Objectives: The aim of this study was to determine organizational characteristics evident in successful telemedicine programs. The study proposed four research questions to identify the key organizational characteristics for successful telemedicine programs.

Methods: Data were collected through an online survey using modified unified theory of acceptance and use of technology (UTAUT) and organizational change readiness (ORC) validated assessments.

Results: Using the UTAUT instrument and the ORC assessment, themes of successful telemedicine programs emerged. Overarching themes of successful programs included being formally structured, forward thinking, seeking to improve the quality of patient care, and being financially stable.

Conclusions: This research provides a data-driven understanding of organizational issues that serve to maximize a telemedicine program's ability to achieve the overall goals and mission of a healthcare organization.

Objectives: Technologies in health care are evolving quickly, with new findings in the area of biotechnological and genetic research being published regularly. A health technology assessment (HTA) is often used to answer the question of whether the new technology should be implemented into clinical practice. International evidence confirms that the results of HTA research sometimes have limited impact on practical implementation and on coverage decisions; the study design is commonly based on the paradigm of stability of both the technology and the environment, which is often not the case. Constructive technology assessment (CTA) was first described in the 1980s. In addition to the traditional HTA elements, this approach also takes into account the technology dynamics by emphasizing sociodynamic processes. With a CTA approach, comprehensive assessment can be combined with an intentional influence in a favorable direction to improve quality.

Methods: In this study, the methodological aspects mainly concerning the diagnostic use of CTA are explained. The methodology will be illustrated using the controlled introduction of a new technology, called microarray analysis, into the clinical practice of breast cancer treatment as a case study. Attention is paid to the operationalization of the phases of development and implementation and the research methods most appropriate for CTA.

Conclusions: In addition to HTA, CTA can be used as a complementary approach, especially in technologies that are introduced in an early stage of development in a controlled way.

Objectives: Values are intrinsic to the use of health technology assessments (HTAs) in health policy, but neglecting value assumptions in HTA makes their results appear more robust or normatively neutral than may be the case. Results of a 2003 survey by the International Network of Agencies for Health Technology Assessment (INAHTA) revealed the existence of disparate methods for making values and ethical issues explicit when conducting HTA.

Methods: An Ethics Working Group, with representation from sixteen agencies, was established to develop a framework for addressing ethical issues in HTA. Using an iterative approach, with email exchanges and face-to-face workshops, a report on Handling Ethical Issues was produced.

Results: This study describes the development process and the agreed upon framework for reflexive ethical analysis that aims to uncover and explore the ethical implications of technologies through an integrated, context-sensitive approach and situates the proposed framework within previous work in the development of ethics analysis in HTA.

Conclusions: It is important that methodological approaches to address ethical reflection in HTA be integrative and context sensitive. The question-based approach described and recommended here is meant to elicit this type of reflection in a way that can be used by HTA agencies. The questions proposed are considered only as a starting point for handling ethics issues, but their use would represent a significant improvement over much of the existing practice.

Objectives: As an initiative of the International Network of Agencies for Health Technology Assessment, an approach to assessment of telemedicine applications was prepared to assist decision makers who are considering introduction and use of this technology.

Methods: Review and commentary drawing on published assessment frameworks and reports of primary evaluations of telemedicine, with particular reference to experience in Finland and Canada.

Results: Elements of the approach included development of a business case (considering population and services, personnel and consumers, delivery arrangements, specifications and costs); subsequent evaluation of the telemedicine application; and follow-up (covering the domains of technical assessment, effectiveness, user assessment of the technology, costs of telemedicine, trials, economic evaluation methods, and sensitivity analysis).

Conclusions: Decision makers should link introduction of new and often costly technology to appraisal of its feasibility, followed by evaluation of the application, including longer term consideration of its sustainability and impact on the healthcare system. As the effectiveness and efficiency of telemedicine applications will often be strongly influenced by local issues, results of assessments may not be generalizable.

