How Doctors and Patients Discuss Routine
Informed Decision Making in the Outpatient Setting
Clarence H. Braddock, III, MD, MPH, Stephan D. Fihn, MD, MPH,
Wendy Levinson, MD, Albert R. Jonsen, PhD, Robert A. Pearlman, MD, MPH
To characterize the informed consent process in
routine, primary care office practice.
Cross-sectional, descriptive evaluation of audio-
Offices of primary care physicians in Portland,
Internists (54%) and family physicians (46%),
and their patients.
MEASUREMENTS AND MAIN RESULTS:
Audiotapes of primary
care office visits from a previous study of doctor-patient com-
munication were coded for the number and type of clinical de-
cisions made. The discussion between doctor and patient was
scored according to six criteria for informed decision making:
description of the nature of the decision, discussion of alter-
natives, discussion of risks and benefits, discussion of related
uncertainties, assessment of the patient’s understanding and
elicitation of the patient’s preference. Discussions leading to
decisions included fewer than two of the six described ele-
ments of informed decision making (mean 1.23, median 1.0),
most frequent of these was description of the nature of the de-
cision (83% of discussion). Discussion of risks and benefits
was less frequent (9%), and assessment of understanding was
rare (2%). Discussions of management decisions were gener-
ally more substantive than discussions of diagnostic decisions
Discussions leading to clinical decisions in
these primary care settings did not fulfill the criteria consid-
ered integral to informed decision making. Physicians fre-
quently described the nature of the decision, less frequently
discussed risks and benefits, and rarely assessed the patient’s
understanding of the decision.
ethics, medical; informed consent; communica-
tion; physician-patient relationship; decision making.
J GEN INTERN MED 1997;12:339–345.
ow well do primary care physicians inform patients
about routine medical decisions? Informed consent is
a widely accepted part of medical practice, yet little is known
about how primary care physicians inform their patients
during routine care. Virtually all clinicians recognize a duty
to obtain the informed consent of patients before surgery,
invasive procedures, and participation in biomedical re-
search. Hospital accreditation standards require documen-
tation of informed consent prior to designated procedures
Furthermore, the courts have established
a common law requirement for informed consent.
Despite the wide acceptance of the general need for in-
formed consent, clinicians have little guidance as to which
clinical decisions need informed consent. Influenced by its
legal tradition, clinicians often equate informed consent with
the practice of obtaining signed authorization for surgery or
an invasive procedure. Some authors have criticized this
limited view of informed consent, suggesting that its ethical
basis requires patient involvement in a much wider range of
clinical decisions, including those involving medication pre-
scriptions and laboratory tests.
Furthermore, many advo-
cate greater involvement of patients in decision making than
mere signing of consent forms. Lidz and colleagues called
this focus on consent signing the “event model” of informed
They suggest that this should be replaced by a
“process model,” focusing instead on promotion of the pa-
tient’s active participation in decision making. Clinicians
should foster the informed participation of patients in medi-
cal decisions by: providing relevant information about the
clinical situation, alternatives, risks and benefits; assessing
the patient’s understanding; and giving the patient a clear
opportunity to voice a preference. This position has been
called “shared decision making” by the President’s Commis-
sion for the Study of Ethical Problems in Medicine and Bio-
medical and Behavioral Research and others.
Received from the the Departments of Medicine (CHB, SDF, RAP)
and Medical History and Ethics (ARJ), University of Washington,
Seattle; the Health Services Research and Development Field
Program (CHB, SDF), the Geriatric Research, Education, and
Clinical Center (RAP), VA Puget Sound Health Care System, Se-
attle; and the Department of Medicine, Oregon Health Sciences
University and Legacy Good Samaritan Hospital (WL), Portland.
Presented in part at the annual meeting of the Society of
General Internal Medicine, San Diego, Calif., May 1995.
Supported in part by the Health Service Research and Devel-
opment Field Program, Veterans Affairs Puget Sound Health
Care System, Seattle, Wash.
Address correspondence and reprint requests to Dr. Braddock:
Education (14A), VA Puget Sound Health Care System, 1660 S.
Columbian Way, Seattle, WA 98108.
