Assessment of the required performance and the development of corresponding program decision rules for neglected tropical diseases diagnostic tests: Monitoring and evaluation of soil-transmitted helminthiasis control programs as a case study.
Assessment of the required performance and the development of corresponding program decision rules for neglected tropical diseases diagnostic tests: Monitoring and evaluation of soil-transmitted helminthiasis control programs as a case study.
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评估被忽视的热带病诊断试验所需的绩效和制定相应的方案决策规则：以土传蠕虫病控制方案的监测和评价为例。
DOI：
10.1371/journal.pntd.0009740
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发表时间：
2021-09
影响因子：
3.8
通讯作者：
Gass KM
中科院分区：
文献类型：
--
作者：
Levecke B;Coffeng LE;Hanna C;Pullan RL;Gass KM
最近，世界卫生组织设立了诊断技术咨询小组，以确定被忽视的热带疾病的诊断需要并确定其优先次序，并最终说明新的诊断测试的最低限度和理想特征（所谓的目标产品概况）。我们开发了两个通用框架：一个是探索和确定所需的灵敏度（正确检测患病人员的概率）和特异性（正确检测无病人员的概率），另一个是基于多类别批次质量保证抽样（MC-LQAS）方法确定相应的样本量和决策规则，该方法考虑了不完美的测试。我们应用这两个框架的监测和评估土壤传播的蠕虫病控制计划。我们的研究表明，特异性，而不是灵敏度将变得更加重要，当程序接近消除的最后阶段，这两个参数的要求是负相关的，导致灵敏度和特异性的多种组合，允许可靠的决策。MC-LQAS框架强调，提高诊断性能会导致相同级别的项目决策的样本量更小。换句话说，具有改进的诊断性能的每个诊断测试的额外成本可以通过现场的较低操作成本来补偿。根据我们的研究结果，我们提出了所需的最低和理想的诊断灵敏度和特异性的诊断测试应用于监测和评价土源性蠕虫病控制方案。世界卫生组织成立了一个咨询小组，以确定被忽视的热带疾病的诊断需求并确定其优先顺序，并最终描述新诊断测试的最低和理想特征。为了支持这个咨询小组，我们开发了两个通用框架，我们将其应用于土壤传播的蠕虫病：一个用于探索和确定所需的灵敏度（正确检测患病人员的概率）和特异性（正确检测无病人员的概率），另一个用于确定相应的样本量和调查期间的决策规则。我们发现，当程序接近消除的最后阶段时，特异性而不是敏感性将变得更加重要，并且对这两个参数的要求是负相关的，从而导致敏感性和特异性的多种组合，从而可以做出可靠的决策。我们还强调，提高诊断性能会导致相同级别的程序决策的样本量更小。换句话说，具有改进的诊断性能的每个诊断测试的额外成本可以通过现场较低的操作成本来补偿。根据我们的研究结果，我们向咨询小组提出了土壤传播蠕虫病控制计划诊断测试所需的性能特征。
Recently, the World Health Organization established the Diagnostic Technical Advisory Group to identify and prioritize diagnostic needs for neglected tropical diseases, and to ultimately describe the minimal and ideal characteristics for new diagnostic tests (the so-called target product profiles (TPPs)). We developed two generic frameworks: one to explore and determine the required sensitivity (probability to correctly detect diseased persons) and specificity (probability to correctly detect persons free of disease), and another one to determine the corresponding samples sizes and the decision rules based on a multi-category lot quality assurance sampling (MC-LQAS) approach that accounts for imperfect tests. We applied both frameworks for monitoring and evaluation of soil-transmitted helminthiasis control programs. Our study indicates that specificity rather than sensitivity will become more important when the program approaches the endgame of elimination and that the requirements for both parameters are inversely correlated, resulting in multiple combinations of sensitivity and specificity that allow for reliable decision making. The MC-LQAS framework highlighted that improving diagnostic performance results in a smaller sample size for the same level of program decision making. In other words, the additional costs per diagnostic tests with improved diagnostic performance may be compensated by lower operational costs in the field. Based on our results we proposed the required minimal and ideal diagnostic sensitivity and specificity for diagnostic tests applied in monitoring and evaluating of soil-transmitted helminthiasis control programs. The World Health Organization established an advisory group to identify and prioritize diagnostic needs for neglected tropical diseases, and to ultimately describe the minimal and ideal characteristics for new diagnostic tests. To support this advisory group, we developed two generic frameworks, which we applied to soil-transmitted helminthiases: one to explore and determine the required sensitivity (probability to correctly detect a diseased person) and specificity (probability to correctly detect a person free of disease), and another one to determine the corresponding samples size and decision rules during surveys. We showed that specificity rather than sensitivity will become more important when the program approaches the endgame of elimination and that the requirements for both parameters are inversely correlated, resulting in multiple combinations of sensitivity and specificity that allow for reliable decision making. We also highlighted that improving diagnostic performance results in smaller sample sizes for the same level of program decision making. In other words, the additional costs per diagnostic tests with improved diagnostic performance can be compensated by the lower operational costs in the field. Based on our results we proposed to the advisory group the required performance characteristics of diagnostic tests for soil-transmitted helminthiasis control programs.
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影响因子：
4.6
作者：
Lagatie O;Verheyen A;Van Asten S;Odiere MR;Djuardi Y;Levecke B;Vlaminck J;Mekonnen Z;Dana D;T'Kindt R;Sandra K;van Outersterp R;Oomens J;Lin R;Dillen L;Vreeken R;Cuyckens F;Stuyver LJ
通讯作者：
Stuyver LJ
影响因子：
3.8
作者：
Levecke, Bruno;Cools, Piet;Vercruysse, Jozef
通讯作者：
Vercruysse, Jozef
DOI：
10.1186/1475-2883-2-s1-s9
发表时间：
2003-10-24
期刊：
Filaria journal
影响因子：
--
作者：
Addiss, David G;Rheingans, Richard;Richards, Frank O
通讯作者：
Richards, Frank O
影响因子：
3.8
作者：
McCarthy JS;Lustigman S;Yang GJ;Barakat RM;García HH;Sripa B;Willingham AL;Prichard RK;Basáñez MG
通讯作者：
Basáñez MG
影响因子：
3.2
作者：
Speich B;Knopp S;Mohammed KA;Khamis IS;Rinaldi L;Cringoli G;Rollinson D;Utzinger J
通讯作者：
Utzinger J