Objectives: This study reports the cost-effectiveness of a preventive intervention, consisting of counseling and specific support for the mother–infant relationship, targeted at women at high risk of developing postnatal depression.

Methods: A prospective economic evaluation was conducted alongside a pragmatic randomized controlled trial in which women considered at high risk of developing postnatal depression were allocated randomly to the preventive intervention (n = 74) or to routine primary care (n = 77). The primary outcome measure was the duration of postnatal depression experienced during the first 18 months postpartum. Data on health and social care use by women and their infants up to 18 months postpartum were collected, using a combination of prospective diaries and face-to-face interviews, and then were combined with unit costs (£, year 2000 prices) to obtain a net cost per mother–infant dyad. The nonparametric bootstrap method was used to present cost-effectiveness acceptability curves and net benefit statistics at alternative willingness to pay thresholds held by decision makers for preventing 1 month of postnatal depression.

Results: Women in the preventive intervention group were depressed for an average of 2.21 months (9.57 weeks) during the study period, whereas women in the routine primary care group were depressed for an average of 2.70 months (11.71 weeks). The mean health and social care costs were estimated at £2,396.9 per mother–infant dyad in the preventive intervention group and £2,277.5 per mother–infant dyad in the routine primary care group, providing a mean cost difference of £119.5 (bootstrap 95 percent confidence interval [CI], −535.4, 784.9). At a willingness to pay threshold of £1,000 per month of postnatal depression avoided, the probability that the preventive intervention is cost-effective is .71 and the mean net benefit is £383.4 (bootstrap 95 percent CI, −£863.3–£1,581.5).

Conclusions: The preventive intervention is likely to be cost-effective even at relatively low willingness to pay thresholds for preventing 1 month of postnatal depression during the first 18 months postpartum. Given the negative impact of postnatal depression on later child development, further research is required that investigates the longer-term cost-effectiveness of the preventive intervention in high risk women.

Objectives: Even when policy makers show interest and evidence-informed and convincing HTA studies are available, use of assessment products is not guaranteed. In this article, we report our experience with knowledge brokering to foster evidence-informed policy making on cost-effective treatment and reimbursement of assisted reproduction in The Netherlands.

Methods: From earlier work in the field of knowledge brokering, we foresaw the need for a deliberative strategy to manage the inherent tension between scientific rigor demanded by researchers and responsiveness to real-time needs demanded by policy makers. Therefore, we structured the process in three distinct steps: (i) agreement about the main messages from the research, (ii) analysis of the policy context and of the meaning of the main messages for the actors involved, and (iii) an invitational meeting to make recommendations for action.

Results: One of the recommendations that would require changes in ministerial policy was followed up instantly, whereas the other recommendation is still under debate. The Dutch Society of Obstetrics and Gynecology activated the revision of two guidelines. The patient organization uses the new scientific insights in informing members and the public. Closing the loop, The Netherlands Organisation for Health Research and Development (ZonMw) funded research to close knowledge gaps that became apparent in the process.

Conclusions: Knowledge brokering is a promising approach to bring HTA into practice. We conclude that the methodologies to feed research results into the policy process are still in an incipient stage and need further development.

Objectives: Uncertainty is pervasive in decision making on new health technologies; therefore, some countries have put systems in place to support decision makers with timely information. An important, but as yet undocumented, determinant of the potential value for decision making of these so-called horizon scanning systems (HSSs) is how the most significant health technologies are selected.

Methods: All thirteen member organizations of EuroScan, a collaborative network for HSSs, were surveyed and interviewed on how they prioritize technologies for assessment.

Results: The majority of HSSs directly serves a customer. Some customers actively request early assessments of new health technologies, thereby diminishing the need for priority setting for the HSSs. All systems express a concern to miss an important technology and/or to select an unimportant technology. Almost all HSSs use explicit selection criteria, but these criteria hardly ever are operationalized. The number of criteria used varies, but costs and health benefit of the technology are always taken into account. The process of reaching a final decision is implicit, undocumented in all but one system, and is based on agreement by consensus.

