Objectives: The aim of this study was to assess whether a multicomponent cognitive behavioral group intervention is preferable to usual care in terms of (healthcare) costs and effects on fear of falling and activity avoidance.

Methods: This economic evaluation was embedded in a randomized controlled trial among 540 community-living adults in the Netherlands, aged 70 years and older who reported fear of falling and fear-induced activity avoidance. The participants allocated to the intervention group received a multicomponent cognitive behavioral group intervention consisting of eight weekly sessions and a booster session. The sessions were aimed at instilling realistic views of falls, reducing fall risk, and increasing activity and safe behavior. Participants in the control group received usual care. Cost outcome measures were healthcare costs, and patient and family costs. Clinical outcomes were fear of falling and activity avoidance. All outcomes were assessed at baseline and at 2, 8, and 14 months by means of registration forms, self-administered questionnaires, and interviews by telephone.

Results: Participants were randomly allocated to intervention (n = 280) and control groups (n = 260). Costs for the intervention program were on average €276 per person. Total costs per person were comparable (€4,925 in intervention group and €4,828 in control group). Furthermore, favorable effects of the program were observed for fear of falling and activity avoidance.

Conclusions: This study showed that the intervention program is preferable to usual care in terms of costs and effects. The program had comparable costs and significantly reduced fear of falling and associated activity avoidance among older community-living persons.

Objectives: The objective of this systematic review was to evaluate the cost-effectiveness of interventions aiming to increase the adherence to highly active antiretroviral therapy (HAART) in HIV-infected patients in developed countries (WHO stratum A).

Methods: A systematic search for comparative health economic studies was conducted in the following databases: EMBASE, MEDLINE, NHS Economic Evaluation Database, CINAHL, HEED, and EconLit. The identified publications were selected by two reviewers independently according to predefined inclusion and exclusion criteria. Furthermore, these were evaluated according to a standardized checklist and finally extracted, analyzed, and summarized.

Results: After reviewing the abstracts and full texts four relevant studies were identified. Different educational programs were compared as well as the Directly Observed Therapy (DOT). A critical aspect to be considered in particular was the poor transparency of the cost data. In three cost-utility analyses the costs per quality-adjusted life-year (QALY) in the baseline scenario were each under USD 15,000. The sensitivity analyses with a presumed maximum threshold of USD 50,000/QALY showed a predominantly cost-effective result. In one study that examined DOT the costs add up to over USD 150,000/QALY.

Conclusions: It seems that adherence interventions for HAART in HIV-infected patients can be cost-effective. Nevertheless, the quality of the included studies is deficient and only a few of the possible adherence interventions are taken into consideration. A final assessment of the cost-effectiveness of adherence interventions in general is, therefore, not possible.

Objectives: Due to a high risk of thromboembolism in patients undergoing major orthopedic surgery, it has become standard practice to give thromboprophylactic treatment. We assessed the relative efficacy and cost-effectiveness of two new oral anticoagulants, rivaroxaban and dabigatran, relative to subcutaneous enoxaparin for the prevention of thromboembolism after total hip replacement (THR) and total knee replacement surgery (TKR).

Methods: We conducted a systematic review of the literature to assess efficacy and safety, and evaluated quality of documentation using GRADE. Cost-effectiveness was assessed by developing a decision model. The model combined two modules; a decision tree for the short-term prophylaxis and a Markov model for the long-term complications and survival gain.

Results: For rivaroxaban compared with enoxaparin, we found statistically significant decreases in deep vein thrombosis, but also a trend toward increased risk of major bleeding. For mortality and pulmonary embolism there were no statistically significant differences between the treatments. We did not find statistically significant differences between dabigatran and enoxaparin for our efficacy and safety outcomes. Assuming a willingness to pay of EUR62,500 per QALY, rivaroxaban following THR had a probability of 38 percent, and enoxaparin following TKR had a probability of 34 percent of being cost-effective. Clinical efficacy had the greatest impact on decision uncertainty.

Conclusions: Dabigatran and rivaroxaban are comparable with enoxaparin following THR and TKR regarding the efficacy and safety outcomes. However, there is great uncertainty regarding which strategy is the most cost-effective. More research on clinical efficacy of rivaroxaban and dabigatran is likely to change our results.

Objectives: The aim of this study was to systematically assess the long-term (≥ 6 months) benefits of epidural steroid injection therapies for patients with low back pain.

