scholarly journals Cardiovascular health technology assessment: recommendations to improve the quality of evidence

Open Heart ◽  
2019 ◽  
Vol 6 (1) ◽  
pp. e000930
Author(s):  
Colin Berry ◽  
David Corcoran ◽  
Kenneth Mangion
Keyword(s):  
Health Technology Assessment ◽  
Technology Assessment ◽  
Cardiovascular Health ◽  
Healthcare Providers ◽  
Health Technology ◽  
Quality Of Evidence ◽  
Individual Trial ◽  
Healthcare Technologies ◽  
New Evidence

The aim of this article is to review the role of Health Technology Assessment (HTA) organisations in appraising and recommending innovative cardiovascular technologies. We consider how bias impairs the quality of evidence from clinical trials involving cardiovascular healthcare technologies. Finally, we provide recommendations to HTA organisations to take account of bias when making guideline recommendations.Clinical research studies of medical devices, diagnostics and interventions in cardiovascular healthcare are susceptible to impairment through bias. While HTA organisations, such as the National Institute of Health and Care Excellence, may require reviewers to take account of bias, there are uncertainties as to how this is achieved, especially in cardiovascular technology trials. This becomes more relevant given that large trials are few in number; therefore, the quality of evidence from an individual trial may have a large bearing on guideline recommendations and clinical practice.HTA organisations should drive improvements in the design and rigour of randomised trials. The evolving landscape of cardiovascular healthcare technologies and related trials presents a challenge for HTA organisations and healthcare providers. The rapid turnover of evidence is externally relevant because the period from the trial publication to implementation of HTA guideline recommendations by healthcare providers may be prolonged, by which time new evidence may have emerged from subsequent trials. Implementation of a cardiovascular healthcare technology including be it a medical device, diagnostic or intervention may have profound implications for healthcare providers. These technologies may have high absolute costs and access may be influenced by socioeconomic and geographic factors.

Opportunities to improve reporting of rapid response in health technology assessment

2021 ◽  
Vol 38 (1) ◽  
Author(s):  
Matheus O. de Almeida ◽  
Thais Montezuma ◽  
Haliton A. de Oliveira Júnior ◽  
Cleusa Pinheiro Ferri
Keyword(s):  
Health Technology Assessment ◽  
Technology Assessment ◽  
Epidemiologic Study ◽  
Health Technology ◽  
Risk Of Bias ◽  
Quality Of Reporting ◽  
Quality Of Evidence ◽  
Health Technologies ◽  
Study Selection

Abstract Introduction Mini health technology assessment (HTA) reports have been used to support policy makers and health systems by providing a timely summary of scientific evidence. The objective of this meta-epidemiologic study was to evaluate the quality of reporting of mini-HTA reports published in Brazil. Methods An electronic search for all mini-HTA reports published between 2014 and March 2019 was conducted in the SISREBRATS and CONITEC databases. The study selection and data extraction were performed by two independent assessors. The following data were extracted: bibliographic data; research question; characteristics of the population, health technologies and outcomes assessed; eligibility criteria; information about searches and study selection; risk of bias assessment; quality of evidence assessment; synthesis of results; and recommendation about the technology evaluated. A descriptive analysis was used to summarize the information retrieved from all the included mini-HTA reports. Results We included 103 mini-HTA reports, the great majority of which (92.3 percent) focused on the coverage of the technologies in the healthcare system, with more than 60 percent being about drugs. Only five mini-HTA reports (4.8 percent) gave reasons for the choice of outcomes, and fifteen (14.5 percent) discriminated between primary and secondary outcomes. All mini-HTAs reported the databases searched and 99 percent of them reported using Medline. Sixty percent of the mini-HTA reported assessing the risk of bias, and 52 percent reported assessing the quality of evidence. Conclusion The quality of reporting of the mini-HTA reports performed in Brazil is insufficient and needs to be improved to guarantee transparency and replicability.

