Objectives: In cost-minimization studies, it is important to establish noninferiority in the clinical effect of the treatments under investigation. The relationship between the proportion of patients reaching the end point in a study, equivalence limit (δ), and power is investigated in the context of cost-minimization studies with dichotomous clinical end points. Two formulations of the null-hypothesis, absolute and relative formulations of δ, will be explored.

Methods: Sensitivity analysis was performed, in which the effect of the predicted proportions and δ on the power in a noninferiority setting was investigated. The patterns found are discussed in terms of the practical relevance within the cost-minimization framework.

Results: Sensitivity analyses show different patterns of results for both null-hypotheses. The differences in these results originate from the way δ is expressed. By expressing δ as absolute difference, power grows quite fast when sample proportions are smaller than expected. In the case of a proportional δ at small sample proportions, the power to establish noninferiority remains low.

Conclusions: To obtain valid results from a cost-minimization study, care has to be taken to adapt the correct methodology for noninferiority testing in clinical outcomes. Defining δ in terms of absolute differences between treatments can lead to obscured results. Although conservative, the expression of δ as a proportion of the effectiveness of the treatment as usual is found to be closer to clinical practice. The inflated δ, resulting from smaller clinical effects than expected when absolute formulation is applied, thus can be avoided.

Objectives: The objective of this study is to analyze statistically the possible determinants and implications of including or not including recommendations in health technology assessments (HTAs).

Methods: A sample of 433 HTAs published by eleven leading institutions or agencies in nine countries was reviewed and analyzed statistically by multiple logistic regression.

Results: The extent of policy and research recommendations in HTAs varies greatly from country to country. The content and scope of HTAs have some impact on recommendations. Extensive assessment of economic and organizational aspects increases the likelihood of including policy recommendations. Extensive assessment of technological and patient aspects increases the likelihood of including research recommendations, whereas extensive focus on economic aspects is negatively related to research recommendations. The most striking result is that the use of external partners for assessment increases the likelihood of including research recommendations in HTAs but not policy recommendations.

Conclusions: HTA commissioners, agencies, institutions, and funding authorities need to be aware of the consequences of the choices they make in advance of assessing health technologies. Outsourcing HTA to external partners suggests a greater likelihood of being told that “more research is needed.” The scope and content of HTAs has an impact on the type of recommendations, and country-specific preferences are strong predictors of recommendations in HTAs.

Objectives: Although disease modifying antirheumatic drugs (DMARDs) are the first choice drugs in the treatment of rheumatoid arthritis, many patients still take nonsteroidal anti-inflammatory drugs (NSAIDs) as well. These drugs may cause serious gastric adverse events with continuous usage. Cyclooxygenase-2 (COX2) inhibitors were supposed to have a gastrointestinal (GI) friendly side effect profile. The aim of the study is to compare three therapeutic strategies: conventional NSAIDs, NSAID in combination with proton pump inhibitors (PPIs), and the selective COX2 inhibitor therapy (celecoxib).

Methods: A decision tree model was developed, for 1 year, to simulate cohorts within the three arms (NSAIDs, NSAID + PPI, celecoxib). The efficacy of the different active agents of NSAIDs in therapeutically relevant doses was assumed to be the same, consequently differences can be seen in the side effect profile of the drugs. Medical costs, the costs of the side effects (GI, cardiovascular [CV] events), and quality-adjusted life-years (QALYs) were calculated to gain an incremental cost-effectiveness ratio (ICER). Evaluations were made from a third party payer's perspective. We performed one-way deterministic sensitivity analyses; the results were displayed in tornado diagrams.

Results: Our model indicates that NSAID + PPI offers extra health gain for extra costs compared with conventional NSAIDs (ICER:14,287 euro/QALY), while it dominates celecoxib because of celecoxib's higher costs and lower effectiveness. According to the sensitivity analyses, QALYs had the highest influence on ICER.

Conclusions: Although COX2 inhibitors have elevated GI efficacy compared with NSAIDs, celecoxib seems to be an adequate choice only for a limited group of patients with specific conditions because of the significantly higher price and CV risk profile.

Objectives: EUnetHTA WP 7 (Strand B) aimed to promote sharing information on new and emerging technologies. The task was to develop a prototype of a newsletter and pilot the processes of production.

Methods: The EuroScan database served as information source on pertinent technologies. To prioritize, a set of criteria for scoring the potential impact and for selecting the technologies for articles was applied and a pilot newsletter was produced.

Results: Being objective and transparent about the content of a newsletter required a method for prioritizing health technologies. Using significance criteria, members of the prioritization panel selected twelve technologies for articles of different length and depth. Potential recipients, surveyed on relevance, content, timeliness, and readability responded mostly positive, but requested more information on cost effectiveness and criticized timeliness.

