Tag: The Lancet

$Significant variations in hip fracture health costs and care between NHS hospitals and regions, study finds$

Significant variations in hip fracture health costs and care between NHS hospitals and regions, study finds

Newswise — There are significant variations in healthcare spending and care delivery across NHS hospitals in England and Wales following hip fracture, a new study aimed at understanding how hospital care impacts patients’ outcomes and costs has revealed.

The study, led by the University of Bristol and funded by Versus Arthritis, highlights the urgent need for evidence-based quality improvement strategies to reduce healthcare spending and improve patient outcomes in the year following a hip fracture. The research is published online in The Lancet Healthy Longevity today [10 July].

Hip fracture is a serious health concern, with more than 70,000 older adults admitted to a UK hospital each year. This study highlights the high healthcare burden associated with breaking a hip.

The research analysed data from national databases for 178,757 hip fracture patients aged 60 years and above in England and Wales, who broke their hip between 2016 and 2019, followed up to just before the pandemic. More than one in four patients died within a year of their hip fracture.

Patients spent an average of 32 days in hospital in the year following a hip fracture, resulting in substantial inpatient costs of on average £14,642 per patient – a cost similar to that incurred in the year after a stroke, and that exceeds costs of many common cancers. But this cost varied substantially between hospitals, with more than a two-fold difference in spending, ranging from £10,867 to £23,188 per patient, between 172 NHS hospitals studied in England and Wales.

The researchers identified that in hospitals where patients are up and about quickly after their operation and where physiotherapy is provided seven days a week, patient costs were lower, and patients spent fewer days in hospital in the year following hip fracture.

The research further highlighted the crucial role of orthogeriatricians – consultant geriatricians who specialise in the care of people with fractures – in hip fracture care.

Dr Petra Baji, Senior Research Associate in Health Economics at Bristol Medical School: Translational Health Sciences (THS) and the paper’s first author, explained: “The findings suggest that having all patients assessed by an orthogeriatrician within the first days of admission could cut healthcare spending by £529 per patient, as well as reduce the chance of dying by 15% in the year following hip fracture.”

Dr Rita Patel, Senior Research Associate in Medical Statistics at Bristol and statistician for the study, added: “If a consultant orthogeriatrician attends hospital clinical governance meetings, a further cost saving of £356 per patient could potentially be achieved, as well as patients spending fewer days spent in the hospital in the year following hip fracture.”

“Hospitals with fracture liaison services also have lower mortality rates and patients spend fewer days in hospital. Our study suggests that rather than increasing the burden on the NHS, providing additional care for patients with orthogeriatrician and fracture liaison services may actually improve NHS efficiency.”

The study highlights the importance of addressing the way hospitals deliver hip fracture care to improve the effectiveness and efficiency of hip fracture services, and the need to develop evidence-based quality improvement strategies across the UK, to achieve financial savings while also improving patient outcomes.

Celia Gregson, Professor in Clinical Epidemiology in the Musculoskeletal Research Unit at the University of Bristol and Chief Investigator of the study, commented, “The variation we have seen in patient outcomes and health spending following hip fracture are difficult to justify on purely clinical grounds, it tells us that the way we organise the delivery of care can be improved nationally.

“By prioritising orthogeriatrician assessment, getting patients out of bed promptly after surgery, providing seven-day physiotherapy, reducing delirium risk for patients, and holding monthly multidisciplinary clinical governance meetings, hospitals stand to improve patient outcomes and reduce their healthcare spending.”

Caroline Aylott, Head of Research Delivery at Versus Arthritis, said: “This research shows the unacceptable state of care for older people who break their hip. The findings show that older people have a high chance of dying within a year of a hip fracture, and that quality of care varies hugely between NHS hospitals in England and Wales.

“As hip fractures mainly affect older people, many of whom live with multiple long-term conditions, this research suggests we are not getting older people’s care right. That must change.

“The study found that better, faster access to orthogeriatricians and fracture liaison services would not only reduce people’s risk of dying and improve chances of a better recovery, but also reduce NHS spending. Just weeks after publication of the NHS workforce plan, the study provides yet further evidence of the desperate and immediate need for a properly resourced NHS.”

The research team has already developed a potential solution, after working with the Royal Osteoporosis Society to develop an innovative toolkit – REDUCE hip fracture service implementation toolkit – informed by the results of their research.

The toolkit is freely available to all healthcare professionals and service managers to support the quality improvement of fracture service provision within the 172 acute hospital settings across England and Wales.

This study follows previous work from the REDUCE study (REducing unwarranted variation in the Delivery of high-qUality hip fraCture services in England and Wales), published last year in Age and Ageing, the journal of the British Geriatrics Society, which focused on patient outcomes of hip fracture patients in the short term.

The study was funded by Versus Arthritis (ref: 22086), the UK’s biggest charity supporting people with arthritis and musculoskeletal conditions, and supported by the National Institute for Health and Care Research Bristol Biomedical Research Centre (NIHR Bristol BRC).

Paper

‘Organisational factors associated with hospital costs and patient mortality in the 365 days following hip fracture in England and Wales (REDUCE): a record-linkage cohort study’ by Petra Baji, Elsa M R Marques, Celia L Gregson et al. in The Lancet Healthy Longevity [open access]

University of Bristol

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July 10, 2023
Metformin reduces long COVID risk
Newswise — MINNEAPOLIS/ST. PAUL (06/09/2023) — In a new study published in The Lancet Infectious Diseases, University of Minnesota researchers found that metformin, a drug commonly used to treat diabetes, prevents the development of long COVID.

The study, called COVID-OUT, investigated if early outpatient COVID-19 treatment with metformin, ivermectin or fluvoxamine could prevent long COVID. Long COVID is a chronic illness that can affect up to 10% of people who have had COVID-19.

