Monday, January 08, 2024

Acute pediatric critical illness definition enables global research

ST. JUDE CHILDREN'S RESEARCH HOSPITAL

(MEMPHIS, Tenn. – January 05, 2023) St. Jude Children’s Research Hospital investigators collaborated with a global group of acute pediatric critical illness experts to reach a consensus definition of the condition. Research on how to improve care in low- and middle-income countries has been stymied because conventional pediatric critical illness definitions are not applicable in these settings. The new, more universal definition, reached by consensus among researchers and clinicians from 40 countries, will enable scientists to study pediatric critical illness more universally, which should lead to improvements in patient outcomes globally. The full definition was published today in The Lancet Global Health.

“We now have a common language for acute pediatric critical illness,” said first and corresponding author Anita Arias, M.D., St. Jude Department of Pediatric Medicine. “That shared understanding will improve data collection globally and increase patient sample size, which will lead to more and better clinical studies of evidence-based interventions.”

The new full definition is: “An infant, child or adolescent with an illness, injury or post-operative state that increases the risk for or results in acute physiological instability (abnormal physiological parameters or vital organ dysfunction or failure) or a clinical support requirement (such as frequent or continuous monitoring, or time-sensitive intervention) to prevent further deterioration or death. The patient can meet this definition by having physiological instability, support requirements or both.”

St. Jude researchers, led by Arias and senior author Asya Agulnik, M.D., MPH, St. Jude Global Critical Care director, coordinated an international group of acute pediatric critical illness researchers and clinicians to assemble the definition. In total, 109 experts from 40 countries contributed. The participants used a method called modified Delphi, which anonymized those involved so they could freely vote and express their opinions on draft statements. The final definition was a consensus among these experts, with particular attention to being more inclusive of hospitals of differing resource levels.

A more inclusive patient-centered definition

Historically, acute pediatric critical illness has had many definitions. Studies from higher-income countries tend to use definitions that include technical or resource-based terminology, such as admission to an Intensive Care Unit (ICU). While that criterion has proven clinically useful, it does not translate to resource-limited health care settings in other countries, which may not have an ICU in their hospitals.

“With our new framework, we’re trying to be more inclusive,” Arias said. “As many hospitals around the world don’t even have an ICU, older definitions were excluding a huge population of patients from research.”

“While the global burden of childhood mortality is mostly in low-and middle-income countries, to date, the study of acute pediatric critical illness has largely been centered on hospitals in high-resource settings,” Agulnik said. “This definition, which allows for classification of patients as critically ill regardless of critical care resources, would address this research disparity by facilitating research in hospitals of all resource settings.”

The focus on ICUs reveals a larger problem: previous definitions excluded patients experiencing acute critical illness but lacking access to critical care resources. To increase inclusivity, the international group recognized the need to define the condition based on the patient’s status rather than on resources, such as specific department admission or intervention use.

“One example of why we needed a new definition is the studies of respiratory failure,” Arias explained. “Traditionally, these studies include patients who are on mechanical ventilation, but the fact that a hospital might not have mechanical ventilation doesn’t mean that the patient doesn't have acute respiratory illness or failure.”

The new definition focuses on the patient to address that need without regard to local resources. It looks at two different states — what is happening with the patient’s bodily systems, and the need for clinical support, such as needing a ventilator, but not the actual materials used to address the patient’s needs.

The framework also provides eight attributes and 28 statements to clarify and explain its application. The entirety of that framework is termed the DEFinition for acute pediatric CRITical illness (DEFCRIT).

Improving care globally

Slow improvement in critical care can be attributed to the historical lack of a standardized and inclusive definition of acute pediatric critical illness, particularly in low- and middle-income countries. Given the difficulty in adapting methods to these settings, even measuring the total burden of critical illness has evaded researchers. DEFCRIT will help lead to a better understanding of the burden of disease and begin to compare populations and interventions in a more standardized and inclusive way.

“We have started bridging a gap for researchers and clinicians to understand the global burden of critical illness,” Arias said. “This could eventually lead to better care delivery by gaining the ability to determine how effective intervention can be in different populations, environments and stages of illness.”

Multiple global groups of pediatric disease researchers have already accepted DEFCRIT. The Pediatric Acute Lung Injury and Sepsis Investigators (PALISI) Network on Behalf of the PALISI Global Health Subgroup is a co-author of the paper. In addition, the World Federation of Pediatric Intensive and Critical Care Societies (WFPICCS) and the Society of Critical Care Medicine (SCCM) both endorsed the framework.

“There was an iniquity in research that we, as a global group, wanted to address,” Arias said. “With a universal DEFCRIT, we’ve stopped impeding research progress. We’re now going to be able to start pushing the field toward improving the care for patients globally through better research.”

