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Siepmann, S., D. Pollmann, R. Geppert, K. D. Wernecke, K. Possinger, and D. Lueftner. "Tissue inhibitor of metalloproteinases 1 (TIMP-1) and tumor type M2 pyruvate kinase (TuM2-PK) were compared with established markers in advanced colorectal cancer." Journal of Clinical Oncology 24, no. 18_suppl (June 20, 2006): 13537. http://dx.doi.org/10.1200/jco.2006.24.18_suppl.13537.
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13537 Background: Recently, a high expression of TIMP-1 was demonstrated by immunohistochemistry in colorectal cancer (CRC). TIMP-1 can also be detected in plasma of those patients (pts). We investigated the longitudinal concentrations of TIMP-1 in 37 pts with advanced CRC and correlated the monitoring performance of TIMP-1 to CEA and CA 19–9 as established markers of tumor load in CRC. In addition, the plasma level of TuM2-PK as novel marker of disease activity was integrated into the analysis. Methods: Plasma TIMP-1 (Bayer Diagnostics/Oncogene Science, Tarrytown/Boston, USA) and TuM2-PK (Schebo Biotech, Giessen, Germany) levels were measured using standardized ELISA assays while serum CEA and CA 19–9 were determined using chemiluminescence immunoassays (Bayer Diagnostics, Tarrytown/NY). The nonparametric analysis of variance for repeated measurements by Brunner was used to test for time effects between the selected 3 time points: 1. baseline at initiation of systemic chemotherapy for metastatic disease; 2: best response; 3: later progression. Results: We grouped 37 pts with regard to best response to chemotherapy as follows: complete or partial remission (CR/PR): n=10; stable disease (SD): n=21; primary progressive disease (PD): n=6. TIMP-1 and TuM2-PK concentrations increased significantly from baseline to progression (p<0.001 and p=0.003, respectively). The plasma levels of patients with objective response (CR/PR) dropped significantly for TuM2-PK (p=0.001) and TIMP-1 (p=0.001), while CA 19–9 and CEA did not change (p=0.94 and p=0.10, respectively). No significant change could be demonstrated in the SD group for TuM2-PK (p=0.26), TIMP-1 (p=0.69) and for CEA (p=0.25), whereas CA 19–9 concentrations decreased significantly (p=0.04). Conclusions: Innovative markers like TIMP-1 and TuM2-PK provided a much higher monitoring quality than established markers like CEA and CA 19–9 in advanced CRC. As the later cancer-associated proteins are recommended by internationally acknowledged guidelines, larger comparative trials are warranted asking the important question whether a replacement of CEA by one or a panel of new markers may provide additional clinical information. No significant financial relationships to disclose.
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Craven, B. Catharine, Lora M. Giangregorio, Isabelle Côté, Lindsie Blencowe, Masae Miyatani, and Mohammad Alavinia. "Using Risk Scores to Estimate Lower Extremity Fragility Fracture Risk among Individuals with Chronic Spinal Cord Injury: A Preliminary Model." Topics in Spinal Cord Injury Rehabilitation 29, suppl (November 16, 2023): 112–13. http://dx.doi.org/10.46292/sci23-00063s.
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Objectives To develop SCI-FX, a risk score to estimate 5-year lower extremity fragility fracture risk among patients living with chronic spinal cord injury (cSCI). Methods Adults with traumatic cSCI (n = 90) participated in a 2-year prospective longitudinal cohort study describing bone mineral density (BMD) change and fracture incidence conducted at the Lyndhurst Centre (University Health Network), University of Waterloo, and Physical Disability Rehabilitation Institute of Québec City. Prior publication and clinical intuition were used to identify fragility fracture risk factors including prior fragility fracture, years post-injury, motor complete injury (AIS A/B), benzodiazepine use, opioid use, and parental osteoporosis. We conducted bivariate analyses to identify variables associated with fracture. Multiple logistic regressions were performed using fragility fracture incidence as the dependent variable and all variables from the univariate analyses with a highly liberal p value at 0.2. Using the odds ratios (ORs) from the multiple logistic regression model, a point system for fragility fracture risk score was developed, and the odds of fracture for each point was estimated. Results All initial variables, with the exception of benzodiazepine exposure, were included in the final model. Conclusion We identified a simple preliminary model for clinicians to estimate 5-year fracture risk among patients with cSCI based on their total score.
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Parameswaran, Shajaky, Thomas P. Walden, Louise Brisbois, and B. Catharine Craven. "Student Competition (Knowledge Generation) ID 1984770." Topics in Spinal Cord Injury Rehabilitation 29, suppl (September 1, 2023): 219. http://dx.doi.org/10.46292/sci23-1984770s.
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Background Following a traumatic spinal cord injury (tSCI), patients prioritize being able to manage their bowels independently. A reduction of independence can impact an individual’s quality of life. The current study investigates the relationships between sphincter control, level of independence and quality of life. We hypothesized that sphincter control would relate strongly to levels of independence and quality of life. Methods Adults with tSCI who consented to participate in the Rick Hansen Spinal Cord Injury Registry at the Lyndhurst Rehabilitation Centre completed community follow-up interviews from 2014-2021. Data was collected at baseline, year 1, 2 and 5 (n = 330). Descriptive data and neurological level of injury (NLI) were collected, along with the Life Satisfaction Questionnaire (LiSAT-11), 36-item Short Form Survey Quality of Life measures (SF-36v2) and the Spinal Cord Independence Measure III (SCIM). Separate analyses were conducted for NLI C1-T10 (upper motor neuron [UMN] [n=280]), and T11-S5 (lower motor neuron [LMN] [n=50]). Associations between sphincter management and life satisfaction were calculated using Spearman’s correlation coefficient, adjusted for age and sex. Results SCIM had a moderate, yet significant relationship with LiSAT-11 (r2=0.48, p<0.001) for LMN, but no relationship for UMN (r2= 0.17, p<0.001). A weak relationship was observed between SCIM and SF-36v2 for LMN (r2=0.30, p=0.014) but no relationship for UMN (r2=0.01, p=0.59). Conclusion Sphincter management scores after rehabilitation discharge are not a strong predictor of life satisfaction following tSCI suggesting that a multifaceted approach is required to assess an individuals’ quality of life post tSCI.
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Eftekhar, Parvin, Dr Cathy Craven, and Sukhvinder Kalsy-Ryan. "Poster (Clinical/Best Practice Implementation) ID 1998248." Topics in Spinal Cord Injury Rehabilitation 29, suppl (September 1, 2023): 195. http://dx.doi.org/10.46292/sci23-1998248s.
