Medical Technology and the Health Care System A Study of the Diffusion of Equipment-Embodied Technology (1979) / Chapter Skim
Currently Skimming:
THE EVALUATION OF EQUIPMENT-EMBODIED TECHNOLOGY
THE EVALUATION OF EQUIPMENT-EMBODIED TECHNOLOGY
Pages 68-84
The Chapter Skim interface presents what we've algorithmically identified as the most significant single chunk of text within every page in the chapter.
Select key terms on the right to highlight them within pages of the chapter.
From page 68... ...
Relevant evaluative criteria vary depending on characteristics of the user and of the technology, particularly the stage that the technology has reached in the process of technological change. Five general evaluative criteria, each more complex than its predecessor and subsuming the previous criteria within its purview, are possible.
|
From page 69... ...
These improvements are often expressed as changes in patient outcomes, measured by indicators such as mortality, morbidity, or patient satisfaction. Because of the difficulty in measuring such changes, effectiveness is usually measured by intermediate results such as changes in therapy or improvements in diagnostic accuracy.30 The effectiveness of a technology may vary widely with the organizational setting in which it is applied or with the level of training or competence of its operators.
|
From page 70... ...
The environment, institutions, social structure, culture, values, and the law may be affected.5 For example, automated medical record keeping could threaten basic privacy rights in the absence of safeguards.140 The evaluation of a new or developing technology might include a prospective look at potential societal impacts in addition to the narrower set of patient benefits included in the previous criterion. In essence, this criterion is an extension of the net social benefit criterion, where nothing is assumed constant and all effects are assumed to interact.
|
From page 71... ...
Natural Barriers to the Generation and Use of Evaluative Information Natural barriers include problems in conducting evaluative studies arising from technical, ethical, cost, and time constraints that limit the quality of the information achievable. These natural barriers argue for a trade-off between the quality of information produced and the costs of obtaining it.
|
From page 72... ...
Other parameters influencing the cost of randomized clinical trials are the number of subjects involved and their degree of hospital insurance coverage. Second, there are often significant ethical problems in conducting a trial.
|
From page 73... ...
A study completed for the National Commission for the Protection of Human Subjects demonstrates that even experts have difficulty predicting what the major technological developments will be within a reasonably short (20-year) period.130 Thus, in the case of the TA method, as in the case of clinical trials, the costs of the method must be weighed against the quality of the information to be obtained.
|
From page 74... ...
of the National Bureau of Standards in l975, recognized the waste inherent in uncoordinated information generation when it reported that: ... a number of government agencies, including state and local, are testing and evaluating medical devices in varying degrees and at various stages in their life cycle.
|
From page 75... ...
. However, the medical devices program will not require studies of the effectiveness of new technology in improving patient outcomes nor will it consider cost-effectiveness or net social benefit.
|
From page 76... ...
However, if the technique had not presented obvious risks to patients, its effectiveness in improving patient outcomes would not have had to be proven prior to diffusion under the medical devices law. It is interesting that while the protection of human subjects in medical experimentation evokes great concern,*
|
From page 77... ...
Several studies have been directed at coordinative technologies such as mobile coronary care;2 automated hospital information systems;11 and telemedicine.81,91 These have generally been funded as part of demonstration projects sponsored by the federal government. The National Center for Health Services Research has played a major role in seeing that these studies were undertaken, but funding cuts in recent years have reduced both the demonstration and evaluation activity dramatically.
|
From page 78... ...
Another area of inadequate information occurs in the development of product standards. While standards have been established for years by voluntary industrial organizations such as the American Association of Clinical Chemists and the American Hospital Association, and while the medical devices law mandates development or adoption of performance standards for much equipment-embodied technology, these have primarily been concerned with safety and reliability and have not addressed significant information needs of the health care market and of developers.
|
From page 79... ...
PROPOSED SOLUTIONS TO THE PROBLEM The lack of and need for systematic approaches to the generation and dissemination of evaluative information on medical technologies have been widely recognized. A group of experts called together by the National Commission for the Protection of Human Subjects130 has suggested that a Board on the Evaluation of Therapeutics and Scientific Advances be established.
|
From page 80... ...
. the clinical significance of new findings; whether validation for efficacy and safety has been adequate, and if not, what more needs to be done; whether costs, ethical or other social impacts need to be identified as points for caution when formal recommendations are made; whether the technical complexity of the new findings suggests the need for further demonstration of feasibilities in local community settings; whether recommendations are phrased for ready understanding and acceptance by health practitioners and include all appropriate cautions.
|
From page 81... ...
However, its legislative mandate is limited, and it cannot be expected to extend its concerns to other evaluative criteria or to technologies that fall outside the definition of a medical device. The National Institutes of Health fund clinical trials as part of their research agendas, and the commitment of funds for such activities relative to program size has been increasing in recent years.
|
From page 82... ...
encourage and foster national and international efforts to standardize equipment-embodied technology to achieve economy of equipment design, safety, and comparability of data; (5) conduct and sponsor research into methodologies for evaluating medical technology; and (6)
|
From page 83... ...
83 such a study when in enough doubt about the procedure's effectiveness. The administrative and analytical costs of evaluative studies should come from a collective funding source, which might include federal dollars or represent a consortium of payers.
|
Key Terms
This material may be derived from roughly machine-read images, and so is provided only to facilitate research.
More
information on Chapter Skim is available.