“The results of this study are important because long COVID can have a significant impact on people’s lives,” said Carolyn Bramante, MD, principal investigator and an assistant professor at the U of M Medical School. “Metformin is an inexpensive, safe and widely available drug, and its use as a preventive measure could have significant public health implications.”

This was a large, placebo-controlled randomized clinical trial which enrolled volunteers across the United States. The study found:
- Those who received metformin were more than 40% less likely to develop long COVID than those who received an identical looking placebo.
- For participants who started metformin less than four days after their COVID symptoms started, metformin decreased the risk of long COVID by 63%.
- The effect was consistent across different demographic populations of volunteers who participated and across multiple viral variants, including the Omicron variant.
- Ivermectin and fluvoxamine did not prevent long COVID.
The study included more than 1,200 participants who were randomly chosen to receive either metformin or placebo, and an additional subset received ivermectin, fluvoxamine or their placebos. Participants were between 30 and 85 years old who qualified as overweight or obese. Over 1,100 of the participants reported on their symptoms for up to 10 months after their initial COVID-19 diagnosis.

“This long-term outcome from a randomized trial is high-quality evidence that metformin prevents harm from the SARS-CoV-2 virus,” said Dr. Bramante, who is also an internist and pediatrician with M Health Fairview. “While half of our trial had been vaccinated, none had been previously infected with the COVID-19 virus. Further research could show whether it is also effective in those with previous infection or in adults with lower body mass index.”

Metformin’s ability to stop the virus was predicted by a simulator developed by U of M Medical School and College of Science and Engineering Biomedical Engineering faculty. The model has been highly accurate to date, successfully predicting, among others, the failure of hydroxychloroquine and the success of remdesivir before the results of clinical trials testing these therapies were announced.

Funding was provided by the Parsemus Foundation, Rainwater Charitable Foundation, Fast Grants and the United Health Foundation.This research was also supported by the National Institutes of Health’s National Center for Advancing Translational Sciences under award number [UL1TR002494, KL2TR002492, and UM1TR004406].

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The University of Minnesota Medical School, School of Public Health, College of Science and Engineering and M Health Fairview served as the lead site. The trial was also conducted at Northwestern University; University of Colorado, Denver; Olive View – UCLA Education & Research Institute in Los Angeles; Optum Health, and with scientific collaboration from partners at the University of North Carolina at Chapel Hill, Vanderbilt University, and Emory University School of Medicine.

The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health’s National Center for Advancing Translational Sciences.

About the University of Minnesota Medical School
The University of Minnesota Medical School is at the forefront of learning and discovery, transforming medical care and educating the next generation of physicians. Our graduates and faculty produce high-impact biomedical research and advance the practice of medicine. We acknowledge that the U of M Medical School, both the Twin Cities campus and Duluth campus, is located on traditional, ancestral and contemporary lands of the Dakota and the Ojibwe, and scores of other Indigenous people, and we affirm our commitment to tribal communities and their sovereignty as we seek to improve and strengthen our relations with tribal nations. For more information about the U of M Medical School, please visit med.umn.edu.
University of Minnesota Medical School

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June 9, 2023
ASCO: Targeted therapy induces responses in HER2-amplified biliary tract cancer

ABSTRACT: 4008

Newswise — CHICAGO ― HER2-targeted bispecific antibody zanidatamab demonstrated durable responses in patients with treatment-refractory HER2-positive biliary tract cancer (BTC), researchers from The University of Texas MD Anderson Cancer Center reported at the 2023 American Society of Clinical Oncology (ASCO) Annual Meeting. The study results also were published today in The Lancet Oncology.

In the first cohort of the global Phase II HERIZON-BTC-01 trial, which included 80 patients with HER2-positive tumors, the confirmed objective response rate (cORR) was 41% with a median duration of response (DOR) of 12.9 months at a median follow-up of 12.4 months. Among the 33 responders, 49% had ongoing responses and 82% had a response lasting more than 16 weeks. This is the largest study of a HER2-targeted drug in BTC.

“Chemotherapy for patients with biliary tract cancers who have progressed on first-line therapy is usually associated with a 5% response rate,” said global trial lead Shubham Pant, M.D., professor of Gastrointestinal Medical Oncology and Investigational Cancer Therapeutics. “These results provide evidence that zanidatamab can achieve durable responses and may offer a new treatment opportunity for patients who previously had limited options.”

Patients with advanced BTC who progress after first-line treatment are offered standard-of-care therapies with limited clinical benefit and only modest improvement in survival. HER2-targeted therapies have improved survival in HER2-positive breast and gastric cancers, but there currently is no approved HER2-targeted therapy for BTC.

Zanidatamab was first evaluated in a Phase I trial led by Funda Meric-Bernstam, M.D., chair of Investigational Cancer Therapeutics. The trial results supported HER2 as an actionable target in various cancer types, including biliary tract cancer. Based on those results, MD Anderson researchers advanced zanidatamab into this Phase II trial for patients with BTC.

Biliary tract cancer, also known as cholangiocarcinoma, develops in the bile ducts, a series of thin tubes that run from the liver to the small intestine. There are three different types of BTC, whose names are based on the location where the cancer forms. According to the American Cancer Society, around 8,000 people in the U.S. are diagnosed each year with BTC. However, the true count likely is higher because these cancers can be hard to diagnose and are often misclassified, Pant explained. The five-year survival rate for metastatic BTC is less than 5%, highlighting an urgent need for new treatments.

This open-label, single-arm trial evaluated the anti-tumor activity of zanidatamab in patients with HER2-amplified advanced BTC, including intrahepatic cholangiocarcinoma, extrahepatic cholangiocarcinoma and gallbladder cancer. The trial was conducted at 67 sites; patients were divided into two cohorts based on HER2 expression (positive or low/negative) by tumor immunohistochemistry. The primary endpoint was cORR in the HER2-positive cohort.

