Introduction
In the fall of 2014, we convened a multidisciplinary task force of stakeholders
including emergency physicians, radiologists, and a patient representative. The main
purposes of this group were to (1) develop a preliminary research agenda for patient
centered outcomes research in the context of emergency diagnostic imaging; and (2) to
present key questions to guide further research in this area for discussion and
prioritization at the consensus conference “Diagnostic Imaging in the Emergency
Department: A Research Agenda to Optimize Utilization” on May 12, 2015 in San
Diego, CA. In preparation for the consensus conference, the task force conducted 12, 1hour conference calls in which the framework for developing the research agenda and
questions for further research were discussed and consensus was achieved using a
modified Delphi method.
A key question proposed by the committee was the following: What is and is not
a patient-centered outcome related to emergency diagnostic imaging? Several outcomes
of potential importance to patients include but are not limited to radiation exposure, fear
and anxiety associated with imaging, degree of life disruption introduced by the
procedure, cost, understanding the results of imaging, the likelihood of an incidental or
unexpected finding, and potential downstream investigations triggered by
incidental/unexpected findings, among others. When determining whether an outcome is
or is not patient-centered, it is informative to consider the working definition of patientcentered outcomes research (PCOR) iteratively formulated and developed by the PatientCentered Outcomes Research Institute (PCORI) after stakeholder and public input that
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was approved by the Board of Governors on March 5, 2012 (Table 1).1 In the context of
diagnostic imaging, intuitively one might consider an outcome such as radiation exposure
or an incidental finding to have important ramifications for the patient and therefore be a
patient centered outcome. However, note that each of the 4 questions that comprise the
definition of PCOR in Table 1 are posed from the patient’s perspective – this implies that
the patient’s perspective is elicited, not presumed, by non-consumer healthcare
stakeholders. Given these considerations, for an outcome to be considered patientcentered, it should be elicited from and identified by patients as important.
Conceptual framework for developing a future research agenda for PCOR in
emergency diagnostic imaging
When developing a patient-centered framework for determining outcomes in
future ED imaging studies, it is important to take a patient’s entire episode of care into
consideration – the decision to visit the ED (pre-ED setting), delivery of care while in the
ED (in-ED setting), and the patient’s post-discharge experience (post-ED setting).
In light of the above considerations and in the context of the proposed framework
for PCOR in emergency diagnostic imaging, the task force sought to address two
overarching research questions:
(1) What outcomes in emergency diagnostic imaging do patients, parents/caregivers and
other key stakeholders (emergency clinicians, radiologists, researchers, payers/policy
makers, healthcare administrators) consider important?
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(2) What methods, tools and approaches best facilitate patient engagement in the decision
to undergo diagnostic imaging?
It was against this backdrop that the task force formulated topics and questions for a
future PCOR agenda in emergency diagnostic imaging. This manuscript addresses the
pre-ED setting and in-ED setting in detail; the post-ED setting is discussed in a separate
manuscript. (reference group 3, manuscript #2)
What outcomes in emergency diagnostic imaging do patients, caregivers and other key
stakeholders consider important?
Pre-ED setting
Sarah Jones, a 30 year-old woman with a history of well-controlled migraine
headaches, is followed closely by her primary care physician for her symptoms. She takes
a beta-blocker daily as a preventative medication and uses an intranasal serotonin
receptor agonist to treat acute breakthrough migraines. One summer weekend, while
visiting relatives away from her home city, she developed a severe migraine after
forgetting to pack and take her migraine medications. Without access to her home
treatment regimen, she sought care at the local emergency department. On presenting to
the ED, she described her symptoms to the triage nurse, including a sudden onset
headache. After a brief consultation with a resident physician, a CT scan of the brain is
ordered and performed despite her history of chronic sudden onset headaches and
multiple brain imaging tests in the past for her headaches.
4
In this vignette, Mrs. Jones’ decision to seek care in the ED was precipitated not
by her desire for additional diagnostic evaluation (in fact she had received many brain
imaging tests in the past for her headaches), but rather her wish for acute pain relief. So
why did she receive a test she did not need or necessarily want? Her treating ED
physician – who did not know Mrs. Jones’s detailed medical history – was concerned
about the nature of her headache. When asked, the physician explained: “patients who
present to the ED are having, by some self-definition, an emergency. My job is to treat
their condition as an emergency, and for Mrs. Jones this meant imaging her brain with a
CT scan.”
