Clinical and financial impact of removing creatine kinase-MB from the routine testing menu in the emergency setting.

CONTEXT: Cardiac troponins T and I have replaced creatine kinase-MB (CK-MB) as the criterion standard for diagnosing myocardial injury. However, many laboratories still routinely perform a high volume of CK-MB testing in conjunction with troponin. PURPOSE: The purpose of this study is to study the clinical and financial impact of removing CK-MB from the routine emergency department (ED) test menu at a large academic medical center. METHODS: Creatine kinase-MB was removed from ED ordering templates and laboratory requisitions (ie, intervention), although the test could still be manually ordered. Data for creatine kinase (CK), CK-MB, and troponin T (TnT) specimens ordered during a 12-month period (6 months preintervention and 6 months postintervention) (n = 14571) was downloaded from our laboratory information system. All specimens with (1) normal TnT (ie, <0.01 ng/mL), (2) elevated CK-MB (ie, >6.6 ng/mL), and (3) elevated CK-MB index (ie, >5) were considered discrepant and independently reviewed by 2 ED clinicians for the presence of an acute coronary syndrome and for documentation of final diagnosis. Creatine kinase, CK-MB, and TnT ED volumes preintervention and postintervention were analyzed to assess laboratory cost savings. RESULTS: Of the 6444 cases included in the analysis, only 17 were discrepant. Of all 17 cases, no patients were diagnosed with acute coronary syndrome. After removing CK-MB from the templates and requisitions, CK-MB and CK volumes decreased by 80% and 76%, respectively, translating to annual reagent cost savings of approximately $47000. CONCLUSIONS: Creatine kinase-MB can be removed from the routine ED test menu without adversely affecting patient care. In addition, substantial cost savings can be achieved by reducing unnecessary CK-MB testing and associated CK orders.

A comparison of registered and published primary outcomes in clinical trials of opioid use disorder: ACTTION review and recommendations.

BACKGROUND AND AIMS: Prospective trial registration can increase research integrity. This Analgesic, Anesthetic, and Addiction Clinical Trial Translations, Innovations, Opportunities, and Networks (ACTTION) review was designed to compare the primary outcomes (PO) reported in registries with associated publications for opioid use disorder (OUD) clinical trials. DESIGN: The World Health Organization's International Clinical Trials Registry Platform (ICTRP) was searched for completed trials (2010 through 2019). Associated publications were identified and paired with trial registry data based on the publication date. MEASUREMENTS: Reviewers independently rated the occurrence of discrepancies between the POs in the registry compared to the publication. An analysis of prospective versus retrospective registration was also completed. FINDINGS: One-hundred and forty trials were identified in the search, and 43 registry-publication pairs evaluated. Only 34 of the 43 pairs could be examined for discrepancies because nine did not report a PO in registry and publication. Of the 34 pairs, only four met rigorous criteria for prospective trial registration and had an exact match of POs. In contrast, the majority of the 34 trials, or 80%, had inconsistent POs (e.g., registered secondary outcomes published as primary; the timing of PO not specified) and/or were retrospectively registered. CONCLUSIONS: Many clinical trials focused on OUD have not met the standards of trial registration, such as consistent reporting of POs and prospective registration. Failure to properly register trial characteristics undermines the validity of research findings and can delay the development of life-saving treatments. Recommendations for improving prospective trial reporting practices are provided.

The prevalence of comorbid chronic pain conditions among patients with temporomandibular disorders: A systematic review.