Authors and funding

The study’s other authors are Abdelhafeez Abdelhafeez, of St. Jude; Teresa Kortz, University of California, San Francisco; Michael Lintner-Rivera, Adnan Bhutta, Indiana University School of Medicine; Nadeem Shafi, University of Tennessee Health Science Center and Le Bonheur Children’s Hospital; Qalab Abbas, Aga Khan University Hospital; Muhammad Ali, Pakistan Institute of Medical Sciences; Hala Ammar, Children’s Hospital of Benghazi; Ali Anwar, Lincoln Memorial University-DeBusk College of Osteopathic Medicine; John Adabie Appiah, Komfo Anokye Teaching Hospital; Jonah Attebery, University of Colorado; Willmer Diaz Villalobos, Unidad de Terapia Intensiva Pediátrica del Hospital Materno Infantil; Daiane Ferreira, Barretos Children’s Hospital; Sebastián González-Dambrauskas, LARed Network, Centro Hospitalario Pereira Rossell and Universidad de la República; Muhammad Irfan Habib, ChildLife Foundation; Jan Hau Lee, KK Women's and Children's Hospital and Duke-NUS Medical School; Niranjan Kissoon, BC Children's Hospital; Atnafu Mekonnen Tekleab, Saint Paul's Hospital Millennium Medical College; Elizabeth Molyneux, Kamuzu University of Health Sciences; Brenda Morrow, University of Cape Town; Vinay Nadkarni, Children's Hospital of Philadelphia; Jocelyn Rivera, Hospital Infantil Teletón de Oncología; Rebecca Silvers, University of California, San Francisco; Mardi Steere, Women’s and Children’s Hospital and Royal Flying Doctor Service; and Daniel Tatay, Hospital de Niños de la Santísima Trinidad.

The study was supported by ALSAC, the fundraising and awareness organization of St. Jude.

St. Jude Media Relations Contacts

Chelsea Bryant

Cell: (256) 244-2048

Desk: (901) 595-0564

chelsea.bryant@stjude.org

media@stjude.org

Rae Lyn Hartley

Cell: (901) 686-2597

raelyn.hartley@stjude.org

media@stjude.org

St. Jude Children’s Research Hospital

St. Jude Children’s Research Hospital is leading the way the world understands, treats and cures childhood cancer, sickle cell disease and other life-threatening disorders. It is the only National Cancer Institute-designated Comprehensive Cancer Center devoted solely to children. Treatments developed at St. Jude have helped push the overall childhood cancer survival rate from 20% to 80% since the hospital opened more than 60 years ago. St. Jude shares the breakthroughs it makes to help doctors and researchers at local hospitals and cancer centers around the world improve the quality of treatment and care for even more children. To learn more, visit stjude.org, read St. Jude Progress blog, and follow St. Jude on social media at @stjuderesearch.

JOURNAL

The Lancet Global Health

DOI

10.1016/S2214-109X(23)00537-5

ARTICLE PUBLICATION DATE

5-Jan-2024

Migrants can be ‘transformative force’ for sustainable development

Peer-Reviewed Publication

UNIVERSITY OF EXETER

Well-managed migration can enable migrants to boost sustainable development, research shows.

Sustainable development means enhancing wellbeing in ways that equitably meet needs of present and future generations.

Migration is often viewed as a threat to this – and to stability and security – while the benefits for migrants and host nations and regions are overlooked.

The new research – a set of studies published in the journal Proceedings of the National Academy of Sciences – shows new policies are needed for managing migration to maximise sustainability, and to minimise involuntary displacement due to conflict or disasters.

The studies are based on evidence from a variety of locations including Thailand, Pacific island nations, the world’s largest refugee camps, and European and American cities.

“Migrants can be a transformative force in their new locations, bringing energy and ideas that can boost economies – including the green transition,” said Professor Neil Adger, from the University of Exeter.

“However, poorly managed migration can deepen inequality and increase environmental damage.”

Professor Bill Clark, of Harvard University, said: “To understand properly the relationships between sustainability and migration, we need a comprehensive assessment that includes people who move in search of opportunities to enhance their wellbeing.

“This new research helps to fill these gaps, showing us the impacts of migration – both positive and negative – on the challenges for sustainability governance.”

Dr Sonja Fransen, of Maastricht University, said: “At present, sustainability and migration are often managed separately.

“We need new policies that manage migration in the interests of people and the planet, both now and into the future.

“Research to date has tended to focus on people fleeing conflict or disasters.”

Dr Ricardo Safra de Campos said: “It is crucial to consider the impact of migration on the places people leave behind, as well as the places they go.

“More than one billion people today are ‘lifetime migrants’, meaning they live in a place distant from where they were born.

