New and dis-improved: on the evaluation and use of less effective, less expensive medical interventions.

The innovation and diffusion of new technologies is in large measure responsible for the persistent rise in the cost of health care. The increasing cost of health care, in turn, will make cost-saving technologies more attractive. When cost-saving technologies lead to better or equivalent outcomes, their acceptance will not be controversial. However, the necessary conditions for the development and clinical acceptance of cost-saving technologies that might diminish the quality of health care have not been systematically considered. Indeed, as the clinical research enterprise has been focused almost entirely on quality-improving (or quality-neutral) innovations, new concepts may need to be introduced for quality-reducing innovations. Although the development of such therapies would, at least in some circumstances, increase overall societal benefits, replacing a standard therapy with a less effective one may conflict with deeply held values, such that conventional cost-effectiveness benchmarks might not apply. In addition, from a clinical research perspective, there are considerable ethical and methodologic hurdles that might impede the development of less expensive, less intensive therapies. In this article, using a hypothetical scenario, the authors consider economic, ethical, and research design issues concerning the innovation and diffusion of less effective, less expensive therapies and introduce 2 concepts--"decremental cost-effectiveness" and "acceptability trials"--that may in part provide a research framework for the study of "new and dis-improved" therapies.     

The diffusion and use of diagnostic imaging equipment in France. The limits of regulation.

The paper presents a French national survey on diagnostic imaging equipment and activity showing that conventional x-ray radiology still dominates and that the rate of diffusion of technological innovations has been very different, being slower than in other industrialized countries for such technologies as CT scanners, nuclear medicine, and magnetic resonance imaging, but on the other hand, very quick for ultrasound and digital angiography. The variety of regulations for this equipment, although it plays an important role, is not sufficient to explain these differences in the rate of diffusion. The paper shows that other explanatory variables must be taken into account, at least in the French context: the situation of the domestic biomedical industry, the relations between private and public sectors of health care delivery, and even the "technical" culture and tradition of French radiologists.     

Diffusion of new technologies: rational and irrational

The diffusion of medical technology, the process by which new clinical procedures and devices come into use in the health care system, is an historical topic, as old as medicine itself. Hospitals, physicians, manufacturers, third-party payers, and patients all are factors in the demand for, and adoption and diffusion of, new medical technologies. The federal government also plays a role both in furthering technology diffusion through federally financed health programs and in attempting to control diffusion by stimulating state certificate of need and other regulatory programs. The history of the CT scanner's diffusion illustrates the problems that can result from the lack of a coherent strategy to control the diffusion of major medical technologies. Some of these same problems are now appearing in the diffusion of magnetic resonance imaging (MRI) devices. In the current health care environment, prospective payment and the continuing period of remarkable technological innovation are major influences on technology diffusion and on initiatives for technology assessment. The diffusion of technology can be made more rational by instituting a formal process to identify technologies (both old and new) that require assessment, by financial support for assessment efforts, by selective reimbursement for clinical trials, and by regionalization of costly procedures.     

Substitutability of a process innovation in medical diagnosis: some empirical results

The health sectors in many countries have been increasing in relative size, and medical innovations have been identified by some as a factor contributing to the rise in health expenditures. This paper begins by reviewing the various approaches that economists have employed to determine the connection, if any, between rising health expenditures and new medical technologies. It is then argued that another way to approach the issue is to determine if innovations have substituted for previously existing technologies. Thus this method cannot be applied to product innovations: it is restricted to process innovations. This procedure is applied to the innovation of fibre optic colonoscopy, a procedure for diagnosing diseases/conditions in the lower gastrointestinal tract. The data relate to private medical practice in Australia which operates on a fee-for-service basis. The empirical results indicate no evidence of substitution of the 'new' for the 'old' technology. Thus, there is some reason to believe that this innovation will have contributed to rising health expenditures for diagnosis of the lower gastrointestinal tract. The paper concludes by considering policy options that could address the issue.     

The geography of institutional psychiatric care in France 1800-2000: historical analysis of the spatial diffusion of specialised facilities for institutional care of mental illness

