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International Journal of Technology Assessment in Health Care

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https://www.readbyqxmd.com/read/27919315/implication-of-alternative-minimal-clinically-important-difference-threshold-estimation-methods-on-technology-assessment
#1
Diana Brixner, Eli O Meltzer, Kellie Morland, Cathryn A Carroll, Ullrich Munzel, Brian J Lipworth
OBJECTIVES: Various minimal clinically important difference (MCID) threshold estimation techniques have been applied to seasonal allergic rhinitis (SAR). The objectives of this study are to (i) assess the difference in magnitude of alternative SAR MCID threshold estimates and (ii) evaluate the impact of alternative MCID estimates on health technology assessment (HTA). METHODS: Data describing change from baseline of the reflective Total Nasal Symptom Score (rTNSS) for four intranasal SAR treatments were obtained from United States Food and Drug Administration-approved prescribing information...
December 6, 2016: International Journal of Technology Assessment in Health Care
https://www.readbyqxmd.com/read/27919309/cost-utility-analysis-of-primary-prophylaxis-compared-with-on-demand-treatment-for-patients-with-severe-hemophilia-type-a-in-colombia
#2
Héctor Eduardo Castro Jaramillo, Mabel Moreno Viscaya, Aurelio E Mejia
OBJECTIVES: This article presents a cost-utility analysis from the Colombian health system perspective comparing primary prophylaxis to on-demand treatment using exogenous clotting factor VIII (FVIII) for patients with severe hemophilia type A. METHODS: We developed a Markov model to estimate expected costs and outcomes (measured as quality-adjusted life-years, QALYs) for each strategy. Transition probabilities were estimated using published studies; utility weights were obtained from a sample of Colombian patients with hemophilia and costs were gathered using local data...
December 6, 2016: International Journal of Technology Assessment in Health Care
https://www.readbyqxmd.com/read/27916010/quality-assessment-of-ethics-analyses-for-health-technology-asssessment
#3
Anna Mae Scott, Kenneth Bond, Iñaki Gutiérrez-Ibarluzea, Björn Hofmann, Lars Sandman
OBJECTIVES: Although consideration of ethical issues is recognized as a crucial part of health technology assessment, ethics analysis for HTA is generally perceived as methodologically underdeveloped in comparison to other HTA domains. The aim of our study is (i) to verify existing tools for quality assessment of ethics analyses for HTA, (ii) to consider some arguments for and against the need for quality assessment tools for ethics analyses for HTA, and (iii) to propose a preliminary set of criteria that could be used for assessing the quality of ethics analyses for HTA...
December 5, 2016: International Journal of Technology Assessment in Health Care
https://www.readbyqxmd.com/read/27916006/budget-impact-analysis-of-belimumab-in-treating-systemic-lupus-erythematosus
#4
Francesca Pierotti, Iaria Palla, Lara Pippo, Valentina Lorenzoni, Giuseppe Turchetti
OBJECTIVES: The study evaluates the costs of systemic lupus erythematosus (SLE) and the budget impact due to the introduction of belimumab in the Italian setting. METHODS: Adaptation to the Italian setting of a budget impact model with a time horizon of 4 years (year 0 without belimumab, years 1-3 with belimumab) to compare treatment, administration, and clinical monitoring costs of standard therapy and of the alternative scenario in which belimumab is administered in addition to the standard therapy to the subgroup of patients selected according to the label approved by the European Medicines Agency...
December 5, 2016: International Journal of Technology Assessment in Health Care
https://www.readbyqxmd.com/read/27766998/changing-health-technology-assessment-paradigms
#5
Don Husereau, Chris Henshall, Laura Sampietro-Colom, Sarah Thomas
OBJECTIVES: Health technology assessment (HTA) has to innovate to best support changing health system environments and to help provide access to valuable innovation under fiscal constraint. METHODS: Issues associated with changing HTA paradigms were identified through scoping and explored through deliberation at a meeting of industry and HTA leaders. RESULTS: Five broad areas of change (engagement, scientific dialogue, research prioritization, adaptive approaches, and real world data) were identified...
