FAST Labs, BAE Systems Inc., Merrimack, NH, United States of America.
PLoS One. 2024 Jan 19;19(1):e0297189. doi: 10.1371/journal.pone.0297189. eCollection 2024.
Determining causality of an adverse drug reaction (ADR) requires a multifactor assessment. The classic Naranjo algorithm is still the dominant assessment tool used to determine causality. But, in spite of its effectiveness, the Naranjo algorithm is manually intensive and impractical for assessing very many ADRs and drug combinations. Thus, over the years, many "automated" algorithms have been developed in an attempt to determine causality. By-and-large, these algorithms are either regression-based or Bayesian. In general, the automatic algorithms have several major drawbacks that preclude fully automated causality assessment. Therefore, signal detection (or causality screening) plays a role in a "first pass" of large ADR databases to limit the number of ADR/drug combinations a skilled human further assesses. In this work a Bayesian signal detector based on analytic combinatorics is developed from a point of view commonly adopted by engineers in the field of radar and sonar signal processing. The algorithm developed herein addresses the commonly encountered issues of misreported data and unreported data. In the framework of signal processing, misreported ADRs are identified as "clutter" (unwanted data) and unreported ADRs are identified as "missed detections". Including the aforementioned parameters provides a more complete probabilistic description of ADR data.
确定药物不良反应(ADR)的因果关系需要进行多因素评估。经典的 Naranjo 算法仍然是用于确定因果关系的主要评估工具。但是,尽管 Naranjo 算法有效,但它需要大量的人工操作,对于评估大量的 ADR 和药物组合来说并不实用。因此,多年来,已经开发了许多“自动化”算法来确定因果关系。总的来说,这些算法要么基于回归,要么基于贝叶斯。通常情况下,这些自动算法有几个主要的缺点,使其无法进行完全自动化的因果关系评估。因此,信号检测(或因果关系筛选)在大型 ADR 数据库的“首次筛选”中起着作用,可以限制需要由熟练的人员进一步评估的 ADR/药物组合的数量。在这项工作中,基于解析组合学的贝叶斯信号检测器是从雷达和声纳信号处理领域工程师常用的角度开发的。本文开发的算法解决了常见的误报数据和未报数据问题。在信号处理框架中,误报的 ADR 被识别为“杂波”(不需要的数据),未报的 ADR 被识别为“漏检”。包含上述参数可以更完整地描述 ADR 数据的概率。