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 The omission of searches by manufacturers for unpublished and ongoing trials was frequently reported by the ERG.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.

The various treatments for periodontal disease must be assessed in light of the recently articulated goals of periodontal therapy to preserve teeth for a lifetime and to enhance esthetics and comfort as well as oral health. This article examines the long-term comparisons of periodontal surgery, curettage, and scaling and root planing in improving attachment levels instead of the more traditional pocket depth.

Health technologies are becoming increasingly complex and contemporary health technology assessment (HTA) is only partly equipped to address this complexity. The project “Integrated assessments of complex health technologies” (INTEGRATE-HTA), funded by the European Commission, was initiated with the overall objective to develop concepts and methods to enable patient-centered, integrated assessments of the effectiveness, and the economic, social, cultural, and ethical issues of complex technologies that take context and implementation issues into account. The project resulted in a series of guidances that should support the work of HTA scientists and decision makers alike.

Objectives: Obstructive sleep apnea is a common disorder with significant morbidity and effects on quality of life. Management can include a range of mechanical, behavioral, and surgical approaches. This paper aims to devise a model of management options to assist in initial cost-effectiveness investigations.

Methods: In the absence of practice pattern data and widely accepted guidelines, we reviewed published literature and devised a model of treatment options to facilitate initial studies of outcomes, costs, and cost-effectiveness.

Results: Obstructive sleep apnea is rarely addressed by conservative behavioral-based strategies because these options, while inexpensive, have only limited effectiveness. Effective treatment most often relies on nasal continuous positive airway pressure, but poor tolerance or compliance sometimes leads to treatment with oral appliances or surgery. Patients treated by one modality may try another if the initial strategy is ineffective. Laboratory evidence that sleep apnea is effectively treated, and long-term follow-up, are necessary regardless of the treatment modality chosen.

Conclusions: Each patient's treatment plan must be individually tailored, but the management model proposed here reflects available evidence-based literature and the authors' impression of current practice patterns. This model should be useful for initial cost-effectiveness investigations.

A central idea underlying the INTEGRATE-HTA project is that many of the interventions that are being used in health care are quite complex. By this, we mean that the relation between the delivery of the intervention on the one hand, and the onset of (desired and undesired) changes may be less straightforward than hoped for. There may be all sorts of reasons for this, varying from a lack of resources, lack of skills, perverse incentives, organizational problems, etc. Not identifying such factors and their potential impact may seriously compromise the policy relevance of a health technology assessment (HTA) (1). However, current approaches and methods in HTA do not seem to be adequately geared to deal with this complexity.

In the last decade, the incidence of mortality caused by malignant disease has risen. Cancer related deaths are more frequent than those caused by infections or accidents, exceeded only by heart and vascular diseases. In most cases, it is not the primary tumor that kills patients, but its metastatic spread: metastases have a fatal outcome more than 90% of cases (1). By the time metastases have occurred, cure is rarely obtained through surgical procedures. Local radiotherapy to distant metastases is also rarely successful in the treatment of disseminated malignancies. Most patients with metastatic disease need a palliative systemic treatment, which means cytotoxic cancer chemotherapy. Its objective is to destroy cancer cells. Systemic chemotherapy has become standard in the last decades for most disseminated malignancies (1).

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.

Objective: To review the assessment and implementation of three screening methods: mammography for breast cancer, screening for prostate cancer, and routine use of ultrasound in pregnancy.

Methods: To review policy documents and published papers dealing with prevention and screening in the Netherlands, focusing on the three screening methods specified.

Results: The results indicate that the Netherlands has an active establishment devoted to health technology assessment (HTA). The Netherlands government has also made prevention a high priority in the health services system. Within prevention policy, HTA is given an important place. The general policy is that prevention programs should meet high standards of effectiveness and efficiency, as well as ethical, legal, and social acceptability. In addition, the Netherlands may be unique in the world in having a specific law requiring that proposals for population screening must be carefully assessed before they are implemented.

Conclusions: The three cases examined in this paper have all been assessed, and the conclusions are similar to those presented in the synthesis published in this issue (33). In the case of mammography, the assessment was followed by a rational implementation of a national screening program for breast cancer. In the other two cases, however, despite negative conclusions from assessment, the tests are frequently carried out, especially in what has been termed opportunistic screening. Prostate cancer screening seems to be spreading rapidly. Use of ultrasound in pregnancy is frequent, not necessarily for medical reasons but because parents wish to have a picture of their fetus. The conclusion is that HTA is well established in the Netherlands, as illustrated in these three cases, and policy is based on the assessments done. However, practice is not in accord with the assessment in the cases of prostate cancer and routine ultrasound. Policies to deal effectively with opportunistic screening are difficult to imagine.

