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https://www.readbyqxmd.com/read/28715491/towards-the-development-of-a-comprehensive-framework-qualitative-systematic-survey-of-definitions-of-clinical-research-quality
#1
Belinda von Niederhäusern, Stefan Schandelmaier, Marie Mi Bonde, Nicole Brunner, Lars G Hemkens, Marielle Rutquist, Neera Bhatnagar, Gordon H Guyatt, Christiane Pauli-Magnus, Matthias Briel
OBJECTIVE: To systematically survey existing definitions, concepts, and criteria of clinical research quality, both developed by stakeholder groups as well as in the medical literature. This study serves as a first step in the development of a comprehensive framework for the quality of clinical research. STUDY DESIGN AND SETTING: We systematically and in duplicate searched definitions, concepts and criteria of clinical research quality on websites of stakeholders in clinical research until no further insights emerged and in MEDLINE up to February 2015...
2017: PloS One
https://www.readbyqxmd.com/read/28709585/patients-come-from-populations-and-populations-contain-patients-a-two-stage-scientific-and-ethics-review-the-next-adaptation-for-single-institutional-review-boards
#2
David Knopman, Eli Alford, Kaitlin Tate, Mark Long, Ara S Khachaturian
INTRODUCTION: For nearly 50 years, institutional review boards (IRB) and independent ethics committees have featured local oversight as a core function of research ethics reviews. However growing complexity in Alzheimer's clinical research suggests current approaches to research volunteer safety is hampering development of new therapeutics. As a partial response to this challenge, the NIH has mandated that all NIH-funded multi-site studies will use a single Institutional Review Board...
July 11, 2017: Alzheimer's & Dementia: the Journal of the Alzheimer's Association
https://www.readbyqxmd.com/read/28700443/assessment-of-conflicts-of-interest-in-robotic-surgical-studies-validating-author-s-declarations-with-the-open-payments-database
#3
Sunil V Patel, David Yu, Basheer Elsolh, Ben M Goldacre, Garrett M Nash
BACKGROUND: Accurate conflict of interest (COI) statements are important, as a known COI may invalidate study results due to the potential risk of bias. OBJECTIVE: To determine the accuracy of self-declared COI statements in robotic studies and identify risk factors for undeclared payments. METHODS: Robotic surgery studies were identified through EMBASE and MEDLINE and included if published in 2015 and had at least one American author. Undeclared COI were determined by comparing the author's declared COI with industry reported payments found in the "Open Payments" database for 2013 and 2014...
July 11, 2017: Annals of Surgery
https://www.readbyqxmd.com/read/28683000/safety-risks-among-home-infusion-nurses-and-other-home-health-care-providers
#4
Pia Markkanen, Catherine Galligan, Margaret Quinn
In the United States, home health care (HHC) is a rapidly growing industry and home infusion therapy is a rapidly growing market. HHC can present substantial occupational safety and health (OSH) risks. This article summarizes major OSH risks relevant to home infusion therapy by illustrating them through real-life scenarios collected systematically using qualitative research methods by the National Institute for Occupational Safety and Health-funded research projects at the University of Massachusetts Lowell...
July 2017: Journal of Infusion Nursing: the Official Publication of the Infusion Nurses Society
https://www.readbyqxmd.com/read/28670647/farming-and-the-geography-of-nutrient-production-for-human-use-a-transdisciplinary-analysis
#5
Mario Herrero, Philip K Thornton, Brendan Power, Jessica R Bogard, Roseline Remans, Steffen Fritz, James S Gerber, Gerald Nelson, Linda See, Katharina Waha, Reg A Watson, Paul C West, Leah H Samberg, Jeannette van de Steeg, Eloise Stephenson, Mark van Wijk, Petr Havlík
BACKGROUND: Information about the global structure of agriculture and nutrient production and its diversity is essential to improve present understanding of national food production patterns, agricultural livelihoods, and food chains, and their linkages to land use and their associated ecosystems services. Here we provide a plausible breakdown of global agricultural and nutrient production by farm size, and also study the associations between farm size, agricultural diversity, and nutrient production...
