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https://www.readbyqxmd.com/read/28453700/a-need-to-simplify-informed-consent-documents-in-cancer-clinical-trials-a-position-paper-of-the-arcad-group
#1
H Bleiberg, G Decoster, A de Gramont, P Rougier, A Sobrero, A Benson, B Chibaudel, J Y Douillard, C Eng, C Fuchs, M Fujii, R Labianca, A K Larsen, E Mitchell, H J Schmoll, D Sprumont, J Zalcberg
Background: In respect of the principle of autonomy and the right of self-determination, obtaining an informed consent of potential participants before their inclusion in a study is a fundamental ethical obligation. The variations in national laws, regulations, and cultures contribute to complex informed consent documents for patients participating in clinical trials. Currently, only few ethics committees seem willing to address the complexity and the length of these documents and to request investigators and sponsors to revise them in a way to make them understandable for potential participants...
May 1, 2017: Annals of Oncology: Official Journal of the European Society for Medical Oncology
https://www.readbyqxmd.com/read/28448195/design-characteristics-of-the-corrona-japan-rheumatoid-arthritis-registry
#2
Hisashi Yamanaka, Mitsumasa Kishimoto, Dimitrios A Pappas, Jeffrey D Greenberg, Joel M Kremer, Yoshiya Tanaka
OBJECTIVES: The primary objective is to prospectively study the comparative safety and effectiveness of older and newer classes of nonbiologic DMARDs (Disease-modifying antirheumatic drugs), biologic DMARDs and targeted synthetic therapies approved for rheumatoid arthritis (RA) in a real-world patient population in Japan. METHODS: Prospective, multicenter, noninterventional, observational study across geographic distribution of both private and public institutions for patients with RA who are newly prescribed one of the following medications: (1) methotrexate; (2) anti-TNF biologic DMARDs; (3) non-TNF biologic DMARDs; and (4) approved JAK inhibitors at the time of enrollment into the registry...
April 27, 2017: Modern Rheumatology
https://www.readbyqxmd.com/read/28447019/a-cross-sectional-study-need-of-equal-respect-for-all-professionals-in-the-institutional-ethics-committees-composition
#3
Ramandeep Kaur, Ajay Francis Christopher, Vikas Gupta, Parveen Bansal
BACKGROUND: The composition of the Institutional Ethics Committee (IEC) with an equal respect plays a major role in evaluating research proposals to ensure the safety of the subjects and ethical quality of research project. It is mandatory that all research projects with an involvement of human subjects should be approved by the IEC before commencement. AIM: To find out the equality of respect to members of IEC irrespective of nature of their profession. MATERIALS AND METHODS: Methods include a cross-sectional study, the general information and member composition, multidisciplinary nature, independent performance, competence, decision capability, professionally biased of IECs in health research institutions of Punjab, India...
April 2017: Perspectives in Clinical Research
https://www.readbyqxmd.com/read/28446524/experiences-attitudes-and-possibilities-for-improvement-concerning-the-cooperation-between-occupational-physicians-rehabilitation-physicians-and-general-practitioners-in-germany-from-the-perspectives-of-the-medical-groups-and-rehabilitation-patients-a-protocol
#4
Susanne Voelter-Mahlknecht, Jan M Stratil, Rainer Kaluscha, Gert Krischak, Monika A Rieger
INTRODUCTION: Rehabilitation measures for patients in the working age primarily aim at maintaining employability, restoring fitness for work or timely return to work (RTW). To facilitate RTW after long sick leave in Germany, both rehabilitation physicians' knowledge about the patients' workplace and communication between the rehabilitation physician and the occupational physician need to be improved. This research will record the experiences and attitudes of occupational physicians, rehabilitation physicians and general practitioners, as well as of rehabilitation patients, to indicate barriers and possibilities for improvement concerning the intersection between workplace and rehabilitation institution...
April 26, 2017: BMJ Open
https://www.readbyqxmd.com/read/28446523/evaluation-of-the-coping-parent-online-universal-programme-study-protocol-for-a-pilot-randomised-controlled-trial
#5
Dawn Adele Owen, Nia Griffith, Judy Hutchings
TRIAL SPONSOR: Bangor University, Brigantia Building, College Road, Bangor, LL57 2AS, UK INTRODUCTION: The COPING parent online universal programme is a web-based parenting intervention for parents of children aged 3-8 years with an interest in positive parenting. The programme focuses on strengthening parent-child relationships and encouraging positive child behaviour. This trial will evaluate whether the intervention is effective in increasing the use of positive parenting strategies outlined in the programme using parent report and blind observation measures...
