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"Health technology assessment"

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https://www.readbyqxmd.com/read/29781145/core-outcome-set-for-gene-therapy-in-haemophilia-results-of-the-corehem-multistakeholder-project
#1
A Iorio, M W Skinner, E Clearfield, D Messner, G F Pierce, M Witkop, S Tunis
BACKGROUND: Gene therapy trial results show potential to cure haemophilia A and haemophilia B. Securing broad access to a cure for a lifelong chronic disease is anticipated to face barriers at the individual and healthcare system levels, which can be partly mitigated by harmonized planning of clinical research studies. The aim of the coreHEM project was to determine the set of outcome measures required to evaluate efficacy, safety, comparative effectiveness and value of gene therapy for haemophilia...
May 20, 2018: Haemophilia: the Official Journal of the World Federation of Hemophilia
https://www.readbyqxmd.com/read/29778325/tranexamic-acid-for-hyperacute-primary-intracerebral-haemorrhage-tich-2-an-international-randomised-placebo-controlled-phase-3-superiority-trial
#2
Nikola Sprigg, Katie Flaherty, Jason P Appleton, Rustam Al-Shahi Salman, Daniel Bereczki, Maia Beridze, Hanne Christensen, Alfonso Ciccone, Ronan Collins, Anna Czlonkowska, Robert A Dineen, Lelia Duley, Juan Jose Egea-Guerrero, Timothy J England, Kailash Krishnan, Ann Charlotte Laska, Zhe Kang Law, Serefnur Ozturk, Stuart J Pocock, Ian Roberts, Thompson G Robinson, Christine Roffe, David Seiffge, Polly Scutt, Jegan Thanabalan, David Werring, David Whynes, Philip M Bath
BACKGROUND: Tranexamic acid can prevent death due to bleeding after trauma and post-partum haemorrhage. We aimed to assess whether tranexamic acid reduces haematoma expansion and improves outcome in adults with stroke due to intracerebral haemorrhage. METHODS: We did an international, randomised placebo-controlled trial in adults with intracerebral haemorrhage from acute stroke units at 124 hospital sites in 12 countries. Participants were randomly assigned (1:1) to receive 1 g intravenous tranexamic acid bolus followed by an 8 h infusion of 1 g tranexamic acid or a matching placebo, within 8 h of symptom onset...
May 15, 2018: Lancet
https://www.readbyqxmd.com/read/29770210/identification-of-publicly-available-data-sources-to-inform-the-conduct-of-health-technology-assessment-in-india
#3
Laura Downey, Neethi Rao, Lorna Guinness, Miqdad Asaria, Shankar Prinja, Anju Sinha, Rajni Kant, Arvind Pandey, Francoise Cluzeau, Kalipso Chalkidou
Background: Health technology assessment (HTA) provides a globally-accepted and structured approach to synthesising evidence for cost and clinical effectiveness alongside ethical and equity considerations to inform evidence-based priorities. India is one of the most recent countries to formally commit to institutionalising HTA as an integral component of the heath resource allocation decision-making process. The effective conduct of HTA depends on the availability of reliable data.   Methods : We draw from our experience of collecting, synthesizing, and analysing health-related datasets in India and internationally, to highlight the complex requirements for undertaking HTA, and explore the availability of such data in India...
2018: F1000Research
https://www.readbyqxmd.com/read/29766842/continuous-low-dose-antibiotic-prophylaxis-to-prevent-urinary-tract-infection-in-adults-who-perform-clean-intermittent-self-catheterisation-the-antic-rct
#4
Robert Pickard, Thomas Chadwick, Yemi Oluboyede, Catherine Brennand, Alexander von Wilamowitz-Moellendorff, Doreen McClurg, Jennifer Wilkinson, Laura Ternent, Holly Fisher, Katherine Walton, Elaine McColl, Luke Vale, Ruth Wood, Mohamed Abdel-Fattah, Paul Hilton, Mandy Fader, Simon Harrison, James Larcombe, Paul Little, Anthony Timoney, James N'Dow, Heather Armstrong, Nicola Morris, Kerry Walker, Nikesh Thiruchelvam
BACKGROUND: People carrying out clean intermittent self-catheterisation (CISC) to empty their bladder often suffer repeated urinary tract infections (UTIs). Continuous once-daily, low-dose antibiotic treatment (antibiotic prophylaxis) is commonly advised but knowledge of its effectiveness is lacking. OBJECTIVE: To assess the benefit, harms and cost-effectiveness of antibiotic prophylaxis to prevent UTIs in people who perform CISC. DESIGN: Parallel-group, open-label, patient-randomised 12-month trial of allocated intervention with 3-monthly follow-up...
