keyword
MENU ▼
Read by QxMD icon Read
search

Surrogate endpoint

keyword
https://www.readbyqxmd.com/read/28078103/the-potential-of-spectral-domain-optical-coherence-tomography-imaging-based-retinal-biomarkers
#1
REVIEW
Prateep Phadikar, Sandeep Saxena, Surabhi Ruia, Timothy Y Y Lai, Carsten H Meyer, Dean Eliott
BACKGROUND: Biomarker", a merged word of "biological marker", refers to a broad subcategory of medical signs that objectively indicate the state of health, and well-being of an individual. Biomarkers hold great promise for personalized medicine as information gained from diagnostic or progression markers can be used to tailor treatment to the individual for highly effective intervention in the disease process. Optical coherence tomography (OCT) has proved useful in identifying various biomarkers in ocular and systemic diseases...
2017: International Journal of Retina and Vitreous
https://www.readbyqxmd.com/read/28069654/reduced-chance-of-hearing-loss-associated-with-therapeutic-drug-monitoring-of-aminoglycosides-in-the-treatment-of-multidrug-resistant-tuberculosis
#2
R van Altena, J A Dijkstra, M E van der Meer, J F Borjas Howard, J G W Kosterink, D van Soolingen, T S van der Werf, J W C Alffenaar
Hearing loss and nephrotoxicity are associated with prolonged treatment duration and higher dosage of amikacin and kanamycin. In our Tuberculosis Center, we have employed therapeutic drug monitoring (TDM) targeting pre-set pharmacokinetic/pharmacodynamic (PK/PD) surrogate endpoints in an attempt to maintain efficacy while preventing (oto-)toxicity. To evaluate this strategy, we retrospectively evaluated medical charts of TB patients treated with amikacin or kanamycin in the period 2000 - 2012.Patients with culture-confirmed multi- or extensively drug resistant tuberculosis (MDR/XDR-TB) receiving amikacin or kanamycin as part of their TB treatment for at least 3 days were eligible for inclusion in this retrospective study...
January 9, 2017: Antimicrobial Agents and Chemotherapy
https://www.readbyqxmd.com/read/28066978/mrecist-to-predict-survival-in-advanced-hcc-analysis-of-two-randomised-phase-ii-trials-comparing-nintedanib-versus-sorafenib
#3
Tim Meyer, Daniel H Palmer, Ann-Lii Cheng, Julia Hocke, Arsène-Bienvenu Loembé, Chia-Jui Yen
BACKGROUND & AIMS: Response Evaluation Criteria in Solid Tumors (RECIST) has been shown to be a poor surrogate for survival benefit with targeted therapy in advanced hepatocellular carcinoma (HCC). METHODS: We investigated whether response evaluated using modified RECIST (mRECIST) predicted overall survival (OS) using data from two Phase II clinical trials. Analyses were conducted on pooled data from 188 patients with advanced HCC treated with nintedanib or sorafenib, of whom 180 were evaluable for response...
January 9, 2017: Liver International: Official Journal of the International Association for the Study of the Liver
https://www.readbyqxmd.com/read/28066627/survival-analyses-in-lung-cancer
#4
EDITORIAL
Kari Chansky, Dragan Subotic, Nathan R Foster, Torsten Blum
BACKGROUND: Although survival analyses represent one of the cornerstones in oncology in general, some aspects of the reported survival data in lung cancer patients are still not fully elucidated. METHODS: After having defined several open questions, an evidence based approach was applied in order to answer these questions. Areas of interest were: (I) possible uncertainties in reported survival data; (II) survival surrogates; (III) recommended methods for evaluating progression free survival (PFS) as a surrogate endpoint in future datasets; (IV) postoperative lung cancer recurrence and survival...
November 2016: Journal of Thoracic Disease
https://www.readbyqxmd.com/read/28065166/the-predictive-capabilities-of-a-novel-cardiovascular-magnetic-resonance-derived-marker-of-cardiopulmonary-reserve-on-established-prognostic-surrogate-markers-in-patients-with-pulmonary-vascular-disease-results-of-a-longitudinal-pilot-study
