Objectives: The National Institutes of Health (NIH) Consensus Development Conference (CDC) was instituted to provide evidence-based guidance on controversial medical issues to researchers, health practitioners, and the public; however, the degree of impact this activity has on stimulating relevant research is unclear. This study examines the impact of CDC statements on the initiation of related NIH-funded research projects.

Methods: Six CDCs from 1998 to 2001 were examined. Research initiatives related to the Conferences' topics were collected through two discrete methods: (i) the overall number of relevant pre- and postconference research activities was compiled using NIH's Information for Management, Planning, Analysis, and Coordination II (IMPAC II) and the Department of Health and Human Services' (DHHS) Computer Retrieval of Information on Scientific Projects (CRISP) grant application and award databases; (ii) for each CDC, the sponsoring institute's conference coordinator and other identified Program Directors were queried for their knowledge of new conference-specific research initiatives sponsored by their institute. The main outcome measure was the total number of requests for applications, requests for proposals, program announcements, broad agency announcements, notices, and funded investigator-initiated research program grants (RO1s) for a given Consensus topic in the 3 years before (baseline measure) and following (measure of impact) a CDC.

Results: As identified through NIH's IMPAC II and DHHS' CRISP grants and announcements databases, the total number of relevant postconference research initiatives increased for five of six CDCs when compared with baseline activity levels; research activities remained constant for the sixth. When inclusion criteria were restricted to institute-identified research initiatives, two of six CDC topics had overall increases in relevant research activity in the postconference period.

Conclusions: CDCs appear to have a positive impact on the stimulation of related NIH-funded research initiatives. Future outcomes evaluations using prospective data collection methods and more robust participation by sponsoring and cosponsoring institutes should strengthen the reliability of the association between new research initiatives on a given topic and their causal relationship to a given CDC.

Introduction: Genetic factors affecting warfarin maintenance dose have been well established, but patient acceptance is a necessary consideration for the successful clinical implementation of warfarin pharmacogenetic testing (WPGT). In this study, we aimed to determine the attitudes toward WPGT among Singaporean Chinese.

Methods: A total of 194 warfarin patients and 187 members of the public completed a structured survey on paper and the Internet, respectively. Attitudes were expressed as willingness to undergo WPGT (single item with 5-point response) and expectations and concerns about WPGT (two multi-item scales). Relationships between attitudes and socio-demographic and clinical variables were explored using Fisher's exact test, Student's t-test, one-way analysis of variance or Pearson's correlation.

Results: Majority of respondents were willing to or neutral about undergoing WPGT. Both patients and public had relatively high expectations (mean [SD]: 3.77 [0.63], and 3.97 [0.55], respectively) and moderately high concerns (mean [SD]: 3.30 [0.69] and 3.33 [0.68], respectively) about WPGT. Willingness to undergo WPGT was associated with gender, educational status, length of warfarin treatment, and number of chronic diseases among warfarin patients, and with history of adverse drug reactions and number of chronic diseases among the public. Higher expectation of WPGT was associated with higher willingness (p < .001 in both populations), while higher concern was associated with lower willingness to undergo WPGT among the public (p = .004) but not among patients (p = .072).

Conclusion: Patient acceptance is not a major barrier to clinical implementation of WPGT but patient education is necessary and the ethical, social, and legal issues should be addressed.

Objectives: This paper aims to describe the added value of combining cost-effectiveness and ethical evaluations when the preferences of the decision maker toward cost-effectiveness evaluation outcomes are not known, with the French national neonatal screening of cystic fibrosis (CF) as a case-study.

Methods: A cost-effectiveness analysis comparing four CF neonatal screening strategies, with or without DNA testing, was performed. Ethical positions toward their outcomes were described. In addition, a post-hoc analysis of the ethical issues being considered relevant from the decision-makers’ perspective was conducted.

Results: Two strategies were found equally cost-effective. Among them, choosing the non-DNA or a DNA-based strategy constrains the decision maker to render a judgement between different ethical issues or disagreements associated with the screening program.

Conclusions: The analysis supports the relevance of combining cost-effectiveness and ethics evaluation in developing health policy, as a way to reveal or clarify the motives associated with health. The choice of the decision maker to favor the DNA-based strategy, which was not originally recommended, creates the opportunity to make explicit the role played by ethical issues in the decision.

Objectives: The relatively high cost of information technology systems may be a barrier to hospitals thinking of adopting this technology. The experiences of early adopters may facilitate decision making for hospitals less able to risk their limited resources. This study identifies the costs to design, develop, implement, and operate an innovative informatics-based registry and disease management system (POPMAN) to manage type 2 diabetes in a primary care setting.