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Background It is essential that individuals with spinal cord injury set their goals prior to their peripheral nerve transfer (PNT) surgery. Goal setting is a significant factor in pre-operative planning and is one way in which we can track performance and outcomes for these patients. Objectives To describe goal types identified by patients managed in the PNT-SCI rehab program at Lyndhurst-UHN. Cite and report the COPM outcomes in the domains of Self-care and Productivity. Methods A retrospective case series was conducted (n=14), charts were reviewed for type of goals and patient’s perception of goal attainment using COPM for a case series of three patients with tetraplegia who received PNT-SCI surgery and comprehensive rehabilitation. The changes in COPM are reported from baseline to 12 months post-surgery. Each patient identified three goals pre-surgery; their goals and the COPM were used to measure change over time. Results Ninety two percent of the identified goals were in the area of Self Care, and 8% were in the Productivity areas. Two of the patients who received PNT-SCI rehabilitation had an increase of 1 on the COPM, while one individual regressed by 2 points. That individual did not receive comprehensive rehabilitation. Conclusion It is known that recovery after PNT-SCI surgery can take 24 or more months. We reported COPM change scores at 12 months post surgery. The MCID is two points for COPM, ideally over 24 months we will see MCID of three or higher.
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Newsome, Jason, Kerri Stipanovich, and Sarah Flaherty. "Comparison of Heparin Administration Using the Rapidpoint™ Coag and Hepcon® HMS." Journal of ExtraCorporeal Technology 36, no. 2 (June 2004): 139–44. http://dx.doi.org/10.1051/ject/2004362139.
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A retrospective chart review was conducted of patients who underwent cardiopulmonary bypass (CPB) to compare the quantities of heparin administered, postoperative blood loss, and homologous blood products transfused during their procedure and subsequent stay in the intensive care unit. The primary purpose of this review was to determine if any difference in heparin administration resulted when two different devices were used for dosing and monitoring heparin. Postoperative blood loss and amount of blood products transfused were also quantified, as any differences would potentially be a result of a difference in administration of heparin. The first group (n = 341) underwent CPB using the Hepcon® HMS, Medtronic Inc., Minneapolis, MN, for heparin dosing and monitoring. The Rapid Point™ Coag, Bayer Healthcare LLC, Tarrytown, NY was used for the second group (n = 345). The two populations were compared for similarity on: age, body surface area (BSA), CPB time (minutes), aortic-cross clamp time (minutes), baseline activated clotting time, and baseline hematocrit. No significant difference was found between the two groups. The second group, using the Rapidpoint™ Coag, received less heparin during CPB than the group using the Hepcon® HMS. In addition, there were decreases in amounts of some blood products transfused as well as mediastinal drainage from the Hepcon® HMS to the Rapidpoint™ Coag group. A summary of the findings can be found in Table 1. A secondary purpose of this study was to determine the influence of hemodilution on the Heparin Management Test (HMT®). Citrated whole blood was diluted to varying degrees at various concentrations to determine whether hemodilution with crystalloid would alter the HMT® measurements. At all heparin levels and degrees of dilution, the HMT® remained stable, with coefficients of variation (CV) of less than 5% at all heparin levels even while incorporating excessive crystalloid dilution (up to 75%).
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Gibbs, Graham. "Peroxidase Activity and Nuclear Density Analysis in the Diagnosis of Acute Myeloid Leukemia." Blood 106, no. 11 (November 16, 2005): 4533. http://dx.doi.org/10.1182/blood.v106.11.4533.4533.
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Awareness of the range of additional parameters offered by many modern hematology analysers is increasing and some have found applications in today’s clinical diagnostic laboratories. In order to determine the white blood cell (WBC) count and differential, the Advia 120 (Bayer Diagnostics, Tarrytown, NY) uses low angle (0–5°) and high angle (5–15°) light scatter measurements to determine size and density of the cellular nuclei following removal of the cytoplasm by phthalic acid, as well as a cytochemical reaction involving hydrogen peroxide and a substrate (4-chloro-1-naphthol) to measure peroxidase activity in white blood cells. The latter are then displayed visually as 2-dimensional cytograms. The utility of these parameters to provide an early indication of the presence of leukemic cells was assessed retrospectively in 25 newly presenting cases of acute myeloid leukemia (AML) without peripheral blood pancytopenia. Using the French-American-British (FAB) classification, the cases comprised M0 (n=1), M1 (n=2), M2 (n=2), M3 (n=2), M4 (n=1), M5 (a+b) (n=4), and M6 (n=1). The remaining 12 patients were unclassified AML (although not M3). Using the classification system described by d’Onofrio (Bloodline Reviews2001; 2-R: 3–6), peroxidase activity was scored from P0 (peroxidase negative) to P6 (intense peroxidase positivity), and nuclear density was scored as D0 (normal profile) or D1 (abnormal mononuclear cell population shifted down and to the left - a region corresponding to the presence of blast cells). 23 out of 25 cases were correctly classified as probable AML (92%), comparing well with the findings of d’Onofrio (95.2%). 21 out of these 23 cases were also categorised correctly according to probable FAB type (91%). Of the 2 cases incorrectly classified, 1 case was classified as probable acute lymphoblastic leukemia (ALL), and 1 case was classified as probable myelodysplastic syndrome (MDS). Of note, only cases of M3 AML are allocated to the P6/D1 classification category. Both cases of M3 AML in this study were P6/D1and none of the remaining cases were misclassified into this category. The risk of associated coagulopathy and the unique response to treatment with all-trans retinoic acid (ATRA) makes prompt detection particularly important within this AML patient subgroup. Although not diagnostic in itself, the use of peroxidase activity and nuclear density analysis cytograms in routine complete blood counts (CBC) provides a valuable early indication of a possible case of AML, allowing the prompt initiation of confirmatory tests.
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Nah, Eun-Hee, Seong Yoon Kim, Seon Cho, Suyoung Kim, and Han-Ik Cho. "Plasma NT-proBNP levels associated with cardiac structural abnormalities in asymptomatic health examinees with preserved ejection fraction: a retrospective cross-sectional study." BMJ Open 9, no. 4 (April 2019): e026030. http://dx.doi.org/10.1136/bmjopen-2018-026030.
