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Abdullah A Alrasheed,1,2 Khalid F Alsadhan,1,2 Nawaf F Alfawzan,2 Nasser M AbuDujain,2 Ali H Alnasser,3 Hisham Almousa3 1Family and Community Medicine Department, College of Medicine, King Saud University, Riyadh, Saudi Arabia; 2Family and Community Medicine Department, King Saud University Medical City, Riyadh, Saudi Arabia; 3College of Medicine, King Saud University, Riyadh, Saudi ArabiaCorrespondence: Abdullah A Alrasheed, Tel +966114670836, Email aalrasheed1@ksu.edu.saBackground: Isotretinoin is an effective treatment for acne but can cause side effects such as changes in blood lipids and liver enzymes. Laboratory monitoring is essential during treatment, but there is variation in monitoring practices.Aim: This study aims to investigate the relationship between isotretinoin therapy and its effects on complete blood count in Saudi Arabia to improve patient outcomes.Methods: The study was a retrospective cohort study conducted at King Khalid University Hospital in Riyadh, Saudi Arabia, between January 2016 and December 2020. Following the inclusion and exclusion criteria, 515 patients were randomly selected for the study. The data was analyzed using SPSS, and descriptive statistics and paired samples t-tests were employed to analyze the data.Results: In this study, 515 patients were enrolled. Of these participants, 76.7% (n=395) were females and 23.3% (n=120) were males. The mean age of the study participants was 23.98± 7.4 years and ranged between 16 and 65 years. The mean dose of Isotretinoin administered was 27.65± 9.6 mg/day, with a range of 10– 60 mg/day. The mean BMI of the study participants was 24.3± 4.1 kg/m2, ranging from 14.3 to 44.8 kg/m2. Regarding the effect of Isotretinoin on laboratory measures, significant statistical differences were found in hemoglobin measurements (t=− 3.379, p=0.001), platelets (t=− 3.169, p=0.002), neutrophils (%) (t=3.107, p=0.002), total cholesterol (t=− 13.017, p=0.000), AST (t=− 6.353, p=0.000), ALT (t=− 4.352, p=0.000), HDL (t=2.446, p=0.015), and LDL (t=− 12.943, p=0.000). However, there were no significant statistical differences in the measurements of WBC, neutrophils (count), or triglycerides. In the Chi-square analysis and Fisher’s Exact test to identify the interaction between BMI, dose, and gender on abnormal lab results, significant interaction was found between participants’ BMI and abnormal HDL measurements (p=0.006). Furthermore, there were significant interactions between Isotretinoin dose (either less than 30 mg/day or 30 mg/day or more) and abnormal neutrophil count (p=0.04), abnormal HDL measurements (p=0.010), and abnormal triglycerides measurements (p=0.020). Moreover, a statistically significant interaction was found between participants’ gender and abnormal hemoglobin measurements (p=0.006), abnormal total cholesterol (p=0.016), abnormal AST measurements (p=0.001), abnormal ALT measurements (p=0.000), abnormal HDL measurements (p=0.000), and abnormal triglycerides measurements (p=0.007).Conclusion: In conclusion, the study found that isotretinoin therapy has significant effects on several laboratory measures, including hemoglobin, platelets, neutrophils, total cholesterol, AST, ALT, HDL, and LDL. The study also revealed significant interactions between BMI, dose, gender, and abnormal lab results.Keywords: Isotretinoin, acne treatment, laboratory monitoring, blood lipids, liver enzymes, Saudi Arabia

Hydroxychloroquine (HCQ) is an immunomodulator used in dermatology and rheumatology. Side effects may be observed on routine monitoring studies before they become clinically apparent. The goal of this retrospective chart review was to assess laboratory abnormalities in dermatologic and rheumatologic patients taking HCQ. Medical records of patients prescribed HCQ were retrospectively reviewed. Demographics, reported side effects, and parameters on baseline and follow-up complete blood count (CBC) and comprehensive metabolic panel (CMP) were recorded and graded. Laboratory abnormalities were considered severe if they were grade 3 or greater according to Common Terminology Criteria for Adverse Events v3.0 and persistent if they continued beyond subsequent laboratory testing. Of 646 eligible charts, 289 had monitoring studies for review. There were 35 severe (grade 3 or 4, 35/289; 12%) adverse events that developed, as noted on CBC or CMP. Of these 35 severe adverse events, 25 self-corrected on subsequent testing, and 10 (10/289, 3%) across 9 patients were persistent, including glomerular filtration rate, alanine transferase, alkaline phosphatase, glucose, hemoglobin and lymphopenia abnormalities. Of these 10 abnormalities, 7/10 (70%) were unlikely due to hydroxychloroquine use according to the calculated Naranjo score for each patient. Severe laboratory abnormalities while taking hydroxychloroquine are rare, even in a population with a high rate of comorbidities. Among the abnormalities observed, the majority of them (70%) were likely due to disease progression or a medication other than hydroxychloroquine. CBC and CMP monitoring for the reason of observing abnormalities while on HCQ should be at the discretion of the prescribing physician. [ABSTRACT FROM AUTHOR]

Hidradenitis suppurativa (HS) is a chronic cutaneous and systemic inflammatory condition. Increasingly, reports have found that immunoglobulins play a role in the exaggerated immune response occurring in severe HS. It is important to recognize these implications as HS patients may present with laboratory abnormalities relating to chronic inflammation and immune activation. If these laboratory abnormalities are mistakenly associated with another disease process, it could lead to invasive workup and treatment, causing harm to patients. We describe the case of a 23-year-old woman with Hurley stage III HS who was hospitalized and found to have persistent immunoglobulin-G4 (IgG4) elevation. Upon discharge, the patient was diagnosed with IgG4-related disease (IgG4-RD) and started treatment with azathioprine. However, the biopsy ultimately was negative for IgG4-RD, and she presented to our clinic several months later with worsening HS disease during an active flare. Physical examination revealed actively draining nodules and sinus tracts in the bilateral axillae, inguinal folds, and mons pubis region. A confusing laboratory marker with HS was observed in this case. IgG4 has the potential to inhibit or activate inflammation depending on the context, and so IgG4 elevation has been noted in varying disease states. IgG4 elevation is observed in chronic inflammatory states and may represent a compensatory response by the body. While no other cases have reported the association between HS and IgG4 elevation, IgG levels have been found to reflect HS disease severity. Therefore, IgG4 could play a potential role in HS disease monitoring, and awareness of this association is important for providers when managing patients with HS.