Conclusions: Dissemination of an EU-wide newsletter would be feasible, but time-consuming. Although a newsletter appears to fulfill a need for information on emerging and new health technologies, it is not considered the right tool to avoid duplication of effort in the present international constellation of horizon scanning for new health technologies. Other options will be pursued as part of future collaborative actions, for example, a core set of early awareness information, or an on-demand electronic information system.

Moderate psychosocial problems identified during early pregnancy in 78 women were found to predispose for various “complications” during gestation, but not for prematurity or obstetrical complications during delivery. However, from a normal postnatal status the children of these mothers demonstrated a significantly unfavorable somatic, as well as psychomotoric development, until the age of 4. Pregnant women with certain psychosocial problems must be early identified and property attended to in order to preclude an adverse child development.

Coronary artery bypass graft surgery (CABGS) has become an important procedure for the treatment of coronary heart disease. Over 100,000 of these surgical procedures are performed each year (1) at an aggregate cost of about $2 billion (2). Despite its current widespread acceptance, this major surgical innovation has generated considerable controversy concerning its effectiveness (3), and there still remains substantial confusion in assessing its overall impact (4).

When there is a scarcity of resources (therapists, modalities), the physical therapist must make decisions about whom to treat and why. This paper discusses ethical dilemmas confronting the therapist and addresses solutions based on approaches of procedural justice and distributive justice.

With a growing number of economic evaluations being conducted alongside trials, there is a need to address, and if necessary, investigate the generalizability of results derived from trials. This paper explores the generalizability of costs from a trial investigating the frequency of breast cancer screening in the United Kingdom.

The focus of this article is on contemporary roots of medical care quality measurement, while it also examines some of the most important historical precedents. Specifically, it singles out Dr. Ernest Avery Codman and his early 20th-century work emphasizing the assessment of outcome as the paramount indicator of medical care quality. The standard that he set for himself and others is the one that late 20th-century researchers must uphold, and to which we must answer.

This article reviews the development, composition, chemistry, recent technological advances, and extent of use of composite resin restorative materials, adhesives, and pit and fissure sealants. The problems related to the clinical behavior of these materials in the oral environment are dealt with, and methods of minimizing their present deficiencies are suggested. Future directions that might be taken to improve these materials and solve some of the inadequacies that these materials exhibit are also discussed.

The use of large data bases in technology assessment offers a number of attractive possibilities for the future. This article outlines the major approaches to technology assessment and how data bases can be used to enhance each approach.

Health information systems are complex combinations of methods of organization and computer technologies. They are idiosyncratic to each country. Chad’s design of a national information system followed a process that can serve as a model for sustainable technology transfer—using consensual decision making and reinforcing administrative reforms while providing strong Ministry leadership and using technical assistance.

Markov modeling was used to evaluate the cost-effectiveness of octreotide in treating carcinoid syndrome and VIPoma. For each condition, using octreotide was associated with doubled survival time. Octreotide was cost-effective for treating carcinoid tumor ($752 per additional year of life, two additional years on average), and cost saving for VIPoma.

Objectives: This study aimed to investigate the screening performance of measuring blood pressure and other variables in identifying those who willdevelop, or die from, ischemic heart disease and stroke and too quantify by howmuch drugs that lower blood pressure will reduce the risk of ischemic heart disease and stroke in those designated “screen positive.”

Health technology assessment needs to relate to contemporary questions which concern public health-care systems: how to keep people healthy, how to focus on the needs of those with chronic disabilities and integrate care between the hospital and the community, how to encourage and audit effective teamwork, and how to establish a consensus about what is effective and affordable. Clinicians have an ethical responsibility to practice efficiently and economically, for profligacy in the care of one patient may mean that another is treated inadequately. For similar reasons, clinicians need to play a full role in the management of services. Advice from health technology assessment is vital and needs to be accurate, relevant, timely, clear, and accessible. As well as being concerned about what works, we need also to eliminate from practice what does not. Regular audit and appraisal of practice against the evidence base should be useful in this respect. Alternative approaches to management, such as the provision of care as opposed to aggressive treatments, need to be evaluated, and health technology assessment needs to consider how services are delivered, not just specific treatments.

Objectives: The aim of this study was to estimate the impact of new medical technologies on public healthcare expenditures in Israel over the period 2000–07.

Methods: For each year, government estimates for the costs of new technologies recommended as high-priority for public funding were summarized. The ratio of projected costs of these technologies to total public healthcare expenditures was calculated and compared with actual governmental budget allocations for new technologies.

