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Waiver informed consent

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https://www.readbyqxmd.com/read/28400900/conjugate-eye-deviation-on-ct-associated-with-worse-outcomes-despite-iv-thrombolysis
#1
Nirav H Shah, Nirav Bhatt, Anita Tipirneni, Diego Condes, Priyank Khandelwal, Jose G Romano
INTRODUCTION: Rapid stroke management has significant implications in patient outcomes. Ipsilateral computed tomography conjugate eye deviation (CT-CED) has been associated with worse outcomes but has never been evaluated as predictive of vascular occlusion. To test the hypothesis that CT-CED is a marker for vascular occlusion, we evaluated patients treated with intravenous tissue plasminogen activator (IV tPA). METHODS: We performed a retrospective analysis of patients with acute ischemic stroke treated with IV tPA at a large tertiary care hospital over an 18-month period...
April 2017: Neurohospitalist
https://www.readbyqxmd.com/read/28394755/prostate-cancer-diffusion-weighted-mr-imaging-for-detection-and-assessment-of-aggressiveness-comparison-between-conventional-and-kurtosis-models
#2
Tsutomu Tamada, Vinay Prabhu, Jianhong Li, James S Babb, Samir S Taneja, Andrew B Rosenkrantz
Purpose To compare standard diffusion-weighted (DW) imaging and diffusion kurtosis (DK) imaging for prostate cancer (PC) detection and characterization in a large patient cohort, with attention to the potential added value of DK imaging. Materials and Methods This retrospective institutional review board-approved study received a waiver of informed consent. Two hundred eighty-five patients with PC underwent 3.0-T phased-array coil prostate magnetic resonance (MR) imaging, including a DK imaging sequence (b values 0, 500, 1000, 1500, and 2000 sec/mm(2)) before prostatectomy...
April 10, 2017: Radiology
https://www.readbyqxmd.com/read/28393537/inadequacy-of-ethical-conduct-and-reporting-of-stepped-wedge-cluster-randomized-trials-results-from-a-systematic-review
#3
Monica Taljaard, Karla Hemming, Lena Shah, Bruno Giraudeau, Jeremy M Grimshaw, Charles Weijer
Background/aims The use of the stepped wedge cluster randomized design is rapidly increasing. This design is commonly used to evaluate health policy and service delivery interventions. Stepped wedge cluster randomized trials have unique characteristics that complicate their ethical interpretation. The 2012 Ottawa Statement provides comprehensive guidance on the ethical design and conduct of cluster randomized trials, and the 2010 CONSORT extension for cluster randomized trials provides guidelines for reporting...
April 1, 2017: Clinical Trials: Journal of the Society for Clinical Trials
https://www.readbyqxmd.com/read/28377915/waiver-of-consent-in-a-trial-intervention-occurring-at-birth-how-do-parents-feel
#4
Wade D Rich, Anup C Katheria
BACKGROUND: We have previously demonstrated that it is difficult to obtain a representative subject sample when conducting a randomized controlled trial (RCT) at or near the time of birth and obtaining antenatal consent. Waiver of consent has been used in neonatal trials, but parents' reactions to being enrolled in these trials have never been reported. METHODS: The parents enrolled in a RCT involving a waiver of consent with a post-delivery discussion were asked to take part in a brief survey...
2017: Frontiers in Pediatrics
https://www.readbyqxmd.com/read/28368663/imaging-features-and-conspicuity-of-invasive-lobular-carcinomas-on-digital-breast-tomosynthesis
#5
Foucauld Chamming's, Ellen Kao, Ann Aldis, Romuald Ferré, Atilla Omeroglu, Caroline Reinhold, Benoit Mesurolle
OBJECTIVES: To review the imaging features of invasive lobular carcinoma (ILC) seen on Digital breast tomosynthesis (DBT) in comparison with invasive ductal carcinoma (IDC), and to evaluate whether DBT could improve conspicuity and tumor size assessment of ILC in comparison with digital mammography (DM). METHODS: Institutional review board with waiver of informed consent was obtained for this retrospective study. Patients with ILC or IDC who underwent DBT and DM at the time of diagnosis were included...
