呼吸标本采集试验（ReSpeCT）：一项随机对照试验，比较 2 岁以下儿童家长和医护人员在家中采集呼吸道样本的质量和及时性。
The Respiratory Specimen Collection Trial (ReSpeCT): A Randomized Controlled Trial to Compare Quality and Timeliness of Respiratory Sample Collection in the Home by Parents and Healthcare Workers From Children Aged <2 Years.
机构信息
Centre of Rehabilitation Research, University of Potsdam, Germany.
PhD Programme, Epidemiology, Braunschweig-Hannover, Germany.
出版信息
J Pediatric Infect Dis Soc. 2020 Apr 30;9(2):134-141. doi: 10.1093/jpids/piy136.
BACKGROUND
Most acute respiratory infection (ARI) research focuses on severe disease and overlooks the burden of community-managed illness. For community-based studies, home-based specimen collection by parents could be a resource-saving alternative to collection by healthcare workers (HCWs). In this study, we compared parent and HCW groups for their likelihood to collect specimens and the timeliness and quality of such collection.
METHODS
In this unblinded randomized controlled trial, parents from Brisbane, Australia, were taught to identify new ARI episodes in their children aged <2 years. When their child had a new ARI, parents either collected a nasal swab from the child (P group) or contacted an HCW who visited to obtain a nasopharyngeal swab (HCW group). We compared the likelihood and timeliness of specimen collection and respiratory pathogen detection. A nested diagnostic study compared paired specimen collections from children in the HCW group.
RESULTS
Included were 76 incident ARI episodes from 31 children and 102 episodes from 33 children in the P and HCW groups, respectively. The proportions of ARIs for which a specimen was collected were similar (P group, 69.7%; HCW group, 72.5%; P = .77), and pathogens were detected in 93.8% and 77.5% of the specimens, respectively (P = .03). The period between ARI onset and specimen collection was shorter in the P group than in the HCW group (mean difference, 1.9 days [95% confidence interval, 0.7-3.0 days]; P < .001). For the 69 paired specimens, viral loads were lower in the parent-collected swabs (mean cycle threshold difference, 4.5 [95% confidence interval, 3.1-5.9]; P < .001).
CONCLUSIONS
Parents and HCWs obtained samples in similar proportions of ARI episodes, but the parents collected the samples fewer days after ARI onset and with a resulting higher likelihood of pathogen identification. This method can be used in population-based epidemiological studies of ARI as a resource-saving alternative.
TRIAL REGISTRATION
ClinicalTrials.gov identifier NCT00966069.
背景
大多数急性呼吸道感染（ARI）研究都集中在严重疾病上，而忽略了社区管理疾病的负担。对于基于社区的研究，家长在家中为孩子采集样本可能是一种节省资源的替代方法，而不是由医护人员（HCWs）采集。在这项研究中，我们比较了家长组和 HCW 组采集样本的可能性，以及采集的及时性和质量。
方法
在这项非盲随机对照试验中，来自澳大利亚布里斯班的家长被教导识别他们 2 岁以下孩子的新 ARI 发作。当孩子出现新的 ARI 时，家长要么从孩子身上采集鼻腔拭子（P 组），要么联系 HCW，让 HCW 上门采集鼻咽拭子（HCW 组）。我们比较了标本采集的可能性和及时性，以及呼吸道病原体的检测情况。一项嵌套诊断研究比较了 HCW 组中儿童的配对标本采集。
结果
共纳入 76 例由 31 名儿童和 102 例由 33 名儿童发生的新 ARI 发作。采集标本的 ARI 比例相似（P 组为 69.7%，HCW 组为 72.5%，P=.77），分别有 93.8%和 77.5%的标本检测到病原体（P=.03）。P 组从 ARI 发病到采集标本的时间间隔短于 HCW 组（平均差异为 1.9 天[95%置信区间为 0.7-3.0 天]；P<.001）。对于 69 对配对标本，家长采集的拭子中病毒载量较低（平均循环阈值差异为 4.5[95%置信区间为 3.1-5.9]；P<.001）。
结论
家长和 HCWs 采集 ARI 样本的比例相似，但家长在 ARI 发病后更早地采集样本，因此更有可能识别病原体。这种方法可以作为一种节省资源的替代方法，用于基于人群的 ARI 流行病学研究。
试验注册
ClinicalTrials.gov 标识符 NCT00966069。
Zotero 插件