The 27th year of the International Journal of Technology Assessment in Health Care (IJTAHC) introduced major changes in editorial work. Submission processes were modernized by introducing Web-based submission at http://mc.manuscriptcentral.com/thc in September 2010. The change has been a learning process to staff, authors, and reviewers alike. During the transition period, responses were often slower than usual, with occasional technical problems. Now that the change is completed, we expect to get back to normal reviewing times. From this issue onward, all manuscripts, including letters, are accepted through the Web site only.

Objectives: The aim of this study is to examine the cost-effectiveness of a group-based peer support intervention in general practice for patients with type 2 diabetes.

Methods: Incremental cost utility analysis combining within trial and beyond trial components to compare the lifetime costs and benefits of alternative strategies: Control: standardized diabetes care; Intervention: group-based peer support in addition to standardized diabetes care. Within trial analysis was based on a cluster randomized controlled trial of 395 patients with type 2 diabetes in the east of Ireland. Beyond trial analysis was conducted using the United Kingdom Prospective Diabetes Study (UKPDS) Outcomes Model. Uncertainty was explored using a range of sensitivity analyses and cost-effectiveness acceptability curves were generated.

Results: Compared with the control strategy, the intervention was associated with an increase of 0.09 (95 percent confidence interval [CI], −0.05 to 0.25) in mean quality-adjusted life-years per patient and savings of €637.43 (95 percent CI, −2455.19 to 1125.45) in mean healthcare cost per patient and €623.39 (95 percent CI, −2507.98 to 1298.49) in mean total cost per patient respectively. The likelihood of the intervention being cost-effective was appreciably higher than 80 percent for a range of potential willingness-to-pay cost-effectiveness thresholds.

Conclusions: Our results suggest that while a group-based peer support intervention shows a trend toward improved risk factor management, we found no significant differences in final cost or effectiveness endpoints between intervention and control. The probabilistic results suggest that the intervention was more cost-effective, with probability values of higher than 80 percent across a range of potential cost-effectiveness threshold values.

Objectives: This study aims to estimate the annual U.S. societal costs associated with treatment of metastatic breast cancer (MBC) patients using an incidence-based cost-of-illness (COI) framework.

Methods: An incidence-based COI model was constructed in which MBC patients were simulated from diagnosis through active treatment, palliative care, and death over 5 years. Key model parameters included: annual incidence of breast cancer in the metastatic stage, utilization of cancer therapies and other medical care resources, treatment-related adverse events, unit costs, work days missed by patient and caregiver, and wage rates. Overall survival was based on SEER data and costs were assigned to living patients monthly, according to their disease management phase. The outcomes measures were total discounted societal costs, cost/year, and cost/patient-year.

Results: The annual incidence of MBC in the United States in 2007 was estimated to be 49,674 patients (de novo and progressed from earlier stages). The total discounted cost to society attributable to MBC was $12.2 billion for the incident cohort, or $98,571 per patient-year. The 5-year direct medical cost of this incident cohort was $9.3 billion, or $75,415 per patient-year. Treatment-related costs (active treatment, toxicity management, and medical follow-up) contributed 44 percent of MBC expenditure, followed by palliative/best supportive care costs (31 percent). Lost productivity accounted for approximately 21 percent of the total cost ($2.6 billion over 5 years or $21,153 per patient-year).

Conclusions: The societal burden of MBC in the United States is substantial. Earlier detection and effective treatment could lead to a significant decrease in costs while improving overall disease prognosis.

Introduction: The supplementation of alanyl-glutamine dipeptide in critically ill patients necessitating total parenteral nutrition (TPN) improves clinical outcomes, reducing mortality, infection rate, and shortening intensive care unit (ICU) hospital lengths of stay (LOSs), as compared to standard TPN regimens.

Methods: A Discrete Event Simulation model that incorporates outcomes rates from 200 Italian ICUs for over 60,000 patients, alanyl-glutamine dipeptide efficacy data synthesized by means of a Bayesian random effects meta-analysis, and national cost data has been developed to evaluate the alternatives from the cost perspective of the hospital. Simulated clinical outcomes are death and infection rates in ICU, death rate in general ward, and hospital LOSs. Sensitivity analyses are performed by varying all uncertain parameter values in a plausible range.

Results: The internal validation process confirmed the accuracy of the model in replicating observed clinical data. Alanyl-glutamine dipeptide on average results more effective and less costly than standard TPN: reduced mortality rate (24.6% ± 1.6% vs. 34.5% ± 2.1%), infection rate (13.8% ± 2.9% vs. 18.8% ± 3.9%), and hospital LOS (24.9 ± 0.3 vs. 26.0 ± 0.3 days) come at a lower total cost per patient (23,409 ± 3,345 vs. 24,161 ± 3,523 Euro).Treatment cost is completely offset by savings on ICU and antibiotic costs. Sensitivity analyses confirmed the robustness of these results.