April 2017: The Lancet. Planetary health
https://www.readbyqxmd.com/read/28667226/a-cross-sectional-analysis-of-pharmaceutical-industry-funded-events-for-health-professionals-in-australia
#6
Alice Fabbri, Quinn Grundy, Barbara Mintzes, Swestika Swandari, Ray Moynihan, Emily Walkom, Lisa A Bero
OBJECTIVES: To analyse patterns and characteristics of pharmaceutical industry sponsorship of events for Australian health professionals and to understand the implications of recent changes in transparency provisions that no longer require reporting of payments for food and beverages. DESIGN: Cross-sectional analysis. PARTICIPANTS AND SETTING: 301 publicly available company transparency reports downloaded from the website of Medicines Australia, the pharmaceutical industry trade association, covering the period from October 2011 to September 2015...
June 30, 2017: BMJ Open
https://www.readbyqxmd.com/read/28664918/embracing-model-based-designs-for-dose-finding-trials
#7
Sharon B Love, Sarah Brown, Christopher J Weir, Chris Harbron, Christina Yap, Birgit Gaschler-Markefski, James Matcham, Louise Caffrey, Christopher McKevitt, Sally Clive, Charlie Craddock, James Spicer, Victoria Cornelius
BACKGROUND: Dose-finding trials are essential to drug development as they establish recommended doses for later-phase testing. We aim to motivate wider use of model-based designs for dose finding, such as the continual reassessment method (CRM). METHODS: We carried out a literature review of dose-finding designs and conducted a survey to identify perceived barriers to their implementation. RESULTS: We describe the benefits of model-based designs (flexibility, superior operating characteristics, extended scope), their current uptake, and existing resources...
June 29, 2017: British Journal of Cancer
https://www.readbyqxmd.com/read/28664575/public-awareness-and-misunderstanding-about-drinkwise-australia-a-cross-sectional-survey-of-australian-adults
#8
Emily Brennan, Melanie A Wakefield, Sarah J Durkin, David H Jernigan, Helen G Dixon, Simone Pettigrew
OBJECTIVE: DrinkWise Australia is an alcohol industry Social Aspects/Public Relations Organisation (SAPRO). We assessed the Australian public's awareness of DrinkWise, beliefs about its funding source, and associations between funding beliefs and perceptions of DrinkWise. METHODS: A total of 467 adult weekly drinkers completed an online cross-sectional survey in February 2016. RESULTS: Half the sample had heard of DrinkWise (48.6%); of these, the proportion aware that DrinkWise is industry funded (37...
June 29, 2017: Australian and New Zealand Journal of Public Health
https://www.readbyqxmd.com/read/28663854/the-ecosystem-that-powered-the-translation-of-oct-from-fundamental-research-to-clinical-and-commercial-impact-invited
#9
Eric A Swanson, James G Fujimoto
25 years is a relatively short period of time for a medical technology to become a standard of care impacting the treatment of millions of people every year. Yet 25 years ago there were no OCT companies, no OCT products, no OCT markets, and only one journal article published using the term OCT (optical coherence tomography). OCT has had a tremendous scientific, clinical, and economic impact on society. Today, it is estimated that there are ~30 Million OCT imaging procedures performed worldwide every year and the OCT system market is approaching $1B per year...
March 1, 2017: Biomedical Optics Express
https://www.readbyqxmd.com/read/28650251/managed-care-peer-led-teaching-an-innovative-learning-approach-outside-the-college-of-pharmacy-core-curriculum
#10
SyHui Tang, Julia Smith, Wilson Lau, Isaac Tse, Christine Tan, Ryan Cotten, Amy Pittenger
BACKGROUND: Managed care pharmacy is a growing field, but there are still limited educational opportunities available in pharmacy school core curricula. Students often seek self-directed learning opportunities to further explore the field. OBJECTIVES: To (a) evaluate practicality and effectiveness of a student-designed managed care pharmacy elective and (b) determine emerging best practices for design and sustainability of peer-led, self-directed courses. METHODS: A managed care elective course was designed as a student, peer-led course during the 2012-2013 school year at the University of Minnesota College of Pharmacy...
