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In our newest Deep Dive interview, Sameer Awsare, MD, FACP, associate executive director for The Permanente Medical Group, addresses biosimilar uptake in the United States and his predictions for the near future, with Associate Editor Matthew Gavidia.

Take a DEEP DIVE Into Medical World News

If 2020 was dominated by the news of how COVID-19 spread across the globe, then 2021 has so far been focused on ending the pandemic through vaccine distribution.

A Timeline of COVID-19 Vaccine Developments in 2021

This AJMC® Profiles in Care provides an in-depth look into the results of the outcomes-based agreement between Boehringer Ingelheim and Highmark Inc.

AJMC® Profiles in Care Launches

Researchers are emphasizing the importance of collaborative management for patients with 

 (SMA) who are pregnant, in a new paper appearing in 

The paper details the case of a 28-year-old woman pregnant with her second child who presented with muscle weakness. Genetic testing revealed an SMA type 3 diagnosis for the woman, with homozygous deletion of 

According to the researchers, this case, which occurred in Indonesia, was the first to use a collaborative, multidisciplinary approach that involved obstetric, neurology, pediatric, and anesthesiology departments at the hospital.

“Pregnancy in SMA patients should be treated comprehensively and managed carefully. Maternal factors such as muscle weakness, deformities, and restrictive ventilatory pattern (lung capacity and compliance reductions), as well as social issues such as stigma and concerns from family and environment may arise,” wrote the researchers. “This pregnancy can be categorized as a high-risk pregnancy since it may lead to complications such as the possibility of preterm labor, miscarriage, intrauterine growth restriction, and maternal back pain due to increasing pressure from abdominal enlargement. These complicated conditions required good teamwork from a multidisciplinary team of health care professionals to maximize the outcomes, both for the mother and her baby.”

Without access to SMA treatments nusinersen or gene replacement therapy in the country, the patient did not receive treatment for her muscle weakness. Despite not receiving treatment, there were no adverse events during the elective cesarean section for either the patient or the baby, who was delivered healthy at 38 weeks gestation.

Following birth, the baby underwent genetic testing and was deemed a carrier, with retention of 

 exons 7 and 8. In addition, up until the publishing of this paper, there were no reports of the baby or the patient’s first child who was also deemed a carrier having any muscle weakness indicating SMA or any neuromuscular disorder.

“Dealing with pregnancy in a patient with SMA is not easy, clinically or socially. However, this report shows that a patient with SMA could have a normal reproductive life while having a marriage and healthy children,” explained the researchers. “Although this is not a common case that will be encountered in routine clinical practice, managing pregnancy in a patient with SMA should be performed collaboratively. By taking every maternal and fetal factor into account, a successful pregnancy and delivery in an SMA patient could be managed well.”

The researchers note that there have been several other reported cases of patients with SMA who are pregnant. Three studies were leveraged by the researchers as they prepared to manage the current case, one of which included 2 women with SMA type 2 who delivered healthy babies by vaginal delivery and cesarean section at 39 weeks. The second study followed a high-risk pregnancy in a 32-year-old patient with severe SMA type 2 who had a planned cesarean section at 28 weeks due to maternal and fetal prematurity, kyphoscoliosis, anticipated cephalopelvic disproportion, and primiparity. The third study covered the case of a patient with SMA type 3 who received a cesarean section at 32 weeks due to abdominal and back pain.

Based on these studies, the researchers tried to prevent premature birth and preserve pregnancy as long as possible, monitored discomfort due to the patient’s deformities, and monitored the baby for any signs of growth retardation.

Setyaningrum C, Harahap I, Nurputra D, Rachman I, Harahap N. Managing pregnancy in a spinal muscular atrophy type III patient in Indonesia: a case report. 

. Published online January 16, 2022. doi:10.1186/s13256-021-03226-1

Articles

According to researchers, this case of a patient with spinal muscular atrophy (SMA) from Indonesia was the first to use a collaborative, multidisciplinary approach that involved obstetric, neurology, pediatric, and anesthesiology departments at a hospital. 

Multidisciplinary Care Emphasized for Pregnant Women With SMA

® since 2019 after receiving his Bachelor's degree at Rutgers University–New Brunswick in journalism and economics.

Dupilumab treatment was associated with reduced all-cause and 

 (AD)–related hospitalization rates among patients with AD, according to study findings published in 

The Journal of Allergy and Clinical Immunology: In Practice

Among patients with AD, incidence of refractory disease, severe flares, and infections have been linked with significantly increased hospitalization rates and costs. In fact, researchers note that about 1 in 5 patients, including children and adults, who have had an AD-related hospitalization experience an all-cause hospital readmission within the next year.