Healthcare innovations often represent important improvements in population welfare, but at what cost, and to whom? Health technology assessment (HTA) is a multidisciplinary process to inform resource allocation. HTA is conventionally anchored on health maximization as the only relevant output of health services. If we accept the proposition that health technologies can generate value outside the healthcare system, resource allocation decisions could be suboptimal from a societal perspective. Incorporating “broader value” in HTA as derived from social values and patient experience could provide a richer evaluative space for informing resource allocation decisions. This article considers how HTA is practiced and what its current context implies for adopting “broader value” to evaluating health technologies. Methodological challenges are highlighted, as is a future research agenda. Ireland serves as an example of a healthcare system that both has an explicit role for HTA and is evolving under a current program of reform to offer universal, single-tier access to public services. There are various ways in which HTA processes could move beyond health, including considering the processes of care delivery and/or expanding the evaluative space to some broader concept of well-being. Methods to facilitate the latter exist, but their adaptation to HTA is still emerging. We recommend a multi-stakeholder working group to develop and advance an international agenda for HTA that captures welfare/benefit beyond health.

Objectives: As health technology assessments (HTA) may have considerable impact on health-care decisions, it is essential to guarantee the expected quality of these assessments. Variations in the methods used or lack of transparency can affect the important role of HTA reports.

Methods: In our study, we analyzed the methods used in two corresponding HTA reports to assess the validity of two key papers, which were included in both reports. Also the discussions and the final conclusions of both reports were compared.

Results: The authors of the two HTA reports used different instruments to assess the validity of the original studies. A minor problem is differences that were found in the assessments of identical validity aspects of the included studies and in the information provided in the HTA reports. A more serious problem was found in both HTA reports which identified the weakness of the key papers and expressed these limitations in the discussions (read mainly by scientists) but not in the conclusions (read mainly by policy-makers).

Conclusions: The results of this study may be important for any institution that prepares recommendations for policy-makers. In the case of HTA reports, no new checklists are necessary as the checklist offered by the INAHTA contains the needed information. It may be necessary, however, to consider an “intramural quality board,” which helps the member organizations guarantee both the transparency of the original studies included in HTA reports and the transparency of the HTA report itself.

The study's purpose was to estimate the potential economic benefit of the optimization of postanesthesia care units (PACUs). A simulation model was designed and used to test the economic impact of a reduction of length of stay. For the studied PACU, a reduction of 25% of length of stay is required to yield significant economic results.

This article studies the issues surrounding the assessment of several home diagnostic tests. First, the authors review the current data and proper use of fecal occult blood and pregnancy tests. Second, they evaluate the roles of blood and urine glucose monitoring in the management of diabetes mellitus and home pressure monitoring in the management of hypertension. The authors conclude that while home measurement of blood pressure or blood sugar can be recommended to improve compliance with medical programs, home fecal occult blood testing, while helpful, has not been fully investigated.

Objectives: This study assesses the use of routinely collected claims data for managed entry agreements (MEA) in the illustrative context of German statutory health insurance (SHI) funds.

Methods: Based on a nonsystematic literature review, the data needs of different MEA were identified. A value-based typology to classify MEA on the basis of these data needs was developed. The typology is oriented toward health outcomes and utilization and costs, key components of a new technology's value. For each MEA type, the suitability of claims data in establishing evidence of the novel technology's value in routine care was systematically assessed. Assessment criteria were data availability, completeness, timeliness, confidentiality, reliability, and validity.

Results: Claims data are better suited to MEA addressing uncertainty regarding the utilization and costs of a novel technology in routine care. In schemes where safety aspects or clinical effectiveness are assessed, the role of claims data is limited because clinical information is not included in sufficient detail.

Conclusions: The suitability of claims data depends on the source of uncertainty and, in consequence, the outcome measures chosen in the agreements. In all schemes, the validity of claims data should be judged with caution as data are collected for billing purposes. This framework may support manufacturers and payers in selecting the most suitable contract type and agreeing on contract conditions. More research is necessary to validate these results and to address remaining medical, economic, legal, and ethical questions of using claims data for MEA.

Abstract The diagnostic process is likely to be limited by one or more of the following factors: (a) ambiguous signal definition, (b) inappropriate data sampling strategy, (c) inadequate signal strength, and (d) misinterpretation of data. Controlled tests suggest that the first two factors largely control performances of common dental diagnostic tasks.

Universities, especially those with medical schools whose academics engage in clinical research, have a vital role in shaping the way in which medical technology is used. Academic clinicians are a bridge between laboratory research, where new technologies are developed, and clinical practice, where these technologies are applied in treating patients. Academic clinicians are particularly suited to doing clinical assessment of medical technologies, and academic clinical departments should devote more time to the assessment and application of technology on a broad scale.

All of the panelists who participated in this conference and contributed to the writing of this statement were identified as having no financial or scientific conflict of interest, and all signed forms attesting to this fact. Unlike the expert speakers who present scientific data at the conference, the individuals invited to participate on the consensus panel are reviewed prior to selection to ensure they are not proponents of an advocacy position with regard to the topic.

The Orphan Drug Act of 1983, along with the discovery of a new use for a known drug and an investor willing to assume the necessary risk, brought about the formation of a start-up pharmaceutical company. The primary incentive of the Orphan Drug Act of seven years of marketing exclusivity provided the protection from competition necessary for recovery of the significant research and development and marketing costs. The orphan product, MetroGel®, for the treatment of rosacea, required approximately five years of development before it was approved for marketing by the Food and Drug Administration. MetroGel® has become the number one drug in the United States for the treatment of rosacea. It currently is marketed in other countries through a licensing agreement with a major pharmaceutical company.