Objectives: A recent randomized, controlled trial in chronic heart failure patients showed that NT-proBNP-guided, intensive patient management (BMC) on top of multidisciplinary care reduced all-cause mortality and heart failure hospitalizations compared with multidisciplinary care (MC) or usual care (UC). We now performed a cost-utility analysis of these interventions from a payer's perspective.

Methods: Costs related to hospitalizations, ambulatory physician and nurse visits, and NT-proBNP testing for the three management strategies were acquired for both Austria (€) and Canada ($) and combined with the survival and quality of life data from the clinical trial for cost-effectiveness analysis. Data on long-term survival, costs, and quality-adjusted life-years (QALY) were extrapolated for a 20-year time horizon using a Markov model, which simulated the progression of disease through beta-blocker use, hospitalizations, and mortality.

Results: BMC was the most cost-effective strategy as it was dominant (cost-saving with improved health outcome) over both MC and UC based on both Austrian and Canadian costs. Incremental cost-effectiveness ratios for MC relative to UC were €3,746 and $5,554 per QALY gained for Austrian and Canadian costs, respectively. The probabilities for BMC being the most cost-effective strategy were 92 percent at a threshold value of Austrian €40,000 and 93 percent at a threshold value of Canadian $50,000.

Conclusions: NT-proBNP-guided, intensive HF patient management in addition to multidisciplinary care not only reduces death and hospitalization but also proves to be cost-effective.

Aortic stenosis (AS) is caused by age-related calcific degeneration of the aortic valve (1). Initially, cases are asymptomatic but, from the point that symptoms first develop, there is rapid progression and if left untreated survival estimates are low (2–3 years) (1). Therefore, managing AS effectively and efficiently is a priority for health systems with increasing healthcare costs and longer life expectancy.

Objectives: This study aimed to investigate the technical documentation of manufacturers on issues of safe use of their device in a home setting.

Methods: Three categories of equipment were selected: infusion pumps, ventilators, and dialysis systems. Risk analyses, instructions for use, labels, and post market surveillance procedures were requested from manufacturers. Additionally, they were asked to fill out a questionnaire on collection of field experience, on incidents, and training activities.

Results: Specific risks of device operation by lay users in a home setting were incompletely addressed in the risk analyses. A substantial number of user manuals were designed for professionals, rather than for patients or lay carers. Risk analyses and user information often showed incomplete coherence. Post market surveillance was mainly based on passive collection of field experiences.

Conclusions: Manufacturers of infusion pumps, ventilators, and dialysis systems pay insufficient attention to the specific risks of use by lay persons in home settings. It is expected that this conclusion is also applicable for other medical equipment for treatment at home. Manufacturers of medical equipment for home use should pay more attention to use errors, lay use and home-specific risks in design, risk analysis, and user information. Field experiences should be collected more actively. Coherence between risk analysis and user information should be improved. Notified bodies should address these aspects in their assessment. User manuals issued by institutions supervising a specific home therapy should be drawn up in consultation with the manufacturer.

In many Western countries, long waiting times for elective surgery are a concern. Major joint replacement is an example of a type of surgery with a high volume of demand and relatively long waiting periods for patients. As populations get older, the prevalence of slowly progressive diseases, such as osteoarthritis (OA) in hip and knee joints, is increasing. Over three-quarters of a million total hip and knee replacement surgeries are done in the United States annually (1). Furthermore, according to March et al. (1997), the costs of OA have been estimated to account for up to 1–2.5 percent of the Gross National Product (GNP) in several developed countries (2). In Finland, a total of 11,104 total joint replacements (TJRs) were performed in 2004 (hip 6,600 and knee 5,905), with the median waiting time of 181 days for the surgery (hip 153 and knee 209 days). Until 2007, the number of TJRs was 17,334 (hip 7,698 and knee 9,636), with a median waiting time of 120 and 142 days, respectively (3;4). The mean waiting time for elective surgical procedures is approximately 3 months in several countries and the maximum waiting times can stretch into years.