The study enrolled 80 patients in the HER2-positive cohort and seven patients in the HER2-low/negative cohort. All patients had received one previous line of gemcitabine-containing therapy. The median age was 64 years and patients were 65.5% Asian, 28.7% white and 5.7% other. Of the trial participants, 52% had gallbladder cancer, 30% had intrahepatic cholangiocarcinoma, and 18% had extrahepatic cholangiocarcinoma.

There were no responses to zanidatamab observed in the HER2-low/negative cohort. Across both cohorts, grade 3 treatment-related adverse events occurred in 18% of patients. Two patients (2.3%) discontinued zanidatamab due to an adverse event. No grade 4 or 5 treatment-related adverse events were reported.

“Given this data, we believe strongly that there should be continued efforts to explore zanidatamab as a viable treatment option for HER2-positive biliary tract cancer,” Pant said. “We are encouraged by the potential impact of zanidatamab on improving patient outcomes.”

Pant and his team still are evaluating progression-free survival and overall survival in these patients. Additionally, clinical trials are underway to further investigate the therapeutic potential of zanidatamab as a monotherapy and in combination with first-line chemotherapy for HER2-positive BTC.

This study was funded by Zymeworks BC Inc. and BeiGene Ltd. Pant has worked in a consulting/advisory role for and received research support from Zymeworks. A full list of co-authors and their disclosures can be found here.

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University of Texas MD Anderson Cancer Center

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June 2, 2023
Metabolic liver disease best treated with surgery

Newswise — Metabolic (bariatric) surgery is more effective than medications and lifestyle interventions for the treatment of advanced non-alcoholic fatty liver disease.

A new paper, published today in The Lancet by King’s College London and the Catholic University of Rome, is the first to compare three active treatments of non-alcoholic Steatohepatitis (NASH) and to specifically investigate the effectiveness of metabolic surgery (weight loss surgery) in a randomised clinical trial.

Non-Alcoholic Fatty Liver Disease (NAFLD) is the most common cause of chronic liver disease, globally affecting 55% of people with type 2 diabetes and 75% of those with obesity. Non-alcoholic steatohepatitis (NASH) is the progressive form of the disease and is characterised by liver cell injury and inflammation, which induce liver fibrosis (scarring of the tissue). Left untreated, it can lead to liver failure and liver cancer, and is one of the leading causes of liver transplant in the western world. NASH also increases risk of cardiovascular disease and overall mortality in patients with obesity or type 2 diabetes. NAFLD/NASH currently affects 12% of adults in the UK; in the USA it is estimated that the condition will affect 27 million people by 2030.

The multi-centre randomised trial was conducted in Italy. The trial compared the efficacy of bariatric and metabolic surgery versus lifestyle modifications and best current medical care in 288 patients.

Pre- and post-operative liver biopsies showed that surgery was more effective in inducing complete reversal of inflammation and cell damage in the liver – the core characteristics of NASH – without worsening of liver fibrosis after 1 year from surgery. The probability of achieving reversal of NASH was 3–5 times higher with metabolic surgery than with medical care. Surgery was also more effective at achieving improvement of at least one stage of liver fibrosis, another pre-specified endpoint of the trial. The two surgical procedures appeared to equally improve NASH.

Researchers say the ability of surgery to control and even improve fibrosis associated with NASH is of special clinical relevance as fibrosis is the main predictor of liver complications and poor cardiovascular outcomes and death in patients with NASH.

Professor Geltrude Mingrone, first author of the report, Professor of Medicine at the Catholic University of Rome and a Professor of Diabetes and Nutrition at King’s College London said: “The results of our study support the use of metabolic surgery as a treatment of NASH, a condition for long considered orphan of effective therapies”.

Professor Francesco Rubino, a senior co-investigator and Chair of Bariatric and Metabolic Surgery at King’s College London and consultant surgeon at King’s College Hospital said: “The presence of NASH predicts a significant risk of complications and mortality in people with severe obesity and type 2 diabetes. The results of this study provide a compelling case for prioritisation of metabolic surgery in this patient population”.

Compared to conventional medical treatment, surgery also resulted in better overall health benefits. While both surgical procedures seemed to equally improve NASH, the gastric bypass group was more effective than sleeve gastrectomy at improving type 2 diabetes and reducing other cardiovascular risk factors associated with NAFLD/NASH.

ENDS

King’s College London

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April 21, 2023
THE LANCET: Health experts call for bold action to prioritize health over profit
Newswise — A new Series published in The Lancet describes how, although commercial entities can contribute positively to health and society, the products and practices of some commercial actors are responsible for escalating rates of avoidable ill health, planetary damage, and social and health inequity. Authors make key recommendations to ensure that contemporary capitalism is compatible with good population health.

The industries that produce just four harmful products – tobacco, alcohol, unhealthy food, and fossil fuels – account for at least a third of global deaths, illustrating the scale and huge economic cost of the problem.

Professor Rob Moodie, Series Lead and Professor of Public Health Melbourne School of Population and Global Health, University of Melbourne, says, “We all want to be part of a society that’s safe, happy and healthy but this will only happen when governments make the health of people and the planet a higher priority than profit. This series isn’t anti-business, it’s pro-health. It’s important that we acknowledge that many businesses play vital roles in society, but we also need to recognise the practices and products of some are making people and the environment sick.”

He adds: “With the rise of non-communicable diseases such as heart disease, cancer and diabetes and the escalating climate crisis, urgent action is needed to address the way businesses contribute to these problems, and in particular, industries that sell harmful products.”

