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https://www.readbyqxmd.com/read/28650924/comparison-of-approaches-for-notification-and-authorization-in-pragmatic-clinical-research-evaluating-commonly-used-medical-practices
#1
Kevin P Weinfurt, Juli M Bollinger, Kathleen M Brelsford, Martina Bresciani, Zachary Lampron, Li Lin, Rachel J Topazian, Jeremy Sugarman
BACKGROUND: For pragmatic clinical research comparing commonly used treatments, questions exist about if and how to notify participants about it and secure their authorization for participation. OBJECTIVE: To determine how patients react when they seek clinical care and encounter one of several different pragmatic clinical research studies. RESEARCH DESIGN: In an online survey using a between-subjects experimental design, respondents read and responded to 1 of 24 hypothetical research scenarios reflecting different types of studies and approaches to notification and authorization (eg, general notification, oral consent, written consent)...
June 23, 2017: Medical Care
https://www.readbyqxmd.com/read/28649453/informed-consent-for-next-generation-nucleotide-sequencing-studies-aiding-communication-between-participants-and-investigators
#2
Rhonda G Kost, Stephen M Poppel, Barry S Coller
INTRODUCTION: Obtaining informed consent from prospective participants for research studies that include next-generation nucleotide sequencing (NGS) presents significant challenges because of the need to explain all the potential implications of participating, including the possible return of "incidental" findings, in easy-to-understand language. METHODS AND RESULTS: After reviewing the consent processes at other institutions, we decided to supplement the protocol-specific informed consent form with the following: (1) a short pamphlet for the prospective participant that includes a series of questions that she or he is encouraged to ask the investigator, and (2) a more detailed companion guide for investigators to help them develop simple-language answers to the questions...
April 2017: Journal of clinical and translational science
https://www.readbyqxmd.com/read/28649418/facilitating-access-to-health-research-through-a-participatory-research-register-a-feasibility-study-in-outpatient-clinics
#3
Verity A Leach, John D McGeagh, Ruta Margelyte, Niamh M Redmond, Axel Walther, Sabi Redwood, Richard M Martin, Jenny L Donovan
BACKGROUND: A research register (Reach West) has been established to facilitate recruitment of people and patients to health-related research. We conducted a prospective feasibility study to investigate the practicality of recruiting through outpatient clinics. METHODS: Patients over 18 years of age attending dental, eye or oncology outpatient clinics in an acute hospital in the West of England were provided with the opportunity to participate in Reach West. In Phase I, recruitment packs were handed to clinic attendees who could place completed consent forms in secure drop-box or return them later on-line or by post...
2018: Pilot and Feasibility Studies
https://www.readbyqxmd.com/read/28649065/poor-adherence-with-ace-inhibitors-is-a-risk-factor-of-cva-with-oral-hypoglycemic-agents-in-diabetic-patients
#4
Muhammad Tariq Aftab, Hasnain Abbas Dharamshi, Ahmed Faraz, Saba Shakeel, Osama Shakeel
Poor adherence with medicine declines the clinical outcome of pharmacotherapy. It may carry serious sequelae especially in case of antihypertensive drugs like cerebrovascular accident (CVA). This study has been planned to find the association of poor adherence with anti-hypertensive with CVA in diabetic and non- diabetic patients. One hundred CVA patients who were admitted through Emergency in Abbasi Shaheed hospital, a tertiary care hospital in Karachi, were recruited from Jun 2013 till Dec 2013. The criteria of inclusion was, diagnosed case of CVA, with primary hypertension, availability of patient's therapeutic record, consent of the patient or legal successor/heir...
March 2017: Pakistan Journal of Pharmaceutical Sciences
https://www.readbyqxmd.com/read/28648434/guidance-on-reuse-of-cardio-vascular-catheters-and-devices-in-india-a-consensus-document
#5
Aditya Kapoor, Amit Vora, Gita Nataraj, Sundeep Mishra, Prafulla Kerkar, C N Manjunath
Reuse of medical device is accepted worldwide. Benefits of reuse include not only cost saving but a favorable impact on environment. However, certain requirements should be met for reuse to be safe and effective. The devices, which can be reused, should be clearly defined, a meticulous process for dis-infection and sterilization followed and its functionality ascertained before use. Further, an appropriate consent should be obtained where necessary and the cost saving entailed should be directly passed on to the patient...
May 2017: Indian Heart Journal
https://www.readbyqxmd.com/read/28648314/direct-cost-for-treating-chronic-kidney-disease-at-an-outpatient-setting-of-a-tertiary-hospital-evidence-from-a-cross-sectional-study
#6
Rajiv Ahlawat, Pramil Tiwari, Sanjay D'Cruz
BACKGROUND: Chronic kidney disease (CKD) has a high morbidity and mortality in developing countries. And this burden is also increasing rapidly in India. Unaffordability due to high cost of medication and hemodialysis remains one of the major barriers in the successful treatment of CKD. OBJECTIVES: To determine the direct cost involved in treating CKD at an outpatient department of a public tertiary care hospital. METHODS: This cross-sectional study was carried out at a public tertiary care hospital...
