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https://www.readbyqxmd.com/read/29932613/human-subject-protection-acceptance-of-data-from-clinical-investigations-for-medical-devices-final-rule
#1
(no author information available yet)
The Food and Drug Administration (FDA or we) is amending its regulations on acceptance of data from clinical investigations for medical devices. We are requiring that data submitted from clinical investigations conducted outside the United States intended to support an investigational device exemption (IDE) application, a premarket notification (510(k)) submission, a request for De Novo classification, a premarket approval (PMA) application, a product development protocol (PDP) application, or a humanitarian device exemption (HDE) application be from investigations conducted in accordance with good clinical practice (GCP), which includes obtaining and documenting the review and approval of the clinical investigation by an independent ethics committee (IEC) and obtaining and documenting freely given informed consent of subjects, which includes individuals whose specimens are used in investigations of medical devices...
February 21, 2018: Federal Register
https://www.readbyqxmd.com/read/29929423/operating-room-nurses-perception-of-professional-values
#2
Camellia Torabizadeh, Fatemeh Darari, Shahrzad Yektatalab
Background and significance of research: Nurses' awareness of professional values and how those values affect their behaviors is an integral part of nursing care. There is a large body of research on nursing professional values, however, a careful survey of the available literature did not yield any studies investigating the status of professional values in operating rooms. OBJECTIVE: This study aims to investigate the perception of operating room nurses of university hospitals toward professional values...
January 1, 2018: Nursing Ethics
https://www.readbyqxmd.com/read/29927917/the-futility-of-fertility-research-barriers-to-embryo-research-in-new-zealand
#3
Lucy Goodman, Lynsey Cree, D D Gareth Jones, Michael Legge, Andrew Shelling, Cynthia Farquhar
AIMS: Successive New Zealand Health Ministers have failed to approve guidelines for research using viable human embryos, which effectively places a blanket ban on all research that "uses" viable human embryos in this country. This includes research that aims to improve currently available reproductive technologies, illustrated by a failed application to ministerial ethics committees for a clinical research project investigating the efficacy of in vitro fertilisation procedures...
June 22, 2018: New Zealand Medical Journal
https://www.readbyqxmd.com/read/29927830/living-donation-of-vascularized-composite-allografts
#4
Bohdan Pomahac, Muayyad Alhefzi, Ericka M Bueno, Sue V McDiarmid, L Scott Levin
Living donation has become a medically and ethically accepted practice in solid organ transplantation. Published proceedings from the international kidney transplant community and from the Ethics Committee of The Transplantation Society (TTS) articulated the general principles as well as specific recommendations for living donation, which remain the backbone of the Centers for Medicare and Medicaid Services (CMS) and Organ Procurement and Transplantation Network (OPTN) requirements and policies.Meanwhile, there have been major advancements in another revolutionary field of transplant medicine: vascularized composite allotransplantation, or VCA...
June 14, 2018: Plastic and Reconstructive Surgery
https://www.readbyqxmd.com/read/29927822/effect-of-piezoelectric-technique-on-auditory-function-on-postoperative-day-one-in-septorhinoplasty-surgery
#5
Adem Emre Ilhan, Yusuf Muhammed Durna, Ahmet Mahmut Tekin, Fahrettin Yilmaz, Yetkin Zeki Yilmaz
AIM: To examine the effect of the piezoelectric application used increasingly for osteotomy and correction of nasal dorsum in septorhinoplasty surgeries on early auditory functions. METHODS: Our study was conducted after the decision of 10840098-604.01.01-E.9057 taken from Istanbul Medipol University Clinical Research Local Ethics Committee. This study was designed to be prospective, randomized and controlled. Twenty patients between 18 and 50 years of age that piezoelectric technique was used in the study group and 10 patients in the same age range who underwent nasal surgery (endoscopic sinus surgery, septoplasty, lower concha radiofrequency and nasal valve surgery) for any reason in the control group were included in the study...
