Abnormal Laboratory Values Research Articles

Retrospective comparative study of laboratory parameters in Covid-19 positive deceased and non-deceased cases

Covid 19 infection came into existence in 2019 and hence the name. It started from a city in China named Wuhan. It continued to affect the whole world, so in 2020 it was declared as a pandemic outbreak and is prevalent worldwide till date. India is still suffering and struggling through its dreadful impact. The objective of this retrospective study is to analyze the laboratory parameters and to predict the severity/mortality related to the infection. A total of 312 hospitalized COVID-19 RTPCR positive patients from 1st April - 15 May 2021 were enrolled. Patients were categorized into deceased and non-deceased groups and their demographic as well as laboratory parameters were collected and compared. Out of 312 patients, 100 succumbed to disease. Majorities were males between 55 to 60 years. The laboratory values of TLC (p<0.0001), Neutrophil count (p<0.0001), Lymphocyte count (p<0.0001), Platelet count (p<0.0001), Neutrophil to Lymphocyte Ratio(NLR) (p<0.0001), plasma D-dimer(p=0.007717), serum CRP level (p=0.000174), serum Lactate dehydrogenase(LDH) level (p<0.0001), serum SGOT (p<0.0001), serum Ferritin (p=0.000085) were statistically significant for deceased as compared to non-deceased group. Serum SGPT was statistically insignificant. The attained results showed deranged laboratory parameters among COVID-19 positive patients. The mortality rate was found to be higher in elderly males as compared to females of same age group. There was significant correlation between the markedly abnormal laboratory values and severity/mortality of the COVID-19 infection, which could help in predicting the outcome of the disease in patients admitted to the hospitals.

A Two Part Case Series on Acquired Hemophilia A

Abstract Introduction/Objective Acquired Hemophilia A is a rare condition with an incidence of 1 per 1.5 million per year. The average age at presentation is 74 years. It is due to spontaneous production of IgG autoantibodies that target endogenous factor viii. This disease should be considered when a patient presents with bleeding, an abnormal prolongation of activated partial thromboplastin time and /or no prior personal or family history of bleeding. Autoimmune disorders and malignancy are common associations. Pregnancy and surgery are common presenting scenarios. Methods/Case Report Case 1: 71 year old female with a history of deep venous thrombosis, and rheumatoid arthritis. Patient presented to the emergency department with a hemoglobin of 4.7 and coagulation studies showed a prolonged partial thromboplastin time of 119 seconds. Imaging revealed retroperitoneal bleeding. A mixing study showed no correction of partial thromboplastin time. The patient was treated with packed red blood cell transfusions until hemodynamically stable. Further coagulation studies revealed a factor VIII activity of 3L and factor VIII inhibitor level of 103 bethesda units. This confirmed suspicion of an acquired factor VIII inhibitor associated with the patient’s rheumatoid arthritis as the source of abnormal lab values and bleeding. Patient was treated with recombinant factor VIIa, novoseven, along with continuous prednisone and cyclophosphamide. Case 2: 82 year old male with history of IgG Kappa Monoclonal Gammopathy of Undetermined Significance. Patient presented with gastrointestinal bleeding and 4g/Dl hemoglobin. He received 5 units of packed red blood cells. Sigmoidoscopy revealed a rectal ulcer causing lower gastrointestinal bleeding. An advanced coagulation study revealed factor VIII activity of 1%, and inhibitor levels of 17 bethesda units. Patient was started on prednisone initially, followed by cyclophosphamide. However, bleeding continued. He was treated with 6 units of recombinant factor VIIa and packed red blood cell transfusions as required to keep hemoglobin levels at 7g/Dl. He was continued on prednisone at an increased dosage and discharged. Results (if a Case Study enter NA) NA. Conclusion Acquired Hemophilia A is a rare disease. It should be suspected anytime there is unprecedented bleeding and/or unexplained prolongation of partial thromboplastin time. It is diagnosed with factor VIII panel, including inhibitor. Treatment includes immunosuppresants, intravenous immunoglobulins, and recombinant factor VIIa.