“Treatment options for moderate-to-severe AD include various systemic immunosuppressants, some of which may increase the risk of infection and serious infection requiring hospitalization,” they added.


 efficacy and safety among adults, adolescents, and young children 6 months and older with moderate-to-severe AD, the study authors sought to explore whether rates of hospitalizations may be ameliorated by the drug.

They conducted a post hoc analysis of pooled data from 7 placebo-controlled, phase 2 or 3 randomized controlled trials involving adult patients with moderate-to-severe AD. Participants were treated with dupilumab 300 mg every 2 weeks or weekly (n = 1841) vs placebo (n = 1091), with or without topical corticosteroids, for 12, 16, or 52 weeks.


The primary outcomes assessed included hospitalization rates (all-cause and AD-related), length of AD-related hospitalizations, and time to first hospitalization.


From the study cohort, 77 hospitalization events were identified (31 in the dupilumab group), of which “AD exacerbation” was the most common reason for hospitalization and was lower in the combined dupilumab vs control groups.


Compared with the control group, patients with moderate-to-severe AD in the combined dupilumab groups exhibited a 62% risk reduction for all-cause hospitalizations (3.8 vs 9.0 events per 100 patient-years [PY]; rate ratio [RR], 0.38; 95% CI, 0.23-0.62; 

 < .001), a 79% risk reduction for AD-related hospitalizations (1.0 vs 4.1 events per 100 PY; RR, 0.21; 95% CI, 0.09-0.51; 

 < .001), and a 30.3-day reduction per 100 PY for overall duration of AD-related hospitalizations (8.6 vs 38.9 days per 100 PY; RR, 0.10; 

Moreover, the individual dupilumab dose regimen groups also showed lower rates for the assessed outcomes vs the control group:

49% risk reduction and 71% risk reduction for all-cause hospitalization in the dupilumab 300 mg every 2 weeks and once-weekly groups, respectively, vs placebo (every 2 weeks: 5.8 vs 9.0 events per 100 PY; RR, 0.51; 95% CI, 0.27-0.95; 

 = .033; weekly: 2.7 vs 9.0 events per 100 PY; RR, 0.29; 95% CI, 0.15-0.55; 

60% risk reduction and 91% risk reduction for AD-related hospitalizations in the dupilumab 300 mg every 2 weeks and once weekly groups, respectively, vs placebo (2.0 vs 4.1 events per 100 PY; RR, 0.40; 95% CI, 0.15-1.08; 

 = .07; 0.4 vs 4.1 events per 100 PY; RR, 0.09; 95% CI, 0.02-0.40; 

28.0-day and 31.6-day reduction per 100 PY for duration of AD-related hospitalizations in the dupilumab 300 mg every 2 weeks and once weekly groups, respectively, vs placebo (10.9 vs 38.9 days per 100 PY; RR, 0.45; 95% CI, 0.07-3.09; 

 = .42: 7.3 vs 38.9 days per 100 PY; RR, 0.02; 95% CI, 0.00-0.16; 

“These analyses show that the efficacy of dupilumab translates into a benefit of reduced hospitalizations, overall and those related to AD,” said the study authors. “Although all-cause hospitalizations may include events that have no relationship to the drug or AD, a reduction of all-cause hospitalizations provides additional information relevant to the safety profile of dupilumab.”


Silverberg JI, Rubini, Pires MC, et al. Dupilumab treatment reduces hospitalizations in adults with moderate-to-severe atopic dermatitis.

. Published online January 12, 2022. doi:10.1016/j.jaip.2021.11.034

Patients with atopic dermatitis (AD) treated with dupilumab showed reduced hospitalization rates and shorter duration of AD-related hospitalizations vs those treated with control therapies.

Dupilumab Significantly Reduces Hospitalization Rates in Patients With Atopic Dermatitis

There is a significant need for quality-improvement initiatives in initial 

 care, as well as prominent geospatial variation in receipt of that care, which remains unexplained, according to a new study that investigated care delivery among patients with stage I to III disease.

This analysis, which was conducted using data from 31,571 (mean [SD] age, 71 [68-75] years) patients, investigated outcomes in connection with 5 care delivery variables: stage I at diagnosis (proxy for screening mammography and timely surgery), chemotherapy receipt, radiation therapy receipt, endocrine therapy (ET) initiation (within a year of diagnosis), and endocrine therapy continuation (3-5 years after diagnosis). The survey was conducted from January 1, 2007, through December 31, 2016, and data analyzed between January and June 2021.

