Does the perceived accuracy of urine drug testing impact clinical decision-making?

Background: Urine drug testing techniques have different rates of false-positive and false-negative test results. However, clinicians may have highly varying perceptions of test accuracy and may compensate for perceived inaccuracy by incorporating other factors into their interpretation of observed test results. Thus, there is the potential for adverse consequences from decisions based on inaccurate test results or interpretation. Methods: We surveyed 466 members of the American Society of Addiction Medicine to examine clinicians' perceptions of the accuracy of 2 types of urine drug tests, immunoassay (IA) and liquid chromatography-tandem mass spectrometry (LC-MS/MS), and the extent to which behavioral and demographic factors influence the interpretation of test results. Participants read 4 brief vignettes describing positive and negative test results in hypothetical patients who differed along several dimensions (gender, age, race/ethnicity, comorbid mental disorder, court-ordered versus voluntary status, treatment compliance). Outcome variables include likelihood of renewed drug use, likelihood of test error, whether to request additional testing, and whether to report the violation to a probation officer. Results: The strongest predictor of study outcomes was treatment compliance (consistent versus inconsistent attendance), as this was the only independent variable to generate effect sizes of medium strength. Significant effect sizes were also found for type of test used (IA versus LC-MS/MS), legal status (court-mandated versus voluntary), presence of a comorbid mental disorder, treatment history, and race, although effect sizes for these variables were small and less consistently observed. Conclusions: These results highlight the potential for error in clinician judgments about urine drug testing. Not only were participants likely to underestimate the accuracy of "confirmatory" LC-MS/MS testing, but vignettes suggested that a number of historical and demographic factors may influence interpretation of test results.

Sleep problems in breast cancer survivors 1-10 years posttreatment.

ABSTRACTObjective:Sleep can affect quality of life (QoL) during cancer survivorship, and symptoms related to poor sleep can be exacerbated. We examined the prevalence, severity, and nature of subjective sleep complaints in women surviving stage I-III breast cancer who were 1-10 years posttreatment. We also examined the demographic, medical, physical, and psychosocial correlates of poor sleep in these women in order to identify the subgroups that may be most in need of intervention. METHOD: A total of 200 patients at a comprehensive cancer center who were 1-10 years posttreatment for primary stage I-III breast cancer with no evidence of disease at the time of enrollment completed a battery of questionnaires on demographics, sleep, physical symptoms, mood, cancer-specific fears, and QoL. RESULTS: The women had a mean age of 57 years (SD = 10.0), with a mean of 63.3 months (SD = 28.8) of post-cancer treatment. Some 38% of these patients were identified as having poor-quality sleep. Women with poor sleep took longer to fall asleep, had more awakenings, and acquired 2 hours less sleep per night than those with good sleep. They also had a lower QoL, greater severity of pain, more concerns about health and recurrence, and increased vasomotor symptoms (p < 0.05). Daytime sleepiness and depression were found to be not significantly correlated with sleep quality. SIGNIFICANCE OF RESULTS: Many breast cancer survivors had severe subjective insomnia, and several breast cancer survivor subgroups were identified as having members who might be most in need of sleep-improvement interventions. Addressing physical symptoms (e.g., vasomotor symptoms and pain) and providing education about the behavioral, social, environmental, and medical factors that affect sleep could result in substantial improvement in the life course of breast cancer survivors.

Definitive LC-MS/MS Drug Monitoring Impacts Substance-use Treatment Planning and Patient Outcomes: A Brief Report.

