Illinois Will Share Data About COVID-19 Outbreaks in Schools

Editor’s note: Find the latest COVID-19 news and guidance in Medscape’s Coronavirus Resource Center.

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This story is a collaboration with the Chicago Tribune.

Students wear masks as they walk to their classroom at Oak Terrace Elementary School in Highwood, Illinois, part of the North Shore school district, on Thursday, September 3, 2020. An analysis conducted by The Associated Press and Chalkbeat shows that race is a strong predictor of which public schools are offering in-person instruction to start the year and which aren’t.

Eight months into the pandemic and following pleas from educators and parents, Illinois has decided it will publish data on the coronavirus’s spread in schools.

The decision comes 2 weeks after a story by ProPublica Illinois and the Chicago Tribune detailed the lack of information available to school officials and parents as they try to decide whether in-person learning is safe. Illinois public health officials told reporters there had been outbreaks in at least 44 school buildings across the state but declined to say where.

Late Wednesday, an Illinois Department of Public Health spokeswoman said publicly for the first time that the state will start sharing the number of cases and outbreaks by school. An outbreak is defined as two or more cases tied to contact at school.

“We have been working to publish school-level data on COVID-19 and look forward to having that live in the coming weeks,” spokeswoman Melaney Arnold said.

That’s good news for school workers such as nurse Kathy Knawa, who is part of a team that has been helping Flossmoor School District 161, south of Chicago, decide when in-person classes should resume. When she tried to research COVID-19 outbreaks in schools that had already reopened, particularly near her district, she couldn’t find comprehensive state data about the number of cases or where they had been identified.

Instead, Knawa found the ProPublica Illinois/Tribune story, which explained how little was publicly known about school-connected outbreaks during the first 7 weeks of the school year.

The lack of specific data from the state is frustrating to Knawa, whose district plans to have some students return to school buildings next week.

“I’m concerned we can’t find out where the outbreaks are,” Knawa said. “I just want to be able to get information in one place. If all the towns surrounding you were having outbreaks, it would be good to know.”

Many other states already publish data on outbreaks in schools. But Illinois so far has released only county-level data about COVID-19 cases in people younger than 20. That age range includes many college students, so it isn’t as helpful to parents and officials in K-12 school districts.

In many parts of Illinois, the school year began more than 2 months ago. Of the school-related outbreaks documented as of early October, most have been small — two or three cases at each school building — according to the state.

IDPH’s delay in making the data available comes as Illinois is grappling with a surge of COVID-19 cases in many communities. The increases have led some schools that had planned to reopen to delay until at least early next year.

On Tuesday, the Lake County Health Department recommended that public and private K-12 schools transition to remote online learning as the county reported “substantial” community transmission of the virus. In response, Grayslake schools decided to delay any decision to return to school until January, while school officials in Mundelein said they are reconsidering plans that would have put students back in the classroom in the coming weeks.

According to Illinois State Board of Education data, last updated in mid-September, about 685,000 students in 69% of districts are attending school in person at least part time. About 1.2 million students continue to learn online only, including at some of the state’s largest school districts.

Chicago Public Schools, by far Illinois’ biggest district, plans to bring back preschool and certain special education students during the second quarter, which begins next month. COVID-19 cases are rising in Chicago, but Chicago Mayor Lori Lightfoot said this week that transmission has been low in private schools that have reopened.

The district last week began posting the number of cases, with school locations, in an online COVID-19 tracker. The site, to be updated weekly, shows 172 adult and five student cases between March 7 and October 10.

Other schools also post detailed information. Among them: New Trier Township High School District 203 and Crystal Lake District 47.

New Trier, in Chicago’s north suburbs, recently began phasing students in at partial capacity but quickly decided to close again because of increased community spread. The district updates an online dashboard twice a week with the number of cases among staff and students as well as the number in quarantine. Seven students and one staff member had active cases as of Monday, according to the dashboard, but officials say none of the cases was linked to transmission at school.

“Local health departments continue to be the best resource for the most up to date data as schools must report all cases directly to them. Most importantly, schools are also required to communicate with parents and guardians as new cases arise,” Arnold said.

Not all districts publicize COVID-19 information about their schools. In west suburban Addison, school social worker Maria Sinkule has been calling on district officials to share data about community and school transmission. Following a hybrid model, with children learning both in person and remotely, preschool and kindergarten students began returning to school earlier this week; older elementary students were to return Thursday.

“I want them to be transparent about what transmission looks like within schools and what are the supports in place for families that need help,” said Sinkule, who is also president of the Illinois Association of School Social Workers. “Some schools are looking out for the community, and there are others that don’t and they aren’t transparent. Without metrics, they can do what they want.”

It’s not clear when the health department will publish the data that educators are pushing for. Arnold promised data “in the coming weeks” but did not say more about the timing.

The state’s largest teachers union has called on IDPH to identify schools with COVID-19 outbreaks, saying “transparency is key.”

“How is a community supposed to decide whether to return to the classroom if they don’t know the true impact this is having across the state?” Illinois Education Association President Kathi Griffin said in a statement. “Health officials inform communities when nursing homes or jails have outbreaks because it impacts those who live and work there. Certainly, communities are entitled to know about outbreaks at schools. It shouldn’t even be a question.”

We plan to continue to report on the impact of COVID-19 in schools — and you can help us. Are you a student, teacher or parent? Is there something you think we should know? Contact us at jodi.cohen@propublica.org or jrichards@chicagotribune.com.

Clarification, Oct. 22, 2020: This story originally said some Chicago Public Schools students will return to classes in November. The district hopes to begin in-person learning for preschool and certain special education students in the second quarter, which begins in November.

Microbleeds Shouldn't Influence Anticoagulation After Stroke

The presence of microbleeds in the brain should not affect the decision to prescribe anticoagulation to patients after an ischemic stroke, new data suggest.

