دورية أكاديمية
أعرض في EDS

Feasibility, acceptability, and safety of a novel device for self-collecting capillary blood samples in clinical trials in the context of the pandemic and beyond.

التفاصيل البيبلوغرافية
العنوان: Feasibility, acceptability, and safety of a novel device for self-collecting capillary blood samples in clinical trials in the context of the pandemic and beyond.
المؤلفون: Dasari H; Clinical Research and Knowledge Transfer Unit on Childhood Asthma, Centre Hospitalier Universitaire Sainte-Justine, Montreal, Quebec, Canada., Smyrnova A; Clinical Research and Knowledge Transfer Unit on Childhood Asthma, Centre Hospitalier Universitaire Sainte-Justine, Montreal, Quebec, Canada., Leng J; Clinical Research and Knowledge Transfer Unit on Childhood Asthma, Centre Hospitalier Universitaire Sainte-Justine, Montreal, Quebec, Canada., Ducharme FM; 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.; Department of Social and Preventive Medicine, School of Public Health, University of Montreal, Québec, Canada.
المصدر: PloS one [PLoS One] 2024 May 29; Vol. 19 (5), pp. e0304155. Date of Electronic Publication: 2024 May 29 (Print Publication: 2024).
نوع المنشور: Journal Article; Randomized Controlled Trial; Multicenter Study
اللغة: English
بيانات الدورية: Publisher: Public Library of Science Country of Publication: United States NLM ID: 101285081 Publication Model: eCollection Cited Medium: Internet ISSN: 1932-6203 (Electronic) Linking ISSN: 19326203 NLM ISO Abbreviation: PLoS One Subsets: MEDLINE
أسماء مطبوعة: Original Publication: San Francisco, CA : Public Library of Science
مواضيع طبية MeSH: Blood Specimen Collection*/methods , Blood Specimen Collection*/instrumentation , Blood Specimen Collection*/adverse effects, Humans ; Child ; Adult ; Male ; Female ; Adolescent ; Child, Preschool ; Middle Aged ; Cross-Sectional Studies ; COVID-19 ; Infant ; Phlebotomy/methods ; Phlebotomy/adverse effects ; Phlebotomy/instrumentation ; Feasibility Studies ; Young Adult ; Pandemics ; Capillaries ; Blood Volume
مستخلص: Background: 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.
Methods: 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.
Results: 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.
Conclusion: 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.
Competing Interests: The authors have read the journal’s policy and have the following competing interests: Francine M. Ducharme has received unrestricted research funds from AstraZeneca, Covis Pharma, GlaxoSmithKline, Merck Canada, Novartis, Teva, Trudell Medical; GlaxoSmithKline and MEDteq in partnership with Thorasys Inc., as well as honorariums for consultancy work from AstraZeneca, Covis Pharma, Sanofi, Teva, and Thorasys Inc. and honorariums as an invited speaker from Covis Pharma, Jean-Coutu Pharmacy and Brunet Pharmacy. There are no patents, products in development or marketed products associated with this research to declare. This does not alter our adherence to PLOS ONE policies on sharing data and materials.
(Copyright: © 2024 Dasari et al. This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.)
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تواريخ الأحداث: Date Created: 20240529 Date Completed: 20240529 Latest Revision: 20240718
رمز التحديث: 20240719
مُعرف محوري في PubMed: PMC11135758
DOI: 10.1371/journal.pone.0304155
PMID: 38809872
قاعدة البيانات: MEDLINE
الوصف
تدمد:1932-6203
DOI:10.1371/journal.pone.0304155