Outlining a cycle of how commercial actors can harm health, they describe the following steps:
1. Commercial actors use their wealth and power to shape regulations and policies in their own interests.
2. Favourable policies stimulate increased sales — and thus consumption — of harmful commercial products, which compounds the harm and cost burden they cause.
3. Favourable policies also enable commercial entities to externalise the costs of harm caused by the production, consumption, and disposal of their products.
4. Externalised costs (eg, paying to treat non-communicable diseases caused by commercial products) are largely met by the states and individuals affected. These costs reduce the resources available to states and individuals to pay for medicines, health care, food, and housing, leaving health systems increasingly unable to cope.
5. Meanwhile, commercial entities enjoy excess profits, fuelling a growing power imbalance between commercial actors and governments who should hold them to account.
The authors argue that a cycle of behaviour by commercial actors and policy makers has insidiously tipped the balance of power increasingly in favour of commercial profits over several decades, which has perpetuated poor health outcomes and inequities. To restore this balance and ensure that contemporary capitalism is compatible with good population health, the authors make key recommendations.

Among these, they call on governments to legislate higher standards for marketing of harmful products, including honest product labelling and protections for people from predatory marketing tactics including via social media. Additionally, they ask businesses to commit to ending lobbying against pro-health policies, including using third parties such as fake grassroots (astroturf) organisations and think tanks to push political agendas. Furthermore, authors congratulate commercial actors and investors who are increasingly adopting alternative financing models that create social value, and promote positive health, social and sustainability outcomes and encourage others to follow this example.

Note to editors:
- Attached is an infographic, which pulls out the key points of the Series.
- The Series papers are available on request.
- Please do reach out if you are interested and we can put you in touch with an author for interview.
Lancet

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March 24, 2023
Phase II Trial Studies Effects of Semaglutide Medication in Patients with NASH

Newswise — Nonalcoholic steatohepatitis (NASH)-related cirrhosis can lead to serious liver-related outcomes. In a phase 2 trial, lead author Rohit Loomba, MD, University of California San Diego School of Medicine, and collaborators, report semaglutide 2.4 mg once weekly in patients with NASH-related cirrhosis did not improve fibrosis without worsening of NASH. However, the drug did lead to marked improvements in cardiometabolic risk parameters, liver enzymes, serum fibrosis biomarkers and liver fat.

UC San Diego Health

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March 15, 2023
Health policy experts call for confronting anti-vaccine activism with life-saving counter narratives

Newswise — Public and private sector health officials and public policymakers should team up immediately with community leaders to more effectively disseminate accurate narratives regarding the life-saving benefits of vaccines to counter widespread, harmful misinformation from anti-vaccine activists in the United States, according to a new Viewpoint piece in The Lancet, led by authors at Boston University School of Public Health (BUSPH), University of California, Riverside (UCR), and The Stanford Internet Observatory Cyber Policy Center (SIO) at Stanford University.

Published in the leading international medical journal on Friday, March 3, the Viewpoint provides valuable insight into the recent developments of US-based anti-vaccine activism and proposes strategies to confront this dangerous messaging.

“Messages of health freedom gained traction during the pandemic, turning members of the public against public health messages and prevention-focused activities, including vaccination,” says second author Timothy Callaghan, associate professor of health law, policy & management at BUSPH, and who was one of three lead writers of the Viewpoint, along with lead author Richard Carpiano, public policy professor at UCR, and third author Renee DiResta, technical research manager at SIO.

In the Viewpoint, the authors and 18 other leading public health experts describe a perfect storm that allowed anti-vaccine activism, once a fringe subculture, to become a well-organized form of right-wing identity with narratives that associate refusing vaccines with personal liberty. This narrative was consistently repeated and amplified by social media influencers, pro-Donald Trump political operatives, and right-wing blogs, podcasts, and other media as the COVID-19 pandemic spread worldwide.

The authors underscore the need to consistently amplify accurate science and information through multiple communication channels, to avoid the spread of inaccurate or misleading information to people through limited sources.

“This is a matter of life and death,” says Carpiano. “People don’t always see it that way. We’ve forgotten how many people have died, have been sick, or continue to get sick from COVID-19 as well as many other vaccine-preventable diseases.”

The paper comes out at a time when more than 1.1 million people have died from COVID-19, and the worldwide toll is estimated at 6.8 million. The disease continues to spread as vaccines have been found to greatly reduce illnesses that require hospitalization or result in death.

Anti-vaccination activism has existed as long as there have been vaccines. But the movement picked up steam in 1998 when British physician Andrew Wakefield published a now-discredited study that falsely claimed a link between childhood vaccines and autism.

In more recent years, however, anti-vaccine messaging shifted in large part from health-effect concerns to conservative and libertarian political identity arguments of medical freedom and parental rights. This was prompted in part by legislative efforts in several states to eliminate personal belief exemptions from school vaccination requirements in response to falling child vaccination rates and vaccine-preventable disease outbreaks. But these arguments were confined to childhood vaccines and were somewhat contained.

Since the COVID-19 pandemic affected the entire population, it brought on a vast expansion of not only anti-vaccine activism, but more broadly, anti-public health activism as people faced the inconveniences of mask-wearing, social distancing, closed restaurants and bars, and cancelations of concerts and other events that draw crowds.

Celebrities, wellness influencers, partisan pundits, and certain scientists and clinicians, among others, joined the fray, often spreading false and misleading claims about vaccinations. The increasing number of voices found larger audiences, which meant more votes for right-wing candidates, and greater monetization of right-leaning social and media outlets.

“As celebrities, influencers, and politicians started speaking out negatively about vaccination, growing segments of the American public were exposed to these messages, shifting troubling proportions of the US public who had previously vaccinated in other contexts against getting vaccinated for COVID-19,” Callaghan says.