Conclusions: The process of making the final decision on which technologies to assess can be improved by applying existing criteria more consistently and transparently. Current practice does not safeguard against missing an important technology. This finding is probably most important to act upon for systems with customers that do not actively request assessment of specific technologies.

Objectives: The aim of this study was to evaluate the success of search strategies in retrieving key documents for a technology assessment report (TAR) on a social care topic.

Methods: This study measured the differential yield of relevant studies from various information sources and evaluated strategies in different databases, with particular reference to capturing randomized controlled trials (RCTs) as a study design.

Results: A combination of four major databases would have found all thirty-two key references. One database alone would have found 78 percent, with another two each locating 59 percent. Sixteen percent of the trials were unique references. In non–health care databases, more sensitive search strategies would have resulted in a higher yield of relevant studies, in part due to inconsistent indexing and in part to attempts to restrict searches to RCTs. Although additional terms could be used to increase the sensitivity of the original strategies, this raises the question of trading off time against exhaustiveness, given the greater number of irrelevant references likely to be retrieved.

Conclusions: A successful search for evidence on this social care topic would be possible using a combination of MEDLINE, EMBASE, the Cochrane Library and PsycINFO, supplemented by only limited use of supplementary databases. In areas such as social care where evidence-based research is not yet well established, attempts to replicate searches based on study design do not seem to be advisable, although this may be an area for future research.

Objectives: This study describes the diffusion of advanced diagnostic devices in India and assess implications for efficiency in resource use and equity.

Methods: Commodity-level import statistics, household survey data, and interviews with medical device sellers are used to assess the spread of diagnostic devices. Published qualitative evidence, case studies of diagnostic service providers, and cross-country analyses are used to identify the reasons underlying the spread of medical devices in India. Case studies of public and private providers and data from 150 hospitals in one Indian state are used to assess efficiency in resource use and the distributive impacts of diagnostic devices.

Results: High-end medical device inflows rose during the 1990s, with both supply- and demand-side factors influencing this trend. Although our results suggest that the overall quantity of advanced diagnostics in India is not excessive, there is some evidence of inefficiency in public facilities and possibly unethical practices in private diagnostic facilities. The unequal geographical distribution of magnetic resonance imaging facilities, coupled with inefficient use of medical devices in public facilities suggests inequality in access.

Conclusions: The study points to major regulatory gaps and health system inefficiencies and suggests ways in which these gaps can be addressed.

Objectives: This study examines the content and role of ethical analysis in health technology assessment (HTA) and horizon scanning publications. It proposes that ethical analysis in HTA is of at least two different types: an ethics of HTA and an ethics in HTA.

Methods: I examine the critical differences between these approaches through the examples of the analysis of genetic screening for breast cancer and home blood glucose testing in diabetes. I then argue that, although both approaches subscribe to similar views concerning HTA and ethics, they use different theoretical and methodological traditions to interpret and explain them.

Results and Conclusions: I conclude by suggesting that we need the interpretive insights of both these approaches, taken together, to explain why ethics has not been able yet to contribute fully to HTA and to demonstrate the scope and complexity of ethical work in this domain.

Objectives: An overview was produced of indicators currently used to assess disease management programs and, based on these findings, provide a framework regarding sets of indicators that should be used when taking the aims and types of disease management programs into account.

Methods: A systematic literature review was performed.

Results: Thirty-six studies met the inclusion criteria. It appeared that a link between aims of disease management and evaluated structure, process, as well as outcome indicators does not exist in a substantial part of published studies on disease management of diabetes and asthma/chronic obstructive pulmonary disease, especially when efficiency of care is concerned. Furthermore, structure indicators are largely missing from the evaluations, although these are of major importance for the interpretation of outcomes for purposes of decision-making. Efficiency of disease management is mainly evaluated by means of process indicators; the use of outcome indicators is less common. Within a framework, structure, process, and outcome indicators for effectiveness and efficiency are recommended for each type of disease management program.

Conclusions: The link between aims of disease management and evaluated structure, process, and outcome indicators does not exist in a substantial part of published studies on disease management. The added value of this study mainly lies in the development of a framework to guide the choice of indicators for health technology assessment of disease management.