BACKGROUND: The management of and monitoring for hematologic adverse events associated with oral cyclin-dependent kinase (CDK) 4/6 inhibitors present unique challenges for providers and patients. Oncology pharmacists need to be familiar with drug manufacturers' recommendations and advance their clinical practice by assisting providers in the care of women with advanced breast cancer. This article highlights one institution's experience of using a pharmacist-driven approach to monitor the hematologic adverse events of CDK4/6 inhibitors and supplements the current literature with real-world patient outcomes. OBJECTIVE: To evaluate the outcomes of a pharmacist-driven approach in the monitoring for hematologic adverse events after receiving CDK4/6 inhibitors in women with advanced breast cancer. METHODS: Women aged ≥18 years with advanced breast cancer who initiated treatment with a CDK4/6 inhibitor at St Luke's Cancer Institute between September 26, 2022, and March 26, 2023, were identified. The prospective analysis identified and excluded patients if they did not initiate treatment with a CDK4/6 inhibitor within the study period. A total of 2 cohorts were identified, including patients who received CDK4/6 inhibitors within a medically integrated pharmacy who were managed by oncology clinical pharmacists (pharmacist-driven approach) and patients who received drugs through external fulfillment and were managed per usual care (non-pharmacist-driven). Data on the demographics and adverse events, such as diarrhea, that resulted from treatment with a CDK4/6 inhibitor were collected from the patients who met the inclusion criteria. RESULTS: A total of 32 patients were analyzed in the prospective chart review, with palbociclib and abemaciclib accounting for the majority of new prescriptions. Overall, >50% of patients managed by oncology clinical pharmacists in the medically integrated pharmacy achieved the manufacturer-recommended laboratory monitoring for neutropenia. Less than 20% of the patients receiving follow-up care outside the medically integrated pharmacy achieved the recommended monitoring, which represents a stark contrast compared with pharmacist-driven management. A total of 4 events of grade 3 neutropenia were observed, and early interventions by oncology clinical pharmacists occurred during treatment cycle 1. CONCLUSION: The results of this observational study show that patients receiving CDK4/6 inhibitors who were monitored by oncology clinical pharmacists obtained the recommended laboratory monitoring, which led to more timely interventions of neutropenia during treatment cycle 1. [ABSTRACT FROM AUTHOR]

Given the growing number of patients receiving direct oral anticoagulant (DOAC), patients requiring rapid neutralization is also increasing in case of major bleedings or urgent surgery/procedures. Idarucizumab is commercialized as a specific antidote to dabigatran while andexanet alfa has gained the Food and Drug Administration and the European Medicines Agency approval as an oral anti-factor Xa inhibitors antidote. Other antidotes or hemostatic agents are still under preclinical or clinical development, the most advanced being ciraparantag. DOAC plasma levels measurement allows to appropriately select patient for antidote administration and may prevent unnecessary prescription of expensive molecules in some acute clinical settings. However, these tests might be inconclusive after some antidote administration, namely andexanet alfa and ciraparantag. The benefit of laboratory monitoring following DOAC reversal remains unclear. Here, we sought to provide an overview of the key studies evaluating the safety and efficacy of DOAC reversal using the most developed/commercialized specific antidotes, to discuss the potential role of the laboratory monitoring in the management of patients receiving DOAC specific antidotes and to highlight the areas that deserve further investigations in order to establish the exact role of laboratory monitoring in the appropriate management of DOAC specific antidotes. Anticoagulation monitoring and specific reversal agent targets DOAC: direct oral anticoagulant; dTT: diluted thrombin time; ECA: ecarin chromogenic assay; ECT: ecarin cloting time. [Display omitted] • Antidotes for direct oral anticoagulant (DOAC) reversal have been developed. • The role of laboratory monitoring in DOAC reversal using antidotes is unclear. • Dabigatran level prior to idarucizumab could predict reversal outcome. • Oral FXa inhibitor levels cannot be easily measured following andexanet alfa. • DOAC measurement using commercialized assays is not possible after ciraparantag. [ABSTRACT FROM AUTHOR]

Despite major advances in prophylaxis, no repeated dosing regimen with currently employed extended-half-life or non-factor products replaces the advantages of a long-term cure in persons with severe congenital hemophilia A and B (HA, HB). They indeed live with the risk of breakthrough bleedings, and treatment is still invasive, both physically and psychologically. Early studies showed that adeno-associated virus-based in vivo gene therapy (AAV-based in vivo GT), could convert haemophilia persons from a severe to mild a phenotype for years. However, the proportion of the hemophilia population likely to benefit from this transformative strategy was uncertain. Current evidence is expanding the eligibility criteria, and helps to predict risks, complications and unexpected side effects of this advanced treatment. Thus, among future options, AAV-based in vivo GT is likely to become the treatment of choice in HA and HB, if real-life data confirm its negligible short-term adverse events. However, while the global use of AAV-based in vivo GT is endorsed as a key objective of future studies in hemophilia, the liberating capability of a potentially one-off treatment on individuals with chronic diseases for whom lifelong cure has been inaccessible so far remains to be thoroughly recognized by government bodies. This is critical for reimbursement agencies to absorb the cost of the cure and calls for a partnership between health care systems and the pharmaceutical industry. However, bridging the gap between the costs of the advanced treatments approved for commercialization and their readiness to persons with HA and HB is still a challenging task. [ABSTRACT FROM AUTHOR]

Despite major advances in prophylaxis, no repeated dosing regimen with currently employed extended-half-life or non-factor products replaces the advantages of a long-term cure in persons with severe congenital hemophilia A and B (HA, HB). They indeed live with the risk of breakthrough bleedings, and treatment is still invasive, both physically and psychologically. Early studies showed that adeno-associated virus-based in vivo gene therapy (AAV-based in vivo GT), could convert hemophilia persons from a severe to mild a phenotype for years. However, the proportion of the hemophilia population likely to benefit from this transformative strategy was uncertain. Current evidence is expanding the eligibility criteria, and helps to predict risks, complications and unexpected side effects of this advanced treatment. Thus, among future options, AAV-based in vivo GT is likely to become the treatment of choice in HA and HB, if real-life data confirm its negligible short-term adverse events. However, while the global use of AAV-based in vivo GT is endorsed as a key objective of future studies in hemophilia, the liberating capability of a potentially one-off treatment on individuals with chronic diseases for whom lifelong cure has been inaccessible so far remains to be thoroughly recognized by government bodies. This is critical for reimbursement agencies to absorb the cost of the cure and calls for a partnership between health care systems and the pharmaceutical industry. However, bridging the gap between the costs of the advanced treatments approved for commercialization and their readiness to persons with HA and HB is still a challenging task.

Direct oral anticoagulants (DOACs) represent a new generation of drugs that have been increasingly used in the prevention and treatment of thromboembolic states. According to the mechanism of anticoagulant action, DOACs are divided into two groups: direct inhibitors of thrombin (dabigatran) and direct inhibitors of activated factor X (FXa) (rivaroxaban, apixaban, edoxaban, betrixaban). Compared to the vitamin K antagonists, DOACs are superior in terms of onset of action, pharmacokinetic and pharmacodynamics properties and fixed daily dose without the need for routine coagulation monitoring. Despite these advantages, there are clinical conditions in which laboratory measurement of DOACs should be performed. Although DOACs have an impact on screening haemostasis assays (prothrombin time, PT; activated partial thromboplastin time, aPTT; and thrombin time, TT), these tests are not appropriate for quantifying drug levels. Therefore, specific quantitative methods (LC-MS/MS as a gold standard method for all DOACs, coagulometric and chromogenic assays for dabigatran, and chromogenic anti-Xa assays with drug-specific calibrators for inhibitors of FXa) should only be used for determination of DOACs concentration. The aim of this review is to present all aspects of laboratory assessment of DOACs, including pre-analytical, analytical and post-analytical factors in the overall testing process with a special accent on the available specific quantitative methods for measurement of DOACs in circulation.

