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https://www.readbyqxmd.com/read/29343970/a-retrospective-examination-of-the-us-food-and-drug-administration-s-clinical-pharmacology-reviews-of-oncology-biologics-for-potential-use-of-therapeutic-drug-monitoring
#1
Brett Fleisher, Sihem Ait-Oudhia
Background: Biologics have gained traction for use in oncology, but have demonstrate clinical variability for efficacy and safety. Therapeutic drug monitoring (TDM) can benefit patients' outcomes from a biologic therapy when the latter has a defined therapeutic window. A clinically relevant therapeutic window may exist for biologics with established exposure-response (E-R) relationships for efficacy and/or safety and a documented maximum tolerated dose (MTD). Additionally, the inter-individual variability (IIV) on the clearance (CL) parameter could determine risks for patients falling outside the proposed therapeutic window...
2018: OncoTargets and Therapy
https://www.readbyqxmd.com/read/29324071/effect-of-task-load-interventions-on-fatigue-in-emergency-medical-services-personnel-and-other-shift-workers-a-systematic-review
#2
Jonathan R Studnek, Allison E Infinger, Megan L Renn, Patricia M Weiss, Joseph P Condle, Katharyn L Flickinger, Andrew J Kroemer, Brett R Curtis, Xiaoshuang Xun, Ayushi A Divecha, Patrick J Coppler, Zhadyra Bizhanova, Denisse J Sequeira, Eddy Lang, J Stephen Higgins, P Daniel Patterson
BACKGROUND: Modifying the task load of Emergency Medical Services (EMS) personnel may mitigate fatigue, sleep quality and fatigue related risks. A review of the literature addressing task load interventions may benefit EMS administrators as they craft policies related to mitigating fatigue. We conducted a systematic review of the peer-reviewed literature to address the following question: "In EMS personnel, do task load interventions mitigate fatigue, mitigate fatigue-related risks, and/or improve sleep?" (PROSPERO 2016:CRD42016040114)...
January 11, 2018: Prehospital Emergency Care
https://www.readbyqxmd.com/read/29277160/elderly-patients-and-gps-perspectives-of-patient-gp-communication-concerning-polypharmacy-a-qualitative-interview-study
#3
Andrea C Schöpf, Maike von Hirschhausen, Erik Farin, Andy Maun
Aim The aim of this study was to explore elderly patients' and general practitioners' (GPs') perceptions of communication about polypharmacy, medication safety and approaches for empowerment. BACKGROUND: To manage polypharmacy, GPs need to know patients' real medication consumption. However, previous research has shown that patients do not always volunteer all information about their medication regimen, for example, such as the intake of over-the-counter medication or the alteration or discontinuation of prescribed medication...
December 26, 2017: Primary Health Care Research & Development
https://www.readbyqxmd.com/read/29250993/pharmaceutical-care-services-to-people-living-with-dementia-in-care-homes-a-qualitative-study-of-community-pharmacists-perceptions
#4
Beryl Navti, Bugewa Apampa
There is a paucity of information on the perceptions of community pharmacists about the nature and effectiveness of pharmaceutical care services they provide to people living with dementia in care homes. This paper explores pharmacists' perceptions of the nature and effectiveness of pharmacy services provided, and their experiences when providing these services. Community pharmacists delivering services to care homes with dementia in Thurrock, Essex and in Medway, Kent, England were invited to participate in the study involving face-to-face interviews...
January 1, 2017: Dementia
https://www.readbyqxmd.com/read/29248033/practicing-safety-a-quality-improvement-intervention-to-test-tools-to-enhance-pediatric-psychosocial-care-for-children-0-3-years
#5
Diane J Abatemarco, Ruth S Gubernick, Marianna D LaNoue, Ryan T Pohlig, Sara R Slovin, Jill A Healy, Steven Kairys
BACKGROUND: Child maltreatment is a significant public health issue in the United States. Yet, fewer than half of pediatricians discuss behavioral, developmental, or parenting issues with parents. OBJECTIVE: This paper describes the testing of bundles of tools and processes, part of a larger intervention, Practicing Safety, targeted at changing physician and staff behavior to identify families at risk for child maltreatment, provide anticipatory guidance, refer to community resources, and follow-up and track at-risk families...
December 18, 2017: Primary Health Care Research & Development
https://www.readbyqxmd.com/read/29241902/scientific-evidence-in-health-technology-assessment-reports-an-in-depth-analysis-of-european-assessments-on-high-risk-medical-devices
#6
Britta Olberg, Sabine Fuchs, Dimitra Panteli, Matthias Perleth, Reinhard Busse
BACKGROUND: The aim of this study was to examine the scientific evidence on clinical effectiveness and safety used in health technology assessments (HTAs) of high-risk medical devices (MDs) in Europe. METHODS: We applied a systematic approach to identify European institutions involved in HTA and to select reports assessing MDs considered high-risk according to the definition in the new German health care regulation §137h. Reports published between 2010 and 2015 were considered in our subsequent analysis...
December 2017: Value in Health: the Journal of the International Society for Pharmacoeconomics and Outcomes Research
https://www.readbyqxmd.com/read/29234493/what-are-the-risks-of-manual-treatment-of-the-spine-a-scoping-review-for-clinicians
#7
REVIEW
Gabrielle Swait, Rob Finch
Background: Communicating to patients the risks of manual treatment to the spine is an important, but challenging element of informed consent. This scoping review aimed to characterise and summarise the available literature on risks and to describe implications for clinical practice and research. Method: A methodological framework for scoping reviews was followed. Systematic searches were conducted during June 2017. The quantity, nature and sources of literature were described...
