1
Introduction and Background

For more than 30 years, clinicians, health services researchers, and others have been investigating the use of advanced telecommunications and computer technologies to improve health care. At the intersection of many of these efforts is telemedicine—a combination of mainstream and innovative information technologies. As defined here, telemedicine is the use of electronic information and communications technologies to provide and support health care when distance separates the participants.

On the commonplace side of the spectrum are familiar uses of the telephone for consultations between patients and clinicians and the use of radio to link emergency medical personnel to medical centers. On the other end of the telemedicine spectrum are largely experimental innovations such as telesurgery in which a surgeon receives visual and tactile information to guide robotic instruments to perform surgery at a distant site. In between these two ends of the spectrum lie an array of video, audio, and data transmission technologies and applications. Some, such as relatively expensive interactive video conferencing, allow clinicians to see, hear, examine, question, and counsel distant patients for "real-time" diagnostic and therapeutic purposes. Others, based on "store and forward" technologies, permit digital images and other information to be saved and transmitted relatively cheaply to consultants who can receive



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--> 1 Introduction and Background For more than 30 years, clinicians, health services researchers, and others have been investigating the use of advanced telecommunications and computer technologies to improve health care. At the intersection of many of these efforts is telemedicine—a combination of mainstream and innovative information technologies. As defined here, telemedicine is the use of electronic information and communications technologies to provide and support health care when distance separates the participants. On the commonplace side of the spectrum are familiar uses of the telephone for consultations between patients and clinicians and the use of radio to link emergency medical personnel to medical centers. On the other end of the telemedicine spectrum are largely experimental innovations such as telesurgery in which a surgeon receives visual and tactile information to guide robotic instruments to perform surgery at a distant site. In between these two ends of the spectrum lie an array of video, audio, and data transmission technologies and applications. Some, such as relatively expensive interactive video conferencing, allow clinicians to see, hear, examine, question, and counsel distant patients for "real-time" diagnostic and therapeutic purposes. Others, based on "store and forward" technologies, permit digital images and other information to be saved and transmitted relatively cheaply to consultants who can receive

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--> and interpret them when convenient, thus offering more scheduling flexibility for those on both ends of the communications link. In addition to patient care, these varied technologies have a multiplicity of current and possible uses in professional education, research, public health, and administration. Such multiple uses potentially allow costs for expensive information and communications investments to be spread more broadly. This report was prompted by the scarcity of careful evaluations of patient care applications of telemedicine. It presents a broad framework for evaluating clinical applications of telemedicine and argues for more systematic and rigorous assessments of their effects on health care quality, accessibility, costs, and acceptability compared to alternative services. For telemedicine, as for any health technology or service, such assessments are essential for several reasons. They can guide policymakers considering whether to encourage telemedicine by stimulating infrastructure development, funding specific telemedicine programs, or reducing policy barriers; provide clinicians and patients appropriate reassurance or caution about telemedicine applications; inform health plan managers pondering whether clinical telemedicine is feasible, cost-effective, and acceptable to patients and clinicians; and help those who have invested in telemedicine find ways to identify problems and improve programs. Because telemedicine is actually a family of quite diverse technologies and applications and because important educational, research, public health, and administrative uses and benefits may be intertwined with patient care uses, the evaluation framework proposed here will have to be adapted to fit different applications and environments. It may also have to be modified to consider links to other clinical and nonclinical programs that share parts of the same technical and human infrastructure. Such modification and adaptations notwithstanding, at the heart of the evaluation framework is a body of principles and methods that form the foundation for health services research and evaluation research generally. This report attempts to relate those principles and methods to the special challenges

