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.

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.

The double burden of communicable and noncommunicable diseases is a major threat to the Indian public health system. AYUSH, an acronym for Ayurveda, Yoga and Naturopathy, Unani, Siddha, Sowa-Rigpa, and Homeopathy, represents the Indian system of medicine recognized by the Government of India. Mainstreaming of AYUSH is one of the key strategies of the Indian government for tackling increasing disease burden through initiatives such as AYUSH wellness centers, telemedicine, and quality control measures for medications in the AYUSH system of medicine. Such investment of resources in health systems may require economic evaluations. However, such evaluations are lacking in the AYUSH system, except for a few in homeopathy and yoga. In the absence of evidence from economic evaluations, researchers and decision makers are guided mostly by clinical efficacy while formulating healthcare strategies. In view of the increasing use of AYUSH across the country, economic evaluations of the AYUSH system are the need of the hour to aid healthcare decision making.

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.

Objectives: In economic evaluations of healthcare technologies, situations arise where data are not randomized and numbers are small. For this reason, obtaining reliable cost estimates of such interventions may be difficult. This study explores two approaches in obtaining cost estimates for pregnant women screened for a fetal cardiac anomaly.

Methods: Two methods to reduce selection bias in health care: regression analyses and propensity scoring methods were applied to the total mean costs of pregnancy for women who received specialist cardiac advice by means of two referral modes: telemedicine and direct referral.

Results: The observed total mean costs of pregnancy were higher for the telemedicine group than the direct referral group (4,918 versus 4,311 GBP). The regression model found that referral mode was not a significant predictor of costs and the cost difference between the two groups was reduced from 607 to 94 GBP. After applying the various propensity score methods, the groups were balanced in terms of sizes and compositions; and again the cost differences between the two groups were smaller ranging from -62 (matching “by hand”) to 333 GBP (kernel matching).

Conclusions: Regression analyses and propensity scoring methods applied to the dataset may have increased the homogeneity and reduced the variance in the adjusted costs; that is, these methods have allowed the observed selection bias to be reduced. I believe that propensity scoring methods worked better for this dataset, because after matching the two groups were similar in terms of background characteristics and the adjusted cost differences were smaller.

Luxembourg's public health insurance is a compulsory insurance for all employees, self-employed professionals, farmers, and pensioners. It is financed through contributions of the insured people, as well as by state taxes. Providers of health care are mainly private nonprofit institutions and self-employed professionals. All healthcare procedures are defined in fee schedules determined by a common decision of the Ministers of Social Security and Health according to proposals of a board of experts. The relative value of a service is also determined by the corresponding fee schedule. Hospitals are financed by individual budgets negotiated between each hospital and the health insurance. These hospital budgets do not cover services provided in hospitals by medical specialists, who are reimbursed on a fee-for-service basis. A law on hospital planning and organization allows the government to restrict the installation in hospitals of very expensive equipment or of equipment for which there is only a limited need in Luxembourg hospitals. Until recently there has been limited interest in or use of health technology assessment (HTA). However, large hospital investments have provoked some interest in the last few years. The Ministry of Health has asked for some HTA studies when a concrete decision had to be taken. Luxembourg decision makers have become more aware that HTA may help them to become more informed about the short- and long-term consequences of the application of health technology.

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.

In the article entitled “Rapid reviews versus full systematic reviews: An inventory of current methods and practice in health technology assessment,” by Watt et al. in volume 24 number 2 (Spring 2008) of International Journal of Technology Assessment in Health Care, the affiliation of Stephen Blamey is incorrectly listed as Department of Health & Ageing. Dr. Blamey is the current Chair of the Medical Services Advisory Committee (MSAC). MSAC is an independent scientific committee comprising individuals with expertise in clinical medicine, health economics, and consumer matters. The Department of Health & Ageing administers funding and operations for MSAC. However, members of MSAC act independently of the Department. As Chair of MSAC, Dr. Blamey can be contacted through the Department. Dr. Blamey is not affiliated with the Department of Health and Ageing and his contribution to the above-mentioned article does not reflect its policy. Dr. Blamey wishes to apologize for this misunderstanding.