Menorrhagia, or heavy regular menstrual bleeding, represents a major health burden to women. Trials comparing abdominal hysterectomy (AH) with transcervical resection of the endometrium (TCRE) for the condition have shown that, although the duration and severity of convalescence is less with TCRE, AH produces a permanent solution to heavy bleeding while TCRE fails in a proportion of women by 2 years. However, by 2 years, TCRE costs only 71% that of AH. This paper presents a cost-utility analysis to assess which procedure is more cost-effective overall. Under most plausible parameter values and on the basis of health state values elicited from a sample of women with menorrhagia, AH is likely to be considered more cost-effective than TCRE if purchasers are willing to pay an additional cost of at least £6,500 per extra quality-adjusted life-year generated by AH.

Objectives: There have been very few assessments of the economics of home telemonitoring, and the quality of evidence has often been weakened by methodological flaws. This has made it difficult to compare telehomecare with traditional home care for the chronic diseases studied. This economic analysis is an attempt to address this gap in the literature.

Methods: We have analyzed the consumption of healthcare services by 95 patients with various chronic diseases over a 21-month period, that is, 12 months before, 4 months during home telemonitoring use, and over 5 months after withdraw of the technology.

Results: Our findings indicate significant benefits to the home telemonitoring program as evidenced by large reductions in number of hospitalizations, length of average hospital stay, and, to a lesser extent, number of emergency room visits. Contrary to expectations, however, the number of home visits by nurses increased both during and after the telemonitoring intervention. In terms of the financial analysis, the telehomecare program resulted in significant savings: the equivalent of over CAD1,557 per patient as calculated on an annualized basis. This represents a net gain of 41 percent as compared to traditional home care.

Conclusions: While the present economic analysis led to positive results, additional assessments should be conducted to confirm the cost-effectiveness of this mode of care delivery.

Objectives: Stress urinary incontinence affects between 10 percent and 50 percent of women. Surgery is commonly recommended for troublesome incontinence that does not respond to nonsurgical management. Tension-free vaginal tape (TVT) is a newer, minimal access surgical sling procedure, which is being increasingly adopted worldwide. The cost-effectiveness of TVT in comparison with other surgical procedures, particularly open colposuspension, is assessed.

Methods: Effectiveness estimates came from a systematic review of TVT compared with other surgical procedures (open and laparoscopic colposuspension, traditional slings, and injectables). Deterministic and probabilistic analyses were used to assess the likelihood of TVT being cost-effective. Sensitivity analyses assessed the impact of changing assumptions about cure rates and costs for TVT, cure rates for retreatment open colposuspension, and proportions of women who choose retreatment.

Results: Reliable estimates of relative effectiveness were difficult to derive because the few randomized controlled comparisons had not been optimally analyzed or fully reported. Results of the economic model suggested that TVT dominates open colposuspension (lower cost and same quality of life years[QALYs]) within 5 years after surgery. Stochastic analysis indicated that the likelihood of TVT being cost-effective was 100 percent if decision-makers are unwilling to pay for additional QALYs. TVT's dominance depended on the assumption fact that retreatment open colposuspension has lower cure rates than a first colposuspension.

Conclusions: Analysis based on current short-term data indicates dominance of TVT over open colposuspension from approximately 5 years. There is a need for longer-term follow-up data from methodologically rigorous randomized trials to provide a sounder basis for estimating the relative benefits and cost implications.

This article examines European Union (EU) and member state regulation of medical devices, particularly: a) the similarities and differences between medical devices and prescription drugs, including the respective industries, market authorization pathways, and boundary issues between the two sectors; b) the political background, current nature, and future prospects for EU medical device regulation; and c) regulatory responsibilities of the member states. Included are definitions of medical devices and in vitro diagnostics, and a brief history of their treatment by European law. The erosion of boundaries between exclusive and shared responsibilities of the EU and member states will be addressed, especially as it affects market approval of medical devices, clinical investigations, labeling and instructions for use, price setting and reimbursement, and evidence-based medicine and healthcare technology assessment. Finally, the article discusses medical device reporting and surveillance systems, which may be the weakest link in the EU integrative process. If patient safety is as important to the EU regulatory scheme as free movement and competitiveness, then both Brussels and member states will require additional resources, as well as measures to overcome obstacles to implementation, evaluation, and accountability.

Objective: To explore whether more could be done to increase the implementation of health technology assessment (HTA) findings.

Methods: A literature review was undertaken to identify the main barriers to implementation, the mechanisms that influence the diffusion and use of health technologies, and evidence of the successful implementation of findings.

