Routine Surveillance Versus Independent Assessment by an Outcome Adjudication Committee in Assessing Patients for Sternal Surgical Site Infections After Cardiac Surgery

2016 ◽  
Vol 37 (5) ◽  
pp. 600-602 ◽  
Author(s):  
Dominik Mertz ◽  
Richard Whitlock ◽  
Alicia Y. Kokoszka ◽  
Stephanie W. Smith ◽  
Alex Carignan ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Cardiac Surgery ◽  
Surgical Site Infections ◽  
Surveillance Data ◽  
Infect Control Hosp ◽  
Routine Surveillance ◽  
Independent Assessment ◽  
Adjudication Committee ◽  
Outcome Adjudication

Based on a cohort of 966 patients, routine surveillance data were not sufficiently accurate for use in clinical trials investigating surgical site infections. Surveillance data can only be used if adequate 90-day follow-up is provided and if cases identified by surveillance are independently reviewed by a blinded outcome adjudication committee.Infect Control Hosp Epidemiol 2016;37:600–602

scholarly journals Should deep-sequenced amplicons become the new gold-standard for analysing malaria drug clinical trials?

2021 ◽  
Author(s):  
Sam Jones ◽  
Katherine Kay ◽  
Eva Maria Hodel ◽  
Maria Gruenberg ◽  
Anita Lerch ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Malaria Transmission ◽  
Gold Standard ◽  
Low Density ◽  
Recurrent Infections ◽  
Routine Surveillance ◽  
Potential Impact ◽  
The Impact ◽  
Statistical Criteria

Background. Regulatory clinical trials are required to ensure the continued supply and deployment of effective antimalarial drugs. Patient follow-up in such trials typically lasts several weeks as the drugs have long half-lives and new infections often occur during this period. “Molecular correction” is therefore used to distinguish drug failures from new infections. The current WHO-recommend method for molecular correction uses length-polymorphic alleles at highly diverse loci but is inherently poor at detecting low density clones in polyclonal infections. This likely leads to substantial underestimates of failure rates, delaying the replacement of failing drugs with potentially lethal consequences. Deep sequenced amplicons (AmpSeq) substantially increase the detectability of low-density clones and may offer a new “gold standard” for molecular correction. Methods. Pharmacological simulation of clinical trials was used to evaluate the suitability of AmpSeq for molecular correction. We investigated the impact of factors such as the number of amplicon loci analysed, the informatics criteria used to distinguish genotyping ‘noise’ from real low density signals, the local epidemiology of malaria transmission, and the potential impact of genetic signals from gametocytes. Results. AmpSeq greatly improved molecular correction and provided accurate drug failure rate estimates. The use of 3 to 5 amplicons was sufficient, and simple, non-statistical, criteria could be used to classify recurrent infections as drug failures or new infections. Conclusions. These results suggest AmpSeq is strongly placed to become the new standard for molecular correction in regulatory trials, with its potential extension into routine surveillance once the requisite technical support becomes established.

Impact of an Automated Surveillance to Detect Surgical-Site Infections in Patients Undergoing Total Hip and Knee Arthroplasty in Brazil

2016 ◽  
Vol 37 (8) ◽  
pp. 991-993 ◽  
Author(s):  
Luciana B. Perdiz ◽  
Deborah S. Yokoe ◽  
Guilherme H. Furtado ◽  
Eduardo A. S. Medeiros
Keyword(s):  
Retrospective Study ◽  
Surgical Site Infection ◽  
Knee Arthroplasty ◽  
Surgical Site Infections ◽  
Infect Control Hosp ◽  
Site Infection ◽  
Total Hip ◽  
Routine Surveillance ◽  
Hip And Knee Arthroplasty ◽  
Automated Surveillance

In this retrospective study, we compared automated surveillance with conventional surveillance to detect surgical site infection after primary total hip or knee arthroplasty. Automated surveillance demonstrated better efficacy than routine surveillance in SSI diagnosis, sensitivity, and predictive negative value in hip and knee arthroplasty.Infect Control Hosp Epidemiol 2016;37:991–993

scholarly journals Should deep-sequenced amplicons become the new gold-standard for analysing malaria drug clinical trials?

