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Surrogate endpoints

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https://www.readbyqxmd.com/read/28319455/joint-model-imputation-to-estimate-the-treatment-effect-on-long-term-survival-using-auxiliary-events
#1
Audrey Mauguen, Stefan Michiels, Virginie Rondeau
Clinical trial duration may be a concern in clinical research, especially in cancer trials where the endpoint is overall survival. A surrogate endpoint can be used as an auxiliary variable to analyze the treatment effect earlier. At an early time point, the high number of censored observations can be compensated by the imputation of the unobserved deaths times. We propose to use predictions of the risk of death from a joint model for a recurrent event and a terminal event, which account for disease relapse information...
February 16, 2017: Journal of Biopharmaceutical Statistics
https://www.readbyqxmd.com/read/28315171/the-dilemma-of-adolescent-varicoceles-do-they-really-have-to-be-repaired
#2
REVIEW
Bryan S Sack, Mattias Schäfer, Michael P Kurtz
The primary indication for varicocele repair in adults, that of failed paternity, must be substituted in the adolescent population with surrogate parameters of testicular size differential and semen analysis. Making recommendations based on these two parameters is incredibly difficult because studies often have contradictory findings, different patient populations, and lack of long-term follow up of the key endpoint, paternity. Therefore, it is not a surprise that recommendations for adolescent varicocele repair are general (with some exceptions) and necessarily so because of limitations in quality of evidence...
May 2017: Current Urology Reports
https://www.readbyqxmd.com/read/28302142/maximum-inspiratory-pressure-as-a-clinically-meaningful-trial-endpoint-for-neuromuscular-diseases-a-comprehensive-review-of-the-literature
#3
REVIEW
Benedikt Schoser, Edward Fong, Tarekegn Geberhiwot, Derralynn Hughes, John T Kissel, Shyam C Madathil, David Orlikowski, Michael I Polkey, Mark Roberts, Harm A W M Tiddens, Peter Young
Respiratory muscle strength is a proven predictor of long-term outcome of neuromuscular disease (NMD), including amyotrophic lateral sclerosis, Duchenne muscular dystrophy, and spinal muscular atrophy. Maximal inspiratory pressure (MIP), a sensitive measure of respiratory muscle strength, one of several useful tests of respiratory muscle strength, is gaining interest as a therapeutic clinical trial endpoint for NMD. In this comprehensive review we investigate the use of MIP as a measure of respiratory muscle strength in clinical trials of therapeutics targeting respiratory muscle, examine the correlation of MIP with survival, quality of life, and other measures of pulmonary function, and outline the role of MIP as a clinically significantly meaningful outcome measure...
March 16, 2017: Orphanet Journal of Rare Diseases
https://www.readbyqxmd.com/read/28299202/the-role-for-infarct-volume-as-a-surrogate-measure-of-functional-outcome-following-ischemic-stroke
#4
Ryan C Turner, Kenneth DiPasquale, Aric F Logsdon, Zhenjun Tan, Zachary J Naser, Jason D Huber, Charles L Rosen, Brandon P Lucke-Wold
The failed translation of proposed therapeutic agents for ischemic stroke from preclinical to clinical studies has led to increased scrutiny of preclinical studies, namely the model and outcome measures utilized. Preclinical studies routinely use infarct volume as an experimental endpoint or measure in studies employing young-adult, healthy male animals despite the fact that clinically, ischemic stroke is a disease of the elderly and improvements in functional outcome from pre- to post-intervention remains the most widely utilized assessment...
December 2016: Journal of Systems and Integrative Neuroscience
https://www.readbyqxmd.com/read/28292317/the-association-of-funding-source-on-effect-size-in-randomized-controlled-trials-2013-2015-a-cross-sectional-survey-and-meta-analysis
#5
Alberto Falk Delgado, Anna Falk Delgado
BACKGROUND: Trials financed by for-profit organizations have been associated with favorable outcomes of new treatments, although the effect size of funding source impact on outcome is unknown. The aim of this study was to estimate the effect size for a favorable outcome in randomized controlled trials (RCTs), stratified by funding source, that have been published in general medical journals. METHODS: Parallel-group RCTs published in The Lancet, New England Journal of Medicine, and JAMA between 2013 and 2015 were identified...
March 14, 2017: Trials
https://www.readbyqxmd.com/read/28289525/cardiovascular-magnetic-resonance-imaging-assessment-of-outcomes-in-acute-myocardial-infarction
#6
REVIEW
Jamal N Khan, Gerry P McCann
Cardiovascular magnetic resonance (CMR) imaging uniquely characterizes myocardial and microvascular injury in acute myocardial infarction (AMI), providing powerful surrogate markers of outcomes. The last 10 years have seen an exponential increase in AMI studies utilizing CMR based endpoints. This article provides a contemporary, comprehensive review of the powerful role of CMR imaging in the assessment of outcomes in AMI. The theory, assessment techniques, chronology, importance in predicting left ventricular function and remodelling, and prognostic value of each CMR surrogate marker is described in detail...
