Objective: The role of classical and Bayesian statistical approaches remains in dispute in health services research and policy. The goal of this study was to determine if results differ when both analytic techniques are used with the same data set.

Design: We searched MEDLINE and related databases for English-language articles published January 1, 1978 through August 31, 1999. We combined Bayesian and classical statistics search terms and their variants with randomized control trials (RCTs) and meta-analyses.

Results: Searches found 18 studies in 14 publications that met all review criteria—nine RCTs, eight meta-analyses, and one epidemiologic estimate. Statistical analyses using both methods agreed in five RCTs , four meta-analyses, and for the epidemiologic estimates. For four RCTs where results disagreed, classical analysis found the experimental intervention was efficacious compared with the control, and Bayesian reanalysis concluded the intervention was not proven efficacious. Classical meta-analyses of the four studies where results disagreed concluded the experimental intervention was not better than the control; Bayesian reanalysis concluded it was efficacious.

Conclusion: Classical and Bayesian methods in this review exhibited important divergence of results. Disagreement on many fundamental beliefs between classical and Bayesian statistics means continuing debate. One way to resolve this debate is for proponents of each technique to decide together the circumstances for use of each method and analytic framework. If the experts do not agree on the methodologic requirements, other decision makers likely will force their own views.

Background: The presence of (distant) metastases affects the therapy (operation) and prognosis of patients with non–small-cell lung cancer (NSCLC). Fifty percent of the operations are futile due to the presence of a locally advanced tumor or distant metastases. Therefore, more accurate preoperative staging is required with respect to the outcomes (reduction of futile operations) and costs. This study examines current staging procedures and assesses possible situations for incorporating positron emission tomography (PET).

Methods: A retrospective analysis was performed to assess actual clinical practice in the staging procedure of 337 patients with NSCLC in two Dutch hospitals. Consequently, by combining these data of actual clinical practice with a literature review, a model was developed to determine the influence of PET on the staging outcomes and the costs. In this model the accuracy and costs of PET can be varied as well as the extent of substitution of conventional diagnostic tests by PET.

Results: Practice variation was found between the two hospitals with regard to the setting in which the diagnostic staging took place (hospitalization, outpatient setting) and the extent of the use of mediastinoscopy. This was reflected in the costs and in the number of (futile) operations.

Conclusion: Hospitalization is the major cost driver in these patients. From a cost viewpoint, the evaluation of PET in a strategy after diagnostic imaging but prior to invasive staging seems most optimal.

The aim of Working Group 1 has been to assess health promotion and disease prevention activities in terms of benefits, risks, and economic, social, and ethical implications as a complement to community health indicators.

Objectives: Different cost-effectiveness analyses have been presented for interferon beta-1b (IFNB) in the treatment of secondary progressive multiple sclerosis (SPMS). All studies have used modeling techniques since any effect on progression of disability achieved during a clinical trial will last beyond the trial. Different approaches to extrapolation have been taken, but generally they have been based on disease progression and relapse rates in clinical trials. The problem with this approach is that the population in clinical trials is a selected group of patients, which has the potential to bias results. A better method for extrapolation is to use epidemiologic data. The objective of this study is to incorporate natural history data for MS into a previously presented cost-utility model and to compare the two methods of extrapolation.

Methods: Clinical trial data were used to model disease progression during the first 3 years in the model. To extrapolate beyond the trial (10 years), data on progression of disability were available from a geographically based epidemiologic study of the natural history of MS in Canada. There were 568 patients who had converted to SPMS during the follow-up that were included in the data set. Mean costs and utilities for each Markov state were calculated from a population-based cross-sectional study in Sweden.

Results: The extrapolation using clinical trial data appears to have underestimated the progression of disability in the long term and thus also the potential benefit of treatment. Using the epidemiologic data, the incremental cost per QALY is SEK 257,000 (US $25,700; US $1 = SEK 10; November 2000) when all costs (direct, informal care, and indirect) are included (discounted 3%). This compares to SEK 342,000 in the previous model. The lower cost-effectiveness ratio is mostly due to a larger QALY gain with treatment than in the previous model (0.217 compared with 0.162).

Conclusion: Cost-effectiveness analysis in SPMS requires that the effect of treatment beyond clinical trials be included. The method of extrapolation clearly affects the results, and when available, epidemiologic data should be used. Using the longitudinal data from Canada, the cost-utility ratios for IFNB-1b in the treatment of SPMS appear well within the acceptable range.

The aim of Working Group 2 has been to develop a system for routine exchange of information concerning ongoing or planned evaluations and their findings, priority setting, and emerging technology.

Objective: To compare the effects of computerized and paper-based versions of guidelines on recently qualified physicians' consultation practices.

