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Academic Medicine
When Guidelines Don't Guide: The Effect of Patient Context on Management Decisionsbased on Clinical Practice Guidelines
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Manuscript Number: AcadMed-D-13-01754
Full Title: When Guidelines Don't Guide: The Effect of Patient Context on ManagementDecisions based on Clinical Practice Guidelines
Article Type: Research Report
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Manuscript Region of Origin: CANADA
Abstract: Purpose: To examine the influence of patient context on physicians' adherence toCPGs.Method: Experiment using an internet-based survey. For each presented case,participant Emergency Medicine (EM) physicians (n=28) and novices (EM residents)(n=28) indicated if a specified test/treatment would be ordered/prescribed. Cases werechosen from 4 domains where CPGs exist, and were constructed to include or excludea "context variable" (CV). We compared the CPG adherence rate in the CV conditionto that in the no CV condition, for both experienced and novice EM physicians. TheCPG adherence rate in CV and non-CV conditions was compared betweenexperienced and novice EM physicians.Results: Experienced physicians were less likely to adhere to CPGs in the CVcondition compared to the no CV condition (56% vs. 80%; OR=0.32, 95%CI: 0.17-0.53,p<0.001). Experienced EM physicians were less likely to adhere to CPGs in the CVcondition when compared to novices (56% vs. 67%; OR=0.62, 95%CI: 0.39-1.0,p=0.039). Experienced and novice EM physicians did not differ in adherence to CPGsin the no CV condition.Conclusion: Participant EM physicians were sensitive to both patient context and thebest clinical evidence of benefit (as per CPGs) when determining the how care shouldbe managed.
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Original submission for review training use only. Do not quote or cite this version. Copyright © by the Association of American Medical Colleges.
When Guidelines Don’t Guide: The Effect of Patient Context on Management
Decisions based on Clinical Practice Guidelines
Corresponding Author:
Brief Title: When Guidelines Don’t Guide
Word Count: 2992; 4145 with Abstract and References
*Manuscript (All Manuscript Text Pages in MS Word format, including References and Figure Legends)
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Original submission for review training use only. Do not quote or cite this version. Copyright © by the Association of American Medical Colleges.
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Original submission for review training use only. Do not quote or cite this version. Copyright © by the Association of American Medical Colleges.
Abstract
Purpose: To examine the influence of patient context on physicians’ adherence to
CPGs.
Method: Experiment using an internet-based survey. For each presented case,
participant Emergency Medicine (EM) physicians (n=28) and novices (EM
residents) (n=28) indicated if a specified test/treatment would be
ordered/prescribed. Cases were chosen from 4 domains where CPGs exist, and
were constructed to include or exclude a “context variable” (CV). We compared the
CPG adherence rate in the CV condition to that in the no CV condition, for both
experienced and novice EM physicians. The CPG adherence rate in CV and non-CV
conditions was compared between experienced and novice EM physicians.
Results: Experienced physicians were less likely to adhere to CPGs in the CV
condition compared to the no CV condition (56% vs. 80%; OR=0.32, 95%CI: 0.17-
0.53, p<0.001). Experienced EM physicians were less likely to adhere to CPGs in the
CV condition when compared to novices (56% vs. 67%; OR=0.62, 95%CI: 0.39-1.0,
p=0.039). Experienced and novice EM physicians did not differ in adherence to
CPGs in the no CV condition.
Conclusion: Participant EM physicians were sensitive to both patient context and
the best clinical evidence of benefit (as per CPGs) when determining the how care
should be managed.
Key Words: Clinical Practice Guidelines, Patient Context, Adherence, Emergency Medicine, Expertise
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Original submission for review training use only. Do not quote or cite this version. Copyright © by the Association of American Medical Colleges.