Objectives: Acute otitis media (AOM) is one of the most common diseases of childhood, representing a major disease burden on the society. New evidence-based guidelines for AOM, focusing on children under 7 years of age, were introduced in Finland in 1999. The aim of this study was to evaluate the cost-effectiveness of implementing those guidelines in Finland.

Methods: A 5-year prospective trial was conducted in thirty community primary healthcare centers in Finland. All AOM patients between 0 and 6 years of age visiting the study health centers for the first time, for this episode of illness, during 1 week in November 1998 (n = 579) and November 2002 (n = 369) were included in this study. The outcome measure was the percentage of symptom-free patients.

Results: The mean direct cost of an AOM episode per patient stayed almost the same after implementing the guidelines, €152 in 1998 and €150 in 2002. After implementing the guidelines, the percentage of symptom-free patients was 10 percentage points higher than before the guidelines. The treatment after the implementation of the guidelines, thus, was a dominant strategy.

Conclusions: Implementing the guidelines to the treatment of AOM in children was associated with extra health benefits at slightly lower direct costs and, thus, is a dominant strategy. The focus of this study was on the short-term effects of the treatment; including long-term effects in the analysis might affect the results.

Objectives: The overall objective of this article was to review the theoretical and conceptual dimensions of how the implementation of clinical practice guidelines (CPGs) is likely to affect treatment costs.

Methods: An important limitation of the extant literature on the cost effects of CPGs is that the main focus has been on clinical adaptation. We submit that the process innovation aspects of CPGs require changes in both clinical and organizational dimensions. We identify five organizational factors that are likely to affect the relationship between CPGs and total treatment costs: implementation, coordination, learning, human resources, and information. We review the literature supporting each of these factors.

Results: The net organizational effects of CPGs on costs depends on whether the cost-reducing properties of coordination, learning, and human resource management offset potential cost increases due to implementation and information management.

Conclusions: Studies of the cost effects of clinical practice guidelines should attempt to measure, to the extent possible, the effects of each of these clinical and organizational factors.

Objectives: The objective of this study was to develop a method to allocate treatment effects when patients switch medication frequently in longitudinal observational studies and apply the approach to assess the cost-effectiveness of treatments in the Schizophrenia Outpatient Health Outcomes (SOHO) study.

Methods: Data were collected on patients at entry to the SOHO study at 3, 6, and 12 months. The 12-month follow-up period was considered as three epochs: 0–3 months, 3–6 months, and 6–12 months. Patients who switched treatment at 3 months had their new treatment considered as a new baseline observation, as these two 3-month observations provide two sets of information on the cost-effectiveness of a drug in the first 3 months after initiation. Multivariate regression analysis was used to adjust for baseline covariates. The model allowed for flexible functional forms, and the cost data were modeled using an exponential mean function. Bootstrapping assessed the uncertainty of the estimated parameters and incremental cost-effectiveness analysis decision rule.

Results and Conclusions: We show the feasibility of the epoch analysis approach using data from the SOHO study comparing two antipsychotics. Estimates for the incremental cost and effectiveness per epoch over the full 12-month period are presented. Using the estimates of 200 bootstrap samples, we demonstrate how one drug is cost-effective compared with another.

Objectives: The objective of this study is to apply a Markov model to compare cost-effectiveness of total knee replacement (TKR) using computer-assisted surgery (CAS) with that of TKR using a conventional manual method in the absence of formal clinical trial evidence.

Methods: A structured search was carried out to identify evidence relating to the clinical outcome, cost, and effectiveness of TKR. Nine Markov states were identified based on the progress of the disease after TKR. Effectiveness was expressed by quality-adjusted life years (QALYs). The simulation was carried out initially for 120 cycles of a month each, starting with 1,000 TKRs. A discount rate of 3.5 percent was used for both cost and effectiveness in the incremental cost-effectiveness analysis. Then, a probabilistic sensitivity analysis was carried out using a Monte Carlo approach with 10,000 iterations.