The result was more people becoming ill.

“Political leaders were sadly, particularly effective anti-vaccine messengers, and because of that, we now have clear disparities in COVID-19 vaccination rates across party lines” he says.

Meanwhile, pro-vaccine messaging has been based on the statements of individual public health experts, such as former director of the National Institute of Allergy and Infectious Diseases Anthony Fauci and director of the US Centers for Disease Control and Prevention Rochelle Walensky, who the authors say are outgunned.

Callaghan, Carpiano, and DiResta were part of the Commission on Vaccine Refusal, Acceptance, and Demand in the USA that The Lancet convened to examine issues surrounding COVID-19 vaccine acceptance uptake, acceptance, and hesitancy. The membership is composed of 21 national experts from public health, vaccine science, law, ethics, public policy, and the social and behavioral sciences.

The group recommends the development of networked communities that simultaneously share information with different audiences about the health and economic benefits of vaccines. This would preempt the well-funded messaging of the antivaccine movement.

“Without concerted efforts to counter the anti-vaccine movement, the USA faces an ever-growing burden of morbidity and mortality from an increasingly under-vaccinated, vaccine hesitant society,” the authors conclude in the paper.

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About Boston University School of Public Health

Founded in 1976, Boston University School of Public Health is one of the top five ranked private schools of public health in the world. It offers master’s- and doctoral-level education in public health. The faculty in six departments conduct policy-changing public health research around the world, with the mission of improving the health of populations—especially the disadvantaged, underserved, and vulnerable—locally and globally.

Boston University School of Public Health

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March 3, 2023
First-of-its-Kind Study Examines the Impact of Cannabis Use on Surgical Patients’ Post-Procedure Healthcare Needs

BYLINE: Jacqueline Mitchell

Newswise — BOSTON – As legislation in multiple states eases former restrictions around medical and recreational cannabis in the United States, an increasing proportion of the population reports use of the drug. Between 2016 and 2018, more than 22 percent of Massachusetts residents reported any prior cannabis use for medical or recreational reasons. However, little is known about cannabis use in patients who undergo surgery or interventional procedures, where cannabis use has important additional clinical implications.

In a new study published in The Lancet’s eClinical Medicine, researchers led by anesthesiologists at Beth Israel Deaconess Medical Center (BIDMC) analyzed de-identified data from patients who underwent non-cardiac surgery in Boston between 2008 and 2020. The scientists found that cannabis users had a higher complexity of co-existing conditions overall, including mood disorders such as depression and substance use disorders. Patients with a diagnosed cannabis use disorder more often required advanced postprocedural healthcare – such as admission to an intensive care unit – compared to non-users. However, patients whose use of cannabis was not classified as a disorder had lower odds of requiring advanced healthcare after surgery compared to patients who never use cannabis.

“Our analysis revealed that cannabis use is very common and has substantially increased among patients undergoing surgery, reflecting trends in the general population; however, differential effects on postprocedural health care utilization were observed between patients with moderate non-medical cannabis use and patients with a cannabis use disorder,” said corresponding author Maximillian S. Schaefer, Director of the Center for Anesthesia Research Excellence at BIDMC. “We hope our data helps make clinicians aware of how different patterns of cannabis use might represent different patient populations, which in turn translates into distinct perioperative risk profiles.”

In this hospital registry study, Schaefer and colleagues analyzed de-identified data from 210,639 adult patients undergoing noncardiac surgery at BIDMC between January 2008 and June 2020. Non-medical cannabis use was identified before procedures during routine, structured interviews about past and ongoing habits of drug use, in accordance with the American Society of PeriAnesthesia Nursing recommendations. Patients with cannabis use disorder were identified through diagnostic codes.

Over the entire study period, the researchers found that more than 16,000 patients, or 7.7 percent, used cannabis prior to surgery, of which 14,045 (87 percent) were identified as non-medical users and 2,166 (13 percent) had a diagnosis of cannabis use disorder. Of all the patients undergoing surgery, a total of 24,516 patients, or 12 percent, required advanced post-procedural healthcare utilization, among which 1,465 patients self-identified as non-medical cannabis users, 418 patients presented with cannabis use disorder and 22,633 patients had no reported ongoing cannabis use.

Overall, patients who self-identified as cannabis users were on average younger, more often male, and more likely to suffer from depression, anxiety and schizoaffective disorders. Substance use disorders related to alcohol, cocaine, IV drugs, prescription medications and psychedelic drugs were more frequent in patients who used cannabis.

“As these comorbidities have been associated with increased complications including arrhythmias and sudden cardiac death after anesthesia, a history of cannabis use disorder might serve as an indicator of potentially complicating factor for patients undergoing anesthesia that in turn contribute to the requirement of higher-level healthcare utilization after surgery,” Schaefer said.

Compared to patients who did not use cannabis, patients with a diagnosis of cannabis use disorder had higher odds of requiring advanced post procedural healthcare utilization. Specifically, a diagnosis of cannabis use disorder was linked with higher odds of a 30-day hospital readmission, compared to patients who did not use cannabis.

By contrast, patients with reported ongoing non-medical cannabis use had lower odds of advanced post-procedural healthcare unit utilization compared to patients who did not use cannabis. Moreover, such use was linked to shorter hospital length of stay than patients who did not use cannabis. Over the course of the study period, the scientists saw the prevalence of cannabis use rise from 5 percent in 2008 to 14 percent by 2020 and observed higher rates of cannabis use among those undergoing surgery than previous studies reported. While the scientists acknowledge the discrepancy could be the result of regional consumption patterns, they suggest their inclusion of ongoing self-reported non-medical cannabis users based on structured pre-admission interviews paints a more accurate picture than findings that identified patients’ cannabis use on diagnostic codes alone.