“It’s more important to know what sort of person has a disease than to know what sort of disease a person has”
-Hippocrates
Introduction
Clinical practice guidelines (CPGs) were introduced to assist clinicians in
determining the appropriate course of action for a given medical condition [1]. The
application of CPGs is intended to promote the standardization of medical practice
along the lines of scientific principles, or the best (available) evidence of
effectiveness. By reducing uncertainty, CPGs might operate to reduce variation in
medical practice (including in the rate of use of healthcare services), and promote
better patient outcomes [2-5].
While medical practice is grounded in clinical science, healthcare
management decisions are often influenced also on what the individual patient
circumstances may be. For example, Andersen and Newman (1973) outline a
number of patient related factors that can influence the use of healthcare services,
including patient’s affordability, access, and attitudes (both personal and family)
towards health and healthcare [6]. Likewise, Ro (1969) argued that what the
physician recommends is mediated in part by their response to each patient’s
“choice conditioning” factors, which may be personal or situational in nature [7].
Thus, even when clinical uncertainty is minimized (e.g. when evidence based CPGs
are available), management decisions may be influenced by other contextual factors.
However, studies tend to ignore this consideration and assume that when
physicians do not adhere to CPGs [8-10], this is a consequence of deficits in
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Original submission for review training use only. Do not quote or cite this version. Copyright © by the Association of American Medical Colleges.
physicians’ knowledge or awareness of CPGs. There is little or no explicit
examination of the context beyond patient preference.
The purpose of this study was to determine if factors related to an individual
patients’ context are associated with deviations in healthcare management from
that recommended by CPGs. Context factors of interest include patient’s occupation,
proximity to care, expectations of treatment, and factors related to home life (e.g.
lives alone). This study focused on point of care management decisions for common
emergency medicine (EM) cases where established CPGs exist. The following
hypothesis was tested:
1) Given a case where an established CPG exists, the rate at which
experienced emergency medicine (EM) physicians’ management decisions will
adhere to CPG will be lower when a mediating factor related to the context of the
patient is presented, compared to when it is not.
Whereas information regarding the most effective treatment for a given
medical condition might be acquired through study of the medical literature,
effectively tailoring care to a given patient’s situation is likely learned through
experience with patients. Thus, one might reasonably expect that more experienced
physicians are more adept at integrating the patient’s context into their
management decisions. The study also tests the following hypothesis related to
expertise:
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Original submission for review training use only. Do not quote or cite this version. Copyright © by the Association of American Medical Colleges.
2) In cases where a factor related to the patient’s context is presented,
experienced EM physicians’ management decisions will less often adhere to CPG
recommendations compared to that of novice EM physicians.
Conversely, to determine whether non-adherence is a consequence of
inadequate knowledge, we also tested the hypothesis that:
3) In cases where factors related to the patient’s context are not presented,
experienced EM physicians’ management decisions will adhere to CPG
recommendations as often as novice EM physicians.
Methods
Participants
Participants were recruited from among both experienced and novice
emergency medicine physicians practicing in three cities in Ontario, Canada
(Hamilton, London, Ottawa). Experienced physicians were residency trained in
Emergency Medicine, and at least five years of practice in EM. The novice EM
physician group was restricted to those enrolled in the first two years of a residency
program in EM. This was done to ensure that participant novices had a working
knowledge of EM related CPGs, but to minimize the influence of clinical experience
on shaping management decisions.
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Original submission for review training use only. Do not quote or cite this version. Copyright © by the Association of American Medical Colleges.
Survey Instrument
Twelve clinical scenarios outlining typical cases EM specialists might
encounter in practice were developed in consultation with an experienced and
certified EM physician (JS). Cases were chosen from among four domains (two
related to diagnostic testing and two related to treatment). Specifically, cases
focused on 1) ordering radiography for suspected ankle injury, 2) ordering
computed tomography (CT) for suspected head injury, 3) prescribing antibiotics for
sore throat (i.e. suspected streptococcal pharyngitis), and 4) prescribing warfarin
for atrial fibrillation, where the patient has been referred to a cardiologist. The
basic cases were developed to meet the terms of one of the following CPGs: Ottawa
Ankle Rule [11]; Canadian CT Head Rule [12]; Centor Score/McIssac Score for Strep
Pharyngitis [13,14]; Atrial Fibrilation CHADS2 Score [15]. Each case was then
paired with one of identical content with added information regarding the “context
variable” (CV). In every case the CV was designed to provide a basis for not
following the CPG. For example, one ankle injury case was a professional hockey
player whose livelihood may be jeopardized if an ankle fracture was missed.