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--> and problems in evaluating telemedicine. It is aimed primarily at policymakers, clinicians, patients, and managers, but it should also provide context and support for researchers and evaluators with an interest in assessing information and telecommunications technologies. Telemedicine In Context Concerns about access to health care have propelled much of the interest in clinical applications of telemedicine. Applications have often concentrated on remote locales in the hope that they could make needed services more available to mountain families, tribal members on Indian reservations in the Southwest and the Dakotas, military personnel on tiny Pacific islands, and ranchers and others scattered across the country's open spaces. The promise has been that telemedicine could be more practical, affordable, and sustainable than traditional programs, including those intended to sustain or expand rural health care facilities and to attract physicians, nurses, and other personnel to remote areas on a short- or long-term basis. That this potential needs to be demonstrated is the thesis of this report. Today, with the nation's health care system undergoing profound changes, telemedicine is attracting attention beyond rural areas. To the extent that telemedicine offers mechanisms for centralizing specialists, reducing costs for specialty care, and supporting primary care clinicians, managed care plans may find certain applications attractive in the urban and suburban areas they typically serve. Some academic medical centers, faced with reduced revenues and exclusion from local managed care networks, are exploring telemedicine options as they seek to develop new regional, national, and international markets for their highly specialized clinicians. Freestanding specialty groups, multiorganization medical consortia, and other entities likewise are investigating telemedicine as they seek far-flung clients for their services. The prospect of a physician surplus coupled with declining personal income has become a real concern for many physicians, particularly specialists (Pew Health Professions Commission, 1995; IOM, 1996). Nurses likewise are facing pressures from decreasing hospital utilization and a reordering of nursing practices in managed care, although these may be offset to some degree by more options in

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--> home, community, and office settings. Intense price competition is threatening the missions and even the existence of some academic health centers, public and community hospitals, community health centers, and other institutions whose costs are increased by education, research, or care for the uninsured and underinsured. In these contexts, the information and telecommunications technologies that constitute telemedicine have the potential to radically reshape health care in both positive and negative ways. In particular, over time, the widespread adoption of clinical applications of telemedicine could fundamentally alter the personal, face-to-face relationship between patient and practitioner that has been the model for medical care for generations. Although economic considerations are stimulating many explorations of telemedicine for clinical, educational, and administrative purposes, health care organizations must also be concerned about how telemedicine could affect the actual and perceived quality of their services. As in other areas, quality assessment and improvement for telemedicine is closely linked to the continued development and implementation of sophisticated clinical, research, administrative, and other information systems. Despite its multiplying uses and users, many forms of clinical telemedicine are still far from being routinely integrated into most facets of health care delivery. Given the scarcity of comprehensive and reliable data and the pace of change, an overall picture of telemedicine's current status must be painted in rather broad strokes. Consider, for example, the dimensions of the U.S. health system (IOM, 1992a): Roughly 250 million patients and potential patients. Most adults have probably used the telephone to get medical advice or information. A growing number of Americans have personal computers and software that allow them to use medical databases (including some developed for clinicians or researchers rather than patients) and communicate with clinicians and others via electronic mail. An unknown, but undoubtedly tiny, fraction of the population has participated in an "electronic housecall," a video consultation with a distant medical specialist, or some other kind of interactive, audiovisual telemedicine application. Over a half-million physicians, 1.5 million nurses, and many other health care professionals. Again, most practitioners have probably

