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Braddock III CH, Edwards KA, Hasenberg NM, Laidley TL, Levinson W. Informed Decision Making in Outpatient Practice: Time to Get Back to Basics. JAMA. 1999;282(24):2313–2320. doi:10.1001/jama.282.24.2313
Author Affiliations: Departments of Medicine (Dr Braddock), Health Services (Dr Braddock), and Medical History and Ethics (Dr Braddock and Ms Edwards), University of Washington, Seattle, and Health Services Research and Development Field Program, VA Puget Sound Health Care System (Dr Braddock and Ms Hasenberg), Seattle, Wash; Cascade Physicians, Portland, Ore (Dr Laidley); and the Division of General Internal Medicine and Geriatrics, University of Chicago, Chicago, Ill (Dr Levinson). Dr Laidley was formerly with the Department of Medicine, University of Washington, and the Health Services Research and Development Field Program, VA Puget Sound Health Care System.
Context Many clinicians have called for an increased emphasis on the patient's
role in clinical decision making. However, little is known about the extent
to which physicians foster patient involvement in decision making, particularly
in routine office practice.
Objective To characterize the nature and completeness of informed decision making
in routine office visits of both primary care physicians and surgeons.
Design Cross-sectional descriptive evaluation of audiotaped office visits during
Setting and Participants A total of 1057 encounters among 59 primary care physicians (general
internists and family practitioners) and 65 general and orthopedic surgeons;
2 to 12 patients were recruited from each physician's community-based private
Main Outcome Measures Analysis of audiotaped patient-physician discussions for elements of
informed decision making, using criteria that varied with the level of decision
complexity: basic (eg, laboratory test), intermediate (eg, new medication),
or complex (eg, procedure). Criteria for basic decisions included discussion
of the nature of the decision and asking the patient to voice a preference;
other categories had criteria that were progressively more stringent.
Results The 1057 audiotaped encounters contained 3552 clinical decisions. Overall,
9.0% of decisions met our definition of completeness for informed decision
making. Basic decisions were most often completely informed (17.2%), while
no intermediate decisions were completely informed, and only 1 (0.5%) complex
decision was completely informed. Among the elements of informed decision
making, discussion of the nature of the intervention occurred most frequently
(71%) and assessment of patient understanding least frequently (1.5%).
Conclusions Informed decision making among this group of primary care physicians
and surgeons was often incomplete. This deficit was present even when criteria
for informed decision making were tailored to expect less extensive discussion
for decisions of lower complexity. These findings signal the need for efforts
to encourage informed decision making in clinical practice.
How well do physicians foster the informed participation of patients
in important clinical decisions? Many clinician-authors have called for a
shift toward a view of informed consent in which the emphasis is on a meaningful
dialogue between physician and patient instead of a unidirectional, dutiful
disclosure of alternatives, risks, and benefits by the physician.1-4 This
expanded view is termed informed decision making.
Despite these calls for more sharing of decision making with patients, we
know little about the extent to which patient-physician discussions of clinical
decisions achieve informed patient participation.
Fully involving patients in clinical decisions is a challenging task
for clinicians, and little training exists on the practice of effective informed
decision making. What guidance exists is often based on legalistic notions
of consent. For instance, the well-known mnemonic PAR
reminds the clinician to disclose the nature of the procedure, alternatives,
and risks in any informed consent discussion. The rationale of this approach
either satisfies an administrative requirement or protects oneself from liability,
rather than viewing the decision-making process as a meaningful path toward
fostering patient involvement.
The challenge to involve patients in decision making has intensified
in recent years, as both the range of important clinical decisions and the
settings in which they occur have changed. To provide guidance to clinicians
in the effective practice of informed decision making, we need a thorough
understanding of how clinicians and patients currently make routine clinical
decisions. However, most studies focus on patient or physician reports of
what ought to take place in clinical decision making.5,6
Still others focus on indirect measures, such as patient recall of patient-physician
Only a few studies have used direct observation of decision making. These
studies suggest that the dialogue recommended by an ethical model of informed
decision making is strikingly rare.12-15
No studies to date have examined the practices of both primary care physicians
and surgeons, studied large samples, evaluated community-based settings, or
evaluated the completeness of informed decision making across the full spectrum
of clinical decisions in office practice.
