Clinicians make judgments under conditions of uncertainty. Decision research has shown that in uncertain situations individuals do not always act rationally, coherently, or to maximize their expected utility. Advocates of clinical guidelines believe that these guidelines will eliminate some of the cognitive biases that the practitioner may introduce into the medical decision-making process in an attempt to reduce its uncertainty. Other physicians have grave doubts about guidelines' application in practice. Guideline implementation lags well behind their development. Studies of practicing physicians and a survey of clinicians in one specialty and setting indicate that experienced clinicians may be implementing guidelines selectively. Many clinicians are concerned that guidelines are based on randomized trials and do not reflect the complexity of the real world, in which a decision's context and framework are important. Their reluctance also may be due to the difficulty of applying general guidelines to specific clinical situations. The problem will only increase in the future. The patients of the 21st century will be older and have more complex disease states. Physicians will have more patient-specific therapies and need to exercise more sophisticated clinical judgment. They may be more willing to use guidelines in making those judgments if research can demonstrate guidelines' effectiveness in improving decision making for individual patients.

Luxembourg's public health insurance is a compulsory insurance for all employees, self-employed professionals, farmers, and pensioners. It is financed through contributions of the insured people, as well as by state taxes. Providers of health care are mainly private nonprofit institutions and self-employed professionals. All healthcare procedures are defined in fee schedules determined by a common decision of the Ministers of Social Security and Health according to proposals of a board of experts. The relative value of a service is also determined by the corresponding fee schedule. Hospitals are financed by individual budgets negotiated between each hospital and the health insurance. These hospital budgets do not cover services provided in hospitals by medical specialists, who are reimbursed on a fee-for-service basis. A law on hospital planning and organization allows the government to restrict the installation in hospitals of very expensive equipment or of equipment for which there is only a limited need in Luxembourg hospitals. Until recently there has been limited interest in or use of health technology assessment (HTA). However, large hospital investments have provoked some interest in the last few years. The Ministry of Health has asked for some HTA studies when a concrete decision had to be taken. Luxembourg decision makers have become more aware that HTA may help them to become more informed about the short- and long-term consequences of the application of health technology.

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: The question addressed here is whether home rehabilitation after stroke is better and/or less expensive than the more conventional alternatives, i.e., rehabilitation during inpatient care, day care, and outpatient visits—alone or in combinations appropriate to disease stage and patient needs. Home rehabilitation is managed by teams of professionals who train patients at home.

Methods: The scientific literature was systematically searched for controlled studies comparing outcomes and costs of home rehabilitation with the more conventional strategies.

Results: The abstracts of 204 papers were evaluated, from which 89 were selected for greater scrutiny. From the 89 studies, we found 7 controlled studies involving 1,487 patients (6 of the 7 were randomized, 4 of the 6 assessed costs). No statistically significant differences, or tendencies toward differences, were revealed as regards the outcome of home rehabilitation versus hospital-based alternatives. Thus, home rehabilitation was neither better nor worse at improving patients' ability to manage on their own or resume social activities. Depression and reduced quality of life were common in all groups of patients and caregivers, irrespective of the rehabilitation strategy. In the four randomized studies that reported on costs, home rehabilitation was found to be less expensive than regular day care, but not less expensive than conventional strategies even though hospital stay was reduced.

Conclusion: The outcomes and costs of home rehabilitation after stroke seem to be comparable to alternative treatment strategies.

Clinical practice guidelines have been available to clinicians for almost two decades, but the consistency of their implementation in practice remains highly variable. This paper describes the various processes and mechanisms used by one managed care organization to develop clinical guidelines and promote their adoption. Some of these mechanisms include provision of individual physician report cards, financial incentives, and various documentation tools that serve as reminders of guideline recommendations and provide an easy format to document recommended services.

There have been measurement challenges in evaluating the effectiveness of selected interventions designed to enhance guideline compliance. Most of these challenges relate to reliability and validity concerns regarding the three primary data sources used in the evaluation process: medical records, administrative claims data, and member survey data. Some of the interventions the health plan has implemented to address these measurement challenges include using hybrid methods of data collection and developing collaborative partnerships with outside organizations to enhance the accuracy and completeness of the available data. Outcomes of these efforts are described, as are physician response and recommendations for future enhancement of practice guidelines.