#5
Timothy J Baillie, Samuel Sidharta, Peter M Steele, Stephen G Worthley, Scott Willoughby, Karen Teo, Prashanthan Sanders, Stephen J Nicholls, Matthew I Worthley
BACKGROUND: No unified method exists to effectively predict and monitor progression of pulmonary arterial hypertension (PAH). We assessed the longitudinal relationship between a novel marker of cardiopulmonary reserve and established prognostic surrogate markers in patients with pulmonary vascular disease. METHODS AND RESULTS: Twenty participants with confirmed (n = 14) or at high risk (n = 6) for PAH underwent cardiovascular magnetic resonance (CMR) at baseline and after ~6 months of guideline-appropriate management...
January 9, 2017: Journal of Cardiovascular Magnetic Resonance
https://www.readbyqxmd.com/read/28064440/dietary-fibre-for-the-prevention-of-recurrent-colorectal-adenomas-and-carcinomas
#6
REVIEW
Yibo Yao, Tao Suo, Roland Andersson, Yongqing Cao, Chen Wang, Jingen Lu, Evelyne Chui
BACKGROUND: This is an update of the Cochrane review published in 2002.Colorectal cancer (CRC) is a major cause of morbidity and mortality in industrialised countries. Experimental evidence has supported the hypothesis that dietary fibre may protect against the development of CRC, although epidemiologic data have been inconclusive. OBJECTIVES: To assess the effect of dietary fibre on the recurrence of colorectal adenomatous polyps in people with a known history of adenomatous polyps and on the incidence of CRC compared to placebo...
January 8, 2017: Cochrane Database of Systematic Reviews
https://www.readbyqxmd.com/read/28061544/findings-from-the-adjuvant-colon-cancer-end-points-accent-collaborative-group-the-power-of-pooled-individual-patient-data-from-multiple-clinical-trials
#7
Lindsay A Renfro, Daniel J Sargent
The Adjuvant Colon Cancer End Points (ACCENT) Collaborative Group was formed 15 years ago to address scientific questions in early stage colon cancer that could best be answered by pooling individual patient data across many randomized clinical trials. Today, the ACCENT database contains detailed information collected from over 40,000 patients enrolled onto 27 major adjuvant colon cancer trials conducted between 1977 and 2009. Since its inception, the ACCENT group has led many sophisticated analyses addressing a variety of clinical questions, such as the long-term survivorship of colon cancer patients by treatment, the time course of oxaliplatin benefit, and support for the use of disease-free survival (DFS) as a surrogate endpoint for overall survival (OS), among many others...
December 2016: Chinese Clinical Oncology
https://www.readbyqxmd.com/read/28057251/proenkephalin-renal-dysfunction-and%C3%A2-prognosis-in-patients-with-acute%C3%A2-heart%C3%A2-failure-a-great-network-study
#8
Leong L Ng, Iain B Squire, Donald J L Jones, Thong Huy Cao, Daniel C S Chan, Jatinderpal K Sandhu, Paulene A Quinn, Joan E Davies, Joachim Struck, Oliver Hartmann, Andreas Bergmann, Alexandre Mebazaa, Etienne Gayat, Mattia Arrigo, Eiichi Akiyama, Zaid Sabti, Jens Lohrmann, Raphael Twerenbold, Thomas Herrmann, Carmela Schumacher, Nikola Kozhuharov, Christian Mueller
BACKGROUND: Proenkephalin A (PENK) and its receptors are widely distributed. Enkephalins are cardiodepressive and difficult to measure directly. PENK is a stable surrogate analyte of labile enkephalins that is correlated inversely with renal function. Cardiorenal syndrome is common in acute heart failure (HF) and portends poor prognosis. OBJECTIVES: This study assessed the prognostic value of PENK in acute HF, by identifying levels that may be useful in clinical decisions, and evaluated its utility for predicting cardiorenal syndrome...
January 3, 2017: Journal of the American College of Cardiology