In addition, no previous studies have used criteria for informed decision
making that reflect the important influence of the complexity of decisions
on the amount of discussion that should reasonably be expected. For example,
in our previous work, we found that many important elements of informed decision
making were absent from decisions about medications and laboratory tests in
routine office practice.16 That study, like
others, applied a single set of criteria for the completeness of informed
decision making to all clinical decisions, which does not acknowledge that
some decisions are less complex than others and may need less substantive
discussion. However, no guidelines exist for how much discussion is adequate
for the completeness of informed decision making for clinical decisions of
The process-oriented approach to informed decision making that we present
here suggests the need for some dialogue about virtually every clinical decision.
We examined a large sample of clinical decisions occurring at offices of various
medical specialties, evaluating community-based practices that permit more
realistic extrapolations to the more common clinical care settings than prior
studies based in teaching hospitals. In addition, we applied a new set of
criteria for the completeness of informed decision making, recognizing that
standards for the completeness of informed decision making should vary with
the complexity of the decision. Using these criteria, we evaluated the completeness
of informed decision making by primary care physicians and surgeons by direct
assessment of audiotapes of routine office visits. The results of this study
will provide data for efforts to improve patient-physician communication and
Using content analysis, we examined the completeness of informed decision
making between physicians and their patients. We adapted methods from an approach
described in our previous work.16 The intent
of our method is to evaluate the completeness of informed decision making
using preestablished and valid criteria. The criteria for informed decision
making used in this study include 7 distinct elements (Table 1): (1) the patient's role in decision making, (2) the nature
of the decision, (3) alternatives, (4) pros (benefits) and cons (risks) of
the alternatives, (5) uncertainties associated with the decision, (6) an assessment
of the patient's understanding of the decision, and (7) an exploration of
the patient's preferences. These criteria represent a synthesis of the bioethics
literature and professional consensus on important elements of informed decision
In our previous work, we applied 6 elements of informed decision making
to every decision. We have since revised our schema to add an additional element,
which is the discussion of the patient's role in decision making. The need
for this new element arises because many patients may be unclear about their
role in decision making and hence, adopt a passive or nonparticipatory style.
Consequently, in certain decisions, particularly complex ones, the patient
may need an explicit invitation to participate in the decision-making process.
Another feature of our revised schema is the inclusion of a sliding
scale in which we apply different criteria for completeness for decisions
of differing complexity. This hierarchy was based on the observation that
requiring complete discussion of all of the proposed elements of informed
decision making for all decisions would be burdensome, unachievable, and unnecessary.23 Rather, we propose that the standard for completeness
of informed decision making ought to respond to the complexity of the decision.
We developed a hierarchy of decision complexity in which all clinical
decisions were categorized as basic, intermediate, or complex (Table 2). We used iterative group techniques among physicians and
laypersons to define completeness for each category of decision complexity,
designating the specific elements required for completeness of informed decision
making (Table 1). These categories
were used in our initial analysis of the completeness of informed decision
making. To illustrate these distinctions further, we provide examples of complete-,
absent-, and partial-informed decision-making discussions in Table 3.
We then used the same group process to assign specific kinds of decisions
(eg, laboratory tests, new medication, or surgery) to each category. We selected
the lowest possible category for each decision. Using this model, we presume
that there are other influences within any decision, such as the information
needs of the individual patient that could bump the decision up a level in
the hierarchy. In this way, we established a moral minimum of elements necessary
for complete discussion of each kind of clinical decision.
