Elements for assessment of telemedicine applications.

OBJECTIVES: As an initiative of the International Network of Agencies for Health Technology Assessment, an approach to assessment of telemedicine applications was prepared to assist decision makers who are considering introduction and use of this technology. METHODS: Review and commentary drawing on published assessment frameworks and reports of primary evaluations of telemedicine, with particular reference to experience in Finland and Canada. RESULTS: Elements of the approach included development of a business case (considering population and services, personnel and consumers, delivery arrangements, specifications and costs); subsequent evaluation of the telemedicine application; and follow-up (covering the domains of technical assessment, effectiveness, user assessment of the technology, costs of telemedicine, trials, economic evaluation methods, and sensitivity analysis). CONCLUSIONS: Decision makers should link introduction of new and often costly technology to appraisal of its feasibility, followed by evaluation of the application, including longer term consideration of its sustainability and impact on the healthcare system. As the effectiveness and efficiency of telemedicine applications will often be strongly influenced by local issues, results of assessments may not be generalizable.     

谈医疗设备的成本管理

医院实施全成本核算后,医疗设备的成本效益受到密切关注。为了帮助设备使用科室提高经营水平,也为院领导和设备主要管部门提供引进设备的决策依据。作者阐述医疗设备成本包括：①设备折旧;②场地费;③维修费;④消耗品费;⑤水电气费;⑥工时费;⑦间接成本费等。与此同时还阐述了设备的运行收入与评价分析的方法。     

Applying Dynamic Simulation Modeling Methods in Health Care Delivery Research—The SIMULATE Checklist: Report of the ISPOR Simulation Modeling Emerging Good Practices Task Force

Health care delivery systems are inherently complex, consisting of multiple tiers of interdependent subsystems and processes that are adaptive to changes in the environment and behave in a nonlinear fashion. Traditional health technology assessment and modeling methods often neglect the wider health system impacts that can be critical for achieving desired health system goals and are often of limited usefulness when applied to complex health systems. Researchers and health care decision makers can either underestimate or fail to consider the interactions among the people, processes, technology, and facility designs. Health care delivery system interventions need to incorporate the dynamics and complexities of the health care system context in which the intervention is delivered. This report provides an overview of common dynamic simulation modeling methods and examples of health care system interventions in which such methods could be useful. Three dynamic simulation modeling methods are presented to evaluate system interventions for health care delivery: system dynamics, discrete event simulation, and agent-based modeling. In contrast to conventional evaluations, a dynamic systems approach incorporates the complexity of the system and anticipates the upstream and downstream consequences of changes in complex health care delivery systems. This report assists researchers and decision makers in deciding whether these simulation methods are appropriate to address specific health system problems through an eight-point checklist referred to as the SIMULATE (System, Interactions, Multilevel, Understanding, Loops, Agents, Time, Emergence) tool. It is a primer for researchers and decision makers working in health care delivery and implementation sciences who face complex challenges in delivering effective and efficient care that can be addressed with system interventions. On reviewing this report, the readers should be able to identify whether these simulation modeling methods are appropriate to answer the problem they are addressing and to recognize the differences of these methods from other modeling approaches used typically in health technology assessment applications.     

Assessing the social impacts of medical technologies

The introduction of a new medical technology can have indirect, unintended, or unanticipated effects on individuals or on social systems. Although these impacts result from the widespread use of the technology, many of them can be predicted while the technology is being developed. A method for systematically identifying and evaluating these impacts is technology assessment. Such an assessment, made while a technology is being developed, could provide useful information for decision making about research and development and in planning for the technology's eventual introduction. Because only a few medical technologies have been formally assessed and because the process of medical technology development is poorly understood, one must be cautious in recommending widespread use of technology assessment. Nevertheless, enough is now known to permit the formulation of approaches that could be used in preliminary attempts at medical technology assessment.Dr. Banta is with the National Center for Health Services Research, Department of Health, Education, and Welfare, Hyattsville, Md. 20782 and Dr. Sanes is with the Department of Physiology, University of California at San Francisco 94117. This paper is based on a report,Development of Medical Terminology: Opportunities for Assessment, prepared for the Senate Committee on Labor and Public Welfare by the Office of Technology Assessment; it was developed by the authors with the assistance of an expert advisory panel chaired by Eugene A. Stead, Jr., M.D. The Office of Technology Assessment was established by statute in 1972 to provide objective policy analysis to committees of Congress on issues concerning science and technology. A health program was developed beginning in 1975. The report cited above is the first product of that program and is available from the U.S. Government Printing Office.     

