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评估SIREN研究中的采血策略:来自英国大量医护人员队列的经验。

Evaluating blood sampling strategies within the SIREN study: the experience from a large cohort of healthcare workers in the UK.

作者信息

Hettiarachchi Nipunadi, Blick Debbie, Coleman Tom, Otter Ashley, Dunne Angela, Khawan Jameel, Linley Ezra, Cole Michelle J, Cairns Michelle, Islam Jasmin, Foulkes Sarah, Hopkins Susan, Hall Victoria, Atti Ana

机构信息

Antimicrobial Resistance and Healthcare Associated Infections Division, United Kingdom Health Security Agency (UKHSA), 10 South Colonnade, Canary Wharf, London, E14 4PU, UK.

Emerging Pathogen Serology, UK , Health Security Agency (UKHSA), Manor Farm Road, Porton, Salisbury, SP4 0 JG, UK.

出版信息

BMC Med Res Methodol. 2025 Jul 1;25(1):165. doi: 10.1186/s12874-025-02599-x.

Abstract

BACKGROUND

Delivering research studies that require a large number of samples to monitor specific populations is complex, often resulting in high costs and intricate logistics. We aim to describe the processes for blood sample collection and management and evaluate alternative sampling methods within a large cohort of healthcare workers in the UK (the SIREN study).

METHODS

We conducted a process evaluation. First, we described blood sample collection and management across different study periods from June 2020 to March 2024 and how these evolved over time. Secondly, we compared alternative methods of blood sampling: venous phlebotomy (hospital-based) vs. capillary sampling (at-home).

RESULTS

The main challenges with blood sampling within SIREN stemmed from the scale and use of decentralised phlebotomy across 135 hospital sites during the COVID-19 pandemic. We adapted our sampling processes as the study progressed, overcoming most of these challenges. When comparing hospital-based and at-home sampling, overall, return rates of samples taken at home were higher than site- based samples (80% vs 71%, respectively). At-home samples took less time to be returned to UKHSA Laboratory for testing compared to hospital-based samples (median 2 days; interquartile (IQ) 2-3) vs 6 days; IQ 3-8). However, at-home samples were more likely to be considered void (4%) when tested compared to hospital-based samples (0%). Cost for hospital-based sampling was almost 3-times higher than at-home sampling (£34.05 vs £11.50, respectively), although larger sample volumes were obtained via hospital-based sampling when compared to at-home sampling (8 ml vs 600 µl of whole blood).

CONCLUSIONS

Sample collection and management in large scale research studies are complex. Our results support at-home blood sampling as an effective and cheaper strategy when compared to hospital-based phlebotomy and therefore should be considered as alternative sampling method for future research.

TRIAL REGISTRATION NUMBER

ISRCTN11041050-registration date 12/01/2021.

摘要

背景

开展需要大量样本以监测特定人群的研究很复杂,往往会导致成本高昂且后勤工作繁琐。我们旨在描述血液样本采集和管理的流程,并评估英国一大群医护人员中的替代采样方法(SIREN研究)。

方法

我们进行了一项过程评估。首先,我们描述了2020年6月至2024年3月不同研究阶段的血液样本采集和管理情况,以及这些情况如何随时间演变。其次,我们比较了血液采样的替代方法:静脉采血(在医院)与毛细血管采样(在家中)。

结果

SIREN研究中血液采样的主要挑战源于COVID-19大流行期间在135个医院站点进行的分散式静脉采血的规模和使用情况。随着研究的推进,我们调整了采样流程,克服了大部分这些挑战。在比较医院采样和家庭采样时,总体而言,在家中采集的样本返回率高于在医院采集的样本(分别为80%和71%)。与医院采集的样本相比,在家中采集的样本返回英国卫生安全局实验室进行检测所需的时间更短(中位数为2天;四分位间距(IQ)为2 - 3天),而医院采集的样本为6天;IQ为3 - 8天)。然而,与医院采集的样本(0%)相比,在家中采集的样本在检测时更有可能被视为无效(4%)。医院采样的成本几乎是家庭采样的3倍(分别为34.05英镑和11.50英镑),尽管与家庭采样相比,通过医院采样获得的样本量更大(全血为8毫升对600微升)。

结论

大规模研究中的样本采集和管理很复杂。我们的结果支持家庭血液采样是一种比医院静脉采血更有效且更便宜的策略,因此应被视为未来研究的替代采样方法。

试验注册号

ISRCTN11041050 - 注册日期2021年1月12日。

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