keyword
https://read.qxmd.com/read/38459367/public-perception-of-participation-in-low-risk-clinical-trials-in-critical-care-using-waived-consent-a-canadian-national-survey
#1
JOURNAL ARTICLE
Dawn Opgenorth, D'Arcy J Duquette, Linda Tyre, Robyn Auld, Kim Crowder, Peggy Gilchrist, Paul J Young, Sean M Bagshaw
PURPOSE: The acceptability of waiver of consent for participation in clinical research in intensive care unit (ICU) settings is uncertain. We sought to survey the Canadian public to assess levels of support, comfort, and acceptability for waived consent for low-risk clinical trials. METHODS: We performed a prospective cross-sectional survey of the Canadian public aged 18 yr or older. The survey was conducted by Ipsos between 19 and 23 November 2020. The survey content was derived from a literature review and in consultation with a patient and family partnership committee...
March 8, 2024: Canadian Journal of Anaesthesia
https://read.qxmd.com/read/38425705/case-study-on-communicating-with-research-ethics-committees-about-minimizing-risk-through-software-an-application-for-record-linkage-in-secondary-data-analysis
#2
JOURNAL ARTICLE
Cason Schmit, Alva O Ferdinand, Theodoros Giannouchos, Hye-Chung Kum
OBJECTIVE: In retrospective secondary data analysis studies, researchers often seek waiver of consent from institutional Review Boards (IRB) and minimize risk by utilizing complex software. Yet, little is known about the perspectives of IRB experts on these approaches. To facilitate effective communication about risk mitigation strategies using software, we conducted two studies with IRB experts to co-create appropriate language when describing a software to IRBs. MATERIALS AND METHODS: We conducted structured focus groups with IRB experts to solicit ideas on questions regarding benefits, risks, and informational needs...
April 2024: JAMIA Open
https://read.qxmd.com/read/38293282/diagnostic-performance-with-and-without-artificial-intelligence-assistance-in-real-world-screening-mammography
#3
JOURNAL ARTICLE
Si Eun Lee, Hanpyo Hong, Eun-Kyung Kim
PURPOSE: To evaluate artificial intelligence-based computer-aided diagnosis (AI-CAD) for screening mammography, we analyzed the diagnostic performance of radiologists by providing and withholding AI-CAD results alternatively every month. METHODS: This retrospective study was approved by the institutional review board with a waiver for informed consent. Between August 2020 and May 2022, 1819 consecutive women (mean age 50.8 ± 9.4 years) with 2061 screening mammography and ultrasound performed on the same day in a single institution were included...
June 2024: European Journal of Radiology Open
https://read.qxmd.com/read/38249837/stakeholder-perspectives-on-data-sharing-from-pragmatic-clinical-trials-unanticipated-challenges-for-meeting-emerging-requirements
#4
JOURNAL ARTICLE
Stephanie R Morain, Juli Bollinger, Kevin Weinfurt, Jeremy Sugarman
INTRODUCTION: Numerous arguments have been advanced for broadly sharing de-identified, participant-level clinical trial data. However, data sharing in pragmatic clinical trials (PCTs) presents ethical challenges. While prior scholarship has described aspects of PCTs that raise distinct considerations for data sharing, there have been no reports of the experiences of those at the leading edge of data-sharing efforts for PCTs, including how these particular challenges have been navigated...
January 2024: Learning Health Systems
https://read.qxmd.com/read/38229113/comparison-of-lung-cancer-occurring-in-fibrotic-versus-non-fibrotic-lung-on-chest-ct
#5
JOURNAL ARTICLE
Mary M Salvatore, Yucheng Liu, Boyu Peng, Hao Yun Hsu, Anjali Saqi, Wei-Yann Tsai, Cheng-Shiun Leu, Sachin Jambawalikar
PURPOSE: Evaluate the behavior of lung nodules occurring in areas of pulmonary fibrosis and compare them to pulmonary nodules occurring in the non-fibrotic lung parenchyma. METHODS: This retrospective review of chest CT scans and electronic medical records received expedited IRB approval and a waiver of informed consent. 4500 consecutive patients with a chest CT scan report containing the word fibrosis or a specific type of fibrosis were identified using the system M*Model Catalyst (Maplewood, Minnesota, U...