April 26, 2017: BMJ Open
https://www.readbyqxmd.com/read/28446521/comparison-of-ticagrelor-pharmacokinetics-and-pharmacodynamics-in-stemi-and-nstemi-patients-pinpoint-protocol-for-a-prospective-observational-single-centre-study
#6
Piotr Adamski, Małgorzata Ostrowska, Joanna Sikora, Karolina Obońska, Katarzyna Buszko, Magdalena Krintus, Grażyna Sypniewska, Michał Piotr Marszałł, Marek Koziński, Jacek Kubica
INTRODUCTION: The most common classification of acute myocardial infarction (AMI) is based on electrocardiographic findings and distinguishes ST-elevation myocardial infarction (STEMI) and non-ST-elevation myocardial infarction (NSTEMI). Both types of AMI differ concerning their epidemiology, clinical approach and early outcomes. Ticagrelor is a P2Y12 receptor inhibitor, constituting the first-line treatment for STEMI and NSTEMI. According to available data, STEMI may be associated with lower plasma concentration of ticagrelor in the first hours of AMI, but currently there are no studies directly comparing ticagrelor pharmacokinetics or antiplatelet effect in patients with STEMI versus NSTEMI...
April 26, 2017: BMJ Open
https://www.readbyqxmd.com/read/28446182/improving-preimplantation-genetic-diagnosis-pgd-reliability-by-selection-of-sperm-donor-with-the-most-informative-haplotype
#7
Mira Malcov, Veronica Gold, Sagit Peleg, Tsvia Frumkin, Foad Azem, Ami Amit, Dalit Ben-Yosef, Yuval Yaron, Adi Reches, Shimi Barda, Sandra E Kleiman, Leah Yogev, Ron Hauser
BACKGROUND: The study is aimed to describe a novel strategy that increases the accuracy and reliability of PGD in patients using sperm donation by pre-selecting the donor whose haplotype does not overlap the carrier's one. METHODS: A panel of 4-9 informative polymorphic markers, flanking the mutation in carriers of autosomal dominant/X-linked disorders, was tested in DNA of sperm donors before PGD. Whenever the lengths of donors' repeats overlapped those of the women, additional donors' DNA samples were analyzed...
April 26, 2017: Reproductive Biology and Endocrinology: RB&E
https://www.readbyqxmd.com/read/28445682/atrial-fibrillation-diagnostic-accuracy-of-coronary-ct-angiography-performed-with-a-whole-heart-230-%C3%A2%C2%B5m-spatial-resolution-ct-scanner
#8
Daniele Andreini, Gianluca Pontone, Saima Mushtaq, Edoardo Conte, Marco Perchinunno, Marco Guglielmo, Valentina Volpato, Andrea Annoni, Andrea Baggiano, Alberto Formenti, Maria Elisabetta Mancini, Virginia Beltrama, Valentina Ditali, Alessandro Campari, Cesare Fiorentini, Antonio L Bartorelli, Mauro Pepi
Purpose To assess image quality, interpretability, diagnostic accuracy, and radiation exposure of a computed tomography (CT) scanner with 16-cm coverage and 230-µm spatial resolution at coronary artery evaluation in patients with atrial fibrillation (AF) by using invasive coronary angiography (ICA) as the reference method and to compare the results with those obtained in patients with sinus rhythm (SR). Materials and Methods Written informed consent and institutional ethics committee approval were obtained...
April 26, 2017: Radiology
https://www.readbyqxmd.com/read/28444853/experimental-type-2-diabetes-induction-reduces-serum-vaspin-but-not-serum-omentin-in-wistar-rats
#9
Cynthia Aparecida de Castro, Karina Ana da Silva, Marina Molina Buffo, Karina Nogueira Zambone Pinto, Fernanda de Oliveira Duarte, Keico Okino Nonaka, Fernanda de Freitas Aníbal, Ana Cláudia Garcia de Oliveira Duarte
Vaspin and omentin are adipose tissue adipokines that have often been related to obesity and its comorbidities. The aim of this study was to investigate the behaviour of serum omentin and vaspin in models of type 2 diabetes. To do this, Wistar rats (~200 g) were randomly divided into two groups: a non-diabetic group (n = 6) and a diabetic group fed on a high-fat diet (n = 6) and a low dose of streptozotocin (Sigma(®) ). All procedures were approved by the Brazilian Ethics Committee. Body weight (BW) and food intake were recorded daily...
