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https://www.readbyqxmd.com/read/28445381/regulatory-advocacy-update-american-society-of-plastic-surgeons-comments-in-response-to-the-u-s-food-and-drug-administration-draft-guidance-documents-on-human-cell-and-tissue-products
#1
J Peter Rubin, Richard A D'Amico, Ricardo Rodriguez, Sydney R Coleman, Paul Cederna, Scot Glasberg, Michael Neumeister, David H Song, Charles Butler, Keith M Hume
The U.S. Food and Drug Administration released draft guidance documents on human cells, tissues, and cellular and tissue-based products regulations. These proposed guidance documents can impact the practice of plastic surgery in the area of tissue grafting procedures. This article describes the relevant issues in these draft guidance documents, and presents the comments provided to the U.S. Food and Drug Administration by the American Society of Plastic Surgeons.
May 2017: Plastic and Reconstructive Surgery
https://www.readbyqxmd.com/read/28444300/reproductive-justice-a-policy-window-for-social-work-advocacy
#2
Brenda D Smith
Reproductive rights are at risk in many parts of the United States. To inspire social workers to act, this article begins by defining and describing the concepts of reproductive rights and reproductive justice. Next, it summarizes threats to reproductive rights in five areas: preventing pregnancy, terminating pregnancy, pregnancy loss, personhood measures, and drug use during pregnancy. Applying John Kingdon's policy streams framework, the article urges more social workers to embrace the current policy window and advocate for pregnant women and others whose reproductive rights are in jeopardy...
April 21, 2017: Social Work
https://www.readbyqxmd.com/read/28443357/informed-consent-and-the-aftermath-of-cardiopulmonary-resuscitation-ethical-considerations
#3
Pamela Bjorklund, Denise M Lund
BACKGROUND: Patients often are confronted with the choice to allow cardiopulmonary resuscitation (CPR) should cardiac arrest occur. Typically, informed consent for CPR does not also include detailed discussion about survival rates, possible consequences of survival, and/or potential impacts on functionality post-CPR. OBJECTIVE: A lack of communication about these issues between providers and patients/families complicates CPR decision-making and highlights the ethical imperative of practice changes that educate patients and families in those deeper and more detailed ways...
January 1, 2017: Nursing Ethics
https://www.readbyqxmd.com/read/28442941/competency-based-tool-for-evaluation-of-community-based-training-in-undergraduate-medical-education-in-india-a-delphi-approach
#4
Hemant Deepak Shewade, Kathiresan Jeyashree, Selvaraj Kalaiselvi, Chinnakali Palanivel, Krishna Chandra Panigrahi
INTRODUCTION: A community-based training (CBT) program, where teaching and training are carried out in the community outside of the teaching hospital, is a vital part of undergraduate medical education. Worldwide, there is a shift to competency-based training, and CBT is no exception. We attempted to develop a tool that uses a competency-based approach for assessment of CBT. METHODS: Based on a review on competencies, we prepared a preliminary list of major domains with items under each domain...
2017: Advances in Medical Education and Practice
https://www.readbyqxmd.com/read/28441219/last-but-not-least-pa-practice-in-mississippi
#5
Tristen A Harris, Kenneth R Butler
This article describes the history of physician assistants (PAs) in Mississippi, the last state to pass legislation allowing for PA practice. A small group of PAs in the state began pursuing a PA practice act in the early 1990s with little political advocacy experience, and in 1994, the American Academy of PAs actively joined "The Battle for Mississippi." In April 2000, after years of PA advocacy, Mississippi passed the bill that would authorize PA practice in the state.
May 2017: JAAPA: Official Journal of the American Academy of Physician Assistants
https://www.readbyqxmd.com/read/28440861/findings-from-the-families-on-track-intervention-pilot-trial-for-children-with-fetal-alcohol-spectrum-disorders-and-their-families
#6
Christie L M Petrenko, Mary E Pandolfino, Luther K Robinson
BACKGROUND: Individuals with fetal alcohol spectrum disorders (FASD) are at high risk for costly, debilitating mental health problems and secondary conditions, such as school disruption, trouble with the law, and substance use. The study objective was to pilot a multi-component intervention designed to prevent secondary conditions in children with FASD and improve family adaptation. METHODS: Thirty children with FASD or prenatal alcohol exposure (PAE) (ages 4 to 8) and their primary caregivers were enrolled...
