academic medicine...condition compared to the no cv condition (56% vs. 80%; or=0.32, 95%ci: 0.17...

Academic Medicine

When Guidelines Don't Guide: The Effect of Patient Context on Management Decisionsbased on Clinical Practice Guidelines

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Full Title: When Guidelines Don't Guide: The Effect of Patient Context on ManagementDecisions based on Clinical Practice Guidelines

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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 Do not quote or cite this version.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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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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“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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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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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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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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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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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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(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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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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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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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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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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http://www.ncbi.nlm.nih.gov/pubmed/23029859

http://www.ncbi.nlm.nih.gov/pubmed/23029859

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.

1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31 32 33 34 35 36 37 38 39 40 41 42 43 44 45 46 47 48 49 50 51 52 53 54 55 56 57 58 59 60 61 62 63 64 65

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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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academic medicine...condition compared to the no cv condition (56% vs. 80%; or=0.32, 95%ci: 0.17...

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