January 16, 2024: Journal of Translational Medicine
https://read.qxmd.com/read/38154902/remap-periop-a-randomised-embedded-multifactorial-adaptive-platform-trial-protocol-for-perioperative-medicine-to-determine-the-optimal-enhanced-recovery-pathway-components-in-complex-abdominal-surgery-patients-within-a-us-healthcare-system
#6
JOURNAL ARTICLE
Jennifer Holder-Murray, Stephen A Esper, Alison R Althans, Joshua Knight, Kathirvel Subramaniam, Joseph Derenzo, Ryan Ball, Shawn Beaman, Charles Luke, Luca La Colla, Nicholas Schott, Brian Williams, Elizabeth Lorenzi, Lindsay R Berry, Kert Viele, Scott Berry, Miranda Masters, Katie A Meister, Todd Wilkinson, William Garrard, Oscar C Marroquin, Aman Mahajan
INTRODUCTION: Implementation of enhanced recovery pathways (ERPs) has resulted in improved patient-centred outcomes and decreased costs. However, there is a lack of high-level evidence for many ERP elements. We have designed a randomised, embedded, multifactorial, adaptive platform perioperative medicine (REMAP Periop) trial to evaluate the effectiveness of several perioperative therapies for patients undergoing complex abdominal surgery as part of an ERP. This trial will begin with two domains: postoperative nausea/vomiting (PONV) prophylaxis and regional/neuraxial analgesia...
December 28, 2023: BMJ Open
https://read.qxmd.com/read/38129598/parental-perspectives-on-a-trial-using-waived-informed-consent-at-birth
#7
JOURNAL ARTICLE
Anup C Katheria, Georg M Schmölzer, Brenda Law, Bradley A Yoder, Erin Clark, Walid El-Naggar, Ana Morales, Rebecca A Dorner, Benjamin Mooso, Wade Rich, Farha Vora, Neil Finer
OBJECTIVES: To determine parental perspectives in a trial with waived consent. STUDY DESIGN: Anonymous survey of birth parents with term infants who were randomized using a waiver of consent, administered after infant discharge. RESULTS: 121 (11%) survey responses were collected. Of the 121 responding parents 111 (92%) reported that this form of consent was acceptable and 116 (96%) reported feeling comfortable having another child participate in a similar study...
December 21, 2023: Journal of Perinatology: Official Journal of the California Perinatal Association
https://read.qxmd.com/read/38065583/facility-based-approach-for-the-management-of-acute-st-segment-elevation-myocardial-infarction-with-cardiogenic-shock-in-a-rural-medical-centre-the-durango-model
#8
JOURNAL ARTICLE
Andrew Joseph Carter, Jad Raffoul, Linden Lane, Leah LeSage, Shelley Langenhorst, Matthew Smolin, Michael Dempsey, David Hughes, Michael Gleason, Steven Weiss, William D Anderson
INTRODUCTION: Cardiogenic shock (CS) complicates 5%-15% of cases of acute myocardial infarction (AMI) with inpatient mortality greater than 40%. The implementation of standardised protocols may improve clinical outcomes in patients with AMI-CS. METHODS AND ANALYSIS: The Durango model is a prospective single-centre registry designed to enable early identification of patients with STEMI-CS to facilitate primary reperfusion therapy with a shock team management algorithm in a rural level II heart attack centre...