Methods: The various cost components of POPMAN were systematically identified and collected.

Results: POPMAN cost $450,000 to develop and operate over 3.5 years (1999–2003). Approximately $250,000 of these costs are one-time expenditures or sunk costs. Annual operating costs are expected to range from $90,000 to $110,000 translating to approximately $90 per patient for a 1,200 patient registry.

Conclusions: The cost of POPMAN is comparable to the costs of other quality-improving interventions for patients with diabetes. Modifications to POPMAN for adaptation to other chronic diseases or to interface with new electronic medical record systems will require additional investment but should not be as high as initial development costs. POPMAN provides a means of tracking progress against negotiated quality targets, allowing hospitals to negotiate pay for performance incentives with insurers that may exceed the annual operating cost of POPMAN. As a result, the quality of care of patients with diabetes through use of POPMAN could be improved at a minimal net cost to hospitals.

Objectives: The news media plays a central role in providing information regarding new medical technologies and exerts an influence on their social perception, understanding, and assessments. This study, therefore, analyzes how healthcare robotics are portrayed in the German print news media. It examines whether the risks and opportunities of new medical technologies are presented in a balanced manner and investigates whether or not print media coverage of these technologies is affected by science-fiction discourse, in which robots appear mostly as a threat to humans.

Methods: Ten years of German print media coverage (2000–2010) have been studied by means of systematic, standardized content analysis.

Results: Reporting focuses predominantly on beneficial advancements in medical practice and the advantages of robotics for patients, medical staff, and society. The results show that the dominant relationship between robots and humans that is transmitted in print media in medical contexts is positive, with robots mostly portrayed as assistants, colleagues, or even friends. Only a small number of articles report ethical questions and risks.

Conclusions: In contrast to science-fiction discourse, the German print media provides a positive picture of robotics to the lay public.

The history of the European cooperation on health technology assessment (HTA) has reached an important milestone with the adoption of the European HTA Regulation (HTA R) 2021/2282 in Dec 2021 (1). Its publication in the Official Journal of the European Union means a lot to those of us who wish to give HTA a stronger role in supporting health policy in favor of sustainable healthcare systems in Europe. The HTA R was prepared well by the European Commission with an impact assessment on policy options for enhanced EU cooperation on HTA (2) in 2017, followed by 3 years of negotiations with Member States. Now the ratified document stipulates that the European Cooperation on HTA will be based on a legal mandate and no longer stay a voluntary project-based initiative. It also means sustainability, since a permanent Secretariat at the European Commission will be set-up under the HTA R.

The unique task and contribution of health technology assessment (HTA) is to help identify those health technologies and their uses that are most likely to preserve and restore a population’s health in a way that is consonant with its values, including, for example, equity and access to high-quality care (1). Such a task is challenging for at least two reasons. First, because of the vast and constantly evolving number and diversity of health technologies and their applications. Second, because of the usual wide variety of competing views within communities and their stakeholders regarding what strategies are likely to be conducive to the goal of preserving and restoring population health. Although perhaps tempting, it would be a grave mistake to hold that the controversies that result from such competing views can be resolved by taking recourse to the facts only. For such controversies are usually fueled by different notions of health and disease and different specifications of values such as equity and individual and collective responsibility for health. For this reason, they cannot be resolved in a satisfactory way without also addressing those normative issues and their interplay with empirical analysis.*

Traditional and complementary medicines are increasingly considered possible options for prevention and symptomatic treatment of the novel coronavirus, COVID-19. With renewed attention on these therapies from researchers and policy makers alike, the well-documented challenges of evaluating their safety and efficacy are once again of global concern. Between 2005 and 2018, the World Health Organization conducted a series of surveys, in which 88 percent of responding member states confirmed that their biggest challenge in traditional medicine was the need for technical guidance on research and evaluation. As a first step in pursuing this need, our commentary summarizes thirteen international and regional guidance documents by three broad categories on evaluating safety, efficacy, and product quality for market-based approval and distribution of these treatments. We highlight the paucity of updated international recommendations on these subjects and identify gaps that could inform the current evidence base. All available guidance note the need for evidence surrounding the efficacy of these treatments and practices but are also quick to caution against methodological difficulties in the conduct of such evaluations. Evidence suggests that improved evaluation methods on efficacy and effectiveness are crucial toward expanding future research into establishing the cost-effectiveness of these therapies, in the context of shifting acceptance, interest, and integration of traditional medicines into health systems, and as another step toward Universal Health Coverage.

Objectives: The International Network of Agencies for Health Technology Assessment (INAHTA) has been tracking activities associated with the clinical use of positron emission tomography (PET) in its members' healthcare systems since 1997 and published its first Joint Project report on PET in 1999. Part 1 of this Joint Project report presents survey results on diffusion, assessment activities, and policy for clinical use related to PET among INAHTA members since 1999.