Abstract Objectives There is scant research about laboratory monitoring in people taking conventional synthetic disease-modifying anti-rheumatic drugs (csDMARDs) for rheumatic disease. Our objective was to conduct a scoping study to assess the range of current attitudes and the variation in practice of laboratory monitoring of csDMARDs by rheumatologists and trainees. Methods Australian and overseas rheumatologists or trainees were invited through newsletter, Twitter and personal e-mail, to complete an anonymous online survey between 1 February and 22 March 2021. Questions focused on laboratory tests requested by csDMARD prescribed, frequency/pattern of monitoring, influence of additional factors and combination therapy, actions in response to abnormal tests, and attitudes to monitoring frequencies. Results were presented descriptively and analysed using linear and logistic regression. Results There were 221 valid responses. Most respondents were from Australia (n = 53, 35%) followed by the US (n = 39, 26%), with a slight preponderance of women (n = 84, 56%), ≥ 11 years in rheumatology practice (n = 83, 56%) and in mostly public practice (n = 79, 53%). Respondents had a wide variation in the frequency and scheduling of tests. In general, respondents reported increasing monitoring frequency if patients had numerous comorbidities or if both methotrexate and leflunomide were being taken concurrently. There was a wide variety of responses to abnormal monitoring results and 27 (40%) considered that in general, monitoring tests are performed too frequently. Conclusions The results demonstrated a wide variation in the frequency of testing, factors that should influence this, and what responses to abnormal test results are appropriate, indicates a likely lack of evidence and the need to define the risks, benefits and costs of different csDMARD monitoring regimens.

A universal calibrator for the determination of all anti-Xa inhibitors would support laboratory processes. We aimed to test the clinical performance of an anti-Xa assay utilizing a universal edoxaban calibrator to determine clinically relevant concentrations of all anti-Xa inhibitors. Following a pilot study, we enrolled 553 consecutive patients taking rivaroxaban, edoxaban, or apixaban from nine study centers in a prospective cross-sectional study. The Technochrom® anti-Xa assay was conducted using the Technoview® edoxaban calibrator. Using ultra-high-performance liquid chromatography-tandem mass spectrometry (LC-MS/MS), anti-Xa inhibitor drug concentrations were determined. Sensitivities and specificities to detect three clinically relevant drug concentrations (30 µgL−1, 50 µgL−1, 100 µgL−1) were determined. Overall, 300 patients treated with rivaroxaban, 221 with apixaban, and 32 with edoxaban were included. The overall correlation coefficient (rs) was 0.95 (95% CI 0.94, 0.96). An area under the receiver operating characteristic curve of 0.96 for 30 µgL−1, 0.98 for 50 µgL−1, and 0.99 for 100 µgL−1 was found. The sensitivities were 92.3% (95% CI 89.2, 94.6), 92.7% (89.4, 95.1), and 94.8% (91.1, 97.0), respectively (specificities 82.2%, 93.7%, and 94.4%). In conclusion, the clinical performance of a universal, edoxaban-calibrated anti-Xa assay was solid and most drug concentrations were predicted correctly. [ABSTRACT FROM AUTHOR]

Purpose Patients receiving biologic therapy for inflammatory bowel disease (IBD) require routine laboratory monitoring to ensure the safety and efficacy of therapy. The purpose of this quality improvement project was to evaluate the implementation of a dashboard to prevent treatment gaps by prospectively identifying patients with IBD and outdated laboratory results receiving biologics. Methods We performed a pre/post analysis of dashboard implementation to assess the number of patients with overdue laboratory work resulting in treatment gaps. The dashboard combined data from the electronic health record (EHR) and pharmacy claims database to identify patients on a biologic with laboratory tests (white blood cell count, liver transaminases, C-reactive protein, and erythrocyte sedimentation rate) completed 5 or more months ago and/or a tuberculosis screen completed 11 or more months ago. After implementation, specialty pharmacists reviewed the dashboard and communicated via EHR if a new prescription and laboratory tests were needed. Messages were sent 4 weeks in advance of the next refill-eligible date. Mixed methods were used for analysis of qualitative data, including surveys, and quantitative data, assessing treatment gap length. Results A total of 40 patients who had outdated laboratory values and required a new prescription (15 before dashboard implementation and 25 after implementation) were included in the analysis. The frequency of a treatment gap decreased from 80% (n = 12) in the preimplementation phase to 32% (n = 8) in the postimplementation phase. The median gap length was shorter after dashboard implementation, decreasing from 21 days (range, 3-97 days) to 11 days (range, 2-23 days). Conclusion Utilization of a quality measures dashboard decreased treatment gaps in patients with IBD receiving biologic therapy. Integrated specialty pharmacists are uniquely positioned to monitor adherence to laboratory monitoring parameters for patients on biologics. [ABSTRACT FROM AUTHOR]

Depending on end-organ involvement, hypertensive crisis is classified as hypertensive urgency or hypertensive emergency. The recognition of a hypertensive crisis will lead to the adequate reduction of blood pressure to ameliorate the incidence of end-organ damage. Hypertensive crises result from dysfunction in the renin-angiotensin-aldosterone system and damage to the vascular bed. They occur commonly in the emergency department setting and can lead to increased mortality rates if not treated. Registered nurses play a vital role in assessing patients and administering medications during hypertensive crises. This article will outline the assessment strategies that registered nurses should implement in critical care units while patients are receiving antihypertensive drugs. We will also underscore the significance of monitoring specific laboratory values to mitigate the potential side effects of these drugs and exclude them when contraindicated. [ABSTRACT FROM AUTHOR]

Regular measurement of fibrinogen as dose guidance in catheter directed thrombolysis (CDT) for acute limb ischaemia (ALI) has recently been dropped from European guidelines based on inconsistent literature. This study aimed to determine whether low fibrinogen levels and high activated partial thromboplastin time (APTT) are associated with an increased major bleeding risk during CDT. All consecutive patients treated with CDT for ALI in two Dutch hospitals between January 2004 and April 2021 were analysed retrospectively. Patients were treated with two dosing regimens (low dose: 50 000 IU/hour; high dose: 100 000 IU/hour) of urokinase and, after 2018, with a single low dose regimen of alteplase (rtPA) due to urokinase manufacturing problems. The incidence of major bleeding and associated APTT and fibrinogen levels were reviewed from patient charts. Of the 443 included cases, 277 underwent CDT with urokinase and 166 with rtPA. The incidence of major bleeding in the whole cohort was 7%. Patients with a fibrinogen levels < 1.0 g/L developed more major bleeding than those in whom the fibrinogen level did not drop below 1.0 g/L (15% vs. 6%; p =.041). Systemic heparinisation during CDT or high (> 80 seconds) APTT were not significantly associated with major bleeding. Angiographic success (47% vs. 72%; p =.003) and 30 day amputation free survival (53% vs. 82%; p <.001) were lower for cases with major bleeding. Older age (odds ratio [OR] 1.06, 95% confidence interval [CI] 1.02 – 1.11), cardiac history (OR 3.35, 95% CI 1.39 – 8.06), high dose regimens (≥ 75 000 IU/hour urokinase; OR 2.67, 95% CI 1.18 – 6.04), and fibrinogen values < 1.0 g/L (OR 5.59, 95% CI 1.98 – 15.77) were independent predictors for major bleeding during CDT. High dose thrombolytic regimens and fibrinogen levels of ≤ 1.0 g/L are associated with more major bleeding during thrombolytic therapy. Major bleeding significantly worsened the clinical outcome. A prospective comparative study is needed to assess the benefit of monitoring fibrinogen levels. [ABSTRACT FROM AUTHOR]

Introduction: Management of haemorrhage depends on the severity of bleeding and associated injuries. In this paper, we present a case of bleeding patient on the anticoagulants for which there was no specific reversal agent. Aim of the study is to present the management of haemorrhage in a patient on anticoagulant therapy in the General Hospital in Loznica, Serbia. Material and methods: Overview of hospital documentation and physician's reports. Case report: In the abscence of a specific reversal agents and laboratory tests, management of haemorrhage included methods of mechanical/surgical haemorrhage control, application of antifibrinolitics and administration of blood products, such as fresh frozen plasma (FFP), combined with forced diuresis and 7-day clinial follow-up period. NOAC treatment was suspended until the complete stopping of bleeding. After the bleeding was stopped, non-vitamin-K oral anticoagulants (NOAC) treatment was resumed with lowered dosis. Conclusion: In the abscence of specific reversal agents, reversion of NOAC effects is possible in minor haemorrhage. Patients with major haemorrhage should be treated with available specific reversal agents and/or prothrombin complex concentrate (PCC). However, this type of therapy is currrently available only in the terciary health care intitutions.