For this patient and countless others, the pathway to the decision to obtain
diagnostic imaging in the emergency department begins before arriving in the ED. When
confronted with symptoms such as pain, weakness or shortness of breath (all of which
can and frequently do trigger a diagnostic imaging test in the ED), patients have choices
that often begin at home. They can choose to seek medical care at all or wait to see if the
symptoms subside. If they do choose to seek care, they may select immediate evaluation
in an ED or choose to be seen in a primary care, urgent care, or specialty care setting.
Depending on their mobility and access to transportation, patients may use emergency
medical services (EMS) or travel by private transportation to seek medical care. Each of
these decisions can lead to alternative downstream diagnostic testing strategies that may
or may not be aligned with the patients’ expectations, values or preferences.
Despite the increasing use of emergency care across all conditions [Tang et al]
and despite the increasing use of diagnostic imaging for ED patients [Larson et al], the
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incidence of patients who seek ED care specifically in order to obtain diagnostic imaging
has not been described in detail. Multiple studies have examined the reasons for ED use
(for both urgent and non-urgent complaints); common findings include: limited access to
a primary care physician, being referred in by a primary care doctor’s office, reduced
access to transportation, and the perceived need for urgent treatment. The EMPATH
study, a prospective multicenter mixed methods analysis of ED patients, identified that
patients actively seek emergency care when they believe they are having a medical
emergency and are unable to access or are dissatisfied with outpatient care. [Ragin et al].
Gindi and Jones, using the 2012 National Health Interview Survey (NHIS) described
reasons for ED use among children, finding that a closed primary care office (particularly
during nights and weekends) was responsible for 75% of recent visits to an ED. [Gindi et
al] Richman and colleagues, in a national observational study, noted an association
between primary care shortages and ED visits by states. [Richman et al] Cheung et al.
found that barriers to timely primary care access such as difficulty getting through on the
telephone, limited clinic hours, and lack of transportation were all associated with greater
emergency care use for patients with Medicaid.[Cheung et al] Weiss and colleagues, in a
survey of adolescents who use the ED, found that PCP referral accounted for 21% of their
most recent visits. [Weiss et al]. Qualitative studies have uncovered more nuanced
reasons for seeking care in the ED for a variety of types of patients, but few-- if any-have identified diagnostic imaging as a reason. Lawson and colleagues interviewed ED
patients with asthma (a condition for which radiography is often overused in ED settings
[Knapp et al]) -- finding the perceived need for urgent treatment and inability to access an
outpatient provider or medication as the primary drivers of ED use. Howard et al
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interviewed ED patients with nonurgent complaints and had similar findings, with limited
primary care access and PCP referrals cited by many of the respondents.[Howard et al]
This body of literature suggests that access to outpatient care, including insurance,
transportation, and other factors, may drive emergency care use. Of note, none of these
studies identified access to imaging as a specific reason for seeking emergency care.
Although ED use is associated with increasing use of diagnostic imaging, the extent to
which factors such as barriers to access and referrals in to the ED are driven by the
diagnostic needs or preferences of patients and their primary care providers remain
uncertain. Specifically, patients present to the ED often because they are sent in or cannot
get timely care elsewhere—but how often do they come in specifically because they
cannot get access to diagnostic imaging? Moreover, how often do they seek emergency
care due to general outpatient access issues, and ultimately receive a diagnostic test that
they do not need or want? These questions, pertaining to how patients end-up in
emergency care settings and the extent to which these factors lead to downstream
diagnostic imaging have yet to be rigorously explored.
Research questions from the Patient Perspective:
1. When does my decision to seek care in an emergency department lead to
diagnostic imaging?
2. How do I choose whether to seek care in an emergency department versus
an urgent care center or outpatient office setting? Does this choice lead to
different diagnostic imaging decisions and/or different outcomes for
patients like me?
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3. To what extent do patients like me make decisions about where to seek
care based on a desire or expectation of imaging?
4. For patients like me, does the decision to present to the ED for imaging
reflect a preference for the least amount of disruption introduced into our
lives when interacting with the medical system?
5. How is it that sometimes patients like me end up with imaging tests that
we don’t need or want? To what extent are these paths set before I even
walk into the healthcare setting?
6. For patients like me, to what degree does the decision to present to the ED
for imaging reflect inadequate access to outpatient testing? How
frequently do patients like me go to the ED for imaging because we can’t
get approval from our insurers for outpatient imaging? How frequently
do patients like me present to the ED for imaging because we were
referred by another provider (such as a PCP)?
