Compliance monitoring

合规性监测
  • 文章类型: Journal Article
    苯二氮卓类药物经常被处方和误用,因此在许多患者人群中进行尿药筛选(UDS)。目前大多数苯二氮卓免疫测定的灵敏度都很差,特别是用于检测尿液中新型苯二氮卓类药物如劳拉西泮的代谢产物。
    我们旨在验证新的定性罗氏苯二氮卓II(BNZ2)免疫测定的临床表现,以及在两个患者人群中比较其与罗氏苯二氮卓类药物(BENZ)测定的性能:急诊科(ED)的UDS和依从性监测。
    进行了初步验证研究,选择含有氯硝西泮和劳拉西泮代谢物的样品。将BNZ2和BENZ测定的性能与作为参考方法的液相色谱-串联质谱(LC-MS/MS)进行比较。灵敏度,特异性,检测假阳性率(FPR)和假阴性率(FNR)。
    我们在最初的验证中验证了性能声明,并证明了类似的精度,阴性和阳性对照的变异系数(CV)分别为12.8%和7.7%,分别。此外,由于劳拉西泮和氯硝西泮代谢物的交叉反应性提高,我们在ED和依从性监测人群中观察到BNZ2检测的临床敏感性较高,FNR较低.尽管有这些改进,BNZ2检测无法检测到27%的LC-MS/MS阳性标本,包括没有处方的使用苯二氮卓类药物的患者的标本。
    由于其改进的性能和快速的周转时间,应在ED中对UDS实施BNZ2测定。然而,该测定不应取代LC-MS/MS测试用于合规性监测,因为未经怀疑的苯二氮卓的使用可能不会被发现。
    UNASSIGNED: Benzodiazepines are frequently prescribed and misused therefore urine drug screening (UDS) is performed in many patient populations. Most current benzodiazepine immunoassays have poor sensitivity, particularly for detecting the metabolites of newer benzodiazepines such as lorazepam in urine.
    UNASSIGNED: We aimed to verify the clinical performance of the new qualitative Roche Benzodiazepines II (BNZ2) immunoassay, as well as compare its performance to the Roche Benzodiazepines Plus (BENZ) assay in two patient populations: UDS in the emergency department (ED) and compliance monitoring.
    UNASSIGNED: An initial verification study was performed, selecting for samples containing clonazepam and lorazepam metabolites. Performance of the BNZ2 and BENZ assays was compared to liquid chromatography-tandem mass spectrometry (LC-MS/MS) as the reference method. Sensitivity, specificity, false positive rate (FPR) and false negative rate (FNR) were determined.
    UNASSIGNED: We verified the performance claims in the initial verification and demonstrated similar precision, with coefficient of variations (CVs) of 12.8% and 7.7% for negative and positive controls, respectively. Furthermore, we observed higher clinical sensitivity and lower FNR with the BNZ2 assay in both the ED and compliance monitoring populations due to improved cross-reactivity for lorazepam and clonazepam metabolites. Despite these improvements, the BNZ2 assay was unable to detect 27% of specimens positive by LC-MS/MS, including specimens from patients using benzodiazepines without prescription.
    UNASSIGNED: Due to its improved performance and rapid turnaround time, the BNZ2 assay should be implemented for UDS in the ED. However, the assay should not replace LC-MS/MS testing for compliance monitoring, as unsuspected benzodiazepine use may go undetected.