“This cohort represents a distinctively different patient population of more general non-medical users,” said Schaefer. “These differential findings in patients who self-identified as ongoing, non-medical cannabis users without a diagnosis of disorder strongly suggest that future studies need to differentiate these two patient populations. Findings based on the identification of cannabis use from diagnostic codes alone might not be applicable to most mainstream cannabis users.”

Co-authors included first author Elena Ahrens, Luca J. Wachtendorf, Laetitia S. Chiarella, Sarah Ashrafian, Aiman Suleiman, Tim M. Tartler, Basit A. Azizi, Guangqing Chen, Amnon A. Berge, Denys Shay, Valerie Banner-Goodspeed, Haobo Ma, and Kevin P. Hill, of BIDMC; Bijan Teja, of University of Toronto; and Matthias Eikermann of Albert Einstein College of Medicine.

This work was supported by an unrestricted, philanthropic grant of Jeff and Judy Buzen. Hill has served as a consultant for Greenwich Biosciences and has received an honorarium from Walters-Klewer as an author. Schaefer received funding for investigator-initiated studies from Merck and Co which do not pertain to this manuscript. Schaefer received honoraria for presentations from Fisher and Paykel healthcare and Mindray medical information international limited period. All other authors declare no competing interests.

Beth Israel Deaconess Medical Center

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February 24, 2023
Targeted therapy momelotinib provides significant symptom and anemia improvements in patients with myelofibrosis

Newswise — Patients with myelofibrosis had clinically significant improvement in disease-related symptoms, including anemia and spleen enlargement, when treated with the targeted therapy momelotinib, according to results from the international Phase III MOMENTUM trial led by researchers at The University of Texas MD Anderson Cancer Center.

The findings, published today in The Lancet, support the use of momelotinib – a potent ACVR1/ALK2 and JAK1/2 inhibitor – over the standard therapy danazol in treating myelofibrosis patients that were resistant, refractory or intolerant to firstline therapy, especially symptomatic patients and those with anemia.

“Current options for managing anemia in our myelofibrosis patients provide only modest and temporary benefits, so we are excited about these findings,” said study lead Srdan Verstovsek, M.D., Ph.D., professor of Leukemia. “The trial results suggest that momelotinib is safe, well-tolerated and can improve one of the most common and debilitating clinical problems for this patient population.”

Myelofibrosis is an uncommon bone marrow cancer that is part of a group of diseases known as myeloproliferative neoplasms. A hallmark of the disease is dysregulated JAK signaling, which disrupts the body’s normal production of blood cells and leads to common symptoms, including an enlarged spleen and anemia. Chronic anemia in these patients is associated with poor prognoses.

Currently approved JAK inhibitors can improve spleen responses and other disease-related symptoms, but they also can worsen anemia. In this trial, momelotinib improved anemia and reduced transfusion dependency in myelofibrosis patients previously treated with a JAK inhibitor. Momelotinib can be administered and maintained at full dose because it does not suppress bone marrow activity like other JAK inhibitors.

The MOMENTUM trial is the first randomized Phase III study to evaluate a JAK1/2 and ACVR1/ALK2 inhibitor in patients with myelofibrosis and anemia. The trial was designed to compare the clinical benefits of momelotinib to danazol, a synthetic androgen currently used to treat anemia in symptomatic myelofibrosis patients.

The study enrolled 195 adult patients from 107 research sites across 21 countries. Trial participants were randomly assigned (2:1) to receive momelotinib plus placebo or danazol plus placebo. Sixty-three percent of participants were male and 37% were female. The median age of participants for the momelotinib group was 71 years and for the danazol group 72 years.

The trial’s primary endpoint was symptom reduction after 24 weeks of treatment, defined as a 50% or more reduction in Myelofibrosis Symptom Assessment Form Total Symptom Score. A significantly greater proportion of patients who received momelotinib saw benefits in their disease symptoms (25%) compared to those receiving danazol (9%).

Patients treated with momelotinib also experienced a significant reduction in their spleen size, with 25% responding after 24 weeks of therapy. Additionally, these patients required fewer blood transfusions compared to those receiving danazol.

The safety profile of momelotinib was comparable to previous clinical trials. The most common non-hematological side effects experienced by trial participants in the momelotinib group included diarrhea, nausea, weakness and itching or irritated skin.

“If approved, momelotinib could offer an effective option for patients with myelofibrosis to improve anemia, splenomegaly and other disease-related symptoms over other approved medications so far,” Verstovsek said. “Momelotinib may also be an ideal partner for combinations with other investigational agents in development to further control myelofibrosis symptoms.”

Patient follow-up is ongoing and long-term survival continues to be monitored.

The research was supported by Sierra Oncology. A full list of collaborating authors and their disclosures can be found with the full paper here.

University of Texas M. D. Anderson Cancer Center

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January 28, 2023
Study shows gardening may help reduce cancer risk, boost mental health

Newswise — Get more exercise. Eat right. Make new friends.

As we compile our lists of resolutions aimed at improving physical and mental health in 2023, new CU Boulder research suggests one addition could have a powerful impact: Gardening.

Funded by the American Cancer Society, the first-ever, randomized, controlled trial of community gardening found that those who started gardening ate more fiber and got more physical activity—two known ways to reduce risk of cancer and chronic diseases. They also saw their levels of stress and anxiety significantly decrease.

The findings were published Jan. 4 in the journal Lancet Planetary Health.

“These findings provide concrete evidence that community gardening could play an important role in preventing cancer, chronic diseases and mental health disorders,” said senior author Jill Litt, a professor in the Department of Environmental Studies at CU Boulder.