DISSEMINATED INVASIVE ASPERGILLUS MASQUERADING AS AMIODARONE-INDUCED THYROTOXICOSIS

DISSEMINATED INVASIVE ASPERGILLUS MASQUERADING AS AMIODARONE-INDUCED THYROTOXICOSIS

S3238 A Case of Concurrent Cholecystitis and Stauffer Syndrome

Introduction: Stauffer syndrome (SS) is a paraneoplastic syndrome seen in some malignancies, most commonly 4-15% of primary renal cell carcinomas, resulting in nephrogenic hepatic dysfunction. SS commonly results in elevated alkaline phosphatase, alanine aminotransferase, aspartate aminotransferase, and prothrombin time (PT) as well as decreased albumin in the absence of liver metastasis. The etiology of SS is unknown, although three have been suggested: elevated interleukin-6, elevated colony stimulating factor or, least likely, autoimmune. We describe a case of a woman presenting with right upper quadrant (RUQ) pain who was found to have indirect predominant hyperbilirubinemia and acute cholecystitis and renal mass on ultrasound. Case Description/Methods: An 81-year-old female presented to an outside hospital for RUQ and epigastric pain that worsened after fatty meals. Imaging showed acute cholecystitis as well as a right renal mass. Physical exam at the time was remarkable only for diffuse tenderness to abdominal palpation, most notably in the RUQ. There was no scleral icterus or costovertebral angle tenderness on exam. Labs on presentation can be seen in Table 1. Given the elevated indirect bilirubin, gastroenterology was consulted and suggested Gilbert syndrome (GS) or SS given their concern for renal cell carcinoma (RCC). The next day the patient underwent a laparoscopic cholecystectomy notable for acute gangrenous cholecystitis with cholelithiasis, and had rapid normalization of bilirubin over 48 hours. The patient followed with outpatient urology for renal biopsy, which was positive for clear cell RCC. Follow up imaging revealed scattered pulmonary nodules up to 1.1cm, with concern for metastasis. Surgery was deemed inappropriate and the patient was conservatively managed, given her wishes to prioritize quality of life and not undergo chemotherapy. (Figure) Discussion: This case illustrates an interesting clinical picture where a patient with confirmed cholecystitis also has a new renal mass, with elevated indirect bilirubin and PT, consistent with SS. The diagnosis of SS is made clinically, with hopeful resolution of abnormal lab values upon RCC resection. In this case, surgery was not indicated, hemolysis was ruled out with stable hemoglobin and normal peripheral smear, and the diagnoses of acute cholecystitis and RCC causing SS was made. In addition to hemolysis, GS, and Criggler-Najjar when working up indirect hyperbilirubinemia, it is imperative to include SS on the differential diagnosis.Figure 1.: CT abdomen with right renal mass. Table 1. - Patient labs on presentation and 2 days post-cholecystectomy Lab Admission Post-Op Day 2 Normal WBC Count (103 cells/uL) 17 14 4.1-9.3 Platelet (103/uL) 246 248 130-350 Hemoglobin (g/dL) 10.6 9.8 11-14.7 Albumin (g/dL) 3.3 2.7 3.5-5.2 Total Bilirubin (mg/dL) 2.8 0.9 0.1-1.2 Indirect Bilirubin (mg/dL) 2.4 0-0.9 Alkaline Phosphatase (IU/L) 96 102 30-115 AST (IU/L) 23 20 5-45 ALT (IU/L) 12 16 5-60 Lipase (U/L) 12 11-82 Prothrombin Time (s) 14.3 9.4-12.9 INR 1.2 0.83-1.14 AST = aspartate transaminase, ALT = alanine transaminase.