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--> used the telephone to discuss patient care; many have participated in continuing medical education by teleconference; and some specialists such as radiologists are gaining considerable experience with the transmission of images for consultation purposes. An increasing number of clinicians have on-line access to the National Library of Medicine's Medline and other resources that allow them to search the medical literature. A growing number of health care organizations have home pages on the World Wide Web that provide information and links to information available at other sites. On-line journals are also springing up, which is raising concern about weakening of the screening and quality assurance functions served by traditional journals' peer review processes. Thousands of hospitals, nursing homes, clinics, and other health care institutions. The number of health care institutions that have advanced telemedicine capacity (e.g., video as well as telephone and fax) is not well documented. A survey of approximately 2,400 rural hospitals conducted for the federal Office of Rural Health Policy found that nearly 20 percent reported some telemedicine services but that 60 percent reported no plans for telemedicine (Jones, 1996). Academic medical centers, community hospitals, and other institutions have created World Wide Web pages that serve both as information sources and as marketing tools. To meet internal needs and external demands, offices and hospitals are being remodeled to better accommodate information technologies that require differently configured space for people and equipment. the electronic patient record is increasingly understood to be a necessity, although practical obstacles to implementation take time to overcome. Hundreds of managed care organizations going under a variety of acronyms, including HMOs (health maintenance organizations), PPOs (preferred providers organizations), and PHOs (physician hospital organizations). For the most part, the committee found that these organizations have more pressing priorities than telemedicine, including implementation of better patient and administrative information systems. To borrow a phrase from clinical practice, "watchful waiting" seems to be a common strategy as decisionmakers monitor the experiences of innovators and early adopters of telemedicine. The integration of clinical, educational, and other applications of telemedicine into health care is inextricably linked to a dynamic telecommunications industry and a developing National Information

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--> Infrastructure (NII). This infrastructure has been likened to "a giant electronic web that will allow each user's computer, telephone, and television to interconnect with others, regardless of their location … and will enable each user to communicate with everyone else who is connected to the web" (Lasker et al., 1995). The NII has been accorded sufficient federal policy importance to be referred to by its initials as if it were a specific organization or technology rather than an evolving concept—a mix of aspirations, strategic plans, fast-changing technologies, and growing user demands and sophistication. A recent report from the National Research Council, tellingly titled The Unpredictable Certainty: Information Infrastructure through 2000, found that "there are as many visions of the information future as there are sectors of the economy helping to create them" (NRC, 1996, p. 3). The technical base for telemedicine applications will also continue to be affected by innovations spurred by consumer electronics, the entertainment industry, and defense department investments. Moreover, as the telecommunications infrastructure expands to provide and support interactive educational, entertainment, retail, and other services at the "point of need" (e.g., home, school), telemedicine can be expected to follow a similar path. For example, the "electronic housecall" has the potential to save some ill or recovering patients the inconvenience or discomfort of an office visit, allow certain hospitalized patients to go home earlier, and avoid some admissions in the first instance. It may also provide preventive services to those who wish to avoid or minimize potential illness. The benefits and costs of home access to telemedicine services compared to alternative services have, however, yet to be systematically demonstrated. Technical, clinical, organizational, and behavioral obstacles to easy use of telemedicine technologies remain, as do policy impediments and uncertainties related to reimbursement, licensure, medical liability, and other concerns. Many programs continue to depend on grants from government and industry, although some applications show more promise of becoming self-sustaining over the long term than others. Overall, the financial and clinical justification for new or continued investment in telemedicine remains incomplete for many decisionmakers, particularly given competing demands on their resources

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--> in a period of significant economic and political uncertainty. Continued support will, in large measure, depend on better evaluation and evidence of the practicality, value, acceptability, affordability, and profitability of telemedicine. The Demand For Evidence Of Effectiveness Although telemedicine faces some particular challenges in the realm of evaluation, it is hardly unique in facing demands for better evidence of its effectiveness and cost-effectiveness. For more than a decade, demand has been growing for better information about the effectiveness of specific health services (OTA, 1978, 1994; Eddy, 1984; Wennberg, 1984; IOM, 1985, 1990a; 1992a; Roper et al., 1988). The commonly cited sources of this demand include the sharp escalation in health care costs during the 1970s and 1980s, the documentation of wide variations in clinical practice, the proliferation of expensive medical technologies, and the publication of studies questioning the appropriateness of a variety of health care practices. In response, a number of public and private initiatives have been launched to extend the evidence base for health care and to improve the use of such knowledge by clinicians, patients, and other decisionmakers (see, e.g., IOM, 1985, 1990a, 1992a; Ball, 1990; PPRC, 1989; OTA, 1994). These initiatives include the establishment in 1989 of the Agency for Health Care Policy and Research, a federal agency with a specific mandate to support research, guidelines development, and other activities to increase knowledge of what works and what does not work in health care. Some medical professional organizations, including the American College of Physicians, have an even longer record of efforts to assess the effectiveness of medical services and develop evidence-based guidelines for clinical practice. Elsewhere in the private sector (often with some public funding), initiatives include research-oriented ventures such as the Medical Outcomes Trust and the Cochrane Collaboration; market-oriented enterprises such as the technology assessment collaboration of the Blue Cross and Blue Shield Association and Kaiser Permanente of Southern California; and hybrid entities such as ECRI (formerly the Emergency Care Research Institute), a nonprofit technology assessment organization in Pennsylvania. With the proliferation of advanced and even amazing new technologies,