Clinical drug monitoring has an increasingly important role in the treatment of substance use disorders. Through semistructured interviews, we asked substance-use counselors about the clinical impact of drug tests on patients' treatment planning and outcomes. This study was conducted around the time of a facility-wide switch to a laboratory utilizing definitive liquid chromatography with tandem mass spectrometry from a laboratory that had utilized the less-sensitive, presumptive immunoassay-based drug-testing methodology. Twelve counselors volunteered to be interviewed, and each counselor chose 2 patients to discuss. Counselors reported that the facility-wide switch to definitive drug testing revealed some patients with newly identified relapses and substance use. They also reported that, as a result of the new information provided by definitive liquid chromatography with tandem mass spectrometry monitoring, 75% of the patients they discussed had a change made to their treatment plan, 79% were provided enhanced education, and 63% had an increase in their treatment intensity. Counselors also reported that 58% of these patients reduced their illicit drug and nonmedical prescription medication use as a result of treatment changes associated with the newly implemented definitive testing. Improvements in therapeutic relationships and honesty were also reported. These preliminary data are consistent with previous data and guidelines, suggesting that the results of definitive drug monitoring inform clinical decision-making and can help clinicians enhance treatment outcomes.

An Online Survey of Patients' Experiences Since the Rescheduling of Hydrocodone: The First 100 Days.

OBJECTIVE: To conduct an Internet patient survey through the National Fibromyalgia & Chronic Pain Association on reactions to the first 100 days following the rescheduling of hydrocodone. METHODS: Face-valid survey questions were created with expert consensus along with repurposed questions used on previous NFMCPA surveys covering domains such as demographics and symptoms. The questionnaire was designed to be administered over the Internet. RESULTS: 6,420 responders met screening criteria and completed the survey. Most (5,181, or 82.5%) had been prescribed hydrocodone for more than 1 year. 2,296, (39.0%) reported no changes in access to hydrocodone, while the majority experienced some barriers. Of those who could no longer get hydrocodone, 1,067 (18.1%) borrowed pain medications, 1,007 (17.1%) turned to marijuana, 773 (13.1%) used alcohol, and 135 (2.3%) used illicit drugs. Most respondents had to visit their healthcare providers more often (N = 3,699, 64.2%) and 1,735 (30.3%) reported some type of issue interacting with their pharmacy. Most felt that the rescheduling was neither a fair nor appropriate solution to the abuse of hydrocodone (N = 4,938, 88.3%). For those still working, 801 (46.2%) reported that they had missed work because of the stricter regulations. 1,462 (27.2%) reported having thoughts of suicide since the rescheduling. SIGNIFICANCE: The unintended consequences for people with chronic pain that have been caused by the rescheduling effort to impede hydrocodone abuse are negatively impacting thousands. These consequences include suffering from being placed on less effective drugs, increased cost, inconvenience, and negative influence on physician-patient and pharmacist-patient relationships.

Counselors' Clinical Use of Definitive Drug Testing Results in Their Work with Substance-Use Clients: a Qualitative Study.

We conducted a psychotherapeutic examination of the use of definitive drug testing (liquid chromatography with tandem mass spectrometry) in the treatment of substance use disorders (SUD). Employing a generic qualitative method (Caelli et al. in International Journal of Qualitative Methods, 2(2), 2003; Merriam, 2009) we asked SUD counselors to provide narratives about cases where drug testing had revealed new or unexpected information about clients' drug-taking behaviors. Semi-structured interviews with 12 SUD counselors were conducted by phone and analyzed for themes derived from the literature. These counselors reported many new positive drug tests in clients previously believed to be adherent with treatment. Key themes assessed in counselors' narratives included initial client denial that was often followed by later acknowledgement of relapse and increased motivation, at times presenting new opportunities for clients to engage in treatment and enhance the therapeutic alliance. These results suggest that definitive drug testing can be used in a non-stigmatizing and therapeutic manner.

A Survey of ASAM Members' Knowledge, Attitudes, and Practices in Urine Drug Testing.