The new results come from a prespecified substudy of the NAVIGATE-ESUS trial, which compared rivaroxaban to aspirin in patients with embolic stroke of undetermined source (ESUS). This substudy investigated whether patients with microbleeds differ with respect to future risk for intracerebral hemorrhage (ICH) and ischemic stroke if taking rivaroxaban or aspirin.

Dr Ashkan Shoamanesh

“We found that microbleeds increased the risk of ischemic stroke, ICH, and mortality, but this increase was the same regardless of which antithrombotic strategy was used,” lead author Ashkan Shoamanesh, MD, McMaster University, Hamilton, Canada, commented to Medscape Medical News.

“This is the first randomized trial ever to have examined the interaction between microbleeds and anticoagulation vs aspirin on clinical outcomes and, as such, is a valuable contribution to the field,” he added. “Our results suggest that we should not consider microbleeds when making the decision of whether to prescribe an anticoagulant or after an ischemic stroke.”

The main NAVIGATE-ESUS trial was stopped early because of increased bleeding in the rivaroxaban group, and anticoagulation is therefore not indicated for patients with ESUS.

However, Shoamanesh pointed out that the underlying disease mechanisms causing microbleeds are similar across stroke subtypes, so these results are likely generalizable to other types of ischemic stroke, such as cardioembolic strokes due to atrial fibrillation.

“Anticoagulants are very effective in patients with cardioembolic stroke, but we hesitate to use them in patients with microbleeds. These results suggest we should not factor in microbleeds in the decision to use anticoagulation. As microbleeds occur in around 30% of such patients, this will affect clinical practice in a meaningful way,” Shoamanesh said.

“Our findings also support the continued use of anticoagulation in patients with ischemic stroke who are incidentally found to have these lesions on imaging,” he added.

The study was published online in JAMA Neurology on October 19.

Of the 7213 NAVIGATE-ESUS participants, 3699 (51%) were eligible for the current analysis on the basis of the fact that their baseline clinical MRI reports contained information on microbleeds. Patients with a prior history of symptomatic ICH were excluded from the NAVIGATE-ESUS trial.

Results showed that microbleeds were present in 395 of the 3699 participants (11%). Factors that were independently associated with microbleeds were advancing age (odds ratio [OR] per year, 1.03); East Asian race/ethnicity (OR, 1.57); hypertension (OR, 2.20); multiterritorial infarcts (OR, 1.95); chronic infarcts (OR, 1.78); and occult ICH (OR, 5.23).

The presence of microbleeds was associated with a 1.5-fold increased risk for recurrent stroke, a fourfold increase in risk for ICH, and a twofold increase in risk for all-cause mortality. Strictly lobar microbleeds were associated with an approximately 2.5-fold increased risk for ischemic stroke.

There were no interactions between microbleeds and treatment assignments (rivaroxaban or aspirin) for recurrent stroke, ischemic stroke, or all-cause mortality. The hazard ratios of ICH for patients taking rivaroxaban were similar for patients with microbleeds (HR 3.1) and for those without microbleeds (HR, 3.0).

“In contrast to questions raised from meta-analyses of observational studies, we found no indication of interaction between the effects of rivaroxaban and cerebral microbleeds, including multiple or strictly lobar microbleeds, for the outcome of ICH. Although our analysis lacks the power to confidently exclude such an effect, there were no suggestive numerical trends identified,” the researchers write.

“The underlying cerebral small vessel diseases for which cerebral microbleeds are a marker are prevalent in populations with stroke of all causes; hence, our reported lack of effect modification may be generalizable to other stroke subtypes beyond the ESUS population reported here,” they add.

“Overall, our results and the existing literature from randomized trials and recent meta-analyses do not support the clinical concern regarding antithrombotic therapy in patients with ischemic stroke and cerebral microbleeds,” they conclude.

“We know the presence of microbleeds on MRI increase the risk of ICH during follow-up, which makes us more careful about use of anticoagulation where microbleeds are present. But microbleeds also increase the risk of ischemic stroke,” Shoamanesh commented.

“While the relative risk of ICH in patients with microbleeds is higher than that for ischemic strokes, because ischemic strokes are much more common, the absolute risk of an ischemic stroke is greater than that of an ICH. And it is absolute risks that are more relevant to clinical practice,” he said.

Shoamanesh stressed that these results should not be extrapolated to patients with a history of ICH. “Whether microbleeds can modify the effect of anticoagulation in ICH survivors towards net harm has yet to be assessed in randomized controlled trials and remains uncertain. MRI substudies of several ongoing trials assessing optimal stroke prevention in ICH survivors with atrial fibrillation, such as the ongoing global ENRICH-AF trial, will ultimately provide more insights in this regard,” he said.

In an accompanying editorial, Laurent Puy, MD, and Charlotte Cordonnier, MD, PhD, Université de Lille, Lille, France, say that Shoamanesh and colleagues have produced more data showing that cerebral microbleeds are markers of the severity of the underlying vessel disease.

“Patients with cerebral microbleeds can be at risk of ICH but, in cohorts of ischemic strokes, they are at even greater risk of recurrent ischemic stroke. In patients at high risk of ischemic stroke, clinicians should stop worrying about a possible bleed and start a solid evidence-based prevention of future ischemic events,” they write.

“The present study could contribute to changing the mindset of clinicians. Because the presence of cerebral microbleeds does not seem to modify the effect of rivaroxaban on clinical outcomes, their use in guiding anticoagulation therapy decision-making is then questionable,” the editorialists conclude. “Current evidence does not justify avoiding antithrombotic medication in patients with stroke based solely on the presence of cerebral microbleeds.”

The study was supported by Bayer AG and Janssen Research and Development LLC. Shoamanesh reports receiving grants, personal fees, or advisory board fees from Bayer AG, Bristol-Myers Squibb, Boehringer Ingelheim, Daiichi-Sankyo, Servier Canada Inc, Janssen, and Bayer Canada during the conduct of the study. Cordonnier reports receiving personal fees from Boehringer Ingelheim and being a steering committee member of the Antithrombotic Treatment With Factor XIa Inhibition to Optimize Management of Acute Thromboembolic Events in Secondary Stroke Prevention (AXIOMATIC-SSP) trial, which is sponsored by Bristol-Myers Squibb.