Likewise, one sore throat case was a nurse who lived in an isolated area and could
not easily follow up an abnormal test. Three pairs of cases were developed for each
domain. Two additional experienced and certified EM physicians reviewed the
cases to assess content and face validity. A brief summary of the cases and their
associated CV are presented in Table 1.
Two surveys were developed based on these cases. Each survey contained
one case from each pair (a total of 12 cases per survey). The surveys were balanced
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Original submission for review training use only. Do not quote or cite this version. Copyright © by the Association of American Medical Colleges.
so that half the cases contained the CV; with each survey the mirror opposite. The
cases appeared on each survey in no particular order according to domain or CV
condition. The order at which each scenario was presented was the same for both
survey instruments. Prior to the presented cases, the survey included questions
regarding participant demographics, and characteristics of practice environment
(described below). Finally, the survey ended with four questions regarding the
participants’ familiarity with each of the above-mentioned CPGs. Participants were
unable to access their answers regarding management decisions once the CPG
familiarity questions were asked to not influence how they responded to the survey.
Data Acquisition
This study used a web-based survey design administered via LimeSurvey.
Participants were randomized to one of the two survey instruments, stratified
according to experience (novice vs. certified EM physician). Once randomized, a
unique survey link was prepared and forwarded to each participant via email. Only
a single survey attempt was possible for each link, and the survey needed to be
completed in a single session. A reminder email was sent out one week after the
initial invitation to encourage participation.
Data regarding the participant’s demographics and work environment were
collected as follows: 1) gender (male/female), 2) experience (novice/EM >5 years
with certification), 3) number of years since completion of EM residency, 4) location
of practice (rural/urban), 5) type of hospital of primary practice
(academic/community), 6) approximate number of cases per shift, 7) approximate
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number of shifts per month, 8) monthly department patient volume. For each
presented case, the participant was asked to indicate if he/she would order the
diagnostic test or prescribe the treatment in question (yes/no). The participant’s
familiarity with each CPG also collected (yes/no).
Participants received a small honorarium for participation in the study. The
dataset was stripped of personal identifiers prior to analyses. The study received
approval by the McMaster University/Hamilton Health Sciences research ethics
board.
Analysis
A Chi-square test was used to compare the frequency of following a CPG
when the CV was present versus that when the CV was not present. This analysis
was conducted in the novice and expert physician groups. A chi-square test was
performed to determine if the frequency of following the CPG in the CV condition
differed between experienced and novice EM physicians. A p-value of 0.05 was
considered significant. All analyses were performed using Microsoft Excel or SPSS
version 20 for Mac OS.
Results
Data was collected from among 28 experienced physicians, and 28 novices
between January and July of 2013, evenly balanced between the two survey forms.
Three participants indicated they were not familiar with the Centor Score/McIssac
Score for Strep Pharyngitis (2 experienced, 1 novice) and three participants
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Original submission for review training use only. Do not quote or cite this version. Copyright © by the Association of American Medical Colleges.
indicated the same for the Atrial Fibrillation CHADS2 Score (2 experienced, 1
novice). Cases related to these CPGs for such participants were removed from the
dataset prior to analyses. All of the participants indicated they worked primarily at
an urban teaching hospital. Participant demographics and characteristics of work
environment are described in Table 2.
