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https://www.readbyqxmd.com/read/27936343/assessing-bioequivalence-and-drug-interchangeability
#1
Meng Chen, Shein-Chung Chow
As indicated by the United States Food and Drug Administration (FDA), approved generic drug products can be used as substitute for their respective innovative drug products. FDA, however, does not indicate that two generic copies of the same innovative drug can be used interchangeably, even though they have been shown to be bioequivalent to the same innovative drug product. As more and more generic drug products become available in the market place, it is a concern whether these approved generic drug products have the same quality, safety/efficacy and hence can be used interchangeably...
December 9, 2016: Journal of Biopharmaceutical Statistics
https://www.readbyqxmd.com/read/27935802/perceptions-on-diabetes-care-provision-among-health-providers-in-rural-tanzania-a-qualitative-study
#2
Mary Mwangome, Eveline Geubbels, Paul Klatser, Marjolein Dieleman
Diabetes prevalence in Tanzania was estimated at 9.1% in 2012 among adults aged 24-65 years - higher than the HIV prevalence in the general population at that time. Health systems in lower- and middle-income countries are not designed for chronic health care, yet the rising burden of non-communicable diseases such as diabetes demands chronic care services. To inform policies on diabetes care, we conducted a study on the health services in place to diagnose, treat and care for diabetes patients in rural Tanzania...
October 22, 2016: Health Policy and Planning
https://www.readbyqxmd.com/read/27935446/sample-size-requirement-in-analytical-studies-for-similarity-assessment
#3
Shein-Chung Chow, Fuyu Song, He Bai
For assessment of biosimilar products, FDA recommends a stepwise approach for obtaining the totality-of-the-evidence for assessing biosimilarity between a proposed biosimilar product and its corresponding innovative biologic product (FDA, 2015). The stepwise approach starts with analytical studies for assessing similarity in critical quality attributes (CQAs) which are relevant to clinical outcomes at various stages of manufacturing process (Christl, 2015). For CQAs that are most relevant to clinical outcomes, FDA requires equivalence test be performed for similarity assessment based on an equivalence acceptance criterion that is obtained using single test value of some selected reference lots (Tsong, 2015)...
December 9, 2016: Journal of Biopharmaceutical Statistics
https://www.readbyqxmd.com/read/27934790/abdomino-endoscopic-perineal-excision-of-the-rectum-for-benign-and-malignant-pathology-technique-considerations-for-true-transperineal-verus-transanal-total-mesorectal-excision-endoscopic-proctectomy
#4
Hazar Al Furajii, Niall Kennedy, Ronan A Cahill
PURPOSE: Transanal minimally invasive surgery using single port instrumentation is now well described for the performance of total mesorectal excision with restorative colorectal/anal anastomosis most-often in conjunction with transabdominal multiport assistance. While non-restorative abdomino-endoscopic perineal excision of the anorectum is conceptually similar, it has been less detailed in the literature. METHODS: Consecutive patients undergoing non-restorative ano-proctectomy including a transperineal endoscopic component were analysed...
January 2017: Journal of Minimal Access Surgery
https://www.readbyqxmd.com/read/27933429/establishing-the-values-for-patient-engagement-pe-in-health-related-quality-of-life-hrqol-research-an-international-multiple-stakeholder-perspective
#5
Kirstie Haywood, Anne Lyddiatt, Samantha J Brace-McDonnell, Sophie Staniszewska, Sam Salek
PURPOSE: Active patient engagement is increasingly viewed as essential to ensuring that patient-driven perspectives are considered throughout the research process. However, guidance for patient engagement (PE) in HRQoL research does not exist, the evidence-base for practice is limited, and we know relatively little about underpinning values that can impact on PE practice. This is the first study to explore the values that should underpin PE in contemporary HRQoL research to help inform future good practice guidance...