Conclusions: Alanyl-glutamine dipeptide is expected to improve clinical outcomes and to do so with a concurrent saving for the Italian hospital.

Background: Keeping clinical practice recommendations up-to-date with a continually evolving evidence base presents challenges. Resources required to update recommendations compete with those needed to evaluate newer treatments.

Methods: We describe an approach developed by the UK National Institute for Health and Clinical Excellence (NICE) for updating clinical practice recommendations for new interventional procedures and we evaluate relevant initial experience of using this system. Depending on whether evidence for a procedure is judged adequate or inadequate for safety and efficacy, use in clinical practice is usually recommended with either “normal” or “special” arrangements for patient consent, data collection and institutional oversight, respectively. We examined whether differences in the state of the evidence at the initial and the updated appraisal of procedures were associated with changed recommendations.

Results: Since 2008, updating of recommendations focuses on procedures with initially inadequate evidence. “Special arrangements” recommendations about eleven procedures were updated after 3.3–6.5 years (median, 5.3 years), and recommendations for six were changed to “normal arrangements.” Overall, procedures with changed (“special-to-normal”) recommendations had a greater increase in the number of patients included in observational studies published since the initial guidance.

Conclusions: Procedures with changed (“special-to-normal”) recommendations generally had greater increases in their evidence base. Although uncertainties about optimal methods for keeping evidence-based recommendations up-to-date remain, this experience should be useful to policy makers in developing processes for prioritizing scarce resources for updating clinical practice recommendations. Further studies are needed about the value placed on “updated” recommendations by clinicians, policy-makers, and patients.

Objectives: The aim of this study was to synthesize best practices for addressing clinical heterogeneity in systematic reviews and health technology assessments (HTAs).

Methods: We abstracted information from guidance documents and methods manuals made available by international organizations that develop systematic reviews and HTAs. We searched PubMed® to identify studies on clinical heterogeneity and subgroup analysis. Two authors independently abstracted and assessed relevant information.

Results: Methods manuals offer various definitions of clinical heterogeneity. In essence, clinical heterogeneity is considered variability in study population characteristics, interventions, and outcomes across studies. It can lead to effect-measure modification or statistical heterogeneity, which is defined as variability in estimated treatment effects beyond what would be expected by random error alone. Clinical and statistical heterogeneity are closely intertwined but they do not have a one-to-one relationship. The presence of statistical heterogeneity does not necessarily indicate that clinical heterogeneity is the causal factor. Methodological heterogeneity, biases, and random error can also cause statistical heterogeneity, alone or in combination with clinical heterogeneity.

Conclusions: Identifying potential modifiers of treatment effects (i.e., effect-measure modifiers) is important for researchers conducting systematic reviews and HTAs. Recognizing clinical heterogeneity and clarifying its implications helps decision makers to identify patients and patient populations who benefit the most, who benefit the least, and who are at greatest risk of experiencing adverse outcomes from a particular intervention.

Objectives: Telemedicine applications could potentially solve many of the challenges faced by the healthcare sectors in Europe. However, a framework for assessment of these technologies is need by decision makers to assist them in choosing the most efficient and cost-effective technologies. Therefore in 2009 the European Commission initiated the development of a framework for assessing telemedicine applications, based on the users’ need for information for decision making. This article presents the Model for ASsessment of Telemedicine applications (MAST) developed in this study.

Methods: MAST was developed through workshops with users and stakeholders of telemedicine.

Results: Based on the workshops and using the EUnetHTA Core HTA Model as a starting point a three-element model was developed, including: (i) preceding considerations, (ii) multidisciplinary assessment, and (iii) transferability assessment. In the multidisciplinary assessment, the outcomes of telemedicine applications comprise seven domains, based on the domains in the EUnetHTA model.

Conclusions: MAST provides a structure for future assessment of telemedicine applications. MAST will be tested during 2010–13 in twenty studies of telemedicine applications in nine European countries in the EC project Renewing Health.

Objectives: The aim of this study is to review how health technology assessments (HTA) of medical tests incorporate intermediate outcomes in conclusions about the effectiveness of tests on improving health outcomes.

Methods: Systematic review of English-language test assessments in the HTA database from January 2005 to February 2010, supplemented by a search of the Web sites of International Network of Agencies for Health Technology Assessment (INAHTA) members.