“From a global perspective, only a quarter to a third of these migrants cross international borders.

“The majority consists of people moving within their countries of birth.

“The vast majority of migrants move voluntarily in search of a better life.

“But a growing number – now perhaps 10% of the total migrant pool – move involuntarily, fleeing social or environmental stresses such as conflict and climate change.

“Global averages, however, are only the beginning of the story.

“Most involuntary migrants end up concentrated in a few places relatively near to the places they are fleeing and pose disproportionate challenges there.”

The studies in the new collection include one that focusses on three atoll islands in the Pacific region.

It found that people’s sense of “belonging” affected the sustainability of those societies. Current patterns of emigration from these areas reduce pressure on natural resources, while emigrant diasporas still support and promote their origin communities through their social and economic ties.

Another paper focusses on Florida, where sea-level rise is expected to lead to outward migration – with younger, economically active adults moving first. Such migration would lead to pressures in destination cities, and aging populations in coastal areas.

Several of the researchers involved in the new studies are working on the MISTY project, an international consortium led by the University of Exeter and funded by Belmont Forum.

The new studies are published in a PNAS special issue entitled: “Migration and sustainable development.”

JOURNAL

Proceedings of the National Academy of Sciences

ARTICLE TITLE

Migration and sustainable development

ARTICLE PUBLICATION DATE

8-Jan-2024

Real-world analysis: COVID-19 vaccine strongly effective for children and adolescents during delta and omicron

Peer-Reviewed Publication

UNIVERSITY OF PENNSYLVANIA SCHOOL OF MEDICINE

Children and adolescents who received one of the main COVID-19 vaccines were significantly protected from the illness and showed no increased signs of cardiac complications compared to young people who were not vaccinated, according to a new real-world study led by researchers from the Perelman School of Medicine at the University of Pennsylvania and Children’s Hospital of Philadelphia (CHOP). When the Delta variant rose to prominence, the study showed that vaccinated young people were 98 percent less likely to be infected than their unvaccinated peers, and data indicated that the vaccine’s effectiveness decline slightly when the Omicron variant became dominant. The paper was published today in Annals of Internal Medicine.

In their analysis of 250,000 patients with around half of them received at least one dose of the BNT162b2 vaccine (the vaccine produced by a collaboration between Pfizer and BioNTech), the researchers—led by Yong Chen, PhD, and Jeffrey Morris, PhD, both professors of Biostatistics at the Perelman School of Medicine, and Christopher Forrest, MD, PhD, a professor of Pediatrics at CHOP and Penn—covered the periods in which the Delta and Omicron variants became dominant, in mid-2021 and 2022, respectively.

While previous clinical trials established that the vaccines provided strong protection against infection for children and adolescents, limited evidence of the vaccine’s performance existed beyond controlled settings. So, the researchers conducted one of the largest COVID-19 vaccine studies of children and adolescents in the United States with the assistance of data from electronic health records gleaned from a national network of pediatric medical centers, known as PEDSnet.

“Our study has longer follow-up than any previous study, which enabled us to evaluate the real-world, long-term durability of vaccine protection against Delta and Omicron variants,” said Chen. “Further, it covered a diverse representation of U.S. pediatric populations from primary care, specialty care, emergency department, testing centers, and inpatient settings.”

One of the main ideas behind the work, as stated by the study’s first authors—Qiong Wu, PhD, a postdoctoral research fellow at Penn Medicine and Jiayi Tong, a PhD candidate in Biostatistics at Penn—was to help address under-reporting in vaccine status to give a clearer picture of its effects.

Yet, infection prevention wasn’t the study’s only area of focus. The researchers also explored potential effects on risk of heart conditions.

“We found no indication of increased cardiac risks during either variant phase,” said Morris.

During the period of time in which the Delta variant of the SARS-CoV-2 virus emerged and became dominant, the researchers found that adolescents (defined as patients who were 12-to 20-years old) who received the vaccine were approximately 98 percent less likely to be infected or have severe disease compared to those who did not receive it, with no evidence of increased cardiac complications or significant waning infection protection over the subsequent four months.

Vaccination proved strongly protective against the Omicron wave, albeit at a lower magnitude than during Delta. Among adolescents, those who were vaccinated were roughly 86 percent less likely to be infected compared to unvaccinated peers, and their protection against severe illness and ICU admission was similarly high, being approximately 85 and 91 percent less likely, respectively, than the unvaccinated.

Among children, (those who were 5-to-11 years old at the time of vaccination during Omicron), the protection against infection was 74 percent better than unvaccinated peers. Their comparative protection against severe illness and ICU admission stood at 76 and 85 percent, respectively.

