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: 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.”

Background: Polyethylene (PE) wear is a major contributor to implant loosening following total knee arthroplasty (TKA). Advanced bearings are therefore required in TKA to reduce or eliminate wear-related loosening. A recently introduced bearing that combines oxidized zirconium with highly cross-linked PE has been shown to drastically reduce wear in in vitro settings, due to its improved tribological characteristics in both tibial and femoral components. However, there are no data on its cost-effectiveness.

Data and Methods: A Markov model was developed to assess the cost-effectiveness of this low-wear bearing from a German societal perspective. The model population was derived from a registry of 75,000 patients requiring TKA. The model allocated patients to receive either a low-wear or standard articulation, and followed them until death. Revisions and re-revision were included. Input values were derived from registry databases or from published reports in the literature. Threshold analysis and probabilistic sensitivity analysis were conducted to estimate model robustness.

Results: The low-wear articulation prevented 24 (2.4 percent) revisions and 8 (0.8 percent) re-revisions. The total incremental cost-effectiveness ratio (ICER) of the low-wear articulation was EUR 16,474 per quality-adjusted life-year (QALY). For patients aged less than 55 years, an ICER of EUR 653 per QALY was observed. For patients aged over 75 years, this value was EUR 83,300. Threshold and probabilistic sensitivity analysis indicated that these findings were reasonably robust.

Conclusion: Low-wear articulations may be considered cost-effective, although the cost effectiveness is age-dependent, with the cost per QALY being significantly lower for younger people than for older people.

A major assessment of magnetic resonance imaging (MRI) in Australia influenced the early use of this technology and informed policy decisions on future MRI services. However, the impact of the assessment, and of government policy, on the subsequent diffusion of MRI has been more modest, reflecting the limitations of the evaluation process in a complex health care system.

This article describes the introduction into physiotherapy practice of Benesh Movement Notation, a method for recording observations of patients’ posture and movement sequences. Assessments of the technique show it to be a reliable and practical tool for clinical use.

Background: Home-fortification is a new strategy of adding micronutrients including zinc and iron to home-made foods. Zinc supplementation may prevent morbidity and mortality related to diarrheal illnesses, and iron supplementation may improve cognitive development, in children.

Objectives: To project clinical and economic effects of home-fortification in children in an urban slum of Karachi, Pakistan.

Methods: This is a cost benefit analysis of 5,000 simulated male and female infants (6–12 months) assigned to micronutrients or placebo for 4 months and followed for 55 years. We linked the effect of zinc on longitudinal prevalence of diarrhea to mortality, and the effect of iron on hemoglobin to IQ scores and lifetime earnings. Cost estimates were based on volumes of resource utilization from the Pakistan Sprinkles Diarrhea study. Main outcome was incremental benefit defined as the gain in lifetime earnings after accounting for the incremental costs of micronutrients over placebo (societal perspective).

Results: Our model projected that the reduction in diarrhea and improvement in hemoglobin concentrations through home-fortification was associated with reduced child mortality, higher IQ scores, and higher earnings. The present value of incremental benefit was $106 (95 percent probability interval = $17 to $193) U.S. dollars, which corresponds to $464.79 ($74.54 to $846.27) international dollars using a purchasing power parity exchange rate.

Conclusions: Home-fortification appears to improve clinical outcomes at a reasonable cost, and may actually be cost beneficial when lifetime earnings are considered.

Questions about the effectiveness of psychosocial interventions in pregnancy are important in any overall evaluation of antenatal care. This article reviews the evidence as to the positive benefit on a range of pregnancy outcomes provided by 35 published and unpublished randomized controlled trials of psychosocial interventions.

In a standard whole-body NMR-scanning machine, the static magnetic field is generated by an electric current driven through large solenoid coils. Dynamic magnetic gradient fields are generated by electric current pulses in coils located at various orientations, thus producing magnetic gradients in x, y, and z directions. The Rf (radiofrequency) radiation is transmitted through a specially shaped coil which also serves as an antenna receiving the NMR signals.

Objectives: International guidelines recommend annual mammography after early breast cancer, but there is no randomized controlled trial evidence to support this schedule over any other. Given that not all women have the same risk of recurrence, it is possible that, by defining different risk profiles, we could tailor mammographic schedules that are more effective and efficient.

Methods: A discrete event simulation model was developed to describe the progression of early breast cancer after completion of primary treatment. Retrospective data for 1,100 postmenopausal women diagnosed with early breast cancer in South Australia from 2000 to 2008 were used to calibrate the model. Women were divided into four prognostic subgroups based on the Nottingham Prognostic Index of their primary tumor. For each subgroup, we compared the cost-effectiveness of three different mammographic schedules for two different age groups.

