Liability Prevention Through Informed Consent: Some New Approaches for
the Clinician
By Thomas G. Gutheil, M.D., Harold Bursztajn, M.D. and Archie Brodsky,
B.A.
The Massachusetts Mental Health Center Program in Psychiatry and the Law
has been at work for several years studying malpractice case law and
performing clinical research on decision-making as it relates to the
issue of informed consent [1]. We have found that one
of the most serious errors commonly committed by clinicians in their
attempt to reduce the risk of suit is their practice of "defensive
medicine." Typical examples of tactics designed to defend oneself
against "the enemy" include mindless and prolific documentation,
and overuse of technology, e.g. repeated or unnecessary laboratory testing.
This approach is regrettably as ineffective a deterrent against liability
action as it is cumbersome to implement. Furthermore, it may provide
the very danger it aims to prevent by jettisoning the most powerful liability
preventive device, the therapeutic alliance.
As part of an ongoing research effort, the Program has been attempting
to devise methods of liability prevention that avoid the trap of defensive
medicine. These are summarized in an article [2] entitled, "Malpractice
Prevention Through the Sharing of Uncertainty: Informed Consent and the
Therapeutic Alliance." In it we suggest that patients come to their
physician with preconceived wishes for magical certainty and the security
that accompanies this belief. When these wishes are inevitably unfulfilled,
some patients sue their physician to express their disappointment at
the absence of this magic. We recommend that doctor and patient frankly
face, and thus share, the UNcertainty inherent in medicine, and that
the patient be "weaned" from wishes for magical certainty.
We suggest that the concepts of informed consent and the therapeutic
alliance offer a framework from which the clinician may collaborate with
the patient in ways that diminish the actual risk of liability.
Pro Forma Consent
Informed consent as a concept is often regarded with suspicion by clinicians
as a burden, a snare, or legalistic charade [3]. For
many clinicians informed consent implies no more or less than the patient's
signature on a form. Obtaining informed consent then, means persuading
the patient to sign the consent form, preferably but not necessarily
after reading it and/or understanding it. Not uncommonly the form is
offered to the patient by the nurse who may feel that no more elaborate
explanation is required than, "The doctor needs you to sign this
so you can have the operation (medication, treatment, procedure)." In
a "worst-case" scenerio, the patient has already received his
or her preoperative medication and is thus tendering "informed consent" from
a state of twilight sleep — a condition not known for its inherent competence.
We have termed this procedure "pro forma informed consent" [4].
Use of the consent form to represent the totality of the informed consent
process presents several problems:
Comprehension Level
In the natural order of things, consent forms perch upon the horns of
a dilemma. If they are long enough to be comprehensive, they are in imminent
danger of being incomprehensible. If short enough to be comprehensible,
they can be faulted as insufficiently comprehensive. In most cases, moreover,
the consent form is designed by the hospital's attorneys who often employ
that curious legal argot known as "boilerplate:" a form of
expression that resembles no human speech but is designed to
"cover all bases". It is the kind of language that expresses
the concept, "give", as "give, devise, bequeath, assign
and otherwise convey," for example.
More problematically, it is a fact not widely recognized that most of
these forms require a reading comprehension level comparable to that
required for reading "Scientific American" — a level that only
a fraction of the average physician's patients can possibly have.
Patient Responses
The responses of patients to these forms when the chips are down, so to
speak, is not very rewarding or reassuring for the clinician who held
hopes that the patient's signature would solve all problems and guard
against liability. In the courtroom patients might say, cheerfully, "The
form? Oh, that. Yeah, I signed it; I had to because the doctor refused
to even look at me until I did, but I sure didn't understand it." If
the attorney for the patient is sufficiently astute, he or she may simply
read the form aloud in court as a very effective way to get the jury
to identify strongly with the patient's reported bewilderment. Needless
to say, this difficulty is only amplified when the patient suffers from
intellectual deficits, has an illness that affects cognition, speaks
English as a second language, or — most confoundingly — speaks no English
at all as some physicians have discovered rather belatedly.
Closure of Process
From our point of view in the Program in Psychiatry and the Law, the major
problem with the consent form transcends its language, the patient's
reaction to it and the circumstances of its signing. The problem with
the form is that it tempts the clinician to consider the process of informed
consent as a discrete event that is over when the signature graces the
dotted line. The clinician is thus lulled into thinking that informed
consent is a hurdle that has already been cleared, never to cross the
path of medical care again. Whether the clinician intends this or not,
the patient may read in this manner an inhibiting deterrence from asking
questions and a discouragement from sharing his or her fears and concerns
with the clinician. The "discovery phase" of a lawsuit (in
which the medical records and related documents are requested and reviewed
by attorneys and experts) is a rather late point in the game for answering
questions.