Filling the research gap

Litt has spent much of her career seeking to identify affordable, scalable and sustainable ways to reduce disease risk, especially among low-income communities.

Gardening seemed an ideal place to start.

“No matter where you go, people say there’s just something about gardening that makes them feel better,” said Litt, who is also a researcher with the Barcelona Institute for Global Health.

But solid science on its benefits is hard to come by. Without evidence, it’s hard to get support for new programs, she said.

Some small observational studies have found that people who garden tend to eat more fruits and vegetables and have a healthier weight. But it has been unclear whether healthier people just tend to garden, or gardening influences health.

Only three studies have applied the gold standard of scientific research, the randomized controlled trial, to the pastime. None have looked specifically at community gardening.

To fill the gap, Litt recruited 291 non-gardening adults, average age of 41, from the Denver area. More than a third were Hispanic and more than half came from low-income households.

After the last spring frost, half were assigned to the community gardening group and half to a control group that was asked to wait one year to start gardening.

The gardening group received a free community garden plot, some seeds and seedlings, and an introductory gardening course through the nonprofit Denver Urban Gardens program and a study partner.

Both groups took periodic surveys about their nutritional intake and mental health, underwent body measurements and wore activity monitors.

A fiber boost

By fall, those in the gardening group were eating, on average, 1.4 grams more fiber per day than the control group—an increase of about 7%.

The authors note that fiber exerts a profound effect on inflammatory and immune responses, influencing everything from how we metabolize food to how healthy our gut microbiome is to how susceptible we are to diabetes and certain cancers.

While doctors recommend about 25 to 38 grams of fiber per day, the average adult consumes less than 16 grams.

“An increase of one gram of fiber can have large, positive effects on health,” said co-author James Hebert, director of University of South Carolina’s cancer prevention and control program.

The gardening group also increased their physical activity levels by about 42 minutes per week. Public health agencies recommend at least 150 minutes of physical activity per week, a recommendation only a quarter of the U.S. population meets. With just two to three visits to the community garden weekly, participants met 28% of that requirement.

Study participants also saw their stress and anxiety levels decrease, with those who came into the study most stressed and anxious seeing the greatest reduction in mental health issues.

The study also confirmed that even novice gardeners can reap measurable health benefits of the pastime in their first season. As they have more experience and enjoy greater yields, Litt suspects such benefits will increase.

Blooming relationships

The study results don’t surprise Linda Appel Lipsius, executive director of Denver Urban Gardens (DUG), a 43-year-old nonprofit that helps about 18,000 people each year grow their own food in community garden plots.

“It’s transformational, even life-saving, for so many people,” Lipsius said.

Many DUG participants live in areas where access to affordable fresh fruits and vegetables is otherwise extremely limited. Some are low-income immigrants now living in apartments—having a garden plot allows them to grow food from their home country and pass on traditional recipes to their family and neighbors.

The social connection is also huge.

“Even if you come to the garden looking to grow your food on your own in a quiet place, you start to look at your neighbor’s plot and share techniques and recipes, and over time relationships bloom,” said Litt, noting that while gardening alone is good for you, gardening in community may have additional benefits. “It’s not just about the fruits and vegetables. It’s also about being in a natural space outdoors together with others.”

Litt said she hopes the findings will encourage health professionals, policymakers and land planners to look to community gardens, and other spaces that encourage people to come together in nature, as a vital part of the public health system. The evidence is clear, she said.

Gardening works.

Researchers from the Colorado School of Public Health, Colorado State University and Michigan State University also contributed to this study.

University of Colorado Boulder

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January 6, 2023
Exámenes de detección guiados por inteligencia artificial usan datos de electrocardiogramas para detectar factores de riesgo ocultos de accidente cerebrovascular

Newswise — ROCHESTER, Minnesota —Los investigadores de Mayo Clinic utilizaron inteligencia artificial para evaluar electrocardiogramas de pacientes en el marco de una estrategia dirigida para detectar fibrilación auricular, un trastorno frecuente del ritmo cardíaco. La fibrilación auricular es un latido cardíaco irregular que puede provocar coágulos sanguíneos que podrían viajar al cerebro y causar un accidente cerebrovascular, y suele ser difícil de diagnosticar. En el estudio descentralizado realizado a través de medios digitales, la inteligencia artificial identificó nuevos casos de fibrilación auricular que no se habrían observado clínicamente en la atención médica de rutina.

En investigaciones anteriores, ya se había desarrollado un algoritmo de inteligencia artificial para identificar a los pacientes con una probabilidad alta de tener fibrilación auricular previamente desconocida. nference y Mayo Clinic otorgaron la licencia del algoritmo para detectar la fibrilación auricular en un ritmo sinusal normal a partir de un electrocardiograma a Anumana Inc., una empresa de tecnología médica impulsada por inteligencia artificial.

El Dr. Peter Noseworthy, cardiólogo electrofisiólogo en Mayo Clinic y autor principal del estudio, declaró: “Creemos que los exámenes de detección de la fibrilación auricular tienen mucho potencial, pero actualmente los resultados son muy pocos, y los costos son muy altos como para posibilitar la detección generalizada. El estudio demuestra que un algoritmo de inteligencia artificial aplicado a un electrocardiograma puede ayudar a dirigir los exámenes de detección a los pacientes que tengan más probabilidades de beneficiarse con ellos”.

Del estudio participaron 1003 pacientes, a quienes se les realizaron controles constantes, y otros 1003 pacientes de atención médica habitual funcionaron como controles del mundo real. Los hallazgos, que se publicaron en The Lancet, mostraron que la inteligencia artificial puede identificar un subgrupo de pacientes de alto riesgo que recibirían más beneficios al hacerse controles cardíacos intensivos adicionales para detectar fibrilación auricular, lo que apoyó la estrategia de detección dirigida y guiada por inteligencia artificial.