May 2018: Health Technology Assessment: HTA
https://www.readbyqxmd.com/read/29766700/health-policy-programs-realised-in-poland-in-2016-2017
#5
Patrycja Kurowska, Anna Królak, Wojciech Giermaziak
Background: Health Policy Program (Program Polityki Zdrowotnej – PPZ) is a state policy tool for engaging local government units into the mechanism of granting provision of health services. Authors show areas in which self-governments most often took preventive health care actions and describe legislative changes in the Act on provision of health services. Objective: The aim of the article is to quantitative and qualitative statement of PPZ prepared in Poland in 2016 and 2017, as well as presenting changing legal situation in the scope of evaluation of these projects...
2018: Roczniki Państwowego Zakładu Higieny
https://www.readbyqxmd.com/read/29760354/development-of-health-technology-assessment-in-china-new-challenges
#6
Yingyao Chen, Yao He, Xunyouzhi Chi, Yan Wei, Lizheng Shi
Health technology assessment (HTA) is a field of scientific policy research that adopts multidisciplinary approaches to conduct systematic evaluation of health technologies and inform decision making. Although achievements have been made by HTA activities among academics, providers, and policy makers, development of the field of HTA in China is fragmented and not yet formally integrated in health policy making processes. All stakeholders need to make more efforts to strengthen HTA knowledge translation and facilitate a decision making process that is based on evidence including HTA findings...
2018: Bioscience Trends
https://www.readbyqxmd.com/read/29754017/reparaci%C3%A3-n-endovascular-para-aneurisma-de-aorta-revisi%C3%A3-n-panor%C3%A3-mica-sobre-su-evidencia-en-el-mundo-y-su-aplicaci%C3%A3-n-en-latinoam%C3%A3-rica
#7
María Calderón, Viviana Brito, Andrea Alcaraz, Lucila Rey-Ares, Federico Augustovski, Sebastián García-Martí, Ariel Bardach, Agustín Ciapponi, Analía López, Andrés Pichón-Riviere
BACKGROUND: Aortic aneurysm (AA) is a pathology with high morbidity and mortality. The management can be expectant, surgical, or through endovascular repair (EVAR). In Latin America the incidence of AA has increased and the analysis of therapeutic options, especially if they are expensive, is fundamental. OBJECTIVE: To analyze available evidence on the effectiveness, safety and coverage policies of the EVAR. METHODOLOGY: Panoramic review in the main bibliographical bases (MEDLINE, LILACS, EMBASE, Cochrane Library, DARE) and generic internet searchers, main health technology assessment (HTA) agencies and health insurance companies...
May 10, 2018: Value in Health Regional Issues
https://www.readbyqxmd.com/read/29753358/handling-data-quality-issues-to-estimate-the-spanish-eq-5d-5l-value-set-using-a-hybrid-interval-regression-approach
#8
Juan M Ramos-Goñi, Benjamin M Craig, Mark Oppe, Yolanda Ramallo-Fariña, Jose Luis Pinto-Prades, Nan Luo, Oliver Rivero-Arias
BACKGROUND: The Spanish five-level EuroQol five-dimensional questionnaire (EQ-5D-5L) valuation study was the first to use the EuroQol Valuation Technology protocol, including composite time trade-off (C-TTO) and discrete choice experiments (DCE). In this study, its investigators noticed that some interviewers did not fully explain the C-TTO task to respondents. Evidence from a follow-up study in 2014 confirmed that when interviewers followed the protocol, the distribution of C-TTO responses widened...
May 2018: Value in Health: the Journal of the International Society for Pharmacoeconomics and Outcomes Research
https://www.readbyqxmd.com/read/29753351/evaluating-and-valuing-drugs-for-rare-conditions-no-easy-answers
#9
Daniel A Ollendorf, Richard H Chapman, Steven D Pearson
We find ourselves in an era of unprecedented growth in the development and use of so-called "orphan" drugs to treat rare diseases, which are poised to represent more than one-fifth of pharmaceutical expenditures by 2022. This widespread use has been facilitated by legislative and regulatory incentives in both the United States and abroad, yet US payers and health systems have not yet made a concerted effort to understand whether and how rare diseases require special considerations on their part and how to adapt traditional methods of health technology assessment and economic evaluation to accommodate these situations...
