scholarly journals Valuing patient engagement: reflexive learning in evidence generation practices for health technology assessment

2021 ◽  
pp. 114048
Author(s):  
Callum J. Gunn ◽  
Neil Bertelsen ◽  
Barbara J. Regeer ◽  
Tjerk Jan Schuitmaker-Warnaar
Keyword(s):  
Health Technology Assessment ◽  
Technology Assessment ◽  
Patient Engagement ◽  
Health Technology ◽  
Evidence Generation

VP165 Landscape Assessment: Patient Engagement In Health Technology Assessment

2017 ◽  
Vol 33 (S1) ◽  
pp. 224-225
Author(s):  
Elisabeth Oehrlein ◽  
Jason Harris ◽  
Nicole Labkoff ◽  
Eleanor Perfetto ◽  
Manal Ziadeh ◽  
...  
Keyword(s):  
Health Technology Assessment ◽  
Technology Assessment ◽  
Patient Engagement ◽  
Public Involvement ◽  
Web Search ◽  
Health Technology ◽  
Public Consultation ◽  
Patient Questionnaire ◽  
Draft Guidance ◽  
Stakeholder Consultation

INTRODUCTION:Understanding the current landscape of patient engagement across value decision-making bodies internationally is a critical first step toward improving the patient centricity of Health Technology Assessment (HTA). This study assessed: (i) Terms and definitions used; (ii) Patient engagement opportunities; (iii) Evidence of patient engagement.METHODS:A sample of country-specific HTA's (HTA; n = 6), professional organizations (PO; n = 4), and collaborations/independent organizations (CO; n = 3) was selected for representativeness. Information was gathered through: (i) targeted web search and (ii) emailing organizations directly. Definitions, HTA methods documents, and the three most recent evaluations were identified, abstracted, and compared. Data were collected between September-October 2016.RESULTS:Numerous terms are used to describe patient engagement: patient input (HTA = 1, PO = 1), patient-group submitted information (HTA = 1), cooperation with patients/users (HTA = 1), public consultation (HTA = 1), patient perspectives (HTA = 1, PO = 1), involvement of people affected (HTA = 1), patient involvement (HTA = 2), patient and public involvement (HTA = 1), lay involvement (HTA = 1), inclusion of patient representative (PO = 3), patient reports (PO = 1), patient preference (PO = 2), public consultation (CO = 1), stakeholder consultation (CO = 1), open input (CO = 1), stakeholder engagement (CO = 1), and patient participation (CO = 1). Opportunities for patient engagement were described as: patient questionnaire (HTA = 2); comment period (HTA = 1; CO = 1); committee participation (HTA = 3; PO = 3); propose topics (HTA = 1); draft guidance (HTA = 1); general stakeholder forum (CO = 1). While organizations outline opportunities for patient engagement, not all organizations have clear evidence the practices are used or have impact. Recent evaluations demonstrate clear evidence of engagement (HTA = 2); Unclear or mixed evidence (HTA = 1; PO = 1; CO = 2); No evidence (HTA = 3; PO = 3; CO = 1).CONCLUSIONS:There is substantial heterogeneity in the terms used to describe patient engagement activities across organizations. While a variety of opportunities for patient engagement are described, lack of clear evidence to how patient engagement practices are consistently used may contribute to the perception that engagement by HTAs.

PP14 Development Of The European Network For Health Technology Assessment Standards Tool For Registries In Health Technology Assessment

2018 ◽  
Vol 34 (S1) ◽  
pp. 70-70
Author(s):  
Emmanuel Gimenez Garcia ◽  
Mireia Espallargues ◽  
Jae Long ◽  
Maja Valentic ◽  
Irena Guzina ◽  
...  
Keyword(s):  
Health Technology Assessment ◽  
Technology Assessment ◽  
Good Practice ◽  
Health Technology ◽  
Registry Data ◽  
European Network ◽  
Real World Data ◽  
The Third ◽  
Evidence Quality ◽  
Evidence Generation

Introduction:Bridging gaps between registry-holders, Health Technology Assessment (HTA) producers and users is one of the aims of the European Network for HTA (EUnetHTA) Joint Action 3. In this context, a post-launch evidence generation tool is being developed, including a quality standards tool for registries in HTA. The standards tool for registries in HTA will enable, among others, registry owners to consistently collect high quality registry data, and HTA agencies to use proper registry data collected by others as evidence for their assessments. The objective is to present the first draft version of the tool structure, which is going to be piloted during the forthcoming months.Methods:A review and description of the currently available first version (November 2017) sections, items and criteria for HTA studies.Results:The tool is divided in three sections; “Methodological Information”, “Essential Standards” and “Additional Requirements”. The first section enables users to analyze not only the ability of the registry to answer to research questions but also to check the registry transparency. The second section encloses the essential elements of good practice and evidence quality (therefore all of them must be met before an HTA report can use the registry data). Finally, the third section includes elements of good practice and evidence quality useful to consider in planning and evaluating registries for specific purposes. Although suggestions are defined, the third section item requirements could depend on the individual HTA agency perspectives and needs.Conclusions:There is a clear growing availability and requirement for real world data for health technology assessment. A piloted and robust registry standards tool for HTA can provide a relevant basis to improve both the evidence generation but also to make more trustful and excellent evaluations.

