Scientific journals bring researchers' findings to their colleagues and other audiences, mediate advances in methodology, and facilitate understanding by dialogue. Differences of opinion can be talked through and mistakes clarified. In some fields, these debates take place rapidly, on the net or in weekly publications. Quarterly journals, such as this, discuss at a slower pace.

Objectives: The Secondary Prevention of Heart disEase in geneRal practicE (SPHERE) trial has recently reported. This study examines the cost-effectiveness of the SPHERE intervention in both healthcare systems on the island of Ireland.

Methods: Incremental cost-effectiveness analysis. A probabilistic model was developed to combine within-trial and beyond-trial impacts of treatment to estimate the lifetime costs and benefits of two secondary prevention strategies: Intervention - tailored practice and patient care plans; and Control - standardized usual care.

Results: The intervention strategy resulted in mean cost savings per patient of €512.77 (95 percent confidence interval [CI], −1086.46–91.98) and an increase in mean quality-adjusted life-years (QALYs) per patient of 0.0051 (95 percent CI, −0.0101–0.0200), when compared with the control strategy. The probability of the intervention being cost-effective was 94 percent if decision makers are willing to pay €45,000 per additional QALY.

Conclusions: Decision makers in both settings must determine whether the level of evidence presented is sufficient to justify the adoption of the SPHERE intervention in clinical practice.

Objectives: The aim of this study was to compare efficacy, safety, and consumption of low-molecular-weight heparins with unfractionated heparin, and to develop a pharmacoeconomic decision model based on meta-analysis data.

Methods: Review and meta-analysis were performed of published randomized control trials directly comparing the safety and efficacy of low-molecular-weight heparins (LMWHs)—that is, nadroparin, enoxaparin, and dalteparin—and unfractionated heparin (UFH) was performed by two reviewers using inclusion/exclusion criteria based on the research objectives. The value of fixed effects and random effects odds ratio (95 percent confidence interval) was calculated for each trial for the composite end point. Subsequently, a pharmacoeconomic decision modeling based on reference pricing methodology was implemented.

Results: In comparison to UFH, all LMWHs have independently demonstrated greater safety and effectiveness. None of the LMWHs demonstrated a significant superiority over each other; therefore, the group of LMWHs was interchangeable and suitable for cost minimization analysis and reference price implementation. Being the least expensive option, dalteparin single DDD price was set as the reference. Introduction of reference pricing for LMWHs would decrease the total expenditure on LMWHs of approximately 30 percent and would result in total savings of 1.830–2.070 thousand LTL in the country of Lithuania (approximately 0.8 million USD) per year.

Conclusions: The meta-analysis results of LMWHs could be used to support a policy on reference-based pricing and pharmacoeconomic decision modeling in healthcare institutions, which would allow a decrease in healthcare expenditures.

Objectives: The method of choice for bariatric surgery remains controversial. The aim of this study was to compare the outcome of laparoscopic Roux-en-Y gastric bypass (L-RYGB) versus laparoscopic adjustable gastric banding (LAGB) using quality-adjusted life-years (QALYs).

Methods: We developed a Markov model of the quality of life and survival of L-RYGB and LAGB in obese patients. Using census data, we estimated the probability of dying and quality of life for each year of each cohort.

Results: For all cohorts, L-RYGB offers the highest advantage in QALYs compared with gastric banding. The youngest cohort showed the greatest discrepancy between the two surgical methods, with 7.8, 6.4, and 4.7 QALYs gained with L-RYGB over LAGB for the age groups 35, 45, and 55, respectively. Those with the highest presurgical body mass index (BMI) acquired the most advantage with L-RYGB, with 2.8, 6.4, and 9.6 QALYs gained with L-RYGB over LAGB for the BMI groups 40, 50, and 60. Males had a slightly higher advantage with L-RYGB, with 6.5 QALYs gained with L-RYGB over LAGB compared with 6.0 QALYs for females.

Conclusions: For the cohorts studied, L-RYGB is the preferred surgical treatment for obesity if the sole metric is QALYs. The young and extremely obese are core groups who will gain the most QALYs following L-RYGB.

