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Surrogate endpoints

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https://www.readbyqxmd.com/read/29238516/antidiabetic-medications-and-mortality-reduction-a-shift-from-surrogate-to-clinical-endpoints
#1
Fariha Hasan, Bilal Hasan
No abstract text is available yet for this article.
December 2017: Therapeutic Advances in Endocrinology and Metabolism
https://www.readbyqxmd.com/read/29225790/update-on-ventilator-associated-pneumonia
#2
REVIEW
Jean-Francois Timsit, Wafa Esaied, Mathilde Neuville, Lila Bouadma, Bruno Mourvllier
Ventilator-associated pneumonia (VAP) is the most frequent life-threatening nosocomial infection in intensive care units. The diagnostic is difficult because radiological and clinical signs are inaccurate and could be associated with various respiratory diseases. The concept of infection-related ventilator-associated complication has been proposed as a surrogate of VAP to be used as a benchmark indicator of quality of care. Indeed, bundles of prevention measures are effective in decreasing the VAP rate. In case of VAP suspicion, respiratory secretions must be collected for bacteriological secretions before any new antimicrobials...
2017: F1000Research
https://www.readbyqxmd.com/read/29223193/quality-indicators-for-evaluating-prehospital-emergency-care-a-scoping-review
#3
Ian Howard, Peter Cameron, Lee Wallis, Maaret Castren, Veronica Lindstrom
Introduction Historically, the quality and performance of prehospital emergency care (PEC) has been assessed largely based on surrogate, non-clinical endpoints such as response time intervals or other crude measures of care (eg, stakeholder satisfaction). However, advances in Emergency Medical Services (EMS) systems and services world-wide have seen their scope and reach continue to expand. This has dictated that novel measures of performance be implemented to compliment this growth. Significant progress has been made in this area, largely in the form of the development of evidence-informed quality indicators (QIs) of PEC...
December 10, 2017: Prehospital and Disaster Medicine
https://www.readbyqxmd.com/read/29222917/diagnostic-modalities-for-non-alcoholic-fatty-liver-disease-nafld-non-alcoholic-steatohepatitis-nash-and-associated-fibrosis
#4
REVIEW
Zobair M Younossi, Rohit Loomba, Quentin M Anstee, Mary E Rinella, Elisabetta Bugianesi, Giulio Marchesini, Brent A Neuschwander-Tetri, Lawrence Serfaty, Francesco Negro, Stephen H Caldwell, Vlad Ratziu, Kathleen E Corey, Scott L Friedman, Manal F Abdelmalek, Stephen A Harrison, Arun J Sanyal, Joel E Lavine, Philippe Mathurin, Michael R Charlton, Zachary D Goodman, Naga P Chalasani, Kris V Kowdley, Jacob George, Keith Lindor
NAFLD is a spectrum comprised of isolated steatosis, NASH, advanced fibrosis, and cirrhosis. The majority of NAFLD subjects do not have NASH and don't carry a significant risk for adverse outcomes (cirrhosis and mortality). Globally, the prevalence of NAFLD is approximately 25%. In Asia, a gradient of high prevalence rates to low rates are noted from urban to rural areas. Given the prevalence of NAFLD, the clinical and economic burden of NAFLD and NASH can be substantial. With increasing recognition as an important liver disease, the diagnosis of NASH still requires a liver biopsy which is suboptimal...
December 9, 2017: Hepatology: Official Journal of the American Association for the Study of Liver Diseases
https://www.readbyqxmd.com/read/29204670/polymyxin-b-immobilized-hemoperfusion-and-mortality-in-critically-ill-adult-patients-with-sepsis-septic-shock-a-systematic-review-with-meta-analysis-and-trial-sequential-analysis
#5
REVIEW
Tomoko Fujii, Riki Ganeko, Yuki Kataoka, Toshi A Furukawa, Robin Featherstone, Kent Doi, Jean-Louis Vincent, Daniela Pasero, René Robert, Claudio Ronco, Sean M Bagshaw
PURPOSE: Polymyxin B-immobilized hemoperfusion (PMX-HP) is an adjuvant therapy for sepsis or septic shock that clears circulating endotoxin. Prior trials have shown that PMX-HP improves surrogate endpoints. We aimed to conduct an evidence synthesis to evaluate the efficacy and safety of PMX-HP in critically ill adult patients with sepsis or septic shock. METHODS: We searched for randomized controlled trials (RCTs) in MEDLINE, EMBASE, the Cochrane Library, the Health Technology Assessment Database, CINAHL, "Igaku Chuo Zasshi", the National Institute of Health Clinical Trials Register, the World Health Organization International Clinical Trials Registry Platform, the University Hospital Medical Information Network Clinical Trials Registry, the reference lists of retrieved articles, and publications by manufacturers of PMX-HP...