JAMA Neurol. Published online October 19, 2020. Abstract, Editorial.

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Lower BP and Better Tumor Control With Drug Combo?

It’s not ready for the clinic, but new research suggests that angiotensin receptor II blockers (ARBs) widely used to treat hypertension may improve responses to cancer immunotherapy agents targeted against the programmed death-1/ligand-1 (PD-1/PD-L1) pathway.

That conclusion comes from an observational study of 597 patients with more than 3 dozen different cancer types treated in clinical trials at the US National Institutes of Health. Investigators found that both objective response rates (ORR) and 3-year overall survival (OS) rates were significantly higher for patients treated with a PD-1/PD-L1 inhibitor who were on ARBs compared with patients who weren’t taking the antihypertensive agents.

An association was also seen between higher ORR and OS rates for patients taking angiotensin converting enzyme (ACE) inhibitors — but it was not statistically significant, reported Julius Strauss, MD, from the Center for Cancer Research at the National Cancer Institute (NCI) in Bethesda, Maryland.

All study patients received PD-1/PD-L1 inhibitors and the ORR for patients treated with ARBs was 33.8%, compared with 19.5% for those treated with ACE inhibitors, and 17% for those who took neither drug. The respective complete response (CR) rates were 11.3%, 3.7%, and 3.1%.

Strauss discussed the data during an online briefing prior to his presentation of the findings during the 32nd EORTC-NCI-AACR Symposium on Molecular Targets and Cancer Therapeutics, which is taking place virtually.

Several early studies have also suggested that angiotensin II, in addition to its effect on blood pressure, can also affect cancer growth by leading to downstream production of two proteins: vascular endothelial growth factor (VEGF) and transforming growth factor beta (TGF-β), he explained.

“Both of these [proteins] have been linked to cancer growth and cancer resistance to immune system attack,” Strauss observed.

He also discussed the mechanics of possible effects. Angiotensin II increases VEGF and TGF-β through binding to the AT1 receptor, but has the opposite effect when it binds to the AT2 receptor, resulting in a decrease in both of the growth factors, he added.

ACE inhibitors prevent the conversion of angiotensin I to angiotensin II, with the result being that the drugs indirectly block both the AT1 and AT2 receptors.

In contrast, ARBs block only the AT1 receptor and leave the AT2­ counter-regulatory receptor alone, said Strauss.

More Data, Including on Overall Survival

Strauss and colleagues examined whether ACE inhibitors and/or ARBs could have an effect on the response to PD-1/PD-L1 immune checkpoint inhibitors delivered with or without other immunotherapies, such as anti-cytotoxic T-lymphocyte-associated protein 4 (CTLA-4) checkpoint inhibitors, or targeted agents such as tyrosine kinase inhibitors (TKIs).

They pooled data on 597 patients receiving PD-1/PD-L1 inhibitors in clinical trials for various cancers, including 71 receiving concomitant ARBs, 82 receiving an ACE inhibitor, and 444 who were not receiving either class of antihypertensives.

The above-mentioned improvement in ORR with ARBs compared with patients not receiving the drug was statistically significant (P = .001), as was the improvement in CR rates (P = .002). In contrast, neither ORR nor CR were significantly better with patients on ACE inhibitors compared with patients not taking these drugs.

In multiple regression analysis controlling for age, gender, body mass index (BMI), tumor type, and additional therapies given, the superior ORR and CR rates with ARBs remained (P = .039 and .002, respectively), while there continued to be no significant additional benefit with ACE inhibitors.

The median overall survival was 35.2 months for patients on ARBs, 26.2 months for those on ACE inhibitors, and 18.8 months for patients on neither drug. The respective 3-year overall survival rates were 48.1%, 37.2%, and 31.5%, with the difference between the ARB and no-drug groups being significant (P = .0078).

In regression analysis controlling for the factors mentioned before, the OS advantage with ARBs but not ACE inhibitors remained significant (P = .006 for ARBs, and .078 for ACE inhibitors).

Strauss emphasized that further study is needed to determine if AT1 blockade can improve outcomes when combined anti-PD-1/PD-L1-based therapy.

It might be reasonable for patients who are taking ACE inhibitors to control blood pressure and are also receiving immunotherapy with a PD-1/PD-L1 inhibitor to be switched to an ARB if it is deemed safe and if further research bears it out, said Strauss in response to a question from Medscape Medical News.

Hypothesis-Generating Study

Meeting co-chair Emiliano Calvo, MD, PhD, from Hospital de Madrid Norte Sanchinarro in Madrid, Spain, who attended the media briefing but was not involved in the study, commented that hypothesis-generating research using drugs already on the market for other indications adds important value to cancer therapy.

James Gulley, MD, PhD, from the Center for Cancer Research at the NCI, also a meeting co-chair, agreed with Calvo.

“Thinking about utilizing the data that already exists to really get hypothesis-generating questions, it also opens up the possibility for real-world data, real-world evidence from these big datasets from [electronic medical records] that we could really interrogate and understand what we might see and get these hypothesis-generating findings that we could then prospectively evaluate,” Gulley said.

The research was funded by the National Cancer Institute. Strauss and Gulley are NCI employees. Calvo disclosed no relevant financial relationships.

32nd EORTC-NCI-AACR Symposium on Molecular Targets and Cancer Therapeutics: Abstract 7. Presented in a briefing October 20 and in a plenary session October 25, 2020.

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Novel Dementia Risk Charts Underline the Role of Lifestyle

Ten-year dementia risk charts that combine cardiovascular and genetic risk factors have been developed by Danish researchers and graphically underline the impact of modifiable lifestyle factors, even in the face of increased genetic risk.