Results: Computer-assisted TKR was a long-term cost-effective technology, but the QALYs gained were small. After the first 2 years, the incremental cost per QALY of computer-assisted TKR was dominant because of cheaper and more QALYs. The incremental cost-effectiveness ratio (ICER) was sensitive to the “effect of CAS,” to the CAS extra cost, and to the utility of the state “Normal health after primary TKR,” but it was not sensitive to utilities of other Markov states. Both probabilistic and deterministic analyses produced similar cumulative serious or minor complication rates and complex or simple revision rates. They also produced similar ICERs.

Conclusions: Compared with conventional TKR, computer-assisted TKR is a cost-saving technology in the long-term and may offer small additional QALYs. The “effect of CAS” is to reduce revision rates and complications through more accurate and precise alignment, and although the conclusions from the model, even when allowing for a full probabilistic analysis of uncertainty, are clear, the “effect of CAS” on the rate of revisions awaits long-term clinical evidence.

Objectives: A comprehensive and systematic assessment (HTA) of early home-supported discharge by a multidisciplinary team that plans, coordinates, and delivers care at home (EHSD) was undertaken and the results were compared with that of conventional rehabilitation at stroke units.

Methods: A systematic literature search for randomized trials (RCTs) on “early supported discharge” was closed in April 2005. RCTs on EHSD without information on (i) death or institution at follow-up, (ii) change in Barthél Index, (iii) length of hospital stay, (iv) intensity of home rehabilitation, or (v) baseline data are excluded. Seven RCTs on EHSD with 1,108 patients followed 3–12 months after discharge are selected for statistical meta-analysis of outcomes. The costs are calculated as a function of the average number of home training sessions. Economic evaluation is organized as a test of dominance (both better outcomes and lower costs).

Results: The odds ratio (OR) for “Death or institution” is reduced significantly by EHSD: OR = .75 (confidence interval [CI], .46–.95), and number needed to treat (NNT) = 14. Referrals to institution have OR = .45 (CI, .31–.96) and NNT = 20. The reduction of the rate of death is not significant. Length of stay is significantly reduced by 10 days (CI, 2.6–18 days). All outcomes have a nonsignificant positive covariance. The median number of home sessions is eleven, and the average cost per EHSD is 1,340 USD. The “action mechanism” and financial barriers to EHSD are discussed.

Conclusions: EHSD is evidenced as a dominant health intervention. However, financial barriers between municipalities and health authorities have to be overcome. For qualitative reasons, a learning path of implementation is recommended where one stroke unit in a region initiates EHSD for dissemination of new experience to the other stroke units.

Objectives: The objective of this study was to develop a model to assess the cost-effectiveness of a new treatment for patients with depression.

Methods: A Markov simulation model was constructed to evaluate standard care for depression as performed in clinical practice compared with a new treatment for depression. Costs and effects were estimated for time horizons of 6 months to 5 years. A naturalistic longitudinal observational study provided data on costs, quality of life, and transition probabilities. Data on long-term consequences of depression and mortality risks were collected from the literature. Cost-effectiveness was quantified as quality-adjusted life-years (QALYs) gained from the new treatment compared with standard care, and the societal perspective was taken. Probabilistic analyses were conducted to present the uncertainty in the results, and sensitivity analyses were conducted on key parameters used in the model.

Results: Compared with standard care, the new hypothetical therapy was predicted to substantially decrease costs and was also associated with gains in QALYs. With an improved treatment effect of 50 percent on achieving full remission, the net cost savings were 20,000 Swedish kronor over a 5-year follow-up time, given equal costs of treatments. Patients gained .073 QALYs over 5 years. The results are sensitive to changes in assigned treatment effects.

Conclusions: The present study provides a new model for assessing the cost-effectiveness of treatments for depression by incorporating full remission as the treatment goal and QALYs as the primary outcome measure. Moreover, we show the usefulness of naturalistic real-life data on costs and quality of life and transition probabilities when modeling the disease over time.

Objectives: The aim of this study was to evaluate the cost-effectiveness of neonatal screening for phenylketonuria (PKU) and medium-chain acyl-coA dehydrogenase (MCAD) deficiency using tandem mass spectrometry (tandem MS).

