scholarly journals Surrogate Outcome Markers and Cerebral Haemodynamics in Carotid Interventions

10.33540/148 ◽  
2020 ◽  
Author(s):  
◽  
Marjolijn Lette Rots





1989 ◽  
Vol 26 (5) ◽  
pp. 511-511 ◽  
Author(s):  
J S Wyatt ◽  
A D Edwards ◽  
D Azzopardi ◽  
C E Richardson ◽  
M Cope ◽  
...  


2021 ◽  
Vol 11 (1) ◽  
Author(s):  
Roubi Kilo ◽  
Silvy Laporte ◽  
Rama Arab ◽  
Sabine Mainbourg ◽  
Steeve Provencher ◽  
...  

AbstractThis study aimed to explore the validity of the use of the net clinical benefit (NCB), i.e. the sum of major bleeding and thrombotic events, as a potential surrogate for all-cause mortality in clinical trials assessing antithrombotics. Published randomized controlled trials testing anticoagulants in the prevention or treatment of venous thromboembolism (VTE) and non-valvular atrial fibrillation (NVAF) were systematically reviewed. The validity of NCB as a surrogate endpoint was estimated by calculating the strength of correlation of determination (R2) and its 95% confidence interval (CI) between the relative risks of NCB and all-cause mortality. Amongst the 125 trials retrieved, the highest R2trial values were estimated for NVAF (R2trial = 0.41, 95% CI [0.03; 0.48]), and acute VTE (R2trial = 0.30, 95% CI [0.04; 0.84]). Conversely, the NCB did not correlate with all-cause mortality in prevention studies with medical (R2trial = 0.12, 95% CI [0.00; 0.36]), surgical (R2trial = 0.05, 95% CI [0.00; 0.23]), and cancer patients (R2trial = 0.006, 95% CI [0.00; 1.00]). A weak correlation between NCB and all cause-mortality was found in NVAF and acute VTE, whereas no correlation was observed in clinical situations where the mortality rate was low. Consequently, NCB should not be considered a surrogate outcome for all cause-mortality in anticoagulation trials.



Circulation ◽  
2018 ◽  
Vol 138 (Suppl_2) ◽  
Author(s):  
Anne V Grossestreuer ◽  
Tuyen Yankama ◽  
Ari Moskowitz ◽  
Anthony Mahoney-Pacheco ◽  
Varun Konanki ◽  
...  

Introduction: Cardiac arrest (CA) outcomes, when dichotomized as survival/non-survival, limit statistical power of interventional studies and do not acknowledge hospital-level factors independent of post-CA sequelae. We explored the Sequential Organ Failure Assessment (SOFA) score at 72 hours post-CA as a surrogate outcome measure for mortality. We also assessed methods to account for death <72 hours post-CA in SOFA score computation. Methods: This was a single center retrospective study of post-CA patients from 1/08-12/17. SOFA score components were abstracted at baseline, 24, 48, and 72h post-CA. Thirteen ways of accounting for missing data were assessed. The outcome was mortality at hospital discharge. Model performance was assessed using area under the receiver-operator characteristic (AUC) curves and Hosmer-Lemeshow goodness of fit statistics. Results: Of 847 patients, 528 (62%) had complete baseline SOFA scores and 205 (24%) had complete scores at 72h. Death <72h occurred in 28%; 45% survived to hospital discharge. SOFA score at 72h without accounting for death had an AUC of 0.62. The best performing SOFA model at 72h with good calibration imputed a 20% increase over the last observed SOFA score in patients who expired <72h with an AUC of 0.79 (95% CI: 0.74-0.83). In terms of change in SOFA at 72h from baseline, the best performing model with good calibration imputed death <72h as the highest possible score (AUC: 0.88 [95% CI: 0.84-0.92]). These results were consistent when analyzing in- and out-of-hospital CA separately, although the change from baseline model was not well calibrated in in-hospital arrests. Conclusions: Without consideration of death, SOFA scores at 72 hours post-CA perform poorly. Imputing for early mortality improved the model. If this imputation structure is validated prospectively, SOFA could provide a scoring system to predict death at hospital discharge and serve as a surrogate outcome measure in interventional studies.



1996 ◽  
Vol 8 (4) ◽  
pp. 336
Author(s):  
B F Matta ◽  
J Lam ◽  
P Smielewiski


2018 ◽  
Vol 39 (10) ◽  
pp. 105009 ◽  
Author(s):  
J S Minhas ◽  
R B Panerai ◽  
T G Robinson




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