The paper presents a set of principles that cover the broad scope of HTA from formulation of the question to effects on the decision-making process. It also provides goals for HTA programs to aim for in producing assessments. The principles are supported by material that includes illustrations from the experience of several programs. The authors have had long contact with the field and are well able to authoritatively discuss a range of methodological and other topics. The paper includes a range of views and details that are relevant to those involved with HTA.

Objectives: Acute otitis media (AOM) is one of the most common diseases of childhood, representing a major disease burden on the society. New evidence-based guidelines for AOM, focusing on children under 7 years of age, were introduced in Finland in 1999. The aim of this study was to evaluate the cost-effectiveness of implementing those guidelines in Finland.

Methods: A 5-year prospective trial was conducted in thirty community primary healthcare centers in Finland. All AOM patients between 0 and 6 years of age visiting the study health centers for the first time, for this episode of illness, during 1 week in November 1998 (n = 579) and November 2002 (n = 369) were included in this study. The outcome measure was the percentage of symptom-free patients.

Results: The mean direct cost of an AOM episode per patient stayed almost the same after implementing the guidelines, €152 in 1998 and €150 in 2002. After implementing the guidelines, the percentage of symptom-free patients was 10 percentage points higher than before the guidelines. The treatment after the implementation of the guidelines, thus, was a dominant strategy.

Conclusions: Implementing the guidelines to the treatment of AOM in children was associated with extra health benefits at slightly lower direct costs and, thus, is a dominant strategy. The focus of this study was on the short-term effects of the treatment; including long-term effects in the analysis might affect the results.

A study was initiated to investigate the impact of information dissemination in Illinois upon the projected rise in the cesarean birth rate over the period from 1986 through 1988. The total cesarean birth rate in Illinois had not changed significantly during this period, whereas the rate of vaginal births after cesarean sections (VBAC) increased by 58.4% (p <.001). Information dissemination may have contributed to stemming an increase in the cesarean birth rate in Illinois while promoting VBAC deliveries.

Hypertension during pregnancy, defined as a diastolic blood pressure of at least 90 mm Hg, occurs in about 7% of Western countries. Primiparity and familial factors are the most important risk factors. Fifty percent of women experienced blood pressure elevation as late as the last month of pregnancy.

Proteinuric hypertension is an important cause of maternal and perinatal mortality. Eclampsia cannot always be prevented. The likelihood of identifying a new case of proteinuric hypertension at any particular visit is very low using traditional antenatal care schedules, and care could be focused on women at higher risk.

Over the past decade the Office of Medical Application of Research (OMAR) of the National Institutes of Health has developed the consensus development conference (18) to assess technologies in cases where the scientific community has been unable, or unwilling, to reach a firm position as to efficacy but which require some better form of assessment than expert opinion (8). Another paper in this issue describes the principles that underlie such conferences (9).

Technologies that promise to enhance the stability of vaccines are likely to be determined by the product-specific physical structure and biological functions of the specific vaccine immunogens. Research may define the extent to which the stability of oral poliovirus vaccine may be improved by the addition of certain antiviral components that bind to the poliovirus capsid or by the application of novel drying technologies.

Technological advances by developed countries are producing safer, more potent vaccines. In addition, the transfer of the technology of vaccine production to some developing countries has been taking place during the past five decades, thereby making possible the participation of developing countries in the production and supply of the essential biologicals that are required for immunization programs. Examples of successful transfers of technology, the decisive elements and factors that contribute to the transfers, and the major obstacles to such transfers are presented.

An educational model is presented that stresses the importance of the interaction between individual characteristics and intentional educational influences on outcome variation. This model is exemplified by an interventional study of patients with insulin-dependent diabetes mellitus who, despite long-term conventional medical treatment, had been unable to achieve satisfactory hemoglobin Aic levels. Treatment modes and their importance for understanding variations in outcomes are discussed from the interactional perspective suggested in the model.

The paper considers the economic characteristics of technology and suggests a categorization based on the economic nature of particular technologies and their effect on the product health care that may be helpful in considering the economics of technology in hospitals.

It reviews the range of economic forces that might be expected to apply to the use of technology in the hospital setting, and notes some of the evidence to support such hypotheses. In considering the limited evidence from the United Kingdom and elsewhere in Europe, the paper contrasts its focus on socio-political, institutional, and organizational factors, rather than the direct economic factors considered in the United States work.

