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https://www.readbyqxmd.com/read/29911104/cell-and-gene-therapies-european-view-on-challenges-in-translation-and-how-to-address-them
#1
Cécile F Rousseau, Romaldas Mačiulaitis, Dariusz Śladowski, Gopalan Narayanan
Advanced therapy medicinal products (ATMPs), i.e ., cell and gene therapy products, is a rapidly evolving field of therapeutic development. A significant proportion of the products are being developed by academia or small/medium-sized enterprises (SMEs). The many challenges in translation posed by this class of products include aspects covering: manufacturing, non-clinical development plan as relevant to clinical trial, marketing authorization, and reimbursement. In this context, the term translation refers to the relevance of non-clinical data in relation to how it impacts on appropriate and efficient clinical development...
2018: Frontiers in Medicine
https://www.readbyqxmd.com/read/29898708/-doing-hymen-reconstruction-an-analysis-of-perceptions-and-experiences-of-flemish-gynaecologists
#2
Els Leye, Emilomo Ogbe, Maaike Heyerick
BACKGROUND: Hymen reconstruction (HR) involves the restoration of the hymeneal membrane's gross anatomical integrity. Among the medical profession, hymen reconstruction receives particular attention and its necessity is debated because the surgery is not medically indicated, and often reveals conflicting social norms on virginity and marriageability between health professionals and their patients. The focus of this paper is not to address the many open questions that the ethics and politics around HR reveal, but rather aims at contributing to the much-needed empirical evidence...
June 13, 2018: BMC Women's Health
https://www.readbyqxmd.com/read/29889752/three-lymphadenectomy-strategies-in-low-risk-endometrial-carcinoma-a-cost-effectiveness-analysis
#3
Rudy S Suidan, Charlotte C Sun, Scott B Cantor, Andrea Mariani, Pamela T Soliman, Shannon N Westin, Karen H Lu, Sharon H Giordano, Larissa A Meyer
OBJECTIVE: To evaluate the cost-utility of three lymphadenectomy strategies in the management of low-risk endometrial carcinoma. METHODS: A decision analysis model compared three lymphadenectomy strategies in women undergoing minimally invasive surgery for low-risk endometrial carcinoma: 1) routine lymphadenectomy in all patients, 2) selective lymphadenectomy based on intraoperative frozen section criteria, and 3) sentinel lymph node mapping. Costs and outcomes were obtained from published literature and Medicare reimbursement rates...
June 6, 2018: Obstetrics and Gynecology
https://www.readbyqxmd.com/read/29889181/measuring-local-public-health-and-primary-care-collaboration-a-practice-based-research-approach
#4
Elizabeth Gyllstrom, Kimberly Gearin, Donald Nease, Betty Bekemeier, Rebekah Pratt
OBJECTIVE: To describe the degree of public health and primary care collaboration at the local level and develop a model framework of collaboration, the Community Collaboration Health Model (CCHM). DESIGN: Mixed-methods, cross-sectional surveys, and semistructured, key informant interviews. SETTING: All local health jurisdictions in Colorado, Minnesota, Washington, and Wisconsin. PARTICIPANTS: Leaders from each jurisdiction were identified to describe local collaboration...
June 7, 2018: Journal of Public Health Management and Practice: JPHMP
https://www.readbyqxmd.com/read/29885778/analysis-of-national-trends-in-hospital-acquired-conditions-following-major-urological-surgery-before-and-after-implementation-of-the-hospital-acquired-condition-reduction-program-%C3%A2-%C3%A2-%C3%A2
#5
Tope L Rude, Nicholas M Donin, Matthew R Cohn, William Meeks, Scott Gulig, Samir N Patel, James S Wysock, Danil V Makarov, Marc A Bjurlin
OBJECTIVE: To define the rates of common Hospital Acquired Conditions (HACs) in patients undergoing major urological surgery over a period of time encompassing the implementation of the Hospital Acquired Condition Reduction program, and to evaluate whether implementation of the HAC reimbursement penalties in 2008 was associated with a change in the rate of HACs. METHODS: Using American College of Surgeons National Surgical Quality Improvement Program (NSQIP) data, we determined rates of HACs in patients undergoing major inpatient urological surgery from 2005 to 2012...