What does meaningful look like? A qualitative study of patient engagement at the Pan-Canadian Oncology Drug Review: perspectives of reviewers and payers

2018 ◽  
Vol 23 (2) ◽  
pp. 72-79 ◽  
Author(s):  
Linda Rozmovits ◽  
Helen Mai ◽  
Alexandra Chambers ◽  
Kelvin Chan
Keyword(s):  
Health Technology Assessment ◽  
Technology Assessment ◽  
Patient Engagement ◽  
Patient Advocacy ◽  
Health Technology ◽  
Assessment Process ◽  
Advocacy Groups ◽  
Oncology Drug ◽  
Patient Advocacy Groups ◽  
Drug Review

Objectives While there is wide support for patient engagement in health technology assessment, determining what constitutes meaningful (as opposed to tokenistic) engagement is complex. This paper explores reviewer and payer perceptions of what constitutes meaningful patient engagement in the Pan-Canadian Oncology Drug Review process. Methods Qualitative interview study comprising 24 semi-structured telephone interviews. A qualitative descriptive approach, employing the technique of constant comparison, was used to produce a thematic analysis. Results Submissions from patient advocacy groups were seen as meaningful when they provided information unavailable from other sources. This included information not collected in clinical trials, information relevant to clinical trade-offs and information about aspects of lived experience such as geographic differences and patient and carer priorities. In contrast, patient submissions that relied on emotional appeals or lacked transparency about their own methods were seen as detracting from the meaningfulness of patient engagement by conflating health technology assessment with other functions of patient advocacy groups such as fundraising or public awareness campaigns, and by failing to provide credible information relevant to deliberations. Conclusions This study suggests that misalignment of stakeholder expectations remains an issue even for a well-regarded health technology assessment process that has promoted patient engagement since its inception. Support for the technical capacity of patient groups to participate in health technology assessment is necessary but not sufficient to address this issue fully. There is a fundamental tension between the evidence-based nature of health technology assessment and the experientially oriented culture of patient advocacy. Divergent notions of what constitutes evidence and how it should be used must also be addressed.

scholarly journals Web-based toolkit to facilitate European collaboration on evidence generation on promising health technologies

2009 ◽  
Vol 25 (S2) ◽  
pp. 68-74 ◽  
Author(s):  
Fabienne Quentin ◽  
Cédric Carbonneil ◽  
Céline Moty-Monnereau ◽  
Elena Berti ◽  
Wim Goettsch ◽  
...  
Keyword(s):  
Health Technology Assessment ◽  
Information Sharing ◽  
Technology Assessment ◽  
Web Site ◽  
Health Technology ◽  
Web Based ◽  
Health Technologies ◽  
European Collaboration ◽  
Evidence Generation ◽  
The Web

Background: Several countries have developed policy frameworks allowing timely access to promising health technologies on the condition that additional evidence is generated. However, an important barrier to evidence generation is the lack of structured collaboration among health technology assessment (HTA) agencies.Objectives: One of the aims of Work Package 7 (WP7) of the European network for Health Technology Assessment (EUnetHTA) Project was to determine the types of structured collaboration that could facilitate evidence generation and to develop a Web-based toolkit to support such collaboration.Methods: Collaboration modalities were defined by all WP7 Partners. Initial emphasis was on information sharing. Standardized forms for information sharing were developed and tested. An information technology development phase followed with the creation of the Web-based toolkit (Web site).Results: Three levels of collaboration were agreed on: (i) sharing information, (ii) coordinated action, and (iii) joint action. The Web site allows access to structured and standardized forms for requesting information, posting information in response to a request, and posting information spontaneously. An online database contains all of the information requested or posted. Pilot tests on twenty-one promising technologies were satisfactory.Conclusions: This new Web site for sharing information on evidence generation should help countries reach robust decisions on the timely adoption of promising health technologies. It will only become fully operational if EUnetHTA Partners supply relevant, accurate, and updated information, and regularly use the Web site.

