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https://www.readbyqxmd.com/read/28212972/variation-in-health-technology-assessment-and-reimbursement-processes-in-europe
#1
Ronald L Akehurst, Eric Abadie, Noël Renaudin, François Sarkozy
BACKGROUND: It has been suggested that differences in health technology assessment (HTA) processes among countries, particularly within Europe, have led to inequity in patient access to new medicines. OBJECTIVES: To provide an up-to-date snapshot analysis of the present status of HTA and reimbursement systems in select European countries, and to investigate the implications of these processes, especially with regard to delays in market and patient access. METHODS: HTA and reimbursement processes were assessed through a review of published and gray literature, and through a series of interviews with HTA experts...
January 2017: Value in Health: the Journal of the International Society for Pharmacoeconomics and Outcomes Research
https://www.readbyqxmd.com/read/28205056/analyzing-health-related-quality-of-life-data-to-estimate-parameters-for-cost-effectiveness-models-an-example-using-longitudinal-eq-5d-data-from-the-shift-randomized-controlled-trial
#2
Alison Griffiths, Noman Paracha, Andrew Davies, Neil Branscombe, Martin R Cowie, Mark Sculpher
INTRODUCTION: The aim of this article is to discuss methods used to analyze health-related quality of life (HRQoL) data from randomized controlled trials (RCTs) for decision analytic models. The analysis presented in this paper was used to provide HRQoL data for the ivabradine health technology assessment (HTA) submission in chronic heart failure. METHODS: We have used a large, longitudinal EuroQol five-dimension questionnaire (EQ-5D) dataset from the Systolic Heart Failure Treatment with the I f Inhibitor Ivabradine Trial (SHIFT) (clinicaltrials...
February 15, 2017: Advances in Therapy
https://www.readbyqxmd.com/read/28202031/making-sense-of-complexity-in-context-and-implementation-the-context-and-implementation-of-complex-interventions-cici-framework
#3
Lisa M Pfadenhauer, Ansgar Gerhardus, Kati Mozygemba, Kristin Bakke Lysdahl, Andrew Booth, Bjørn Hofmann, Philip Wahlster, Stephanie Polus, Jacob Burns, Louise Brereton, Eva Rehfuess
BACKGROUND: The effectiveness of complex interventions, as well as their success in reaching relevant populations, is critically influenced by their implementation in a given context. Current conceptual frameworks often fail to address context and implementation in an integrated way and, where addressed, they tend to focus on organisational context and are mostly concerned with specific health fields. Our objective was to develop a framework to facilitate the structured and comprehensive conceptualisation and assessment of context and implementation of complex interventions...
February 15, 2017: Implementation Science: IS
https://www.readbyqxmd.com/read/28195244/health-technology-assessment-introducing-a-vacuum-based-preservation-system-for-biological-materials-in-the-anatomic-pathology-workflow
#4
R Saliceti, E Nicodemo, A Giannini, A Cortese
INTRODUCTION: The objective of this work is to assess the implementation of a newly introduced medical equipment technology for the vacuum-based preservation of biological materials within an Anatomic Pathology service. METHODS: The approach selected for the analysis is the Health Technology Assessment (HTA ), a comprehensive evaluation method based on relevant scientific evidence and designed to support healthcare decision makers in purchasing, replacing or disposing of technologies...
March 2016: Pathologica
https://www.readbyqxmd.com/read/28174528/anxious-individuals-are-impulsive-decision-makers-in-the-delay-discounting-task-an-erp-study
#5
Lisheng Xia, Ruolei Gu, Dandan Zhang, Yuejia Luo
Impulsivity, which is linked to a wide range of psychiatric disorders, is often characterized by a preference for immediate but smaller rewards over delayed but larger rewards. However, debate exists on the relationship between anxiety and impulsivity. Here we use event-related potential (ERP) components as biomarkers in the temporal discounting task to examine the effect of anxiety on inter-temporal decision-making. Our behavioral results indicated that the high trait anxiety (HTA) group made significantly more immediate choices than the low trait anxiety (LTA) group...