Methods: We identified randomized controlled trials by database searches up to October 2011 and by additional hand searches without language restrictions. Randomized controlled trials on the effects of epidurals for low back pain with follow-up for at least 6 months were included. Outcomes considered were pain relief, functional improvement in 6 to 12 months after epidural steroid injection treatment and the number of patients who underwent subsequent surgery. Meta-analysis was performed using a random-effects model.

Results: Twenty-nine articles were selected. The meta-analysis suggested that a significant treatment effect on pain was noted at 6 months of follow-up (weighted mean difference [WMD], −0.41; 95 percent confidence interval [CI], −0.66 to −0.16), but was no longer statistically significant after adjusting for the baseline pain score (WMD, −0.19; 95 percent CI, −0.61 to 0.24). Epidural steroid injection did not improve back-specific disability more than a placebo or other procedure. Epidural steroid injection did not significantly decrease the number of patients who underwent subsequent surgery compared with a placebo or other treatments (relative risk, 1.02; 95 percent CI, 0.83 to 1.24).

Conclusions: A long-term benefit of epidural steroid injections for low back pain was not suggested at 6 months or longer. Introduction of selection bias in the majority of injection studies seems apparent. Baseline adjustment is essential when we evaluate pain as a main outcome of injection therapy.

Objectives: Mechanical circulatory support through left ventricular assist devices (LVADs) improves survival and quality of life for patients with end-stage heart failure who are ineligible for cardiac transplantation. Our aim was to calculate the cost-effectiveness of continuous-flow LVADs.

Methods: A cost-utility analysis from a societal perspective was performed. A lifetime Markov model was set up in which continuous-flow LVAD was compared with optimal medical therapy (OMT). The treatment effect was modeled indirectly combining the results of the REMATCH trial comparing OMT with a pulsatile-flow LVAD and the HeartMate II Destination Therapy Trial comparing a pulsatile-flow LVAD with a continuous-flow LVAD. Cost data were based on real-world financial data of sixty-nine patients with a HeartMate II implantation from the University Medical Centre Utrecht (the Netherlands). One-way and probabilistic sensitivity analyses were performed.

Results: Comparing the continuous-flow HeartMate II with OMT, 3.23 (95 percent confidence interval [CI], 2.18–4.49) life-years were gained (LYG) or 2.83 (95 percent CI, 1.91–3.90) quality-adjusted life-years (QALYs). The cost of an LVAD implant was approximately €126,000, of which the device itself represented the largest cost, being €70,000. Total incremental costs amounted to €299,100 (95 percent CI, 190,500–521,000). This resulted in an incremental cost-effectiveness ratio of €94,100 (95 percent CI, 59,100–160,100) per LYG or €107,600 (95 percent CI, 66,700–181,100) per QALY. Sensitivity analyses showed these results were robust.

Conclusions: Although LVAD destination therapy improves survival and quality of life, it remains a relatively expensive intervention which renders the reimbursement of this therapy questionable.

Objectives: The aim of this study is to evaluate the cost-effectiveness of a patient-direct mailed advance notification letter on participants of a National Bowel Cancer Screening Program (NBCSP) in Australia, which was launched in August 2006 and offers free fecal occult blood testing to all Australians turning 50, 55, or 65 years of age in any given year.

Methods: This study followed a hypothetical cohort of 50-year-old, 55-year-old, and 65-year-old patients undergoing fecal occult blood test (FOBT) screening through a decision analytic Markov model. The intervention compared two strategies: (i) advance letter, NBCSP, and FOBT compared with (ii) NBCSP and FOBT. The main outcome measures were life-years gained (LYG), quality-adjusted life-years (QALYs) gained and incremental cost-effectiveness ratio.

Results: An advance notification screening letter would yield an additional 54 per 100,000 colorectal cancer deaths avoided compared with no letter. The estimated cost-effectiveness was $3,976 per LYG and $6,976 per QALY gained.

Conclusions: An advance notification letter in the NBCSP may have a significant impact on LYG and cancer deaths avoided. It is cost-effective and offers a feasible strategy that could be rolled out across other screening program at an acceptable cost.