OBJECTIVES: Urine drug testing (UDT) can play an important role in addiction medicine. Indeed, the American Society of Addiction Medicine (ASAM) recently released a white paper, detailing the history of UDT, emphasizing recent advances in the laboratory and clinical science of UDT, and discussed the potential for broadening clinical utility of UDT. We conducted a survey of ASAM members to better understand their knowledge, attitudes, and practices with regard to UDT. METHODS: ASAM leadership along with clinical and laboratory experts developed a large pool of items on knowledge, attitudes, and practices around the use and implementation of UDT. These were condensed and converted to a web-based format. Two mass e-mails were sent for recruitment to the survey, with the first e-mail resulting in an open rate of 37% and the follow-up e-mail having an open rate of 34%. RESULTS: A total of 365 respondents completed the survey, with 51% indicating they were Board Certified in Addiction Medicine/Addiction Psychiatry. Up to 93% of respondents indicated they were waivered to prescribe buprenorphine, and 20% indicated that they were certified as a Medical Review Officer (MRO). A total of 93% felt confident in their ability to interpret the results of UDT, 90% used UDT to monitor both medication and illicit substance use, and 79% either agreed (48%) or strongly agreed (31%) with the statement "it is important to do adulteration testing for aberrant behavior." Urine drug testing was most likely to be ordered "when a patient is demonstrating problematic behavior" (70%), and for "baseline testing for new patients plus random selection of current patients" (57%). SIGNIFICANCE: The survey revealed that UDT is widely used and highly integrated into the assessment and management of people with addictions undergoing treatment by ASAM members. Greater than 94% of respondents use testing to determine adherence, to monitor abstinence, and to detect an early relapse. The majority felt confident in their ability to interpret and use UDT results, and the vast majority had reportedly used it in changing patient management. Education gaps do exist, however, and should be the focus of future education efforts on UDT.

A primer on definitive gas and liquid chromatography drug testing: What clinicians need to know.

OBJECTIVE: To describe the differences between mass spectrometry technologies and compare and contrast them with immunoassay techniques of urine drug testing (UDT). Highlight the potential importance of the differences among these technologies for clinicians so as to allow them make decisions in their use in patient care. METHODS: Review of mass spectrometry techniques, including gas chromatography, liquid chromatography, and time-of-flight techniques. RESULTS: The potential clinical implications of these technologies stemming from their scope and accuracy are presented. SIGNIFICANCE: UDT is an important clinical tool, though there are differences in technology and testing processes with important implications for clinical decision making. It is crucial, therefore, that clinicians have an understanding of the technologies behind the tests they order, so that their interpretation and use of results are based on an understanding of the strengths and weaknesses of the technologies used.

Specimen validity testing in urine drug monitoring of medications and illicit drugs: clinical implications.

OBJECTIVE: To discuss the importance of specimen validity testing (SVT) in urine drug testing (UDT) and the clinical role it plays in identifying efforts to subvert the UDT process. METHODS: A discussion of the clinical impact of SVT is presented. RESULTS: A discussion of pH, specific gravity, creatinine, and oxidation for monitoring the adulteration of UDT samples is presented along with the clinical significance of such tests. SIGNIFICANCE: SVT has a significant place in healthcare efforts to measure patient adherence, behavior, and honesty in communication with clinicians. SVT is typically ordered by treating clinicians who use the results to make therapeutic decisions regarding specific medical problems of their patient, including those related to medication and illicit drug use. In the absence of SVT, a healthcare provider may fail to identify a patient's adulteration of their urine sample in an attempt at deceiving the provider. Moreover, the presence of some underlying medical conditions may obfuscate the UDT results.

Trends in drug use from urine drug testing of addiction treatment clients.

OBJECTIVE: Urine drug testing (UDT) can play an important role in the care of patients in recovery from addiction, and it has become necessary for providers and programs to utilize specific, accurate testing beyond what immunoassay (IA) provides. DESIGN: A database of addiction treatment and recovery programs was sampled to demonstrate national trends in drug abuse and to explore potential clinical implications of differing results due to the type of testing utilized. SETTING: Deidentified data was selected from a national laboratory testing company that had undergone liquid chromatography tandem mass spectrometry (LC-MS/MS). PATIENTS/PARTICIPANTS: A total of 4,299 samples were selected for study. INTERVENTIONS: Descriptive statistics of the trends are presented. RESULTS: In total, 48.5 percent (n = 2,082) of the samples were deemed in full agreement between the practice reports and the results of LC-MS/MS testing. The remaining 51.5 percent of samples fell into one of seven categories of unexpected results, with the most frequent being detection of an unreported prescription medication (n = 1,097). CONCLUSIONS: Results of UDT demonstrate that more than half of samples yield unexpected results from specimens collected in addiction treatment. When comparing results of IA and LC-MS/MS, it is important to consider the limits of IA in the detection of drug use by these patients.