Experienced physicians were significantly less likely to follow CPG
recommendations in the presence of a CV compared to when the CV was not present
(56% vs. 80%; OR=0.32, 95%CI: 0.17-0.53, p<0.001). The rate at which novices
followed CPG recommendations also differed between conditions (67% for CV
condition vs. 79% for no CV; OR=0.53, 95%CI: 0.31-0.9, p=0.013). In the absence of
CV, experienced physicians and novices were equally likely to adhere to CPGs (80%
for experts vs. 79% for novices, OR=1.05, 95%CI: 0.59-1.8, p=0.85). However
experienced EM physicians were less likely to follow CPG recommendations in the
CV condition when compared to novices (56% vs. 67%; OR=0.62, 95%CI: 0.39-1.0,
p=0.039). Subsequent analyses of the data indicated that the results were not
driven by any particular physician. Rather, management responses from the
majority of participants followed the pattern described above, with a higher
proportion doing so in the expert group (see Table 2). Figure 1 shows the rate of
adherence to CPGs for both the experienced and novice physicians in both the CV
and no CV conditions.
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Discussion
Both experienced and novice physicians’ management decisions reflected
CPGs in the majority of cases where the CV was not presented. However, the
management decisions of physicians were less likely to reflect those recommended
in CPGs when physicians were presented cases that included the CV. This
observation supports our hypothesis that a patient’s context influences how
physicians manage care, even when CPGs are available and known. While the rate at
which experienced and novice physicians’ management decisions reflected CPGs did
not differ when a CV was not presented (thus, supporting our third hypothesis),
experienced physicians were less likely to follow CPGs in the CV condition when
compared to novices. This supports our second hypothesis that the extent to which
a physician will adhere to CPGs when presented information related to a patient’s
context is to some extent based on experience.
Studies have investigated the reasons for incomplete adherence by
physicians to CPGs (e.g., [8-10]). The majority of these studies focused on lack of
awareness or knowledge of current CPGs, and lack of belief or trust in published
CPGs as the primary culprits (see systematic reviews [8,9]). For example, in a
systematic review, Choudhry, Fletcher, and Soumerai (2005) observed an inverse
relationship between physician experience and quality of care (most often defined
as CPG adherence in their study), which the authors attributed to a lack of sufficient
“factual knowledge” (p.269) among experienced physicians [16].
Our findings do not support the notion that adherence is related primarily to
physicians’ knowledge of CPGs (e.g. [16]). With the exception of a few participants
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Original submission for review training use only. Do not quote or cite this version. Copyright © by the Association of American Medical Colleges.
(described above), the participants indicated near universal familiarity with the
case-related CPGs, and management decisions reflected these CPGs in the majority
of cases in the control (i.e. “no CV”) condition, irrespective of EM experience.
Despite this demonstrated knowledge, management decisions deviated from CPGs
more often in the presence of a contextual factor (i.e. “CV”). These observations
imply that the “lack of adherence” among physicians may not be a function of their
level of CPG knowledge, but rather due to their sensitivity to each patient’s unique
needs. In other words, management decisions, while based on the best available
evidence, are tailored according to the physician’s perception of potential benefit
given the whole experience of the patient. Furthermore, the data presented may
suggest that this “tailoring” becomes more pronounced with experience.
Advocates for CPG acknowledge the tension between guideline provisions
and the realities of clinical practice. The Canadian Medical Association Handbook on
Clinical Practice Guidelines states, “that CPGs are not intended to provide guidance in
all circumstances and for all patients” (p.3)[17], as the authors recognize that “their
more general nature renders them insensitive to the particular circumstances of
individual cases” (p.3)[17]. Likewise, Woolf et al. (1999) raise concern that “the
frequently touted benefit of clinical guidelines – more consistent practice patterns
and reduced variation – may come at the expense of reducing individualized care for
patients with special needs” (p.529) [3]. This position is even supported by key
advocates of the evidence-based medicine (EBM) paradigm for management of care.
