Nipunadi Hettiarachchi, Debbie Blick, Tom Coleman, Ashley Otter, Angela Dunne, Jameel Khawan, Ezra Linley, Michelle J Cole, Michelle Cairns, Jasmin Islam, Sarah Foulkes, Susan Hopkins, Victoria Hall, Ana Atti
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Secondly, we compared alternative methods of blood sampling: venous phlebotomy (hospital-based) vs. capillary sampling (at-home).</p><p><strong>Results: </strong>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%). 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引用次数: 0
摘要
背景：提供需要大量样本来监测特定人群的研究是复杂的，往往导致高成本和复杂的物流。我们的目的是描述血液样本收集和管理的过程，并在英国一大批卫生保健工作者中评估替代采样方法（SIREN研究）。方法：进行工艺评价。首先，我们描述了从2020年6月到2024年3月不同研究期间的血液样本收集和管理，以及这些样本如何随着时间的推移而演变。其次，我们比较了不同的血液采样方法：静脉静脉切开术（医院为基础）和毛细血管采样（家庭）。结果：在2019冠状病毒病大流行期间，135家医院分散采血的规模和使用导致了SIREN内血液采样的主要挑战。随着研究的进展，我们调整了采样过程，克服了大多数这些挑战。在比较医院和家庭抽样时，总体而言，在家取样的回收率高于现场取样（分别为80%和71%）。与医院样品相比，家庭样品返回UKHSA实验室进行检测所需的时间更短(中位数为2天；四分位数（IQ） 2-3 vs 6天；智商3 - 8)。然而，与医院样品（0%）相比，在测试时，家庭样品更有可能被认为是无效的（4%）。医院取样的成本几乎是家庭取样的3倍（分别为34.05英镑和11.50英镑），尽管与家庭取样相比，通过医院取样获得的样本量更大（8毫升对600微升全血）。结论：在大规模研究中样本采集和管理是复杂的。我们的研究结果表明，与医院的静脉切开术相比，在家采血是一种有效且更便宜的策略，因此应考虑将其作为未来研究的替代采血方法。试验注册号：isrctn11041050 -注册日期12/01/2021。
Evaluating blood sampling strategies within the SIREN study: the experience from a large cohort of healthcare workers in the UK.
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.
期刊介绍：
BMC Medical Research Methodology is an open access journal publishing original peer-reviewed research articles in methodological approaches to healthcare research. Articles on the methodology of epidemiological research, clinical trials and meta-analysis/systematic review are particularly encouraged, as are empirical studies of the associations between choice of methodology and study outcomes. BMC Medical Research Methodology does not aim to publish articles describing scientific methods or techniques: these should be directed to the BMC journal covering the relevant biomedical subject area.
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