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Health technology assessment: an Australian perspective.

Like many other countries, Australia has placed increasing emphasis on the assessment of medical technologies over the past decade. This emphasis is shaped in part by financial constraints, and in part by the organization of the health care system and its dominance by publicly-funded hospitals. Two committees, the Superspecialty Services Subcommittee of the Australian Health Ministers' Advisory Council, and the National Health Technology Advisory Panel have been particularly influential in developing guidelines for technology assessment. These guidelines emphasize not only the accumulation of primary data during the implementation of a new technology, but also a follow-up process for on-going evaluation of the contributions of a particular technology to clinical care. Presently the two committees are being merged into one agency named the Australian Health Technology Advisory Committee. This agency will be given enhanced authority to guide the diffusion and utilization of new technologies into the delivery process for health care.

Australia↗

Implications of new technology for pharmacy education and practice.

Specific knowledge and skills needed by pharmacists in an era of advancing health-care technology are presented, and the most important modern technologic developments in health care are described briefly. Implementation of new technology in health care will be affected by cost considerations and by social trends such as shifting population demographics, an increase in diseases of lifestyle, consumerism, and self-care. Technologic advances in the following areas are described: computerized information networks, bioelectronics, biotechnology, computer graphics, diagnostic imaging, and drug development in space and in the oceans. Diseases are noted for which diagnosis and treatment using new technology is promising. The roles of interferon and monoclonal antibodies are described, and trends in development of new drugs and drug delivery systems are traced. A new philosophical basis for pharmacy education that is consistent with the needs of a technologically oriented society is needed. Practitioners will look to their professional societies for assistance in identifying and implementing the new technology.

Antibodies, Monoclonal↗

Group processes of decision making for hospital-based technology assessment committees.

There are a variety of group-judgment methods to resolve controversial issues in health care. Meta-analysis and group judgment methods such as consensus conferences are attempts to bring diverse elements of information together for synthesis. Leape notes that a significant body of literature exists regarding the techniques used to elicit opinions from groups. Organizational structures and functions of groups vary in terms of the natures of interactions among group members and the manners in which final conclusions are reached and expressed. The introduction of the process of technology assessment into the hospital setting introduces a problem inherent in the introduction of somewhat academic processes into the operational real world of interpersonal relations, administrative and medical staff interactions, staff costs, and institutional priorities. Hospital administrative processes are based on the committee approach. Medical staff credentialing, drug formularies, and administrative policies are all developed, approved, and implemented through committees. It would seem logical that if technology assessment is to be effective in the hospital setting, then those same group decision processes inherent in committees should be used in technology assessment. Relatedly, if technology assessment is to be successful in the hospital setting, then how can the limited resources of hospital-based staff be best utilized to carry through the assessment of elected technologies? This paper discusses group decision processes, particularly as they relate to technology assessment. The processes of particular interest are those that focus on group interactions rather than theory-based decision processes. The purpose for the paper is to provide to clinical engineering management and senior hospital management background information to use in the formulation of the operating parameters of a hospital-based technology assessment committee.

Biomedical Engineering↗

Evaluation of new diagnostic technologies: bronchoalveolar lavage and the diagnosis of ventilator-associated pneumonia.

OBJECTIVE: To present criteria to aid intensive care workers in the assessment of diagnostic technologies, using the example of bronchoalveolar lavage for the evaluation of ventilator-associated pneumonia. DATA SOURCES: MEDLINE was used to search for articles published from 1969 to the present that concerned diagnostic tests, diagnostic technology, pneumonia, and critically ill patients. STUDY SELECTION: Clinical investigations, case control studies, case series, and experimental data on the use of bronchoalveolar lavage. Studies of diagnostic technology were also included. DATA EXTRACTION: We extracted relevant data in duplicate, independently. DATA SYNTHESIS: Diagnostic technology assessment should begin by establishing the capability of the technology under ideal or laboratory conditions, followed by an exploration of the range of possible uses as well as the accuracy of the test. Bronchoalveolar lavage is a well-established technology for the diagnosis of pneumonia in immunocompromised patients. Studies of the accuracy of bronchoalveolar lavage in ventilator-dependent but nonimmunocompromised patients have shown promising diagnostic accuracy. Accuracy, however, is insufficient for dissemination of a test; an evaluation of the impact of a test on management decisions and, most importantly, on patient outcome, is required. Investigators have not addressed the full impact of bronchoalveolar lavage, and, even if the test is accurate, there are reasons to doubt whether patients will be better off if the test becomes part of routine clinical practice. CONCLUSIONS: We present guidelines for the assessment of diagnostic technology, and apply them to bronchoalveolar lavage for the evaluation of ventilator-associated pneumonia. Bronchoalveolar lavage has been studied in both the laboratory and clinical setting, and the diagnostic sensitivity and specificity of this technique are high. Further randomized trials evaluating management decisions and patient benefit would facilitate decisions regarding the appropriate dissemination of bronchoalveolar lavage.