Objectives: Approximately 10–15 percent of individuals with diabetes mellitus develop foot ulcers, which precede 85 percent of amputations. Increased oxygen, through the use of hyperbaric oxygen therapy (HBOT), has been suggested to encourage ulcer healing thus reducing the risk of amputation. The objective of this systematic review is to evaluate the efficacy of systemic HBOT for nonhealing ulcers of the lower limb in diabetes patients.

Methods: A systematic search, using controlled and keyword terms focusing on “HBOT” and “lower limb diabetic ulcers,” was conducted. Databases searched included Medline, EMBASE, CINAHL, PubMed, Wiley's Cochrane Library, and Biosis. Randomized controlled trials (RCTs) and observational studies were included. Pooled estimates of outcomes were determined when appropriate.

Results: Of the 654 citations identified, 157 articles underwent full-text review. Data were abstracted from twelve publications (six RCTs and six comparative observational studies). Pooled analysis of the RCT and observational data showed that treatment with HBOT reduced the risk of major amputation by 60 percent (p = .29) and 61 percent (p = .003) compared with standard wound care, respectively. The RCT data revealed that the relative risk of having an unhealed wound following HBOT was 0.54 (p = .10) and 0.24 (p < .0001) based on observational data.

Conclusions: Due to the limited RCT evidence, it is not possible to conclusively establish the benefits and harms of treating diabetic lower limb ulcers with HBOT. No significant effects on amputation rates were found in the RCT evidence and in the high quality studies, no difference was found.

Objectives: We assessed the impacts of a Citizens’ Reference Panel on the deliberations of a provincial health technology advisory committee and its secretariat, which produce, recommendations for the use of health technologies in Ontario, Canada.

Methods: A fourteen-member citizens’ reference panel was convened five times between February 2009 and May 2010 to participate in informed, facilitated discussions to inform the assessment of individual technologies and provincial health technology assessment processes more generally. Qualitative data collection methods were used to document observed and perceived impacts of the citizens’ panel on the health technology assessment (HTA) process.

Results: Panel impacts were observed for all technologies reviewed, at two different stages in the HTA process, and represented macro- (raising awareness) and micro-level (informing recommendations) impacts. These impacts were shaped by periodic opportunities for direct and brokered exchange between the Panel and the expert advisory committee to clarify roles, foster accountability, and build trust. Our findings offer new insights about one of the main considerations in the design of deliberative participatory structures—how to maintain the independence of a citizens’ panel while ensuring that their input is considered at key junctures in the HTA process.

Conclusions: Citizens’ panels can exert various impacts on the HTA process. Ensuring these types of structures include opportunities for direct exchange between citizens and experts, to clarify roles, promote accountability, and build trust will facilitate their impacts in a variety of settings.

Objectives: We conducted a systematic review of quantitative research regarding patients’ preferences, perspectives and values for ventilation among chronic obstructive pulmonary disease (COPD) patients. Our objective was to explore the feasibility and desirability of incorporating patient preferences within the health technology assessment (HTA) process by working through a case study.

Methods: Medical and economic databases were searched for studies published in English from 1990 through March 4, 2011. Studies were selected based on title and abstract. Due to the heterogeneity of the studies, data were analyzed using a narrative synthesis approach.

Results: Among 1833 identified citations, twelve studies met our inclusion criteria. Ten of these studies pertained to COPD patient preferences for ventilation. Results indicate that a significant proportion of COPD patients are willing to forgo ventilation, particularly when it is expressed as “indefinite life support” (60–78 percent) rather than as temporary modality. Results indicate that patient preferences for mechanical or noninvasive ventilation cannot be predicted by covariates (e.g., age, quality of life) or by others who are frequently called upon to make decisions are their behalf.

Conclusions: We found that it is indeed feasible to conduct a systematic review of quantitative preference-related evidence for an HTA topic. However, the process of conducting this preference-related case study also revealed several challenges because there is a high degree of variation in taxonomy, instrumentation, and study design. Therefore, we do not recommend it as a routine part of the HTA process, but we suggest that it is a promising area to pursue for preference-sensitive technological decisions.

Objectives: The aim of this paper is to develop a methodological framework to facilitate the application of Multi-Criteria Decision Analysis (MCDA) for a comprehensive economic evaluation of disease management programs (DMPs).

Methods: We studied previously developed frameworks for the evaluation of DMPs and different methods of MCDA and we used practical field experience in the economic evaluation of DMPs and personal discussions with stakeholders in chronic care.