FDA/DEA/PDMP/UDT: alphabet soup or sensible and integrated risk management?

OBJECTIVE: Both prescription drug monitoring programs (PDMP) and urine drug testing (UDT) are recommended as parts of an ongoing risk management approach for controlled substance prescribing. The authors provide an editorial and commentary to discuss the unique contributions of each to promote better clinical decision making for prescribers. DESIGN: A commentary is employed along with brief discussion comparing four states with an active PDMP in place to three states without an active PDMP as it relates back to findings on UDT in those states from a laboratory conducting liquid chromatography tandem mass spectrometry. CONCLUSIONS: The commentary focuses on the place of both tools (UDT and PDMP) in risk management efforts. The argument is made that relying on a PDMP alone would lead to clinical decisions that may miss a great deal of problematic or aberrant behaviors.

The complexity model: a novel approach to improve chronic pain care.

OBJECTIVE: More than 25% of the US population experiences chronic pain; yet few physicians specialize in the field of pain medicine. This article will review a theoretical model of care that stratifies treatment and patients by level and type of complexity and promotes communication between specialist and primary care providers. DISCUSSION: The undertreatment of pain was recently brought to national attention to encourage both clinicians and patients to advocate for improved pain care. The specialty of pain medicine and models of care, challenges of managing pain in a primary care setting, and the reliance on an opioid-focused approach are reviewed. An evolved model of pain care based on the complexity of pain and emphasizing a dynamic collaboration between the primary care provider and the pain specialist is discussed. CONCLUSIONS: From the perspective of the busy clinician, the treatment of chronic pain can be overwhelming. The scarcity of trained pain practitioners and the burgeoning number of patients with chronic pain necessitate a new approach that values the complex nature of chronic pain and offers a practical blueprint to meet these challenges.

Clinicians' perspective on the use of immunoassay versus definitive laboratory quantitation methodologies for medication monitoring.

Treating chronic pain is complicated. Primary care doctors and others are called on to treat the vast majority of patients with pain, to do so in brief visits and to do it safely. This is a tall order, but it is possible to do it well when the proper tools are employed to aid the clinician in diagnosing and monitoring the patient. Among these tools, the one that has been most useful is urine drug testing. Prescribers can perform presumptive screens with the immunoassay method in my office, but this method has limitations in accuracy and specificity and sensitivity. When medically necessary, it makes sense to seek definitive testing from the laboratory to confirm results of immunoassay tests with chromatographic testing and/or when there is the possibility of a false negative in the office. These "false negatives" are extremely common, with patients using nonprescribed opioids and illicit medications often go undetected if one were to stop at the office-based result. These patients are in danger of addiction and overdose, and this added information is crucial in efforts to treat pain and avoid these complications.

Exploring rates of abnormal pharmacogenetic findings in a pain practice.

