To describe the type and level of ethical integration in published health technology assessment (HTA) reports and systematically identify the ethical approaches utilized.

A literature search was conducted with the Google™ search engine using the keyword “ethic” between 1 January 2015 and 20 August 2019. Only HTA assessment reports with a section on ethics were retained and classified according to their level of ethical integration: no ethical analysis, ethical issues highlighted, assessments according to legal or social norms, and assessments from a moral or axiological perspective—using a qualitative methodology to distinguish such integration.

This review yielded 188 reports with a section identified as being on ethics, produced by seventeen HTA agencies in eleven countries. One hundred and thirty-six reports did not develop an ethical analysis, thirty-one highlighted ethical issues, seventeen conducted a norm-based ethical assessment using a descriptive approach grounded in social norms, and four developed an assessment grounded in a moral or axiological perspective. The bioethical “four-principles” framework was used, but mainly for presenting ethical issues and not as a moral framework.

The majority of reports featuring a section on ethics mention ethical considerations without ethical analysis. Ethical issues are grouped with legal, social, and organizational issues and treated as contextual considerations that decision makers should be aware of. When reports present systematic norm-based ethical assessments from a descriptive perspective or ethical assessment based on a moral or axiological perspective, there is a tendency to ground these analyses in frameworks created for the purpose and reliant on a concept of ethics supporting them.

Technological and computational advancements offer new tools for the collection and analysis of real-world data (RWD). Considering the substantial effort and resources devoted to collecting RWD, a greater return would be achieved if real-world evidence (RWE) was effectively used to support Health Technology Assessment (HTA) and decision making on medical technologies. A useful question is: To what extent are RWD suitable for generating RWE?

We mapped existing RWD sources in Europe for three case studies: hip and knee arthroplasty, transcatheter aortic valve implantation (TAVI) and mitral valve repair (TMVR), and robotic surgery procedures. We provided a comprehensive assessment of their content and appropriateness for conducting the HTA of medical devices. The identification of RWD sources was performed combining a systematic search on PubMed with gray literature scoping, covering fifteen European countries.

We identified seventy-one RWD sources on arthroplasties; ninety-five on TAVI and TMVR; and seventy-seven on robotic procedures. The number, content, and integrity of the sources varied dramatically across countries. Most sources included at least one health outcome (97.5%), with mortality and rehospitalization/reoperation the most common; 80% of sources included resource outcomes, with length of stay the most common, and comparators were available in almost 70% of sources.

RWD sources bear the potential for the HTA of medical devices. The main challenges are data accessibility, a lack of standardization of health and economic outcomes, and inadequate comparators. These findings are crucial to enabling the incorporation of RWD into decision making and represent a readily available tool for getting acquainted with existing information sources.

Peer review of searches is a process whereby both the search strategies and the search process description are reviewed, ideally using an evidence-based checklist.

As the search strategy underpins any well-conducted evidence synthesis, its quality could affect the final result. Evidence shows, however, that search strategies are prone to error.

There is increasing awareness and use of the PRESS Evidence-Based Checklist and peer review of search strategies, at the outset of evidence syntheses, prior to the searches being run, and this is now recommended by a number of evidence synthesis organizations.

Searches for evidence syntheses should be peer reviewed by a suitably qualified and experienced librarian or information specialist after being designed, ideally, by another suitably qualified and experienced librarian or information specialist. Peer review of searches should take place at two important stages in the evidence synthesis process; at the outset of the project prior to the searches being run and at the prepublication stage. There is little empirical evidence, however, to support the effectiveness of peer review of searches. Further research is required to assess this. Those wishing to stay up to date with the latest developments in information retrieval, including peer review of searches, should consult the SuRe Info resource (http://www.sure-info.org), which seeks to help information specialists and others by providing easy access to the findings from current information retrieval methods research and thus support more research-based information retrieval practice.

Conventional appraisal and reimbursement processes are being challenged by the increasing number of rare disease treatments (RDTs) with a small evidence base and often a high price. Processes to appraise RDTs vary across countries; some use standard processes, others have separate processes or adapted processes that explicitly deal with rare disease specificities. The objective of this study was to examine the impacts of different appraisal processes for two RDTs.

A case study analysis was conducted using countries with different forms of appraisal processes for RDTs for which public health technology assessment (HTA) reports were available. Two contrasting RDTs were chosen according to the criteria: rare versus ultra-rare treatment, affecting child versus adult, life-threatening versus disabling. Information from public HTA reports for each country's RDT appraisal was extracted into templates, allowing a systematic comparison of the appraisals across countries and identification of the impact of the different processes in practice.