April 25, 2017: International Journal of Experimental Pathology
https://www.readbyqxmd.com/read/28443991/risk-assessment-and-incidence-of-falls-in-adult-hospitalized-patients
#10
Thiana Sebben Pasa, Tânia Solange Bosi De Souza Magnago, Janete De Souza Urbanetto, Mari Angela Meneghetti Baratto, Bruna Xavier Morais, Jéssica Baldissera Carollo
OBJECTIVES: assess the risk of falls in adult hospitalized patients and verify the incidence of the event in this environment. METHOD: cohort study, with approval by the Research Ethics Committee, which monitored 831 patients hospitalized at a university hospital. The Morse Fall Scale (MFS) was used to assess the risk and patients with high risk (≥45 points) were considered exposed to falls. RESULTS: the mean MFS score was 39.4 (±19.4) points...
April 20, 2017: Revista Latino-americana de Enfermagem
https://www.readbyqxmd.com/read/28438182/forced-fluid-removal-versus-usual-care-in-intensive-care-patients-with-high-risk-acute-kidney-injury-and-severe-fluid-overload-ffaki-study-protocol-for-a-randomised-controlled-pilot-trial
#11
Rasmus E Berthelsen, Theis Itenov, Anders Perner, Jens-Ulrik Jensen, Michael Ibsen, Andreas Emil Kryger Jensen, Morten Bestle
BACKGROUND: Intravenous administration of fluids is an essential part of critical care. While some fluid administration is likely beneficial, there is increasing observational evidence that the development of fluid overload is associated with increased mortality. There are no randomised trials to confirm this association in patients with acute kidney injury. We aim to perform a pilot trial to test the feasibility of forced fluid removal compared to standard care in patients with acute kidney injury and severe fluid overload, the FFAKI trial...
April 24, 2017: Trials
https://www.readbyqxmd.com/read/28437155/eyelid-reconstruction-using-the-hughes-tarsoconjunctival-advancement-flap-long-term-outcomes-in-122-consecutive-cases-over-a-13-year-period
#12
James McKelvie, Reid Ferguson, Stephen G J Ng
This article evaluates the complications and long term functional and cosmetic outcomes of tarsoconjunctival advancement flaps for repairing a range of lower eyelid defects in a large cohort of consecutive cases. A retrospective series of 122 consecutive cases of eyelid reconstruction using tarsoconjunctival-advancement flaps was conducted at Waikato Hospital, or Hamilton Eye Clinic, New Zealand. All cases of lid reconstruction using tarsoconjunctival-advancement flaps between January 1, 2001 until April 3, 2014 were included for analysis...
April 24, 2017: Orbit
https://www.readbyqxmd.com/read/28431539/pain-intervention-for-people-with-dementia-in-nursing-homes-pid-study-protocol-for-a-quasi-experimental-nurse-intervention
#13
Andrea Koppitz, Georg Bosshard, Geneviève Blanc, Hannele Hediger, Sheila Payne, Thomas Volken
BACKGROUND: It is estimated that 19 to 83% of people with dementia suffer from pain that is inadequately treated in the last months of life. A large number of healthcare workers who care for these people in nursing homes lack appropriate expertise and may therefore not always recognise, assess and treat pain in those with dementia who have complex problems on time, properly and efficiently. The aim of this intervention trial is to identify care needs of people with dementia suffering from pain living in a nursing home...
April 21, 2017: BMC Palliative Care
https://www.readbyqxmd.com/read/28431515/the-effectiveness-of-creating-an-online-life-story-book-on-persons-with-early-dementia-and-their-informal-caregivers-a-protocol-of-a-randomized-controlled-trial
#14
Teuntje R Elfrink, Sytse U Zuidema, Miriam Kunz, Gerben J Westerhof
BACKGROUND: Dementia has a high burden for patients, informal caregivers and society. Given changes in care systems, more persons with dementia will live longer at home. However, living at home (with dementia) with a good quality of life is not easy to achieve. Dementia is often accompanied by neuropsychiatric symptoms like apathy, agitation, depression, and anxiety, which have a negative impact on quality of life. Whereas cognitive deterioration can hardly be influenced, it is possible to reduce neuropsychiatric symptoms...
April 21, 2017: BMC Geriatrics
https://www.readbyqxmd.com/read/28425315/caring-in-nursing-homes-to-promote-autonomy-and-participation
#15
Maria Hedman, Elisabeth Häggström, Anna-Greta Mamhidir, Ulrika Pöder
BACKGROUND: Autonomy and participation are threatened within the group of older people living in nursing homes. Evidence suggests that healthcare personnel act on behalf of older people but are still excluding them from decision-making in everyday care. OBJECTIVE: The purpose was to describe registered nurses' experience of caring for older people in nursing homes to promote autonomy and participation. RESEARCH DESIGN: A descriptive design with a phenomenological approach was used...