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--> one temptation for evaluators and decisionmakers is to focus primarily on the technical features of particular technologies and, to some degree, lose sight of clinical, administrative, educational, or other problems that they purport to address. To counter this temptation, many have urged that those devising technology assessments, guidelines for clinical practice, and similar tools start by considering clinical, organizational, and social needs and goals and then examining the benefits, risks, and costs of alternative technologies or programs within this context. This report endorses that perspective. Most of the initiatives to improve the evidence base for health care involve both the collection and analysis of data about specific services and the development of better research tools and databases. The latter work includes efforts to design less expensive and more realistic methods of testing the effectiveness of alternative clinical practices; construct better measures of health outcomes and of care processes, delivery system characteristics, and other variables that may affect outcomes; devise statistical and other tools that provide more meaningful and credible analysis and presentation of data; build computer-based patient records and other electronic information systems that provide relatively easy and fast access to large databases and that permit the application of powerful statistical methods for analyzing and displaying those data; create decision support tools and learning systems that assist clinicians and patients in evaluating information, preferences, and options; formulate strategies for providing information to patients, clinicians, and others in ways that promote informed decisions and stimulate desired changes in behaviors and outcomes; and assess the effect of information and decision-support strategies on behaviors and outcomes. Evaluations of telemedicine applications can build on these efforts as well as on a body of evaluation research concepts and methods developed in areas such as psychology, education, and welfare policy. Such evaluations can—in common with this report—likewise

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--> build on the work of a number of investigators and organizations, who have undertaken evaluations of telemedicine applications and whose contributions are reviewed in later chapters of this report. Study Origins And Approach The concept for this study emerged from discussions between staff of the National Library of Medicine (NLM) and the Institute of Medicine (IOM) that began in late 1994. The NLM has a long history of supporting the development of information and communications technologies to assist health researchers, clinicians, policymakers, and, increasingly, patients. For example, through Medline, Grateful Med, and Loansome Doc, the NLM has made it easier to search medical literature and find specific information for education or problem solving. The NLM has also funded a number of telemedicine demonstration projects (see Appendix A). Although a variety of demonstration and evaluation projects have been valuable in demonstrating basic feasibility and safety, most have not been guided by a systematic framework for evaluating the impact of clinical telemedicine on the quality, accessibility, or cost of health care. Recognizing this deficiency, the National Library of Medicine (with assistance from the Health Care Financing Administration) asked the Institute of Medicine to develop a framework and related set of criteria for evaluating clinical applications of telemedicine. The evaluative focus was to be on the quality, accessibility, and cost of health care, not on technical hardware and software issues. To undertake the requested study, the IOM appointed a 15-member committee of experts in telemedicine, medical informatics, health care delivery, health services research, quality assurance, economics, and public policy analysis. The committee met three times between July 1995 and February 1996. Staff from the NLM, the Health Care Financing Administration, the Department of Defense, the Office of Rural Health Policy of the Department of Health and Human Services, the federal Joint Working Group on Telemedicine, and other interested groups were invited to committee meetings. In addition, IOM staff and committee attended a number of meetings organized by these agencies and various private organizations. During its deliberations, the committee identified several working principles that reflected its appreciation of the complicated and