Bronchoalveolar Lavage Fluid↗

Prevalence of medical technology assistance among children in Massachusetts in 1987 and 1990.

In 1987 and 1990 in Massachusetts, surveys were conducted to determine the size, pattern of distribution, and trends in the population of children assisted by medical technology. The authors obtained an unduplicated count of all Massachusetts children from 3 months to 18 years of age who used one or more of the following: tracheostomy, respirator, oxygen, suctioning, gastrostomy, jejunal or nasogastric feedings, ostomies, urethral catheterization, ureteral diversion, intravenous access, or dialysis. By comparing counts obtained from medical and educational sources, the authors were able to perform a capture-recapture analysis to estimate the overall number of children dependent upon these technologies. The number of children identified in our surveys increased from 1,085 in 1987 to 1,540 in 1990. However, the capture-recapture analysis yielded estimates of 2,147 plus or minus 230 for 1987 and 2,237 plus or minus 131 for 1990. This suggests that the population of children dependent upon medical technology was essentially stable during this period, and that the 42 percent increase in the number of children identified in our survey reflected improved sampling techniques. During the 3 years, shifts in the pattern of technology use were noted, however. Use of oxygen and gastrostomy increased, and urostomy use declined. A change in the age distribution of the children was also documented, with a shift in the preponderence of technology use from 12 to 24 months in 1987 to children in the first year of life in 1990. Using the 1990 estimate and the 1990 U.S. census figures, an overall prevalence estimate of 0.16 percent was calculated. Applying this to the U.S.child population yields an estimate of 101,800 children assisted by medical technology nationwide(assuming comparable technology use in other States). This information will facilitate policy analysis and program planning on regional and national levels for this medically complex group of children.

Adolescent↗

Cost escalation in health-care technology--possible solutions.

Solutions to cost escalation due to health-care technology are proposed. It is argued that proper systems analysis, technology assessment, and planning would result in net savings and improved cost-benefits. Identification of needs early in the technological life cycle can positively influence the final form of the chosen technology. A national centre for technology assessment is proposed. Arguments in favour of a local medical equipment manufacturing industry, emulating overseas examples, are advanced, appropriateness being the main criterion. Analysis of the cost breakdown of imported technology suggests ways of reducing costs considerably, while stimulating the local economy. Digital telecommunications technology and its application to rural health care is cited as an example of a potentially worthwhile investment in making overall coverage more equitable.

Computers↗

The clinical usefulness of glucated haemoglobin in diabetes care evaluated by use of a medical technology assessment strategy.

With the introduction of measurements of glycated haemoglobin in a single blood sample as an index of long-term blood glucose control, the clinically usefulness of these measurements was questioned. The aim of this study was to evaluate measurements of glycated haemoglobin as a new test for metabolic regulation in diabetes management by use of a medical technology assessment strategy. Technology assessment in medicine has been defined as "the art and science of evaluating medical practices", but the strategy has to be adjusted to the medical technology in question always including the following three stages: (a) problem definition and identification of medical technology, (b) analysis by testing the technology with consideration to its benefit and harm, its costs, and its social consequences, and (c) synthesis of the accumulated knowledge about the technology. Based on the out-put from the problem definition we found it necessary to investigate some of the identified problems ourselves before implementation of routine measurements of glycated haemoglobin. Several studies were accomplished to validate the laboratory technology in terms of analytical reliability and its clinical usefulness. We wanted to (1) define goals of analytical quality of assays of glycated haemoglobin based on clinical goals, (2) establish a laboratory method for measurements of glycated haemoglobin fulfilling the defined goals, (3) investigate the ability of measurements of glycated haemoglobin to characterize impaired glucose tolerance, (4) evaluate the clinical usefulness of measurements of glycated haemoglobin in the assessment of metabolic regulation in non-insulin-dependent diabetes mellitus (NIDDM), (5) compare physicians' assessment of metabolic control in insulin-dependent diabetes mellitus (IDDM) with measurements of glycated haemoglobin and determine whether knowledge of glycated haemoglobin values would result in improved metabolic control, and (6) evaluate the organizational and economical consequences of introducing regular measurements of glycated haemoglobin. The analysis required a multi-disciplinary approach. Based on our own studies and the available data information we found that measurements of glycated haemoglobin should be regarded the most clinically appropriate test of long-term glycemia and should be introduced into routine management of adult patients with IDDM and NIDDM with the following guidelines concerning methodologies, clinical utility, organizational consequences. The individual laboratory has to establish and secure its own method since at present we are still without an internationally accepted reference method or reference material. The method should measure HbA1c without measuring the labile intermediate pre-HbA1c and provide separate detection of haemoglobin variants. We investigated the analytical goals for the performance characteristics of assays based on biological variation and on the clinical significance of a certain change in concentrations in the individual. Different strategies lead to different analytical goals of CVA between 2-4%. An oral glucose tolerance test is still required to establish the diagnosis of diabetes. Measurements of glycated haemoglobin have been suggested as an alternative but a considerable overlap between the WHO-defined groups of normal and impaired glucose tolerance was observed. In patients with IDDM our studies demonstrated the limitations of traditional clinical judgement and the laboratory procedures in providing an accurate assessment of blood glucose control and that knowledge of HbA1c values allowed the clinician to identify patients in poor glycemic control and lead to improvement in glycemic control. In patients with NIDDM our study showed that measurements of HbA1c provided information that was otherwise not obtainable in the usual clinical setting in primary health care. Measurements of glycated haemoglobin were easily accepted by patients with diabetes. (ABSTRACT TRUNCA