2017: Frontiers in Behavioral Neuroscience
https://www.readbyqxmd.com/read/28166237/no-benefits-of-statins-for-sudden-cardiac-death-prevention-in-patients-with-heart-failure-and-reduced-ejection-fraction-a-meta-analysis-of-randomized-controlled-trials
#6
Muaamar Al-Gobari, Hai-Ha Le, Mor Fall, François Gueyffier, Bernard Burnand
BACKGROUND AND OBJECTIVES: Statins showed mixed results in heart failure (HF) patients. The benefits in major HF outcomes, including all-cause mortality and sudden cardiac death (SCD), have always been discordant across systematic reviews and meta-analyses. We intended to systematically identify and appraise the available evidence that evaluated the effectiveness of statins in clinical outcomes for HF patients. DESIGN: Systematic review and meta-analysis. DATA SOURCES: We searched, until April 28, 2016: Medline, Embase, ISI Web of Science and EBM reviews (Cochrane DSR, ACP journal club, DARE, CCTR, CMR, HTA, and NHSEED), checked clinicaltrials...
2017: PloS One
https://www.readbyqxmd.com/read/28164534/expression-of-hcv-alternative-reading-frame-protein-core-1-f-in-baculovirus-expression-system-and-its-evaluation-for-assessment-of-specific-anti-core-1-antibody-in-iranian-hcv-infected-patients
#7
Pooneh Rahimi, Rouhollah Vahabpour, Farideh Sadat Sajadian Fard, Fatemeh Motevalli, Fatemeh Fotouhi Chahouki, Mohammad Reza Aghasadeghi, Azam Bolhassani, Seyed Mehdi Sadat, Ehsan Mostafavi, Nasir Mohajel, Ali Jahanian-Najafabadi, Mohammad Reza Amiran
BACKGROUND: Hepatitis C virus (HCV) genome contains an overlapping reading frame which results in alternative core protein (ARFP). Baculovirus expression system was used as a powerful eukaryotic vector system to express core+1/F protein for the first time. This recombinant core+1/F protein was used to assess the anti-core+1 antibody in anti-HCV drug resistant and sustained virologic response (SVR) patients. METHODS: The core+1 coding sequence from HCV genotype 1 was designed and synthesized in pUC57 vector...
October 1, 2016: Clinical Laboratory
https://www.readbyqxmd.com/read/28155899/fingolimod-alters-the-transcriptome-profile-of-circulating-cd4-cells-in-multiple-sclerosis
#8
Jörg Friess, Michael Hecker, Luisa Roch, Dirk Koczan, Brit Fitzner, Ines Charlotte Angerer, Ina Schröder, Kristin Flechtner, Hans-Jürgen Thiesen, Alexander Winkelmann, Uwe Klaus Zettl
Multiple sclerosis is a demyelinating disease affecting the central nervous system. T cells are known to contribute to this immune-mediated condition. Fingolimod modulates sphingosine-1-phosphate receptors, thereby preventing the egress of lymphocytes, especially CCR7-expressing CD8+ and CD4+ T cells, from lymphoid tissues. Using Affymetrix Human Transcriptome Arrays (HTA 2.0), we performed a transcriptome profiling analysis of CD4+ cells obtained from the peripheral blood of patients with highly active relapsing-remitting multiple sclerosis...
February 3, 2017: Scientific Reports
https://www.readbyqxmd.com/read/28146605/stretch-for-the-treatment-and-prevention-of-contractures
#9
REVIEW
Lisa A Harvey, Owen M Katalinic, Robert D Herbert, Anne M Moseley, Natasha A Lannin, Karl Schurr
BACKGROUND: Contractures are a common complication of neurological and non-neurological conditions, and are characterised by a reduction in joint mobility. Stretch is widely used for the treatment and prevention of contractures. However, it is not clear whether stretch is effective. This review is an update of the original 2010 version of this review. OBJECTIVES: The aim of this review was to determine the effects of stretch on contractures in people with, or at risk of developing, contractures...
January 9, 2017: Cochrane Database of Systematic Reviews
https://www.readbyqxmd.com/read/28139093/adoption-decisions-for-medical-devices-in-the-field-of-cardiology-results-from-a-european-survey
#10
Maximilian H M Hatz, Jonas Schreyögg, Aleksandra Torbica, Giuseppe Boriani, Carl R B Blankart
Decisions to adopt medical devices at the hospital level have consequences for health technology assessment (HTA) on system level and are therefore important to decision makers. Our aim was to investigate the characteristics of organizations and individuals that are more inclined to adopt and utilize cardiovascular devices based on a comprehensive analysis of environmental, organizational, individual, and technological factors and to identify corresponding implications for HTA. Seven random intercept hurdle models were estimated using the data obtained from 1249 surveys completed by members of the European Society of Cardiology...