https://www.readbyqxmd.com/read/28056466/subacute-subclinical-brain-infarctions-after-transcatheter-aortic-valve-implantation-negatively-impact-cognitive-function-in-long-term-follow-up
#9
Alexander Ghanem, Jonas Dörner, Leonie Schulze-Hagen, Andreas Müller, Marius Wilsing, Jan-Malte Sinning, Julian Lütkens, Christian Frerker, Karl-Heinz Kuck, Ingo Gräff, Hans Schild, Nikos Werner, Eberhard Grube, Georg Nickenig
AIMS: To date every post-procedural cerebrovascular embolic event (CVE) is dreaded for its potential to accelerate cognitive decline after transcatheter aortic valve implantation (TAVI). This study differentiates the impact of acute (procedural) and post-acute cerebrovascular embolic events (CVEs) on cognitive performance. METHODS: Magnetic resonance imaging (MRI) before, early and late after TAVI was performed to quantify embolic burden. Quantification of diffusion- and T1-weighted lesions, as well as white-matter and total brain volumes, as well as cognitive function testing (MMSE) were assessed in 28 patients with a medium follow-up period of 34 months...
2017: PloS One
https://www.readbyqxmd.com/read/28052109/defining-surrogate-endpoints-for-clinical-trials-in-severe-falciparum-malaria
#10
Atthanee Jeeyapant, Hugh W Kingston, Katherine Plewes, Richard J Maude, Josh Hanson, M Trent Herdman, Stije J Leopold, Thatsanun Ngernseng, Prakaykaew Charunwatthana, Nguyen Hoan Phu, Aniruddha Ghose, M Mahtab Uddin Hasan, Caterina I Fanello, Md Abul Faiz, Tran Tinh Hien, Nicholas P J Day, Nicholas J White, Arjen M Dondorp
BACKGROUND: Clinical trials in severe falciparum malaria require a large sample size to detect clinically meaningful differences in mortality. This means few interventions can be evaluated at any time. Using a validated surrogate endpoint for mortality would provide a useful alternative allowing a smaller sample size. Here we evaluate changes in coma score and plasma lactate as surrogate endpoints for mortality in severe falciparum malaria. METHODS: Three datasets of clinical studies in severe malaria were re-evaluated: studies from Chittagong, Bangladesh (adults), the African 'AQUAMAT' trial comparing artesunate and quinine (children), and the Vietnamese 'AQ' study (adults) comparing artemether with quinine...
2017: PloS One
https://www.readbyqxmd.com/read/28039123/interpretation-of-surrogate-endpoints-in-the-era-of-the-21st-century-cures-act
#11
Kevin Knopf, Michael Baum, William S Shimp, Charles L Bennett, Dinah Faith, Marc L Fishman, William J M Hrushesky
No abstract text is available yet for this article.
December 30, 2016: BMJ: British Medical Journal
https://www.readbyqxmd.com/read/28035202/nonalcoholic-steatohepatitis-and-endpoints-in-clinical-trials
#12
William N Hannah, Dawn M Torres, Stephen A Harrison
Nonalcoholic fatty liver disease (NAFLD) is now the leading cause of liver disease in developed countries, and the rates of NAFLD continue to rise in conjunction with the obesity pandemic. While the majority of patients with isolated steatosis generally have a benign course, a diagnosis of nonalcoholic steatohepatitis (NASH) carries a significantly higher risk for progression of disease, cirrhosis, and death. Pharmacologic therapeutic interventions in NASH have largely proven to be ineffective or unappealing due to long-term side-effect profiles, and the majority of patients cannot achieve or sustain targeted weight loss goals, necessitating an urgent need for therapeutic trials and drug development...
December 2016: Gastroenterology & Hepatology
https://www.readbyqxmd.com/read/28033508/pathological-complete-response-in-invasive-breast-cancer-treated-by-skin-sparing-mastectomy-and-immediate-reconstruction-following-neoadjuvant-chemotherapy-and-radiation-therapy-comparison-between-immunohistochemical-subtypes
#13
J Barrou, M Bannier, M Cohen, E Lambaudie, A Gonçalves, P Bertrand, M Buttarelli, P Opinel, N Sterkers, A Tallet, C Zinzindohoué, G Houvenaeghel
