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.

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.

This article begins by sketching out the constitutional arrangements in Italy for the distribution of powers among different levels of government. The more important characteristics of the health system are then examined in some detail, the aim being to provide a sufficient basis for understanding the analysis of technology policy which follows later. The mechanisms used for funding medical technology are next described, after which data available on the diffusion of medical equipment are illustrated. Medical technology policies at the national and regional level are examined and an attempt made to appraise their effectiveness. The article concludes with a brief analysis of the possible role played by private medicine in the diffusion of medical technology in ltaly.

In Japan, preventive health services have been heavily concentrated in mass screening. This prioritization is also true in the field of school health. Annual mass health screenings have been provided to 21.3 million children from kindergarten to university level under the School Health Law. In 1973, periodic health examinations were extended to include screenings for renal and heart diseases. This extensive screening program has been introduced without any evidence supporting its effectiveness. Although available data relative to these screenings in Japan were examined, neither the efficacy of the tests nor the effectiveness of the screenings were observed. Moreover, costs for the tests during the initial phase amounted to US $120 million and $65 million, respectively.

The majority of the 26 technology assessment articles from the Coronary Artery Surgery Study (CASS) follow the original purpose of the registry and evaluate the therapeutic capabilities of coronary artery bypass graft surgery. However, these registry data have also been used to identify risk factors for cardiovascular disease, to test diagnostic technologies, and to evaluate technological processes. Consideration of quality of life issues and the availability of cost data provide valuable additions to the continued use of the CASS for technology assessment.

Public health care systems in countries all over the world are confronted with increasing difficulties. The problems are mainly economic, but they also reflect difficulties of adaptation to changes both in society as a whole and within the health care services.

The atmosphere of a crisis results from internal struggles within the health care system and with other welfare and social services that face economical difficulties, while confronting accelerated demographical, social, technological, and cultural changes.

The situation is more acute because of the inability of modern society to provide the public health care system with resources (human and financial) according to the expectations that have developed in the welfare state since the end of World War II.

New welfare policy, adjusted to the changes that occur within the society, is needed. In this struggle, the public health services find themselves in the center of the discussion as one of the whole of public social services and in competition with other public welfare systems.

Economical and organizational problems are the most acute and attract a great deal of interest, and they are amply discussed in many articles and conferences. I shall not deal with them in this article.

The authors of the paper argue that Norway's national health service, despite public perceptions, is both inexpensive and technologically advanced. Norway has a highly regulated medical system at both the national and local levels, and many distribution issues take the form of political debate. As a result, the authors believe that medical care and equipment is equitably distributed, but perhaps over-densely, throughout the country. Although the overall picture is optimistic, there is some concern that technologies, health care priorities, and decision-making processes should be more carefully examined by consensus conferences, advisory groups, and experts in technology assessment.

Many of the practices carried out during antenatal care improve the well-being of mother or baby and reduce the burden of adverse perinatal outcome. Other practices have either not been evaluated or have been shown to be ineffective. Evidence from randomized clinical trials provides the best evidence about the effectiveness of these practices.

This article surveys the gradual diffusion of diagnostic technologies into homes in Sweden. The author speculates on the advantages and prospective problems of home care. In addition, the article proposes some general guides to assure that new technologies provide genuine benefits for the patient.

A search of literature using the Connecticut Tumor Registry (CTR) for technology assessment produced eight articles. These articles represent a small but apparently increasing percentage (2%) of total CTR publications. By keeping pace with the development and dissemination of medical technologies, the population-based CTR has been useful for assessing them, especially their adverse effects.

The contrasting cycles of changing caries prevalence in developing and industrialized countries are described, as they relate to differing needs in technology. Using this contrast as a background, the selective needs for technology in measurement, adequate quality of treatment and materials, appropriate personnel, and simplicity and mobility in equipment are discussed.

Objectives: Clinical research data are often collected on paper and later inputted onto an electronic database. This method is time consuming and potentially introduces errors. Therefore, to make primary data collection more efficient and less error prone we aimed to develop a touch-screen application for data collection in a psoriatic arthritis research clinic and compared it with the pre-existing paper-based system.

Methods: We developed a Web application using Java and optimized it for the iPad®. It highlights missing fields for physicians in real time, and only permits submission of data collection form after corrections are made. For its evaluation, seven physicians participated, and before each patient visit they were randomly assigned paper or iPad® data entry. Number of errors, length of visit, and time between clinic visit and completion of data entry were measured.

Results: A total of 106 patients seen in the clinic who agreed to participate were randomly assigned to be evaluated by clinic physicians using the iPad® (fifty-three patients) or a paper protocol (fifty-three patients). On average, 3.34 omissions were found per paper form, of which 2.24 would have been detected on the iPad®. The iPad® increased the mean patient encounter time from 37.2 minutes to 46.5 minutes, but eliminated delay between a clinic visit and its data entry.

Conclusions: Entering data using the iPad® application makes the patient encounter slightly longer, but reduces “missing fields.” It also eliminates the delay between clinic visit and data entry thus improving the efficiency of clinical data capture in a research setting.

Fostering innovation for societal gain has been a core attribute of technology assessment (TA) since its inception. Although many observers were concerned that TA would be a means by which government would impede the development and use of technology, this was not the intent of policy makers or the agencies that conducted the original TAs.

Objectives: Conducting economic evaluation in the context of clinical studies is common but has been the subject of extensive discussion due to its limitations. Various standard approaches and guidelines how such studies should be conducted have been proposed, but there is very limited information available about how common these studies are, what type of data that is collected, and how the quality of the protocols compares to the suggested standards. This study examines the prevalence and study design of health economic evaluations conducted alongside clinical trials in Sweden between 1995 and 2005.

Methods: A systematic assessment of clinical trial protocols that had arrived as applications to the Medical Products Agency between 1995 and 2005 was performed. Only protocols arriving during the first half of odd years within the time period were included.

Results: A total number of 680 protocols from 1995 to 2005 were examined, and among them, 14.4 percent included a health economic part. With the exception of year 2001, a trend toward an increased prevalence of economic evaluations next to clinical trials can be seen.

Conclusions: This study shows that economic evaluations alongside clinical trials are becoming more common, although most trials still lack a health economic part of the protocol. The information about the economic evaluation provided in the protocols is in many cases scarce, possibly due to the fact that there currently are no generally accepted and applied guidelines for economic evaluations in clinical trial protocols. Introducing requirements for detailed study plans also for the economic evaluation should improve the quality of economic evaluations alongside clinical trials.