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Clinical ethics evaluation

Silvia Librada Flores, Emilio Herrera Molina, Fátima Díaz Díez, María José Redondo Moralo, Cristina Castillo Rodríguez, Kathleen McLoughlin, Julian Abel, Tamen Jadad Garcia, Miguel Ángel Lucas Díaz, Inmaculada Trabado Lara, María Dolores Guerra-Martín, María Nabal
BACKGROUND: End-of-life needs can be only partly met by formalized health and palliative care resources. This creates the opportunity for the social support network of family and community to play a crucial role in this stage of life. Compassionate communities can be the missing piece to a complete care model at the end of life. OBJECTIVE: The main objective of this study is to evaluate the REDCUIDA (Redes de Cuidados or Network of Care) intervention for the development and management of networks of care around people with advanced disease or at the end of life...
October 12, 2018: JMIR Research Protocols
Kyeore Bae, Eunseok Kim, Jeong June Choi, Mi Kyung Kim, Hwa-Seung Yoo
Although anticancer traditional Korean medicine treatment (ACTKMT) is widely applied to patients with cancer together with, or in place of, conventional cancer treatment in Korea, the cohort evidence on its clinical effects is lacking. Therefore, this prospective cohort study is designed to evaluate the effect of ACTKMT on the survival and the clinical outcomes for patients being treated at an integrative oncology clinic.This is a single center, prospective cohort study of patients within 1 year after the diagnosis of primary lung, breast, gastric, colorectal, hepatic, uterine, or ovarian cancer...
October 2018: Medicine (Baltimore)
Zhimin Li, Jun Gao, Tianyu Wang, Yongning Li
To investigate effects of microvascular decompression (MVD) surgical treatment on hemifacial spasm.A retrospective analysis of 320 adult patients (95 male cases, 29.7% and 225 female cases, 70.3%) with hemifacial spasm treated by surgery was conducted between February 2007 to June 2016, with an average age of 49.3 years and average disease course of 4.9 years. All the 320 cases of patients received MVD. After surgery, all patients were followed up for an average of 2.3 years. Surgical effects were evaluated based on the patients' symptoms and signs...
October 2018: Medicine (Baltimore)
Ara Tekian, Martin Borhani, Sarette Tilton, Eric Abasolo, Yoon Soo Park
BACKGROUND: This study examines the alignment of quantitative and qualitative assessment data in end-of-rotation evaluations using longitudinal cohorts of residents progressing throughout the five-year general surgery residency. METHODS: Rotation evaluation data were extracted for 171 residents who trained between July 2011 and July 2016. Data included 6069 rotation evaluations forms completed by 38 faculty members and 164 peer-residents. Qualitative comments mapped to general surgery milestones were coded for positive/negative feedback and relevance...
September 29, 2018: American Journal of Surgery
Marcello Ienca, Agata Ferretti, Samia Hurst, Milo Puhan, Christian Lovis, Effy Vayena
Big data trends in biomedical and health research enable large-scale and multi-dimensional aggregation and analysis of heterogeneous data sources, which could ultimately result in preventive, diagnostic and therapeutic benefit. The methodological novelty and computational complexity of big data health research raises novel challenges for ethics review. In this study, we conducted a scoping review of the literature using five databases to identify and map the major challenges of health-related big data for Ethics Review Committees (ERCs) or analogous institutional review boards...
2018: PloS One
Ruud A F Verhees, Wybo Dondorp, Carel Thijs, G J Dinant, André Knottnerus
The effectiveness of influenza vaccination in the elderly has long been a topic of debate, fueled by the absence of direct evidence on its effect on mortality. It is argued that new placebo-controlled trials should be undertaken to resolve this uncertainty. However, such trials may be ethically questionable. We provide an overview of the ethical challenges of an influenza vaccine efficacy trial designed to evaluate mortality in the elderly. An important condition in the justification of a trial is the existence of genuine uncertainty regarding the answer to a research question...
September 6, 2018: Nederlands Tijdschrift Voor Geneeskunde
Brian Holoyda, Renee Sorrentino, Susan Hatters Friedman, John Allgire
Bestiality, or human-animal intercourse, has been a concern of the legal and mental health communities for many years. Ancient legal codes delineated punishments for those who engaged in the behavior, denoting a moral and general societal concern surrounding bestiality dating to ancient times. Despite this longstanding interest in and legal efforts to punish humans for having sex with animals, there has been little research on the behavior. Current available research has largely been siloed based on the populations studied, making it difficult to render any firm conclusions about bestiality's prevalence, frequency, and the risk posed by those who have sex with animals...
