Adequate methods are urgently needed to guarantee the good practice of health technology assessment (HTA) for technologies with novel properties. The aim of the study was to construct a conceptual framework to help understand the innovation of HTA methods (IHTAM). The construction of the IHTAM framework was based on two scoping reviews, one on the current practice of innovating methods, that is existing HTA frameworks, and one on theoretical foundations for innovating methods outside the HTA discipline. Both aimed to identify and synthesize concepts of innovation (i.e., innovation processes and roles of stakeholders in innovation). Using these concepts, the framework was developed in iterative brainstorming sessions and subsequent discussions with representatives from various stakeholder groups. The framework was constructed based on twenty documents on innovating HTA frameworks and fourteen guidelines from three scientific disciplines. It includes a generic innovation process consisting of three phases (“Identification,” “Development,” and “Implementation”) and nine subphases. In the framework, three roles that HTA stakeholders can play in innovation (“Developers,” “Practitioners,” and “Beneficiaries”) are defined, and a process on how the stakeholders innovate HTA methods is included. The IHTAM framework visualizes systematically which elements and stakeholders are important to the development and implementation of novel HTA methods. The framework could be used by all stakeholders involved in HTA innovation to learn how to engage dynamically and collaborate effectively throughout the innovation process. HTA stakeholders in practice have welcomed the framework, though additional testing of its applicability and acceptance is essential.

Objectives: Various minimal clinically important difference (MCID) threshold estimation techniques have been applied to seasonal allergic rhinitis (SAR). The objectives of this study are to (i) assess the difference in magnitude of alternative SAR MCID threshold estimates and (ii) evaluate the impact of alternative MCID estimates on health technology assessment (HTA).

Methods: Data describing change from baseline of the reflective Total Nasal Symptom Score (rTNSS) for four intranasal SAR treatments were obtained from United States Food and Drug Administration-approved prescribing information. Treatment effects were then compared with anchor-based MCID thresholds derived by Barnes et al. and thresholds obtained from an Agency for Healthcare Research and Quality (AHRQ) panel.

Results: The change in rTNSS score from baseline, represented as the average of the twice-daily recorded scores of the rTNSS, was -2.1 (p < .001) for azelastine hydrochloride 0.10%, 1.35 (p = .014) for ciclesonide, and -1.47 (p < .001) for fluticasone furoate. The change in the rTNSS score from baseline, represented by sum of the AM and PM score, was -2.7 for MP-AzeFlu (p < .001). The rTNSS change from baseline for each product was compared with anchor-based MCID threshold and the AHRQ panel estimates. Comparison of the observed treatment effect to the anchor-based and AHRQ panel MCID thresholds results in different conclusions, with clinically important differences being inferred when anchor-based estimates serve as the reference point.

Conclusion: The AHRQ panel MCID threshold for the rTNSS was twelve times larger than the anchor-based estimates resulting in conflicting recommendations on whether different SAR treatments provide clinically meaningful benefit.

Introduction: Many governments have introduced health technology assessment (HTA) as an important tool to manage the uptake and use of health-related technologies efficiently. Although surgeons play a central role in the uptake and diffusion of new technologies, little is known about their opinion and understanding of the HTA role and process.

Methods: A cross-sectional pilot study was conducted using an online questionnaire which was distributed to Fellows of the Royal Australasian College of Surgeons over a 4-week period. Information was sought about knowledge and views of the HTA process. Descriptive statistics were used to summarize the data, frequencies, and proportions were calculated.

Results: Sixty-two surgeons completed the survey; of these, 55 percent reported their primary work place as a public hospital. Twenty-four percent of the participants reported that they had never heard of the HTA agency and 60 percent reported that surgical procedures are most likely to be introduced in the Australian healthcare system at the public hospital level (which is beyond the HTA's scope and dealt with at a state level). However, 61 percent considered that decisions about funding and adoption of new technologies should take place at the national level.

Conclusions: This survey provides some evidence that many surgeons remain unaware of the federal government's HTA process but still value evidence-based information. In order for HTA to be an effective aid to rational adoption of health-related technologies, there is a need for an evidence-based approach that is integrated and is accepted and understood by the medical professions.

In assessing technologies for disabled people, the aims of habilitative or rehabilitative interventions, the concepts of disability and handicap, and the potential of existing and emerging technologies in various social arenas, as well as the structure of service delivery systems, are of importance. A discussion of these issues in the light of previous work on cost and effectiveness in the field is given.

While laparoscopic cholecystectomy is now widely used, diffusion of other laparoscopic surgical methods has been more modest. Uptake of most laparoscopic methods has been influenced by considerations of effectiveness compared with open surgery, competing minimally invasive therapies, and the inconvenience and cost of technical change.

For several decades, major advances in medicine have increased dramatically our ability to prevent, diagnose, and manage a wide variety of chronic and acute health problems. However, medical innovations also pose significant economic, social, and ethical questions. How do we best utilize scarce medical resources? How do we balance anticipated benefits against the dollar cost or associated risk? What is the impact on total health care spending now and in future years? As concern over these issues grows concomitant with increased health care spending, technology assessment is often promoted as a method for determining whether a biomedical innovation should be encouraged to disseminate rapidly in order to maximize its benefits to individual patients, or constrained to develop slowly in order to minimize collective costs or risks. But, the art and practice of evaluating medical technologies, especially innovations still in the research and development phase, are not well developed (6;8;11;14;16;34;35).

Once the effects of short-term data analysis of new medical technology appear clear, additional or long-term analyses are infrequently performed on subsequent information. This often leads to incomplete understanding of the technology's full medical, social, and economic effects.