May 2017: Value in Health Regional Issues
https://www.readbyqxmd.com/read/28648148/debt-counselling-for-depression-in-primary-care-an-adaptive-randomised-controlled-pilot-trial-decoder-study
#7
Mark B Gabbay, Adele Ring, Richard Byng, Pippa Anderson, Rod S Taylor, Caryn Matthews, Tirril Harris, Vashti Berry, Paula Byrne, Elliot Carter, Pam Clarke, Laura Cocking, Suzanne Edwards, Richard Emsley, Mauro Fornasiero, Lucy Frith, Shaun Harris, Peter Huxley, Siw Jones, Peter Kinderman, Michael King, Liv Kosnes, Daniel Marshall, Dave Mercer, Carl May, Debbie Nolan, Ceri Phillips, Tim Rawcliffe, Alexandra V Sardani, Elizabeth Shaw, Sam Thompson, Jane Vickery, Brian Wainman, Mark Warner
BACKGROUND: Depression and debt are common in the UK. Debt Counselling for Depression in Primary Care: an adaptive randomised controlled pilot trial (DeCoDer) aimed to assess the clinical effectiveness and cost-effectiveness of the addition of a primary care debt counselling advice service to usual care for patients with depression and debt. However, the study was terminated early during the internal pilot trial phase because of recruitment delays. This report describes the rationale, methods and findings of the pilot study, and implications for future research...
June 2017: Health Technology Assessment: HTA
https://www.readbyqxmd.com/read/28648121/spontaneous-otoacoustic-emission-recordings-during-contralateral-pure-tone-activation-of-medial-olivocochlear-reflex
#8
E Bulut, L Öztürk
We hypothesized that cochlear frequency discrimination occurs through medial olivocochlear efferent (MOCE)-induced alterations in outer hair cell (OHC) electromotility, which is independent from basilar membrane traveling waves. After obtaining informed consent, volunteers with normal hearing (n = 10; mean age: 20.6 ± 1.2 years) and patients with unilateral deafness (n = 10; mean age: 30.2 ± 17.9 years) or bilateral deafness (n = 8; mean age: 30.7 ± 13.8 years) underwent a complete physical and audiological examination, and audiological tests including transient evoked otoacoustic emission and spontaneous otoacoustic emission (TEOAE and SOAE, respectively)...
June 26, 2017: Physiology International
https://www.readbyqxmd.com/read/28648100/the-replacement-of-assertive-outreach-services-by-reinforcing-local-community-teams-a-replication-study-reporting-comparative-outcomes-and-patient-reported-experience
#9
Mike Firn, Maria Alonso-Vicente, Dieneke Hubbeling, Jess Holley, Sarah Jane White, Ben Jones
BACKGROUND: This is the third in a series of papers on patient outcomes and other consequences of the withdrawal of specialist assertive outreach (AO) teams. We previously reported positive outcomes for patients receiving a less intensive service at up to four years, but had not systematically interviewed patients. AIMS: To test the generalizability of earlier findings through replication in another service. To complement the analysis of service utilisation with patient reported experience between the two treatment models...
June 24, 2017: Journal of Mental Health
https://www.readbyqxmd.com/read/28647725/percutaneous-coronary-intervention-patients-and-cardiologists-experiences-of-the-informed-consent-process-in-northern-england-a-qualitative-study
#10
Joy Probyn, Joanne Greenhalgh, Janet Holt, Dwayne Conway, Felicity Astin
OBJECTIVE: Informed consent is central to ethical medical practice, but little is known about how the process takes place in clinical practice. Percutaneous coronary intervention (PCI) is a common revascularisation procedure. Studies report that patients overestimate benefits, forget the risks and are unaware of alternative treatments. The aim of this study was to describe PCI patients' and cardiologists' experiences of the informed consent process in acute care settings. DESIGN/SETTING/PARTICIPANTS: A qualitative study with a maximum variation sample of elective and acute PCI patients and cardiologists taking their consent, recruited from a district general hospital and tertiary centre...
