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AHRQ Evidence reports and summaries AHRQ Evidence Reports, Numbers 1-60 24. Telemedicine for the Medicare Population Evidence Report/Technology Assessment Number 24 Prepared for: Contract No. 290-97-0018 Prepared by: AHRQ Publication No. 01-E012 July 2001 ISBN: 1-58763-044-3 On December 6, 1999, under Public Law 106-129, the Agency for Health Care Policy and Research (AHCPR) was reauthorized and renamed the Agency for Healthcare Research and Quality (AHRQ). The law authorizes AHRQ to continue its research on the cost, quality, and outcomes of health care and expands its role to improve patient safety and address medical errors. This report may be used, in whole or in part, as the basis for development of clinical practice guidelines and other quality enhancement tools, or a basis for reimbursement and coverage policies. AHRQ or U.S. Department of Health and Human Services endorsement of such derivative products may not be stated or implied. PrefaceThe Agency for Healthcare Research and Quality (AHRQ), through its Evidence-based Practice Centers (EPCs), sponsors the development of evidence reports and technology assessments to assist public- and private-sector organizations in their efforts to improve the quality of health care in the United States. The reports and assessments provide organizations with comprehensive, science-based information on common, costly medical conditions and new health care technologies. The EPCs systematically review the relevant scientific literature on topics assigned to them by AHRQ and conduct additional analyses when appropriate prior to developing their reports and assessments. To bring the broadest range of experts into the development of evidence reports and health technology assessments, AHRQ encourages the EPCs to form partnerships and enter into collaborations with other medical and research organizations. The EPCs work with these partner organizations to ensure that the evidence reports and technology assessments they produce will become building blocks for health care quality improvement projects throughout the Nation. The reports undergo peer review prior to their release. AHRQ expects that the EPC evidence reports and technology assessments will inform individual health plans, providers, and purchasers as well as the health care system as a whole by providing important information to help improve health care quality. We welcome written comments on this evidence report. They may be sent to: Director, Center for Practice and Technology Assessment, Agency for Healthcare Research and Quality, 6010 Executive Blvd., Suite 300, Rockville, MD 20852.
Objectives. The goal of this report was to assess telemedicine services that substitute for face-to-face medical diagnosis and treatment and that may apply to the Medicare population. We focused on three distinct telemedicine study areas -- store-and-forward, self-monitoring/testing, and clinician-interactive services. Search Strategy.We conducted two searches -- a general-literature search for information about ongoing telemedicine programs, activities, and services throughout the world, and a search in the peer-reviewed literature for studies assessing the efficacy and cost of telemedicine in the study areas. The former search included literature databases, the World Wide Web, and other resources, while the latter focused on peer-reviewed articles in the MEDLINE, EMBASE, CINAHL, and HealthSTAR databases. We also identified relevant from experts and reference lists in relevant papers. Selection Criteria.The criterion for inclusion in the general literature review was that the article described an activity in at least one of the three study areas. The inclusion criteria for the systematic review were that the study was relevant to at least one of the three study areas; addressed at least one key question in the analytic framework for that study area; and contained reported results. We excluded articles that did not study the Medicare population (e.g., children and pregnant adults) or used a service that historically required face-to-face encounters (e.g., not radiology or pathology diagnosis). Data Collection and Analysis.We used the articles included in the general-literature review to develop an inventory of relevant programs and activities. The abstracted data were entered into a relational database for aggregation and interpretation. For the systematic review, included articles were categorized by the key question(s) they addressed. For each study area, we constructed a summary table of activities and the strength of the evidence for each key question. Main ResultsA total of 455 telemedicine programs were identified, representing 30 medical specialties and serving many diverse populations. The number of telemedicine encounters has increased steadily. The evidence for the diagnostic effectiveness of store-and-forward telemedicine is strongest in dermatology. The benefit is more equivocal for other specialties, as it is for improved access, provider or patient satisfaction, and cost benefit. The evidence for self-monitoring/testing telemedicine is equivocal for all specialties, with positive results tempered by compromised study designs. The benefit of clinician-interactive telemedicine services is also questionable, with teledermatology faring less well and the results in other specialties limited by marginal study designs. Conclusions.Existing telemedicine programs demonstrate that the technology can be made operational, but most of the studies assessing the efficacy or cost are insufficient to permit definitive statements about the evidence supporting (or not supporting) the use of telemedicine. Future studies should focus on the use of telemedicine in conditions where burden of illness and/or barriers to access for care are significant. Recent innovations in the design of randomized controlled trials for emerging technologies should be adopted. Journals publishing telemedicine-evaluation studies must set high standards for methodologic quality so that evidence reports need not rely on studies with marginal methodologies. This document is in the public domain and may be used and reprinted without permission except those copyrighted materials noted for which further reproduction is prohibited without the specific permission of copyright holders. Suggested citation:Hersh WR, Wallace JA, Patterson PK, et al. Telemedicine for the Medicare Program. Evidence Report/Technology Assessment No. 24 (Prepared by Oregon Health Sciences University, Portland, OR under Contract No. 290-97-0018). AHRQ Publication No. 01-E012. Rockville (MD) Agency for Healthcare Research and Quality. July 