Adult↗

Synergistic benefits of combined technologies in complex, minimally invasive surgical procedures. Clinical experience and educational processes.

The new burden surgical technology must assume demands not only improved efficiency and reduced risk, but also diminished cost and resource utilization. To this end, we have instituted the use of multiple, sequential technologies in complex, minimally invasive procedures: laparoscopic gastric surgery (44 cases), spine procedures (38 cases), and colectomies (96 cases). The technologies include head-mounted display, 3-D optics, robotic arm, harmonic scalpel, and optical access trocars. The combined use of these technologies shortened operative times, diminished use of personnel, and as associated with no technical mishap. Surgeon concentration and control of the operative environment were increased. In an effort to promote combined use of technologies, a structured teaching process was designed and implemented. It required five (average) experiences for efficient, hands-on implementation of combined technologies. We conclude that combined use of sophisticated technologies is safe and efficient; is accomplished by structured, moderately intense educational experience; and diminishes cost and use of human resources.

Clinical Competence↗

Emerging medical technologies and emerging conceptions of health.

Using ideas gleaned from the philosophy of technology of Martin Heidegger and Hans Jonas and the philosophy of health of Georges Canguilhem, I argue that one of the characteristics of emerging medical technologies is that these technologies lead to new conceptions of health. When technologies enable the body to respond to more and more challenges of disease, we thus establish new norms of health. Given the continued development of successful technologies, we come to expect more and more that our bodies should be able to respond to ever-new challenges of environment and disease by establishing ever-new norms of health. Technologies may aim at the prevention and treatment of disease, but they also bring about modifications of what we consider normal for the human being. Thus, new norms of health arise from technological innovation.

Biotechnology↗

Creating an organizational awareness of ethical responsibility about information technology.

In a time of rapid technological and social change, business organizations must help their employees develop a new appreciation of how social and ethical values are being shaped and challenged by evolving information technologies. Many ethical and social conflicts have arisen around the advanced information technology used today. The emerging technologies continue to create situations not previously encountered. There are numerous risks facing corporations involved in the use of computing technology. Leaders of organizations looking ahead to assess the impact of technological changes can try to prepare their employees for the future. This paper addresses the urgent need for individuals in corporations to become more knowledgeable about computing technologies and their impact.

Ethics, Professional↗

Formal training in advanced surgical technologies enhances the surgical residency.