It suggests that the multiplicity of forces at work make cross-national, empirical, and policy analyses very difficult. Indeed, without more economic appraisal the effect of differences in technology adoption cannot be evaluated.

The availability of new vaccines for pediatric use provides an unprecedented opportunity to prevent serious infectious diseases and their associated morbidity and mortality. However, each new product entails the need for additional injections that could become so numerous as to discourage the administration of new vaccines. This challenge can be overcome by mixing individual vaccines before delivery such that multiple vaccines are administered as single combination vaccines. Technical, clinical, manufacturing, regulatory and marketing issues relative to combination vaccines in general are the major challenges for ongoing and future development.

Background: The most effective sources to search to identify adverse effects data for medical devices are currently unknown.

Methods: The included studies from a systematic review of the safety of recombinant human bone morphogenetic protein-2 (rhBMP-2) for spinal fusion were used for analysis. For each source searched, a record was made for each relevant publication of whether it was retrieved by the search strategy used and whether it was available in the database but not retrieved. To account for multiple publications of the same study, a record was made of the relevant studies identified. The sensitivity, precision, and number needed to read were calculated as well as the minimum combination of sources to identify all the publications or studies.

Results: There were eighty-two publications (forty-nine studies) included in the systematic review. Only one article was available in a database searched but not retrieved by our search strategy. Science Citation Index (SCI) and EMBASE both achieved the highest sensitivity (62 percent), followed closely by MEDLINE/PubMED (56 percent). With the search strategies used, the minimum combination of sources needed to identify all the publications was SCI, EMBASE, CENTRAL, and either MEDLINE or PubMED, in addition to reference checking, contacting authors and an automated current awareness service. In relation to identifying all the relevant studies, the minimum combination of studies was similar with the exclusion of CENTRAL.

Conclusions: To identify all the relevant publications or studies included in this case study systematic review, several different sources needed to be searched.

Objective: The aim of this study was to investigate malaria elimination in Ethiopia. Ethiopia has planned to eliminate malaria by 2015 in areas of unstable malaria transmission and in the entire country by 2020. However, there is a shortage and maldistribution of the health workforce in general and malaria experts in particular. Training, motivating, and retaining the health workforce involved in malaria control is one strategy to address the shortage and maldistribution of the health workforce to achieve the goal of elimination.

Methods: Policy options include the following: (i) in-service training (educational outreach visits, continuing education meetings and workshops, audit and feedback, tailored interventions, and guideline dissemination) may improve professional practice; (ii) recruiting and training malaria specialists together with academic support, career guidance, and social support may increase the number of malaria experts; and (iii) motivation and retention packages (such as financial, educational, personal, and professional support incentives) may help motivate and retain malaria professionals.

Results: Implementation strategies include the following: (i) massive training of health personnel involved in malaria elimination and malaria experts (requiring special training) at different levels (national, sub-national, District & community levels), and (ii) recruiting highly qualified health personnel and retention and motivation mechanisms are needed.

Conclusions: The lack of adequately trained human resources and personnel attrition are major challenges to effectively implement the planned multi-faceted malaria elimination by 2020 strategy in Ethiopia. Although a reduction in malaria incidence has been observed in the last 3-4 years, maintaining this success and achieving the malaria elimination goal with the present human resource profile will be impossible. A clear strategy for developing the capacity of the health workers in general, and malaria experts in particular, and retaining and motivating staff are crucial for malaria control and elimination.

Objectives: To study the effects of health financing systems on patient care-seeking behavior in rural China.

Methods: A multistage sampling method was used to select county, township, and village health facilities. A total of 1,232 outpatients was interviewed during two weeks.

Results: Health-financing systems appeared to influence patient behavior. In the insured group, the proportion of patients being hospitalized was higher than that in the uninsured group. Among the different insurance schemes, the private insurance group had the highest proportion of self-medication, but the cooperative insurance group had the lowest; the government insurance group had the most delay days, but the cooperative insurance group had the fewest. A logistic regression analysis suggested that only “out-of-pocket” payment might decrease the access to hospitalization.

Conclusions: The empirical data suggest that health-financing systems appear to influence patient behavior for prescription and access to health care, especially some costly health care, that is, hospitalization. The data also suggest that China needs to increase the coverage of health insurance, especially in rural areas to improve the access to health care.This article resulted from a collaborative research project between IHCAR, Karolinska Institutet and School of Public Health, Fudan University (former Shanghai Medical University)-Health care financing in transitional society-financially supported by the Swedish International Development Cooperation Agency (Sida). Many thanks to Vinod Diwan, Lennart Bogg, and Göran Tomson at IHCAR and Clas Rehnberg at the Stockholm School of Economics for their assistance in the preparation of the article.