June 7, 2018: Urology
https://www.readbyqxmd.com/read/29884092/cost-effective-adjustments-to-nursing-home-staffing-to-improve-quality
#6
John R Bowblis, Amy Restorick Roberts
Health care providers face fixed reimbursement rates from government sources and need to carefully adjust staffing to achieve the highest quality within a given cost structure. With data from the Certification and Survey Provider Enhanced Reports (1999-2015), this study holistically examined how staffing levels affect two publicly reported measures of quality in the nursing home industry, the number of deficiency citations and the deficiency score. While higher staffing consistently yielded better quality, the largest quality improvements resulted from increasing administrative registered nurses and social service staffing...
June 1, 2018: Medical Care Research and Review: MCRR
https://www.readbyqxmd.com/read/29865252/a-15-year-ecological-comparison-for-the-market-dynamics-of-minnesota-community-pharmacies-from-2002-to-2017
#7
Anthony W Olson, Jon C Schommer, Ronald S Hadsall
Background: Understanding the factors that influence the market entry, exit, and stability of community pharmacies (i.e., market dynamics) is important for stakeholders ranging from patients to health policymakers and small business owners to large corporate institutions. Objective: The study's first objective was to describe the market dynamics of community pharmacies for Minnesota counties in 2002, 2007, 2012, and 2017 by associating county (a) population density and (b) metropolitan designation with the change in the number of 'All community pharmacies,' 'Chain community pharmacies', and 'Independent community pharmacies'...
June 2, 2018: Pharmacy (Basel, Switzerland)
https://www.readbyqxmd.com/read/29851367/the-third-national-telemedicine-telehealth-service-provider-showcase-conference-advancing-telehealth-partnerships
#8
Dale C Alverson, Elizabeth A Krupinski, Kristine A Erps, Nancy S Rowe, Ronald S Weinstein
INTRODUCTION: As telemedicine and telehealth services are experiencing increasing rates of adoption, industry leaders and healthcare service providers are becoming increasingly focused on human resource issues encountered in the delivery of a broad range of telehealth services. To create a forum for the discussion of many interrelated elements of telehealth service industry, a national conference entitled "Telemedicine & Telehealth Service Provider Showcase" (SPS) Conference was established in 2014, and repeated in 2016 and 2017, in Arizona...
May 31, 2018: Telemedicine Journal and E-health: the Official Journal of the American Telemedicine Association
https://www.readbyqxmd.com/read/29847224/utilization-of-outpatient-telehealth-services-in-parity-and-nonparity-states-2010-2015
#9
Jillian B Harvey, Shawn Valenta, Kit Simpson, Mark Lyles, James McElligott
Background and Introduction: Telehealth is a promising approach to improving healthcare access and quality. While coverage for telehealthcare has expanded, reimbursement remains one of the biggest barriers to provider adoption. Thirty-four states and the District of Columbia have enacted parity legislation requiring private insurance companies to provide some level of reimbursement coverage for telehealth services. MATERIALS AND METHODS: The purpose of this article is to describe the trends in telehealth utilization from 2010 to 2015 for privately insured patients...
May 30, 2018: Telemedicine Journal and E-health: the Official Journal of the American Telemedicine Association
https://www.readbyqxmd.com/read/29799850/the-impact-of-alternative-pricing-methods-for-drugs-in-california-workers-compensation-system-fee-schedule-pricing
#10
Leslie Wilson, Fatema A Turkistani, Wei Huang, Dang M Tran, Tracy Kuo Lin
INTRODUCTION: California's Workers' Compensation System (CAWCS) Department of Industrial Relations questioned the adequacy of the current Medi-Cal fee-schedule pricing and requested analysis of alternatives that maximize price availability and maintain budget neutrality. OBJECTIVES: To compare CAWCS pharmacy-dispensed (PD) drug prices under alternative fee schedules, and identify combinations of alternative benchmarks that have prices available for the largest percentage of PD drugs and that best reach budget neutrality...
