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Informed consent

Antoun Nader, Mark C Kendall, David W Manning, Matthew Beal, Rohit Rahangdale, Robert Dekker, Gildasio S De Oliveira, Eric Kamenetsky, Robert J McCarthy
BACKGROUND AND OBJECTIVES: A single-dose adductor canal block can provide postoperative analgesia for patients undergoing total knee arthroplasty (TKA). The purpose of this study was to assess postoperative opioid consumption after ultrasound-guided single-injection bupivacaine compared with saline adductor canal block for patients undergoing TKA. METHODS: After institutional review board approval, written informed consent was obtained from patients (>18 years old) undergoing elective TKA...
November 2016: Regional Anesthesia and Pain Medicine
Hye Jin Yoo, Sung Hwan Hong, Hye Yeon Oh, Ja-Young Choi, Hee Dong Chae, Joong Mo Ahn, Heung Sik Kang
Purpose To determine the agreement of fat-suppressed (FS) fluid-attenuated inversion-recovery (FLAIR) magnetic resonance (MR) imaging and contrast material-enhanced (CE) T1-weighted MR imaging for the assessment of peripatellar synovitis. Materials and Methods The institutional review board approved this retrospective study and waived the requirement for patient informed consent. Thirty-three patients with knee pain underwent 3-T MR imaging. The protocol consisted of routine clinical sequences followed by the FLAIR FS sequence (inversion time, 2200 msec) and CE T1-weighted imaging...
October 24, 2016: Radiology
Alexis Klengel, Patrick Stumpp, Steffen Klengel, Ina Böttger, Nadja Rönisch, Thomas Kahn
Purpose To compare single-shot echo-planar diffusion-weighted imaging-derived apparent diffusion coefficient (ADC) maps with fat-saturated (FS) proton density (PD)-weighted turbo spin-echo (TSE) imaging in the detection of bone marrow lesions (BMLs) after knee trauma. Materials and Methods Institutional review board approval was obtained from Leipzig University. Written informed consent was waived. Three radiologists retrospectively re-examined 97 consecutive patients with reported knee trauma who underwent 1...
October 24, 2016: Radiology
Sonia Merino, Nekane Ibarluzea, Hiart Maortua, Begoña Prieto, Idoia Rouco, Maria-Asunción López-Aríztegui, Maria-Isabel Tejada
Fragile X-associated tremor/ataxia syndrome (FXTAS) and fragile X-associated primary ovarian insufficiency (FXPOI) are definitely related to the fragile X mental retardation 1 (FMR1) premutation (PM). Additional medical problems have also been associated with the PM, such as fibromyalgia, endocrine, and psychiatric disorders. To improve our understanding in the field, we reviewed all PM carriers and their reasons for any medical referrals from 104 fragile X families molecularly diagnosed in our laboratory and living in the Spanish Basque Country...
October 21, 2016: Genes
Nancy M Heddle, Richard J Cook, Donald M Arnold, Yang Liu, Rebecca Barty, Mark A Crowther, P J Devereaux, Jack Hirsh, Theodore E Warkentin, Kathryn E Webert, David Roxby, Magdalena Sobieraj-Teague, Andrea Kurz, Daniel I Sessler, Priscilla Figueroa, Martin Ellis, John W Eikelboom
Background Randomized, controlled trials have suggested that the transfusion of blood after prolonged storage does not increase the risk of adverse outcomes among patients, although most of these trials were restricted to high-risk populations and were not powered to detect small but clinically important differences in mortality. We sought to find out whether the duration of blood storage would have an effect on mortality after transfusion in a general population of hospitalized patients. Methods In this pragmatic, randomized, controlled trial conducted at six hospitals in four countries, we randomly assigned patients who required a red-cell transfusion to receive blood that had been stored for the shortest duration (short-term storage group) or the longest duration (long-term storage group) in a 1:2 ratio...
October 24, 2016: New England Journal of Medicine
V Villamil, N A Méndez Aguirre, T Martínez Menchón, O Girón Vallejo, M Fernández Ibieta, P Y Reyes Ríos, I Martínez Castaño, J Rojas Ticona, A Sánchez Sánchez, L Hernández Sánchez, J I Ruiz Jiménez
INTRODUCTION: Segmental cervico facial hemangiomas are defined as those longer than 5 cm, affecting a specific facial area. These lesions can be eventually associated with the PHACE syndrome. Our aim is to propose neonatal treatment with propranolol, showing its efficacy/safety, given the scarce evidence on its neonatal use. CLINICAL OBSERVATION: After written informed consent, four patients with segmental facial hemangioma were treated with propranolol in the neonatal period...
April 20, 2016: Cirugía Pediátrica: Organo Oficial de la Sociedad Española de Cirugía Pediátrica
Md Nazmul Hasan, Nur Kabidul Azam, Md Nasir Ahmed, Akinori Hirashima
Snakebite is the single most important toxin-related injury, causing substantial mortality in many parts of the Africa, Asia and the Americas. Incidence of snakebite is usually recorded in young people engaged in active physical work in rural areas. The various plant parts used to treat snakebite included whole plant, leaves, barks, roots and seeds. Most bites in Bangladesh are recorded between May and October with highest number in June. Lower and upper limbs are most common sites of snakebite, but it may happen in other sites as well...