During the Omicron wave, the data showed some reduction in effectiveness in the four months following vaccination, while the vaccinated actually had a lower risk of cardiac complications during this time period.

In a follow-up study, the researchers are conducting further work to characterize the direct and indirect impacts of vaccination on outcomes tied to Long COVID, the phenomenon in which symptoms related to the illness linger for months or even years.

Additionally, the researchers believe even longer-term work is needed to better understand how well the vaccines continue to protect their recipients.

“Children and adolescents were the last age group to be enrolled in COVID-19 vaccine clinical trials. Although the pandemic has been declared over, the risk of COVID-19 is present throughout U.S. communities,” Forrest said. “Thus, more information is needed on effectiveness of vaccination delivered to children and adolescents during more recent time periods.”

This research was funded, in part, by the National Institutes of Health (OT2HL161847-01, 1R01LM012607, 1R01AI130460, 1R01AG073435, 1R56AG074604, 1R01LM013519, 1R56AG069880, 1R01AG077820, 1U01TR003709) and the Patient-Centered Outcomes Research Institute’s Project Program Awards (ME-2019C3-18315 and ME-2018C3-14899).

JOURNAL

Annals of Internal Medicine

METHOD OF RESEARCH

Data/statistical analysis

SUBJECT OF RESEARCH

People

U$A

Study highlights barriers to contraceptive access for disabled Medicare enrollees

Peer-Reviewed Publication

UNIVERSITY OF PITTSBURGH

PITTSBURGH — Contraceptive use is low among reproductive-aged people with disabilities who are enrolled in Medicare, according to a new study from the University of Pittsburgh that highlights how lack of contraceptive coverage by Medicare may prevent disabled enrollees from accessing contraception.

Published today in the January issue of Health Affairs, the study provides the first national overview of contraceptive use among enrollees in Medicare, the government health insurance for people over 65 and for people with qualifying disabilities. The researchers say that policy changes are needed to expand contraception coverage in Medicare and to ensure more equitable health care for people with disabilities, who already face barriers to reproductive health care and have higher rates of pregnancy complications and deaths than nondisabled people.

“The federal government requires that commercial insurers and Medicaid cover all contraceptive methods without cost sharing, but there is no similar requirement for Medicare, which means that disabled enrollees may not be able to access contraception or their preferred method of contraception,” said lead author Jacqueline Ellison, Ph.D., M.P.H., assistant professor in the Department of Health Policy and Management at the Pitt School of Public Health. “People with disabilities are already marginalized and experience barriers to accessing health care. It is unjust that they face additional cost-related barriers to receiving their contraceptive method of choice.”

Medicare does not require coverage for contraception to prevent pregnancies but may cover certain contraceptives for clinical indications such as endometriosis. Oral contraception may also be covered by Part D, an optional drug coverage benefit that costs extra. Patients may also be covered for other contraceptive methods by enrolling in Medicare Advantage, which is provided by private companies that contract with Medicare, but the scope of coverage depends on the company.

This complicated insurance landscape means that people with disabilities may not be able to access contraception or may be forced to pay out of pocket to access their preferred method of contraception.

In 2019, Medicare was the primary health insurance coverage for about 1.38 million reproductive-aged females with disabilities: About 941,000 had traditional Medicare and about 444,000 had Medicare Advantage. To understand more about patterns of contraceptive use among this population, Ellison and her team used two databases of insurance claims to analyze a study sample representing 17.2% of traditional Medicare and 9.5% of Medicare Advantage populations.

The researchers found that contraceptive use was low among reproductive-aged females with disabilities. Just 14.3% of traditional Medicare enrollees and 16.3% of those with Medicare Advantage had an insurance claim for contraception in 2019. In comparison, another study found that about 25% of reproductive-aged females with Medicaid — which is required to cover all forms of contraception — had such a claim in 2018.

The analysis also showed variation in contraceptive methods by type of Medicare coverage. For example, Medicare Advantage enrollees were about four times more likely to use an intrauterine device and 10 times more likely to have tubal ligation than those with traditional Medicare.

“This variation isn’t due to patient preference: There’s no reason that people with Medicare Advantage would be so much more likely than those with traditional Medicare to prefer using the intrauterine device or undergoing tubal sterilization,” explained Ellison. “This is a function of Medicare not requiring coverage for the full range of contraceptive methods.”

Medicare enrollees with noncontraceptive indications — such as acne, endometriosis, menstrual pain and irregular bleeding — were nearly twice as likely to use contraceptives as those without such an indication. This finding may highlight the importance of contraceptives for reasons beyond pregnancy prevention, or it may reflect clinicians documenting such an indication to help their patients get contraception when they otherwise would not have coverage.