Methods: A systematic review of clinical efficacy evidence and cost-effectiveness modeling of screening in newborn infants within a UK National Health Service perspective was performed. Marginal costs, life-years gained, and cost-effectiveness acceptability curves are presented.

Results: Substituting the use of tandem MS for existing technologies for the screening of PKU increases costs with no increase in health outcomes. However, the addition of screening for MCAD deficiency as part of a neonatal screening program for PKU using tandem MS, with an operational range of 50,000 to 60,000 specimens per system per year, would result in a mean incremental cost of −£17,298 (−£129,174, £66,434) for each cohort of 100,000 neonates screened. This cost saving is associated with a mean incremental gain of 57.3 (28.0, 91.4) life-years.

Conclusions: Cost-effectiveness analysis using economic modeling indicates that substituting the use of tandem MS for existing technologies for the screening of PKU alone is not economically justified. However, the addition of screening for MCAD deficiency as part of a neonatal screening program for PKU using tandem MS would be economically attractive.

Objectives: To assess the cost-effectiveness of brief physiotherapy intervention versus usual physiotherapy management in patients with neck pain of musculoskeletal origin in the community setting.

Methods: A cost-effectiveness analysis was conducted alongside a multicenter pragmatic randomized controlled clinical trial. Individuals 18 years of age and older with neck pain of more than 2 weeks were recruited from physiotherapy departments with referrals from general practitioners (GPs) in the East Yorkshire and North Lincolnshire regions in the United Kingdom. A total of 139 patients were allocated to the brief intervention, and 129 to the usual physiotherapy. Resource use data were prospectively collected on the number of physiotherapy sessions, hospital stay, specialist, and GP visits. Quality-adjusted life years (QALYs) were estimated using EQ-5D data collected at baseline, 3 and 12 months from the start of the treatment. The economic evaluation was conducted from the U.K. National Health System perspective.

Results: On average, brief intervention produced lower costs (£−68; 95 percent confidence interval [CI], £−103 to £−35) and marginally lower QALYs (−0.001; 95 percent CI, −0.030 to 0.028) compared with usual physiotherapy, resulting in an incremental cost per QALY of £68,000 for usual physiotherapy. These results are sensitive to patients' treatment preferences.

Conclusions: Usual physiotherapy may not be good value for money for the average individual in this trial but could be a cost-effective strategy for those who are indifferent toward which treatment they receive.

Objectives: Although measuring the utilization of ambulatory and home-based healthcare resources is an essential component of economic analyses, very little methodological attention has been devoted to the development and evaluation of resource costing tools. This study evaluated a newly developed tool, the Ambulatory and Home Care Record (AHCR), which comprehensively evaluates costs incurred by the health system and care recipients and their unpaid caregivers.

Methods: The level of agreement between self-reports from 110 cystic fibrosis care recipients and administrative data was assessed for four categories of health services: home-based visits with healthcare professionals, ambulatory visits with healthcare professionals, laboratory and diagnostic tests, and prescription medications.

Results: Agreement between care recipients' reports on the AHCR and administrative data ranged from moderate (kappa=0.41; 95 percent confidence interval, 0.16–0.61) for physician specialist visits to perfect (kappa=1.0) for physiotherapy visits.

Conclusions: By evaluating and standardizing a resource and costing tool, such as the AHCR, economic evaluations may be improved and comparisons of the resource implications for different services and for diverse populations are possible.

Objectives: The objective of this study was to analyze preferences for activities comprised in comprehensive cardiac rehabilitation programs among former cardiac patients from three different hospitals in Copenhagen County, Denmark.

Methods: A discrete choice experiment was applied to elicit the preferences for the offer of participation in various cardiac rehabilitation program activities: smoking cessation course, physical exercise program, personal meetings with cardiac nurse, group meetings managed by cardiac nurses, and nutritional counseling guidance. The questionnaire was sent to 742 former cardiac patients. We had a response rate of 69 percent.