As in other European countries, specialised psychiatric hospitals were established throughout France during the 19th Century. The construction of these hospitals can be considered as the concrete expression of a therapeutic innovation which recognized insanity as an illness that could be treated in such specialised institutions. The spatial diffusion of these innovative institutions through 19th and 20th century France is analysed and we explore how far this can be understood through theories of diffusion of innovations including geographical models of hierarchical and expansion diffusion (or whether other conceptual models are more appropriate). The research reported here particularly focuses on the period 1800-1961. It involved the construction of an original historical database of both psychiatric hospitals and information on the cities where these institutions were located. This was used to examine and interpret the different phases of development of psychiatric institutions and the parts of the country and types of geographical setting where they were concentrated. A multiple correspondence analysis was then performed to examine the connections between different aspects of the diffusion process. The study shows the limitations of classical models of spatial diffusion, which are found to be consistent with some, but not all aspects of the development of psychiatric institutions in France. An alternative political ecology approach seems more appropriate to conceptualise the various processes involved; national policies, social representations, medicalisation of care of mental illness, and urban and economic growth all seem to be associated with the emergence of a variable and complex pattern. This paper also opens a large field of research. Compared with other western countries, the geography of French psychiatric care is relatively under-researched, although there has been a strong spatial dimension to mental health policy in the country. This analysis provides a context for studies of more contemporary processes of French deinstitutionalisation, which is strongly structured by the past heritage of these large asylum facilities.     

The role of action research in the investigation and diffusion of innovations in health care: the PRIDE project

In this article, the authors discuss the role of action research in relation to the investigation and practical implementation of innovations in health care. The diffusion of innovations is an essential component of the modernization of health services worldwide. However, the literature shows that it is not an easy process to research. A paradox is noted that although action research has much to offer, it has had only a limited impact in the innovation field. Drawing on an example of a project in the United Kingdom, the authors discuss whether action research is a valuable method in the study of the diffusion of innovations. They analyze its strengths and limitations as a "whole systems approach" that combines researching with developing and diffusing innovations. They argue that it is best suited to the study of innovation diffusion where there is a need for high level of adaptation in each new setting.     

How medical specialists appraise three controversial health innovations: scientific, clinical and social arguments

Medical specialists play a pivotal role in health innovation evaluation and policy making. Their influence derives not only from their expertise, but also from their social status and the power of their professional organisations. Little is known, however, about how medical specialists determine what makes a health innovation desirable and why. Our qualitative study investigated the views of 28 medical specialists and experts from Quebec and Ontario (Canada) on three controversial innovations: electroconvulsive therapy, prostate-specific antigen screening and prenatal screening for Down's syndrome. Our findings indicate that the scientific, clinical and social arguments of medical specialists combine to create a relatively consistent narrative for each innovation. Our comparative analysis suggests that these narratives bring about a 'soft' resolution to controversies, which relies on a more or less tacit understanding of the social desirability of innovations and which sets the stage for their routinisation. Such an unpacking of medical specialists' arguments both for and against new technologies is needed because such arguments may easily be considered authoritative and because there are few forums for debating the social desirability of innovations not generally deemed to be highly controversial.     

Medical technology procurement in Europe: A cross-country comparison of current practice and policy

Procurement policy can influence the diffusion of medical devices into national health systems, but limited comparative evidence exists on how countries procure such technologies. This paper discusses the procurement of select medical devices across five countries (England, France, Germany, Italy, and Spain) based on a review of published and grey literature and policy documents, as well as expert interviews. All countries have introduced various regulatory or policy measures that implicitly or explicitly influence device procurement, from lists of devices for purchase to changes in financing mechanisms. There has also been movement toward more centralized procurement with the introduction of purchasing groups or consortiums, notably in England, France, Germany, and Italy. While a number of stakeholder groups are involved in purchasing activities, a greater, more formalized role for physicians and governments is needed to ensure that technologies procured best meet patient needs and align with national health care priorities and other sectoral objectives. A general theme across all national procurement systems was a focus on cost-containment, but like other areas of technology policy (e.g., coverage), basing purchasing decisions on a broader range of criteria, such as quality and health outcomes, might better allow governments to achieve value for money and support patient access to beneficial innovations. More research is needed, however, to substantiate the role and influence of procurement on balancing the adoption and affordability of medical technologies.     

Organizational technologies for transforming care: measures and strategies for pursuit of IOM quality aims

Progress on the Institute of Medicine's (IOM's) 6 aims to bridge the "quality chasm" requires both measurement and the concerting of multiple organizational technologies. The basic thesis of this article is that rapid progress on the IOM's multiple aims calls for transformative change within and among healthcare organizations. The promise of a number of types of transformative approaches is closely linked to their ability to simultaneously build upon several organizational technologies: clinical, social, information, and administrative technologies. To encourage and advance such efforts, this article identifies illustrative measures of attainment of the IOM's 6 aims or targeted areas for improvement that reflect the contributions of the 4 organizational technologies. It discusses examples of relationships between the IOM aims and the organizational technologies considered. Finally, the article offers illustrations of the interplay of these organizational technologies and IOM aims-across an array of organizational innovations with transformative potential. Included among such innovations are information technology in the form of electronic medical records, computer-based physician order entry, and patient health records; organization-wide patient-centered cultural change such as Studer's Hardwiring Excellence; Six Sigma and Toyota Production Management/LEAN; major clinical technology change, for example, minimally invasive cardiac surgery and broader treatment innovations such as disease management.     