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--> volatile state of the health care system and that shaped its examination of telemedicine and its analysis of evaluation strategies. These principles, which include a mix of practical and normative judgments or assumptions and which are one basis for the evaluation framework presented in Chapter 6, included the following:1 Neither health care nor telemedicine is static. Systematic ways of evaluating and monitoring the impact of social, economic, and technological changes will always be needed. Research on the outcomes and effectiveness of new and established health care technologies is a necessary element of evaluation and monitoring strategies. The computer-based patient record, which will become a necessary and integral part of health care, is fundamental for monitoring strategies. Technology evaluations and decisions should not, in general, be dominated by a preoccupation with the characteristics and demands of individual technologies but rather should derive from the clinical, financial, institutional, and social objectives and needs of those who may benefit or suffer from the technologies. Committee and staff reviewed the literature on telemedicine, making use of computer-based information resources sponsored by the NLM and other organizations. Although the committee recognized a number of interesting telemedicine initiatives in other countries, it concentrated its limited time and resources on the United States.2 Committee members and staff participated in site visits, conference calls, and meetings with a variety of individuals and groups. A six-member technical advisory panel (see p. iv) met with 1   The committee drew on a variety of studies that elaborate on many of the listed points. They include IOM reports on health services research (1979, 1995a), computer-based patient records (1991), technology assessment and effectiveness research (1985, 1990a), clinical research (1990b, 1994a), health data systems (1994b), quality assessment and improvement (1989, 1990c), and clinical practice guidelines (1992b). Other agencies have likewise produced important reports on these topics (see, e.g., Shortell and Reinhardt, 1992; OTA, 1986a, 1994, 1995; PPRC, 1989, 1995). 2   Staff created an inventory of telemedicine projects and evaluations, but the committee concluded that the documentation of completed and ongoing projects was so uneven that the inventory, although useful for the committee, should not be published with the report. In addition, various government agencies were moving through surveys and other means to develop inventories and make them available electronically (Puskin et al., 1995).

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--> the study committee in November 1995 to assist it in defining key evaluation questions and criteria and to provide written comments on preliminary materials drafted by the committee. Committee members prepared background papers on economic and behavioral issues, and these have been incorporated into various sections of this report. The committee reviewed a draft manuscript and discussed final conclusions and recommendations at its third and final meeting in February 1996. This document, which was submitted for outside review in accordance with IOM and National Research Council procedures and policies, constitutes the committee's formal report. Terms And Definitions As more and more people use computers and advanced telecommunications technologies at work and at home, the arcane language of these technologies—bits and bytes, analog and digital signals, pixels and bandwidths—is slowly diffusing, but it remains far from common parlance in most medical settings. Reflecting its dependence on these technologies, the field of telemedicine is replete with highly technical terms and abbreviations. This report tries to avoid jargon when possible and to define clearly those technical terms that are necessary. Because even terms that are in relatively common use may have a variety of explicit—and implicit—definitions, several key terms and concepts are defined and discussed below. Other terms will be defined as they are used in later chapters. A glossary and list of abbreviations are also provided for reference (see Appendix B). Telemedicine The committee sought a definition of telemedicine that was parsimonious, consistent with customary social or professional usage, and not easily misunderstood or misused. The group began by reviewing a number of suggested definitions.3 The common elements of these definitions were (a) information or telecommunications 3   The definitions consulted by the committee included these: "the investigation, monitoring and management of patients, and the education of patients and staff using systems which allow ready access to expert advice, no matter where the patient is located" (Van Goord and Christensen, 1992, cited in Gott, 1995, p. 10).