Results: The framework includes different objectives and criteria that are relevant for the evaluation of DMPs, indicators that can be used to measure how DMPs perform on these criteria, and distinguishes between the development and implementation phase of DMPs. The objectives of DMPs are categorised into a) changes in the process of care delivery, b) changes in patient lifestyle and self-management behaviour, c) changes in biomedical, physiological and clinical health outcomes, d) changes in health-related quality of life, and e) changes in final health outcomes. All relevant costs of DMPs are also included in the framework. Based on this framework we conducted a MCDA of a hypothetical DMP versus usual care.

Conclusions: We call for a comprehensive economic evaluation of DMPs that is not just based on a single criterion but takes into account multiple relevant criteria simultaneously. The framework we presented here is a step towards standardising such an evaluation.

Introduction: Many governments have introduced health technology assessment (HTA) as an important tool to manage the uptake and use of health-related technologies efficiently. Although surgeons play a central role in the uptake and diffusion of new technologies, little is known about their opinion and understanding of the HTA role and process.

Methods: A cross-sectional pilot study was conducted using an online questionnaire which was distributed to Fellows of the Royal Australasian College of Surgeons over a 4-week period. Information was sought about knowledge and views of the HTA process. Descriptive statistics were used to summarize the data, frequencies, and proportions were calculated.

Results: Sixty-two surgeons completed the survey; of these, 55 percent reported their primary work place as a public hospital. Twenty-four percent of the participants reported that they had never heard of the HTA agency and 60 percent reported that surgical procedures are most likely to be introduced in the Australian healthcare system at the public hospital level (which is beyond the HTA's scope and dealt with at a state level). However, 61 percent considered that decisions about funding and adoption of new technologies should take place at the national level.

Conclusions: This survey provides some evidence that many surgeons remain unaware of the federal government's HTA process but still value evidence-based information. In order for HTA to be an effective aid to rational adoption of health-related technologies, there is a need for an evidence-based approach that is integrated and is accepted and understood by the medical professions.

Objectives: No guidelines exist in the approach that Evidence Review Groups (ERGs) should take to appraise search methodologies in the manufacturer's submission (MS) in Single Technology Appraisals (STA). As a result, ERGs are left to appraise searches using their own approach. This study investigates the limitations of manufacturers' search methodologies as critiqued by ERGs in published STA reports and to provide a recommended checklist.

Methods: Limitations from search critiques in 83 ERG reports published in the NIHR Web site between 2006 and May 2011 were extracted. The limitations were grouped into themes. Comparisons were made between limitations reported in the clinical effectiveness versus cost-effectiveness searches.

Results: Twelve themes were identified, six relating to the search strategy, source, limits, filters, translation, reporting, and missing studies. The search strategy theme contained the most limitations. Missing studies were frequently found by the ERG group in the clinical effectiveness searches. The omission of searches by manufacturers for unpublished and ongoing trials was frequently reported by the ERG. By contrast, failure of the manufacturer to report strategies was the most common limitation in the cost-effectiveness searches. Themes with the most frequent limitations in both types of searches are search strategy, reporting and source.

Conclusions: It is recommended that a checklist that has reporting, source and search strategy elements be used in the appraisal of manufacturer's searches during the STA process.

Objectives: The aim of this study was to present the first four collaborative health technology assessment (HTA) processes on health technologies of different types and life cycles targeted toward diverse HTA users and facilitators, as well as the barriers of these collaborations.

Methods: Retrospective analysis, through four case studies, was performed on the first four collaboration experiences of agencies participating in the EUnetHTA Joint Action project (2010–12), comprising different types and life cycles of health technologies for a diverse target audience, and different types of collaboration. The methods used to initiate collaboration, partner contributions, the assessment methodology, report structure, time frame, and factors acting as possible barriers to and facilitators of this collaboration were described.

Results: Two ways were used to initiate collaboration in the first four collaborative HTA processes: active brokering of information, so-called “calls for collaboration,” and individual contact between agencies after identifying a topic common to two agencies in the Planned and Ongoing Projects database. Several success factors are recognized: predefined project management, high degree of commitment to the project; adherence to timelines; high relevance of technology; a common understanding of the methods applied and advanced experience in HTA; finally, acceptance of English-written reports by decision makers in non–English-speaking countries. Barriers like late identification of collaborative partners, nonacceptance of English language and different methodology of assessment should be overcome.

