Real-world evidence in patient-related outcomes (PROs) of metastatic castrate-resistant prostate cancer (mCRPC) patients treated with abiraterone acetate plus prednisone (AA+P).

2018 ◽  
Vol 36 (6_suppl) ◽  
pp. 196-196 ◽  
Author(s):  
Geoffrey Gotto ◽  
Vincent Fradet ◽  
Darrel Drachenberg ◽  
Robert Sabbagh ◽  
Ricardo A. Rendon ◽  
...  
Keyword(s):  
Real World ◽  
Metastatic Cancer ◽  
Abiraterone Acetate ◽  
Cognitive Status ◽  
Continuous Variables ◽  
Absolute Change ◽  
The Mean ◽  
Clinically Significant ◽  
Moca Score ◽  
Over Time

196 Background: Oral androgen biosynthesis inhibitor, abiraterone acetate plus prednisone (AA+P), has shown to improve survival and patient-related outcomes (PROs) in clinical trials. The COSMiC study (Canadian Observational Study in Metastatic Cancer of the Prostate; ClinicalTrials.gov: NCT02364531) set out to prospectively amass real-world data on mCRPC patients (pts) managed with AA+P in communities within Canada. Here, we report the interim analysis of their PROs. Methods: At planned data cutoff in Sept 2017 after a median follow-up of 33.8 months, 264 pts were enrolled in 39 sites across Canada. Their FACT-P (Functional Assessment of Cancer Therapy – Prostate) and MoCA (Montreal Cognitive Assessment) were evaluated at baseline as well as at weeks 12, 24, 48 and 72 after AA+P initiation. A 10-point decrease denotes clinically significant degradation in FACT-P and a total MoCA score of > = 26 is considered normal. Descriptive analysis was utilized with continuous variables. Changes from baseline were summarized using mean (SD). Results: At a median age of 77 among 264 pts, 230, 185, 110 and 63 pts were available for analysis at their week 12, 24, 48, and 72 assessments respectively. The mean baseline FACT-P total score was 111.2 (19.44) with a < 3-point absolute change from baseline at subsequent assessments, denoting no clinically significant change in functional status over time. The mean baseline MoCA score was 25.2 (4.50), yet all subsequent assessments scored above 26 and a mean absolute change from baseline of < 1, showing an absence of cognitive decline over time. PSA value was available for 221 pts, 64.3% (142/221) and 34.4% (76/221) achieved a PSA decline of > 50% and 90% respectively. All-grade treatment-related adverse events were reported in 63 pts, with 11% who have had AA+P discontinuation or interruption. Conclusions: COSMiC represents the largest Canadian mCRPC cohort treated with AA+P with real world prospective evaluation of PROs. This data demonstrated the maintenance in quality of life and cognitive status over the course of the study, and underscores the importance of PRO utilization in this complex patient population. Clinical trial information: NCT02364531.

scholarly journals Real-world evidence in patient-reported outcomes (PROs) of metastatic castrate-resistant prostate cancer (mCRPC) patients treated with abiraterone acetate + prednisone (AA+P) across Canada: Final results of COSMiC

2020 ◽  
Vol 14 (12) ◽  
Author(s):  
Geoffrey Gotto ◽  
Darrel E. Drachenberg ◽  
Joseph Chin ◽  
Richard Casey ◽  
Vincent Fradet ◽  
...  
Keyword(s):  
Prostate Cancer ◽  
Real World ◽  
Patient Reported Outcomes ◽  
Short Form ◽  
Metastatic Cancer ◽  
Abiraterone Acetate ◽  
Cognitive Status ◽  
Patient Reported ◽  
Castrate Resistant Prostate Cancer ◽  
Castrate Resistant

