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: The aim of this study was to describe the evolution of a cost-utility model used to inform the UK National Institute for Health and Clinical Excellence's (NICE) most recent decisions on the cost-utility of drug treatments for Alzheimer's disease (AD), and to explore the impact of structural assumptions on the cost-utility results.

Methods: Changes informed by noted limitations of the decision model used in NICE's previous decisions (in 2006) were made cumulatively to the original decision model for donepezil compared with best supportive care (for patients with mild to moderate AD). Deterministic and probabilistic analyses were undertaken for each cumulative change of the model. The expected value of perfect information (EVPI) of parameter estimates and structural assumptions was also calculated.

Results: Cumulative changes to the decision model highlighted how the results of the original model (incremental cost-effectiveness ratio of £81,000 per quality-adjusted life-year gained) related to those of the new model (where donepezil was estimated to be cost-saving), mainly due to uncertainty in the incremental cost of donepezil treatment over best supportive care (ranging from -£600 to £3,000 per patient). The partial EVPI analysis reflected this finding where further information on treatment discontinuations and cost parameter estimates were shown to be valuable in terms of reducing decision uncertainty.

Conclusions: Assessing the evolution of the cost-utility model helped to identify and explore structural differences between cohort-based models and is likely to be useful for decision models in other disease areas. This approach makes the structural uncertainty explicit, forcing decision makers to address structural uncertainty in addition to parameter uncertainty.

Objectives: We studied the cost-effectiveness of tenofovir and entecavir in e antigen positive (CHBe+) and negative (CHBe-) chronic hepatitis B.

Methods: Using a multicenter survey including 544 patients we measured patient quality of life and attributable costs by clinical disease stage. Natural disease progression was studied in 278 patients in a single center. A Markov model was constructed to follow hypothetical cohorts of treated and untreated 40-year-old CHBe+ and CHBe- patients and 50-year-old patients with compensated cirrhosis.

Results: We did not find an improvement in quality of life when viral load was reduced under treatment. Transition rates to liver cirrhosis were found to be age-dependent. Assuming equal effectiveness, tenofovir dominates the entecavir strategy because of its lower price in Belgium. The incremental cost-effectiveness ratio (ICER) of tenofovir after 20 years is more favorable for treating Caucasian cirrhotic patients (mean ICER €29,000/quality-adjusted life-year [QALY]) compared with treating non-cirrhotic patients (mean ICER €110,000 and 131,000/QALY for CHB e+ and e-, respectively). Within the non-cirrhotic patients the ICER decreases with increasing cohort starting age from 30 to 50 years.

Conclusions: Results of long-term models for tenofovir or entecavir treatment of CHB need to be interpreted with caution as long-term trials with hard end points are lacking. Especially the effect on HCC remains highly uncertain. Based on cost-effectiveness considerations such antiviral treatment should be targeted at patients with cirrhosis or at risk of rapid progression to this disease stage.

There is an expectation that the value of a new technology will be considered by decision makers in determining whether to provide subsidy. What constitutes the elements of value and how these may be weighted is not transparent, however, and further work needs to be done to determine the circumstances and mechanisms of their application. In the end, judgment will still be needed even if greater formalization of the value construct is developed.

Background: The current study aimed to determine the accuracy of UHear™, a downloadable audiometer on to an iPod Touch©, when compared with conventional audiometry.

Methods: Participants were enrolled primary school scholars. A total number of eighty-six participants (172 ears) were included. Of these eighty-six participants, forty-four were female and forty-two were male; with the age ranging from 8 years to 10 years (mean age, 9.0 years). Each participant underwent two audiological screening evaluations; one by means of conventional audiometry and the other by means of UHear™. Otoscopy and tympanometry was performed on each participant to determine status of their outer and middle ear before each participant undergoing pure tone air conduction screening by means of conventional audiometer and UHear™. The lowest audible hearing thresholds from each participant were obtained at conventional frequencies.

Results: Using the Paired t-test, it was determined that there was a significant statistical difference between hearing screening thresholds obtained from conventional audiometry and UHear™. The screening thresholds obtained from UHear™ were significantly elevated (worse) in comparison to conventional audiometry. The difference in thresholds may be attributed to differences in transducers used, ambient noise levels and lack of calibration of UHear™.

