Pain Management Center of Paducah, Paducah, KY, USA.
Pain Physician. 2010 Jan-Feb;13(1):E1-E22.
Therapeutic use, overuse, abuse, and diversion of controlled substances in managing chronic non-cancer pain continues to be an issue for physicians and patients. It has been stated that physicians, along with the public and federal, state, and local government; professional associations; and pharmaceutical companies all share responsibility for preventing abuse of controlled prescription drugs. The challenge is to eliminate or significantly curtail abuse of controlled prescription drugs while still assuring the proper treatment of those patients. A number of techniques, instruments, and tools have been described to monitor controlled substance use and abuse. Thus, multiple techniques and tools available for adherence monitoring include urine drug testing in conjunction with prescription monitoring programs and other screening tests. However, urine drug testing is associated with multiple methodological flaws. Multiple authors have provided conflicting results in relation to diagnostic accuracy with differing opinions about how to monitor adherence in a non-systematic fashion. Thus far, there have not been any studies systematically assessing the diagnostic accuracy of immunoassay with laboratory testing.
A diagnostic accuracy study of urine drug testing.
An interventional pain management practice, a specialty referral center, a private practice setting in the United States.
To compare the information obtained by point of care (POC) or in-office urine drug testing (index test) to the information found when all drugs and analytes are tested by liquid chromatography tandem mass spectroscopy (LC/MS/MS) reference test in the same urine sample.
The study is designed to include 1,000 patients with chronic pain receiving controlled substances. The primary outcome measure is the diagnostic accuracy. Patients will be tested for various controlled substances, including opioids, benzodiazepines, and illicit drugs. The diagnostic accuracy study is performed utilizing the Standards for Reporting of Diagnostic Accuracy Studies (STARD) initiative which established reporting guidelines for diagnostic accuracy studies to improve the quality of reporting. The prototypical flow diagram of diagnostic accuracy study as described by STARD will be utilized.
Results of diagnostic accuracy and correlation of clinical factors in relation to threshold levels, prevalence of abuse, false-positives, false-negatives, influence of other drugs, and demographic characteristics will be calculated.
The limitations include lack of availability of POC testing with lower cutoff levels.
This article presents a protocol for a diagnostic accuracy study of urine drug testing. The protocol also will permit correlation of various clinical factors in relation to threshold levels, prevalence of abuse, false-positives, false-negatives, influence of other drugs, and demographic characteristics.
NCT 01052155.
在管理慢性非癌症疼痛方面，治疗性使用、过度使用、滥用和转移管制物质仍然是医生和患者面临的问题。有人指出，医生、公众以及联邦、州和地方政府、专业协会以及制药公司都有责任防止管制处方药物的滥用。挑战在于消除或大大减少管制处方药物的滥用，同时确保适当治疗这些患者。已经描述了许多监测管制物质使用和滥用的技术、仪器和工具。因此，有多种技术和工具可用于监测药物依从性，包括与处方监测计划和其他筛选测试一起进行尿液药物测试。然而，尿液药物测试存在多个方法学缺陷。多位作者在与不同意见相关的诊断准确性方面提供了相互矛盾的结果，即如何以非系统的方式监测依从性。到目前为止，还没有任何研究系统地评估免疫测定法与实验室检测的诊断准确性。
尿液药物检测的诊断准确性研究。
美国一家介入性疼痛管理实践、专业转诊中心、私人诊所。
将通过即时检测（POC）或门诊尿液药物测试（指标测试）获得的信息与同一尿液样本中通过液相色谱串联质谱（LC/MS/MS）参考测试测试所有药物和分析物时获得的信息进行比较。
该研究计划纳入 1000 名接受管制物质的慢性疼痛患者。主要结局指标是诊断准确性。将对各种管制物质进行测试，包括阿片类药物、苯二氮䓬类药物和非法药物。诊断准确性研究利用《诊断准确性研究报告标准》（STARD）倡议进行设计，该倡议为诊断准确性研究制定了报告指南，以提高报告质量。将使用 STARD 描述的诊断准确性研究的典型流程图。
将计算诊断准确性和与阈值水平、滥用流行率、假阳性、假阴性、其他药物影响以及人口统计学特征相关的临床因素的相关性。
局限性包括缺乏具有较低截止值的即时检测。
本文介绍了尿液药物检测诊断准确性研究的方案。该方案还将允许与各种临床因素相关的阈值水平、滥用流行率、假阳性、假阴性、其他药物影响以及人口统计学特征的相关性。
NCT 01052155。
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