April 25, 2017: Alcoholism, Clinical and Experimental Research
https://www.readbyqxmd.com/read/28440796/the-importance-of-international-collaboration-for-rare-diseases-research-a-european-perspective
#7
REVIEW
D Julkowska, C P Austin, C M Cutillo, D Gancberg, C Hager, J Halftermeyer, A H Jonker, L P L Lau, I Norstedt, A Rath, R Schuster, E Simelyte, S van Weely
Over the last two decades, important contributions were made at national, European and international levels to foster collaboration into rare diseases research. The European Union (EU) has put much effort into funding rare diseases research, encouraging national funding organizations to collaborate together in the E-Rare programme, setting up European Reference Networks for rare diseases and complex conditions, and initiating the International Rare Diseases Research Consortium (IRDiRC) together with the National Institutes of Health in the USA...
April 25, 2017: Gene Therapy
https://www.readbyqxmd.com/read/28435081/a-multiple-streams-analysis-of-the-decisions-to-fund-gender-neutral-hpv-vaccination-in-canada
#8
REVIEW
Gilla K Shapiro, Juliet Guichon, Gillian Prue, Samara Perez, Zeev Rosberger
In Canada, the human papillomavirus (HPV.) vaccine is licensed and recommended for females and males. Although all Canadian jurisdictions fund school-based HPV vaccine programs for girls, only six jurisdictions fund school-based HPV vaccination for boys. The research aimed to analyze the factors that underpin government decisions to fund HPV vaccine for boys using a theoretical policy model, Kingdon's Multiple Streams framework. This approach assesses policy development by examining three concurrent, but independent, streams that guide analysis: Problem Stream, Policy Stream, and Politics Stream...
April 20, 2017: Preventive Medicine
https://www.readbyqxmd.com/read/28434926/scoping-review-to-develop-common-data-elements-for-lumbar-spinal-stenosis
#9
Allen Heinemann, Jason Raad, Venu Akuthota, Neil Segal, Kristian P Nitsch, Monica Rho, Leighton Chan, Ellen Casey, Joel Press, Gwendolyn Sowa, Jennifer Moore
BACKGROUND CONTEXT: Common Data Elements (CDE) represent an important tool for understanding and classifying health outcomes across settings. While CDE's have been developed for a number of disorders, to date CDEs for Lumbar Spinal Stenosis (LSS) have not been fully developed. To facilitate the identification of CDEs and measures to assess them, this technical study leverages The International Classification of Functioning, Disability and Health (ICF), peer-reviewed research, and a panel of experts to identify CDEs specific to LSS...
April 18, 2017: Spine Journal: Official Journal of the North American Spine Society
https://www.readbyqxmd.com/read/28434650/global-kidney-health-2017-and-beyond-a-roadmap-for-closing-gaps-in-care-research-and-policy
#10
REVIEW
Adeera Levin, Marcello Tonelli, Joseph Bonventre, Josef Coresh, Jo-Ann Donner, Agnes B Fogo, Caroline S Fox, Ron T Gansevoort, Hiddo J L Heerspink, Meg Jardine, Bertram Kasiske, Anna Köttgen, Matthias Kretzler, Andrew S Levey, Valerie A Luyckx, Ravindra Mehta, Orson Moe, Gregorio Obrador, Neesh Pannu, Chirag R Parikh, Vlado Perkovic, Carol Pollock, Peter Stenvinkel, Katherine R Tuttle, David C Wheeler, Kai-Uwe Eckardt
The global nephrology community recognises the need for a cohesive plan to address the problem of chronic kidney disease (CKD). In July, 2016, the International Society of Nephrology hosted a CKD summit of more than 85 people with diverse expertise and professional backgrounds from around the globe. The purpose was to identify and prioritise key activities for the next 5-10 years in the domains of clinical care, research, and advocacy and to create an action plan and performance framework based on ten themes: strengthen CKD surveillance; tackle major risk factors for CKD; reduce acute kidney injury-a special risk factor for CKD; enhance understanding of the genetic causes of CKD; establish better diagnostic methods in CKD; improve understanding of the natural course of CKD; assess and implement established treatment options in patients with CKD; improve management of symptoms and complications of CKD; develop novel therapeutic interventions to slow CKD progression and reduce CKD complications; and increase the quantity and quality of clinical trials in CKD...