Conclusion: The UHear™ is not as accurate as conventional audiometry in determining hearing thresholds during screening of school-aged children. Caution needs to be exercised when using such measures and research evidence needs to be established before they can be endorsed and used with the general public.

The assessment of value within healthcare is undergoing a major transformation. Gone are the days when a new mechanism of action alone would be regarded as a high value innovation. Today, there is much more of an emphasis on what are the outcomes (i.e., mortality and morbidity benefits), how does this compare with the current standard of care and what is the impact to the usage of healthcare resources. This emphasis is quite understandable given the financial crisis we are experiencing with an ever growing and aging population that is placing considerable strain on the healthcare system.

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: 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.

Purpose: The aim of this study was to compare the general health-related quality of life (HRQoL), the metabolic control (HbA1c), the anthropometric measurement, and the cardiorespiratory fitness (expressed by VO2max) in youths with type 1 diabetes treated with continuous subcutaneous insulin infusion (CSII) to those receiving multiple daily injections (MDI). We looked for factors influencing the HRQoL and metabolic control.

Methods: A total of 239 patients treated with CSII (51 girls and 53 boys) or MDI (64 girls and 71 boys) between ages 8 and 18 years were assessed with the Pediatric Quality of Life Inventory, Generic Core Scales, and Diabetes Module. VO2max was evaluated using the 20-meter shuttle run test.

Results: CSII group had significantly better HRQoL according to both child self-report and parent proxy-report. Youths with CSII reported better physical, emotional, and school-related functioning, and had less diabetes-related fear and symptoms than the MDI group. There were no significant differences in body mass index z-scores, insulin doses, HbA1c, and VO2max between the groups. HRQoL was predicted by the CSII therapy (β = −0.220; p = .000) and the VO2max (β = 0.386; p = .000), other clinical and anthropometric parameters had no effect; the HbA1c was predicted only by VO2max (β = −0.353; p = .000).

Conclusions: Diabetic youths treated with CSII therapy have better HRQoL than those treated with MDI. There are no differences between the investigated groups in anthropometric data, glycated hemoglobin, and physical fitness. Moreover, good physical fitness has an important role in achieving better metabolic control and HRQoL, which underlines the importance of regular aerobic exercise in the treatment and care of type 1 diabetes in childhood.

Objectives: In this study, we explored crucial factors that explain a person's attitude toward and his or her assessment of telemedical systems. Special focus lies on the link between the perspective of physicians (telemedicine users) and technicians (telemedicine designers) to find potential barriers hindering the broad application of telemedical systems in hospitals and doctors’ offices.

Methods: A survey among medical professionals (n = 34), technical professionals (n = 39), and a control group (n = 44) was conducted. The collected data were assessed in terms of domain knowledge, attitudes toward telemedicine, and potential implementation barriers.

Results: Participants favored the conventional method over telemedical monitoring in regards to privacy, security, and time efficiency. In contrast, telemedicine was preferred with reference to efficiency of data analysis, long-term care, and emergency adequacy. Significant differences between the professional groups were found regarding perceived cost effectiveness, patients’ compliance, privacy protection, and false alarm sensitivity. Medical professionals exhibited the most reluctance toward using telemedical treatments.

Conclusions: The perceived drawbacks are attributed to a general uncertainty about the reliability of telemedical systems, in combination with concerns about personal data privacy, security, and loss of control. The reported fear of not being able to correctly use and handle the systems assumes a low usability of devices. To acquaint medical professionals with the benefits and limitations of telemedical systems, telemonitoring and tele-treatment should be included in the education of medical personnel at an early stage.

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.

Background: Digital media can be integrated in tele-monitoring solutions, serving as the main interface between the patient and the caregiver. Consequently, the selection of the most appropriate digital medium for the specified target group is critical to ensure compliance with the tele-monitoring system.

Objectives: This pilot study aims to gather insights from patients with chronic obstructive pulmonary disease (COPD) on the ease-of-use, efficacy, effectiveness, and satisfaction of different types of digital media.

