This paper presents the framework for a one-semester course to give physicians a better understanding of the core concepts of technology assessment, using medical instrumentation technology as a vehicle to stimulate the discussion of technology assessment and its applications. An assessment matrix has been developed as an organizational tool to identify issues in assessment to be addressed under each topic and to identify those issues that are of key importance to particular technologies. At the end of the class, the physician-student should be able to identify major types of medical instrumentation and the instrument's principal application(s), to identify the techniques of technology assessment, and to analyze the economic, ethical, and legal issues that are applicable to instrumentation.

The longer you can look back, the better you can look forward

—Sir Winston Churchill

Objectives: To compare the hospitalization day price, and the hospitalization costs 100 years ago with the present situation.

Methods: Municipal and hospital archives of two cities, Maastricht in The Netherlands and Tongeren in Belgium, were studied systematically for reports of costs. These were compared with the present accounts.

Results: Starting from the second part of the nineteenth century, an official day price was calculated each year by averaging the total hospital expenditures by the total number of hospitalization days. Of all expenditures, nutrition accounted for nearly 50% of expenses. Differences with the current situation are striking. Nowadays, the day price is a negotiated tariff. Management and salaries make up more than 70% of the present expenditures.

Conclusions: Hospitalization day prices have been used for approximately 150 years to determine hospitalization costs. Since then, the total hospital expenditures and the relative cost components have changed considerably. Compared with the spending power of people, the cost of one day in the hospital increased substantially.

Economic techniques have been used for several years to evaluate health care expenditures, and there is reasonable agreement amongst economists as to the appropriate methodology. Comprehensive reviews of techniques and applications can be found in Drummond (3,4), Culyer and Horisberger (2) and a report from the Office of Technology Assessment (7). More recently Williams (13) has addressed the problems of evaluating a developing technology and Wagner (10) the specific problems of diagnostic technologies.

In less than four years, the techniques of gene transfer have been taken from the laboratory and translated into numerous clinical trials. Although gene therapy was initially designed for the molecular repair of monogenic deficiency diseases, most of the current studies of gene therapy are targeting cancer.

There are situations where, for many reasons, an innovation considered revolutionary in several respects is widely accepted by those whose ways of doing things are transformed by it. The innovation represents a “winning combination” in that it combines such attractive elements that each party, for its own reasons, will desire its adoption and work toward that common goal. In France, and particularly in the Assistance Publique de Paris and in the Hospices Civils de Lyon, such has been the case with the German-made Dornier extracorporeal lithotriptor, an innovation that makes it possible to destroy kidney stones without surgery.

Drug regulation in the United States has been the subject of extensive public literature and has been studied more thoroughly than any other aspect of American governmental regulation. Yet it remains mired in criticism and debate that, over the years, have threatened not only the existing regulatory system but also the stability of the American drug industry itself. This article summarizes the history of drug regulation in the United States, discusses the basic structure of the American regulatory system as it exists today, and relates some of the more important controversies that continue to surround this subject.

Few would argue that the randomized clinical trial is the most definitive instrument available for measuring the safety and efficacy of a new medical technology, be it drug, device, or procedure. Randomization removes the potential for bias in the allocation of subjects to the intervention group or to the control group. In addition, randomization tends to produce comparable groups which can be further strengthened by stratification and by stratified analyses. The randomized controlled trial guarantees validity of statistical tests, as long as the sample size is large enough to avoid type-II error.

Toxicity implies an adverse effect. It may be caused by an overdose of any substance or combination of substances, either by an initial high dose or by the accumulation of a toxic substance over a long period of time. Thus, toxicity is dose dependent. It is also a relative term in that therisk involved must be evaluated and the available alternatives assessed.

In 1852 Florence Nightingale wrote, “It is valuable to have one place in the hospital where postoperative and other patients needing close attention can be watched”. Almost 100 years later, an American “anesthesia study commission” concluded that one-third of postoperative deaths in the first 24 hours could have been prevented by better nursing care. Yet it is only in the last 25 years that designated intensive care units have become a feature of acute hospitals in developed countries. In the United States, intensive care beds now comprise 15% of acute beds, and they cost at least two to three times more than ordinary ward beds. Over half the difference between “activity and treatment” in hospitals in the United States and in the United Kingdom is attributed to the much lower provision of intensive care in Britain (1), where such units comprise only 1% of acute hospital beds. Selection for intensive care is therefore more stringent than in the United States, as it is for other high technology procedures (e.g., coronary artery surgery and renal dialysis). However, even in the United States there is now reluctant recognition not only that health care as a whole has to be rationed, but also that unlimited access to high technology medicine is not always in the best interests of patients and their families. In particular the cost-benefit ratio of intensive care for certain types of patients has recently come under scrutiny at an NIH Consensus Development Conference (2) and at the Massachusetts General Hospital (3).

