“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.
