ABSTRACT
Background. COVID-19 presents a serious health risk to pregnant people and pregnancy outcomes. However, pregnant people were not included in pivotal phase III COVID-19 vaccine efficacy trials. Methods. We used Cox regression models in a cohort study to determine hazard ratios (HR) of a PCR positive test ("infection") comparing vaccinated with unvaccinated pregnant persons in Kaiser Permanente Northern California. HRs were adjusted for age, race/ethnicity, type of insurance coverage, geographical area, BMI, preexisting diabetes, hypertension, parity, time since pregnancy onset and smoking status. Vaccine effectiveness (VE), calculated as 1 minus adjusted HR, was estimated for fully vaccinated < 150 and >= 150 days prior to infection. VE was estimated for before and during Delta, and Omicron. We also calculated incidence rates of COVID-pneumonia associated hospitalization by vaccination status. Results. Among 68836 pregnancies between 12/15/2020 and 3/31/2022, 21834 (31.7%) were fully vaccinated and 5980 (8.7%) were boosted by the end of pregnancy. Compared with unvaccinated persons, the HRs of infection for fully vaccinated < 150 days prior were 0.13 (95% CI: 0.07 - 0.23;VE=87% [77% - 93%]) before Delta;0.25 (CI: 0.20 - 0.30;VE=75% [70% - 80%]) during Delta and 0.76 (CI: 0.61 - 0.94;VE= 24% [16% - 39%]) during Omicron. The HRs for >= 150 days prior were 0.38 (CI: 0.31 - 0.46;VE=62 % [54% - 69%]) during Delta and 1.04 (CI: 0.89 - 1.22;VE= -0.04% [-0.22% - 0.11%]) during Omicron. The HRs for boosted persons were 0.10 (CI: 0.04 - 0.25;VE= 90% [75% - 96%]) during Delta and 0.42 (CI: 0.34 - 0.52;VE=58% [48% - 66%]) during Omicron periods. Incidence rates (IR) per 1000 person-years for hospitalization before delta were 0.75 among unvaccinated and zero among vaccinated. During Delta, the IR was 6.64 for unvaccinated and zero for fully vaccinated and boosted. During Omicron, the IR was 10.27 for unvaccinated, zero for fully vaccinated < 150 days prior, 2.48 for fully vaccinated >= 150 days prior and zero for those boosted. Conclusion. COVID-19 vaccines protect against infection and hospitalization among pregnant people. However, vaccine effectiveness against infection wanes over time and was lower during Omicron. Booster doses are necessary for continuous protection.
ABSTRACT
Background and Aims: The COVID-19 pandemic profoundly impacted clinical services globally, including colorectal cancer (CRC) testing such as fecal immunochemical test (FIT) screening and colonoscopy. We investigated the impact of the pandemic on FIT and colonoscopy utilization, and colorectal neoplasia detection in a large community-based population in the United States. Methods: We performed a retrospective cohort study of patients ages 18-89 years undergoing FIT screening or colonoscopy in 2019 and 2020 within Kaiser Permanente Northern California (KPNC), a large integrated healthcare organization. We calculated percentage changes in FIT kits mailed, FITs completed, positive FITs, colonoscopies performed overall and by indication, and colorectal neoplasia detection (advanced adenoma and CRC) in 2020 compared to 2019. Results: FIT kit mailings ceased in mid- March through April 2020 but rebounded thereafter leading to an 8.7% increase in total FIT kits mailed in 2020 compared to 2019. However, with the later mailing of FIT kits, there were 9.0% fewer FITs completed and 10.1% fewer positive tests in 2020 compared to 2019. Colonoscopy volumes nadired in April 2020, with a 79.4% reduction compared with April 2019, but recovered to near pre-pandemic monthly volumes in September through December 2020. However, overall, there was a 26.9% decline in colonoscopies performed in 2020 compared to 2019. Declines of 41.5%, 38,3%, 19.9%, and 20.0% were seen for screening, surveillance, diagnostic, and FIT positive colonoscopies, respectively, in 2020 compared to 2019. With the gradual recovery of colonoscopy volumes after the initial pandemic lockdown, by November and December 2020 the numbers of patients with advanced adenomas or CRC detected by colonoscopy