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ObjectivesStage B heart failure (HF) is defined as an asymptomatic abnormality of the heart structure or function. The circulating level of N-terminal pro-B-type natriuretic peptide (NT-proBNP) is elevated in symptomatic patients with left ventricular (LV) dysfunction caused by a structural or functional abnormality. This study investigated the association of the NT-proBNP level with echocardiography-detected cardiac structural or diastolic abnormalities in asymptomatic subjects with preserved LV systolic function (ejection fraction >50%).MethodsWe retrospectively studied 652 health examinees who underwent echocardiography and an NT-proBNP test at a health-promotion centre in Seoul, between January 2016 and September 2018. The left ventricular mass index (LVMI) and the left atrial dimension (LAD) were used as markers for structural abnormalities, and the mean e’ velocity and mitral early flow velocity/early diastolic tissue velocity (E/e’) ratio were used as markers for diastolic dysfunction. The plasma NT-proBNP level was measured using electrochemiluminescence immunoassay (DPC Immulite 2000 XPi, Siemens Healthcare Diagnostics, Tarrytown, New York, USA).ResultsSubjects with preclinical structural abnormalities were older and had a higher body mass index (BMI), higher blood pressure, lower high-density lipoprotein cholesterol level, higher NT-proBNP level, and higher E/e’ (p<0.05). Multivariate regression analysis indicated that the factors associated with a higher NT-proBNP level were older age, female sex, lower BMI, higher creatinine level, higher LVMI and higher LAD (p<0.01).ConclusionDiastolic dysfunction is not associated with higher NT-proBNP levels, whereas preclinical cardiac structural abnormalities, as well as older age, female sex, lower BMI, and higher creatinine level, are associated with higher NT-proBNP levels.
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Little, Dustin J., Christina M. Yuan, John S. Thurlow, Verena Gounden, Sonia Q. Doi, Alison Pruziner, Kevin C. Abbott, Brett J. Theeler, and Stephen W. Olson. "Effects of Traumatic Amputation on β-Trace Protein and β2-Microglobulin Concentrations in Male Soldiers." American Journal of Nephrology 42, no. 6 (2015): 436–42. http://dx.doi.org/10.1159/000443775.
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Background: Serum creatinine (SCr) levels are decreased following traumatic amputation, leading to the overestimation of glomerular filtration rate (GFR). β-Trace protein (BTP) and β2-microglobulin (B2M) strongly correlate with measured GFR and have not been studied following amputation. We hypothesized that BTP and B2M would be unaffected by traumatic amputation. Methods: We used the Department of Defense Serum Repository to compare pre- and post-traumatic amputation serum BTP and B2M levels in 33 male soldiers, via the N Latex BTP and B2M nephelometric assays (Siemens Diagnostics, Tarrytown, N.Y., USA). Osterkamp estimation using DEXA scan measurements was used to establish percent estimated body weight loss (%EBWL). Results were analyzed for small (3-5.9% EBWL), medium (6-13.5%), and large (>13.5%) amputation subgroups; and for a control group matched 1:1 to the 12 large amputation subjects. Paired Student's t test was used for comparisons. Results: Mean serum BTP levels were unchanged in controls, all amputees, and the small and medium amputation subgroups. BTP appeared to decrease following large %EBWL amputation (p = 0.05). Mean serum B2M levels were unchanged in controls, all amputees, and the small and medium amputation subgroups. B2M appeared to increase following large %EBWL amputation (p = 0.05). Conclusions: BTP and B2M levels are less affected than SCr by amputation, and should be considered for future study of GFR estimation. BTP and B2M changes following large %EBWL amputation require validation and may offer insight into non-GFR BTP and B2M determinants as well as increased cardiovascular disease and mortality following amputation. This is a work of the US Government and is not subject to copyright protection in the USA. Foreign copyrights may apply. Published by S. Karger AG, Basel
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Burmester, G. R., J. P. Morello, O. Hagino, A. Praestgaard, S. Fiore, and M. C. Genovese. "SAT0100 ASSOCIATION BETWEEN LOW HEMOGLOBIN AND RADIOGRAPHIC PROGRESSION OVER 52 WEEKS IN PATIENTS WITH RHEUMATOID ARTHRITIS: RESULTS FROM A PHASE 3 TRIAL OF SARILUMAB." Annals of the Rheumatic Diseases 79, Suppl 1 (June 2020): 983. http://dx.doi.org/10.1136/annrheumdis-2020-eular.2008.
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Background:Anemia is a common comorbidity in patients with rheumatoid arthritis (RA).Objectives:Assess whether low hemoglobin (Hb) identifies a subgroup of patients at increased risk of joint damage progression, and investigate whether sarilumab modulates this risk.Methods:The 52-week, double-blind, Phase 3 MOBILITY trial (NCT01061736) in patients with active RA and inadequate response to methotrexate (n = 1197) demonstrated the tolerability and efficacy (clinical and radiographic) of subcutaneous sarilumab 150 and 200 mg every 2 weeks versus placebo, both in combination with methotrexate (MTX). In thispost hocanalysis, baseline characteristics and radiographic outcomes in MOBILITY were analyzed by baseline Hb category (low or normal) according to World Health Organization criteria, with low Hb defined as <120 g/L for women and <130 g/L for men. NominalPvalues are presented.Results:A total of 414 patients (35%) had low Hb at baseline. Patients with low Hb were more likely than patients with normal Hb to be female (86% vs 79%, respectively), Asian (14% vs 5%), younger (mean age 49 vs 51 years), and to have lower body weight (mean 69 vs 77 kg); all nominalP<0.01. Duration of RA, prior biologic use, rheumatoid factor positivity, and baseline tender and swollen joint counts were similar between patients with low and normal baseline Hb, but there was a nominally significant difference in C-reactive protein (mean 30.2 [SD 28.5] vs 17.3 [18.5] mg/L;P<0.0001). Patients with low Hb generally