OP75 Facts And Values In Health Technology Assessment: The Case Of Non-Invasive Prenatal Testing

2019 ◽  
Vol 35 (S1) ◽  
pp. 19-19
Author(s):  
Bart Bloemen ◽  
Maarten Jansen ◽  
Wouter Rijke ◽  
Wija Oortwijn ◽  
Gert Vanderwilt
Keyword(s):  
Health Technology Assessment ◽  
Technology Assessment ◽  
Prenatal Testing ◽  
Health Technology ◽  
Non Invasive ◽  
Relevant Evidence ◽  
Healthcare Technologies ◽  
General Abstract ◽  
Structured Questionnaire

IntroductionHealth Technology Assessment (HTA) is where facts and values meet: the evidence that is considered relevant to the assessment of a technology depends on the value framework used. In the context of the European project VALIDATE (Values in doing assessments of healthcare technologies), we assessed to what extent this interplay between facts and values is acknowledged in HTA reports on non-invasive prenatal testing (NIPT). Our aim is to gain a better understanding of this fact-value relationship, and to contribute to the development of capacity for ethical analyses in HTA.MethodsFive reviewers independently analyzed HTA reports on NIPT, obtained from the National Institute for Health Research (NIHR) HTA database, by answering a structured questionnaire on: (i) arguments, values, and conclusions; (ii) relations between values and collected evidence; (iii) operationalizations of the values involved. Ethical argumentation was analyzed using the method of specifying norms. This method holds that for general, abstract ethical principles to reach concrete cases, principles need to be specified in such a way as to achieve maximal coherence between different value commitments and practice. The results of the analysis were discussed in joint meetings to arrive at a consensus on interpretation.ResultsOur results show that the pivotal role of values in defining what counts as relevant evidence and why, is rarely acknowledged. The same holds for the importance of specifying values as a means to achieve greater coherence between the use of healthcare technologies and a range of values.ConclusionsThere is ample room for improvement in clarifying the role of values in HTA: they can serve to explain and justify what evidence is considered relevant to the assessment of a healthcare technology. Recognizing that abstract values need specification in order to reach concrete cases opens up new opportunities for exploring in what way values are affected by healthcare technologies.

PP206 Health Technology Assessment Guidance In The United Kingdom: Addressing Issues Specific To Medical Devices

2021 ◽  
Vol 37 (S1) ◽  
pp. 26-26
Author(s):  
Scott Gibson ◽  
Sita Saunders ◽  
Amanda Hansson Hedblom ◽  
Maximilian Blüher ◽  
Rafael Torrejon Torres ◽  
...  
Keyword(s):  
United Kingdom ◽  
Health Technology Assessment ◽  
Medical Devices ◽  
Technology Assessment ◽  
Healthcare Providers ◽  
Economic Assessment ◽  
Health Technology ◽  
Training Costs ◽  
Medical Technologies ◽  
The United Kingdom

IntroductionThe United Kingdom spends approximately GBP4.2 billion (USD5.6 billion; EUR4.7 billion) each year on medical devices, but healthcare providers receive little health technology assessment (HTA) guidance on cost-effective device procurement. Our objective was to assess the availability of HTA guidance for medical technologies and to identify key challenges related to the economic assessment of these technologies.MethodsNational Institute for Health and Care Excellence technology appraisal (TA) and Medical Technologies Evaluation Programme (MTEP) appraisals published online between November 2009 and October 2020 were identified. The “case for adoption” recommendation, type of devices, and critiques of economic analyses for each MTEP appraisal were extracted and categorized.ResultsIn comparison to 415 publicly available TAs for pharmaceuticals, only 45 medical technologies have been appraised through the MTEP. MTEP-submitted technologies can be categorized into diagnostic (7), monitoring (3), prophylaxis (5), therapeutic (28), and other (2). Furthermore, 11 were implants, seven were used by patients, and 27 had provider interaction. Major points of MTEP criticism were a failure to model cost consequences, training costs, and organizational impact. There was also the barrier of transferring costs across budgeting divisions.ConclusionsIn comparison to HTA guidance for pharmaceuticals, there is a dearth of medical device guidance. Therapeutic and implantable devices appear to be disproportionately overrepresented in the MTEP process. This may be because their appraisal is most akin to pharmaceuticals, for which HTA processes are well established. To encourage more HTAs of medical devices, HTA guidance should elaborate on issues specifically related to medical devices.

