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https://www.readbyqxmd.com/read/28214229/-iso%C3%A2-9001%C3%A2-certification-of-innovation-and-clinical-research-departments-extending-the-scope-of-health-assessment
#1
C Sambou, S Guillemaut, M Morelle, A Achache, A-G Le Corroller, D Perol, L Perrier
BACKGROUND: The International organization for standardization (ISO) is the world leader in providing industrial and commercial standards and certifications. Beyond medical devices, four French clinical research and innovation departments have received an ISO 9001 certification (the standard for quality management). Simultaneously, medico-economic studies have become increasingly important in the public decision process. Using the clinical research and innovation department from the Léon-Bérard Cancer Center as an example, the purpose of this article is to show how the scope of the ISO 9001 certification has been extended to cover medico-economic studies...
February 14, 2017: Revue D'épidémiologie et de Santé Publique
https://www.readbyqxmd.com/read/28214168/medication-adherence-a-practical-measurement-selection-guide-using-case-studies
#2
Leah L Zullig, Phil Mendys, Hayden B Bosworth
OBJECTIVES: Medication adherence is a complex problem and can be evaluated using a variety of methods. There is no single or perfect strategy to assess adherence. The "best" measure depends on contextual factors. Our objective is to provide a practical, illustrative guide for selecting the most appropriate measure of medication adherence in common contexts. METHODS: We present three case studies - from the perspectives of an academic researcher, health care payer, and clinical care provider - to describe common problems and processes for measuring medication adherence, as well as proposing possible solutions...
February 10, 2017: Patient Education and Counseling
https://www.readbyqxmd.com/read/28213903/specifics-of-fetuin-a-levels-in-distinct-types-of-chronic-heart-failure
#3
Michael Lichtenauer, Bernhard Wernly, Vera Paar, Ilonka Rohm, Christian Jung, Atilla Yilmaz, Uta C Hoppe, Paul Christian Schulze, Daniel Kretzschmar, Rudin Pistulli
INTRODUCTION: Fetuin-A has been described to correlate inversely with vascular calcification both in animal models but also in patients with heart and renal disease. In this current study, we sought to investigate whether fetuin-A might be a useful marker for the discrimination of ischemic (ICM) from dilated cardiomyopathy (DCM). METHODS: A total of 124 non-consecutive patients were included in this study, 59 patients suffered from ICM and 65 patients from DCM. Serum samples were obtained during out-patient visits and analyzed for fetuin-A by ELISA...
February 18, 2017: Journal of Clinical Laboratory Analysis
https://www.readbyqxmd.com/read/28213598/informing-efficient-randomised-controlled-trials-exploration-of-challenges-in-developing-progression-criteria-for-internal-pilot-studies
#4
Kerry N L Avery, Paula R Williamson, Carrol Gamble, Elaine O'Connell Francischetto, Chris Metcalfe, Peter Davidson, Hywel Williams, Jane M Blazeby
OBJECTIVES: Designing studies with an internal pilot phase may optimise the use of pilot work to inform more efficient randomised controlled trials (RCTs). Careful selection of preagreed decision or 'progression' criteria at the juncture between the internal pilot and main trial phases provides a valuable opportunity to evaluate the likely success of the main trial and optimise its design or, if necessary, to make the decision not to proceed with the main trial. Guidance on the appropriate selection and application of progression criteria is, however, lacking...
February 17, 2017: BMJ Open
https://www.readbyqxmd.com/read/28212969/lessons-learned-when-introducing-pharmacogenomic-panel-testing-into-clinical-practice
#5
Marc B Rosenman, Brian Decker, Kenneth D Levy, Ann M Holmes, Victoria M Pratt, Michael T Eadon
OBJECTIVES: Implementing new programs to support precision medicine in clinical settings is a complex endeavor. We describe challenges and potential solutions based on the Indiana GENomics Implementation: an Opportunity for the Underserved (INGenious) program at Eskenazi Health-one of six sites supported by the Implementing GeNomics In pracTicE network grant of the National Institutes of Health/National Human Genome Research Institute. INGenious is an implementation of a panel of genomic tests...