What leads to better health care innovation? Arguments for an integrated policy-oriented research agenda

This essay is based on the recognition that the current 'downstream' health services research and policy approach to innovation misses the mark on one crucial point. It has not addressed how to promote the design of innovations that are likely to be more valuable than others. Re-visiting the ways in which health services research could inform innovation processes, this paper suggests that three attributes make innovations especially compelling from a health care system perspective: relevance; usability; and sustainability. These could be used as a starting point for outlining a policy-oriented research agenda that could bridge upstream design processes, and downstream needs and priorities. Given the pace at which innovations come about and the complexity of health care systems, we believe that both research and policy should be able to contribute significantly to the shaping of socially valuable technological change in health care. Recognizing that such a long-term goal cannot be reached through a linear, rationalistic process, our paper offers preliminary arguments to start to reconcile the health policy and innovation agendas.     

Service delivery innovations at Mayo Clinic

Mayo Clinic has a long-standing reputation as a leader in the basic and clinical sciences. However, there is little in the published literature about Mayo Clinic's contributions to the delivery of health care services. This article is an overview of what Mayo brought to health care delivery between the 1860s and the 1980s, highlighting some of the lesser-known innovations that have influenced health care delivery on a national and international level such as the development of group practice and medical specialties, the creation of medical records, the use of allied health care providers, and facility design.     

Medical technology and inequity in health care: the case of Korea

There has been a rapid influx of high cost medical technologies into the Korean hospital market. This has raised concerns about the changes it will bring for the Korean health care sector. Some have questioned whether this diffusion will necessarily have positive effects on the health of the overall population. Some perverse effects of uncontrolled diffusion of technologies have been hinted in recent literature. For example, there is a problem of increasing inequity with the adoption of expensive technologies. Utilization of most of the expensive high technology services is not covered by national health insurance schemes; examples of such technologies are Ultra Sonic, CT Scanner, MRI, Radiotherapy, EKG, and Lithotripter. As a result, the rich can afford expensive high technology services while the poor cannot. This produces a gradual evolution of classes in health service utilization. This study examines how health service utilization among different income groups is affected by the import of high technologies. It discusses changes made within the health care system, and explains the circumstances under which the rapid and excessive diffusion of medical technologies occurred in the hospital sector.     

Creating, improving, and innovating

Technological innovations have fundamentally changed the science and practice of medicine. Increased awareness of the need to enhance processes and systems supporting delivery of safe, accessible, affordable health care has sparked an interest in creativity and innovation as essential skills in quality management. This article considers four points regarding the role of creativity and innovation in health care quality management: Creativity and innovation are essential skills in improving and enhancing health care processes and health care delivery systems; creativity is a personal characteristic that can be enhanced; innovation, the legacy of creativity, begins with values-centered design; and innovations emerge in many sizes and forms.     

PRICE CONTROLS FOR MEDICAL INNOVATIONS IN A LIFE CYCLE PERSPECTIVE

We study the market for new medical technologies from a life cycle perspective, incorporating the fact that healthcare utilization is biased towards old age. Contrary to conventional wisdom, we find that price controls on medical innovations can expand investment in medical R&D and results in Pareto superior social outcomes, a consequence of the price controls' ability to increase saving. Importantly, this finding occurs only when the price cap regime is extensive: selective regulation on few technologies – such as pharmaceuticals alone – have the conventional negative effect on innovation. Copyright © 2013 John Wiley & Sons, Ltd.     

How do medical device manufacturers’ websites frame the value of health innovation? An empirical ethics analysis of five Canadian innovations

While every health care system stakeholder would seem to be concerned with obtaining the greatest value from a given technology, there is often a disconnect in the perception of value between a technology’s promoters and those responsible for the ultimate decision as to whether or not to pay for it. Adopting an empirical ethics approach, this paper examines how five Canadian medical device manufacturers, via their websites, frame the corporate “value proposition” of their innovation and seek to respond to what they consider the key expectations of their customers. Our analysis shows that the manufacturers’ framing strategies combine claims that relate to valuable socio-technical goals and features such as prevention, efficiency, sense of security, real-time feedback, ease of use and flexibility, all elements that likely resonate with a large spectrum of health care system stakeholders. The websites do not describe, however, how the innovations may impact health care delivery and tend to obfuscate the decisional trade-offs these innovations represent from a health care system perspective. Such framing strategies, we argue, tend to bolster physicians’ and patients’ expectations and provide a large set of stakeholders with powerful rhetorical tools that may influence the health policy arena. Because these strategies are difficult to counter given the paucity of evidence and its limited use in policymaking, establishing sound collective health care priorities will require solid critiques of how certain kinds of medical devices may provide a better (i.e., more valuable) response to health care needs when compared to others.     