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  • 文章类型: Journal Article
    新型尼古丁和烟草产品,如电子烟(EC)加热的烟草产品或尼古丁袋已被讨论为可燃香烟和其他有毒形式的烟草产品的危害较小的替代品。它们减少危害的潜力在于从吸烟到新产品的有效过渡。已经发表了许多关于ECs停止功效的研究,结果相互矛盾。然而,一项全面的Cochrane综述对ECs的停止疗效具有高度确定性。这促使我们进行审查,以确定常见研究设计中的弱点,并总结研究设计中关于新尼古丁产品作为戒烟辅助手段的潜力的最佳实践。从Medline检索到的120篇文章被认为是合格的。该领域的大多数研究都是介入性试验,而观察性研究在戒烟评估中起着次要作用。在77%的报告中,主要对ECs的功效进行了评估,而加热烟草(17%)和不可燃产品(11%)的调查频率较低。确定疗效的措施是基于问卷的评估以及使用文件/患病率和禁欲率。研究的持续时间和样本量差异很大,中位数为3个月,参与者为156.5人,分别。在这次审查的帮助下,我们发现了常见研究设计中的几个弱点.纵向试验的一个主要限制是缺乏适用于在较长时间内验证使用状态的合规措施。完全依靠自我报告。此外,参与者戒烟的动机很少被定义,并且在大多数研究中没有考虑到深刻的熟悉期.这些弱点在多大程度上影响研究结果超出了本综述的范围。我们鼓励研究人员考虑从这次审查中得出的建议,以便以更可靠的方式确定产品的滥用责任和停止功效。最后,我们想提请注意低收入和中等收入国家缺少的数据,这些国家需要最紧急的戒烟策略来对抗吸烟流行。
    New types of nicotine and tobacco products like electronic cigarettes (ECs), heated tobacco products or nicotine pouches have been discussed as less harmful alternatives to combustible cigarettes and other toxic forms of tobacco products. Their harm reduction potential lay in the efficient transition away from smoking to those new products. Numerous studies addressing the cessation efficacy of ECs have been published with contradictory outcomes. Yet, a comprehensive Cochrane review concluded with high certainty on the cessation efficacy of ECs. This prompted us to perform a review to identify weaknesses in common study designs and to summarize best practices for the study design on the potential of new nicotine products as cessation aids. 120 articles retrieved from Medline were found to be eligible. Most of the studies in the field were interventional trials while observational studies played a minor role in the evaluation of smoking cessation. Efficacy was predominantly assessed for ECs in 77% of the reports while heated tobacco (17%) and non-combustible products (11%) were less frequently investigated up to now. Measures to determine the efficacy were questionnaire-based assessments as well as use documentation/prevalence and abstinence rates. Studies varied largely in their duration and sample size with medians of 3 months and 156.5 participants, respectively.With the help of this review, we identified several weaknesses in the common study designs. One major limitation in longitudinal trials was the lack of compliance measures suited to verify the use status over longer time periods, relying solely on self-reports. Moreover, the motivation of the participants to quit was rarely defined and a profound familiarization period was not taken into account for the majority of the studies. To what extent such weaknesses influence the outcome of the studies was beyond the scope of this review. We encourage researchers to consider the recommendations which resulted from this review in order to determine the abuse liability and cessation efficacy of the products in a more robust manner. Finally, we like to call attention to the missing data for low- and middle-income countries which would require quitting strategies most urgently to combat the tobacco smoking epidemic.
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  • 文章类型: Journal Article
    随着关于船舶压载水中水生生物排放的国际法规生效,港口州当局将需要一个抽样设备,以便合规检查员可能用于样品收集。重要的是,该设备必须易于操作,可快速连接到压载水管,可靠地收集流经管道的压载水的代表性样品。现有的取样装置目前在这些方面不足。因此,我们已经开发,制造,并验证了一种新的采样橇。这种设计可以调节流速和流速,促进同时,方便收集≥50μm的生物体和其他生物样品。在这项研究中,我们对传统净采样装置之间的采样结果进行了比较分析,使用陆基实验来评估创新采样橇的准确性和精度。研究结果表明,尽管<10μm生物体浓度存在显著差异,取样橇,作为传统网和其他防滑设备的替代品,已经证明了巨大的潜力和可行性。
    As international regulations on aquatic organism discharge in ships\' ballast water take effect, port state authorities will need a sampling device for compliance inspectors to potentially use for sample collection. Importantly, the device must be easily operable, quickly connectable to the main ballast water pipe, and reliable in collecting a representative sample of the ballast water flowing through the pipe. Existing sampling devices currently fall short in these aspects. Therefore, we\'ve developed, manufactured, and validated a new sampling skid. This design enables the regulation of flow velocity and flow rate, facilitating the simultaneous, convenient collection of organisms ≥50 μm and other biological samples. In this study, we conducted a comparative analysis of sampling outcomes between traditional net sampling devices, using land-based experiments to assess the accuracy and precision of the innovative sampling skid. The findings show that, despite significant differences in <10 μm organism concentrations, the sampling skid, as an alternative to traditional net and other skid devices, has demonstrated substantial potential and feasibility.