“For each metric, total variance was attributed proportionally to 4 domains—random, patient factors (eg, age, race and ethnicity, socioeconomic status), region (health service area [HSA]), and unexplained—using hierarchical multivariable modeling,” the authors explained.

The retrospective population-based cohort study gleaned its data from the Surveillance, Epidemiology, and End Results–Medicare database for patients who received a diagnosis from 2007 through 2013, and the primary goal was to get a clear view of the extent of geospatial variation in breast cancer care.

Among the 5 metrics evaluated, patient factors likely had the least influence on variation in breast cancer care, at 1% to 4%, while region/HSA appeared to have the most influence, at 24% to 48%. In addition, for region/HSA variance, the blame may lie with ET initiation (28%) and ET continuation (39%). Most patients received radiation (81.6%), received chemotherapy (72.8%), initiated ET (48.8%), or continued ET (52.1%).

Still, 35% to 54% of care variation remained unexplained, the investigators highlighted.

Despite county-level data showing wide swings in breast cancer–related mortality—from 11.2 to 51.6 deaths per 100,000 women—and certain patient populations proving to be at higher risk of death from the disease—Black individuals, low-income people, older adults, and patients living in rural areas—the authors noted there is a lack of research on the impact of geographic factors on disease outcomes. Two important questions remain unanswered, they said:

How much of the observed variability in breast cancer care can be attributed to patient factors vs region and how much is simply owing to randomness?

To the extent that breast cancer care varies by region, which regions demonstrate the lowest performance?

In fact, in this study, most participants were non-Hispanic White vs Black (83.7% vs 6.1%), lived in an all-urban vs an all-rural area (60.2% vs 8.0%), were aged 70 to 74 years vs 75 to 79 years (39.3% vs 26.6%), and had no comorbidities vs having 2 or more (64.1% vs 13.4%). These numbers were seen despite fewer instances of stage I disease and receipt of treatment among patients of an older age, with multiple comorbidities, and who are Black. Especially among Black patients, ET use is much less, the authors noted.

In fact, "the ET metrics demonstrated the largest total observed variance, the lowest absolute performance, and the strongest association with region/HSA,” the authors concluded. “This is remarkable, considering that ET confers an impressive one-third reduction in the risk of death from breast cancer in the first 15 years after diagnosis.”

Next steps, they said, should focus on the portion of geospatial variation that remains unexplained, especially where doing so can help to optimize the delivery of ET.

Hassett MJ, Tramontano AC, Uno H, Ritzwoller DP, and Punglia RS. Geospatial disparities in the treatment of curable breast cancer across the US. 

. Published online January 27, 2022. doi:10.1001/jamaoncol.2021.7337

This new analysis among patients with stage I to III breast cancer investigated outcomes in connection with 5 care delivery variables: stage I at diagnosis, chemotherapy receipt, radiation therapy receipt, endocrine therapy initiation, and endocrine therapy continuation.


Persistent Care Variations Uncovered in New Breast Cancer Study 

Three authors from institutions in the Denver, Colorado area conducted a review evaluating the roles of sex, ancestry, senescence, and aging (SAnSA) in the development of nontuberculous mycobacterial (NTM) pulmonary disease (PD).

Journal of Clinical Tuberculosis and Other Mycobacterial Diseases

, also highlighted molecular tools and biomarkers to contextualize SAnSA in NTM PD.

More than 86,000 Americans live with NTM PD, which typically adults age 65 and older.

“Aging is a risk factor for the development of a number of medical conditions including PD and increased susceptibility to respiratory infections,” the authors explained. “Consequently, aging can cause the progressive accumulation of cellular metabolic products and increased DNA damage, resulting in the development of a low-grade inflammatory phenotype commonly referred as ‘inflammaging’.”

Many past studies have found NTM PD disproportionately affects older White women. One study included in the review found that women were 1.1 to 1.6 times more likely to develop NTM PD compared with men, and a Japanese study showed that women were more likely to experience more severe NTM PD than men. According to the review authors, this has been shown to be caused by more cavitation in the lung, lower body mass index, and extensive treatment history in women.

Ancestry also plays a role in the disease, as genealogical ancestry can provide a biogeographic history of genetic variations that can be generalized to a population. While not widely studied in regard to respiratory diseases, ancestry has helped in other research on pulmonary function, coronary artery risk, and asthma in African populations, as well as on COPD risk among Native Americans and pulmonary fibrosis in Europeans.

Where someone lives geographically—regardless of their ethnicity—may also contribute to NTM exposure, as some areas have high levels of air pollution and other hazards that can affect gene expression in people with respiratory disease.