2018: PloS One
https://www.readbyqxmd.com/read/29783966/perceptions-and-attitudes-toward-performing-risk-assessment-for-periodontal-disease-a-focus-group-exploration
#11
Thankam Thyvalikakath, Mei Song, Titus Schleyer
BACKGROUND: Currently, many risk assessment tools are available for clinicians to assess a patient's periodontal disease risk. Numerous studies demonstrate the potential of these tools to promote preventive management and reduce morbidity due to periodontal disease. Despite these promising results, solo and small group dental practices, where most people receive care, have not adopted risk assessment tools widely, primarily due to lack of studies in these settings. The objective of this study was to explore the knowledge, attitudes, and beliefs of dental providers in these settings toward risk-based care through focus groups...
May 21, 2018: BMC Oral Health
https://www.readbyqxmd.com/read/29779551/emerging-roles-for-peer-providers-in-mental-health-and-substance-use-disorders
#12
Susan A Chapman, Lisel K Blash, Kimberly Mayer, Joanne Spetz
INTRODUCTION: The purpose of this study was to identify and assess states with best practices in peer provider workforce development and employment. A growing body of research demonstrates that peer providers with lived experience contribute positively to the treatment and recovery of individuals with behavioral health needs. Increased employment opportunities have led to policy concerns about training, certification, roles, and reimbursement for peer provider services. METHODS: A case study approach included a national panel of subject matter experts who suggested best practice states...
June 2018: American Journal of Preventive Medicine
https://www.readbyqxmd.com/read/29757843/strategies-used-to-facilitate-the-discussion-of-advance-care-planning-with-older-adults-in-primary-care-settings-a-literature-review
#13
Guillermina R Solis, Bibiana M Mancera, Megan Johnson Shen
BACKGROUND AND PURPOSE: The purpose of this literature review was to evaluate strategies used in primary care settings to initiate advance care planning (ACP) conversations leading to the completion of an advance directive (AD). Approximately 50% of older adults have an AD; few talk to their primary care provider (PCP) about end-of-life wishes. The Institute of Medicine report and recent changes in Medicare reimbursement policies create opportunities for PCPs to address ACP in primary care settings...
May 2018: Journal of the American Association of Nurse Practitioners
https://www.readbyqxmd.com/read/29752253/barriers-and-facilitators-affecting-patient-portal-implementation-from-an-organizational-perspective-qualitative-study
#14
Laura Kooij, Wim G Groen, Wim H van Harten
BACKGROUND: The number of patient portals is rising, and although portals can have positive effects, their implementation has major impacts on the providing health care institutions. However, little is known about the organizational factors affecting successful implementation. Knowledge of the specific barriers to and facilitators of various stakeholders is likely to be useful for future implementations. OBJECTIVE: The objective of this study was to identify the barriers to and facilitators of patient portal implementation facing various stakeholders within hospital organizations in the Netherlands...
May 11, 2018: Journal of Medical Internet Research
https://www.readbyqxmd.com/read/29733728/strategies-for-clinical-implementation-precision-oncology-at-three-distinct-institutions
#15
Lincoln D Nadauld, James M Ford, Daryl Pritchard, Thomas Brown
Despite rapid advances in molecular diagnostics and targeted therapeutics, the adoption of precision medicine into clinical oncology workflows has been slow. Questions about clinical utility, inconsistent reimbursement for molecular diagnostics, and limited access to targeted therapies are some of the major hurdles that have hampered clinical adoption. Despite these challenges, providers have invested in precision medicine programs in an ongoing search for innovative care models to deliver improved patient outcomes and achieve economic gains...
