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.