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为高危产科患者提供现场 COVID-19 疫苗接种:初步发现。

Offering onsite COVID-19 vaccination to high-risk obstetrical patients: initial findings.

机构信息

Department of Obstetrics and Gynecology, Washington University School of Medicine in St. Louis, 660 S. Euclid Ave., St. Louis, MO 63110.

Department of Obstetrics and Gynecology, Washington University School of Medicine in St. Louis, 660 S. Euclid Ave., St. Louis, MO 63110.

出版信息

Am J Obstet Gynecol MFM. 2021 Nov;3(6):100478. doi: 10.1016/j.ajogmf.2021.100478. Epub 2021 Sep 2.

Abstract

OBJECTIVE

The COVID-19 pandemic has had a disproportionate effect on pregnant women, with higher rates of viral infection and disease severity. The development of highly effective vaccines has significantly reduced SARS-CoV-2 transmission and clinical disease. However, vaccine uptake has been low in the pregnant population. The Centers for Disease Control and Prevention guidance suggests that limited vaccine access, not vaccine hesitancy, has driven the lower uptake rates in at-risk populations. We describe our experience with vaccination uptake rates among high-risk obstetrical patients before and after onsite BNT162b2 messenger RNA vaccination availability in outpatient clinics as part of a pilot program to improve vaccine access among pregnant patients.

STUDY DESIGN

This was a quality improvement project at a single academic medical center. Onsite vaccination was available once a week at 2 high-risk obstetrical clinics staffed by obstetrical residents, maternal-fetal medicine (MFM) fellows, and MFM attendings were selected for our vaccine pilot program. Onsite vaccinations were immediately available for use in the clinic starting May 11, 2021. Data were collected over a 4-week period (April 27, 2021, to May 20, 2021), which included 4 clinic days before onsite vaccine availability (April 27, 2021 to May 10, 2021) and 4 days with onsite vaccine availability (May 11, 2021, to May 20, 2021). Patients were considered exposed to onsite vaccination if they had any clinic visits during the latter 2 weeks of the study period. All patients were counseled by providers at each visit using our institution's standardized COVID-19 vaccination discussion tool designed for pregnant and breastfeeding patients. Counseling was documented in each patient's chart per the American College of Obstetricians and Gynecologists. Before and throughout the study period, pregnancy was listed as a qualifying condition for priority vaccination in Missouri and Illinois. At this time, vaccinations were readily available in the local area surrounding our clinical space. Data on vaccine administration were collected via the Missouri and Illinois state databases over a period of 1 month after the pilot program was closed, allowing for the collection of data on patients who pursued vaccination offsite for scheduling or personal reasons. This project was deemed exempt by the Office for Human Research Protections.

RESULTS

We reviewed data from 124 clinic visits, where a total of 93 individual patients were seen in the 4-week period; 6 had previously been vaccinated at external sites and the remaining 87 were eligible (Figure). The majority of our patient population was non-Hispanic Black women with public or no insurance (Table). Of the 32 eligible patients seen and counseled before onsite vaccination availability, 1 (3%) proceeded to receive the vaccination offsite. Of the 55 eligible patients seen and counseled after onsite vaccination availability, 2 (3%) proceeded with onsite vaccination and an additional 4 (7%) proceeded with vaccination offsite. Onsite vaccination availability did not significantly increase the vaccination rates (3% vs 11%; P=.22). Of the 55 eligible patients counseled during onsite vaccination availability, 25 were seen and counseled exclusively during the onsite vaccination pilot period and none of these patients accepted onsite vaccination or pursued vaccination offsite.

CONCLUSION

Because only 3% of eligible, high-risk obstetrical patients proceeded with onsite vaccination, our experience suggests that vaccine hesitancy, not availability, is a critical driver of the low vaccination rates in this population. Although a larger sample size may have demonstrated statistical difference, the overall low vaccination uptake rate forced the closure of our pilot program over concerns for wasted vaccination doses. In a population at high risk for progression to severe COVID-19, only 14% of our study population was vaccinated, whereas Missouri reported a 41% vaccination rate during this time. These findings suggest that increased access alone may not improve vaccination rates in obstetrical patients even after counseling by expert clinicians. These findings are limited by the pre/post nature of the comparison, exposing the sample to bias as vaccination recommendations and population sentiment was rapidly evolving during this time period. However, the consistency of counseling and patient population provided by a single clinical setting limited other sources of bias during the study period. Vaccine hesitancy is multifactorial and complex and urgently requires more evaluation in this high-risk population. Vaccine hesitancy in pregnancy is well documented, but early reports suggest that the COVID-19 vaccination uptake rate is markedly lower than that of other vaccines during pregnancy. Our finding that none of the women who were seen exclusively during the onsite vaccination period accepted vaccination may suggest that repeat clinic visits and the associated establishment of rapport and trust is a vital part of vaccine decision making. Earlier intervention, before patient views on novel therapeutics such as vaccinations can be formulated and fixed, may aid in uptake. Further qualitative work and inclusion of pregnant women in vaccine trials is an initial step.