April 3, 2017: British Journal of Radiology
https://www.readbyqxmd.com/read/28363714/the-effects-of-requiring-parental-consent-for-research-on-adolescents-risk-behaviors-a-meta-analysis
#6
Chao Liu, Ronald B Cox, Isaac J Washburn, Julie M Croff, Hugh C Crethar
PURPOSE: Requiring parental consent may result in sampling biases that confound scientific conclusions and stifle the representation of children most at risk for adverse outcomes. This study aims to investigate whether active parental consent, compared with passive parental consent, creates a bias in response rate, demographic makeup, and adverse outcomes in adolescent samples. METHODS: A meta-analysis was performed on peer-reviewed articles and unpublished dissertations from 1975 to 2016 in five computerized databases ERIC, PsycINFO, MEDLINE, PubMed and ProQuest...
March 28, 2017: Journal of Adolescent Health: Official Publication of the Society for Adolescent Medicine
https://www.readbyqxmd.com/read/28321137/navigating-the-institutional-review-board-irb-process-for-pharmacy-related-research
#7
Marjorie Shaw Phillips, Osama Abdelghany, Susan Johnston, Rachel Rarus, Jennifer Austin-Szwak, Craig Kirkwood
Pharmacists' specialized training and knowledge qualify them to lead and engage in research pertaining to optimal medication use. Performing research promotes pharmacy professionalism and fosters interdisciplinary collaboration. To conduct research appropriately, one must have thorough knowledge of when institutional review board (IRB) approval is required and how to successfully navigate IRB processes. The overarching mission of the IRB overseeing research at an organization per federal guidelines is to protect the rights and welfare of human subjects participating in research...
February 2017: Hospital Pharmacy
https://www.readbyqxmd.com/read/28304099/impact-of-shoulder-sonography-on-clinical-decision-making
#8
Michael V Friedman, Travis J Hillen, David V Holland, James M Essenberg, Jennifer L Demertzis
OBJECTIVES: To assess the impact of musculoskeletal shoulder sonography (US) on clinical decision making. METHODS: This Health Insurance Portability and Accountability Act-compliant retrospective study received Institutional Review Board approval with a waiver of informed consent. Consecutive musculoskeletal shoulder US examinations ordered over a 12-month period were retrospectively reviewed. The medical records of each patient were analyzed, recording immediate pre- and post-US treatment plans...
March 17, 2017: Journal of Ultrasound in Medicine: Official Journal of the American Institute of Ultrasound in Medicine
https://www.readbyqxmd.com/read/28275835/-ethical-aspects-of-clinical-trials-in-rare-diseases
#9
Joerg Hasford, Armin Koch
It is estimated that there are about four million people suffering from rare diseases in Germany. For roughly the last 20 years, there has been an increasing interest in therapeutic research for rare diseases. Drug research is highly regulated via numerous laws, regulations and ethical conventions that do not offer any waivers for clinical trials in rare diseases. Thus the ethical assessment of the clinical trial application for a rare disease is basically the same as for a common disease. As the ethical standards of clinical research, for example regarding informed consent, are derived from constitutional rights and have been codified in the German drug law, it is no surprise that they cannot depend on the frequency of a disease...
March 8, 2017: Bundesgesundheitsblatt, Gesundheitsforschung, Gesundheitsschutz
https://www.readbyqxmd.com/read/28221096/clinical-performance-of-synthesized-two-dimensional-mammography-combined-with-tomosynthesis-in-a-large-screening-population
#10
Mireille P Aujero, Sara C Gavenonis, Ron Benjamin, Zugui Zhang, Jacqueline S Holt
Purpose To compare the clinical performance of synthesized two-dimensional (s2D) mammography combined with digital breast tomosynthesis (DBT) with that of full-field digital mammography (FFDM) alone and FFDM combined with DBT in a large community-based screening population by analyzing recall rate, positive predictive value, and cancer detection rate. Materials and Methods This was a retrospective study approved by the institutional review board and was HIPAA compliant with waiver of informed consent. A total of 78 810 screening mammograms from October 11, 2011, to June 30, 2016, were retrospectively collected...