Braddock et al., Informed Decision Making
Informed consent is therefore relevant not only to in-
vasive medical procedures but also to other decisions
such as prescription of potentially toxic medications or
initiating a diagnostic evaluation that might eventuate in
expensive or invasive procedures. Such decisions warrant
the informed participation of the patient. Informed partic-
ipation is the product of a thoughtful dialogue between
physician and patient leading to a decision. In this article,
we shall refer to this informed participation as “informed
We know little about the extent to which primary care
physicians involve their patients in decision making in
the ambulatory setting. To gain insight into which view of
informed consent operates in outpatient practice, we
sought to characterize the extent of physician-patient dis-
cussions leading to clinical decisions during routine, pri-
mary care office visits. If clinicians apply the broader con-
cept of informed decision making, then many routine but
important decisions should be preceded by the kind of
thoughtful dialogue described above. Conversely, if the
narrower concept of informed consent predominates,
which links informed consent to a signed authorization
reserved for surgery or invasive procedures, then patient
involvement in the typical outpatient clinical decision
would be minimal.
Previously, researchers have mostly used indirect
methods to determine the extent of informed consent,
such as assessing patient perceptions or recall.
methods allow only limited inference about actual deci-
sion making practices. A few authors have used direct ob-
servation via participant observers or audiotaping to
study informed consent practices.
Wu and colleagues
studied the type and relative frequency of clinical deci-
sions needing informed consent on inpatient medical
wards, but not in the outpatient setting.
the extent of informed consent for nonsteroidal anti-
inflammatory agents prescribed in a rheumatology clinic.
Lidz and Meisel directly observed informed consent dis-
cussions on a surgical ward, cardiology ward, and surgical
To our knowledge, no study has looked
at the extent of informed consent across the broad range
of clinical decisions in outpatient office practice. We ana-
lyzed audiotapes of typical primary care visits in a com-
munity setting to address these issues.
We performed a cross-sectional, retrospective analy-
sis of doctor-patient encounters that had been recorded
on audiotape as part of an earlier randomized trial of an
educational program to improve communication skills.
For the earlier study, 53 primary care physicians were
recruited from the metropolitan area of Portland, Oregon.
From a total of 473 audiotaped encounters with these
physicians, we randomly sampled two office visits with
different patients for a random sample of physician par-
ticipants. We selected 88 visits, involving 44 physicians.
All 88 visits occurred before the physicians received any
of the training in communication that was part of the ran-
domized trial. No physician was aware that his or her per-
formance in informing patients was being evaluated.
Using data from a pilot qualitative study of 20 audio-
taped office visits, and our own clinical experience, we de-
veloped and tested a system to classify the most common
clinical decisions in office practice into mutually exclusive
categories. We defined a clinical decision as “a verbal
statement committing to a particular course of action.”
Three coders, a physician (CHB) and two graduate stu-
dents in medical ethics, were trained with the pilot study
tapes, including joint tape-listening sessions with discus-
sion of the coding, independent coding of the pilot study
tapes, and feedback on tape coding from the principal in-
vestigator. The 88 tapes in the actual study were coded
directly from the audiotapes without transcription. Each
tape was randomly assigned to one of the coders.
The coders categorized all clinical decisions during
each office visit according to the classification scheme de-
scribed above. They also graded the extent of discussion
leading to each decision according to the presence or ab-
sence of each of six elements of informed decision making
(Table 1). This list represents a synthesis by the authors
of ethical models of informed consent in the bioethics lit-
An element was counted as present if dis-
cussed at all, however briefly.
Interobserver agreement among the three coders was
calculated for a random sample of 20 tapes, defined as
percentage of complete agreement on a given decision. For
example, if a decision was made to give a new prescription
for ibuprofen, complete agreement required that both cod-
ers recognize the same event and assign the same code,
Table 1. Elements of Informed Decision Making
1. Discussion of the clinical issue and nature of the decision
to be made
2. Discussion of the alternatives
3. Discussion of the pros (or benefits) and cons (or risks) of
4. Discussion of uncertainties associated with the decision
5. Assessment of patient’s understanding
6. Asking the patient to express a preference
These six elements were developed from synthesis of important
models of informed consent in bioethics literature (see text).
During audiotape coding, elements were counted as present if any
discussion occurred, however brief.
Volume 12, June 1997
i.e., “new medication.” There was complete agreement on
54 (77%) of 70 decisions. Of the 16 disagreements, 14
were decisions identified by only one of two coders. In the
other two cases, the coders disagreed about the classifica-
tion of a clinical decision identified by both.