Hospital Readmissions After Total Joint Arthroplasty: An Updated Analysis and Implications for Value-Based Care

BackgroundWhile risk factors have been published for readmissions following primary total joint arthroplasty, little is known about the etiology of those costly adverse events. In this study, we sought to identify the reasons for 30-day readmission following primary total joint arthroplasty in a contemporary national patient sample. MethodsThe American College of Surgeons National Surgical Quality Improvement Program was queried to identify 367,199 patients who underwent primary total knee (TKA) or hip arthroplasty (THA) between 2011 and 2018. The primary outcomes were the annual rates of 30-day readmissions and the causes of those readmissions. ResultsThe 30-day readmission rate trended downward from 4.5% in 2011 to 3.3% in 2018. Medical complications accounted for 52.6% and 38.5% of readmissions following TKA and THA, respectively. Diseases of the circulatory system, abnormal laboratory values, and diseases of the digestive system were the leading causes of medical readmissions. Surgical complications accounted for 37.7% and 50.7% of readmissions following TKA and THA, respectively. Surgical site infections/wound disruption and venous thromboembolism were the leading two causes of surgical readmissions for THA and TKA. Prosthetic complications—namely dislocations and periprosthetic fractures—were the third leading cause of surgical readmissions for THA. For TKA, musculoskeletal conditions—namely pain and hematoma—were the third leading cause of surgical readmissions. ConclusionMedical complications accounted for half of all TKA readmissions and more than a third of THA readmissions. This could penalize institutions participating in value-based payment programs or dissuade others who are considering participation in such programs.

Valproic-induced Fanconi syndrome: Clinical features, risk factors, diagnosis and management.

ObjectiveAlthough Fanconi syndrome (FS) induced by valproate (VPA) has occasionally been reported, the detailed clinical features of the disease remain unclear. The aim of this study was to elucidate the clinical features of patients with VPA-induced FS.MethodsWe searched Chinese and English databases for all original studies, clinical reports, and case reports on VPA-induced FS published before March 2022.ResultsA total of 29 articles including 54 patients (28 males and 24 females) were included. The patients had a median age of 7 years (range 2–34 years), had severely disabled (87.0%), tube feeding (64.8%), and received an average of 1.8 medications other than VPA. The median duration of VPA treatment was 4 years (range 0.7–15.5). Pathological fractures (25.9%), unexplained fever (11.1%), muscle weakness (9.3%), and edema (9.3%) were the most common symptoms, while 18 patients were diagnosed in incidental laboratory tests. Blood tests revealed hypokalemia (69.2%), hypophosphatemia (98.0%), and hypouricemia (93.3%). Urinalysis revealed glucosuria (96.1%), proteinuria (100.0%), generalized hyperaminoaciduria (100.0 %), β2 macroglobulin (100.0%). Decreased percent total reabsorption of phosphate (%TRP) found in 94.1% of patients, and increased fractional excretion of uric acid (FEUA) were found in 100% of patients. The median time to resolution of FS after discontinuation of drug therapy was 3 months (range 0.25–18).ConclusionsThe possibility of FS needs to be considered with long-term VPA administration, especially in young, tube-fed, severely disabled patients who are co-administered with anticonvulsants. Patients receiving VPA should have regular blood and urine tests. Abnormal laboratory values returned to normal levels after VPA discontinuation.

Predicting Abnormalities in Laboratory Values of Patients in the Intensive Care Unit Using Different Deep Learning Models: Comparative Study.

