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Waiver informed consent

Brian Shiner, Christine Leonard Westgate, Vanessa Simiola, Richard Thompson, Paula P Schnurr, Joan M Cook
Objective: Available studies on implementation of evidence-based psychotherapy (EBP) for patients attending Department of Veterans Affairs (VA) residential post-traumatic stress disorder (PTSD) programs rely on therapist self-report of EBP delivery. Patient-level data on receipt of EBP are needed both to corroborate therapist self-report and to understand patient factors that predict receipt of EBPs for PTSD. Materials and Methods: We identified 159 therapists from 38 VA residential PTSD programs who responded to a survey about EBP implementation during the 2015 fiscal year (FY15)...
March 14, 2018: Military Medicine
Nathaniel P Roberson, Jonathan R Dillman, Sara M O'Hara, William R DeFoor, Pramod P Reddy, Richard M Giordano, Andrew T Trout
BACKGROUND: The incidence of pediatric nephrolithiasis in the United States is increasing. There is a paucity of literature comparing the diagnostic performance of computed ultrasound (US) to tomography (CT) in the pediatric population. OBJECTIVE: To determine the diagnostic performance of renal US for nephrolithiasis in children using a clinical effectiveness approach. MATERIALS AND METHODS: Institutional review board approval with a waiver of informed consent was obtained for this retrospective, HIPAA-complaint investigation...
February 23, 2018: Pediatric Radiology
Giuseppe Corrias, Sandra Huicochea Castellanos, Ryan Merkow, Russel Langan, Vinod Balachandran, Monica Ragucci, Gabriella Carollo, Marcello Mancini, Luca Saba, Lorenzo Mannelli
RATIONALE AND OBJECTIVES: To determine the impact of second-opinion assessment on cancer staging and patient management in patients with pancreatic ductal adenocarcinoma. METHODS AND MATERIALS: This retrospective study was approved by our institutional review board with a waiver of informed consent. Second-opinion reports between January 1, 2009 and December 31, 2013, alongside outside reports for 65 consecutive cases of biopsy-proven pancreatic adenocarcinomas, were presented in random order to two experienced abdominal surgeons who independently reviewed them blinded to the origin of the report, images of the examinations, and patient identifier...
January 16, 2018: Academic Radiology
Jieming Fang, Johannes Boos, Marcela Pecora Cohen, Jonathan B Kruskal, Ronald Eisenberg, Bettina Siewert, Olga R Brook
PURPOSE: The aim of this study was to evaluate radiologists' experiences with patient interactions in the era of open access of patients to radiology reports. METHODS: This prospective, nonrandom survey of staff and trainee radiologists (n = 128) at a single large academic institution was performed with approval from the institutional review board with a waiver of the requirement to obtain informed consent. A multiple-choice questionnaire with optional free-text comments was constructed with an online secure platform (REDCap) and distributed via departmental e-mail between June 1 and July 31, 2016...
January 2, 2018: Journal of the American College of Radiology: JACR
Eyal Itshayek, Carlos Candanedo, Shifra Fraifeld, Amir Hasharoni, Leon Kaplan, Josh E Schroeder, José E Cohen
BACKGROUND & CONTEXT: Metastatic epidural spinal cord compression (MESCC) is a disabling consequence of disease progression. Surgery can restore/preserve physical function, improving access to treatments that increase duration of survival; however, advanced patient age may deter oncologists and surgeons from considering surgical management. PURPOSE: Evaluate the duration of ambulation and survival in elderly patients following surgical decompression of MESCC...