Methods: Two arm cluster randomized controlled trial. Physicians were randomized to receive computerized or textbook-based versions of the same guidelines for a 4-week study period. Physicians' compliance with guideline recommendations about laboratory, radiological, physical and other examinations, procedures, nonpharmacologic and pharmacologic treatments, physiotherapy, and referrals were measured by case note review.

Results: There were 139 recently qualified physicians working in 96 primary healthcare centers in Finland who participated in the study. Data on 4,633 patient encounters were abstracted, of which 3,484 were suitable for further analysis. Physicians' compliance with guidelines was high (over 80% for use of laboratory, radiology, physical examinations, and referrals). There were no significant differences in physicians' consultation practices in any of the measured outcomes between the computerized and textbook group.

Conclusion: Guidelines are a useful source of information for recently qualified physicians working in primary care. However, the method of presentation of the guidelines (electronic or paper) does not have an effect on guideline use or their impact on decisions. Other factors should be considered when choosing the method of presentation of guidelines, such as information-seeking time, ease of use during the consultation, ability to update, production costs, and the physicians' own preferences.

This paper investigates the structural reliability of a discrete choice experiment within health technology assessment. Two versions of a discrete choice experiment, in the form of a self-completion questionnaire, were randomly administered to two samples of women who had recently given birth as part of an exercise to determine women's preferences for alternative modes of intrapartum care. In the first questionnaire, two of the attributes had only their highest and lowest levels included, while in the second questionnaire all three levels for these two attributes were included. The levels included for all other attributes remained the same throughout both questionnaires. The evidence relating to the structural reliability of the discrete choice experiment in this context was mixed. The results indicated that the relative importance of the two attributes in which the levels were varied increased as the number of levels for these attributes increased. However, the relative importance of the attributes in which the levels were not varied remained relatively stable throughout. The results provide evidence in support of a psychological effect whereby respondents place more importance upon specific attributes as the number of levels for these attributes increases. It is recommended that further research of both a qualitative and quantitative nature should be undertaken to assess the potential importance (or otherwise) of a psychological effect relating to the number of levels chosen for attributes within discrete choice experiments in health technology assessment.

Objectives: This review included the following objectives: a) to synthesize recommendations made by public agencies in Western countries concerning screening for osteoporosis; b) to compare these recommendations and sort out the similarities and discrepancies; and c) to propose a strategy for the fight against osteoporosis and fragility fractures.

Methods: Eleven reports published by publicly financed agencies were included in the analysis: three international, four North American and four European agencies. Transcriptions of recommendations and arguments were classified using criteria for evaluation of screening technologies.

Results: Of eight reports that made a recommendation on mass screening, four made a recommendation against the use of densitometry, two remained vague with a conditionally positive recommendation, and two made no recommendation, arguing insufficient scientific evidence. Concerning screening of asymptomatic women in the perimenopause period, recommendations were uniformly opposed to the use of bone densitometry in five of nine reports, and the other four made no recommendation, arguing insufficient scientific evidence. Some of the discrepancies can be explained by the different definitions given to osteoporosis and by the confusion of terms between screening and diagnostic testing. A strategy is proposed to ensure that all women who are at risk of osteoporosis and fragility fracture have access to preventive measures. This strategy is based on the complementarity and coordination of roles between health promotion interventions and clinical interventions.

Conclusions: Prevention of osteoporosis and fragility fractures is an attainable goal. Existing resources are currently badly targeted. Compromises must be negotiated between the different stakeholders and biomedical disciplines to achieve efficiency and accessibility in the reduction of fragility fractures. A first compromise to reconcile social and scientific realities would be to use a best-evidence synthesis instead of an evidence-based medicine approach in future analyses and recommendations by public authorities. A second compromise would be to recognize the complementary roles of public health and clinical professionals toward the common objective of preventing fragility fractures.

The aim of Working Group 3 has been to identify possible joint assessments and to coordinate findings and existing resources within the community to support joint assessments.

Alcohol-related problems are common in society. Large population studies from the United States have shown that 10% to 15% of all men and approximately 5% of all women suffer from chronic alcohol dependency. In these groups, approximately one-fourth are in a phase of active abuse.

The aim of Working Group 4 has been to develop and disseminate best practice in undertaking and reporting assessments, and to identify needs for methodologic development.

Objectives: Potential problems concerning waiting list management are often monitored using mean waiting times based on empirical samples. However, the appropriateness of mean waiting time as an indicator of access can be questioned if a waiting list is not managed well, e.g., if the queue discipline is violated. This study was performed to find out about the queue discipline in waiting lists for elective surgery to reveal potential discrepancies in waiting list management.

Methods: There were 1,774 waiting list patients for hallux valgus or varicose vein surgery or sterilization. The waiting time distributions of patients receiving surgery and of patients still waiting for an operation are presented in column charts. The charts are compared with two model charts. One model chart presents a high queue discipline (first in—first out) and another a poor queue discipline (random) queue.