The research was presented at the European Atherosclerosis Society (EAS) 2020 Virtual Congress, held online this year due to the COVID-19 pandemic, and simultaneously published October 7 in the European Heart Journal.

Ida Juul Rasmussen, MD, PhD, Department of Clinical Biochemistry, Copenhagen University Hospital Rigshospitalet, combined data from more than 60,000 patients — more than 2000 with dementia — with a median follow-up of 10 years.

By combining genetic risk factors with gender and age, as well as lifestyle factors — such as diabetes, smoking, and educational level — they were able to develop a series of risk charts similar to those for cardiovascular risk from the Framingham study.

This showed that a women at least 80 years of age with the highest genetic risk factors who had diabetes, smoked, and had a low educational level would have a 66% risk for dementia over 10 years; this would drop to 45% if she did not smoke or have diabetes and had a higher educational level.

With this pattern repeated across age groups and in both men and women, Rasmussen said that “the overall message from this study is that a healthy cardiovascular risk lifestyle attenuates genetic susceptibility for dementia.”

She added that “by combining genetic risk factors and modifiable risk factors, we are indeed able to identify the individuals at the highest risk of a future dementia disease that would benefit the most” from an intensive lifestyle intervention.

Ralph L. Sacco, MD, professor and chair of neurology and executive director at the Evelyn F. McKnight Brain Institute, Leonard Miller School of Medicine, University of Miami, told theheart.org | Medscape Cardiology that an “important message” of the study is that lifestyle factors still have an appreciable impact on the risk for dementia, even in those at high genetic risk.

“I think the novelty here is the combination of cardiovascular lifestyle factors and the genetics,” Sacco said.

“In the past, there are numerous scores that have been developed on the lifestyle side, some developed on the genetic side, but this group combined both, and I think that makes it an important and well-done comprehensive risk model.”

However, Sacco noted that there were some limitations to the study, saying that the way in which some of the risk factors were defined “is pretty, I would say, crude,” citing, for example, the threshold for hypertension of 140/90 mm Hg blood pressure or medications, or 4 hours a week for high physical activity.

He also believes that the concept of the tables may not fit with the way in which, “nowadays, everybody works with an app and a portable device,” allowing them to enter continuous measures rather than rely on “categorical definitions.”

Sacco added that the very idea of using risk stratification to assign individuals to lifestyle interventions to lower their risk for dementia is a hotly debated issue.

“The high-risk approach means you screen people, and then those at highest risk you then intervene,” he explained. “However, some of the interventions here are very common and probably would have benefit across the whole population. So the other approach is the population-based approach, where everybody should exercise, not smoke, get their blood sugar under control. And those are such ubiquitous, general-population messages, I’m not sure you need to define people at high risk to promote those important behavioral changes.”

Dementia “Greatest Challenge”

Rasmussen explained that “dementia is one of the greatest challenges for health and social care in the 21st century and…by 2050, it is estimated that more than 130 million individuals will be living with dementia worldwide.”

She said that one of the main issues is that much of the underlying biology remains unknown. Consequently, “we don’t have any easily assessable biomarkers and there are no curative treatments.”

A report from the Lancet Commission on dementia prevention, intervention, and care nevertheless suggested that up to 40% of dementia cases are preventable, primarily through tackling cardiovascular risk factors.

Rasmussen said that these estimates are based on the results of the Finnish FINGER trial, which showed that, with a 2-year intervention, cognitive function could be improved or maintained in at-risk elderly individuals from the general population.

“However, the intervention was massive,” she said, “and very demanding for the participants and, of course, way too expensive to implement generally in the population. Therefore, we wanted to generate a risk-stratification tool to identify the individuals at the highest risk for a future dementia disease to include in such intensive interventions.”

They gathered data from the Copenhagen General Population Study and the Copenhagen City Heart Study, and were able include 61,664 individuals, of whom 2,158 had dementia. The median age of the participants was 60 years, and they were followed-up for a median of 10 years.

They gathered baseline data on a range of cardiovascular risk factors, including diabetes, hypertension, smoking, physical activity, and alcohol intake. Educational attainment was also determined.

Assays were also used to genotype the patients and determine apolipoprotein E (APOE) status, as well as the total number of risk alleles on genome-wide association study (GWAS).

In women, the modifiable risk factors for all-cause dementia with the highest hazard ratios for all ages were 1.54 (95% CI, 1.22 – 1.93) for diabetes versus no diabetes, 1.17 (95% CI, 1.04 – 1.32) for smoking versus no smoking, and 1.27 (95% CI, 1.13 – 1.42) for low versus high education.

The risk factors with the highest hazard ratios in men for all ages were 1.26 (95% CI, 1.01 – 1.57) for diabetes versus no diabetes, 1.35 (95% CI, 1.18 -1.55) for low versus high physical activity, and 1.38 (95% CI, 1.20 – 1.58) for low versus high education.

Regression analysis was then used generate 10-year absolute risk score stratified by gender, age, the presence or absence of diabetes, low or high educational attainment, smoking or no smoking, APOE genotype, and the number of GWAS risk alleles.

This showed that, for women, the highest 10-year risk of all-cause dementia was highest for those aged 80 to 100 years who had the APOE ε44 genotype, 22 to 31 GWAS risk alleles, diabetes, and low education, and who smoked, at 66%.

Rasmussen highlighted, however, that, for women 80 to 100 years with the APOE ε44 genotype and 22 to 31 GWAS risk alleles but who did not have diabetes, did not smoke, and had higher educational attainment, the 10-year risk for all-cause dementia was much lower, at 45%.

This pattern was repeated across the age groups, with, for example, women aged 70 to 79 years in the highest risk group having a 10-year risk for all-cause dementia of 48%, falling to 30% for those who did not smoke, did not have diabetes, and had higher educational attainment.