June 24, 2017: BMJ Open
https://www.readbyqxmd.com/read/28647721/effects-of-a-peer-support-programme-for-youth-social-services-employees-experiencing-potentially-traumatic-events-a-protocol-for-a-prospective-cohort-study
#11
Stephane Guay, Nicole Tremblay, Jane Goncalves, Henriette Bilodeau, Steve Geoffrion
INTRODUCTION: The use of peer support programmes to help workers experiencing potentially traumatic events (PTE) has increased in high-risk organisations in the last decades. However, the scientific evidence of its effectiveness is still very limited. This paper aims to describe the protocol of a prospective cohort study that assesses the efficacy of a peer support programme among youth social services employees exposed to a PTE at work on psychological well-being, work functioning and needs of support...
June 24, 2017: BMJ Open
https://www.readbyqxmd.com/read/28647576/robotic-assisted-excision-of-a-urachal-diverticulum
#12
Pamela Frazzini Padilla, Soo Kwon
OBJECTIVE: To demonstrate a combined robotic assisted laparoscopic technique with concomitant cystoscopy use for excision of a urachal diverticulum, to ensure complete resection of diverticulum and bladder cuff. DESIGN: Step-by-step demonstration and explanation of the procedure using video illustration. IRB/Ethics Committee ruled that approval was not required for this case report, however patient consent was obtained. SETTING: Vesicourachal diverticula account for approximately 3-5% of congenital urachal anomalies...
June 21, 2017: Journal of Minimally Invasive Gynecology
https://www.readbyqxmd.com/read/28647388/characterization-of-breast-masses-in-digital-breast-tomosynthesis-and-digital-mammograms-an-observer-performance-study
#13
Heang-Ping Chan, Mark A Helvie, Lubomir Hadjiiski, Deborah O Jeffries, Katherine A Klein, Colleen H Neal, Mitra Noroozian, Chintana Paramagul, Marilyn A Roubidoux
RATIONALE AND OBJECTIVES: This study aimed to compare Breast Imaging Reporting and Data System (BI-RADS) assessment of lesions in two-view digital mammogram (DM) to two-view wide-angle digital breast tomosynthesis (DBT) without DM. MATERIALS AND METHODS: With Institutional Review Board approval and written informed consent, two-view DBTs were acquired from 134 subjects and the corresponding DMs were collected retrospectively. The study included 125 subjects with 61 malignant (size: 3...
June 21, 2017: Academic Radiology
https://www.readbyqxmd.com/read/28646368/tnf%C3%AE-blockers-followed-by-continuation-of-sulfasalazine-and-methotrexate-combination-a-retrospective-study-on-cost-saving-options-of-treatment-in-spondyloarthritis
#14
Aswin M Nair, P Sandhya, Bijesh Yadav, Debashish Danda
High cost deters continuous use of tumor necrosis factor α blockers (TNFi) in developing countries. The objective of this study was to evaluate outcome and expenditure incurred in Spondyloarthritis (SpA) patients beyond a year of follow-up after receiving four doses of infliximab (IFX) over and above background therapy of methotrexate (MTX) and sulfasalazine (SSZ) combination. Electronic medical records were screened for patients with SpA satisfying the Assessment of Spondyloarthritis International Society (ASAS) criteria between 2008 and 2014...
June 23, 2017: Clinical Rheumatology
https://www.readbyqxmd.com/read/28645986/feasibility-study-of-a-randomised-controlled-trial-to-investigate-the-effectiveness-of-using-a-humanoid-robot-to-improve-the-social-skills-of-children-with-autism-spectrum-disorder-kaspar-rct-a-study-protocol
#15
Silvana E Mengoni, Karen Irvine, Deepshikha Thakur, Garry Barton, Kerstin Dautenhahn, Karen Guldberg, Ben Robins, David Wellsted, Shivani Sharma
INTRODUCTION: Interventions using robot-assisted therapy may be beneficial for the social skills development of children with autism spectrum disorder (ASD); however, randomised controlled trials (RCTs) are lacking. The present research aims to assess the feasibility of conducting an RCT evaluating the effectiveness of a social skills intervention using Kinesics and Synchronisation in Personal Assistant Robotics (Kaspar) with children with ASD. METHODS AND ANALYSIS: Forty children will be recruited...
June 22, 2017: BMJ Open
https://www.readbyqxmd.com/read/28645985/a-study-protocol-for-a-randomised-controlled-trial-of-an-interactive-web-based-intervention-cancercope
#16
Suzanne K Chambers, Lee Ritterband, Frances Thorndike, Lisa Nielsen, Joanne F Aitken, Samantha Clutton, Paul Scuffham, Philippa Youl, Bronwyn Morris, Peter Baade, Jeffrey Dunn
INTRODUCTION: Approximately 35% of patients with cancer experience clinically significant distress, and unmet psychological supportive care needs are prevalent. This study describes the protocol for a randomised controlled trial (RCT) to assess the efficacy and cost-effectiveness of an internet-based psychological intervention for distressed patients with cancer. METHODS AND ANALYSIS: In phase I, the intervention was developed on an interactive web platform and pilot tested for acceptability using a qualitative methodology with 21 patients with cancer...