OP135 Confirmatory Versus Explorative Endpoints In Drug Approval Versus Health Technology Assessment

2017 ◽  
Vol 33 (S1) ◽  
pp. 63-64
Author(s):  
Ines Niehaus ◽  
Charalabos-Markos Dintsios
Keyword(s):  
Health Technology Assessment ◽  
Technology Assessment ◽  
Drug Approval ◽  
Health Technology ◽  
Benefit Assessment ◽  
Benefit Ratio ◽  
Early Benefit Assessment ◽  
The Impact ◽  
Early Benefit

INTRODUCTION:The early benefit assessment of drugs in Germany and their preceded market authorization pursue different objectives, resulting in divergent decision-making strategies. This is reflected inter alia by the diverse inclusion of confirmatory endpoints within the assessments of oncological drugs. The pharmaceutical manufacturers are facing the challenge of meeting the requirements for both evaluation processes by the available evidence and avoiding hereby negative early benefit assessments. This is mainly due to the concept of mutually relevant clinical trials.METHODS:Identification and gathering of the endpoints is based on a specifically developed guide. The extracted data from the documents of completed assessments up to July 2015 are used to estimate both separately and together the impact of explorative in relation to confirmatory endpoints on the drug approval and early benefit assessment, by contrasting the European Medicines Agency's risk-benefit-ratio and the benefit-harm-balancing of the national Health Technology Assessment (HTA) jurisdiction.RESULTS:Twenty-one of fourty-one studies’ oncological assessments could be included in the endpoint analysis. From a procedural point of view both the drug approval and the early benefit assessment seem to be not confirmatory since they include explorative endpoints as well. Yet, drug approval is in terms of quality of endpoints more confirmatory than early benefit assessment since it contains a higher proportion of primary endpoints. The latter implies only in 67 percent of the assessments a primary endpoint to be relevant for the benefit-harm-balancing. Moreover, explorative mortality endpoints reached the highest agreement and explorative endpoints capturing health-related quality of life no agreement, referring to the mutual relevance of endpoints for the risk-benefit-ratio and the benefit-harm-balancing.CONCLUSIONS:The missing information transparency of the assessment reports compared to the information offered within the early benefit assessment makes an assignment of endpoints with respect to the mutually relevant clinical trial sometimes troublesome. To warrant, in the long run, a broader confirmatory basis for decisions in health care supported by HTA, a closer inter-institutional cooperation of approval authorities and German HTA jurisdictions seems favorable.

scholarly journals Implementing health technology assessment in Kuwait: a qualitative study of perceived barriers and facilitators

2019 ◽  
Vol 35 (6) ◽  
pp. 422-426 ◽  
Author(s):  
Basshar Darawsheh ◽  
Evi Germeni
Keyword(s):  
Developing Countries ◽  
Health Technology Assessment ◽  
Technology Assessment ◽  
Qualitative Interviews ◽  
Healthcare Providers ◽  
Health Technology ◽  
Barriers And Facilitators ◽  
Policy Makers ◽  
Face To Face ◽  
Key Stakeholders