Senescence refers to the irreversible loss of somatic cell proliferation and is a widely recognized marker of age. However, senescent cells remain metabolically active and secrete an array biologically active molecules called the senescence-associated secretory phenotype (SASP). Because most studies on mycobacterial PD have been reported in the context of 

, the authors noted that more research to differentiate the effect of senescence versus inflammaging on NTM PD is needed.

“However, from other generalized studies on senescence, an enhanced SASP response can be triggered by tumor suppressor p21 activation of p38 mitogen-activated protein kinase and Janus-activated kinases resulting in the activation of the proinflammatory transcription factor nuclear factor κB (NFκB),” the authors said. “Upon NFκB activation, multiple inflammatory proteins such as cytokines, chemokines, proteases, and growth factors increase particularly during chronic PD.”

The final category in SAnSA is aging, which can alter the respiratory system’s physiological and molecular function. Adjusted odds ratio (OR) for NTM PD by age group showed the lowest OR (7.4; 95% CI, 2.9-19.3) for people aged younger than 18 and the highest OR (106.4; 95% CI, 42.0-270.0) for people aged 65 and older. Additionally, the disease is rare in women younger than 50.

FEV1 and FVC are indicators of lung volume that peak at age 25 and decline slowly with age alongside lung capacity, and depressed beating of lung cilia can begin as early as age 40.

“Decreased respiratory muscle strength, as much as 20%, is commonly observed in individuals over 70 years of age,” the authors said. “Physiological changes in the lung also occurs across the lifespan caused by exposure to common cellular stressors such as cigarette smoke or oxidative stress due to an imbalance of natural antioxidants and reactive oxygen species.”

While molecular biomarkers of NTM PD and age-related changes in the lung microbiome are not as heavily studied, the authors noted 3 established molecular markers of senescence and 1 marker of aging that could be applied in further research: sirtuins, α-Klotho, senescence marker protein-30 (SMP30), and age marker mTOR.

As current therapeutics are inefficient at controlling NTM PD progression, the review suggested senolytic therapies and potentially a caloric restriction (CR) diet, with exercise to slow down age-related PD.

“An alternative to CR is intermittent fasting regimes and changes in diet regimes that give sufficient CR to activate anti-aging pathways,” the authors noted. “Such options are currently being explored in animal models, but the effectiveness of CR, diet changes, and increased exercise in age-related PD and NTM is yet to be realized.”

Fifor A, Krukowski K, Honda JR. Sex, ancestry, senescence, and aging (SAnSA) are stark drivers of nontuberculous mycobacterial pulmonary disease. 

. 2022;26:100297. doi:10.1016/j.jctube.2022.100297

The review discussed the roles of sex, ancestry, senescence, and aging in the development of nontuberculous mycobacterial pulmonary disease. 

Review Evaluates Factors of Pulmonary Disease Subtype Development

Pfizer, Moderna Begin Trials for Omicron-Specific Boosters

Moderna has begun testing a booster dose of its COVID-19 vaccine specifically designed to fight off the Omicron variant, as reported by 

 The news comes just 1 day after Pfizer and BioNTech announced the start of a trial for their Omicron-specific dose. Moderna also shared results from a small laboratory study that suggests the protection against Omicron infection provided by their authorized booster shot will likely fade 6-fold over the course of 6 months. Although Omicron seems to evade the antibodies created as a result of receiving the authorized vaccines, causing breakthrough cases to rise, the vaccines still provide significant protection against hospitalization and death.

14.5 Million Americans Signed Up for Health Insurance 

, 14.5 million Americans signed up for health insurance since November 1, 2021. The increased enrollment largely is due to the passage of the Biden administration’s pandemic relief package and the reopening of an online health insurance marketplace in 2021. Of the 14.5 million, 10 million of those people enrolled through HealthCare.gov during the open enrollment period, which President Biden claimed is the highest number of people to ever sign up during open enrollment. The president announced that 1 in 7 uninsured Americans received coverage between the end of 2020 and September 2021, with lower-income people gaining coverage at the fastest rate.

Medicare Shares Nursing Home Staffing Information

Medicare’s website for consumers to research nursing home facilities is now available to the public and will provide information on staff turnover and weekend nurse coverage, according to the 

. The website dubbed “Care Compare” comes as COVID-19 cases and death rates at nursing homes begin to rise again, despite the Biden administration increasing efforts to vaccinate residents and staff. Additionally, major upgrades of federal requirements for nursing home staffing are stalled in Congress along with President Biden’s other social and climate legislation. CMS said that it researched links between staff turnover and quality of care, finding that as turnover decreased, the overall quality of care went up.

