Difference between revisions of "Journal:A web application to support the coordination of reflexive, interpretative toxicology testing"
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==Background== | ==Background== | ||
Urine drug monitoring is an increasingly important tool for primary care physicians (PCPs) and pain specialists to monitor patients on chronic opioid therapy. [1] Routine and random monitoring for all patients on long-term opioid therapy is recommended prior to starting and throughout drug therapy. [2] There are various analytical methods and matrices available for patient monitoring. Urine [[Drug test|drug testing]] (UDT) has become the “gold-standard” for detecting illicit drug use and monitoring ongoing therapy. Urine is non-invasive, readily available, and contains higher concentrations of drugs and metabolites compared with other matrices. [[Immunoassay]] testing, commonly referred to as urine drug screening, detects the presence of selected drugs and/or metabolites based on a detection threshold. Typically, the immunoassay functions as the initial evaluation for the potential detection of drugs, but because it lacks specificity for analytes of the same drug class, it can lead to false-positive and -negative results. Therefore, drug screens are often coupled with a confirmatory detection method for more specific testing. [[Chromatography]] is generally reserved for confirmatory or definitive testing following immunoassay screening. Historically, [[gas chromatography–mass spectrometry]] (GC–MS) was the standard for confirmatory testing. However, [[Liquid chromatography–mass spectrometry]]–[[tandem mass spectrometry]] (LC-MS/MS) has gained favor over GC-MS due to reduced complexity of [[Sample (material)|sample]] preparation methods and the broader applicability of LC-MS/MS to different drug classes. [3, 4] | |||
Many [[Laboratory|laboratories]] are equipped to support UDT. [1,3,4,8,9] A major challenge of staged drug testing (i.e., screening and confirmatory assays) is the review and interpretation of the large number of quantitative and qualitative results that is generated by screening and confirmatory methods. [5,6,7] Pharmacokinetic mechanisms dictate how quickly and how much of a drug and its metabolites appear in an individual's urine, which can be challenging for physicians who have limited understanding due to reviewing a limited number of these results. [5] An incorrect interpretation of the LC-MS/MS results could mistakenly suggest that a patient used a non-prescribed medication. Additionally, the potential for [[analyte]]s to co-elute could affect the signal of the analytes, influencing the overall accuracy of the LC-MS/MS test. [4] | |||
Yang ''et al.'' [9] described that adding interpretative comments from a trained laboratory director to urine drug screening results can greatly impact both the clinician and patient. Clinicians may not understand the analytical method limitations, and any resulting misinterpretation of the results may lead to a patient's stigmatization or inappropriate termination from care. The authors further reported an increase in urine drug screen orders with interpretive comments, indicating that clinicians value the interpretation made by a trained director. Because accurate interpretation of results often requires the integration of documented clinical information, medication data, test results, pharmacokinetics, and test limitations and interferences, assigning a trained [[Pathology|pathologist]] or [[Clinical chemistry|clinical chemist]] who is familiar with interpreting clinical [[information]], as well as the biochemistry and testing methods to provide an interpretation of the results, is a valuable tool in ensuring the correct diagnosis for patients. | |||
One challenge laboratories and laboratory directors face with UDT is that there may be results from several tests that inform whether additional testing is required and need to be integrated to provide an interpretation given the specific clinical context. Within the Department of Laboratory Medicine and Pathology at University of Washington Medicine (UW Medicine), we have formulated a urine drug testing ordering protocol and interpretation workflow. Clinicians may select from a menu of panels that are based on the assessed patient's risk of treatment non-compliance. Panels include an [[immunoassay]] drug screen and confirmation LC-MS/MS assays for opioids, amphetamines, benzodiazepines, and alcohol. For example, a low-risk patient panel consists of an immunoassay drug screen, and aberrant or unexpected results can lead the reviewing pathologist to order one or more of the confirmation tests. On top of the interpretation challenges, turnaround times (TAT) for the different tests are unevenly distributed. Most [[laboratory information system]]s (LISs) are not equipped to track, collect, and display the different results in an effective and informative manner to support this workflow. | |||
The aim of this project was to design and implement a web-based software application that centralizes test results for pathologist review, performs the [[quality control]] (QC) calculations for the complex LC-MS/MS analysis of opioids and their metabolites, functions as a user input form for pathologist interpretation entry, and auto-files results into the LIS. | |||
==Methods== | |||
Revision as of 17:28, 13 June 2023
| Full article title | A web application to support the coordination of reflexive, interpretative toxicology testing |
|---|---|
| Journal | Journal of Pathology Informatics |
| Author(s) | Pablo, Abed; Laha, Thomas J.; Breit, Nathan; Hoffman, Noah G.; Hoofnagle, Andrew N.; Baird, Geoffrey S.; Mathias, Patrick C. |
| Author affiliation(s) | University of Washington School of Medicine |
| Primary contact | Email: pcm10 at uw dot edu |
| Year published | 2023 |
| Volume and issue | 14 |
| Article # | 100303 |
| DOI | 10.1016/j.jpi.2023.100303 |
| ISSN | 2153-3539 |
| Distribution license | Creative Commons Attribution 4.0 International |
| Website | https://www.sciencedirect.com/science/article/pii/S2153353923001177 |
| Download | https://www.sciencedirect.com/science/article/pii/S2153353923001177/pdfft (PDF) |
 |
This article should be considered a work in progress and incomplete. Consider this article incomplete until this notice is removed. |
Abstract
Background: Reflexive laboratory testing workflows can improve the assessment of patients receiving pain medications chronically, but complex workflows requiring pathologist input and interpretation may not be well-supported by traditional laboratory information systems (LISs). In this work, we describe the development of a web application that improves the efficiency of pathologists and laboratory staff in delivering actionable toxicology results.
