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https://www.readbyqxmd.com/read/29124055/regulatory-and-scientific-advancements-in-gene-therapy-state-of-the-art-of-clinical-applications-and-of-the-supporting-european-regulatory-framework
#1
REVIEW
Marta Carvalho, Bruno Sepodes, Ana Paula Martins
Advanced therapy medicinal products (ATMPs) have a massive potential to address existing unmet medical needs. Specifically, gene therapy medicinal products (GTMPs) may potentially provide cure for several genetic diseases. In Europe, the ATMP regulation was fully implemented in 2009 and, at this point, the Committee for Advanced Therapies was created as a dedicated group of specialists to evaluate medicinal products requiring specific expertise in this area. To date, there are three authorized GTMPs, and the first one was approved in 2012...
2017: Frontiers in Medicine
https://www.readbyqxmd.com/read/29094375/collaborative-targeted-learning-using-regression-shrinkage
#2
Mireille E Schnitzer, Matthew Cefalu
Causal inference practitioners are routinely presented with the challenge of model selection and, in particular, reducing the size of the covariate set with the goal of improving estimation efficiency. Collaborative targeted minimum loss-based estimation (CTMLE) is a general framework for constructing doubly robust semiparametric causal estimators that data-adaptively limit model complexity in the propensity score to optimize a preferred loss function. This stepwise complexity reduction is based on a loss function placed on a strategically updated model for the outcome variable through which the error is assessed using cross-validation...
November 2, 2017: Statistics in Medicine
https://www.readbyqxmd.com/read/29088918/the-application-of-molecular-topology-for-ulcerative-colitis-drug-discovery
#3
Carolina L Bellera, Mauricio E Di Ianni, Alan Talevi
Although the therapeutic arsenal against ulcerative colitis has greatly expanded (including the revolutionary advent of biologics), there remain patients who are refractory to current medications while the safety of the available therapeutics could also be improved. Molecular topology provides a theoretic framework for the discovery of new therapeutic agents in a very efficient manner, and its applications in the field of ulcerative colitis have slowly begun to flourish. Areas covered: After discussing the basics of molecular topology, the authors review QSAR models focusing on validated targets for the treatment of ulcerative colitis, entirely or partially based on topological descriptors...
November 1, 2017: Expert Opinion on Drug Discovery
https://www.readbyqxmd.com/read/29074146/community-pharmacists-beliefs-regarding-improvement-of-star-ratings-scores-using-the-theory-of-planned-behavior
#4
David L George, Michael J Smith, JoLaine R Draugalis, Eleni L Tolma, Shellie L Keast, Justin B Wilson
OBJECTIVES: The Centers for Medicare and Medicaid Services (CMS) is moving toward a value-based model, which includes the Five-Star Quality Rating System (Star Ratings). Prescription Drug Plans include multiple pharmacy measures associated with adherence and patient safety that contribute to CMS Star Ratings scores. This study, using the Theory of Planned Behavior (TPB), explored factors associated with community pharmacists' beliefs to improve Star Ratings scores. DESIGN: Exploratory, qualitative, use of focus groups, and the TPB...
October 23, 2017: Journal of the American Pharmacists Association: JAPhA
https://www.readbyqxmd.com/read/29073314/the-sdm-3-circle-model-a-literature-synthesis-and-adaptation-for-shared-decision-making-in-the-hospital
#5
Stephanie Rennke, Patrick Yuan, Brad Monash, Rebecca Blankenburg, Ian Chua, Stephanie Harman, Debbie S Sakai, Adeena Khan, Joan F Hilton, Lisa Shieh, Jason Satterfield
Patient engagement through shared decision-making (SDM) is increasingly seen as a key component for patient safety, patient satisfaction, and quality of care. Current SDM models do not adequately account for medical and environmental contexts, which may influence medical decisions in the hospital. We identified leading SDM models and reviews to inductively construct a novel SDM model appropriate for the inpatient setting. A team of medicine and pediatric hospitalists reviewed the literature to integrate core SDM concepts and processes and iteratively constructed a synthesized draft model...