Methodology of constructive technology assessment in health care

OBJECTIVES: Technologies in health care are evolving quickly, with new findings in the area of biotechnological and genetic research being published regularly. A health technology assessment (HTA) is often used to answer the question of whether the new technology should be implemented into clinical practice. International evidence confirms that the results of HTA research sometimes have limited impact on practical implementation and on coverage decisions; the study design is commonly based on the paradigm of stability of both the technology and the environment, which is often not the case. Constructive technology assessment (CTA) was first described in the 1980s. In addition to the traditional HTA elements, this approach also takes into account the technology dynamics by emphasizing sociodynamic processes. With a CTA approach, comprehensive assessment can be combined with an intentional influence in a favorable direction to improve quality. METHODS: In this study, the methodological aspects mainly concerning the diagnostic use of CTA are explained. The methodology will be illustrated using the controlled introduction of a new technology, called microarray analysis, into the clinical practice of breast cancer treatment as a case study. Attention is paid to the operationalization of the phases of development and implementation and the research methods most appropriate for CTA. CONCLUSIONS: In addition to HTA, CTA can be used as a complementary approach, especially in technologies that are introduced in an early stage of development in a controlled way.     

Health technology assessment and policy decisions on hyperbaric oxygen treatment

OBJECTIVES: To provide information to health authorities and others on the effectiveness of hyperbaric oxygen treatment (HBOT) and the impact on health services should an additional HBOT facility be established in the provincial health care system. METHODS: A literature review on the clinical use of HBOT was conducted, drawing on MEDLINE, EMBASE, and HealthSTAR. For each of 13 conditions, the effectiveness of HBOT was assessed, with reference to a widely used classification of level of evidence. Cost implications were considered for each condition for which there was sufficient evidence of effectiveness. The perspective was that of the payer. RESULTS: Good evidence of effectiveness exists for HBOT for four conditions and HBOT is established as the clinical standard of care for two others. Available evidence did not support the routine use of HBOT for a further seven indications. An additional 59-87 patients per year would be eligible for HBOT if a second facility were established in the province. Improvement in quality of life could be expected for 30-60 persons per year. A new facility would result in identified additional annual expenditure of $108,000. Capital costs could exceed $600,000. CONCLUSIONS: On the basis of the available evidence on benefits and costs to routine health care, there did not seem to be a particularly strong case for establishing a second HBOT center in the province. Following the assessment, the health authority made a decision not to provide funding for this additional service.     

Measuring the Effectiveness of Real-World Evidence to Ensure Appropriate Impact

The value of real-world evidence (RWE) in medicines regulation and health technology assessment has been increasingly emphasized. Nevertheless, although RWE is increasingly used, there has been limited systematic evidence of its value. A recent study that examined the role and impact of RWE in regulatory assessments conducted through the European Medicines Agency provided such evidence. Results of the study demonstrated RWE was important to decision making, particularly for certain questions such as the quantification of adverse events, the evaluation of risk minimization measures, and the assessment of product usage. The study suggested, however, that in many of the assessments further RWE would have been valuable and concluded that RWE has, as yet, played a limited role in hypothesis generation and in the assessment of medication effectiveness. This study had been possible only because of the transparency of the European Medicines Agency decision making. Ensuring transparency of RWE evidence collection, study design and conduct, and of decision making based on this evidence will facilitate further development of the uses and value of RWE.Keywords: benefit-risk assessment; medicines regulation; real-world evidence; regulatory decision making.     

Health technology assessment in Luxembourg

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

Multiple Criteria Decision Analysis for Health Technology Assessment

ObjectivesMulticriteria decision analysis (MCDA) has been suggested by some researchers as a method to capture the benefits beyond quality adjusted life-years in a transparent and consistent manner. The objectives of this article were to analyze the possible application of MCDA approaches in health technology assessment and to describe their relative advantages and disadvantages.MethodsThis article begins with an introduction to the most common types of MCDA models and a critical review of state-of-the-art methods for incorporating multiple criteria in health technology assessment. An overview of MCDA is provided and is compared against the current UK National Institute for Health and Clinical Excellence health technology appraisal process. A generic MCDA modeling approach is described, and the different MCDA modeling approaches are applied to a hypothetical case study.ResultsA comparison of the different MCDA approaches is provided, and the generic issues that need consideration before the application of MCDA in health technology assessment are examined.ConclusionsThere are general practical issues that might arise from using an MCDA approach, and it is suggested that appropriate care be taken to ensure the success of MCDA techniques in the appraisal process.     