December 28, 2017: Spine Journal: Official Journal of the North American Spine Society
Markus Sauer, Julius M Weinrich, Christoph Fraune, Georg Salomon, Pierre Tennstedt, Gerhard Adam, Dirk Beyersdorff
OBJECTIVES: To evaluate the accuracy of assessment of neurovascular bundle (NVB) infiltration using multiparametric magnetic resonance imaging (mpMRI) and PI-RADS V2 prior to prostatectomy. METHODS: The ethics committee approved this retrospective study with waiver of informed consent. N=198 consecutive patients with biopsy proved cancer underwent standardized mpMRI at 3T prior to surgery. NVB infiltration was assessed for each side (a total of 396). Maximum PI-RADS V2 scores were determined for the posterolateral areas adjacent to the NVBs...
January 2018: European Journal of Radiology
Andrea Franconeri, Jieming Fang, Benjamin Carney, Almamoon Justaniah, Laura Miller, Hye-Chun Hur, Louise P King, Roa Alammari, Salomao Faintuch, Koenraad J Mortele, Olga R Brook
OBJECTIVES: To evaluate clarity and usefulness of MRI reporting of uterine fibroids using a structured disease-specific template vs. narrative reporting for planning of fibroid treatment by gynaecologists and interventional radiologists. METHODS: This is a HIPAA-compliant, IRB-approved study with waiver of informed consent. A structured reporting template for fibroid MRIs was developed in collaboration between gynaecologists, interventional and diagnostic radiologists...
December 15, 2017: European Radiology
Scott Yh Kim, James Flory, Clare Relton
BACKGROUND: With increasing emphasis on pragmatic trials, new randomized clinical trial designs are being proposed to enhance the "real world" nature of the data generated. We describe one such design, appropriate for unmasked pragmatic clinical trials in which the control arm receives usual care, called "Trials within Cohorts" that is increasingly used in various countries because of its efficiency in recruitment, advantages in reducing subject burden, and ability to better mimic real-world consent processes...
February 2018: Clinical Trials: Journal of the Society for Clinical Trials
Maya Elizabeth Kessler, Rickey E Carter, David A Cook, Daryl Jon Kor, Paul M McKie, Laurie J Pencille, Marianne R Scheitel, Rajeev Chaudhry
INTRODUCTION: Clinical practice guidelines facilitate optimal clinical practice. Point of care access, interpretation and application of such guidelines, however, is inconsistent. Informatics-based tools may help clinicians apply guidelines more consistently. We have developed a novel clinical decision support tool that presents guideline-relevant information and actionable items to clinicians at the point of care. We aim to test whether this tool improves the management of hyperlipidaemia, atrial fibrillation and heart failure by primary care clinicians...
December 4, 2017: BMJ Open
Ted Rosenberg, Rory Lattimer, Patrick Montgomery, Christian Wiens, Liran Levy
Background: The association between interstitial lung disease (ILD) and selective serotonin reuptake inhibitors and serotonin norepinephrine reuptake inhibitors (SSRI/SNRI) has been previously described in published case reports. However, its prevalence may be more common than expected. We examined the association between SSRI/SNRI usage and presence of ILD and or bronchiectasis (ILD/B) in an elderly population. Methods: We conducted a retrospective case series and case-control study involving all 296 eligible elderly patients in one primary care geriatric practice in Victoria, BC, Canada...
2017: Clinical Interventions in Aging
Emily S Orscheln, Jonathan R Dillman, Alexander J Towbin, Lee A Denson, Andrew T Trout
PURPOSE: To establish the relationship between penetrating complications and bowel luminal narrowing/stricturing disease in pediatric Crohn disease (CD). MATERIALS AND METHODS: This retrospective study was IRB-approved and HIPAA compliant with waiver of informed consent. CT and MRI examinations describing intra-abdominal penetrating complications in CD patients ≤ 18 years old between January 1, 2009 and March 31, 2016 were reviewed to document: type of complication, affected bowel segment, minimum bowel luminal diameter, maximum upstream diameter, location of penetrating complication relative to luminal narrowing, length of narrowed bowel segment, and the presence of active bowel wall inflammation...
November 22, 2017: Abdominal Radiology
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
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
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
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...
December 2017: British Journal of Radiology
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
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
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
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
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
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