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Sabine Fuchs, Britta Olberg, Dimitra Panteli, Matthias Perleth, Reinhard Busse
OBJECTIVES: Health Technology Assessment (HTA) of Medical devices (MDs) and MD-based procedures can be challenging due to the unique features and particularities of this group of technologies, such as device-operator interaction. The aim of this study was to (1) clarify, and supplement earlier findings on European HTA institutions' structural, procedural and methodological characteristics with regard to the assessment of MDs and to (2) capture the institutions' perceptions regarding challenges and future trends...
September 14, 2016: Health Policy
Jessica Tajana Mattivi, Barbara Buchberger
OBJECTIVES: Rapid reviews can be conducted in a narrower time frame, as compared to systematic reviews, by featuring restrictions. To estimate the validity of the results, assessment of methodological quality is required. Our aim was to analyze the methodological restrictions of rapid reviews compared with systematic reviews using the AMSTAR checklist and assess its feasibility for rapid reviews. METHODS: A systematic search for literature on rapid reviews of surgical interventions was conducted in three databases: Medline, Embase, and the Cochrane library...
October 18, 2016: International Journal of Technology Assessment in Health Care
Georgi Iskrov, Tsonka Miteva-Katrandzhieva, Rumen Stefanov
BACKGROUND: Limited resources and expanding expectations push all countries and types of health systems to adopt new approaches in priority setting and resources allocation. Despite best efforts, it is difficult to reconcile all competing interests, and trade-offs are inevitable. This is why multi-criteria decision analysis (MCDA) has played a major role in recent uptake of value-based reimbursement. MCDA framework enables exploration of stakeholders' preferences, as well as explicit organization of broad range of criteria on which real-world decisions are made...
2016: Frontiers in Public Health
Debjani Mueller, Iñaki Gutiérrez-Ibarluzea, Tara Schuller, Marco Chiumente, Jeonghoon Ahn, Andres Pichon-Riviere, Sebastian García-Martí, David Grainger, Elizabeth Cobbs, Marco Marchetti
OBJECTIVES: Health technology assessment (HTA) yields information that can be ideally used to address deficiencies in health systems and to create a wider understanding of the impact of different policy considerations around technology reimbursement and use. The structure of HTA programs varies across different jurisdictions according to decision-maker needs. Moreover, conducting HTA requires specialized skills. Effective decision making should include multiple criteria (medical, economic, technical, ethical, social, legal, and cultural) and requires multi-disciplinary teams of experts working together to produce these assessments...
October 17, 2016: International Journal of Technology Assessment in Health Care
Ruth Ruiz Esparza-Garrido, Juan Manuel Rodríguez-Corona, Javier Enrique López-Aguilar, Marco Antonio Rodríguez-Florido, Ana Claudia Velázquez-Wong, Rubí Viedma-Rodríguez, Fabio Salamanca-Gómez, Miguel Ángel Velázquez-Flores
Expression changes for long non-coding RNAs (lncRNAs) have been identified in adult glioblastoma multiforme (GBM) and in a mixture of adult and pediatric astrocytoma. Since adult and pediatric astrocytomas are molecularly different, the mixture of both could mask specific features in each. We determined the global expression patterns of lncRNAs and messenger RNA (mRNAs) in pediatric astrocytoma of different histological grades. Transcript expression changes were determined with an HTA 2.0 array. lncRNA interactions with microRNAs and mRNAs were predicted by using an algorithm and the LncTar tool, respectively...
October 13, 2016: Molecular Neurobiology
Michael Ermisch, Anna Bucsics, Patricia Vella Bonanno, Francis Arickx, Alexander Bybau, Tomasz Bochenek, Marc van de Casteele, Eduardo Diogene, Jurij Fürst, Kristina Garuolienė, Martin van der Graaff, Jolanta Gulbinovič, Alan Haycox, Jan Jones, Roberta Joppi, Ott Laius, Irene Langner, Antony P Martin, Vanda Markovic-Pekovic, Laura McCullagh, Einar Magnusson, Ellen Nilsen, Gisbert Selke, Catherine Sermet, Steven Simoens, Robert Sauermann, Ad Schuurman, Ricardo Ramos, Vera Vlahovic-Palcevski, Corinne Zara, Brian Godman
Payers are a major stakeholder in any considerations and initiatives concerning adaptive licensing of new medicinal products, also referred to as Medicines Adaptive Pathways to patients (MAPPs). Firstly, the scope and necessity of MAPPs need further scrutiny, especially with regard to the definition of unmet need. Conditional approval pathways already exist for new medicines for seriously debilitating or life-threatening diseases and only a limited number of new medicines are innovative. Secondly, MAPPs will result in new medicines on the market with limited evidence about their effectiveness and safety...