January 1, 2017: Nursing Ethics
https://www.readbyqxmd.com/read/28425250/retrospective-analysis-of-maternal-fetal-and-neonatal-outcomesof-intrahepatic-cholestasis-of-pregnancy-at-gazi-university
#16
Berrin Günaydin, Merih Bayram, Melis Altuğ, Semra Cevher, Nuray Bozkurt
BACKGROUND/AIM: Maternal, fetal, and neonatal outcomes in parturients with intrahepatic cholestasis of pregnancy (ICP) have been retrospectively documented. We aimed to present pregnancy outcomes of parturients with ICP who underwent delivery. The study was conducted during a 1-year period. MATERIALS AND METHODS: After ethics committee approval, data from 1 January to 31 December 2015 were collected to identify parturients with ICP. RESULTS: Ten out of 37 patients underwent normal spontaneous vaginal delivery (NSVD), and the remaining 27 parturients underwent cesarean section (CS)...
April 18, 2017: Turkish Journal of Medical Sciences
https://www.readbyqxmd.com/read/28424796/external-data-required-timely-response-by-the-trial-steering-data-monitoring-committee-for-the-naloxone-investigation-n-alive-pilot-trial
#17
Sheila M Bird, John Strang, Deborah Ashby, John Podmore, J Roy Robertson, Sarah Welch, Angela M Meade, Mahesh K B Parmar
The prison-based N-ALIVE pilot trial had undertaken to notify the Research Ethics Committee and participants if we had reason to believe that the N-ALIVE pilot trial would not proceed to the main trial. In this paper, we describe how external data for the third year of before/after evaluation from Scotland's National Naloxone Programme, a related public health policy, were anticipated by eliciting prior opinion about the Scottish results in the month prior to their release as official statistics. We summarise how deliberations by the N-ALIVE Trial Steering-Data Monitoring Committee (TS-DMC) on N-ALIVE's own interim data, together with those on naloxone-on-release (NOR) from Scotland, led to the decision to cease randomization in the N-ALIVE pilot trial and recommend to local Principal Investigators that NOR be offered to already-randomized prisoners who had not yet been released...
March 2017: Contemporary Clinical Trials Communications
https://www.readbyqxmd.com/read/28422848/teriparatide-as-a-nonoperative-treatment-for-tibial-and-femoral-fracture-nonunion-a-case-report
#18
Li Xiaofeng, Xu Daxia, Chen Yunzhen
RATIONALE: Fracture nonunion is a great challenge for orthopedic surgeons. Many surgical interventions are associated with significant pain and heavy economic burden. Therefore, our aim was to evaluate the outcomes of a new nonoperative treatment for fracture nonunion. PATIENT CONCERNS: A 44-year-old man suffered closed fractures of the right tibia and left femur. Eleven months after surgery, there was no radiographic healing between fracture fragments. DIAGNOSES: Fracture nonunion of the right tibia and left femur...
April 2017: Medicine (Baltimore)
https://www.readbyqxmd.com/read/28421889/overall-assessment-of-human-research-and-ethics-committees-in-the-united-arab-emirates
#19
Mahera Abdulrahman, Satish Chandrasekhar Nair
Growing demand for human health research in the United Arab Emirates (UAE) has prompted the need to develop a robust research ethics oversight. Examination of the structure, function, and practices of the human research ethics committees (HRECs), followed by evaluation of standards for measuring research output, was conducted. Results indicate that among the HRECs, 90% followed International Council for Harmonization-Good Clinical Practice guidelines, 66.6% have been in operation for more than 5 years, 95% reviewed proposals within 8 weeks, and 56% reviewed for scientific merit apart from ethics...
April 2017: Journal of Empirical Research on Human Research Ethics: JERHRE
https://www.readbyqxmd.com/read/28421885/recognizing-risk-and-vulnerability-in-research-ethics-imagining-the-what-ifs
#20
Elizabeth Peter, Judith Friedland
Research ethics committees (RECs) may misunderstand the vulnerability of participants, given their distance from the field. What RECs identify as the vulnerabilities that were not adequately recognized in protocols and how they attempt to protect the perceived vulnerability of participants and mitigate risks were examined using the response letters sent to researchers by three university-based RECs. Using a critical qualitative method informed by feminist ethics, we identified an overarching theme of recognizing and responding to cascading vulnerabilities and four subthemes: identifying vulnerable groups, recognizing potentially risky research, imagining the "what ifs," and mitigating perceived risks...
April 2017: Journal of Empirical Research on Human Research Ethics: JERHRE
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