February 26, 2017: World Journal of Cardiology
https://www.readbyqxmd.com/read/28280607/pathologic-complete-response-and-disease-free-survival-are-not-surrogate-endpoints-for-5-year-survival-in-rectal-cancer-an-analysis-of-22-randomized-trials
#7
Fausto Petrelli, Karen Borgonovo, Mary Cabiddu, Mara Ghilardi, Veronica Lonati, Sandro Barni
BACKGROUND: We performed a literature-based analysis of randomized clinical trials to assess the pathologic complete response (pCR) (ypT0N0 after neoadjuvant therapy) and 3-year disease-free survival (DFS) as potential surrogate endpoints for 5-year overall survival (OS) in rectal cancer treated with neoadjuvant (chemo)radiotherapy (CT)RT. METHODS: A systematic literature search of PubMed, EMBASE, the Web of Science, SCOPUS, CINAHL, and the Cochrane Library was performed...
February 2017: Journal of Gastrointestinal Oncology
https://www.readbyqxmd.com/read/28279371/carotid-plaque-lipid-content-and-fibrous-cap-status-predict-systemic-cv-outcomes-the-mri-substudy-in-aim-high
#8
Jie Sun, Xue-Qiao Zhao, Niranjan Balu, Moni B Neradilek, Daniel A Isquith, Kiyofumi Yamada, Gádor Cantón, John R Crouse, Todd J Anderson, John Huston, Kevin O'Brien, Daniel S Hippe, Nayak L Polissar, Chun Yuan, Thomas S Hatsukami
OBJECTIVES: The aim of this study was to investigate whether and what carotid plaque characteristics predict systemic cardiovascular outcomes in patients with clinically established atherosclerotic disease. BACKGROUND: Advancements in atherosclerosis imaging have allowed assessment of various plaque characteristics, some of which are more directly linked to the pathogenesis of acute cardiovascular events compared to plaque burden. METHODS: As part of the event-driven clinical trial AIM-HIGH (Atherothrombosis Intervention in Metabolic Syndrome with Low HDL/High Triglycerides: Impact on Global Health Outcomes), subjects with clinically established atherosclerotic disease underwent multicontrast carotid magnetic resonance imaging (MRI) to detect plaque tissue composition and high-risk features...
March 2017: JACC. Cardiovascular Imaging
https://www.readbyqxmd.com/read/28277807/magnetic-resonance-imaging-and-transient-elastography-in-the-management-of-nonalcoholic-fatty-liver-disease-nafld
#9
Ma Ai Thanda Han, Rola Saouaf, Walid Ayoub, Tsuyoshi Todo, Edward Mena, Mazen Noureddin
Nonalcoholic fatty liver disease (NAFLD) is the most common cause of chronic liver disease and cirrhosis worldwide and the second most common cause of liver transplantation in major medical centers. Because liver steatosis and fibrosis severity are related to disease morbidity and mortality, the extent of disease, and disease progression, they need to be assessed and monitored. In addition, innovation with new drug developments requires disease staging and monitoring in both phase 2 and 3 clinical trials. Currently, disease assessment in both clinical practice and research is mostly performed by liver biopsy, an invasive, procedure with risks...
March 9, 2017: Expert Review of Clinical Pharmacology
https://www.readbyqxmd.com/read/28276870/renal-sympathetic-denervation-for-treatment-of-patients-with-heart-failure-summary-of-the-available-evidence
#10
Wail Nammas, Juhani Koistinen, Tuomas Paana, Pasi P Karjalainen
Heart failure syndrome results from compensatory mechanisms that operate to restore - back to normal - the systemic perfusion pressure. Sympathetic overactivity plays a pivotal role in heart failure; norepinephrine contributes to maintenance of the systemic blood pressure and increasing preload. Cardiac norepinephrine spillover increases in patients with heart failure; norepinephrine exerts direct toxicity on cardiac myocytes resulting in a decrease of synthetic activity and/or viability. Importantly, cardiac norepinephrine spillover is a powerful predictor of mortality in patients with moderate to severe HF...
February 10, 2017: Annals of Medicine
https://www.readbyqxmd.com/read/28276821/current-and-future-treatment-options-in-non-alcoholic-steatohepatitis-nash
#11
Nikos Lazaridis, Emmanuel Tsochatzis
Non-alcoholic steatohepatitis (NASH) is a chronic liver disease that can progress to cirrhosis and hepatocellular carcinoma. Diagnosis of NASH requires a liver biopsy and is defined as presence of hepatic steatosis, ballooning and lobular inflammation with or without fibrosis. Although NASH is the most common cause of liver disease in the west world and among the top three indications for liver transplantation, there are no universally accepted pharmacological therapies and therapeutic advances have been slow...
