., first author of the study, discussing the findings is available here.

###

About Mayo Clinic Proceedings
Mayo Clinic Proceedings is a monthly peer-reviewed journal that publishes original articles and reviews on clinical and laboratory medicine, clinical research, basic science research, and clinical epidemiology. The journal, sponsored by Mayo Foundation for Medical Education and Research as part of its commitment to physician education, has been published for 95 years and has a circulation of 127,000.

About Mayo Clinic
Mayo Clinic is a nonprofit organization committed to innovation in clinical practice, education and research, and providing compassion, expertise and answers to everyone who needs healing. Visit the Mayo Clinic News Network for additional Mayo Clinic news.

Media contact:

• Terri Malloy, Mayo Clinic Public Affairs, newsbureau@mayo.edu

The post Mayo Clinic research finds AI-enabled ECGs may identify patients at greater risk of stroke, cognitive decline appeared first on Mayo Clinic News Network.