October 10, 2018: Behavioral Sciences & the Law
Ayse Coskun Beyan, Yucel Demiral, Arif Cimrin
OBJECTIVE: Occupational diseases (OD) are among the most significant issues of work life, with economic, medical, social, and ethical aspects. The majority of studies concerning OD focus on the causes or medical outcomes of OD. There are a limited number of studies investigating the social and economic impacts of being diagnosed with an OD. One of the important social aspects of OD is the employability of workers after an OD diagnosis. The aim of this study is to evaluate the changes in employment status after the OD diagnosis process...
October 10, 2018: Journal of Occupational Health
Helen Chester, Paul Clarkson, Linda Davies, Jane Hughes, Muhammad Saiful Islam, Narinder Kapur, Martin Orrell, Julie Peconi, Rosa Pitts, Fiona Poland, Ian Russell, David Challis
BACKGROUND: There is a growing need for an evidence-based approach to home support for people with dementia and their carers following diagnosis but research on the effectiveness and cost-effectiveness of different approaches is sparse. The Dementia Early Stage Cognitive Aids New Trial (DESCANT) will evaluate the clinical and cost-effectiveness of a range of memory aids, training and support to people with mild to moderate dementia and their carers at home and compares that intervention with treatment as usual...
October 10, 2018: Trials
Fei Gao, Donglin Zeng, Helen Wei, Xuena Wang, Joseph G Ibrahim
In many clinical studies, patients may experience the same type of event of interest repeatedly over time. However, the assessment of treatment effects is often complicated by the rescue medication uses due to ethical reasons. For example, in the motivating trial in studying the Immune Thrombocytopenia (ITP), when the interest lies in evaluating the treatment benefit of investigational product (IP) on reducing patient's repeated bleeding, rescue medication such as platelet transfusions may be allowed to raise platelet counts...
August 2018: Statistics in Biosciences
Elza Padilha Ferri, Camila de Barros Gallo, Clery Saad Abboud, Wellington Hideaki Yanaguizawa, Anna Carolina Ratto Tempestini Horliana, Daniela de Fatima Teixeira da Silva, Christiane Pavani, Sandra Kalil Bussadori, Fabio Daumas Nunes, Raquel Agnelli Mesquita-Ferrari, Kristianne Porta Santos Fernandes, Maria Fernanda Setúbal Destro Rodrigues
INTRODUCTION: Oral lichen planus (OLP) is an idiopathic chronic mucocutaneous disease with a wide range of clinical manifestations, including white reticular patches, erosive/ulcerative and atrophic lesions, both associated with intense symptomatology. Topical corticosteroids are commonly used as standard therapy. However, patients frequently present relapses after the discontinuation of treatment as well as developing resistance to corticosteroid therapy. Photobiomodulation (PBM) has been shown to be a potential therapeutic tool to treat inflammatory disorders, including OLP...
October 8, 2018: BMJ Open
Laurent Van Camp, Paul Deak, Marc Haspeslagh, Kenneth Coenegrachts
OBJECTIVE: To evaluate a dynamic contrast-enhanced CT-protocol and compare this method with standard of care monophasic portovenous CT for detection of colorectal liver metastases. MATERIALS AND METHODS: A dynamic contrast-enhanced CT protocol was developed to detect liver metastasis in patients suffering from colorectal cancer, in clinical practice. The study was approved by the Hospital Ethics Committee. Written informed consent was obtained from all patients...
October 2018: European Journal of Radiology
Xiao Li, Qi Zhao, Jingshang Wang, Jisheng Wang, Hengheng Dai, Haisong Li, Bin Wang
INTRODUCTION: Diabetes mellitus erectile dysfunction (DMED) is a common complication of long-term hyperglycemia. With the increasing of diabetic patients, the number of DMED patients is gradually growing up, which has a serious impact on the quality of life of patients. PDE5 inhibitors have good clinical efficacy in DMED patients. This study is designed to evaluate the efficacy and safety of PDE5 inhibitors in DMED patients. METHODS AND ANALYSIS: We will systematically search all randomized controlled trials (RCTs) by electronic and manual search...
October 2018: Medicine (Baltimore)
Katherine Morton, Sarah Voss, Joy Adamson, Helen Baxter, Karen Bloor, Janet Brandling, Sean Cowlishaw, Tim Doran, Andrew Gibson, Nils Gutacker, Dan Liu, Sarah Purdy, Paul Roy, Christopher Salisbury, Arabella Scantlebury, Anu Vaittinen, Rose Watson, Jonathan Richard Benger
INTRODUCTION: Pressure continues to grow on emergency departments in the UK and throughout the world, with declining performance and adverse effects on patient outcome, safety and experience. One proposed solution is to locate general practitioners to work in or alongside the emergency department (GPED). Several GPED models have been introduced, however, evidence of effectiveness is weak. This study aims to evaluate the impact of GPED on patient care, the primary care and acute hospital team and the wider urgent care system...