January 2017: Value in Health: the Journal of the International Society for Pharmacoeconomics and Outcomes Research
https://www.readbyqxmd.com/read/28212967/decision-making-on-medical-innovations-in-a-changing-health-care-environment-insights-from-accountable-care-organizations-and-payers-on-personalized-medicine-and-other-technologies
#6
Julia R Trosman, Christine B Weldon, Michael P Douglas, Patricia A Deverka, John B Watkins, Kathryn A Phillips
BACKGROUND: New payment and care organization approaches, such as those of accountable care organizations (ACOs), are reshaping accountability and shifting risk, as well as decision making, from payers to providers, within the Triple Aim context of health reform. The Triple Aim calls for improving experience of care, improving health of populations, and reducing health care costs. OBJECTIVES: To understand how the transition to the ACO model impacts decision making on adoption and use of innovative technologies in the era of accelerating scientific advancement of personalized medicine and other innovations...
January 2017: Value in Health: the Journal of the International Society for Pharmacoeconomics and Outcomes Research
https://www.readbyqxmd.com/read/28212953/the-influence-of-genotype-information-on-psychiatrists-treatment-recommendations-more-experienced-clinicians-know-better-what-to-ignore
#7
Alan J McMichael, Marco Boeri, Jonathan J Rolison, Joe Kane, Francis A O'Neill, Ric Scarpa, Frank Kee
BACKGROUND: This study applies attribute nonattendance to medical decision making. We aimed to demonstrate how this type of analysis can be used in medical decision making to assess whether psychiatrists were influenced in their treatment recommendations by information on the genotype of a patient, despite knowing the patient's response to treatment as measured by the Positive and Negative Syndrome Scale. A patient's genetic information may be used to predict their response to therapy; such information, however, becomes redundant, and should not influence decisions, once a clinician knows the patient's actual response to treatment...
January 2017: Value in Health: the Journal of the International Society for Pharmacoeconomics and Outcomes Research
https://www.readbyqxmd.com/read/28211251/burden-of-rheumatoid-arthritis-from-a-societal-perspective-a-prevalence-based-study-on-cost-of-illness-for-patients-with-rheumatoid-arthritis-in-china
#8
Hao Hu, Luan Luan, Keqin Yang, Shu-Chuen Li
AIM: To provide a comprehensive estimation of the economic burden of rheumatoid arthritis (RA) in China, especially for patients from less developed areas, and to explore the cost transferability between regions to assist healthcare decision-making. METHODS: The study was conducted in south and north China from May 2013 to December 2013. The burden of RA was investigated by interviewing participants with a questionnaire battery containing socio-demographic, cost of illness (COI) and medical treatments...
February 17, 2017: International Journal of Rheumatic Diseases
https://www.readbyqxmd.com/read/28210788/surgical-management-of-degenerative-meniscus-lesions-the-2016-esska-meniscus-consensus
#9
Ph Beaufils, R Becker, S Kopf, M Englund, R Verdonk, M Ollivier, R Seil
PURPOSE: A degenerative meniscus lesion is a slowly developing process typically involving a horizontal cleavage in a middle-aged or older person. When the knee is symptomatic, arthroscopic partial meniscectomy has been practised for a long time with many case series reporting improved patient outcomes. Since 2002, several randomised clinical trials demonstrated no additional benefit of arthroscopic partial meniscectomy compared to non-operative treatment, sham surgery or sham arthroscopic partial meniscectomy...
February 16, 2017: Knee Surgery, Sports Traumatology, Arthroscopy: Official Journal of the ESSKA
https://www.readbyqxmd.com/read/28210563/neoadjuvant-therapy-for-treatment-of-breast-cancer-the-way-forward-or-simply-a-convenient-option-for-patients
#10
COMMENT
Abhishek Chatterjee, John K Erban
The complexity of managing early stage breast cancer is well known. Optimal treatment is increasingly multidisciplinary and in the modern era informed by sophisticated molecular tools to help select and guide therapy. Major phase III trials have determined that the order of systemic therapy relative to surgery does not influence important endpoints such as event free survival and overall survival (OS), but questions remain as to how best to utilize these most essential services. For example, there is still uncertainty regarding the ideal timing, intensity, and duration of proposed therapy...