December 7, 2023: Open Heart
https://read.qxmd.com/read/38024010/the-role-of-ultrasound-features-in-predicting-the-breast-cancer-response-to-neoadjuvant-chemotherapy
#9
JOURNAL ARTICLE
Mohamed T El-Diasty, Ghofran A Ageely, Sara Sawan, Razan M Karsou, Salwa I Bakhsh, Ahmed Alharthy, Yasser Noorelahi, Arwa Badeeb
Background Neoadjuvant chemotherapy (NACT) has become the standard of care for locally advanced breast cancer. This study investigates whether baseline ultrasound features can predict complete pathological response (pCR) after NACT. Methods This retrospective study was approved by the Institutional Review Board of King Abdulaziz University Hospital, Jeddah, Saudi Arabia, with a waiver of informed consent. Records of female patients aged over 18 years with locally advanced breast cancer treated with NACT from 2018 to 2020 were reviewed...
November 2023: Curēus
https://read.qxmd.com/read/38010648/consideration-and-disclosure-of-group-risks-in-genomics-and-other-data-centric-research-does-the-common-rule-need-revision
#10
JOURNAL ARTICLE
Carolyn Riley Chapman, Gwendolyn P Quinn, Heini M Natri, Courtney Berrios, Patrick Dwyer, Kellie Owens, Síofra Heraty, Arthur L Caplan
Harms and risks to groups and third-parties can be significant in the context of research, particularly in data-centric studies involving genomic, artificial intelligence, and/or machine learning technologies. This article explores whether and how United States federal regulations should be adapted to better align with current ethical thinking and protect group interests. Three aspects of the Common Rule deserve attention and reconsideration with respect to group interests: institutional review board (IRB) assessment of the risks/benefits of research; disclosure requirements in the informed consent process; and criteria for waivers of informed consent...
November 27, 2023: American Journal of Bioethics: AJOB
https://read.qxmd.com/read/37993148/stratification-of-risk-for-emergent-intracranial-abnormalities-in-children-with-headaches-a-pediatric-emergency-care-applied-research-network-pecarn-study-protocol
#11
JOURNAL ARTICLE
Daniel S Tsze, Nathan Kuppermann, T Charles Casper, Bradley J Barney, Lawrence P Richer, Danica B Liberman, Pamela J Okada, Claudia R Morris, Sage R Myers, Jane K Soung, Rakesh D Mistry, Lynn Babcock, Sandra P Spencer, Michael D Johnson, Eileen J Klein, Kimberly S Quayle, Dale W Steele, Andrea T Cruz, Alexander J Rogers, Danny G Thomas, Jacqueline M Grupp-Phelan, Tiffani J Johnson, Peter S Dayan
INTRODUCTION: Headache is a common chief complaint of children presenting to emergency departments (EDs). Approximately 0.5%-1% will have emergent intracranial abnormalities (EIAs) such as brain tumours or strokes. However, more than one-third undergo emergent neuroimaging in the ED, resulting in a large number of children unnecessarily exposed to radiation. The overuse of neuroimaging in children with headaches in the ED is driven by clinician concern for life-threatening EIAs and lack of clarity regarding which clinical characteristics accurately identify children with EIAs...
November 22, 2023: BMJ Open
https://read.qxmd.com/read/37961362/parental-perspectives-on-a-trial-using-waived-informed-consent-at-birth
#12
Anup Katheria, Georg Schmolzer, Brenda Law, Bradley Yoder, Erin Clark, Walid El-Naggar, Ana Morales, Rebecca Dorner, Benjamin Mooso, Wade Rich, Farha Vora, Neiil Finer
Objectives To determine parental perspectives in a trial with waived consent. Study Design: Biological parents of non-vigorous term infants randomized using a waiver of consent for a delivery room intervention completed an anonymous survey after discharge. Results 121 survey responses were collected. Most responding parents reported that this form of consent was acceptable (92%) and that they would feel comfortable having another child participate in a similar study (96%). The majority (> 90%) also reported that the information provided after randomization was clear to understand future data collection procedures...