INTRODUCTION: Surgeons have been consistently instructed to use better tools by which to improve upon a patient's medical care. Since the first laparoscopic cholecystectomy, the desire for advanced surgical technologies has continued. This surgical breakthrough has been one of many changes in modern surgical and medical therapy that now represents the standard of care. The aim of this article is to examine the changes in surgical technologies that occurred in the past 15 years, evaluate the possible solutions that have been discussed and formally present the results of a formal training rotation in advanced surgical technologies at the University of Louisville, Department of Surgery. METHODS: Questionnaires were sent to 36 former residents who had completed the residency and the advanced surgical technologies rotation to evaluate the success of their training. RESULTS: From its inception in 1998 to 2004, the residents have performed a total of 1097 procedures, or an average of 35 cases per month. Much of the exposure was gained in advanced laparoscopy, including laparoscopic nissen fundoplication, gastric band, gastric bypass, splenectomy, colon resection, small-bowl resection donor nephrectomy, and hepatic ablation. Similarly, an evaluation of the 2 procedures that in the late 1990s were considered advanced surgical procedures--sentinal node biopsy and endovascular procedures--shows that the number of these procedures performed on this rotation has fallen over the past 2 years. The overall impression of the rotation from these former residents was either integral or essential in 70% and was helpful in 20%. CONCLUSION: The number of demands impacting medical education have never been this numerous or complex. The rapid advances in science, systems, and information technology provide numerous advances in surgical training that continue to be the requirement and responsibility of general surgical training. The cultural changes in surgery include the team approach to provide services in surgical technologies, focus on the aging population, and outcomes assessment. The learning curve, for any and all of these procedures, is inevitably steep, and traditional resident training too often focuses on the more conventional procedures done in routine rotations. The need for formal training in advanced surgical technologies continues to be of utmost importance in these rapidly evolving times.

Adult↗

Relevance of PCDD/PCDF formation for the evaluation of POPs destruction technologies--review on current status and assessment gaps.

One important criterion for assessment of a POPs destruction technology is the potential formation of new POPs and other toxic by-products, in particular whether the highly toxic PCDDs/PCDFs are formed and under which operation conditions their formation is relevant. For incineration processes the formation mechanisms of PCDDs/PCDFs have been investigated thoroughly and strategies and technologies were developed to minimize their formation and emission. A detailed assessment of non-combustion technologies with respect to PCDD/PCDF formation is, however, lacking to date. A comparison of reaction conditions for PCDD/PCDF formation from precursor formation studies and actual applied conditions of a broad range of POPs destruction technologies in the present paper indicates that the operation conditions for a number of destruction technologies have the potential to generate high concentrations of PCDDs/PCDFs if dioxin precursors are present and that also PCDD/PCDF de novo formation can take place. Therefore a strategy and regulations for a more profound assessment and monitoring of the fate of PCDD/PCDF formation and emission is essential for the evaluation of POP destruction technologies and for a sound risk management of POPs. The present paper aims to provide a critical impulse in this respect, discusses the relevant formation pathways with respect to POPs destruction technologies and proposes a basic framework on how evaluations may be performed.

Benzofurans↗

[Assisted reproductive technologies after conservative management of borderline or invasive ovarian tumours].

OBJECTIVE: Ovulation induction, the usual resort of Assisted Reproductive Technologies (ART), has been suspected of carrying a responsibility in the genesis of ovarian tumours. For patients with a borderline or invasive ovarian tumour, treated by conservative surgery and desiring to become pregnant, the problem is thus of a possible resort to the Assisted Reproductive Technologies. PATIENTS AND METHODS: This is a multicenter, national and retrospective study. 40 operated patients between January 1971 and January 2001 have been included. 27 patients (67.5%) had a borderline tumour, 10 (25%) a non-epithelial tumour (germinal or stromal) and 3 (7.5%) an epithelial invasive carcinoma. All these patients have benefited from a conservative surgical management of fertility. The Assisted Reproductive Technologies were simple stimulation for 5 women and IVF for the 35 others. The effectiveness and the risks of Assisted Reproductive Technologies have been estimated respectively by the number of pregnancies obtained and the recurrence rates. RESULTS: With a global follow-up of 372 months (January 1971: date of the primary surgical procedure--June 2002: closing of the study), 17 patients have obtained 17 pregnancies with the Assisted Reproductive Technologies, rate of 42.5% (17/40): 1 spontaneous abortion, 16 delivery with 23 children (triple pregnancies and 3 twin pregnancies). 3 patients treated for a borderline tumour have had a recurrence after induction of ovulation. Among the 40 patients, no one presented an evolved disease at the last news. The patients who had a recurrence had a delay to begin the Assisted Reproductive Technologies significantly lower than the patients who had no recurrence. DISCUSSION AND CONCLUSION: The assisted reproductive technologies for patients who had been treated for a borderline or invasive ovarian tumour, and who were infertile in spite of conservative management, have allowed 42.5% of these women to obtain a pregnancy and does not seem to increase significantly the risk of recurrence.

Adult↗

New technology.