Objective: The aim of this study was to elicit willingness to pay (WTP) for allergen-specific subcutaneous injection immunotherapy (SCIT) in a cohort of respondents suffering from allergic-rhinoconjunctivitis (a-RC)/asthma, and to investigate how patients self-select to SCIT according to need.

Methods: A random sample of the general population was screened for a-RC/asthma and asked if they were willing to consider SCIT. They were asked to state their WTP for SCIT by way of a discrete choice question (DC-q), an open-ended WTP question (o-WTP-q), and questions relating to their sociodemographic background and the severity of their a-RC/asthma. The characteristics of respondents demanding SCIT were compared with the characteristics of respondents who have actually received SCIT to establish possible barriers to demand.

Results: Our results suggest that respondents do well in self-selecting themselves to SCIT on the basis of need according to disease burden measured in terms of a-RC classification, number of contacts with a general practitioner, number of sick days, and potential quality-adjusted life-year loss. Mean WTP for SCIT was estimated at €655 (median, €267) (o-WTP-q) and €903 (95 percent confidence limit, 348–1,459) (DC-q).

Conclusion: Characteristics of respondents, who consider SCIT and are willing to pay for SCIT, suggest that allergy sufferers select themselves appropriately according to need and not according to other characteristics, such as income or education. There is a significant discrepancy between those who hypothetically consider SCIT and those demanding SCIT in real life. This study suggests that there are barriers to entry related to age and education, but not to income.

Background: Contrast-induced acute kidney injury (CI-AKI) is defined as a deterioration in renal function after administration of radiologic iodinated contrast media (CM). Iodixanol, showed a lower CI-AKI incidence than low-osmolar contrast media (LOCM). A cost-effectiveness analysis was performed comparing iodixanol and LOCM in intravenous (IV) setting in Italy.

Methods: A Markov model was developed. Patients moved across four health states: CI-AKI free, CI-AKI, myocardial infarction, and death. The simulation horizon was lifetime with 1-month cycles. Costs and outcomes were discounted at 3.5 percent rate. CI-AKI incidence was considered from published literature across different definitions. Cost-effectiveness of iodixanol was assessed in terms of incremental cost per life-year gained. Net monetary benefit (NMB) was also calculated. Both deterministic and probabilistic sensitivity analyses were performed.

Results: Base-case results showed an average survival increase of 0.51 life-years and a savings of €7.25 for iodixanol versus LOCM. The cost-effectiveness of iodixanol was confirmed when other scenarios were explored, such as varying CI-AKI definition, sub-populations with specified risk factors, CM hospital bids prices, and inclusion of adverse drug reactions of allergic nature. An NMB ranging between €6,007.25 and €30,007.25 was calculated.

Conclusion: Base-case results show that IV iodixanol is cost-effective compared with LOCM in the Italian clinical setting of a hospital computed tomography radiology practice. However, some caution is due, mainly linked to inherent limitations of the modeling technique and to the lack of agreement on CI-AKI incidence data in the clinical literature.

Objectives: To identify core issues that contribute to the gap between pre-marketing clinical research and practice as seen from the perspective of medical practice, as well as possible changes and potential barriers for closing this gap.

Methods: Interviews with 47 physicians and pharmacists who were liaised to drug regulation through their role in the pre- and post-marketing shaping of new cardiovascular drugs. Data were analyzed using methods of grounded theory and analytical evaluations.

Results: Six core issues were identified that referred to the standards in drug regulation, the organization of the regulatory system, and conflicting interests. Pre-marketing trials should focus more on populations and research questions relevant to medical practice. In particular, variability in drug responses between subgroups of patients and demonstration of effectiveness should become major principles in drug regulation. An interactive post-marketing process in which public interests are represented was considered necessary to further guide research and development according to the needs in daily practice. Strategies for change could be applied within the present system of drug regulation, or affect its basic principles. Regulatory authorities were primarily identified to initiate changes, but many other parties should be involved. Barriers for change were identified regarding differences in interests between parties, organizational matters, and with respect to broader healthcare policies.

Conclusions: Based on the respondents' opinions, there is a need to focus regulatory standards more on the needs in medical practice. Therefore, regulatory authorities should further develop their influence in the pre- and post-marketing drug development process, together with other parties involved, in order to bridge the gap between clinical research and medical practice.