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--> technologies, (b) distance between participants, and (c) health or medical uses. The definitions differed in whether they (a) singled out clinical applications or also covered other uses and (b) incorporated the concept of an integrated structure or system. The committee definition incorporates the three common elements. Clinical applications are treated as one category of applications of telemedicine. The committee viewed the degree of system integration not as a defining characteristic but, rather, as a major variable or factor to be considered in planning, implementing, evaluating, and redesigning telemedicine programs to achieve desired outcomes. Thus, as cited on the first page of this report, telemedicine is defined as the use of electronic information and communications technologies to provide and support health care when distance separates the participants.4 Several elements of this definition warrant comment.     "the use of telecommunications techniques at remote sites for the purpose of enhancing diagnoses, expediting research, and improving treatment of illnesses" (Weis, 1993, p. 151). "the practice of health care delivery, diagnosis, consultation, treatment, transfer of medical data, and education using … audio, visual, and data communications" (Kansas Telemedicine Policy Group, 1993, p. 1.6). "the use of telecommunications technology as a medium for providing health care services for persons that are at some distance from the provider" (Grigsby et al., 1993, p. 1.3). "the use of two-way, interactive telecommunications video systems to examine patients from remote locations, to facilitate medical consultations, and to train health care professionals" (Council on Competitiveness, 1994, p. 6). "the use of telecommunications technologies to provide medical information and services" (Perednia and Allen, 1995, p. 483). "an integrated system of health care [sic] delivery and education that employs telecommunications and computer technology as a substitute for face-to-face contact between provider and client" (Bashshur, 1995, p. 19). "the use of information technology to deliver medical services and information from one location to another" (OTA, 1995, p. 224). "an infrastructure for furnishing an array of individual services that are performed using telecommunications technologies" (PPRC, 1995, p. 135). "telemedicine encompasses all of the health care, education, information and administrative services that can be transmitted over distances by telecommunications technologies" (Lipson and Henderson, 1995, p. I-1-4). "the use of modern telecommunications and information technologies for the provision of clinical care to individuals at a distance and the transmission of information to provide that care" (Puskin, et al., 1995, p. 394). 4   Derivative terms include: teleconferencing, teleconsultation, telementoring, telepresence, and telemonitoring as well as terms related to specific clinical fields such as teleradiology, teledermatology, and telepsychiatry. The first five terms are defined in the glossary (Appendix B).

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--> First, the committee recognized that video conferencing is sometimes perceived as the defining mode of telemedicine, but the committee's definition more broadly encompasses telephone conversations, transmission of still images, and other communications as well. Further, although the means of transferring information from one location to another (i.e., telecommunications media) are important, they are only a part of the technological base of telemedicine. More generally, information technologies include computer-based means for capturing, storing, manipulating, analyzing, retrieving, and displaying data. Second, the committee's definition covers both clinical and nonclinical applications of telemedicine. As shown in Table 1.1, current uses fall into several broad categories. Clinical applications of telemedicine, the focus of this report, involve the first category—patient care, including diagnostic, treatment, and other medical decisions or services for particular patients. Nonclinical uses of telemedicine, such as continuing medical education and management meetings, do not involve decisions about care for specific patients. The clinical-nonclinical boundary is not sharp, however. In particular, a primary care physician who views or participates in consultations for a series of similar patients may in the process learn how to diagnose or manage a clinical problem without consultation in most subsequent cases. (To the extent that such learning is one explicit objective of the consultation, the label "telementoring" may be applied.) Moreover, nonclinical uses of telemedicine for administrative or educational purposes may contribute to the effectiveness of clinical applications by encouraging greater familiarity and acceptance of sophisticated telecommunications technologies and by spreading certain capital and operating costs over a larger base. Third, geographic separation or distance between the participants is a defining characteristic of telemedicine. (The term distance medicine is sometimes used as a synonym for telemedicine.) Although many of the technologies employed in telemedicine (e.g., computers) are also used when distance is not an obvious issue (e.g., within a radiology department), telemedicine came into being to overcome problems arising from geographic separation between people who need health care and those who could provide or support an important element of that care.