The Bipersonal Field
In the Program we suggest that a remedy for these difficulties can be
derived from viewing the consent process as a two-person field which
encompasses doctor and patient and extends indefinitely over time. We
once stated it in this way:
"...physicians must stop thinking of informed consent as a formality
(the recital of options and the signing of the form) and enter into it
with their patients as a process of mutual discovery. Informed consent
as we envision it here is not an empty gesture toward liability reduction
but an interaction between physician and patient, a dialogue intended
not only to satisfy this legal requirement but to do more as well. The
real clinical opportunity offered by informed consent is that of transforming
uncertainty from a threat to the doctor-patient alliance into the very
basis on which an alliance can be formed. This is particularly important,
since a sense of working together with the doctor may be one of the major
elements in avoiding negative reactions to treatment [e.g., a lawsuit]." [5]
While some hospitals have eschewed consent forms for these reasons (using
progress notes instead), other institutions require their use; clearly,
if your hospital requires use of a consent form, it is folly not to use
it. But the liability-reducing principles of the ongoing dialogue, within
a relationship based on frank confrontation with uncertainty, should
be used as an essential supplement to the sheets of paper. This shift
of perspective moves pro forma informed consent to informed consent as
process.
Informed Consent as Process
By use of this term we mean to imply that informed consent is not an event
but an ongoing dynamic interchange between doctor and patient that evolves
as the two confront the vicissitudes of illness and treatment. An essential
aspect of this process is the open discussion of risks and benefits of
each phase of intervention. This has two advantages.
First, the translation of risks and benefits into language that the patient
can understand is itself supportive and fosters the patient's trust as
well as a commitment to active engagement in follow-up care. Second,
such discussion provides the clinician an additional opportunity to review
the reasoning which underlies the recommended intervention in explicit
risk-benefit terms. This approach actually represents an informal clinical
version of decision analysis. [6] Such a review, moreover,
helps to challenge overly facile hindsight reasoning ("You should
have weighed the risks and benefits") in case of a tragic outcome
leading to litigation.
The Open Door Policy
The last element of this model might be styled the "open door policy" of
informed consent. Simply stated, this means that the clinician's aim
is to convey to the patient that "the door [of communication] is
always open" to discussion of side effects, newly arising questions
or concerns and the like. Especially given the well-demonstrated absence
of reliable retention of clinical information by patients in the stressful
situation of contemplated medical procedures, this policy is more effective
than mere information overload, as it is sometimes practiced.
The power of this model is best demonstrated by the realization that surprise
at unanticipated outcomes (e.g., side effects, unwanted sequelae), more
than the bad outcomes themselves, is the major trigger of animosity.
The knowledge that the door is open markedly decreases the experience
of being alone with one's calamity from the unreachable caretaker whose
apparent failure now confronts the patient.
Conclusion
We have suggested several approaches to the thorny problem of informed
consent in the realities of clinical practice. We suggest that informed
consent is not a legalistic snare and pitfall but an occasion and opportunity
for the practice of sound liability prevention as opposed to the specious
practice of defensive medicine.
By approaching informed consent as a process, as a bipersonal field wherein
an open-door policy prevails, the clinician turns a potential legal constraint
to distinct clinical advantage: improved care, better relationship with
patients and decreased risk of liability. ■
Footnotes
-
Bursztajn H, Feinbloom K Hamm R, Brodsky A: Medical
Choices, Medical Chances: How Patients, Families and Physicians Can
Cope With Uncertainty. New York, Delacorte Press, 1981.
Gutheil TG, Appelbaum PS: Clinical Handbook of Psychiatry and the
Law. New York, McGraw-Hill, 1982.
-
Gutheil TG, Bursztajn H, Brodsky A: Malpractice
Prevention Through the Sharing of Uncertainty: Informed Consent and
the Therapeutic Alliance. N Eng J Med 311: 49-51,1984.
-
Id.
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Bursztajn H, Gutheil TG, Cummins B: Medicolegal Issues in Inpatient
Psychiatry. In: Sederer L (ed), Inpatient Psychiatry: Diagnosis
and Treatment, 2nd Ed. Baltimore, Williams and Wilkins,
1986.
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Gutheil TG, Bursztajn H Brodsky A, Supra n.2.
-
Bursztajn H, Hamm K, Gutheil TG, Brodsky A: A
Decision-Analytic Approach to Medical Malpractice Law: Formal Proposals
and Informal Syntheses. Med Decis Making 4:401-414,1984.
Thomas G. Gutheil, M.D. and Harold Bursztajn,
M.D. are co-directors of the Program in Psychiatry and the
Law at The Massachusetts Mental Health Center, and both serve
on the faculty of Harvard Medical School Archie Brodsky, B.A.,
is Senior Research Associate for the Program in Psychiatry and
the Law, Massachusetts Mental Health Center. Dr. Gutheil has
consulted on malpractice cases in 24 states and has written extensively
on liability prevention in national and international professional
literature.