PP136 How To Apply Health Technology Assessment To Large Scale e-Health Processes

2019 ◽  
Vol 35 (S1) ◽  
pp. 63-64
Author(s):  
Gro-Hilde Severinsen ◽  
Line Silsand ◽  
Anne Ekeland

IntroductionThere are enormous expectations for e-health solutions to support high quality healthcare services, with accessibility, and effectiveness as key goals. E-health encompasses a wide range of information and communication technologies applied to health care, and focuses on combining clinical activity, technical development, and political requirements. Hence, e-health solutions must be evaluated in relation to the desired goals, to justify the high costs of such solutions.MethodsHealth technology assessment (HTA) aims to produce rational decisions for purchasing new technologies and evaluating healthcare investments, like drugs and medical equipment, by measuring added value in relation to clinical effectiveness, safety, and cost effectiveness. It is desired to also apply HTA assessment on large scale e-health solutions, but traditional quantitative HTA methodology may not be applicable to complex e-health systems developed and implemented as ongoing processes over years. Systematic reviews and meta-analyses of these processes risk being outdated when published, therefore action research designed to work with complex, large scale programs may be a more suitable approach.ResultsIn the project, we followed the development of a new process-oriented electronic patient record system (EPR) in northern Norway. Part of the process was structuring clinical data to be used in electronic forms within the system. This was the first time a health region structured the clinical data and designed the forms; receiving feedback alongside the process was very important. The goal was to use structured forms as a basis for reusing EPR data within and between systems, and to enable clinical decision support.DiscussionAfter designing a prototype of a structured form, we wrote an assessment report focusing on designing a methodology for such development, which stakeholders to include, and how to divide the work between the health region and the system vendor. The answers to such questions will have both practical and economic consequences for designing the next phase of the process.

2017 ◽  
Vol 33 (5) ◽  
pp. 570-576 ◽  
Author(s):  
Kristin Bakke Lysdahl ◽  
Kati Mozygemba ◽  
Jacob Burns ◽  
Jan Benedikt Brönneke ◽  
James B. Chilcott ◽  
...  

Objectives: Despite recent development of health technology assessment (HTA) methods, there are still methodological gaps for the assessment of complex health technologies. The INTEGRATE-HTA guidance for effectiveness, economic, ethical, socio-cultural, and legal aspects, deals with challenges when assessing complex technologies, such as heterogeneous study designs, multiple stakeholder perspectives, and unpredictable outcomes. The objective of this article is to outline this guidance and describe the added value of integrating these assessment aspects.Methods: Different methods were used to develop the various parts of the guidance, but all draw on existing, published knowledge and were supported by stakeholder involvement. The guidance was modified after application in a case study and in response to feedback from internal and external reviewers.Results: The guidance consists of five parts, addressing five core aspects of HTA, all presenting stepwise approaches based on the assessment of complexity, context, and stakeholder involvement. The guidance on effectiveness, health economics and ethics aspects focus on helping users choose appropriate, or further develop, existing methods. The recommendations are based on existing methods’ applicability for dealing with problems arising with complex interventions. The guidance offers new frameworks to identify socio-cultural and legal issues, along with overviews of relevant methods and sources.Conclusions: The INTEGRATE-HTA guidance outlines a wide range of methods and facilitates appropriate choices among them. The guidance enables understanding of how complexity matters for HTA and brings together assessments from disciplines, such as epidemiology, economics, ethics, law, and social theory. This indicates relevance for a broad range of technologies.


Author(s):  
Maria Benkhalti ◽  
Manuel Espinoza ◽  
Richard Cookson ◽  
Vivian Welch ◽  
Peter Tugwell ◽  
...  

Abstract Objectives Health technology assessment (HTA) can impact health inequities by informing healthcare priority-setting decisions. This paper presents a novel checklist to guide HTA practitioners looking to include equity considerations in their work: the equity checklist for HTA (ECHTA). The list is pragmatically organized according to the generic HTA phases and can be consulted at each step. Methods A first set of items was based on the framework for equity in HTA developed by Culyer and Bombard. After rewording and reorganizing according to five HTA phases, they were complemented by elements emerging from a literature search. Consultations with method experts, decision makers, and stakeholders further refined the items. Further feedback was sought during a presentation of the tool at an international HTA conference. Lastly, the checklist was piloted through all five stages of an HTA. Results ECHTA proposes elements to be considered at each one of the five HTA phases: Scoping, Evaluation, Recommendations and Conclusions, Knowledge Translation and Implementation, and Reassessment. More than a simple checklist, the tool provides details and examples that guide the evaluators through an analysis in each phase. A pilot test is also presented, which demonstrates the ECHTA's usability and added value. Conclusions ECHTA provides guidance for HTA evaluators wishing to ensure that their conclusions do not contribute to inequalities in health. Several points to build upon the current checklist will be addressed by a working group of experts, and further feedback is welcome from evaluators who have used the tool.