Results: Numerous barriers to the implementation of HTA findings exist at the public policy, health- care professional, and general public levels. Several mechanisms for influencing the use of health technologies exist, and there are some examples of findings being implemented through these mechanisms. However, there are also concerns about the aggressive implementation of findings. A balanced approach to the implementation of HTAs is required.

Conclusion: The main elements of a successful implementation strategy are: a) defining a clear policy question; b) defining a clear research question; c) making recommendations commensurate with the evidence; d) identifying the implementation mechanism; e) paying attention to incentives and disincentives; and f) clarifying the roles and responsibilities of the various parties. Further research is also required into several aspects of implementation.

Objectives: The use of ultrasonography and computed tomography (CT) in the diagnosis of appendicitis in adult patients was compared.

Methods: Systematic review and meta-analysis of current evidence in two clinical situations: unselected nonpregnant, adult patients with symptoms of appendicitis, and more selective use in only those patients who still have an equivocal diagnosis subsequent to routine clinical investigations.

Results: Meta-analysis of eligible studies shows CT to have better sensitivity and specificity than ultrasound in both clinical situations.

Conclusions: Application of these findings in clinical practice and/or policy would need to evaluate the better diagnostic performance of CT against its cost and availability. In addition, it is imperative that future studies be conducted in patient populations that are well-defined with respect to prior investigations. Sequelae of false-negative and false-positive diagnoses should also be evaluated.

Objectives: Health technology assessment (HTA) was established in Austria in the 1990s and, since then, it has gained considerable importance. In this study, we aim to analyze whether the HTA reports that have been produced at the Institute for Technology Assessment (ITA) and at the Ludwig Boltzmann Institute for HTA (LBI-HTA) have had an impact on decision making within the Austrian health care system.

Methods: We selected all reports that were intended for supporting (i) reimbursement/investment or (ii) disinvestment decisions. Eleven full HTA reports and fifty-eight rapid assessments fulfilled the inclusion criteria. We used interview data and administrative data on volumes, tariffs and expenditure of products/services to analyze whether and how reports were in reality used in decision making and what the consequences for health care expenditure and resource distribution have been.

Results: Five full HTA reports and fifty-six rapid technology assessments were used for reimbursement decisions. Four full HTA reports and two rapid assessments were used for disinvestment decisions and resulted in reduced volumes and expenditure. Two full HTA reports showed no impact on decision making. Impact was most evident for hospital technologies.

Conclusions: HTA has played some role in reducing volumes of over-supplied hospital technologies, resulting in reduced expenditure for several hospital providers. Additionally, it has been increasingly included in prospective planning and reimbursement decisions of late, indicating re-distribution of resources toward evidence-based technologies. However, further factors may have influenced the decisions, and the impact could be considerably increased by systematically incorporating HTA into the decision-making process in Austria.

The Uniform Data System for Medical Rehabilitation (UDSmr) provides a method for uniform assessment of the severity of patient disability and the outcomes of medical rehabilitative care. The effectiveness and efficiency of medical rehabilitation services may be analyzed using the Functional Independence Measure (FIM), the functional assessment component of the UDS, and other data. Program evaluation models based on the UDSMR and the FIM are useful for measuring resource cost of disability.

We present the prospective economic evaluation that served as a secondary endpoint for the FIRST study, a randomized international multicenter trial of patients with severe congestive heart failure. Although the clinical results of this study were disappointing, we demonstrated the feasibility of incorporating prospective economic evaluation in phase III clinical trials.

As more countries use HTA to inform decisions on the reimbursement of health technologies, harmonization of evidence requirements between jurisdictions has been proposed, mainly on the grounds of improved efficiency. Harmonization has the potential to avoid duplication of effort for both manufacturers and HTA bodies involved in preparing and reviewing HTA submissions for innovative technologies. However, it also carries risks of loss of local control over decisions, the application of general data standards which are not universally accepted and slowing the rate of development of innovation in the analytical disciplines supporting HTA. This study reviews the issues associated with harmonization taking into account the perspectives of the multiple stakeholders. This study draws on experiences from recent initiatives intended to promote the harmonization of HTA and experience from related fields, particularly regulatory approval of new medical technologies.