exhibited more joint damage progression over 52 weeks than patients with normal Hb (Table). In the sarilumab + MTX groups, joint damage progression was mitigated compared with placebo + MTX in patients with low Hb and in patients with normal Hb. Mean change from baseline in Hb at 52 weeks in the placebo + MTX, sarilumab 150 mg + MTX, and sarilumab 200 mg + MTX groups was +3.7 (SD 10.8), +14.7 (12.1), and +14.0 (10.5) g/L, respectively, in patients with low Hb at baseline, and –2.5 (9.9), +6.2 (9.3), and +8.0 (9.9) g/L in patients with normal Hb at baseline.Table.Mean change from baseline (SD) in radiographic measures of joint damagePlacebo+ MTXSarilumab 150 mg+ MTXSarilumab 200 mg+ MTXLow Hb (n = 140)Normal Hb (n = 258)Low Hb (n = 145)Normal Hb (n = 255)Low Hb (n = 129)Normal Hb (n = 270)mTSS3.75 (9.00)2.29 (6.98)1.20*** (5.58)0.73** (4.07)0.60*** (4.13)0.08*** (4.83)Joint space narrowing1.52 (3.71)1.22 (3.92)0.79* (3.17)0.30** (2.70)0.50** (2.93)0.06*** (3.33)Erosion score2.24 (6.24)1.07 (3.91)0.41*** (3.18)0.44* (2.05)0.10*** (2.13)0.02*** (2.19)NominalP*<0.05, **<0.01, ***<0.001 versus placebo by rank ANCOVA model stratified by prior biologic use and region; mTSS, modified total Sharp scoreConclusion:Overall, sarilumab slowed joint damage progression in patients with RA. Additionally, in those patients with low Hb, who may suffer greater damage than those with normal Hb, sarilumab also increased Hb.Acknowledgments:Study funding and medical writing support (Matt Lewis, PhD, of Adelphi Communications Ltd, Macclesfield, UK) were provided by Sanofi Genzyme (Cambridge, MA, USA) and Regeneron Pharmaceuticals, Inc. (Tarrytown, NY, USA) in accordance with Good Publication Practice (GPP3) guidelines.Disclosure of Interests:Gerd Rüdiger Burmester Consultant of: AbbVie Inc, Eli Lilly, Gilead, Janssen, Merck, Roche, Pfizer, and UCB Pharma, Speakers bureau: AbbVie Inc, Eli Lilly, Gilead, Janssen, Merck, Roche, Pfizer, and UCB Pharma, Jean-Pierre Morello Shareholder of: Regeneron Pharmaceuticals, Inc., Employee of: Regeneron Pharmaceuticals, Inc., Owen Hagino Shareholder of: Sanofi, Employee of: Sanofi, Amy Praestgaard Employee of: Sanofi Genzyme, Stefano Fiore Shareholder of: Sanofi, Employee of: Sanofi, Mark C. Genovese Grant/research support from: Abbvie, Eli Lilly and Company, EMD Merck Serono, Galapagos, Genentech/Roche, Gilead Sciences, Inc., GSK, Novartis, Pfizer Inc., RPharm, Sanofi Genzyme, Consultant of: Abbvie, Eli Lilly and Company, EMD Merck Serono, Genentech/Roche, Gilead Sciences, Inc., GSK, Novartis, RPharm, Sanofi Genzyme
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Kratz, Alexander, Laura Rubattu, Micheline Maier-Redelsperger, Giovanni Amendola, Paolo Danise, Giuseppe d’Onofrio, Gina Zini, et al. "Automated Pre-Classification of Anemia Based on the Results of a Routine Automated Hematology System." Blood 106, no. 11 (November 16, 2005): 2253. http://dx.doi.org/10.1182/blood.v106.11.2253.2253.
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Abstract Laboratory workup of the cause of anemia requires clinical staff to develop a differential diagnosis based on routine CBC parameters and to subsequently order confirmatory tests. The number of parameters to be reviewed and the complexity of calculations which are performed by individuals on a routine basis is necessarily limited. The wealth of information in the many novel parameters and the complex patterns provided by modern hematology analyzers are frequently not utilized in routine clinical care. The use of computers for pre-classification of common RBC disorders would provide immediate information to order reflex confirmatory tests on the first sample, thereby improving patient care and allowing significant cost savings. Eleven European sites collected 2,303 data files from hematologically normal patients and individuals diagnosed with at least one of 36 RBC disorders. Samples were run on the ADVIA 120 Hematology System (Bayer HealthCare LLC, Diagnostics Division, Tarrytown, NY), an automated cell counter used in routine clinical hematology laboratories worldwide. Based on their representation within this database, a subset of 5 diseases (β-thalassemia heterozygote, β-thalassemia homozygote, Hb S homozygote, Hb SC, and hereditary spherocytosis; n=779 samples) and 123 normal cases were selected and used to develop a neural-network based computer program, the Computer Assisted RBC Disorder (CARD) Classification tool. The CARD utilizes hundreds of routine and novel CBC, differential and reticulocyte parameters available from the ADVIA 120 and 2120 Hematology Systems to determine possible causes of a patient’s anemia. We evaluated the CARD by using it to classify 273 new cases from 9 worldwide centers. The program correctly identified 93% of the cases. The majority of misidentifications were due to normal cases being classified as abnormal. 2 Hb S homozygote and one β-thalassemia heterozygote samples were misidentified as Hb SC. Only 2 of 137 abnormal cases, which were β-thalassemia heterozygote, were misclassified as normal. The performance of the tool for the presence of any hemoglobinopathy/thalassemia investigated was: sensitivity: 99%; specificity: 90%; PPV: 90%, NPV: 98%. This neural network-based computer program has demonstrated excellent performance with a validation set of samples and demonstrates the potential for using information from automated hematology analyzers to screen for the presence of certain hemoglobinopathies and to provide real-time information to direct an anemia workup. CARD TOOL ACCURACY # Correct # Incorrect Normal 122 14 β-Thalassemia Heterozygote 99 3 β-Thalassemia Homozygote 18 0 Hb S Homozygote 11 2 Hb SC 2 0 Hereditary Spherocytosis 2 0 TOTAL 254 (93%) 19 (7%)
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Fleischmann, R., M. C. Genovese, K. Maslova, H. Leher, A. Praestgaard, and G. R. Burmester. "SAT0106 LONG-TERM SAFETY AND EFFICACY OF SARILUMAB OVER 5 YEARS IN PATIENTS WITH RHEUMATOID ARTHRITIS WITH 1 OR >1 PRIOR TUMOR NECROSIS FACTOR INHIBITOR FAILURES." Annals of the Rheumatic Diseases 79, Suppl 1 (June 2020): 987.2–987. http://dx.doi.org/10.1136/annrheumdis-2020-eular.332.