Author(s):  
Hannah Sievers ◽  
Angelika Joos ◽  
Mickaël Hiligsmann

Abstract Objective This study aims to assess stakeholder perceptions on the challenges and value of real-world evidence (RWE) post approval, the differences in regulatory and health technology assessment (HTA) real-world data (RWD) collection requirements under the German regulation for more safety in drug supply (GSAV), and future alignment opportunities to create a complementary framework for postapproval RWE requirements. Methods Eleven semistructured interviews were conducted purposively with pharmaceutical industry experts, regulatory authorities, health technology assessment bodies (HTAbs), and academia. The interview questions focused on the role of RWE post approval, the added value and challenges of RWE, the most important requirements for RWD collection, experience with registries as a source of RWD, perceptions on the GSAV law, RWE requirements in other countries, and the differences between regulatory and HTA requirements and alignment opportunities. The interviews were recorded, transcribed, and translated for coding in Nvivo to summarize the findings. Results All experts agree that RWE could close evidence gaps by showing the actual value of medicines in patients under real-world conditions. However, experts acknowledged certain challenges such as: (i) heterogeneous perspectives and differences in outcome measures for RWE generation and (ii) missing practical experience with RWD collected through mandatory registries within the German benefit assessment due to an unclear implementation of the GSAV. Conclusions This study revealed that all stakeholder groups recognize the added value of RWE but experience conflicting demands for RWD collection. Harmonizing requirements can be achieved through common postlicensing evidence generation (PLEG) plans and joint scientific advice to address uncertainties regarding evidence needs and to optimize drug development.


Author(s):  
Patricia Coelho de Soárez ◽  
Vera Lúcia Edais Pepe ◽  
Hillegonda Maria Dutilh Novaes

Abstract In Brazil, there is no consensus on the concept of hospital-based health technology assessment (HB-HTA). There is great variability in the existing models and difficulty in evaluating their results—whether in respect of clinical decisions, quality of care, and hospital policy and management or in respect of optimizing the use of resources. This study aims to discuss the experiences of HB-HTA, its integration into the regulatory system for the adoption of new technologies into the Brazilian public (SUS) (Unified Health System), and its main challenges. During a workshop, a panel of specialists in HTA and/or HB-HTA was formed, representative of four different perspectives: (i) Health services and health technology assessment units, (ii) Academia, (iii) Secretary of State for Health, and (iv) the Federal SUS sector. This was followed by discussion, a preliminary consensus, contributions from the audience, a plenary session, and a final consensus. HB-HTA is not institutionalized, nor is it part of the regulation system for the adoption of new technologies in the SUS. The main challenges are the difficulties in creating qualified teams, financial support, and sustainability. The work of these bodies in respect of the evaluation of new technologies deserves further studies analyzing the relationship between the pressure for adoption from the hospital team and industry professionals and legal rulings. It is necessary to strengthen HB-HTA culture and implement this policy in hospital management, making assessment bodies a part of managerial and decision-making processes in hospitals, and develop regional collaborative networks and a national network of HTA.


Author(s):  
Rossella Tomaiuolo ◽  
Pietro Derrico ◽  
Matteo Ritrovato ◽  
Massimo Locatelli ◽  
Frida Milella ◽  
...  

