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.

There is growing interest globally in using real-world data (RWD) and real-world evidence (RWE) for health technology assessment (HTA). Optimal collection, analysis, and use of RWD/RWE to inform HTA requires a conceptual framework to standardize processes and ensure consistency. However, such framework is currently lacking in Asia, a region that is likely to benefit from RWD/RWE for at least two reasons. First, there is often limited Asian representation in clinical trials unless specifically conducted in Asian populations, and RWD may help to fill the evidence gap. Second, in a few Asian health systems, reimbursement decisions are not made at market entry; thus, allowing RWD/RWE to be collected to give more certainty about the effectiveness of technologies in the local setting and inform their appropriate use. Furthermore, an alignment of RWD/RWE policies across Asia would equip decision makers with context-relevant evidence, and improve timely patient access to new technologies. Using data collected from eleven health systems in Asia, this paper provides a review of the current landscape of RWD/RWE in Asia to inform HTA and explores a way forward to align policies within the region. This paper concludes with a proposal to establish an international collaboration among academics and HTA agencies in the region: the REAL World Data In ASia for HEalth Technology Assessment in Reimbursement (REALISE) working group, which seeks to develop a non-binding guidance document on the use of RWD/RWE to inform HTA for decision making in Asia.

We challenge assumptions that have guided much research and policy aimed at understanding and reducing medical practice variation. Paramount is the focus on doctors as the cause of variation to the neglect of other possible influences. Some research literature suggests that patients, families, and the community context of practice may also influence treatment decisions. Failure to question present assumptions, despite weak evidence in support of them, may account for inability to explain persistent practice variation, develop appropriate implementable guidelines, or anticipate the effect on treatment decisions of greater patient involvement. In this paper, we discuss the weak response to the NIH Consensus Conference on early stage breast cancer because it may have reflected these problems. We urge a more complex and more empirical approach in explaining treatment choice and guidelines sensitive to the potential for value differences.

Objectives: Given the resource-intensive nature of stroke rehabilitation, it is important that services be delivered in an evidence-based and cost-efficient manner. The objective of this review was to assess the evidence on the relative cost or cost-effectiveness of three rehabilitation services after stroke: stroke unit care versus care on another hospital ward, early supported discharge (ESD) services versus “usual care,” and community or home-based rehabilitation versus “usual care.”

Methods: A systematic literature review of cost analyses or economic evaluations was performed. Study characteristics and results (including mean total cost per patient) were summarized. The level of evidence concerning relative cost or cost-effectiveness for each service type was determined qualitatively.

Results: Fifteen studies met the inclusion criteria: three on stroke unit care, eight on ESD services, and four on community-based rehabilitation. All were classified as cost-consequences analysis or cost analysis. The time horizon was generally short (1 year or less). The comparators and the scope of costs varied between studies.

Conclusions: There was “some” evidence that the mean total cost per patient of rehabilitation in a stroke unit is comparable to care provided in another hospital ward. There is “moderate” evidence that ESD services provide care at modestly lower total costs than usual care for stroke patients with mild or moderate disability. There was “insufficient” evidence concerning the cost of community-based rehabilitation compared with usual care. Several methodological problems were encountered when analyzing the economic evidence.

Objectives: Rapid reviews are characterized as an accelerated evidence synthesis approach with no universally accepted methodology or definition. This modified Delphi consensus study aimed to develop a comprehensive set of defining characteristics for rapid reviews that may be used as a functional definition.

Methods: Expert panelists with knowledge in rapid reviews and evidence synthesis were identified. In the first round, panelists were asked to answer a seventeen-item survey addressing a variety of rapid review topics. Results led to the development of statements describing the characteristics of rapid reviews that were circulated to experts for agreement in a second survey round and further revised in a third round. Consensus was reached if ≥70 percent of experts agreed and there was stability in free-text comments.