Pfizer and Moderna announced commencement of trials for Omicron-specific booster shots; 14.5 million Americans gained health coverage since November 2021; Medicare’s website for consumers to research nursing home staffing is up and running.

What We’re Reading: Omicron-Specific Vaccine Trials; Health Insurance Enrollment Gains; Public Nursing Home Staffing Data

Videos

Kashyap Patel, MD, and Jason Starr, DO, explain the various potential uses for MRD results and how they guide treatment decisions.

MRD Results and Guiding Treatment Decisions

Jason Starr, DO, discusses MRD assessments, including: when they are done, where the testing takes place, and how often they are recommended.

MRD Assessments

During the peripartum period—the 3-month period before and after giving birth—anxiety and depression can lead to lower quality of life for mothers. A 

 connected peripartum depression and anxiety to 

 and biological rhythms in late pregnancy and postpartum.

“Our findings highlight the importance of stabilizing the internal biological clock during the peripartum period to maintain healthy mood and minimize anxiety,” Benicio Frey, senior study author of the study and professor in the department of psychiatry and behavioral neurosciences at McMaster University, said in a 

An estimated 15% to 18% of women experience anxiety and 7% to 13% of women experience depression during the peripartum period, according to past research, and the current study is the largest observational analysis known to date examining longitudinal trends in sleep and biological rhythms in the peripartum period.

A cohort of 100 women in their third trimester of pregnancy were recruited from obstetric and midwifery practices, family physicians’ offices, ultrasound clinics, and from an outpatient psychiatric clinic in Ontario, Canada from November 2015 to May 2018.

Researchers gathered subjective and objective measures of sleep patterns and biological rhythms, including 2 weeks of actigraphy (wearable technology for sleep monitoring) at each visit. In total, 73 participants returned for follow-ups at 1 to 3 weeks postpartum, a common time for “postpartum blues” onset; and 6 to 12 weeks postpartum, when there is a higher incidence of postpartum depression.

The Epworth Sleepiness Scale (ESS) for daytime sleepiness and the Pittsburgh Sleep Quality Index (PSQI) were used to measure sleep quality, and the Biological Rhythms Interview of Assessment in Neuropsychiatry (BRIAN) evaluated subjective disruptions in biological rhythms. Participants were interviewed using the Mini-International Neuropsychiatric Interview (MINI) Version 6 to assess current psychological mood state and diagnosis. Further assessments were done to determine each patient’s risk for postpartum depression, manic symptoms, and anxiety.

Researchers identified several variables that are linked to depression and anxiety. A higher circadian quotient, a measure of biological rhythm strength, and higher mean activity counts during rest states at night were both strongly associated with increased depressive symptoms.

A higher probability of transitioning from rest to active states (pRA)—meaning more fragmentation of sleep—was associated with less depressive symptoms at 1 to 3 weeks and 6 to 12 weeks postpartum, the latter being a time when risk of developing postpartum depression is higher.

“While these results might sound counterintuitive at first, they may indicate that mothers with lower depressive symptoms were more actively responsive to the babies’ needs overnight, since these same variables were not predictive of depressive symptoms in late pregnancy,” the authors wrote. Higher pRA peripartum was also predictive of lower anxiety postpartum.

Overall, the findings suggest that subjective biological rhythm disruptions are associated with increased depressive and anxiety symptoms peripartum, which aligns with findings that objective biological rhythm disturbances are linked to these symptoms.

Changes in sleep patterns were also observed in the study cohort, but biological rhythm changes were most significantly associated with depressive and anxiety symptoms.

“Given the findings, future efforts should be made to standardize evidence-based interventions targeting these biological rhythms variables identified by our team, either as treatment or prevention strategies,” Frey said.

Slyepchenko A, Minuzzi L, Reilly JP, Frey BN. Longitudinal changes in sleep, biological rhythms, and light exposure from late pregnancy to postpartum and their impact on peripartum mood and anxiety. 

. Published online January 18, 2022. doi:10.4088/JCP.21m13991

A recent study found an association between biological rhythms affecting sleep late in pregnancy and postpartum and depressive or anxiety symptoms. 

Biological Rhythms Outweigh Sleep Quantity Changes in Peripartum Depressive and Anxiety Symptoms

Receiving 2 doses of either the Pfizer-BioNTech or Moderna messenger RNA (mRNA) vaccine against COVID-19 was found to be safe and immunogenic in a group of patients with 

 (MM), investigators of a recent study concluded.