June 20, 2018: Journal of Craniofacial Surgery
https://www.readbyqxmd.com/read/29926769/review-of-scientific-self-experimentation-ethics-history-regulation-scenarios-and-views-among-ethics-committees-and-prominent-scientists
#6
Brian P Hanley, William Bains, George Church
We examine self-experimentation ethics history and practice, related law, use scenarios in universities and industry, and attitudes. We show through analysis of the historical development of medical ethics and regulation, from Hippocrates through Good Clinical Practice that there are no ethical barriers to self-experimentation. When the self-experimenter is a true investigator, there is no other party to be protected from unethical behavior. We discuss the n-of-1 issue in self-experiments, and make suggestions for improving experiment design...
June 21, 2018: Rejuvenation Research
https://www.readbyqxmd.com/read/29926240/cerebral-oximetry-for-cardiac-surgery-a-preoperative-comparison-of-device-characteristics-and-pitfalls-in-interpretation
#7
Kensuke Kobayashi, Tadashi Kitamura, Satoshi Kohira, Shinzo Torii, Toshiaki Mishima, Hirotoki Ohkubo, Yuki Tanaka, Akihiro Sasahara, Takuma Fukunishi, Yuki Ohtomo, Rihito Horikoshi, Yuta Murai, Kagami Miyaji
Regional cerebral oximetry using near-infrared spectroscopy devices is commonly used for detecting cerebral ischemia during cardiopulmonary bypass, and aim to avoid poor cerebral perfusion which may result in perioperative neurological impairment. Today, several devices that can detect cerebral ischemia are commercially available. Although these devices operate on the same measurement principles, their algorithms for detecting and calculating cerebral ischemia are different and no criteria for directly comparing values measured by such different devices exist...
June 20, 2018: Journal of Artificial Organs: the Official Journal of the Japanese Society for Artificial Organs
https://www.readbyqxmd.com/read/29924147/assessment-of-health-functioning-of-older-adults-who-consume-psychoactive-substances
#8
Vania Dias Cruz, Silvana Sidney Costa Santos, Jamila Geri Tomaschewski-Barlem, Bárbara Tarouco da Silva, Celmira Lange, Daiane Porto Gautério de Abreu, Flávia Seles Oliveira
OBJECTIVE: To assess the health/functioning of the older adult who consumes psychoactive substances through the International Classification of Functioning, Disability and Health, considering the theory of complexity. METHOD: Qualitative case study, with 11 older adults, held between December 2015 and February 2016 in the state of Rio Grande do Sul, using interviews, documents and non-systematic observation. It was approved by the ethics committee. The analysis followed the propositions of the case study, using the complexity of Morin as theoretical basis...
May 2018: Revista Brasileira de Enfermagem
https://www.readbyqxmd.com/read/29923073/perioperative-platelet-rich-plasma-prp-in-total-hip-arthroplasty-through-the-hardinge-approach-protocol-to-study-the-effectiveness-for-gluteus-medius-healing
#9
Anni Aavikko, J Puhakka, J Haapala, J Kukkonen, K Mäkelä, J Kosola
BACKGROUND: Platelet-rich plasma (PRP) has been used to support tendon regeneration mainly in sports medicine. PRP is a concentrate of platelet-rich plasma proteins derived from whole blood by centrifugation to remove erythrocytes and leukocytes. PRP has high amounts of platelets which may promote healing tendons affected by degenerative conditions. These platelets contain growth factors and are known to facilitate the regeneration of injured tendon structures. Total hip arthroplasty (THA) through the Hardinge approach may leave the patient with impaired gait and poor regeneration of the gluteus medius tendon if the tendon is not reattached properly after closure of the surgical wound...
June 19, 2018: Journal of Experimental Orthopaedics
https://www.readbyqxmd.com/read/29921685/stepped-wedge-cluster-randomised-controlled-trial-to-assess-the-effectiveness-of-an-optimisation-strategy-for-general-anaesthesia-on-postoperative-morbidity-and-mortality-in-elderly-patients-the-opti-aged-study-a-study-protocol
#10
Serge Molliex, Sylvie Passot, Emmanuel Futier, Marlène Bonnefoi, Florence Rancon, Yannick Lemanach, Bruno Pereira
INTRODUCTION: Elderly patients constitute an increasingly large proportion of the high-risk surgical group. In adult patients, several specific intraoperative approaches such as cardiac output-guided haemodynamic therapy, depth of anaesthesia monitoring (DAM) or lung-protective ventilation (LPV) are designed to reduce postoperative mortality and surgical complications. However, none of these approaches has been specifically performed in the elderly, and no evaluation of a multimodal optimisation strategy for general anaesthesia has been achieved in this population...