“People with disabilities are more vulnerable to interference by guardians and clinicians in their reproductive decision making,” said Ellison. “It’s critical that, while ensuring access to the full range of contraceptive methods, we protect people with disabilities against such interference by ensuring contraceptive care provided in the Medicare program is truly person-centered.”

Other authors on the study were Sabnum Pudasainy, M.S., Deirdre Quinn, Ph.D., M.P.H, Sonya Borrero, M.D., M.S., Iris Olson, M.P.H., Qingwen Chen, M.S., and Marian Jarlenski, Ph.D., M.P.H., all of Pitt; and Meghan Bellerose, M.P.H., and Theresa I. Shireman, Ph.D., of Brown University.

This research was supported by the National Institute for Reproductive Health (5717077).

JOURNAL

Health Affairs

DOI

10.1377/hlthaff.2023.00286

METHOD OF RESEARCH

Data/statistical analysis

SUBJECT OF RESEARCH

Not applicable

ARTICLE TITLE

Contraceptive Use Among Traditional Medicare And Medicare Advantage Enrollees

ARTICLE PUBLICATION DATE

8-Jan-2024

U$A

New research identifies high rates and common causes of diagnostic errors in hospitals across the nation

Efforts and initiatives are underway across the country to address and prevent the causes of diagnostic errors

Peer-Reviewed Publication

BRIGHAM AND WOMEN'S HOSPITAL

Almost a quarter of patients who were admitted to the ICU or died in 29 hospitals in the United States experienced a diagnostic error

Efforts and initiatives are underway across the country to address and prevent the causes of diagnostic errors

A new study from researchers from Brigham and Women’s Hospital, a founding member of the Mass General Brigham healthcare system, in collaboration with researchers at the University of California San Francisco, has shed light on the rate and impact of diagnostic errors in hospital settings. In an analysis of electronic health records from 29 hospitals across the country of 2,428 patients who had either been transferred to an intensive care unit (ICU) or died in the hospital, the researchers found 550 patients (23%) experienced a diagnostic error, the majority of which were harmful to the patient. The researchers also determined the most common causes of diagnostic errors. The study was published January 8 in the journal JAMA Internal Medicine.

“We know diagnostic errors are dangerous and hospitals are obviously interested in reducing their frequency, but it’s much harder to do this when we don’t know what’s causing these errors or what their direct impact is on individual patients,” said senior author Jeffrey L. Schnipper, MD, MPH, of the Brigham’s Division of General Internal Medicine and Primary Care. “We found that diagnostic errors can largely be attributed to either errors in testing, or errors in assessing patients, and this knowledge gives us new opportunities to solve these problems.”

Diagnostic errors are defined in medicine as any failure to either accurately explain a patient’s health problem or a failure to communicate that information to the patient. Some national efforts are currently underway to detect and address their causes, including DECODE, a Diagnostic Centers of Excellence program at Brigham and Women’s Hospital that focuses on decreasing diagnostic errors in medical imaging by implementing and evaluating a highly resilient system for care planning and coordination, as well as a peer learning system for clinical providers. Other projects underway that involve BWH researchers include projects to address cases and causes of delayed diagnosis of cancer, explore how electronic health records contribute to diagnostic errors and more.

To date, few studies have quantified the prevalence of diagnostic errors in hospitals or their most common underlying causes. In this study, cases were assessed for diagnostic errors by teams of two physicians who received extensive training in error adjudication and utilized multiple quality control steps. They found that 550 of the patients in their cohort (23%) experienced a diagnostic error in the hospital. Of these, 486 (17% of all patients) experienced some form of harm because of these errors. Of the 1,863 patients who died, the researchers judged that a diagnostic error was a contributing factor in 121 cases (6.6%).

“It appears to be that only a minority of deaths in hospitals are linked to diagnostic errors, but even a single patient death that might have been prevented with a better diagnostic process is one death too many,” said Schnipper.

The researchers found that most errors were attributable to errors in assessing patients, or errors in ordering and interpreting diagnostic tests.

“These two parts of the diagnostic process feed directly into each other,” said Schnipper. “If you don’t think of the correct possible diagnosis during your assessment of a patient, you’re not going to order the right tests. And if you order the wrong test or order the right test but misinterpret the result, this will inevitably change how you then assess a patient.”

While the research demonstrates the dangers that diagnostic errors can pose to patients, the researchers maintain that the rate of diagnostic errors in their specific population of patients, which were all patients who experienced bad outcomes, does not represent the general rate of diagnostic errors across hospitals. The researchers are next exploring how health systems can implement surveillance systems to catch diagnostic errors as they occur, compare results across hospitals, and start pilot testing possible solutions.

“Our study does not tell us the overall frequency of diagnostic errors in the hospital, but it does tell us that there’s more we can be doing to prevent these types of errors from occurring,” said Schnipper.

