Clinical Research and Knowledge Transfer Unit on Childhood Asthma, Centre Hospitalier Universitaire Sainte-Justine, Montreal, Quebec, Canada.
Department of Pediatrics, University of Montréal, Quebec, Canada.
PLoS One. 2024 May 29;19(5):e0304155. doi: 10.1371/journal.pone.0304155. eCollection 2024.
Home blood self-collection devices can enable remote monitoring, but their implementation requires validation. Our objectives were to explore (i) the impact of sampling sites and topical analgesia on capillary blood volume and pain perception and (ii) the safety, acceptability, and failure of capillary self-collection among adults and children using the Tasso-SST device.
We conducted a two-phase study. The investigational phase consisted of two on-site cross-sectional studies in healthy adult participants (≥ 12 years) and children (1-17 years) with their accompanying parent. Adults received 4 capillary samplings, where puncture sites and topical analgesia were randomized in a factorial design, and a venipuncture; children (and one parent) had one capillary sampling. The two co-primary outcomes were blood volume and pain. The implementation phase was conducted in two multicentre trials in participants choosing remote visits; blood volume, collection failure, adverse events, and satisfaction were documented.
In the investigational phase, 90 participants and 9 children with 7 parents were enrolled; 15 adults and 2 preschoolers participated in the implementation phase. In the adult investigational study, the device collected a median (25%, 75%) of 450 (250, 550) μl of blood with no significant difference between the puncture site, topical analgesia, and its interaction. Using topical analgesia reduced pain perception by 0.61 (95% CI: 0.97, 0.24; P <0.01) points on the 11-point scale; the pain reduction varied by puncture site, with the lower back showing the most significant decrease. Overall, combining all studies and phases, the median volume collected was 425 (250, 500) μl, and the device failure rate was 4.4%; minor adverse effects were reported in 8.9% of the participants, all were willing to use the device again.
Capillary blood self-collection, yielding slightly less than 500 μl, proves to be a safe and relatively painless method for adults and children, with high satisfaction and low failure rates. The puncture site and topical analgesia do not affect blood volume, but topical analgesia on the lower back could reduce pain.
家庭自采血设备可以实现远程监测，但需要对其进行验证。我们的目标是探索：（i）采样部位和局部镇痛对毛细血管血量和疼痛感知的影响；（ii）使用 Tasso-SST 设备时，成年人和儿童的安全性、可接受性和毛细血管自采血的失败率。
我们进行了一项两阶段研究。在研究阶段，我们对健康的成年参与者（≥12 岁）和儿童（1-17 岁）及其陪同的父母进行了两项现场横断面研究。成年参与者接受了 4 次毛细血管采血，穿刺部位和局部镇痛采用析因设计，同时还进行了一次静脉采血；儿童（和一位家长）接受了 1 次毛细血管采血。两个主要结局指标是血量和疼痛。实施阶段在选择远程就诊的参与者中进行了两项多中心试验，记录了血量、采集失败、不良事件和满意度。
在研究阶段，共纳入了 90 名参与者和 9 名儿童及其 7 位家长；有 15 名成年参与者和 2 名学龄前儿童参加了实施阶段。在成年参与者的研究中，该设备采集了 450（250，550）μl 的血液，中位数（25%，75%），穿刺部位、局部镇痛及其相互作用之间无显著差异。使用局部镇痛可使 11 分制疼痛评分降低 0.61（95%CI：0.97，0.24；P<0.01）分；疼痛减轻程度因穿刺部位而异，下背部的疼痛减轻最明显。总体而言，在所有研究和阶段中，采集的血量中位数为 425（250，500）μl，设备失败率为 4.4%；8.9%的参与者报告了轻微的不良反应，所有人都愿意再次使用该设备。
毛细血管自采血采集的血量略少于 500μl，对于成年人和儿童来说是一种安全且相对无痛的方法，满意度高，失败率低。穿刺部位和局部镇痛不会影响血量，但在下背部使用局部镇痛可以减轻疼痛。