December 8, 2016: Quality of Life Research
https://www.readbyqxmd.com/read/27933149/venous-thromboembolism-capture-on-electronic-systems-in-obstetrics-patients-at-st-thomas-hospital
#6
Aminah Noor Ahmad, Megan Leyla Byrne, Nazia Imambaccus, Dawid Hubert, Anna Gateley, Salwa Abdullahi Idle, Jilly Lloyd
Venous thromboembolism (VTE) is one of the leading causes of maternal mortality in the UK. Therefore, timely VTE risk assessment is essential in all obstetrics patients. The Commissioning for Quality and Innovation (CQUIN) payment framework set a target for trusts to complete a VTE risk assessment within 24 hours of admission for 95% of patients. A combination of factors, including lack of integration between multiple IT systems, means that this CQUIN target is currently not being met for obstetric patients in the Hospital Birth Centre at Guys and St Thomas' NHS Trust...
2016: BMJ Quality Improvement Reports
https://www.readbyqxmd.com/read/27931395/urban-stormwater-characterization-control-and-treatment
#7
Jason R Vogel, Trisha L Moore
The following review presents a synthesis of 181 journal articles published during 2015 that represent progress toward better characterizing, controlling, and treating urban stormwater runoff. The review is structured by general topical areas related to (1) stormwater quality and quantity characterization; (2) engineered stormwater control and treatment practices, including erosion and sediment control, stormwater ponds, constructed stormwater wetlands, bioretention, permeable pavement, greenroofs, and rainwater harvesting systems; and (3) watershed-scale modeling and optimization of stormwater control and treatment practices...
October 2016: Water Environment Research: a Research Publication of the Water Environment Federation
https://www.readbyqxmd.com/read/27931371/water-reclamation-and-reuse
#8
Chunkai Huang, Ping Zeng, Sen Yang, Yanxi Shao, Yang Liu
A review of the literature published in 2015 on topics relating to water reclamation and reuse is presented. The review is divided into the following sections: (1) General: extent of reuse, research needs, guidelines and monitoring, health effects; (2) Treatment technologies: integrated process design, membrane treatment, membrane bioreactors, electrocoagulation, ion exchange and adsorption, disinfection, wetlands, managed aquifer recharge; (3) Planning and management: public acceptance and education, economics/pricing, water quality planning and management and project/case studies...
October 2016: Water Environment Research: a Research Publication of the Water Environment Federation
https://www.readbyqxmd.com/read/27931369/biosolids-and-sludge-management
#9
Kari Fitzmorris Brisolara, Helena Ochoa
This review section covers journal articles and conference papers related to biosolids and sludge management that were published in 2015. The literature review has been divided into the following sections: Biosolids regulations and management issues; Biosolids characteristics, quality and measurement including microconstituents, pathogens, nanoparticles and metals; Sludge treatment technologies including pretreatment and sludge minimization, conditioning and dewatering, digestion, composting and innovative technologies; Disposal and reuse including combustion/incineration, agricultural uses and innovative uses; Odor and air emissions; and Energy issues...
October 2016: Water Environment Research: a Research Publication of the Water Environment Federation
https://www.readbyqxmd.com/read/27930279/use-of-a-novel-accounting-and-grouping-method-for-major-trunk-injuryanalysis-of-data-from-a-statewide-trauma-financial-survey
#10
Kyla D Joubert, Charles D Mabry, Kyle J Kalkwarf, Richard D Betzold, Horace J Spencer, Kara M Spinks, Austin Porter, Saleema Karim, Ronald D Robertson, Michael J Sutherland, Robert T Maxson
Major trunk trauma is common and costly, but comparisons of costs between trauma centers (TCs) are rare. Understanding cost is essential to improve quality, manage trauma service lines, and to facilitate institutional commitment for trauma. We have used results of a statewide trauma financial survey of Levels I to IV TC to develop a useful grouping method for costs and clinical characteristics of major trunk trauma. The trauma financial survey collected billing and clinical data on 75 per cent of the state trauma registry patients for fiscal year 2012...
September 2016: American Surgeon
https://www.readbyqxmd.com/read/27928442/creating-the-ideal-patient-experience
#11
Purcărea Th V
Healthcare industry continues to evolve under conditions of intense competition in approaching health prevention, protection, and promotion. Therefore, healthcare providers are challenged to always ensure better patient experience, winning patients' satisfaction, and loyalty and remain competitive on today's healthcare market. Healthcare markets bring together professionals and their patients into real collaborative relationships, which empower patients to contribute to the healthcare improvement. Within this competitive landscape, which is also characterized by digital health tools boosting patients' awareness and controlling their own health, medical providers need to be perceived as skilled and trustworthy in relying on patients' needs, expectations, and sacrifices are required in order to obtain the promised benefits...
