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E position statement
0016-5107/91/3706-0668$03.00 GASTROINTESTINAL ENDOSCOPY Copyright © 1991 by the American Society for Gastrointestinal Endoscopy
Technology assessment and the AISIGIE position statement As the complexity and costs of medical practice increase, greater attention will be focused on assuring the appropriate use of available or new technologies and the elimination of outmoded ones. With regard to endoscopic technologies, the A/S/G/E endorses the comprehensive assessments necessary to make these determinations and to assure the highest standards of patient care. This statement describes various aspects of the technology assessment process and the role the A/S/G/E may take in such activities. Important elements of any endoscopic technology include its safety, efficacy, feasibility, appropriate indications, and cost. Other significant features about which primary data are desirable include the cost effectiveness, social aspects, economic impact, and ethical consequences associated with the technology's use. Although the strongest primary data generally result from randomized clinical trials, highly useful information is gained from less rigorous forms of technology assessment including non-randomized clinical trials, case studies, sample surveys, epidemi010gic methods, meta-analysis, and mathematical modeling. When adequate evidence from well-designed clinical studies is unavailable, group judgment methods may be used to evaluate available data and provide an informed opinion. Although such data syntheses are helpful, the A/S/G/E encourages a greater commitment of resources for studies to provide primary data about endoscopic technologies. The stage of development of an endoscopic device or method may have a strong bearing on the degree to which it may be assessed. Technologies may be classified as emerging, new, established, or outmoded. For emerging technologies, which includes those under evaluation in initial clinical trials, or new technologies, which are beyond the trial stage but are not yet in widespread use, preliminary status reports may be all that are possible. Appropriate methods of assessment and conclusions may change as more information becomes available. In the case of established technologies, many have escaped careful scrutiny for safety and efficacy and are still appropriate candidates for assessment. Newer methods may provide better alter-
668
natives to established ones in specific clinical situations and comparative studies are then desirable. Additionally, new applications of an established technology may be proposed some time after its initial introduction and additional assessments are then appropriate. The A/S/G/E promotes efforts at providing assessments of endoscopic technologies at each of these stages. The diffusion of new technologies into practice depends upon several factors. These include the results of device evaluation as outlined above, the clinical importance of the problem addressed by the technology, and practical considerations such as the ease with which a new method may be applied. The effectiveness by which information about a new technology is disseminated to pertinent clinicians is also vital to its ultimate adoption into widespread practice. Similarly, communication about the relative or absolute ineffectiveness of a technology is an important mechanism leading to its elimination from clinical practice. The A/S/G/E serves an essential role to communicate information about new or established endoscopic devices and techniques. Numerous governmental and private sector organizations are involved in the technology assessment process. The A/S/G/E is available to provide consultation when requested by public agencies such as the Food and Drug Administration, among others. In addition, collaboration in assessment efforts with other medical associations, health insurers, and policy research groups is welcomed. By such involvement, the A/S/G/E may offer the expertise of its members in the planning of studies or interpretation of data about endoscopic technologies. The A/S/G/E through its numerous committees, educational functions, and publications will continue to evaluate the application of currently available devices and the development and assessment of new endoscopic technologies. The goal of these activities is to assure the highest quality of physician practice and patient care. (Adopted by AISIGIE Governing Board, February 1991)
GASTROINTESTINAL ENDOSCOPY
Technology assessment and the AISIGIE position statement As the complexity and costs of medical practice increase, greater attention will be focused on assuring the appropriate use of available or new technologies and the elimination of outmoded ones. With regard to endoscopic technologies, the A/S/G/E endorses the comprehensive assessments necessary to make these determinations and to assure the highest standards of patient care. This statement describes various aspects of the technology assessment process and the role the A/S/G/E may take in such activities. Important elements of any endoscopic technology include its safety, efficacy, feasibility, appropriate indications, and cost. Other significant features about which primary data are desirable include the cost effectiveness, social aspects, economic impact, and ethical consequences associated with the technology's use. Although the strongest primary data generally result from randomized clinical trials, highly useful information is gained from less rigorous forms of technology assessment including non-randomized clinical trials, case studies, sample surveys, epidemi010gic methods, meta-analysis, and mathematical modeling. When adequate evidence from well-designed clinical studies is unavailable, group judgment methods may be used to evaluate available data and provide an informed opinion. Although such data syntheses are helpful, the A/S/G/E encourages a greater commitment of resources for studies to provide primary data about endoscopic technologies. The stage of development of an endoscopic device or method may have a strong bearing on the degree to which it may be assessed. Technologies may be classified as emerging, new, established, or outmoded. For emerging technologies, which includes those under evaluation in initial clinical trials, or new technologies, which are beyond the trial stage but are not yet in widespread use, preliminary status reports may be all that are possible. Appropriate methods of assessment and conclusions may change as more information becomes available. In the case of established technologies, many have escaped careful scrutiny for safety and efficacy and are still appropriate candidates for assessment. Newer methods may provide better alter-
668
natives to established ones in specific clinical situations and comparative studies are then desirable. Additionally, new applications of an established technology may be proposed some time after its initial introduction and additional assessments are then appropriate. The A/S/G/E promotes efforts at providing assessments of endoscopic technologies at each of these stages. The diffusion of new technologies into practice depends upon several factors. These include the results of device evaluation as outlined above, the clinical importance of the problem addressed by the technology, and practical considerations such as the ease with which a new method may be applied. The effectiveness by which information about a new technology is disseminated to pertinent clinicians is also vital to its ultimate adoption into widespread practice. Similarly, communication about the relative or absolute ineffectiveness of a technology is an important mechanism leading to its elimination from clinical practice. The A/S/G/E serves an essential role to communicate information about new or established endoscopic devices and techniques. Numerous governmental and private sector organizations are involved in the technology assessment process. The A/S/G/E is available to provide consultation when requested by public agencies such as the Food and Drug Administration, among others. In addition, collaboration in assessment efforts with other medical associations, health insurers, and policy research groups is welcomed. By such involvement, the A/S/G/E may offer the expertise of its members in the planning of studies or interpretation of data about endoscopic technologies. The A/S/G/E through its numerous committees, educational functions, and publications will continue to evaluate the application of currently available devices and the development and assessment of new endoscopic technologies. The goal of these activities is to assure the highest quality of physician practice and patient care. (Adopted by AISIGIE Governing Board, February 1991)
GASTROINTESTINAL ENDOSCOPY