Accounting for the sedative and analgesic effects of medication changes during patient participation in clinical research studies: measurement development and application to a sample of institutionalized geriatric patients.
Accounting for the sedative and analgesic effects of medication changes during patient participation in clinical research studies: measurement development and application to a sample of institutionalized geriatric patients.
复制标题
考虑患者参与临床研究期间药物变化的镇静和镇痛效果：测量开发和应用于住院老年患者样本。
DOI：
10.1016/j.cct.2007.06.004
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发表时间：
2008
影响因子：
2.2
通讯作者：
Williams,ChristiannaS
中科院分区：
文献类型：
--
作者：
Sloane,Philip;Ivey,Jena;Roth,Mary;Roederer,Mary;Williams,ChristiannaS
研究背景迄今为止，还没有任何系统允许研究者在无法控制药物使用的临床试验参与者中调整药物的总体镇静和/或镇痛效果，或药物的变化。这在行为和补充/替代疗法的临床试验以及涉及老年或慢性病患者的研究中很常见，在试验期间，他们的持续医疗护理仍在继续。本文介绍了发展，并说明了使用，我们开发的方法来解决这个问题，在其中我们产生单一的连续变量来代表每天的镇静和镇痛负荷的多种medications. METHODS药物的非药物干预的临床试验中的90名研究参与者从药物管理记录中提取了多个治疗期间。一个专家小组的三个学术临床药剂师和老年病学家会见了开发一个系统，每个研究药物可以分配一个镇静和镇痛效果rating. PROTESTThe两个措施，当应用到90个制度化的人与阿尔茨海默氏病的数据，导致变量与中度偏态分布，是一致的镇痛和镇静使用在长期护理人群的临床概况。研究参与者平均每天接受1.89种镇痛药物，每天的镇痛负荷为2.96;镇静类药物日用药量为2.07次，平均日负荷量为11.41次。创建了研究药物，根据其作用强度将药物分为不同类别，并指定评级以表达总体镇静和镇痛作用。这些变量可能有助于比较患者和人群，并在未来的研究中控制药物效应。
BACKGROUNDTo date, no system has been published that allows investigators to adjust for the overall sedative and/or analgesic effects of medications, or changes in medications, in clinical trial participants for whom medication use cannot be controlled. This is common in clinical trials of behavioral and complementary/alternative therapies, and in research involving elderly or chronically ill patients for whom ongoing medical care continues during the trial. This paper describes the development, and illustrates the use, of a method we developed to address this issue, in which we generate single continuous variables to represent the daily sedative and analgesic loads of multiple medications.METHODSMedications for 90 study participants in a clinical trial of a nonpharmacological intervention were abstracted from medication administration records across multiple treatment periods. An expert panel of three academic clinical pharmacists and a geriatrician met to develop a system by which each study medication could be assigned a sedative and analgesic effect rating.RESULTSThe two measures, when applied to data on 90 institutionalized persons with Alzheimer's disease, resulted in variables with moderately skewed distributions that are consistent with the clinical profile of analgesia and sedation use in long-term care populations. The average study participant received 1.89 analgesic medications per day and had a daily analgesic load of 2.96; the corresponding figures for sedation were 2.07 daily medications and an average daily load of 11.41.CONCLUSIONSA system of classifying the sedative and analgesic effects of non-study medications was created that divides drugs into categories based on the strength of their effects and assigns a rating to express overall sedative and analgesic effects. These variables may be useful in comparing patients and populations, and to control for drug effects in future studies.