We were also interested in evaluating the completeness of informed decision
making using less stringent criteria for completeness. First, we analyzed
completeness of all decisions, regardless of complexity, using criteria based
on a schema that mostly emphasizes information disclosure. Following the PAR
mnemonic, we defined completeness as the presence of any discussion of the
nature of the decision (element 2), alternatives (element 3), and pros and
cons (element 4). As these disclosure-oriented approaches do not make distinctions
between decisions of varying complexity, we applied the PAR definition of
completeness to all decisions (basic, intermediate, and complex).
The second modification was to analyze all decisions by the least stringent
basic criteria. We assert that some minimum level of discussion should be
expected for any important clinical decision. We analyzed all decisions using
these minimum criteria, identified as the all-basic analysis. In our model,
the all-basic criterion is the lowest level of acceptable dialogue for any
clinical decision, operationalizing a moral minimum for informed decision
making. For example, a complete decision using this minimum criteria would
be, "I'd like you to take this new medicine to manage your blood pressure
(element 2). Okay (element 7)?" (Table 3).
We obtained audiotapes from a 1993 study about the relationship between
patient-physician communication and malpractice claims. Physicians were identified
from the databases of 2 physician-controlled insurance companies in Colorado
and Oregon based on their malpractice history (50% with 2 or more claims)
and specialty. Fifty-nine primary care physicians (general internal medicine
and family medicine) and 65 surgeons (general and orthopedic surgery) participated.
All were in community-based practices. Details of the recruitment process
are outlined elsewhere.24
Approximately 10 patients were recruited on a convenience basis from
the waiting area of each participating physician (range, 2-12). Initial visits
were included for surgery patients, while primary care patients had seen their
physician at least twice. All patients were English speaking, older than 18
years, and not in acute distress. The original study was approved by the institutional
review board of Legacy Good Samaritan Hospital (Portland, Ore). Physicians
and patients gave informed consent to a study of communication but were unaware
of our subsequent focus on informed decision making.
Four trained coders, blinded to identifying characteristics of participants,
coded the audiotapes. Coders were trained by 2 of the authors (C.H.B. and
K.A.E.) over several weeks through detailed definitions of the elements, joint
audiotape listening sessions with discussion of the coding, and independent
coding of separate pilot study audiotapes.
Each audiotape was randomly assigned to a coder and was coded directly
without transcription. Coders identified all clinical decisions during each
office visit. A decision was defined as a verbal commitment to a definitive
course of action. Discussions of possible decisions that did not reach a definitive
commitment were not included in our data. The coders were also asked to note
whether decisions were physician-initiated or patient-initiated. They then
recorded the presence of the 7 informed decision-making elements in the discussion
of that decision. An element was counted as present if mentioned at all, however
briefly. Elements were counted as present whether offered by the patient or
We evaluated interobserver agreement among the 4 coders by randomly
selecting 10% of the audiotapes for double coding. These audiotapes were recoded
by another coder who was blinded to the results of prior coding. Overall agreement
regarding the presence of any decision was good, with percentage agreement
of 73% and κ of 0.44. The κ statistic regarding identification
of the specific type of decision was 0.58. A κ statistic was also calculated
for agreement on the presence or absence of each of the informed decision-making
elements (element 1, 0.39; element 2, 0.61; element 3, 0.47; element 4, 0.53;
element 5, 0.19; element 6, 0.28; and element 7, 0.55). Five percent of the
audiotapes were selected at random intervals throughout the coding period
and coded twice by the same coder to assess coder drift and intrarater reliability.
The κ statistics for intrarater reliability for decision codes ranged
from 0.53 to 0.66.
The unit of analysis for this study was the individual clinical decision
(N = 3552). Descriptive analysis focused on the completeness of informed decision
making for each decision, which was determined by using criteria for completeness
for the corresponding decision category. If all the required elements for
the relevant decision category were discussed, informed decision making was
considered complete. If none of the required elements were present, then informed
decision making was labeled absent.
To apply less stringent standards for completeness of informed decision
making, we repeated the analysis of completeness using the 2 modifications
described above, analyzing all decisions regardless of complexity by the PAR
definition and by the all-basic definition.
