668 Utilizing Risk Score Assessment to Maximize Sleep Research Participant Safety During the COVID-19 Pandemic

Abstract

IntroductionResearch study recruitment has been profoundly affected by the COVID-19 pandemic, demonstrated by significant delays or pauses. Various guidelines pertaining to in-person visits have applied to research. Some call for exclusion of participants that the CDC has labeled “at increased risk”.1 For obstructive sleep apnea (OSA) studies, these guidelines have caused a sharp decrease in the number of new participants. This decrease is due to high rates of OSA comorbidities including obesity and diabetes. New evidence-based risk scores have been developed using individual- and community-level factors. The use of more refined COVID-19 risk scores can help protect patient safety while allowing research to continue.MethodsThe risk score assessment used for this study (COVID-19 Mortality Risk Calculator; Johns Hopkins University, Baltimore, MD)2 is evidence-based and uses a set of risk factors and community-level pandemic dynamics in the state of residence.3,4 It was compared to the list of CDC medical conditions that are considered to put an individual “at increased risk.” Both measures were calculated retrospectively on current participants to determine how many could safely attend in-person visits based on each risk assessment method.ResultsSample characteristics of the 110 participants were: mean age: 49.5±13.7(24–76); mean BMI: 32.3±5.3(20.9–46.1); mean AHI: 24.3±21.4(5.1–110). Mortality Risk Calculator scores were: 91(82.7%) close to/lower than average [Level 1]; 12(10.9%) moderately elevated; 6(5.5%) substantially elevated; 1(0.9%) high; and 0(0%) very high [Level 5]. Using CDC guidance, 63 (57.3%) had at least one at-risk condition and 47 (42.7%) had 0. Using only Level 1 of the Risk Calculator would allow an additional 28 (25%) participants to attend in-person visits; using Levels 1 and 2 would allow an additional 40 (37%) participants.ConclusionPolicies based on CDC at-risk conditions resulted in higher levels of participant exclusion in research during the COVID-19 pandemic than use of an evidence-based Mortality Risk Calculator. This analysis shows that researchers can use risk-adjusted scores to make informed decisions about study participation that balances both participant safety and research study progress.Support (if any)This project was supported in part by Department of Veteran Affairs VA HSRD IIR 16–277, VA RRD D2651-R, and VA San Diego Healthcare System Research Service.