While ethics has been identified as a core component of health technology assessment (HTA), there are few examples of practical, systematic inclusion of ethics analysis in HTA. Some attribute the scarcity of ethics analysis in HTA to debates about appropriate methodology and the need for ethics frameworks that are relevant to local social values. The “South African Values and Ethics for Universal Health Coverage” (SAVE-UHC) project models an approach that countries can use to develop HTA ethics frameworks that are specific to their national contexts.

The SAVE-UHC approach consisted of two phases. In Phase I, the research team convened and facilitated a national multistakeholder working group to develop a provisional ethics framework through a collaborative, engagement-driven process. In Phase II, the research team refined the model framework by piloting it through three simulated HTA appraisal committee meetings. Each simulated committee reviewed two case studies of sample health interventions: opioid substitution therapy and either a novel contraceptive implant or seasonal influenza immunization for children under five.

The methodology was fit-for-purpose, resulting in a context-specified ethics framework and producing relevant findings to inform application of the framework for the given HTA context.

The SAVE-UHC approach provides a model for developing, piloting, and refining an ethics framework for health priority-setting that is responsive to national social values. This approach also helps identify key facilitators and challenges for integrating ethics analysis into HTA processes.

This article presents the mapping of horizons scanning systems (HSS) for medical devices, conducted by the Medical Devices Working Group of the International Horizon Scanning Initiative (IHSI MDWG). It provides an overview of the identified HSS, highlights similarities and differences between the systems, and lessons learned.

Potentially relevant HSS were identified through literature searches, scan of an overview of EuroScan members, and input from the IHSI MDWG members. Structured information was collected from organizations that confirmed having an HSS for medical devices.

Sixteen initiatives could be identified, of which 11 are currently ongoing. The purposes of the HSS range from raising awareness of trends and new developments to managing informed decisions on innovative health services in hospitals. The time-horizon is most often 3 years up to a few months before market entry. Three models of identification of new technologies crystallized: a reactive (stakeholders outside HSS inform), a pro-active (actively searching multifold sources), and a hybrid model. Prioritization is often conducted by separate committees via scoring or debate. The outputs focus either on in-depth information of single technologies or on a class of technologies or on technologies in specific disease areas.

The identified HSS share the common experience that horizon scanning (HS) for medical devices is a resource-intensive exercise that requires a dedicated and skilled team. Insights into the identified HSS and their experiences will be used in the continued work of the IHSI MDWG on its proposal for an IHSI HSS for medical devices.

Health technologies are fundamental in an operational health system. Medical devices, in particular, are crucial for disease prevention, diagnosis, treatment and rehabilitation. Recognizing this important role of health technologies, the World Health Assembly adopted, in May 2007, resolution WHA60.29, which addresses issues arising from inadequate installation and use of health technologies, as well as the need to formulate national strategies for the implementation of evaluation, planning, procurement and management systems for health technologies, in collaboration with personnel dedicated to the evaluation of health technologies and biomedical engineering. Maintenance management computer systems and software have evolved to help maintain medical equipment and control associated costs. A Computerized Maintenance Management System contains a database about an organization's maintenance operations.

The pilot study of observational and descriptive design will include all the medical/laboratory equipment that the Research Institute of Health Sciences (IICS) has that meets the inclusion criteria. The work will be carried out at the IICS, which aims to develop a computerized system for the maintenance of equipment that allows the linking of Quick Response (QR) codes to an application (WebApp) by means of cameras in smartphones, able to relate each QR code (attached to a medical/laboratory equipment) to its corresponding URL, and thus able to access all the technical information of each IICS team and therefore monitor their maintenance (preventive, corrective, predictive), history, spare parts, budgets, and technical specifications.

We have a database of all medical devices installed in the research center; we look forward to developing the program to include the data. The project focuses on the effective tool for decision making regarding the evaluation of the installed sanitary technology and those that will be installed.

The study proposes an effective solution for maintenance management, using data that supports administrative decisions regarding the acquisition of equipment in the future; that is, the system can contribute when it comes to evaluating installed and acquired sanitary technology.

Stunting increases a child's susceptibility to diseases, increases mortality, and is associated over long term with reduced cognitive abilities, educational achievement, and productivity. We aimed to assess the most effective public health nutritional intervention to reduce stunting in Myanmar.

We searched the literature and developed a conceptual framework for interventions known to reduce stunting. We focused on the highest impact and most feasible interventions to reduce stunting in Myanmar, described policies to implement them, and compared their costs and projected effect on stunting using data-based decision trees. We estimated costs from the government perspective and calculated total projected cases of stunting prevented and cost per case prevented (cost-effectiveness). All interventions were compared to projected cases of stunting resulting from the current situation (e.g., no additional interventions).

Three new policy options were identified. Operational feasibility for all three options ranged from medium to high. Compared to the current situation, two were similarly cost-effective, at an additional USD 598 and USD 667 per case of stunting averted. The third option was much less cost-effective, at an additional USD 27,741 per case averted. However, if donor agencies were to expand their support in option three to the entire country, the prevalence of 22.5 percent would be reached by 2025 at an additional USD 667 per case averted.

A policy option involving immediate expansion of the current implementation of proven nutrition-specific interventions is feasible. It would have the highest impact on stunting and would approach the WHO 2025 target.

Various forms of outcomes-based or risk-sharing agreements have been implemented since early 2000s as a way of access to innovative medicinal products. This study aims to summarize the international experience of performance-based risk-sharing arrangements (PBRSAs) and identify the preconditions for a successful implementation of such schemes. Their implications for the Chinese healthcare market are discussed.