In men, the 10-year risk of all-cause dementia for those aged 80 to 100 years and with the APOE ε44 genotype, 22 to 31 GWAS risk alleles, diabetes, low education, and smoking, was 60%.

Again, this fell to 39% in those who did not have diabetes, did not smoke, and had higher educational attainment but were still at genetic risk. Among men 70 to 79 years, the corresponding 10-year risks for all-cause dementia were 42% and 26%.

The team was also able to use the data to develop 20-year risk charts for all-cause dementia, finding that women aged 50 to 60 years with the APOE ε44 genotype and 22 to 31 GWAS risk alleles had a 17% risk for dementia if they had midlife hypertension.

For women in the same age and genetic risk groups but without midlife hypertension, this risk dropped to 12%.

Among men, the highest risk was again in those with midlife hypertension, aged 50 to 60 years and with the APOEε44 genotype and 22 to 31 GWAS risk alleles, at 14%, falling to 10% in those without midlife hypertension.

Potentially Important Step Forward”

In an editorial accompanying the study, Andrew Sommerlad, MD, PhD, and Naaheed Mukadam, MD, PhD, from the Division of Psychiatry, University College London, say that the development of the dementia risk charts is a “potentially important step forward.”

They argue that “it facilitates the identification of high-risk individuals based on a range of risk factors, which could help to target prevention toward those who need it most,” and therefore “yield greater impact.”

“The pessimism felt by those who assume that dementia is an inevitable consequence of ageing, or that a positive family history of dementia indicates that they will follow the same disease course, is misplaced, according to this study and previous research, which has shown the likely modifiability of dementia risk with positive lifestyle approaches, even in the face of unmodifiable age, genotype, and sex.”

Sommerlad and Mukadam add a note of caution, however, saying that “the evidence for dementia being truly preventable is, however, scarce,” adding: “Only one randomized controlled trial has successfully reduced risk from dementia, with effective management of hypertension.”

In addition, they believe that “improving public understanding of dementia is a key component of prevention,” and, due to dementia’s “economic, social, and individual costs,” it “should be a priority for all those at risk as well as policymakers and clinicians.”

The work was supported by the Danish Medical Research Council, the Research Council at Rigshospitalet, the Danish Alzheimer Research Foundation, the Lundbeck Foundation, and the M.L. Jørgensen & Gunnar Hansen’s Fund. No relevant financial relationships declared.

88th European Atherosclerosis Society (EAS) Virtual Congress 2020. Presented October 7, 2020.

Eur Heart J. Published online October 6, 2020. Abstract

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How the Direction of Healthcare Could Change From the Election

With the national election about 2 weeks away, the direction that healthcare policy takes could vary significantly depending on how the nation votes in the presidential and congressional races.

Speaking at the Medical Group Management Association (MGMA) annual conference, organization officials broke down four potential outcomes of the 2020 elections and what those scenarios will mean for the nation’s healthcare.

The first scenario is the status quo, with Republicans maintaining their majority in the Senate, Democrats retaining control of the House of Representatives, and Donald Trump re-elected as president.

“I think you could expect to see the House to continue, at a high level, its investigations and hearings,” Drew Voytal, MGMA associate director of government affairs, said. “The Senate would continue their judicial appointments from President Trump and those political divisions within Congress and between the House and the president would continue as much as we see today and have seen in the past.”

Specific to healthcare, “I think the status quo would still continue,” Voytal added. “The Trump administration, [HHS Secretary Alex] Azar, and [CMS Administrator Seema] Verma would continue their approach to ‘Patients Over Paperwork.’ We can debate on the effectiveness of that program as well as limited approach to expanding access whenever you discuss healthcare reform. The status quo would bring the status quo.”

In the second scenario, Democrats remain in control of the House and take control over the Senate, while President Trump is re-elected. On a high level, Matt Devino, MGMA associate director of government affairs, said there would be some similarities with scenario one. In healthcare, “we would expect in this scenario for the Trump administration to continue its approach to ‘Patients Over Paperwork’ and there would be a limited approach to expanding access to healthcare.”

He added that that there would be zero agreement between the president and Congress on reform, “we wouldn’t expect a tremendous amount to end up happening,” Devino continued.

What happens if former Vice President Joe Biden wins the presidential election, but status quo is maintained in Congress? “You could expect at a high-level Senate Republicans would block Biden’s judicial nominations. That seems to be a hallmark of [Senate Majority Leader] Mitch McConnell, R-Ky, during the Obama years. Those political divisions would continue, but this time it would be the House and presidency versus the Senate,” Voytal said.

For healthcare, “major healthcare reform would be stalled again because the Senate would be under control of the Republicans and there would have to be major compromises between the two parties.”

Voytal suggested that a Biden administration “would look to continue value-based care but would seek to stand out from maybe the past approaches from the Trump administration.”

The Biden campaign has not yet tipped its hand on how it will approach a large-scale healthcare reform effort.

Finally, what could happen under the scenario where the Democrats maintain control of the House, flip the Senate, and Joe Biden is elected into the White House?

“In this scenario, with Democratic control across the board, we would expect access to coverage expanded,” Devino said. “Vice President Biden’s platform includes support for a public option, Medicare eligibility being reduced to the age of 60, and additional low-income assistance to obtain healthcare coverage.” He noted that there would be opposition to a single-payer system, or Medicare for All.

Devino also noted that there would be legislative support for a number of other initiatives, including surprise-billing reform and drug-pricing reform, as well as continued support for value-based care.

And while large-scale healthcare reform may only be likely under the fourth scenario, MGMA officials expect that there could still be action taken on some smaller issues that had bipartisan traction prior to the COVID-19 pandemic, including surprise billing, drug pricing, and ensuring coverage of people with pre-existing conditions.

“We fully expect these discussions to continue going on [and for] new efforts to tackle these issue,” Voytal said. “Do look for those topics to be touched on in the coming year ahead, regardless of what shakes out after the election.”