BACKGROUND: There are many inefficiencies related to oral chemotherapy (OC) laboratory monitoring and follow-up in the ambulatory clinic setting. Patients with cancer prescribed OC have a higher risk of adverse events when there is inconsistent laboratory test result reporting and follow-up from their oncology provider. OBJECTIVES: The aim of this article is to improve OC laboratory monitoring by identifying potential barriers and opportunities for reliable communication between patients and providers in the outpatient clinical setting. METHODS: A literature review found 76 articles, of which 15 were selected for review. Six themes were synthesized and discussed. FINDINGS: Healthcare systems use technology, standard pathways, and clear patient–provider communication following laboratory testing to ensure patient safety. Implementing and testing evidence-based solutions and structured frameworks to identify gaps in outpatient laboratory monitoring and follow-up can improve patient satisfaction and safety during OC treatment. [ABSTRACT FROM AUTHOR]

Hidradenitis suppurativa (HS) is a chronic cutaneous and systemic inflammatory condition. Increasingly, reports have found that immunoglobulins play a role in the exaggerated immune response occurring in severe HS. It is important to recognize these implications as HS patients may present with laboratory abnormalities relating to chronic inflammation and immune activation. If these laboratory abnormalities are mistakenly associated with another disease process, it could lead to invasive workup and treatment, causing harm to patients. We describe the case of a 23-year-old woman with Hurley stage III HS who was hospitalized and found to have persistent immunoglobulin-G4 (IgG4) elevation. Upon discharge, the patient was diagnosed with IgG4-related disease (IgG4-RD) and started treatment with azathioprine. However, the biopsy ultimately was negative for IgG4-RD, and she presented to our clinic several months later with worsening HS disease during an active flare. Physical examination revealed actively draining nodules and sinus tracts in the bilateral axillae, inguinal folds, and mons pubis region. A confusing laboratory marker with HS was observed in this case. IgG4 has the potential to inhibit or activate inflammation depending on the context, and so IgG4 elevation has been noted in varying disease states. IgG4 elevation is observed in chronic inflammatory states and may represent a compensatory response by the body. While no other cases have reported the association between HS and IgG4 elevation, IgG levels have been found to reflect HS disease severity. Therefore, IgG4 could play a potential role in HS disease monitoring, and awareness of this association is important for providers when managing patients with HS., Competing Interests: The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest., (Copyright © 2024 Gauger, Fritz and Burgin.)

In this letter, we discuss the topic of necessity of routine laboratory monitoring during isotretinoin treatment for acne. According to Park and colleagues, it is advisable to monitor the levels of triglycerides, alanine aminotransferase, and aspartate aminotransferase every 5 to 6 months. Additionally, the levels of total cholesterol and low-density lipoprotein should be checked within the first two months of treatment. Isotretinoin is a commonly prescribed agent mainly used to treat acne. Despite its high effectiveness, it necessitates regular monitoring of laboratory parameters due to its side effect profile. Currently, there remains a lack of consensus on the appropriate frequency for monitoring these parameters during treatment with isotretinoin. This letter will provide insight into this complex and controversial topic. Based on existing literature, we concluded that the incidence of changes in lipid and liver aminotransferase levels during isotretinoin treatment for acne was low and likely clinically insignificant. For generally healthy people, we recommend testing lipid and liver profiles once at baseline and a second time at the peak dosage. However, frequent testing might still be beneficial in certain populations of patients., Competing Interests: Conflict-of-interest statement: All authors declare that they have no conflict of interest to disclose., (©The Author(s) 2024. Published by Baishideng Publishing Group Inc. All rights reserved.)

Prothrombinase-induced clotting time (PiCT) is proposed as a rapid and inexpensive laboratory test to measure direct oral anticoagulant (DOAC) drug levels. In a prospective, multicenter cross-sectional study, including 851 patients, we aimed to study the accuracy of PiCT in determining rivaroxaban, apixaban, and edoxaban drug concentrations and assessed whether clinically relevant drug levels could be predicted correctly. Citrated plasma samples were collected, and the Pefakit® PiCT was utilized. Ultra-high performance liquid chromatography-tandem mass spectrometry (LC-MS/MS) was performed to measure drug concentrations. Cut-off levels were established using receiver-operating characteristics curves. We calculated sensitivities and specificities with respect to clinically relevant drug concentrations. Spearman's correlation coefficient between PiCT and drug concentrations was 0.85 in the case of rivaroxaban (95% CI 0.82, 0.88), 0.66 for apixaban (95% CI 0.60, 0.71), and 0.78 for edoxaban (95% CI 0.65, 0.86). The sensitivity to detect clinically relevant drug concentrations was 85.1% in the case of 30 µg L−1 (95% CI 82.0, 87.7; specificity 77.9; 72.1, 82.7), 85.7% in the case of 50 µg L−1 (82.4, 88.4; specificity 77.3; 72.5, 81.5), and 85.1% in the case of 100 µg L−1 (80.9, 88.4; specificity 73.2%; 69.1, 76.9). In conclusion, the association of PiCT with DOAC concentrations was fair, and the majority of clinically relevant drug concentrations were correctly predicted. [ABSTRACT FROM AUTHOR]

Current laboratory monitoring may not be optimal.A retrospective chart review was performed on thelaboratory results of 246 patients who were treatedwith isotretinoin for acne over a 9-year period. Testsobtained were CBC, lipid panel, AST, ALT, CK, GGT,and C-reactive protein. Thirty-five patients had anelevated AST and 35 of these had an elevated CK; 32had an elevated ALT and 11 of these had an elevatedCK. Thirteen patients had an elevated GGT; in 5 thiswas the only abnormality, whereas 8 had a GGTelevation accompanied by an elevated AST or ALT.Two had an elevated GGT and an elevated CK withnormal AST and ALT. Fifty-two patients had a singleepisode of elevated CK, of which 22 were female.However, 57 had multiple CK elevations and only onewas female. Thirty-five patients had CK elevations

