Department of General Practice, University Medical Center, Göttingen, Germany.
Department of Rheumatology and Immunology, Hannover Medical School, Hannover, Germany.
PLoS One. 2023 May 25;18(5):e0286014. doi: 10.1371/journal.pone.0286014. eCollection 2023.
BACKGROUND/AIMS: The COVID-19 pandemic situation poses new challenges for research. Ethical issues might arise if especially vulnerable individuals for severe COVID-19 course expose themselves because of participation in studies to a higher risk of infection for study purposes. How is the feasibility and acceptance of self-organized blood sample collections to measure anti-SARS-CoV-2 Spike IgG antibodies in persons with a high risk for a severe COVID-19 disease progression? METHODS: Persons with a high risk for a severe COVID-19 disease progression (immunocompromised, oncology patients or over 80 years old) were recruited between January and September 2021 to send in blood samples (at least 500 μl) 1 month and 6 months after second COVID-19 vaccination. Participants were given the choice of drawing capillary or venous blood themselves or having blood drawn by health professionals belonging to either the study's own research team or the personnel found in local practices or clinics. Participants were surveyed via a telephone interview in December 2021 and January 2022 about their choice of blood sampling methods and influence of blood collection choice upon study participation. RESULTS: Data from 360 participants was collected via telephone follow-up. First blood samples were collected by the participants themselves (35.8%), local practices or clinics (31.9%) and the research team (22.5%). Second blood samples were mostly collected in local practices or clinics (35.6%) followed by participants themselves (25.9%) and the research team (11.5%). Blood samples were not collected in 2.5% and 19.1% of persons during first and second blood draw, respectively. Only 2% of blood samples did not reach the laboratory or were not analyzable. About one-fourth (26%) of participants stated that they would not have participated in the study if it would have been required to travel to the university hospital to give their blood sample. CONCLUSIONS: Participants were able to self-organize blood collection, making use of several different blood sample methods. Nearly all blood samples were analyzable when self-collected and sent in by post. One-fourth of the participants would not have participated in the study if required to give their blood sample in the study location. TRIAL REGISTRATION: German Clinical Trial Registry, DRKS00021152.
背景/目的：新冠疫情形势给研究带来了新的挑战。如果特别易受重症 COVID-19 影响的个体因为参与研究而面临更高的感染风险，那么可能会出现伦理问题。对于那些有发生重症 COVID-19 疾病进展高风险的个体，自行组织采集血液样本以测量抗 SARS-CoV-2 刺突 IgG 抗体的可行性和接受程度如何？
方法：2021 年 1 月至 9 月期间，招募了有发生重症 COVID-19 疾病进展高风险的个体（免疫功能低下、肿瘤患者或 80 岁以上），要求他们在第二次 COVID-19 接种后 1 个月和 6 个月时自行寄送（至少 500μl）血液样本。参与者可以选择自行采集毛细血管或静脉血，也可以选择由隶属于研究团队或当地诊所或实践的医务人员采集血液。在 2021 年 12 月和 2022 年 1 月期间，通过电话访谈对参与者进行调查，了解他们对采血方法的选择以及采血方式选择对参与研究的影响。
结果：通过电话随访收集了 360 名参与者的数据。第一次血液样本由参与者本人（35.8%）、当地诊所或实践（31.9%）和研究团队（22.5%）采集。第二次血液样本主要在当地诊所或实践中采集（35.6%），其次是参与者本人（25.9%）和研究团队（11.5%）。第一次和第二次采血时，分别有 2.5%和 19.1%的人没有采集血液样本。只有 2%的血液样本未送达实验室或无法分析。大约四分之一（26%）的参与者表示，如果需要前往大学医院采集血样，他们将不会参与该研究。
结论：参与者能够自行组织采血，同时利用了多种不同的采血方法。当自行采集并通过邮寄方式送检时，几乎所有的血液样本都可进行分析。如果需要在研究地点采集血样，将有四分之一的参与者不会参与该研究。
试验注册：德国临床试验注册处，DRKS00021152。
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