CONTEXT: Even if neoadjuvant chemotherapy (NACT) and oncoplastic techniques have increased the breast conserving surgery rate, mastectomy is still a standard for multifocal or extensive breast cancers (BC). In the prospect of increasing breast reconstruction, an alternative therapeutic protocol was developed combining NACT with neoadjuvant radiation therapy (NART), followed by mastectomy with immediate breast reconstruction (IBR). The oncological safety of this therapeutic plan still needs further exploration...
December 26, 2016: Breast: Official Journal of the European Society of Mastology
https://www.readbyqxmd.com/read/28032901/structure-of-proof-of-concept-studies-that-precede-a-nonalcoholic-steatohepatitis-development-program
#14
R N Williams, C Filozof, B J Goldstein, K Cusi
Surrogate endpoints for clinical proof of concept (POC) trials in nonalcoholic steatohepatitis (NASH) are based upon expert pathological review of liver biopsies. During early development, these long-term POC studies (≥48 weeks) add cost and time to the "Go/No Go" decision process. However, it is possible to conduct short-term noninvasive POC studies utilizing biomarkers and magnetic resonance imaging. Here, we discuss the use of shorter noninvasive POC studies relative to biopsy-driven studies for drug development in NASH...
November 7, 2016: Clinical Pharmacology and Therapeutics
https://www.readbyqxmd.com/read/28018853/mri-flair-lesion-segmentation-in-multiple-sclerosis-does-automated-segmentation-hold-up-with-manual-annotation
#15
Christine Egger, Roland Opfer, Chenyu Wang, Timo Kepp, Maria Pia Sormani, Lothar Spies, Michael Barnett, Sven Schippling
INTRODUCTION: Magnetic resonance imaging (MRI) has become key in the diagnosis and disease monitoring of patients with multiple sclerosis (MS). Both, T2 lesion load and Gadolinium (Gd) enhancing T1 lesions represent important endpoints in MS clinical trials by serving as a surrogate of clinical disease activity. T2- and fluid-attenuated inversion recovery (FLAIR) lesion quantification - largely due to methodological constraints - is still being performed manually or in a semi-automated fashion, although strong efforts have been made to allow automated quantitative lesion segmentation...
2017: NeuroImage: Clinical
https://www.readbyqxmd.com/read/28017631/nonalcoholic-fatty-liver-disease-and-the-risk-of-clinical-cardiovascular-events-a-systematic-review-and-meta-analysis
#16
REVIEW
Toufik Mahfood Haddad, Shadi Hamdeh, Arun Kanmanthareddy, Venkata M Alla
OBJECTIVE: Numerous studies have assessed the association between Nonalcoholic fatty liver disease (NAFLD) and cardiovascular disease (CVD). However, results have been conflicting due to variability in definitions of NAFLD and ascertainment of CVD, often combining clinical and surrogate endpoints. We therefore systematically reviewed published literature to assess the association between NAFLD and clinical cardiovascular events (CVE) and performed a meta-analysis. METHODS: We searched PubMed, Medline, Cochrane, CINAHL, and Web of Science databases using terms "nonalcoholic fatty liver disease", "nonalcoholic steatohepatitis", "cardiovascular disease", and their combinations to identify prospective studies published from inception through March 2016...
December 15, 2016: Diabetes & Metabolic Syndrome
https://www.readbyqxmd.com/read/28004899/evidence-overview-benefit-of-cerebral-protection-devices-during-carotid-artery-stenting
#17
Jan A Vos
Embolic Protection Devices (EPD's) are often used during Carotid Angioplasty and Stenting (CAS) to reduce procedural cerebral emboli. This manuscript seeks to present an overview of evidence on EPD's during CAS. There are three categories of EPD's: Distal Occlusion (DO-EPD), Filter (F-EPD) and Proximal Occlusion (PO-EPD). DO and F-EPD's have the disadvantage that the device has to be advanced through the stenosis, without protection and that the device may damage the distal internal carotid artery (ICA). F-EPD's have the advantage of maintaining antegrade flow throughout the procedure...