AbstractObjectivesThis study sought to explore main barriers and facilitators to implementing health technology assessment (HTA) in Kuwait from the perspective of key stakeholders.MethodsSemi-structured qualitative interviews were conducted with ten key stakeholders: seven healthcare providers working at various departments of the Kuwaiti Ministry of Health (MOH), and three academics with substantial experience in teaching HTA or related fields. Interviews were conducted face-to-face, audio-recorded, and transcribed verbatim. Data were analyzed using an inductive thematic approach.ResultsParticipating stakeholders reported several factors that might act as a barrier to building HTA in Kuwait: minimal awareness of HTA, lack of institutional and human capacity, a fragmented healthcare system, poor communication between researchers and policy makers, the country's wealth, politics, as well as data quality, availability, and sharing. Institutionalizing HTA as a politically empowered body, enforcing its recommendation by law, and benefiting from neighboring countries' experiences were suggested as possible ways to move forward.ConclusionStudies exploring the unique challenges that high-income developing countries may face in implementing HTA are still scarce. The results of this study are consistent with evidence coming from other developing countries, while also suggesting that the abundance of financial resources in the country is a double-edged sword; it has the potential to facilitate the development of HTA capacity, but also hinders recognizing the need for it.

OP127 Analysis Of The Competencies To Be Acquired In Health Technology Assessment

2017 ◽  
Vol 33 (S1) ◽  
pp. 59-59 ◽  
Author(s):  
Marco Chiumente ◽  
Iñaki Gutiérrez-Ibarluzea ◽  
Jani Mueller
Keyword(s):  
Health Technology Assessment ◽  
Technology Assessment ◽  
Core Competencies ◽  
Health Technology ◽  
Multidisciplinary Teams ◽  
Health Technologies ◽  
Program Description ◽  
To Receive ◽  
Masters Degree

INTRODUCTION:Health Technology Assessment (HTA) is a multidisciplinary activity that systematically examines different dimensions related to the direct and indirect consequences of health technologies when implemented in healthcare systems. HTA is developed by multidisciplinary teams in order to cover all the mentioned dimensions. However, the quality of the processes produced by HTA teams will depend upon the competencies that those teams will acquire and incorporate including knowledge, skills and attitudes (1). The aim of this research was to determine how well these dimensions and competencies are covered in HTA academic Masters degree courses and manuals.METHODS:We analyzed what had been done in terms of competencies definition in HTA: how it has been reflected; theoretically and according to the authors, and how competencies can be structured; know-how and values. We explored HTA manuals and HTA academic Masters degree courses. We searched in Google with specific terms: building capacities, HTA, programs, Masters, diplomas. We used the HTAi vortal and the information related to courses (for example Masters degrees) and HTA agencies and network webpages for programs. The inclusion criteria were formal programs that describe HTA capacity building and not partial teaching of certain aspects of HTA and we excluded non-recognized institutions, or where there was no description of the programs or lack of detail regarding objectives and competencies to be achieved.RESULTS:We found 105 courses or programs and analyzed 8 reports and 3 manuals. The main challenges that we faced were: that information was difficult to retrieve, not similarly structured, difficulties to find key information in webpages, no program description at all in some cases and the need to contact institutions staff or register as a student to receive the information and finally, it was difficult to obtain contact details of key people. We structured the information on competencies in knowledge, skills and attitudes.CONCLUSIONS:The analyzed Masters degree courses and manuals did not cover all of the dimensions of HTA analysis in an equal and standardized way. The ethical, legal, social and organizational aspects were lacking in some of the programs, while, on the contrary, clinical and economic aspects were substantially included. On the basis of the information retrieved it would be good to define core competencies for HTA.

scholarly journals Health Technology Assessment Report on Vagus Nerve Stimulation in Drug-Resistant Epilepsy

2020 ◽  
Vol 17 (17) ◽  
pp. 6150
Author(s):  
Carlo Efisio Marras ◽  
Gabriella Colicchio ◽  
Luca De Palma ◽  
Alessandro De Benedictis ◽  
Giancarlo Di Gennaro ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Health Technology Assessment ◽  
Vagus Nerve ◽  
Nerve Stimulation ◽  
Technology Assessment ◽  
Vagus Nerve Stimulation ◽  
Palliative Treatment ◽  
Health Technology ◽  
Drug Resistant