The difference in frequency of all clinical decisions
was compared with that of decisions involving office pro-
cedures (i.e., requiring a signed informed consent form),
in order to test the assumption that such procedures are
rare in typical office practice. We tested for significance of
this difference using the paired Student’s
test and Wil-
coxon Signed-Rank Test.
For the remainder of our analysis, the focus was on
clinical decisions that occurred during an office visit. The
unit of analysis was therefore the individual visit (
Comparisons of the extent of discussion leading to differ-
ent types of clinical decisions were made using the
tingency table method or one-way analysis of variance
(ANOVA). Nonparametric approximations for the
mer’s V statistic) and one-way ANOVA (Kruskall-Wallis)
methods were used for nominal variables, such as deci-
sion type, or variables that did not meet assumptions for
the parametric method. When multiple comparisons were
made, tests for significance used the least significant dif-
ference method, two-tailed at the .05 level. In the analysis
of discussion between physicians and patients, which fo-
cused on the extent of discussion leading to each clinical
decision, the unit of analysis was the clinical decision.
Of the 88 encounters randomly selected for coding, 7
could not be coded because of technical problems, leaving
81 analyzable office visits.
Characteristics of Participants
Eighty-three percent of the physician participants
were men. Except for one Asian American, all the physi-
cians were white. Fifty-four percent were practicing gen-
eral internists, and 46% were family physicians. The pa-
tients were mostly women (66%) and white (95%); 92%
had at least a high school diploma, and 63% had at least
some college education.
Frequency and Types of Clinical Decisions
All 81 office visits had at least one decision, with an
average of 3.20 clinical decisions per visit (range 1–8, 95%
confidence interval [CI] 2.85, 3.54). The most common
types of decisions were new medications (19% of clinical
decisions), diagnostic laboratory tests (15%), specific di-
etary and physical activity regimens (11%), and screening
tests (8%) (Table 2). Clinical decisions about procedures
that would require a signed informed consent form were
significantly less common than those that did not require
.0001), occurring in only 8 (10%) of 81 visits (mean
0.1, 95% CI 0.003, 0.16).
Extent of Discussion Leading to Clinical Decisions
The discussions leading to clinical decisions often
failed to meet the criteria for informed decision making,
usually lacking most of the six elements. Of 262 discus-
sions, 15% included no observable evidence of any of
these elements, while 51% included only one element.
The following examples illustrate this, as in the case of a
diagnostic test ordered with no mention by the physician
of the reason for the test or how the result might be used.
, 81-year-old woman with an episode of
mid-epigastric pain a few days prior to visit:
Table 2. Extent of Discussion for Different Types of Clinical Decisions
Type of Clinical Decision Frequency(%) Mean Number of Elements Discussed 95% Confidence Interval
New medication 19 1.41 1.17–1.65
Medication renewal 17 1.36 1.05–1.66
15 1.13 0.88–1.37
Office procedure 6 1.56 1.01–2.11
Specific dietary regimen 6 1.27 0.88–1.66
Specific physical activity 5 1.15 0.74–1.57
Routine x-ray/ imaging study 4 1.00 0.52–1.48
Specialist referral 3 1.71 1.02–2.41
Medication dosage change 3 1.33 0.67–2.00
Cholesterol screening 3 1.14 0.50–1.78
Physical therapy referral 2 1.33 0.79–1.88
Cervical cancer screening 2 1.00 0.61–1.94
Shows the most common clinical decisions in routine office visits and their frequency. The mean number (and 95% confidence interval) of in-
formed decision making elements discussed for each is also shown. A higher number of elements means more extensive discussion took
Braddock et al., Informed Decision Making
MD: Does it hurt right here?
Patient: Ouch! Yes, that’s . . .
MD: Have you had any chest pain.
Patient: No, it’s more down here.
MD: We better get an EKG. Wait here; I’ll be right
There was also a case in which the physician pre-
scribed a medication without stating its name or
what it was for.
, woman with abdominal pain worse after
Patient: I’m having a lot of trouble with gas.
MD: When did this lower abdominal trouble start?
Patient: I’ve been having trouble with my stomach for
MD: If you eat, does it affect the pain?
Patient: Seems like it’s worse.