BACKGROUND: This systematic review was designed to evaluate the presence of comorbid conditions among patients with temporomandibular disorders (TMDs). TYPES OF STUDIES REVIEWED: The authors reviewed studies that reported the prevalence or incidence of chronic pain conditions or psychiatric disorders (anxiety, mood, personality disorders) among patients with any type of TMD. The authors calculated sample size-weighted prevalence estimates when data were reported in 2 or more studies for the same comorbid condition. RESULTS: A total of 9 prevalence studies and no incidence studies were eligible for review; 8 of the studies examined chronic pain comorbidities. Weighted estimates showed high prevalence of pain comorbidities across studies, including current chronic back pain (66%), myofascial syndrome (50%), chronic stomach pain (50%), chronic migraine headache (40%), irritable bowel syndrome (19%), and fibromyalgia (14%). A single study examined psychiatric disorders and found that current depression was the most prevalent disorder identified (17.5%). CONCLUSIONS AND PRACTICAL IMPLICATIONS: There is a high prevalence of comorbid chronic pain conditions among patients with TMDs, with more than 50% of patients reporting chronic back pain, myofascial syndrome, and chronic stomach pain. Psychiatric disorders among patients with different types of TMDs were studied less commonly in this pain population. Knowledge of the distribution of these and other comorbid disease conditions among patients with different types of TMDs can help dentists and other health care providers to identify personalized treatment strategies, including the coordination of care across medical specialties.

The Prevalence of Psychiatric and Chronic Pain Comorbidities in Fibromyalgia: an ACTTION systematic review.

Fibromyalgia (FM) is a chronic widespread pain condition that overlaps with multiple comorbid health conditions and contributes to considerable patient distress. The aim of this review was to provide a systematic overview of psychiatric and chronic pain comorbidities among patients diagnosed with FM and to inform the development of recommendations for the design of clinical trials. Thirty-one, cross-sectional, clinical epidemiology studies that evaluated patients diagnosed with FM were included for review. None of the reviewed studies reported on the incidence of these comorbidities. Sample size-weighted prevalence estimates were calculated when prevalence data were reported in 2 or more studies for the same comorbid condition. The most prevalent comorbidity across all studies reviewed was depression/major depressive disorder (MDD) with over half of the patients included having this diagnosis in their lifetime (weighted prevalence up to 63%). In addition, nearly one-third of FM patients examined had current or lifetime bipolar disorder, panic disorder, or post-traumatic stress disorder. Less common psychiatric disorders reported included generalized anxiety disorder, obsessive compulsive disorder, and specific phobias (agoraphobia, social phobia). There were fewer studies that examined chronic pain comorbidities among FM patients, but when evaluated, prevalence was also high ranging from 39% to 76% (i.e., chronic tension-type or migraine headache, irritable bowel syndrome, myofascial pain syndrome, and temporomandibular disorders). The results of the review suggest that depression and chronic pain conditions involving head/jaw pain and IBS were elevated among FM patients compared to other conditions in the clinic-based studies. In contrast, anxiety-related disorders were much less common. Addressing the presence of these comorbid health conditions in clinical trials of treatments for FM would increase the generalizability and real-world applicability of FM research.

Increased Patient Satisfaction and a Reduction in Pre-Analytical Errors Following Implementation of an Electronic Specimen Collection Module in Outpatient Phlebotomy.

BACKGROUND: Patient satisfaction in outpatient phlebotomy settings typically depends on wait time and venipuncture experience, and many patients equate their experiences with their overall satisfaction with the hospital. METHODS: We compared patient service times and preanalytical errors pre- and postimplementation of an integrated electronic health record (EHR)-laboratory information system (LIS) and electronic specimen collection module. We also measured patient wait time and assessed patient satisfaction using a 5-question survey. RESULTS: The percentage of patients waiting less than 10 minutes increased from 86% preimplementation to 93% postimplementation of the EHR-LIS (P ≤.001). The median total service time decreased significantly, from 6 minutes (IQR, 4-8 minutes), to 5 minutes (IQR, 3-6 minutes) (P = .005). The preanalytical errors decreased significantly, from 3.20 to 1.93 errors per 1000 specimens (P ≤.001). Overall patient satisfaction improved, with an increase in excellent responses for all 5 questions (P ≤.001). CONCLUSIONS: We found several benefits of implementing an electronic specimen collection module, including decreased wait and service times, improved patient satisfaction, and a reduction in preanalytical errors.

The Benefits and Challenges of an Interfaced Electronic Health Record and Laboratory Information System: Effects on Laboratory Processes.

