Background: Ethics has been part of health technology assessment (HTA) from its beginning in the 1970s, and is currently part of HTA definitions. Several methods in ethics have been used in HTA. Some ...approaches have been developed especially for HTA, such as the Socratic approach, which has been used for a wide range of health technologies. The Socratic approach is used in several ways, and there is a need for harmonization to promote its usability and the transferability of its results. Accordingly, the objective of this study was to stimulate experts in ethics and HTA to revise the Socratic approach.
Methods: Based on the current literature and experiences in applying methods in ethics, a panel of ethics experts involved in HTA critically analyzed the limitations of the Socratic approach during a face-to-face workshop. On the basis of this analysis a revision of the Socratic approach was agreed on after deliberation in several rounds through e-mail correspondence.
Results: Several limitations with the Socratic approach are identified and addressed in the revised version which consists of a procedure of six steps, 7 main questions and thirty-three explanatory and guiding questions. The revised approach has a broader scope and provides more guidance than its predecessor. Methods for information retrieval have been elaborated.
Conclusion: The presented revision of the Socratic approach is the result of a joint effort of experts in the field of ethics and HTA. Consensus is reached in the expert panel on an approach that is considered to be more clear, comprehensive, and applicable for addressing ethical issues in HTA.
Objectives: The INTEGRATE-HTA project provided methodology to evaluate complex technologies. This study provides guidance on how to retrieve and critically appraise available evidence on moderators ...and predictors of treatment effects and on patient preferences for treatment outcomes as a source of complexity.
Methods: Search filters for PubMed were developed by hand-searching a large volume of articles reporting on relevant aspects. Search terms were retrieved from selected papers and algorithmically combined to find the optimal combination of search terms. For the development of the appraisal checklists literature was searched in PubMed and Google Scholar together with citation chasing. For the CHecklist for the Appraisal of Moderators and Predictors (CHAMP) a Delphi procedure was used to value a set of eligible appraisal criteria retrieved from the literature.
Results: Search filters were developed optimized for different accuracy measures. The final version of CHAMP consists of a seventeen questions covering the design, analysis, results and transferability of results of moderator and predictor analysis. The final checklist for appraisal of literature on patient preferences for treatment outcomes consist of six questions meant to help the user to identify relevant quality issues together with a guidance toward existing tools concerning the appraisal of specific preference elicitation methods.
Conclusions: Incorporating knowledge on subgroups for whom a specific treatment will produce more benefit holds the promise of better targeting and, ultimately, enhancing overall effectiveness and efficiency of healthcare technology. Finally, incorporating information on preferences for treatment outcomes will foster health technology assessment that addresses outcomes that are important to patients.
Background:
Stakeholders are people with an interest in a topic. Internationally, stakeholder involvement in palliative care research and health technology assessment requires development. ...Stakeholder involvement adds value throughout research (from prioritising topics to disseminating findings). Philosophies and understandings about the best ways to involve stakeholders in research differ internationally. Stakeholder involvement took place in seven countries (England, Germany, Italy, Lithuania, the Netherlands, Norway and Poland). Findings informed a project that developed concepts and methods for health technology assessment and applied these to evaluate models of palliative care service delivery.
Aims:
To report on stakeholder involvement in the INTEGRATE-HTA project and how issues identified informed project development.
Design:
Using stakeholder consultation or a qualitative research design, as appropriate locally, stakeholders in seven countries acted as ‘advisors’ to aid researchers’ decision making. Thematic analysis was used to identify key issues across countries.
Setting/participants:
A total of 132 stakeholders (82 professionals and 50 ‘lay’ people) aged ⩾18 participated in individual face-to-face or telephone interviews, consultation meetings or focus groups.
Results:
Different stakeholder involvement methods were used successfully to identify key issues in palliative care. A total of 23 issues common to three or more countries informed decisions about the intervention and comparator of interest, sub questions and specific assessments within the health technology assessment.
Conclusion:
Stakeholders, including patients and families undergoing palliative care, can inform project decision making using various involvement methods according to the local context. Researchers should consider local understandings about stakeholder involvement as views of appropriate and feasible methods vary. Methods for stakeholder involvement, especially consultation, need further development.
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NUK, OILJ, SAZU, UKNU, UL, UM, UPUK
Selective internal radiation therapy is a form of intra-arterial brachytherapy used to treat primary liver cancer and liver metastases. This article aims to provide an overview of the clinical, ...economic, organizational legal, social and ethical impact of selective internal radiation therapy using SIR-Spheres Y-90 resin microspheres in the treatment of patients with unresectable, liver-dominant metastatic colorectal cancer who are refractory to or intolerant of chemotherapy. A systematic literature review was performed by querying PubMed, Scopus, EBSCO, CRD and GIN. Two reviewers blindly screened the records retrieved against predefined inclusion/exclusion criteria. The selected studies where summarized following a simplified version of the EuNetHTA Core Model® 2.1. The studies included evaluated selective internal radiation therapy in first-line or further-line treatment and showed a good safety and tolerability profile and significant improvement in efficacy expressed as time to liver progression, progression-free survival and overall survival. Selective internal radiation therapy should be provided in specialized centres and administered by a multidisciplinary team. A hub-and-spoke network could be a viable option to guarantee access to this technology across jurisdictions. The lack of a specific diagnosis-related group tariff accounting for the cost of the device could be seen as the major obstacle to a fair diffusion of this technology. The economic evaluations currently available show the cost-effectiveness of this technology in the population under study. Selective internal radiation therapy using SIR-Spheres Y-90 resin microspheres appears to be a clinically effective and cost-effective option in the treatment of metastatic colorectal cancer patients who are chemotherapy refractory or chemotherapy intolerant.
