PCORI Biweekly COVID-19 Scan: People with Compromised Immune Systems, Addressing Depression in Adolescents (May 12-25, 2022)
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.
The infectious diseases that we thought we understood well, such as acute hepatitis and monkeypox, seem to be following unusual new patterns. Some experts think that 2 years of COVID-19 precautions might have increased our susceptibility to viruses that we used to encounter regularly, and that we should be ready for unexpected outbreaks of diseases caused by influenza, respiratory syncytial virus, and enterovirus D68.
In addition to the new cautions about established viruses, our picture of what long COVID looks like, and who has it, is becoming clearer by using studies of electronic health records (EHR) and international classification of disease (ICD) codes. One study revealed that 75% of patients diagnosed with the new ICD-10 code (U09.9) for “Post COVID-19 condition, unspecified” had not been hospitalized for COVID-19. Another found that among patients who have recovered from COVID-19, one in five aged 18–64 years and one in four aged 65 years or older experienced at least 1 post-COVID condition (or Post-Acute Sequelae of COVID-19 [PASC]). A third study used machine learning to create the first non–survey driven clinical description of post-COVID conditions that might provide more accurate diagnoses and identify patients who have not self-reported.
Some think that the pandemic, the disruptions to daily life, and the concern about future outbreaks have taken a toll on Americans’ mental health. Many companies have launched promising smartphone app-based interventions during the pandemic (see Topics to Watch for one aimed at adolescents). Despite the potential, downloads and monthly active user rates have been on the decline recently. Furthermore, the FDA plans a transition back to a stricter regulatory pathway that might delay uptake even further.
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.
Estimation and Monitoring of SARS-CoV-2 Immunity in People with Compromised Immune Systems
At a Glance
- People with compromised immune systems might not mount sufficient immune responses to vaccines against SARS-CoV-2, which increases their risk of serious illness and death from COVID-19.
- Higher preexposure SARS-CoV-2 neutralizing antibody (NAb) levels are associated with better clinical outcomes. Quantifying and monitoring NAbs might provide useful information regarding individual risk and health care options to those in vulnerable populations.
- However, the FDA advises that although antibody tests can play an important role in identifying individuals exposed to the SARS-CoV-2 virus, these tests should not be used to determine immunity or protection against COVID-19 at any time, especially after vaccination.
- Despite this, manufacturers are developing and marketing tests to quantify SARS-CoV-2 NAbs for purposes other than identifying those with an immune response from prior infection.
- Quantitative antibody testing might cost between $150 and $300 per patient.
Although COVID-19 vaccines improve patient outcomes within the general population, some individuals with compromised immune systems might not mount an immune response that provides an adequate level of protection against COVID-19. Several diagnostics are now available to quantify an individual’s response to vaccination.
Neutralizing antibodies (NAbs) protect cells by blocking SARS-CoV-2 from binding or entering host cells. NAb levels are highly predictive of protection from symptomatic SARS-CoV-2 infection, and NAb assays have helped guide the development of COVID-19 vaccines. Circulating antibodies naturally diminish over time, but immune memory from vaccination generally prevents severe infection. These data could be valuable to those at highest risk. For example, studies of patients with multiple myeloma suggest NAb monitoring could help guide COVID-19 treatment and disease management.
Several manufacturers now provide blood tests to quantify circulating antibody levels and enable their tracking over time. These include the IMMUNO-COV and COVID-19 Immune Index tests. Each is given by prescription only. Samples must be taken by a physician or certified phlebotomist before being sent to a participating lab for processing. Due to this, results might take several days. Novel cell-based approaches for quantifying SARS-CoV-2 NAbs are also under development, and might expedite processing. The manufacturer of the Immuno-COV kit suggests regular testing every 3 to 6 months or 14 days after any infection, vaccine, or booster. According to a 2020 news source, the IMMUNO-COV test costs $300. According to the manufacturer, the COVID-19 Immune Index test kits for the Spike protein cost $150.
Despite the availability and marketing of these tests, it is important to note that on May 19, 2021, the FDA cautioned that antibody tests are only currently approved to detect past exposure to the SARS-CoV-2 virus itself. The FDA stated more research is needed to interpret tests in other scenarios, and they should not be used to evaluate immunity from COVID-19 following vaccination.
