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https://www.readbyqxmd.com/read/28629573/added-value-of-prone-ct-in-the-assessment-of-honeycombing-and-classification-of-usual-interstitial-pneumonia-pattern
#1
Minjae Kim, Sang Min Lee, Jae-Woo Song, Kyung-Hyun Do, Hyun Joo Lee, Soyeoun Lim, Jooae Choe, Kye Jin Park, Hyo Jung Park, Hwa Jung Kim, Joon Beom Seo
OBJECTIVE: To retrospectively investigate whether prone CT improves identification of honeycombing and classification of UIP patterns in terms of interobserver agreement and accuracy using pathological results as a reference standard. MATERIALS AND METHODS: Institutional review board approval with waiver of patients' informed consent requirement was obtained. HRCTs of 86 patients with pathologically proven UIP, NSIP and chronic HP between January 2011 and April 2015 were evaluated by 8 observers...
June 2017: European Journal of Radiology
https://www.readbyqxmd.com/read/28562210/lateral-sinus-dural-arteriovenous-fistulas-sinovenous-outflow-restriction-outweighs-cortical-venous-reflux-as-a-parameter-associated-with-hemorrhage
#2
Yong-Sin Hu, Chung-Jung Lin, Hsiu-Mei Wu, Wan-Yuo Guo, Chao-Bao Luo, Chih-Chun Wu, Wen-Yuh Chung, Kang-Du Liu, Huai-Che Yang, Cheng-Chia Lee
Purpose To investigate whether sinovenous outflow restriction (SOR) is more strongly associated with hemorrhage than cortical venous reflux (CVR) in patients with lateral sinus dural arteriovenous fistulas (DAVFs). Materials and Methods An institutional review board approved this retrospective study and waiver of informed consent was obtained. From 1995 to 2016, 163 cases of lateral sinus DAVFs were included and divided into hemorrhagic and nonhemorrhagic groups based on initial presentation. Their angiograms and magnetic resonance images were evaluated, with two evaluators independently grading CVR and SOR...
May 30, 2017: Radiology
https://www.readbyqxmd.com/read/28502809/challenges-of-informed-consent-for-pragmatic-trials
#3
Shona Kalkman, Ghislaine Jmw van Thiel, Mira Gp Zuidgeest, Iris Goetz, Boris M Pfeiffer, Diederick E Grobbee, Johannes Jm van Delden
The Innovative Medicines Initiative's (IMI) GetReal consortium aims to develop strategies to incorporate real world evidence earlier into the drug life cycle to better inform health care decision-makers on the comparative risks and benefits of new drugs. Pragmatic trials are currently explored as a means to generate such evidence in routine care settings. The traditional informed consent model for randomized clinical trials has been argued to pose substantial hurdles to the practicability of pragmatic trials: it would lead to recruitment difficulties, reduced generalizability of the results and selection bias...
May 11, 2017: Journal of Clinical Epidemiology
https://www.readbyqxmd.com/read/28467143/contrast-enhanced-us-assisted-percutaneous-nephrostomy-a-technique-to-increase-success-rate-for-patients-with-nondilated-renal-collecting-system
#4
Bao X Liu, Guang L Huang, Xiao H Xie, Bo W Zhuang, Xiao Y Xie, Ming D Lu
Purpose To perform a single-center study of contrast material-enhanced ultrasonography (US)-assisted percutaneous nephrostomy (PCN) for patients with nondilated renal collecting system. Materials and Methods An international review board approved this retrospective study with waiver of informed consent for participation, and the study was approved by the Ethical Committee. From November 2011 to September 2015, 47 patients (mean age, 51.9 years ± 16.2 [standard deviation]; range, 18-80 years) with clinical necessity of urinary drainage, urinary diversion, or provision of access to the collecting system and with nondilated renal collecting system who underwent contrast-enhanced US-assisted PCN for 48 kidneys were included...
May 3, 2017: Radiology
https://www.readbyqxmd.com/read/28466184/thirty-day-emergency-room-visits-and-hospital-admissions-after-outpatient-non-vascular-image-guided-procedures
#5
Quang Nguyen, Sahil V Mehta, Jieming Fang, Robert Sheiman, Robert Kane, Muneeb Ahmed, Ammar Sarwar, Bettina Siewert, Olga R Brook
PURPOSE: To evaluate the rate of post-procedure emergency department (ED) visits and hospital admissions following outpatient non-vascular image-guided interventions performed under moderate sedation and to identify common and preventable causes of emergency department visits and hospital admissions. MATERIALS AND METHODS: Institutional review board approval was acquired for this HIPAA-compliant retrospective study with waiver of informed consent. 1426 consecutive patients undergoing 1512 outpatient image-guided procedures under moderate sedation from November 2012 to August 2014 were included...
May 2, 2017: Abdominal Radiology
https://www.readbyqxmd.com/read/28462442/microwave-ablation-of-lung-tumors-near-the-heart-a-retrospective-review-of-short-term-procedural-safety-in-ten-patients
#6
Aaron W P Maxwell, Terrance T Healey, Damian E Dupuy
OBJECTIVES: To evaluate the rate of short-term complications associated with microwave ablation of lung tumors located near the heart. METHODS: This HIPAA-compliant study was performed with a waiver for informed consent. Patients who underwent microwave ablation of lung tumors located 10 mm or less from the heart were identified by retrospective chart review. Both primary and metastatic tumors were included. Only tumors directly adjacent to one of the four cardiac chambers were included...
May 1, 2017: Cardiovascular and Interventional Radiology
https://www.readbyqxmd.com/read/28449032/comparing-outcomes-and-cost-of-3-surgical-treatments-for-sagittal-synostosis-a-retrospective-study-including-procedure-related-cost-analysis
#7
Sarah T Garber, Michael Karsy, John R W Kestle, Faizi Siddiqi, Stephen P Spanos, Jay Riva-Cambrin
BACKGROUND: Neurosurgical techniques for repair of sagittal synostosis include total cranial vault (TCV) reconstruction, open sagittal strip (OSS) craniectomy, and endoscopic strip (ES) craniectomy. OBJECTIVE: To evaluate outcomes and cost associated with these 3 techniques. METHODS: Via retrospective chart review with waiver of informed consent , the last consecutive 100 patients with sagittal synostosis who underwent each of the 3 surgical correction techniques before June 30, 2013, were identified...
April 25, 2017: Neurosurgery
https://www.readbyqxmd.com/read/28400900/conjugate-eye-deviation-on-ct-associated-with-worse-outcomes-despite-iv-thrombolysis
#8
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
#9
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...
July 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
#10
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
#11
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
#12
COMPARATIVE STUDY
Foucauld Chamming's, Ellen Kao, Ann Aldis, Romuald Ferré, Atilla Omeroglu, Caroline Reinhold, Benoit Mesurolle
OBJECTIVE: 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 tumour 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...
May 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
#13
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
#14
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
#15
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
#16
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
#17
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
#18
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
#19
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
#20
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
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