CONTEXT: - A recent government regulation incentivizes implementation of an electronic health record (EHR) with computerized order entry and structured results display. Many institutions have also chosen to interface their EHR with their laboratory information system (LIS). OBJECTIVE: - To determine the impact of an interfaced EHR-LIS on laboratory processes. DESIGN: - We analyzed several different processes before and after implementation of an interfaced EHR-LIS: the turnaround time, the number of stat specimens received, venipunctures per patient per day, preanalytic errors in phlebotomy, the number of add-on tests using a new electronic process, and the number of wrong test codes ordered. Data were gathered through the LIS and/or EHR. RESULTS: - The turnaround time for potassium and hematocrit decreased significantly (P = .047 and P = .004, respectively). The number of stat orders also decreased significantly, from 40% to 7% for potassium and hematocrit, respectively (P < .001 for both). Even though the average number of inpatient venipunctures per day increased from 1.38 to 1.62 (P < .001), the average number of preanalytic errors per month decreased from 2.24 to 0.16 per 1000 specimens (P < .001). Overall there was a 16% increase in add-on tests. The number of wrong test codes ordered was high and it was challenging for providers to correctly order some common tests. CONCLUSIONS: - An interfaced EHR-LIS significantly improved within-laboratory turnaround time and decreased stat requests and preanalytic phlebotomy errors. Despite increasing the number of add-on requests, an electronic add-on process increased efficiency and improved provider satisfaction. Laboratories implementing an interfaced EHR-LIS should be cautious of its effects on test ordering and patient venipunctures per day.

7-aminoclonazepam is superior to clonazepam for detection of clonazepam use in oral fluid by LC-MS/MS.

BACKGROUND: Clonazepam (CLON) is not only frequently prescribed in addiction management but is also commonly abused. Therefore many addiction clinics perform oral fluid (OF) testing, which unlike urine is not subject to adulteration, to monitor CLON compliance. However, CLON and other benzodiazepines can be challenging to detect in OF due to their weakly acidic nature and their presence in low concentrations. We determined the optimal technical and clinical approach for the detection of CLON use using OF. METHODS: We measured CLON and its primary metabolite 7-aminoclonazepam (7AC) by liquid chromatography-tandem mass spectrometry in OF specimens over a 2 month period. The samples were collected using the Orasure Intercept OF sample collection device. RESULTS: One hundred samples were presumptive-positive for 7AC and/or CLON. 91 (91.0%) confirmed positive for 7AC (median, range: 4.2, 0.5-316.7 ng/ml) using the ion ratio test, while only 44 of the 100 (44.0%) samples confirmed positive for CLON (median, range: 3.7, 0.5-217.2 ng/ml) using the ion ratio test. In OF the levels of 7AC were approximately 2.4-fold higher than CLON. The use of 7AC as an analyte for the detection of both CLON compliance and undisclosed use is also recommended. CONCLUSIONS: 7AC should be the analyte measured in OF for the detection of CLON use.

Significant Reduction in Preanalytical Errors for Nonphlebotomy Blood Draws After Implementation of a Novel Integrated Specimen Collection Module.

OBJECTIVES: Most preanalytical errors at our institution occur during nonphlebotomy blood draws. We implemented an electronic health record (EHR), interfaced the EHR to the laboratory information system, and designed a new specimen collection module. We studied the effects of the new system on nonphlebotomy preanalytical errors. METHODS: We used an electronic database of preanalytical errors and calculated the number and type of the most common errors in the emergency department (ED) and inpatient nursing for 3-month periods before (August-October 2014) and after (August-October 2015) implementation. The level of staff compliance with the new system was also assessed. RESULTS: The average monthly preanalytical errors decreased significantly from 7.95 to 1.45 per 1,000 specimens in the ED (P < 0001) and 11.75 to 3.25 per 1,000 specimens in inpatient nursing (P < 0001). The rate of decrease was similar for mislabeled, unlabeled, wrong specimen received and no specimen received errors. Most residual errors (80% in the ED and 67% in inpatient nursing) occurred when providers did not use the new system as designed. CONCLUSIONS: Implementation of a customized specimen collection module led to a significant reduction in preanalytical errors. Improved compliance with the system may lead to further reductions in error rates.