Introduction: Abiraterone acetate plus prednisone (AA+P) has shown to significantly improve survival. COSMiC, a Canadian Observational Study in Metastatic Cancer of the Prostate, set out to prospectively amass real-world data on metastatic castrate-resistant prostate cancer (mCRPC) patients managed with AA+P in Canada. Here, we report their patient-reported outcomes (PROs). Methods: After a median followup of 67.1 weeks, 254 patients were enrolled across 39 sites. Functional Assessment of Cancer Therapy-Prostate (FACT-P), Montreal Cognitive Assessment (MoCA), Brief Pain Inventory-Short form (BPI-SF), Brief Fatigue Inventory (BFI), and Current Health Satisfaction in Prostate Cancer (CHS-PCa) were evaluated at baseline, as well as at weeks 12, 24, 48, and 72 after AA+P initiation. Descriptive analysis was used with continuous variables. Changes from baseline were summarized using mean (standard deviation [SD]). Results: At a median age of 76.6 (8.94), baseline FACT-P total score was 111.3 (19.56) with no significant change in their functional status observed from baseline over time. The median baseline MoCA score was 25.2 (4.52), yet subsequent assessments showed an absence of cognitive decline while under treatment. Similarly, no meaningful changes were detected in BPI, BFI, and CHS-PCa during the 72-week study period, thus suggesting that patients’ PROs were well-maintained throughout AA+P treatment. Prostate-specific antigen (PSA) response with >50% decline was 66.4%. Safety profile was consistent with the known side effect of AA+P. Conclusions: COSMiC represents the largest Canadian mCRPC cohort treated with AA+P with real-world, prospective evaluation of PROs. This data demonstrated the maintenance in quality of life and cognitive status over the course of the study and underscores the importance of PRO use in this complex patient population.

scholarly journals POS0619 MODELLING OF DISEASE ACTIVITY IN PATIENTS WITH INFLAMMATORY ARTHROPATHIES TREATED WITH ETANERCEPT ORIGINATOR OR BIOSIMILAR AS FIRST-LINE BIOLOGIC IN AN AUSTRALIAN REAL-WORLD DATASET

2021 ◽  
Vol 80 (Suppl 1) ◽  
pp. 547.1-547
Author(s):  
C. Deakin ◽  
G. Littlejohn ◽  
H. Griffiths ◽  
T. Smith ◽  
C. Osullivan ◽  
...  
Keyword(s):  
Disease Activity ◽  
Clinical Data ◽  
Real World ◽  
Rank Test ◽  
P Value ◽  
Continuous Variables ◽  
Linear Quadratic ◽  
First Line ◽  
Modest Improvement ◽  
Over Time