BackgroundIn recent years, the volume of medical knowledge and health data has increased rapidly. For example, the increased availability of electronic health records (EHRs) provides accurate, up-to-date, and complete information about patients at the point of care and enables medical staff to have quick access to patient records for more coordinated and efficient care. With this increase in knowledge, the complexity of accurate, evidence-based medicine tends to grow all the time. Health care workers must deal with an increasing amount of data and documentation. Meanwhile, relevant patient data are frequently overshadowed by a layer of less relevant data, causing medical staff to often miss important values or abnormal trends and their importance to the progression of the patient’s case.ObjectiveThe goal of this work is to analyze the current laboratory results for patients in the intensive care unit (ICU) and classify which of these lab values could be abnormal the next time the test is done. Detecting near-future abnormalities can be useful to support clinicians in their decision-making process in the ICU by drawing their attention to the important values and focus on future lab testing, saving them both time and money. Additionally, it will give doctors more time to spend with patients, rather than skimming through a long list of lab values.MethodsWe used Structured Query Language to extract 25 lab values for mechanically ventilated patients in the ICU from the MIMIC-III and eICU data sets. Additionally, we applied time-windowed sampling and holding, and a support vector machine to fill in the missing values in the sparse time series, as well as the Tukey range to detect and delete anomalies. Then, we used the data to train 4 deep learning models for time series classification, as well as a gradient boosting–based algorithm and compared their performance on both data sets.ResultsThe models tested in this work (deep neural networks and gradient boosting), combined with the preprocessing pipeline, achieved an accuracy of at least 80% on the multilabel classification task. Moreover, the model based on the multiple convolutional neural network outperformed the other algorithms on both data sets, with the accuracy exceeding 89%.ConclusionsIn this work, we show that using machine learning and deep neural networks to predict near-future abnormalities in lab values can achieve satisfactory results. Our system was trained, validated, and tested on 2 well-known data sets to ensure that our system bridged the reality gap as much as possible. Finally, the model can be used in combination with our preprocessing pipeline on real-life EHRs to improve patients’ diagnosis and treatment.

Effect of bacterium in the malignant wounds of soft tissue sarcoma.

Malignant wounds (MWs) are rare skin lesions, which accompany ulceration, necrosis and infection caused by infiltration or damage by malignant tumor. The present study aimed to investigate the bacterial etiology implicated in MW in soft tissue sarcoma (STS), and the effectiveness of culture-guided perioperative antibacterial administration. A retrospective evaluation was conducted on medical records of patients who presented with MW between 2006 and 2020. A total of seven patients were included in the present study, in whom all tumors were relatively large (>5 cm) and high-grade. Subsequently, five patients underwent limb-sparing surgery, and three patients had distant metastases with a 5-year overall survival of 71%. Preoperative microbiological sampling from the wound identified 11 different bacterial strains in five patients. The infections were polymicrobial with an average of 2.6 strains isolated per patient (1 aerobic, 1.6 anaerobic bacteria). They were predominantly methicillin-sensitive Staphylococcus aureus. Patients with MWs from STS reported symptoms, including bleeding (71%), exudation (71%) and malodorous wound (43%) at the initial presentation; these completely resolved after surgery. All but one patient reported pain at the MW site with an average numeric rating scale of 4.4 at presentation that decreased to 1.4 (P=0.14) and 0.6 (P=0.04) one and two weeks after surgery, respectively. The patients had elevated C-reactive protein (71%), anemia (57%), low albumin (86%) and renal/liver dysfunction (14–29%). One patient was diagnosed with sepsis. Surgical resection afforded symptomatic relief and resolution of abnormal laboratory values. Although selected antibiotics were administered in four patients based on the preoperative antibiotic sensitivity test, surgical site infection (SSI) occurred in three patients. Therefore, the effectiveness of the selected antibiotics based on the results of the preoperative culture in preventing SSI needs to be investigated in the future. In conclusion, physicians should keep in mind that although surgical resection can improve the symptoms and abnormal values in laboratory examination form MW, it is accompanied with a high rate of SSI and poor prognosis.

Preoperative evaluation of coagulation status in neuromodulation patients.