Objectives: We studied the cost-effectiveness of tenofovir and entecavir in e antigen positive (CHBe+) and negative (CHBe-) chronic hepatitis B.

Methods: Using a multicenter survey including 544 patients we measured patient quality of life and attributable costs by clinical disease stage. Natural disease progression was studied in 278 patients in a single center. A Markov model was constructed to follow hypothetical cohorts of treated and untreated 40-year-old CHBe+ and CHBe- patients and 50-year-old patients with compensated cirrhosis.

Results: We did not find an improvement in quality of life when viral load was reduced under treatment. Transition rates to liver cirrhosis were found to be age-dependent. Assuming equal effectiveness, tenofovir dominates the entecavir strategy because of its lower price in Belgium. The incremental cost-effectiveness ratio (ICER) of tenofovir after 20 years is more favorable for treating Caucasian cirrhotic patients (mean ICER €29,000/quality-adjusted life-year [QALY]) compared with treating non-cirrhotic patients (mean ICER €110,000 and 131,000/QALY for CHB e+ and e-, respectively). Within the non-cirrhotic patients the ICER decreases with increasing cohort starting age from 30 to 50 years.

Conclusions: Results of long-term models for tenofovir or entecavir treatment of CHB need to be interpreted with caution as long-term trials with hard end points are lacking. Especially the effect on HCC remains highly uncertain. Based on cost-effectiveness considerations such antiviral treatment should be targeted at patients with cirrhosis or at risk of rapid progression to this disease stage.

Background: The current study aimed to determine the accuracy of UHear™, a downloadable audiometer on to an iPod Touch©, when compared with conventional audiometry.

Methods: Participants were enrolled primary school scholars. A total number of eighty-six participants (172 ears) were included. Of these eighty-six participants, forty-four were female and forty-two were male; with the age ranging from 8 years to 10 years (mean age, 9.0 years). Each participant underwent two audiological screening evaluations; one by means of conventional audiometry and the other by means of UHear™. Otoscopy and tympanometry was performed on each participant to determine status of their outer and middle ear before each participant undergoing pure tone air conduction screening by means of conventional audiometer and UHear™. The lowest audible hearing thresholds from each participant were obtained at conventional frequencies.

Results: Using the Paired t-test, it was determined that there was a significant statistical difference between hearing screening thresholds obtained from conventional audiometry and UHear™. The screening thresholds obtained from UHear™ were significantly elevated (worse) in comparison to conventional audiometry. The difference in thresholds may be attributed to differences in transducers used, ambient noise levels and lack of calibration of UHear™.

Conclusion: The UHear™ is not as accurate as conventional audiometry in determining hearing thresholds during screening of school-aged children. Caution needs to be exercised when using such measures and research evidence needs to be established before they can be endorsed and used with the general public.

Purpose: The aim of this study was to compare the general health-related quality of life (HRQoL), the metabolic control (HbA1c), the anthropometric measurement, and the cardiorespiratory fitness (expressed by VO2max) in youths with type 1 diabetes treated with continuous subcutaneous insulin infusion (CSII) to those receiving multiple daily injections (MDI). We looked for factors influencing the HRQoL and metabolic control.

Methods: A total of 239 patients treated with CSII (51 girls and 53 boys) or MDI (64 girls and 71 boys) between ages 8 and 18 years were assessed with the Pediatric Quality of Life Inventory, Generic Core Scales, and Diabetes Module. VO2max was evaluated using the 20-meter shuttle run test.

Results: CSII group had significantly better HRQoL according to both child self-report and parent proxy-report. Youths with CSII reported better physical, emotional, and school-related functioning, and had less diabetes-related fear and symptoms than the MDI group. There were no significant differences in body mass index z-scores, insulin doses, HbA1c, and VO2max between the groups. HRQoL was predicted by the CSII therapy (β = −0.220; p = .000) and the VO2max (β = 0.386; p = .000), other clinical and anthropometric parameters had no effect; the HbA1c was predicted only by VO2max (β = −0.353; p = .000).