February 2017: Health Economics
https://www.readbyqxmd.com/read/28139087/linking-the-regulatory-and-reimbursement-processes-for-medical-devices-the-need-for-integrated-assessments
#11
Oriana Ciani, Britni Wilcher, Anoukh van Giessen, Rod S Taylor
Much criticism has been directed at the licencing requirements for medical devices (MDs) as they often result in a lack of robust evidence to inform health technology assessment (HTA) decisions. To better understand the current international decisional framework on MD technologies, we undertook three linked research studies: a review of the device regulatory procedures, a survey of current HTA practices and an empirical comparison of HTA reports of drugs versus MDs. Our review confirms that current device regulatory processes across the globe are substantially less stringent than drugs...
February 2017: Health Economics
https://www.readbyqxmd.com/read/28139086/key-recommendations-from-the-medtechta-project
#12
Rosanna Tarricone, Aleksandra Torbica, Michael Drummond
There are particular characteristics of Medical Devices, such as the device-user interaction, the incremental nature of innovation and the broader organizational impact that lead to additional challenges for health technology assessment (HTA). The project explored key aspects of the conduct and methods of HTA for MDs. Systematic reviews and original research studies were conducted to determine improvements in processes and methods that could enhance the potential for HTA and optimize the diffusion of MDs. Regulatory processes for MDs should be more closely aligned, the HTA evaluative framework should be harmonized and processes for conditional coverage and evidence development should be used...
February 2017: Health Economics
https://www.readbyqxmd.com/read/28139084/challenges-in-the-assessment-of-medical-devices-the-medtechta-project
#13
Rosanna Tarricone, Aleksandra Torbica, Michael Drummond
Assessing medical devices (MDs) raises challenges which require us to reflect on whether current methods are adequate. Major features of devices are: (i) device-operator interaction can generate learning curve effects; (ii) incremental nature of innovation needs to be addressed by careful identification of the alternatives for comparative and incremental cost-effectiveness analysis; and (iii) broader organizational impact in terms of training and infrastructure, coupled with dynamic pricing, requires a more flexible approach to costing...
February 2017: Health Economics
https://www.readbyqxmd.com/read/28128008/introduction-of-high-risk-medical-devices-national-measures-that-can-be-taken-under-the-current-european-legislation-to-put-the-patient-interest-central
#14
Mattias Neyt, Hanne Baeyens, Céline Pouppez, Pierre Slegers, Frank Hulstaert, Sabine Stordeur, Irm Vinck
BACKGROUND: High-risk medical devices may not always provide a therapeutic added value to patients. In Europe, no proof of efficacy is required to receive a CE label, making it difficult for policymakers to decide on reimbursement of (often expensive) high-risk medical devices. We explore, within the framework of the European legislation, the possibilities at a national level for a guided introduction of such devices. RESEARCH DESIGN AND METHODS: HTA and legal experts worked in close collaboration with medical specialists and government representatives making a legal analysis of what is possible under the (revised) European and national legislation...
January 27, 2017: Expert Review of Medical Devices
https://www.readbyqxmd.com/read/28125369/payer-perspectives-on-patient-reported-outcomes-in-health-care-decision-making-oncology-examples
#15
Andrew P Brogan, Carla DeMuro, Amy M Barrett, Denise D'Alessio, Vasudha Bal, Susan L Hogue
BACKGROUND: Health authorities and payers increasingly recognize the importance of patient perspectives and patient-reported outcomes (PROs) in health care decision making. However, given the broad variety of PRO endpoints included in clinical programs and variations in the timing of PRO data collection and country-specific needs, the role of PRO data in reimbursement decisions requires characterization. OBJECTIVES: To (a) determine the effect of PRO data on market access and reimbursement decisions for oncology products in multiple markets and (b) assess the effect of PRO data collected after clinical progression on payer decision making...
February 2017: Journal of Managed Care & Specialty Pharmacy
https://www.readbyqxmd.com/read/28118846/ecological-validity-of-cost-effectiveness-models-of-universal-hpv-vaccination-a-protocol-for-a-systematic-review
#16
Giampiero Favato, Emmanouil Noikokyris, Riccardo Vecchiato
BACKGROUND: Sexually transmitted infection with high-risk, oncogenic strains of human papillomavirus (HPV) still induces a relevant burden of diseases on both men and women. Although vaccines appear to be highly efficacious in preventing the infection of the most common high-risk strains (HPV 6, 11, 16, 18), important questions regarding the appropriate target population for prophylactic vaccination are still debated. Models in the extant literature seem to converge on the cost-effectiveness of high coverage (>80%) of a single cohort of 12-year-old girls...