Habitualmente, los electrocardiogramas se hacen para diagnosticar una variedad de trastornos, pero como la fibrilación auricular puede durar poco, es baja la posibilidad de detectar un episodio durante un rastreo por electrocardiograma de 10 segundos. Los pacientes pueden someterse a enfoques de control cardíaco intermitentes o continuos que tienen tasas de detección más altas, pero se requieren muchos recursos para aplicarlos a todo el mundo, y los controles pueden ser molestos y costosos para los pacientes.

En este punto, puede ser útil el electrocardiograma guiado por inteligencia artificial. El algoritmo de inteligencia artificial puede identificar pacientes que, aunque tengan un ritmo cardiaco normal el día en que se hacen el electrocardiograma, puedan tener un riesgo mayor de episodios de fibrilación auricular no detectada en otros momentos. Luego, estos pacientes pueden hacerse controles adicionales para confirmar el diagnóstico.

“Los programas de exámenes de detección tradicionales seleccionan pacientes según la edad (mayores de 65 años) o la presencia de afecciones como la hipertensión arterial. Estos enfoques tienen sentido porque la edad avanzada es uno de los factores de riesgo de fibrilación auricular más importantes. Sin embargo, no es factible realizar controles cardíacos intensivos de manera reiterada a más de 50 millones de adultos mayores en todo el país”, señaló la Dra. Xiaoxi Yao, investigadora de resultados médicos del Departamento de Medicina Cardiovascular y del Centro Robert D. y Patricia E. Kern para la Ciencia de Brindar Atención Médica de Mayo Clinic. La Dra. Yao es autora sénior del estudio.

“El estudio muestra que un algoritmo de inteligencia artificial puede seleccionar un subgrupo de adultos mayores a los que los controles intensivos podrían beneficiar más. Si esta nueva estrategia se implementara de forma generalizada, podría reducir la fibrilación auricular sin diagnosticar y prevenir accidentes cerebrovasculares y la muerte de millones de pacientes alrededor del mundo”, indicó la Dra. Yao.

El próximo paso en esta investigación es un ensayo híbrido multicéntrico enfocado en la eficacia de la implementación del proceso de trabajo del electrocardiograma guiado por inteligencia artificial en diversos entornos clínicos y poblaciones de pacientes.

“Esperamos que este enfoque sea especialmente valioso en entornos de pocos recursos, en los que las tasas de fibrilación auricular sin diagnosticar pueden ser particularmente altas y pueden ser limitados los recursos para detectarla. Sin embargo, hace falta más trabajo para superar los obstáculos de implementación, y los estudios futuros deben evaluar las estrategias de exámenes de detección dirigidos en estos entornos”, expresó el Dr. Noseworthy.

“Ahora que demostramos que son posibles los exámenes de detección de fibrilación auricular dirigidos por inteligencia artificial, también debemos mostrar que los pacientes con fibrilación auricular detectada mediante exámenes se benefician del tratamiento para prevenir accidentes cerebrovasculares”, señaló el Dr. Noseworthy. “Nuestro objetivo final es prevenir los accidentes cerebrovasculares. Creo que el estudio actual nos ha llevado un paso más cerca”.

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Información sobre Mayo Clinic

Mayo Clinic es una organización sin fines de lucro comprometida con la innovación en la práctica clínica, la educación y la investigación que ofrece atención experta y respuestas a todos los que necesitan recobrar la salud. Visite la Red Informativa de Mayo Clinic para obtener más noticias de Mayo Clinic.

Mayo Clinic

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November 21, 2022
NIH’s Climate and Health Initiative tackles global health effects associated with a changing climate

Newswise — Media Availability

What: Leaders from the National Institutes of Health discuss the agency’s plan to address the risk to human health posed by a changing climate in a commentary published in The Lancet. As floods, hurricanes, tornados, wildfires, and heat waves become more extreme, the risk to human health grows, exacerbating existing health threats and creating new public health challenges around the world.

The authors, a coalition of leaders at NIH, outline how the NIH Climate Change and Health Initiative is uniquely poised to lead and engage with communities and agencies globally to address the health effects associated with climate change.

Article: The NIH Climate Change and Health Initiative and Strategic Framework: addressing the threat of climate change to health. The Lancet, November 2022. https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(22)02163-8/fulltext

Who: The following NIH leaders are available for interviews:

Richard P. Woychik, Ph.D., director of the National Institute of Environmental Health Sciences. He is the lead author on The Lancet commentary, and the chair of the Executive Committee leading the NIH Climate Change and Health Initiative.

Gary H. Gibbons, M.D., director of the National Heart, Lung, and Blood Institute.

Roger I. Glass, M.D., Ph.D., director of the Fogarty International Center.

Joshua A. Gordon, M.D., Ph.D., director of the National Institute of Mental Health

Eliseo J. Pérez-Stable, M.D., director of the National Institute of Minority Health and Health Disparities.

NOTE FOR REPORTERS: This commentary is under embargo until 7:30 p.m. EDT on Friday, Nov. 4, 2022.

Comment pieces are written by experts in the field, and represent their own views, rather than necessarily the views of The Lancet or any Lancet specialty journal. Unlike Articles containing original research, not all Comments are externally peer reviewed.

About the National Institutes of Health (NIH): NIH, the nation’s medical research agency, includes 27 Institutes and Centers and is a component of the U.S. Department of Health and Human Services. NIH is the primary federal agency conducting and supporting basic, clinical and translational medical research, and is investigating the causes, treatments and cures for both common and rare diseases. For more information about NIH and its programs, visit https://www.nih.gov.

National Institute of Environmental Health Sciences (NIEHS)

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November 4, 2022