Authorship: Authors of the study include Andrew D. Auerbach, Tiffany M. Lee, Colin C. Hubbard, Sumant R. Ranji, Katie Raffel, Gilmer Valdes, John Boscardin, Anuj K. Dalal (BWH), Alyssa Harris, and Ellen Flynn for the UPSIDE Research Group.

Disclosures: The authors declare no competing interests.

Funding: This study was supported by the Agency for Healthcare Research and Quality (R01HS027369).

Paper cited: Auerbach, AD et al. “Diagnostic errors in hospitalized adults who died or were transferred to intensive care” JAMA Internal Medicine DOI: 10.1001/jamainternmed.2023.7347

JOURNAL

JAMA Internal Medicine

DOI

10.1001/jamainternmed.2023.7347

METHOD OF RESEARCH

Observational study

SUBJECT OF RESEARCH

People

ARTICLE TITLE

Diagnostic errors in hospitalized adults who died or were transferred to intensive care

ARTICLE PUBLICATION DATE

8-Jan-2024

Hospital care at home benefits medically complex, socially vulnerable patients

Current acute hospital care at home waiver expires December 2024

Peer-Reviewed Publication

AMERICAN COLLEGE OF PHYSICIANS

Annals of Internal Medicine Tip Sheet  

@Annalsofim
Below please find summaries of new articles that will be published in the next issue of Annals of Internal Medicine. The summaries are not intended to substitute for the full articles as a source of information. This information is under strict embargo and by taking it into possession, media representatives are committing to the terms of the embargo not only on their own behalf, but also on behalf of the organization they represent.
----------------------------

1. Hospital care at home benefits medically complex, socially vulnerable patients

Current acute hospital care at home waiver expires December 2024

Abstract: https://www.acpjournals.org/doi/10.7326/M23-2264

URL goes live when the embargo lifts

A study of more than 5,000 adults found that acute hospital care at home (AHCaH) may provide important benefits to a diverse group of medically complex and socially vulnerable patients. Hospital care at home also was associated with low mortality, escalation, and readmission rates. However, the current AHCaH waiver issued by the Centers for Medicare & Medicaid Services (CMS) is set to expire in December 2024. The report is published in Annals of Internal Medicine.

Hospitalization is the standard of care for acute illness, but hospital care is often expensive, unsafe, and uncomfortable. Prior research has shown that compared with traditional inpatient hospital care, patients cared for in AHCaH have improved experiences and physical activity levels, with lower rates of mortality, readmission, and discharge to skilled-nursing facilities. In November 2020, the Centers for Medicare & Medicaid Services issued the AHCaH waiver, creating a regulatory and payment pathway for hospitals to deliver AHCaH. However, this waiver is set to expire in December 2024.

Researchers from Brigham and Women’s Hospital and Harvard Medical School analyzed data for 5,132 patients receiving AHCaH between July 2022 and June 2023. Of the patients studied, 42.5 percent had heart failure, 43.3 percent had chronic obstructive pulmonary disease, 22.1 percent had cancer, and 16.1 percent had dementia. AHCaH was associated with low rates of mortality, escalation, skilled nursing facility use, and readmission. According to the authors, their data provide preliminary evidence on national uptake and suggest that AHCaH is an important care model to manage acute illness, including among socially vulnerable and medically complex patients. They suggest that these data should help inform ongoing policy deliberations.

Media contacts: For an embargoed PDF, please contact Angela Collom at acollom@acponline.org. To speak with the corresponding author, David M. Levine, MD, MPH, MA, please email Haley Bridger at hbridger@mgb.org.

----------------------------

2. In real world study, BNT162b2 bivalent vaccine provides substantial protection against severe illness from Delta and Omicron variants in pediatric patients

Abstract: https://www.acpjournals.org/doi/10.7326/M23-1754      

URL goes live when the embargo lifts  

In a real-world study, the BNT162b2 bivalent vaccine proved to be highly effective against COVID-19 during the Delta period. There was a moderate decline in effectiveness against the Omicron variant after 4 months, but the vaccine still provided significant protection against severe outcomes, including hospital admissions. The vaccine was safe, with no indication of heart-related complications. The findings are published in Annals of Internal Medicine.

Researchers from the University of Pennsylvania Perelman School of Medicine used electronic health record data from a national network of U.S. pediatric medical centers to assess the real-world effectiveness of BNT162b2 among children and adolescents during the periods when the Delta and Omicron variants of SARS-CoV-2 were predominant. The researchers used a novel comparative effectiveness research method and adjusted for underreporting issues in vaccination status.