Pharmacogenetic testing (PGT) is part of increasing efforts to personalize medicine, hopefully leading to better medication selection with more effective, less toxic therapies. Pharmacogenetic testing has relevance for chronic pain treatment, given the frequent comorbidities and polypharmacy. This retrospective study explored the prevalence of polymorphisms in a specialty pain practice in Louisiana. Pharmacogenetic testing was conducted for the cytochrome P450 (CYP) enzymes CYP2B6, CYP2C19, and CYP2D6, or the uridine diphosphate-glucuronosyltransferase 2 family polypeptide B15 (UGT2B15) enzyme utilizing a noninvasive, saliva-based test based on clinical decision-making. The sample consisted of 61 men (58.7%) and 41 women (39.4%), with an average age of 46.7 years (range = 23-83, SD = 11.5 years). Across all tests, 164 (42.3%) were extensive, 99 (25.5%) were intermediate, 28 (7.2%) were ultrarapid, and 27 (7%) were poor metabolizers. Only three patients who had been tested were found to be extensive (normal) for all four genes. These data demonstrate that genetic polymorphisms were frequently encountered. Consideration should be given to obtaining PGT as an aspect of evaluation and treatment planning when working with patients in need of specialty pain consultation and care. Caution is needed, as this brief report encompasses results from a single pain practice in one geographic location with a potentially distinct prevalence of genetic polymorphisms. Further prospective study is needed.

The chronic pain patient and functional assessment: use of the 6-Minute Walk Test in a multidisciplinary pain clinic.

OBJECTIVE: For chronic pain treatment, guidelines and regulatory agencies have defined functional improvement as a primary goal, especially when chronic opioid therapy is used. Functional improvement is frequently evaluated by qualitative questioning. This pilot study sought to establish a simple and inexpensive measure of functional change for a chronic pain population. METHODS: Using a multidisciplinary pain clinic standard physical therapy approach for all entering chronic pain patients, multiple functional tests were performed, including the 6-Minute Walk Test. Data was collected by retrospective chart review, at entry to the clinic and 3-6 months later and compared using simple t-test statistics on 45 patients. RESULTS: The average distance walked at center admission was 272.87 yards. At 3-6 month clinical retesting, the distance had improved significantly to 339.04 yards (p<0.0001). NRS scores at 3-6 months were also improved from baseline (p<0.001). CONCLUSIONS: While suggestive, this study has significant limitations. Not all patients entering into the clinic were included in this study, only those who had completed the necessary testing. Further, chart reviews are complicated by the accuracy with which data is recorded. This study is intriguing and presents positive data for a simple, inexpensive and reproducible test for physical functioning in a chronic pain population. Further study is warranted based on these descriptive results.

Frequency, characteristics, and correlates of pain in a pilot study of colorectal cancer survivors 1-10 years post-treatment.

OBJECTIVE: The long-term effects of disease and treatment in colorectal cancer (CRC) survivors are poorly understood. This study examined the prevalence and characteristics of pain in a sample of CRC survivors up to 10 years post-treatment. DESIGN: One hundred cancer-free CRC survivors were randomly chosen from an institutional database and completed a telephone survey using the Brief Pain Inventory, Neuropathic Pain Questionnaire-Short Form, Quality of Life Cancer Survivor Summary, Brief Zung Self-Rating Depression Scale, Zung Self-Rating Anxiety Scale, and Fear of Recurrence Questionnaire. RESULTS: Participants were primarily Caucasian (90%) married (69%) males (53.5%) with a mean age of 64.7 years. Chronic pain was reported in 23% of CRC survivors, with a mean moderate intensity rating (mean = 6.05, standard deviation = 2.66) on a 0-10 rating scale. Over one-third (39%) of those with pain attributed it to their cancer or treatment. Chi-square and t-test analyses showed that survivors with pain were more likely to be female, have lower income, be more depressed and more anxious, and show a higher endorsement of suicidal ideation than CRC survivors without chronic pain. On average, pain moderately interfered with daily activity. CONCLUSIONS: Chronic pain is likely a burdensome problem for a small but not inconsequential minority of CRC survivors requiring a biopsychosocial treatment approach to improve recognition and treatment. Open dialogue between clinicians and survivors about physical and emotional symptoms in long-term follow-up is highly recommended.

Development and implementation of a palliative care consultation tool.

