Objectives: The aim of this study was to estimate the expected cost and clinical benefits associated with the use of drotrecogin alfa (activated) (Xigris; Eli Lilly and Company; Indianapolis, IN) in the French hospital setting.

Methods: The recombinant human activated PROtein C Worldwide Evaluation in Severe Sepsis (PROWESS) study results (1,271 patients with multiple organ failure) were adjusted to 9,948 hospital stays from a database of Parisian area intensive-care units (ICUs)—the CubRea (Intensive Care Database User Group) database. The analysis features a decision tree with a probabilistic sensitivity analysis.

Results: The cost per life year gained (LYG) of drotrecogin treatment for severe sepsis with multiple organ failure (European indication) was estimated to be $11,812. At the hospital level, the drug is expected to induce an additional cost of $7,545 per treated patient. The incremental cost-effectiveness ratio ranges from $7,873 per LYG for patients receiving three organ supports during ICU stay to $17,704 per LYG for patients receiving less than two organ supports.

Conclusions: Drotrecogin alfa (activated) is cost-effective in the treatment of severe sepsis with multiple organ failure when added to best standard care. The cost-effectiveness of the drug increases with baseline disease severity, but it remains cost-effective for all patients when used in compliance with the European approved indication.

Objectives: Ongoing developments in design have improved the outlook for left-ventricular assist device (LVAD) implantation as a therapy in end-stage heart failure. Nevertheless, early cost-effectiveness assessments, based on first-generation devices, have not been encouraging. Against this background, we set out (i) to examine the survival benefit that LVADs would need to generate before they could be deemed cost-effective; (ii) to provide insight into the likelihood that this benefit will be achieved; and (iii) from the perspective of a healthcare provider, to assess the value of discovering the actual size of this benefit by means of a Bayesian value of information analysis.

Methods: Cost-effectiveness assessments are made from the perspective of the healthcare provider, using current UK norms for the value of a quality-adjusted life-year (QALY). The treatment model is grounded in published analyses of the Randomized Evaluation of Mechanical Assistance for the Treatment of Congestive Heart Failure (REMATCH) trial of first-generation LVADs, translated into a UK cost setting. The prospects for patient survival with second-generation devices is assessed using Bayesian prior distributions, elicited from a group of leading clinicians in the field.

Results: Using established thresholds, cost-effectiveness probabilities under these priors are found to be low (∼.2 percent) for devices costing as much as £60,000. Sensitivity of the conclusions to both device cost and QALY valuation is examined.

Conclusions: In the event that the price of the device in use would reduce to £40,000, the value of the survival information can readily justify investment in further trials.

Objectives: This study was designed to assess the sensitivity of three Ovid MEDLINE search filters developed to identify studies reporting health state utility values (HSUVs), to improve the performance of the best performing filter, and to validate resulting search filters.

Methods: Three quasi-gold standard sets (QGS1, QGS2, QGS3) of relevant studies were harvested from reviews of studies reporting HSUVs. The performance of three initial filters was assessed by measuring their relative recall of studies in QGS1. The best performing filter was then developed further using QGS2. This resulted in three final search filters (FSF1, FSF2, and FSF3), which were validated using QGS3.

Results: FSF1 (sensitivity maximizing) retrieved 132/139 records (sensitivity: 95 percent) in the QGS3 validation set. FSF1 had a number needed to read (NNR) of 842. FSF2 (balancing sensitivity and precision) retrieved 128/139 records (sensitivity: 92 percent) with a NNR of 502. FSF3 (precision maximizing) retrieved 123/139 records (sensitivity: 88 percent) with a NNR of 383.

Conclusions: We have developed and validated a search filter (FSF1) to identify studies reporting HSUVs with high sensitivity (95 percent) and two other search filters (FSF2 and FSF3) with reasonably high sensitivity (92 percent and 88 percent) but greater precision, resulting in a lower NNR. These seem to be the first validated filters available for HSUVs. The availability of filters with a range of sensitivity and precision options enables researchers to choose the filter which is most appropriate to the resources available for their specific research.