Methods: Five off-the-shelf digital media devices were tested on nine patients at CIRO+ in Horn, The Netherlands. Usability was evaluated by asking patients to use each device to answer questions related to their symptoms and health status. Subsequently, patients completed a paper-based device usability questionnaire, which assessed prior experience with digital media, device dimensions, device controllability, response speed, screen readability, ease-of-use, and overall satisfaction. After testing all the devices, patients ranked the devices according to their preference.

Results: We identified the netbook as the preferred type of device due to its good controllability, fast response time, and large screen size. The smartphone was the least favorite device as patients found the size of the screen to be too small, which made it difficult to interact with.

Conclusion: The pilot study has provided important insights to guide the selection of the most appropriate type of digital medium for implementation in tele-monitoring solutions for patients with COPD. As the digital medium is an important interface to the patient in tele-monitoring solutions, it is essential that patients feel motivated to interact with the digital medium on a regular basis.

Objective: The aim of this study was to present a clear process of synthesizing test accuracy data when conducting economic evaluations of diagnostic tests for health technology assessment (HTA) assessors and health economists.

Methods: We appraised the methods advocated for using diagnostic test accuracy data in economic evaluations. We used a case study of fetal anemia in which data from a screening test are used in combination with a confirmatory test.

Results: We developed a step-by-step guide and consider two scenarios: when data on test accuracy from several studies are based on (i) the same test threshold for positivity and (ii) different test thresholds.

Conclusions: We conclude that each approach has its strengths and limitations. We show that the optimal operating point of the test should be identified to determine the true cost-effectiveness of the test. We advocate that these issues require a multidisciplinary team of health economists, decision modelers and statisticians.

Objectives: The aim of this study was to implement a set of indicators to assess the quality of care of a new healthcare model for prevention of colorectal cancer in a high-risk population.

Methods: Information was obtained retrospectively from electronic clinical records, review of documentation, and a survey. The high-risk clinic for colorectal cancer was created in Barcelona (Spain) in 2006. All users at greater risk of colorectal cancer assessed through the new healthcare model were included. Twenty-one indicators were computed using defined formulas and standards. Logistic regression models were computed to analyze factors related to adherence to the screening and surveillance prevention strategies.

Results: A total of 1,275 users were included. Eight of seventeen indicators reached the quality standard (80 percent structure, 50 percent process, and 17 percent outcome), whereas four indicators did not have a previously defined standard. The overall adherence to the screening and surveillance program was 67 percent. Users aged 59 and older had almost two times greater probabiblity (95 percent confidence interval [CI], 1.3–3.1) of adherence than younger users; users with surveillance colonoscopies presented a 7.4 times (95 percent CI, 4.6–11.7) greater probability of adherence than those with screening colonoscopies.

Conclusions: The indicators have been shown to be feasible and valid tools to identify areas of improvement in this new model, such as information systems, continuity of care, and communication among professionals. Because this was the first time these indicators were applied to assess the high-risk clinic for colorectal cancer, further implementation is required to improve the interpretability of results.

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: Depression is common in diabetes and linked to a wide range of adverse outcomes. UK policy indicates that depression should be treated using conventional psychological treatments in a stepped care framework. This review aimed to identify current economic evidence of psychological treatments for depression among people with diabetes.

Method: Electronic search strategies (conducted in MEDLINE, EMBASE, PsycINFO, CINAHL, NHS EED) combined clinical and economic search terms to identify full economic evaluations of the relevant interventions. Prespecified screening and inclusion criteria were used. Standardized data extraction and critical appraisal were conducted and the results summarized qualitatively.

Results: Excluding duplicates, 1,516 studies for co-morbid depression and diabetes were screened. Four economic evaluations were identified. The studies found that the interventions improved health status, reduced depression and were cost-effective compared with usual care. The studies were all U.S.-based and evaluated collaborative care programs that included psychological therapies. Critical appraisal indicated limitations with the study designs, analysis and results for all studies.