2001. SummaryOverview Telemedicine is the use of telecommunications technology for medical diagnostic, monitoring, and therapeutic purposes when distance separates the users. Because modern computer and communications technology has the ability to capture and quickly transmit textual, audio, and video information, many have advocated its use to improve health care in rural areas, in the home, and in other places where medical personnel are not readily available. There is a growing call for telemedicine services to be covered as part of health insurance, though its benefits and costs are not clear. This report assesses specific telemedicine study areas, with a focus on those that would substitute for face-to-face medical diagnosis and treatment of the Medicare population. Thus, this report targets face-to-face clinical specialties (as opposed to radiology and pathology) and the Medicare population (adults as opposed to children and pregnant women). The report identifies health care services that could be provided using telemedicine and describes existing programs in three categories of telemedicine: store-and-forward, self-monitoring/testing, and clinician-interactive services. It also summarizes scientific evidence on the efficacy, safety, and cost-effectiveness of these services; identifies gaps in the evidence; and makes recommendations for evaluating telemedicine services. Store-and-forward telemedicine services collect clinical data, store them, and then forward them to be interpreted later. These systems have the ability to capture and store digital still or moving images of patients, as well as audio and text data. A store-and-forward system eliminates the need for the patient and the clinician to be available at the same time and place. Store-and-forward is therefore an asynchronous, non-interactive form of telemedicine. It is usually employed as a clinical consultation (as opposed to an office or hospital visit). A key question associated with store-and-forward telemedicine is, Can store-and-forward telemedicine consultations be acceptable alternatives to real-time consultations? Self-monitoring/testing telemedicine services enable physicians and other health care providers to monitor physiologic measurements, test results, images, and sounds, usually collected in a patient's residence or a care facility. Post-acute-care patients, patients with chronic illnesses, and patients with conditions that limit their mobility often require close monitoring and followup. Telemedicine programs use a variety of strategies to accomplish this monitoring while reducing the need for face-to-face visits that may be inconvenient or costly for the patient. The close monitoring afforded by these approaches may allow better care through earlier detection of problems, and may therefore reduce costs. Clinician-interactive telemedicine services are real-time clinician-patient interactions that, in the conventional approach, require face-to-face encounters between a patient and a physician or other health care provider. Examples of clinician-interactive services that might be delivered by telemedicine include online office visits, consultations, hospital visits, and home visits, as well as a variety of specialized examinations and procedures. Reporting the EvidenceFor each of the three study areas, an analytic framework was developed to guide the review of the literature. This framework includes questions answered by general descriptions of telemedicine programs (question 1a for each study area) as well as those answered by a systematic review of the evidence from peer-reviewed literature (the remaining questions for each study area). Store-and-Forward TelemedicineThe use of store-and-forward telemedicine services in Medicare-eligible patient populations was examined, asking the following questions comparing telemedicine to face-to-face medical encounters:
The use of self-monitoring/testing telemedicine services in Medicare-eligible patient populations was examined, asking the following questions relative to face-to-face encounters:
The use of clinician-interactive telemedicine services in Medicare-eligible patient populations was examined, asking the following questions comparing telemedicine to face-to-face encounters:
The Evidence-based Practice Center (EPC) team that developed this report sought to identify procedures, programs, and services in the three study areas. Members of the team first conducted a general literature search for information about ongoing telemedicine programs and activities within each program throughout the world (question 1a for each of the study areas). They then searched for peer-reviewed literature for the systematic review (the remaining questions for each study area). Both literature searches used the MEDLINE, EMBASE, CINAHL, and HealthSTAR electronic bibliographic databases. They also searched through telemedicine reports and compilations, including their reference lists, as well as Internet sites. Finally, they contacted known telemedicine experts to find additional resources to identify and describe telemedicine programs. The criterion for inclusion in the general literature review was that the article described an activity in at least one of the three telemedicine study areas. The inclusion criteria for the systematic review were that the study was relevant to at least one of the three study areas, addressed at least one key question in the analytic framework for that study area, and contained reported results. Exclusion criteria for the systematic review were that the study population was not relevant to the Medicare population (i.e., children and pregnant adults) or that the service did not historically require face-to-face encounters (e.g., radiology or pathology diagnosis). The team used the articles included in the general literature review to develop an inventory of relevant programs and activities. The abstracted data were entered into a relational database for aggregation and interpretation. For the systematic review, included articles were categorized by the key question(s) they addressed. The included studies for each study area and key question were critically appraised to determine the strengths and limitations of the most important studies following a detailed rationale for the appraisal of study characteristics related to quality. For each study area, team members constructed a summary table of activities with the strength of the evidence for each key question. The summary tables indicate which procedures or services are either supported or not supported by evidence in published studies. Thus, they essentially identify gaps in telemedicine research by identifying