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Background:A proportion of adult patients with rheumatoid arthritis (RA) are refractory to tumor necrosis factor inhibitors (TNFi), and treatment with subsequent biologics is commonly associated with reduced response. Sarilumab is a human IL-6 receptor inhibitor approved for the treatment of adults with moderate to severely active RA. In the Phase 3 TARGET study (NCT01709578), significant improvements in the signs and symptoms of RA and physical function were shown with sarilumab plus conventional synthetic disease-modifying antirheumatic drugs (csDMARDs) versus placebo in patients refractory to TNFi.Objectives:To investigate long-term safety and efficacy of subcutaneous sarilumab over 5 years in patients with 1 or >1 TNFi treatment failure prior to their enrollment in TARGET, who continued onto the open-label extension (OLE) study, EXTEND (NCT01146652).Methods:In the 24-week randomized controlled trial (RCT), patients received placebo, sarilumab 150 mg, or sarilumab 200 mg every 2 weeks (q2w), and were eligible to receive open-label sarilumab 200 mg q2w in the OLE. Dose reduction to 150 mg q2w was permitted per investigator’s discretion, or to manage laboratory abnormalities. Safety outcomes are presented for the entire follow-up period from RCT baseline through the OLE. Efficacy was assessed using Clinical Disease Activity Index (CDAI) score.Results:Of the 546 patients randomized in the RCT, 454 (83%) entered the OLE, of whom 339 had 1 TNFi failure and 115 had >1 TNFi failure. Patients with >1 TNFi failure were older and had a longer duration of RA than patients with 1 TNFi failure (mean age [SD] 55.3 [12.6] and 52.5 [11.9] years, mean RA duration [SD] 13.9 [9.1] and 11.1 [8.8] years, respectively). Kaplan–Meier estimates of the probability of continuation at 5 years were similar between groups: 48% and 54% for patients with >1 and 1 TNFi failure, respectively. At the time of data cut-off (January 15, 2019) 199/546 patients (36%) had discontinued through the RCT and OLE. The rates per 100 patient-years of treatment-emergent adverse events (AEs) and AEs leading to discontinuation for patients with >1 and 1 TNFi failure were 290.6 and 197.9, and 6.5 and 8.1, respectively. Clinical efficacy of sarilumab was sustained in the OLE through 5 years in both groups, regardless of initial treatment in the RCT (Table).TableMean CDAI and proportion of CDAI respondersTreatment allocation in 24-week RCTPlacebo+DMARDSarilumab 150 mg+DMARDSarilumab 200 mg+DMARD(n=156)(n=145)(n=153)TNFi failures1>11>11>1CDAI, mean (SD)RCT baseline43.7 (12.7)42.5 (10.3)42.0 (13.0)44.3 (13.5)42.1 (13.5)48.5 (13.0)Change after 216 weeks’ follow-up−30.9 (17.5)−32.6 (15.2)−33.3 (15.8)−33.1 (12.7)−30.3 (13.6)−36.0 (18.1)CDAI ≤10, n (%)*OLE baseline48 (42)14 (33)59 (53)16 (47)56 (49)20 (51)After 216 weeks’ follow-up24 (21)10 (24)29 (26)7 (21)29 (25)8 (21)*Nonresponder imputationConclusion:The long-term safety and efficacy of sarilumab were similar in patients with 1 or >1 prior TNFi failure over 5 years’ follow-up. Clinical efficacy could be sustained through 5 years of treatment.Acknowledgments:Study funding and medical writing support (Joseph Hodgson, PhD, Adelphi Communications Ltd, Macclesfield, UK) provided by Sanofi Genzyme (Cambridge, MA, USA) and Regeneron Pharmaceuticals, Inc. (Tarrytown, NJ, USA) in accordance with GPP3 guidelines.Disclosure of Interests:Roy Fleischmann Grant/research support from: AbbVie, Akros, Amgen, AstraZeneca, Bristol-Myers Squibb, Boehringer, IngelhCentrexion, Eli Lilly, EMD Serono, Genentech, Gilead, Janssen, Merck, Nektar, Novartis, Pfizer, Regeneron Pharmaceuticals, Inc., Roche, Samsung, Sandoz, Sanofi Genzyme, Selecta, Taiho, UCB, Consultant of: AbbVie, ACEA, Amgen, Bristol-Myers Squibb, Eli Lilly, Gilead, GlaxoSmithKline, Novartis, Pfizer, Sanofi Genzyme, UCB, Mark C. Genovese Grant/research support from: Abbvie, Eli Lilly and Company, EMD Merck Serono, Galapagos, Genentech/Roche, Gilead Sciences, Inc., GSK, Novartis, Pfizer Inc., RPharm, Sanofi Genzyme, Consultant of: Abbvie, Eli Lilly and Company, EMD Merck Serono, Genentech/Roche, Gilead Sciences, Inc., GSK, Novartis, RPharm, Sanofi Genzyme, Karina Maslova Shareholder of: Sanofi Genzyme, Employee of: Sanofi Genzyme, Henry Leher Shareholder of: Regeneron Pharmaceuticals, Inc., Employee of: Regeneron Pharmaceuticals, Inc., Amy Praestgaard Employee of: Sanofi Genzyme, Gerd Rüdiger Burmester Consultant of: AbbVie Inc, Eli Lilly, Gilead, Janssen, Merck, Roche, Pfizer, and UCB Pharma, Speakers bureau: AbbVie Inc, Eli Lilly, Gilead, Janssen, Merck, Roche, Pfizer, and UCB Pharma
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Choy, E., V. Bykerk, Y. Lee, G. St John, H. Van Hoogstraten, K. Ford, A. Praestgaard, and A. Sebba. "SAT0102 NONINFLAMMATORY PAIN IS A FREQUENT PHENOMENON IN RHEUMATOID ARTHRITIS AND RESPONDS WELL TO TREATMENT WITH SARILUMAB." Annals of the Rheumatic Diseases 79, Suppl 1 (June 2020): 984.1–985. http://dx.doi.org/10.1136/annrheumdis-2020-eular.2015.