Conclusions: The review highlighted the paucity of evidence in this area. The four studies indicated the potential of interventions to reduce depression and be cost-effective compared with usual care. Two studies reported costs per QALY gained of USD 267 to USD 4,317, whilst two studies reported the intervention dominated usual care, with net savings of USD 440 to USD 612 and net gains in patient free days or QALYs.

Objectives: An overview was produced of approaches currently used to evaluate chronic disease management in selected European countries. The study aims to describe the methods and metrics used in Europe as a first to help advance the methodological basis for their assessment.

Methods: A common template for collection of evaluation methods and performance measures was sent to key informants in twelve European countries; responses were summarized in tables based on template evaluation categories. Extracted data were descriptively analyzed.

Results: Approaches to the evaluation of chronic disease management vary widely in objectives, designs, metrics, observation period, and data collection methods. Half of the reported studies used noncontrolled designs. The majority measure clinical process measures, patient behavior and satisfaction, cost and utilization; several also used a range of structural indicators. Effects are usually observed over 1 or 3 years on patient populations with a single, commonly prevalent, chronic disease.

Conclusions: There is wide variation within and between European countries on approaches to evaluating chronic disease management in their objectives, designs, indicators, target audiences, and actors involved. This study is the first extensive, international overview of the area reported in the literature.

Objectives: The aim of this study was to evaluate the comparative effectiveness of anti-vascular endothelial growth factor therapy in the treatment of diabetic macular edema (DME).

Methods: Searches focused on reports concerning treatment of DME with aflibercept, bevacizumab, pegaptanib, or ranibizumab published between January 2000 and June 30, 2012, with comparisons to laser photocoagulation, sham injection, or other control (e.g., triamcinolone). Effectiveness was based on best-corrected visual acuity (BCVA), in terms of letters gained. Direct meta-analyses were conducted on BCVA for each anti-vascular endothelial growth factor (VEGF) agent; indirect comparisons also were performed for each anti-VEGF pair.

Results: A total of fifteen randomized controlled trials (eleven fair- or good-quality) and eight observational studies were included. No direct comparative studies were identified. Improvement in visual acuity versus control was seen with all agents (range: 4–9 letters); outcomes were consistent across multiple timepoints. Meta-analyses showed no statistically significant and/or consistent differences between agents in BCVA changes or the percentage of patients gaining more than ten letters. No discernible differences in the potential harms of anti-VEGFs, including ocular events, MI, stroke, and other cardiovascular events, as well as death, were noted between aflibercept, pegaptanib, and ranibizumab. Data on harms for bevacizumab were underreported.

Conclusions: All anti-VEGF agents are effective in improving visual acuity in comparison to laser photocoagulation. Evidence is insufficient to distinguish the performance of any single anti-VEGF agent over others. The safety of bevacizumab remains the greatest element of uncertainty.

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.

Objective: Technological change accounts for approximately 25 percent of health expenditure growth. To date, limited research has been published on case studies of disinvestment and resource allocation decision making in clinical practice. Our research objective is to systematically review and catalogue the application of frameworks and tools for disinvestment and resource allocation decision making in health care.

Methods: An electronic literature search was executed for studies on disinvestment, obsolete and ineffective technologies, and priority healthcare setting, published from January 1990 until January 2012. Databases searched were MEDLINE, MEDLINE In-Process and Other Non-Indexed Citations, Embase, The Cochrane Library, PubMed, and HEED.

Results: Fourteen case studies on the application of frameworks and tools for disinvestment and resource allocation decisions were included. Most studies described the application of program budgeting and marginal analysis (PBMA), and two reports used health technology assessment (HTA) methods for coverage decisions in a national fee-for-service structure. Numerous healthcare technologies and services were covered across the studies. We describe the multiple criteria considered for decision making, and the strengths and limitations of these frameworks and tools are highlighted.

Conclusions: Disinvestment and resource allocation decisions require evidence to ensure their transparency and objectivity. PBMA was used to assess resource allocation of health services and technologies in a fixed budget jurisdiction, while HTA reviews focused on specific technologies, principally in fee-for-service structures. Future research can review the data requirements and explore opportunities to increase the quantity of available evidence for disinvestment and resource allocation decisions.