2021 ◽  
Author(s):  
Sam Jones ◽  
Katherine Kay ◽  
Eva Maria Hodel ◽  
Maria Gruenberg ◽  
Anita Lerch ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Malaria Transmission ◽  
Gold Standard ◽  
Low Density ◽  
Recurrent Infections ◽  
Routine Surveillance ◽  
Potential Impact ◽  
The Impact ◽  
Statistical Criteria

Background. Regulatory clinical trials are required to ensure the continued supply and deployment of effective antimalarial drugs. Patient follow-up in such trials typically lasts several weeks as the drugs have long half-lives and new infections often occur during this period. Molecular correction is therefore used to distinguish drug failures from new infections. The current WHO-recommend method for molecular correction uses length-polymorphic alleles at highly diverse loci but is inherently poor at detecting low density clones in polyclonal infections. This likely leads to substantial underestimates of failure rates, delaying the replacement of failing drugs with potentially lethal consequences. Deep sequenced amplicons (AmpSeq) substantially increase the detectability of low-density clones and may offer a new gold standard for molecular correction. Methods. Pharmacological simulation of clinical trials was used to evaluate the suitability of AmpSeq for molecular correction. We investigated the impact of factors such as the number of amplicon loci analysed, the informatics criteria used to distinguish genotyping noise from real low density signals, the local epidemiology of malaria transmission, and the potential impact of genetic signals from gametocytes. Results. AmpSeq greatly improved molecular correction and provided accurate drug failure rate estimates. The use of 3 to 5 amplicons was sufficient, and simple, non-statistical, criteria could be used to classify recurrent infections as drug failures or new infections. Conclusions. These results strongly endorse the deployment of AmpSeq as the standard for molecular correction in regulatory trials, with its potential extension into routine surveillance once the requisite technical support becomes established.

“Blame it on the comorbidities” A 5-year follow-up of 53 chronic dialysis-dependent patients who underwent cardiac surgery

2014 ◽  
Vol 62 (S 01) ◽  
Author(s):  
O. Deutsch ◽  
N. Rippinger ◽  
K. Spiliopoulos ◽  
W. Eichinger ◽  
B. Gansera
Keyword(s):  
Cardiac Surgery ◽  
Chronic Dialysis

ZAP: The role of routine surveillance data in understanding the geography and timing of Salmonella on UK pig farms.

2007 ◽  
Author(s):  
Helen Clough ◽  
Jean Sanderson ◽  
Patrick Brown ◽  
Alexander Miller ◽  
Alasdair J. C. Cook
Keyword(s):  
Surveillance Data ◽  
Routine Surveillance ◽  
Pig Farms

Risk scoring by CHADS2 and CHA2DS2-VASc as predictors for long-term outcomes after surgical ablation for atrial fibrillation

2020 ◽  
Vol 41 (Supplement_2) ◽  
Author(s):  
D Lauritzen ◽  
H.J Vodstrup ◽  
T.D Christensen ◽  
M Onat ◽  
R Christensen ◽  
...  
Keyword(s):  
Atrial Fibrillation ◽  
Cardiac Surgery ◽  
Isolation Procedure ◽  
Survival Times ◽  
Long Term Outcomes ◽  
Surgical Ablation ◽  
Follow Up Study ◽  
Risk Scoring

Abstract Background Following catheter ablation for atrial fibrillation (AF), CHADS2 and CHA2DS2-VASc have utility in predicting long-term outcomes. However, it is currently unknown if the same holds for patients undergoing surgical ablation. Purpose To determine whether CHADS2 and CHA2DS2-VASc predict long-term outcomes after surgical ablation in concomitance with other cardiac surgery. Methods In this prospective, follow-up study, we included patients who underwent biatrial ablation - or pulmonary vein isolation procedure concomitantly with other cardiac surgery between 2004 and 2018. CHADS2 and CHA2DS2-VASc scores were assessed prior to surgery and categorized in groups as 0–1, 2–4 or ≥5. Outcomes were death, AF, and AF-related death. Follow-up was ended in April 2019. Results A total of 587 patients with a mean age of 68.7±0.4 years were included. Both CHADS2 and CHA2DS2-VASc scores were predictors of survival p=0.005 and p<0.001, respectively (Figure). For CHADS2, mean survival times were 5.9±3.7 years for scores 0–1, 5.0±3.0 years for scores 2–4 and 4.3±2.6 years for scores ≥5. For CHA2DS2-VASc mean survival times were 7.3±4.0 years for scores 0–1, 5.6±2.9 years for scores 2–4 and 4.8±2.1 years for scores ≥5. The incidence of death was 20.1% for CHADS2 0–1, 24.8% for CHADS2 2–4, and 35.3% for CHADS2 ≥5, p=0.186. The incidence of AF was 50.2% for CHADS2 0–1, 47.9% for CHADS2 2–4, and 76.5% for CHADS2 ≥5, p=0.073. The incidence of AF related death was 13.0% for CHADS2 0–1, 16.8% for CHADS2 2–4, and 35.3% for CHADS2 ≥5, p=0.031. The incidence of death was 16.8% for CHA2DS2-VASc 0–1, 26.2% for CHA2DS2-VASc 2–4, and 45.0% for CHA2DS2-VASc ≥5, p=0.001. The incidence of AF was 49.6% for CHA2DS2-VASc 0–1, 52.5% for CHA2DS2-VASc 2–4, and 72.5% for CHA2DS2-VASc ≥5, p=0.035. The incidence of AF related death was 12.2% for CHA2DS2-VASc 0–1, 16.0% for CHA2DS2-VASc 2–4, and 42.5% for CHA2DS2-VASc ≥5, p<0.001. Conclusion Both CHADS2 and CHA2DS2-VASc scores predict long-term outcomes after surgical ablation for AF. However, CHA2DS2-VASc was superior in predicting death, AF, and AF-related death. Survival curves Funding Acknowledgement Type of funding source: None