January 25, 2017: Systematic Reviews
https://www.readbyqxmd.com/read/28109266/team-based-care-for-improving-hypertension-management-among-outpatients-tbc-hta-study-protocol-for-a-pragmatic-randomized-controlled-trial
#17
Valérie Santschi, Grégoire Wuerzner, Arnaud Chiolero, Bernard Burnand, Philippe Schaller, Lyne Cloutier, Gilles Paradis, Michel Burnier
BACKGROUND: Blood pressure (BP) is poorly controlled among a large proportion of hypertensive outpatients. Innovative models of care are therefore needed to improve BP control. The Team-Based Care for improving Hypertension management (TBC-HTA) study aims to evaluate the effect of a team-based care (TBC) interprofessional intervention, involving nurses, community pharmacists and physicians, on BP control of hypertensive outpatients compared to usual care in routine clinical practice. METHODS/DESIGN: The TBC-HTA study is a pragmatic randomized controlled study with a 6-month follow-up which tests a TBC interprofessionnal intervention conducted among uncontrolled treated hypertensive outpatients in two ambulatory clinics and among seven nearby community pharmacies in Lausanne and Geneva, Switzerland...
January 21, 2017: BMC Cardiovascular Disorders
https://www.readbyqxmd.com/read/28106292/23-hydroxytormentic-acid-protects-human-dermal-fibroblasts-by-attenuating-uva-induced-oxidative-stress
#18
Hae Jeong Youn, Ki Bbeum Kim, Hyo-Sun Han, In-Sook An, Kyu Joong Ahn
BACKGROUND: Ultraviolet A (UVA), one of the major components of sunlight, can penetrate the dermal layer of the skin and generate reactive oxygen species (ROS). It causes alterations in the dermal connective tissue and gene expression, inflammation, photoaging, and DNA damage. AIMS: Therefore, the harmful effects of UVA and strategies to reduce it have been consistently investigated. 23-Hydroxytormentic acid (23-HTA) has been demonstrated to improve drug-induced nephrotoxicity and exhibit several free radical scavenging effects with other molecules...
January 20, 2017: Photodermatology, Photoimmunology & Photomedicine
https://www.readbyqxmd.com/read/28076587/-interventions-to-improve-access-to-health-services-by-indigenous-peoples-in-the-americas
#19
Miguel Araujo, Cecilia Moraga, Evelina Chapman, Jorge Barreto, Eduardo Illanes
Objective: Synthesize evidence on effectiveness of interventions designed to improve access to health services by indigenous populations. Methods: Review of systematic reviews published as of July 2015, selecting and analyzing only studies in the Region of the Americas. The bibliographic search encompassed MEDLINE, Lilacs, SciELO, EMBASE, DARE, HTA, The Cochrane Library, and organization websites. Two independent reviewers selected studies and analyzed their methodological quality...
November 2016: Revista Panamericana de Salud Pública, Pan American Journal of Public Health
https://www.readbyqxmd.com/read/28072765/phase-ii-study-of-the-pi3k-inhibitor-bkm120-in-patients-with-advanced-or-recurrent-endometrial-carcinoma-a-stratified-type-i-type-ii-study-from-the-gineco-group
#20
P-E Heudel, M Fabbro, C Roemer-Becuwe, M C Kaminsky, A Arnaud, F Joly, S Roche-Forestier, J Meunier, C Foa, B You, F Priou, Y Tazi, A Floquet, F Selle, D Berton-Rigaud, A Lesoin, E Kalbacher, A Lortholary, L Favier, I Treilleux, I Ray-Coquard
: Backround:Patients with metastatic endometrial carcinoma have a poor prognosis and PIK3CA mutations and amplifications are common in these cancers. This study evaluated the efficacy and safety of the pure PI3K inhibitor BKM120 in advanced or recurrent endometrial carcinoma. METHODS: This phase II, multicentre, single-arm, double strata (histological low grade (LG) or high grade (HG)) open-label study enrolled patients with histologically confirmed advanced or recurrent endometrial carcinoma who had received not more than one prior chemotherapy regimen...
January 2017: British Journal of Cancer
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