Objectives: The purpose of this health technology assessment (HTA), commissioned by the German Federal Ministry of Health and Social Security, was to systematically review the evidence for the effectiveness and cost-effectiveness of antiviral treatment (AVT) with interferon (INF) or peginterferon (PegIFN) in combination with ribavirin (RBV) in treatment-naïve patients with chronic hepatitis C (CHC) and to apply these data in the context of the German health-care system.

Methods: We performed a systematic literature search on effectiveness and cost-effectiveness of AVT and summarized results using meta-analysis and evidence tables. We applied the German Hepatitis C Model (GEHMO), a decision-analytic Markov model, to determine long-term clinical effectiveness, costs, and incremental cost-effectiveness ratios (ICER) of the examined treatment strategies. Model parameters were derived from German databases, published international randomized clinical trials (RCT), and a Cochrane Review.

Results: Overall, nine RCTs, two HTA reports, one Cochrane review, two meta-analyses, and seven economic evaluations met the inclusion criteria. These studies indicate that PegIFN+RBV achieved the highest sustained virological response rates (SVR) (54–61 percent), followed by IFN+RBV (38–54 percent) and IFN monotherapy (11–21 percent). Based on our meta-analysis, PegIFN+RBV reduced cases without SVR by 17 percent compared with INF+RBV. International cost-effectiveness studies indicate that INF+RBV is cost-effective when compared with INF monotherapy. For PegIFN+RBV, our decision analysis yielded an ICER of €9,800 per quality-adjusted life-year gained.

Conclusions: This HTA suggests that initial combination therapy prolongs life, improves quality of life, and is cost-effective in patients with CHC. Peginterferon plus ribavirin is the most effective and efficient treatment among the examined options. However, because not all chronic hepatitis C patients will develop progressive liver disease, a thorough assessment of the eligibility and appropriateness of treatment with combination therapy must be performed in each individual patient.

Background: The way in which a health technology is used in any particular health system depends on the decisions and actions of a variety of stakeholders, the local culture, and context. In 2009, the HTAi Policy Forum considered how health technology assessment (HTA) could be improved to optimize the use of technologies (in terms of uptake, change in use, or disinvestment) in such complex systems.

Methods: In scoping, it was agreed to focus on initiatives to implement evidence-based guidance and monitoring activities. A review identified systematic reviews of implementation initiatives and monitoring activities. A two-day deliberative workshop was held to discuss key papers, members’ experiences, and collectively address key questions. This consensus paper was developed by email and finalized at a postworkshop meeting.

Results: Evidence suggests that the impact and use of HTA could be increased by ensuring timely delivery of relevant reports to clearly determined policy receptor (decision-making) points. To achieve this, the breadth of assessment, implementation initiatives such as incentives and targeted, intelligent dissemination of HTA result, needs to be considered. HTA stakeholders undertake a variety of monitoring activities, which could inform optimal use of a technology. However, the quality of these data varies and is often not submitted to an HTA.

Conclusions: Monitoring data should be sufficiently robust so that they can be used in HTA to inform optimal use of technology. Evidence-based implementation initiatives should be developed for HTA, to better inform decision makers at all levels in a health system about the optimal use of technology.

Objectives: A comprehensive and systematic assessment (HTA) of early home-supported discharge by a multidisciplinary team that plans, coordinates, and delivers care at home (EHSD) was undertaken and the results were compared with that of conventional rehabilitation at stroke units.

Methods: A systematic literature search for randomized trials (RCTs) on “early supported discharge” was closed in April 2005. RCTs on EHSD without information on (i) death or institution at follow-up, (ii) change in Barthél Index, (iii) length of hospital stay, (iv) intensity of home rehabilitation, or (v) baseline data are excluded. Seven RCTs on EHSD with 1,108 patients followed 3–12 months after discharge are selected for statistical meta-analysis of outcomes. The costs are calculated as a function of the average number of home training sessions. Economic evaluation is organized as a test of dominance (both better outcomes and lower costs).

Results: The odds ratio (OR) for “Death or institution” is reduced significantly by EHSD: OR = .75 (confidence interval [CI], .46–.95), and number needed to treat (NNT) = 14. Referrals to institution have OR = .45 (CI, .31–.96) and NNT = 20. The reduction of the rate of death is not significant. Length of stay is significantly reduced by 10 days (CI, 2.6–18 days). All outcomes have a nonsignificant positive covariance. The median number of home sessions is eleven, and the average cost per EHSD is 1,340 USD. The “action mechanism” and financial barriers to EHSD are discussed.