The incidence of hemorrhage in patients who undergo deep brain stimulation (DBS) and spinal cord stimulation (SCS) is between 0.5% and 2.5%. Coagulation status is one of the factors that can predispose patients to the development of these complications. As a routine part of preoperative assessment, the authors obtain prothrombin time (PT), partial thromboplastin time (PTT), and platelet count. However, insurers often cover only PT/PTT laboratory tests if the patient is receiving warfarin/heparin. The authors aimed to examine their experience with abnormal coagulation parameters in patients who underwent neuromodulation. Patients who underwent neuromodulation (SCS, DBS, or intrathecal pump implantation) over a 9-year period and had preoperative laboratory values available were included. The authors determined abnormal values on the basis of a clinical protocol utilized at their practice, which combined the normal ranges of the laboratory tests and clinical relevance. This protocol had cutoff values of 12 seconds and 39 seconds for PT and PTT, respectively, and < 120,000 platelets/μl. The authors identified risk factors for these abnormalities and described interventions. Of the 1767 patients who met the inclusion criteria, 136 had abnormal preoperative laboratory values. Five of these 136 patients had values that were misclassified as abnormal because they were within the normal ranges at the outside facility where they were tested. Fifty-one patients had laboratory values outside the ranges of our protocol, but the surgeons reviewed and approved these patients without further intervention. Of the remaining 80 patients, 8 had known coagulopathies and 24 were receiving warfarin/heparin. The remaining 48 patients were receiving other anticoagulant/antiplatelet medications. These included apixaban/rivaroxaban/dabigatran anticoagulants (n = 22; mean ± SD PT 13.7 ± 2.5 seconds) and aspirin/clopidogrel/other antiplatelet medications (n = 26; mean ± SD PT 14.4 ± 5.8 seconds). Eight new coagulopathies were identified and further investigated with hematological analysis. New anticoagulants and antiplatelet medications are not monitored with PT/PTT, but they affect coagulation status and laboratory values. Although platelet function tests aid in a subset of medications, it is more difficult to assess the coagulation status of patients receiving novel anticoagulants. PT/PTT may provide value preoperatively.

54-Year-Old Woman With Altered Mental Status and Abdominal Pain

54-Year-Old Woman With Altered Mental Status and Abdominal Pain

P1047: REAL-WORLD SAFETY OF RUXOLITINIB IN PATIENTS WITH INTERMEDIATE OR HIGH RISK OF PRIMARY MYELOFIBROSIS, POST-POLYCYTHEMIA VERA MYELOFIBROSIS OR POST-ESSENTIAL THROMBOCYTHEMIA MYELOFIBROSIS IN CHINA

Background: Ruxolitinib, a potent and selective inhibitor of Janus kinase 1 (JAK1)/JAK2 tyrosine kinases, was approved for treatment of intermediate- and high-risk patients with myelofibrosis (MF) based on the findings from the pivotal studies, COMFORT I and II. Although an Asia regional study was conducted, the enrolled Chinese population was limited (N=63). Aims: We aimed to evaluate the safety profile and the treatment of ruxolitinib in Chinese patients with MF under routine clinical practice. Methods: This was a retrospective, non-interventional, multicenter, post-marketing surveillance study collecting data up to 48 weeks after ruxolitinib initiation. Patients aged ≥18 years with a confirmed diagnosis of intermediate or high-risk primary MF (PMF), post-polycythemia vera MF (PPV-MF) or post-essential thrombocythemia MF (PET-MF) who had received or were currently receiving ruxolitinib treatment per clinical judgment according to China approved label were included. Results: In total, 480 patients from 20 sites were enrolled and 428 patients completed the study treatment. The most reported reasons for treatment discontinuation were death (17.3%), adverse events (AE, 7.7%) and abnormal laboratory value (5.8%). Gender distribution were balance (male 51.6% vs female 48.4%) with median age of 61.0 years and median BMI of 22.5 kg/m2. Majority of the patients were diagnosed with PMF (69.8%), followed by PPV-MF (15.7%), and PET-MF (14.5%). The information on dosing and safety is detailed in Table 1. Ruxolitinib dosing was according to the local approved label (median initial daily dose 30.0 mg). The median time from first diagnosis to medication was 1.5 months. Overall, patients received ruxolitinib for a median of 11.1 months with median dose intensity of 28.7 mg/day. The most prescribed dose was 15 mg BID across varying durations of exposure to ruxolitinib (up to 48 weeks). A total of 196 (40.8%) patients had dose modification. On-treatment AE and serious AE (SAE) were reported in 361 (75.2%) and 57 (11.9%) patients, respectively. Of those, 60.2% and 6.0%, were related to study drug, respectively. The severity of majority of the AE were grade 2 and 3 (26.7 & 25.2%, respectively) while SAE were grade 3 & 4 (3.5% & 4.4%, respectively). A total of 4.0% and 2.3% of patients reported AEs and SAEs leading to discontinuation. The most commonly reported AEs were anemia (47.3%), decreased platelet count (22.1%), and abnormal liver function (12.7%). The most commonly reported SAEs were anemia (3.8%), platelet count decreased (1.0%), infectious pneumonia and pulmonary inflammation (both 0.8%). On-treatment AESI was reported by 18 (3.8%) patients, consisted of bleeding events (2.3%), serious or opportunistic infections (0.8%), and second primary malignancies (SPM, 0.6%). The SPM were pulmonary malignant tumors (n=2) and liver cancer (n=1). A total of 18 on-treatment deaths (MF progression=9, AE=4, and others=5) were reported. During the study period, we found that the number of patients with efficacy data were decreasing with time (baseline=183&116, Week 16=126 & 96, Week 32=90 & 62, Week 48=38 & 19 for spleen size measurement and total symptom score, respectively). This reflects the need for improve compliance in disease management. Image:Summary/Conclusion: This was the largest ruxolitinib real-world study in China. The safety profile of ruxolitinib in patients with intermediate- or high-risk PMF, PPV-MF, or PET-MF was generally consistent with previous global and Chinese studies of MF. The incidence of SPM was lower than that reported previously4. No new unexpected safety signals have been identified.