October 2016: Journal of Medicine and Life
https://www.readbyqxmd.com/read/27927667/life-after-prostate-cancer-diagnosis-protocol-for-a-uk-wide-patient-reported-outcomes-study
#12
Amy Downing, Penny Wright, Richard Wagland, Eila Watson, Therese Kearney, Rebecca Mottram, Majorie Allen, Victoria Cairnduff, Oonagh McSorley, Hugh Butcher, Luke Hounsome, Conan Donnelly, Peter Selby, Paul Kind, William Cross, James W H Catto, Dyfed Huws, David H Brewster, Emma McNair, Lauren Matheson, Carol Rivas, Johana Nayoan, Mike Horton, Jessica Corner, Julia Verne, Anna Gavin, Adam W Glaser
BACKGROUND: Prostate cancer and its treatment may impact physically, psychologically and socially; affecting the health-related quality of life of men and their partners/spouses. The Life After Prostate Cancer Diagnosis (LAPCD) study is a UK-wide patient-reported outcomes study which will generate information to improve the health and well-being of men with prostate cancer. METHODS AND ANALYSIS: Postal surveys will be sent to prostate cancer survivors (18-42 months postdiagnosis) in all 4 UK countries (n=∼70 000)...
December 7, 2016: BMJ Open
https://www.readbyqxmd.com/read/27926675/improvement-in-total-joint-replacement-quality-metrics-year-one-versus-year-three-of-the-bundled-payments-for-care-improvement-initiative
#13
John M Dundon, Joseph Bosco, James Slover, Stephen Yu, Yousuf Sayeed, Richard Iorio
BACKGROUND: In January 2013, a large, tertiary, urban academic medical center began participation in the Bundled Payments for Care Improvement (BPCI) initiative for total joint arthroplasty, a program implemented by the Centers for Medicare & Medicaid Services (CMS) in 2011. Medicare Severity-Diagnosis Related Groups (MS-DRGs) 469 and 470 were included. We participated in BPCI Model 2, by which an episode of care includes the inpatient and all post-acute care costs through 90 days following discharge...
December 7, 2016: Journal of Bone and Joint Surgery. American Volume
https://www.readbyqxmd.com/read/27926620/tapping-magnet%C3%A2-s-culture-of-innovation-to-improve-the-patient-experience
#14
Jennifer Rainer
As incentives grow for healthcare organizations to improve the patient experience, an increasing number choose to add consumers directly into their leadership structures. In this final installment about the value of patient and family advisory councils, the senior director of quality at a large, Magnet®-recognized Texas hospital explains how tapping into a well-established Magnet culture helped the organization adopt innovative approaches that produced positive change. Based on an interview with the author, she notes that seeing basic issues through patients' eyes challenged long-held beliefs and led to improvements in a wide variety of areas...
January 2017: Journal of Nursing Administration
https://www.readbyqxmd.com/read/27925142/dg-connect-funded-projects-on-information-and-communication-technologies-ict-for-old-age-people-beyond-silos-carewell-and-smartcare
#15
W Keijser, E de Manuel-Keenoy, M d'Angelantonio, P Stafylas, P Hobson, G Apuzzo, M Hurtado, J Oates, J Bousquet, A Senn
Information and communication technologies (ICT) are promising for the long-term care of older and frequently frail people. These innovations can improve health outcomes, quality of life and efficiency of care processes, while supporting independent living. However, they may be disruptive innovations. As all European member states are facing an increasing complexity of health and social care, good practices in ICT should be identified and evaluated. Three projects funded by DG CNECT are related to Active and Healthy Ageing (AHA) and frailty: (i) BeyondSilos, dealing with independent living and integrated services, (ii) CareWell, providing integrated care coordination, patient empowerment and home support and (iii) SmartCare, proposing a common set of standard functional specifications for an ICT platform enabling the delivery of integrated care to older patients...