April 2017: Expert Review of Gastroenterology & Hepatology
https://www.readbyqxmd.com/read/28261960/neurofilament-light-chain-in-cerebrospinal-fluid-and-prediction-of-disease-activity-in-clinically-isolated-syndrome-and-relapsing-remitting-multiple-sclerosis
#12
I Håkansson, A Tisell, P Cassel, K Blennow, H Zetterberg, P Lundberg, C Dahle, M Vrethem, J Ernerudh
BACKGROUND AND PURPOSE: Improved biomarkers are needed to facilitate clinical decision-making and as surrogate endpoints in clinical trials in multiple sclerosis (MS). We assessed whether neurodegenerative and neuroinflammatory markers in cerebrospinal fluid (CSF) at initial sampling could predict disease activity during 2 years of follow-up in patients with clinically isolated syndrome (CIS) and relapsing-remitting MS. METHODS: Using multiplex bead array and enzyme-linked immunosorbent assay, CXCL1, CXCL8, CXCL10, CXCL13, CCL20, CCL22, neurofilament light chain (NFL), neurofilament heavy chain, glial fibrillary acidic protein, chitinase-3-like-1, matrix metalloproteinase-9 and osteopontin were analysed in CSF from 41 patients with CIS or relapsing-remitting MS and 22 healthy controls...
March 6, 2017: European Journal of Neurology: the Official Journal of the European Federation of Neurological Societies
https://www.readbyqxmd.com/read/28260416/prognostic-factors-versus-markers-of-response-to-treatment-versus-surrogate-endpoints-three-different-concepts
#13
Maria Pia Sormani
Multiple sclerosis is a highly heterogeneous disease; the quantitative assessment of disease progression is problematic for many reasons, including the lack of objective methods to measure disability and the long follow-up times needed to detect relevant and stable changes. For these reasons, the importance of prognostic markers, markers of response to treatments and of surrogate endpoints, is crucial in multiple sclerosis research. Aim of this report is to clarify some basic definitions and methodological issues about baseline factors to be considered prognostic markers or markers of response to treatment; to define the dynamic role that variables must have to be considered surrogate markers in relation to specific treatments...
March 2017: Multiple Sclerosis: Clinical and Laboratory Research
https://www.readbyqxmd.com/read/28244635/effect-of-linagliptin-on-pulse-wave-velocity-in-early-type-2-diabetes-release-a-randomized-double-blind-controlled-26-week-trial
#14
Stefanie A de Boer, Hiddo J L Heerspink, Luis E Juárez Orozco, Arie M van Roon, Pieter W Kamphuisen, Andries J Smit, Riemer H J A Slart, Joop D Lefrandt, Douwe J Mulder
AIMS: To evaluate the effects of the DPP-4 inhibitor linagliptin on aortic pulse wave velocity (PWV) as a surrogate marker of arterial stiffness and early atherosclerosis in early type 2 diabetes subjects. MATERIALS AND METHODS: A total of 45 type 2 diabetes subjects (median age 63 (IQR: 54-66) years, 61% male, mean hemoglobinA1c (HbA1c ) 6.3 ± 0.4 % (45 ± 4.6 mmol/mol)) without cardiovascular disease and naïve to antidiabetic treatment were randomized (1:1) to treatment with linagliptin 5 mg once daily or placebo for 26 weeks in a double-blind fashion...
February 28, 2017: Diabetes, Obesity & Metabolism
https://www.readbyqxmd.com/read/28224402/assessment-of-correlation-between-early-and-late-efficacy-endpoints-to-identify-potential-surrogacy-relationships-in-non-hodgkin-lymphoma-a-literature-based-meta-analysis-of-108-phase-ii-and-phase-iii-studies
#15
Rui Zhu, Dan Lu, Yu-Waye Chu, Akiko Chai, Michelle Green, Nancy Zhang, Jin Yan Jin
Correlations between early and late efficacy endpoints were assessed to identify potential surrogate endpoints for overall survival (OS) or progression-free survival (PFS) with clinical trial-level data in three non-Hodgkin lymphoma (NHL) subtypes: diffuse large B-cell lymphoma (DLBCL), follicular lymphoma (FL), and mantle cell lymphoma (MCL). One hundred and eight phase II-III trials (129 trial arms) in DLBCL, FL, and MCL were identified and included in the database. Correlations between efficacy endpoints were analyzed using weighted linear regression and Pearson's coefficient of determination (R (2))...