The Utility of Frequent Laboratory Monitoring for Patients on Tumor Necrosis Factor-Alpha Inhibitors in Dermatology.

IntroductionTumor necrosis factor-alpha inhibitors (TNF-ai) are becoming increasingly common to use among patients with skin disease. To safely take these medications, it is recommended to monitor laboratory values routinely; however, the utility of this practice and the risk-benefit of frequent laboratory monitoring has not been explored fully in patients with skin disease. The purpose of this study was to evaluate the necessity of routine laboratory monitoring in patients taking a TNF-ai with a dermatological disease.MethodsRetrospective chart review evaluated laboratory abnormalities (complete blood counts and liver function tests) in adult patients who took a TNF-ai for a dermatologic disease at The University of Kansas Hospital.ResultsThere were 27 patients included for a total of 45 entries. The most common skin disease was hidradenitis suppurativa (23/45) and infliximab (22/45) was most the commonly used medication. Of the 45 entries, there were only seven patients that developed abnormal monitoring laboratory values related to initiation of TNF-ai. These abnormalities were transient and most frequently occurred after 12 months, with 2 of the 45 resulting in no discontinuation or dose reduction of TNF-ai. One patient discontinued medication due to anemia that did not improve after medication withdrawal.ConclusionsLaboratory abnormalities due to TNF-ai were infrequent and when they did occur were transient and mild. The study was limited by the small sample size of patients, and larger prospective studies are needed to evaluate these findings fully. However, dermatologists may be able to employ less frequent laboratory monitoring safely for patients on TNF-ai.

Abstract CT178: A phase 1/2, open-label study to assess safety, tolerability, biodistribution, radiation dosimetry and PET imaging characteristics of [18F]FPyGal in comparison to in-vitro diagnostic for the assessment of senescence in oncological patients

Abstract The authors did not submit an updated abstract. The original abstract should be considered final. Citation Format: Christian LaFougere, Brigitte Gueckel, Helmut Dittmann, Martina Hinterleitner, Nils Trautwein, Jonathan Cotton, Gabriele Kienzle, Stephan Singer, Gerald Reischl, Ulrich Lauer, Bernd Pichler, Lars Zender. A phase 1/2, open-label study to assess safety, tolerability, biodistribution, radiation dosimetry and PET imaging characteristics of [18F]FPyGal in comparison to in-vitro diagnostic for the assessment of senescence in oncological patients [abstract]. In: Proceedings of the American Association for Cancer Research Annual Meeting 2022; 2022 Apr 8-13. Philadelphia (PA): AACR; Cancer Res 2022;82(12_Suppl):Abstract nr CT178.