Objectives: This article examines the challenges for health technology assessment (HTA) in the light of new developments of personalized health care, focusing on European HTA perspectives.

Methods: Using the example of the Integrated Genome Research Network – Mutanom (IG Mutanom) project, with focus on personalized cancer diagnostics and treatment, we assess the scope of current HTA and examine it prospectively in the context of the translation of basic and clinical research into public health genomics and personalized health care.

Results: The approaches developed within the IG-Mutanom project are based on innovative technology potentially providing targeted therapies for cancer; making translation into clinical practice requires a novel course of action, however. New models of HTA are needed that can account for the unique types of evidence inherent to individualized targeted therapies. Using constructive health technology assessment (CTA) models is an option, but further suitable models should be developed.

Conclusions: Integrative, systems biology-based approaches toward personalized medicine call for novel assessment methods. The translation of their highly innovative technologies into the practice of health care requires the development of new HTA concepts.

Objectives: Hospital readmission rate is currently used as a quality of care indicator, although its validity has not been established. Our aims were to identify the frequency and characteristics of potential avoidable readmissions and to compare the assessment of quality of care derived from readmission rate with other measure of quality (judgment of experts).

Methods: Design: cross-sectional observational study; Setting: acute care hospital located in Marbella, South of Spain; Study participants: random sample of patients readmitted at the hospital within six months from discharge (n=363); Interventions: review of clinical records by a pair of observers to assess the causes of readmissions and their potential avoidability; Main measures: logistic regression analysis to identify the variables from the databases of hospital discharges which are related to avoidability of readmissions. Determination of sensitivity and specificity of different definitions of readmission rate to detect avoidable situations.

Results: Nineteen percent of readmissions were considered potentially avoidable. Variables related to readmission avoidability were (i) time elapsed between index admission and readmission and (ii) difference in diagnoses of both episodes. None of the definitions of readmission rate used in this study provided adequate values of sensitivity and specificity in the identification of potentially avoidable readmissions.

Conclusions: Most readmissions in our hospital were unavoidable. Thus, readmission rate might not be considered a valid indicator of quality of care.

The differential staining cytotoxicity (DiSC) assay involves in vitro drug panel testing against patient tumor cells to identify optimal therapy. This observational study investigated whether DiSC assay guided treatment could improve outcome in patients with chronic lymphocytic leukemia. A cohort of 178 patients were categorized either as sensitive to drugs in vitro and receiving a sensitive drug in vivo, sensitive in vitro but not treated with a sensitive drug, or having disease resistant to all drugs tested in vitro. Response and survival for these patient categories were compared using multivariate regression techniques. Patients receiving a sensitive drug, compared with those who though having sensitivity did not, had a higher remission rate (odds ratio, 6.5; 95% CI, 2.91–14.53) and reduced death rate (hazard ratio, 0.29; 95% CI, 0.16–0.53). Having adjusted for all known confounding factors, the results suggest that in vitro drug sensitivity is an important independent prognostic variable to include in future trials, and that the DiSC assay may be a cost-effective use of health resources: the estimated incremental cost-effectiveness was £1,470 per life-year gained. A randomized controlled trial is required to confirm the benefit and estimate reliably the potential impact of assay-guided choice of therapy.

Objectives: This paper explores the use of evidence, focusing on economic evidence in particular, in the development of local health policies through an in-depth study of Health Improvement Programmes (HImPs) in England.

Methods: A questionnaire was sent to the person responsible for coordinating the development of the HImP in each of the 102 English health authorities. In addition, semi-structured interviews were conducted with 10 HImP leaders, and a random sample of 26 HImP documents was reviewed using a standard pro forma.

Results: Of the 102 mail questionnaires sent out, 68 (67%) were returned. It was found that those developing HImPs had multiple objectives, only some of which (e.g., efficiency in healthcare provision) would necessarily require evidence. Where evidence was used, this was a mixture of internal (experiential) and external (empirical) evidence, with the balance (66%) being in favor of the latter. Government reports and guidance from the National Institute for Clinical Excellence (NICE), were the main sources of external evidence, rather than published papers. Key barriers to the use of economic evidence were lack of time and availability and the difficulties in synthesizing information at the local level.

