Abstract Details

Title Strategies for Behavioral Research in Neurology: Lessons Learned During the COVID-19 Pandemic and Applications for the Future

Topic Practice, Policy, and Ethics

Presentation(s) P1 - Poster Session 1 (9:00 AM-5:00 PM)

Poster/Presentation
Number 450

Objective The study has three aims: 1) highlight challenges of clinical behavioral trials in neurology during the COVID-19 pandemic, 2) determine approaches to maximize generalizability of pandemic-era studies, and 3) offer strategies for future successful behavioral trials.

Background

Behavioral therapies are safe, effective treatments for many neurological conditions. However, over 20,000 clinical trials have been affected by the COVID-19 pandemic, with high impact on behavioral studies that require increased in-person interactions to deliver the therapeutic intervention.

Design/Methods We reviewed existing literature on clinical trials to evaluate the pandemic’s influences upon clinical behavioral studies in neurology, including study design, participant recruitment, demographics, and adherence. Using Pubmed and Google Scholar, we conducted a search of peer-reviewed articles based on the following key terms: “pandemic clinical trials,” “neurology,” “inequities,” and “adherence.” The review focused on 43 articles published from 2000 to 2021.

Results Common themes surrounding the pandemic’s impact are noted in the following statements. Social-distancing guidelines disrupted protocols for behavioral studies, given difficulty shifting from in-person to virtual settings. Traditional routes of recruitment (e.g., brochures) were hindered, whereas digital methods (e.g., social media) were popularized. Transforming trials into virtual settings resulted in the exclusion of some diverse participants without access to required digital tools. Adherence has been affected variably, with increased rates for participants with more flexible schedules versus possible decreased adherence/motivation for those with pandemic-related psychological changes (e.g., depression).

Conclusions Future clinical behavioral trials might: 1) broaden recruitment using newly popularized digital techniques, 2) improve trial access for diverse populations, 3) expand protocols to include virtual and in-person participation, 4) increase patient adherence and retention, and 5) incorporate measures to evaluate for mood- and anxiety-related comorbidities into statistical analysis. As these strategies are integrated, more research is needed to devise methods to protect clinical trials from pandemic-related or other disruptions in the future.

Authors/Disclosures
Kazi S. Maisha PRESENTER	Ms. Maisha has nothing to disclose.
Mia T. Minen, MD, FAAN (NYULMC Neurology)	The institution of Dr. Minen has received research support from NIH. Dr. Minen has received intellectual property interests from a discovery or technology relating to health care. Dr. Minen has received personal compensation in the range of $500-$4,999 for serving as a First Contact-Primary Care Advisory Board Member with American Headache Society . Dr. Minen has received personal compensation in the range of $500-$4,999 for serving as a Consultant for PCORI grant on migraine evidence based map for stakeholders with ECRI .
Ami Cuneo, MD (University of Washington)	Dr. Cuneo has nothing to disclose.

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