December 4, 2017: Intensive Care Medicine
https://www.readbyqxmd.com/read/29202744/biomarkers-of-collagen-turnover-are-related-to-annual-change-in-fev1-in-patients-with-chronic-obstructive-pulmonary-disease-within-the-eclipse-study
#6
Diana J Leeming, Inger Byrjalsen, Jannie M B Sand, Asger R Bihlet, Peter Lange, Ruth Thal-Singer, Bruce E Miller, Morten A Karsdal, Jørgen Vestbo
BACKGROUND: Change in forced expiratory volume in one second (FEV1) is important for defining severity of chronic obstructive pulmonary disease (COPD). Serological neoepitope markers of collagen turnover may predict rate of change in FEV1. METHODS: One thousand COPD subjects from the observational, multicentre, three-year ECLIPSE (Evaluation of COPD Longitudinally to Identify Predictive Surrogate Endpoints) study (NCT00292552, trial registration in February 2006) were included...
December 4, 2017: BMC Pulmonary Medicine
https://www.readbyqxmd.com/read/29194288/area-at-risk-can-be-assessed-by-iodine-123-meta-iodobenzylguanidine-single-photon-emission-computed-tomography-after-myocardial-infarction-a-prospective-study
#7
Christophe Hedon, Fabien Huet, Fayçal Ben Bouallegue, Hélène Vernhet, Jean-Christophe Macia, Thien-Tri Cung, Florence Leclercq, Stéphane Cade, Frédéric Cransac, Benoit Lattuca, D'Arcy Vandenberghe, Aurélie Bourdon, Meriem Benkiran, Fabien Vauchot, Richard Gervasoni, Emmanuel D'estanque, Denis Mariano-Goulart, François Roubille
BACKGROUND: Myocardial salvage is an important surrogate endpoint to estimate the impact of treatments in patients with ST-segment elevation myocardial infarction (STEMI). AIM: The aim of this study was to evaluate the correlation between cardiac sympathetic denervation area assessed by single-photon emission computed tomography (SPECT) using iodine-123-meta-iodobenzylguanidine (I-MIBG) and myocardial area at risk (AAR) assessed by cardiac magnetic resonance (CMR) (gold standard)...
November 29, 2017: Nuclear Medicine Communications
https://www.readbyqxmd.com/read/29186296/adjuvant-therapy-in-renal-cell-carcinoma-does-higher-risk-for-recurrence-improve-the-chance-for-success
#8
R A Figlin, B C Leibovich, G D Stewart, S Negrier
The success of targeted therapies, including inhibitors of the vascular endothelial growth factor pathway or the mammalian target of rapamycin, in the treatment of metastatic renal cell carcinoma (RCC) led to interest in testing their efficacy in the adjuvant setting. Results from the first trials are now available with other studies due to report imminently. This review provides an overview of adjuvant targeted therapy in RCC, including interpretation of currently available conflicting data and future direction of research...
November 24, 2017: Annals of Oncology: Official Journal of the European Society for Medical Oncology
https://www.readbyqxmd.com/read/29182969/simulated-developmental-and-reproductive-impacts-on-amphibian-populations-and-implications-for-assessing-long-term-effects
#9
Jill A Awkerman, Sandy Raimondo
Fish endpoints measured in early life stage toxicity tests are often used as representative of larval amphibian sensitivity in Ecological Risk Assessment (ERA). This application potentially overlooks the impact of developmental delays on amphibian metamorphosis, and thereby reduced survival, in amphibian populations constrained by habitat availability. Likewise, the effects of reduced productivity or altered sexual development as a result of chemical exposure are not presented in terms of lower population fecundity in these surrogate tests...