June 19, 2018: BMJ Open
https://www.readbyqxmd.com/read/29916833/the-development-and-rationale-for-ceca-s-case-based-study-guide
#11
George J Agich
This article discusses the approach of the Clinical Ethics Consultation Advisory Committee (CECA) in developing A Case-Based Study Guide for Addressing Patient-Centered Ethical Issues in Health Care. This article addresses the processes used by the CECA, its use of pivot questions intended to encourage critical reflection, and the target audience of this work. It first considers the salience of case studies in general education and their relevance for training ethics consultants. Second, it discusses the enfolding approach used in presenting the case material designed to engage the trainee in the details of the case while stimulating critical reflection...
2018: Journal of Clinical Ethics
https://www.readbyqxmd.com/read/29916832/the-work-of-asbh-s-clinical-ethics-consultation-affairs-committee-development-processes-behind-our-educational-materials
#12
Coutenay R Bruce, Jane Jankowski, Barbara L Chanko, Anne Cordes, Barrie J Humberman, Liza-Marie Johnson, Deborah L Kasman, Aviva Katz, Ellen M Robinson, Katherine Wasson, George E Hardart
The authors of this article are previous or current members of the Clinical Ethics Consultation Affairs (CECA) Committee, a standing committee of the American Society for Bioethics and Humanities (ASBH). The committee is composed of seasoned healthcare ethics consultants (HCECs), and it is charged with developing and disseminating education materials for HCECs and ethics committees. The purpose of this article is to describe the educational research and development processes behind our teaching materials, which culminated in a case studies book called A Case-Based Study Guide for Addressing Patient-Centered Ethical Issues in Health Care (hereafter, the Study Guide)...
2018: Journal of Clinical Ethics
https://www.readbyqxmd.com/read/29916827/ttapp-together-take-a-pause-and-ponder-a-critical-thinking-tool-for-exploring-the-public-private-lives-of-patients
#13
Leslie Kuhnel
The broad use of social networking and user-generated content has increased the online footprint of many individuals. A generation of healthcare professionals have grown up with online search activities as part of their everyday lives. Sites like Facebook, Twitter, and Instagram have given the public new ways to share intimate details about their public and private lives and the lives of their friends and families. As a result, careproviders have the ability to find out more about their patients with just the tap of a key or the click of a mouse...
2018: Journal of Clinical Ethics
https://www.readbyqxmd.com/read/29916425/a-comparative-study-of-the-informed-consent-process-with-or-without-audiovisual-recording
#14
B H Figer, M Chaturvedi, S J Thaker, N J Gogtay, U M Thatte
Background.: The Central Standard Drugs Control Organization (CDSCO) issued an administrative order in November 201 3 mandating audiovisual (AV) recording of the informed consent process for all regulatory studies. At this point, a phase 2/3 trial ongoing at our centre had recruited 45 participants using the written, informed consent process. Another 40 participants were recruited after the order and underwent AV recording of the consent process. We assessed the difference in participants' understanding between the two consenting processes as the trial fortuitously had both forms of consent...
September 2017: National Medical Journal of India
https://www.readbyqxmd.com/read/29916416/need-for-ethics-support-in-clinical-practice-and-suggestion-for-an-ethics-consultation-service-views-of-nurses-and-physicians-working-in-italian-healthcare-institutions
#15
Cinzia Leuter, Cristina Petrucci, Valeria Caponnetto, Carmen La Cerra, Loreto Lancia
INTRODUCTION: Ethics Consultation Services (ECS) and Ethical Committees manage several aspects of clinical ethical issues. In Italy there are only Ethical Committees, and, although they should also perform ethical consultations, their activity is limited to approving clinical trial protocols. AIM: To analyse the opinions of a sample of Nurses and Physicians about their motivations to ask for an ethical consultation. METHODS: A cross-sectional study was conducted on a sample of Italian Nurses and Physicians...
