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.

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.

Background: This article describes the lessons learned from an international pilot assessment using the first version of the HTA Core Model® and Guidelines for rapid Relative Effectiveness Assessment (REA) of pharmaceuticals based on input from three different perspectives: the assessors, the users (health technology assessment organisations) and the marketing authorisation holder.

Methods: A pilot assessment was performed of pazopanib for the treatment of advanced or metastatic renal cell carcinoma for which 54 individuals from 22 EUnetHTA member organisations from 16 European countries gave their contribution. The work was divided in eight domain teams. Subsequently, results of these domain teams were synthesised in one pilot report. Feedback on the outcomes of the pilot was gathered throughout the project and through structured surveys.

Results: The first version of the assessment was produced in six months and consisted of 55 question and answer pairs, 8 domain reports and a synthesis section that combined the results from the different domains. The organisation of the pilot required intense coordination. Main points of criticism on the assessment were the lengthiness of the document and overlap of information throughout the assessment.

Conclusions: A reduction in the number of authoring organisations and individuals participating is necessary to avoid information overlap and increase efficiency in undertaking the assessment. Involving several organisations (e.g. five) in an in-depth review could still ensure the benefit of broad participation from various countries. The focus of a rapid REA should be on the first four domains of the Model.

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.

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.

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: The aim of this study was to describe the techniques used in achieving consensus on common standards to be implemented in the EUnetHTA Information Management System (IMS); and to describe how interoperability between tools was explored.

Methods: Three face to face meetings were organized to identify and agree on common standards to the development of online tools. Two tools were created to demonstrate the added value of implementing interoperability standards at local levels. Developers of tools outside EUnetHTA were identified and contacted.

Results: Four common standards have been agreed on by consensus; and consequently all EUnetHTA tools have been modified or designed accordingly. RDF Site Summary (RSS) has demonstrated a good potential to support rapid dissemination of HTA information. Contacts outside EUnetHTA resulted in direct collaboration (HTA glossary, HTAi Vortal), evaluation of options for interoperability between tools (CRD HTA database) or a formal framework to prepare cooperation on concrete projects (INAHTA projects database).

Conclusions: While being entitled a project on IT infrastructure, the work program was also about people. When having to agree on complex topics, fostering a cohesive group dynamic and hosting face to face meetings brings added value and enhances understanding between partners. The adoption of widespread standards enhanced the homogeneity of the EUnetHTA tools and should thus contribute to their wider use, therefore, to the general objective of EUnetHTA. The initiatives on interoperability of systems need to be developed further to support a general interoperable information system that could benefit the whole HTA community.

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.

Objective: An economic evaluation of the resources used for mechanically ventilated patients using various measures for the benefits of extending life.

Methods: Regression analysis is applied to New York State discharge data for patients under DRG 475 during 1992–96 to predict age-specific survival rates and payments per life saved. Sensitivity analysis is used to compare benefits of extending life associated with different economic values of life with the payments per life saved at each age.

Results: Payments per life saved decreased over time, primarily due to reduced reimbursements. Payments exceeded the age-adjusted and the quality-of-life and age-adjusted benefits for all economic values of life at ages 90 and older.

Conclusions: Since the benefits of extending life associated with DRG 475 exceed the payments per life saved at most ages, economic evaluations may be best applied with psychosocial evaluations to allocate resources more ethically.

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.

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.

We analyze Argentina's demographic and socioeconomic data as the context for understanding its health sector. Health expenditures and the number of physicians are high in Argentina. Health coverage is extensive, but covers only about 50% of the per capita expenditures. The high expenditures in health do not correlate with improvements of indicators such as infant and general mortality. Evaluations of the way health care is provided are insufficient. Argentina's “medical-intensive” model of health is responsible for the expansion of the “small-ticket technology”, which accounts for a significant proportion of the increase in health expenditures. With this picture, we believe that health decision-makers could benefit from cost-effectiveness analysis (CEA), because this technique stresses the relationship between expenditures and appropriately defined goals. As a demonstration project, we look at the way that technology is used in Argentina using CEA to assess anesthesia procedures. The results of our study show that increasing the use of N2O would save us $670,000 per year, and 10,300 years of life to surgical patients of all ages.

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.

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.

The improved survival rate of premature infants with respiratory failure is attributable to advances in mechanical ventilation, although an adverse consequence has been an increased incidence of bronchopulmonary dysplasia (BPD) (1;32). Positive pressure ventilation with its attendant “barotrauma” is suspected in the causation of BPD. While many attempts to alter respirator variables, such as pressure and time components, have produced optimal patterns for gas exchange, evidence is lacking to support any one pattern that minimizes the incidence of chronic lung injury. The high incidence of BPD has promoted a search for alternative methods of ventilation that might reduce lung injury through a reduction in peak pressure applied to the lung. Additional motivation has come from the need for oxygenation when mechanical ventilation has failed or pulmonary interstitial emphysema has developed. Less compelling reasons have come from the desire to avoid high swings in thoracic pressure that might adversely affect cardiac output, venous return, and cerebral blood flow.

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.

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).