We used 2-tailed t tests to compare the mean
number of decisions for primary care physicians and surgeons. We compared
the distribution for decisions of differing complexity using the χ2 test. We compared completeness of informed decision making between
primary care physicians and surgeons using a 2-tailed Fisher exact test. Data
were analyzed using SPSS software (SPSS Inc, Chicago, Ill).
We reviewed 1105 audiotapes. Forty-eight audiotapes were excluded from
analysis because of poor audiotape quality or interrupted visits (n = 21)
or because the encounters contained no clinical decisions (n = 27). We analyzed
1057 audiotapes, which contained 3552 decisions.
Participants' demographic characteristics have been presented in detail
elsewhere.24 Most patients were white (85%)
and had some college education (63%). The median age was 51 years and 55%
were women. Compared with primary care patients, those seeing surgeons were
slightly younger, more often white, slightly more educated, and of higher
The physicians were mostly white (92%) and male (94%); 59 were primary
care physicians and 65 were orthopedic or general surgeons. The number of
years since graduation from medical school ranged from 12 to 41 years. Almost
all physicians practiced within solo practices (41% primary care, 26% surgery)
or single specialty groups (44% primary care, 68% surgery). On average, primary
care physicians reported spending 45 hours per week with patients, surgeons
reported 58 hours per week.
Primary care physician visits lasted a mean of 16.5 minutes (95% confidence
interval [CI], 16.0-17.0) and included discussion of a median of 3 patient
concerns (range of 1-12 as reported on the physician exit questionnaires).
The most frequent medical problems were hypertension, depression, diabetes
mellitus, gastrointestinal tract disorders, and musculoskeletal problems.
Visits with surgeons lasted a mean of 13.6 minutes (95% CI, 13.3-13.8)
and included discussion of a median of 2 concerns (range, 1-8). For orthopedic
surgeons, the most common reasons for visits were shoulder disorders, acute
knee injuries, and fractures. For general surgeons, the most common reasons
included breast disease, abdominal hernia, and cholecystitis or cholelithiasis.
The majority of encounters had 3 or fewer clinical decisions (29.8%
with 1 decision, 26.3% with 2 decisions, and 19.5% with 3 decisions). The
basic category (n = 1857 [52.3%]) accounted for the majority of all decisions.
There were 1478 (41.6%) intermediate decisions and 217 (6.1%) complex decisions.
Most decisions were initiated by the physician (85.8%).
The most common types of decisions for primary care physicians were
medication decisions (33.4%), follow-up appointments (14.0%), and routine
laboratory tests (11.0%). For surgeons, the most common decisions were follow-up
appointments (19.6%), medication decisions (12.9%), and counseling regarding
activities of daily living (12.8%) (Table
Overall, surgeons made more decisions than primary care physicians (1921
and 1631, respectively). However, primary care physicians made more decisions
per visit on average than surgeons. The mean number of decisions per visit
for primary care physicians was 2.75 (95% CI, 2.67-2.83) while surgeons had
2.51 (95% CI, 2.44-2.58; P<.001). Furthermore,
there was a significant difference in the distribution of decision complexity
between the 2 groups. Primary care physicians made more intermediate decisions
than surgeons (48.6% vs 35.7%), while surgeons made more basic (56% vs 47.9%)
and more complex (8.3% vs 3.5%) decisions (P<.001).
Overall, the completeness of informed decision making was low. When
examined across all decision categories, few decisions (9.0%) met criteria
for completeness of informed decision making. Completeness of discussion of
decisions varied by decision complexity. Whereas 17.2% of basic decisions
were complete, none of the intermediate and only 1 (0.5%) of the complex decisions
were complete. Within the basic category, there was variation in the proportion
of decisions that were complete. For instance, 20.9% of the decisions about
activities of daily living were complete, whereas routine laboratory test
decisions were only complete in 10% of cases.