April 20, 2017: Lancet
https://www.readbyqxmd.com/read/28433107/patient-support-groups-in-the-management-of-wilson-disease
#11
Mary L Graper, Michael L Schilsky
Patient support groups serve an important function for those affected by a disease but especially for people with a rare disease. Because of the complexity of Wilson disease there are some unique and difficult problems faced by groups that advocate for these patients. We give a comparative overview of the differences between groups that support people with more common diseases and groups that serve the rare disease population. The history and current status of the Wilson Disease Association and other worldwide Wilson disease groups are described and information about other organizations that support Wilson disease in additional ways is explained...
2017: Handbook of Clinical Neurology
https://www.readbyqxmd.com/read/28431546/health-care-public-reporting-utilization-user-clusters-web-trails-and-usage-barriers-on-germany-s-public-reporting-portal-weisse-liste-de
#12
Christoph Pross, Lars-Henrik Averdunk, Josip Stjepanovic, Reinhard Busse, Alexander Geissler
BACKGROUND: Quality of care public reporting provides structural, process and outcome information to facilitate hospital choice and strengthen quality competition. Yet, evidence indicates that patients rarely use this information in their decision-making, due to limited awareness of the data and complex and conflicting information. While there is enthusiasm among policy makers for public reporting, clinicians and researchers doubt its overall impact. Almost no study has analyzed how users behave on public reporting portals, which information they seek out and when they abort their search...
April 21, 2017: BMC Medical Informatics and Decision Making
https://www.readbyqxmd.com/read/28430547/enhancing-insights-into-pulmonary-vascular-disease-pvd-through-a-precision-medicine-approach-a-joint-nhlbi-cmref-workshop-report
#13
John H Newman, Stuart Rich, Steven H Abman, John H Alexander, John Barnard, Gerald J Beck, Raymond L Benza, Todd M Bull, Stephen Y Chan, Hyung J Chun, Declan Doogan, Jocelyn Dupuis, Serpil C Erzurum, Robert P Frantz, Mark Geraci, Hunter Gillies, Mark Gladwin, Michael P Gray, Anna R Hemnes, Roy S Herbst, Adrian F Hernandez, Nicholas S Hill, Evelyn M Horn, Kendall Hunter, Zhi-Cheng Jing, Roger Johns, Sanjay Kaul, Steven M Kawut, Tim Lahm, Jane A Leopold, Greg D Lewis, Stephen C Mathai, Vallerie V McLaughlin, Evangelos D Michelakis, Steven D Nathan, William Nichols, Grier Page, Marlene Rabinovitch, Jonathan Rich, Franz Rischard, Sharon Rounds, Sanjiv J Shah, Victor F Tapson, Naomi Lowy, Norman Stockbridge, Gail Weinmann, Lei Xiao
The Division of Lung Diseases of the National Heart, Lung and Blood Institute, (NHLBI) and the Cardiovascular Medical Education and Research Fund (CMREF), held a workshop to discuss to leverage of the anticipated scientific output from the recently launched "Redefining Pulmonary Hypertension (PH) through Pulmonary Vascular Disease Phenomics" (PVDOMICS) program. PVDOMICS is a protocol driven network to analyze PH patient populations to define novel pulmonary vascular disease (PVD) phenotypes. Basic, translational and clinical investigators, patient advocacy organizations, regulatory agencies, and pharmaceutical industry experts discussed the application of precision medicine to PVD clinical trials...
April 21, 2017: American Journal of Respiratory and Critical Care Medicine
https://www.readbyqxmd.com/read/28428245/thematic-analysis-of-us-stakeholder-views-on-the-influence-of-labour-nurses-care-on-birth-outcomes
#14
Audrey Lyndon, Kathleen Rice Simpson, Joanne Spetz
BACKGROUND: Childbirth is a leading reason for hospital admission in the USA, and most labour care is provided by registered nurses under physician or midwife supervision in a nurse-managed care model. Yet, there are no validated nurse-sensitive quality measures for maternity care. We aimed to engage primary stakeholders of maternity care in identifying the aspects of nursing care during labour and birth they believe influence birth outcomes, and how these aspects of care might be measured...