October 30, 2023: Research Square
https://read.qxmd.com/read/37953003/when-ethics-and-the-law-collide-a-multicenter-demonstration-cohort-study-of-pre-exposure-prophylaxis-provision-to-adolescent-men-who-have-sex-with-men-and-transgender-women-in-brazil
#13
JOURNAL ARTICLE
Eliana Miura Zucchi, Laura Ferguson, Laio Magno, Inês Dourado, Dirceu Greco, Dulce Ferraz, Unai Tupinambas, Alexandre Grangeiro
PURPOSE: To explore legal and ethical challenges related to adolescents' participation in human immunodeficiency virus (HIV) research that may affect their best interests. METHODS: We analyzed the ethical principles and legal aspects of the participation of 15-17-year-old men who have sex with men and transgender women in the pre-exposure prophylaxis (PrEP) 1519 study, a PrEP demonstration cohort study in three Brazilian cities. The analyses of ethics review committees' (ERCs) evaluations and court decisions followed ethical and human rights principles...
December 2023: Journal of Adolescent Health
https://read.qxmd.com/read/37899128/towards-a-harmonized-bronchopulmonary-dysplasia-definition-a-study-protocol-for-an-international-delphi-procedure
#14
JOURNAL ARTICLE
Trixie A Katz, Eduardo Bancalari, Sanne J Gordijn, Rosemary D Higgins, Tetsuya Isayama, Erik A Jensen, Martin Offringa, J Jane Pillow, Prakesh S Shah, Roger F Soll, Benjamin Stoecklin, Suzanne M Mugie, Anton H van Kaam, Wes Onland
INTRODUCTION: Bronchopulmonary dysplasia (BPD) remains the most common complication of preterm birth with lifelong consequences. Multiple BPD definitions are currently used in daily practice. Uniformity in defining BPD is important for clinical care, research and benchmarking. The aim of this Delphi procedure is to determine what clinicians and researchers consider the key features for defining BPD. With the results of this study, we hope to advance the process of reaching consensus on the diagnosis of BPD...
October 2023: BMJ Paediatrics Open
https://read.qxmd.com/read/37864663/-out-of-the-blue-a-qualitative-study-exploring-the-experiences-of-women-and-next-of-kin-receiving-unexpected-results-from-bra-strap-research-gene-panel-testing
#15
JOURNAL ARTICLE
April Morrow, Catherine Speechly, Alison Luk Young, Kathy Tucker, Rebecca Harris, Nicola Poplawski, Lesley Andrews, Tu Nguyen Dumont, Judy Kirk, Melissa C Southey, Amanda Willis
In the genomic era, the availability of gene panel and whole genome/exome sequencing is rapidly increasing. Opportunities for providing former patients with new genetic information are also increasing over time and recontacting former patients with new information is likely to become more common. Breast cancer Refined Analysis of Sequence Tests-Risk And Penetrance (BRA-STRAP) is an Australian study of individuals who had previously undertaken BRCA1 and BRCA2 genetic testing, with no pathogenic variants detected...
October 21, 2023: Journal of Genetic Counseling
https://read.qxmd.com/read/37817417/safety-and-outcomes-with-combination-therapy-with-sarilumab-and-baricitinib-for-severe-covid-19-respiratory-infection-in-cancer-patients
#16
JOURNAL ARTICLE
Ana Paula Velez, Guy Handley, Austin Morison, Ju Hee Katzman, Olga Kinkhova, Rod Quiltz, John Greene, Yanina Pasikhova
OBJECTIVES: This study aims to describe the clinical outcomes of combination therapy with sarilumab and baricitinib for severe novel Coronavirus-19 (COVID-19) infection in cancer patients. With this study, we aim to evaluate the role of expanded immunotherapy for severely ill patients with COVID-19 respiratory infections with limited options. The secondary objective is to assess the safety of combination therapy with sarilumab and baricitinib for severe COVID-19 infection. METHODS: This was a retrospective cohort study of patients admitted to Moffitt Cancer Center with COVID-19 infection between January 2020 and April 2022...