移动式加速器术中放射治疗辐射场剂量水平的测量与分析

目的掌握移动式加速器(简称加速器)术中放射治疗时在手术室及其外围产生的辐射水平,制订手术室可行的屏蔽设计方案,加强术中放射治疗的防护管理。方法以某医院设置的1台Mobetron移动式加速器和术中放射治疗场所为研究对象,采用12MeV电子束、输出量率1000cGy/min进行模拟术中放射治疗,分别使用LiF(Mg,Cu,P)热释光剂量计(TLD)和6150-AD型环境剂量率仪对术中放射治疗手术室内及其外围的辐射水平进行测量。结果 (1)术中放射治疗手术室内的辐射场剂量水平及其分布:Z=75cm平面(治疗床平面)内,加速器前方100cm处的剂量率为40.8～62.8mGy/h,后方100cm处的剂量率为0.13～11.2mGy/h;加速器前方和侧向300cm处的剂量率为2.05～6.35mGy/h。(2)术中放射治疗辐射安全设置状况及手术室外围的辐射水平:术中放射治疗手术室及其准备间设为控制区,防护门均与出束联锁;照射时东墙外走廊(中间隔有准备间)最高剂量率为9.0μGy/h,北墙外控制室内最高剂量率为19.5μGy/h,西墙外清洁走廊和南墙外、楼下场所最高剂量率分别为24.2、14.5和23.0μGy/h。结论加速器在手术室内产生的辐射主要为轫致辐射的杂散辐射,但应相对固定术中放射治疗场所并结合实测辐射值制订并优化场所的屏蔽设计方案。     

Debating the Desirability of New Biomedical Technologies: Lessons from the Introduction of Breast Cancer Screening in the Netherlands

Health technology assessment (HTA) was developed in the 1970s and 1980s to facilitate decision making on the desirability of new biomedical technologies. Since then, many of the standard tools and methods of HTA have been criticized for their implicit normativity. At the same time research into the character of technology in practice has motivated philosophers, sociologists and anthropologists to criticize the traditional view of technology as a neutral instrument designed to perform a specific function. Such research suggests that the tools and methods of more traditional forms of HTA are often inspired by an ‘instrumentalist’ conception of technology that does not fit the way technology actually works. This paper explores this hypothesis for a specific case: the assessments and deliberations leading to the introduction of breast cancer screening in the Netherlands. After reconstructing this history of HTA ‘in the making’ the stepwise model of HTA that emerged during the process is discussed. This model was rooted indeed in an instrumentalist conception of technology. However, a more detailed reconstruction of several episodes from this history reveals how the actors already experienced the inadequacy of some of the instrumentalist presuppositions. The historical case thus shows how an instrumentalist conception of technology may result in implicit normative effects. The paper concludes that an instrumentalist view of technology is not a good starting point for HTA and briefly suggests how the fit between HTA methods and the actual character of technology in practice might be improved.     

Technology assessment, priority setting, and appropriate care in Dutch health care

This article provides a critical analysis of the impact of health technology assessment (HTA) on priority setting in The Netherlands. It describes the limited steering powers of the Dutch government; its complex interactions with insurers, health-care providers, and patients; and the role of HTA in this context as an attempt to rationalize the debate about cost-effectiveness issues. HTA has been drawn upon for decision making on the health insurance package. Also, HTA findings have been linked to the national guideline development programs of the medical community. However, these impacts by no means have been straightforward. We argue that the political nature of the priority-setting debate asks for a broader approach to what constitutes HTA, and how it should be drawn upon in priority setting. Suggestions are made on how to do justice to the social dynamics of decision making and the behavior of stakeholders in health-care systems.     

How important are individual,household and commune characteristics in explaining utilization of maternal health services in Vietnam?

Using Vietnam's latest National Household Survey data for 2001-2002 this paper assesses the influence of individual, household and commune-level characteristics on a woman's decision to seek prenatal care, on the number of prenatal visits, and on the choice between giving birth at a health facility or at home. The decision to use any care and the number of prenatal visits is modeled using a two-part model. A random intercept logistic model is used to capture the influence of unobserved commune-specific factors found in the data regarding a woman's decision to give birth at a health facility rather than at home. The results show that access to prenatal care and delivery assistance is limited by observed barriers such as low income, low education, ethnicity, geographical isolation and a high poverty rate in the community. More specifically, more prenatal visits increase the likelihood of giving birth at a health facility. Having compulsory health insurance increases the odds of giving birth at a health facility for middle and high income women. In contrast, health insurance for the poor increases the likelihood of having more prenatal visits but has little effect on the place of delivery. These results suggest that the existing safe motherhood programs should be linked with the objectives of social development programs such as poverty reduction, and that policy makers need to view both the individual and the commune as appropriate units for policy targeting.     