After the examination, the physician makes his pre-
MD: We’ll check the stool for blood, though it looks
ok. Then we’ll give you some meds.
The patient has some questions about the medica-
tion, but still it’s not made clear.
MD: I’ll give you this, and something in addition . . .
something else that should help.
Patient: Which one is that? [silent pause] You don’t
know what it is?
MD: I know what it is.
Patient: I just want to see if I’ve had it before.
MD: You haven’t had it before.
Patient: Is it Metoclopramide?
The mean number of elements of informed decision
making included per discussion was 1.30 (95% CI 1.19,
1.41). Twenty-four percent of discussions included 2 ele-
ments, 6% included three, 2% included four, and 1%
included five. None of the discussions included all six
elements, although some were extensive. The following
exchange about whether the patient should get an influ-
enza vaccination included discussion of the nature of the
decision, alternatives, the risks and benefits, uncertainty,
and an expression of the patient’s preferences.
Patient: How do you feel about me getting a flu shot?
MD: Well, how do you feel about getting a flu shot?
Patient: I’ve been kind of leery because both times my
husband ever had one he ended up in the hospital
sick. And both times my dad had took them he had
the flu worse than if he hadn’t.
MD: The way they produce the flu vaccine is such
that you can get a mild case of the flu from it, but
the chances of doing that are very small, and you
have to sort of weigh that against what are the
chances of you getting a serious illness if you get
the flu . . . As you age it is a little greater. If you
have other underlying diseases, which you really
do not, it’s also greater.
Patient: Okay, I’ll probably get it.
MD: The fact that you’re going to be exposed to a lot
of people who may get the flu . . . is probably a rea-
son to have it.
The extent of discussion varied according to the type
of clinical decision. Decisions about management in-
cluded significantly more elements of informed decision
making than those in the diagnostic category. (
.05) Similarly, 11% of discussions leading to
management decisions included three or more elements,
compared with only 3% of discussions leading to diagnos-
tic decisions (
Despite these trends between the two general catego-
ries of clinical decisions, few differences were seen be-
tween discussions leading to specific types of decisions
(Table 2). The one exception was discussion leading to of-
fice procedures, which included significantly more ele-
ments than discussion leading to routine diagnostic labo-
ratory tests (one-way ANOVA, corrected for multiple
When substantive discussion leading to a clinical de-
cision took place, the element most frequently included
was the nature of the clinical problem behind the decision
(83% of discussions) (Fig. 1). Discussion of risks and ben-
efits was less frequent (9%). The least frequently included
element was discussion of the patient’s degree of under-
The extent to which individual elements of informed
decision making were discussed varied according to the
type of clinical decision. In general, management deci-
sions were more likely to include discussion of alterna-
tives and of risks and benefits than diagnostic decisions.
Eighteen percent of discussions of management decisions
included mention of alternatives, compared with only 4%
of discussions of diagnostic decisions (
larly, 12% of management category discussions included
reference to risks and benefits compared with only 1% of
diagnostic category discussions (
.008). There were no
statistically significant differences between the diagnostic
and management categories in discussion of the other el-
ements of informed decision making.
Comparisons of discussion of individual elements of
informed decision making among specific types of clinical
decisions revealed similar patterns. Discussion of risks
and benefits was more likely for decisions to perform of-
fice procedures (included in 13% of discussion), prescribe
new medications (10%), and change medication dosage
(22%) than for diagnostic laboratory tests (3%), imaging
studies (0%), and dietary or activity regimens (0%). These
differences were statistically significant (Cramer’s
.03). The other major difference was in discus-
Volume 12, June 1997
sion of uncertainty. Discussions leading to office proce-
dures and new prescriptions more commonly included
notions of uncertainty than for the other types of deci-
sions (13% and 16%, respectively, Cramer’s
This study coexamined the extent of discussion be-
tween physicians and patients leading to important clinical
decisions in office practice. Important clinical decisions
were common but were rarely preceded by substantive dis-
cussion. Discussion leading to clinical decisions tended to
be more extensive for management decisions, particularly
new prescriptions. The discussion of alternatives, risks
and benefits, and uncertainty was also more common for
Our definition of informed consent as informed deci-
sion making suggests that substantive discussions be-
tween doctors and patients should take place prior to a
wide variety of clinical decisions. This study identifies the
common clinical decisions in office practice for which such
discussion would be important. This includes decisions re-
garding medications, diagnostic laboratory tests, and im-
aging studies. Decisions regarding office procedures that
require a signed informed consent form, however, are rare.