Background:The availability of biosimilars as non-proprietary versions of established biologic disease-modifying anti-rheumatic drugs (bDMARDs) is enabling greater access for patients with rheumatic diseases to effective medications at a lower cost. Since April 2017 both the originator and a biosimilar for etanercept (trade names Enbrel and Brenzys, respectively) have been available for use in Australia.Objectives:[1]To model effectiveness of etanercept originator or biosimilar in reducing Disease Activity Score 28-joint count C reactive protein (DAS28CRP) in patients with rheumatoid arthritis (RA), psoriatic arthritis (PsA) or ankylosing spondylitis (AS) treated with either drug as first-line bDMARD[2]To describe persistence on etanercept originator or biosimilar as first-line bDMARD in patients with RA, PsA or ASMethods:Clinical data were obtained from the Optimising Patient outcomes in Australian rheumatoLogy (OPAL) dataset, derived from electronic medical records. Eligible patients with RA, PsA or AS who initiated etanercept originator (n=856) or biosimilar (n=477) as first-line bDMARD between 1 April 2017 and 31 December 2020 were identified. Propensity score matching was performed to select patients on originator (n=230) or biosimilar (n=136) with similar characteristics in terms of diagnosis, disease duration, joint count, age, sex and concomitant medications. Data on clinical outcomes were recorded at 3 months after baseline, and then at 6-monthly intervals. Outcomes data that were missing at a recorded visit were imputed.Effectiveness of the originator, relative to the biosimilar, for reducing DAS28CRP over time was modelled in the matched population using linear mixed models with both random intercepts and slopes to allow for individual heterogeneity, and weighting of individuals by inverse probability of treatment weights to ensure comparability between treatment groups. Time was modelled as a combination of linear, quadratic and cubic continuous variables.Persistence on the originator or biosimilar was analysed using survival analysis (log-rank test).Results:Reduction in DAS28CRP was associated with both time and etanercept originator treatment (Table 1). The conditional R-squared for the model was 0.31. The average predicted DAS28CRP at baseline, 3 months, 6 months, 9 months and 12 months were 4.0 and 4.4, 3.1 and 3.4, 2.6 and 2.8, 2.3 and 2.6, and 2.2 and 2.4 for the originator and biosimilar, respectively, indicating a clinically meaningful effect of time for patients on either drug and an additional modest improvement for patients on the originator.Median time to 50% of patients stopping treatment was 25.5 months for the originator and 24.1 months for the biosimilar (p=0.53). An adverse event was the reason for discontinuing treatment in 33 patients (14.5%) on the originator and 18 patients (12.9%) on the biosimilar.Conclusion:Analysis using a large national real-world dataset showed treatment with either the etanercept originator or the biosimilar was associated with a reduction in DAS28CRP over time, with the originator being associated with a further modest reduction in DAS28CRP that was not clinically significant. Persistence on treatment was not different between the two drugs.Table 1.Respondent characteristics.Fixed EffectEstimate95% Confidence Intervalp-valueTime (linear)0.900.89, 0.911.5e-63Time (quadratic)1.011.00, 1.011.3e-33Time (cubic)1.001.00, 1.007.1e-23Originator0.910.86, 0.960.0013Acknowledgements:The authors acknowledge the members of OPAL Rheumatology Ltd and their patients for providing clinical data for this study, and Software4Specialists Pty Ltd for providing the Audit4 platform.Supported in part by a research grant from Investigator-Initiated Studies Program of Merck & Co Inc, Kenilworth, NJ, USA. The opinions expressed in this paper are those of the authors and do not necessarily represent those of Merck & Co Inc, Kenilworth, NJ, USA.Disclosure of Interests:Claire Deakin: None declared, Geoff Littlejohn Consultant of: Over the last 5 years Geoffrey Littlejohn has received educational grants and consulting fees from AbbVie, Bristol Myers Squibb, Eli Lilly, Gilead, Novartis, Pfizer, Janssen, Sandoz, Sanofi and Seqirus., Hedley Griffiths Consultant of: AbbVie, Gilead, Novartis and Lilly., Tegan Smith: None declared, Catherine OSullivan: None declared, Paul Bird Speakers bureau: Eli Lilly, abbvie, pfizer, BMS, UCB, Gilead, Novartis

Assessment of urologists experience with abiraterone acetate and with a real-world trial: Results obtained from a Canadian Observational Study in Metastatic Cancer of the Prostate (COSMiC).

2017 ◽  
Vol 35 (6_suppl) ◽  
pp. 238-238
Author(s):  
Andrew Feifer ◽  
Vincent Fradet ◽  
Darrel Drachenberg ◽  
Geoffrey Gotto ◽  
Ricardo A. Rendon ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Observational Study ◽  
Real World ◽  
Active Sites ◽  
Metastatic Cancer ◽  
Abiraterone Acetate ◽  
Ease Of Use ◽  
Therapeutic Area ◽  
Patient Reported ◽  
Cancer Of The Prostate

238 Background: Abiraterone Acetate (AA) is a selective inhibitor of the androgen biosynthesis and has significantly improved OS for mCRPC patients. Canadian Observational Study in Metastatic Cancer of the Prostate (COSMiC) is a Non-Interventional Observational Study pPhase IV clinical trial; NCT02364531) specifically designed to (1) collect real-world drug-specific outcomes (clinical and patient reported outcomes) and (2) assess urologists experience with incorporation of AA in their practice. Here we report data collected from COSMiC trial on the success of AA integration into the urology practice and physicians experience in participating in the trial. Methods: (1) A comprehensive questionnaire was developed to assess urologists experience with (a) integration and usage of AA in their practice and (b) COSMiC trial. (2) Questionnaire was sent to the active trial sites (47 sites) and collected data from 30 sites is summarized here. Results: 93.3% of participants in COSMiC trial were urologists (63.3% community vs. 30% academic). The ease of use and success in integration of AA in urology practice was rated easy by 50% of the participants, easy once they overcame few barriers by 46.7% and challenging by 3.3%. Drug-related barriers identified included time involvement (50%), resource issues such as nursing support (23.3%), and lack of appropriate infrastructure (33.3%). 90% of the active sites indicated that treating mCRPC patients with AA will be part of their practice post-trial. As part of this report we also assessed and identified physicians barriers in participating in COSMiC trial. 86.7% of the sites reported that trials such as COSMiC will add value to the therapeutic area and 93.3% of the sites reported interest in participating in trials of this nature in future. Conclusions: This report indicates that integration of AA in urology practices is considered easy and manageable for most urologists, in some cases after overcoming few initial barriers. There is high interest in participating in future real-world trials of this nature among urologists and such studies add value to the therapeutic area. Clinical trial information: NCT02364531.