May 2018: Value in Health: the Journal of the International Society for Pharmacoeconomics and Outcomes Research
https://www.readbyqxmd.com/read/29753347/economic-modeling-considerations-for-rare-diseases
#10
Isobel Pearson, Ben Rothwell, Andrew Olaye, Christopher Knight
OBJECTIVES: To identify challenges that affect the feasibility and rigor of economic models in rare diseases and strategies that manufacturers have employed in health technology assessment submissions to demonstrate the value of new orphan products that have limited study data. METHODS: Targeted reviews of PubMed, the National Institute for Health and Care Excellence's (NICE's) Highly Specialised Technologies (HST), and the Scottish Medicines Consortium's (SMC's) ultra-orphan submissions were performed...
May 2018: Value in Health: the Journal of the International Society for Pharmacoeconomics and Outcomes Research
https://www.readbyqxmd.com/read/29753344/challenges-in-research-and-health-technology-assessment-of-rare-disease-technologies-report-of-the-ispor-rare-disease-special-interest-group
#11
Sandra Nestler-Parr, Daria Korchagina, Mondher Toumi, Chris L Pashos, Christopher Blanchette, Elizabeth Molsen, Thomas Morel, Steven Simoens, Zoltán Kaló, Ruediger Gatermann, William Redekop
BACKGROUND: Successful development of new treatments for rare diseases (RDs) and their sustainable patient access require overcoming a series of challenges related to research and health technology assessment (HTA). These impediments, which may be unique to RDs or also apply to common diseases but are particularly pertinent in RDs, are diverse and interrelated. OBJECTIVE: To develop for the first time a catalog of primary impediments to RD research and HTA, and to describe the cause and effect of individual challenges...
May 2018: Value in Health: the Journal of the International Society for Pharmacoeconomics and Outcomes Research
https://www.readbyqxmd.com/read/29751764/challenges-to-decision-making-processes-in-the-national-hta-agency-in-brazil-operational-procedures-evidence-use-and-recommendations
#12
Tania Yuka Yuba, Hillegonda Maria Dutilh Novaes, Patrícia Coelho de Soárez
BACKGROUND: The quality of the evidence used in health technology assessment (HTA) agency reports has been considered essential for decision-making processes and their legitimacy. In Brazil, CONITEC is the agency responsible for defining data mandatory for the submission of proposals for the incorporation of new technologies. The objective of this study was to analyse CONITEC recommendation reports, the type of scientific evidence used in them and their compliance with operational procedures...
May 11, 2018: Health Research Policy and Systems
https://www.readbyqxmd.com/read/29750751/the-impact-of-patient-characteristics-and-disease-specific-factors-on-first-line-treatment-decisions-for-braf-mutated-melanoma-results-from-a-european-expert-panel-study
#13
Paolo A Ascierto, Lars Bastholt, Pier F Ferrucci, Johan Hansson, Iván Márquez Rodas, Miranda Payne, Caroline Robert, Luc Thomas, Jochen S Utikal, Pascal Wolter, Amber Kudlac, Harriet Tuson, Jan McKendrick
Treatment decisions for advanced melanoma are increasingly complex and guidelines provide limited advice on how to choose between immunotherapy and targeted therapy for first-line treatment. A Delphi study was carried out to understand which patient characteristics and disease-related factors inform clinicians' choices of first-line treatment for BRAF-mutated melanoma. Twelve European melanoma specialists experienced in using immunotherapies and targeted agents participated in a double-blind two-phase Delphi study...
May 10, 2018: Melanoma Research
https://www.readbyqxmd.com/read/29740729/a-novel-flash-glucose-monitoring-system-in-patients-with-diabetes-mellitus-type-1-and-2-which-are-the-pieces-of-evidence-for-payer-decision-makers
#14
Salvatore Corrao, Biagio Nativo, Giuseppe Natoli, Marika Lo Monaco, Francesco Perticone
A rigorous health technology assessment is necessary to evaluate a new technology. However, healthcare regulatory agencies have less restrictive rules about medical devices, despite some recent warnings about this relevant matter. The evaluation should have at least two key issues, which require attention. The first one is its effectiveness, and the second one is its economic sustainability. In this paper, we deal with a novel glucose-sensing technology as a case study to examine the matter in depth. An evidence-based point of view is used to highlight this important issue...
May 8, 2018: Internal and Emergency Medicine
https://www.readbyqxmd.com/read/29739352/nature-and-reporting-characteristics-of-uk-health-technology-assessment-systematic-reviews
#15
Christopher Carroll, Eva Kaltenthaler
BACKGROUND: A recent study by Page et al. (PLoS Med. 2016;13(5):e1002028) claimed that increasing numbers of reviews are being published and many are poorly-conducted and reported. The aim of the present study was to assess how well reporting standards of systematic reviews produced in a Health Technology Assessment (HTA) context compare with reporting in Cochrane and other 'non-Cochrane' systematic reviews from the same years (2004 and 2014), as reported by Page et al. (PLoS Med. 2016;13(5):e1002028)...
