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Lessons for Technology Assessment

Continuous recording instruments are invaluable research tools. If there is a central criticism of fetal heart monitor usage, it is that the monitors were adopted for routine use without the research background necessary to understand their limitations. Fetal heart monitors illustrate that data, as opposed to information, increase the risk of litigation. This happens because plaintiffs' attorneys thrive on ambiguity. If a patient is injured, the plaintiff's attorney will comb the records for anything that cannot be clearly explained to portray as the cause of the injury. This is countered to some extent by the highly filtered nature of traditional medical records. Continuously recorded streams of ambiguous instrument output, in contrast, provide a gold mine of exploitable ambiguity.

It is critical that new instruments be evaluated for the reliability of their intrinsic measurements and for the clinical significance of those measurements. Do the data resolve clinical questions or merely complicate them? This question becomes more interesting as hospitals purchase clinical information systems that feed the outputs of various monitors into a computer-based continuous-recording system. The assumption is that since these instruments are already in place, their output must be useful. It is possible, however, that many existing measurements are useful only in the larger context of patient care. Like a fetal heart rate observed without the context of the mother, their readings may be much less valuable as retrospective records. Given that efficacy testing is a recent innovation for medical devices, it is also possible that some existing measurements are clinically irrelevant. This means that their outputs will be randomly related to the patient's condition, creating that ambiguity so valuable to plaintiffs' attorneys.

Clinical instruments provide data, not necessarily information that aids in clinical decision making. The data create noise that can obscure significant clinical information while providing clear hindsight to those who would second-guess the physician's actions. Real-time clinical information systems take this to the extreme. Some of these systems carefully log the output of every monitor in the CCU, allow free text comments by CCU personnel who have not necessarily seen all the recorded data, and create the expectation that all data will be recorded. This last expectation may be the most damaging, given the traditional presumption that missing information is assumed to support the plaintiff's case. Unless these systems are carefully thought through and tested, it may be that the connector that is used to connect most real-time recording systems will someday be renamed the plaintiff's best friend.

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