Conclusions: Timely and efficient, different collaborative HTA processes on relative efficacy/effectiveness and safety on different types and life cycles of health technologies, targeted toward diverse HTA users in Europe are possible. There are still barriers to overcome.

Objectives: The aim of this study was to explore factors that influenced decision making in the assessment of new health technology in Korea.

Methods: We analyzed the decision-making results of the Committee for New Health Technology Assessment (CnHTA) on fifty-three new nondrug health technologies in Korea from July 2007 to December 2010. The scope of the committee was mainly limited to safety and efficacy/effectiveness, and every decision was based on a systematic review of the literature. The committee was composed of healthcare professionals, policy makers, lawyers, and representatives from nongovernmental organizations. Decisions made on therapeutic interventions were included, while those on diagnostic procedures were excluded.

Results: Factors that positively influenced decisions were lower complication rate than existing technology, similar or greater effectiveness compared with existing technology, ability to save critical organs, absence of alternative intervention, decreased invasiveness, expansion of patient's set of choices, and similarity to the mechanism of existing technology. Factors that negatively influenced decisions were higher complication rates than existing technology, lower effectiveness than comparable technology, low levels of evidence, unknown mechanisms of intervention, inconsistency, lack of long-term outcomes, lack of comparative data, nonstandardized technology, heterogeneity between control and treatment, excessively diverse indications, and nongeneralizability.

Conclusions: This qualitative analysis of past decision-making results provided us with clues on the values that decision makers on the Korean CnHTA considered in terms of safety and effectiveness. These findings will help us develop appraisal guidelines and enhance the objectivity of decision-making processes in Korea.

Objectives: The aim of this study was to examine the use of implicit and explicit Bayesian methods in health technology assessments and to identify whether this has changed over time.

Methods: A review of all health technology assessment (HTA) reports of secondary research published by the UK National Institute of Health Research (NIHR) between 1997 and 2011. Data were extracted on the use and implementation of Bayesian methods, whether defined as such by the original authors (i.e., explicit) or not (i.e., implicit).

Results: A total of 155 of 375 (41 percent) NIHR HTA reports, identified as relevant to this review, contained a Bayesian analysis. Of these, 128 (83 percent) contained an implicit Bayesian analysis, 3 (2 percent) an explicit Bayesian analysis and 24 (15 percent) both implicit and explicit Bayesian analyses. Of the twenty-seven reports that explicitly used Bayes theorem, only six included prior information in the form of (informative) prior distributions. Over time, the percentage of HTA reports that used Bayesian (implicit and/or explicit) methods increased from 0 percent in 1997 to nearly 80 percent in 2011.

Conclusions: This review has shown that there has been an increase in the use of Bayesian methods in HTA, which is likely to be a result of the increase in freely available resources to implement the approach. Areas where Bayesian methods have the potential to advance healthcare evaluations in the future are considered in the discussion.

Objectives: A linked evidence approach (LEA) is the synthesis of systematically acquired evidence on the accuracy of a medical test, its impact on clinical decision making and the effectiveness of consequent treatment options. We aimed to assess the practical utility of this methodology and to develop a decision framework to guide its use.

Methods: As Australia has lengthy experience with LEA, we reviewed health technology assessment (HTA) reports informing reimbursement decisions by the Medical Services Advisory Committee (August 2005 to March 2012). Eligibility was determined according to predetermined criteria and data were extracted on test characteristics, evaluation methodologies, and reported difficulties. Fifty percent of the evidence-base was independently analyzed by a second reviewer.

Results: Evaluations of medical tests for diagnostic (62 percent), staging (27 percent), and screening (6 percent) purposes were available for eighty-nine different clinical indications. Ninety-six percent of the evaluations used either the full LEA methodology or an abridged version (where evidence is linked through to management changes but not patient outcomes). Sixty-one percent had the full evidence linkage. Twenty-five percent of test evaluations were considered problematic; all involving LEA (n = 22). Problems included: determining test accuracy with an imperfect reference standard (41 percent); assessing likely treatment effectiveness in test positive patients when the new test is more accurate than the comparator (18 percent); and determining probable health benefits in those symptomatic patients ruled out using the test (13 percent). A decision framework was formulated to address these problems.

Conclusions: LEA is useful for evaluating medical tests but a stepped approach should be followed to determine what evidence is required for the synthesis.