Reports from Belgium, England, France, Germany, Italy, Netherlands, Norway, Scotland, Sweden, and the USA were selected for nusinersen (for spinal muscular atrophy) and voretigene neparvovec (for inherited retinal disorders). Countries with separate or adapted processes had more consistent approaches for managing RDT-related issues during appraisal, such as stakeholder involvement and criteria to address the specificities of RDTs, creating more transparency in decision-making.

Findings suggest that separate or adapted approaches for RDT appraisal may facilitate more structured, consistent decision-making and better management of RDT specificities.

A growing number of evaluation frameworks have emerged over recent years addressing the unique benefits and risk profiles of new classes of digital health technologies (DHTs). This systematic review aims to identify relevant frameworks and synthesize their recommendations into DHT-specific content to be considered when performing Health Technology Assessments (HTAs) for DHTs that manage chronic noncommunicable disease at home.

Searches were undertaken of Medline, Embase, Econlit, CINAHL, and The Cochrane Library (January 2015 to March 2020), and relevant gray literature (January 2015 to August 2020) using keywords related to HTA, evaluation frameworks, and DHTs. Included framework reference lists were searched from 2010 until 2015. The EUNetHTA HTA Core Model version 3.0 was selected as a scaffold for content evaluation.

Forty-four frameworks were identified, mainly covering clinical effectiveness (n = 30) and safety (n = 23) issues. DHT-specific content recommended by framework authors fell within 28 of the 145 HTA Core Model issues. A further twenty-two DHT-specific issues not currently in the HTA Core Model were recommended.

Current HTA frameworks are unlikely to be sufficient for assessing DHTs. The development of DHT-specific content for HTA frameworks is hampered by DHTs having varied benefit and risk profiles. By focusing on DHTs that actively monitor/treat chronic noncommunicable diseases at home, we have extended DHT-specific content to all nine HTA Core Model domains. We plan to develop a supplementary evaluation framework for designing research studies, undertaking HTAs, and appraising the completeness of HTAs for DHTs.

Established and emerging technologies—such as wearable sensors, smartphones, mobile apps, and artificial intelligence—are shaping positive healthcare models and patient outcomes. These technologies have the potential to become precision health (PH) innovations. However, not all innovations meet regulatory standards or have the required scientific evidence to be used for health applications. In response, an assessment framework was developed to facilitate and standardize the assessment of innovations deemed suitable for PH.

A scoping literature review undertaken through PubMed and Google Scholar identified approximately 100 relevant articles. These were then shortlisted (n = 12) to those that included specific metrics, criteria, or frameworks for assessing technologies that could be applied to the PH context.

The proposed framework identified nine core criteria with subcriteria and grouped them into four categories for assessment: technical, clinical, human factors, and implementation. Guiding statements with response options and recommendations were used as metrics against each criterion.

The proposed framework supports health services, health technology innovators, and researchers in leveraging current and emerging technologies for PH innovations. It covers a comprehensive set of criteria as part of the assessment process of these technologies.

The objective of this exploratory analysis is to reflect and discuss which criteria of multiple criteria decision analysis (MCDA) would be relevant as part of value determination when appraising healthcare interventions in the Lebanese context.

A workshop was conducted as part of the International Society for Pharmacoeconomics and Outcomes Research (ISPOR) Lebanon Chapter and included the two frameworks: Evidence and Value: Impact on Decision Making (EVIDEM) and Advance Value Framework. Thirty-seven participants expressed their individual preferences through a qualitative and a quantitative exercise.

In the qualitative analysis of both frameworks, participants unanimously agreed on the relevance of comparative efficacy, safety, and impact of medical costs. In EVIDEM, disease severity and unmet needs were also considered to be important criteria by more than 90 percent of the participants. In the quantitative analysis of both frameworks, disease severity ranked first (a mean normalized weight of .1 in EVIDEM and .27 in Advance Value Framework), followed by the size of the population (.09), the type of therapeutic benefit at the patient level (.09) and population level (.08), and the efficacy (.07) in EVIDEM. In the Advance Value Framework, the combined unmet need/disease severity criteria were followed by direct and meaningful end points (.15), safety (.12), contraindications (.08), and indirect surrogate end points (.07).

The results were concordant with those reported in countries that have conducted similar surveys such as France, Italy, and Spain. The MCDA methodology could be used as a cornerstone to enhance evidence-based discussions among Lebanese stakeholders involved in evaluation and decision-making purposes.