The researchers found that during the Delta variant period, the BNT162b2 vaccine showed an estimated effectiveness of 98.4 percent against getting infected with COVID-19 among adolescents. The effectiveness didn't significantly decrease after receiving the first vaccine dose. During the Omicron variant period, the effectiveness against documented infection among children dropped to 74.3 percent. However, the vaccine seemed to provide significant protection against more severe infection and hospital admission due to COVID-19. Among adolescents, the effectiveness against Omicron infection was 85.5 percent, with higher effectiveness against more severe outcomes. The effectiveness of the vaccine against the Omicron variant declined four months after the first dose but then stabilized. An analysis did not find an increased risk of heart-related complications after vaccination.

Media contacts: For an embargoed PDF, please contact Angela Collom at acollom@acponline.org. To speak with the corresponding author, Yong Chen, PhD, please email ychen123@pennmedicine.upenn.edu.

---------------------------- 

3. Two doses of the herpes zoster vaccine provides strong and lasting protection against shingles

Abstract: https://www.acpjournals.org/doi/10.7326/M23-2023
URL goes live when the embargo lifts
A real-world study of the recombinant zoster vaccine (RZV) found that two doses provided strong and lasting protection against herpes zoster , or shingles, even in patients at higher risk for the disease , such as those taking corticosteroids. The findings are published in Annals of Internal Medicine.

Shingles is a painful rash with complications that include persistent burning pain at the site of the initial rash, known as postherpetic neuralgia. The incidence and severity of shingles increase markedly with age and immunocompromising conditions. A 2-dose series of RZV has been shown to be very effective in clinical trials, but the long-term effectiveness has not been extensively studied in real-world settings.

Researchers from Kaiser Permanente Northern California studied data from the Vaccine Safety Datalink to evaluate the real-world effectiveness of RZV against acquiring shingles. The outcome was incident shingles defined by a diagnosis with an antiviral prescription. The researchers used a Cox regression model to compare the risk of getting shingles in people who were vaccinated versus those who were not. Other factors that could affect the risk, such as age or other health conditions were accounted for in the model. The researchers found that the RZV vaccine provided a high level of protection that didn't decrease much over 4 years. Among people taking corticosteroids, medications that can weaken the immune system, the vaccine still showed substantial effectiveness. According to the authors, this is important because people on corticosteroids are at a higher risk of getting shingles. The study also revealed that the effectiveness of just one dose of the vaccine decreased after a year, supporting the current recommendation for people to get a second dose. These findings support the existing guideline recommending a two-dose regimen for optimal protection.

Media contacts: For an embargoed PDF, please contact Angela Collom at acollom@acponline.org. To speak with the corresponding author, Ousseny Zerbo, PhD, please e-mail ousseny.x.zerbo@kp.org.

----------------------------

JOURNAL

Annals of Internal Medicine

DOI

10.7326/M23-2264

METHOD OF RESEARCH

News article

SUBJECT OF RESEARCH

People

ARTICLE TITLE

Acute Hospital Care at Home in the United States: The Early National Experience

ARTICLE PUBLICATION DATE

9-Jan-2024

Study of national data demonstrates the value of acute hospital care at home

Mass General Brigham researchers found low rates of mortality, less use of skilled nursing facilities, and less need for escalation in patient care for patients taken care of at home instead of in the hospital

Peer-Reviewed Publication

MASS GENERAL BRIGHAM

Since the Centers for Medicare and Medicaid Services launched the Acute Hospital Care at Home (AHCaH) Waiver in 2020, thousands of patients from across 300 hospitals in 37 states have been treated in their homes. Yet little is understood about these patients’ outcomes on a national level, and the waiver will end in December 2024 unless there is an act from Congress. A new study by investigators from Mass General Brigham analyzed outcomes from AHCaH for a diverse group of patients across America. The study provides preliminary evidence suggesting that home hospital is an important care model for managing acute illness, including among socially vulnerable and medically complex patients. Results are published in a research letter in Annals of Internal Medicine.

“For hundreds of years, since the inception of hospitals, we’ve told patients to go to a hospital to get acute medical care. But in the last 40 years, there’s been a global movement to bring care back to the home,” said corresponding author David Michael Levine, MD, MPH, MA, clinical director for research and development for Mass General Brigham’s Healthcare at Home. “We wanted to conduct this national analysis so there would be more data for policymakers and clinicians to make an informed decision about extending or even permanently approving the waiver to extend opportunities for patients to receive care in the comfort of home.”

Advances in healthcare technology have made it more possible than ever to offer treatment options to patients in their home rather than requiring office or hospital visits. Mass General Brigham is a recognized leader in acute hospital care at home, with a Home Hospital program that serves 66 neighborhoods across greater Boston. In addition, Levine and other investigators from across Mass General Brigham are conducting rigorous, national-level research to present data relevant to clinicians, patients, caregivers and policymakers to inform decisions about the acute hospital care at home model.

