• Martin Christopher Mahoney, Eunhee Park, Nicolas J Schlienz, CeCe Duerr, and Larry W Hawk.
• Roswell Park Cancer Institute, Elm & Carlton Streets, Buffalo, US.
• JMIR Form Res. 2021 Apr 13.

BackgroundThe SARS-2-coronavirus (aka covid-19) pandemic caused disruptions in ongoing clinical trials and likely accelerated interest in conducting research studies remotely.ObjectiveA quasi-experimental, mixed methods approach was utilized to examine the rates of visit completion as well as opinions and experiences of participants enrolled in an on-going clinical trial of smoking cessation who were required to change from in-person clinic visits to remote visits using video or phone conferencing due to the covid-19 pandemic.MethodsFor quantitative comparisons we used a quasi-experimental design, comparing a cohort of participants followed during the pandemic (n=23, covid-19 cohort) to a comparable cohort of participants followed over a similar time period in calendar years 2018 & 2019 (n=51, pre-covid-19 cohort), to examine rates for completion of scheduled visits and biospecimen collection. For the qualitative component, interviews were conducted with participants who experienced the transition from "in-person" to "remote visits".ResultsFor quantitative comparisons we used a quasi-experimental design, comparing a cohort of participants followed during the pandemic (n=23, covid-19 cohort) to a comparable cohort of participants followed over a similar time period in calendar years 2018 & 2019 (n=51, pre-covid-19 cohort), to examine rates for completion of scheduled visits and biospecimen collection. For the qualitative component, interviews were conducted with participants who experienced the transition from "in-person" to "remote visits".ConclusionsEven in the context of a rapid transition from in-person to remote visits necessitated by the covid-19 pandemic, rates of visit completion and return of biospecimens remained high. Participants were generally accepting of the transition. Further research is needed to identify the optimal mix of in-person and remote visits beyond the pandemic context and to better understand how these changes might impact study outcomes.ClinicaltrialClinicaltrials.gov NCT NCT03262662, https://clinicaltrials.gov/ct2/show/study/NCT03262662.

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