July 2017: Journal of Managed Care & Specialty Pharmacy
https://www.readbyqxmd.com/read/28649450/the-northwest-participant-and-clinical-interactions-network-increasing-opportunities-for-patients-to-participate-in-research-across-the-northwestern-united-states
#11
Laura-Mae Baldwin, Laurie Hassell, Cindi Laukes, Michelle Doyle, Anne Reedy, Brenda Mollis, Sandra Albritton, Elizabeth Ciemins, Robert Coker, Jeannine Brant, Katherine R Tuttle, Laura Baker, Bonnie Ramsey
INTRODUCTION: The Institute of Translational Health Sciences (ITHS) promotes and supports translational research collaboration between clinicians, communities, and investigators across the five-state Washington, Wyoming, Alaska, Montana, and Idaho (WWAMI) region. The ITHS has developed a collaborative regional clinical research network, the Northwest Participant & Clinical Interactions Network (NW PCI), involving 12 diverse clinical health systems and academic institutions. METHODS: This descriptive article details NW PCI's development, infrastructure and governance, tools, characteristics, and initial outcomes...
April 2017: Journal of clinical and translational science
https://www.readbyqxmd.com/read/28649143/sugar-price-supports-and-taxation-a-public-health-policy-paradox
#12
Abby Dilk, Dennis A Savaiano
Domestic US sugar production has been protected by government policy for the past 82 years, resulting in elevated domestic prices and an estimated annual (2013) $1.4 billion dollar "tax" on consumers. These elevated prices and the simultaneous federal support for domestic corn production have ensured a strong market for high-fructose corn syrup. Americans have dramatically increased their consumption of caloric sweeteners during the same period. Consumption of "empty" calories (ie, foods with low-nutrient/high-caloric density)-sugar and high-fructose corn syrup being the primary sources-is considered by most public health experts to be a key contributing factor to the rise in obesity...
May 2017: Nutrition Today
https://www.readbyqxmd.com/read/28646886/implementation-science-for-ambulatory-care-safety-a-novel-method-to-develop-context-sensitive-interventions-to-reduce-quality-gaps-in-monitoring-high-risk-patients
#13
Kathryn M McDonald, George Su, Sarah Lisker, Emily S Patterson, Urmimala Sarkar
BACKGROUND: Missed evidence-based monitoring in high-risk conditions (e.g., cancer) leads to delayed diagnosis. Current technological solutions fail to close this safety gap. In response, we aim to demonstrate a novel method to identify common vulnerabilities across clinics and generate attributes for context-flexible population-level monitoring solutions for widespread implementation to improve quality. METHODS: Based on interviews with staff in otolaryngology, pulmonary, urology, breast, and gastroenterology clinics at a large urban publicly funded health system, we applied journey mapping to co-develop a visual representation of how patients are monitored for high-risk conditions...
June 24, 2017: Implementation Science: IS
https://www.readbyqxmd.com/read/28645203/neurosurgical-randomized-controlled-trials-distance-travelled
#14
Tej D Azad, Anand Veeravagu, Vaishali Mittal, Rogelio Esparza, Eli Johnson, John P A Ioannidis, Gerald A Grant
BACKGROUND: The evidence base for many neurosurgical procedures has been limited. We performed a comprehensive and systematic analysis of study design, quality of reporting, and trial results of neurosurgical randomized controlled trials (RCTs). OBJECTIVE: To systematically assess the design and quality characteristics of neurosurgical RCTs. METHODS: From January 1961 to June 2016, RCTs with >5 patients assessing any 1 neurosurgical procedure against another procedure, nonsurgical treatment, or no treatment were retrieved from MEDLINE, Scopus, and Cochrane Library...
June 21, 2017: Neurosurgery
https://www.readbyqxmd.com/read/28639415/anti-vascular-endothelial-growth-factor-for-diabetic-macular-oedema-a-network-meta-analysis
#15
REVIEW
Gianni Virgili, Mariacristina Parravano, Jennifer R Evans, Iris Gordon, Ersilia Lucenteforte
BACKGROUND: Diabetic macular oedema (DMO) is a common complication of diabetic retinopathy. Antiangiogenic therapy with anti-vascular endothelial growth factor (anti-VEGF) modalities can reduce oedema and thereby improve vision and prevent further visual loss. These drugs have replaced laser photocoagulation as the standard of care for people with DMO. OBJECTIVES: The 2014 update of this review found high-quality evidence of benefit with antiangiogenic therapy with anti-VEGF modalities, compared to laser photocoagulation, for the treatment of DMO...