, patients with MM experienced mild reactions to both doses of the vaccines against SARS-CoV-2, the virus that causes COVID-19. Previously, patients with MM were largely left out of vaccine clinical trials, leading a lot of vaccine hesitancy among the MM population, who are considered to be at higher risk for severe COVID-19 complications.

“These findings can provide reassurance to MM patients who are hesitant to receive SARS‐CoV‐2 mRNA vaccines,” the investigators wrote.

Patients with MM have a 34% inpatient mortality rate due to COVID-19 complications. Because patients with MM and other immunocompromised populations were excluded from vaccine trials, data on the effects of mRNA COVID-19 vaccines are critical to patients and their providers.

The investigators used a social media campaign to recruit 44 patients with MM aged 18 years or older without a history of COVID-19. The study extended from December 17, 2020, to March 18, 2021. The median age of the patients was 64 years, and 68% of the cohort was women. Additionally, 39% were not on any therapies at baseline and 98% of the cohort was White. The Pfizer-BioNTech vaccine and the Moderna vaccine were distributed to 22 patients each.

The participants were given a questionnaire about local reactions, systemic reactions, and adverse events 1 week after receiving each dose. Local reactions included injection site pain, swelling, and erythema. Systemic reaction consisted of fatigue, headache, myalgia, chills, fever, diarrhea, and vomiting. Adverse events could include anaphylaxis, incident neurologic diagnoses, or infections.

Overall, 80% of local and 71% of systemic reactions were mild. The most common local reaction observed was injection site pain, occurring in 75% of the cohort after the first dose and 73% after the second dose. The most reported systemic reaction was fatigue, occurring in 39% after dose 1 and 64% after dose 2. That was followed by headache, which was reported in 32% of patients after dose 1 and 50% after dose 2, and myalgia, which was found in 32% of the cohort after dose 1 and 41% after dose 2. No participants were reported to develop anaphylaxis, SARS-CoV-2 infection, or incident neurologic diagnoses

The investigators noted that the rates of local and systemic reactions were in line with previous clinical trial data for the vaccines.

One month after administration of the second dose, the participants underwent SARS-CoV-2 antibody testing. Antibodies were detected in 41 (93%) of patients, of whom 25 were taking a therapy for MM and 16 were not. The 2 participants receiving MM therapy who did not have detectable antibodies were taking teclistamab or a combination therapy of lenalidomide and ixazomib.

The study’s small sample size was listed as a limitation. Additionally, the antibody assays had a low dynamic range, and monoclonal protein concentrations were not measured.

“Due to these limitations, we do not yet know the degree to which detectable antibody levels impact the clinical presentation and severity of COVID-19 in patients with MM….Future investigations should include larger samples, examine the role of specific medications in vaccine response, and examine cellular immunity,” the investigators suggested.

Greenberg RS, Ruddy JA, Boyarsky BJ, et al. Safety and antibody response to two-dose SARS-CoV-2 messenger RNA vaccination in patients with multiple myeloma. 

. 2021;21:1354. doi:10.1186/s12885-021-09097-5

Study results showed that both the Pfizer-BioNTech and Moderna COVID-19 vaccines were safe and effective in patients with multiple myeloma, which investigators hope will improve vaccine hesitancy in the high-risk population.

Study Supports Pfizer, Moderna COVID-19 Vaccines’ Safety in Patients With Multiple Myeloma

 of the Medicare Shared Savings Program (MSSP), showing that the number of accountable care organizations (ACOs) in the program grew to 483 in 2022, up from 477 in 2021.

The National Association of ACOs (NAACOS) called the numbers “disappointing” and noted that participation in the ACO program was lower than it has been since it reached a high of 517 organizations in 2020. 

CMS projects that over 11 million people with 

 will be in physician practices that are part of MSSP ACOs in 2022, compared with 10.7 million last year, an increase of about 3%.

“With one in every five health care dollars paid by Medicare, we can strengthen and transform our health care system,” CMS Administrator Chiquita Brooks-LaSure 

. “Accountable Care Organizations present an invaluable opportunity to move Medicare toward person-centered care.”

CMS said 66 new ACOs joined the program and 140 existing ACOs renewed their participation. The number of ACOs that are in a track that qualifies as an Advanced Alternative Payment Model (APM) increased from 34% to 50%. 

In an APM, providers receive additional rewards for delivering higher-quality care at lower costs in exchange for taking on higher levels of financial risk.

There are 284, or 59%, of ACOs in 2-sided risk arrangements in 2022, and 199, or 41%, in 1-sided risk arrangements. 

By revenue, 56% of ACOs are low revenue and 44% are high revenue, the report said.