January 2016: International Journal of Technology Assessment in Health Care
https://www.readbyqxmd.com/read/27766992/neoadjuvant-transcatheter-arterial-chemoembolization-for-biliary-tumor-thrombosis-a-retrospective-study
#6
Yangyang Shen, Pang Li, Kai Cui, Zhendan Wang, Fachang Yu, He Tian, Sheng Li
OBJECTIVES: Curative hepatectomy and tumor thrombectomy for hepatocellular carcinoma with complicating biliary tumor thrombosis (HCC/BTT) is associated with high surgical morbidity and mortality. This retrospective study evaluated the effectiveness and safety of neoadjuvant transcatheter arterial chemoembolization (TACE) in HCC/BTT patients scheduled for curative resection. METHODS: Thirty consecutive patients with diagnosed HCC/BTT were hospitalized for neoadjuvant TACE and elective curative liver resection (group A; n=20) or curative liver resection alone (group B; n=10)...
January 2016: International Journal of Technology Assessment in Health Care
https://www.readbyqxmd.com/read/27751191/using-the-amstar-checklist-for-rapid-reviews-is-it-feasible
#7
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...
January 2016: International Journal of Technology Assessment in Health Care
https://www.readbyqxmd.com/read/27751189/treatment-after-acute-coronary-syndrome-analysis-of-patient-s-priorities-with-analytic-hierarchy-process
#8
Axel C Mühlbacher, Susanne Bethge, Anika Kaczynski
BACKGROUND: Cardiovascular disease is one of the most common causes of death worldwide, with many individuals having experienced acute coronary syndrome (ACS). How patients with a history of ACS value aspects of their medical treatment have been evaluated rarely. The aim of this study was to determine patient priorities for long-term drug therapy after experiencing ACS. METHODS: To identify patient-relevant treatment characteristics, a systematic literature review and qualitative patient interviews were conducted...
January 2016: International Journal of Technology Assessment in Health Care
https://www.readbyqxmd.com/read/27745567/capacity-building-in-agencies-for-efficient-and-effective-health-technology-assessment
#9
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...
January 2016: International Journal of Technology Assessment in Health Care
https://www.readbyqxmd.com/read/27724987/defining-rapid-reviews-a-modified-delphi-consensus-approach
#10
Shannon E Kelly, David Moher, Tammy J Clifford
OBJECTIVES: Rapid reviews are characterized as an accelerated evidence synthesis approach with no universally accepted methodology or definition. This modified Delphi consensus study aimed to develop a comprehensive set of defining characteristics for rapid reviews that may be used as a functional definition. METHODS: Expert panelists with knowledge in rapid reviews and evidence synthesis were identified. In the first round, panelists were asked to answer a seventeen-item survey addressing a variety of rapid review topics...
January 2016: International Journal of Technology Assessment in Health Care
https://www.readbyqxmd.com/read/27719689/cost-effectiveness-of-structured-education-in-children-with-type-1-diabetes-mellitus
#11
Hasan Basarir, Alan Brennan, Richard Jacques, Daniel Pollard, Katherine Stevens, Jennifer Freeman, Jerry Wales, Katherine Price
OBJECTIVES: Kids in Control OF Food (KICk-OFF) is a 5-day structured education program for 11- to 16-year-olds with type 1 diabetes mellitus (T1DM) who are using multiple daily insulin injections. This study evaluates the cost-effectiveness of the KICk-OFF education program compared with the usual care using data from the KICk-OFF trial. METHODS: The short-term within-trial analysis covers the 2-year postintervention period. Data on glycated hemoglobin (HbA1c), severe hypoglycemia, and diabetic ketoacidosis (DKA) were collected over a 2-year follow-up period...
January 2016: International Journal of Technology Assessment in Health Care
https://www.readbyqxmd.com/read/27691993/emergence-of-drivers-for-the-implementation-of-health-technology-assessment
#12
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...
January 2016: International Journal of Technology Assessment in Health Care
https://www.readbyqxmd.com/read/27691992/early-cost-effectiveness-analysis-of-new-medical-tests-response
#13
Alison Florence Smith, Andrew Sutton, Bethany Shinkins
As strong advocates and adopters of early cost-effectiveness modeling for test evaluation, we were excited to see the recent article "The Early Bird Catches the Worm: Early Cost-Effectiveness Analysis of New Medical Tests," in which Buisman and colleagues present a succinct and generalizable framework for conducting this type of analysis. The authors have done an excellent job in identifying and summarizing the key components of this methodology, as well as highlighting fundamental differences between early analyses versus the traditional late-stage approach...