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  • 文章类型: Journal Article
    准确评估压载水的群落组成和生物浓度对于有效管理至关重要。然而,缺乏标准化的全球抽样方法对实现这一目标提出了挑战。不一致阻碍了地区和船只之间的数据比较,妨碍有效的压载水处理和排放调节。这项研究进行了陆基测试,以建立合适的方法。对于≥50μm和≥10μm至<50μm的生物体,推荐的最大流速为50升/分钟;对于<10μm的生物体,25L/min建议防止细胞损坏。取样应涵盖大量的排放持续时间。为了确保代表性,≥50μm的生物需要≥1m3,而≥10μm至<50μm和<10μm的生物需要20L。最终目标是评估跨区域和船舶类型的压载水的标准化方法,促进有效管理,遏制入侵物种,保护水生生态系统。
    Accurate assessment of ballast water\'s community composition and organism concentrations is crucial for effective management. Yet, the lack of standardized global sampling methods presents challenges to achieving this objective. Inconsistencies hinder data comparison across regions and vessels, impeding efficient ballast water treatment and discharge regulation. This study conducted land-based tests to establish suitable methodologies. For organisms ≥50 μm and ≥10 μm to <50 μm, the recommended max flow rate is 50 L/min; for <10 μm organisms, 25 L/min is advised to prevent cell damage. Sampling should cover substantial discharge durations. To ensure representation, ≥50 μm organisms require ≥1m3, while ≥10 μm to <50 μm and <10 μm organisms need 20 L. The ultimate aim is standardized methods for assessing ballast water across regions and vessel types, facilitating effective management to curb invasive species and protect aquatic ecosystems.
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  • 文章类型: Systematic Review
    矫形器通常用于缓解肌肉骨骼和神经系统疾病的症状;然而,由于许多原因,患者停止佩戴建议的矫形器。当考虑矫形器的有效性时,需要有一个客观的方法来监测参与者是否按照指示佩戴矫形器,因为如果不这样做,矫形器将无法按预期工作。这篇综述旨在确定,总结,并比较用于测量应用于四肢矫形器的依从性的客观方法。数据库(Scopus,WebofScience,Embase,CINAHL,和MEDLINE)搜索符合条件的研究。在最终审查中接受了23项研究,包括五项使用上肢矫形器的研究,两个使用髋关节矫形器,和十五个使用下肢矫形器的人。为了客观衡量合规性,研究利用温度传感器,压力传感器,加速度计,一个步数计数器,或传感器的组合。所有类型的传感器都有自己的优点和缺点,应根据特定于研究的参数进行选择。传感器衍生的监测提供了定量,在临床和研究环境中都有益的客观数据。监测合规性的理想解决方案将包括客观和用户报告的方面,结合起来,将提供处方矫正治疗的全方位图片。
    Orthoses are commonly prescribed to relieve symptoms for musculoskeletal and neurological conditions; however, patients stop wearing orthoses as recommended for many reasons. When considering the effectiveness of orthoses, there needs to be an objective way to monitor whether participants wear the orthosis as instructed, because if this is not followed, the orthoses will not work as intended. This review aimed to identify, summarise, and compare objective methods used to measure compliance with orthoses applied to the extremities. Databases (Scopus, Web of Science, Embase, CINAHL, and MEDLINE) were searched for eligible studies. Twenty-three studies were accepted in the final review, including five studies that employed upper limb orthoses, two that employed hip orthoses, and fifteen that employed lower limb orthoses. To measure compliance objectively, studies utilised temperature sensors, pressure sensors, accelerometers, a step counter, or a combination of sensors. All sensor types have their own advantages and disadvantages and should be chosen based on study-specific parameters. Sensor-derived monitoring provides quantitative, objective data that are beneficial in both clinical and research settings. The ideal solution to monitoring compliance would consist of both objective and user-reported aspects that, in combination, would provide an all-encompassing picture of the orthotic treatment prescribed.