As strong advocates and adopters of early cost-effectiveness modeling for test evaluation, we were excited to see the recent article “The Early Bird Catches the Worm: Early Cost-Effectiveness Analysis of New Medical Tests,” in which Buisman and colleagues present a succinct and generalizable framework for conducting this type of analysis. The authors have done an excellent job in identifying and summarizing the key components of this methodology, as well as highlighting fundamental differences between early analyses versus the traditional late-stage approach. As the number of medical tests coming to market continues to grow, there is an ever growing need to develop rigorous methodology in this area, and we commend the authors for this timely work.

Background: The number of new medical devices for individual use that are launched annually exceeds the assessment capacity of the French national health technology assessment (HTA) agency. This has resulted in hospitals, and particularly university hospitals (UHs), developing hospital-based HTA initiatives to support their decisions for purchasing innovative devices. However, the methodologies used in such hospitals have no common basis. The aim of this study was to assess a mini-HTA model as a potential solution to harmonize HTA methodology in French UHs.

Methods: A systematic review was conducted on Medline, Embase, Health Technology Assessment database, and Google Scholar to identify published articles reporting the use of mini-HTA tools and decision support-like models. A survey was also carried out in eighteen French UHs to identify in-house decision support tools. Finally, topics evaluated in the Danish mini-HTA model and in French UHs were compared using Jaccard similarity coefficients.

Results: Our findings showed differences between topics evaluated in French UHs and those assessed in decision support models from the literature. Only five topics among the thirteen most evaluated in French UHs were similar to those assessed in the Danish mini-HTA model. The organizational and ethical/social impacts were rarely explored among the surveyed models used in French UHs when introducing new medical devices.

Conclusions: Before its widespread and harmonized use in French UHs, the mini-HTA model would first require adaptations to the French context.

The Belgian healthcare system has a Bismarck-type compulsory health insurance, covering almost the entire population, combined with private provision of care. Providers are public health services, independent pharmacists, independent ambulatory care professionals, and hospitals and geriatric care facilities. Healthcare responsibilities are shared between the national Ministries of Public Health and Social Affairs, and the Dutch-, French-, and German-speaking Community Ministries of Health. The national ministries are responsible for sickness and disability insurance, financing, determination of accreditation criteria for hospitals and heavy medical care units, and construction of new hospitals. The six sickness and disability insurance funds are responsible for reimbursing health service benefits and paying disability benefits. The system's strength is that care is highly accessible and responsive to patients. However, the healthcare system's size remained relatively uncontrolled until recently, there is an excess supply of certain types of care, and there is a large number of small hospitals. The national government created a legal framework to modernize the insurance system to control budgetary deficits. Measures for reducing healthcare expenditures include regulating healthcare supply, healthcare evaluation, medical practice organization, and hospital budgets. The need to control healthcare facilities and quality of care in hospitals led to formal procedures for opening hospitals, acquiring expensive medical equipment, and developing highly specialized services. Reforms in payment and regulation are being considered. Health technology assessment (HTA) has played little part in the reforms so far. Belgium has no formal national program for HTA. The future of HTA in Belgium depends on a changing perception by providers and policy makers that health care needs a stronger scientific base.

Objectives: This study aims to describe how a negative reimbursement decision—based on the health technology assessment (HTA) report of a nondrug intervention—affects healthcare providers in Germany.

Methods: Knee arthroscopy was chosen as an example, because as of April 2016 this procedure is no longer reimbursed for osteoarthritis, but is still covered for other indications, including meniscal lesions. The exclusion followed an HTA report prepared by the Institute for Quality and Efficiency in Health Care (IQWiG). Here, we examine how the decision to revoke reimbursement for arthroscopy was perceived by the surgical community. Information was collected from official hospital statistics, the internet, and informal interviews with orthopedic surgeons.

Results: In 2015, a total of 37,920 arthroscopic procedures were performed for knee osteoarthritis in Germany. Several surgical societies were unhappy with the negative decision, which was issued as a directive in November 2015, and they challenged the decision-making process as well as the underlying scientific evidence. In March 2016, fifteen societies issued joint recommendations on how to differentiate osteoarthritis from other knee diseases and how to document other diseases in a way that inspections by representatives of health insurance funds would not detect any deficiencies. In informal interviews, orthopedic surgeons indicated that miscoding of the principal diagnosis (meniscal tear rather than knee osteoarthritis) is to be expected, especially in the hospital sector.