OBJECTIVE: Palliative care services are becoming more commonplace in hospitals and have the potential to reduce hospital costs through length of stay reduction and remediation of symptoms. However, there has been little systematic attempt to identify when a palliative care consultation should be triggered in a hospital, and there is some evidence that these services are under-utilized and not fully understood. METHOD: In an initial attempt to address when a consultation might be appropriate, we attempted to pilot test a novel palliative care screening tool to help guide clinician judgment in this regard. A one-page, face-valid instrument was developed using expert opinion. RESULTS: The sample comprised 33 men (44.6%) and 41 women (55.4%) with an average age of 63.4 years (SD = 13.8) and an average length of stay of 22.7 days (SD = 10.1). The most significant symptom was pain, indicated as moderate-to-severe in 23 patients (31%). This was followed by fatigue (n = 10, 13.5%) and nausea (n = 6, 8.1%). At unit entry, 20 patients (33%) had moderate or severe pain. Upon discharge, this number had been reduced to 12/60 (20%). Chi-Square analysis showed a significant decrease in pain rankings overall (χ2 = 36.3, p < 0.0001). The average total tool score was 7.5 (SD = 3.1). Using an initial threshold of 12 to trigger a palliative care referral, 64 patients (86.5%) would not have received a referral and 10 (13.5%) would have. Of these 10 patients, 2 (20%) did not receive a palliative care consultation while they were hospitalized. SIGNIFICANCE OF RESULTS: The tool we developed increased consultations over the time period in which it was used, compared with the same time period 1 year prior. Although the threshold developed for triggering referrals seemed artificially high, the implementation of the screening tool did increase referrals.

Ethical considerations in urine drug testing.

Recent passage of a House Bill in the state of Washington led to a commentary on whether mandates for urine drug testing of pain patients represented a breach of the Fourth and Fourteenth Amendment rights of patients. Issues over true consent to such tests and potential view of warrantless searches were discussed. The authors address these concerns in a broader context of risk management and stratification efforts, along with discussion about the need for a tailored approach in this arena and consideration of cost burden for such tests. Finally, the argument is made that social justice issues need to be considered (along with issues of autonomy, beneficence, and nonmaleficence).

Addictions in pain clinics and pain treatment.

A great deal of fear exists in the world of pain management on the part of both healthcare professionals and some patients where issues of abuse, misuse, and addiction are concerned. While it might be easy to consider all pain patients as "drug seekers" or addicts, the reality remains that most pain patients are genuine; we therefore must retain pain management efforts for the many, while being aware and cognizant of the few who have problems such as addiction. To begin to separate these entities, definitions and hallmarks of addiction are explored along with discussion of screening tools that can be employed to help identify problematic patients. In addition, the concepts of dependence and tolerance are defined and separated from old notions of addiction. Finally, issues related to engaging in a multidisciplinary approach are discussed along with caveats regarding prescribing to patients who have histories or ongoing issues of addiction.

Multimodal approaches to optimize outcomes of chronic opioid therapy in the management of chronic pain.

OBJECTIVE: To review clinical strategies for long-term opioid management as well as strategies to assess and monitor patients with moderate to severe chronic pain who may be at risk for aberrant drug-related behaviors. DESIGN: A symposium was held to disseminate a review of opioid use strategies, including use of the Universal Precautions in Pain Medicine as well as the Federation of State Medical Boards Model Policy for Prescribing Controlled Substances (FSMB model policy). These include continual reassessment of pain and risk, treatment agreements, compliance monitoring, urine drug screening, documentation, compliance with the law, and patient education. Additionally, the use of multimodal strategies to treat patients, with techniques such as cognitive-behavioral therapy, is discussed as an essential part of a comprehensive pain management plan. SETTING: The review summarizes a continuing medical education (CME)-accredited symposium conducted at the American Pain Society Annual Meeting in Baltimore, Maryland, in May 2010. RESULTS: Recommendations for the management and monitoring of long-term opioid therapy for patients with chronic noncancer pain are rooted in evidence-based clinical guidelines, which also provide guidance for the identification of aberrant behaviors or overt addiction. CONCLUSIONS: Vigilance and frequent interactions may sometimes be inadequate to prevent problematic behaviors; therefore, pharmacologic strategies designed to deter abusive behaviors are also discussed.