Conclusions: Based on responses to our survey, the main ways of increasing the use of evidence in the development of local health policies in England are to produce more evidence-based national guidance and to produce accessible summaries of the available literature for local decision makers.

Objective: The Israeli National Health Insurance Law stipulates a National List of Health Services (NLHS) to which all residents are entitled from their HMOs. This list has been updated annually for almost a decade using a structured review and decision-making process. Although this process has been described in detail in previous papers, none of these have fully addressed legitimacy and fairness. We examine the legitimacy and fairness of the process of updating the NLHS in Israel.

Methods: We assessed the priority-setting process for compliance with the four conditions of accountability for reasonableness outlined by Daniels and Sabin (relevance, publicity, appeals, and enforcement). These conditions emphasize transparency and stakeholder engagement in democratic deliberation.

Results: Our analysis suggests that the Israeli process for updating the NLHS does not fulfill the appeals and enforcement conditions, and only partially follows the publicity and relevance conditions, outlined in the accountability for reasonableness framework. The main obstacles for achieving these goals may relate to the large number of technologies assessed each year within a short time frame, the lack of personnel engaged in health technology assessment, and the desire for early adoption of new technologies.

Conclusions: The process of updating the NLHS in Israel is unique and not without merit. Changes in the priority-setting process should be made to increase its acceptability among the different stakeholders.

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: Calculations of healthcare costs rarely disclose the specific approach used to allocate the cost of hospitalizations by diagnosis. However, the type of approach used can have a major impact on the findings in the case of significant comorbidities. The present analyses compared three approaches for attributing Medicare DRG reimbursements (which were used as surrogates for average costs) for hospitalization by diagnosis.

Methods: Medical resource utilization data from the National Hospital Discharge Survey were analyzed using each of three allocation approaches: a) attributing 100% of the cost of hospitalization to the disease when it was the first-listed diagnosis; b) attributing a portion of the cost of hospitalization to the disease, depending on its position in the list of diagnoses and the relevance of any comorbidities; and c) an incremental analysis of cost based upon the hospitalization experiences of an age and gender matched cohort. These three approaches were applied to the cost of hospitalization for chronic obstructive pulmonary disease (COPD).

Results: The first approach projected 206,098 hospitalizations at $3,449 per hospitalization for a projected U.S. annual total of $711 million. The second approach projected 681,547 hospitalizations at $3,205 per hospitalization for a projected U.S. annual total of $2.2 billion. The third approach also projected 681,547 hospitalizations, but at $2,361 per hospitalization, for a projected U.S. annual total of $1.6 billion.

Conclusions: Expanding from the example on COPD, the limitations of each approach are described and their applications to other conditions are presented.

Objectives and Methods: Many authors have argued that ethical, legal, and social issues (“ELSIs”) should be explicitly integrated into health technology assessment (HTA), yet doing so poses challenges. This discussion may be particularly salient for technologies viewed as ethically complex, such as genetic screening. Here we provide a brief overview of contemporary discussions of the issues from the HTA literature. We then describe key existing policy evaluation frameworks in the fields of disease screening and public health genomics. Finally, we map the insights from the HTA literature to the policy evaluation frameworks, with discussion of the implications for HTA in genetic screening.

Results and Conclusions: A critical discussion in the HTA literature considers the definition of ELSIs in HTA, highlighting the importance of thinking beyond ELSIs as impacts of technology. Existing HTA guidance on integrating ELSIs relates to three broad approaches: literature synthesis, involvement of experts, and consideration of stakeholder values. The thirteen key policy evaluation frameworks relating to disease screening and public health genomics identified a range of ELSIs relevant to genetic screening. Beyond straightforward impacts of screening, these ELSIs require consideration of factors such as the social and political context surrounding policy decisions. The three broad approaches to addressing ELSIs described above are apparent in the screening/genomics literatures. In integrating these findings we suggest that the method chosen for addressing ELSIs in HTA for genetic screening may determine which ELSIs are prioritized; and that an important challenge is the lack of guidance for evaluating such methods.

