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https://www.readbyqxmd.com/read/29164641/five-criteria-for-using-a-surrogate-endpoint-to-predict-treatment-effect-based-on-data-from-multiple-previous-trials
#1
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
#2
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
#3
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
#4
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
#5
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
#6
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
#7
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
#8
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
#9
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
https://www.readbyqxmd.com/read/29126416/adjunctive-use-of-physostigmine-salicylate-anticholium%C3%A2-in-perioperative-sepsis-and-septic-shock-study-protocol-for-a-randomized-double-blind-placebo-controlled-monocentric-trial-anticholium%C3%A2-per-se
#10
Johannes B Zimmermann, Nadine Pinder, Thomas Bruckner, Monika Lehmann, Johann Motsch, Thorsten Brenner, Torsten Hoppe-Tichy, Stefanie Swoboda, Markus A Weigand, Stefan Hofer
BACKGROUND: Severe sepsis and septic shock remain a major challenge, even in modern intensive care. In Germany, about 68,000 patients die annually because of septic diseases, characterized by a complex systemic inflammatory response. Causal treatment of the underlying infection is essential for successful management of sepsis, but the course can be positively influenced by supportive and adjuvant measures. The cholinergic anti-inflammatory pathway (CAP) represents a new approach to adjunctive therapy of septic diseases and can be pharmacologically activated by the acetylcholinesterase inhibitor physostigmine (Anticholium®)...
November 10, 2017: Trials
https://www.readbyqxmd.com/read/29123374/anti-cd20-cell-therapies-in-multiple-sclerosis-a-fixed-dosing-schedule-for-ocrelizumab-is-overkill
#11
Jagannadha Avasarala
Anti-CD 20 therapies have found significant uses in multiple sclerosis (MS). Based singularly on the accumulated evidence with the use of rituximab (RTX; Rituxan, Genentech, and Biogen) in neuroimmunological diseases, ocrelizumab (OCR; Ocrevus, Genentech) was developed as a treatment option for MS and selectively targets CD20 B cells, a cell surface antigen found on pre-B cells, mature, and memory B cells, but not on lymphoid stem cells and plasma cells. On the basis of indirect evidence, elimination of the antigen-presenting capabilities and antigen nonspecific immune functions of B cells appear to be central to the therapeutic efficacy of anti-CD20 B-cell therapies...
2017: Drug Target Insights
https://www.readbyqxmd.com/read/29113385/association-between-body-mass-index-and-presence-of-carotid-plaque-among-low-income-adults-aged-45-years-and-older-a-population-based-cross-sectional-study-in-rural-china
#12
Yongzhong Lou, Bin Li, Lan Su, Zhenhong Mu, Minghao Sun, Hongfei Gu, Jingxian Ni, Yanan Wu, Jun Tu, Jinghua Wang, Xianjia Ning
Carotid plaque is a good surrogate endpoint for assessing arterial atherosclerosis, and atherosclerosis is a reliable predictor of cardiovascular diseases. However, the effect of body mass index on carotid plaque is unknown. Therefore, we aimed to explore the association between body mass index and carotid plaque in a low-income Chinese population. Residents aged ≥45 years and free of stroke and cardiovascular diseases were enrolled and divided into four groups based on body mass index. B-mode ultrasonography was performed to measure carotid plaque...
October 6, 2017: Oncotarget
https://www.readbyqxmd.com/read/29112316/a-modified-dose-response-model-that-describes-the-relationship-between-hemagglutination-inhibition-titer-and-protection-against-influenza-infection
#13
Yin Huang, Steven A Anderson, Richard A Forshee, Hong Yang
AIMS: Develop a model for quantifying the risk of an adverse human response to influenza virus infection as a function of exposure dose and pre-exposure antibody titer level. METHODS AND RESULTS: We evaluated the relationship between hemagglutination inhibition (HI) titer (as a measure of specific antibody response) and protection against influenza infection and modeled this relationship by incorporating HI titer as a variable into dose-response models. Using a Maximum Likelihood Estimation approach, the resulting model was capable of providing statistically acceptable fits to most available data...
November 7, 2017: Journal of Applied Microbiology
https://www.readbyqxmd.com/read/29100553/translatability-score-revisited-differentiation-for-distinct-disease-areas
#14
REVIEW
Alexandra Wendler, Martin Wehling
BACKGROUND: Translational science supports successful transition of early biomedical research into human applications. In 2009 a translatability score to assess risk and identify strengths and weaknesses of a given project has been designed and successfully tested in case studies. The score elements, in particular the contributing weight factors, are heterogeneous for different disease areas; therefore, the score was individualized for six areas (cardiovascular, oncology, psychiatric, anti-viral, anti-bacterial/fungal and monogenetic diseases)...
November 3, 2017: Journal of Translational Medicine
https://www.readbyqxmd.com/read/29092955/lesiontracker-extensible-open-source-zero-footprint-web-viewer-for-cancer-imaging-research-and-clinical-trials
#15
Trinity Urban, Erik Ziegler, Rob Lewis, Chris Hafey, Cheryl Sadow, Annick D Van den Abbeele, Gordon J Harris
Oncology clinical trials have become increasingly dependent upon image-based surrogate endpoints for determining patient eligibility and treatment efficacy. As therapeutics have evolved and multiplied in number, the tumor metrics criteria used to characterize therapeutic response have become progressively more varied and complex. The growing intricacies of image-based response evaluation, together with rising expectations for rapid and consistent results reporting, make it difficult for site radiologists to adequately address local and multicenter imaging demands...