A universal calibrator for the determination of all anti-Xa inhibitors would support laboratory processes. We aimed to test the clinical performance of an anti-Xa assay utilizing a universal edoxaban calibrator to determine clinically relevant concentrations of all anti-Xa inhibitors. Following a pilot study, we enrolled 553 consecutive patients taking rivaroxaban, edoxaban, or apixaban from nine study centers in a prospective cross-sectional study. The Technochrom® anti-Xa assay was conducted using the Technoview® edoxaban calibrator. Using ultra-high-performance liquid chromatography-tandem mass spectrometry (LC-MS/MS), anti-Xa inhibitor drug concentrations were determined. Sensitivities and specificities to detect three clinically relevant drug concentrations (30 µgL−1, 50 µgL−1, 100 µgL−1) were determined. Overall, 300 patients treated with rivaroxaban, 221 with apixaban, and 32 with edoxaban were included. The overall correlation coefficient (rs) was 0.95 (95% CI 0.94, 0.96). An area under the receiver operating characteristic curve of 0.96 for 30 µgL−1, 0.98 for 50 µgL−1, and 0.99 for 100 µgL−1 was found. The sensitivities were 92.3% (95% CI 89.2, 94.6), 92.7% (89.4, 95.1), and 94.8% (91.1, 97.0), respectively (specificities 82.2%, 93.7%, and 94.4%). In conclusion, the clinical performance of a universal, edoxaban-calibrated anti-Xa assay was solid and most drug concentrations were predicted correctly.

The routine monitoring of direct oral anticoagulants (DOACs) may be considered in patients with renal impairment, patients who are heavily obese, or patients requiring elective surgery. Using the heparin-binding copolymer (HBC) and polybrene, we aimed to develop a solution for monitoring the anticoagulant activity of DOACs in human plasma in the interfering presence of unfractionated heparin (UFH) and enoxaparin. The thrombin time (TT) and anti-factor Xa activity were monitored in pooled plasma from healthy volunteers. In these tests, plasma with dabigatran or rivaroxaban was mixed with UFH or enoxaparin and then incubated with HBC or polybrene, respectively. HBC and polybrene neutralized heparins and enabled monitoring of anticoagulant activity of dabigatran in the TT test. Both agents allowed for accurate measurement of anti-factor Xa activity in the plasma containing rivaroxaban and heparins in the concentration range reached in patients' blood. Here, we present diagnostic tools that may improve the control of anticoagulation by eliminating the contamination of blood samples with heparins and enabling the monitoring of DOACs' activity. [ABSTRACT FROM AUTHOR]

Objective: Tuberculosis (TB) is the leading cause of death in HIV-positive people. In Kenya, 140 000 new TB cases occurred in 2019, and 13 000 HIV-positive patients died due to TB. The objective of this study was to investigate the role of high-sensitivity C-reactive protein (HS-CRP) in TB diagnosis and the prediction of mortality in HIV-positive patients. Methods: The IDEA-TB Study enrolled HIV-positive adult patients attending three DREAM centres in Kenya who were suspected of having TB. A lateral flow urine lipoarabinomannan assay (LF-LAM), serum HS-CRP, and GeneXpert MTB/RIF assay (Xpert MTB/RIF) were performed. Six-month survival was evaluated. Results: A total of 574 patients were enrolled. The median (interquartile range) age, body mass index, and CD4 count were 45 years (37–54 years), 20.5 kg/m2 (18.5–23.69 kg/m2), and 477 cells/mL (290–700 cells/mL), respectively. TB was confirmed in 87 (15.2%) patients. Concordance between the Xpert MTB/RIF and LF-LAM tests was 87.1%. HS-CRP was higher in TB patients (35.39 mg/l vs 9.21 mg/l). Malnutrition and elevated HS-CRP were associated with TB: odds ratio (OR) 2.5 (95% confidence interval (CI) 1.14–5.72) and OR 6.6 (95% CI 3.87–11.52), respectively. Nine (1.6%) patients died during follow-up. No single factor was associated with mortality. Only the combination of malnutrition and elevated HS-CRP was highly predictive of death (odds ratio (OR) 9.8, 95% CI 1.88–50.95); the association was stronger in TB patients (33.3% vs 1.0%; OR 47.6, 95% CI 7.03–322.23). Conclusion: TB diagnosis in HIV-positive patients remains challenging. HS-CRP could play a role in predicting early mortality in symptomatic patients.

Background and objectives: Outpatient parenteral antimicrobial therapy (OPAT) for infections has been in use for nearly 40 years, and although it has been found safe and efficacious, its use has been studied primarily among otherwise healthy patients. We aimed to develop and evaluate an OPAT program for patients with cancer, particularly solid tumors. Methods: We implemented multiple quality improvement interventions between June 2018 and January 2020. We retrospectively and prospectively collected data on demographics, the completeness of infectious diseases (ID) physician consultation notes, rates of laboratory test result monitoring, ID clinic follow-up, and 30-day outcomes, including unplanned OPAT-related readmissions, OPAT-related emergency center visits, and deaths. Results: Completeness of ID provider notes improved from a baseline of 77 to 100% (p <.0001) for antimicrobial recommendations, 75 to 97% (p <.0001) for follow-up recommendations, and 19 to 98% (p <.0001) for laboratory test result monitoring recommendations. Completion of laboratory tests increased from a baseline rate of 24 to 56% (p =.027). Thirty-day unplanned OPAT-related readmission, ID clinic follow-up, 30-day emergency center visit, and death rates improved without reaching statistical significance. Conclusions: Sustained efforts, multiple interventions, and multidisciplinary engagement can improve laboratory test result monitoring among solid tumor patients discharged with OPAT. Although demonstrating a decrease in unplanned readmissions through institution of a formal OPAT program among patients with solid malignancies may be more difficult compared with the general population, the program may still result in improved safety. [ABSTRACT FROM AUTHOR]

Chemical, analytical and biological laboratories use a variety of different solvents and gases. Many of these compounds are harmful or even toxic to laboratory personnel. Permanent monitoring of the air quality is therefore of great importance regarding the greatest possible occupational safety and the detection of dangerous situations in the work process. An increasing need exists for the development and application of small and portable sensor solutions that enable personal monitoring and that can be flexibly adapted to different environments and situations. Different sensor principles are available for the detection of gases and solvent vapors, which differ in terms of their selectivity and sensitivity. Besides simple sensing elements, integrated sensors and smart sensors are increasingly available, which, depending on their scope of functions, require a distinct effort in integration. This chapter gives an overview of available sensors and their integration options, and describes ready-to-use sensor systems for personal monitoring in life science laboratories. [ABSTRACT FROM AUTHOR]

Measles vaccination In Russian Federation was introduced in 1967. It was assumed that the twodose vaccination regime would lead to a decrease in the incidence and elimination of measles. A number of studies have shown that up to 10% of individuals who received two doses of measles vaccine do not develop a specific humoral immunity, or do not maintain it at a protective level. This fact may contribute to gradual accumulation of persons susceptible for measles infection in the population, thus leading to emergence of new viral outbreaks in the future. The aim of this study was to perform dynamic monitoring of the post-vaccination measles immunity. The study involved 149 people. All the examined persons were divided into 2 groups. The group of comparison included persons, aged 19 to 51 years, in whom absence of measles immunity was serologically confirmed (n = 76). This group was twice vaccinated with live measles culture vaccine (NPO “Microgen”, Russia). Determination of IgG to measles virus was carried out 1 month after vaccination and revaccination. The control group consisted of persons with documented evidence of double immunization against measles virus, with laboratory-confirmed measles immunity (n = 73), aged 19 to 53 years. The comparative dynamics of development and contents of antibodies in the comparison-control groups were considered, with respect to the WHO age classification. Basic and postvaccinal dynamic determination of IgG to measles virus in serum was performed by ELISA using the “VectoKor-IgG” test system (Vector-Best, Novosibirsk). When analyzing the results of the study, it was noted that the level of measles immunity group in older persons from control group (over 45 years old) was initially higher, than in younger subjects. Among young people, the titers of specific measles antibodies reached the values of the control group of the corresponding age after the first vaccination, whereas the level of specific measles antibodies in older age group was significantly lower compared to the control group even after revaccination. A month after the first immunization, 4 people did not reach the protective level of anti-measles IgG. However, revaccination allowed them to form anti-measles immunity. In the course of our work, a case of non-response to vaccination was identified. Thus, our study showed a sufficient interindividual variability in humoral immune responses to measles vaccination.