Looking into the black box of “Medical Innovation”: rising health expenditures by illness type

There is agreement among health economists that on the whole medical innovation causes health care expenditures (HCE) to rise. This paper analyzes for which diagnoses HCE per patient have grown significantly faster than average HCE. We distinguish decedents (patients in their last 4 years of life) from survivors and use a unique dataset comprising detailed HCE of all members of a regional health insurance fund in Upper Austria for the period 2005–2018. Our results indicate that among decedents in particular, the expenditures for treatment of neoplasms have exceeded the general trend in HCE. This confirms that medical innovation for this group of diseases has been particularly strong over the last 15 years. For survivors, we find a noticeable growth in cases and cost per case for pregnancies and childbirth, and also for treatment of mental and behavioral disorders. We discuss whether these findings contradict the widespread interpretation of cost-increasing innovations as “medical progress” and offer some policy recommendations.

     

Medical technology in the United States. The last decade.

This paper reviews the evolution of U.S. policy toward medical technology in areas such as cost containment, regulation of devices and drugs, and third party reimbursement. In addition the authors chronicle the diffusion of major medical technologies, procedures, and organizational innovations in the United States. Finally, the article provides tentative observations on the effect of recent policy changes and concludes with some recommendations for the future.     

The Swedish Council on Technology Assessment in Health Care.

During its first year of operation (1988) the Swedish Council on Technology Assessment in Health Care focused on nine areas. Additional activities will be added as need requires and resources permit. Also, preparations for 1989 projects have begun. The nine areas include: identification of technologies needing assessment, including international comparisons; review and synthesis of the value of preoperative routines; review and synthesis of the value of gastroscopy for diagnosing stomach pain; assessment of different treatment methods for back pain; assessment of the value of vascular surgery for vascular spasms in the legs; organization of a strategy conference concerning medical technology assessment in Sweden; creation of a strategy that addresses an international review of medical technology, future technologies in health care, waiting lists for medical care--the importance of medical technology, resource utilization and organizational and educational aspects of introducing new technology in health care, and costs and medical technology; translation of foreign assessment studies, with comments; national and international cooperation. SCTA has discussed the need for assessing specific technology such as bone marrow transplantation and surgical treatment of epilepsy. SCTA's Scientific Advisory Committee has additionally considered the following subjects for future projects: medical, social, and economic consequences of alternative technologies screening for prostate, colorectal, breast, and cervical cancer; costs, indications, and medical benefit of surgery for varicose vains; and modern urology technologies, particularly those related to prostate care.     

Beyond usability: designing effective technology implementation systems to promote patient safety

Evidence is emerging that certain technologies such as computerized provider order entry may reduce the likelihood of patient harm. However, many technologies that should reduce medical errors have been abandoned because of problems with their design, their impact on workflow, and general dissatisfaction with them by end users. Patient safety researchers have therefore looked to human factors engineering for guidance on how to design technologies to be usable (easy to use) and useful (improving job performance, efficiency, and/or quality). While this is a necessary step towards improving the likelihood of end user satisfaction, it is still not sufficient. Human factors engineering research has shown that the manner in which technologies are implemented also needs to be designed carefully if benefits are to be realized. This paper reviews the theoretical knowledge on what leads to successful technology implementation and how this can be translated into specifically designed processes for successful technology change. The literature on diffusion of innovations, technology acceptance, organisational justice, participative decision making, and organisational change is reviewed and strategies for promoting successful implementation are provided. Given the rapid and ever increasing pace of technology implementation in health care, it is critical for the science of technology implementation to be understood and incorporated into efforts to improve patient safety.     

Strategic response by providers to specialty hospitals, ambulatory surgery centers, and retail clinics

Radical innovation and disruptive technologies are frequently heralded as a solution to delivering higher quality, lower cost health care. According to the literature on disruption, local hospitals and physicians (incumbent providers) may be unable to competitively respond to such "creative destruction" and alter their business models for a host of reasons, thus threatening their future survival. However, strategic management theory and research suggest that, under certain conditions, incumbent providers may be able to weather the discontinuities posed by the disrupters. This article analyzes 3 disruptive innovations in service delivery: single-specialty hospitals, ambulatory surgical centers, and retail clinics. We first discuss the features of these innovations to assess how disruptive they are. We then draw on the literature on strategic adaptation to suggest how incumbents develop competitive responses to these disruptive innovations that assure their continued survival. These arguments are then evaluated in a field study of several urban markets based on interviews with both incumbents and entrants. The interviews indicate that entrants have failed to disrupt incumbent providers primarily as a result of strategies pursued by the incumbents. The findings cast doubt on the prospects for these disruptive innovations to transform health care.