For example, when determining if CPG recommendations are applicable to a patient,
Wilson and colleagues (1995) suggest, “You should look for information that must
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Original submission for review training use only. Do not quote or cite this version. Copyright © by the Association of American Medical Colleges.
be obtained from and provided to patients for patient preferences that should be
considered. It is important to consider whether the values assigned (implicitly or
explicitly) to outcomes could differ enough from your patients’ preferences to
change a decision about whether to adopt a recommendation” (p.1632) [18].
Despite this awareness, best practices for CPG development endorse a process
which gives emphasis to evidence derived from randomized controlled trials (RCT)
[19-21). This is problematic, as one could argue that RCTs “devalue” (or are not
designed to take into account) potentially important aspects of the individual that
cannot be (easily) quantified [22], and that RCTs do not account for the fact that to
patients, “illness is inseparable from other aspects of existence” (p.1237) [22]. For
this reason it is understandable that some physicians believe that CPGs are
impractical or too rigid to apply to individual patients [23]. It would seem that in
practice, physicians who participated in our study are aware of this tension and
modify practice to accommodate for context.
Hughes and colleagues (2013) and Boyd et al. (2005) argue that CPGs are in
some cases inappropriate for individuals with multimorbidity, as strict adherence to
multiple guidelines would result in an unreasonable treatment burden (both
medical and “non-medical”) – a feature that is not consistently accounted for in
CPGs [24,25]. Even if one were to consider patient preferences, as is suggested by
advocates of EBM, the role of patient values and preferences in determining how
care will be managed receives little attention among prominent CPGs (e.g. [26]). In
some cases, consideration of the individual patient’s circumstance or “special needs”
has been incorporated into CPGs. For example, the decision to prescribe highly
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Original submission for review training use only. Do not quote or cite this version. Copyright © by the Association of American Medical Colleges.
active antiretroviral therapy (HAART) in HIV-infected individuals must balance the
potential benefits of therapy with the risk of drug resistance as a result of non-
adherence by the individual [27,28]. Thus, a consideration of an individual’s non-
adherence potential is incorporated into the CPGs for HAART [29]. However, the
extent to which other CPGs consider adherence and/or other contextual or “non-
medical” factors that might affect care, or how they should be integrated with
“medical” factors/trial evidence into management decisions is not clearly described
in the literature.
This study was not designed to determine precisely why some physicians’
management decisions differ from CPG recommendations in some cases and not
others (irrespective of the presence of context), nor could it determine if those
deviations we attributed to context would result in better patient outcomes.
However, if one considers patient context to be a justifiable reason to deviate from
CPGs this would have significant implications on how we examine variation or
quality of care. Where there is good evidence of benefit for a particular therapy or
diagnostic test given a particular health status, any differences between populations
that cannot be accounted for by differences in clinical variables (i.e. health status)
might be considered “unwarranted”. In the event that the populations also differed
in “context” independent of health status, one might incorrectly consider the
residual variation “unwarranted” unless the “context” were measured and
incorporated into the analyses [30]. Consideration of “context” would mark a shift
in the approach to quantifying variation, where previous research primarily
accounted for population differences in demographics and in some cases disease
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Original submission for review training use only. Do not quote or cite this version. Copyright © by the Association of American Medical Colleges.
severity [31]. Furthermore, CPGs might imply that there is a “correct” rate of use
that should not differ between populations after accounting for health status. The
data presented here might bring into question the concept of a universal “correct”
rate of use; rather, what is considered correct in each population may depend on
local characteristics related to the “context” of that population [31,32].
Limitations
This study has several limitations that are typical of experimental designs.
Most notably is the extent to which results based on hypothetical cases are
generalizable to actual practice. However recent evidence suggests that, in
acquisition of diagnostic skills, written cases can be considered interchangeable
with video or live simulations [33]. Thus, these findings may be generalizable to
management decision-making. This study only looked at management decisions
within a single specialty. Additional studies examining the effects of patient context
on management decisions relative to CPGs among physicians from a variety of
specialties, and from various communities are required to confirm the presented
findings. Unfortunately, finer analyses according to management domain were not
possible given data limitations. Thus, while it appears that no particular domain
was driving the lack of adherence to CPGs, such could not be confirmed or denied
based on the collected data.