April 2018: Annali Dell'Istituto Superiore di Sanità
https://www.readbyqxmd.com/read/29915640/standardized-review-and-approval-process-for-high-cost-medication-use-promotes-value-based-care-in-a-large-academic-medical-system
#16
REVIEW
Raghu Durvasula, Janet Kelly, Anneliese Schleyer, Bradley D Anawalt, Shabir Somani, Timothy H Dellit
Background: As healthcare costs rise and reimbursements decrease, healthcare organization leadership and clinical providers must collaborate to provide high-value healthcare. Medications are a key driver of the increasing cost of healthcare, largely as a result of the proliferation of expensive specialty drugs, including biologic agents. Such medications contribute significantly to the inpatient diagnosis-related group payment system, often with minimal or unproved benefit over less-expensive therapies...
April 2018: American Health & Drug Benefits
https://www.readbyqxmd.com/read/29914545/effectiveness-of-endoscopic-totally-extraperitoneal-tep-hernia-correction-for-clinically-occult-inguinal-hernia-effect-study-protocol-for-a-randomized-controlled-trial
#17
Marleen M Roos, Egbert-Jan M M Verleisdonk, Floris B M Sanders, Arno W Hoes, Rebecca K Stellato, Geert W J Frederix, Rogier K J Simmermacher, Josephina P J Burgmans
BACKGROUND: Groin pain is a frequent complaint in surgical practice with an inguinal hernia being at the top of the differential diagnosis. The majority of inguinal hernias can be diagnosed clinically. However, patients with groin pain without signs of an inguinal hernia on anamnesis or physical examination provide a diagnostic challenge. If ultrasonography shows a hernia that could not be detected clinically, this entity is called a clinically occult hernia. It is debatable if this radiological hernia is the cause of complaints in all patients with inguinal pain...
June 18, 2018: Trials
https://www.readbyqxmd.com/read/29914461/ethical-challenges-assessed-in-the-clinical-ethics-committee-of-psychiatry-in-the-region-of-southern-denmark-in-2010-2015-a-qualitative-content-analyses
#18
H Bruun, S G Lystbaek, E Stenager, L Huniche, R Pedersen
BACKGROUND: The aim of this article is to give more insight into what ethical challenges clinicians in mental healthcare experience and discuss with a Clinical Ethics Committee in psychiatry in the Region of Southern Denmark. Ethical considerations are an important part of the daily decision-making processes and thereby for the quality of care in mental healthcare. However, such ethical challenges have been given little systematic attention - both in research and in practices. METHODS: A qualitative content analysis of 55 written case-reports from the Clinical Ethics Committee...
June 19, 2018: BMC Medical Ethics
https://www.readbyqxmd.com/read/29914340/erratum
#19
(no author information available yet)
Pekçetin, S., Salar, S., İnal, Ö., & Kayıhan, H. (2018). Validity of the Turkish Occupational Self Assessment for Elderly Individuals. Occupation, Participation and Health, 38, 105-112. DOI: 10.1177/1539449217743457 On page 106 of the above-mentioned article, the institutional details were removed at two instances and left as "removed for blinding purposes." The updated correct sentences are: Ethical approval was obtained from the Trakya University Scientific Research Ethics Committee prior to the study...
July 2018: OTJR: Occupation, Participation and Health
https://www.readbyqxmd.com/read/29911622/spinal-disulfide-hmgb1-but-not-all-thiol-hmgb1-induces-mechanical-hypersensitivity-in-a-tlr4-dependent-manner
#20
N M Agalave, S AbdelMoaty, P Lundback, U Andersson, H Harris, C I Svensson
Aims Increasing evidence indicates that extracellular high mobility group box-1 protein (HMGB1) is involved in the pathogenesis of inflammatory and autoimmune disease. Data from our laboratory demonstrates that HMGB1 contributes to nociceptive behavior in a model of rheumatoid arthritis-induced pain. HMGB1 binds to multiple receptors, including toll like receptor (TLR) 2, TLR4 and receptor for advanced glycation end products (RAGE). When the cysteine in position C106 is in the reduced thiol form and C23 and C45 are engaged in a disulfide bridge (disulfide HMGB1), the molecule functions as a cytokine-inducing TLR4 ligand...
December 29, 2017: Scandinavian Journal of Pain
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