普通人群中四种不同的严重急性呼吸综合征冠状病毒2（SARS-CoV-2）监测策略的有效性和成本效益（CoV-Surv研究）：一项采用整群抽样的双因素随机对照多臂试验的研究方案
Effectiveness and cost-effectiveness of four different strategies for SARS-CoV-2 surveillance in the general population (CoV-Surv Study): study protocol for a two-factorial randomized controlled multi-arm trial with cluster sampling.
作者信息
Deckert Andreas, Anders Simon, De Allegri Manuela, Nguyen Hoa Thi, Souares Aurélia, McMahon Shannon, Meurer Matthias, Burk Robin, Sand Matthias, Koeppel Lisa, Hein Lena Maier, Roß Tobias, Adler Tim, Siems Tobias, Brugnara Lucia, Brenner Stephan, Herbst Konrad, Kirrmaier Daniel, Duan Yuanqiang, Ovchinnikova Svetlana, Boerner Kathleen, Marx Michael, Kräusslich Hans-Georg, Knop Michael, Bärnighausen Till, Denkinger Claudia
机构信息
Heidelberg Institute of Global Health, University of Heidelberg, Im Neuenheimer Feld 324, 69120, Heidelberg, Germany.
Center for Molecular Biology Heidelberg (ZMBH), University of Heidelberg, Im Neuenheimer Feld 282, 69120, Heidelberg, Germany.
出版信息
Trials. 2021 Sep 26;22(1):656. doi: 10.1186/s13063-021-05619-5.
BACKGROUND
To achieve higher effectiveness in population-based SARS-CoV-2 surveillance and to reliably predict the course of an outbreak, screening, and monitoring of infected individuals without major symptoms (about 40% of the population) will be necessary. While current testing capacities are also used to identify such asymptomatic cases, this rather passive approach is not suitable in generating reliable population-based estimates of the prevalence of asymptomatic carriers to allow any dependable predictions on the course of the pandemic.
METHODS
This trial implements a two-factorial, randomized, controlled, multi-arm, prospective, interventional, single-blinded design with cluster sampling and four study arms, each representing a different SARS-CoV-2 testing and surveillance strategy based on individuals' self-collection of saliva samples which are then sent to and analyzed by a laboratory. The targeted sample size for the trial is 10,000 saliva samples equally allocated to the four study arms (2500 participants per arm). Strategies differ with respect to tested population groups (individuals vs. all household members) and testing approach (without vs. with pre-screening survey). The trial is complemented by an economic evaluation and qualitative assessment of user experiences. Primary outcomes include costs per completely screened person, costs per positive case, positive detection rate, and precision of positive detection rate.
DISCUSSION
Systems for active surveillance of the general population will gain more importance in the context of pandemics and related disease prevention efforts. The pandemic parameters derived from such active surveillance with routine population monitoring therefore not only enable a prospective assessment of the short-term course of a pandemic, but also a more targeted and thus more effective use of local and short-term countermeasures.
TRIAL REGISTRATION
ClinicalTrials.gov DRKS00023271 . Registered November 30, 2020, with the German Clinical Trials Register (Deutsches Register Klinischer Studien).
背景
为了在基于人群的新型冠状病毒2（SARS-CoV-2）监测中实现更高的效率，并可靠地预测疫情的发展过程，有必要对没有明显症状的感染者（约占人群的40%）进行筛查和监测。虽然目前的检测能力也用于识别此类无症状病例，但这种较为被动的方法并不适合生成基于人群的无症状携带者患病率的可靠估计值，从而无法对疫情的发展过程做出任何可靠的预测。
方法
本试验采用双因素、随机、对照、多组、前瞻性、干预性、单盲设计，采用整群抽样，有四个研究组，每个研究组代表一种基于个体自行采集唾液样本的不同SARS-CoV-2检测和监测策略，然后将样本送至实验室进行分析。该试验的目标样本量为10000份唾液样本，平均分配到四个研究组（每组2500名参与者）。策略在受试人群组（个体与所有家庭成员）和检测方法（无预筛查调查与有预筛查调查）方面有所不同。该试验还辅以经济评估和用户体验的定性评估。主要结果包括每个完全筛查者的成本、每个阳性病例的成本、阳性检出率以及阳性检出率的精确度。
讨论
在大流行和相关疾病预防工作的背景下，针对普通人群的主动监测系统将变得更加重要。因此，通过这种主动监测与常规人群监测得出的大流行参数不仅能够对大流行的短期发展过程进行前瞻性评估，还能更有针对性地、从而更有效地利用当地和短期应对措施。
试验注册
ClinicalTrials.gov DRKS00023271。于2020年11月30日在德国临床试验注册中心（Deutsches Register Klinischer Studien）注册。
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