2016: Frontiers in Pharmacology
Ying Zheng, Feng Pan, Sonja Sorensen
As the number of interventions available in a therapeutic area increases, the relevant decision questions in health technology assessment (HTA) expand to compare treatment sequences instead of discrete treatments and identify optimal sequences or position for a particular treatment in a sequence. The objective of this work was to review approaches used to model treatment sequences and provide practical guidance on conceptualizing whether and how to model sequences in health economic models. Economic models including treatment sequencing assessed by the National Institute for Health and Care Excellence were reviewed, as these assessments generally provide both policy relevance and comprehensive model detail...
October 8, 2016: PharmacoEconomics
Marcel Mertz, Hannes Kahrass, Daniel Strech
BACKGROUND: Modern standards for evidence-based decision making in clinical care and public health still rely solely on eminence-based input when it comes to normative ethical considerations. Manuals for clinical guideline development or health technology assessment (HTA) do not explain how to search, analyze, and synthesize relevant normative information in a systematic and transparent manner. In the scientific literature, however, systematic or semi-systematic reviews of ethics literature already exist, and scholarly debate on their opportunities and limitations has recently bloomed...
October 3, 2016: BMC Medicine
Sabine E Grimm, Simon Dixon, John W Stevens
BACKGROUND: Health technology assessments (HTAs) that take account of future price changes have been examined in the literature, but the important issue of price reductions that are generated by the reimbursement decision has been ignored. OBJECTIVES: To explore the impact of future price reductions caused by increasing uptake on HTAs and decision making for medical devices. METHODS: We demonstrate the use of a two-stage modeling approach to derive estimates of technology price as a consequence of changes in technology uptake over future periods on the basis of existing theory and supported by empirical studies...
September 2016: Value in Health: the Journal of the International Society for Pharmacoeconomics and Outcomes Research
Rachael Frost, Sara Levati, Doreen McClurg, Marian Brady, Brian Williams
OBJECTIVE: To systematically review methods for measuring adherence used in home-based rehabilitation trials, and evaluate their validity, reliability and acceptability. DATA SOURCES: Phase 1: We searched CENTRAL, EED and HTA (Jan 2000-April 2013) to identify adherence measures used in randomised controlled trials of allied health professional home-based rehabilitation interventions. Phase 2: We searched Medline, Embase, CINAHL, AMED, PsycINFO, CENTRAL, ProQuest and Web of Science (inception-April 2015) for measurement property assessments (MPAs) for each measure...
October 1, 2016: Archives of Physical Medicine and Rehabilitation
Martin Zavadil, Vladimír Rogalewicz, Ivana Kubátová, Veronika Matloňová, Kristýna Salačová
Hospital-based HTA (HB-HTA) consists in implementation of assessment activities "in" or "for" hospitals; hence, it covers processes and methods supporting organization and execution of health technology assessment (HTA) at the level of individual hospitals. This process is multidisciplinary, systematic and evidence-based.HB-HTA objectives and methods differ from the classic utilization of HTA at the national regulator level. Most experience and information concerning HB-HTA has originated in two large recent projects: activities of the HB-HTA Interest Group of the HTAi international association established in 2006, and the AdHopHTA European research project (20122015)...
2016: Casopís Lékar̆ů C̆eských
Anna R Gagliardi, Ariel Ducey, Pascale Lehoux, Sue Ross, Patricia Trbovich, Anthony Easty, Chaim Bell, Julie Takata, Christof Pabinger, David R Urbach
INTRODUCTION: Some cardiovascular devices are licensed based on limited evidence, potentially exposing patients to devices that are not safe or effective. Research is needed to ascertain if the same is true of other types of medical devices. Knee arthroplasty is a widely-used surgical procedure yet implant failures are not uncommon. The purpose of this study was to characterize available evidence on the safety and effectiveness of knee implants. METHODS: A review of primary studies included in health technology assessments (HTA) on total (TKA) and unicompartmental knee arthroplasty (UKA) was conducted...
2016: PloS One
Keith Syrett
This brief commentary seeks to develop the analysis of Daniels, Porteny and Urrutia of the implications of expansion of the scope of health technology assessment (HTA) beyond issues of safety, efficacy, and cost-effectiveness. Drawing in particular on experience in the United Kingdom, it suggests that such expansion can be understood not only as a response to the problem of insufficiency of evidence, but also to that of legitimacy. However, as expansion of HTA also renders it more visibly political in character, it is plausible that its legitimacy may be undermined, rather than enhanced by, independence from the policy process...