November 25, 2017: Ecotoxicology and Environmental Safety
https://www.readbyqxmd.com/read/29169736/examining-the-effects-of-age-on-health-outcomes-of-chronic-obstructive-pulmonary-disease-results-from-the-genetic-epidemiology-of-chronic-obstructive-pulmonary-disease-study-and-evaluation-of-chronic-obstructive-pulmonary-disease-longitudinally-to-identify
#10
Amit D Parulekar, Carlos Martinez, Chu-Lin Tsai, Nicholas Locantore, Mustafa Atik, Abebaw M Yohannes, Christina C Kao, Hassan Al-Azzawi, Ali Mohsin, Robert A Wise, Marilyn G Foreman, Dawn L Demeo, Elizabeth A Regan, Barry J Make, Aladin M Boriek, Laura E Wiener, Nicola A Hanania
RATIONALE: The prevalence of chronic obstructive pulmonary disease (COPD) and its associated comorbidities increase with age. However, little is understood about differences in the disease in patients over 65 years of age compared with younger patients. OBJECTIVES: To determine disease characteristics of COPD and its impact in older patients compared with younger patients. METHODS: We examined baseline characteristics of patients with COPD (global obstructive lung disease stage II-IV) in 2 large cohorts: Genetic Epidemiology of COPD Study (COPDGene) and Evaluation of COPD Longitudinally to Identify Predictive Surrogate Endpoints (ECLIPSE)...
December 1, 2017: Journal of the American Medical Directors Association
https://www.readbyqxmd.com/read/29167693/approving-cancer-treatments-based-on-endpoints-other-than-overall-survival-an-analysis-of-historical-data-using-the-pace-continuous-innovation-indicators%C3%A2-cii
#11
Neon Brooks, Mario Campone, Silvia Paddock, Scott Shortenhaus, David Grainger, Jacqueline Zummo, Samuel Thomas, Rose Li
Background: There is an active debate about the role that endpoints other than overall survival (OS) should play in the drug approval process. Yet the term 'surrogate endpoint' implies that OS is the only critical metric for regulatory approval of cancer treatments. We systematically analyzed the relationship between U.S. Food and Drug Administration (FDA) approval and publication of OS evidence to understand better the risks and benefits of delaying approval until OS evidence is available...
2017: Drugs in Context
https://www.readbyqxmd.com/read/29164641/five-criteria-for-using-a-surrogate-endpoint-to-predict-treatment-effect-based-on-data-from-multiple-previous-trials
#12
Stuart G Baker
A surrogate endpoint in a randomized clinical trial is an endpoint that occurs after randomization and before the true, clinically meaningful, endpoint that yields conclusions about the effect of treatment on true endpoint. A surrogate endpoint can accelerate the evaluation of new treatments but at the risk of misleading conclusions. Therefore, criteria are needed for deciding whether to use a surrogate endpoint in a new trial. For the meta-analytic setting of multiple previous trials, each with the same pair of surrogate and true endpoints, this article formulates 5 criteria for using a surrogate endpoint in a new trial to predict the effect of treatment on the true endpoint in the new trial...
November 21, 2017: Statistics in Medicine
https://www.readbyqxmd.com/read/29163828/surrogate-endpoint-for-overall-survival-in-assessment-of-adjuvant-therapies-after-curative-treatment-for-hepatocellular-carcinoma-a-re-analysis-of-meta-analyses-of-individual-patients-data
#13
Hong-Bo Huan, Li-Li Wu, Wan-Yee Lau, Xu-Dong Wen, Liang Zhang, Da-Peng Yang, Xi-Shu Wang, Ping Bie, Feng Xia
The gold standard endpoint to evaluate the effect of treatment for hepatocellular carcinoma (HCC) is overall survival (OS), but it requires a longer follow-up period to observe. This study aimed to identify whether disease-free survival (DFS) could be used as a surrogate endpoint for OS to assess the efficacy of adjuvant therapies after curative treatment (surgical resection and ablation) for HCC patients. A systematic review was conducted to identify trials about curative treatment combined with or without adjuvant therapies (interferon, IFN; or transarterial chemoembolization, TACE) for HCC...