Recently new opportunities are emerging for improving the way patients with Haemophilia A are treated. Among these opportunities, efmoroctocog alfa is a first-in-class recombinant factor VIII-Fc ...fusion protein (rFVIIIFc) produced by recombinant DNA technology with an extended half-life compared with conventional FVIII preparations. The available evidence coming from an Italian HTA report indicates that efmoroctocog alfa provides an effective alternative to conventional FVIII preparations (including standard rFVIIIs) for the management of Haemophilia A. Moreover, by reducing the frequency of injections required, it has the potential to reduce treatment burden, and hence improve adherence to prophylaxis and patient Quality-of-Life.
There is no consensus on who might be qualified to conduct ethical analysis in the field of health technology assessment (HTA). Is there a specific expertise or skill set for doing this work? The aim ...of this article is to (i) clarify the concept of ethics expertise and, based on this, (ii) describe and specify the characteristics of ethics expertise in HTA.
Based on the current literature and experiences in conducting ethical analysis in HTA, a group of members of the Health Technology Assessment International (HTAi) Interest Group on Ethical Issues in HTA critically analyzed the collected information during two face-to-face workshops. On the basis of the analysis, working definitions of "ethics expertise" and "core competencies" of ethics experts in HTA were developed. This paper reports the output of the workshop and subsequent revisions and discussions online among the authors.
Expertise in a domain consists of both explicit and tacit knowledge and is acquired by formal training and social learning. There is a ubiquitous ethical expertise shared by most people in society; nevertheless, some people acquire specialist ethical expertise. To become an ethics expert in the field of HTA, one needs to acquire general knowledge about ethical issues as well as specific knowledge of the ethical domain in HTA. The core competencies of ethics experts in HTA consist of three fundamental elements: knowledge, skills, and attitudes.
The competencies described here can be used by HTA agencies and others involved in HTA to call attention to and strengthen ethical analysis in HTA.
"This work is aimed at critically illustring the eight-year experience of the Master in “Clinical Bioethics Consultation” (2013-2020). This advanced second-level Master was promoted in 2013 by the ...Catholic University of the Sacred Heart of Rome, and co-worked by other Italian clinical as well as academic institutions (University Campus Bio-medico of Rome, Insubria University of Varese, “Federico II” University of Naples, Lanza Foundation of Padua, Local Health and Social Care Unit n. 7 (ULSS) of Veneto Region, Treviso; Ospedale San Giovanni Calibita Fatebenefratelli – Isola Tiberina, Rome, and Italian Group for clinical ethics consultation (GIBCE)). To this aim, it first will discuss two points: on the one hand, an epistemological one, i.e. the justification of the activity of ethics consultant in clinical settings supported by the authors; on the other hand, a pedagogical one, i.e. the identification of the learning needs clinical bioethics gives birth to. The second part of the work will focus on the experience of the Master, explaining its basic features (objectives, methods, contents, evaluation tools, etc), offering a critical review, and identifying the challenges this initiative has to face in the next future. "
Objectives: Internationally, funders require stakeholder involvement throughout health technology assessment (HTA). We report successes, challenges, and lessons learned from extensive stakeholder ...involvement throughout a palliative care case study that demonstrates new concepts and methods for HTA.
Methods: A 5-step “INTEGRATE-HTA Model” developed within the INTEGRATE-HTA project guided the case study. Using convenience or purposive sampling or directly / indirectly identifying and approaching individuals / groups, stakeholders participated in qualitative research or consultation meetings. During scoping, 132 stakeholders, aged ≥ 18 years in seven countries (England, Italy, Germany, The Netherlands, Norway, Lithuania, and Poland), highlighted key issues in palliative care that assisted identification of the intervention and comparator. Subsequently stakeholders in four countries participated in face–face, telephone and / or video Skype meetings to inform evidence collection and / or review assessment results. An applicability assessment to identify contextual and implementation barriers and enablers for the case study findings involved twelve professionals in the three countries. Finally, thirteen stakeholders participated in a mock decision-making meeting in England.
Results: Views about the best methods of stakeholder involvement vary internationally. Stakeholders make valuable contributions in all stages of HTA; assisting decision making about interventions, comparators, research questions; providing evidence and insights into findings, gap analyses and applicability assessments. Key challenges exist regarding inclusivity, time, and resource use.
Conclusion: Stakeholder involvement is feasible and worthwhile throughout HTA, sometimes providing unique insights. Various methods can be used to include stakeholders, although challenges exist. Recognition of stakeholder expertise and further guidance about stakeholder consultation methods is needed.
Objectives: The aim of this study was to identify and discuss appropriate approaches to integrate ethical inquiry in health technology assessment (HTA).
Methods: The key question is how ethics can be ...integrated in HTA. This is addressed in two steps: by investigating what it means to integrate ethics in HTA, and by assessing how suitable the various methods in ethics are to be integrated in HTA according to these meanings of integration.
Results: In the first step, we found that integrating ethics can mean that ethics is (a) subsumed under or (b) combined with other parts of the HTA process; that it can be (c) coordinated with other parts; or that (d) ethics actively interacts and changes other parts of the HTA process. For the second step, we found that the various methods in ethics have different merits with respect to the four conceptions of integration in HTA.
Conclusions: Traditional approaches in moral philosophy tend to be most suited to be subsumed or combined, while processual approaches being close to the HTA or implementation process appear to be most suited to coordinated and interactive types of integration. The article provides a guide for choosing the ethics approach that appears most appropriate for the goals and process of a particular HTA.
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