October 18, 2017: Journal of Hospital Medicine: An Official Publication of the Society of Hospital Medicine
https://www.readbyqxmd.com/read/29073186/ethical-issues-in-the-development-and-implementation-of-nutrition-related-public-health-policies-and-interventions-a-scoping-review
#6
Thierry Hurlimann, Juan Pablo Peña-Rosas, Abha Saxena, Gerardo Zamora, Béatrice Godard
BACKGROUND: The limited integration of ethics in nutrition-related public health policies and interventions is one major concern for those who have the task of implementing them. Ethical challenges that are overlooked during the development of such interventions could raise serious ethical issues during their implementation and even after. As a result, these decision makers need technical support and ethical guidance for adaptation of interventions to local (cultural, social, economic, etc...
2017: PloS One
https://www.readbyqxmd.com/read/29065775/a-risk-factor-analysis-of-medical-litigation-judgments-related-to-fall-injuries-in-korea
#7
Insook Kim, Seonae Won, Mijin Lee, Won Lee
The aim of this study was to find out the risk factors through analysis of seven medical malpractice judgments related to fall injuries. The risk factors were analysed by using the framework that approaches falls from a systems perspective and comprised people, organisational or environmental factors, with each factor being comprised of subfactors. The risk factors found in each of the seven judgments were aggregated into one framework. The risk factors related to patients (i.e. the people factor) were age, pain, related disease, activities and functional status, urination state, cognitive function impairment, past history of fall, blood transfusion, sleep endoscopy state and uncooperative attitude...
January 1, 2017: Medicine, Science, and the Law
https://www.readbyqxmd.com/read/29030096/medical-safety-huddles-in-rehabilitation-a-novel-patient-safety-strategy
#8
Meiqi Guo, Gaetan Tardif, Mark Bayley
OBJECTIVE: To describe the implementation process, outcomes, and lessons learned in the implementation of medical safety huddles, a novel patient safety monitoring strategy that promotes physician engagement with patient safety. DESIGN: Single-centre observational study. SETTING: The Brain and Spinal Cord Injury Rehabilitation Program (BSCIRP) at an urban, academic adult rehabilitation hospital. PARTICIPANTS: 18 physicians associated with the program...
October 10, 2017: Archives of Physical Medicine and Rehabilitation
https://www.readbyqxmd.com/read/29024416/review-article-a-systematic-review-of-emergency-department-incident-classification-frameworks
#9
REVIEW
Matthew Murray, Sally McCarthy
As in any part of the hospital system, safety incidents can occur in the ED. These incidents arguably have a distinct character, as the ED involves unscheduled flows of urgent patients who require disparate services. To aid understanding of safety issues and support risk management of the ED, a comparison of published ED specific incident classification frameworks was performed. A review of emergency medicine, health management and general medical publications, using Ovid SP to interrogate Medline (1976-2016) was undertaken to identify any type of taxonomy or classification-like framework for ED related incidents...
October 11, 2017: Emergency Medicine Australasia: EMA
https://www.readbyqxmd.com/read/28994386/-integrating-clinical-research-into-epidemic-response-the-field-perspective-in-the-ebola-experience
#10
Denis Malvy, Daouda Sissoko, Alseny-Modet Camara
During the 2013-2016 west African Ebola outbreak that affected West Africa, accelerated clinical trials, testing unproven but promising and potentially lifesaving experimental interventions emerged as a key component of the global outbreak. In 2017, no Ebola medical countermeasures had proven antiviral efficacy in patients. However, in September 2014, the World Health Organization inventoried a list of potential drug candidates developed or repurposed with demonstrated antiviral efficacy in vitro or in animal models...
October 2017: Médecine Sciences: M/S
https://www.readbyqxmd.com/read/28986035/estimating-the-full-public-health-value-of-vaccination
#11
Bradford D Gessner, David Kaslow, Jacques Louis, Kathleen Neuzil, Katherine L O'Brien, Valentina Picot, Tikki Pang, Umesh D Parashar, Mitra Saadatian-Elahi, Christopher B Nelson
There is an enhanced focus on considering the full public health value (FPHV) of vaccination when setting priorities, making regulatory decisions and establishing implementation policy for public health activities. Historically, a therapeutic paradigm has been applied to the evaluation of prophylactic vaccines and focuses on an individual benefit-risk assessment in prospective and individually-randomized phase III trials to assess safety and efficacy against etiologically-confirmed clinical outcomes. By contrast, a public health paradigm considers the population impact and encompasses measures of community benefits against a range of outcomes...