June 23, 2017: BMJ Open
https://www.readbyqxmd.com/read/28645979/the-2015-middle-childhood-survey-mcs-of-mental-health-and-well-being-at-age-11-years-in-an-australian-population-cohort
#17
Kristin R Laurens, Stacy Tzoumakis, Kimberlie Dean, Sally A Brinkman, Miles Bore, Rhoshel K Lenroot, Maxwell Smith, Allyson Holbrook, Kim M Robinson, Robert Stevens, Felicity Harris, Vaughan J Carr, Melissa J Green
PURPOSE: The Middle Childhood Survey (MCS) was designed as a computerised self-report assessment of children's mental health and well-being at approximately 11 years of age, conducted with a population cohort of 87 026 children being studied longitudinally within the New South Wales (NSW) Child Development Study. PARTICIPANTS: School Principals provided written consent for teachers to administer the MCS in class to year 6 students at 829 NSW schools (35.0% of eligible schools)...
June 23, 2017: BMJ Open
https://www.readbyqxmd.com/read/28645976/a-combined-randomised-and-observational-study-of-surgery-for-fractures-in-the-distal-radius-in-the-elderly-crossfire-a-study-protocol
#18
Ian A Harris, Justine M Naylor, Andrew Lawson, Rachelle Buchbinder, Rebecca Ivers, Zsolt Balogh, Paul Smith, Rajat Mittal, Wei Xuan, Kirsten Howard, Arezoo Vafa, Piers Yates, Bertram Rieger, Geoff Smith, Ilia Elkinson, Woosung Kim, Mellick Chehade, Jai Sungaran, Kim Latendresse, James Wong, Sameer Viswanathan, Martin Richardson, Kush Shrestha, Herwig Drobetz, Phong Tran, Jeremy Loveridge, Richard Page, Raphael Hau, Roger Bingham, Jonathan Mulford, Ian Incoll
Fractures of the distal radius are common and occur in all age groups. The incidence is high in older populations due to osteoporosis and increased falls risk. Considerable practice variation exists in the management of distal radius fractures in older patients ranging from closed reduction with cast immobilisation to open reduction with plate fixation. Plating is currently the most common surgical treatment. While there is evidence showing no significant advantage for some forms of surgical fixation over conservative treatment, and no difference between different surgical techniques, there is a lack of evidence comparing two of the most common treatments used: closed reduction and casting versus plating...
June 23, 2017: BMJ Open
https://www.readbyqxmd.com/read/28645974/assessing-medical-student-knowledge-and-attitudes-about-shared-decision-making-across-the-curriculum-protocol-for-an-international-online-survey-and-stakeholder-analysis
#19
Marie-Anne Durand, Renata Yen, Paul J Barr, Nan Cochran, Johanna Aarts, France Légaré, Malcolm Reed, A James O'Malley, Peter Scalia, Geneviève Painchaud Guérard, Glyn Elwyn
INTRODUCTION: Shared decision making (SDM) is a goal of modern medicine; however, it is not currently embedded in routine care. Barriers include clinicians’ attitudes, lack of knowledge and training and time constraints. Our goal is to support the development and delivery of a robust SDM curriculum in medical education. Our objective is to assess undergraduate medical students’ knowledge of and attitudes towards SDM in four countries. METHODS AND ANALYSIS: The first phase of the study involves a web-based cross-sectional survey of undergraduate medical students from all years in selected schools across the United States (US), Canada and undergraduate and graduate students in the Netherlands...
June 23, 2017: BMJ Open
https://www.readbyqxmd.com/read/28645254/comparing-self-and-provider-collected-swabbing-for-hpv-dna-testing-in-female-to-male-transgender-adult-patients-a-mixed-methods-biobehavioral-study-protocol
#20
Sari L Reisner, Madeline B Deutsch, Sarah M Peitzmeier, Jaclyn M White Hughto, Timothy Cavanaugh, Dana J Pardee, Sarah McLean, Elliot J Marrow, Matthew J Mimiaga, Lori Panther, Marcy Gelman, Jamison Green, Jennifer Potter
BACKGROUND: Cervical cancer, nearly all cases of which are caused by one of several high-risk strains of the human papillomavirus (hr-HPV), leads to significant morbidity and mortality in individuals with a cervix. Trans masculine (TM) individuals were born with female reproductive organs and identify as male, man, transgender man, or another diverse gender identity different from their female assigned sex at birth. Routine preventive sexual health screening of TM patients is recommended, including screening for cervical cancer and other sexually transmitted infections (STIs); however, as many as one in three TM patients are not up-to-date per recommended U...
June 23, 2017: BMC Infectious Diseases
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