Abstract Objective In vitro diagnostic tests for SARS-COV-2, also known as serological tests, have rapidly spread. However, to date, mostly single-center technical and diagnostic performance's assessments have been carried out without an intralaboratory validation process and a health technology assessment (HTA) systematic approach. Therefore, the rapid HTA for evaluating antibody tests for SARS-COV-2 was applied. Methods The use of rapid HTA is an opportunity to test innovative technology. Unlike traditional HTA (which evaluates the benefits of new technologies after being tested in clinical trials or have been applied in practice for some time), the rapid HTA is performed during the early stages of developing new technology. A multidisciplinary team conducted the rapid HTA following the HTA Core Model® (version 3.0) developed by the European Network for Health Technology Assessment. Results The three methodological and analytical steps used in the HTA applied to the evaluation of antibody tests for SARS-COV-2 are reported: the selection of the tests to be evaluated; the research and collection of information to support the adoption and appropriateness of the technology; and the preparation of the final reports and their dissemination. Finally, the rapid HTA of serological tests for SARS-CoV-2 is summarized in a report that allows its dissemination and communication. Conclusions The rapid-HTA evaluation method, in addition to highlighting the characteristics that differentiate the tests from each other, guarantees a timely and appropriate evaluation, becoming a tool to create a direct link between science and health management.


Author(s):  
Morteza Arab-Zozani ◽  
Mobin Sokhanvar ◽  
Edris Kakemam ◽  
Tahereh Didehban ◽  
Soheil Hassanipour

This article describes the characteristics of the health system and reviews the history of health technology assessment (HTA) in Iran, including its inception, processes, challenges, and lessons learned. This study was conducted by analyzing existing documents, reports, and guidelines related to HTA and published articles in the field. HTA in Iran has been established since the late 2000s and was first introduced as a secretariat by the Deputy of Health at the Ministry of Health and Medical Education. The mission of the HTA office is to systematically assess technologies to improve evidence-informed decision making. Despite its 10 years of existence, HTA in Iran still faces some challenges. The most pressing problems currently facing HTA in Iran include conflicts of interest among researchers performing the HTAs, the absence of a systematic structure for identifying and introducing new technologies, the lack of interest in HTA results among high-level policy makers, and the lack of external oversight for HTA projects.


2017 ◽  
Vol 33 (S1) ◽  
pp. 33-34
Author(s):  
Mark Clowes

INTRODUCTION:One of the challenges of large scale Health Technology Assessment (HTA) projects is managing the large volume of studies retrieved by the requisite comprehensive literature searches. At the scoping stage of the project, a pragmatic judgement needs to be made as to how sensitive the search strategy should be in order to find all the relevant papers without returning an overwhelming volume of irrelevant studies.METHODS:For this HTA (evaluating prognostic and predictive markers in rheumatoid arthritis), the research team already had prior knowledge of several key markers of interest, but wanted to ensure that no others had been missed. Advice from practising clinicians was obtained, but for additional validation, a broad scoping search was conducted for ‘rheumatoid arthritis’ using the sensitive Haynes filters for prognostic (1) and clinical prediction (2) studies. Unsurprisingly, this initial search retrieved too many studies for them all to be admitted to the full review; but once those dealing with known markers had been removed, a sample of the remaining records was loaded into a software visualization tool (3) to display “heat maps” of frequently occurring terms and phrases.RESULTS:On this occasion, no additional markers were identified, however this provided reassurance that the advice obtained from clinicians was comprehensive, enabling the HTA team to proceed confidently with its evaluation of the selected markers.CONCLUSIONS:Visualization offers an alternative means of exploring and interrogating large text archives, and has the potential to complement the role of traditional search methods in identifying literature for systematic reviews and health technology assessments. As processing power increases and more and more full-text papers become available open access, it may provide a solution to some of the limitations associated with comprehensive searching.


2017 ◽  
Vol 33 (S1) ◽  
pp. 137-138
Author(s):  
Ionela Gheorghiu ◽  
Alain Lesage ◽  
Adam Mongodin ◽  
Marlène Galdin