A systematic literature review (in PubMed) was conducted to review the evidence on the nature and performance of PBRSAs in the past 10 years. Grey literature was searched for reports in government websites of the countries in scope.

The search identifies 463 records from PubMed and 3 additional records from other sources. Thirty-one publications are included in the final review. The following preconditions were identified to support a successful implementation of PBRSAs: (1) Identify meaningful and feasible outcome measurements; (2) Establish an effective and efficient data collection infrastructure; (3) Control of the implementation costs; (4) Develop governance and administrative infrastructure to allow delisting and rebate/refund; (5) Clarify personal data protection issues.

The implementation of PBRSAs has proven to be challenging. Although the Chinese healthcare system is not yet well equipped to implement such schemes, some recent changes may pave the way to successful PBRSAs for particular innovative products.

Increasingly, health technology assessment (HTA) organizations have instituted mechanisms for involving patients in assessment and review processes. The reasons are obvious—to understand the “patient experience” with a disease and to ensure that patient perspectives are considered during deliberations about the value of new treatments. More recently there have been efforts to engage the public in HTAs and HTA-informed decision-making processes. However, the goals of these efforts have not been well articulated. This may be attributable to the lack of a shared definition of “the public”. The objective of this study was to develop a common understanding of the term “the public” within the context of HTA.

The following were conducted: a survey of HTA organizations; a systematic review; consultation with Health Technology Assessment international's Special Interest Group on Patient and Citizen Involvement; and a workshop comprising representatives from patient organizations, industry, and HTA bodies in Canada.

In many HTA processes, the terms “public” and “patients” are synonymous. Definitions found in scholarly articles vary and depend on the rationale for involving the public in a particular issue. Through consultations it became clear that, in the context of HTA, the definition depends on understanding what is missing from current deliberations around the value of new health technologies. There was consensus among workshop participants that: (i) “patients” and “the public” are not the same; (ii) the role of the public may be to ensure societal values are reflected in HTAs and HTA-informed decision-making processes (e.g. serving an audit function); and (iii) a legitimate definition of “the public” could be: “A non-aligned community member with no commercial or professional interest in the HTA process who is not a patient or member of a stakeholder group”.

Consensus on the use of the terms “patient” and “public” will support rigorous, evidence-based public and patient engagement in HTA. The proposed definition indicates a way forward in this debate.

Multi-stakeholder interactions have evolved at product and policy levels. There is a need to assess the current and future landscape of interactions between companies, and regulatory and HTA agencies to address challenges and identify areas for improvement.

The aims of this study were to review the current interactions within and across regulatory and HTA agencies, and companies’ experiences in engaging in these activities; to assess the added value of interactions as well as limitations; to explore the future ecosystem for stakeholder interactions.

Three separate questionnaires were developed for companies, regulators and HTA agencies, respectively, to assess their experiences and perceptions. The responses were analyzed using descriptive statistics and discussed at a multi-stakeholder workshop. Key outcomes from the surveys and workshop discussion were reported.

All seven regulators and seven HTA agencies in the survey indicated that they had stakeholder interactions. More formal collaboration occurred with regulators compared with HTA agencies. All nine companies have taken early advice but indicated the need for future prioritization. Success indicators can be built at the product and therapy levels, with the added value of faster patient access. Four principles were proposed for the future ecosystem: separate remit and functions between regulators and HTA; align processes; converge evidence requirements where possible; increase transparency.

This research brought together regulators, HTA agencies, companies to examine how they interact with one another. We propose measures of value and make recommendations on future evolution to enable better evidence generation and improve regulatory and HTA decision-making.

Randomized controlled trials (RCTs) of complex interventions are conducted in a context-specific environment. Principal trial reports, with a focus on main results, are unable to document adequately the context for an intervention, for example, word limits. Important context may be included in “sibling studies” (that is, studies conducted alongside the main trial, for example, process evaluations, and qualitative studies (1). This presentation explores (i) to what extent is it possible to use a systematic and parsimonious method to identify sibling studies and (ii) what is the potential value of yield from these studies?

The systematic CLUSTER approach (2) to follow up of index studies (Citations, Lead authors, Unpublished materials, Scholar, Theories, Early examples Related projects) has demonstrated the value of retrieved items in qualitative terms. However, the CLUSTER approach is painstaking and laborious and may be prohibitive within a time-tight Health Technology Assessment (HTA). A streamlined CLUSTER approach, using freely available Publish or Perish Software integrated with Google Scholar and Microsoft Excel, offers an economical way of building up “clusters” of study reports. A case study of a UK National Institute for Health Research (NIHR)-funded HTA on the management of medically unexplained symptoms in primary care, utilizing quantitative and qualitative research studies, is used to examine the practical application of the approach.

Systematic comparison of yield from sifting with yield from the Publish or Perish software reveals (i) major trials for which corresponding qualitative studies were not previously identified, (ii) qualitative studies identified independently from, and potentially unlinked to, associated trials, (iii) associated trial reports (for example, protocols, feasibility studies, etc), economic evaluations and systematic reviews, and (iv) commentaries and correspondence; all with the potential to enhance understanding of trial context.

The potential of the Publish or Perish-enabled CLUSTER approach to identify trials or qualitative studies, through “joining up” and mapping of clusters, potentially missed from separate quantitative/qualitative sift processes, means that it should be considered for any HTA that seeks to integrate quantitative and qualitative studies.