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  • 文章类型: Journal Article
    UNASSIGNED: Public health experts recommend school-based policies as a population based approach to increase youth physical activity. The purpose of this case study is to describe one, largely rural, state\'s efforts to translate this recommendation into practice. Details about the genesis, implementation and evolution of two state level policies (physical education and physical activity), as well as in-house efforts of a State Department of Education to monitor policy compliance and challenges encountered are described. Two specific years are highlighted, due to policy and monitoring enhancements made during those particular time periods.
    UNASSIGNED: Data for this paper come from the West Virginia Department of Education for two time periods: 2013-2014 and 2014-2015 (n=369 elementary schools). Descriptive statistics for quantitative data and content analysis for qualitative data were used to document school level compliance and provide context for implementation challenges.
    UNASSIGNED: Greater than 70% of school principals reported achievement of physical education and physical activity policy expectations for each year. Limited staff was the predominant explanation for nonfulfillment of physical education expectations, followed by lack of time and facilities. Recess and classroom-based physical activity were the primary strategies used to comply with the physical activity expectations. PE and PA policy compliance varied significantly by certain school characteristics in each school year studied.
    UNASSIGNED: Further investigation is warranted on how states translate public health policy recommendations into practice, including how physical education and physical activity policies are developed and monitored at the state level and how to support states and schools with monitoring and implementation challenges.
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  • 文章类型: Journal Article
    Good-quality emission data are essential to validate national climate commitments and implement domestic policies. However, conventional bottom-up data collection is costly and subject to potential manipulation by stakeholders when data pass through their hands, which could pose challenges on the efficiency and effectiveness of compliance monitoring especially in developing countries. Satellite observations, specifically OCO-2 XCO2 measurements, are utilized in this study to develop a relatively independent and timely dataset for screening the attainment statuses of national and subnational CO2 mitigation goals in China\'s 13th Five-Year Plan (FYP, 2016-2020). We establish CO2 emission estimation models at both pixel and provincial levels. As interpolated with the pixel-level model, CO2 emissions of prefecture-level municipalities indicate that approximately three fifth of them had accomplished their individualized FYP mitigation goals by 2019, while our provincial-level estimation suggests that three quarters of provinces had attained theirs. More resources for compliance monitoring could thus be directed to other presumably-unattaining local governments. National aggregate absolute emissions showed 8.0-18.3% reduction in 2019 across three provincial models from the 2015 level, while national CO2 intensity dropped by 28.8-36.8% to imply attaining the 18% reduction goals.
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    文章类型: Journal Article
    Clinicians frequently order urine drug testing (UDT) for patients on chronic opioid therapy (COT), yet often have difficulty interpreting test results accurately.
    To evaluate the implementation and effectiveness of a laboratory-generated urine toxicology interpretation service for clinicians prescribing COT.
    Type II hybrid-convergent mixed methods design (implementation) and pre-post prospective cohort study with matched controls (effectiveness).
    Four ambulatory sites (2 primary care, 1 pain management, 1 palliative care) within 2 US academic medical institutions.
    Interpretative reports were generated by the clinical chemistry laboratory and were provided to UDT ordering providers via inbox message in the electronic health record (EHR). The Partners Institutional Review Board approved this study.Participants were primary care, pain management, and palliative care clinicians who ordered liquid chromatography-mass spectrometry UDT for COT patients in clinic. Intervention was a laboratory-generated interpretation service that provided an individualized interpretive report of UDT results based on the patient\'s prescribed medications and toxicology metabolites for clinicians who received the intervention (n = 8) versus matched controls (n = 18).Implementation results included focus group and survey feedback on the interpretation service\'s usability and its impact on workflow, clinical decision making, clinician-patient relationships, and interdisciplinary teamwork. Effectiveness outcomes included UDT interpretation concordance between the clinician and laboratory, documentation frequency of UDT results interpretation and communication of results to patients, and clinician prescribing behavior at follow-up.