scholarly journals Real-World Experience with Bezlotoxumab for Prevention of Recurrence of Clostridioides difficile Infection

2020 ◽  
Vol 10 (1) ◽  
pp. 2
Author(s):  
Rosa Escudero-Sánchez ◽  
María Ruíz-Ruizgómez ◽  
Jorge Fernández-Fradejas ◽  
Sergio García Fernández ◽  
María Olmedo Samperio ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Real World ◽  
Recurrence Rates ◽  
Factors Associated ◽  
Clostridioides Difficile ◽  
Multicentre Cohort Study ◽  
Clostridioides Difficile Infection ◽  
Prevention Of Recurrence ◽  
Multicentre Cohort

Bezlotoxumab is marketed for the prevention of recurrent Clostridioides difficile infection (rCDI). Its high cost could be determining its prescription to a different population than that represented in clinical trials. The objective of the study was to verify the effectiveness and safety of bezlotoxumab in preventing rCDI and to investigate factors related to bezlotoxumab failure in the real world. A retrospective, multicentre cohort study of patients treated with bezlotoxumab in Spain was conducted. We compared the characteristics of cohort patients with those of patients treated with bezlotoxumab in the pivotal MODIFY trials. We assessed recurrence rates 12 weeks after completion of treatment against C. difficile, and we analysed the factors associated with bezlotoxumab failure. Ninety-one patients were included in the study. The cohort presented with more risk factors for rCDI than the patients included in the MODIFY trials. Thirteen (14.2%) developed rCDI at 12 weeks of follow-up, and rCDI rates were numerically higher in patients with two or more previous episodes (25%) than in those who had fewer than two previous episodes of C. difficile infection (CDI) (10.4%); p = 0.09. There were no adverse effects attributable to bezlotoxumab. Despite being used in a more compromised population than that represented in clinical trials, we confirm the effectiveness of bezlotoxumab for the prevention of rCDI.

scholarly journals Disability improvement as a clinically relevant outcome in clinical trials of relapsing forms of multiple sclerosis

2021 ◽  
pp. 135245852110002
Author(s):  
Bruce AC Cree ◽  
Jeffrey A Cohen ◽  
Anthony T Reder ◽  
Davorka Tomic ◽  
Diego Silva ◽  
...  
Keyword(s):  
Multiple Sclerosis ◽  
Clinical Trials ◽  
Therapeutic Benefit ◽  
Disease Modifying Therapies ◽  
Long Term Follow Up ◽  
Post Hoc ◽  
Switch Group ◽  
Relevant Outcome

Background: Disease-modifying therapies (DMTs) can reduce the risk of disability worsening in patients with relapsing forms of multiple sclerosis (RMS). High-efficacy DMTs can lead to confirmed or sustained disability improvement (CDI and SDI). Objective and Methods: Post hoc analyses of data from the TRANSFORMS, FREEDOMS, and FREEDOMS II trials and their extensions assessed the effects of fingolimod (0.5–1.25 mg/day) on stabilizing or improving disability over ⩽8 years in participants with RMS. CDI and SDI rates were compared between participants initially randomized to fingolimod, interferon (IFNβ-1a), or placebo. Results: At 8 years’ follow-up in TRANSFORMS, 35.1% (95% confidence interval [CI], 28.2%–43.1%) of assessed participants in the IFNβ-1a–fingolimod switch group and 41.9% (36.6%–47.6%) on continuous fingolimod experienced CDI; disability did not worsen in approximately 70%. Similar results were seen in the combined FREEDOMS population. Proportionally fewer TRANSFORMS participants achieved SDI in the IFNβ-1a–fingolimod switch group than on continuous fingolimod (5.4% [3.0%–9.5%] vs 14.2% [10.8%–18.4%], p = 0.01). Conclusion: CDI and SDI are outcomes of interest for clinical trials and for long-term follow-up of participants with RMS. Monitoring CDI and SDI in addition to disability worsening may facilitate understanding of the therapeutic benefit of RMS treatments.

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