Background: Vagus nerve stimulation (VNS) is a palliative treatment for medical intractable epileptic syndromes not eligible for resective surgery. Health technology assessment (HTA) represents a modern approach to the analysis of technologies used for healthcare. The purpose of this study is to assess the clinical, organizational, financial, and economic impact of VNS therapy in drug-resistant epilepsies and to establish the congruity between costs incurred and health service reimbursement. Methods: The present study used an HTA approach. It is based on an extensive detailed bibliographic search on databases (Medline, Pubmed, Embase and Cochrane, sites of scientific societies and institutional sites). The HTA study includes the following issues: (a) social impact and costs of the disease; (b) VNS eligibility and clinical results; (c) quality of life (QoL) after VNS therapy; (d) economic impact and productivity regained after VNS; and (e) costs of VNS. Results: Literature data indicate VNS as an effective treatment with a potential positive impact on social aspects and on quality of life. The diagnosis-related group (DRG) financing, both on national and regional levels, does not cover the cost of the medical device. There was an evident insufficient coverage of the DRG compared to the full cost of implanting the device. Conclusions: VNS is a palliative treatment for reducing seizure frequency and intensity. Despite its economic cost, VNS should improve patients’ quality of life and reduce care needs.

scholarly journals Development of health technology assessment in Lithuania

2009 ◽  
Vol 25 (S1) ◽  
pp. 140-142 ◽  
Author(s):  
Jankauskiene Danguole
Keyword(s):  
Health Care ◽  
Health Technology Assessment ◽  
Technology Assessment ◽  
Policy Development ◽  
Sickness Fund ◽  
Health Technology ◽  
Major Step ◽  
Ministry Of Health ◽  
History Of ◽  
Healthcare Technologies

Objectives: To describe how Lithuania is attempting to develop health technology assessment (HTA) structures.Methods: The case study of the history of development of HTA in Lithuania is presented.Results: Historical steps of HTA development are as follows: in 1993, a few conferences on HTA; eight people were trained in Sweden at SBU; the book First Steps of HTA in Lithuania (5) was issued together with SBU in 1993; participation in the International Society of Technology Assessment in Health Care (ISTAHC) conferences; participation in development of training courses and European networks of HTA; new people in HTA were trained in health accreditation service, Sickness Fund, and Ministry of Health. The major step was establishment of an evidence-based medicine library.In 1994, Article 54 in the Health Care System Law, which declares that the use of healthcare technologies that have not been assessed or approved shall be prohibited, except in cases provided by law, was passed. The procedure of healthcare technologies assessment and approval was to be established by the Ministry of Health Care. A policy of HTA was approved with the program for HTA in 1999 in the Ministry of Health. Currently, enthusiasts of HTA fully realize that technology assessment is a developing frontier for creative and constructive thinking from all disciplinary view points.Conclusions: Unfortunately, in this country, there is still a very small demand for HTA reports from the decision-maker's side. Hopefully joining the network of European Union Network for Health Technology Assessment (EUnetHTA) will give a new challenge for further policy development.

The Alberta hip and knee replacement project: A model for health technology assessment based on comparative effectiveness of clinical pathways

2009 ◽  
Vol 25 (02) ◽  
pp. 113-123 ◽  
Author(s):  
Katherine L. Gooch ◽  
Douglas Smith ◽  
Tracy Wasylak ◽  
Peter D. Faris ◽  
Deborah A. Marshall ◽  
...  
Keyword(s):  
Health Technology Assessment ◽  
Knee Replacement ◽  
Study Design ◽  
Technology Assessment ◽  
Comparative Effectiveness ◽  
Clinical Pathways ◽  
Controlled Trial ◽  
Health Technology ◽  
Randomized Controlled