Decision making in acquiring medical technologies in Israeli medical centers: a preliminary study

OBJECTIVE: This preliminary study had two objectives: a) charting the considerations relevant to decisions about acquisition of new medical technology at the hospital level; and b) creating a basis for the development of a research tool that will examine the function of the Israeli health system in assessment of new medical technologies. METHODS: A comprehensive literature review and in-depth interviews with decision makers at different levels allowed formulation of criteria considered by decision makers when they decide to purchase and use (or disallow the use) of new medical technology. The resulting questionnaire was sent to medical center directors, along with a letter explaining the goals of the study. The questionnaire included 31 possible considerations for decision making concerning the acquisition of new medical technology by medical centers. The interviewees were asked to indicate the relevance of each consideration in the decision-making process. REULTS: The most relevant criteria for the adoption of new technologies related to the need for a large capital investment, clinical efficacy of the technology as well as its influence on side effects and complication rates, and a formal approval by the Ministry of Health. Most interviewees stated that pressures exerted by the industry, by patients, or by senior physicians in the hospital are less relevant to decision making. Very small and usually not statistically significant differences in the ranking of hospital directors were found according to the hospitals' ownership, size, or location. CONCLUSIONS: The present study is a basis for a future study that will map and describe the function of hospital decision makers within the area of new technology assessment and the decision-making process in the adoption of new healthcare technologies.     

Psychiatric decision making in the 90's: the coming era of decision support

Guidelines for how mental health care is allocated form a pivotal point on the fulcrum balancing preservation of quality care and containment of costs. Advances in information system technology are creating new opportunities for research-based decision support tools in this area. Such tools can systematically and reliably scale the domains of evidence used in psychiatric assessment in order to more precisely describe the severity of impairment and point to appropriateness of care decisions. The first psychiatric decision support tools were introduced in the 1960s in response to changes in the mental health community, but research in this area tended to have limited inter-rater reliability or validity. More recently, several computerized decision support tools have been developed, with a stronger research base and consequently a wider application. These tools are reviewed, and one such tool is described in greater depth to illustrate the possibilities of computer technology and the direction in which decision support software is headed.     

The use and impact of rapid health technology assessments

OBJECTIVES: To consider the impact of rapid health technology assessments undertaken as part of a program in a provincial healthcare system in response to urgent requests for advice. METHODS: Review of the development and preparation of 20 rapid assessment reports, communication with decision makers within the healthcare system, and appraisal of data subsequent to preparation of the reports. RESULTS: Fourteen of the assessments were judged to have had an influence on policy and other decisions, as judged by responses from those who had requested advice. Another four were considered to have provided guidance, while having less immediate influence on decisions, and two others had no apparent impact. Quality of the assessments was considered acceptable, on the basis of literature that subsequently became available and from comments received. CONCLUSIONS: These brief reports are considered to be a useful component of a health technology assessment program. However, they should be regarded as provisional appraisals and followed up with more detailed evaluation where possible.     

Whither trial‐based economic evaluation for health care decision making?

The randomised controlled trial (RCT) has developed a central role in applied cost-effectiveness studies in health care as the vehicle for analysis. This paper considers the role of trial-based economic evaluation in this era of explicit decision making. It is argued that any framework for economic analysis can only be judged insofar as it can inform two key decisions and be consistent with the objectives of a health care system subject to its resource constraints. The two decisions are, firstly, whether to adopt a health technology given existing evidence and, secondly, an assessment of whether more evidence is required to support this decision in the future. It is argued that a framework of economic analysis is needed which can estimate costs and effects, based on all the available evidence, relating to the full range of possible alternative interventions and clinical strategies, over an appropriate time horizon and for specific patient groups. It must also enable the accumulated evidence to be synthesised in an explicit and transparent way in order to fully represent the decision uncertainty. These requirements suggest that, in most circumstances, the use of a single RCT as a vehicle for economic analysis will be an inadequate and partial basis for decision making. It is argued that RCT evidence, with or without economic content, should be viewed as simply one of the sources of evidence, which must be placed in a broader framework of evidence synthesis and decision analysis.     