April 2017: Radiology
https://www.readbyqxmd.com/read/28184961/renal-mass-biopsy-and-thermal-ablation-should-biopsy-be-performed-before-or-during-the-ablation-procedure
#11
Shane A Wells, Vincenzo K Wong, Tyler A Wittmann, Meghan G Lubner, Sara L Best, Timothy J Ziemlewicz, J Louis Hinshaw, Fred T Lee, E Jason Abel
PURPOSE: To determine if renal mass biopsy should be performed before or during the ablation procedure with emphasis on complications and rate of ablation for renal cell carcinomas (RCC), benign tumors, and small renal masses without a histologic diagnosis. METHODS: This HIPAA-compliant, single-center retrospective study was performed under a waiver of informed consent from the institutional review board. Two hundred eighty-four consecutive patients with a small renal mass (≤4...
February 9, 2017: Abdominal Radiology
https://www.readbyqxmd.com/read/28125076/recontacting-participants-for-expanded-uses-of-existing-samples-and-data-a-case-study
#12
Stephanie C Chen, Benjamin E Berkman, Sara Chandros Hull
PURPOSE: Facilitating genomic research may require the use of samples and data collected via consent processes that did not include specific descriptions of secondary uses. We explore whether a waiver of consent with notification and the option to withdraw (WNOW) is a viable alternative to written informed consent for secondary uses of samples and data. METHODS: We developed a retrospective case study of a rare-disease protocol involving 1,978 participants that implemented WNOW for genomic data-sharing activities...
January 26, 2017: Genetics in Medicine: Official Journal of the American College of Medical Genetics
https://www.readbyqxmd.com/read/28068789/pragmatic-trial-of-video-education-in-nursing-homes-the-design-and-rationale-for-a-pragmatic-cluster-randomized-trial-in-the-nursing-home-setting
#13
Vincent Mor, Angelo E Volandes, Roee Gutman, Constantine Gatsonis, Susan L Mitchell
Background/Aims Nursing homes are complex healthcare systems serving an increasingly sick population. Nursing homes must engage patients in advance care planning, but do so inconsistently. Video decision support tools improved advance care planning in small randomized controlled trials. Pragmatic trials are increasingly employed in health services research, although not commonly in the nursing home setting to which they are well-suited. This report presents the design and rationale for a pragmatic cluster randomized controlled trial that evaluated the "real world" application of an Advance Care Planning Video Program in two large US nursing home healthcare systems...
April 2017: Clinical Trials: Journal of the Society for Clinical Trials
https://www.readbyqxmd.com/read/28062801/wire-escalation-in-emergent-revascularization-procedures-of-internal-carotid-artery-occlusions-the-use-of-high-tip-stiffness-microguidewires
#14
José E Cohen, Ronen R Leker, John M Gomori, Eyal Itshayek
OBJECTIVE: We examined the usefulness and safety of high tip stiffness cardiac microguidewires in the endovascular revascularization of selected cases of internal carotid artery (ICA) occlusion. METHODS: Files of patients with acute ischemic symptoms due to ICA occlusions managed from August 2010 to August 2016 by urgent endovascular revascularization were retrospectively reviewed with a waiver of informed consent. Cases where there was escalation to stiff tipped cardiovascular microguidewires after at least two failed attempts to cross the carotid occlusion with standard neuro-microguidewires were included...
January 6, 2017: Journal of Neurointerventional Surgery
https://www.readbyqxmd.com/read/27977329/reducing-artifacts-during-arterial-phase-of-gadoxetate-disodium-enhanced-mr-imaging-dilution-method-versus-reduced-injection-rate
#15
Young Kon Kim, Wei-Chan Lin, Kyunghyun Sung, Steven S Raman, Daniel Margolis, Yaeji Lim, Seonhye Gu, David Lu
Purpose To compare two contrast material-administration protocols (dilution vs slow injection) in terms of their effectiveness in arterial phase artifact reduction at gadoxetic acid-enhanced magnetic resonance (MR) imaging. Materials and Methods This HIPAA-compliant retrospective case-controlled cohort study was approved by the institutional review board, with a waiver of informed patient consent. A total of 318 consecutive patients undergoing gadoxetic acid-enhanced MR imaging were placed into one of two subcohorts of 159 consecutive patients each: the dilution subcohort (gadoxetic acid was diluted 1:1 with saline and injected at a rate of 2...
