scholarly journals A Systematic Review of the Value Assessment Frameworks Used within Health Technology Assessment of Omics Technologies and Their Actual Adoption from HTA Agencies

Author(s):  
Ilda Hoxhaj ◽  
Laurenz Govaerts ◽  
Steven Simoens ◽  
Walter Van Dyck ◽  
Isabelle Huys ◽  
...  

Background: Omics technologies, enabling the measurements of genes (genomics), mRNA (transcriptomics), proteins (proteomics) and metabolites (metabolomics), are valuable tools for personalized decision-making. We aimed to identify the existing value assessment frameworks used by health technology assessment (HTA) doers for the evaluation of omics technologies through a systematic review. Methods: PubMed, Scopus, Embase and Web of Science databases were searched to retrieve potential eligible articles published until 31 May 2020 in English. Additionally, through a desk research in HTA agencies’ repositories, we retrieved the published reports on the practical use of these frameworks. Results: Twenty-three articles were included in the systematic review. Twenty-two frameworks, which addressed genetic and/or genomic technologies, were described. Most of them derived from the ACCE framework and evaluated the domains of analytical validity, clinical validity and clinical utility. We retrieved forty-five reports, which mainly addressed the commercial transcriptomic prognostics and next generation sequencing, and evaluated clinical effectiveness, economic aspects, and description and technical characteristics. Conclusions: A value assessment framework for the HTA evaluation of omics technologies is not standardized and accepted, yet. Our work reports that the most evaluated domains are analytical validity, clinical validity and clinical utility and economic aspects.

2020 ◽  
Vol 36 (S1) ◽  
pp. 13-13
Author(s):  
Laurenz Govaerts ◽  
Ilda Hoxhaj ◽  
Steven Simoens ◽  
Walter Van Dyck ◽  
Isabelle Huys ◽  
...  

IntroductionOmics technologies enable the measurements of genes (genomics), mRNA (transcriptomics), proteins (proteomics) and metabolites (metabolomics) and thus proved to be valuable tools for personalized decision-making in clinical practice. For their evaluation, a health technology assessment (HTA) framework is not standardized and accepted, yet. Therefore, we aim at designing an omics-technologies HTA evaluation framework to facilitate their assessment, through a mixed-method approach. This work is part of the ExACT project, which aims to produce a range of tools to facilitate the implementation of precision health in clinical practice.MethodsA systematic review was conducted to identify the existing HTA frameworks used for the evaluation of omics-technologies. Desk research on the HTA agencies’ websites was performed to identify the reports on omics-technologies HTA evaluation frameworks used by these agencies. A questionnaire evaluating HTA agencies’ experience on evaluation of omics-technologies was designed. The new framework will be elaborated based on the findings from the three methodological steps, and will be validated through a Delphi process.ResultsTwenty-three articles were included in the systematic review. The main identified HTA frameworks were ACCE and “Evaluation of Genomic Applications in Practice and Prevention” (EGAPP). The desk research showed that these frameworks were seldom used by HTA agencies, which for the evaluation of omics-technologies mostly refer to the HTA Core Model®, mainly assessing the following domains: clinical effectiveness and economic evaluation. Data collection process of the questionnaire HTA agencies’ experience is in progress.ConclusionsAlthough two main HTA frameworks for the evaluation of omics-technologies have been identified, these frameworks are sporadically used by HTA agencies in their practice. The particular interest of HTA agencies on clinical effectiveness and economic evaluation, might potentially reflect the uncertainty and difficulties when evaluating omics-technologies. This could indicate that these HTA frameworks are not feasible and practical to be used in routine HTA agency processes for omics technologies, emphasizing the need for a new framework. Our methodological approach might contribute to the development of a new HTA framework, feasible and practical to use not only for HTA agencies.


2016 ◽  
Vol 20 (2) ◽  
pp. 1-302 ◽  
Author(s):  
Susan Baxter ◽  
Maxine Johnson ◽  
Lindsay Blank ◽  
Anna Cantrell ◽  
Shelagh Brumfitt ◽  
...  