移动式加速器术中放射治疗的辐射防护与安全评价

目的 评估移动式加速器术中放射治疗(IORT)的辐射防护与安全状况,为IORT临床应用中的辐射安全提供指导.方法 以某医院拟用的1台MOBETRON移动式加速器及其场所为研究目标,确定IORT的工作负荷及场所外围人员的年剂量管理目标值,估算极端情况下IORT室外围的辐射水平和人员所受的剂量,核算IORT治疗场所的辐射屏蔽.结果 该IORT治疗室在仅采用相当于普通X射线诊断装置的屏蔽条件下,治疗室外与靶不同距离关注位置的剂量率为:东墙外35～78 μSv/h;南墙外89 μSv/h,西墙外70 ～ 84 μSv/h,北墙外75～106 μSv/h; IORT室楼下普通治疗室64 μSv/h,室顶外围空间为45μSv/h.估算出年累积出束5h时场所外围职业人员的年剂量最高为0.53 mSv,公众所受年剂量低于0.1 mSv,均满足剂量管理目标值的要求.加速器IORT设备及场所设置有相应的安全联锁、防护设施与管理措施,可有效制约设备运行照射时人员误入和误留IORT室的风险.结论 在普通手术室中施行移动式加速器IORT时,在工作负荷极小的条件下采取针对低能辐射的屏蔽防护可达到剂量管理目标要求,但应相对固定IORT场所,并根据工作负荷和剂量率控制要求对治疗室增设相应的屏蔽.     

Efficacy of intraoperative radiotherapy targeted to the abdominal lymph node area in patients with esophageal carcinoma

We investigated whether intraoperative radiotherapy (IORT) during curative surgery for esophageal carcinoma is useful or not. The cases of 117 patients diagnosed with thoracoabdominal esophageal carcinoma who underwent curative surgery between 1986 and 2007 were reviewed: 72 patients received IORT (IORT group) and 45 did not (non-IORT group). Upper abdominal lymphadenectomy was performed in 115 patients (98.5%). Seventy patients (59.8%) received chemotherapy and 80 patients (68.4%) received external radiotherapy. IORT encompassed the upper abdominal lymph node area. A single-fraction dose of 20–30 Gy was delivered using high-energy electrons. Median follow-up duration for patients was 7.4 years. The 5-year overall survival rate did not significantly differ between the IORT and non-IORT groups. However, the 5-year abdominal control rate was significantly higher in the IORT group (89.2%) than in the non-IORT group (72.9%; P = 0.022). We next focused on a patient subgroup with a primary lesion in the lower thoracic or abdominal esophagus or measuring >6 cm in length since this subgroup is probably at high risk of upper abdominal lymph node metastasis. Of the 117 patients, 75 belonged to this subgroup, and among them 45 received IORT. Both univariate and multivariate analysis revealed the survival rate was significantly higher in patients who received IORT than in those who did not (P = 0.033 univariate; 0.026 multivariate). There were no obvious perioperative complications solely attributed to IORT. IORT for esophageal carcinoma will likely be effective for patients with a primary lesion in the lower thoracic or abdominal esophagus, or with a long lesion.     

Framework for describing and classifying decision-making systems using technology assessment to determine the reimbursement of health technologies (fourth hurdle systems)

OBJECTIVES: Australia, Canada, and many European countries now use various forms of health technology assessment (HTA) in decision making regarding the reimbursement of drugs and other health technologies. To achieve a better understanding of the potential for use of HTA in this context, an analytical framework was developed to describe and classify existing fourth hurdle systems. METHODS: Based on a review of published literature, and official documentation, the key aspects of a fourth hurdle system were identified at two levels: policy implementation and individual technology decision. Characteristics of the systems were grouped under four main headings: constitution and governance, objectives, use of evidence and decision processes, and accountability. The comprehensiveness and relevance of this framework was assessed by an independent group of experts in HTA. A pilot study was undertaken, using only published sources, to test the feasibility of obtaining the information needed to complete the framework. RESULTS: The framework was found to be sufficiently broad to encompass all the issues of interest regarding the systems, but the proportion of information available from published sources was variable between sections of the framework and between countries, with average availability of 45 percent. CONCLUSIONS: The analytical framework will help researchers and policy makers in individual countries to understand their own systems and will allow some preliminary sharing of experience between countries. More experience of its application is needed to judge whether it will provide the basis for more formal comparison of systems and whether it will determine their appropriateness for particular decision contexts.