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Background:Inflammation is clearly a key driver of pain in rheumatoid arthritis (RA). However, in some patients the level of pain exceeds what would be expected based on the amount of synovitis observed, which may indicate the presence of noninflammatory pain (NIP). Interleukin-6 (IL-6) has been shown in animal models to increase sensitization to pain and may play a role in NIP.Objectives:To assess the effect of sarilumab, a human IL-6 receptor inhibitor approved for the treatment of adults with moderate to severely active RA, on NIP and disease activity, stratified by baseline (BL) NIP status.Methods:The analysis included data from three Phase 3 studies of sarilumab: MOBILITY (NCT01061736), MONARCH (NCT02332590), and TARGET (NCT01709578). Patients received double-blind placebo or sarilumab 150 mg or 200 mg subcutaneously (SC) every 2 weeks (q2w), plus weekly csDMARD (MOBILITY and TARGET), or adalimumab 40 mg or sarilumab 200 mg SC q2w as monotherapy (MONARCH).NIP was defined using an established formula: tender 28-joint count (TJC) – swollen 28-joint count (SJC) ≥7.1,2Patients were assessed for NIP at study BL and for change in NIP status at Weeks 12 and 24. The proportion of patients achieving ACR20/50/70, Clinical Disease Activity Index (CDAI) ≤10, and DAS28-CRP <3.2 at Week 24 was assessed in patients with and without BL NIP. No inferential statistics were performed.Results:Of 2112 patients in the analysis, 490 (23%) met the criteria for NIP at study BL: MOBILITY, n = 294/1197 (25%); MONARCH, n = 90/369 (24%); TARGET, n = 106/546 (19%). BL demographics were similar for patients with or without BL NIP: mean age (SD) was 52.6 (10.7) versus 51.2 (12.3) years, and 85% versus 81% were female. Patients with BL NIP had higher CDAI, DAS28-CRP, pain Visual Analog Scale (VAS), and TJC at BL versus patients without NIP (Table). Of patients with NIP at BL, those who received sarilumab were more likely to have no NIP at Weeks 12 and 24 versus patients who received placebo or adalimumab (Figure 1). The percentage of patients achieving improvements in disease activity at Week 24 was greater for sarilumab versus adalimumab among both patients with and without BL NIP, and these differences were larger among patients with BL NIP for all assessments except ACR50 (Figure 2).Table.Baseline characteristicsPatients with TJC – SCJ ≥7Mean (SD)Yes (n = 490)No (n = 1622)Duration of RA, years9.1 (8.6)9.7 (8.4)TJC, 0–2821.7 (4.7)14.3 (6.2)SJC, 0–2810.7 (4.3)13.1 (6.0)CRP, mg/L22.7 (27.0)22.9 (24.0)HAQ-DI, 0–31.8 (0.6)1.7 (0.6)DAS28-CRP6.4 (0.7)5.9 (0.9)CDAI46.0 (9.4)40.4 (13.0)Pain VAS72.3 (18.2)67.0 (20.7)Conclusion:NIP was prevalent at BL in the patient populations assessed. Among patients with BL NIP, a lower proportion continued to have NIP at Weeks 12 and 24 when treated with sarilumab versus placebo or adalimumab. Patients with and without BL NIP had greater improvements in pain when treated with sarilumab versus adalimumab. The difference in clinical improvement was greater among patients with BL NIP versus without BL NIP for most measures. These trends support the emerging concept that mechanisms other than direct inflammation may contribute to pain in RA, potentially mediated via IL-6 signaling.References:[1]Durán J et al.Rheumatology. 2015;54:2166–70[2]Pollard LC et al.Rheumatology. 2010;49:924–8Acknowledgments:Study funding and medical writing support (Joseph Hodgson, PhD, Adelphi Communications Ltd, Macclesfield, UK) provided by Sanofi Genzyme (Cambridge, MA, USA) and Regeneron Pharmaceuticals, Inc. (Tarrytown, NJ, USA) in accordance with GPP3 guidelines.Disclosure of Interests:Ernest Choy Grant/research support from: Amgen, Bio-Cancer, Chugai Pharma, Ferring Pharmaceuticals, Novimmune, Pfizer, Roche, UCB, Consultant of: AbbVie, Amgen, AstraZeneca, Biogen, Boehringer Ingelheim, Bristol-Myers Squibb, Celgene, Chelsea Therapeutics, Chugai Pharma, Daiichi Sankyo, Eli Lilly, Ferring Pharmaceuticals, GlaxoSmithKline, Hospita, Ionis, Janssen, Jazz Pharmaceuticals, MedImmune, Merck Sharp & Dohme, Merrimack Pharmaceutical, Napp, Novartis, Novimmune, ObsEva, Pfizer, R-Pharm, Regeneron Pharmaceuticals, Inc., Roche, SynAct Pharma, Sanofi Genzyme, Tonix, UCB, Speakers bureau: Amgen, Boehringer Ingelheim, Bristol-Myers Squibb, Chugai Pharma, Eli Lilly, Hospira, Merck Sharp & Dohme, Novartis, Pfizer, Regeneron Pharmaceuticals, Inc., Roche, Sanofi-Aventis, UCB, Vivian Bykerk: None declared, Yvonne Lee Shareholder of: Cigna-Express Scripts, Grant/research support from: Pfizer, Consultant of: Highland Instruments, Inc., Gregory St John Shareholder of: Regeneron Pharmaceuticals, Inc., Employee of: Regeneron Pharmaceuticals, Inc., Hubert van Hoogstraten Shareholder of: Sanofi, Employee of: Sanofi, Kerri Ford Shareholder of: Sanofi Genzyme, Employee of: Sanofi Genzyme, Amy Praestgaard Employee of: Sanofi Genzyme, Anthony Sebba Consultant of: Genentech, Gilead, Lilly, Regeneron Pharmaceuticals Inc., Sanofi, Speakers bureau: Lilly, Roche, Sanofi
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Marionneaux, Steven M., Peter G. Maslak, Nenita Francisco, Virgil Chan, Justin Hanenberg, Jean Lynch, Josephine Rafael, Jingqiu Yao, and Conchita Chua. "Potential Clinical Impact of Inaccurate Automated Platelet Counts in the Setting of Severe Thrombocytopenia." Blood 120, no. 21 (November 16, 2012): 3428. http://dx.doi.org/10.1182/blood.v120.21.3428.3428.
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Abstract Abstract 3428 Severe thrombocytopenia is not an uncommon finding in the setting of hematologic malignancies. The key to a successful outcome often lies in the ability to support the patient through periods of cytopenia by adopting an aggressive transfusion strategy for platelets. Therefore, an accurate assessment of the platelet count is of utmost importance particularly as it relates to various levels which “trigger” prophylactic platelet transfusion. However, the accuracy and precision of conventional platelet counting methods have been shown to be suspect in severely thrombocytopenic samples. We investigated the accuracy of several commercial hematology analyzers currently available in clinical practice which use optical, impedance and immunologic platelet determination methods and assessed whether biased results could have an impact on decisions regarding platelet transfusion. Four-hundred three (403) EDTA-anticoagulated samples collected from patients with hematologic malignancies and a platelet count of < 50 × 10e3/uL were selected from the standard workflow processed in the hematology laboratories at MSKCC. Samples were split and tested within 8 hours of collection using optical based methods on the Advia 2120i (Siemens, Tarrytown, NY) and CELL-DYN Sapphire (Abbott Diagnostics, Santa Clara, CA). During the study, an additional analyzer became available, the XE-2100 (Sysmex, Kobe, Japan) which enumerates platelets by impedance and optical technology. One hundred twenty seven (127) of the 403 samples were split and tested by the Sysmex analyzer. Platelet counts from each method were then compared using the CD61 immunoplatelet determination (Abbott, Santa Clara, CA) as the reference value. The CD61 immunoplatelet method was chosen as the reference standard because we found excellent correlation in linear regression between this method and phase microscopy (r =0.99, y = −0.96 + 0.88x; n = 37). Also, the International Counsel for Standardization in Haematology and the International Society for Laboratory Hematology recommend the counting of specifically labelled platelets (CD41, CD61) by flow cytometry as a reference method for the enumeration of platelets. Bland-Altman difference plots were used to visualize the agreement between the reference and test methods and the paired t-test evaluated the statistical significance of the difference between methods. We then compared the number of platelet transfusion indications (at various platelet thresholds) as determined by all methods with potential transfusion decisions made using the reference method. There was a statistically significant positive bias among the optical and impedance methods compared with CD61 enumeration. Using various platelet transfusion decision points, the number of patients who were at risk for under transfusion (platelet count above threshold when reference result is < threshold) ranged from 1–2 % at a threshold of 50k/uL to 30–40 % when the threshold was lowered to 10k/uL. These results highlight the limitations in the accuracy of optical and impedance methods, particularly in the setting of severe thrombocytopenia. Since prophylactic platelet transfusions are by and large based on standard “triggers,” an overestimation of the platelet count may lead to under-transfusion, especially in patients at the highest risk for hemorrhage. Clinicians should be aware of the limitations of automated platelet determinations and consider this when making medical decisions regarding supportive transfusions. Disclosures: Marionneaux: Abbott Diagnostics: Consultancy.