November 1, 2017: Cancer Research
https://www.readbyqxmd.com/read/29078817/long-term-effects-of-high-dose-pitavastatin-on-diabetogenicity-in-comparison-with-atorvastatin-in-patients-with-metabolic-syndrome-less-dm-study-protocol-for-a-randomized-controlled-trial
#16
Jun-Bean Park, Ji-Hyun Jung, Yeonyee E Yoon, Hack-Lyong Kim, Seung-Pyo Lee, Hyung-Kwan Kim, Yong-Jin Kim, Goo-Yeong Cho, Dae-Won Sohn
BACKGROUND: The diabetogenic action of statins remains a concern, particularly in patients at high risk for diabetes receiving intensive statin therapy. Despite the risk of diabetes with statin use being considered a potential class effect, recent studies have suggested that pitavastatin exerts neutral or favorable effects on diabetogenicity. However, no randomized trial has compared the long-term effects of pitavastatin with those of other statins on glycemic control in populations at high risk for diabetes...
October 27, 2017: Trials
https://www.readbyqxmd.com/read/29071575/time-until-partial-response-in-metastatic-adrenocortical-carcinoma-long-term-survivors
#17
Delphine Vezzosi, Christine Do Cao, Ségolène Hescot, Jérôme Bertherat, Magali Haissaguerre, Vanina Bongard, Delphine Drui, Christelle De La Fouchardière, Frédéric Illouz, Françoise Borson-Chazot, Bodale Djobo, Amandine Berdelou, Antoine Tabarin, Martin Schlumberger, Claire Briet, Philippe Caron, Sophie Leboulleux, Rossella Libe, Eric Baudin
A partial response (PR) has been proposed as a surrogate for overall survival in advanced adrenocortical carcinoma (ACC). The primary endpoint of the study was to characterize the time until a PR in patients with metastatic ACC treated with a standard therapy is achieved. Long-term survivors were selected to allow evaluation of delayed tumor response to mitotane. Records from patients with metastatic ACC that survived for > 24 months were retrieved. Tumor response was analyzed according to the Response Evaluation Criteria in Solid Tumors (RECIST) 1...
October 25, 2017: Hormones & Cancer
https://www.readbyqxmd.com/read/29069927/how-to-perform-a-cost-effectiveness-analysis-with-surrogate-endpoint-renal-denervation-in-patients-with-resistant-hypertension-denerhtn-trial-as-an-example
#18
Julie Bulsei, Meryl Darlington, Isabelle Durand-Zaleski, Michel Azizi
Whilst much uncertainty exists as to the efficacy of renal denervation (RDN), the positive results of the DENERHTN study in France confirmed the interest of an economic evaluation in order to assess efficiency of RDN and inform local decision makers about the costs and benefits of this intervention. The uncertainty surrounding both the outcomes and the costs can be described using health economic methods such as the non-parametric bootstrap. Internationally, numerous health economic studies using a cost-effectiveness model to assess the impact of RDN in terms of cost and effectiveness compared to antihypertensive medical treatment have been conducted...
October 26, 2017: Blood Pressure
https://www.readbyqxmd.com/read/29067237/ipragliflozin-lowers-small-dense-low-density-lipoprotein-cholesterol-levels-in-japanese-patients-with-type-2-diabetes-mellitus
#19
Yukihiro Bando, Hitomi Tohyama, Keiko Aoki, Hideo Kanehara, Azusa Hisada, Kazuhiro Okafuji, Daisyu Toya
AIMS: This preliminary randomized, parallel-group comparative study evaluated the efficacy of ipragliflozin for reduction of small dense low-density lipoprotein cholesterol (sd LDL-C) levels in Japanese patients with type 2 diabetes mellitus (T2DM). METHODS: Sixty-two patients with T2DM (age, 56 ± 8 years; hemoglobin A1c levels, 8.1 ± 0.9%; BMI, 27.5 ± 3.3 kg/m(2)) were randomly assigned in a 2:1 ratio to receive ipragliflozin (50 mg/day) (treatment group; n = 40) or continued treatment (control group; n = 22) for 12 weeks...
December 2016: Journal of Clinical & Translational Endocrinology
https://www.readbyqxmd.com/read/29053157/current-applications-of-multiparameter-flow-cytometry-in-plasma-cell-disorders
#20
REVIEW
T Jelinek, R Bezdekova, M Zatopkova, L Burgos, M Simicek, T Sevcikova, B Paiva, R Hajek
Multiparameter flow cytometry (MFC) has become standard in the management of patients with plasma cell (PC) dyscrasias, and could be considered mandatory in specific areas of routine clinical practice. It plays a significant role during the differential diagnostic work-up because of its fast and conclusive readout of PC clonality, and simultaneously provides prognostic information in most monoclonal gammopathies. Recent advances in the treatment and outcomes of multiple myeloma led to the implementation of new response criteria, including minimal residual disease (MRD) status as one of the most relevant clinical endpoints with the potential to act as surrogate for survival...
October 20, 2017: Blood Cancer Journal
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