procedures that are currently being delivered or could be delivered by telemedicine, but for which there is no evidence of efficacy in the peer-reviewed, scientific literature. FindingsGeneral Observations Through the EPC team's review of the general literature, they identified 455 telemedicine programs, of which 362 are in the United States. Among U.S. programs, 111 are located at academic medical centers and 68 are in hospital-based health care networks; 80 are federal, military, or Department of Veterans Affairs medical centers. Over 30 medical specialties are represented. Many programs include more than one activity. The most common telemedicine activities are consultations or second opinions (290), diagnostic test interpretation (169), chronic disease management (130), posthospitalization or postoperative followup (102), emergency room triage (95), and "visits" by a specialist (78). About 50 programs provide services in patients' homes. Many diverse populations are served by telemedicine. More programs serve rural patients than any other group. Of the 455 programs catalogued in the general literature review, approximately 120 (26 percent) provide health care to rural populations. Telemedicine also serves a large number of veterans and elderly. The numbers of telemedicine encounters increased steadily throughout the 1990s, with significantly more consults in 1997 and 1998 than in previous years. A total of 177 articles were determined to potentially have evidence for the efficacy of one of the three study areas, and were included in the systematic review. After exclusion criteria were applied, there were 15 articles that assessed store-and-forward telemedicine, 14 articles that evaluated self-monitoring/testing, and 48 articles that assessed clinician-interactive services. A total of nine randomized controlled trials were identified, one in store-and-forward, six in self-monitoring/testing, and two in clinician-interactive services. Specific ResultsIndividual studies were assessed for evidence based on criteria applicable to the study question. Each question was analyzed from the framework of Medicare-eligible patient populations, relative to face-to-face medical encounters. Studies were too heterogeneous and their quality varied too much to undertake any quantitative aggregate analysis, i.e., meta-analysis. Store-and-Forward TelemedicineWhile store-and-forward telemedicine programs operate in many clinical domains, studies assessing the efficacy are lacking for most of them. In addition, for settings where studies have been done, the quality of the evidence is of insufficient quality to judge the efficacy of store-and-forward telemedicine. Teledermatology is the most-studied clinical specialty in store-and-forward telemedicine; its diagnostic accuracy and patient management decisions being made are comparable to those of in-person clinical encounters. It may improve access to care and have adequate patient acceptance.
Self-monitoring/testing telemedicine is used less frequently than the other two types of telemedicine studied in this report. It is most commonly used for management of chronic diseases or specific conditions, such as heart disease, diabetes mellitus, or asthma. As with store-and-forward telemedicine, there are programs operating in many clinical domains where there is little evidence from peer-reviewed studies to support its use. Some studies show it results in comparable outcomes, improves access, increases satisfaction with care delivered, and may be cost effective.
Clinician-interactive telemedicine is used in more heterogeneous clinical specialties than store-and-forward. As with store-and-forward, however, few studies assess efficacy. Furthermore, for many settings where studies have been done, the evidence for efficacy is of insufficient quality to judge how well clinician-interactive telemedicine works. Unlike store-and-forward telemedicine, several studies showed interactive teledermatology to be inferior to in-person consultation in making diagnostic and appropriate management decisions, though many of these were done with older technology, unlike the store-and-forward studies. In several other clinical specialties, clinician-interactive telemedicine shows comparable diagnostic accuracy, and in emergency medicine one randomized controlled trial shows it to have comparable health outcomes. Some studies demonstrate improved access to care, patient and provider satisfaction, and reduced costs of care, though most have problematic designs.
This report finds that the use of telemedicine is small but growing. Active programs demonstrate that the technology can work, and their growing number indicates that telemedicine can be used beneficially from clinical and economic standpoints. The longevity of these programs, however, is not clear, and many may fail to survive beyond initial funding or enthusiasm. The evidence for the efficacy of telemedicine technology is less clear. The problem is not that studies have strong evidence against efficacy, but rather that their methodologies preclude definitive statements. Many of them have small sample sizes that preclude statistical power, and the settings of others may not be equivalent to clinical settings. Still others focus on patient populations that might be less likely than others to benefit from improved health services, such as people who have complex chronic diseases. Future ResearchThe EPC team recommends that, in the future, diseases with a high burden of illness and barriers to access to care should receive the highest priority for telemedicine research. Systematic observation of the effect of a telemedicine service should begin as soon as possible with the use of patient registries, and research on telemedicine in practice networks should be encouraged. Randomized controlled trials that assess patient outcomes and costs related to entire episodes of care should be encouraged, and demonstration projects avoided. The fact that telemedicine is an emerging technology is not a reason for failing to perform randomized controlled trials. Rather, new methodologies such as "tracker trials" should be used to assess telemedicine systematically. There is also a need for basic research in telemedicine to refine target populations for services, refine interventions prompted by them, develop standardized tools to measure effectiveness and harm, and assess the effect of different methods of delivery and payment. Finally, journals publishing telemedicine evaluation studies must set high standards for methodologic quality so that those who make decisions on coverage of telemedicine services need not rely on studies with marginal methodologies. |