Our objective was to assess how, and to what extent, a systems-level perspective is considered in decision-making processes for health interventions by illustrating how studies define the boundaries of the system in their analyses and by defining the decision-making context in which a systems-level perspective is undertaken.

We conducted a scoping review following the Joanna Briggs Institute methodology. MEDLINE, EMBASE, Cochrane Library, and EconLit were searched and key search concepts included decision making, system, and integration. Studies were classified according to an interpretation of the “system” of analysis used in each study based on a four-level model of the health system (patient, care team, organization, and/or policy environment) and using categories (based on intervention type and system impacts considered) to describe the decision-making context.

A total of 2,664 articles were identified and 29 were included for analysis. Most studies (16/29; 55%) considered multiple levels of the health system (i.e., patient, care team, organization, environment) in their analysis and assessed multiple classes of interventions versus a single class of intervention (e.g., pharmaceuticals, screening programs). Approximately half (15/29; 52%) of the studies assessed the influence of policy options on the system as a whole, and the other half assessed the impact of interventions on other phases of the disease pathway or life trajectory (14/29; 48%).

We found that systems thinking is not common in areas where health technology assessments (HTAs) are typically conducted. Against this background, our study demonstrates the need for future conceptualizations and interpretations of systems thinking in HTA.

To assess the adherence of economic evaluations to the recommendations on principles of economic evaluation as stated in the country-specific guidelines for three countries across different income groups, namely, Canada, South Africa, and Egypt.

Searches were undertaken in three databases to identify economic evaluations meeting predefined inclusion criteria. Methodological and reporting standards listed in the country-specific guidelines were converted into discrete binary variables to calculate mean adherence scores. Quality appraisal was done using Drummond's checklist. Stratified analysis was undertaken to identify independent variables affecting adherence.

We identified forty-four, seventy-nine, and sixteen economic evaluations for Canada, South Africa, and Egypt, respectively. The mean adherence score was the highest for Canada (71%), followed by South Africa (65%) and Egypt (60%). Adherence to guidelines was positively correlated with quality of studies, r = .72. Furthermore, the mean adherence score was significantly (p < .05) higher for studies using a cost-utility analysis design (72%), having local/national funding aid (72%), undertaken by a health economist (71%) and for pharmacoeconomic evaluations (70%).

The quality of economic evaluations improves with adherence to country-specific guidelines. Locally funded and health-economist led health technology assessments (HTAs) should be encouraged for greater adherence to the guidelines. The HTA researchers and the HTA bodies should lay emphasis on adherence to the country-specific guidelines for improving the quality of HTA evidence.

As health technology assessment (HTA) seeks to combine complex sets of evidence, values, and perspectives to support open, accountable, and transparent decision making, uncertainty is inherent. Uncertainty is present in the clinical and economic inputs that inform HTA and is a critical factor during context-specific deliberations where the evidence is weighed and decisions are made, taking uncertainty into account through either financial or evidence-generation mechanisms. The presence and impact of uncertainty must also be communicated to all relevant stakeholders during the HTA output stage. This article summarizes the 2021 HTAi Global Policy Forum discussion on “Considering and Communicating Uncertainty in HTA” that debated some of the key challenges and opportunities regarding uncertainty in HTA. Through a combination of small and large group discussions, core themes related to the topic of uncertainty in HTA were identified. These discussions revealed that: utilization of a life cycle/HTA management approach helps manage uncertainty; genuine stakeholder input and engagement (and not just consultation) can clarify uncertainty; tolerance of risk, the relationship of risk to uncertainty, and the context in which uncertainty is considered is critical; transparent and early dialogues could be increased to further reduce the uncertainty during HTA; and communicating uncertainty in HTA outputs is critical. The paper ends with suggested next steps that HTA agencies and stakeholders (such as industry, patients, regulators, payers, and others) might take to move the field forward. The paper promotes further discussion on aspects of uncertainty that should be more openly discussed, debated, and addressed.

We evaluated the early impact of a new hospital-based health technology assessment (HB-HTA) program, called Smart Innovation, at the University of Washington Medical Center (UWMC).

We compared the UWMC's utilization trends for two surgical procedures to control hospitals by evaluating the difference before and after adoption decisions: (i) a new filter for transcatheter aortic valve replacement (TAVR) procedures that treat aortic valve stenosis and (ii) microwave ablation (MWA) for treating hepatocellular carcinoma. We used descriptive statistics to assess the difference between the UWMC and controls for TAVR and MWA procedures and multivariate difference-in-differences (DID) analyses to test for statistical significance.