This suggests that applying a traditional concept of in-
formed consent, often equated with written permission for
invasive procedures, could result in missed opportunities
to involve patients in the entire range of important clinical
decisions in office practice.
The other important finding of this study is that dis-
cussions between physicians and patients leading to clin-
ical decisions, so central to this broader concept of in-
formed consent, typically included few of the important
elements of informed decision making. Although one ele-
ment, the description of the clinical decision, was dis-
cussed quite frequently, most discussions did not include
the other elements of alternatives, risks and benefits, ex-
pression of uncertainty, assurance of understanding, and
expression of patient preference. Discussion leading to
management decisions tended to be more substantive,
but still fell far short of fulfilling all these criteria. These
findings suggest that informed decision making, as de-
scribed by the President’s Commission and others, is not
often achieved in routine office practice.
There are most likely several reasons for failure to
achieve this ideal. First, one might ask if clinicians should
engage in discussions that include all six elements of in-
formed decision making before every clinical decision.
Even a casual analysis of routine clinical practice sug-
gests the answer is no, that extensive discussion is more
important for some kinds of clinical decisions than for
others. Although there is substantial evidence that pa-
tients generally want and expect to be involved in decision
making, some authors have suggested that they would
rather leave some decisions to physicians.
suggests that this kind of “sliding scale” for the extent of
FIGURE 1. How frequently each element of informed decision making was part of physician-patient discussion.
Braddock et al., Informed Decision Making
discussion leading to clinical decisions may already be an
accepted tenet in medical practice. Physicians in this
study typically held more extensive discussions about of-
fice procedures than about diagnostic laboratory tests.
They were also more likely to discuss risks and benefits
for new medication prescriptions than for imaging stud-
ies. Nevertheless, the findings of this study show that the
importance of substantive discussion is underrecognized,
even for clinical decisions recognized to be genuinely im-
portant, such as office procedures and new medication
prescriptions. Furthermore, the ethical basis of informed
consent, in our view, necessitates some level of discussion
for virtually all clinical decisions.
The ethical purpose of informed consent is to foster
the ability of patients to make informed, autonomous
choices. Many bioethicists assert that the related ethical
concepts of respect for autonomy and respect for persons
entail a duty for physicians to provide the information
necessary for the patient to be an informed participant in
health care decisions.
As stated above, this con-
cept of informed consent focuses on meaningful dialogue
about virtually all decisions. Even fairly routine decisions,
such as the decision to perform a routine blood test or
electrocardiogram, need some form of dialogue to ensure
the informed participation of the patient. As decisions be-
come more important and complex, the level of dialogue
needed becomes more extensive as well, leading to the
comprehensive kinds of exchanges commonplace before
invasive or risky surgical procedures.
Another reason physicians may not achieve the ideal
level of informed consent is that they are too busy. Pres-
sures to reduce the costs of care may be at odds with the
need to spend more time in discussion with patients.
Most clinicians presume the additional time needed for
such discussion to be substantial, though this belief is
Insurers do not reimburse for extra time spent
in lengthy discussions, though some authors have sug-
gested that they should.
Many health care systems are
beginning to explore the use of other health care provid-
ers, support staff, and new interactive technologies in this
Medical schools and residency training pro-
grams need to emphasize communication skills required
to conduct brief, focused, yet comprehensive discussions
leading to medical decisions.
A third reason clinicians may not fully discuss rou-
tine yet important medical decisions is a failure to recog-
nize these decisions as warranting the same kind of atten-
tion to patient involvement as an invasive procedure.
Perhaps this is a consequence of the inpatient-dominated
training of physicians, in which important medical deci-
sions are more likely to involve surgery or invasive proce-
dures. As medical care moves increasingly into ambula-
tory settings, clinicians and educators need to expand
their views of informed consent and recognize that seem-
ingly routine clinical decisions deserve thoughtful discus-
sion and sharing of decision making.
