SEPTI ADE PAMUJI / SHUTTERSTOCK.COM
COVID-19 has generated an outpouring of fast-paced, late-breaking new developments. The majority of countries (188) around the world have reported cases of COVID-19.1 As of April 1, 2020, the Centers for Disease Control and Prevention had reported cases in every U.S. jurisdiction (50 states, District of Columbia, Puerto Rico, Guam, the Northern Mariana Islands and the U.S. Virgin Islands).2 Research, by nature, is methodical. During a pandemic, however, research methods may need altered.
Given the new urgency to find an answer, a treatment and a resolution to the pandemic, what happens to the millions of unrelated research studies already in process?
Members of the ARP Research Subcommittee, in collaboration with the ARP president and members of the ACR Committee on Research and Early Career Investigator Subcommittee, shared the following observations of how the COVID-19 pandemic has affected their research. Common themes were loss, delay and change.
Loss of Staff
As students comply with isolation requirements, they are no longer on campus to assist with research studies. Dina Jones, PT, PhD, a professor of orthopedics and physical therapy at West Virginia University, Morgantown, says, “I am now assembling mailings, ordering supplies, calling participants to review their medications, writing newsletters and entering study data into the database on my own.”
Although researchers oversee all phases of their studies, the loss of student support adds time and effort for the investigator. It is also a loss of experience for the student.
Research publications identify the principal investigator, co-investigators, scientists, research coordinators and statisticians, but integral members of any research study also include support staff, both clerical and administrative. Although a well-planned budget includes laboratory or clinical supplies, the support staff ensures supplies are available.
Elizabeth Volkmann, MD, MS, an assistant professor of medicine in the Division of Rheumatology, University of California, Los Angeles, acknowledges the impact on her research of the loss of a study coordinator, who was deployed to necessary clinical operations during the pandemic. That loss has an impact on data collection, recruiting and reporting.
Cross training staff across studies becomes salient, especially among new staff.
Research does not occur in a silo. It requires a team. “In my role as biostatistics team leader,” says Rebecca Cleveland, PhD, assistant professor, Thurston Arthritis Research Center, Department of Medicine, University of North Carolina, Chapel Hill, “[I’ve found that] right now, we do not have the daily interactions [that] are important in the exchange of ideas and finding solutions to complex problems. Further, research study data collection has mostly come to a halt, leaving principal investigators with time to refocus attention on getting analyses and papers out the door. Because of this, our group’s need for statistical support has increased greatly.
“My statistical team is fantastic. It has been amazing to see them jump into and embrace the added workload without skipping a beat. This pandemic has made me grateful for my team and made me realize that we can be productive even in the midst of something like the coronavirus pandemic.”
Interaction and communication among study teams have changed. Charmayne Dunlop-Thomas, MS, MPH, associate director of research projects, Emory University School of Medicine, Atlanta, notes that she “recognizes how we rely on our in-person dynamics and energies to fuel the brainstorming collaborative process.”
The impact of the reduced in-person social support is evident. Communication involves more than spoken or written words. Facial expression, intonation and gestures carry additional information and meaning that can be lost on telephone calls with team members and be less evident on video calls.
Loss of Data
One of the greatest losses is the loss of data. Insufficient preliminary data has prevented Melanie Smith, MD, PhD, a rheumatology fellow at the Hospital for Special Surgery, New York, from submitting a grant application for funding. When universities close, written questionnaires, surveys and spreadsheets can be transferred to remote locations. Some clinical (e.g., body weight) and performance-based (e.g., gait speed) data cannot be obtained.
ARP President Janet Poole, PhD, OTR/L, professor and division chief of the occupational therapy graduate program in the School of Medicine, University of New Mexico, Albuquerque, says, “In rehabilitation research, participants come to us for assessments that can only be done in person, such as measuring balance, joint range of motion and dexterity.”
Animal models cannot be taken home. The sacrifice of animal models cannot be replaced. Grant Schulert, MD, PhD, assistant professor, Division of Rheumatology, Cincinnati Children’s Hospital Medical Center, and Department of Pediatrics, University of Cincinnati College of Medicine, says, “We have completely shut down laboratory-based research in line with institutional restrictions. We are also very limited in recruiting patients for studies, both because they are not being seen physically at our location and because clinical research is suspended for all but high-priority, newly diagnosed patients.”
