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Waiver informed consent

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https://www.readbyqxmd.com/read/28993074/obtaining-waivers-of-parental-consent-a-strategy-endorsed-by-gay-bisexual-and-queer-adolescent-males-for-health-prevention-research
#1
Dalmacio Flores, Ross McKinney, Joyell Arscott, Julie Barroso
BACKGROUND: Requiring parental consent in studies with sexual minority youth (SMY) can sometimes be problematic as participants may have yet to disclose their sexual orientation, may not feel comfortable asking parents' permission, and may promote a self-selection bias. PURPOSE: We discuss rationale for waiving parental consent, strategies to secure waivers from review boards, and present participants' feedback on research without parents' permission. METHODS: We share our institutional review board proposal in which we made a case that excluding SMY from research violates ethical research principles, does not recognize their autonomy, and limits collection of sexuality data...
September 18, 2017: Nursing Outlook
https://www.readbyqxmd.com/read/28981400/clinical-outcomes-of-radiofrequency-ablation-for-early-hypovascular-hcc-a-multicenter-retrospective-study
#2
Dong Ho Lee, Jeong Min Lee, Tae Wook Kang, Hyunchul Rhim, So Yeon Kim, Yong Moon Shin, Jung Wook Seo, Moon Hyung Choi, Kyung Bun Lee
Purpose To retrospectively evaluate the clinical outcomes of radiofrequency ablation (RFA) for early hypovascular hepatocellular carcinomas (HCCs) and to compare them with those of typical hypervascular HCCs. Materials and Methods This retrospective multicenter study received institutional review board approval, with a waiver of the need to obtain informed consent. A total of 56 patients (male-to-female ratio, 40:16; mean age, 61.8 years; age range, 33-87 years) with pathologically proven early HCCs that did not meet the noninvasive diagnosis criteria and who were initially treated with RFA at one of five university-affiliated hospitals between January 2009 and December 2013 comprised the study group...
October 5, 2017: Radiology
https://www.readbyqxmd.com/read/28960624/talking-to-the-people-that-really-matter-about-their-participation-in-pandemic-clinical-research-a-qualitative-study-in-four-european-countries
#3
Nina H Gobat, Micaela Gal, Christopher C Butler, Steve A R Webb, Nicholas A Francis, Helen Stanton, Sibyl Anthierens, Hilde Bastiaens, Maciek Godycki-Ćwirko, Anna Kowalczyk, Mariona Pons-Vigués, Enriqueta Pujol-Ribera, Anna Berenguera, Angela Watkins, Prasanth Sukumar, Ronald G Moore, Kerenza Hood, Alistair Nichol
BACKGROUND: Pandemics of new and emerging infectious diseases are unpredictable, recurrent events that rapidly threaten global health and security. We aimed to identify public views regarding provision of information and consent to participate in primary and critical care clinical research during a future influenza-like illness pandemic. METHODS: Descriptive-interpretive qualitative study, using focus groups (n = 10) and semi-structured interviews (n = 16), with 80 members of the public (>18 years) in Belgium, Spain, Poland and the UK...
September 27, 2017: Health Expectations: An International Journal of Public Participation in Health Care and Health Policy
https://www.readbyqxmd.com/read/28937263/imaging-features-of-breast-cancers-on-digital-breast-tomosynthesis-according-to-molecular-subtype-association-with-breast-cancer-detection
#4
Su Hyun Lee, Jung Min Chang, Sung Ui Shin, A Jung Chu, Ann Yi, Nariya Cho, Woo Kyung Moon
OBJECTIVE: To evaluate imaging features of breast cancers on digital breast tomosynthesis (DBT) according to molecular subtype and to determine whether the molecular subtype affects breast cancer detection on DBT. METHODS: This was an institutional review board--approved study with a waiver of informed consent. DBT findings of 288 invasive breast cancers were reviewed according to Breast Imaging Reporting and Data System lexicon. Detectability of breast cancer was quantified by the number of readers (0-3) who correctly detected the cancer in an independent blinded review...
October 9, 2017: British Journal of Radiology
https://www.readbyqxmd.com/read/28932767/patient-specific-workup-of-adrenal-incidentalomas
#5
REVIEW
Romy R de Haan, Johannes B R Visser, Ewoud Pons, Richard A Feelders, Uzay Kaymak, M G Myriam Hunink, Jacob J Visser
PURPOSE: : To develop a clinical prediction model to predict a clinically relevant adrenal disorder for patients with adrenal incidentaloma. MATERIALS AND METHODS: : This retrospective study is approved by the institutional review board, with waiver of informed consent. Natural language processing is used for filtering of adrenal incidentaloma cases in all thoracic and abdominal CT reports from 2010 till 2012. A total of 635 patients are identified. Stepwise logistic regression is used to construct the prediction model...