October 2016: Journal of Traditional and Complementary Medicine
Jody Lyneé Madeira, Barbara Andraka-Christou
Though intended to educate patients on the risks, benefits, side effects and alternatives within medical treatment, informed consent documents may have unanticipated consequences for patients. Patients may regard these forms as little more than a ritual to access treatment. Or patients may perceive that these forms exist to protect doctors rather than to contribute to a meaningful, patient-protective educational interaction. To rehabilitate the informed consent project, this essay considers the baggage that informed consent documents have acquired through practical use, explores patients' and providers' lived experience of informed consent, and considers whether a multimedia consent application would be a viable solution to the various difficulties that currently erode perceptions of and confidence in the informed consent process...
April 2016: Journal of Law and the Biosciences
C Samanci, D Alis, F E Ustabasioglu, E Ozmen, A K Ucar, M Aslan, H A Habibi, S Bakan, B Ozcabi, S O Evliyaoğlu, I Adaletli
PURPOSE: The purpose of this study was to assess the diagnostic value of measuring the apparent diffusion coefficient (ADC) of ovarian stroma in polycystic ovary syndrome (PCOS). MATERIALS AND METHODS: This study was approved by the institutional review board and informed consent was obtained from each women. A total of 17 women (mean age, 22.2 years±5.1 [SD]; range, 16-33 years) with a diagnosis of PCOS according to the Androgen Excess and PCOS Society criteria and 18 healthy women (mean age, 22...
October 20, 2016: Diagnostic and Interventional Imaging
M Alexander, J B Burch, S E Steck, C-F Chen, T G Hurley, P Cavicchia, N Shivappa, J Guess, H Zhang, S D Youngstedt, K E Creek, S Lloyd, K Jones, J R Hébert
PURPOSE: Colorectal cancer (CRC) is one of the most common and preventable forms of cancer but remains the second leading cause of cancer-related death. Colorectal adenomas are precursor lesions that develop in 70-90 % of CRC cases. Identification of peripheral biomarkers for adenomas would help to enhance screening efforts. This exploratory study examined the methylation status of 20 candidate markers in peripheral blood leukocytes and their association with adenoma formation. METHODS: Patients recruited from a local endoscopy clinic provided informed consent and completed an interview to ascertain demographic, lifestyle, and adenoma risk factors...
October 22, 2016: International Journal of Colorectal Disease
Takuya Sekiguchi, Yoshihiro Hagiwara, Haruki Momma, Masahiro Tsuchiya, Kaoru Kuroki, Kenji Kanazawa, Yutaka Yabe, Masashi Koide, Nobuyuki Itaya, Eiji Itoi, Ryoichi Nagatomi
PURPOSE: Serious arm injuries in youth baseball players have been increasing. Though a breakage in the kinetic chain could affect arm injuries, an association between arm injuries and insufficient support of the trunk and lower extremities is not well understood. The purpose of this study was to investigate the association of low back and knee pain with elbow and/or shoulder complaints among youth baseball players. METHODS: A self-administered questionnaire and document informed consent were mailed to youth athletes belonging to the Miyagi Amateur Sports Association...
October 22, 2016: Knee Surgery, Sports Traumatology, Arthroscopy: Official Journal of the ESSKA
Sonia Johnson, Luke Sheridan Rains, Steven Marwaha, John Strang, Thomas Craig, Tim Weaver, Paul McCrone, Michael King, David Fowler, Stephen Pilling, Louise Marston, Rumana Z Omar, Meghan Craig, Mark Hinton
BACKGROUND: Around 35-45 % of people in contact with services for a first episode of psychosis are using cannabis. Cannabis use is associated with delays in remission, poorer clinical outcomes, significant increases in the risk of relapse, and lower engagement in work or education. While there is a clear need for effective interventions, so far only very limited benefits have been achieved from psychological interventions. Contingency management (CM) is a behavioural intervention in which specified desired behavioural change is reinforced through financial rewards...
October 22, 2016: Trials
Jie Meng, Lijing Zhu, Li Zhu, Huanhuan Wang, Song Liu, Jing Yan, Baorui Liu, Yue Guan, Yun Ge, Jian He, Zhengyang Zhou, Xiaofeng Yang
BACKGROUND: To explore the role of apparent diffusion coefficient (ADC) histogram shape related parameters in early assessment of treatment response during the concurrent chemo-radiotherapy (CCRT) course of advanced cervical cancers. METHODS: This prospective study was approved by the local ethics committee and informed consent was obtained from all patients. Thirty-two patients with advanced cervical squamous cell carcinomas underwent diffusion weighted magnetic resonance imaging (b values, 0 and 800 s/mm(2)) before CCRT, at the end of 2nd and 4th week during CCRT and immediately after CCRT completion...