“Following multiple years of flat or declining ACO growth, today’s announcement is disappointing and should send a wake-up call to an administration whose goal is to have all traditional Medicare patients in an accountable care model by 2030,” NAACOS 

The MSSP launched in 2012. Last year, as part of a "strategic refresh" by the CMS Innovation Center, CMS set a goal to have every Medicare fee-for-service beneficiary in an ACO by 2030. 

In its annual Medicare Shared Savings Program (MSSP) report, CMS said the number of accountable care organizations joining increased, but a trade group said the results should have been better.


Number of Accountable Care Organizations Joining MSSP in 2022 Grew Slightly, CMS Says

Researchers examining the dietary habits of participants in 2 long-running health studies found that patients with 

(PD) who included 3 or more servings per week of foods high in flavonoids had lower all-cause mortality rates.

Through the findings of other studies, flavonoids already have a reputation for being neuroprotective, but the authors said not much is known about their effect in people already diagnosed with PD. To that end, they examined the intake of these compounds before and after diagnosis.

Data for the studies came from 2 sources: the Nurses’ Health Study (NHS) and the Health Professionals Follow-up Study (HPFS). The NHS began in 1976 with 121,700 female registered nurses aged 30 to 55 years, and the HPFS began 10 years later with 51,529 male health professionals aged 40 to 75 years.

The researchers, from multiple universities, included 599 women from the NHS and 652 men from the HPFS who were diagnosed with PD during follow-up and had dietary data available. The average age for both groups at the time of PD diagnosis was about 72.

Participants in these studies answered questionnaires at the start and then biennially, with food-specific questions asked every 4 years. Intake of different types of flavonoids was calculated by multiplying the flavonoid content of each food by its frequency.

The diagnosis of PD was self-reported at first, and then confirmed by a neurologist who reviewed medical records. The average length of follow-up was 33 years.

Over the duration of the study, there were 944 deaths, or 75% of the 1251 participants, with 513 deaths from PD, 112 from cardiovascular diseases, and 69 from various cancers.

In both groups, those who consumed more flavonoids were more likely to have other healthy habits: they never smoked, were more physically active, and had higher intakes of vitamin C, vitamin E, and beta-carotene.

A higher consumption of flavonoids before a diagnosis was associated with a lower risk of dying from any cause in men, but not in women, after adjusting for age, smoking status, total energy intake, and other covariates. The authors were not certain if the differences were due to chance, or if genetics, inflammatory factors, or hormones play a role. 

The analysis showed that a higher total flavonoid intake before PD diagnosis was linked with a lower future risk for all-cause mortality after PD diagnosis in men (hazard ratio [HR] comparing 2 extreme quartiles = 0.53; 95% CI, 0.39-0.71; 

<.001) but not in women (HR = 0.93; 95% CI, 0.68-1.28; 

However, after diagnosis, there were no differences between men and women on the effect on mortality and flavonoid consumption.

One limitation of the study is that results were not adjusted to consider the severity of PD at the beginning of the study. The authors also noted that the participants in the NHS and HPFS were mostly White individuals from the health care professions, so results may not be applicable to other groups. In addition, some data may have been misclassified.

The research was published Thursday in the online issue of 

 and was supported by the National Institute of Neurological Disorders and Stroke.

Zhang X, Molsberry SA, Yeh TS, et al. Intake of flavonoids and flavonoid-rich foods, and mortality risk among individuals with Parkinson disease: A prospective cohort study. 

. Published online January 26, 2022. doi:10.1212/WNL.0000000000013275

People with Parkinson disease who regularly consumed flavonoids like berries, red wine, tea, and apples had lower rates of death than people who didn’t, according to a new study.



Berries, Red Wine Linked to Longer Survival in Patients With Parkinson Disease

Patients with chronic rhinosinusitis with 

 (CRSwNP), with and without comorbid asthma and aspirin-exacerbated respiratory disease (AERD), exhibited significantly improved outcomes when treated with mepolizumab, according to study findings published in 

Journal of Allergy and Clinical Immunology

In the treatment of CRSwNP, the standard of care consists of topical intranasal corticosteroids, short courses of systemic corticosteroids, and endoscopic sinus surgery. Although these treatments may provide short-term relief, researchers said that additional treatment options are needed due to safety and symptom recurrence issues linked with these therapeutic approaches.

“Patients with severe CRSwNP and comorbid asthma, AERD, and patients who present with eosinophilic infiltration experience the greatest burden of disease,” they noted. “Of significance, these patients experience greater numbers of sinus surgeries, high corticosteroid use, and long-term disease recurrence with standard of care than patients without these disease characteristics.”