scholarly journals The NIMO Scandinavian Study: A Prospective Observational Study of Iron Isomaltoside Treatment in Patients with Iron Deficiency

2017 ◽  
Vol 2017 ◽  
pp. 1-7 ◽  
Author(s):  
Svein Oskar Frigstad ◽  
Anne Haaber ◽  
Antal Bajor ◽  
Jan Fallingborg ◽  
Per Hammarlund ◽  
...  
Keyword(s):  
Iron Deficiency ◽  
Prospective Observational Study ◽  
Intravenous Iron ◽  
Lower Probability ◽  
Significant Treatment ◽  
The Mean ◽  
Clinically Significant ◽  
High Doses ◽  
One Year ◽  
Over Time

Background. Intravenous iron allows for efficient and well-tolerated treatment in iron deficiency and is routinely used in diseases of the gastrointestinal tract. Objective. The aims of this study were to determine the probability of relapse of iron deficiency over time and to investigate treatment routine, effectiveness, and safety of iron isomaltoside. Methods. A total of 282 patients treated with iron isomaltoside were observed for two treatments or a minimum of one year. Results. Out of 282 patients, 82 had Crohn’s disease and 67 had ulcerative colitis. Another 133 patients had chronic blood loss, malabsorption, or malignancy. Patients who received an iron isomaltoside dose above 1000 mg had a 65% lower probability of needing retreatment compared with those given 1000 mg. A clinically significant treatment response was shown, but in 71/191 (37%) of patients, anaemia was not corrected. The mean dose given was 1100 mg, lower than the calculated total iron need of 1481 mg. Adverse drug reactions were reported in 4% of patients. Conclusion. Iron isomaltoside is effective with a good safety profile, and high doses reduce the need for retreatment over time. Several patients were anaemic after treatment, indicating that doses were inadequate for full iron correction. This trial is registered with NCT01900197.

scholarly journals Use of Routine Bloodwork on General Internal Medicine Inpatients: A Retrospective Cohort Study

Blood ◽  
2019 ◽  
Vol 134 (Supplement_1) ◽  
pp. 56-56
Author(s):  
William K Silverstein ◽  
Adina S. Weinerman ◽  
Rick Wang ◽  
Lisa K. Hicks ◽  
R. Sacha Bhatia ◽  
...  
Keyword(s):  
Internal Medicine ◽  
Cohort Study ◽  
General Internal Medicine ◽  
Retrospective Cohort Study ◽  
Retrospective Cohort ◽  
General Internal ◽  
Routine Blood ◽  
The Mean ◽  
Clinically Significant ◽  
Over Time

