PCORI Biweekly COVID-19 Scan: Mental Health Screening in Schools, Post-Exposure Prophylaxis (September 16-29, 2021)
Briefing
The Briefing provides an at-a-glance view of some important developments in the information universe surrounding COVID-19. The views presented here are solely those of ECRI Horizon Scanning and have not been vetted by other stakeholders.
In 2020, a bright spot in the pandemic was that it was having a lesser impact on children than might have been expected from a respiratory virus. That no longer seems to be the case. National data from June 26 through August 14, 2021, show a 10-fold increase in weekly hospitalization rates among children aged 0 to 4 years. And, in the week prior to September 23, nearly 207 000 children had a new case of COVID-19 in states where the American Academy of Pediatrics and the Children’s Hospital Association collected data.
Many, including epidemiologist Larry Brilliant, warn that the pandemic cannot end until children younger than 12 years are vaccinated. That future is around the corner now, because Pfizer has announced positive top-line results from its COVID-19 vaccine trial in children from 5 to <12 years of age. Pfizer has submitted the data to the US Food and Drug Administration (FDA) and said it would soon request Emergency Use Authorization (EUA) from the FDA for use in this younger age group. Pfizer is also expected to have immune response and safety data for children 2 to <5 years of age and children 6 months to <2 years of age before the end of the year.
The return to school by kindergartners through 12th grade students has prompted the Centers for Disease Control and Prevention (CDC) to study the effectiveness of masking to prevent COVID-19 spread in classrooms. One comparison of schools from 2 Arizona counties showed that schools without mask requirements were 3.5 times more likely to have COVID-19 outbreaks as were those with mask requirements. A recent ECRI clinical evidence assessment also concluded that SARS-CoV-2 transmission among students is relatively rare in schools that implement masking as part of a bundle with other mitigation strategies.
All of this might affect the mental health of our children. See Topics to Watch for a trend in screening programs that aim to identify kids who are at-risk for mental health conditions.
ECRI Horizon Scanning has selected the topics below as those with potential for impact relative to COVID-19 in the United States within the next 12 months. All views presented are preliminary and based on readily available information at the time of writing.
Because these topics are rapidly developing, we cannot guarantee the accuracy of this information after the date listed on this publication. In addition, all views expressed in the commentary section are solely those of ECRI Horizon Scanning and have not been vetted by other stakeholders. Topics are listed in alphabetical order.
Increased Routine Pediatric Mental Health Screening in Schools to Mitigate Mental Health Effects of the COVID-19 Pandemic
At a Glance
- The expansion of routine mental health screening programs for all children in elementary and secondary schools might help address the ongoing mental health effects of the COVID-19 pandemic for children and adolescents.
- Although schools routinely screen children for physical health, universal mental health screening has not been widely or consistently implemented, primarily because of time, resources, and costs.
- Proactively identifying students who are at risk of developing mental health issues and increasing access to care might improve mental health and academic performance.
- Multiple states are reporting an increase in mental health services offered in schools, funded in part by the Elementary and Secondary School Emergency Relief Fund, part of the Coronavirus Aid, Relief, and Economic Security (CARES) Act.
Description
Providing routine mental health screening in K-12 schools for all children is one approach used to identify children with mental health needs early. The expansion of these programs could help address the ongoing mental health effects of the COVID-19 pandemic.
The pandemic has taken a toll on the mental health of children and adolescents, with studies reporting that children are experiencing high levels of stress, worry, helplessness, and social problems, as well as increased rates of new or worsening mental health conditions. Although schools routinely screen children for physical health (eg, hearing, vision), universal mental health screening has not been widely or consistently implemented, primarily because of time, resources, and costs. However, it is increasingly being recognized as an important component of comprehensive school-based support systems.
The majority of children with mental health issues do not seek help and are not identified until after emotional or behavioral issues have already manifested. Proactively identifying students who are at risk of developing mental health issues and increasing access to care might improve mental health and academic performance.
Multiple states have reported an increase in mental health services in schools, funded in part by the Elementary and Secondary School Emergency Relief Fund, part of the CARES Act of 2020. Toolkits are available that provide free, validated screening tools and guidance for school mental health programs, including the Ready, Set, Go, Review: Screening for Behavioral Health Risk in Schools toolkit and the School Health Assessment and Performance Evaluation (SHAPE) System.
Commentary
The expansion of routine pediatric mental health screening programs might be an efficient way to mitigate the mental health effects of the COVID-19 pandemic. The increased focus on and funding for pediatric mental health could lead to the widespread use of mental health screenings in schools.
Early feedback from ECRI internal stakeholders suggested that proactively addressing pediatric mental health issues might provide an opportunity for early intervention, reduce the prevalence of mental health conditions, and increase awareness of mental health issues. Caregivers might not recognize mental health issues in children and may be unwilling or unable to obtain mental health services for their child. Disparities might be reduced by ensuring that all students have equal access to mental health assessments and mental health services.
Over time, these programs might reduce the burden of mental health issues on families, schools, and health care systems. The disruptive potential of this intervention might be limited by the need for parental consent and sufficient, appropriately trained staff.
- Category: Public health, systems, and management
- Areas of potential impact: Patient outcomes, population health outcomes, patient management, health care disparities, health care delivery and process
Molnupiravir Post-Exposure Prophylaxis for COVID-19
At a Glance
- Molnupiravir is an investigational oral nucleoside analogue prodrug that is being developed as a post-exposure prophylaxis for patients living with someone with confirmed COVID-19.
- Molnupiravir purportedly is converted in the body to a cytidine analogue that is incorporated into viral RNA during replication to create a large error rate, resulting in nonfunctional virus.