The utility of laboratory testing for pediatric patients undergoing isotretinoin treatment.

Isotretinoin, the most effective treatment for severe cystic acne, involves laboratory monitoring. In this retrospective case series of 130 pediatric patients taking isotretinoin, there were significant increases in cholesterol (143.9mg/dl to 155.3mg/dl), triglycerides (81.8mg/dl to 115.2mg/dl), and low-density lipoprotein (82.0mg/dl to 98.1mg/dl), and a decrease in high-density lipoprotein (50.0mg/dl to 44.7mg/dl) from baseline to follow-up (p < .05); there were no significant changes in liver enzymes. None of the patients had clinical sequelae (triglyceride-induced pancreatitis, retinoid-induced hepatotoxicity) related to their abnormal lab values. These findings question the utility of laboratory monitoring for prevention of severe clinical sequelae in pediatric patients, and suggest testing based on individualized risk factors may be more appropriate.

Development and assessment of PharmaCheck: an electronic screening tool for the prevention of twenty major adverse drug events

BackgroundAdverse drug events (ADEs) can be prevented by deploying clinical decision support systems (CDSS) that directly assist physicians, via computerized order entry systems, and clinical pharmacists performing medication reviews as part of medical rounds. However, physicians using CDSS are known to be exposed to the alert-fatigue phenomenon. Our study aimed to assess the performance of PharmaCheck—a CDSS to help clinical pharmacists detect high-risk situations with the potential to lead to ADEs—and its impact on clinical pharmacists’ activities.MethodsTwenty clinical rules, divided into four risk classes, were set for the daily screening of high-risk situations in the electronic health records of patients admitted to our General Internal Medicine Department. Alerts to clinical pharmacists encouraged them to telephone prescribers and suggest any necessary treatment adjustments. PharmaCheck’s performance was assessed using the intervention’s positive predictive value (PPV), which characterizes the proportion of interventions for each alert triggered. PharmaCheck’s impact was assessed by considering clinical pharmacists as a filter for ruling out futile alerts and by comparing the final clinical PPV with a pharmacist (the proportion of interventions that led to a change in the medical regimen) to the final clinical PPV without a pharmacist.ResultsOver 132 days, 447 alerts were triggered for 383 patients, leading to 90 interventions (overall intervention PPV = 20.1%). By risk class, intervention PPVs made up 26.9% (n = 65/242) of abnormal laboratory value alerts, 3.1% (4/127) of alerts for contraindicated medications or medications to be used with caution, 28.2% (20/71) of drug–drug interaction alerts, and 14.3% (1/7) of inadequate mode of administration alerts. Clinical PPVs reached 71.0% (64/90) when pharmacists filtered alerts and 14% (64/242) if they were not doing it.ConclusionPharmaCheck enabled clinical pharmacists to improve their traditional processes and broaden their coverage by focusing on 20 high-risk situations. Alert management by pharmacists seemed to be a more effective way of preventing risky situations and alert-fatigue than a model addressing alerts to physicians exclusively. Some fine-tuning could enhance PharmaCheck's performance by considering the information quality of triggers, the variability of clinical settings, and the fact that some prescription processes are already highly secured.