Results: Funding all new high-priority medical technologies would have increased healthcare expenditures by 2.1 percent per year. Government allocations for new technologies raised expenditures by 1.0 percent per year.

Conclusions: New medical technologies significantly increase healthcare expenditures in Israel. Budgetary constraints have reduced their actual impact by 52 percent. This study indicates the need for an annual addition of 2 percent to public healthcare budget for funding new high-priority technologies.

Objectives: U.S. expenditures on medical devices ($70 billion in 2003) are one of the fastest growing components of hospital costs. Physicians’ selection of medical devices lacks an evidence base on the comparative clinical effectiveness of these products. Comparative studies (e.g., vendor 1 versus vendor 2, technology A versus technology B) are increasingly promoted in the public sector as a means of cost containment, value-based purchasing, and quality improvement. This study illustrates how hospitals and physicians can conduct comparative technology assessments of product performance.

Methods: Surgeons evaluated comparable medical devices manufactured by eight different vendors in standardized surgical procedures. Devices included sutures and endomechanical products, which account for $2.5 billion of total device spending. Evaluations covered multiple performance dimensions, including ergonomics, functionality, clinical acceptability, and vendor preference.

Results: One vendor's products garnered consistently high ratings from surgeons, while two other vendors garnered consistently low ratings. Differences in ratings were statistically significant and persist when controlling for physician background characteristics and prior experience. Study results were used by a large hospital group purchasing organization to select which vendors to contract with for these products.

Conclusions: Comparative technology evaluations assist physicians and hospitals in making cost-effective purchases of devices. These evaluations provide robust information on the performance of products routinely used by clinicians. Such evaluations can be carefully designed to have scientific rigor and clinical credibility.

Objectives: Vaccinating healthy children is proposed as a strategy to produce a herd effect and protect vulnerable groups. The Hutterite Influenza Prevention Study investigated this strategy, comparing communities with or without childhood influenza immunization programs. There are costs associated with vaccination therefore there may be a trade-off between these costs and the benefits of avoiding influenza cases. This evaluation estimates the cost-effectiveness of immunizing only healthy children in preventing cases of influenza within entire communities.

Methods: Effect data and resource utilization were collected during the trial. Cost data were collected from payer, literature and Internet sources. A two-stage bootstrap (TSB) with shrinkage correction was used to estimate average costs and effects. The incremental cost effectiveness ratio (ICER) and sample uncertainty around this estimate were calculated from the TSB results.

Results: Mean costs per patient for the treatment and control arms were $69.07 and $32.66 (difference $36.41). Mean number of influenza cases for the treatment and control arms were 0.04 and 0.27 (difference 0.23). ICER was $164.12 ($28.38, $2767.75) per case of influenza averted.

Conclusions: Immunizing healthy children for influenza is more costly, yet more effective than no immunization in preventing cases in the sample. At a cost of $164.12 to prevent a case of influenza, immunizing healthy children to protect all community members may be considered costeffective. Estimated results are conservative as the influenza season was mild and the sample population was healthy. In a more severe season with a less healthy population the ICER is expected to decrease.

Objectives: An economic evaluation was performed of empirical antisecretory therapy versus test for Helicobacter pylori in the management of dyspepsia patients presenting in primary care.

Methods: A randomized trial in 106 general practices in the County of Funen, Denmark, was designed to include prospective collection of clinical outcome measures and resource utilization data. Dyspepsia patients (n=722) presenting in general practice with more than 2 weeks of epigastric pain or discomfort were managed according to one of three initial management strategies: (i) empirical antisecretory therapy, (ii) testing for Helicobacter pylori, or (iii) empirical antisecretory therapy, followed by Helicobacter pylori testing if symptoms improved. Cost-effectiveness and incremental cost-effectiveness ratios of the strategies were determined.

Results: The mean proportion of days without dyspeptic symptoms during the 1-year follow-up was 0.59 in the group treated with empirical antisecretory therapy, 0.57 in the H. pylori test-and-eradicate group, and 0.53 in the combination group. After 1 year, 23 percent, 26 percent, and 22 percent, respectively, were symptom-free. Applying the proportion of days without dyspeptic symptoms, the cost-effectiveness for empirical treatment, H. pylori test and the combination were 12,131 Danish kroner (DKK), 9,576 DKK, and 7,301 DKK, respectively. The incremental cost-effectiveness going from the combination strategy to empirical antisecretory treatment or H. pylori test alone was 54,783 DKK and 39,700 DKK per additional proportion of days without dyspeptic symptoms.

Conclusions: Empirical antisecretory therapy confers a small insignificant benefit but costs more than strategies based on test for H. pylori and is probably not a cost-effective strategy for the management of dyspepsia in primary care.