Objectives: This study aims to examine the impact of European Union (EU) law relating to information technology (IT) on health systems.

Methods: The study identifies EU directives relating to IT, analyzes them in terms of their impact on the use of IT in health systems, and outlines their implications for health technology assessment (HTA). Analysis is based on a review of literature identified through relevant databases and Internet searches.

Results: Developments in IT have serious implications for EU health systems, presenting policy makers with new challenges. The European Commission has adopted a range of legal measures to protect consumers in the “information society” However, as few of them are health-specific, it is not evident that they have implications for health, health systems, or HTA, and they may not be effective in protecting consumers in the health sector.

Conclusions: In light of the growing importance of IT in the health sector, legal and nonlegal measures need to be further developed at EU and international level. Where possible, future initiatives should pay attention to the particular characteristics of health goods and services and health systems. Although definitions of HTA usually recognize the importance of evaluating both the indirect, unintended consequences of health technologies and the legal aspects of their application, it seems that, in practice, HTA often overlooks or underestimates legislative matters. Those involved in HTA should be aware of the legal implications of using IT to provide health goods and services and compile, store, transfer, and disseminate health information electronically.

Objectives: This paper describes the development and findings for a policy brief on “Advancing the Integration of Palliative Care into the National Health System” and the subsequent use of this report.

Methods: Key stakeholders involved with palliative care helped identify the problem and potential policy solutions to scale up these services within the health system. A working group of national stakeholder representatives and external reviewers commented on and contributed to successive drafts of the report. Research describing the problem, policy options and implementation considerations was identified by reviewing government documents, routinely collected data, electronic literature searches, contact with key informants, and reviewing the reference lists of relevant documents that were retrieved.

Results: The palliative burden is not only high but increasing due to the rise in population and life expectancy. A few options for holistic, supportive care include: Home-based care increases chances of a peaceful death for the terminally ill surrounded by their loved ones; supporting informal caregivers improves their quality of life and discharge planning reduces unscheduled admissions and has the potential to free up capacity for acute care services. A combination of strategies is needed to effectively implement the proposed options as discussed further in this article.

Conclusions: The policy brief report was used as a background document for two stakeholder dialogues whose main outcome was that a comprehensive national palliative care policy should be instituted to include all the options, which need to be integrated within the public health system. A draft policy is now in process.

Objectives: Health technology assessment (HTA) has been used as input in decision making worldwide for more than 25 years. However, no uniform definition of HTA or agreement on assessment methods exists, leaving open the question of what influences the choice of assessment methods in HTAs. The objective of this study is to analyze statistically a possible relationship between methods of assessment used in practical HTAs, type of assessed technology, type of assessors, and year of publication.

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

Results: The study shows that outsourcing of HTA reports to external partners is associated with a higher likelihood of using assessment methods, such as meta-analysis, surveys, economic evaluations, and randomized controlled trials; and with a lower likelihood of using assessment methods, such as literature reviews and “other methods.” The year of publication was statistically related to the inclusion of economic evaluations and shows a decreasing likelihood during the year span. The type of assessed technology was related to economic evaluations with a decreasing likelihood, to surveys, and to “other methods” with a decreasing likelihood when pharmaceuticals were the assessed type of technology.

Conclusions: During the period from 1989 to 2002, no major developments in assessment methods used in practical HTAs were shown statistically in a sample of 433 HTAs worldwide. Outsourcing to external assessors has a statistically significant influence on choice of assessment methods.

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.

Objectives: Internationally, funders require stakeholder involvement throughout health technology assessment (HTA). We report successes, challenges, and lessons learned from extensive stakeholder involvement throughout a palliative care case study that demonstrates new concepts and methods for HTA.

Methods: A 5-step “INTEGRATE-HTA Model” developed within the INTEGRATE-HTA project guided the case study. Using convenience or purposive sampling or directly / indirectly identifying and approaching individuals / groups, stakeholders participated in qualitative research or consultation meetings. During scoping, 132 stakeholders, aged ≥ 18 years in seven countries (England, Italy, Germany, The Netherlands, Norway, Lithuania, and Poland), highlighted key issues in palliative care that assisted identification of the intervention and comparator. Subsequently stakeholders in four countries participated in face–face, telephone and / or video Skype meetings to inform evidence collection and / or review assessment results. An applicability assessment to identify contextual and implementation barriers and enablers for the case study findings involved twelve professionals in the three countries. Finally, thirteen stakeholders participated in a mock decision-making meeting in England.