Results: A panel of sixty-six experts participated. Consensus was reached on ten of eleven statements describing the characteristics of rapid reviews. According to the panel, rapid reviews aim to meet the requirements and timelines of a decision maker and should be conducted in less time than a systematic review. They use a variety of approaches to accelerate the evidence synthesis process, tailor the methods conventionally used to carry out systematic reviews, and use the most rigorous methods that the delivery time frame will allow.

Conclusions: This study achieved consensus on ten statements describing the defining characteristics of rapid reviews based on the opinion of a panel of knowledgeable experts. Areas of disagreement were also highlighted. Findings emphasize the role of the decision maker and stress the importance of transparent reporting.

Objectives: This study explores several variables of the EQ-5D child version, a multi-attribute utility instrument, in children with chronic conditions.

Methods: A convenience sample was selected from hospital outpatient records and school records. The sample included children aged 7–18 years with the following chronic conditions: asthma, rheumatic disorders, diabetes, and speech/language and/or hearing disorders. The practicality, convergent validity, and discriminant power were compared with a generic quality of life questionnaire for children (TACQOL) and the 2-week test–retest reliability was assessed.

Results: A total of 182 children or their parents completed the first questionnaire and 161 children/parents completed both questionnaires. The practicality of the EQ-5D was good. Low to moderate correlations were found between the utilities and VAS scores and the TACQOL scales. The discriminant power of the EQ-5D items was low overall and was greater for children with a rheumatic disorder than for children with the other conditions. In the subset of children who experienced no health change between the test and the retest, the reliability of the EQ-5D was moderate to high.

Conclusions: The EQ-5D seems suitable for children, although the use of an additional disease-specific questionnaire is still recommended. The EQ-5D seems the most suitable for children with a chronic physical condition and appears to be reliable for children with a stable health status.

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: 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.

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.

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: 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.

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: 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: Although there is increased awareness of patient and public involvement (PPI) among health technology assessment (HTA) organizations, evaluations of PPI initiatives are relatively scarce. Our objective as members of Health Technology Assessment International's (HTAi's) Patient and Citizen Involvement Group (PCIG) was to advance understanding of the range of evaluation strategies adopted by HTA organizations and their potential usefulness.

Methods: In March 2016, a survey was sent to fifty-four HTA organizations through the International Network of Agencies for Health Technology Assessment (INAHTA) and contacts of members of HTAi's PCIG. Respondents were asked about their organizational structure; how patients and members of the public are involved; whether and how PPI initiatives have been evaluated, and, if so, which facilitators and challenges to evaluation were found and how results were used and disseminated.

Results: Fifteen (n = 15) programs from twelve countries responded (response rate 27.8 percent) that involved patients (14/15) and members of the public (10/15) in HTA activities. Seven programs evaluated their PPI activities, including participant satisfaction (5/7), process (5/7) and impact evaluations (4/7). Evaluation results were used to improve PPI activities, identify education and training needs, and direct strategic priorities. Facilitators and challenges revolved around the need for stakeholder buy-in, sufficient resources, senior leadership, and including patients in evaluations.

Conclusions: A small but diverse set of HTA organizations evaluate their PPI activities using a range of strategies that reflect the range of rationales and approaches to PPI in HTA. It will be important for HTA organizations to draw on evaluation theories and methods.

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.

This study summarizes the experience with health technology assessment (HTA) at the European level. Geographically, Europe includes approximately fifty countries with a total of approximately 730 million people. Politically, twenty-seven of these countries (500 million people) have come together in the European Union. The executive branch of the European Union is named the European Commission, which supports several activities, including research, all over Europe and in many other parts of the world. The European Commission has promoted HTA by several policy positions and has funded a series of projects aimed at strengthening HTA in Europe. Around fifteen of the European countries now have formal national programs on HTA and some also have regional public programs. All countries that are members of the European Union and do not have a national approach to HTA have an interest in becoming more involved. The HTA projects sponsored by the European Commission have focused on networking and collaboration among established agencies and institutions for HTA, however, also on capacity building, support, and facilitation in creating mechanisms for HTA in European countries that still do not have any program in the field.