Conclusions: HTA can have a significant impact on the provision of health services, but various loopholes allow physicians to undermine policy decisions. Therefore, it is important to involve all stakeholders in HTA and to convince them of the benefits of evidence-based medicine.

In their article “Assessment of MAST in European Patient-Centered Telemedicine Pilots” published in this journal (1), Anne Granstrøm Ekeland and Astrid Grøttland describe the results from a questionnaire study of how MAST (Model for Assessment of Telemedicine) (2) was used and perceived by the project managers in twenty-one studies of telemedicine in the European project RENEWING HEALTH.

In Brazil, there is no consensus on the concept of hospital-based health technology assessment (HB-HTA). There is great variability in the existing models and difficulty in evaluating their results—whether in respect of clinical decisions, quality of care, and hospital policy and management or in respect of optimizing the use of resources. This study aims to discuss the experiences of HB-HTA, its integration into the regulatory system for the adoption of new technologies into the Brazilian public (SUS) (Unified Health System), and its main challenges. During a workshop, a panel of specialists in HTA and/or HB-HTA was formed, representative of four different perspectives: (i) Health services and health technology assessment units, (ii) Academia, (iii) Secretary of State for Health, and (iv) the Federal SUS sector. This was followed by discussion, a preliminary consensus, contributions from the audience, a plenary session, and a final consensus. HB-HTA is not institutionalized, nor is it part of the regulation system for the adoption of new technologies in the SUS. The main challenges are the difficulties in creating qualified teams, financial support, and sustainability. The work of these bodies in respect of the evaluation of new technologies deserves further studies analyzing the relationship between the pressure for adoption from the hospital team and industry professionals and legal rulings. It is necessary to strengthen HB-HTA culture and implement this policy in hospital management, making assessment bodies a part of managerial and decision-making processes in hospitals, and develop regional collaborative networks and a national network of HTA.

Objectives: The aim of this study was to determine the role of community preference information from discrete choice studies of colorectal cancer (CRC) screening in health technology assessment (HTA) reports and subsequent policy decisions.

Methods: We undertook a systematic review of discrete choice studies of CRC screening. Included studies were reviewed to assess the policy context of the research. For those studies that cited a recent or pending review of CRC screening, further searches were undertaken to determine the extent to which community preference information was incorporated into the HTA decision-making process.

Results: Eight discrete choice studies that evaluated preferences for CRC screening were identified. Four of these studies referred to a national or local review of CRC screening in three countries: Australia, Canada, and the Netherlands. Our review of subsequently released health policy documents showed that while consideration was given to community views on CRC, policy was not informed by discrete choice evidence.

Conclusions: Preferences and values of patients are increasingly being considered “evidence” to be incorporated into HTA reports. Discrete choice methodology is a rigorous quantitative method for eliciting preferences and while as a methodology it is growing in profile, it would appear that the results of such research are not being systematically translated or integrated into HTA reports. A formalized approach is needed to incorporate preference literature into the HTA decision-making process.

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.

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: Earlier treatment of publicly funded patients may achieve health gains that justify the additional costs of reducing waiting times. This study reports on the cost-effectiveness of implementing a private contracting model to meet alternative maximum waiting time targets for publicly funded patients undergoing total knee replacement surgery in Australia.

Methods: A linked decision tree and cohort Markov model was developed and populated and validated using secondary data sources to represent the pathways, costs, and quality adjusted life-years (QALYs) gained of non-urgent patients with alternative waiting times for total knee replacement surgery to a maximum age of 100 years.

Results: Assuming public waiting times are reduced through the purchase of private services, additional QALYs are gained at an incremental cost of less than $40,000. Value could be increased if lower private prices could be negotiated. Results are also sensitive to the rate of deterioration in function while waiting for surgery and the impact of functional status at the time of surgery on postsurgery outcomes.

Conclusions: More evidence on the value of expanded capacity or new models of care may inform new funding models to support such investments and reduced prices for new technologies, leading to more efficient and sustainable publicly funded healthcare systems.