Background:The Alberta Hip and Knee Replacement Project developed a new evidence-based clinical pathway (NCP) for total hip (THR) and knee (TKR) replacement. The aim was to facilitate the delivery of services in a timely and cost-effective manner while achieving the highest quality of care for the patient across the full continuum of care from patient referral to an orthopedic surgeon through surgery, recovery, and rehabilitation. The purpose of this article is to provide an overview of the study design, rationale, and execution of this project as a model for health technology assessment based on comparative effectiveness of alternative clinical pathways.Methods:A pragmatic randomized controlled trial study design was used to evaluate the NCP compared with the standard of care (SOC) for these procedures. The pragmatic study design was selected as a rigorous approach to produce high quality evidence suitable for informing decisions between relevant interventions in real clinical practice. The NCP was evaluated in three of the nine regional health authorities (RHAs) in Alberta with dedicated central intake clinics offering multidisciplinary care teams, constituting 80 percent of THR and TKR surgeries performed annually in Alberta. Patients were identified in the offices of twenty orthopedic surgeons who routinely performed THR or TKR surgeries. Evaluation outcome measures were based on the six dimensions of the Alberta Quality Matrix for Health (AQMH): acceptability, accessibility, appropriateness, effectiveness, efficiency and safety. Data were collected prospectively through patient self-completed questionnaires at baseline and 3 and 12 months after surgery, ambulatory and inpatient chart reviews, and electronic administrative data.Results:The trial design was successful in establishing similar groups for rigorous evaluation. Of the 4,985 patients invited to participate, 69 percent of patients consented. A total of 3,434 patients were randomized: 1,712 to SOC and 1,722 to the NCP. The baseline characteristics of patients in the two study arms, including demographics, comorbidity as measured by CDS and exposure to pain medications, and health-related quality of life, as measured by Western Ontario and McMaster Universities Osteoarthritis Index and Short Form-36, were similar.Conclusions:The Alberta Hip and Knee Replacement Project demonstrates the feasibility and advantages of applying a pragmatic randomized controlled trial to ascertain comparative effectiveness. This is a model for health technology assessment that incorporates how clinical pathways can be effectively evaluated.

scholarly journals Resource allocation and health technology assessment in Australia: Views from the local level

2009 ◽  
Vol 25 (02) ◽  
pp. 134-140 ◽  
Author(s):  
Gisselle Gallego ◽  
Kees van Gool ◽  
Dianne Kelleher
Keyword(s):  
Decision Making ◽  
Health Service ◽  
Health Technology Assessment ◽  
Technology Assessment ◽  
Online Survey ◽  
Local Level ◽  
Healthcare Providers ◽  
Health Technology ◽  
Health Technologies ◽  
Decision Making Processes

Objectives:Several studies have shown that a key determinant of successful health technology assessment (HTA) uptake is a clear, fair, and consistent decision-making process for the approval and introduction of health technologies. The aim of this study was to gauge healthcare providers' and managers' perceptions of local level decision making and determine whether these processes offer a conducive environment for HTA. An Area Health Service (AHS) aimed to use the results of this study to help design a new process of technology assessment and decision making.Methods:An online survey was sent to all health service managers and healthcare providers working in one AHS in Sydney, Australia. Questions related to perceptions of current health technology decisions in participants' own institution/facility and opinions on key criteria for successful decision-making processes.Results:Less than a third of participants agreed with the statements that local decision-making processes were appropriate, easy to understand, evidence-based, fair, or consistently applied. Decisions were reportedly largely influenced by total cost considerations as well as by the central state health departments and the Area executive.Conclusions:Although there are renewed initiatives in HTA in Australia, there is a risk that such investments will not be productive unless policy makers also examine the decision-making contexts within which HTA can successfully be implemented. The results of this survey show that this is especially true at the local level and that any HTA initiative should be accompanied by efforts to improve decision-making processes.

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