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.

Today, computers are used in several important and fast-growing medical imaging modalities, such as digital subtraction angiography, positron emission tomography, magnetic resonance imaging, nuclear medicine, and diagnostic ultrasound. The ultimate test for the computer in medical imaging will be its ability to replace traditional film-based radiography as the mechanism for displaying, communicating, and storing imaging information. This transition will require radiologists and other imagers to accept information in digital form. The speed of that acceptance depends on the economic incentives of the health care system. These are changing as a result of cost containment, which is moving away from fee-for-service toward bundled payment. The increase in capitated health plans will encourage the development of digital radiography systems that realistically trade-off the perceived quality needs of radiologists with the costs of producing and operating such systems.

As critics such as Thomas McKeown (12) have pointed out, Western medicine is concerned firstly with the promotion of medical care and only secondarily with the promotion of health care. Medical care and health care are not necessarily the same thing. There are ways of caring for people's health which do not involve medical examinations, procedures, and drugs—they involve such activities as health education, preventive health care, self-help, and community support. However, since these alternative routes to health mostly lie outside the theory and practice of professional medical care provision, their impact on health and illness is largely unexamined.

The assessment of medical technologies has to answer several questions ranging from safety and effectiveness to complex economical, social, and health policy issues. The type of data needed to carry out such evaluation depends on the specific questions to be answered, as well as on the stage of development of a technology.

Basically two types of data may be distinguished: (a) general demographic, administrative, or financial data which has been collected not specifically for technology assessment; (b) the data collected with respect either to a specific technology or to a disease or medical problem.

On the basis of a pilot inquiry in Europe and bibliographic research, the following categories of type (b) data bases have been identified: registries, clinical data bases, banks of factual and bibliographic knowledge, and expert systems. Examples of each category are discussed briefly. The following aims for further research and practical goals are proposed: criteria for the minimal data set required, improvement to the registries and clinical data banks, and development of an international clearinghouse to enhance information diffusion on both existing data bases and available reports on medical technology assessments.

Objectives: We describe a new evidence-based method for screening and evaluating emerging medical technologies. Washington State agencies, under legislative direction, have granted authority to its agency Medical Directors and policy leaders to make coverage decisions on medical technologies using a “dossier” process. The dossier process is employed when technology advocates or manufacturers request Washington State healthcare purchasers to pay for new and emerging technologies. This offers the advocate an opportunity to submit scientific evidence and information classically associated with a more formal health technology assessment.

Methods: The submitted information is independently reviewed and summarized for Washington State's public healthcare purchasers allowing a more standardized coverage decision for all public purchasers in Washington State.

Results: This process has allowed Washington State to make twelve evidence-based coverage decisions at a fraction of the cost of classic technology assessment. To date, of twelve reviews over 6 years, one health technology was approved for coverage, ten were not covered and one did not require a coverage decision.

Conclusions: This evidence-based dossier process has yielded high-value coverage decisions of new and emerging medical technologies for public healthcare purchasers in Washington State.

Objectives: A series of randomized controlled trials have demonstrated that screening for colorectal cancer (CRC) using the fecal occult blood (FOB) test can decrease mortality from this disease. These findings were used to develop an actuarial model to estimate the impact that a FOB screening program for colorectal cancer would have on the Canadian population.

Methods: The mortality experience of the year 2000 cohort of Canadians fifty to seventy-four years of age, with follow-up extending to 2010, was modelled according to three scenarios: no screening, annual screening, biennial screening. The primary screening tool was the FOB test using unrehydrated samples, with follow-up of positive test results using colonoscopy. The framework of the model was developed based on published findings from the relevant randomized controlled trials, available data, and a literature review that yielded parameter values for some model items.

Results: During the 10-year follow-up of the cohort, we estimated that 4,444 and 2,827 deaths would be averted with annual and biennial FOB screening, respectively. We estimated that for an annual FOB screening program, approximately 3,400 FOB tests would be required to prevent one death, whereas 2,700 tests would be required within a biennial program.

Conclusions: Our analysis documents the population health impact of using the FOB test to screen for CRC. Additional information on the natural history of the disease, and Canadian pilot data are needed to better model the effectiveness of population-based FOB screening programs.