There was substantial variation across categories in the frequency with
which individual elements were discussed (range, 1.5%-71%) (Table 5). Patients were often told the nature of the intervention
(basic, 66.1%; complex, 83.9%), but there was seldom discussion of alternatives
(5.5%-29.5%), pros and cons (2.3%-26.3%), or uncertainties associated with
the decision (1.1%-16.6%). Physicians occasionally discussed the patient's
role in decision making (5%-18.4%) and elicited patient preferences (17.8%-27.2%).
Physicians rarely explored whether patients understood the decision (0.9%-6.9%).
The extent of discussion consistently increased with decision complexity
(Figure 1). We found a statistically
significant increase in the frequency of discussion of individual elements
when we compared basic with complex decisions. The most striking increases
were in alternatives (5-fold increase), pros and cons (10-fold increase),
and uncertainties (16-fold increase). Discussion of the patient's role, discussion
of the nature of the decision, and ascertainment of patient preference also
showed significant increases from basic to complex categories (χ2 analysis of trend for each element, P<.001).
We reanalyzed completeness using the PAR criteria (described earlier)
and found the proportion of complete discussions overall was lower (3.1%).
Compared with the initial analysis, completeness was lower in the basic category
(0.5%), while discussions were somewhat more frequently complete in the intermediate
category (4.6%). Discussions of complex decisions were much more frequently
complete by this definition, 15.2% compared with 0.5% using the initial criteria
We reanalyzed completeness of informed decision making using the all-basic
criteria. This analysis sets the moral minimum for completeness, applying
the least stringent criteria for basic decisions to all decisions regardless
of their complexity. Although this improved the overall proportion of complete
decisions, fewer than 1 in 5 decision discussions (20.4%) were complete by
this minimum measure. The proportion of complete decisions improved in both
the intermediate (21.9%) and complex (38.2%) categories.
Considering the low interrater reliability for elements 5 and 6, we
also reran the initial analysis for completeness excluding these elements.
The results remained largely unchanged with 0.3% of intermediate decisions
complete but no change in completeness of complex decisions.
Our focus in this analysis was on decisions rather than individual visits.
However, when analyzing decisions by specialty, surgeons had a higher proportion
of completeness in informed decision-making discussions than primary care
physicians. For basic decisions, 18.0% of decisions were complete for surgeons
vs 16.1% for primary care physicians (Fisher exact test, P = .03). When all decisions were analyzed using the PAR criteria,
3.7% of decisions were complete for surgeons vs 2.4% for primary care physicians
(Fisher exact test, P = .02). Finally, when all decisions
were analyzed by the moral minimum of the all-basic criteria, surgeons still
had a larger proportion of completeness in informed decision making (21.8%
compared with 18.9% for primary care physicians; Fisher exact test, P = .03) (Table 7).
Length of visit and length of relationship were not significantly associated
with completeness in informed decision making for primary care physicians
In this study, we set out to determine the completeness with which physicians
involved patients in routine, but important, clinical decisions in office
practice. We analyzed these discussions with criteria that sought to balance
an ethical ideal with practical reality by taking into account important differences
in decision complexity. We found that surgeons and primary care physicians
in office practice infrequently had complete discussions of clinical decisions
with their patients.
These findings suggest that the ethical model of informed decision making
is not routinely applied in office practice. This low level of informed decision
making suggests that physicians' typical practice is out of step with ethical
ideals. There are practical implications of this missing practice. Inadequate
efforts to foster patient involvement in decision making may impair the patient-physician
relationship. Furthermore, there are quality-of-care concerns, since there
is mounting evidence that inadequate patient involvement may interfere with
patient acceptance of treatment and adherence with medical regimens.25
Noting the minimal levels of completeness across decision categories,
we decided to reanalyze the data using modified standards. These additional
analyses also address the concern that our evaluation sets too high a standard
for decision making. Though these analyses (PAR and all-basic) revealed modest
improvement in overall completeness of informed decision making, primary care
physicians and surgeons frequently made decisions without discussing the intervention
with the patient or seeking their involvement. By the most minimal definition
consistent with an ethical framework, decision making in clinical practice
may fall short of a basic level of patient involvement in routine decisions.