May 2018: Health Affairs
https://www.readbyqxmd.com/read/29724229/financial-management-of-large-multi-center-trials-in-a-challenging-funding-milieu
#16
Olivia Lovegreen, Danielle Riggs, Myrlene A Staten, Patricia Sheehan, Anastassios G Pittas
BACKGROUND: Randomized clinical trials that have public health implications but no or low potential for commercial gain are predominantly funded by governmental (e.g., National Institutes of Health (NIH)) and not-for-profit organizations. Our objective was to develop an alternative clinical trial site funding model for judicious allocation of declining public research funds. METHODS: In the Vitamin D and Type 2 Diabetes (D2d) study, an NIH-supported, large clinical trial testing the effect of vitamin D supplementation on incident diabetes in 2423 participants at high risk for diabetes, a hybrid financial management model for supporting collaborating clinical sites was developed and applied...
May 3, 2018: Trials
https://www.readbyqxmd.com/read/29709553/chronic-pre-operative-opioid-use-is-a-risk-factor-for-increased-complications-resource-use-and-costs-after-cervical-fusion
#17
Nikhil Jain, John L Brock, Frank M Phillips, Tristan Weaver, Safdar N Khan
BACKGROUND CONTEXT: As healthcare transitions to value-based models, there has been an increased focus on patient factors that can influence peri- and post-operative adverse events, resource use, and costs. Many studies have reported risk factors for systemic complications after cervical fusion, but none have studied chronic opioid therapy (COT) as a risk factor. PURPOSE: To answer the following questions from a large cohort of patients who underwent primary cervical fusion for degenerative pathology: (1) What is the patient profile associated with pre-operative COT? (2) Is pre-operative COT a risk factor for 90-day systemic complications, emergency department (ED) visits, readmission, and one-year adverse events? (3) What are the risk factors and one-year adverse events related to long-term post-operative opioid use? and (4) How much did payers reimburse for management of complications and adverse events? STUDY DESIGN: Retrospective review of Humana commercial insurance data (2007-Q3 2015)...
April 27, 2018: Spine Journal: Official Journal of the North American Spine Society
https://www.readbyqxmd.com/read/29687758/association-between-outpatient-orthopedic-surgery-costs-and-healthcare-facility-characteristics
#18
Yuichi Watanabe, Yoshinori Nakata
Purpose The purpose of this paper is to examine the association between outpatient orthopedic surgery costs and Japan's healthcare facilities using a large-scale Japanese medical claims database. Design/methodology/approach The authors obtained reimbursement claims data for 8,588 patients who underwent orthopedic surgery between April 1 and September 30, 2014 at 3,347 Japanese healthcare facilities. Regression analysis, using ordinary least squares, examined the association between outpatient orthopedic surgery costs and healthcare facility characteristics...
April 16, 2018: International Journal of Health Care Quality Assurance
https://www.readbyqxmd.com/read/29686869/a-review-of-the-australian-healthcare-system-a-policy-perspective
#19
REVIEW
Sunil K Dixit, Murali Sambasivan
This article seeks to review the Australian healthcare system and compare it to similar systems in other countries to highlight the main issues and problems. A literature search for articles relating to the Australian and other developed countries' healthcare systems was conducted by using Google and the library of Victoria University, Melbourne. Data from the websites of the Commonwealth of Australia, the Australian Institute of Health and Welfare, the Australian Productivity Commission, the Organisation for Economic Co-operation and Development and the World Bank have also been used...
2018: SAGE Open Medicine
https://www.readbyqxmd.com/read/29680407/accelerating-alzheimer-s-disease-drug-innovations-from-the-research-pipeline-to-patients
#20
Dana P Goldman, Howard Fillit, Peter Neumann
In June 2017, a diverse group of experts in Alzheimer's disease convened to discuss how to accelerate getting new drugs to patients to both prevent and treat the disease. Participants concluded that we need a more robust, diversified drug development pipeline. Strategic policy measures can help keep new Alzheimer's disease therapies (whether to treat symptoms, prevent onset, or cure) affordable for patients while supporting innovation and facilitating greater information sharing among payers, providers, researchers, and the public, including a postmarket surveillance study system, disease registries, innovative payment approaches, harmonizing federal agency review requirements, allowing conditional coverage for promising therapeutics and technology while additional data are collected, and opening up channels for drug companies to communicate with payers (and each other) about data and outcomes...
June 2018: Alzheimer's & Dementia: the Journal of the Alzheimer's Association
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