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Simple Test May Predict Alzheimer's Years Before Symptoms

A simple language test developed using artificial intelligence (AI) is able to predict, with a high level of accuracy, which cognitively normal individuals will go on to develop Alzheimer’s disease (AD), new research suggests.

The findings show that the test has a 70% accuracy rate in predicting AD onset years before cognitive decline begins and is more accurate than traditional predictive methods, such as neuropsychological testing.

“The bottom line is that we’re finding tiny markers that when you put them together are providing a significant amount of information to predict dementia,” study author Guillermo Cecchi, PhD, Computational Biology Center, IBM Research, Yorktown Heights, New York, told Medscape Medical News.

The researchers are hopeful the new results will eventually lead to the use of simple, inexpensive speech probes that detect early dementia and that monitor its progression.

“The value of this [type of test] is that it can be done quickly; it’s not intrusive and can done at any time,” said Cecci.

The study was published online October 22 in eClinicalMedicine.

The Cookie Thief

A key priority in AD research is developing early interventions to decrease risk, delay onset, and/or slow disease progression. This requires identifying patients who are likely to benefit from such interventions, and this is where language comes in.

Research shows that various aspects of language are an important component of age-related cognitive decline. Even mundane linguistic abilities, such as object naming, engage extensive brain networks.

For the study, the investigators used data from the Framingham Heart Study (FHS), a longitudinal investigation of more than 5000 individuals spanning several decades. As part of the FHS, participants complete a neuropsychological test battery that includes the cookie-theft picture description task (CTT) from the Boston Aphasia Diagnostic Examination.

In this test, study participants are asked to describe in writing the cookie-theft picture. The picture depicts three characters in a kitchen ― a woman at an overflowing sink; a boy reaching into a cookie jar in the cupboard; and a girl expecting to get a cookie from the boy. Investigators extracted linguistic variables from responses to the CTT. In total, 87 linguistic variables were computed.

Using these variables, researchers developed computer models to predict whether a participant would develop mild cognitive impairment (MCI) leading to AD.

A review panel with at least one neurologist and one neuropsychologist reviewed possible cognitive decline and dementia cases. They based a diagnosis of AD on criteria from the National Institute of Neurological and Communicative Disorders and Stroke–Alzheimer’s Disease and Related Disorders Association.

Case patients included those who developed MCI because of AD at or before age 85. Age-, sex-, and education-matched control persons included those who remained dementia-free until at least age 85.

From more than 3000 responses to the CTT, the researchers created models with which to test 80 participants – 40 case patients, and 40 control persons.

Analyses showed that future onset of AD was associated with repetitiveness, misspellings, and telegraphic speech, which is defined as speech that lacks fluid grammatical structure and continuity.

Another important variable, said Cecchi, is the “granularity” of “reference” or lack of such reference, for example, referring to the older woman in the picture as a “mother” or “wife” instead of the using the more general term, “woman.”

Using linguistic variables yielded significant predictive power, with an area under the curve of 0.74 and an accuracy of 0.70. The mean time to diagnosis of AD was 7.59 years.

The researchers noted that the model is based on data that were collected when study participants were cognitively normal. The study showed that predictions were harder regarding participants who had a college degree than regarding less-educated participants.

Linguistic competence is a behavioral marker of educational and occupational attainment, both of which have been suggested to increase “cognitive reserve,” the investigators note.

The study showed that it is much easier to predict conversion to AD in women than men. The authors note that the prevalence of AD is significantly higher in women than men and that the rate of progression after onset of cognitive impairment is faster in women.

Performance was better with predictive models that used linguistic variables than predictive models that incorporated more traditional variables associated with AD risk, such as neuropsychological test scores, demographic information, and APOE status. For disease predictions based on a combination of these traditional variables, the accuracy was 59%, said Cecchi.

The authors note that neuropsychological tests and other biomarkers, including cerebrospinal fluid assessments and brain imaging, have been used to predict progression of MCI to AD. In addition, there have been very promising results using neurofilament light chain for disease progression for patients at early presymptomatic stages of familial AD.

“However, these are still technologically or logistically demanding, and require significant specialist involvement,” they note.

Cecchi and his colleagues hope this new research will lead to the development of a simple, accessible tool to accurately assess AD risk.

Cecchi envisions a simple test that can be used regularly by clinicians and family members alike to track a patient’s disease progression, thereby dispensing with the need for long appointments at the doctor’s office.

Patients who were identified by the test as being at risk could potentially make lifestyle changes to help delay cognitive decline. These could include following a healthy diet, becoming physically active, and enhancing social and cognitive engagement, said Cecchi.

In addition, physicians could use this tool to identify patients who might benefit from enrollment in clinical trials of potential preventive therapies, he said.

Exciting but Early Research

Commenting on the research for Medscape Medical News, Heather Snyder, PhD, vice president of medical and scientific relations, the Alzheimer’s Association, described the research as “exciting” and “intriguing” but cautioned that it’s still “early work.”

Research into identifying speech or language biomarkers of cognitive change is “definitely” one of the “emerging new areas,” said Snyder. The Alzheimer’s Association has funded studies in this area.

“We are increasingly seeing studies that are looking at, and trying to understand, speech and speech patterns and how that might be an indicator of what might be happening in the brain,” she said.

However, Snyder pointed out that the current study used a rather small and “pretty defined population of individuals.”

She also noted that language is tied into hearing and other senses. “So this is not as straightforward as it might seem.”

She emphasized that there is definitely some work still to be done before this type of test will be useful as a diagnostic tool

Pfizer, Inc, provided funding to obtain the data from the Framingham Heart Study Consortium and to support the involvement of IBM Research in the initial phase of the study. Cecchi worked as a salaried employee of IBM Corp for the full duration of the project. IBM holds a patent for the extraction of one of the features used in the linguistic model.