Introduction Choosing Wisely (CW) recommendations in Canada and the United States advise against routine blood work on stable inpatients because it is unlikely to improve patient care, is associated with anemia and pain, and increases costs. While numerous local quality improvement initiatives have effectively reduced the use of routine blood work (RBW), no population-level analyses have assessed the use of RBW on hospitalized patients in the CW era. This study aimed to describe the use of RBW between 2010 and 2017 by physicians caring for General Internal Medicine (GIM) inpatients at 7 hospitals. We hypothesized that RBW use would decrease over time and that increased use of RBW would be associated with greater reductions in hemoglobin. Methods We performed a retrospective cohort study using the General Medicine Inpatient Initiative (GEMINI) database, based in Ontario, Canada. The GEMINI database contains clinical and administrative data for all patients admitted to a GIM service at seven hospitals (5 academic centres; 2 community hospitals) in Toronto and Mississauga. We included all patients included in the GEMINI database, admitted from April 1, 2010 (prior to CW Canada), to March 31, 2017 (3 years after CW Canada's launch). Patients were excluded if they were admitted with a bleeding diagnosis, underwent an endoscopic or surgical procedure, were admitted to an Intensive Care Unit, or were admitted to hospital for less than 72 hours or greater than 30 days. Patients that received a blood transfusion during the first 48 hours of admission, or did not have hemoglobin measured within their first 48 hours of admission were also excluded. Physicians were excluded if they were the most responsible physician (MRP) for fewer than 100 admissions. Our primary outcome was the mean volume of RBW ordered per patient per day by the MRP. RBW was defined as complete blood count, electrolytes, extended electrolytes, creatinine, liver panel, INR, or PTT. To examine changes in the distribution of RBW ordering over time, we report RBW use at the following physician percentiles: 10, 25, 50, 75, 90. Prior analyses of the relationship between RBW use and reduction in Hgb in hospital are confounded (sicker patients receive more bloodwork). To avoid this confounding, we examined change in Hgb among patients of physicians stratified by RBW use. Patients are quasirandomly allocated to physicians in GIM, and thus, observed differences can be attributed to physician practice, not patient factors. We report the mean change in Hgb as a continuous outcome, and also percentage of patients who experienced a clinically significant reduction in Hgb, which was prespecified as at least 10 g/L. Statistical significance was determined using Chi-square tests for categorical variables, and Kruskall-Wallis tests for continuous variables. Results We included 65,507 hospital admissions. The mean volume of RBW ordered per patient per day significantly decreased from 2010 to 2016, for all percentiles (p&lt;0.001 for all percentiles; as an example: 7.23cc in 2010 to 6.17cc in 2016 for patients admitted to physicians in the 25-50th percentile) (Figure 1). The mean volume of RBW ordered per patient per day significantly decreased from 2010 to 2016 in all but one hospital (Figure 2). However, the spread between the 10th and 90th percentile physicians did not change much between 2010 (1.77cc/patient/day) and 2016 (1.84 cc/patient/day). There was a dose-response relationship between MRP use of RBW and reductions in patient Hgb (Table 1). Compared to patients of MRPs in the lowest 10% of RBW use, patients of physicians in the highest 10% had a greater mean reduction in Hgb (4.93 g/L vs 3.34 g/L, p&lt;0.001), and were more likely to have a clinically significant reduction in Hgb (23.1% vs. 18.7%, p&lt;0.001). Conclusion This large, multi-centre cohort study demonstrated that greater use of RBW on GIM inpatients was associated with clinically significant reductions in Hgb. To our knowledge, this is the first study to rigorously demonstrate that greater use of RBW may be associated with clinically meaningful reductions in Hgb, independent of patient-level confounding. We further found that RBW use decreased overall with time, and in 6 out of 7 hospitals, between 2010 and 2017. However, the spread between 10th and 90th percentile physicians has not changed, suggesting that opportunities still exist to reduce RBW use at both the hospital and physician level. Disclosures No relevant conflicts of interest to declare.

scholarly journals Relationship Between Orthostatic Hypotension and Cognitive Functions in Multiple System Atrophy: A Longitudinal Study

2021 ◽  
Vol 12 ◽  
Author(s):  
Sofia Cuoco ◽  
Immacolata Carotenuto ◽  
Arianna Cappiello ◽  
Sara Scannapieco ◽  
Maria Claudia Russillo ◽  
...  
Keyword(s):  
Cognitive Impairment ◽  
Mild Cognitive Impairment ◽  
Multiple System Atrophy ◽  
Orthostatic Hypotension ◽  
Cognitive Functions ◽  
Cognitive Status ◽  
Normal Cognition ◽  
Moca Score ◽  
Over Time