Results: Annual mammographic follow-up was not cost-effective for most postmenopausal women. Two yearly mammography was cost-effective for all women with excellent prognosis tumors; and for women with good prognosis tumors if high compliance rates can be achieved. Annual mammography for 5 years and 2 yearly surveillance thereafter (a mixed schedule) may be cost-effective for 50- to 69-year-old women with moderate prognosis tumors, and for women aged 70–79 years with poor prognosis tumors. For younger women with poor prognosis tumors, annual mammography is potentially cost-effective.

Conclusions: Our results suggest that mammographic follow-up could be tailored according to risk of recurrence. If validated with larger datasets, this could potentially set the stage for personalized mammographic follow-up after breast cancer.

Objectives: Optional scientific advice (SA) for the early benefit assessment of pharmaceuticals is offered by the German decision maker, the Federal Joint Committee (FJC). The aim of this study was to elicit manufacturers’ experiences with the SA procedures offered by the FJC to date.

Methods: A preliminary survey on a small sample size was conducted. Subsequently, a questionnaire comprising eight items, which was developed on the basis of that survey, was used. Data were analyzed using qualitative and quantitative approaches.

Results: The elicitation, including a sample of 25 percent of the completed advice, highlighted the following, regarding the process as well as to the content shortcomings of the SA procedures from an industrial perspective: inconsistencies, FJC's lack of expertise in conducting clinical trials, partially incomplete answers. and a low willingness of the FJC to engage in dialogue with industry were criticized. On the other hand, the majority of respondents expressed a positive attitude concerning unambiguousness, completeness, traceability, discussion atmosphere, and the protocol of the advice. Early SA, before pivotal trials start, showed a significantly higher completeness compared with late SA with respect to endpoints and study duration. Within 4 years the quality of FJC's propositions on some topics improved significantly.

Conclusions: Only a few statistically significant differences were detectable between early versus late SA. A positive trend in industry's perception of the SA can be observed over time. A more active involvement of additional stakeholders and the incorporation of procedural elements from other healthcare systems could improve the quality of the SA offered by the FJC.

The 1983 Orphan Drug Act was designed in response to market and regulatory disincentives that limited industrial interest in developing drugs needed by people in the United States with rare diseases and conditions. These disincentives evolved from changes in the pharmaceutical industry and in regulatory testing requirements. In the eight years since the Act and subsequent amendments have been in effect, the law has been associated with the new development and approval of 40 marketed drugs and 12 biologicals to treat rare (orphan) diseases. An additional 281 drugs and 141 biologicals have been entered into development and designated as orphans. Finally, the law has mandated exploration of whether the incentives of the Act are necessary and appropriate for stimulating industrial development of orphan medical drugs and devices. Despite this progress, controversies have arisen over three profitable orphan products that have benefited from the law's provisions. This has created the need for continued assessment of the Act's benefits and costs.

Objectives: To determine the need for and implement health technology assessment (HTA) to inform decision making and policy within a regional health care system in Calgary (Alberta, Canada).

Methods: Published literature and organizational materials for the Calgary Health Region (CHR) and HTA units worldwide were reviewed. Key individuals within the provincial health ministry (Alberta Health and Wellness), CHR, the University of Calgary (U of C), funding agencies, and HTA organizations were consulted in a structured fashion. A structure for a regional HTA program was developed, taking into account relationships between these organizations.

Results: A locally focused HTA and implementation unit was deemed desirable. The Calgary Health Technology Implementation Unit (CaHTIU) was established. The CaHTIU was designed to efficiently integrate with CHR planning as well as undertake independent research activities. HTA activities focus primarily on CHR needs and are managed by a Health Technology Advisory Committee (HTAC) that consists of CHR management and other key individuals. Working groups contribute to and coordinate HTAs and implementation under the leadership of the unit Director, and include content as well as management individuals. The unit cooperates where appropriate with extant Canadian HTA organizations.

Conclusions: The Calgary HTA unit is unique in Canada, because it functions within a regional health care system as well as a research institution. Advantages include a local focus in terms of applied HTAs, a systematic process for implementation of recommendations, and a collaborative atmosphere for research within the U of C.This work was supported by the Calgary Health Technology Implementation Unit. The authors thank Dr. Lloyd Sutherland of the University of Calgary and Dr. Dev Menon of the Institute of Health Economics for their important roles in the formation of the Calgary Health Technology Implementation Unit.

Objectives: This study aimed to validate the accuracy of data retrieved in a prospective multicenter trial, the purpose of which was an economic evaluation of two techniques of surgery for colon cancer.