Time away from the lab can mean restarting certain projects or abandoning experiments.3 Dr. Poole had two research projects planned. One was an online fatigue intervention. “One of our variables was depression. I did not think we would see much positive change when people are stressed and anxious over the coronavirus, so that study will be delayed,” she says.
“We will not be able to collect in-lab outcomes,” says Joshua Stefanik, MSPT, PhD, an assistant professor at Northeastern University, Boston. “We are working on how best to analyze participants who do not have the opportunity to complete study treatment visits and in-lab outcomes. We are also working on ways to collect patient-reported outcomes via surveys.”
Loss of Time
Time is a commodity that cannot be regained. “I am finding some investigators have additional time to work on research with hopes of getting a lot done, while others have higher clinical demands with less time for research,” says Cynthia Crowson, PhD, professor of medicine and biostatistics, Mayo Clinic, Rochester, Minn.
As investigators are pulled to direct patient care, little time remains in the 24-hour day to pursue research. Loss of dedicated or protected time not only affects current projects, but delays the creation of new initiatives.
Delays
For human studies, delay in treatment or data collection may have an unknown impact on results. Dr. Jones states, “There is only one, in-person intervention workshop left to complete [in one particular study]. It is postponed until the site reopens. We may have to explore other delivery options if groups cannot convene within the next several months. In addition, we are measuring healthcare utilization, and participants are reporting less utilization since the pandemic started.”
There may be delays for graduate students if they cannot finish their projects, although many universities are flexible with deadlines and allow presentation of final theses/dissertations via online platforms. Presentations of projects, graduations and commencement of new careers are delayed. Delays are inevitable when changes to projects are required.
Changes
Dr. Stefanik moved human subject research to mailed or emailed questionnaires. As other options are explored to complete current studies, every change in protocol requires Institutional Review Board (IRB) approval. Some IRBs have issued new guidelines asking researchers to establish formal plans that limit virus risk to study participants and staff, revisit data collection procedures, and submit protocol changes to the IRB for review and approval.
Funding sources may also require changes in budget, reporting, protocol and timing. Understanding the expectations of funding agencies is pivotal.
After all the time and work to complete a study, dissemination is the goal. The inability to travel to meetings to present research has affected the research of Dr. Volkmann. Adapting to other presentation platforms requires collaboration with information technology (IT) staff. Understanding IT access needs for clinical platforms, as well as research, may include changes to shared drives or shared team access.
Themes
Common themes reported by researchers during this pandemic include loss of staff, loss of data, loss of time, delays and changes. Each of these areas will have unknown impacts on current and future projects.
A constant underlying theme is the resiliency of researchers to adapt and move forward in the quest for knowledge and answers.
The authors, members of the ARP Research Subcommittee, wrote this article in collaboration with the ARP president and members of the ACR Committee on Research and ACR Early Career Investigator Subcommittee.
References
- Johns Hopkins University & Medicine. COVID-19 dashboard by the Center for Systems Science and Engineering at Johns Hopkins University. https://coronavirus.jhu.edu/map.html. 2020 May 20.
- Centers for Disease Control and Prevention. Coronavirus Disease 2019 Website. Content source: National Center for Immunization and Respiratory Diseases, Division of Viral Diseases. https://www.cdc.gov/coronavirus/2019-ncov/cases-updates/cases-in-us.html.
- Lenert L, McSwain BY. Balancing health privacy, health information exchange and research in the context of COVID-19 pandemic. J Am Med Infor Assoc. 2020 Mar. doi: 10.1093/jamia/ocaa039.
Acknowledgments
The authors thank the following ARP/ACR members for their contributions to this article: ARP President Janet Poole, PhD, OTR/L; Grant Schulert, MD, PhD, and Elizabeth Volkmann, MD, MS, from the ACR Early Career Investigator Subcommittee; and Melanie Smith, MD, PhD, from the ACR Committee on Research.