Results: A total of 149 HTAs from eight countries were assessed. Half evaluated tests for screening or diagnosis, a third for disease classification (including staging, prognosis, monitoring), and a fifth for multiple purposes. In seventy-one HTAs (48 percent) only diagnostic accuracy was reported, while in seventeen (11 percent) evidence of health outcomes was reported in addition to accuracy. Intermediate outcomes, mainly the impact of test results on patient management, were considered in sixty-one HTAs (41 percent). Of these, forty-seven identified randomized trials or observational studies reporting intermediate outcomes. The validity of these intermediate outcomes as a surrogate for health outcomes was not consistently discussed; nor was the quality appraisal of this evidence. Clear conclusions about whether the test was effective were included in approximately 60 percent of HTAs.

Conclusions: Intermediate outcomes are frequently assessed in medical test HTAs, but interpretation of this evidence is inconsistently reported. We recommend that reviewers explain the rationale for using intermediate outcomes, identify the assumptions required to link intermediate outcomes and patient benefits and harms, and assess the quality of included studies.

Objectives: This study aims to compare two different search methods for determining the scope of a requested systematic review or health technology assessment. The first method (called the Direct Search Method) included performing direct searches in the Cochrane Database of Systematic Reviews (CDSR), Database of Abstracts of Reviews of Effects (DARE) and the Health Technology Assessments (HTA). Using the comparison method (called the NHS Search Engine) we performed searches by means of the search engine of the British National Health Service, NHS Evidence.

Methods: We used an adapted cross-over design with a random allocation of fifty-five requests for systematic reviews. The main analyses were based on repeated measurements adjusted for the order in which the searches were conducted.

Results: The Direct Search Method generated on average fewer hits (48 percent [95 percent confidence interval {CI} 6 percent to 72 percent], had a higher precision (0.22 [95 percent CI, 0.13 to 0.30]) and more unique hits than when searching by means of the NHS Search Engine (50 percent [95 percent CI, 7 percent to 110 percent]). On the other hand, the Direct Search Method took longer (14.58 minutes [95 percent CI, 7.20 to 21.97]) and was perceived as somewhat less user-friendly than the NHS Search Engine (−0.60 [95 percent CI, −1.11 to −0.09]).

Conclusions: Although the Direct Search Method had some drawbacks such as being more time-consuming and less user-friendly, it generated more unique hits than the NHS Search Engine, retrieved on average fewer references and fewer irrelevant results.

Objectives: This study reports on the Brazilian experience of developing a specialized bulletin, the Brazilian Health Technology Assessment Bulletin (BRATS), on health technology assessments (HTA).

Methods: The editorial process, format, and dissemination strategy of the publication are presented. A critical appraisal of the available issues was made using the checklist for HTA reports of the International Network of Agencies for Health Technology Assessment. The initial impact was estimated based on a retrospective observational measurement of the types of publications that cite the bulletin as a source of information. The publications citing BRATS were identified using Google Scholar.

Results: Since June 2008, fourteen issues of the bulletin have been produced. BRATS has not presented any significant limitation that would compromise generalizations of its results within the Brazilian context. The initial impact of the bulletin, however, has been small, which may be due to its exclusively electronic dissemination format and technical language. We found nine publications citing BRATS in Google Scholar.

Conclusions: It is hoped that the bulletin will promote the continuity of HTA actions among health-sector managers and professionals in Brazil.

Objectives: We compared Polish and Scottish Health Technology Assessment (HTA) process in order to elicit recommendations for future development of HTA methodological guidelines in Poland.

Methods: We studied the differences between Polish and Scottish HTA methodological guidelines. HTA recommendations issued by Polish HTA agency (AHTAPol) in the period January 1 through December 31, 2008, were benchmarked to HTA guidance published by Scottish Medical Consortium (SMC) for the same drug technology.

Results: The Scottish HTA methodological guidelines were more instructive in terms of clinical and economic evaluations than Polish guidelines. SMC evaluated forty-eight of sixty-eight drug technologies appraised by AHTAPoL. There were thirty drug technologies that received similar guidance in both countries and eighteen with contradictory HTA recommendations. In Scotland, there were more positive HTA recommendations than there were in Poland. While comments about efficacy or safety were commonplace among reasons for negative recommendations in Poland, insufficient justification of treatment's cost in relation to benefits was the most often cited reason for rejection in Scotland. SMC tended to recommend restricted use to specific sub-populations for several drug technologies negatively appraised by AHTAPoL.

Conclusions: The comparison between SMC and AHTAPoL suggests that there is potential room of improvement of the Polish HTA methodological guidelines. Comparative effectiveness and safety, subgroup analysis, and adaptation of models to local settings were identified as key areas for further development of Polish HTA methodological guidelines.

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.