PP385 Using Common Data Models And Data Networks For Evidence Generation In Health Technology Assessment

2020 ◽  
Vol 36 (S1) ◽  
pp. 32-32
Author(s):  
Seamus Kent ◽  
Jacoline Bouvy
Keyword(s):  
Health Technology Assessment ◽  
Technology Assessment ◽  
Healthcare Delivery ◽  
Health Technology ◽  
Data Models ◽  
Medical Decision ◽  
Data Networks ◽  
Common Data Model ◽  
Analytical Tools ◽  
Evidence Generation

IntroductionDifferences between healthcare datasets in structure, content, and coding systems are widely recognized as significant barriers to generating robust evidence for regulatory and medical decision making. As a result, there is a growing interest in using common data models embedded within large data networks. By standardizing the structure, contents, and semantics of disparate healthcare databases, common data models like the Observational and Medical Outcomes Partnerships common data model (OMOP-CDM) enable multidatabase studies to be undertaken at speed and in a transparent way. To date, little attention has been given to their potential role in health technology assessment (HTA).MethodsWe identify the uses of observational data in generating evidence in HTA, some common analytical challenges faced in their estimation, and the infrastructural, technical, and data reusability constraints that limit its wider use. We discuss where and how the OMOP-CDM could overcome these barriers in relation to different types of evidence requirements.ResultsThe OMOP-CDM increases the interoperability of otherwise disparate datasets, allowing reliable evidence to be generated from multidatabase studies at speed and transparently. The current analytical tools are best suited for clinical characterization and population-level effect estimation. Further developments to these tools are required to support analyses common in HTA like parametric survival modeling. Differences in costing methods as well as the structure of healthcare delivery between countries may limit the feasibility and value of standardization.ConclusionsThe OMOP-CDM has the potential to support reliable and timely evidence generation in HTA. The analytical tools should be further developed to support common HTA use cases.

Ethical Challenges Related to Patient Involvement in Health Technology Assessment

2019 ◽  
Vol 35 (4) ◽  
pp. 253-256 ◽  
Author(s):  
Meredith Vanstone ◽  
Julia Abelson ◽  
Julia Bidonde ◽  
Kenneth Bond ◽  
Raquel Burgess ◽  
...  
Keyword(s):  
Health Technology Assessment ◽  
Technology Assessment ◽  
Patient Engagement ◽  
Patient Involvement ◽  
Technology Policy ◽  
Health Technology ◽  
Ethical Challenges ◽  
Policy Decisions ◽  
The Past ◽  
Ethical Violations

AbstractIncluding information and values from patients in HTA has the potential to improve both the process and outcomes of health technology policy decisions. Accordingly, funding and structural incentives to include patients in HTA activities have increased over the past several years. Unfortunately, these incentives have not yet been accompanied by a corresponding increase in resources, time, or commitment to responsiveness. In this Perspectives piece, we reflect on our collective experiences participating in, conducting, and overseeing patient engagement activities within HTA to highlight the ethical challenges associated with this area of activity. While we remain committed to the idea that patient engagement activities strengthen the findings, relevance, and legitimacy of health technology policy, we are deeply concerned about the potential for these activities to do ethical harm. We use this analysis to call for action to introduce strong protections against ethical violations that may harm patients participating in HTA engagement activities.

PP32 Joint Early Dialogs Between Medical Device Regulation and Health Technology Assessment

2019 ◽  
Vol 35 (S1) ◽  
pp. 43-43
Author(s):  
Petra Schnell-Inderst ◽  
Claudia Wild
Keyword(s):  
High Risk ◽  
Health Technology Assessment ◽  
Medical Device ◽  
Technology Assessment ◽  
Health Technology ◽  
European Medicines Agency ◽  
Scientific Advice ◽  
Market Approval ◽  
Evidence Generation ◽  
Medical Device Regulation

IntroductionIn Europe, the new Medical Device Regulation (MDR) and In Vitro Diagnostics Regulation (IVDR) that entered into force 2017 will have to be applied until 2020 and 2022, respectively. Under the old regulation, there was a large gap between evidence requirements for market approval and market access for high risk (class IIb and III) medical devices (MD). The MDR/IVDR will require appropriate clinical investigations for these MD classes. Despite the different purpose of market approval and surveillance and reimbursement decisions, there are possible synergies with regard to evidence generation, for example, design of pivotal trials and post-launch evidence generation with observational data. In the MDR, early scientific advice can be provided by expert panels of the European Commission if requested by MD developers. For medicinal products, the European network for Health Technology Assessment (EUnetHTA) has established joint early dialogs (JED) of HTA agencies with the European Medicines Agency and manufacturers. A similar approach might be possible with the Medical Device Coordination Group (MDCG). The objective was to explore possible synergies for JED with the MDCG and EUnetHTA.MethodsIn 2018, EUnetHTA established a task force for HTA and MDR/IVDR. A workshop, which will explore possible synergies and activities on JED as well as the viewpoints of stakeholders will be held in May 2019. Participants will be Directorate-Generals GROW (Internal Market, Industry, Entrepreneurship and SME) and SANTE (Health and Food Safety), EUnetHTA members assessing MD, representatives of national competent authorities, Team Notified Bodies, MedTech Europe, patient representatives and academia.ResultsA report on the presentations, the results of the discussion, and next steps in a possible collaboration will be presented.ConclusionsJoint early scientific advice to manufacturers on the European level for evidence generation by HTA agencies and the MDCG has the potential to streamline evidence generation in the life cycle of high risk MD.

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