Introduction: The aim of this study is to investigate the impact of orthostatic hypotension (OH) on cognitive functions in patients with multiple system atrophy (MSA) followed over time.Methods: Thirty-two MSA patients were enrolled and underwent a comprehensive neuropsychological battery; at baseline (T0) 15 out of 32 patients presented OH, assessed by means of orthostatic standing test. All patients underwent a follow-up (T1) evaluation 12 months after baseline. Thirteen out of 32 patients also underwent a second follow-up (T2) evaluation at 24 months. Changes over time on different neuropsychological tasks were compared between patients with and without OH by means of Mann-Whitney's U-test. Moreover, clinical categories of normal cognition, mild cognitive impairment, and dementia were determined, and changes at T1 and T2 in global cognitive status were compared between patients with and without OH.Results: At T0, patients with OH had better performance on words/non-words repetition task (p = 0.02) compared to patients without OH. Compared to patients without OH, patients with OH performed worse on semantic association task (p &lt; 0.01) at T1 and on Stroop test-error effect (p = 0.04) at T2. The percentage of patients with worsened cognitive status at T1 was higher among patients with OH than among patients without OH (93 vs. 59%, p = 0.03). OH (β = −4.67, p = 0.01), education (β = 0.45, p = 0.02), age (β = 0.19, p = 0.03), and Montreal Cognitive Assessment battery (MOCA) score at T0 (β = −0.26, p = 0.04) were significant predictors of global cognitive status worsening at T1.Discussion: We found that global cognitive status worsened at 1-year follow-up in 93% of patients with OH, and OH, along with age, education, and MOCA score, predicted cognitive worsening over time. To clarify the relationship between OH and cognitive dysfunction in MSA, we suggest the use of clinical categories of normal cognition, mild cognitive impairment, and dementia in further longitudinal studies on MSA patients with and without OH.

Abstract 311: Selection of Optimal Predictor and Critical Thresholds for Return of Spontaneous Circulation Using Non-Invasive Frequency-Domain Diffuse Optical Spectroscopy During Cardiopulmonary Resuscitation

Circulation ◽  
2018 ◽  
Vol 138 (Suppl_2) ◽  
Author(s):  
Tiffany S Ko ◽  
Wensheng Guo ◽  
Constantine D Mavroudis ◽  
Ryan W Morgan ◽  
Wesley M Baker ◽  
...  
Keyword(s):  
Frequency Domain ◽  
Optical Spectroscopy ◽  
Sensitivity Threshold ◽  
Invasive Monitoring ◽  
Diffuse Optical Spectroscopy ◽  
Absolute Change ◽  
Critical Thresholds ◽  
Non Invasive ◽  
The Mean ◽  
Over Time

Introduction: We have shown that during CPR, novel non-invasive monitoring of cerebral tissue oxygenation (StO 2 , %) and total hemoglobin concentration (THC, μmol/L) by frequency-domain diffuse optical spectroscopy (FD-DOS) is associated with ROSC in a swine model of pediatric cardiac arrest. Our objective is to find the optimal non-invasive predictor for ROSC and assess feasibility of a stable critical threshold over time in early CPR. Hypothesis: Stable critical thresholds with high sensitivity or specificity for ROSC may be established in early CPR (<10 min) from non-invasive cerebral StO 2 and THC measurements initiated at CPR start. Methods: One-month-old swine (n=31) underwent 7 minutes of asphyxia, induction of ventricular fibrillation, and up to 20 minutes of CPR till ROSC or death (no ROSC). Absolute StO 2 and THC and absolute and relative change from 1 minute into CPR (time for chest molding and FD-DOS placement) were evaluated as ROSC predictors over time. For each variable, an ROC curve and two critical thresholds, maximizing specificity (=1) or sensitivity (=1), were determined at 1-min intervals from 2-10 minutes of CPR using univariate logistic regression. Optimal predictor was selected by highest mean AUC. A stable specificity or sensitivity threshold was feasible if the mean threshold had a specificity or sensitivity >0.9 over all intervals, respectively. Results: Absolute change in StO 2 (ΔStO 2 ) had the highest mean (SD) AUC of 0.90 (0.07). Consistently >0.8, the AUC exceeded 0.9 after 7 minutes of CPR ( see Fig. ). The mean specificity threshold (ΔStO 2 = +5.1%) and sensitivity threshold (ΔStO 2 = +1.4%) achieved an overall specificity of 0.93 and sensitivity of 0.98, respectively. Conclusions: Non-invasive monitoring of absolute change in StO 2 was most predictive of ROSC and stable critical thresholds with high specificity or sensitivity were established in early CPR. Future work will independently validate this promising tool for CPR optimization.