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Original submission for review training use only. Do not quote or cite this version. Copyright © by the Association of American Medical Colleges.
Conclusion
Clinical Practice Guidelines are developed to assist physicians in determining
the best course of care for patients. While CPGs might provide opportunity to
maximize outcomes at the population level, they are not designed to account for the
unique needs of individual patients. The data presented here suggests that EM
physicians are sensitive to both individual patient context and the best clinical
evidence of benefit (as per CPGs) when determining the how care should be
managed. Additional research is needed to determine the extent to which
consideration of “context” does result in better patient-important outcomes. If
deemed important, the “context” of patients should be considered when examining
why physicians might not adhere to CPG recommendations. Furthermore, as many
physicians in this study seemed to respond to context when determining how care
would be managed, studies examining practice variation might benefit from a
consideration of systematic differences in that context between populations when
identifying the sources of variation.
Acknowledgements
Competing Interests
The authors have no competing interests to declare.
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Original submission for review training use only. Do not quote or cite this version. Copyright © by the Association of American Medical Colleges.
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Original submission for review training use only. Do not quote or cite this version. Copyright © by the Association of American Medical Colleges.
Case Descriptor CPG indicates Context Variable Ankle 1 46 yr M trauma L ankle No X-ray Pursued by police Ankle 2 21 yr M trauma R ankle No X-ray Pro hockey player Ankle 3 36 yr F trauma R ankle No X-ray Civil suit Head 1 62 yr M minor head injury No CT Lives alone Head 2 47 yr F minor head injury No CT Chair of the hospital board Head 3 93 yr M head injury CT Advanced Alzheimer’s Strep 1 21 yr F sore throat No Abx Mother is a nurse who works
in the ED Strep 2 5 yr M sore throat No Abx Family members recently
treated for suspected strep, anxious parents
Strep 3 46 yr F sore throat No Abx Nurse practitioner, leaves for isolated community tomorrow
AF 1 54 y F palpitations No warfarin Vascular Surgeon AF 2 64 y M palpitations Warfarin Alcoholic AF 3 78 y F palpitations Warfarin Unreliable patient
Table 1: A brief summary of the survey cases and their associated context variables. Computed Tomography (CT); Antibiotics (Abx).
Experienced EM Novice EM Total n n n
Number 28 28 56 Female 8 13 21 ED Census
>25000 – 50000 4 3 7 >50000-75000 17 10 27
>75000 7 15 22
Mean (SD) Mean (SD) Mean (SD) Years in Emergency Medicine (post certification)
14.9 (8.3) n/a n/a
Shifts/month 13.4 (5.8) 14.4 (3.1) 13.9 (14.6) Patients/shift 26.7 (7.5) 11.4 (2.4) 19 (9.5)
Followed CPGs CV condition 3.25 (1.5) 3.96 (1.3) 3.61 (1.4)
No CV condition 4.64 (0.99) 4.68 (1.4) 4.66 (1.2) n n n
CV/no CV <1 20 16 36 CV/no CV >1 2 4 6 CV/no CV =1 6 8 14
Table 2: Participant demographics, characteristics of work environment, and rate of adherence to CPGs. CV/no CV is the ratio of how many times the participant followed the CPGs in Cv condition cases compared to no CV condition cases.
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Original submission for review training use only. Do not quote or cite this version. Copyright © by the Association of American Medical Colleges.
Figure 1. Rate of adherence to CPGs for both experienced and novice physicians, in both the CV and no CV conditions.
0
10
20
30
40
50
60
70
80
90
no CV CV
experienced
novice
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Original submission for review training use only. Do not quote or cite this version. Copyright © by the Association of American Medical Colleges.
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