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Kivitz, A., J. E. Gottenberg, M. Bergman, M. Iglesias-Rodriguez, G. St John, C. Qiu, H. Van Hoogstraten, and L. Bessette. "AB0301 SARILUMAB AS MONOTHERAPY OR IN COMBINATION WITH CONVENTIONAL SYNTHETIC DMARDS IN PATIENTS WITH RHEUMATOID ARTHRITIS: 12-WEEK TREATMENT RESULTS FROM A MULTICENTER, OPEN-LABEL, PROSPECTIVE, SINGLE-ARM OBSERVATIONAL STUDY." Annals of the Rheumatic Diseases 79, Suppl 1 (June 2020): 1450.1–1450. http://dx.doi.org/10.1136/annrheumdis-2020-eular.1972.
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Background:Due to strict inclusion/exclusion criteria, randomized controlled trials (RCTs) may not represent the heterogeneous rheumatoid arthritis (RA) population encountered in routine clinical practice; longitudinal observational studies are needed to complement learnings from RCTs. The PROspective sarilumab (preFILled syringe/pen) multinational, obsErvational Study (PROFILE) is collecting information on treatment strategies and sarilumab usage patterns and adherence in routine clinical practice for up to 52 weeks in patients with moderate-to-severe RA.Objectives:In this planned interim analysis, we report baseline characteristics of patients prescribed sarilumab in routine clinical practice and the efficacy and safety of sarilumab after 12 weeks of treatment.Methods:Adults with RA (2010 ACR/EULAR criteria) can enroll in this multinational, open-label, single-arm, Phase 4 study if, per their treating physicians’ judgment, they are to initiate treatment with sarilumab as mono- or combination (with csDMARD) therapy, in accordance with local labeling/prescribing information, ≤4 weeks prior to or ≤8 weeks after study Visit 1 (signed informed consent and disease characteristics documented); 1000 patients are planned for enrollment. Concomitant use of biologic or targeted synthetic DMARDs (b/tsDMARDs) is not permitted. Primary endpoint is change from baseline in Clinical Disease Activity Index (CDAI) score at Weeks 24 and 52. Statistical analyses are descriptive.Results:This analysis included 291 patients who reached, or discontinued before, the Week 12 visit, of whom 108 (37%) received sarilumab mono- and 183 (63%) received combination therapy. At baseline (BL), the monotherapy group had longer disease duration and a smaller proportion of b/tsDMARD-naïve patients than the combination therapy group (9.7 vs 8.7 years and 39% vs 53%). Baseline and week 12 CDAI values were available in 132 patients. Mean (SD) BL CDAI scores for the monotherapy and combination groups were 26.7 (13.1) and 27.0 (14.4). At Week 12, CDAI scores were improved by −9.1 (17.5) and −10.5 (13.9), and 37% (19/51) of patients receiving monotherapy and 48% (45/93) of those receiving combination therapy had achieved low disease activity (CDAI ≤10). Remission (CDAI ≤2.8) was achieved by 12% (6/51) of monotherapy and 20% (19/93) of combination-therapy patients. Overall, 55 (19%) discontinued sarilumab: 27 (9%) for an adverse event (AE), 19 (7%) for insufficient response, 4 (1%) for noncompliance, 5 (2%) for other reasons. Severe AEs leading to treatment discontinuation were leukopenia and neutropenia (n=1 patient), peripheral swelling (1), lung cancer (1), and fatigue (1). Ten patients (3%) had a treatment-emergent serious AE.Conclusion:In this planned interim analysis, sarilumab mono- or combination therapy resulted in improved disease outcomes, assessed by CDAI, at Week 12, an important treat-to-target time point. Safety and efficacy were consistent with Phase 3 trial findings, with no new safety signals, although interim results must be interpreted with caution. Future analyses will evaluate efficacy and safety after 24 and 52 weeks of treatment in routine clinical practice.Acknowledgments:Study funding and medical writing support (Laura George, Adelphi Communications Ltd, Macclesfield, UK) were provided by Sanofi Genzyme (Cambridge, USA) and Regeneron Pharmaceuticals, Inc. (Tarrytown, USA) in accordance with Good Publication Practice (GPP3) guidelines.Disclosure of Interests:Alan Kivitz Shareholder of: AbbVie, Amgen, Gilead, GSK, Pfizer Inc, Sanofi, Consultant of: AbbVie, Boehringer Ingelheim,,Flexion, Genzyme, Gilead, Janssen, Novartis, Pfizer Inc, Regeneron, Sanofi, SUN Pharma Advanced Research, UCB, Paid instructor for: Celgene, Genzyme, Horizon, Merck, Novartis, Pfizer, Regeneron, Sanofi, Speakers bureau: AbbVie, Celgene, Flexion, Genzyme, Horizon, Merck, Novartis, Pfizer Inc, Regeneron, Sanofi, Jacques-Eric Gottenberg Grant/research support from: Bristol-Myers Squibb, Pfizer, Roche, Consultant of: AbbVie, Bristol-Myers Squibb, Janssen, Lilly, MSD, Pfizer, Roche, UCB, Speakers bureau: AbbVie, Bristol-Myers Squibb, Gilead, Janssen, Lilly, MSD, Pfizer, Roche, UCB, Martin Bergman Shareholder of: Johnson & Johnson – stockholder, Consultant of: AbbVie, BMS, Celgene Corporation, Genentech, Janssen, Merck, Novartis, Pfizer, Sanofi – consultant, Speakers bureau: AbbVie, Celgene Corporation, Novartis, Pfizer, Sanofi – speakers bureau, Melitza Iglesias-Rodriguez Shareholder of: Sanofi Genzyme, Employee of: Sanofi Genzyme, Gregory St John Shareholder of: Regeneron Pharmaceuticals, Inc., Employee of: Regeneron Pharmaceuticals, Inc., Chunfu Qiu Shareholder of: Sanofi Genzyme, Employee of: Sanofi Genzyme, Hubert van Hoogstraten Shareholder of: Sanofi, Employee of: Sanofi, Louis Bessette Grant/research support from: AbbVie, Amgen, Bristol-Myers Squibb, Celgene, Eli Lilly, Janssen, Merck, Novartis, Pfizer, Roche, Sanofi, UCB Pharma, Consultant of: AbbVie, Amgen, Bristol-Myers Squibb, Celgene, Eli Lilly, Janssen, Merck, Novartis, Pfizer, Roche, Sanofi, UCB Pharma, Speakers bureau: AbbVie, Amgen, Bristol-Myers Squibb, Celgene, Eli Lilly, Janssen, Merck, Novartis, Pfizer, Sanofi
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Evans, L. M., M. Dilks, and B. M. Goldsmith. "A-359 Performance of Measured TCO2 on the epoc Analyzer." Clinical Chemistry 69, Supplement_1 (September 27, 2023). http://dx.doi.org/10.1093/clinchem/hvad097.317.