Method: Before designing the application, we set out to understand the entire workflow, including the laboratory workflow and pathologist review. Additionally, we gathered requirements and specifications from stakeholders. Finally, to assess the performance of the implementation of the application, we surveyed stakeholders and documented the approximate amount of time that is required in each step of the workflow.
Results: A web-based application was chosen for the ease of access for users. Relevant clinical data was routinely received and displayed in the application. The workflows in the laboratory and during the interpretation process served as the basis of the user interface (UI). With the addition of auto-filing software, the return on investment (ROI) was significant. The laboratory saved the equivalent of one full-time employee in time by automating file management and result entry.
Discussion: Implementation of a purpose-built application to support reflex and interpretation workflows in a clinical pathology practice has led to a significant improvement in laboratory efficiency. Custom- and purpose-built applications can help reduce staff burnout, reduce transcription errors, and allow staff to focus on more critical issues around quality.
Keywords: Python, laboratory workflows, custom web application, quality control, mass spectrometry
Background
Urine drug monitoring is an increasingly important tool for primary care physicians (PCPs) and pain specialists to monitor patients on chronic opioid therapy. [1] Routine and random monitoring for all patients on long-term opioid therapy is recommended prior to starting and throughout drug therapy. [2] There are various analytical methods and matrices available for patient monitoring. Urine drug testing (UDT) has become the “gold-standard” for detecting illicit drug use and monitoring ongoing therapy. Urine is non-invasive, readily available, and contains higher concentrations of drugs and metabolites compared with other matrices. Immunoassay testing, commonly referred to as urine drug screening, detects the presence of selected drugs and/or metabolites based on a detection threshold. Typically, the immunoassay functions as the initial evaluation for the potential detection of drugs, but because it lacks specificity for analytes of the same drug class, it can lead to false-positive and -negative results. Therefore, drug screens are often coupled with a confirmatory detection method for more specific testing. Chromatography is generally reserved for confirmatory or definitive testing following immunoassay screening. Historically, gas chromatography–mass spectrometry (GC–MS) was the standard for confirmatory testing. However, Liquid chromatography–mass spectrometry–tandem mass spectrometry (LC-MS/MS) has gained favor over GC-MS due to reduced complexity of sample preparation methods and the broader applicability of LC-MS/MS to different drug classes. [3, 4]
Many laboratories are equipped to support UDT. [1,3,4,8,9] A major challenge of staged drug testing (i.e., screening and confirmatory assays) is the review and interpretation of the large number of quantitative and qualitative results that is generated by screening and confirmatory methods. [5,6,7] Pharmacokinetic mechanisms dictate how quickly and how much of a drug and its metabolites appear in an individual's urine, which can be challenging for physicians who have limited understanding due to reviewing a limited number of these results. [5] An incorrect interpretation of the LC-MS/MS results could mistakenly suggest that a patient used a non-prescribed medication. Additionally, the potential for analytes to co-elute could affect the signal of the analytes, influencing the overall accuracy of the LC-MS/MS test. [4]
Yang et al. [9] described that adding interpretative comments from a trained laboratory director to urine drug screening results can greatly impact both the clinician and patient. Clinicians may not understand the analytical method limitations, and any resulting misinterpretation of the results may lead to a patient's stigmatization or inappropriate termination from care. The authors further reported an increase in urine drug screen orders with interpretive comments, indicating that clinicians value the interpretation made by a trained director. Because accurate interpretation of results often requires the integration of documented clinical information, medication data, test results, pharmacokinetics, and test limitations and interferences, assigning a trained pathologist or clinical chemist who is familiar with interpreting clinical information, as well as the biochemistry and testing methods to provide an interpretation of the results, is a valuable tool in ensuring the correct diagnosis for patients.
One challenge laboratories and laboratory directors face with UDT is that there may be results from several tests that inform whether additional testing is required and need to be integrated to provide an interpretation given the specific clinical context. Within the Department of Laboratory Medicine and Pathology at University of Washington Medicine (UW Medicine), we have formulated a urine drug testing ordering protocol and interpretation workflow. Clinicians may select from a menu of panels that are based on the assessed patient's risk of treatment non-compliance. Panels include an immunoassay drug screen and confirmation LC-MS/MS assays for opioids, amphetamines, benzodiazepines, and alcohol. For example, a low-risk patient panel consists of an immunoassay drug screen, and aberrant or unexpected results can lead the reviewing pathologist to order one or more of the confirmation tests. On top of the interpretation challenges, turnaround times (TAT) for the different tests are unevenly distributed. Most laboratory information systems (LISs) are not equipped to track, collect, and display the different results in an effective and informative manner to support this workflow.
The aim of this project was to design and implement a web-based software application that centralizes test results for pathologist review, performs the quality control (QC) calculations for the complex LC-MS/MS analysis of opioids and their metabolites, functions as a user input form for pathologist interpretation entry, and auto-files results into the LIS.
Methods
References
Notes
This presentation is faithful to the original, with only a few minor changes to presentation, spelling, and grammar. In some cases important information was missing from the references, and that information was added.