EClinicalMedicine. Published online October 22, 2020. Full text

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Acute Care Measure Could Reduce Hospital Readmission Penalties

About one in four hospitals would see their penalty status change under the Hospital Readmissions Reduction Program (HRRP) if penalties were determined using “excess days in acute care” (EDAC), a more comprehensive measure of hospital use after discharge, instead of looking only at 30-day readmissions.

The EDAC measure captures all days spent in acute care settings within 30 days of discharge, including emergency department (ED) visits, observation stays, and unplanned readmissions.

In the study, published online October 13 in Annals of Internal Medicine, half of hospitals in the highest-performing group under the more blunt 30-day readmissions measure would fall to a lower-performing group if EDAC were used.

Conversely, a similar number of low-performing hospitals would jump to a higher stratum.

“We know that linking the 30-day readmission measure to penalties under the HRRP has led to intensified efforts to treat patients in the ED or as observation stays,” said lead author Rishi Wadhera, MD, MPP, MPhil Beth Israel Deaconess Medical Center, Boston. “While this makes hospitals’ readmission rates look lower, it’s not clear that these shifts are actually good for patient care.”

Given the $3 billion in penalties assessed by Centers for Medicare & Medicaid Services (CMS) under the HRRP since its implementation in 2012, a switch to EDAC could help pull some struggling hospitals back from the brink.

Of particular concern, said Wadhera, is evidence showing that small rural and less resourced hospitals might be taking the brunt of those penalties.

“Large hospitals have the capacity and infrastructure to treat patients in the ER or place them in observation status, such that these encounters won’t count as readmissions. Small rural hospitals don’t have that capacity and may be unfairly penalized,” he suggested.

This new study compared the impact of the standard 30-day readmissions measure with the EDAC measure in 3173 hospitals that participated in the HRRP in 2019.

Because of ongoing concerns regarding unintended consequences associated with the 30-day readmissions measure, including a possibility of increased mortality among patients admitted with heart failure and pneumonia, there have been numerous calls from the clinician and health policy communities, including a recent one in JAMA from Ashish K. Jha, MD, MPH, Brown University School of Public Health, Providence, Rhode Island, to replace the metric with a more comprehensive measure of hospital use.

EDAC was developed for CMS and has been publicly reported since 2017, but is not included in the HRRP. Like the 30-day readmissions measure, however, it does not fully adjust for risk factors like frailty and medical complexity.

The EDAC measure would diminish the perverse incentive to avoid readmitting patients who come back to the hospital.

“One advantage of the EDAC measure is that it’s comprehensive and less gameable, because it counts all hospital encounters after discharge, including ED visits, observation stays, and/or readmissions. The EDAC measure would diminish the perverse incentive to avoid readmitting patients who come back to the hospital and allow for fairer comparisons of hospital performance,” said Wadhera.

“But at best, switching from 30-day readmissions to the EDAC measure would be a small, incremental step forward, and would not address other major issues like inadequate risk adjustment. The HRRP is a deeply flawed program and it’s time for CMS to move on,” he added.

Value-Based Care Needs a “Course Correction”

“Although the EDAC measure captures the use of acute care hospital resources, both it and the readmissions metric are poorly designed to measure quality of care and patient safety,” writes Saul N. Weingarten MD, MPP, PhD, Tufts University, Boston, in an editorial.

He said the continued use of the readmissions measure as an indicator of quality of care or as a means to determine reimbursement is “empirically suspect.”

In comments to theheart.org | Medscape Cardiology, J. Michael McWilliams, MD, PhD, from Harvard Medical School, Boston, was appreciative of these efforts to better understand the impact of alternative payment models.

“Quality measurement is important for evaluation and monitoring progress, so the authors should be applauded for trying to move the science of measurement forward,” he said.

He’s not sold, however, on the EDAC fix, and thinks that given the “intractable problems” with HRRP, the way forward “is not to try to fix the readmissions measure but rather to abandon the program. We need to start taking about other ways to improve quality and stop expending so much energy on attempts to make pay-for-performance programs work,” he said.

It appears that the CMS might agree. Around the same time the Wadhera report was released, CMS Administrator Seema Verma told a virtual audience that the Center for Medicare & Medicaid Innovation (CMMI) needs a “course correction in model design and portfolio selection if value-based care is to advance.”

Her comments were made during an online event hosted by the CMS Health Care Payment Learning & Action Network, a group of public and private healthcare leaders working to provide thought leadership, strategic direction, and ongoing support to accelerate adoption of alternative payment models (APMs).

In her comments, reported by Home Health Care News, Verma said that of the 54 payment models developed by CMMI since its formation, only five have been shown to offer significant cost savings.

But the fixes, she suggested, revolve around making models more often mandatory and designed in ways that shift the financial risk to participants. There is also a need for better benchmarks to measure value, she said.

“It’s been a very disappointing decade for pay-for-performance programs like the HRRP. CMS wants to believe that linking payment to performance on quality measures has resulted in marked improvements in care, but a large body of evidence suggests otherwise,” said Wadhera.

“Policymakers and front-line clinicians need to work together to create more innovative approaches to motivate improvements in care delivery,” he added.

The authors reported no conflict of interest.

Ann Intern Med. Published online October 13, 2020. Abstract, Editorial

Fertility Journal Editors Oppose Supreme Court Nominee

A Supreme Court nominee’s 2006 decision to ally herself with a group that takes a controversial stance on assisted reproduction led editors of a medical journal to make an unprecedented decision and weigh in on a political question.

Writing in an editorial earlier this month, the editors of Fertility and Sterility urge a rejection of the nomination of Judge Amy Coney Barrett for the Supreme Court.

At issue is Barrett’s link to a group whose executive director has been quoted as supporting the criminalization of the discarding of frozen embryos or selective reduction through the in vitro fertilization (IVF) process. Barrett has not made clear publicly whether she shares this view, saying her role as a judge keeps her from expressing opinions.