Conclusions: Diabetic youths treated with CSII therapy have better HRQoL than those treated with MDI. There are no differences between the investigated groups in anthropometric data, glycated hemoglobin, and physical fitness. Moreover, good physical fitness has an important role in achieving better metabolic control and HRQoL, which underlines the importance of regular aerobic exercise in the treatment and care of type 1 diabetes in childhood.

Objective: The aim of this study was to present a clear process of synthesizing test accuracy data when conducting economic evaluations of diagnostic tests for health technology assessment (HTA) assessors and health economists.

Methods: We appraised the methods advocated for using diagnostic test accuracy data in economic evaluations. We used a case study of fetal anemia in which data from a screening test are used in combination with a confirmatory test.

Results: We developed a step-by-step guide and consider two scenarios: when data on test accuracy from several studies are based on (i) the same test threshold for positivity and (ii) different test thresholds.

Conclusions: We conclude that each approach has its strengths and limitations. We show that the optimal operating point of the test should be identified to determine the true cost-effectiveness of the test. We advocate that these issues require a multidisciplinary team of health economists, decision modelers and statisticians.

Objectives: An overview was produced of approaches currently used to evaluate chronic disease management in selected European countries. The study aims to describe the methods and metrics used in Europe as a first to help advance the methodological basis for their assessment.

Methods: A common template for collection of evaluation methods and performance measures was sent to key informants in twelve European countries; responses were summarized in tables based on template evaluation categories. Extracted data were descriptively analyzed.

Results: Approaches to the evaluation of chronic disease management vary widely in objectives, designs, metrics, observation period, and data collection methods. Half of the reported studies used noncontrolled designs. The majority measure clinical process measures, patient behavior and satisfaction, cost and utilization; several also used a range of structural indicators. Effects are usually observed over 1 or 3 years on patient populations with a single, commonly prevalent, chronic disease.

Conclusions: There is wide variation within and between European countries on approaches to evaluating chronic disease management in their objectives, designs, indicators, target audiences, and actors involved. This study is the first extensive, international overview of the area reported in the literature.

Objectives: The aim of this study was to develop an health technology assessment (HTA) decision tool to support the decision-making process on health technologies for hospital decision makers in cross-border regions.

Methods: Several methods were used to collect information necessary to develop the cross-border mini-HTA decision tool. The literature was inventoried on HTA in border regions and local settings and the use of HTA by local decision makers. Semi-structured interviews with hospital decision makers in cross-border regions were also performed. Based on group discussion of the resulting information, it was decided to use the Danish mini-HTA guideline as a starting point for development of the decision tool. After finishing the first version of the decision tool it was tested in two pilot studies

Results: Some questions in the Danish mini-HTA guideline were not relevant. Other questions needed rephrasing and questions about cross-border situations were added. The pilots showed several missing topics, including legal questions and reimbursement issues. The final decision tool consists of three sections: a general section, a section for hospitals not cooperating cross-border and a section for hospitals that are cooperating with hospitals across a national or regional border.

Conclusions: Based on our literature search, this may be the first cross-border mini-HTA decision tool. The decision tool will be of help for healthcare professionals and decision makers in border settings who would like to use HTA evidence to support their decision-making process.

Objectives: To obtain further information from members of the International Network of Agencies for Health Technology Assessment (INAHTA) on the involvement of consumers in their programs.

Methods: A questionnaire for a survey was developed and sent to member agencies in November 2010. Survey responses were compared with those from an earlier survey conducted in 2005.

Results: Of the thirty-three agencies that provided responses, 67 percent involve consumers in some aspects of their health technology assessment (HTA) programs, compared with 57 percent in 2005. As in the earlier survey, most agencies reporting involvement have contact with consumer or patient organizations and a large minority also involve individual consumers. Summaries of HTA reports that are intended to be easily understood by consumers are prepared by 84 percent of the agencies, and 42 percent involve consumers in dissemination of HTA material. In both areas, there was some increase from the levels previously reported.