October 22, 2016: Radiation Oncology
Emily F M Fitzpatrick, Alexandra L C Martiniuk, Heather D'Antoine, June Oscar, Maureen Carter, Elizabeth J Elliott
BACKGROUND: When conducting research with Indigenous populations consent should be sought from both individual participants and the local community. We aimed to search and summarise the literature about methods for seeking consent for research with Indigenous populations. METHODS: A systematic literature search was conducted for articles that describe or evaluate the process of seeking informed consent for research with Indigenous participants. Guidelines for ethical research and for seeking consent with Indigenous people are also included in our review...
October 22, 2016: BMC Medical Ethics
David J Pulford, Philipp Harter, Anne Floquet, Catherine Barrett, Dong Hoon Suh, Michael Friedlander, José Angel Arranz, Kosei Hasegawa, Hiroomi Tada, Peter Vuylsteke, Mansoor R Mirza, Nicoletta Donadello, Giovanni Scambia, Toby Johnson, Charles Cox, John K Chan, Martin Imhof, Thomas J Herzog, Paula Calvert, Pauline Wimberger, Dominique Berton-Rigaud, Myong Cheol Lim, Gabriele Elser, Chun-Fang Xu, Andreas du Bois
BACKGROUND: The focus on translational research in clinical trials has the potential to generate clinically relevant genetic data that could have importance to patients. This raises challenging questions about communicating relevant genetic research results to individual patients. METHODS: An exploratory pharmacogenetic analysis was conducted in the international ovarian cancer phase III trial, AGO-OVAR 16, which found that patients with clinically important germ-line BRCA1/2 mutations had improved progression-free survival prognosis...
October 21, 2016: BMC Medical Ethics
Srikanth Boddu, Marc Dinkin, Maria Suurna, Kelly Hannsgen, Xem Bui, Athos Patsalides
OBJECTIVE: Evaluate the role of venous sinus stenting in the treatment of pulsatile tinnitus among patients with Idiopathic Intracranial Hypertension (IIH) and significant venous sinus stenosis. SUBJECTS AND METHODS: A written informed consent approved by the Weill Cornell institutional review board was signed and obtained from the study participants. Thirty-seven consecutive patients with IIH and venous sinus stenosis who were treated with venous sinus stenting between Jan...
2016: PloS One
Neena Kapoor, Daniel M Blumenthal, Stacy E Smith, Ivan K Ip, Ramin Khorasani
Purpose To determine whether there were sex differences in full professorship after accounting for factors known to influence academic advancement. Materials and Methods Institutional review board approval was obtained for this HIPAA-compliant study, with waiver of informed consent. In this cross-sectional study, the authors used a comprehensive 2014 physician database (5089 academic radiologists, inclusive of all U.S. academic radiologists in 2014; 11.3% of all U.S. radiologists) containing information on physician age, years since residency, National Institutes of Health funding, scientific publications (first or last author and total), clinical trial investigation, and clinical volume measured according to 2013 Medicare reimbursement...
October 21, 2016: Radiology
Marilyn J Hammer, Patricia Eckardt, Margaret Barton-Burke
The primary goal of the thousands of registered trials in cancer research is to extend survival. With evaluation of efficacy, safety, and tolerability, healthcare providers must ensure that the principles described in the Belmont Report are upheld and that patients are truly informed when signing a consent form. In this article, two cases are highlighted, and reasons for participating in clinical trials are discussed. Challenges, such as healthcare literacy, patients' dedication to their healthcare providers, and choosing between multiple trials, are also explored...
November 1, 2016: Oncology Nursing Forum
Michael O Childress, José A Ramos-Vara, Audrey Ruple
OBJECTIVE To determine the effect of prednisone omission from a multidrug chemotherapy protocol on outcome in dogs with peripheral nodal lymphomas. DESIGN Single-center, nonblinded, parallel-group, randomized, controlled trial. ANIMALS 40 client-owned dogs with a histopathologically confirmed diagnosis of peripheral nodal lymphoma and an expected survival time of > 4 weeks with treatment. PROCEDURES Treatment consisted of a combination of L-asparaginase, cyclophosphamide, doxorubicin, vincristine, and prednisone (L-CHOP) or an identical protocol except for the omission of prednisone (L-CHO)...
November 1, 2016: Journal of the American Veterinary Medical Association
Jayita De, Anne P F Wand, Peter I Smerdely, Glenn E Hunt
OBJECTIVE: To measure the diagnostic accuracy of the 4A's test in screening for delirium in geriatric inpatients from culturally diverse backgrounds. METHODS: A prospective study was conducted with patients admitted to the geriatric and orthogeriatric services of a tertiary teaching hospital. Consenting participants aged 65 years and over were screened for delirium with the 4AT by nursing staff within 72 h of admission. The diagnosis of delirium was made separately by expert assessors, responsible for the participant's clinical care, blinded to the 4AT score, within 30 min of the 4AT assessment using the DSM 5 criteria and the Confusion Assessment Method...
October 20, 2016: International Journal of Geriatric Psychiatry
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