October 3, 2017: Vaccine
https://www.readbyqxmd.com/read/28983881/alzheimer-s-disease-and-driving-review-of-the-literature-and-consensus-guideline-from-belgian-dementia-experts-and-the-belgian-road-safety-institute-endorsed-by-the-belgian-medical-association
#12
Jan Versijpt, Mark Tant, Ingo Beyer, Jean-Christophe Bier, Patrick Cras, Peter P De Deyn, Patrick De Wit, Olivier Deryck, Bernard Hanseeuw, Margareta Lambert, Jean-Claude Lemper, Eric Mormont, Mirko Petrovic, Gaetane Picard, Eric Salmon, Kurt Segers, Anne Sieben, Evert Thiery, Jos Tournoy, Maurits Vandewoude, Manfredi Ventura, Jurn Verschraegen, Sebastiaan Engelborghs, Tom Goffin, Michel Deneyer, Adrian Ivanoiu
Alzheimer's disease (AD) is a highly prevalent condition and its prevalence is expected to further increase due to the aging of the general population. It is obvious that the diagnosis of AD has implications for driving. Finally, driving discussions are also emotionally charged because driving is associated with independence and personal identity. However, it is not clear how to implement this in clinical practice and the Belgian law on driving is rather vague in its referral to neurodegenerative brain diseases in general nor does it provide clear-cut instructions for dementia or AD compared to for example driving for patients with epilepsy and as such does not prove to be very helpful...
October 5, 2017: Acta Neurologica Belgica
https://www.readbyqxmd.com/read/28964589/global-regional-and-subregional-classification-of-abortions-by-safety-2010-14-estimates-from-a-bayesian-hierarchical-model
#13
Bela Ganatra, Caitlin Gerdts, Clémentine Rossier, Brooke Ronald Johnson, Özge Tunçalp, Anisa Assifi, Gilda Sedgh, Susheela Singh, Akinrinola Bankole, Anna Popinchalk, Jonathan Bearak, Zhenning Kang, Leontine Alkema
BACKGROUND: Global estimates of unsafe abortions have been produced for 1995, 2003, and 2008. However, reconceptualisation of the framework and methods for estimating abortion safety is needed owing to the increased availability of simple methods for safe abortion (eg, medical abortion), the increasingly widespread use of misoprostol outside formal health systems in contexts where abortion is legally restricted, and the need to account for the multiple factors that affect abortion safety...
September 27, 2017: Lancet
https://www.readbyqxmd.com/read/28942913/a-focused-review-of-safety-considerations-in-cancer-rehabilitation
#14
REVIEW
Susan Maltser, Adrian Cristian, Julie K Silver, G Stephen Morris, Nicole L Stout
Cancer and its treatments introduce various adverse effects that may affect survivors' physical, cognitive and psychological functioning. Frequently both tolerance to activity and exercise are affected as well. Rehabilitation providers should have substantive knowledge about the effect of cancer progression and common side effects associated with antineoplastic treatment to safely integrate rehabilitation interventions. Rehabilitation may mitigate loss of function and disability; however, these patients are among the most medically complex that providers treat...
September 2017: PM & R: the Journal of Injury, Function, and Rehabilitation
https://www.readbyqxmd.com/read/28935219/medical-abortion-can-be-provided-safely-and-effectively-by-pharmacy-workers-trained-within-a-harm-reduction-framework-nepal
#15
Anand Tamang, Mahesh Puri, Sazina Masud, Deepak Kumar Karki, Diksha Khadka, Minal Singh, Poonam Sharma, Subash Gajurel
OBJECTIVES: To examine the treatment efficacy, safety and satisfaction of women using medical abortion (MA) pills provided by pharmacists following an education intervention based on a harm reduction approach. STUDY DESIGN: This was an operations research study over a six-month period in 2015, using a non-inferiority design. We provided training to dispense MA pills, based on a harm reduction approach, to a group of pharmacy workers in Makwanpur district (GROUP 2)...
