While the country waits for efforts, such as Operation Warp Speed, to bring safe and effective vaccines to market, public health interventions remain key to battling the pandemic. For example, one model estimates that without lockdown policies, there might have been 14 times more infections in the United States. However, lockdowns are now ending in most areas across the nation.

About 40% to 45% of those infected with coronavirus have no symptoms, and a survey of self-identified “long-haulers” suggests that some patients might experience mild symptoms for up to 40 days or longer. Therefore, contact tracing (see Topics to Watch) might help prevent further spread of coronavirus until an effective vaccine is available.

Operation Warp Speed has chosen five leaders in the vaccine race: AstraZeneca in collaboration with Oxford University, Johnson & Johnson, Merck, Moderna, Inc (see Topics to Watch), and Pfizer Inc. However, commercial availability may be further away than many were hoping. Moderna, Inc leads the race with data expected in March 2021. AstraZeneca follows close behind with data expected in May 2021.

With deaths continuing to occur, treatment remains paramount. States are exploring ways of getting treatments to where the critically ill are or getting the critically ill to where the treatments are (see Topics to Watch).

Description

Software developers from around the world are collaborating to combat COVID-19 by creating contact tracing tools that can inform individuals, governments, and public health agencies about the spread of coronavirus. For example, Apple Inc and Google LLC have launched exposure notification systems​ using Bluetooth-enabled devices (eg, smartphones) to track physical proximity between people. Users of the system can opt to report a COVID-19 diagnosis, thereby allowing for efficient contact tracing by alerting users whose devices come near their own.

Additionally, access to the data can be granted to public health systems, which can provide advice on next steps for potentially exposed users. The wireless networking company EnGenius Technologies developed a new feature for its cloud platform that detects proximity of user devices, using Wi-Fi. The developers claim that their systems protect users' privacy and will not collect location data or disclose user identities to others.

Commentary

Contact tracing software systems might be part of an effective strategy to mitigate the spread of coronavirus. Data gathered from smartphones could inform public health policies and quarantine measures that could help slow or stop the spread of infection.

However, early responses from ECRI internal stakeholders raised concerns about privacy issues—despite assurances from software developers—about the potential of data retention for wider surveillance, as well as the potential for intentionally or inadvertently revealing individuals’ identities or health status. Therefore, developers and state health departments should be transparent about all data use and security risks and concerns to reassure and promote opt-in and reporting of COVID-19 diagnoses.

• Area of Potential Impact: Patient outcomes, population health, health care delivery and process, health care disparities
• Category: Systems and Management

Description

mRNA-1273 (Moderna, Inc) is a vaccine against coronavirus that encodes a protein normally expressed on the surface of the virus. The mRNA vaccine purportedly enters host antigen-presenting cells and induces expression of the viral protein, which acts to elicit a host immune response against the virus to prevent future infection. mRNA-1273 is in phase 2 development with primary completion expected March 2021. The company reported positive interim phase 1 results after healthy adults (n = 30) were given 2 doses of either 25 or 100 µg of vaccine.

At day 43, all patients with available neutralizing antibody data (n = 8) purportedly had neutralizing antibody levels “at or above levels generally seen in convalescent sera.” Tested in mice, the vaccine also provided full protection against pulmonary viral replication. On May 12, 2020, FDA granted mRNA-1273 Fast Track designation. The manufacturer is finalizing the protocol for a pivotal phase 3 trial expected to begin in July 2020.

Commentary

Safe and effective preventive vaccines against coronavirus are key to ensuring long-term public health should the pandemic persist or resurge. Reducing infection risk will improve patient and population health outcomes and enable more relaxed social distancing protocols. Effective vaccines could also reduce costs associated with treating severe infections. Early feedback from ECRI internal stakeholders suggested that preliminary results from mRNA-1273 were encouraging regarding safety and immunogenicity; however, they raised concerns that mRNA technology was largely unproven and cautioned that historical precedent shows that most vaccines in development will likely be unsuccessful.

Stakeholders also expressed concerns that mRNA-1273 was tested only in healthy volunteers. To determine its effectiveness, stakeholders concluded, mRNA-1273 needs to be studied in populations hardest hit by COVID-19, including those with comorbidities.

• Area of Potential Impact: Patient outcomes, population health, clinician and/or caregiver safety, health care delivery and process, health care disparities, health care costs
• Category: Vaccines and Prophylaxis

Description

The Arizona Department of Health Services has launched a statewide patient load–balancing system to help with transferring patients between facilities during the COVID-19 public health emergency. The Arizona Surge Line is a 24/7 toll-free call line for health care providers, where a surge line transfer agent reviews critical care availability for each hospital in the state and transfers the call to the appropriate destination, thereby assisting with interfacility transfer of patients with presumed or confirmed COVID-19 or transfer of patients to post-acute care facilities.

The surge line may also provide clinical consultation if a transfer is declined or delayed. This might trigger other states to create similar statewide hubs with real-time visibility into bed capacity and availability of ventilators across all facilities and health care systems.

Commentary

A statewide surge line system might support timely care to COVID-19 patients in critical condition and might help reduce serious illness and death. Early feedback from ECRI internal stakeholders suggested that a statewide surge line would streamline critical care operations by enabling effective coordination and resource management among hospitals.

This would improve efficiency in patient load management and might facilitate timely and appropriate care to critically ill patients. Some stakeholders raised concerns about safely transporting these patients to other facilities. In addition, patients and their families might face the financial burden of additional out-of-pocket costs from insurance coverage restrictions and transportation costs.

• Area of Potential Impact: Patient outcomes, population health, clinician and/or caregiver safety, health care delivery and process, health care disparities, health care costs
• Category: Systems and Management

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.