were comparable to those same months in 2019. However, the total number of patients with advanced adenomas or CRC detected by colonoscopy declined by 26.9% and 8.7%, respectively, in 2020 compared to 2019. Conclusions: The COVID-19 pandemic led to fewer FIT screenings and colonoscopies performed in 2020 compared with 2019. However, after the lifting of regional lockdowns, FIT screenings exceeded, and colonoscopy volumes nearly reached numbers from those same months in 2019. Overall, the pandemic led to 27% and 9% reductions in advanced adenoma and CRC detection, respectively, in 2020 compared to 2019, validating concerns about the potential for stage progression for cancers that went undetected due to the pandemic. Strategies to identify high-risk patients for expedited colonoscopy procedure scheduling and resolve remaining colonoscopy procedure backlogs are needed to mitigate this risk.(Figure Presented)Figure 1. Number of FIT kits mailed, completed, and positive in 2019 and 2020(Figure Presented)Figure 2. Number of colonoscopies and advanced adenomas and colorectal cancers detected by colonoscopy in 2019 and 2020
ABSTRACT
BACKGROUND AND AIM: Colorectal cancer (CRC) screening reduces CRC mortality by early detection and CRC incidence by polypectomy. Kaiser Permanente Northern California (KPNC) initiated organized CRC screening in 2006 using annual mailed fecal immunochemi-cal test (FIT) screening and opportunistic colonoscopy, with high screening rates. Public health guidance related to the COVID-19 pandemic led to elective colonoscopies and mailed FIT outreach being paused in March 2020. This study evaluated the impact of the pandemic on CRC screening at KPNC. METHODS: For January-December 2019 and January-October 2020, we evaluated: the KPNC screening-eligible population aged 50-75;those up to date with screening due to colonoscopy;eligible for a FIT;mailed a FIT kit;completed a FIT;completed a follow-up colonoscopy after a positive FIT;completed a colonoscopy unrelated to a positive FIT;and up to date with screening by end of follow-up (i.e., 2019 and end of October 2020, respectively). RESULTS: There were 913,873 and 941,763 eligible members in 2019 and 2020;151,252 (16.6%) and 150,407 (16.0%) were up to date with screening due to prior colonoscopy, leaving 762,621 and 791,356 eligible for FIT, respectively. Compared to 2019, when FIT kits were mailed to 627,260 of 762,621 (82.3%) FIT-eligible members, FIT kits were mailed to 521,239 of 791,356 (65.9%) eligible members by the end of October 2020, with mailings ongoing. Declines in FIT mailings occurred in March-May 2020 but rebounded quickly thereafter (Fig 1a). FIT kits were returned by 504,152 of 762,621 (66.1%) members in 2019, and 365,972 of 791,356 (46.2%) members through October 2020, with lower returns in March-June 2020 (Fig 1b). In 2019, 11,119 of 15,402 (72.2%) FIT-positive patients received a follow-up colonoscopy by year end, and through October 2020, 6,856 of 10,922 (62.8%) received a follow-up colonoscopy after a positive FIT (Fig 1c). Another 14,420 of 762,621 (1.9%) and 9,902 of 791,356 (1.3%) members completed a colonoscopy during 2019 and 2020, respectively (Fig 2). By the end of 2019, 665,541 of 913,873 (72.8%) were up to date with screening, and through October 2020, 522,215 of 941,763 (55.5%) were up to date with screening (Fig 2). CONCLUSION: The COVID-19 pandemic resulted in temporary delays in the mailing and return of FITs;and a reduction in colonoscopies performed, due, in part, to patient reluctance to respond to FIT outreach or complete follow-up colonoscopy during the pandemic. Also, fewer individuals were up to date with screening, although outreach continues through December 2020. The organized mailed FIT program allowed for the rapid resumption of outreach;however, follow-up is needed to assess the impact of screening delays on CRC outcomes and to identify ways to improve adherence with FIT screening, including colonoscopy follow-up after a positive FIT.(Figure presented) (Figure presented) (Figure presented) (Figure presented)