INTRODUCTION:Our Hospital-based Health Technology Assessment unit (HB-HTA) was founded in 2011 following the nomination of Louis-H. Lafontaine hospital as the Montreal University Mental Health Institute (IUSMM). From the beginning, the HB-HTA has been supporting and advising the Chief Executive Officer of IUSMM in the decision-making process concerning the implementation of new technologies and practices in mental health. Since 2015, the HB-HTA is part of the East of Montreal Regional Integrated Health and Social Services Centre (CIUSSS de l'Est-de-l’Île de Montréal), continuing to support decisions in mental health. Currently, the HB-HTA unit is nested in the Quality, Performance and Ethics department.METHODS:Formed by a coordinator, a scientific advisor and a manager, the HB-HTA team plans, organizes and sets up the evaluation activities. The unit benefits from the support of a Steering Committee which consists of representatives of clinical, administrative and research directions, as well as of health users and families. This committee determine the strategic orientation of the HB-HTA unit, prioritize the projects, approves the evaluation products and gives indications on the knowledge transfer process.RESULTS:To answer the decision questions, our HB-HTA unit employs two types of products: evaluation reports and informative notes. Based on an exhaustive literature search and consultations with stakeholders, the evaluation reports offer recommendations to support the decision-making process. The informative notes are rapid responses based on a partial literature search. The nature of this type of analysis does not allow the formulation of recommendations, however, a conclusion of the consulted literature is offered.CONCLUSIONS:Based on the work of our HB-HTA unit, some important decisions were made by the IUSMM. As an example, the systematic screening of psychiatric patients for drug and alcohol was not favored by our institution; rather than this, priority was given to staff training, in order to better identify and treat psychiatric patients with substance abuse comorbidity.


2017 ◽  
Vol 33 (S1) ◽  
pp. 46-46
Author(s):  
Bjørn Hofmann

INTRODUCTION:Several health technologies used for therapy can also be used for health enhancement. Drugs stimulating cognitive abilities are but one example. Health Technology Assessment (HTA) has not been developed for assessing enhancements. This raises the question of how HTA should address the blurred distinction between therapy and enhancement. Should we (i) carve out a distinction between therapy and enhancement and limit HTA to therapy, (ii) use HTA for both therapy and enhancement (with some modifications), or (iii) should we develop a separate health enhancement assessment (HEA)?METHODS:A literature search of the medical, philosophical, and bioethical literature was conducted for debates, arguments, and suggested solutions to the issue of therapy versus enhancement.RESULTS:The same improvement in health may be therapeutic in one patient, but an enhancement in another. Moreover, both therapy and enhancement share the same goal: increased health and wellbeing. A wide range of arguments try to establish a difference between therapy and enhancement. They refer to naturalness, rehabilitation, normality, species-typical functioning/potential, disease, sustainability, and responsibility. On closer scrutiny few of these arguments do the job in bolstering the therapy-enhancement distinction. We already use a wide range of means to extend human abilities. Moreover, the therapy-enhancement distinction raises a wide range of ethical issues that are relevant for the assessment of a number of emerging health technologies.CONCLUSIONS:Existing HTA methodology can address a wide range of non-therapeutic health enhancements. However, a series of broader issues related to the goal of health care and responsibility for altering human evolution may not be addressed within traditional HTA frameworks. Specific HEAs may therefore be helpful.


2019 ◽  
Vol 35 (S1) ◽  
pp. 57-57
Author(s):  
Ricardo Bertoglio Cardoso ◽  
Luciane Cruz ◽  
Marina Aziz ◽  
Sandro Miguel ◽  
Mírian Cohen ◽  
...  

IntroductionIn Brazil, hospital-based health technology assessment (HB-HTA) units have been implemented countrywide since early 2000 to improve decision-making processes. Multiple-criteria decision analysis (MCDA) can provide a deeper understanding of a given subject. The present study used MCDA to evaluate capacity building among HB-HTA units in Brazil.MethodsThis study analyzed preliminary data from a survey developed and sent to all HB-HTA units in Brazil in 2018. The survey comprised 116 questions covering a wide range of aspects. Initially, an expert panel was organized, and 46 objective questions (out of 116) were selected by four experts. Next, these experts classified the selected questions by weighting them according to their relative importance. A Likert scale was used to identify the levels of importance, which were converted to weights ranging from zero to one. The experts then defined a final importance score threshold of 60 percent to classify units as fully operational. Grades below this threshold indicated the need for a more detailed evaluation. Of the 80 survey questionnaires, 23 were evaluated by the proposed method.ResultsImportance weights for each classification were defined as follows: personnel (25%); level of expertise (31%); work production (31%); and infrastructure (13%). The mean final importance score for the HB-HTA units was 68 percent. The maximum and minimum scores achieved were 95 percent and 15 percent, respectively. The HB-HTA units had been established for an average of 6 years, and ten of the 23 units were classified as fully operational.ConclusionsThe multicriteria method presented by this study simplified HB-HTA unit evaluation, reducing the subjectivity of results. Final importance scores for each unit's categories indicated which areas need improvement. Results from the study indicated that infrastructure and personnel could be greatly enhanced, even though the production profile was satisfactory.


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