Conclusions: The survey results suggest that there is a trend to increased involvement of consumers by the INAHTA agencies in their programs but that the level of involvement remains relatively limited. The manner of consumer participation varies between agencies.

Objectives: In Austria, research in health technology assessment (HTA) has been conducted since the 1990s. The aim of this study is to analyze whether the HTA research program of the Institute of Technology Assessment (ITA) and the Ludwig Boltzmann Institute for HTA (LBI-HTA) have had an impact on the Austrian healthcare system.

Methods: We applied qualitative and quantitative empirical research methods, such as interviewing, download analysis, questionnaire, retrospective routine data analysis, and media analysis. Data were analyzed according to a conceptual framework, considering seven impact categories (awareness, acceptance, process, decision, practice, final outcomes, enlightenment) and different target groups.

Results: A rising number of downloads and single HTA reports with high media interest were identified. Interviews showed that HTA reports have increasingly been used for investment and reimbursement decisions, as well as for the preparation of negotiations. Economic impact was indicated by decreased expenditures due to HTA recommendations. Overall, knowledge about evidence-based medicine increased and, in places, an “HTA culture” can be recognized. Yet, several decision-making processes occur at all levels without the use of HTA.

Conclusions: The analysis demonstrated an impact within all predefined categories; however, it depends on the system level and its target groups. HTA reports are primarily used by hospital management, (social) insurances, and the Austrian Ministry of Health. Nevertheless, there is still potential to increase the impact of HTA. Therefore, the inclusion of HTA in decision-making processes in Austria needs to move from a voluntary basis to a mandatory one.

Objectives: The aim of this study was to estimate the relationship between the financial impact of a new drug and the recommendation for reimbursement by the Australian Pharmaceutical Benefits Advisory Committee (PBAC).

Methods: Data in the PBAC summary database were abstracted for decisions made between July 2005 and November 2009. Financial impact—the upper bound of the values presented in the PBAC summary database—was categorized as ≤A$0, >A$0 up to A$10 million, A$10 million up to A$30 million, and >A$30 million per year. Descriptive, logistic, survival, and recursive partitioning decision analyses were used to estimate the relationship between the financial impact of a new drug indication and the recommendation for reimbursement. Multivariable analyses controlled for other clinical and economic variables, including cost per quality-adjusted life-year gained.

Results: Financial impact was a significant predictor of the recommendation for reimbursement. In the logistic analysis, the odds ratios of reimbursement for drug submissions with financial impacts ≥A$10 million to ≥A$30 million or >A$0 to <A$10 million compared with ≤A$0 were 0.12 (95 percent confidence interval [CI]: 0.03–0.51) and 0.16 (95 percent CI: 0.04–0.60), respectively. In the recursive partition decision analysis, the first split of the data was for submissions with a positive financial impact compared with those with a zero or negative financial impact.

Conclusions: In Australia, financial impact on the drug budget is an important determinant of whether a new drug is recommended for reimbursement when cost-effectiveness estimates and other clinical and economic variables are controlled.

Pharmaceutical manufacturers, regulators, patients, providers, and payers all have a shared interest in improving health outcomes for patients with cancer. Each plays an important role in helping to achieve this common goal. Pharmaceutical manufacturers seek to develop new medicines that are supported by robust and clinically meaningful evidence of their safety, efficacy, and effectiveness. Regulators authorize these medicines based on evaluations of their safety and efficacy. Patients and providers together make treatment decisions and desire access to the most effective treatment options. Payers appraise new medicines with the goal of ensuring access to those medicines that constitute efficient uses of healthcare expenditure. Profits generated from the sale of the medicines provide a return to the manufacturer, which helps to drive continued research and development in an effort to improve patient health outcomes and societal well-being. Many payers have initiated health technology assessment (HTA) activities to inform decision making in light of the rising costs of health care. Given the financial constraints imposed as a result of the global economic crisis, HTAs are likely to become increasingly important as payers seek value for money solutions to major health problems. Successful collaboration and aligning incentives across stakeholders is critical to ensuring that patients are able to access the most effective medicines.