Our Academy has proposed this primer, The Ethical Otolaryngologist, to serve as guide to help individual otolaryngologists determine the ethical nature of technologic advancements. Ultimately, each otolaryngologist will decide for himself or herself what he or she believes to be ethical. However, we otolaryngologists should make these decisions while recalling our sworn responsibility to our patients and our responsibility to our chosen profession in otolaryngology. Examples and questions that were presented are intended to assist each of us in making ethical determinations about the care we render to patients. There are many facets to the ethical implications of new technology touched on in this chapter, and they include the following: 1. Categories of new technology and technology assessment studies. 2. Otolaryngologists adopting or developing new technologies. 3. Otolaryngologists teaching and learning new technologies. 4. Supervision of clinical applications of new technologies. In conclusion, nearly all of us who are otolaryngologists have entered this aspect of health care because we enjoy patient contact, the challenges of surgery, the continuing education process, and above all, we are interested in helping our patients prevent and alleviate disease. Our training has encouraged us to put the patient's best interests above all else. This is our utmost ethical responsibility.

Education, Medical, Continuing↗

Innovation and regulation in human implant technologies: developing comparative approaches.

Human implant technologies are subject to continual innovation and proliferation, raising important issues for technology testing, healthcare sciences, clinical performance and risk assessment, and regulation. The regulatory environment of medical devices is being shaped by harmonisation of standards in the European Union. The aim of this paper is to compare the histories and current regulatory environment of two technologies, breast implants and artificial hips, and to consider the implications of this comparison for a sociological healthcare research agenda to investigate the issues raised. The main focus is upon developments in the United Kingdom. Major points of contrast between the two technologies include the institutional contexts in which clinical evidence has been marshalled for government attention; the relative importance of strategic alliances between clinicians and manufacturers in the innovation process; the degree of public controversy evident; the varying definitions of an 'adverse incident' within medical device vigilance systems; and in the UK the presence of a national register for breast implants but not for hip implants. Inter-national contrasts in these dimensions are noted. The analysis suggests that improved understanding is required of the institutional, organisational and professional processes involved in implant technology innovation and regulation. A comparative research agenda is proposed, focusing upon: innovativeness and proliferation; safety and technological standards; clinical and social outcomes; and consumer/user information and choice. It is concluded that research in these areas will enhance the 'evidence-base' for the evaluation of human implant technologies in the context of their innovatory and regulatory environments.

Breast Implants↗

Distributing and transferring medical technology. A view from Latin America and the Caribbean.

Great variation exists in the health care delivery systems throughout Latin America and the Caribbean. In general, medical technology is concentrated in large cities at private hospitals that serve a small, elite segment of the population. What is missing in most of these countries is a clearly defined social policy guaranteeing distribution of medical technology to all segments of society. While data is scarce, it appears that political and economic concerns, rather than medical concerns, determine what and how much technology will be available to all segments of the society. Products are sometimes imported that compete with domestically produced ones. Moreover, transfers of technology often fail to include the necessary knowledge to make imported technology truly useful. However, current economic crises throughout the region are forcing changes in policies; as a result, there is a new emphasis on domestic production of technology over imports and the evaluation of medical technology for its appropriate use in Latin America and the Caribbean.

Developing Countries↗

Current topics on cytokine removal technologies.

It has been widely accepted that cytokines play important roles in the development of organ failure in various pathophysiological conditions of critically ill patients. Various new technologies, including continuous renal replacement therapy, have been developed for the removal of causative humoral mediators in sepsis or other critical conditions. Nonselective blood purification technologies, such as hemofiltration and plasma exchange, are applied in cytokine removal technology. However, the more selective blood purification technologies, such as adsorption, and the combination of those technologies, should be considered in future applications. Only through a prospective randomized controlled study can it be elucidated whether or not these technologies have efficacy in the treatment of sepsis and critically ill patients with hypercytokinemia. We should join and discuss the design of future clinical trials with a standardized strategy for the evaluation of the technologies.

Adsorption↗

Information technology creeps into rural general practice.

This study looked at the effect of information technology on rural medical practice. Eight GPs in rural medical practice in Victoria were interviewed, and World Wide Web sites were accessed for information relevant to the rural GPs use of information technology. The results indicated that rural GPs are developing their use of information technology according to their needs. The use of information technology is changing the nature of rural medical practice, and bringing more support and information to rural GPs. However, some of the technologies now available are of little perceived use to the GPs, and GPs with good support staff are better able to take advantage of the technology than GPs with little or inadequate support. The findings of this study have implications for policies being implemented to increase the availability of information technology to support rural health care.

Diffusion of Innovation↗