Objectives: Influenza (vernacular name, flu) is a viral infection that causes a high consumption of resources. Several studies have been carried out to provide an economic evaluation of the vaccination programs against influenza. Nevertheless, there is still a lack of evidence about the dynamic effects resulting from the reduction of the transmission power. This study considers the impact on contagiousness of alternative strategies against influenza in people aged 50–64 in Italy, France, Germany, and Spain.

Methods: By using the Influsim 2.0 dynamic model, we have determined the social benefits of different coverage levels in every country compared with the ones currently recommended. We have subsequently performed a Budget Impact Analysis to determine whether the currently recommended coverage results from an optimal budget allocation. A probabilistic sensitivity analysis was also conducted.

Results: We found that in Germany, the optimal coverage level is 38.5 percent, in France 32.4 percent, in Italy 32.75 percent, and 28.3 percent in Spain. By extending the coverage level, social saving tends to increase up to 100 percent for France and Italy and up to 80 percent for Germany and Spain.

Conclusions: Decision makers should allocate the budget for vaccination against influenza consistently with the estimation of the optimal coverage level and with the dynamic effects resulting from the reduction of the transmission power.

Objectives: Health technology assessment (HTA) programs influence practice on a broad scale through reimbursement decisions or national guidelines. Hospital-based HTA programs inform clinical decisions at the local level. Typically, they do this by adapting general HTA to their local setting, or by creating new HTA. However, unlike payer-based HTA organizations, hospital-based HTA organizations can also integrate local data into their reports.

Methods: We describe two examples of local data integrated into hospital-based HTA. In the first, qualitative data were used to select a new cardiac catheterization lab. In the second, quantitative data was used to inform a decision on whether to continue telemedicine services to critical care units. Local evidence sources included equipment service records, and interviews with physicians, technicians, and administrative staff in the first example, and the hospital's administrative and claims databases in the second example.

Results: In each case, there was little evidence from the peer-reviewed literature that could be applied to the decision. In the first example, staffing patterns and local preferences had considerable bearing on technology choices. In the second example, local outcomes data from administrative records were decisive.

Conclusions: Hospital-based HTA using local data can fill gaps in the published evidence, and also improve the generalizability of evidence to the local setting. To take advantage of local evidence, health systems should encourage the development of hospital-based HTA centers, seek out local preference data, and maintain databases of patient outcomes and utilization of services.

Objectives: The aim of this study was to review, systematically and critically, evidence used to derive estimates of cost-effectiveness of human immunodeficiency virus (HIV) screening.

Methods: A systematic review was conducted. Searched were three main electronic bibliographic databases from 1993 to 2008 using key words including HIV, mass screening, HAART, economic evaluation, cost-effectiveness analysis, modeling. We included studies of sexually transmitted HIV infection in both sexes, including studies comparing diagnostic testing protocols and partner notification. Outcomes included were cases of HIV infection detected, deterioration to the AIDS state, secondary transmission of HIV, the quality-adjusted life-years/survival, costs, and cost-effectiveness of HIV screening.

Results: Eighty-four papers were identified; ten of which were formal economic evaluations, one cost study, three effectiveness studies, and three systematic reviews of HIV prevention programs. The predominant assertion was that HIV screening is cost-effective; methodological problems, such as the preponderance of static models which are inappropriate for infectious diseases, varying perspectives from which the studies were analyzed, and arbitrary threshold incremental cost-effectiveness ratio levels, limited the validity of these findings, and their usefulness in informing health policy decisions.

Conclusions: The majority of published economic evaluations are based on inappropriate static models. This flaw renders the results of these studies as inconclusive and the purported cost-effectiveness of HIV screening debatable. The results of this review could form a basis for consideration of further research and analysis by health economists into the cost-effectiveness of HIV screening.

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: The UK National Institute for Health and Clinical Excellence (NICE) has been widely hailed as an international leader in health technology assessment. The objectives of its guidance are to ensure uniformity in healthcare provision, and promote a systematic and accountable way to allocate resources. However, research relating to the implementation of guidance is limited, and little is known about how it influences decision making at the consultation level or how useful it is to individual patients.

Methods: In-depth interviews were undertaken with professionals involved in healthcare provision at the community level, and with clinical professionals and patients providing or receiving care for morbid obesity and breast cancer (n = 52).