Objectives: Despite the considerable and growing body of research about the clinical effectiveness of long-term psychoanalytic treatment, relatively little attention has been paid to economic evaluations, particularly with reference to the broader range of societal effects. In this cost-utility study, we examined the incremental cost-effectiveness ratio (ICER) of psychoanalysis versus psychoanalytic psychotherapy.

Methods: Incremental costs and effects were estimated by means of cross-sectional measurements in a cohort design (psychoanalysis, n = 78; psychoanalytic psychotherapy, n = 104). Quality-adjusted life-years (QALYs) were estimated for each treatment strategy using the SF-6D. Total costs were calculated from a societal perspective (treatment costs plus other societal costs) and discounted at 4 percent.

Results: Psychoanalysis was more costly than psychoanalytic psychotherapy, but also more effective from a health-related quality of life perspective. The ICER—that is, the extra costs to gain one additional QALY by delivering psychoanalysis instead of psychoanalytic psychotherapy—was estimated at €52,384 per QALY gained.

Conclusions: Our findings show that the cost-utility ratio of psychoanalysis relative to psychoanalytic psychotherapy is within an acceptable range. More research is needed to find out whether cost-utility ratios vary with different types of patients. We also encourage cost-utility analyses comparing psychoanalytic treatment to other forms of (long-term) treatment.

In light of growing demands for public accountability, the broadening scope of health technology assessment organizations (HTAOs) activities and their increasing role in decision-making underscore the importance for them to demonstrate their performance. Based on Parson's social action theory, we propose a conceptual model that includes four functions an organization needs to balance to perform well: (i) goal attainment, (ii) production, (iii) adaptation to the environment, and (iv) culture and values maintenance. From a review of the HTA literature, we identify specific dimensions pertaining to the four functions and show how they relate to performance. We compare our model with evaluations reported in the scientific and gray literature to confirm its capacity to accommodate various evaluation designs, contexts of evaluation, and organizational models and perspectives. Our findings reveal the dimensions of performance most often assessed and other important ones that, hitherto, remain unexplored. The model provides a flexible and theoretically grounded tool to assess the performance of HTAOs.

Objectives: To compare methods and results among four health technology assessment organizations in different countries.

Methods: All assessment reports published between 1999 and 2001 by VATAP (United States), NICE (United Kingdom), CCOHTA (Canada), and AETS (Spain), were reviewed. Detailed information about the organization, the technology assessed, the methods used, and the recommendations made were collected. A descriptive analysis of the variables, as well as comparisons of means and proportions, was performed.

Results: Sixty-one reports assessing seventy-six technologies were published: nine (11.8 percent) by VATAP, thirty-nine (51.3 percent) by NICE, twenty (26.3 percent) by CCOHTA, and eight (10.5 percent) by AETS. A total of 64.5 percent of the technologies assessed were related to a high prevalence disease in the corresponding country. Most of the assessments addressed treatments (73.7 percent) and were mostly drugs (56.6 percent) and devices (23.7 percent). Most organizations used reviews of effectiveness and economic evaluations (64.5 percent), systematic reviews (21.1 percent), and original economic evaluations (36.7 percent). In 38.1 percent, the technology was recommended; the rest of the cases had no formal recommendations.

Conclusions: Critical issues for future technology assessment efforts are making assessment processes more consistent, transparent, and evidence-based; formalizing the inclusion of economic and ethical considerations; and making more explicit the prioritization process for selecting technologies for assessment and reassessment.

Health technology assessment (HTA) seeks to inform health policy makers by using the best scientific evidence on the medical, social, economic, and ethical implications of investments in health care. Technology is broadly defined to include the drugs, devices, medical, and surgical procedures used in health care, as well as measures for prevention and rehabilitation of disease, and the organizational and support systems in which health care is provided.