Results: Views about the best methods of stakeholder involvement vary internationally. Stakeholders make valuable contributions in all stages of HTA; assisting decision making about interventions, comparators, research questions; providing evidence and insights into findings, gap analyses and applicability assessments. Key challenges exist regarding inclusivity, time, and resource use.

Conclusion: Stakeholder involvement is feasible and worthwhile throughout HTA, sometimes providing unique insights. Various methods can be used to include stakeholders, although challenges exist. Recognition of stakeholder expertise and further guidance about stakeholder consultation methods is needed.

Objectives: The regularly structured adaptation of health technology assessment (HTA) programs is of utmost importance to sustain the relevance of the products for stakeholders and to justify investment of scarce financial resources. This study describes internal adjustments and external measures taken to ensure the Horizon Scanning Programme in Oncology (HSO) is current.

Methods: Formal evaluation methods comprising a survey, a download, an environmental analysis, and a Web site questionnaire were used to evaluate user satisfaction.

Results: The evaluation showed that users were satisfied with HSO outputs in terms of timeliness, topics selected, and depth of information provided. Discussion of these findings with an expert panel led to changes such as an improved dissemination strategy and the introduction of an additional output, that is, the publication of a league table of emerging oncology drugs. The rather high level of international usage and the environmental analysis highlighted a considerable overlap in topics assessed and, thus, the potential for international collaboration. As a consequence, thirteen reports were jointly published based on eleven “calls for collaboration.” To further facilitate collaboration and the usability of reports for other agencies, HSO reports will be adjusted according to tools developed at a European level.

Conclusions: Evaluation of the impact of HTA programs allows the tailoring of outputs to fit the needs of the target population. However, within a fast developing HTA community, estimates of impact will increasingly be determined by international collaborative efforts. Refined methods and a broader definition of impact are needed to ultimately capture the efficiency of national HTA programs.

The development of various symphysis fundus (SF) growth charts and the use of SF height measurements in the diagnosis of small-for-gestational-age (SGA) births and the prediction of newborn complications are reviewed. Measurement precision and accuracy are also discussed. It is concluded that further research of this simple, low cost, harmless, and widespread technology to detect fetal growth disturbances in routine prenatal care is warranted.

Chinese hospitals in the 1980s are in the midst of a technological revolution. Based upon data from several regions in China, this paper describes the political, organizational, economic, and philosophical changes which have accompanied the shift in focus from primary care medicine to high technology tertiary care. The increased authority of physicians, greater contact with the West, and increased funding for medical equipment are key factors in these changes. Although the Chinese state continues to control the administration and financing of most hospitals, the decentralizing reforms of Deng Xiaoping have undermined its ability to effectively plan for, and assess new technology. At present, limited resources prevent most regions from excessive technology acquisition, but the state must rebuild its planning capacity in order to foster rational allocation of scarce medical resources.

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.

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.

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.

Objectives: Health technology assessment (HTA) yields information that can be ideally used to address deficiencies in health systems and to create a wider understanding of the impact of different policy considerations around technology reimbursement and use. The structure of HTA programs varies across different jurisdictions according to decision-maker needs. Moreover, conducting HTA requires specialized skills. Effective decision making should include multiple criteria (medical, economic, technical, ethical, social, legal, and cultural) and requires multi-disciplinary teams of experts working together to produce these assessments. A workshop explored the multi-disciplinary skills and competencies required to build an effective and efficient HTA team, with a focus on low- and middle-income settings.

Methods: This proceeding summarizes main points from a workshop on capacity building, drawing on presentations and group discussions among attendees including different points of view.

Results and Conclusions: The workshop and thus this study would have benefited from a larger variety of stakeholders. Therefore, the conclusions arising from the workshop are not the opinion of a representative sample of HTA professionals. Nonetheless, organizations and speakers were carefully selected to provide a valuable approach to this theme. Thus, these proceedings highlight some of the gaps and needs in the education and training programs offered worldwide and calls for further investigation.

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.

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.

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.