Effect of a clinical decision support system on early action on immunological treatment failure in patients with HIV in Kenya: a cluster randomised controlled trial
Effect of a clinical decision support system on early action on immunological treatment failure in patients with HIV in Kenya: a cluster randomised controlled trial
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DOI：
10.1016/s2352-3018(15)00242-8
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发表时间：
2016-02-01
期刊：
影响因子：
16.1
通讯作者：
de Keizer, Nicolette
中科院分区：
文献类型：
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作者：
Oluoch, Tom;Katana, Abraham;de Keizer, Nicolette
背景临床决策支持系统(CDSS)是将一组规则应用于存储在电子健康记录中的数据以提供可操作的建议的计算机程序。我们的目标是建立一个CDSS来支持在接受抗逆转录病毒疗法(ART)的HIV患者中检测免疫治疗失败是否会改善适当和及时的行动。方法我们在肯尼亚西部Siaya县的HIV诊所有资格接受ART的成年人和儿童(年龄=18个月)中进行了这项前瞻性、整群随机对照试验。卫生机构被随机分配(1：1)，通过区组随机化(区块大小为2)和计算机生成的随机数序列，单独使用电子健康记录(对照)或使用CDSS(干预)。设施按类型和登记参加艾滋病毒护理的患者数量进行匹配。主要的结果衡量标准是不同组之间免疫治疗失败和有记录的临床行动的患者比例的差异。我们使用具有随机效应的广义线性混合模型来分析聚集数据。这项试验在ClinicalTrials.gov注册，编号NCT0163480。发现在2012年9月1日至2014年1月31日期间，13家诊所，包括41062名患者，被随机分配到对照组(n=6)或干预组(n=7)。每个站点的数据收集花费了12个月的时间。在符合ART条件的患者中，10478名患者中有10358名(99%)在对照地点接受了ART，而在11028名患者中有10991名(99%)在干预地点接受了ART。在这些患者中，对照组有1125例(11%)和干预组有1342例(12%)免疫治疗失败，其中332例(30%)和727例(54%)得到了适当的治疗。有CDSS警报的临床医生对治疗失败采取适当措施的可能性高于没有决策支持系统的医生(调整后的优势比3.18，95%可信区间1.02-9.87)。解释CDSS显著提高了对免疫治疗失败采取适当和及时行动的可能性。我们预计，一旦各国实施2015年世卫组织关于扩大病毒载量监测的建议，我们的发现将适用于对接受抗逆转录病毒治疗的艾滋病毒患者进行病毒学监测。
Background A clinical decision support system (CDSS) is a computer program that applies a set of rules to data stored in electronic health records to off er actionable recommendations. We aimed to establish whether a CDSS that supports detection of immunological treatment failure among patients with HIV taking antiretroviral therapy (ART) would improve appropriate and timely action.Methods We did this prospective, cluster randomised controlled trial in adults and children (aged >= 18 months) who were eligible for, and receiving, ART at HIV clinics in Siaya County, western Kenya. Health facilities were randomly assigned (1: 1), via block randomisation (block size of two) with a computer-generated random number sequence, to use electronic health records either alone (control) or with CDSS (intervention). Facilities were matched by type and by number of patients enrolled in HIV care. The primary outcome measure was the difference between groups in the proportion of patients who experienced immunological treatment failure and had a documented clinical action. We used generalised linear mixed models with random effects to analyse clustered data. This trial is registered with ClinicalTrials.gov, number NCT01634802.Findings Between Sept 1, 2012, and Jan 31, 2014, 13 clinics, comprising 41 062 patients, were randomly assigned to the control group (n=6) or the intervention group (n=7). Data collection at each site took 12 months. Among patients eligible for ART, 10 358 (99%) of 10 478 patients were receiving ART at control sites and 10 991 (99%) of 11 028 patients were receiving ART at intervention sites. Of these patients, 1125 (11%) in the control group and 1342 (12%) in the intervention group had immunological treatment failure, of whom 332 (30%) and 727 (54%), respectively, received appropriate action. The likelihood of clinicians taking appropriate action on treatment failure was higher with CDSS alerts than with no decision support system (adjusted odds ratio 3.18, 95% CI 1.02-9.87).Interpretation CDSS significantly improved the likelihood of appropriate and timely action on immunological treatment failure. We expect our findings will be generalisable to virological monitoring of patients with HIV receiving ART once countries implement the 2015 WHO recommendation to scale up viral load monitoring.