2017: European Journal of Radiology Open
https://www.readbyqxmd.com/read/28923007/patients-beliefs-regarding-informed-consent-for-low-risk-pragmatic-trials
#6
Rafael Dal-Ré, Antonio J Carcas, Xavier Carné, David Wendler
BACKGROUND: The requirement to obtain written informed consent may undermine the potential of pragmatic randomized clinical trials (pRCTs) to improve evidence-based care. This requirement could compromise trials statistical power or even force it to close them down prematurely. However, recent data from the U.S. and Spain suggest that a majority of the public endorses written consent for low-risk pRCTs. The present manuscript assesses whether this view is shared by patients. METHODS: This was a cross-sectional, probability-based survey, with a 2 × 2 factorial design, assessing support for written informed consent versus verbal consent or general notification for two low-risk pRCTs in hypertension, one comparing 2 drugs with similar risk/benefit profiles and the other comparing the same drug being taken in the morning or at night...
September 18, 2017: BMC Medical Research Methodology
https://www.readbyqxmd.com/read/28915851/assessment-of-consent-models-as-an-ethical-consideration-in-the-conduct-of-prehospital-ambulance-randomised-controlled-clinical-trials-a-systematic-review
#7
Stephanie Armstrong, Adele Langlois, Despina Laparidou, Mark Dixon, Jason P Appleton, Philip M Bath, Helen Snooks, A Niroshan Siriwardena
BACKGROUND: We sought to understand the main ethical considerations when conducting clinical trials in the prehospital ambulance based setting. METHODS: A systematic review of the literature on randomised controlled trials in ambulance settings was undertaken. A search of eight databases identified published studies involving recruitment of ambulance service users. Four independent authors undertook abstract and full-text reviews to determine eligibility and extract relevant data...
September 16, 2017: BMC Medical Research Methodology
https://www.readbyqxmd.com/read/28865448/pediatric-supraglottic-airway-devices-in-clinical-practice-a-prospective-observational-study
#8
Maren Kleine-Brueggeney, Anne Gottfried, Sabine Nabecker, Robert Greif, Malte Book, Lorenz Theiler
BACKGROUND: Supraglottic airway devices (SGA) are commonly used in pediatric anesthesia and serve as primary or back-up devices for difficult airway management. Most SGA are marketed without proper clinical evaluation. The purpose of this study was to evaluate the performance of the pediatric LMA Supreme™, Air-Q® and Ambu® Aura-i™. METHODS: This prospective observational study was performed at Bern University Hospital, Switzerland. With ethics committee approval and a waiver for written informed consent 240 children undergoing elective surgery with an ASA class I-III and a weight of 5-30 kg were included...
September 2, 2017: BMC Anesthesiology
https://www.readbyqxmd.com/read/28834092/therapy-related-explants-after-spinal-cord-stimulation-results-of-an-international-retrospective-chart-review-study
#9
Jean-Pierre Van Buyten, Frank Wille, Iris Smet, Carin Wensing, Jennifer Breel, Edward Karst, Marieke Devos, Katja Pöggel-Krämer, Jan Vesper
OBJECTIVES: Clinical trials of spinal cord stimulation (SCS) have largely focused on conversion from trial to permanent SCS and the first years after implant. This study evaluates the association of type of SCS and patient characteristics with longer-term therapy-related explants. MATERIALS AND METHODS: Implanting centers in three European countries conducted a retrospective chart review of SCS systems implanted from 2010 to 2013. Ethics approval or waiver was obtained, and informed consent was not required...
October 2017: Neuromodulation: Journal of the International Neuromodulation Society
https://www.readbyqxmd.com/read/28822109/consumer-attitudes-towards-the-establishment-of-a-national-australian-familial-cancer-research-database-by-the-inherited-cancer-connect-iccon-partnership
#10
Laura Forrest, Gillian Mitchell, Letitia Thrupp, Lara Petelin, Kate Richardson, Lyon Mascarenhas, Mary-Anne Young
Clinical genetics units hold large amounts of information which could be utilised to benefit patients and their families. In Australia, a national research database, the Inherited Cancer Connect (ICCon) database, is being established that comprises clinical genetic data held for all carriers of mutations in cancer predisposition genes. Consumer input was sought to establish the acceptability of the inclusion of clinical genetic data into a research database. A qualitative approach using a modified nominal group technique was used to collect data through consumer forums conducted in three Australian states...
