Development and clinical trials of a new Software ENgine for the Assessment & Optimization of drug and non-drug Therapy in Older peRsons-猫眼课题宝

用于评估的新软件引擎的开发和临床试验

DOI：

发表时间：

2019

期刊：

影响因子：

通讯作者：

中科院分区：

文献类型：

作者：

E. Blanco;María Rosa García;R. Ocaña;Lorena Aguilar;Jennifer Valdellós;I. Bellido;Gabriel Ariza

摘要：已知，不适当的处方和相关的不良药物治疗在接触多药(同时服用多种药物)的多发病老年人中很常见。STOP/START标准旨在识别可能不适当的药物或PIM(STOP)和潜在的处方遗漏或PPO(START)的情况，构成了参议员项目的基础。在科克进行的单中心临床试验表明，停止/启动标准作为一种干预措施，显著减少了多病态老年多药联用患者的不适当处方、药物不良反应(ADR)和每月药物成本。近年来在比利时和以色列进行的使用STOP/START标准作为干预的其他试验表明，与标准药物治疗相比，不适当的药物治疗、多药联用、药物成本和多发病老年人的下降都显著减少。参议员的中心目标是设计、开发和验证一种软件引擎，该引擎包括将老年多种疾病患者的不良药物治疗降至最低的基本功能(包括停止/开始标准)。然后，将在一项涉及6个不同欧洲国家的更大规模的多中心随机对照临床试验中，与单独进行标准药学护理相比，与标准药学护理一起对Senerator软件引擎进行评估。参议员还检查了在15种常见的、患有多种疾病的老年人中常见的“顶端”情况下各种疗法的证据基础。参议员试验的第一阶段(观察性)涉及来自6个临床地点的644名患者，我们在其中测试了(I)一种基于患有多种疾病的老年人ADR常见表现的触发列表的新的ADR确定方法，以及(Ii)一种复杂的电子病例报告表，其存储单个患者数据并将其链接到大型药物文件数据库的能力。第二阶段，随机干预阶段，涉及1,537名患有急性疾病的老年患者，在授予协议之外的临床医生的护理下住院ID：305930项目网站

Executive Summary: Inappropriate prescribing and associated adverse pharmacotherapy are known to be common in multi-morbid older people exposed to polypharmacy (multiple medications at once). STOPP/START criteria designed to identify instances of potentially inappropriate medications or PIM’s (STOPP) and potential prescribing omissions or PPO’s (START) formed the basis of the SENATOR project. Single centre clinical trials carried out in Cork where STOPP/START criteria were developed prior to SENATOR indicated that STOPP/START criteria as an intervention signi cantly reduced inappropriate prescribing, adverse drug reactions (ADRs) and monthly medication costs in multi-morbid older patients with polypharmacy. Other trials carried out in Belgium and Israel in recent years using STOPP/START criteria as an intervention demonstrated signi cant reductions in inappropriate medication, polypharmacy, medication costs and falls in multi-morbid older people compared to standard pharmaceutical care. The central aim of SENATOR was to design, develop and validate a software engine that included essential features for minimizing adverse pharmacotherapy (including STOPP/START criteria) in older multi-morbid patients. The SENATOR software engine would then be evaluated in tandem with standard pharmaceutical care compared to standard pharmaceutical care alone in a larger scale multi-centre randomized controlled clinical trial involving 6 different European countries. SENATOR also examined the evidence base for the various therapies in 15 common “ONTOP” conditions commonly encountered in older multi-morbid people. Phase 1 (observational) of the SENATOR trial involved 644 patients enrolled from the 6 clinical sites in which we tested (i) a novel ADR ascertainment method based on a Trigger List of common manifestations of ADRs in older people with multi-morbidity, and (ii) a complex electronic case report form for its capacity to store and link individual patient data to a large Drug File database. Phase 2, the randomization intervention phase, involved 1537 older patients hospitalized with acute illness under the care of clinicians other than Grant agreement ID: 305930  Project website

Development and clinical trials of a new Software ENgine for the Assessment & Optimization of drug and non-drug Therapy in Older peRsons

用于评估的新软件引擎的开发和临床试验

文献摘要

被引文献

相似文献