Results: Although NICE guidance was generally well-regarded, in practice it was of more importance and usefulness to managerial than clinical professionals. Clinicians used a patchy approach to implementation depending on whether recommendations accorded with their personal interpretation of the evidence available, and whether funding was available locally. Many patients had not heard of NICE, and clinical professionals did not alert them to its existence. Even where patients knew about relevant guidance, they were rarely able to use it to assert their right to treatment.

Conclusions: These findings challenge the perception that NICE guidance results in consistent and accountable decision making, and the limited accessibility and usefulness of guidance to patients suggests more information and support is needed at the point of provision if these objectives are to be achieved.

Background: Clearly the benefits of a treatment must not be outweighed by the adverse effects. If researchers fail to incorporate adverse effects adequately in models, this could limit the validity of the results obtained. In the worst case, interventions that are cost-effective may be shown not to be. The aim of this research was to review current practice when incorporating adverse effects in economic models.

Methods: A survey of HTA reports commissioned by the National Institute for Health Research (NIHR) Health Technology Assessment programme, published between 2004 and 2007 was conducted. All reports which investigated the clinical and cost-effectiveness of a health technology using a systematic review and an economic model framework were included.

Results: A total of eighty reports met the inclusion criteria. Of the models including adverse effects (43/80), 67 percent used a clinical adverse effects parameter, 79 percent a cost of adverse effects parameter, 86 percent used one of these, and 60 percent used both. Of the thirty-seven models that did not include adverse effects, eighteen justified this omission, most commonly lack of data; nineteen appeared to make no explicit consideration of adverse effects in the model.

Conclusions: In many cases, poor reporting made it difficult to ascertain if there had been any consideration of adverse effects. We suggest that the findings of this survey support a call for much clearer and explicit reporting of adverse effects, or their exclusion, in decision models and for explicit recognition in future guidelines that “all relevant outcomes” should include some consideration of adverse events.

Objectives: The prime objective of this study was to investigate whether sponsorship by the pharmaceutical industry affected the results of full economic evaluations (FEE) based on modeling. In particular, we focused on the flourishing literature based on Markov models, by far the most widely exploited tool for estimating lifetime costs and benefits.

Methods: We made a literature search of the international database PubMed to find all the studies on pharmacological treatments based on Markov models published in English in the period January 1, 2004 to June 30, 2009. We selected the FEEs focused on single drugs only, specifically cost-effectiveness and cost-utility analyses. Two hundred articles including FEEs based on Markov models were considered eligible. For the analysis, we classified the FEEs into two groups according to whether or not they had financial backing from the pharmaceutical industry. We then assessed the main conclusions, which were classified as (i) “favorable,” (ii) “doubtful,” and (iii) “unfavorable.”

Results: Of the 200 articles, 138 (69 percent) were sponsored and 162 (81 percent) reached favorable conclusions. Sponsored studies were much more likely to report favorable conclusions than nonsponsored ones (95 percent and 50 percent, p < .001), the former even omitting unfavorable conclusions.

Conclusions: The review found a substantial share of studies supported by the pharmaceutical industry, almost all concluding in favor of the drug studied, without any unfavorable conclusions at all. These results confirm also in the field of pharmacoeconomic studies that the best way of limiting confounding factors is by clearly distinguishing assessors from manufacturers and marketers of any new technology.

There is increasing emphasis on providing patient-focused health care and ensuring patient involvement in the design of health services. As health technology assessment (HTA) is meant to be a multidisciplinary, wide-ranging policy analysis that informs decision making, it would be expected that patients’ views should be incorporated into the assessment. However, HTA is still driven by collection of quantitative evidence to determine the clinical and cost effectiveness of a health technology. Patients’ perspectives about their illness and the technology are rarely included, perhaps because they are seen as anecdotal, biased views. There are two distinct but complementary ways in which HTAs can be strengthened by: (i) gathering robust evidence about the patients’ perspectives, and (ii) ensuring effective engagement of patients in the HTA process from scoping, through evidence gathering, assessment of value, development of recommendations and dissemination of findings. Robust evidence eliciting patients’ perspectives can be obtained through social science research that is well conducted, critically appraised and carefully reported, either through meta-synthesis of existing studies or new primary research. Engagement with patients can occur at several levels and we propose that HTA should seek to support effective patient participation to create a fair deliberative process. This should allow two-way flow of information, so that the views of patients are obtained in a supportive way and fed into decision-making processes in a transparent manner.