The Dutch healthcare system is not a single overall plan, but has evolved from a constantly changing mix of institutions, regulations, and responsibilities. The resulting system provides high-quality care with reasonable efficiency and equal distribution over the population. Every Dutch citizen is entitled to health care. Health insurance is provided by a mix of compulsory national insurance and public and private insurance schemes. Hospitals generally have a private legal basis but are heavily regulated. Supraregional planning of high-tech medical services is also regulated. Hospitals function under fixed, prospective budgets with regulation of capital investments. Independent general practitioners serve a gatekeeper role for specialist and hospital services and are paid by capitation or fee for service. Specialists are paid by fee for service. All physicians' fees are controlled by the Ministry of Economic Affairs. Coverage of benefits is an important method of controlling the cost of services. There is increasing concern about health care quality. Health technology assessment (HTA) has become increasingly visible during the last 15 years. A special national fund for HTA, set up in 1988, has led to many formal and informal changes. HTA has evolved from a research activity into policy research for improving health care on the national level. In 1993 the government stated formally that enhancing effectiveness in health care was one of its prime targets and that HTA would be a prime tool for this purpose. The most important current issue is coordination of HTA activities, which is now undertaken by a new platform representing the important actors in health care and HTA.

Objective: To adjust patients' time trade-off (TTO) scores using information on their utility functions for survival time to derive a measure of health state utility equivalent to the standard gamble (SG).

Methods: A sample of 199 cardiovascular patients were asked three TTO and SG questions (to assess their own health state), and three certainty equivalent questions (to assess their utility function for survival time) in an interview.

Results: Patients' utility functions for time were increasingly concave, but being unable to model this successfully, a constant function with an averaged level of concavity was used. The raw TTO scores were significantly higher than SG scores, while the adjusted TTO scores were equivalent to the SG.

Conclusions: Raw time trade-off scores will give biased estimates of health state utility when patients' utility functions for time are not linear, but these can be adjusted to yield true utilities. The constant proportional risk-posture assumption of the conventional QALY model, on which previous attempts to adjust time trade-offs have been based, was not supported by the data.

Objectives: To compare the cost-effectiveness of a multidisciplinary rehabilitation program with traditional treatment within primary care in terms of the health-related quality of life (HRQOL) in patients with prolonged musculoskeletal disorders (MSD) on the one hand and the costs to society on the other. Predictors of total costs, such as motivation, socio-economic level, age, pain, and working environment, were investigated.

Methods: A prospective, matched, controlled 2-year follow-up study was designed. The main outcome measures were HRQOL using the Nottingham Health Profile (NHP) and patient-specific total costs due to society. The cost-effectiveness was expressed as a quotient of the total costs to society/NHP global score difference value.

Results: Patients with prolonged MSD generate substantial total costs to society, chiefly in the area of indirect costs. Multidisciplinary rehabilitation improved HRQOL more cost-effectively. Motivation was revealed as a predictor of total costs. The relationship in savings in terms of indirect costs between the highly-motivated and the less-motivated patients was calculated at 4:1.

Conclusions: The large group of patients with prolonged MSD generate substantial total costs, and even small reductions in direct and indirect costs could be of importance to society. The multidisciplinary rehabilitation program applied here was more cost-effective as compared with conventional treatment within primary care when it came to improving the patients' perceived HRQOL. Motivation could be a predictor of total costs, which has to be addressed in the process of identifying the patient as a partner in the rehabilitation process.

Objective: An economic evaluation of the resources used for mechanically ventilated patients using various measures for the benefits of extending life.

Methods: Regression analysis is applied to New York State discharge data for patients under DRG 475 during 1992–96 to predict age-specific survival rates and payments per life saved. Sensitivity analysis is used to compare benefits of extending life associated with different economic values of life with the payments per life saved at each age.

Results: Payments per life saved decreased over time, primarily due to reduced reimbursements. Payments exceeded the age-adjusted and the quality-of-life and age-adjusted benefits for all economic values of life at ages 90 and older.

Conclusions: Since the benefits of extending life associated with DRG 475 exceed the payments per life saved at most ages, economic evaluations may be best applied with psychosocial evaluations to allocate resources more ethically.