Levine and colleagues looked at clinical characteristics and outcomes from all of the 5,858 patients from across the U.S. who were cared for under the AHCaH Waiver, using Medicare fee-for-service Part A claims filed between July 1 2022 and June 30 2023. Then they studied whether these clinical characteristics varied across different demographic groups.

Fifty-four percent of the patients were female, 85.2 percent were white, 61.8 percent were over 75 years old, and 18.1 percent were disabled. The mean household income was $83,932.

When the team studied hospitalizations among all these patients, they found a 0.5 percent mortality rate and 6.2 percent escalation rate (returning to the hospital for at least 24 hours). In addition, within 30 days of discharge, 2.6 percent of patients used a skilled nursing facility, 3.2 percent died, and 15.6 percent were readmitted.

“Home hospital care appears quite safe and of high quality from decades of research — you live longer, get readmitted less often, and have fewer adverse events.” Levine says. “If people had the opportunity to give this to their mom, their dad, their brother, their sister … they should.”

The patients included in the current study had medically complex conditions, including 42.5 percent with heart failure, 43.3 percent with chronic obstructive pulmonary disease, 22.1 percent with cancer, and 16.1 percent with dementia. The five most common discharge diagnoses were heart failure, respiratory infection (including COVID), sepsis, kidney/urinary tract infections, and cellulitis.

“There are a number of reasons we think hospital-level care is better at home,” Levine said. “For one, the discharge process is smoother since we show patients how to take care of themselves right in their homes, where they are also more likely to be upright and move more. In addition, the clinical team has a greater ability to educate and act on the social determinants of health that we see in the home. For example, we can discuss a patient’s diet right in the kitchen or link a patient with resources when we see the cupboards are bare.”

The outcomes were also stratified by patients of Black and Latine race and ethnicity, dual-eligible status, and by disability status. The findings were consistent across all groups.

“It was reassuring to see that there were not clinically meaningful differences in outcomes across marginalized populations, because we know that there are massive disparities in outcomes for traditional hospitalization,” Levine said. “This suggests home hospital can really reach a diverse group of patients and families.”

Still, the findings are limited to observational data, and additional research is necessary to compare the measured outcomes to those at brick-and-mortar hospitals. Levine’s team is also currently studying home hospital care for rural patients, who were not well represented in the current study.

"For decades, home hospital care has been offered all around the world,” Levine said. “This is an important moment in the United States where we might see a paradigm shift in how we deliver a sizeable portion of health care.”

Authorship: Additional authors include Jeffrey Souza, Jeffrey Schnipper (BWH), Thomas Tsai (BWH), Bruce Leff, and Bruce Landon.

Disclosures: Levine reports a PI-initiated grant and co-development from Biofourmis as well as fees from The MetroHealth System. Leff reports affiliations with Medically Home, Dispatch Health, Chartis Health and Kenes. Landon reports grants from the Agency for Healthcare Research and Quality (AHRQ) and the National Institute on Aging (NIA).

Funding: NIH Funding 5P01AG032952-13.

Paper cited: Levine, DM et al. “Acute Hospital Care at Home in The United States: The Early National Experience” Annals DOI: 10.7326/M23-2264

For More Information:

###

About Mass General Brigham
Mass General Brigham is an integrated academic health care system, uniting great minds to solve the hardest problems in medicine for our communities and the world. Mass General Brigham connects a full continuum of care across a system of academic medical centers, community and specialty hospitals, a health insurance plan, physician networks, community health centers, home care, and long-term care services. Mass General Brigham is a nonprofit organization committed to patient care, research, teaching, and service to the community. In addition, Mass General Brigham is one of the nation’s leading biomedical research organizations with several Harvard Medical School teaching hospitals. For more information, please visit massgeneralbrigham.org.

JOURNAL

Annals of Internal Medicine

DOI

10.7326/M23-2264

METHOD OF RESEARCH

Observational study

SUBJECT OF RESEARCH

People

ARTICLE TITLE

Acute Hospital Care at Home in The United States: The Early National Experience

ARTICLE PUBLICATION DATE

9-Jan-2024

COI STATEMENT

Levine reports a PI-initiated grant and co-development from Biofourmis as well as fees from The MetroHealth System. Leff reports affiliations with Medically Home, Dispatch Health, Chartis Health and Kenes. Landon reports grants from the Agency for Healthcare Research and Quality (AHRQ) and the National Institute on Aging (NIA). Disclosures can be viewed at www.acponline.org/authors/icmje/ConflictOfInterestForms.do?msNum¼M23-2264.