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--> TABLE 1.1 Categories and Examples of Telemedicine Applications Category Examples Patient care Radiology consultations; postsurgical monitoring; triage of emergency patients Professional education Continuing medical education programs; on-line information and education resources; individual mentoring and instruction Patient education On-line help services for patients with chronic health problems Research Aggregation of data from multiple sites; conducting and coordinating research at multiple sites Public health Access to care for disadvantaged groups; poison control centers; disease reporting Health care administration Video conferences for managers of integrated health systems; utilization and quality monitoring Classifying Clinical Applications of Telemedicine As noted above, clinical applications of telemedicine involve care for particular individuals, although any given transaction may also serve educational, administrative, or research purposes. In a report that considered telemedicine in the context of provider payment policies, Grigsby et al. (1994a) proposed a broad classification scheme for these applications (see also PPRC, 1995).5 The committee 5   The nine categories in this classification covered: (1) initial urgent evaluation of patients; triage decisions; pretransfer arrangements; (2) medical and surgical follow-up, including medication checks; (3) supervision and consultation for primary care encounters in sites where a physician is not available; (4) routine consultations and second opinions based on history, physical exam findings, and available test data; (5) transmission of diagnostic images; (6) extended diagnostic workups or short-term management of self-limited conditions; (7) management of chronic disease and conditions requiring a specialist not available locally; (8) transmission of medical data; and (9) public health, preventive medicine, and patient education.

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--> slightly revised this classification by aggregating similar applications to produce six general categories: initial urgent evaluation of patients for triage, stabilization, and transfer decisions; supervision of primary care by nonphysician providers when a physician is not available locally; one-time or continuing provision of specialty care when a specialist is not available locally; consultation, including second opinions; monitoring and tracking of patient status as part of follow-up care or management of chronic problems; and use of remote information and decision analysis resources to support or guide care for specific patients. This classification scheme includes a mix of several different dimensions related to the clinical problem, the process of care, and the kind of clinical information involved in a particular clinical application of telemedicine. Each of these dimensions, in turn, involves several possible subdimensions, as depicted in Table 1.2. In this report, the site that organizes and provides telemedicine services is called the central or consulting site and the site at which the patient is located or from which patient data are initially sent is called the remote, satellite, or distant site. Those at the central site are often specialist physicians but they may also be primary care physicians, nurse practitioners, psychologists, nutritionists, and other personnel. Evaluation Evaluation is a broad term applied to a variety of methods and strategies for identifying the effects and assessing the value, feasibility, or other qualities of a technology, program, or policy. In developing an evaluation framework, the committee construed its task as delineating the basic concepts of evaluation and relating them to the particular issues raised by telemedicine. Evaluations may compare particular clinical interventions (e.g., psychotherapy versus drug treatment for mental disorders) or the programs or systems organized to provide health care services (e.g., inpatient versus outpatient mental health care). Evaluations may

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--> TABLE 1.2 Dimensions, Subdimensions, and Examples of Patient Care Relevant to Telemedicine Applications Dimension Subdimension and Examples Clinical problems Urgency, complexity, pathophysiology, and persistence. Applications may vary depending on whether they involve emergency or urgent problems for which prompt evaluation and management is important acute problems that may be evaluated and treated on a scheduled basis and that have generally predictable periods of resolution following treatment chronic problems that require monitoring and management over a long time period. Processes of care Type of care, source of care, source of clinical information. Applications may vary depending on whether they involve prevention, diagnosis, treatment, rehabilitation, or monitoring generalist care or specialty care remote-site clinicians, patients, or technical personnel interactive examination or questioning of a patient (or patient data) or deferred use of recorded information. Clinical information Aural, visual, numerical, textual.a Applications may vary depending on whether they involve sounds (e.g., speech, chest sounds) pictures (e.g., still photos, full-motion video, radiologic images) graphic data (e.g., electrocardiograms); or alpha-numeric text (e.g., patient history, lab results, practice guidelines). a Of the five major kinds of sensory data (sight, sound, touch, smell, taste), telemedicine routinely transmits only the first two, but these two provide most of the core sensory information for clinical decisionmaking. The transmission of tactile data, which is important for many diagnostic, management, and treatment purposes, is largely experimental (e.g., the "virtual glove" that would allow remote palpation of patients); and the transmission (not just the description) of odors and flavors is, for now, largely unexplored.