June 12, 2016: International Journal of Health Policy and Management
Anthony J Culyer
Daniels, Porteny and Urrutia et al make a good case for the idea that that public decisions ought to be made not only "in the light of" evidence but also "on the basis of" budget impact, financial protection and equity. Health technology assessment (HTA) should, they say, be accordingly expanded to consider matters additional to safety and cost-effectiveness. They also complain that most HTA reports fail to develop ethical arguments and generally do not even mention ethical issues. This comment argues that some of these defects are more apparent than real and are not inherent in HTA - as distinct from being common characteristics found in poorly conducted HTAs...
May 16, 2016: International Journal of Health Policy and Management
Kyriakos Souliotis, Eirini Agapidaki, Lily Evangelia Peppou, Chara Tzavara, George Samoutis, Mamas Theodorou
Although the importance of patient participation in the design and evaluation of health programs and services is well-documented, there is scarcity of research with regard to patient association (PA) participation in health policy decision-making processes. To this end, the present study aimed to validate further a previously developed instrument as well as to investigate the degree of PA participation in health policy decision-making in Cyprus. A convenient sample of 114 patients-members of patients associations took part in the study...
June 20, 2016: International Journal of Health Policy and Management
Hector Eduardo Castro Jaramillo, Ornella Moreno-Mattar, Diana Osorio-Cuevas
BACKGROUND: Health technology assessment (HTA) examines the consequences of the application of health technologies and is aimed at better informing decision-makers. Over the past 30 years, different countries have implemented HTA organizations. Colombia established by law its own HTA agency (IETS) in 2011 which started operations in November 2012. The aim of this study was to assess the feasibility of conducting and using HTA to inform decision-making in this context. Through a qualitative approach, ten "drivers" emerged with the ability to help or hinder HTA development in this context: availability and quality of data, implementation strategy, cultural aspects, local capacity, financial support, policy/political support, globalization, stakeholder pressure, health system context, and usefulness perception...
October 3, 2016: International Journal of Technology Assessment in Health Care
Hector Eduardo Castro Jaramillo, Mireille Goetghebeur, Ornella Moreno-Mattar
OBJECTIVES: In 2012, Colombia experienced an important institutional transformation after the establishment of the Health Technology Assessment Institute (IETS), the disbandment of the Regulatory Commission for Health and the reassignment of reimbursement decision-making powers to the Ministry of Health and Social Protection (MoHSP). These dynamic changes provided the opportunity to test Multi-Criteria Decision Analysis (MCDA) for systematic and more transparent resource-allocation decision-making...
October 3, 2016: International Journal of Technology Assessment in Health Care
Martin Hua, Tristan Boonstra, Patrick J Kelly, Andrew Wilson, Jonathan C Craig, Angela C Webster
OBJECTIVES: The Medical Services Advisory Committee (MSAC) makes recommendations to the Australian Government for funding health technologies under the Medicare Benefits Schedule (MBS). Differences in public, clinical, commercial, and political opinions on health expenditure emphasize the importance of defensible funding decisions. We aimed to evaluate the quality of health technology assessment (HTA) reports over time and among health technologies assessed for MSAC. MAIN OUTCOME MEASURES: A cohort study was performed of HTA reports prepared for MSAC between 1998 and 2013...
October 3, 2016: International Journal of Technology Assessment in Health Care
Jörg Ruof, Thomas Staab, Charalabos-Markos Dintsios, Jakob Schröter, Friedrich Wilhelm Schwartz
OBJECTIVES: The aim of this study was to compare post-authorisation measures (PAMs) from the European Medicines Agency (EMA) with data requests in fixed-termed conditional appraisals of early benefit assessments from the German Federal Joint Committee (G-BA). METHODS: Medicinal products with completed benefit assessments during an assessment period of 3.5 years were considered. PAMs extracted from European Public Assessment Reports (EPARs) were compared with data requests issued by the G-BA in the context of conditional appraisals...
December 2016: Health Economics Review
Sally Wortley, Jackie Street, Wendy Lipworth, Kirsten Howard
Purpose Public engagement in health technology assessment (HTA) is increasingly considered crucial for good decision making. Determining the "right" type of engagement activity is key in achieving the appropriate consideration of public values. Little is known about the factors that determine how HTA organizations (HTAOs) decide on their method of public engagement, and there are a number of possible factors that might shape these decisions. The purpose of this paper is to understand the potential drivers of public engagement from an organizational perspective...
September 19, 2016: Journal of Health Organization and Management
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