Results: We found that preferences differed with respect to gender and age and that the offer of participation in cardiac rehabilitation activities was not highly valued by older patients, in particular among older men.

Conclusions: The discrete choice experiment proved a valuable instrument for the measurement of preferences for cardiac rehabilitation. The study provides important information on patients' preferences for cardiac rehabilitation for healthcare professionals and decision makers.

Objectives: The costs of comprehensive cardiac rehabilitation are established and compared to the corresponding costs of usual care. The effect on health-related quality of life is analyzed.

Methods: An unprecedented and very detailed cost assessment was carried out, as no guidelines existed for the situation at hand. Due to challenging circumstances, the cost assessment turned out to be ex-post and top-down.

Results: Cost per treatment sequence is estimated to be approximately €976, whereas the incremental cost (compared with usual care) is approximately €682. The cost estimate is uncertain and may be as high as €1.877.

Conclusions: Comprehensive cardiac rehabilitation is more costly than usual care, and the higher costs are not outweighed by a quality of life gain. Comprehensive cardiac rehabilitation is, therefore, not cost-effective.

Objectives: The Human Genome Project has led to a multitude of new potential screening targets on the level of human DNA. The aim of this systematic review is to critically summarize the evidence from health economic evaluations of genetic screening in the literature.

Methods: Based on an extensive explorative search, an appropriate algorithm for a systematic database search was developed. Twenty-one health economic evaluations were identified and appraised using published quality criteria.

Results: Genetic screening for eight conditions has been found to be investigated by health economic evaluation: hereditary breast and ovarian cancer, familial adenomatous polyposis (FAP) colorectal cancer, hereditary nonpolyposis colorectal carcinoma (HNPCC), retinoblastoma, familial hypercholesterolemia, hereditary hemochromatosis, insulin-dependent diabetes mellitus, and cystic fibrosis. Results range from dominated to cost-saving. Population-wide genetic screening may be considered cost-effective with limited quality of evidence only for three conditions. The methodology of the studies was of varying quality. Cost-effectiveness was primarily influenced by mutation prevalence, genetic test costs, mortality risk, effectiveness of treatment, age at screening, and discount rate.

Conclusions: Health economic evidence on genetic screening is limited: Only few conditions have properly been evaluated. Based on the existing evidence, healthcare decision makers should consider the introduction of selective genetic screening for FAP and HNPCC. As genetic test costs are declining, the existing evaluations may warrant updating. Especially in the case of hereditary hemochromatosis, genetic population screening may be about to turn from a dominated to a cost-effective or even cost-saving intervention.

Objectives: The present study evaluated the cost-effectiveness of a behavioral graded exercise therapy (GET) program compared with usual care (UC) in terms of the performance of daily activities by patients with chronic shoulder complaints in primary care.

Methods: A total of 176 patients were randomly assigned either to GET (n=87) or to UC (n=89). Clinical outcomes (main complaints, shoulder disability [SDQ] and generic health-related quality of life [EQ-5D], and costs [intervention costs, direct health care costs, direct non–health-related costs, and indirect costs]) were assessed during the 12-week treatment period and at 52 weeks of follow-up.

Results: Results showed that GET was more effective than UC in restoring daily activities as assessed by the main complaints instrument after the 12-week treatment period (p=.049; mean difference, 7.5; confidence interval [CI], 0.0–15.0). These effects lasted for at least 52 weeks (p=.025; mean difference 9.2; CI, 1.2–17.3). No statistically significant differences were found on the SDQ or EQ5D. GET significantly reduced direct health care costs (p=.000) and direct non–health care costs (p=.029). Nevertheless, total costs during the 1-year follow-up period were significantly higher (p=.001; GET=€530 versus UC=€377) due to the higher costs of the intervention. Incremental cost-effectiveness ratios for the main complaints (0–100), SDQ (0–100), and EQ-5D (−1.0–1.0) were €17, €74, and €5,278 per unit of improvement, respectively.

Conclusions: GET proved to be more effective in the short- and long-term and reduces direct health care costs and direct non–health care costs but is associated with higher costs of the intervention itself.