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--> focus on processes or outcomes or both. The outcomes of interest may be relatively restricted (e.g., safety but not effectiveness or costs) or a wide range of outcomes may be examined. Evaluations of efficacy such as randomized clinical trials test interventions under strictly controlled conditions to minimize the impact of "extraneous" variables, whereas evaluations of effectiveness attempt to test interventions under ordinary conditions and to identify how such extraneous variables affect results (Brook and Lohr, 1985). For purposes of this report, an evaluation criterion is a measure, indicator, standard, or similar basis for describing outcomes or making judgments. Examples of criteria in common use in evaluations include mortality, hospital length of stay, and patient satisfaction. The committee focused on the set of basic concerns about the quality, accessibility, and cost of health care that lie at the core of most health services research and technology assessments. Because a comprehensive presentation of specific criteria appropriate for the heterogeneity of telemedicine applications was beyond the committee's resources, this report sets forth criteria in the form of questions with examples of the kinds of measures or standards that would be applied to particular telemedicine applications. Drawing from a widely cited 1990 IOM report, the committee agreed that quality of care is "the degree to which health care services for individuals and populations increase the likelihood of desired health outcomes and are consistent with current professional knowledge" (IOM 1990c, p. 21). Consistent with the concepts set forth in a 1993 report (IOM, 1993a), the committee defined access as the timely receipt of appropriate health care. Costs measure the value of resources expended for an activity or objective. They are generally measured in dollars but are sometimes expressed in other units (e.g., travel time, days lost from work, treatment delays) without monetary conversion. These concepts and related evaluation topics (e.g., cost-effectiveness) are discussed further in later chapters of this report. Although many telemedicine evaluations will focus on individual patient care, the growth of managed care and the debate over allocating resources for health care will direct more evaluations toward populations, including but not limited to those enrolled in managed care plans. Analyses may compare the costs, benefits, and risks of alternative services for an entire population or may concentrate on

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--> outcomes for the least healthy or most vulnerable groups in a population (e.g., elderly individuals, teenage mothers). For example, a telemedicine application might target a high-risk group to test whether telemonitoring, on-line information services, and early intervention could reduce total medical costs compared to conventional care. Structure Of The Report This chapter has described the origins of this project and presented principles and definitions on which the remaining chapters build. The rest of this report provides a broad context and framework for evaluations that would expand information for decisionmakers considering telemedicine. The next four chapters provide context. Chapter 2 reviews the evolution of telemedicine and illustrates the range of current applications. Chapter 3 considers the technical and human infrastructure of telemedicine, and Chapter 4 discusses policy issues with an emphasis on professional licensure, malpractice, medical privacy, payment for services, and telecommunications law. Chapter 5 reviews telemedicine evaluation frameworks and selected evaluation projects identified by the committee. As noted earlier, the focus is on programs in the United States. The committee sets forth basic principles of evaluation and proposes elements for telemedicine evaluation in Chapter 6. Chapter 7 is organized around the quality, access, and cost outcomes but also considers patient and provider acceptance of telemedicine. The report concludes in Chapter 8 with the committee's findings and recommendations. One theme runs through this report. Although telemedicine involves a large and quite varied assortment of clinical practices, devices, and organizational arrangements, its applications should be subject conceptually to the same evaluation principles as apply (or should apply) to other technologies in health care.