The classical oral anticoagulants are increasingly being replaced in clinical practice by new antithrombotic drugs, which act by enabling direct inhibition of coagulation factor IIa (FIIa) or factor Xa (FXa). These drugs have multiple acronyms, including NOACs (new, non-vitamin K antagonist) or DOACs (direct oral anticoagulants), and currently include dabigatran (FIIa inhibitor), and rivaroxaban, apixaban, and edoxaban (FXa inhibitors). These drugs are approved for stroke prevention in patients with non-valvular atrial fibrillation and the prevention and treatment of venous thromboembolism. The "mantra" that DOACs do not require laboratory monitoring is not entirely correct because laboratory testing for drug effects is needed in many situations, because they influence hemostasis tests and in situations in which urgent measurement of DOACs is required. This should be very important to consider in the clinical situation for numbers of indications and increasing numbers of patients on DOACs therapy. The main aim of this article is to provide practical issues to general laboratory testing for DOACs, as well as to help avoid diagnostic errors associated with hemostasis testing. The assays for DOAC quantification must be available in medical centers on a whole day basis, to facilitate optimal drug management in conditions when things go wrong or in urgent cases of immediate reversal of anticoagulation or appropriate administration of a specific antidote.

BackgroundApplying a single anti-Xa assay, calibrated to unfractionated heparin to measure rivaroxaban, apixaban, and edoxaban would simplify laboratory procedures and save healthcare costs.AimWe hypothesized that a heparin-calibrated anti-Xa assay would accurately measure rivaroxaban, apixaban, and edoxaban drug concentrations and correctly predict clinically relevant drug levels.MethodsThis analysis is part of the Simple-Xa study, a prospective multicenter cross-sectional study conducted in clinical practice. Patients treated with rivaroxaban, apixaban, or edoxaban were included. Anti-Xa activity was measured using the Siemens INNOVANCE® Heparin assay. Drug concentrations were determined using ultra-high performance liquid chromatography-tandem mass spectrometry (LC-MS/MS). Cut-off levels were determined in a derivation dataset (50% of patients) and sensitivities and specificities were calculated in a verification dataset (50% of patients).ResultsOverall, 845 patients were available for analysis. Correlation coefficients (rs) between the heparin-calibrated anti-Xa assay and drug concentrations were 0.97 (95% CI 0.97, 0.98) for rivaroxaban, 0.96 (0.96, 0.97) for apixaban, and 0.96 (0.94, 0.99) for edoxaban. The area under the receiver operating characteristics curve (ROC) was 0.99 for all clinically relevant drug concentrations. In the verification dataset, the sensitivity was 94.2% (95% CI 90.8–96.6) for 30 μg L–1, 95.8% (92.4–98.0) for 50 μg L–1, and 98.7% (95.5–99.9) for 100 μg L–1. Specificities were 86.3% (79.2–91.7), 89.8% (84.5–93.7), and 88.7% (84.2–92.2), respectively.ConclusionIn a large prospective study in clinical practice, a strong correlation of heparin-calibrated anti-Xa measurements with LC-MS/MS results was observed and clinically relevant drug concentrations were predicted correctly.

Background: The thrombin generation assay (TG) is a promising approach to measure the degree of anticoagulation in patients treated with direct oral anticoagulants (DOAC). A strong association with plasma drug concentrations would be a meaningful argument for the potential use to monitor DOAC.Objectives: We aimed to study the correlation of TG with rivaroxaban, apixaban, and edoxaban drug concentrations in a large, prospective multicenter cross-sectional study.Methods: Five-hundred and fifty-nine patients were included in nine tertiary hospitals. The Technothrombin® TG was conducted in addition to an anti-Xa assay; LC-MS/MS was performed as the reference standard.Results: Correlation (rs) between thrombin generation measurements and drug concentrations was −0.72 for peak thrombin generation (95% confidence interval, CI, −0.77, −0.66), −0.55 for area under the curve (AUC; 95% CI −0.61, −0.48), and 0.80 for lag time (95% CI 0.75, 0.84). In contrast, rs was 0.96 with results of the anti-Xa activity (95% CI 0.95–0.97). Sensitivity with regard to the clinically relevant cut-off value of 50 μgL−1 was 49% in case of peak thrombin generation (95% CI, 44, 55), 29% in case of AUC (95% CI, 24, 34), and 64% in case of lag time (95% CI, 58, 69). Sensitivity of the anti-Xa assay was 95% (95% CI, 92, 97).Conclusions: The correlation of thrombin generation measurements with DOAC drug concentrations was weak, and clinically relevant drug levels were not predicted correctly. Our results do not support an application of TG in the monitoring of DOAC.

Background/objectives: Literature regarding the cost and necessity of laboratory monitoring during oral antifungal treatment in adults has recently been published. However, consensus guidelines for the treatment and monitoring of pediatric patients with systemic antifungals for onychomycosis are lacking. We sought to evaluate both the practice trends and perspectives of pediatric dermatology providers who treat pediatric onychomycosis. Methods: An electronic survey was administered to providers belonging to the Society for Pediatric Dermatology (SPD) and/or Pediatric Dermatology Research Alliance (PeDRA) regarding their clinical practice and reasoning for laboratory monitoring during the treatment of pediatric onychomycosis. Results: One hundred and twenty‐one providers completed the survey (12.5%). 77% identified themselves as pediatric dermatologists. A majority practice in the academic setting (51%), and 54% were primarily only pediatric providers. All respondents prescribe oral terbinafine for onychomycosis. 88% of respondents always or almost always confirm the diagnosis of onychomycosis prior to prescribing oral terbinafine for onychomycosis. 39% always or almost always routinely order baseline laboratory tests while 40% never or almost never do. 41% never or almost never order monitoring laboratory tests during treatment while 32% always or almost always do. 91.5% have never discovered a significant reaction to terbinafine with routine monitoring. Conclusion: Pediatric dermatology providers are very likely to confirm the diagnosis of onychomycosis prior to systemic treatment. Significant variability was found in pretreatment and treatment laboratory monitoring, reasons for laboratory monitoring or deferral of testing, and timing of testing among providers. Knowledge of current practice trends as well as provider perspectives may be useful in the future development of consensus guidelines. [ABSTRACT FROM AUTHOR]