May 8, 2018: BMC Medical Research Methodology
https://www.readbyqxmd.com/read/29737274/antiepileptic-drug-monitoring-in-pregnancy-empire-a-double-blind-randomised-trial-on-effectiveness-and-acceptability-of-monitoring-strategies
#16
Shakila Thangaratinam, Nadine Marlin, Sian Newton, Annalise Weckesser, Manny Bagary, Lynette Greenhill, Rachel Rikunenko, Maria D'Amico, Ewelina Rogozińska, Andrew Kelso, Kelly Hard, Jamie Coleman, Ngawai Moss, Tracy Roberts, Lee Middleton, Julie Dodds, Angela Pullen, Sandra Eldridge, Alexander Pirie, Elaine Denny, Doug McCorry, Khalid S Khan
BACKGROUND: Pregnant women with epilepsy on antiepileptic drugs (AEDs) may experience a reduction in serum AED levels. This has the potential to worsen seizure control. OBJECTIVE: To determine if, in pregnant women with epilepsy on AEDs, additional therapeutic drug monitoring reduces seizure deterioration compared with clinical features monitoring after a reduction in serum AED levels. DESIGN: A double-blind, randomised trial nested within a cohort study was conducted and a qualitative study of acceptability of the two strategies was undertaken...
May 2018: Health Technology Assessment: HTA
https://www.readbyqxmd.com/read/29733227/health-technology-assessment-in-saudi-arabia
#17
Sinaa Al-Aqeel
The Saudi government, similar to any other government, is committed to making public spending more efficient, using resources more effectively, and limiting waste. Health technology assessment (HTA) is a tool that informs policy and decision makers regarding the formulation of safe and effective policies that are patient-focused and help to achieve efficiency when allocating limited healthcare resources. Areas covered: After a brief description of HTA in the international context, this review provides a brief introduction to Saudi Arabia's healthcare system, followed by a delineation of the decision maker(s) and influencers and the decision-making process for pricing and reimbursement...
May 7, 2018: Expert Review of Pharmacoeconomics & Outcomes Research
https://www.readbyqxmd.com/read/29731212/no-292-abnormal-uterine-bleeding-in-pre-menopausal-women
#18
Sukhbir Singh, Carolyn Best, Sheila Dunn, Nicholas Leyland, Wendy Lynn Wolfman
BACKGROUND: Abnormal uterine bleeding is the direct cause of a significant health care burden for women, their families, and society as a whole. Up to 30% of women will seek medical assistance for this problem during their reproductive years. This guideline replaces previous clinical guidelines on the topic and is aimed to enable health care providers with the tools to provide the latest evidence-based care in the diagnosis and the medical and surgical management of this common problem...
May 2018: Journal of Obstetrics and Gynaecology Canada: JOGC, Journal D'obstétrique et Gynécologie du Canada: JOGC
https://www.readbyqxmd.com/read/29731210/no-249-asymptomatic-endometrial-thickening
#19
Wendy Wolfman
OBJECTIVE: To formulate clinical recommendations for the assessment of endometrial thickening when it is found on ultrasound in a postmenopausal patient without bleeding. OUTCOMES: Ensure that women with asymptomatic thickening and endometrial polyps found on ultrasound are managed appropriately. EVIDENCE: Published literature was retrieved through searches of English language articles from the EMBASE, Cochrane, and PubMed databases for relevant peer-reviewed articles dating from 1970 to 2009, using appropriate controlled vocabulary (e...
May 2018: Journal of Obstetrics and Gynaecology Canada: JOGC, Journal D'obstétrique et Gynécologie du Canada: JOGC
https://www.readbyqxmd.com/read/29729905/access-to-orphan-drugs-comparison-across-balkan-countries
#20
REVIEW
Ana V Pejcic, Georgi Iskrov, Mihajlo Michael Jakovljevic, Rumen Stefanov
The aim of this study was to compare orphan drug access in a sample of Balkan countries: five EU Member States (Bulgaria, Croatia, Greece, Romania, Slovenia) and two EU Candidates (Serbia, Montenegro). The comparative analysis was based on a cross-sectional study and included medicinal products with an active orphan designation and market authorisation on January 1, 2017. Access to orphan drugs is an ongoing challenge in these countries. Three clusters of countries were identified in terms of orphan drug access: Greece and Slovenia, making the top tier, Romania, Bulgaria, and Croatia, being in the middle, and EU Candidates, Serbia and Montenegro, forming the bottom tier, where a substantial number of EU market approved orphan drugs was not even registered...
April 26, 2018: Health Policy
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