The Portuguese healthcare system is often portrayed as a National Health Service (NHS) model, characterized by universal coverage, comprehensive benefits, nearly free services, national tax financing, and public ownership or control of the factors of production. However, in reality the system fails to accomplish these features in a complete way. There coexist a number of occupation-related health insurance schemes that were originally intended to be integrated into the NHS. In addition, in key areas the NHS does not provide the wide range of services it promises. The public sector has a predominant role in the provision of hospital stays and general practitioner consultations, but the private sector provides a major portion of specialist consultations, dental consultations, and diagnostic services. Major problems in the system led to health reforms in the 1990s. New reform proposals include some specific steps concerning health technology, including standards for medical equipment based on quality, geographic distribution, sustainability, and cost-effectiveness. A new National Plan of Health Equipment was completed in 1998, aimed at improving the distribution of equipment. Despite reforms, healthcare expenditures continue to rise. There is general agreement that gains in efficiency could be made. This situation is beginning to encourage interest in health technology assessment (HTA) in Portugal, although these activities are not yet very developed. Recently, legislation requiring presentation of economic evaluations for new pharmaceutical products was enacted. Present plans also call for the creation in the future of a national agency for HTA.

Objective: To assess the effect of the use of cochlear implants (CI) on the health status of postlingually deaf adults.

Methods: Participants comprised 45 postlingually deaf adult multichannel CI users and 46 deaf candidates on the waiting list for a CI. The latter group acted as control subjects to corroborate the validity of retrospective completion of the questionnaires by the CI recipients. Three HRQOL instruments were used: a) a specially developed CI questionnaire (NCIQ); b) a generic HRQOL questionnaire (SF-36); and c) a health-state classification system (HUI-2) suited to estimate single preference scores.

Results: Retrospectively estimated pre-implant scores in the CI user group corresponded very well with the scores in the control group. Postimplant scores in the CI users were substantially higher in all six domains (p < .001) of the NCIQ than the scores in the control group. Effects due to a CI were also observed with the SF-36 in five of the seven domains (p < .01). Statistically significant differences between the two groups (p = .001) were observed in two of the six domains of the HUI-2.

Conclusions: All three questionnaires detected improvements in HRQOL due to CI use. To make a detailed assessment of the effect of a CI on functional outcomes and well-being, a special purpose HRQOL instrument is far more adequate than a general HRQOL instrument. This study also showed that a CI affects several other health domains besides auditory performance. The effect of CI use on general functioning and well-being proved to be considerable.

Healthcare policy, medical practice, and cost of care are no longer considered distinct entities. Each is an integral factor in determining not only what, but how, patient care will be delivered. Clinical practice guidelines are the lynchpin that connects them. This paper addresses the various components of the clinical practice guideline—cost alliance.

Objective: To examine the bidirectional influence of choice of care on costs and of cost of care on decision making.

Methods: The literature was used to identify cost-related factors that influence development of guidelines and change in physician practice behavior. In a MEDLINE search with modifiers to the keywords “clinical practice guidelines,” particular attention was paid to identifying surveys of practitioners. An analysis, prompted by a recently published guideline, of treating penetrating intraperitoneal colon injuries by different surgical approaches (primary repair versus diverting colostomy) exemplified how implementation of a guideline can affect the cost of care. Inpatient cost estimates, adjusted for medical inflation and cost-to-charge ratios and reported in 1999 U.S. dollars, were developed using data from 1996 and 1997 discharge databases from California and Massachusetts.

Results: The results showed that a substantial savings in hospital costs was achieved when a primary repair surgical technique, as advocated by the guideline, was used. The effect of cost influences on the development of clinical practice guidelines was established by demonstrating the cyclical effect between usual and customary practices, guideline implementation, changing practice patterns, and the economic considerations influencing the process.

Conclusions: A growing, albeit uneasy, alliance between costs and clinical practice guidelines is evident.

Objectives: To compare outcome attributes of three available technologies for stem cell transplantation—bone marrow transplantation (BM), peripheral blood cell transplantation (PB), and cord blood transplantation (CB). To compare the cost per recipient for the three technologies, incorporating all donor and antigen matching functions, as well as the transplantation procedures.

Methods: Review of relevant literature using the CancerLit and HealthSTAR databases (plus earlier searches of MEDLINE and Embase) to summarize outcome differences. Estimations of cost per transplant using models drawing on Canadian experience.

Results: The literature review indicated that PB may have a modest advantage over BM in terms of outcomes. The literature indicated that CB has longer engraftment times (although this may be due to inadequate controls). Our modeling exercise indicated that costs for PB and BM are similar. CB has a higher cost per recipient, due in large part to the higher testing costs for every donated unit.