Methods: INAHTA members were surveyed in 2003–2004.

Results: Twenty-seven INAHTA agencies (69 percent response rate) from nineteen countries responded to the survey. Dedicated PET systems are the most universally installed systems to date. Mobile scanners and modified gamma cameras are used occasionally as lower cost alternatives, and interest in PET–computed tomography hybrid models is rising despite limited assessment of impact on service planning. PET was used and assessed most commonly for managing patients with cancer. All respondents reported having some form of public funding for clinical PET frequently linked to data collection for the purpose of gathering evidence to refine clinical use and guide resource allocation toward indications that maximize clinical and cost-effectiveness.

Conclusions: The use of HTA within a continuous quality improvement framework can help optimize scarce resources for evaluation and use of high cost diagnostic technologies such as PET, particularly where potential clinical or cost-effectiveness is considerable but conclusive evidence is lacking.

Objectives: The aim of this study is to describe and illustrate a method to obtain early estimates of the effectiveness of a new version of a medical device.

Methods: In the absence of empirical data, expert opinion may be elicited on the expected difference between the conventional and modified devices. Bayesian Mixed Treatment Comparison (MTC) meta-analysis can then be used to combine this expert opinion with existing trial data on earlier versions of the device. We illustrate this approach for a new four-pole implantable cardioverter defibrillator (ICD) compared with conventional ICDs, Class III anti-arrhythmic drugs, and conventional drug therapy for the prevention of sudden cardiac death in high risk patients. Existing RCTs were identified from a published systematic review, and we elicited opinion on the difference between four-pole and conventional ICDs from experts recruited at a cardiology conference.

Results: Twelve randomized controlled trials were identified. Seven experts provided valid probability distributions for the new ICDs compared with current devices. The MTC model resulted in estimated relative risks of mortality of 0.74 (0.60–0.89) (predictive relative risk [RR] = 0.77 [0.41–1.26]) and 0.83 (0.70–0.97) (predictive RR = 0.84 [0.55–1.22]) with the new ICD therapy compared to Class III anti-arrhythmic drug therapy and conventional drug therapy, respectively. These results showed negligible differences from the preliminary results for the existing ICDs.

Conclusions: The proposed method incorporating expert opinion to adjust for a modification made to an existing device may play a useful role in assisting decision makers to make early informed judgments on the effectiveness of frequently modified healthcare technologies.

Objectives: No guidelines exist in the approach that Evidence Review Groups (ERGs) should take to appraise search methodologies in the manufacturer's submission (MS) in Single Technology Appraisals (STA). As a result, ERGs are left to appraise searches using their own approach. This study investigates the limitations of manufacturers' search methodologies as critiqued by ERGs in published STA reports and to provide a recommended checklist.

Methods: Limitations from search critiques in 83 ERG reports published in the NIHR Web site between 2006 and May 2011 were extracted. The limitations were grouped into themes. Comparisons were made between limitations reported in the clinical effectiveness versus cost-effectiveness searches.

Results: Twelve themes were identified, six relating to the search strategy, source, limits, filters, translation, reporting, and missing studies. The search strategy theme contained the most limitations. Missing studies were frequently found by the ERG group in the clinical effectiveness searches. The omission of searches by manufacturers for unpublished and ongoing trials was frequently reported by the ERG. By contrast, failure of the manufacturer to report strategies was the most common limitation in the cost-effectiveness searches. Themes with the most frequent limitations in both types of searches are search strategy, reporting and source.

Conclusions: It is recommended that a checklist that has reporting, source and search strategy elements be used in the appraisal of manufacturer's searches during the STA process.

Objectives: This study reports on the Brazilian experience of developing a specialized bulletin, the Brazilian Health Technology Assessment Bulletin (BRATS), on health technology assessments (HTA).

Methods: The editorial process, format, and dissemination strategy of the publication are presented. A critical appraisal of the available issues was made using the checklist for HTA reports of the International Network of Agencies for Health Technology Assessment. The initial impact was estimated based on a retrospective observational measurement of the types of publications that cite the bulletin as a source of information. The publications citing BRATS were identified using Google Scholar.

Results: Since June 2008, fourteen issues of the bulletin have been produced. BRATS has not presented any significant limitation that would compromise generalizations of its results within the Brazilian context. The initial impact of the bulletin, however, has been small, which may be due to its exclusively electronic dissemination format and technical language. We found nine publications citing BRATS in Google Scholar.

Conclusions: It is hoped that the bulletin will promote the continuity of HTA actions among health-sector managers and professionals in Brazil.