The examples in Table 1 and Table 3 illustrate the minimal nature of
the discussions that physicians conducted in the audiotapes.
In general, surgeons had more completeness of informed decision making
than primary care physicians. Surgeons have more experience in obtaining written
consent for surgery, which may carry over into being more accustomed to discussing
other decisions with patients. A recent study of patient-surgeon communication
demonstrates that surgeons spend almost half of their visit time educating
and counseling patients, significantly more than primary care physicians in
this type of conversation.26 The full explanation
of this apparent difference warrants further study.
Our model of informed decision making represents a usable framework
for involving patients in decision making. Although some patients may wish
for more discussion of a particular decision than our model requires, we used
a minimal standard for communication. Any particular instance of a decision
could become more complex, depending on questions and concerns of both patient
and physician. Our model emphasizes patient understanding and explicit discussion
of the patient's role in decision making, in part so that patients are given
a clear opportunity to expand the nature of the discussion to fit their needs.
Our model's sliding scale further prevents the physician from being saddled
with the onerous task of having lengthy involved discussions about every clinical
decision. Finally, the model maintains a critical link to the ethical foundations
of informed decision making, and thereby balances the ideal of theory with
the reality of practice.
There are some limitations to this study. As a cross-sectional study,
we do not have the benefit of observing the patient-physician relationship
over time. Some of the conversations involving decisions may be incomplete
because the physician and patient are quite familiar with each other's values,
information needs, and decision-making style. Only longitudinal studies of
patient-physician decision-making interactions will lay this issue to rest.
However, even within a long-term relationship, we argue that our moral minimum
would still hold in which the physician at least describes the intervention
and solicits patient input before proceeding.
In addition, the physicians who participated in this study were mostly
white and male, which could limit the generalizability of these findings.
Also, the quality of decision making may have improved since the time the
data were collected in 1993. Although there has been increasing interest in
patient-centered care, its impact on practice remains unknown.
Because we developed and used a new method for audiotape analysis, it
is important to demonstrate that this method is valid and reliable. We believe
that our method is a valid characterization of communication in the area of
decision making. The method was derived from a synthesis of theoretical constructs
about ideal informed decision making and bolstered by iterative group discussions
between clinicians and laypersons. Furthermore, the consistent trends in patterns
of overall completeness, with completeness increasing with decision complexity
despite different definitions of complete, provides further evidence of the
validity of our method. Overall, our intrarater and interrater reliability
were good, with the exception of low κ statistics for elements 5 and
6. The low reliability of elements 5 and 6 limits our findings only minimally
because the majority of decisions were basic, requiring neither element 5
nor 6. As we discovered, completeness for intermediate and complex decisions
also remained largely unaffected by the exclusion of these elements.
Most other studies of informed decision making have examined patient
recall, patient reports of adequacy of discussion, or analysis of informed
Our approach has the distinct advantage of relying on direct observation of
how decision making actually takes place. While there is no evidence in the
literature that audiotape recording of visits influences communication, it
is likely that any influence it may have would lead to more discussion around
decisions as opposed to less.
For too long, informed consent in clinical practice has been influenced
by an interpretation of informed decision making as a legal obligation in
which the emphasis is full disclosure, rather than an ethical obligation toward
mutual decision making by fostering understanding. Furthermore, most emphasis
has been on informed consent for invasive procedures or participation as a
research subject. Turning attention to decision making in office practice
reveals that this emphasis has not created a positive model of informed decision
making that is relevant and achievable in clinical practice in which the majority
of decisions are less than complex. Promotion of the patient's understanding,
thereby fostering informed participation, is the essence of informed decision
A new conception of informed decision making can provide a framework
for evaluating the adequacy of current practice, as we have illustrated in
this study. It can also serve as a framework for developing skills and behaviors
that enhance communication and trust, thereby improving the patient-physician
relationship and increasing the potential for the beneficial outcomes that