Objectives: The aim of this study was to describe a current practical approach of priority setting of health technology assessment (HTA) research that involves multi-criteria decision analysis and a deliberative process.

Methods: Criteria related to HTA prioritization were identified and grouped through a systematic review and consultation with a selection committee. Criteria were scored through a pair-wise comparison approach. Criteria were pruned based on the average weights obtained from consistent (consistency index < 0.2) responders and consensus. HTA proposals are ranked based on available information and a weighted criteria score. The rank, along with additional contextual information and discussion among committee members, is used to achieve consensus on HTA research priorities.

Results: Six of eleven criteria represented > 75 percent of the weight behind committee member decisions to conduct an HTA. These criteria were disease burden, clinical impact, alternatives, budget impact, economic impact, and available evidence. Since May 2006, committees have considered 102 proposals at sixteen biannual in-person advisory committee meetings. These have selected twenty-nine research priorities for the HTA program.

Conclusions: The approach works well and was easy to implement. Feedback from committee members has been positive. This approach may assist HTA and other research agencies in better priority setting by informing the selection of the most important and policy-relevant topics in the presence of a wide variety of research proposals. This may in turn lead to efficiently allocating resources available for HTA research.

Objectives: The English National Horizon Scanning Centre routinely scans thirty-five sources to identify new and emerging health technologies. The aim of the study was to develop and apply evaluation criteria and scores to assess the value of sources, and to identify a cutoff score below which sources would be recommended for removal from routine horizon scanning. Criteria to evaluate each source scanned could result in a more efficient approach in the selection process.

Methods: Evaluation criteria were developed following a review of the literature and discussions with horizon analysts. Proposed criteria were piloted on a random selection of six sources, and then applied to all thirty-five sources. The criteria were assessed using the Analytic Hierarchy Process.

Results: Eight criteria were identified as being most relevant for assessing the value of scanning sources. The three most important (primary) criteria were coverage (approximate percentage of relevant information), quality (reliable, accurate, objective), and efficiency (estimated time to identify one potentially significant health technology or other relevant information). Seven sources fell beneath the cutoff score and were recommended for removal from routine scanning.

Conclusions: The criteria were considered useful in the assessment of current sources, and have the potential to be used to assess new ones. These criteria may be useful for other horizon scanning centers to pilot and validate.

We read the recently published study by Lo Scalzo et al. (4). The study is a short version of a more extensive report published on the Italian Ministry of Health Web site (1). A careful evaluation of both documents reveals several critical issues that cast doubts on the correctness of their conclusions. Usually, decisions about clinical practice should be based on levels of evidence in literature and on the strength of recommendations issued in the guidelines of international scientific societies, many of which rely on the Oxford system (Oxford Center for Evidence based Medicine) (http://cebm.jr2.ox.ac.uk/docs/level.html). As far as diagnostic tests are concerned, the Oxford system assigns the highest level of evidence to systematic reviews supported by homogeneous results. The same system assigns the second highest level of evidence to the “independent blind comparison of an appropriate spectrum of consecutive patients all of whom have undergone both the diagnostic test and the reference standard,” while the expert's opinion ranks at the lowest level. Surprisingly, the authors flatly dismissed all sequential studies that fulfill the criteria of independent blind comparison, based on the fact that they were not randomized. At the same time, they cited as source data the results of a questionnaire presented to the attendees of an Italian meeting, never published in literature, which is plainly an “expert opinion.”

The comments by Spada et al. (which are similar in style and content to the ones already made by the authors on the Italian Ministry of Health Web site) are based on misunderstandings and manipulations. The essence of systematic reviews is to sum up available knowledge and minimize bias. The latter is done by a priori stating study inclusion criteria both in the protocol and in the full HTA report (see Fig. 1, p. 299) and assessing methodological quality of included studies using an instrument which was specified in the protocol text and never changed (the Quality Assessment Diagnostic Accuracy Studies checklist or QUADAS). The purpose of inclusion criteria and bias minimization efforts is to ensure that what is included in a review is both relevant and contributes evidence weighted by its reliability to answer the study question (in our case the diagnostic performance of WCE in the small bowel). The high number of excluded studies is thus irrelevant, although it is a common feature of systematic reviews. What matters is what the included studies tell us.