2016: Journal of Nutrition, Health & Aging
https://www.readbyqxmd.com/read/27925090/storytelling-a-care-technology-in-continuing-education-for-active-ageing
#16
Nadia Pinheiro da Costa, Sandra Helena Isse Polaro, Eloá Aparecida Caliari Vahl, Lucia Hisako Takase Gonçalves
Objective: assessing relevance and effectiveness of care/educational technology in the form of "storytelling" as a strategy in the cultivation of active ageing (AA) for elderly users of a Basic Health Unit (BHU), from the Amazon region. Method: convergent care research (CCR) held in a BHU in Belém, state of Pará, with eight elderly ladies for testing this technology. An active ageing assessment questionnaire and WHOQOL-BREF - quality of life assessment were applied...
November 2016: Revista Brasileira de Enfermagem
https://www.readbyqxmd.com/read/27924107/newborn-healthcare-in-urban-india
#17
REVIEW
J Sharma, D Osrin, B Patil, S B Neogi, M Chauhan, R Khanna, R Kumar, V K Paul, S Zodpey
The rapid population growth in urban India has outpaced the municipal capacity to build essential infrastructures that make life in cities safe and healthy. Local and national governments alike are grappling with the challenges of urbanization with thousands migrating from villages to cities. Thus, urbanization in India has been accompanied by a concentration of poverty and urban public healthcare has emerged as one of the most pressing priorities facing our country. Newborn mortality rates in urban settings are lower than rural areas, early neonatal deaths account for greater proportion than late neonatal deaths...
December 2016: Journal of Perinatology: Official Journal of the California Perinatal Association
https://www.readbyqxmd.com/read/27924105/innovating-affordable-neonatal-care-equipment-for-use-at-scale
#18
REVIEW
V Sashi Kumar, V K Paul, K Sathasivam
The care of small and sick neonates requires biomedical technologies, such as devices that can keep babies warm (radiant warmers and incubators), resuscitate (self-inflating bags), track growth (weighing scales), treat jaundice (phototherapy units) and provide oxygen or respiratory support (hoods, continuous positive airway pressure (CPAP) devices and ventilators). Until the 1990s, most of these products were procured through import at a high cost and with little maintenance support. Emerging demand and an informal collaboration of neonatologists, engineers and entrepreneurs has led to the production of good quality equipment of several high-volume categories at affordable cost in India...
December 2016: Journal of Perinatology: Official Journal of the California Perinatal Association
https://www.readbyqxmd.com/read/27923491/experimental-design-for-determination-of-effects-of-superdisintegrant-combinations-on-liquisolid-system-properties
#19
Barbora Vraníková, Sylvie Pavloková, Jan Gajdziok
The preparation of liquisolid systems presents a promising and innovative possibility for enhancing dissolution profiles and improving the bioavailability of poorly soluble drugs. This study aims to evaluate the differences in the properties of liquisolid systems containing combinations of 3 commercially used superdisintegrants (sodium starch glycolate, crospovidone, and croscarmellose sodium). Multiple regression models and contour plots were used to study how the amount and the type of superdisintegrant used affected the quality parameters of liquisolid tablets...
December 3, 2016: Journal of Pharmaceutical Sciences
https://www.readbyqxmd.com/read/27922462/fostering-evidence-based-quality-improvement-for-patient-centered-medical-homes-initiating-local-quality-councils-to-transform-primary-care
#20
Susan E Stockdale, Jessica Zuchowski, Lisa V Rubenstein, Negar Sapir, Elizabeth M Yano, Lisa Altman, Jacqueline J Fickel, Skye McDougall, Timothy Dresselhaus, Alison B Hamilton
BACKGROUND: Although the patient-centered medical home endorses quality improvement principles, methods for supporting ongoing, systematic primary care quality improvement have not been evaluated. We introduced primary care quality councils at six Veterans Health Administration sites as an organizational intervention with three key design elements: (a) fostering interdisciplinary quality improvement leadership, (b) establishing a structured quality improvement process, and (c) facilitating organizationally aligned frontline quality improvement innovation...
December 3, 2016: Health Care Management Review
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