Methods: Within the Swedish contribution of the COLOR trial (Colon Cancer Open or Laparoscopic Resection), an economic evaluation of open versus laparoscopic surgical techniques was conducted. Data were collected by case record forms (CRF), patient diaries, and telephone surveys every 2 weeks. The study period was 12 weeks, and the perspective was societal. Data from the first consecutive forty patients to complete the health economic study protocol were validated. Retrieved data were compared with data from medical records and data from local social security offices for agreement.

Results: Statistically significant differences were found for duration of anesthesia, length of surgery, number of outpatient consultations by doctors and district nurses, complication rate, and the use of central venous lines. No significant differences were observed concerning length of hospital stay, disposable instruments cost, and time off work, all of which heavily influence total costs.

Conclusions: The present method of data collection regarding resources used in this setting seems to produce accurate data for economic evaluation; however, relative to complication rates, the method did not retrieve accurate data.

There has been a rapid growth of healthcare technology assessment (HTA) activities among health service researchers and physicians in Japan in the younger generation since the mid-1980s. HTA has become visible since the Ministry of Health, Labor, and Welfare (MHLW) set up the several committees related to HTA in the late 1990s. The MHLW had to participate in regulatory and administrative reform, coping with the serious economic stagnation since 1991, following the economic recession in the 1980s. However, HTA has not been developed as expected. The most important failure is that the application of HTA to health policy has been neglected by the MHLW. Only application to clinical practice has been implemented by developing evidence-based clinical practice guidelines. The MHLW had the main aim of containing costs by reducing excess or useless healthcare services through guidelines, rather than to implement a radical reform. Without a central organization for HTA, several researchers have still continued to do HTA studies, but most researchers and physicians promoting HTA have been moved into diverse related areas. Ultimately, increasing efficiency may be the only way of reconciling rising demands for health care with public financing constraints. Therefore, the reconsideration and reorganization of HTA, which covers not only healthcare services but also the healthcare system as a whole, is becoming an urgent matter for healthcare reform.

In this theme section on early awareness and alert (EAA) systems and activities, we are pleased to present a series of articles covering the structure of EAA systems, their development and integration into decision making for the adoption and use of new and emerging health technologies, and the methods used by current networks, systems, and organizations.

Objectives: Lung cancer has been the most common cancer since 1985, accounting for 12–13 percent of cancer cases worldwide. Newer targeted therapies with potential increased survival benefits may not be affordable to patients. Many countries use arbitrary thresholds to determine whether a medical intervention is cost-effective. As such, many effective, albeit expensive, therapies are not being reimbursed. To understand the value placed on effective therapies, this study evaluates the patient and public willingness to pay (WTP) for a quality-adjusted life-year (QALY) for lung cancer treatments using Thailand as an example.

Methods: A total of 300 subjects responded to hypothetical lung cancer health states, described by three levels of severity and two levels of side effects, and provided their valuation of the level of quality of life and their WTP to improve from one state to another.

Results: The patients with the lowest income and general public were willing to pay more than twice the threshold for acceptability in Thailand (US Dollar 5,123/QALY [Thai Baht 160,000/QALY]). This increased significantly by wealth category. Patients’ WTP was associated with quality of life, financial difficulties, health insurance, diarrhea, and wealth.

Conclusions: The current study highlights the value patients and general public place on effective lung cancer therapies.

Objectives: The aim of this study was to evaluate the cost-utility of Docetaxel with doxorubicin and cyclophosphamide (TAC) and 5-fluorouracil, doxorubicin, cyclophosphamide (FAC) in node-positive breast cancer patients in the south of Iran.

Methods: A double blind study was done on a cohort of 100 patients suffering from breast cancer with node-positive over 8 months in the radiotherapy center of Namazi hospital, Shiraz-Iran. Health-related quality of life was assessed using questionnaire (QLQ-C30) from European Organization for Research and Treatment of Cancer (EORTC). QLQ-C30 scale scores were mapped to 15D and EuroQol 5D utilities to measure the quality-adjusted life-years (QALYs).Third party payer point of view was applied to measure and value the cost of treatments. Cost data were extracted from hospital and health insurance organizations. Robustness of the results was checked through a two way sensitivity analysis.

Results: TAC was associated with higher deterioration in HRQoL during treatment and higher improvements over 4 months follow-up. On average, the cost of treatment per patient in TAC was 15 times higher than FAC (p < .001). In overall, TAC was resulted in lower QALYs and higher cost over study period.

Conclusions: FAC was a dominant option versus TAC in short-term. The higher improvement in HRQoL over follow-up in TAC may not compensate the more intensive deterioration caused during treatment in short-term. The short time horizon of study may limit the generalizability of our findings and, hence, there is a need to conduct long-term economic evaluation studies whenever data is available to inform decision making.