The findings of this study are consistent with those of
previous studies of informed consent practices. Louis Harris
and Associates evaluated physician self-reports of in-
formed consent practices and found that although 96% of
physicians routinely reported obtaining consent for surgi-
cal procedures, less than half did so for routine blood tests,
diagnostic radiographs, or minor office procedures. Re-
garding disclosure, the physicians reported disclosing po-
tential side effects 93% of the time, while patients re-
ported receiving such information only 69% of the time.
This gap highlights the weakness of evaluating physician
practice with self-reporting. Although the difference could
also be explained by imperfect patient recall, other stud-
ies suggest that physician self-evaluation tends to overes-
Sulmasy and colleagues found that
physician disclosure of information to patients undergoing
routine medical procedures ranged from 90% for explain-
ing the procedure to 53% for explaining the alternatives.
This study has several strengths, one being the direct
observation of physician behavior in discussions leading
to routine clinical decisions. This has distinct advantages
over indirect reports such as surveys or self-reports,
which are susceptible to bias and problems with recall.
Only a few studies of informed consent have used direct
Lidz and Meisel studied in-
formed consent practices for inpatient and outpatient
surgery and cardiology patients, using a participant ob-
server method. They directly observed interactions be-
tween physicians and 43 cardiology and 58 surgical pa-
tients. Through analysis of field notes and audiotapes,
they found that information disclosure tended to be more
formal and complete during inpatient consent than out-
patient. In a limited analysis of 15 outpatient clinical de-
cisions, however, they observed that patient involvement
in decision making was more extensive in the outpatient
Our study used similar techniques to Lidz and
Meisel, though on a much larger sample of outpatients
and a much broader range of clinical decisions.
Wu and Pearlman evaluated communication sur-
rounding informed consent for inpatient medical proce-
dures, using direct observation. They found that although
the rationale for the procedures was discussed frequently,
the alternatives, risks, and benefits were discussed signif-
icantly less often.
Still, their study concentrated on inpa-
tient practice, and on medical procedures. Our study, by
contrast, applies a direct observation approach to the full
range of outpatient clinical decisions, a distinct strength.
Some possible limitations of this study should be ad-
dressed. One limitation of audiotapes is the inability to
capture nonverbal communication. Because the analysis of
discussion in our study focused mostly on information ex-
change, however, this is of less importance. Many authori-
ties in doctor-patient communication assert that nonverbal
communication is felt to be more important for social and
emotional support in the doctor-patient encounter than
for information exchange.
Second, discussion leading to decisions may have
taken place during other visits, resulting in an underesti-
Volume 12, June 1997
mation of the extent of physician-patient discussion re-
lated to a given decision. Furthermore, physicians and
patients may have already established a method of deci-
sion making, in which a low level of information exchange
might represent an acceptable norm to each. In an effort
to ascertain the extent of this problem, we compared dis-
cussions related to decisions to prescribe a new medica-
tion with decisions concerning renewal of a medication.
Our thinking was that new medication prescriptions rep-
resent an example of decisions that were not likely to be
discussed in previous visits. We found no evidence that
discussions for new medications were any more substan-
tive, even though one might expect more detailed conver-
sations, including intended benefits and side effects.
Because we used a new method for analyzing and cod-
ing the audiotaped office visits, the reliability of this
method must be closely examined. We believe our method
to be valid and reliable. Our method quantitates certain
clear, identifiable verbal behaviors, hence meeting impor-
tant criteria for communication analysis. The interobserver
agreement in coding of 77% was well within the range of
70% to 90% that is typical for audiotape coding methods.
The physicians studied were volunteers in a study of
communication skills and may not have been representa-
tive of physicians in general. If anything, we suspect they
would have engaged in more extensive discussions than
the average physician. Also, the participants did not know
that their performance relative to informed decision mak-
ing was being evaluated.
In summary, we found that numerous decisions are
made in each office visit, and often involve medications and
diagnostic tests. Despite the recognized need to involve pa-
tients in these decisions, discussions leading up to routine
clinical decisions were lacking in several important ele-
ments of informed decision making. Our findings suggest
the need for larger, longitudinal studies of informed deci-
sion making practices, to further characterize factors that
influence the extent of dialogue between physicians and
patients and to test strategies to yield improvement.
The authors acknowledge the assistance of Kelly Edwards,
MA, for her work on conceptualizing the audiotape coding
method and tape coding, and Nicole Hasenberg, MPH, for
diligent tape coding.
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