Conclusions: Current literature is inadequate to provide an outcomes comparison of CB, PB, and BM. Viewed from a system-wide perspective, CB is a higher cost technique. However, PB and CB are emerging as technologies, and so our results should be viewed alongside the notion that there may be a steep learning curve in these technologies.

Objective: To evaluate the appropriateness of the use of hip joint replacements (HJRs) using explicit criteria developed by an expert panel.

Methods: Observational study. Nine hundred ninety-seven patients from five hospitals with a diagnosis of osteoarthritis, avascular necrosis, hip fracture, or revision who were undergoing HJR were consecutively included in the study during a 1-year period. The appropriateness of the indication was judged by explicit criteria. Complications were recorded at the time of the intervention and 3 months postoperatively.

Results: Of the 1,030 interventions, 604 were for osteoarthritis, 31 avascular necrosis, 191 fractures, and 204 revisions. No differences were found among the hospitals for the main clinical and patient variables. Indications for surgery were considered appropriate in 59% of cases, uncertain in 32%, and inappropriate in 8%, mainly in the osteoarthritis group. Differences were found in the rates of appropriateness among some centers. The complication rate did not differ among the groups based on the level of appropriateness of the procedure.

Conclusions: The appropriate use of HJR, as measured by the criteria established by the panel, identified a moderate percentage of inappropriate indications. Those equivocal and inappropriate cases demand further studies to identify patients with an adequate risk-to-benefit ratio from this procedure.

The Spanish Constitution of 1978 established a healthcare system available to everyone and free at the point of service. The General Health Law of 1986 also established the framework for a National Health System (NHS). The Constitution and the law form the regulatory framework for the devolution of healthcare services to the Autonomous Regions. All the 17 Autonomous Regions have complete power regarding public health and planning. However, responsibilities on healthcare financing, organization, provision, and management have devolved to only seven Autonomous Regions. Financial support for health services comes mostly from taxes. Global budgets are a mechanism used by hospitals to control the acquisition of medium and low health technology. Major capital investments for health technology are controlled by the central government in 10 Autonomous Regions (population coverage of 38%) and by the Regional Health Services in the seven remaining Autonomous Regions. In 1995 a regulation for basing the introduction of new procedures and medical equipment on the assessment of safety, efficacy, and efficiency was issued. Health technology assessment (HTA) has a long history in Spain, beginning with the Advisory Board on High Technology in the government of Catalonia in 1984. This board evolved into the Catalan Agency for HTA (CAHTA) in 1994. The Basque Country established a unit for HTA in 1992 (Osteba) and the Andalusian government created an agency in 1996 (AETSA). A national agency for HTA (AETS) was established in 1994. These different programs coordinate their work and together act as an Advisory Committee of the Interregional Council of the NHS.

Objective: We reviewed and appraised the methods by which the issue of the learning curve has been addressed during health technology assessment in the past.

Method: We performed a systematic review of papers in clinical databases (BIOSIS, CINAHL, Cochrane Library, EMBASE, HealthSTAR, MEDLINE, Science Citation Index, and Social Science Citation Index) using the search term “learning curve.”

Results: The clinical search retrieved 4,571 abstracts for assessment, of which 559 (12%) published articles were eligible for review. Of these, 272 were judged to have formally assessed a learning curve. The procedures assessed were minimal access (51%), other surgical (41%), and diagnostic (8%). The majority of the studies were case series (95%). Some 47% of studies addressed only individual operator performance and 52% addressed institutional performance. The data were collected prospectively in 40%, retrospectively in 26%, and the method was unclear for 31%. The statistical methods used were simple graphs (44%), splitting the data chronologically and performing a t test or chi-squared test (60%), curve fitting (12%), and other model fitting (5%).

Conclusions: Learning curves are rarely considered formally in health technology assessment. Where they are, the reporting of the studies and the statistical methods used are weak. As a minimum, reporting of learning should include the number and experience of the operators and a detailed description of data collection. Improved statistical methods would enhance the assessment of health technologies that require learning.

Objective: To examine the relative importance of factors influencing health insurers' coverage of new genetic technologies.

Methods: A national survey in which the decision makers for private health insurers were asked whether they would cover cystic fibrosis (CF) carrier screening, testing for genetic susceptibility to breast cancer (BRCA test), and medical costs of a clinical trial of gene therapy for CF under a variety of conditions.