scholarly journals Epidemiology of Hospital Onset Staphylococcus aureus Bloodstream Infections (HO-SA-BSI) in the Era of MRSA LabID Reporting

2020 ◽  
Vol 41 (S1) ◽  
pp. s216-s217
Author(s):  
Cassandra Salgado ◽  
Stephanie O’Driscoll ◽  
Shruti Puri ◽  
Adrienne Lorek ◽  
Scott Curry
Keyword(s):  
Staphylococcus Aureus ◽  
Methicillin Resistance ◽  
Previous History ◽  
Bloodstream Infections ◽  
Mortality Rates ◽  
Attributable Mortality ◽  
Continuous Variables ◽  
The Mean ◽  
Few Data ◽  
Over Time

Background: Acute-care hospitals began reporting methicillin-resistant Staphylococcus aureus (MRSA) LabID facility-wide inpatient events to the NHSN in 2013. Few data are available regarding the epidemiology of these patients. Methods: We conducted a retrospective cohort study of patients who developed hospital onset Staphylococcus aureus bloodstream infections (HO-SA-BSIs) to describe the epidemiology (characteristics and outcomes) from January 2014 through June 2019 and to compare MRSA LabID BSIs to HO-MSSA BSIs. Proportions were compared using 2 and continuous variables using the Kruskal-Wallis test (EpiInfo). Results: Overall, 264 HO-SA BSIs occurred over the study period (2.21 per 10,000 patient days), 160 HO-MSSA BSIs (1.34 per 10,000 patient days), and 104 MRSA LabID BSIs (0.869 per 10,000 patient days). These rates have not significantly changed over time (Fig. 1). Most of these patients were men (64%); 42.4% were African-American; mean age was 43.5 years; mean Charlson comorbidity index was 3.2; 67.8% were admitted for medical care (vs surgical); and 13.3% had a previous history of S. aureus infection. Of all HO-SA-BSIs, 49.2% were acquired in the ICU, 53.8% were primary BSIs, and 37.9% were catheter associated. Patients were hospitalized a mean of 19.9 days prior to HO-SA BSI, and the mean overall length of stay was 48.5 days. Compared to HO-MSSA BSIs, there were no significant differences in these characteristics among MRSA LabID BSIs except that a significantly greater proportion were catheter associated (46.2% vs 32.5%; OR, 1.78; 95% CI, 1.07–2.96; P = .04). Overall, 101 patients (38.3%) died: 41 with MRSA LabID BSI (39.4%) and 60 with HO-MSSA BSI (37.5%). Mortality rates have not changed significantly over time. The mean number of days to death was 154.2, and 59 patients (22.3%) died during incident hospitalization: 26.9% of MRSA patients and 19.4% of MSSA BSI patients. Moreover, 28.3% of patients were readmitted within 30 days of discharge from incident hospitalization, and compared to HO-MSSA BSI, this rate was significantly higher among MRSA LabID BSI patients (34.2% vs 24.8%; OR, 2.07; 95% CI, 1.09–3.93; P = .03). Among those who died, 58.4% died during hospitalization, 52.5% died within 30 days, 66.3% died within 60 days, and 74.3% had died within 90 days. Also, 47.5% died as a result of their HO-SA BSI, and compared to HO-MSSA BSI, this rate was significantly higher among those with MRSA LabID-BSI (63.4% vs 36.7%; OR, 2.99; 95% CI, 1.31–6.83; P = .02). Conclusions: Among patients with HO-SA BSI, methicillin-resistance continues to be associated with higher attributable mortality, and in our study, higher rates of 30-day readmission. There has been no significant change in HO-SA BSI rates (MSSA or MRSA) since reporting for MRSA LabID events began. Furthermore, mortality rates have not changed and remain high for both MRSA BSI and MSSA BSI patients. Given these findings, MSSA LabID event reporting should be considered.Funding: NoneDisclosures: None

scholarly journals Radiological Growth Patterns of Prolactinomas and Nonfunctioning Adenomas