May 2017: Radiology
https://www.readbyqxmd.com/read/27922974/training-and-validating-a-deep-convolutional-neural-network-for-computer-aided-detection-and-classification-of-abnormalities-on-frontal-chest-radiographs
#16
Mark Cicero, Alexander Bilbily, Errol Colak, Tim Dowdell, Bruce Gray, Kuhan Perampaladas, Joseph Barfett
OBJECTIVES: Convolutional neural networks (CNNs) are a subtype of artificial neural network that have shown strong performance in computer vision tasks including image classification. To date, there has been limited application of CNNs to chest radiographs, the most frequently performed medical imaging study. We hypothesize CNNs can learn to classify frontal chest radiographs according to common findings from a sufficiently large data set. MATERIALS AND METHODS: Our institution's research ethics board approved a single-center retrospective review of 35,038 adult posterior-anterior chest radiographs and final reports performed between 2005 and 2015 (56% men, average age of 56, patient type: 24% inpatient, 39% outpatient, 37% emergency department) with a waiver for informed consent...
May 2017: Investigative Radiology
https://www.readbyqxmd.com/read/27893857/shear-wave-elastography-for-the-differential-diagnosis-of-breast-papillary-lesions
#17
Jin Chung, Won Kyung Lee, Eun-Suk Cha, Jee Eun Lee, Jeoung Hyun Kim, Young Hoon Ryu
OBJECTIVE: To evaluate the diagnostic performance of shear-wave elastography (SWE) for the differential diagnosis of breast papillary lesions. METHODS: This study was an institutional review board-approved retrospective study, with a waiver of informed consent. A total of 79 breast papillary lesions in 71 consecutive women underwent ultrasound and SWE prior to biopsy. Ultrasound features and quantitative SWE parameters were recorded for each lesion. All lesions were surgically excised or excised using an ultrasound-guided vacuum-assisted method...
2016: PloS One
https://www.readbyqxmd.com/read/27875106/neoadjuvant-systemic-therapy-in-breast-cancer-association-of-contrast-enhanced-mr-imaging-findings-diffusion-weighted-imaging-findings-and-tumor-subtype-with-tumor-response
#18
Gorane Santamaría, Xavier Bargalló, Pedro Luis Fernández, Blanca Farrús, Xavier Caparrós, Martin Velasco
Purpose To investigate the performance of tumor subtype and various magnetic resonance (MR) imaging parameters in the assessment of tumor response to neoadjuvant systemic therapy (NST) in patients with breast cancer and to outline a model of pathologic response, considering pathologic complete response (pCR) as the complete absence of any residual invasive cancer or ductal carcinoma in situ (DCIS). Materials and Methods This was an institutional review board-approved retrospective study, with waiver of the need to obtain informed consent...
November 22, 2016: Radiology
https://www.readbyqxmd.com/read/27875105/renal-cell-carcinoma-comparison-of-renal-nephrometry-and-padua-scores-with-maximum-tumor-diameter-for-prediction-of-local-recurrence-after-thermal-ablation
#19
COMPARATIVE STUDY
Aaron W P Maxwell, Grayson L Baird, Jason D Iannuccilli, William W Mayo-Smith, Damian E Dupuy
Purpose To evaluate the performance of the radius, exophytic or endophytic, nearness to collecting system or sinus, anterior or posterior, and location relative to polar lines (RENAL) nephrometry and preoperative aspects and dimensions used for anatomic classification (PADUA) scoring systems and other tumor biometrics for prediction of local tumor recurrence in patients with renal cell carcinoma after thermal ablation. Materials and Methods This HIPAA-compliant study was performed with a waiver of informed consent after institutional review board approval was obtained...
May 2017: Radiology
https://www.readbyqxmd.com/read/27875104/ct-guided-native-medical-renal-biopsy-cortical-tangential-versus-non-tangential-approaches-a-comparison-of-efficacy-and-safety
#20
Bo Liu, Matthew O'Dell, Miguel Flores, Joseph Limback, Melissa Kendall, Julie Pepe, Jeremy R Burt, Francisco Contreras, Andrew R Lewis, Thomas J Ward
Purpose To review a single-center experience with the cortical tangential approach during computed tomography (CT)-guided native medical renal biopsy and to evaluate its efficacy and safety compared with those of a non-cortical tangential approach. Materials and Methods This retrospective study received institutional review board approval, with a waiver of the HIPAA requirement for informed consent. The number of cores, glomeruli, and complications were reviewed in 431 CT-guided medical renal biopsies performed between July 2007 and September 2015...
April 2017: Radiology
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