The UWMC experienced a 10 percent reduction in TAVR procedures compared with controls following the implementation of the TAVR Sentinel filter. The DID regression model indicated a 1.5 reduction in the number of TAVR procedures per quarter at the UWMC between the pre- and post period, which was not statistically significant (p-value: .87). The UWMC experienced a 51 percent reduction in utilization when compared with controls for MWA procedures in the pre- and post periods. The DID model for MWA indicated an 18.8 decrease in utilization per quarter during the study period for the UWMC, which was statistically significant (p-value: .0007). For MWA procedures, the UWMC experienced a $647,658 dollar reduction in total costs in the post period compared with controls.

When the UWMC used HB-HTA methods for technology adoption, there was a reduction in utilization and total costs when compared with controls; however, when the UWMC adopted a new technology without using HB-HTA methods, there was no difference in utilization.

For the assessment of videorasterstereography compared with radiography for monitoring idiopathic scoliosis, new tools given by the INTEGRATE-HTA methodology were included within the frame set by the authority. In contrast to the usual linear approach by covering the single domains' safety and efficacy, costs, and ethical, legal, socio-cultural and organizational issues (ELSOI) separately, the methodology is based on the assumption of interactions of different aspects of the domains. From the very beginning, these interactions are captured systematically using various tools and are repeatedly discussed with stakeholders.

Relevant databases were systematically searched for studies and question catalogues were processed in order to be able to search for specific aspects in orienting bibliographic research. An initial logic model was developed and successively expanded. A synoptic table showing multiple mapping of aspects to domains, a complexity checklist, and a semantic complex highlighting the socio-cultural impact of the disease were newly developed.

Four diagnostic studies with high risk of bias were included. For the clinical outcome, Cobb angle standard deviations up to 8.2 degrees and average measurement differences up to 8.8 degrees were determined. These differences in measurement accuracy correspond to those observed for purely radiographic measurements in other studies. In addition to freedom from radiation as the greatest advantage, there were clear arguments in favor of videorasterstereography when considering ELSOI, for example less harm.

Using INTEGRATE-HTA contributes to identify interactions between domains and to significantly expand the perspective on a technology. It improves patient-centered understanding and facilitates discussions.

We aimed to perform a systematic review of economic evaluations of drug-coated balloons (DCBs) and drug-eluting stents (DESs) in peripheral artery disease (PAD) and to assess the level of evidence of relevant studies. The purpose was not to present economic findings.

A systematic review was performed using four electronic databases to identify health economic evaluation studies reporting on the use of DCBs and DESs in PAD. The methodological and reporting quality of the studies was assessed using three different tools, the Drummond, Cooper, and CHEERS (Consolidated Health Economic Evaluation Reporting Standards) checklists.

Six articles were included in this review of the 1,728 publications identified. Four studies were cost-effectiveness analyses and two cost–utility analyses. According to the Cooper hierarchy scale, the studies used good-quality data sources. The level of evidence used for clinical effect sizes, safety data, baseline clinical data, and costs was of high quality in general. In contrast, an evaluation of the reporting quality suggested that essential information was lacking.

The present study demonstrates that clinical data used in economic evaluations of DCBs and DESs in PAD are from clinical studies of high quality in general. However, the quality of reporting represents a concern when interpreting the results provided by these economic studies.

There is no health system that has the resources to evaluate all technologies. The presence of a clear process to prioritize health technologies for assessment by health technology assessment (HTA) agencies is a good practice principle recognized at the international level. The objective of Health Technology Assessment International's 2020 Latin American Policy Forum (LatamPF) was to explore how to improve the way HTA agencies in Latin America identify and prioritize technologies for assessment.

This paper is based on a background document, a survey, and the deliberations of the members of the LatamPF (forty-six participants from eleven countries) using a design thinking methodology.

Participants agreed that a lack of clear prioritization mechanisms results in HTA processes and decisions that are perceived to be of low transparency and overly exposed to political or interest group pressures. The LatamPF identified barriers and recommended actions to improve HTA prioritization mechanisms in Latin America. The criteria identified as the most important to be taken into consideration by HTA agencies in the region when prioritizing a technology for assessment were: the burden of illness, the potential clinical benefit, the alignment with national health priorities, the potential impact on equity, a lack of treatment alternatives for patients, and the potential economic impact.

Forum participants agreed that the establishment of transparent prioritization processes is a key element for all health systems. Improvements in these processes will strengthen HTA and provide greater legitimacy to decision making.