Results: Respondents' coverage of the two tests and of medical costs of clinical trials was low at the time of the study (4%–15.5% of insurers.) Their coverage of CF carrier screening and BRCA testing would be increased significantly if the group tested was restricted to those at high risk, if detection rates were higher and costs lower, and if testing was endorsed by a national professional group or consensus conference. Coverage of the medical costs of a trial of CF gene therapy would be significantly more likely if the trial was restricted to children or adults with severe CF, safety and effectiveness was proven, and therapy could be administered in a regional hospital or an outpatient setting rather than in a research hospital.

Conclusions: Health insurers play a critical role in the diffusion of new genetic technologies. The validity of genetic tests and the safety and effectiveness of new therapies are primary factors influencing health insurers' coverage. Lower costs and approval of professional groups are other factors associated with increased coverage.

Sweden has a welfare system that is based on the fundamental principle that all citizens are entitled to good health and medical care, regardless of where they live or what their economic circumstances are. Health and medical care are considered to be public sector responsibilities. However, there is growing interest in establishing more private alternatives to public care. An important characteristic of the Swedish healthcare system is its decentralization, with a major role for county councils. County councils are now merging into larger administrative units (region). The whole Swedish system is in the process of reform, mainly because of perceptions that it was too rigid and had insufficient patient orientation. An important factor in the reforms is that power in the system will be even more decentralized and will have greater public input. This change is seen as calling for increased central follow-up and evaluation of matters such as social, ethical, and economic aspects. Although the state has decentralized control, it still attempts to control the general direction of the system through regulation, subsidy, recommendations, and guidelines. An important actor in the system is the Swedish Council on Technology Assessment in Health Care (SBU). SBU began in 1987 with assessments of health technologies, but its success has recently led policy makers to extend its coverage to dental care. Health technology assessment is increasingly visible to policy makers, who find it useful in decision making.

Objectives: To examine determinants of use of cardiac procedures after acute myocardial infarction and identify variation factors.

Methods: Observational prospective cohort study of 2,519 patients in 48 centers with a two-level logistic-regression analysis.

Results: Elderly patients were less likely to undergo pre- and inhospital thrombolysis (odds ratios, 0.71 and 0.64; 95% CI, 0.62–0.81 and 0.58–0.69, respectively). The elderly, females, and patients with heart failure on admission were less likely to undergo noninvasive tests (0.74, 0.62, and 0.51; 95% CI, 0.67–0.81, 0.46–0.83, and 0.38–0.68, respectively) and coronary angiography (0.38, 0.53, and 0.67; 95% CI, 0.34–0.42, 0.38–0.74, and 0.52–0.86, respectively) but not revascularization. Hospital factors were more difficult to interpret.

Conclusions: Elderly, women, and heart failure patients underwent fewer cardiac procedures than lower-risk patients. Physicians should change their attitude toward these groups and use advanced procedures, bearing in mind the patients' needs rather than good procedural outcomes.

Objective: To explore the impact of methodologic issues on the results of meta-analyses. The following issues were examined: the type of literature search strategy used; inclusion or exclusion of non–peer-reviewed studies; the inclusion or exclusion of non-English language publications; the effect of trial quality; and the inclusion or exclusion of non–placebo-controlled studies.

Methods: The International Study of Perioperative Transfusion (ISPOT) meta-analyses were used to evaluate each of the methodologic issues. The 10 meta-analyses consisted of technologies to reduce the need for perioperative red blood cell transfusion. The number of trials for each of the meta-analyses varied from 2 to 45. Both EMBASE and MEDLINE searches were conducted, including the use of systematic search strategies.

Results: MEDLINE identified the vast majority of trials. Alone, MEDLINE would have missed 8 studies compared to 10 for EMBASE. Use of the systematic search strategies greatly reduced the number of articles to be reviewed compared to open searches. Type of publication, country of study origin, inclusion of non-English publications, and trial quality had very little impact on the estimates of effect. The use of placebo versus open-label control affected the magnitude of the odds ratio for two of the meta-analyses. The results of the two meta-analyses were not statistically significant if only placebo-controlled trials were included.

Conclusions: While methodologic issues had very little impact on the ISPOT meta-analyses, further studies are needed in a variety of other clinical settings. Because MEDLINE, coupled with a review of the references in the identified trials, identified the vast majority of trials, one needs to consider the costs and benefits of searching EMBASE and the pursuance of unpublished and unindexed trials.