Focal Acute Pyelonephritis in Two Months Pregnant Woman: A Case Report

Acute pyelonephritis is a bacterial infection of the renal pelvis and parenchyma, most commonly seen in young women. Complicated and uncomplicated pyelonephritis, xanthogranulomatous pyelonephritis, and tuberculosis are all urinary tract infections for which imaging evaluation adds diagnostic information important for patient care. The incidence of focal acute pyelonephritis parallels that of lower urinary tract infection, approximately five times more common in female with a sharp increase following puberty. Diagnosis is typically based on characteristics clinical feature and abnormal laboratory values. Imaging aids further assessment. Here we present a case of young pregnant women who reported with severe right loin pain and burning micturition for an emergency ultrasound. Ultrasound showed features of acute pyelonephritis. Routine urine examination showed plenty of pus cells and absence of RBC. Considering risk: benefit ratio, the clinician performed CT scan which confirms the diagnosis.&#x0D; Sir Salimullah Med Coll J 2022; 30: 93-95

Estimands for Continuous Longitudinal Outcomes in the Presence of Treatment Discontinuation—A Simulation Study in Hyperkalemia Treatments

The ICH-E9 (R1) addendum guideline requires a precise description of the treatment effect of interest, named “estimand”, reflecting the clinical question posed by the trial objective, in each specific therapeutic setting. In clinical trials evaluating maintenance treatments, such as hyperkalemia treatments, one of the intercurrent events is planned treatment discontinuation due to abnormal laboratory values (outside the acceptable range). When using longitudinal data for evaluation, the mixed model for repeated measures, responder analysis, and survival analysis are often used to deal with intercurrent events. Under composite variable or hypothetical strategies, prioritized composite outcome or the last rank carried forward can also be considered. In this study, we propose a prioritized composite outcome in clinical trials evaluating maintenance treatments with treatment discontinuation. In addition, the estimand for each analysis was defined, and operating characteristics were evaluated. Simulation studies indicate the usefulness of the prioritized composite outcome using the composite variable strategy and the mixed model for repeated measures using the hypothetical strategy.

AKATSUKI study: a prospective, multicentre, phase IV study evaluating the safety of emicizumab under and immediately after immune tolerance induction therapy in persons with congenital haemophilia A with factor VIII inhibitors

IntroductionFor persons with haemophilia A with factor (F) VIII inhibitors (PwHAwI), immune tolerance induction (ITI) therapy is indicated for inhibitor eradication; however, since PwHAwI on ITI were excluded from the...

Pseudohyponatremia in pregnancy

Introduction: Ordering multiple laboratory tests has become commonplace in contemporary medical practice. Clinicians are sometimes surprised by abnormal test results that are unrelated to the chief complaint. Misguided attempts to correct abnormal lab values can potentially compromise patient safety. We report what we believe to be a rare occurrence of pseudohyponatremia complicating pregnancy.

The Pitfalls of Abnormal Laboratory Value Interpretation in Vaccine Clinical Trials: The Example of Asymptomatic Transient Neutropenia.

Hematological and clinical chemistry measurements are an integral part of vaccine safety monitoring. While adopting a conservative approach is important to exclude potential risks for patients, the rationale and methodology underlying the assessment of given adverse events have to be well grounded to avoid raising unfounded concerns. Using asymptomatic transient neutropenia as an example, this paper aims to address the complexity of interpreting abnormal hematological values in vaccine clinical trials and to evaluate the validity of using neutrophil count cut-off points to assess neutropenia in the context of safety monitoring. The validity of the neutrophil count cut-off point methodology was assessed in terms of content validity (i.e., the extent to which a single neutrophil count below the cut-off point corresponds to a clinically significant adverse event), criterion validity (i.e., the extent to which a neutrophil count below a given cut-off point correlates with another manifestation of neutropenia, namely bacteremia), and construct validity (i.e., the exactness of the assumption that a neutrophil count below a given cut-off point corresponds to a reactogenic event caused by the vaccination). We argue that, because of within-individual physiological fluctuations, variations according to population demographics, and poor predictive potential with regard to neutropenia-associated infection, the application of the cut-off point methodology to neutropenia safety monitoring presents major limitations. Based on this assessment, we conclude that hematological laboratory values must be evaluated on a case-by-case basis by investigators to determine their clinical significance.