Cataract is the most common reason for visual problems in old age. The introduction of intraocular lens (IOL) implantation revolutionized cataract surgery. Since the IOL technique was established in Sweden in the early 1980s, the demand for surgery has been increasing, leading to lengthy waiting lists. To shorten some of the most troublesome waiting lists, national and local governments (county councils) in Sweden introduced a maximum waiting time guarantee in 1992. The assessment of the guarantee made in this article shows that ophthalmic surgery units vary in their adoption of the guarantee, leading to different levels of goal achievement in waiting times for their patients. The less successful units could be divided into two groups: one where the units have a low operation rate, and one where the units chose not to follow the recommendations in priority setting made in the guarantee.

This paper investigates the theoretical properties of healthy-years equivalents (HYEs) and quality-adjusted life-years (QALYs). A distinction is made between ex ante HYEs (EA-HYEs) and expected HYEs (EXP-HYEs) and between risk-neutral quality-adjusted life-years (RN-QALYs) and risk-adjusted quality adjusted life-years (RA-QALYs). In the case of certainty, HYEs always rank health profiles according to individual preferences, whereas QALYs only rank health profiles according to individual preferences if constant proportional trade-off holds for all health states and if additive independence of quality in different periods holds. In the case of uncertainty, EA-HYEs always rank risky health profiles the same way as expected utility. The assumptions needed for the other measures to rank risky health profiles the same way as expected utility are: risk neutrality with respect to healthy time for EXP-HYEs; risk neutrality with respect to time in all health states and additive independence of quality in different periods for RN-HYEs; and constant proportional risk posture with respect to time in all health states and additive independence of quality in different periods for RA-QALYs.

Objectives: A systematic review of the cost-effectiveness of abdominal aortic aneurysm (AAA) repair was conducted. Although open surgery has been considered the gold standard for prevention of AAA rupture, emerging less-invasive endovascular treatments have led to increased interest in evaluating the cost and cost-effectiveness of treatment options.

Methods: A systematic review of studies published in MEDLINE between 1999 and 2005 reporting the cost and/or cost-effectiveness of endovascular and/or open surgical repair of nonruptured AAAs was conducted. Case series studies with less than fifty patients per treatment were excluded.

Results: Of twenty eligible articles, three were randomized controlled trials, twelve case series, four Markov models, and one systematic review. Regardless of time frame, all studies found that endovascular repair costs more than open surgery. Although the high cost of the endovascular prosthesis was partially offset by reduced intensive care, hospital length of stay, operating time, blood transfusions, and perioperative complications, hospital costs were still greater for endovascular than open surgical repair. For patients medically fit for open surgery, mid-term costs were greater for endovascular repair with no difference in overall survival or quality of life. For patients medically unfit for open surgery, endovascular repair costs more than no intervention with no difference in survival.

Conclusions: Although conclusions regarding the cost-effectiveness of AAA treatment options are time dependent and vary by institutional perspective, from a societal perspective, endovascular repair is not currently cost-effective for patients with large AAA regardless of medical fitness.

Objectives: We were interested in health coverage in women's magazines in the United States and how it compared with articles in medical journals, women's health interests, and women's greatest health risks.

Methods: We examined 12 issues of Good Housekeeping (GH) and Woman's Day (WD) and 63 issues of the New England Journal of Medicine (NEJM) and the Journal of the American Medical Association (JAMA). We tallied the most common health questions of women presenting to the University of Michigan's Women's Health Resource Center (WHRC) during the same period.

Results: Less than a fifth of the magazine articles dealt with health-related topics. Of those, a third dealt with diet, with the majority emphasizing weight loss rather than eating for optimal health. Few of the articles cited research studies, and even fewer included the name of the journal in which the study was published. In JAMA and NEJM, less than one-fifth of original research studies dealt with women's health topics, most commonly pregnancy-related issues, hormone replacement therapy, breast and ovarian cancer, and birth defects. At the same time, the most common requests for information at the WHRC related to pregnancy, fertility, reproductive health, and cancer.

Conclusion: The topics addressed in women's magazines do not appear to coincide with the topics addressed in leading medical journals, nor with women's primary health concerns or greatest health risks. Information from women's magazines may be leading women to focus on aspects of health and health care that will not optimize risk reduction.