Table 1.
Analysis set for each outcome and definition.
Fig 1.
Eligibility assessment, covariate assessment, and follow-up windows relative to time 0 for the cohort design.
AE = adverse event; COVID-19 = coronavirus disease 2019; LTC = long-term care; SNF = skilled nursing facility. a Gaps in insurance coverage of a maximum of 31 days were permitted in MarketScan. b Pregnancy status identified in MarketScan only. c Outcome-specific washout windows were applied only to analyses of individual AEs, not to the base study cohort. d Bell’s palsy and encephalitis/encephalomyelitis. e All outcomes other than Bell’s palsy and encephalitis/encephalomyelitis. f Occurrence of the event of interest or censoring at the earliest of the following: disenrollment from the database (gaps in insurance coverage of a maximum of 31 days were permitted in MarketScan); death (available in Medicare only); end of the study period (10 December 2020); or the day before COVID-19 diagnosis in comparators for both the comparator and the individual with COVID-19 to whom they were matched. Follow-up for the cohort design was not censored at the end of the 41-day risk window as was done for the self-controlled risk interval design. Note: The cohort entry period (the time during which all Time 0 dates must occur) began on 1 April 2020, but lookback periods may have extended before 1 April 2020, as far back as 2 April 2019. Note: This figure displays the analyses with follow-up starting on the day after Time 0, and Time 0 included in the washout windows. Additional analyses were performed with follow-up beginning on Time 0, and the washout windows ending on the day before Time 0.
Fig 2.
Eligibility Assessment, Covariate Assessment, Risk Windows, and Reference Windows Relative to Time 0 for the Self-Controlled Risk Interval Design.
AE = adverse event; AED = adverse event date; COVID-19 = coronavirus disease 2019. a Gaps of up to 31 days were permitted in MarketScan. b Latest of the following: 365 days after the beginning of continuous enrollment; beginning of the study period (1 June 2020). c Earliest of the following: 41 days; disenrollment from the database (gaps in insurance coverage of a maximum of 31 days were permitted); death (available in Medicare only); end of the study period (10 December 2020). d Earliest of the following: 365 days; disenrollment from the database (gaps insurance coverage of a maximum of 31 days were permitted); death (available in Medicare only); end of the study period (10 December 2020). e Length of outcome-specific washout window varied by outcome. Note: Covariates for descriptive purposes were evaluated relative to Time 0 using the same process and assessment windows used for the cohort design. Note: The study entry period (the calendar time during which all Time 0 dates must have occurred) began on 1 June 2020. However, lookback periods may have extended before 1 June 2020. Note: This figure displays the analyses with the risk window starting on the day after Time 0. Additional analyses were performed with the risk window beginning on Time 0.
Table 2.
Characteristics of included individuals for SCRI and cohort analyses.
Table 3.
Association of a COVID-19 diagnosis with adverse events, cohort design, follow-up starting on the day after time 0.
Table 4.
Association of a COVID-19 diagnosis with adverse events, SCRI design, marketscan and medicare, follow-up starting on the day after time 0.
Fig 3.
Estimated Association of a COVID-19 Diagnosis With Neurologic or Immune-Mediated Outcomes: Analysis Starting Follow-Up on the Day After Time 0.
CI = confidence interval; HR = hazard ratio; NA = not applicable; NE = not estimable; RI = relative incidence; SCRI = self-controlled risk interval. Note: Encephalitis/encephalomyelitis was not evaluated with the SCRI design because of its known high case fatality rate.