2023: Cancer Control: Journal of the Moffitt Cancer Center
https://read.qxmd.com/read/37793926/night-work-season-and-alertness-as-occupational-safety-hazards-in-the-arctic-protocol-for-the-noralert-observational-crossover-study-among-norwegian-process-operators
#17
JOURNAL ARTICLE
Dagfinn Matre, Mikael Sallinen, Andrew J K Phillips, Line Victoria Moen, Kristian Bernhard Nilsen, Fred Haugen
INTRODUCTION: The objective of this study is to determine the effects of night work, Arctic seasonal factors and cold working environments on human functions relevant to safety. The study aims to quantify the contribution of (1) several consecutive night shifts, (2) seasonal variation on sleepiness, alertness and circadian rhythm and (3) whether a computational model of sleep, circadian rhythms and cognitive performance can accurately predict the observed sleepiness and alertness. METHODS AND ANALYSIS: In an observational crossover study of outdoor and indoor workers (n=120) on a three-shift schedule from an industrial plant in Norway (70 °N), measurements will be conducted during the summer and winter...
October 4, 2023: BMJ Open
https://read.qxmd.com/read/37787414/development-of-a-lived-experience-panel-to-inform-the-design-of-embedded-pragmatic-trials-of-dementia-care-interventions
#18
JOURNAL ARTICLE
Antonia V Bennett, Kyra O'Brien, Monica Moreno, Kerry Lanigan, Katie Maslow, Carolyn A Malone, Laura C Hanson, Sheryl Zimmerman, Jason Karlawish, Emily A Largent, María P Aranda, Ladson Hinton, Brenda P Nicholson, Louise Phillips, Sam Fazio, Gary Epstein-Lubow
BACKGROUND: The National Institute on Aging (NIA) Imbedded Pragmatic Alzheimer's Disease and Alzheimer's Related Dementia Clinical Trials (IMPACT) Collaboratory convened a Lived Experience Panel (LEP) to inform the development of research priorities and provide input on conducting embedded pragmatic clinical trials (ePCTs) of dementia care interventions. Given the importance of people with lived experience to dementia research, and the unique considerations of engaging people with dementia, we report on our process for the recruitment, selection, and initial convening of the IMPACT LEP...
October 3, 2023: Journal of the American Geriatrics Society
https://read.qxmd.com/read/37746492/a-wider-scope-of-analysis-on-38-silver-diamine-fluoride
#19
JOURNAL ARTICLE
Haifa AlKhodier, Ghadeer Molla, Nouf AlAjaji, Nuha A Alkanhal, Mona AlSaykhan
This research was conducted to further support previous studies on the effectiveness of 38% silver diamine fluoride on caries arrest. In addition, the number of applications, time between subsequent applications, type of teeth (primary vs. permanent), final restoration following treatment, and the type of restoration, if any, were assessed. It is a retrospective longitudinal study that was conducted using a chart review technique for which a waiver of informed consent was obtained. The research participants' privacy was ensured and protected...
August 2023: Curēus
https://read.qxmd.com/read/37736991/systematic-evaluation-of-imaging-features-of-early-bladder-cancer-using-computed-tomography-performed-before-pathologic-diagnosis
#20
JOURNAL ARTICLE
Rubab F Malik, Renu Berry, Brandyn D Lau, Kiran R Busireddy, Prasan Patel, Sunil H Patel, Elliot K Fishman, Trinity J Bivalacqua, Pamela T Johnson, Farzad Sedaghat
BACKGROUND: Bladder cancer is the sixth most common malignancy in the United States (US). Despite its high prevalence and the significant potential benefits of early detection, no reliable, cost-effective screening algorithm exists for asymptomatic patients at risk. Nonetheless, reports of incidentally identified early bladder cancer on CT/MRI scans performed for other indications are emerging in the literature. This represents a new opportunity for early detection, with over 80 million CT scans performed in the US yearly, 40% of which are abdominopelvic CTs...
September 11, 2023: Tomography: a Journal for Imaging Research
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