Tjaden Ashley H, Fette Lida M, Edelstein Sharon L, Gibbs Michael, Hinkelman Amy N, Runyon Michael, Santos Roberto P, Weintraub William S, Yukich Joshua, Uschner Diane
The Biostatistics Center, George Washington University, Rockville, MD 20852, USA.
Department of Emergency Medicine, Atrium Health, Charlotte, NC 28204, USA.
Vaccines (Basel). 2022 Jun 24;10(7):1016. doi: 10.3390/vaccines10071016.
: Observational studies of SARS-CoV-2 vaccine effectiveness depend on accurate ascertainment of vaccination receipt, date, and product type. Self-reported vaccine data may be more readily available to and less expensive for researchers than assessing medical records. : We surveyed adult participants in the COVID-19 Community Research Partnership who had an authenticated Electronic Health Record (EHR) (N = 41,484) concerning receipt of SARS-CoV-2 vaccination using a daily survey beginning in December 2020 and a supplemental survey in September-October 2021. We compared self-reported information to that available in the EHR for the following data points: vaccine brand, date of first dose, and number of doses using rates of agreement and Bland-Altman plots for visual assessment. Self-reported data was available immediately following vaccination (in the daily survey) and at a delayed interval (in a secondary supplemental survey). : For the date of first vaccine dose, self-reported "immediate" recall was within ±7 days of the date reported in the "delayed" survey for 87.9% of participants. Among the 19.6% of participants with evidence of vaccination in their EHR, 95% self-reported vaccination in one of the two surveys. Self-reported dates were within ±7 days of documented EHR vaccination for 97.6% of the "immediate" surveys and 92.0% of the "delayed" surveys. Self-reported vaccine product details matched those in the EHR for over 98% of participants for both "immediate" and "delayed" surveys. : Self-reported dates and product details for COVID-19 vaccination can be a good surrogate when medical records are unavailable in large observational studies. A secondary confirmation of dates for a subset of participants with EHR data will provide internal validity.
对严重急性呼吸综合征冠状病毒2(SARS-CoV-2)疫苗有效性的观察性研究依赖于对疫苗接种情况、日期和产品类型的准确确定。对于研究人员来说,自我报告的疫苗数据可能比评估医疗记录更容易获得且成本更低。
我们对参与COVID-19社区研究伙伴关系且拥有经过验证的电子健康记录(EHR)(N = 41484)的成年参与者进行了调查,从2020年12月开始通过每日调查以及2021年9月至10月的补充调查来了解他们接种SARS-CoV-2疫苗的情况。我们将自我报告的信息与EHR中关于以下数据点的信息进行了比较:疫苗品牌、首剂接种日期以及接种剂次数,使用一致性率和布兰德-奥特曼图进行视觉评估。自我报告的数据在接种后立即(在每日调查中)以及在延迟一段时间后(在二次补充调查中)均可获得。
对于首剂疫苗接种日期,87.9%的参与者自我报告的“即时”回忆日期在“延迟”调查中报告日期的±7天内。在其EHR中有疫苗接种证据的19.6%的参与者中,95%在两项调查中的一项中自我报告接种了疫苗。对于97.6%的“即时”调查和92.0%的“延迟”调查,自我报告的日期在EHR记录的接种日期的±7天内。对于“即时”和“延迟”调查,超过98%的参与者自我报告的疫苗产品细节与EHR中的一致。
在大型观察性研究中无法获取医疗记录时,自我报告的COVID-19疫苗接种日期和产品细节可以作为很好的替代。对有EHR数据的一部分参与者的日期进行二次确认将提供内部有效性。