Available data for the Federal Republic of Germany on mortality, hospitalization, and work loss due to gastric and duodenal ulcer and gastritis/duodenitis allowed long-term analysis of direct and indirect impacts on the population from 1975 through 1984. Mortality rates declined for all ages (ρ ≤ 0.01) except for those age 75 and older, and nearly equally for all study diagnoses. Hospital discharge rates for all diagnoses rose slowly and steadily, while those for persons diagnosed with gastric ulcer, duodenal ulcer or gastritis/duodenitis declined sharply (ρ = 0.04). Declines of hospital discharges were greater for men than for women. The ongoing decline in rates of mortality and hospital discharges increased after 1977. Rates of work loss per 10,000 population-at-risk for study diagnoses were either stable or increasing until 1979, after which there was a marked decline (ρ = 0.03 for gastric ulcer, ρ = 0.02 for duodenal ulcer, ρ = 0.008 for gastritis/duodenitis). Work loss due to study diseases declined as a percentage of work loss for all diseases during the later study years. Only by examining many years' data could the accelerating declines be discerned, not only for mortality and hospitalizations, which have been examined before, but also for work loss, an infrequently analyzed effect of disease.

Antenatal care was established in Norway during the 1930s. Unlike the other Nordic countries, care is provided by general practitioners, not be midwives. Guidelines were first issued in 1984 after a debate about the quality of the care. This article reports providers' compliance to important parts of the guidelines.

Genetic diagnostic techniques increasingly permit the detection of predisposition to illness long before the onset of the disease process itself. Medicine is on the verge of becoming a predictive science as well as a diagnostic and therapeutic one. Genetic diagnosis could have profound effects on many aspects of our health care system, including the prestige and effectiveness of preventive medicine, the competitive behavior of health care organizations and insurance companies, access to private health insurance, the ability of primary care physicians to serve as gatekeepers, and other matters. This article examines the range of potential effects of the new genetic diagnostics on the organization and financing of health care. For purposes of illustration the authors examine in detail the possible consequences of genetic tests for predisposition to two diseases: Reye's Syndrome and lung cancer in smokers.

This article contends that the German social and economic situation is conducive to the rapid diffusion of innovative medical technology. While there is public control over hospital facilities, the pluralistic health care system and decentralized government responsibilities contribute to an essentially laissez faire regulatory environment. There is perfunctory planning and regulation for major medical expenditures, but the essential constraints are financial. This is no comprehensive program for the assessment of diagnostic technologies and the effective imposition of guidelines depends on the cooperative effort of various financing organizations, professional interests, and public pressure groups.

Antenatal care in Denmark is shared between general practitioners, midwives, and hospital departments. A minimum of 9 visits is officially recommended for all pregnant women. In 1987, 80% made 10 or more visits. An inadequate number of visits in relation to recommendations was most frequent in the lowest social group. Risk of stillbirth and neonatal death varied substantially between social groups even after taking account of number of visits made.

It was in 1967 that the first patient went from Tunbridge Wells to the Brompton Hospital for pacemaker implantation. The recipient was a typically robust female octogenarian and while the eminent cardiologist was engaged in his task, she tapped him on the shoulder. “Young man” she said, “how many of these operations have you done?” He replied, somewhat modestly, “About 300,” expecting her to compliment him on his expertise. Instead, she said “Well, if you've done that many you should know to keep your patient's feet warm. Cover them up!” This anecdote aptly illustrates the contention implied in my title that a new and somewhat disruptive dimension in the form of technology has entered the field of medicine, a view which has attracted considerable support from various quarters (14; 16).

This paper considers economic forces on the organization and use of technology in hospitals from a U.S. perspective. U.S. hospitals are moving from a period of very loose financial constraints to one in which the demand side of the market is likely to exert much greater discipline. Theory and limited evidence suggest some important effects on the adoption and use of technology, leading in general to more emphasis on cost reduction and less emphasis on costly quality improvements. Also discussed are economic influences on the movement of technology out of the hospital and on the development of new technologies. Finally, some peculiarities of very high cost technologies are noted.

Our present-day health sectors are increasingly characterized by both rapid technological change and growing visibility of its considerable consequences in terms of the quality and costs of health care. Improved health care decision-making in such an environment requires adequate and timely information on the benefits, risks, and costs of health care technology. Whereas traditionally, technology assessment focused predominantly on evaluating efficacy and (short-term) safety in a more or less “controlled” environment, an interesting shift in emphasis is now occurring. There is a growing recognition that improved information is also needed on the health and economic outcomes of technology as used in everyday clinical practice, i.e., on its effectiveness, cost-effectiveness, and long-term safety in normal “uncontrolled” daily medical life. Moreover, because the treatment of particular clinical conditions (such as stable angina, gallstones, or prostatism) increasingly involves choices among alternative diagnostic and therapeutic options, these assessments should ideally provide effectiveness and cost-effectiveness information for all the various technological alternatives involved.

This paper assesses the impact of mechanisms for financing intensive home health care services in the United States on their utilization. As lengths of stay have decreased in response to prospective payment methods for hospitals, demand has increased for intensive and complex services provided to patients in the home. Third-party payers, however, are willing to satisfy only some of this potential demand that their reimbursement policies have generated. It is the policies of payers rather than the safety and effectiveness of devices and procedures that are the major constraints on the expansion of intensive home health care. We describe the effects of these policies on who receives intensive home health care services, who provides them, what services are provided, how their quality is monitored, and what they cost.

Cooperation in midwifery research between Zambia and Sweden is ongoing. Joint studies on gastric suctioning and maternity routines are used as examples, and breastfeeding is discussed from a global perspective. The midwife, who also interprets responses from mothers, is an important member of an assessment team. Cooperation over cultural boundaries is feasible and mutually rewarding.