Results: There were significant differences in waiting list management across hospitals and patient categories. Examples of a poor queue discipline were found in queues for hallux valgus and varicose vein operations.

Conclusions: A routine waiting list reporting should be used to guarantee the quality of waiting list management and to pinpoint potential problems in access. It is important to monitor not only the number of patients in the waiting list but also the queue discipline and the balance between demand and supply of surgical services. The purpose for this type of reporting is to ensure that the priority setting made at health policy level also works in practise.

Objectives: Systematic reviews and meta-analyses of individual patient data involve the central collection, validation, and reanalysis of raw data from randomized controlled trials. Checking individual patient data before its inclusion in a meta-analysis involves a number of different procedures that can be both time- and resource-intensive. We therefore aimed to assess the utility of data checking by investigating whether checks made any appreciable difference to the results of an individual patient data meta-analysis.

Methods: Data that were included in a meta-analysis of postoperative radiotherapy in non–small-cell lung cancer were used in a comparison of checked and unchecked data to investigate whether checking impacted the final results of the meta-analysis. Data “as received” were compared with fully checked and with followed-up data.

Results: Checking influenced the results, in this case mainly due to the exclusion of a single trial that failed to meet checking procedures. Checking data from most trials had only a small effect and did not materially alter the overall results of the meta-analysis.

Conclusions: Although data checking and cleaning is time-consuming, and for the majority of trials may make little difference to the analysis, such procedures provide a useful safeguard against rare occurrences of data with major problems. Checking may also lend additional confidence in the data set, which may be particularly important when using unpublished data that has not been subject to standard peer review.

The aim of Working Group 5 is to develop and coordinate education and support networks for individuals and organizations undertaking or using assessment of health interventions and to identify needs in the field and assist in the establishment of new provisions.

Objective: To assess the impact of endometrial ablation on the utilization of hysterectomy in U.S. women with benign uterine conditions.

Methods: Data are from the State Inpatient and Ambulatory Surgery Databases of the Healthcare Cost and Utilization Project for six states, 1990–97. Women who underwent hysterectomy (ICD-9-CM codes 68.3, 68.4, 68.5, 68.51, 68.59, 68.9) and endometrial ablation (68.23, 69.29) and had benign uterine conditions (ICD-9-CM code 218.0 and CCS groupings 47, 171, 173, 175, 176, 215) were extracted. Comparative rates, length of stay, total charges, age, payer, hospital, and teaching status of the hospital are reported.

Results: The rates of hysterectomy decreased in three states: Colorado (37% decrease; 33 per 10,000 women in 1990 to 21 per 10,000 in 1997), Maryland (18% decrease; 17/10,000 in 1990 to 14/10,000 in 1997), and New Jersey (11% decrease; 9/10,000 to 8/10,000); were static in two states (Connecticut and New York) and increased in one state, Wisconsin (11% increase; 19/10,000 in 1994 to 21/10,000 in 1997). The rates for endometrial ablation increased in all states. The ratio of hysterectomy rates to endometrial ablation rates fell in each state across the 7 years. In two states (New York and New Jersey) the rate of endometrial ablation was equivalent to the rate of hysterectomies by 1997. The total combined rate for hysterectomy and endometrial ablation for women with benign uterine conditions for each state increased by more than 10%, with the exception of Maryland, which had an increase of only 5%, and Colorado, which had a decline of 23%.

Conclusions: In the six states studied, the diffusion of endometrial ablation has had a varying impact on hysterectomy rates among women with benign uterine conditions. However, endometrial ablation is used as an additive medical technology rather than a substitute.

According to the HTA-Europe report, health technology assessment (HTA) has the potential to influence health policy in the fields of research and development, regulation of pharmaceuticals, devices, and services, quality assurance, reimbursement, education and training of healthcare providers, and consumer education (1). To identify and bridge the gaps between HTA production and implementation, the goal of Working Group 6 was to approach the use of HTA in policy and practice on the aggregate policy level as well as in the local context, such as in hospitals. Members of Working Group 6 included both users (e.g., members of decision-making bodies) and producers (e.g., members of HTA agencies) of HTA reports. The aim of the working group was to identify three types of information on HTA implementation and impact. These included identifying successful examples of the implementation of HTA results, examples of structures that require HTA information as part of the decision-making process, and finally, identifying groups and persons who use HTA frequently and are willing to share their experiences with other HTA users and producers.

Objectives: An index approach for measuring the reduction in daily activities of patients suffering from an eye disease associated with progressive visual loss is proposed. The approach is illustrated using data collected from patients with cataract.