June 22, 2017: Cochrane Database of Systematic Reviews
https://www.readbyqxmd.com/read/28637441/impact-of-tobacco-industry-and-other-corporations-in-the-defeat-of-the-1994-clinton-health-care-plan
#16
Michael Givel
BACKGROUND: The primary reason cited by many scholars for the defeat of the Clinton Administration's 1994 health care reform bill has long been identified as Health Insurance Association of America and National Federation of Independent Businesses opposition to the bill. Given this predominant consensus combined with sizeable proposed funding for the bill by a large tobacco product tax, this manuscript examined what the tobacco industry's role was in whole or part in defeating the Clinton health care bill...
June 21, 2017: BMC Public Health
https://www.readbyqxmd.com/read/28636762/european-diabetes-research-and-its-funding-2002-2013
#17
M Begum, G Lewison, S Sommariva, O Ciani, R Tarricone, R Sullivan
AIM: This study examined the outputs of research papers in diabetes from 31 European countries between 2002 and 2013, and their funding. METHODS: Diabetes research papers in the Web of Science were identified by means of a filter based on journals and title words. For 2009-2013 papers, the funders were coded to show their sector and nationality. RESULTS: Europe published 40 547 diabetes papers in the 12 years between 2002 and 2013. Denmark, Sweden and Finland published the most relative to their wealth, but the UK published the most absolutely despite an apparently low burden (as measured by disability-adjusted life years)...
June 21, 2017: Diabetic Medicine: a Journal of the British Diabetic Association
https://www.readbyqxmd.com/read/28636448/ebola-virus-training-a-needs-assessment-and-gap-analysis
#18
Kevin Yeskey, Joseph Hughes, Betsy Galluzzo, Nina Jaitly, James Remington, Deborah Weinstock, Joy Lee Pearson, Jonathan D Rosen
In response to the 2014 Ebola virus disease outbreak, the Worker Training Program embarked on an assessment of existing training for those at risk for exposure to the virus. Searches of the recent peer-reviewed literature were conducted for descriptions of relevant training. Federal guidance issued during 2015 was also reviewed. Four stakeholder meetings were conducted with representatives from health care, academia, private industry, and public health to discuss issues associated with ongoing training. Our results revealed few articles about training that provided sufficient detail to serve as models...
May 2017: Health Security
https://www.readbyqxmd.com/read/28633984/herbal-medicinal-products-in-pregnancy-which-data-are-available
#19
REVIEW
Jacqueline Wiesner, Werner Knöss
This review aims to highlight recent approaches concerning usage of (traditional) herbal medicinal products in pregnancy and to discuss appropriate strategies to handle limited information. Therefore, published monographs of the Committee on Herbal Medicinal products (HMPC) and selected publicly funded webpages, medicinal handbooks, publications and industry and health care organisations webpages were evaluated. While within the monographs of the HMPC a rather conservative approach could be found (mainly because of lacking nonclinical and/or clinical studies), all other sources display a wide variety of information or assessments, thereby often giving contradictory recommendations...
June 17, 2017: Reproductive Toxicology
https://www.readbyqxmd.com/read/28626425/lemons-or-squeezed-for-resources-information-symmetry-and-asymmetric-resources-in-biotechnology
#20
Arthur Neuberger, Nektarios Oraiopoulos, Donald L Drakeman
Thousands of biotech companies are developing promising products, but have insufficient resources to complete the clinical testing process, while large, well-funded companies have increasingly focused on the need to access external innovation. As a result, licensing deals are an essential and growing part of this industry. Yet, casting a shadow over the licensing market is the classic Lemons Problem: Does asymmetrical information put licensees at a severe disadvantage, leading to a market dominated by inferior opportunities, with the best products retained for internal development? Our analysis of clinical stage products developed over three decades shows that there is no Lemons Problem...
2017: Frontiers in Pharmacology
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