Monitoring the immune response to the SARS-CoV-2 virus could increase awareness and inform health care decisions for people with compromised immune systems. However, geographic disparities might increase if individuals in remote areas cannot access these NAb tests. Early stakeholder comments suggested that NAb testing might help guide decisions on public health measures (masking/social distancing) for people with compromised immune systems.
However, stakeholders raised concerns about wasted resources (eg, cost of testing, staffing) from repeated testing. There is a lack of evidence about whether the results would inform treatment decisions for these individuals if they have been vaccinated and still have low NAb levels. Although this could change the process of determining who needs a vaccine booster, more research is necessary before determining if this is a reliable method for guiding management for people with a weakened immune system.
- Categories: Screening and diagnostics
- Areas of potential impact: Patient outcomes, population health, health care delivery and process, health care costs, and health care disparities
SparkRx to Reduce Symptoms of Depression in Adolescents
At a Glance
- SparkRx is a prescription digital therapeutic that offers a self-guided program intended to reduce symptoms of depression in adolescents. Delivered through a smartphone application (app), it is a 5-week-long structured program that is accessed on-demand and independently by the user.
- Rates of depression and health care provider shortages have both risen during the COVID-19 pandemic. SparkRx might help increase adolescent access to mental health care for depression and alleviate mental health care provider shortages.
- Preliminary data from a completed unphased clinical trial in 227 adolescents aged 13 to 21 years suggested SparkRx significantly decreased depression symptoms and increased the remission rate compared with a control intervention.
- SparkRx is currently available to eligible patients with an access code under the FDA’s enforcement policy for digital health devices for treating psychiatric disorders during the COVID-19 public health emergency.
SparkRx is a smartphone app-based digital therapeutic developed by Limbix Health, Inc (San Francisco, California) that offers a self-guided program intended to reduce symptoms of depression in adolescents aged 13 to 22 years.
Rates of depression in adolescents increased during the COVID-19 pandemic, as did health care provider shortages. Because SparkRx can be used on-demand at home, it might help increase adolescent access to mental health care and help circumvent current health care provider shortages.
SparkRx is a 5-week-long, structured intervention based on cognitive behavioral therapy (CBT). It is an automated, self-guided intervention designed to teach skills, such as mood tracking, behavioral activation (engaging in activities that promote better mood), problem-solving, mindfulness, and avoiding symptom relapse, to enhance the awareness of the relationship between mood and behavior. The app also provides education on these topics, and users complete weekly depression assessments.
This digital therapeutic was studied in an unphased clinical trial in 227 adolescents aged 13 to 21 years. Preliminary data reported in late 2021 showed SparkRx significantly reduced depression symptoms compared with a control intervention and led to a higher rate of remission (21% vs 4%). An additional pivotal trial is planned.
The SparkRx app is currently available for free download under the FDA’s enforcement policy for digital health devices for treating psychiatric disorders during the COVID-19 public health emergency. An access code can be obtained through the patient’s health care provider. We were unable to find information regarding the potential cost of SparkRx to treat depression symptoms if it is cleared or approved by the FDA.
SparkRx represents a novel approach to delivering adolescent mental health care.
Early feedback from internal ECRI stakeholders suggested that although more substantial data are needed to determine SparkRx’s efficacy, the intervention has numerous potential benefits. It might significantly reduce depression symptoms and prevent progression to clinically diagnosable major depressive disorder. More adolescents might receive care if SparkRx results in reduced stigma of seeking mental health care and is less expensive compared with traditional therapy. It is likely to be used adjunctively to traditional therapy, but it might be used singly by patients unable to afford alternatives, thereby reducing health disparities.
A large benefit of the app is that it is easy to download and available for use 24/7, which might also increase patient access and engagement in treatment. This device-based interaction might be preferable among adolescents to traditional face-to-face interaction. If successful, this app might serve as a model for future app-based interventions and indications. Data privacy is an ongoing concern that will need to be addressed.
- Categories: Treatment
- Areas of potential impact: Patient outcomes, health care delivery and process, health care disparities, health care costs, protected health information security
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.
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: June 3, 2022
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