Method: The approach uses recently developed methods based on index theory together with measurements of daily activities. In a simulation based on observations of visual acuity and daily activities in patients with cataract, indexes of changes in benefits were estimated for varying levels of visual acuity.

Results: Results show the development of loss in benefits resulting from a progressive deterioration in visual acuity. The results indicate a 40% loss in benefits at low levels of visual acuity, equivalent to a potential increase in benefits of 75% for these individuals following successful treatment.

Conclusions: The proposed index approach may prove useful for measuring reductions in daily activities resulting from the progressive loss of vision in eye disease. The approach has successfully measured the reduction in daily activities in patients with cataract and may be applicable in patients with other eye diseases, including age-related macular degeneration and open-angle glaucoma.

Objective: Somatic gene therapy is a new method in the rapidly expanding field of molecular medicine. Due to recent encouraging results and the promising prospect for some disease groups, Norwegian health authorities wanted to assess somatic therapy with evidence-based standards for strategic use. This article presents the results of this assessment, discussed in the context of the policy-making process in Norway, including ethical and legislational considerations.

Methods: Clinical gene therapy protocols, ongoing or completed with published results, where available, were identified through a systematic survey of descriptive protocols and publications. Preclinical literature was also reviewed.

Results: Gene therapy is dominated by preclinical and clinical research. Most of the gene therapy protocols identified are in early phases (phases I and II) with only a few patients in each study. Of the protocols included in the assessment, only three phase III studies are represented. Except for the use of soluble antisense oligonucleotides against cytomegalovirus eye infection, gene therapy is presently not an established treatment modality. Promising results have been observed in treatment of cancer and cardiovascular diseases and, most recently, in inherited severe combined immunodeficiency and hemophilia. Several interesting principles addressing a large panel of conditions are currently being developed and tested.

Conclusions: Gene therapy is developing into an important medical concept that needs to be included within the Norwegian healthcare system. It is recommended that the Norwegian Ministry of Health and Social Affairs fund a national program to boost infrastructure in selected scientific groups both in preclinical and clinical research. The national procedures regulating approval of gene therapy trials should be made more efficient while at the same time allowing for proper control and ethical considerations. It is emphasized that gene therapy trials should be carefully monitored for side effects.

The question in the title will be addressed by first answering the question: What is a technological imperative? A review of the literature makes it clear that there are many descriptions and explanations of the technological imperative in health care, and that not all of them are important to consider. One conception of the technological imperative that is important is the one that implies that technology reduces our responsibility toward our actions. I argue that that this conception cannot be justified. That is, there is no imperative that frees us from our responsibility for developing, producing, advertising, assessing, implementing, using, and banishing technology in health care. On the contrary, the increased possibilities provided by technology result in an increased responsibility. That is, there is no technological imperative, but technology promotes a moral imperative; in particular, it promotes a moral imperative to proper assessment.

Objectives: An assessment of the current status of magnetic resonance imaging (MRI) was undertaken to provide input for future government decisions on the introduction of new technologies in Asia. The objective of the study is to describe and explain the diffusion pattern of this costly technology in several Asian settings.

Methods: Data on the diffusion pattern of MRI for different Asian countries (the Republic of Korea, Malaysia, Indonesia, the Philippines and Thailand) and regions (the cities of Shanghai and Hong Kong in China and the state of Tamil Nadu in India) were obtained from national representatives of professional bodies by using standardized questionnaires for the year 1997–98. In addition, utilization data were collected at the hospital level in three countries before and after the economic crisis in the region. For four countries plus Hong Kong, background information on the legal framework for “big ticket” technologies was collected.

Results: Since the introduction of the first MRI in the region in 1987, the number of MRIs has gradually increased both in public and private facilities in Asia. In 1998 the average number of MRI machines installed varied from less than 0.5 machine per million population to more than 5 machines per million population. The maintenance and operating costs, and not the absence of regulation, account for the low number of MRIs in the Philippines and Malaysia. Overall, installed MRIs have low magnetic field strength, vary with respect to brand and type, and are mostly in the private sector and in the urban areas of the region. The diffusion pattern of MRIs in countries of the Asian region appears to follow two types of patterns of diffusion: one set of countries seems to be composed of mostly early adopters and another set of countries appears to be composed mostly of late adopters.

Conclusions: Total number of MRIs per population in this region, though quite small compared to most OECD countries, reflects a higher share of the country's healthresource devoted to expensive high-technology devices. It is difficult to state the appropriate number of MRIs for each country; however, the study shows that there are observable problems in terms of efficiency, equity, and quality of MRI services. The research team proposes a few key recommendations to counteract these problems. Purchasing and regulatory bodies must be empowered with skill and knowledge of health technology assessment. Likewise, the fundamental problems resulting from inefficient and unfair health financing should not be overlooked, so that there is more equitable use of the technology.