February 2017: Gland Surgery
https://www.readbyqxmd.com/read/28210286/bilastine-in-allergic-rhinoconjunctivitis-and-urticaria-a-practical-approach-to-treatment-decisions-based-on-queries-received-by-the-medical-information-department
#11
REVIEW
Amalia Leceta, Ander Sologuren, Román Valiente, Cristina Campo, Luis Labeaga
BACKGROUND: Bilastine is a safe and effective commonly prescribed non-sedating H1-antihistamine approved for symptomatic treatment in patients with allergic disorders such as rhinoconjunctivitis and urticaria. It was evaluated in many patients throughout the clinical development required for its approval, but clinical trials generally exclude many patients who will benefit in everyday clinical practice (especially those with coexisting diseases and/or being treated with concomitant drugs)...
2017: Drugs in Context
https://www.readbyqxmd.com/read/28209701/patient-and-citizen-innovation-council-in-family-practice
#12
Ron T Garnett, Jane Bowman, Joanne Ganton
PROBLEM ADDRESSED: Patient engagement is integral to the Patient's Medical Home model. Patient-centred care is more than what happens in the examination room. Decisions around clinic processes, work flow, and initiative prioritization also warrant a patient perspective. OBJECTIVE OF PROGRAM: The Academic Family Medicine Clinic at the South Health Campus in Calgary, Alta, identified a need for patient and community advisory expertise regarding clinic initiatives and quality improvement...
February 2017: Canadian Family Physician Médecin de Famille Canadien
https://www.readbyqxmd.com/read/28209605/do-failures-in-non-technical-skills-contribute-to-fatal-medical-accidents-in-japan-a-review-of-the-2010-2013-national-accident-reports
#13
Masashi Uramatsu, Yoshikazu Fujisawa, Shinya Mizuno, Takahiro Souma, Akinori Komatsubara, Tamotsu Miki
OBJECTIVES: We sought to clarify how large a proportion of fatal medical accidents can be considered to be caused by poor non-technical skills, and to support development of a policy to reduce number of such accidents by making recommendations about possible training requirements. DESIGN: Summaries of reports of fatal medical accidents, published by the Japan Medical Safety Research Organization, were reviewed individually. Three experienced clinicians and one patient safety expert conducted the reviews to determine the cause of death...
February 16, 2017: BMJ Open
https://www.readbyqxmd.com/read/28207807/how-much-is-a-child-worth-providers-and-patients-views-and-responses-concerning-ethical-and-policy-challenges-in-paying-for-art
#14
Robert Klitzman
Infertility treatments remain expensive and in many countries are covered by little, if any, insurance, raising critical questions concerning how patients and providers view and make decisions regarding these challenges. In-depth semi-structured interviews of approximately 1 hour were conducted with 37 IVF providers and 10 patients (17 physicians, 10 other providers and 10 patients), and were systematically analyzed. These data suggest current insurance policies and legislation pose critical ethical and logistical challenges for both patients and providers...
2017: PloS One
https://www.readbyqxmd.com/read/28206672/assessment-of-a-novel-point-of-care-ultrasound-curriculum-s-effect-on-competency-measures-in-family-medicine-graduate-medical-education
#15
Paul Bornemann
OBJECTIVES: Point-of-care ultrasound has been shown to decrease the use of expensive diagnostic studies and improve quality outcome measures. Currently, there is a large desire for training in family medicine residencies, but very few programs have established curricula. We sought to develop a family medicine residency curriculum and evaluate it with tools we developed. We wanted our curriculum to be easy to adopt by other residency programs, even if they did not have many well-trained ultrasound faculty...