BackgroundDespite many years of research, there is no certainty regarding the cause of stuttering. Although numerous interventions have been developed, a broad-based systematic review across all forms of intervention for adults and children was needed including views and perceptions of people who stutter.ObjectiveThe aims of the study were to report the clinical effectiveness of interventions for people who stutter (or clutter), to examine evidence regarding the views of people who stutter and the views of professionals regarding interventions.Data sourcesA systematic review of quantitative and qualitative literature was carried out between August 2013 and April 2014. The following electronic databases were searched: (1) MEDLINE, (2) EMBASE, (3) The Cochrane Library (including The Cochrane Database of Systematic Reviews, Cochrane Central Register of Controlled Trials, Database of Abstracts of Reviews of Effects, Health Technology Assessment Database and NHS Economic Evaluations Database), (4) PsycINFO, (5) Science Citation Index, (6) Social Science Citation Index, (7) Cumulative Index to Nursing and Allied Health Literature, (8) ASSIA, (9) Linguistics and Language Behavior Abstracts, (10) Sociological Abstracts and (11) the EPPI Centre. Reference lists of included papers and other reviews were screened and also key journals in the subject area were hand-searched.Review methodsThe searches aimed to identify (1) evidence of clinical effectiveness in populations of pre-school children, school-aged children, adolescents and adults, and (2) data relating to perceptions of barriers and facilitators to intervention clinical effectiveness among staff and people who stutter. A metasynthesis of the two linked elements via development of a conceptual model was also carried out to provide further interpretation of the review findings.ResultsA systematic search of the literature identified a large number of potentially relevant studies. Of these, 111 studies examining the clinical effectiveness of interventions, 25 qualitative papers and one mixed-methods paper met the criteria for inclusion in this review. Review of the effectiveness literature indicated evidence of positive outcomes across all types of interventions. Virtually all evidence we identified reported at least some positive effect for some participants. However, there was evidence of considerable individual variation in outcome for study participants. The qualitative literature highlighted the need for programmes to be tailored to individual need with variation at the levels of the intervention, the individual and interpersonal/social elements. Metasynthesis of the data highlighted the complexity of elements that need to be considered in evaluation of long-term impacts following stuttering interventions.LimitationsAround two-thirds of the studies were considered to be at higher risk of bias. The heterogeneous nature and variability in outcomes meant that we were unable to complete a meta-analysis.ConclusionsAlthough much of the evidence we identified was from studies at risk of bias, it is suggested that most available interventions for stuttering may be of benefit to at least some people who stutter. There is a requirement for greater clarity regarding what the core outcomes following stuttering intervention should be and also enhanced understanding of the process whereby interventions effect change. Further analysis of those for whom interventions have not produced a significant benefit may provide additional insights into the complex intervention–outcomes pathway.Study registrationThis study is registered as PROSPERO CRD42013004861.FundingThe National Institute for Health Research Health Technology Assessment programme.


2018 ◽  
Vol 34 (4) ◽  
pp. 368-377 ◽  
Author(s):  
Alexandre Barna ◽  
Teresita M Cruz-Sanchez ◽  
Karen Berg Brigham ◽  
Cong-Tri Thuong ◽  
Finn Boerlum Kristensen ◽  
...  

Objectives:Multi-analyte assays with algorithmic analyses (MAAAs) use combinations of circulating and clinical markers including omics-based sources for diagnostic and/or prognostic purposes. Assessing MAAAs is challenging under existing health technology assessment (HTA) methods or practices. We undertook a scoping review to explore the HTA methods used for MAAAs to identify the criteria used for clinical research and reimbursement purposes.Methods:This review included only non-companion (stand-alone) tests that are actionable and that have been evaluated by leading HTA or insurer/reimbursement bodies up to September 2017.Results:Twenty-five reports and articles evaluating seventeen MAAAs were examined, most of which have been developed in oncology. The two main models used were the EUnetHTA Core model and the Evaluation of Genomic Applications in Practice and Prevention ACCE framework. Clinical validity and utility criteria were used, as were economic, ethical, legal, and social aspects. Economic evidence on MAAAs was scarce, and there is no consensus on whether the perspectives used are sufficiently broad to include all relevant stakeholders.Conclusions:Clinical utility and efficiency were the most used criteria, with stronger evidence needed linking the use of the algorithm with the clinical outcomes in real-life practice. HTA bodies must as well consider questions related to the analytical validity of MAAAs or with organizational aspects. The two main models, the EUnetHTA Core model and the ACCE framework, could be adapted to the assessment of MAAAs.


2018 ◽  
Vol 34 (5) ◽  
pp. 447-457 ◽  
Author(s):  
Christian A. Bellemare ◽  
Pierre Dagenais ◽  
Suzanne K.-Bédard ◽  
Jean-Pierre Béland ◽  
Louise Bernier ◽  
...  

Objectives:Integration of ethics into health technology assessment (HTA) remains challenging for HTA practitioners. We conducted a systematic review on social and methodological issues related to ethical analysis in HTA. We examined: (1) reasons for integrating ethics (social needs); (2) obstacles to ethical integration; (3) concepts and processes deployed in ethical evaluation (more specifically value judgments) and critical analyses of formal experimentations of ethical evaluation in HTA.Methods:Search criteria included “ethic,” “technology assessment,” and “HTA”. The literature search was done in Medline/Ovid, SCOPUS, CINAHL, PsycINFO, and the international HTA Database. Screening of citations, full-text screening, and data extraction were performed by two subgroups of two independent reviewers. Data extracted from articles were grouped into categories using a general inductive method.Results:A list of 1,646 citations remained after the removal of duplicates. Of these, 132 were fully reviewed, yielding 67 eligible articles for analysis. The social need most often reported was to inform policy decision making. The absence of shared standard models for ethical analysis was the obstacle to integration most often mentioned. Fairness and Equity and values embedded in Principlism were the values most often mentioned in relation to ethical evaluation.Conclusions:Compared with the scientific experimental paradigm, there are no settled proceedings for ethics in HTA nor consensus on the role of ethical theory and ethical expertise hindering its integration. Our findings enable us to hypothesize that there exists interdependence between the three issues studied in this work and that value judgments could be their linking concept.