“We don’t have a full sense of what she believes or of the ground that she stands on,” Craig S. Niederberger, MD, co-editor-in-chief of the journal, told Medscape Medical News in an interview. “It was so unsettling that we felt that it was important for our patients and for our field that we get this word out.”

The editorial marks the first time in 70 years that the journal has weighed in on a Supreme Court nomination, write Niederberger, Co-Editor-in-Chief Antonio Pellicer, MD, and Associate Editor Eve Feinberg, MD.

The move, though, comes in the wake of several other journals making unusual forays into politics. The editors of the The New England Journal of Medicine, Scientific American, Nature, and The Lancet Oncology have all weighed in on the presidential election in recent weeks. Editors said the potential risk to their publications’ reputations as nonpartisan arbiters of science was necessary because of the current administration’s attacks on research, mishandling of climate change, and bungling the response to the COVID-19 pandemic, Medscape Medical News reported previously.

Unlike the editors of those journals, who could point to specific anti-science actions taken by the Trump administration, the editors of Fertility and Sterility could only look to possible hints at how Barrett might rule if presented with a case involving IVF.

Weighing the Evidence

Barrett in 2006 signed an ad run by St Joseph County Right to Life of South Bend, Indiana, which earlier this year changed its name to Right to Life Michiana. The ad appeared in the South Bend Tribune, stating: “We, the following citizens of Michiana, oppose abortion on demand and defend the right to life from fertilization to natural death.”

Earlier this month, The Guardian reported that Jackie Appleman, the executive director of Right to Life Michiana, said that the organization supports criminalizing the discarding of frozen embryos or selective reduction through the IVF process.

However, in an email exchange with Medscape Medical News, Appleman declined to confirm that her group seeks the passage of laws against discarding of embryos.

“We don’t take a position (condemn or condone) fertility treatments,” Appleman wrote. “We do condemn the practice of discarding embryos, which sometimes happens in IVF because this destroys innocent human life.”

This stance raised alarms in the IVF community where many patients and physicians already face difficult choices about unused embryos. Sen. Tammy Duckworth (D-IL), who used IVF to become a mother, urged her colleagues to reject Barrett’s nomination. Barrett’s signature on the St Joseph County Right to Life letter “demonstrates a lack of judgment, an absence of due diligence and a derision toward families like mine who were only able to have children with the help of methods and assistance,” Duckworth wrote in an October 2 letter to fellow senators.

Criminalization and an “Anti-Family Stance”

Niederberger told Medscape Medical News that he and co-editor Pellicer enlisted Feinberg’s help in considering whether and how to proceed in terms of drawing attention to the IVF concerns. The three ultimately decided the journal needed to make a statement about the IVF discussion that arose around Barrett’s nomination.

“It wasn’t fun to do this. It was hard,” Niederberger said. “It is not a natural place for us to go.”

In their editorial, the three fertility experts say seating Barrett on the Supreme Court could prove a threat to IVF if laws were passed to punish physicians in case of lost embryos.

“Frighteningly, any procedure that might risk the embryo’s viability would put physicians at risk for criminal violation. Letting supernumerary embryos go or those that were aneuploid or affected with a single gene disorder would be illegal,” they wrote.

“Physicians would be forced to transfer all embryos, resulting in greater health risk to women and lower pregnancy rates as has been repeatedly demonstrated in countries that do not impose these restrictions,” the editors added. “Scientific advances in the field would come to an immediate and devastating halt without the ability to continue reproductive research.”

These kinds of legal restrictions against IVF would deprive many people of their chance to have biological children, Niederberger told Medscape Medical News.

“In my view, it’s really an anti-family stance,” he said.

Persisting Questions

Approximately 1.7% of all infants born in the United States every year are conceived using assisted reproductive technology, with IVF being the main treatment used, according to the Centers for Disease Control and Prevention.

Barrett’s views are of extreme interest to both would-be parents struggling with infertility and the physicians who treat them, said Sen. Richard Blumenthal (D-CT). He pressed Barrett to clarify her views on IVF during a Senate Judiciary Committee hearing on her nomination that ran from October 12 to 15.

“Is making IVF a crime constitutional?” Blumenthal asked Barrett.

Barrett said it would be improper for her as a current federal judge and as a nominee to express opinions, beyond commenting on those she had made public before serving on the bench. She said this had also been true for earlier Supreme Court nominees who appeared before the committee. Thus Barrett, who serves on the Court of Appeals for the Seventh Circuit, declined to clarify her views on IVF.

“We can’t answer questions in the abstract that would have to be decided in the course of the judicial process,” Barrett said.

The scenario in which the Supreme Court would rule on IVF would require a challenge to a future law passed limiting the use of this technology, Barrett said.

Blumenthal said he was disappointed by Barrett’s replies, saying people looking to use IVF to start families and their physicians would find her lack of clarity on this topic to be concerning.

Groups that are seeking to make abortion and family planning illegal usually try to steer clear about debates about IVF, several experts said.

“If you want to say you have family values and this is the only way a patient can build a family, you don’t want to come out and say you’re against it,” explained Marcelle Cedars, MD, director of the Center for Reproductive Health at the University of California San Francisco.

There have been efforts made in the United States in recent years to pass laws that put physicians and women at legal risk in cases where pregnancies are interrupted, Cedars said. These are part of the so-called personhood movement, including a failed 2011 Mississippi ballot measure. Families who had children with IVF helped defeat the measure, as it raised concerns that physicians would hesitate to perform IVF due to fear of criminal charges if embryos didn’t survive.

Cedars told Medscape Medical News she was pleased to see that the editors of Fertility and Sterility highlighted the consequences of potential laws that would reflect a drive to preserve all embryos. These might suit those like Barrett, who argue that life begins at conception, but it is an opinion not shared by other Americans, she said.

“I get very concerned, as do many others, when people who have very strongly supported this theological concept are in positions where that interpretation can affect healthcare for a much broader population,” Cedars said.

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