Prothrombinase-induced clotting time (PiCT) is proposed as a rapid and inexpensive laboratory test to measure direct oral anticoagulant (DOAC) drug levels. In a prospective, multicenter cross-sectional study, including 851 patients, we aimed to study the accuracy of PiCT in determining rivaroxaban, apixaban, and edoxaban drug concentrations and assessed whether clinically relevant drug levels could be predicted correctly. Citrated plasma samples were collected, and the Pefakit® PiCT was utilized. Ultra-high performance liquid chromatography-tandem mass spectrometry (LC-MS/MS) was performed to measure drug concentrations. Cut-off levels were established using receiver-operating characteristics curves. We calculated sensitivities and specificities with respect to clinically relevant drug concentrations. Spearman’s correlation coefficient between PiCT and drug concentrations was 0.85 in the case of rivaroxaban (95% CI 0.82, 0.88), 0.66 for apixaban (95% CI 0.60, 0.71), and 0.78 for edoxaban (95% CI 0.65, 0.86). The sensitivity to detect clinically relevant drug concentrations was 85.1% in the case of 30 µg L−1 (95% CI 82.0, 87.7; specificity 77.9; 72.1, 82.7), 85.7% in the case of 50 µg L−1 (82.4, 88.4; specificity 77.3; 72.5, 81.5), and 85.1% in the case of 100 µg L−1 (80.9, 88.4; specificity 73.2%; 69.1, 76.9). In conclusion, the association of PiCT with DOAC concentrations was fair, and the majority of clinically relevant drug concentrations were correctly predicted.

Background: The objectives of this retrospective cohort study are to describe rates of adherence to laboratory testing 6 months to 3 years post–liver transplantation and to examine demographic and clinical factors related to lab non‐adherence and the association with medication adherence and clinical outcomes. Methods: Medical chart review was conducted for 54 youth (mean age = 5.0 years) transplanted between 2003 and 2014. Lab adherence (≥80%) was measured as the proportion of completed labs out of the number expected. Immunosuppressant drug‐level variability was used as a proxy for medication adherence. Clinical outcomes included LAR, viral infection, hospitalization, and non‐routine clinic visit ≥12 months after transplant. Results: Lab adherence decreased substantially over time. Single‐parent household (aOR 5.86; 95% CI: 1.38‐24.93) and no history of early rejection (aOR 3.96; 95% CI: 1.04‐15.24) were independently associated with non‐adherence. Lab non‐adherence was significantly associated with medication non‐adherence (P <.05), LAR (P =.02), and non‐routine clinic visits (P =.03). Conclusions: Systematic monitoring of lab adherence may help in identifying pediatric LT recipients at increased risk for excessive healthcare use and adverse outcomes possibly due to poor disease management. [ABSTRACT FROM AUTHOR]

We assessed laboratory monitoring after combination antiretroviral therapy initiation among 3678 patients in a large US multisite clinical cohort, censoring participants at last clinic visit, combination antiretroviral therapy change, or 3 years. Median days (interquartile range) to first hematologic, hepatic, renal, and lipid tests were 30 (18-53), 31 (19-56), 33 (20-59), and 350 (96-1106), respectively. At 1 year, approximately 80% received more than 2 hematologic, hepatic, and renal tests consistent with guidelines. However, only 40% received 1 or more lipid tests. Monitoring was more frequent in specific subgroups, likely reflecting better clinic attendance or clinician perception of higher susceptibility to toxicities.

• Elevated high-sensitivity C-reactive protein levels were associated with TB test results in HIV-positive Kenyan patients. • Malnutrition and elevated HS-CRP were found to be associated with TB in HIV-positive patients. • Combined malnutrition and elevated HS-CRP waere correlated with short-term mortality, especially in TB-negative patients. • HS-CRP could play a role in HIV care services as a predictor of TB infection and short-term mortality. Tuberculosis (TB) is the leading cause of death in HIV-positive people. In Kenya, 140 000 new TB cases occurred in 2019, and 13 000 HIV-positive patients died due to TB. The objective of this study was to investigate the role of high-sensitivity C-reactive protein (HS-CRP) in TB diagnosis and the prediction of mortality in HIV-positive patients. The IDEA-TB Study enrolled HIV-positive adult patients attending three DREAM centres in Kenya who were suspected of having TB. A lateral flow urine lipoarabinomannan assay (LF-LAM), serum HS-CRP, and GeneXpert MTB/RIF assay (Xpert MTB/RIF) were performed. Six-month survival was evaluated. A total of 574 patients were enrolled. The median (interquartile range) age, body mass index, and CD4 count were 45 years (37–54 years), 20.5 kg/m2 (18.5–23.69 kg/m2), and 477 cells/mL (290–700 cells/mL), respectively. TB was confirmed in 87 (15.2%) patients. Concordance between the Xpert MTB/RIF and LF-LAM tests was 87.1%. HS-CRP was higher in TB patients (35.39 mg/l vs 9.21 mg/l). Malnutrition and elevated HS-CRP were associated with TB: odds ratio (OR) 2.5 (95% confidence interval (CI) 1.14–5.72) and OR 6.6 (95% CI 3.87–11.52), respectively. Nine (1.6%) patients died during follow-up. No single factor was associated with mortality. Only the combination of malnutrition and elevated HS-CRP was highly predictive of death (odds ratio (OR) 9.8, 95% CI 1.88–50.95); the association was stronger in TB patients (33.3% vs 1.0%; OR 47.6, 95% CI 7.03–322.23). TB diagnosis in HIV-positive patients remains challenging. HS-CRP could play a role in predicting early mortality in symptomatic patients. [ABSTRACT FROM AUTHOR]

Background: Swine enzootic pneumonia (SEP), caused by the bacterium Mycoplasma hyopneumoniae, is one of the main respiratory diseases of pigs. The purpose of this study was to evaluate the frequency of SEP in one farm with an independent production system, low level of technification and high losses in the meat packing plant, based on slaughterhouse, clinical and laboratory monitoring. Materials, Methods & Results: This study consisted of three monitoring steps, divided into 3 periods: P1, P2 and P3. In the first step of the study, slaughterhouse reports were analyzed and slaughtering was monitored at one meatpacking plant in Santa Maria, RS, Brazil. The second step of the study started by drawing up a profile of the farm that supplied the pigs to the aforementioned slaughterhouse, after which clinical monitoring was performed on three occasions. The third step of the study (laboratory monitoring) involved collecting lung fragments containing suspected SEP lesions from the meatpacking plant and subjecting them analysis. The average measured enzootic pneumonia (EP) in P3 was 38.54% (P < 0.05) higher than in P1 and 29.79 higher than in P2. The mean frequency of pulmonary emphysema (PE) in P3 was 59.13% (P < 0.05) higher than in P1 and 48.04% higher than in P2. The mean number of lung adhesions (LA) did not differ statistically (P > 0.05) between P1, P2 and P3. As for the mean frequency of pulmonary hepatization (PH), P3 was 48.80% higher (P < 0.05) than P1 and 41.78% higher than P2. With regard to the mean frequency of craniodorsal lung lesions (CLL), P3 was 48.26% higher (P < 0.05) than P1 and 40.77% higher than P2. The mean frequency of disseminated lesions (DL) and the pneumonia severity index (PSI) showed no statistical difference (P > 0.05) between the 3 evaluated periods. On the other hand, in the finishing period (FP), the frequency of coughing and sneezing was 37.56% (P < 0.05) higher in P1 than in P3. The frequency of coughing and sneezing evaluated in the nursery phase (CF) did not differ (P > 0.05) between periods. The samples sent to the laboratory MicroVet tested positive for M. hyopneumoniae, Influenza virus and Pasteurella multocida capsular type A. In the samples sent to the laboratory LABAC, the mean PCRmo (PCR for identification of Mollicutes) did not differ (P > 0.05) in the analyzed periods, although the presence of DNA from bacteria of the class Mollicutes was confirmed in the fragments. In addition, the mean results of PCRmy (PCR for identification of M. hyopneumoniae) also did not differ (P > 0.05), although they revealed positivity for M. hyopneumoniae. Discussion: In relationship to the mean frequency of PE in each analyzed period, our study revealed an increase in the number of pulmonary lesions at slaughter during the periods under analysis. This finding is in agreement with those of other authors, who explain that pneumonias is one of the main health problems for swine producers. Some lesions are identified more frequently in routine inspections in meatpacking plants, including pulmonary emphysema, lung adhesions and pneumonia caused by M. hyopneumoniae. In our study, we found that the clinical signs of respiratory distress decline between the periods under evaluation, but during slaughter, the lesions suggestive of SEP continued to show an upward trend, mainly because they were chronic. Other authors state that several control measures should be adopted to ensure good zootechnical indices, including vaccination, strategic medication and the reduction of risk factors, thereby minimizing the level of M. hyopneumoniae infection in the herd. [ABSTRACT FROM AUTHOR]