- Its developers have begun a phase 3, randomized, placebo-controlled trial enrolling 1332 participants living with someone infected with COVID-19. The trial’s estimated primary completion date is in April 2022.
- An interim analysis of the phase 3 MOVe-OUT trial in at-risk adults with mild-to-moderate COVID-19 found that molnupiravir reduced the risk of hospitalization or death by approximately 50% through Day 29.
- The company announced plans to submit an application for an EUA to the FDA as soon as possible for treating mild to moderate COVID-19. The US government agreed to purchase 1.7 million courses of molnupiravir from the manufacturer for $700 per course.
Description
Molnupiravir (Merck, Kenilworth, New Jersey), formerly known as MK-4482 and EIDD-2801, is an oral antiviral drug under investigation as a prophylactic treatment for individuals exposed to SARS-CoV-2.
Molnupiravir is a prodrug of the nucleoside analogue N4-hydroxycytidine (NHC), which is converted into its active form within cells. The drug is designed to prevent replication of SARS-CoV-2 by inducing errors in the viral genome. The active form is incorporated into viral RNA during the replication cycle, increasing the mutation rate. This purportedly leads to error catastrophe, in which a large number of mutations render the virus nonfunctional.
Laboratory studies with human cell cultures have demonstrated that molnupiravir can inhibit propagation of multiple coronaviruses, including SARS-CoV-2. By inhibiting SARS-CoV‑2, molnupiravir might prevent exposure to SARS-CoV-2 from causing COVID-19 and could prevent subsequent infectious spread of the virus to other individuals.
Molnupiravir is being studied in an ongoing phase 3, randomized, placebo-controlled trial enrolling 1332 patients who reside in households with a person who has COVID-19. Preliminary data from the trial is expected before the end of 2021, and the trial has a primary completion date of April 2022. An interim analysis of the phase 3 MOVe-OUT trial in at-risk adults with mild-to-moderate COVID-19 found that molnupiravir reduced the risk of hospitalization or death by approximately 50% through Day 29. The company announced plans to apply for an EUA from the FDA as soon as possible for treating mild to moderate COVID-19. The US government agreed to purchase 1.7 million courses of molnupiravir for $700 per course.
Commentary
Post-exposure prophylaxis with molnupiravir might improve health outcomes for individuals at high risk of developing COVID-19, by preventing infection and subsequent viral spread. As an oral drug, molnupiravir might provide an alternative to monoclonal antibody treatments, which require intravenous infusion or subcutaneous injections and are indicated only for high-risk individuals.
Early feedback from ECRI internal stakeholders suggests that if effective, molnupiravir might improve individual health outcomes, by giving the body more time to mount an immune response against the virus and prevent uncontrolled infection. The therapy might be particularly useful for people with high-risk occupations or who have high-risk individuals at home, for whom disparities might be reduced. The accessibility and convenience of a drug that can be given more readily in outpatient settings might change the standard of care for exposed individuals.
Stakeholders expressed concerns that molnupiravir would increase upfront health care costs but noted that those costs might be offset by preventing serious disease complications that could lead to costly hospitalizations and resource use.
- Category: Treatment and prophylaxis
- Areas of potential impact: Patient health outcomes, population health outcomes, care setting, health care disparities, health care costs
Horizon scanning is a systematic process that serves as an early warning system to inform decision makers about possible future opportunities and threats. Health care horizon scanning identifies technologies, innovations, and trends with potential to cause future shifts or disruptions—positive or negative—in areas such as access to care, care delivery processes, care setting, costs of care, current treatment models or paradigms, health disparities, health care infrastructure, public health, and patient health outcomes.
The PCORI Health Care Horizon Scanning System (HCHSS) conducts horizon scanning to better inform its patient-centered outcomes research investments. Initially, PCORI defined the HCHSS project scope to focus on interventions with high potential for disruption in the United States in 5 priority areas: Alzheimer’s disease and other dementias, cancer, cardiovascular diseases, mental and behavioral health conditions, and rare diseases. In addition, the system captures high-level disruptive trends across all clinical areas, which may lead PCORI to expand the project scope to include other priority areas in the future.
In early 2020, the COVID-19 pandemic created a fast-moving, widespread public health crisis. In May 2020, PCORI expanded its HCHSS to elucidate the landscape of potentially impactful applications for COVID-19. The HCHSS COVID-19 supplement scans for, identifies, monitors, and reports on emerging and available COVID-19-related treatments, diagnostics, preventive measures, management strategies, and systems changes with potential for high impact to patient outcomes—for individuals and populations—in the United States in the next 12 months.
The HCHSS COVID-19 supplement produces 3 main outputs:
- Biweekly COVID-19 Scans (eg, this document) provide ECRI Horizon Scanning with a vehicle to inform PCORI and the public in a timely manner of important topics of interest identified during ongoing scanning and topic identification or through the ECRI stakeholder survey process.
- Status Reports (quarterly) briefly list and describe all COVID-19-related topics identified, monitored, and recently archived.
- High Impact Reports (every 4 months) highlight those topics that ECRI internal stakeholders (eg, physicians, nurses, allied health professionals, public health professionals, first responders, health systems experts, clinical engineers, researchers, business and finance professionals, and information technology professionals) have identified as having potential for high impact relative to COVID-19 in the United States.
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Commentary in this COVID-19 Scan reflects preliminary views of ECRI Horizon Scanning and internal ECRI stakeholders.
The information contained in this document has not been vetted by other stakeholders.
We welcome your comments on this Scan. Send them by email to [email protected].
Posted: October 6, 2021
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