February 16, 2017: Journal of Ultrasound in Medicine: Official Journal of the American Institute of Ultrasound in Medicine
https://www.readbyqxmd.com/read/28205411/perceptions-of-doppler-ultrasound-for-rheumatoid-arthritis-disease-activity-assessment-and-education
#16
Fredrick Joshua, Christine Bailey, Mona Marabani, Evange Romas, Raymond White, Peter Wong
AIM: The aim of this qualitative study was to report the findings of the Defining rheumatoid arthritis progression using Doppler Ultrasound in Clinical practice (DEDUCE) Medical Practice Activity, which was developed to facilitate the utilization of Doppler ultrasound (DUS) by Australian rheumatologists in the treatment of patients with rheumatoid arthritis (RA). METHOD: Twenty-one rheumatologists recruited a total of 80 patients with RA in Disease Activity Score of 28 joints (DAS28) remission for DUS assessment and completed a pre- and post-activity questionnaire assessing their experience with DUS, as well as a 6-month follow-up questionnaire...
February 16, 2017: International Journal of Rheumatic Diseases
https://www.readbyqxmd.com/read/28203120/international-lessons-in-new-methods-for-grading-and-integrating-cost-effectiveness-evidence-into-clinical-practice-guidelines
#17
REVIEW
Kathryn M Antioch, Michael F Drummond, Louis W Niessen, Hindrik Vondeling
Economic evidence is influential in health technology assessment world-wide. Clinical Practice Guidelines (CPG) can enable economists to include economic information on health care provision. Application of economic evidence in CPGs, and its integration into clinical practice and national decision making is hampered by objections from professions, paucity of economic evidence or lack of policy commitment. The use of state-of-art economic methodologies will improve this. Economic evidence can be graded by 'checklists' to establish the best evidence for decision making given methodological rigor...
2017: Cost Effectiveness and Resource Allocation: C/E
https://www.readbyqxmd.com/read/28203061/herding-a-new-phenomenon-affecting-medical-decision-making-in-multiple-sclerosis-care-lessons-learned-from-discutir-ms
#18
Gustavo Saposnik, Jorge Maurino, Angel P Sempere, Christian C Ruff, Philippe N Tobler
PURPOSE: Herding is a phenomenon by which individuals follow the behavior of others rather than deciding independently on the basis of their own private information. A herding-like phenomenon can occur in multiple sclerosis (MS) when a neurologist follows a therapeutic recommendation by a colleague even though it is not supported by best practice clinical guidelines. Limited information is currently available on the role of herding in medical care. The objective of this study was to determine the prevalence (and its associated factors) of herding in the management of MS...
2017: Patient Preference and Adherence
https://www.readbyqxmd.com/read/28202839/cost-outcome-description-of-peg-ifn-%C3%AE-2b-rbv-for-hepatitis-c-results-based-on-the-interferon-database
#19
Maiko Akutagawa, Yohei Kawasaki, Atsuko Kawasaki, Kazuki Ide, Hiroshi Yamada, Naohiko Masaki
Economic evaluation of drugs is used in decision-making on medical care and public policy. Recently, real-world data (RWD) have been used in the analysis. In this study, we discuss the risk and benefits of using RWD for economic evaluation. We conducted a cost-outcome description with RWD from a nationwide registry providing information on hepatitis treatment in Japan and estimated the utility of the analysis. We evaluated the cost-outcome description of peginterferon plus ribavirin (PEG-IFN-α2b + RBV) treatment in hepatitis C virus (HCV)-infected patients...
February 15, 2017: Biological & Pharmaceutical Bulletin
https://www.readbyqxmd.com/read/28202330/ethical-issues-in-cesarean-delivery
#20
REVIEW
Frank A Chervenak, Laurence B McCullough
Cesarean delivery is the most common and important surgical intervention in obstetric practice. Ethics provides essential guidance to obstetricians for offering, recommending, recommending against, and performing cesarean delivery. This chapter provides an ethical framework based on the professional responsibility model of obstetric ethics. This framework is then used to address two especially ethically challenging clinical topics in cesarean delivery: patient-choice cesarean delivery and trial of labor after cesarean delivery...
January 23, 2017: Best Practice & Research. Clinical Obstetrics & Gynaecology
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