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.

In a national survey of medical directors at 231 U.S. private health care plans that cover over two thirds of the privately insured population, we studied whether medical directors are aware when a new technology, such as laser therapy, is being used in procedures for which claims are submitted, the factors alerting them to such use, and the factors prompting them to make a specific coverage decision for the technology. We also examined possible associations between health plans' characteristics (HMO versus indemnity, size, profit status, and time in operation) and their medical directors' awareness of the use of technologies, factors alerting medical directors to their use, and factors prompting specific coverage decisions. The majority of plans were generally not aware that laser technology was being used when it was billed under a general billing code, raising the possibility that less effective or less safe technologies could be introduced rapidly into the treatment of insured populations. Nonprofit and older plans were less likely to be aware that lasers were used in some procedures than for-profit and younger plans.

A cost-effectiveness study compared visual laser ablation of the prostate (VLAP) with transurethral resection (TURP). Achieving equivalent outcomes, VLAP was more expensive than TURP. The result was sensitive to various assumptions, suggesting that VLAP might prove to be the preferred technology. Problems inherent in economic evaluation of emerging technologies are discussed.

The Children's Vaccine Initiative (CVI) will result in profound changes in immunization practice. Before the CVI is fully developed, it will present numerous challenges to regulatory practice that will require new applications of existing ideas and innovative solutions to practical issues, especially in combining existing vaccines.

The practice of medicine is intrinsically a cooperative activity, involving not only a number of individuals but requiring access to a wide variety of types of data, produced and maintained by different people. Achieving seamless, integrated access to these data requires a new infrastructure of information systems that supports the construction of applications designed to incorporate and use external information resources. The term groupware may be used to connote this collective set of information resources and tools for access to them. Groupware will generate a variety of new kinds of products and services with implications for medical libraries, electronic publishing, and academic and professional collaboration.

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.*

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.

This paper presents data on the diffusion to dentists of information from the May 1981 American Dental Association conference and December 1983 National Institutes of Health (NIH) conference on pit and fissure sealants. A mail survey was sent to 521 (72.2¼ returned) randomly selected dentists in general practice and all 47 (76.6¼ returned) pedodontists in the State of Washington. Approximately 70¼ of the dentists were aware that the conferences had taken place and a little over 50¼ were aware of the conference recommendations. Awareness was related to: being a pedodontist, number of continuing education hours taken, number of refereed journals read, and being an officer in a dental organization

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.

Abstract Despite the quantity of material on medical issues which journalists typically receive, and the tremendous public interest in health news, journalists are only rarely able to provide medical information of any real value to the public. Good news, no matter how tentative, always gets more attention than critical assessment. Deadlines pressure journalists to look only at the surface of the issues that they describe, and few have the expertise necessary to judge the importance of their stories. When accurate, authoritative information is available in a structured format; however, the news media can publicize medical findings rapidly, effecting significant changes in public behavior.

Policy makers, health care providers, and the general public need valid information about the benefits and harmful effects of drugs and technologies to be able to make rational choices in their acquisition, distribution, and use. Effective communication is important for quality choices of drugs and other technologies. In effective communication, the choice of messages and media must correspond to the culture and beliefs of the target groups to make them comprehend and adopt the conclusions. Messages must be presented on a regular basis. Most regulatory agencies do not have enough resources to mount effective communication programs. Private advertising agencies and other stakeholders have definite roles. Valid knowledge must be the basis of dialogues to reduce emotional disputes among various benefit groups in society.

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.