Using Real-World Data to Understand the Impact of COVID-19 on Oncology Patient Care

When the coronavirus disease 2019 (COVID-19) pandemic and stay-at-home orders swept across the country in March, oncology care—like nearly every aspect of the US health care system—was dramatically affected. As efforts to reduce exposure to the coronavirus ramped up, nonemergency surgical procedures were halted, screening procedures were delayed, and the amount of new cancer diagnoses declined. In addition, some clinical trials were shelved, and treatment regimens were disrupted due to COVID-19 illness or fear of getting infected. In a 2-part series, we will explore the implications of these disruptions to oncology treatment patterns and the potential impact on patient outcomes. In this article, we will look at how real-world data (RWD) on treatment patterns, complications, and the viability of treatment modification options gathered during COVID-19 can provide insights to inform future cancer care.

Unprecedented Impact on Cancer Care Oncologists normally are well-equipped to make clinical decisions regarding treatment for their patients. However, COVID-19 has added an unprecedented layer of complexity, forcing oncologists to predict what would happen if surgery, chemotherapy, or radiation were delayed due to state restrictions or COVID-19 hardships. Questions to ponder include: Will treatment increase the risk of coronavirus infection? Will delaying treatment allow for the growth or spread of the cancer? Are there alternative treatments that are less risky but perhaps not as effective? What if patients lose their jobs and health insurance?

Unprecedented Impact on Cancer Care Oncologists normally are well-equipped to make clinical decisions regarding treatment for their patients. However, COVID-19 has added an unprecedented layer of complexity, forcing oncologists to predict what would happen if surgery, chemotherapy, or radiation were delayed due to state restrictions or COVID-19 hardships. Questions to ponder include: Will treatment increase the risk of coronavirus infection? Will delaying treatment allow for the growth or spread of the cancer? Are there alternative treatments that are less risky but perhaps not as effective? What if patients lose their jobs and health insurance?

COVID-19 Enhancements to Electronic Health Records

To get a longitudinal view of the patient journey, it is critical to evaluate clinical facts, such as relevant biomarkers, disease staging, and disease progression. This information, along with key demographic and patient characteristics, is widely available through real-time tracking of clinical and claims data elements across unif ied electronic health records (EHR) and reimbursement systems. McKesson’s iKnowMedSM oncology EHR captures outpatient medical histories from community oncology practices in The US Oncology Network and has been used to help understand the real-world utilization and outcomes associated with a number of oncology agents.

In addition to looking at the impact of treatment disruptions, it is also important to ensure the data are complete, high quality, and generalizable across broad populations. In order to track and record information related to COVID-19, McKesson developed a new feature in its EHR that lets practices in The US Oncology Network document results of screening patients at the door.

Beginning in mid-March, practices started gathering clinical data about symptoms (fever, cough, fatigue) and risk factors, such as recent local or international travel. Practices also are recording if patients were tested for COVID-19 and the test results. To date, practices in The US Oncology Network have screened more than 100,000 patients. This is the beginning of a COVID-19 database that can be used to determine whether patients’ treatment courses and outcomes were altered, as well as if patients had complications because they were positive for COVID-19.

Initial Insights from COVID-19 Database

Analyzing RWD and the COVID-19 database will enable the oncology community to innovate for the future by building predictive models and algorithms that help us inform cancer care decisions. While we are just beginning to analyze the data, there are some interesting early indicators:

•Treatment Modification Indicators: We’re starting to see a variety of treatment modifications, such as dose reductions and switching to schedules with a longer interval between treatments when indicated. We expect there will be a lot to learn about what happens when doses are modified or time is extended between treatments—information that can be used for updated labeling.

• Surge of Care at Community Clinics: Due to stay-at-home orders and hesitation to travel long distances, patients who might have normally gone to an academic medical center or larger hospital are seeking second opinions and treatment at community oncology clinics.

•Telemedicine Explosion: Telemedicine offered immediate relief to patients—and caregivers— wanting to reduce their exposure to the coronavirus. Although every visit cannot be virtual, this represents a huge shift in oncology care.

Informing Future Cancer Care

During the stay-at-home process, most cancer surgeries and biopsies were considered elective. One analysis that we plan to conduct is to look at the impact of delays in diagnosing and staging disease, and, ultimately, starting treatment. Specifically, we want to determine whether more patients are presenting with more advanced disease. If we see more initial diagnoses of advanced disease than we saw before the pandemic, we have data to support changing practices so that biopsies are not elective in future events.

Outcomes and changes to treatment patterns associated with treatment delays, longer intervals, or delays in diagnoses and staging cannot be tested in a standard randomized clinical trial. However, as we’ve seen during the pandemic, these data are critical to helping clinicians make informed decisions on behalf of their patients. We are proud to work with the oncology community to leverage RWD to learn from this pandemic and provide critical insights to inform future cancer care.

Marcus Neubauer, MD, is the Chief Medical Officer for The US Oncology Network, and Sarah A. Alwardt, PhD, is the Vice President of Data, Evidence, and Insights Operations for McKesson

>>> See Part 2 of this series.