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Abstract Background The epoc Blood Analysis System (Siemens, Tarrytown, NY) performs blood gases, electrolytes, and metabolites using a Blood Gas, Electrolyte and Metabolite (BGEM) Test Card on 92 uL of whole blood. The BGEM Test Card uses potentiometric sensors to measure sodium, potassium, chloride, ionized calcium, pH, pCO2; amperometric sensors to measure pO2, glucose, creatinine, and lactate; and a conductometric sensor to measure hematocrit. Results are available in 3–10 minutes, depending upon the time of sample injection. TJUH implemented epoc in its ICUs in 2012 to provide rapid, whole blood Point of Care (POC) results and has expanded to other locations (Emergency Department, Outpatient Radiology, Cardiothoracic Surgery). While previous epoc cards provided calculated TCO2 (cTCO2), Siemens recently added measured TCO2 (mTCO2; combination of potentiometric sensors and calculation) to its BGEM card. We evaluated this card for future use. Methods Precision and method comparison studies were performed at our Center City location. Inter- and intra-precision studies were performed on two levels of controls (Eurotrol, Elizabethtown, KY). Whole blood was collected in heparinized syringes from 20 patients. Comparison studies were performed on the ABL800 (Radiometer, Brea, CA). We simultaneously compared epoc mTCO2 against epoc cTCO2 and against the cTCO2 on the ABL800. Results Intra-assay precision for epoc mTCO2 (n = 20, 2 devices) was 0.8%CV and 2.3%CV for Levels 1 and 3, respectively. Inter-assay precision for epoc mTCO2 (n = 20, 2 devices over 10 days) was 1.1%CV and 3.3%CV for Levels 1 and 3, respectively. Method comparison for epoc mTCO2 (n = 20) was: mean = 22.9, median = 22.1, r2 = 0.9174, y = 0.9751x + 1.2925. In comparison, method comparison for epoc cTCO2 (n = 20) was: mean = 24.7, median = 23.9, r2 = 0.9165 y = 0.9855x + 2.8559. Conclusion The epoc measured TCO2 studies show better correlation to the Radiometer ABL800 than the epoc calculated cTCO2, and it is considered acceptable for implementation at our Center City sites where epoc is currently in use.
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Dilks, M., L. M. Evans, and B. M. Goldsmith. "A-357 Performance of Blood Urea Nitrogen on the epoc Analyzer." Clinical Chemistry 69, Supplement_1 (September 27, 2023). http://dx.doi.org/10.1093/clinchem/hvad097.316.
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Abstract Background The epoc Blood Analysis System (Siemens, Tarrytown, NY) performs blood gases, electrolytes, and metabolites using a Blood Gas Electrolyte and Metabolite (BGEM) Test Card panel on 92 uL of whole blood. The BGEM Test Card uses potentiometric sensors to measure sodium, potassium, chloride, ionized calcium, pH, pCO2; amperometric sensors to measure pO2, glucose, creatinine, and lactate; and a conductometric sensor to measure hematocrit. Results are available in 3–10 minutes, depending upon the time of sample injection. TJUH implemented the epoc in its ICUs in 2012 to provide rapid, whole blood Point of Care (POC) results, then expanded to other locations (Emergency Department, Outpatient Radiology, Cardiothoracic Surgery). Siemens recently added a potentiometric sensor for measurement of Blood Urea Nitrogen (BUN) to its BGEM card. We evaluated this card for possible future use. Methods Precision and method comparison studies were performed at our Center City location. Inter- and intra-precision studies were performed on two levels of controls (Eurotrol, Elizabethtown, KY). Remnant whole blood was collected from 30 patients. Comparison studies were performed on the Piccolo Xpress (Abbott, Princeton, NJ), which provides a whole blood BUN measurement using a coupled-enzyme reaction. Results Intra-assay precision for epoc BUN (n = 20, 2 devices) was 2.8%CV and 6.5%CV for Levels 1 and 3, respectively. Inter-assay precision for epoc BUN (n = 20, 2 devices over 10 days) was 2.4%CV and 7.1%CV for Levels 1 and 3, respectively. Method comparison for BUN (n = 30) was: mean = 42, median = 29, r2 = 0.9889, y = 0.8840x-3.6416. Conclusion The epoc BUN studies showed comparable results when compared to the Piccolo Xpress. Previous studies showed good correlation between whole blood on the Piccolo Xpress and plasma on the Roche Cobas c702 which is also a coupled-enzyme reaction; therefore the test is considered acceptable for implementation at our Center City sites where epoc is currently in use.
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"Operational Analysis: A Case Study of Two Hotels in Financial Distress. Elisa S. Moncarz and Richard N. Kron. International Journal of Hospitality Management, vol. 12, no. 2, May 1993, pp. 175-96. Pergamon Press Inc., 660 White Plains Road, Tarrytown, NY 10591-5153. $219 annual subscription." Journal of Travel Research 32, no. 3 (January 1994): 76. http://dx.doi.org/10.1177/004728759403200354.
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"A Model of Hotel Occupancy Performance for Monitoring and Marketing in the Hotel Industry. D. Jeffrey and N. J. Hubbard. International Journal of Hospitality Management, vol. 13, no. 1, pp. 57-71. Elsevier Science Inc., 660 White Plains Road, Tarrytown, NY 10591-5153. $245 annual subscription." Journal of Travel Research 33, no. 2 (October 1994): 63–64. http://dx.doi.org/10.1177/004728759403300283.
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