Conclusions: EHSD is evidenced as a dominant health intervention. However, financial barriers between municipalities and health authorities have to be overcome. For qualitative reasons, a learning path of implementation is recommended where one stroke unit in a region initiates EHSD for dissemination of new experience to the other stroke units.

Objectives: This study assesses whether pegylated interferon and ribavirin is cost-effective compared with no antiviral treatment provided in routine clinical practice, for different patient subgroups.

Methods: The cost-effectiveness analysis (CEA) uses a Markov decision model to estimate the lifetime cost per quality-adjusted life-year (QALY) of antiviral treatment compared with no treatment. The model is populated with data on sustained virological responses, costs, and transition probabilities all taken from a large representative sample of UK cases and centers (Trent HCV database).

Results: The CEA found that pegylated interferon and ribavirin was cost-effective for most patient subgroups. The CEA found that for patients with genotype non-1, the intervention led to cost reductions and gains of at least 0.5 QALYs. For genotype 1 cases with mild or moderate disease, and younger cirrhotic patients (aged 40 or less), costs per QALY remained below £20,000 ($40,000 or €29,000). For genotype 1 cases with cirrhosis aged 50, the mean cost per QALY rose to over £60,000 ($120,000 or €87,000).

Conclusions: The study concludes that, based on cost and effectiveness data collected from routine clinical practice, treatment with pegylated interferon and ribavirin is generally cost-effective. The study shows that there are variations according to patient subgroup and for older (aged 50 or over) genotype 1 patients with cirrhosis, antiviral treatment appears less cost-effective.

Objectives: To estimate willingness to pay (WTP) for effective treatment in a sample of obese individuals and to examine whether WTP is associated with factors reflecting the severity of obesity as well as a number of other variables such as age, sex, education, and income.

Methods: WTP and data on the severity of obesity were collected from the study, Swedish Obese Subjects. Associations between WTP, income, and obesity-related factors were analyzed by linear regression.

Results: The mean age was 47 years (range, 37 through 59 years) and the mean body mass index (BMI) was 39.6 kg/m2 (n = 3,549). Average personal monthly income was SEK 13,000 (≈ US $1,585), average WTP was SEK 26,900 (≈ US $3,280) and the median value was SEK 10,900 (≈ US $1,330). A high WTP was associated with high personal and household income, high weight, high education, female sex, poor perceived health, low current age, and low age at onset of obesity. Over 50% of the patients deemed it necessary to borrow money to cover their WTP. When adding a loan to the regression analysis, the associations between WTP and perceived health, age, and gender disappeared.

Conclusion: Obese patients are willing to pay approximately twice their monthly salary for effective treatment and a higher WTP is associated with higher weight and poorer perceived health.

Objectives: High-quality clinical evidence is most often lacking when novel high-risk devices enter the European market. At the same time, a randomized controlled trial (RCT) is often initiated as a requirement for obtaining market access in the US. Should coverage in Europe be postponed until RCT data are available? We studied the premarket clinical evaluation of innovative high-risk medical devices in Europe compared with the US, and with medicines, where appropriate.

Methods: The literature and regulatory documents were checked. Representatives from industry, Competent Authorities, Notified Bodies, Ethics Committees, and HTA agencies were consulted. We also discuss patient safety and the transparency of information.

Results: In contrast to the US, there is no requirement in Europe to demonstrate the clinical efficacy of high-risk devices in the premarket phase. Patients in Europe can thus have earlier access to a potentially lifesaving device, but at the risk of insufficiently documented efficacy and safety. Variations in the stringency of clinical reviews, both at the level of Notified Bodies and Competent Authorities, do not guarantee patient safety. We tried to document the design of premarket trials in Europe and number of patients exposed, but failed as this information is not made public. Furthermore, the Helsinki Declaration is not followed with respect to the registration and publication of premarket trials.

Conclusions: For innovative high-risk devices, new EU legislation should require the premarket demonstration of clinical efficacy and safety, using an RCT if possible, and a transparent clinical review, preferably centralized.