Objectives: National guidelines in Botswana recommend baseline CD4 count measurement and both CD4 and HIV viral load (VL) monitoring post‐antiretroviral therapy (ART) initiation. We evaluated the utility of CD4 count measurement in Botswana in the era of universal ART. Methods: CD4 and VL data were analysed for HIV‐infected adults undergoing CD4 count measurement in 2015–2017 at the Botswana Harvard HIV‐Reference Laboratory. We determined (1) the proportion of individuals with advanced HIV disease (CD4 count < 200 cells/µL) at initial CD4 assessment, (2) the proportion with an initial CD4 count ≥ 200 cells/µL experiencing a subsequent decline in CD4 count to < 200 cells/µL, and (3) the proportion of these immunologically failing individuals who had virological failure. Logistic regression modelling examined factors associated with advanced HIV disease. CD4 count trajectories were assessed using locally weighted scatterplot smoothing (LOWESS) regression. Results: Twenty‐five per cent (3571/14 423) of individuals with an initial CD4 assessment during the study period had advanced HIV disease at baseline. Older age [≥ 35 years; adjusted odds ratio (aOR) 1.9; 95% confidence interval (CI) 1.8–2.1] and male sex were associated with advanced HIV disease. Fifty per cent (7163/14 423) of individuals had at least two CD4 counts during the study period. Of those with an initial CD4 count ≥ 200 cells/µL, 4% (180/5061) experienced a decline in CD4 count to < 200 cells/µL; the majority of CD4 count declines were in virologically suppressed individuals and transient. Conclusions: One‐quarter of HIV‐positive individuals in Botswana still present with advanced HIV disease, highlighting the importance of baseline CD4 count measurement to identify this at‐risk population. Few with a baseline CD4 count ≥ 200 cells/µL experienced a drop below 200 cells/µL, suggesting limited utility for ongoing CD4 monitoring. [ABSTRACT FROM AUTHOR]

The most important direction in the system of anti-epidemic protection of the population and military personnel from dangerous infectious and natural focal diseases is epidemiological monitoring with the obligatory use of laboratory methods of detection of pathogens and their markers. On separate territories of placement of the military units which are a part of the southern military district, there are centers of natural and focal infections of dangerous infectious diseases (plague, tularemia, cholera). The article presents the results of laboratory studies during epidemiological monitoring of natural focal and dangerous infectious diseases, which can be used by the military medical service as an information basis for decision-making on the organization of anti-epidemic protection of troops in the event of emergency situations of biological and social nature in these areas.

The paper discusses the problem of laboratory monitoring in therapy with disease-modifying antirheumatic drugs (DMARDs) and biological agents (BAs) in patients with rheumatoid arthritis (RA). Due to the risk of adverse reactions, in particular to that of cardiovascular diseases, hepatotoxicity, hematological disorders, deterioration of renal function, infections, and bleeding caused by the use of DMARDs and BAs, recommendations are needed to have a list of tests for laboratory monitoring during this therapy and the frequency of their implementation in patients with RA.

In the United States, uptake of daily oral pre-exposure prophylaxis (PrEP) to prevent HIV continues to grow albeit at a slower than desired pace. Innovations in PrEP delivery systems may partially address structural challenges related to PrEP uptake and PrEP persistence, such as difficulty in attending clinic visits or completing laboratory testing. To study PrEP services offered by a telehealth company called Nurx, we conducted 31 in-depth interviews with prospective or current patients. We hypothesized that patients would find the quarterly laboratory monitoring requirements to be onerous especially in light of receiving all other aspects of PrEP care through a telehealth delivery system. However, interviewees characterized navigating laboratory systems as relatively easy and complying with the quarterly monitoring as a supplementary benefit of PrEP use. Our research illustrates that quarterly monitoring requirements are meaningful to some telehealth PrEP users and may facilitate persistent engagement in receipt of PrEP care. [ABSTRACT FROM AUTHOR]

It is a common practice to monitor blood tests in patients receiving long-term trimethoprim-sulfamethoxazole (TMP-SMZ) prophylaxis for recurrent urinary tract infections. This multicenter, randomized, placebo-controlled trial enrolled 607 children aged 2 to 71 months with vesicoureteral reflux diagnosed after symptomatic urinary tract infection. Study participants received TMP-SMZ (n = 302) or placebo (n = 305) and were followed for 2 years. Serum electrolytes (n ≥ 370), creatinine (n = 310), and complete blood counts (n ≥ 206) were measured at study entry and at the 24-month study conclusion. We found no significant electrolyte, renal, or hematologic abnormalities when comparing the treatment and placebo groups. We observed changes in several laboratory parameters in both treatment and placebo groups as would normally be expected with physiologic maturation. Changes were within the normal range for age. Long-term use of TMP-SMX had no treatment effect on complete blood count, serum electrolytes, or creatinine. Our findings do not support routine monitoring of these laboratory tests in children receiving long-term TMP-SMZ prophylaxis. [ABSTRACT FROM AUTHOR]

Assay discrepancies can occur with laboratory monitoring of FVIII and FIX replacement therapy, particularly for the extended half‐life products. This guideline collates current published data and provides advice on appropriate choice of assays for laboratory measurement of replacement therapy for patients with Haemophilia A and B without inhibitors. It is recommended that each haemophilia centre should ensure that appropriate laboratory assays are available for FVIII and FIX products in local clinical use. Patient samples should be assayed against calibrators traceable to WHO Plasma International Standards. Assay discrepancies are common especially for the extended half‐life FVIII and FIX products, and assays of these products may need to be verified with the specific CFC being used. [ABSTRACT FROM AUTHOR]

The direct oral anticoagulant drugs (DOAC) are generally safe and effective in several clinical settings including acute venous thromboembolic disease, prophylaxis in the postoperative setting, prevention of thromboembolism in patients with non-valvular atrial fibrillation, and in the management of acute coronary syndrome. The relatively short half-life, rapid onset of action, and predictable pharmacokinetics should simplify periprocedural use of the DOAC. The aim of this work is to propose and summarize periprocedural management of patients treated with the DOAC in dental practice and to inform about the principal specifications of this treatment.