摘要

目的

新冠疫情对孕妇产生了不成比例的影响,导致更高的病毒感染率和疾病严重程度。高效疫苗的开发显著降低了 SARS-CoV-2 的传播和临床疾病。然而,孕妇群体的疫苗接种率较低。美国疾病控制与预防中心的指导意见表明,在高风险人群中,疫苗接种率较低的原因不是疫苗犹豫,而是疫苗可及性有限。我们描述了在门诊诊所提供 BNT162b2 信使 RNA 疫苗作为提高孕妇疫苗接种率的试点项目之前和之后,高危产科患者的疫苗接种率。

研究设计

这是一家学术医疗中心的质量改进项目。高危产科诊所每周提供一次现场疫苗接种服务,由产科住院医师、母胎医学(MFM)研究员和 MFM 主治医生负责。我们的疫苗试点项目选择了这些医生。从 2021 年 5 月 11 日开始,现场接种疫苗立即在诊所使用。数据收集在 4 周内进行(2021 年 4 月 27 日至 5 月 20 日),包括现场疫苗接种前的 4 个诊所日(2021 年 4 月 27 日至 5 月 10 日)和 4 个有现场疫苗接种的日子(2021 年 5 月 11 日至 5 月 20 日)。如果患者在研究期间的最后 2 周内有任何诊所就诊,则认为他们接触过现场疫苗接种。每位患者在每次就诊时都由提供者使用我们机构为孕妇和哺乳期患者设计的标准化 COVID-19 疫苗讨论工具进行咨询。根据美国妇产科医师学会的规定,咨询情况记录在每位患者的病历中。在此之前和整个研究期间,密苏里州和伊利诺伊州都将怀孕列为优先接种疫苗的条件。此时,我们的临床区域周围有充足的疫苗供应。在试点项目结束后的一个月内,通过密苏里州和伊利诺伊州的州数据库收集疫苗接种数据,以便收集因预约或个人原因选择在非现场接种疫苗的患者的数据。该项目被 Office for Human Research Protections 认定为豁免。

结果

我们审查了 124 次就诊的数据,在这 4 周内共对 93 名个体患者进行了就诊;其中 6 名患者之前在外部地点接种过疫苗,其余 87 名患者符合条件(图)。我们的患者群体主要是非西班牙裔黑人女性,她们的保险情况为公共保险或无保险(表)。在现场疫苗接种前可获得性之前,有 32 名符合条件的患者接受了咨询,其中 1 名(3%)选择在非现场接种疫苗。在现场疫苗接种后可获得性之后,有 55 名符合条件的患者接受了咨询,其中 2 名(3%)选择在现场接种疫苗,另有 4 名(7%)选择在非现场接种疫苗。现场疫苗接种的可获得性并没有显著提高疫苗接种率(3% 对 11%;P=.22)。在现场疫苗接种可获得性期间接受咨询的 55 名符合条件的患者中,有 25 名仅在现场疫苗接种试点期间接受了咨询,但这些患者均未接受现场接种或选择在非现场接种疫苗。

结论

由于只有 3%的高危产科患者符合条件并接受了现场接种,我们的经验表明,疫苗犹豫而不是疫苗可及性是导致该人群疫苗接种率低的关键因素。尽管更大的样本量可能显示出统计学差异,但总体低疫苗接种率使得我们不得不担心浪费疫苗剂量,因此提前关闭了我们的试点项目。在 COVID-19 进展为重症的高风险人群中,我们的研究人群中只有 14%的人接种了疫苗,而密苏里州在这段时间的接种率为 41%。这些发现表明,即使由专家临床医生进行咨询,增加疫苗的可及性可能也不会提高产科患者的疫苗接种率。这些发现受到了比较的前后性质的限制,因为在疫苗接种建议和人群观念在此期间迅速演变的情况下,该样本存在偏见。然而,由于在研究期间,单一临床环境提供了一致的咨询和患者群体,因此其他来源的偏倚受到了限制。疫苗犹豫是多因素的,而且很复杂,迫切需要在高危人群中进行更多的评估。在怀孕期间对疫苗犹豫不决的情况已有相关记录,但早期报告表明,COVID-19 疫苗接种率明显低于怀孕期间的其他疫苗。我们发现,在现场疫苗接种期间仅接受咨询的女性中没有一人接受疫苗接种,这可能表明,重复的诊所就诊以及随之而来的建立联系和信任,是疫苗决策的重要组成部分。在患者对新型治疗方法(如疫苗)的看法形成之前尽早进行干预,可能有助于提高疫苗接种率。进一步的定性研究和包括孕妇在内的疫苗试验是一个初步步骤。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/6c5a/8411583/99da08085039/gr1_lrg.jpg

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