September 18, 2017: Contraception
https://www.readbyqxmd.com/read/28934402/a-world-health-organization-field-trial-assessing-a-proposed-icd-11-framework-for-classifying-patient-safety-events
#16
Alan J Forster, Burnand Bernard, Saskia E Drösler, Yana Gurevich, James Harrison, Jean-Marie Januel, Patrick S Romano, Danielle A Southern, Vijaya Sundararajan, Hude Quan, Saskia E Vanderloo, Harold A Pincus, William A Ghali
Objective: To assess the utility of the proposed World Health Organization (WHO)'s International Classification of Disease (ICD) framework for classifying patient safety events. Setting: Independent classification of 45 clinical vignettes using a web-based platform. Study participants: The WHO's multi-disciplinary Quality and Safety Topic Advisory Group. Main outcome measure(s): The framework consists of three concepts: harm, cause and mode...
August 1, 2017: International Journal for Quality in Health Care
https://www.readbyqxmd.com/read/28901995/therapeutic-food-claims-a-global-perspective
#17
Bruce P Burnett, Gerard Mullin
PURPOSE OF REVIEW: Medical foods in the United States, and foods for special medical purposes in other countries, are food formulations used to manage specific chronic diseases or conditions under medical or physician supervision. The process of reviewing and approving food claims for health benefits varies widely from country to country. RECENT FINDINGS: CODEX Alimentarius, a 187-country and one-member (European Union) organization, has standardized not only nutrition labeling and food safety worldwide but has also recently taken on a prominent role in analyzing therapeutic and health claims for food in member countries by providing a framework to study these issues...
November 2017: Current Opinion in Clinical Nutrition and Metabolic Care
https://www.readbyqxmd.com/read/28885221/the-establishment-of-the-drug-naming-committee-to-restrict-look-alike-medication-names-in-iran-a-qualitative-study
#18
Nazanin Abolhassani, Ali Akbari Sari, Arash Rashidian, Mansoor Rastegarpanah
BACKGROUND: Medication errors is a prominent issue on the health policy agenda due to its significant human and financial costs; confusing drug names are one of the most common causes of them. This issue necessitates the adoption of a mechanism to restrict such a confusion before approving drug names. OBJECTIVE: Following the establishment of a committee and developed relevant criteria as mechanisms to address the issue of drug names similarity Iran, there were problems in this process...
2017: International Journal of Risk & Safety in Medicine
https://www.readbyqxmd.com/read/28885218/off-label-use-of-medicines-the-need-for-good-practice-guidelines
#19
Marc Dooms, James Killick
BACKGROUND: 'Off-label use' is the term used for the prescription and dispensing of a medicinal product for any indication, patient group, route of administration, dosage or treatment regimen other than that listed in the Summary of Product Characteristics. OBJECTIVE: In this article the authors present a brief overview of current practices of off-label use in Europe and the applicable European law and jurisprudence. They then go on to present a set of guidelines for best practice in off-label use which underlines the need for guidance on prescription to be firmly rooted in the need to ensure patient safety above all other concerns...
2017: International Journal of Risk & Safety in Medicine
https://www.readbyqxmd.com/read/28882134/a-conceptual-framework-for-patient-centered-fertility-treatment
#20
Elizabeth A Duthie, Alexandra Cooper, Joseph B Davis, Katherine D Schoyer, Jay Sandlow, Estil Y Strawn, Kathryn E Flynn
BACKGROUND: Patient-centered care is a pillar of quality health care and is important to patients experiencing infertility. In this study we used empirical, in-depth data on couples' experiences of infertility treatment decision making to inform and revise a conceptual framework for patient-centered fertility treatment that was developed based on health care professionals' conceptualizations of fertility treatment, covering effectiveness, burden, safety, and costs. METHODS: In this prospective, longitudinal mixed methods study, we collected data from both members (separately) of 37 couples who scheduled an initial consult with a reproductive specialist...
September 7, 2017: Reproductive Health
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