The explosion in digital health products has left National Health Service commissioners in the UK wondering how they can possibly sift out what works and what provides maximum benefit for the service and for patients.
The Early Value Assessment for Medtech will offer a rapid assessment of digital products, devices and diagnostics for clinical effectiveness and value for money. The goal of this new approach is that the service and patients will be able to benefit sooner.
Early Value Assessment is being designed to draw in the most promising and impactful medical technologies where the evidence base is still emerging, starting with digital products, in areas where there is greatest need. Whether its empowering patients to better manage their own health and seek clinical advice, reducing admissions and waiting lists or supporting clinicians and other front-line staff to provide better quality care this new program will help to alleviate system pressures as the NHS recovers from the COVID pandemic.
In this accelerated approach, the first two pilot digital health topics will begin their early value assessments this month (June) with a view to publishing findings in October. This is much faster than a full NICE Medtech evaluation meaning benefits will be realized sooner, while companies generate more evidence required for a full NICE evaluation at a later stage.
The first two pilots are digital apps for depression and anxiety in children and others will quickly follow in adult mental health, early cancer diagnosis, cardiovascular disease and other areas that support elective recovery following the pandemic.
In this ‘fast-track’ approach, NICE is working closely with NHS England and all its system partners to help develop commercial and data collection arrangements to support the technologies that go through early value assessment in adoption and scaling and to make this new program of work deliver on the potential of digital health for patients.
The short-term consequences from COVID-19 have been described after the initial “acute” infection passes. These have included not only a variety of physical symptoms, but also psychiatric symptoms have been reported. A team of VA researches has been shining a light on various dangerous and enduring consequences that can arise following the initial COVID bout. These COVID complications include mental health disorders.
A study published this week in the British Medical Journal (BMJ) by researchers with the VA St. Louis Health Care System focused on mental health disorders following COVID-19 infection. They found that, even in people not needing hospitalization while infected with COVID-19, serious health issues related to mental health could persist, or pop up, in the weeks and months following the acute stage. They describe that the reasons for the increased mental health risks after COVID are not completely clear. Biologic changes may occur in the body that affect the brain, and nonbiologic changes such as social isolation and trauma may also be at play.
The researchers analyzed medical records in a database within VA, which operates the largest integrated health care system in the United States. The analysis included nearly 154,000 patients who had tested positive for COVID-19 in a defined time frame from March 2020 into January 2021. (The time frame predated the delta and omicron variants, as well as wide availability of vaccines.) A comparison was made of these patients’ health information with data from more than 11 million people who had not had COVID-19 infection—about half of them from the same time frame and the other half from a pre-pandemic timespan.
The research group compared the mental health risks for those who had COVID-19 and survived the first 30 days of infection with the same health outcomes among those who were not infected. Over a study period of about a year, the researchers identified elevated risks for issues such as anxiety, depression, stress disorders, opioid use, substance use disorders, and sleep conditions.
“We’ve all suffered some sort of distress from this pandemic—maybe a measure of anxiety or difficulty sleeping,” says lead investigator Al-Aly. “But these challenges are magnified, especially in those who were admitted to the hospital during the acute part of their COVID battle but also in many who experienced only mild or moderate symptoms.”
Compared to those who did not have COVID, those in the COVID group had a 60 percent higher risk of having any mental health disorder or mental health-related prescriptions.
Findings by the type of mental health issue were:
Anxiety: 35 percent higher risk in the COVID-19 group
Depression: 39 percent higher risk
Sleep disorder: 41 percent higher risk
Opioid use: 76 percent higher risk
Opioid use disorder: 34 percent higher risk
Non-opioid substance use disorders: 20 percent higher risk.
Given the large number of people with COVID-19, these findings could translate into a huge impact in the United States and around the world, the authors point out. A strength of our research was the large number of patients and the ability to leverage the breadth and depth of the VA’s electronic health records system,” highlights Al-Aly. As a pioneer in the use of electronic health records, VA “can offer answers to questions about areas including the pandemic that would be hard for others to address.”
The researchers were a multidisciplinary research team for making the rigorous analysis possible brought together public health experts from across disciplines, successfully marrying the medical and research perspectives. An Editorial in the BMJ by lead researcher points out that mental health disorders represent one part of the multifaceted nature of long covid which can affect nearly every organ system (including the brain, heart, and kidneys). Our results should be used to promote awareness of this risk among people with covid-19 and to guide efforts for the early identification and treatment of affected individuals.
Research Article: Xie Y, Xu E, Al-Aly Z. Risks of mental health outcomes in people with covid-19: cohort study. BMJ 2022; 376 (Published 16 February 2022)