January 2016: International Journal of Technology Assessment in Health Care
https://www.readbyqxmd.com/read/27691990/testing-multi-criteria-decision-analysis-for-more-transparent-resource-allocation-decision-making-in-colombia
#14
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...
January 2016: International Journal of Technology Assessment in Health Care
https://www.readbyqxmd.com/read/27691988/quality-of-health-technology-assessment-reports-prepared-for-the-medical-services-advisory-committee
#15
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...
January 2016: International Journal of Technology Assessment in Health Care
https://www.readbyqxmd.com/read/27670693/public-and-patient-involvement-in-health-technology-assessment-a-framework-for-action
#16
Julia Abelson, Frank Wagner, Deirdre DeJean, Sarah Boesveld, Franςois-Pierre Gauvin, Sally Bean, Renata Axler, Stephen Petersen, Shamara Baidoobonso, Gaylene Pron, Mita Giacomini, John Lavis
OBJECTIVE: As health technology assessment (HTA) organizations in Canada and around the world seek to involve the public and patients in their activities, frameworks to guide decisions about whom to involve, through which mechanisms, and at what stages of the HTA process have been lacking. The aim of this study was to describe the development and outputs of a comprehensive framework for involving the public and patients in a government agency's HTA process. METHODS: The framework was informed by a synthesis of international practice and published literature, a dialogue with local, national and international stakeholders, and the deliberations of a government agency's public engagement subcommittee in Ontario, Canada...
January 2016: International Journal of Technology Assessment in Health Care
https://www.readbyqxmd.com/read/27670589/health-technology-assessment-of-medical-devices-in-europe-processes-practices-and-methods
#17
Sabine Fuchs, Britta Olberg, Dimitra Panteli, Reinhard Busse
OBJECTIVES: To review and compare current Health Technology Assessment (HTA) activities for medical devices (MDs) across European HTA institutions. METHODS: A comprehensive approach was adopted to identify institutions involved in HTA in European countries. We systematically searched institutional Web sites and other online sources by using a structured tool to extract information on the role and link to decision making, structure, scope, process, methodological approach, and available HTA reports for each included institution...
January 2016: International Journal of Technology Assessment in Health Care
https://www.readbyqxmd.com/read/27624983/treatment-switching-in-cancer-trials-issues-and-proposals
#18
Chris Henshall, Nicholas R Latimer, Lloyd Sansom, Robyn L Ward
OBJECTIVES: Treatment switching occurs when patients in a randomized clinical trial switch from the treatment initially assigned to them to another treatment, typically from the control to experimental treatment. This study discusses the issues this raises and possible approaches to addressing them in trials of cancer drugs. METHODS: Stakeholders from around the world were invited to a 1.5-day Workshop in Adelaide, Australia. This study attempts to capture the key points from the discussion and the perspectives of the various stakeholder groups, but is not a formal consensus statement...
January 2016: International Journal of Technology Assessment in Health Care
https://www.readbyqxmd.com/read/27624982/treatment-switching-statistical-and-decision-making-challenges-and-approaches
#19
Nicholas R Latimer, Chris Henshall, Uwe Siebert, Helen Bell
OBJECTIVES: Treatment switching refers to the situation in a randomized controlled trial where patients switch from their randomly assigned treatment onto an alternative. Often, switching is from the control group onto the experimental treatment. In this instance, a standard intention-to-treat analysis does not identify the true comparative effectiveness of the treatments under investigation. We aim to describe statistical methods for adjusting for treatment switching in a comprehensible way for nonstatisticians, and to summarize views on these methods expressed by stakeholders at the 2014 Adelaide International Workshop on Treatment Switching in Clinical Trials...
January 2016: International Journal of Technology Assessment in Health Care
https://www.readbyqxmd.com/read/27624559/scientific-and-social-value-judgments-for-orphan-drugs-in-health-technology-assessment
#20
Elena Nicod, Panos Kanavos
OBJECTIVES: We explore how broader aspects of a treatment's value and the impact of the condition on patients not captured by routine health technology assessment (HTA) methods using clinical and economic evidence, defined as "other considerations," may influence HTA processes in different settings. METHODS: Countries included were England, Scotland, Sweden, and France. Data sources were the publicly available reports on HTA recommendations. Ten drugs with European Medicines Agency orphan designation and appraised in England were selected...
January 2016: International Journal of Technology Assessment in Health Care
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