2017 ◽  
Vol 33 (S1) ◽  
pp. 168-169
Author(s):  
Francesco Faggiano ◽  
Martina Andellini ◽  
Federico Nocchi ◽  
Carlo Capussotto ◽  
Francesca Sabusco ◽  
...  

INTRODUCTION:The purpose of the study was to evaluate different type and manufacturers of intensive care ventilators in order to support the healthcare decision-making process about the choice to adopt the best available technology for ventilation of pediatric patient in intensive care units at Bambino Gesù Children's Hospital.METHODS:The technology assessment process was developed by using a new methodology, the Decision-oriented Health Technology Assessment (HTA) (DoHTA), a new implementation of the European Network for Health Technology Assessment (EUnetHTA) CoreModel, integrating the Analytic Hierarchy Process (1). A literature review was carried out to gather evidence on safety and overall effectiveness of different kind of intensive care ventilators, with several ventilation modalities and strategies. The synthesis of scientific evidence, and results of the specific context analysis resulted in the definition of components of the decisional hierarchy structure, consisting in detailed characteristics of the technology's performances covering the aspects on feasibility, safety, efficacy, costs, and organizational and technical characteristics of the technology. A subgroup of these indicators has been included in a checklist form for the evaluation of different type and manufacturers of intensive care ventilators, each of which was tested in three independent runs performed in three different departments. In addition, an economic evaluation was also carried out.RESULTS:Preliminary DoHTA results showed that the domains with the highest impacts within the evaluation are safety and clinical effectiveness (34.8 percent and 25.7 percent, respectively) followed by organizational aspects, technical characteristics of technology and costs and economic evaluation. The final objective is to define the alternatives’ ranking through a comparison between alternative technologies’ performances.CONCLUSIONS:The technology assessment project allowed to identify strengths and limits of the most recent intensive care ventilator’ models in the specific contexts of use by involving all health professionals interested, and eventually identify the best option for the hospital.


2017 ◽  
Vol 44 (10) ◽  
pp. 800-826 ◽  
Author(s):  
B. Häggman-Henrikson ◽  
P. Alstergren ◽  
T. Davidson ◽  
E. D. Högestätt ◽  
P. Östlund ◽  
...  

BMJ Open ◽  
2021 ◽  
Vol 11 (12) ◽  
pp. e052049
Author(s):  
Christine Mpundu-Kaambwa ◽  
Gang Chen ◽  
Kim Dalziel ◽  
Nancy Devlin ◽  
Julie Ratcliffe

IntroductionMeasures of health-related quality of life (HRQoL), accompanied by the values (or utilities) required to estimate quality-adjusted life-years, are crucial for determining health benefits within economic evaluation and health technology assessment. Several generic and condition-specific measures or instruments of HRQoL, accompanied by values, currently exist for application with child populations. However, there is a lack of a structured summary of guidelines and recommendations for applying these measures in practice. This protocol describes a systematic review of guidelines and recommendations for child and proxy completion of child-specific measures of HRQoL. The aims of the review are to (1) identify and summarise published guidelines and recommendations for existing child-specific measures of HRQoL, (2) determine whether the identified guidelines and recommendations differ by instrument and child characteristics, (3) identify current gaps in these guidelines and recommendations and (4) identify best practices for child self and proxy assessment in paediatric HRQoL measurement for economic evaluation and health technology assessment.Methods and analysisThe review will identify, collate and synthesise published guidelines and recommendations for existing child-specific utility measures of HRQoL. Electronic databases to be searched include the Cochrane Library, Medline, Scopus, Web of Science, EconLit, PsycINFO, CINAHL, Embase and Informit. The search will be extended to websites of (1) international organisations for health technology assessment, (2) regulation, health economics and HRQoL outcomes research and (3) instrument developers. Three reviewers will independently screen titles and abstracts against the inclusion criteria. A narrative synthesis will describe the key features of the guidelines identified.Ethics and disseminationEthical approval is not required as the proposed systematic review will not use primary data. A paper of the systematic review will be submitted to a peer-reviewed journal for publication.PROSPERO registration numberCRD42020207160.


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