    Among the 8 intervention clinicians (median age 58 [IQR 16.5] years; 2 women [25%]) on a Likert scale from 1 (\"strongly disagree\") to 5 (\"strongly agree\"), 7 clinicians reported at 6 months postintervention that the interpretation service was easy to use (mean 5 [standard deviation {SD}, 0]); improved results comprehension (mean 5 [SD, 0]); and helped them interpret results more accurately (mean 5 [SD, 0]), quickly (mean 4.67 [SD, 0.52]), and confidently (mean 4.83 [SD, 0.41]). Although there were no statistically significant differences in outcomes between cohorts, clinician-laboratory interpretation concordance trended toward improvement (intervention 22/32 [68.8%] to 29/33 [87.9%] vs. control 21/25 [84%] to 23/30 [76.7%], P = 0.07) among cases with documented interpretations.
    This study has a low sample size and was conducted at 2 large academic medical institutions and may not be generalizable to community settings.
    Interpretations were well received by clinicians but did not significantly improve laboratory-clinician interpretation concordance, interpretation documentation frequency, or opioid-prescribing behavior.
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  • 文章类型: Journal Article
    OBJECTIVE: Therapeutic use, misuse, abuse, and diversion of controlled substances in managing chronic non-cancer pain remain a major concern for physicians, the government, payers, and patients. The challenge remains finding effective diagnostic tools that can be clinically validated to eliminate or substantially reduce the abuse of controlled prescription drugs, while still assuring the proper treatment of those patients in pain. Urine drug testing still remains an important means of adherence monitoring, but questions arise as to its relevance and effectiveness. This review examines the role of UDT, determines its utility in current clinical practice, and investigates its relevance in current chronic pain management.
    RESULTS: A review was conducted according to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) statement. Literature was searched from year 2000 to present examining the relevance and role of UDT in monitoring chronic opioid therapy along with reliability and accuracy, appropriate use, overuse, misuse, and abuse. There are only a limited number of reviews and investigations on UDT, despite the fact that clinicians who prescribe controlled medications for chronic states commonly are expected to utilize UDT. Therefore, despite highly prevalent use, there is a limited publication base from which to draw in this present study. Regardless of experience or training background, physicians and healthcare providers can much more adequately assess opioid therapy with the aid of UDT, which often requires confirmatory testing by a laboratory for clinical and therapeutic prescribing decisions. It has become a strongly recommended aspect of pain care with controlled substances locally, regionally, and nationally. Incorporating UDT for all patients in whom chronic opioid therapy is undertaken is consistent with state and national guidelines and best practice strategies. Practice standards vary as to the frequency of UDT locally, regionally, and nationally, however.
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  • 文章类型: Journal Article
    长期有效的治疗对于控制阻塞性睡眠呼吸暂停(OSA)和预防合并症至关重要。据报道,OSA患者比气道正压通气(PAP)更容易接受口腔矫治器治疗。现在可以通过温度微传感器客观地记录口腔矫治器的使用情况。使用市售微传感器芯片的研究报告了1年的数据,高依从率(>80%),虽然是小样本。有机会进一步使用这项技术来了解个人的依从性因素和模式,并获得治疗有效性的客观指标,特别是对于长期健康结果,并允许与PAP进行比较。
    Long-term effective therapy is essential for obstructive sleep apnea (OSA) control and preventing comorbidity. OSA patients are often reported to be more receptive to oral appliance therapy over positive airway pressure (PAP). Oral appliance usage can now be objectively recorded by temperature microsensors. Studies using commercially available microsensor chips have reported data out to 1 year, with high rates of adherence (>80%), albeit in small samples. There is opportunity to further use this technology to understand individual adherence factors and patterns and in obtaining objective measures of treatment effectiveness, particularly for longer-term health outcomes and allowing comparison to PAP.
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