October 27, 2017: Oncotarget
https://www.readbyqxmd.com/read/29159946/extracellular-volume-with-bolus-only-technique-in-amyloidosis-patients-diagnostic-accuracy-correlation-with-other-clinical-cardiac-measures-and-ability-to-track-changes-in-amyloid-load-over-time
#14
Giulia Zumbo, Sharon V Barton, Douglas Thompson, Min Sun, Amna Abdel-Gadir, Thomas A Treibel, Daniel Knight, Ana Martinez-Naharro, Lane Thirusha, Julian D Gillmore, James C Moon, Philip N Hawkins, Marianna Fontana
BACKGROUND: Extracellular volume (ECV) by T1 mapping requires the contrast agent distribution to be at equilibrium. This can be achieved either definitively with a primed contrast infusion (infusion ECV), or sufficiently with a delay postbolus (bolus-only ECV). For large ECV, the bolus-only approach measures higher than the infusion ECV, causing some uncertainty in diseases such as amyloidosis. PURPOSE: To characterize the relationship between the bolus-only and current gold-standard infusion ECV in patients with amyloidosis...
November 21, 2017: Journal of Magnetic Resonance Imaging: JMRI
https://www.readbyqxmd.com/read/29158541/dysregulation-of-mitochondrial-function-and-biogenesis-modulators-in-adipose-tissue-of-obese-children
#15
R Zamora-Mendoza, H Rosas-Vargas, M T Ramos-Cervantes, P Garcia-Zuniga, H Perez-Lorenzana, P Mendoza-Lorenzo, A Perez-Ortiz, J Estrada, A Miliar-Garcia, E Lara-Padilla, G Ceballos, A Rodriguez, F Villarreal, I Ramirez-Sanchez
BACKGROUND/OBJECTIVES: We aimed to evaluate mitochondrial biogenesis (MB), structure, metabolism, and dysfunction in abdominal adipose tissue from male pediatric patients with obesity. SUBJECTS/METHODS: Samples were collected from five children with obesity (percentile ⩾95) and five eutrophic boys (percentile ⩾5/⩽85) (8-12 years old) following parental informed consent. We analyzed the expression of key genes involved in MB (SIRT1, PPARγ, PGC1α, NRF1, NRF2, and TFAM) and surrogates for mitochondrial function/structure/metabolism (porin, TOMM20, complex I and V, UCP1, UCP2, SIRT3, SOD2) by Western blot...
November 21, 2017: International Journal of Obesity: Journal of the International Association for the Study of Obesity
https://www.readbyqxmd.com/read/29156022/anaortic-off-pump-versus-clampless-off-pump-using-the-pas-port-device-versus-conventional-coronary-artery-bypass-grafting-mid-term-results-from-a-matched-propensity-score-analysis-of-5422-unselected-patients
#16
Nobuyuki Furukawa, Oliver Kuss, Konstantin Preindl, André Renner, Anas Aboud, Kavous Hakim-Meibodi, Michael Benzinger, Thomas Pühler, Stephan Ensminger, Buntaro Fujita, Tobias Becker, Jan F Gummert, Jochen Börgermann
OBJECTIVES: Meta-analyses from observational and randomized studies have demonstrated benefits of off-pump surgery for hard and surrogate endpoints. In some of them, increased re-revascularization was noted in the off-pump groups, which could impact their long-term survival. Therefore, we analyzed the course of all patients undergoing isolated coronary surgery regarding the major cardiac and cerebrovascular event (MACCE) criteria. METHODS: A prospective register was taken from a high-volume off-pump center recording all anaortic off-pump (ANA), clampless off-pump (PAS-Port) and conventional (CONV) coronary artery bypass operations between July 2009 and June 2015...