2017 ◽  
Vol 44 (5) ◽  
pp. 508-513 ◽  
Author(s):  
Syed Ali Imran ◽  
Jai Shankar ◽  
Andrea L.O. Hebb ◽  
Sidney E. Croul ◽  
David B. Clarke
Keyword(s):  
Visual Field ◽  
Field Testing ◽  
Growth Patterns ◽  
Categorical Variables ◽  
Continuous Variables ◽  
Chi Square ◽  
Mri Scans ◽  
Chi Square Test ◽  
The Mean ◽  
Clinically Significant

AbstractObjectives: To compare growth patterns of nonfunctioning and prolactin-producing pituitary macroadenomas, and to find whether their specific growth patterns are associated with clinically significant effects on vision. Materials and Methods: From our comprehensive provincial neuropituitary registry, we retrospectively identified 35 randomly selected patients each with nonfunctioning adenomas and prolactinomas >10 mm in any dimension. MRI scans were analyzed to determine the superior and inferior growth, volume, and maximum craniocaudal height of the adenomas. Patients underwent visual field testing at diagnosis. Continuous variables were compared using Student’s t test, the Mann–Whitney U test, and ANOVA. Categorical variables were compared using the chi-square test. Results: The mean height of prolactinomas (23.2±11.3 mm) was similar to nonfunctioning adenomas (22.3±9.3 mm, p=0.8), and so were mean tumor volumes (prolactinoma=5.9±8 ml vs. nonfunctioning adenoma=4.8±5 ml, p=0.47). However, the mean suprasellar growth for prolactinomas was 2.9±5.3 mm and 7.3±4.7 mm for nonfunctioning adenomas (p<0.001), and the mean infrasellar growth was 10.2±8.0 and 5.0±6.6 mm, respectively (p=0.04). The inferior growth pattern of prolactinomas was associated with a significantly lower likelihood of having visual field abnormalities (11.4 vs. 57.1%, p<0.001). Conclusions: Prolactinomas have predominantly inferior growth compared to nonfunctioning adenomas and are less likely to cause vision changes.

Immunologic Assessment of Patients Treated with Bovine Fibrin as a Hemostatic Agent

1996 ◽  
Vol 76 (06) ◽  
pp. 0925-0931 ◽  
Author(s):  
John F Carroll ◽  
Keith A Moskowitz ◽  
Niloo M Edwards ◽  
Thomas J Hickey ◽  
Eric A Rose ◽  
...  
Keyword(s):  
Coagulation Factors ◽  
Allergic Reactions ◽  
Factor V ◽  
Normal Range ◽  
Serum Samples ◽  
Human Fibrinogen ◽  
Bovine Thrombin ◽  
Thrombotic Complications ◽  
The Mean ◽  
Clinically Significant

SummaryTwenty-one cardiothoracic surgical patients have been treated with fibrin as a topical hemostatic/sealing agent, prepared from bovine fibrinogen clotted with bovine thrombin. Serum samples have been collected before treatment with fibrin and postoperatively between 1 and 9 days, 3 and 12 weeks, and 6 and 8 months. The titers of anti-bovine fibrinogen antibodies, measured by ELISA specific for immunoglobulins IgG or IgM, increased to maximal values after about 8 or 6 weeks, respectively. After 8 months, IgG titers were on average 20-fold lower than the mean maximal value, while IgM titers returned to the normal range. IgG was the predominant anti-bovine fibrinogen immunoglobulin as documented by ELISA, affinity chromatography and electrophoresis. Anti-bovine fibrinogen antibodies present in patients reacted readily with bovine fibrinogen, but did not cross-react with human fibrinogen as measured by ELISA or by immunoelectrophoresis. A significant amount of antibodies against bovine thrombin and factor V has been found, many cross-reacting with the human counterparts. No hemorrhagic or thrombotic complications, or clinically significant allergic reactions, occurred in any patient, in spite of antibody presence against some bovine and human coagulation factors. The treatment of patients with bovine fibrin, without induction of immunologic response against human fibrinogen, appeared to be an effective topical hemostatic/sealing measure.

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