In findings of the phase 3, randomized, double-blind, 52-week SYNAPSE study, mepolizumab—a targeted, humanized anti–interleukin-5 (IL-5) monoclonal antibody—demonstrated efficacy and safety in the treatment of CRSwNP. Moreover, initial results showed promise in patients with comorbid asthma and a high baseline blood eosinophil count (BEC).

Researchers conducted an exploratory analysis to further assess the efficacy of 4-weekly subcutaneous mepolizumab 100 mg (n = 206) vs placebo plus standard of care (n = 201) in adults with severe, bilateral CRSwNP requiring revision surgery. Participants were stratified by the presence of comorbid asthma or comorbid AERD and by baseline BEC.

Primary end points assessed included the change in total endoscopic nasal polyp score at week 52 and nasal obstruction visual analog scale (VAS) score from weeks 49 to 52. “Subgroup analyses by comorbid asthma and AERD status, and post hoc by BEC, were exploratory,” they added.


Of the 407 patients included in the intention-to-treat population, 289 had comorbid asthma, 108 had AERD, and 371 and 278 reported BEC counts of at least 150 cells/mcL or at least 300 cells/mcL, respectively.


In their findings, a significantly greater proportion of patients from the mepolizumab group exhibited greater than or equal to 1-point improvement from baseline in nasal polyp score compared with the placebo group across comorbid conditions:

Baseline BEC subgroup of less than 150 cells/mcL: 55.0% vs 31.3%

Baseline BEC subgroup of at least 150 cells/mcL: 49.5% vs 28.1%

Baseline BEC subgroup of less than 300 cells/mcL: 50.7% vs 29.0%

Baseline BEC subgroup of at least 300 cells/mcL: 50.4% vs 28.1%


A similar trend was observed in patients without comorbid asthma or AERD. Regarding the nasal obstruction VAS score, more patients overall showed a improvement greater than 3 points from baseline during weeks 49 to 52 with mepolizumab vs placebo (60.2% vs 36.3%; 

< .0001). This trend was also similar patient subgroups, except for those with baseline BEC less than 150 cells/mcL.


Bachert C, Sousa AR, Han JK, et al. Mepolizumab for chronic rhinosinusitis with nasal polyps: treatment efficacy by comorbidity and blood eosinophil count. 

. Published online January 7, 2022. doi:10.1016/j.jaci.2021.10.040

Mepolizumab was found to reduce nasal polyp size and nasal obstruction in patients with chronic rhinosinusitis with nasal polyps regardless of the presence of potentially exacerbating comorbidities.

Mepolizumab Associated With Significant Improvement of  Chronic Rhinosinusitis With Nasal Polyps, Comorbidities

 since 2019 and has a BA in philosophy and journalism & professional writing from The College of New Jersey. 

Findings of the ObserVational survey of the Epidemiology, tReatment and Care Of MigrainE (OVERCOME) 2018 cohort published in 

 revealed that slow but steady progress is being made with regard to diagnosis and preventive treatment of 

However, authors cautioned that unmet needs persist in this patient population, especially among those with episodic migraine, and highlighted the heterogeneity of this condition.

Migraine affects approximately 15% of the US population, and “monitoring patterns of consultation, diagnosis, and treatment provides a method for assessing the quality of ongoing medical care and identifying barriers to better outcomes,” researchers explained.

To help meet this goal, OVERCOME (US) was developed as a longitudinal, multicohort, web-based study. In the current report, authors outlined initial findings of the OVERCOME 2018 cohort baseline cross-sectional survey. The study includes both migraineurs and those without migraine who completed the survey between September and November of 2018.

All participants (n = 97,478) were at least 18 years old and of these, 21,143 individuals made up the migraine cohort (low frequency episodic migraine [LFEM], 12,299 [58.2%]; moderate frequency EM [MFEM], 4070 [19.2%]; high frequency EM [HFEM], 2291 [10.8%]; and chronic migraine [CM], 2483 [11.7%]).

Researchers set out to determine if those with 0 to 3 monthly headache days (LFEM) differed from the other patient cohorts (MFEM: 4-7 monthly headache days; HFEM: 8-14 monthly headache days; CM: ≥15 monthly headache days). The majority of respondents (74.2%) were women and the mean (SD) patient age was 42.2 (15) years.

Having at least moderate disability was common (n = 8965; 42.4%).

Around half (n = 10,783; 51.0%) had consulted a medical professional for migraine care in the past year.

4792 (22.7%) of respondents were currently using a triptan.

An analysis of data collected in 2018 shows that more work is needed to address unmet needs in episodic migraine. 