February 21, 2017: AAPS Journal
https://www.readbyqxmd.com/read/28217229/evaluation-of-the-characteristics-of-rotational-activation-at-high-dominant-frequency-and-complex-fractionated-atrial-electrogram-sites-during-atrial-fibrillation
#16
Koji Kumagai, Kentaro Minami, Daisuke Kutsuzawa, Shigeru Oshima
BACKGROUND: High-dominant frequency (DF) and continuous complex fractionated atrial electrogram (CFAE) sites as surrogates for localized sources maintaining atrial fibrillation (AF) are potential AF ablation targets. This study aimed to evaluate the characteristics of a rotational activation at high-DF and continuous CFAE sites in AF patients. METHODS: Thirty-two consecutive AF patients (5 paroxysmal and 27 non-paroxysmal) underwent ablation using the NavX system...
February 2017: Journal of Arrhythmia
https://www.readbyqxmd.com/read/28213367/antibiotic-prophylaxis-for-infective-endocarditis-a-systematic-review-and-meta-analysis
#17
Thomas J Cahill, James L Harrison, Paul Jewell, Igho Onakpoya, John B Chambers, Mark Dayer, Peter Lockhart, Nia Roberts, David Shanson, Martin Thornhill, Carl J Heneghan, Bernard D Prendergast
OBJECTIVE: The use of antibiotic prophylaxis (AP) for prevention of infective endocarditis (IE) is controversial. In recent years, guidelines to cardiologists and dentists have advised restriction of AP to high-risk groups (in Europe and the USA) or against its use at all (in the UK). The objective of this systematic review was to appraise the evidence for use of AP for prevention of bacteraemia or IE in patients undergoing dental procedures. METHODS: We conducted electronic searches in Medline, Embase, Cochrane Library and ISI Web of Science...
February 17, 2017: Heart: Official Journal of the British Cardiac Society
https://www.readbyqxmd.com/read/28205339/doing-it-hard-in-the-bush-aligning-what-gets-measured-with-what-matters
#18
Malcolm I McDonald, Kenny D Lawson
What gets measured gets managed. Funding of health services is substantially determined by operational activity and specific outcome indicators. In day-to-day clinical decision-making, surrogate markers, such as glycosylated haemoglobin and blood pressure, are commonly used to modify risks of 'hard' outcomes that include kidney failure, ischaemic cardiac events, stroke and all-cause mortality. In many settings, surrogates are all we have to go on. As a consequence, current health funding models heavily rely on surrogate-based key performance indicators [KPIs]...
February 16, 2017: Australian Journal of Rural Health
https://www.readbyqxmd.com/read/28203068/ectopic-fat-accumulation-in-patients-with-copd-an-eclipse-substudy
#19
Mickaël Martin, Natalie Almeras, Jean-Pierre Després, Harvey O Coxson, George R Washko, Isabelle Vivodtzev, Emiel Fm Wouters, Erica Rutten, Michelle C Williams, John T Murchison, William MacNee, Don D Sin, François Maltais
BACKGROUND: Obesity is increasingly associated with COPD, but little is known about the prevalence of ectopic fat accumulation in COPD and whether this can possibly be associated with poor clinical outcomes and comorbidities. The Evaluation of COPD Longitudinally to Identify Predictive Surrogate Endpoints (ECLIPSE) substudy tested the hypothesis that COPD is associated with increased ectopic fat accumulation and that this would be associated with COPD-related outcomes and comorbidities...
2017: International Journal of Chronic Obstructive Pulmonary Disease
https://www.readbyqxmd.com/read/28202439/variable-reliability-of-surrogate-measures-of-insulin-sensitivity-after-roux-en-y-gastric-bypass
#20
Kirstine N Bojsen-Moller, Carsten Dirksen, Maria S Svane, Nils B Jørgensen, Jens J Holst, Erik A Richter, Sten Madsbad
Roux-en-Y gastric bypass (RYGB) induces weight loss and improves insulin sensitivity when evaluated by the hyperinsulinemic-euglycemic clamp (HEC). Surrogate indices of insulin sensitivity calculated from insulin and glucose concentrations at fasting or after an oral glucose tolerance test (OGTT) are frequently used, but have not been validated after RYGB. Our aim was to evaluate whether surrogate indices reliably estimate changes in insulin sensitivity after RYGB. Four fasting (inverse-HOMA-IR, HOMA2-%S, QUICKI, revised-QUICKI) and three OGTT-derived surrogates (Matsuda, Gutt, OGIS) were compared with HEC-estimated peripheral insulin sensitivity (Rd or Rd/I, depending on how the index was originally validated) and the tracer-determined hepatic insulin sensitivity index (HISI) in patients with preoperative type 2 diabetes (n=10) and normal glucose tolerance (n=10) 1 week, 3 months and 1 year postoperatively...
February 15, 2017: American Journal of Physiology. Regulatory, Integrative and Comparative Physiology
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