October 3, 2018: BMJ Open
Alexander Sidelmann Christensen, Heidi Storgaard, Sofie Hædersdal, Torben Hansen, Filip Krag Knop, Tina Vilsbøll
INTRODUCTION: Hepatocyte nuclear factor 1α (HNF1A)-diabetes is the most common monogenetic subtype of diabetes. Strict glycaemic control is crucial for a good prognosis for patients with HNF1A-diabetes. Sulfonylurea (SU) is used as a first-line therapy in HNF1A-diabetes. However, SU therapy may be problematic as it confers a high risk of hypoglycaemia. We hypothesise that low dose of SU in combination with a dipeptidyl peptidase 4 inhibitor provides a safer and more efficacious treatment in patients with HNF1A-diabetes compared with SU as monotherapy...
October 3, 2018: BMJ Open
Michael R Rose, Sam Norton, Chiara Vari, Victoria Edwards, Lance McCracken, Christopher D Graham, Aleksandar Radunovic, Trudie Chalder
INTRODUCTION: In adults, muscle disease (MD) is often a chronic long-term condition with no definitive cure. It causes wasting and weakness of the muscles resulting in a progressive decline in mobility, alongside other symptoms, and is typically associated with reduced quality of life (QoL). Previous research suggests that a psychological intervention, and in particular Acceptance and Commitment Therapy (ACT), may help improve QoL in MD. ACT is a newer type of cognitive behavioural treatment that aims to improve QoL by virtue of improvement in a process called psychological flexibility...
October 3, 2018: BMJ Open
Lina Davies Forsman, Katarina Niward, Yi Hu, Rongrong Zheng, Xubin Zheng, Ran Ke, Weiping Cai, Chao Hong, Yang Li, Yazhou Gao, Jim Werngren, Jakob Paues, Johanna Kuhlin, Ulrika S H Simonsson, Erik Eliasson, Jan-Willem Alffenaar, Mikael Mansjö, Sven Hoffner, Biao Xu, Thomas Schön, Judith Bruchfeld
INTRODUCTION: Individualised treatment through therapeutic drug monitoring (TDM) may improve tuberculosis (TB) treatment outcomes but is not routinely implemented. Prospective clinical studies of drug exposure and minimum inhibitory concentrations (MICs) in multidrug-resistant TB (MDR-TB) are scarce. This translational study aims to characterise the area under the concentration-time curve of individual MDR-TB drugs, divided by the MIC for Mycobacterium tuberculosis isolates, to explore associations with markers of treatment progress and to develop useful strategies for clinical implementation of TDM in MDR-TB...
October 4, 2018: BMJ Open
Bruno Bonnechère, Bart Jansen, Inès Haack, Lubos Omelina, Véronique Feipel, Serge Van Sint Jan, Massimo Pandolfo
BACKGROUND: Friedreich ataxia (FRDA) is a disease with neurological and systemic involvement. Clinical assessment tools commonly used for FRDA become less effective in evaluating decay in patients with advanced FRDA, particularly when they are in a wheelchair. Further motor worsening mainly impairs upper limb function. In this study, we tested if serious games (SG) developed for rehabilitation can be used as an assessment tool for upper limb function even in patients with advanced FRDA...
October 4, 2018: Journal of Neuroengineering and Rehabilitation
Clare Kreiter, Marie O'Shea, Catherine Bruen, Paul Murphy, Teresa Pawlikowska
While medical educators appear to believe that admission to the medical school should be governed, at least in part, by human judgement, there has been no systematic presentation of evidence suggesting it improves selection. From a fair testing perspective, legal, ethical, and psychometric considerations, all dictate that the scientific evidence regarding human judgement in selection should be given consideration. To investigate the validity of using human judgements in admissions, multi-disciplinary meta-analytic research evidence from the wider literature is combined with studies from within medical education to provide evidence regarding the fairness and validity of using interviews and holistic review in medical school admissions...
December 2018: Medical Education Online
Joan Melendez-Munoz, Meirav Braverman, Anna Rosamilia, Natharnia Young, Alison Leitch, Joseph K-S Lee
INTRODUCTION: Single incision slings (SIS) were introduced in an attempt to decrease the complications associated with retropubic and transobturator slings. The TVT Abbrevo is a modification of the TVT-O with a reduced length and less immediate postoperative pain. The Miniarc SIS has been shown to be equivalent to outside-in transobturator sling, Monarc at 12 month follow-up. OBJECTIVE: To evaluate objective and subjective outcomes of MiniArc SIS and TVT Abbrevo midurethral sling (MUS) in women with stress urinary incontinence...
September 27, 2018: European Journal of Obstetrics, Gynecology, and Reproductive Biology
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