December 22, 2016: Journal of Cardiovascular Surgery
https://www.readbyqxmd.com/read/28003033/short-physical-performance-battery-and-all-cause-mortality-systematic-review-and-meta-analysis
#18
Rita Pavasini, Jack Guralnik, Justin C Brown, Mauro di Bari, Matteo Cesari, Francesco Landi, Bert Vaes, Delphine Legrand, Joe Verghese, Cuiling Wang, Sari Stenholm, Luigi Ferrucci, Jennifer C Lai, Anna Arnau Bartes, Joan Espaulella, Montserrat Ferrer, Jae-Young Lim, Kristine E Ensrud, Peggy Cawthon, Anna Turusheva, Elena Frolova, Yves Rolland, Valerie Lauwers, Andrea Corsonello, Gregory D Kirk, Roberto Ferrari, Stefano Volpato, Gianluca Campo
BACKGROUND: The Short Physical Performance Battery (SPPB) is a well-established tool to assess lower extremity physical performance status. Its predictive ability for all-cause mortality has been sparsely reported, but with conflicting results in different subsets of participants. The aim of this study was to perform a meta-analysis investigating the relationship between SPPB score and all-cause mortality. METHODS: Articles were searched in MEDLINE, the Cochrane Library, Google Scholar, and BioMed Central between July and September 2015 and updated in January 2016...
December 22, 2016: BMC Medicine
https://www.readbyqxmd.com/read/27992772/the-role-of-imperfect-surrogate-endpoint-information-in-drug-approval-and-reimbursement-decisions
#19
Katalin Bognar, John A Romley, Jay P Bae, James Murray, Jacquelyn W Chou, Darius N Lakdawalla
Approval of new drugs is increasingly reliant on "surrogate endpoints," which correlate with but imperfectly predict clinical benefits. Proponents argue surrogate endpoints allow for faster approval, but critics charge they provide inadequate evidence. We develop an economic framework that addresses the value of improvement in the predictive power, or "quality," of surrogate endpoints, and clarifies how quality can influence decisions by regulators, payers, and manufacturers. For example, the framework shows how lower-quality surrogates lead to greater misalignment of incentives between payers and regulators, resulting in more drugs that are approved for use but not covered by payers...
December 11, 2016: Journal of Health Economics
https://www.readbyqxmd.com/read/27966231/assessing-a-surrogate-predictive-value-a-causal-inference-approach
#20
Ariel Alonso, Wim Van der Elst, Paul Meyvisch
Several methods have been developed for the evaluation of surrogate endpoints within the causal-inference and meta-analytic paradigms. In both paradigms, much effort has been made to assess the capacity of the surrogate to predict the causal treatment effect on the true endpoint. In the present work, the so-called surrogate predictive function (SPF) is introduced for that purpose, using potential outcomes. The relationship between the SPF and the individual causal association, a new metric of surrogacy recently proposed in the literature, is studied in detail...
December 13, 2016: Statistics in Medicine
keyword
keyword
62484
1
2
Fetch more papers »
Fetching more papers... Fetching...
Read by QxMD. Sign in or create an account to discover new knowledge that matter to you.
Remove bar
Read by QxMD icon Read
×

Search Tips

Use Boolean operators: AND/OR

diabetic AND foot
diabetes OR diabetic

Exclude a word using the 'minus' sign

Virchow -triad

Use Parentheses

water AND (cup OR glass)

Add an asterisk (*) at end of a word to include word stems

Neuro* will search for Neurology, Neuroscientist, Neurological, and so on

Use quotes to search for an exact phrase

"primary prevention of cancer"
(heart or cardiac or cardio*) AND arrest -"American Heart Association"