April 20, 2017: BMJ Quality & Safety
https://www.readbyqxmd.com/read/28428111/reproductive-healthcare-experiences-of-women-with-cerebral-palsy
#15
Katharine Hayward, Angela Y Chen, Elizabeth Forbes, Rachel Byrne, Marcia B Greenberg, Eileen G Fowler
BACKGROUND: Little is known about pregnancy rates in women with disabilities in general and even less is known about women with child-onset disabilities such as cerebral palsy (CP). HYPOTHESIS: We hypothesized that discussions about pregnancy with healthcare providers and pregnancy rates for woman with CP would be related to their functional levels. METHODS: Survey methodology was used to gather information about demographics, function, whether women were asked about their desire for children, pregnancy outcomes, and services offered during pregnancy and postpartum...
April 5, 2017: Disability and Health Journal
https://www.readbyqxmd.com/read/28427338/-working-is-out-of-the-question-a-qualitative-text-analysis-of-medical-certificates-of-disability
#16
Guri Aarseth, Bård Natvig, Eivind Engebretsen, Anne Kveim Lie
BACKGROUND: Medical certificates influence the distribution of economic benefits in welfare states; however, the qualitative aspects of these texts remain largely unexplored. The present study is the first systematic investigation done of these texts. Our aim was to investigate how GPs select and mediate information about their patients' health and how they support their conclusions about illness, functioning and fitness for work in medical certificates. METHODS: We performed a textual analysis of thirty-three medical certificates produced by general practitioners (GP) in Norway at the request of the Norwegian Labour and Welfare Administration (NAV)...
April 20, 2017: BMC Family Practice
https://www.readbyqxmd.com/read/28426359/reductions-in-hard-drug-use-among-homeless-youth-receiving-a-strength-based-outreach-intervention-comparing-the-long-term-effects-of-shelter-linkage-versus-drop-in-center-linkage
#17
Xiamei Guo, Natasha Slesnick
OBJECTIVES: The current study sought to test hard drug use outcomes for youth receiving a strengths-based outreach and advocacy intervention that linked youth to either a shelter or a drop-in center. METHODS: Homeless youth (14-24 years old) were engaged by research assistants (RAs) at soup kitchens, parks, libraries, and other locations that homeless youth were known to frequent. Youth were randomly assigned to receive six months of advocacy that focused on linking youth to a drop-in center (n = 40) or to a crisis shelter (n = 39)...
June 7, 2017: Substance Use & Misuse
https://www.readbyqxmd.com/read/28426309/lgbtq-health-surveillance-data%C3%A2-%C3%A2-power
#18
Randall L Sell
Despite decades of research and advocacy, sexual and gender minorities are still not equitably included in health research and surveillance in the United States. In 1990, as I was beginning graduate school, I wrote on a piece of paper "Data = Power." This was my take on ACT UP's (AIDS Coalition to Unleash Power) "Silence = Death." I created this personal motto because I had been working in the late 1980s on evaluations of some of the earliest federally funded HIV/AIDS prevention programs while attending ACT UP's first demonstration at the Food and Drug Administration in 1988 and attending its action to "Storm the NIH" (National Institutes of Health) in 1990...
April 20, 2017: American Journal of Public Health
https://www.readbyqxmd.com/read/28426304/a-significant-and-quiet-threat-to-public-health-in-the-united-states-state-preemption
#19
Jennifer L Pomeranz, Mark Pertschuk
State and local governments traditionally protect the health and safety of their populations more strenuously than does the federal government. Preemption, when a higher level of government restricts or withdraws the authority of a lower level of government to act on a particular issue, was historically used as a point of negotiation in the legislative process. More recently, however, 3 new preemption-related issues have emerged that have direct implications for public health. First, multiple industries are working on a 50-state strategy to enact state laws preempting local regulation...
April 20, 2017: American Journal of Public Health
https://www.readbyqxmd.com/read/28426284/participatory-genomic-research-ethical-issues-from-the-bottom-up-to-the-top-down
#20
Heide Aungst, Michelle L McGowan, Jennifer R Fishman
Participatory approaches to genomic research manifest along a continuum from bottom-up citizen-science initiatives designed to liberate scientific inquiry from the constraints of traditional research institutional contexts and professional practices to top-down investigator-initiated studies designed to expose the public to scientific research processes and build their support and enthusiasm for genomic research. With foundations as varied as open science, crowdsourcing, patient advocacy, social media, the digitization of health, and the neoliberalization of academic research, a range of ethical frameworks inform the modes of participatory genomic research...
April 19, 2017: Annual Review of Genomics and Human Genetics
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