Population Health Research Institute, McMaster University, Hamilton General Hospital Campus, 237 Barton Street East, Hamilton, ON, Canada.
Implement Sci. 2011 Aug 3;6:90. doi: 10.1186/1748-5908-6-90.
Some drugs have a narrow therapeutic range and require monitoring and dose adjustments to optimize their efficacy and safety. Computerized clinical decision support systems (CCDSSs) may improve the net benefit of these drugs. The objective of this review was to determine if CCDSSs improve processes of care or patient outcomes for therapeutic drug monitoring and dosing.
We conducted a decision-maker-researcher partnership systematic review. Studies from our previous review were included, and new studies were sought until January 2010 in MEDLINE, EMBASE, Evidence-Based Medicine Reviews, and Inspec databases. Randomized controlled trials assessing the effect of a CCDSS on process of care or patient outcomes were selected by pairs of independent reviewers. A study was considered to have a positive effect (i.e., CCDSS showed improvement) if at least 50% of the relevant study outcomes were statistically significantly positive.
Thirty-three randomized controlled trials were identified, assessing the effect of a CCDSS on management of vitamin K antagonists (14), insulin (6), theophylline/aminophylline (4), aminoglycosides (3), digoxin (2), lidocaine (1), or as part of a multifaceted approach (3). Cluster randomization was rarely used (18%) and CCDSSs were usually stand-alone systems (76%) primarily used by physicians (85%). Overall, 18 of 30 studies (60%) showed an improvement in the process of care and 4 of 19 (21%) an improvement in patient outcomes. All evaluable studies assessing insulin dosing for glycaemic control showed an improvement. In meta-analysis, CCDSSs for vitamin K antagonist dosing significantly improved time in therapeutic range.
CCDSSs have potential for improving process of care for therapeutic drug monitoring and dosing, specifically insulin and vitamin K antagonist dosing. However, studies were small and generally of modest quality, and effects on patient outcomes were uncertain, with no convincing benefit in the largest studies. At present, no firm recommendation for specific systems can be given. More potent CCDSSs need to be developed and should be evaluated by independent researchers using cluster randomization and primarily assess patient outcomes related to drug efficacy and safety.
一些药物的治疗范围较窄,需要监测和调整剂量,以优化其疗效和安全性。计算机临床决策支持系统(CCDSS)可以提高这些药物的净效益。本研究的目的是确定 CCDSS 是否可以改善治疗药物监测和剂量调整的护理过程或患者结局。
我们进行了一项决策者-研究人员伙伴关系的系统评价。我们纳入了之前综述中的研究,并在 2010 年 1 月前在 MEDLINE、EMBASE、循证医学评价数据库和 Inspec 数据库中检索新的研究。通过两位独立评审员选择评估 CCDSS 对护理过程或患者结局影响的随机对照试验。如果至少 50%的相关研究结局具有统计学显著意义,则认为研究具有阳性效应(即 CCDSS 显示改善)。
共确定了 33 项随机对照试验,评估了 CCDSS 对维生素 K 拮抗剂(14 项)、胰岛素(6 项)、茶碱/氨茶碱(4 项)、氨基糖苷类(3 项)、地高辛(2 项)、利多卡因(1 项)或多方面方法(3 项)管理的影响。很少采用整群随机化(18%),CCDSS 通常是独立的系统(76%),主要由医生使用(85%)。总体而言,30 项研究中有 18 项(60%)改善了护理过程,19 项研究中有 4 项(21%)改善了患者结局。所有评估胰岛素剂量以控制血糖的可评估研究均显示改善。荟萃分析显示,维生素 K 拮抗剂剂量的 CCDSS 显著改善了治疗范围内的时间。
CCDSS 有可能改善治疗药物监测和剂量调整的护理过程,特别是胰岛素和维生素 K 拮抗剂的剂量调整。然而,这些研究规模较小,质量通常较低,对患者结局的影响不确定,最大规模的研究中没有令人信服的益处。目前,无法针对特定系统提出确切的建议。需要开发更有效的 CCDSS,并由独立研究人员使用整群随机化进行评估,主要评估与药物疗效和安全性相关的患者结局。