2017: Chiropractic & Manual Therapies
https://www.readbyqxmd.com/read/29233155/a-meta-model-for-computer-executable-dynamic-clinical-safety-checklists
#8
Shan Nan, Pieter Van Gorp, Xudong Lu, Uzay Kaymak, Hendrikus Korsten, Richard Vdovjak, Huilong Duan
BACKGROUND: Safety checklist is a type of cognitive tool enforcing short term memory of medical workers with the purpose of reducing medical errors caused by overlook and ignorance. To facilitate the daily use of safety checklists, computerized systems embedded in the clinical workflow and adapted to patient-context are increasingly developed. However, the current hard-coded approach of implementing checklists in these systems increase the cognitive efforts of clinical experts and coding efforts for informaticists...
December 12, 2017: BMC Medical Informatics and Decision Making
https://www.readbyqxmd.com/read/29226226/work-based-assessment-and-co-production-in-postgraduate-medical-training
#9
Eric S Holmboe
Assessment has always been an essential component of postgraduate medical education and for many years focused predominantly on various types of examinations. While examinations of medical knowledge and more recently of clinical skills with standardized patients can assess learner capability in controlled settings and provide a level of assurance for the public, persistent and growing concerns regarding quality of care and patient safety worldwide has raised the importance and need for better work-based assessments...
2017: GMS Journal for Medical Education
https://www.readbyqxmd.com/read/29222286/improving-emergency-department-based-care-of-sickle-cell-pain
#10
REVIEW
Jeffrey A Glassberg
Pain is the leading cause of emergency department (ED) visits for individuals living with sickle cell disease (SCD). The care that is delivered in the ED is often cited by patients with SCD as the area of health care in greatest need of improvement. In 2014, the National Heart, Lung, and Blood Institute released guidelines for the care of SCD, including recommendations for the management of acute sickle cell pain in the ED. These guidelines provide a framework to understand the elements of ideal emergency sickle cell pain care; however, they do not provide guidance on barriers and facilitators to achieving these ideals in the complex system of the ED...
December 8, 2017: Hematology—the Education Program of the American Society of Hematology
https://www.readbyqxmd.com/read/29211054/barriers-and-facilitators-for-information-exchange-during-over-the-counter-consultations-in-community-pharmacy-a-focus-group-study
#11
Liza J Seubert, Kerry Whitelaw, Fabienne Boeni, Laetitia Hattingh, Margaret C Watson, Rhonda M Clifford
Consumers are confident managing minor ailments through self-care, often self-medicating from a range of over-the-counter (OTC) medicines available from community pharmacies. To minimise risks, pharmacy personnel endeavour to engage in a consultation when consumers present with OTC enquiries however they find consumers resistant. The aim was to determine stakeholder perspectives regarding barriers and facilitators for information exchange during OTC consultations in community pharmacies and to understand the elicited themes in behavioural terms...
December 6, 2017: Pharmacy (Basel, Switzerland)
https://www.readbyqxmd.com/read/29193591/patient-perceptions-of-deterioration-and-patient-and-family-activated-escalation-systems-a-qualitative-study
#12
Jessica Guinane, Alison M Hutchinson, Tracey Bucknall
AIM: To investigate the experiences of patients who received a Medical Emergency Team (MET) review following a period of clinical deterioration and their views about the potential use of a Patient and Family Activated Escalation System (PFAES). BACKGROUND: Delay or failure by health professionals to respond to clinical deterioration remains a patient safety concern. Patients may sometimes identify subtle cues of early deterioration prior to changes in vital signs...
November 30, 2017: Journal of Clinical Nursing
https://www.readbyqxmd.com/read/29172978/application-of-the-fda-biosimilar-extrapolation-framework-to-make-off-label-determinations
#13
Edward Li, Ernesto Lobaina
BACKGROUND: The FDA's extrapolation framework allows for a biosimilar to obtain licensure for indications that were not explicitly studied in the context of a clinical trial by extending conclusions from studies in 1 population to make inferences in other populations. Within routine clinical care, drugs and biologics are routinely used for medically accepted off-label indications. The appropriateness of these products for off-label indications are typically curated by compendia and guidelines, which have established processes and criteria for reviewing and evaluating the evidence to make such determinations...
December 2017: Journal of Managed Care & Specialty Pharmacy
https://www.readbyqxmd.com/read/29157254/the-implementation-of-medical-revalidation-an-assessment-using-normalisation-process-theory
#14
Abigail Tazzyman, Jane Ferguson, Charlotte Hillier, Alan Boyd, John Tredinnick-Rowe, Julian Archer, Sam Regan de Bere, Kieran Walshe
BACKGROUND: Medical revalidation is the process by which all licensed doctors are legally required to demonstrate that they are up to date and fit to practise in order to maintain their licence. Revalidation was introduced in the United Kingdom (UK) in 2012, constituting significant change in the regulation of doctors. The governing body, the General Medical Council (GMC), envisages that revalidation will improve patient care and safety. This potential however is, in part, dependent upon how successfully revalidation is embedded into routine practice...
November 21, 2017: BMC Health Services Research
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
#15
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
#16
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
#17
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
#18
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
#19
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
#20
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
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