October 1, 2017: European Journal of Cardio-thoracic Surgery
https://www.readbyqxmd.com/read/29153198/n-terminal-b-type-natriuretic-peptide-in-heart-failure
#17
REVIEW
Arthur Mark Richards
Plasma amino-terminal pro-B-type natriuretic peptide (NT-proBNP) is a guideline-mandated biomarker in heart failure (HF). Used as an inclusion criterion for therapeutic trials, NT-proBNP enriches trial populations and is a valid surrogate endpoint. Its diagnostic performance is best validated in acute decompensated HF (ADHF). NT-proBNP offers prognostic information independent of standard clinical predictors and refines risk stratification. With the advent of combined angiotensin 2 type 1 receptor blockade and neprilysin inhibition (ARNI) NT-proBNP retains its relationship to cardiac status and is the marker of choice in assessment of possible ADHF and in serial monitoring of HF patients receiving ARNI treatment...
January 2018: Heart Failure Clinics
https://www.readbyqxmd.com/read/29149743/multigenerational-effects-of-salinity-in-six-clonal-lineages-of-daphnia-longispina
#18
C Venâncio, R Ribeiro, A M V M Soares, I Lopes
Sea level rise, as a consequence of climate changes, is already causing seawater intrusion in some freshwater coastal ecosystems worldwide. The increase in salinity at these freshwater coastal ecosystems may occur gradually (through groundwater) or abruptly (through extreme weather events). Moreover, many of them are also being altered and threatened by anthropogenic activities. Accordingly, the present study aimed at assessing the multigenerational lethal and sublethal effects caused by increased salinity in six clonal lineages of the freshwater cladoceran Daphnia longispina differing in their sensitivity to lethal levels of copper...
November 14, 2017: Science of the Total Environment
https://www.readbyqxmd.com/read/29143170/circumferential-strain-acquired-by-cmr-early-after-acute-myocardial-infarction-adds-incremental-predictive-value-to-late-gadolinium-enhancement-imaging-to-predict-late-myocardial-remodeling-and-subsequent-risk-of-sudden-cardiac-death
#19
Anthony A Holmes, Jorge Romero, Jeffrey M Levsky, Linda B Haramati, Newton Phuong, Leila Rezai-Gharai, Stuart Cohen, Lina Restrepo, Luis Ruiz-Guerrero, John D Fisher, Cynthia C Taub, Luigi Di Biase, Mario J Garcia
PURPOSE: Late adverse myocardial remodeling after acute myocardial infarction (AMI) is strongly associated with sudden cardiac death (SCD). Cardiac magnetic resonance (CMR) performed early after AMI can predict late remodeling and SCD risk with moderate accuracy. This study assessed the ability of CMR-measured circumferential strain (CS) to add incremental predictive information to late gadolinium enhancement (LGE). METHODS: Patients with an AMI and LVEF < 50% were screened for inclusion...
November 15, 2017: Journal of Interventional Cardiac Electrophysiology: An International Journal of Arrhythmias and Pacing
https://www.readbyqxmd.com/read/29138546/prediction-models-for-exacerbations-in-different-copd-patient-populations-comparing-results-of-five-large-data-sources
#20
Martine Hoogendoorn, Talitha L Feenstra, Melinde Boland, Andrew H Briggs, Sixten Borg, Sven-Arne Jansson, Nancy A Risebrough, Julia F Slejko, Maureen Pmh Rutten-van Mölken
Background and objectives: Exacerbations are important outcomes in COPD both from a clinical and an economic perspective. Most studies investigating predictors of exacerbations were performed in COPD patients participating in pharmacological clinical trials who usually have moderate to severe airflow obstruction. This study was aimed to investigate whether predictors of COPD exacerbations depend on the COPD population studied. Methods: A network of COPD health economic modelers used data from five COPD data sources - two population-based studies (COPDGene(®) and The Obstructive Lung Disease in Norrbotten), one primary care study (RECODE), and two studies in secondary care (Evaluation of COPD Longitudinally to Identify Predictive Surrogate Endpoint and UPLIFT) - to estimate and validate several prediction models for total and severe exacerbations (= hospitalization)...
2017: International Journal of Chronic Obstructive Pulmonary Disease
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