August 18, 2017: Journal of Community Genetics
https://www.readbyqxmd.com/read/28760215/interventions-supporting-long-term-adherence-and-decreasing-cardiovascular-events-island-pragmatic-randomized-trial-protocol
#11
RANDOMIZED CONTROLLED TRIAL
Noah Ivers, J-D Schwalm, Holly O Witteman, Justin Presseau, Monica Taljaard, Tara McCready, Beth Bosiak, Jennifer Cunningham, Shelley Smarz, Laura Desveaux, Jack V Tu, Clare Atzema, Garth Oakes, Wanrudee Isaranuwatchai, Sherry L Grace, R Sacha Bhatia, Madhu Natarajan, Jeremy M Grimshaw
BACKGROUND: Guidelines recommend cardiac rehabilitation and long-term use of cardiac medications for most patients who have had a myocardial infarction (MI), but adherence to these secondary prevention treatments is suboptimal. METHODS: This is a multicenter, pragmatic, 3-arm randomized trial. Eligible patients (n = 2,742) with obstructive coronary artery disease are randomized post-MI to usual care or 1 of 2 intervention arms. Patients in the first intervention arm receive mail-outs sent on behalf of their cardiologist at 4, 8, 20, 32, and 44 weeks post-MI; content is designed to address determinants of adherence and facilitate discussion between the patient and their health care team...
August 2017: American Heart Journal
https://www.readbyqxmd.com/read/28744692/frequency-of-acute-longus-colli-tendinitis-on-ct-examinations
#12
John Boardman, Emanuel Kanal, Patrick Aldred, Joseph Boonsiri, Chijindu Nworgu, Feng Zhang
PURPOSE: We attempted to determine the frequency of acute longus colli tendinitis on diagnostic CT imaging performed at a large multicenter health care system. By correlating with the pre-imaging clinical information, we investigated which patient presentations should lead the radiologist to increased suspicion for this condition. METHODS: Images from a total of 8101 adult CT examinations of the neck and cervical spine performed over a 3-month period were evaluated by researchers independent of the original clinical report...
July 25, 2017: Emergency Radiology
https://www.readbyqxmd.com/read/28712619/ethics-of-informed-consent-for-pragmatic-trials-with-new-interventions
#13
Shona Kalkman, Scott Y H Kim, Ghislaine J M W van Thiel, Diederick E Grobbee, Johannes J M van Delden
OBJECTIVES: Pragmatic trials evaluate the comparative benefits, risks, and burdens of health care interventions in real-world conditions. Such studies are now recognized as valuable to the perimarketing stage of drug development and evaluation, with early pragmatic trials (EPTs) being explored as a means to generate real-world evidence at the time of regulatory market approval. In this article, we present an analysis of the ethical issues involved in informed consent for EPTs, in light of the generally recognized concern that traditional ethical rules governing randomized clinical trials, such as lengthy informed consent procedures, could threaten the "real world" nature of such trials...
July 2017: Value in Health: the Journal of the International Society for Pharmacoeconomics and Outcomes Research
https://www.readbyqxmd.com/read/28654338/small-intracranial-aneurysms-diagnostic-accuracy-of-ct-angiography
#14
Zhen Lu Yang, Qian Qian Ni, U Joseph Schoepf, Carlo N De Cecco, Han Lin, Taylor M Duguay, Chang Sheng Zhou, Yan E Zhao, Guang Ming Lu, Long Jiang Zhang
Purpose To assess the accuracy of computed tomographic (CT) angiography for diagnosis of cerebral aneurysms 5 mm or smaller, with digital subtraction angiography (DSA) as the reference standard, in a large patient cohort Materials and Methods This retrospective study was approved by the local institutional review board with a waiver of written informed consent. A total of 1366 patients who underwent cerebral CT angiography followed by DSA were included. The performance of CT angiography for depiction of aneurysms was evaluated by two readers on a per-patient and per-aneurysm basis and based on size of aneurysm, location, and status of rupture...
December 2017: Radiology
https://www.readbyqxmd.com/read/28629573/added-value-of-prone-ct-in-the-assessment-of-honeycombing-and-classification-of-usual-interstitial-pneumonia-pattern
#15
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
#16
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...
November 2017: Radiology
https://www.readbyqxmd.com/read/28502809/challenges-of-informed-consent-for-pragmatic-trials
#17
Shona Kalkman, Ghislaine J M W van Thiel, Mira G P Zuidgeest, Iris Goetz, Boris M Pfeiffer, Diederick E Grobbee, Johannes J M van Delden
The GetReal consortium of the Innovative Medicines Initiative 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
#18
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...
October 2017: Radiology
https://www.readbyqxmd.com/read/28466184/thirty-day-emergency-room-visits-and-hospital-admissions-after-outpatient-non-vascular-image-guided-procedures
#19
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...
October 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
#20
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
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