7. If I call EMS and travel by ambulance compared to seeking alternative
transportation the hospital, does this impact the likelihood of imaging
independent of how sick I am?
8. Within my local region, will some care settings be more likely to perform
diagnostic tests on me for the same condition compared to other
equivalent types of care settings?
In ED-setting
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Logan Smith, a 10-year old boy, is brought to the ED by his parents after a
sledding injury. He was sledding head first, unhelmeted, down a hill when he lost control
of the sled and struck his head on a plastic garbage can at the bottom. According to his
father, who witnessed the event, he didn’t respond to his name or answer questions for
nearly 30 seconds and subsequently began to cry. After being consoled by his father and
friends, he got up and began sledding again. After 30 minutes of additional play, he
complained that his “tummy” hurt and subsequently vomited. His father called his
mother and they both agreed to take Logan to the ED to get “checked out.” After arrival
to the ED and waiting 1 hour in the waiting room, Logan is taken to a treatment room
and seen by a clinician. The clinician’s pager interrupts the story, which is being told by
the father. After stepping out to answer the page from a consulting physician and
signing a 72-hour hold for a boarded psychiatric patient, the clinician returns to Logan’s
treatment room to complete the history and physical examination. She determines that
there are no abnormalities on examination and that Logan is now active and behaving
normally. The clinician, after formulating her gestalt regarding the risk for traumatic
brain injury, and taking into consideration perceived parental anxiety, decides to order a
head CT to relieve parental anxiety and rule out bleeding in or around the brain with
certainty before rushing to the next patient.
In this vignette Logan Smith is brought to the ED by his parents for evaluation
after a minor head trauma. This scenario highlights several factors potentially
influencing the decision to obtain diagnostic imaging in the ED setting. A recent article
by Hess and colleagues2 proposes an approach to group each of these factors: (1) factors
related to the patient/caregiver; (2) factors related to the treating clinician; (3) factors
9
related to the clinical setting/healthcare delivery system; and (4) strengths and limitations
of the scientific evidence base. Factors related to the patient/caregiver might include
medical acuity, decision-making capacity, expectations and preferences, willingness to
engage in the decision-making process, and potential socioeconomic, cultural, and
educational disparities that may impede transformation from an uninformed to an
informed preference. Factors related to the clinician influencing decision-making might
include cognitive load at the time of the clinical encounter, understanding of the evidence
relevant to the decision at hand, perceived equipoise of the decision, ability to educate the
patient/caregiver regarding factors relevant to the decision such that they are empowered
to apply their values and preferences, and willingness to engage the patient/caregiver in
shared decision-making. Factors related to the clinical setting might include time
available to communicate with patients, the responsibility of the clinician to balance
responsibility for the individual patient versus the population of patients in the ED at that
moment in time, and availability of follow-up structures. Factors related to the strength
of the scientific evidence base might include the availability of a rigorously developed
and validated prediction rule from which reliable estimates of risk can be obtained,3
whether patient-centered decision tools exist to facilitate risk communication, and the
degree to which they have undergone testing in trials,4 among other factors. Table 2
outlines the major categories potentially influencing the decision to obtain diagnostic
imaging and several factors within each category.
Shared decision making (SDM), a collaborative process in which patients and
clinicians make health care decisions together, taking into account the best scientific
evidence available, as well as the patient’s values and preferences, is being increasingly
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advocated for in both national health policy and clinical guidelines. (refs ACA, AHA
advanced heart failure guidelines). Although few disagree with SDM from a conceptual
perspective, application to clinical practice, particularly in a busy, chaotic clinical setting
such as the ED, is a challenging prospect. In addition to the factors influencing the
decision-making process outlined in Table 2, the clinical scenarios in which SDM might
be both feasible and appropriate have not been clearly delineated. Even after a
reasonable scenario for SDM has been selected – such as the decision to obtain a head CT
in low to moderate risk pediatric minor head trauma in which there exists a well-validated
decision rule3 and a decision aid4 to educate and engage parents in the decision-making
process – which risk levels are appropriate for SDM, what the effect of SDM might be of
engaging low risk patients in whom CT is not indicated, moderate risk patients in whom
observation or head CT are both reasonable options, or high risk patients in whom head
CT is clearly indicated is another area for further research. Finally, developing patientcentered contextually sensitive approaches to decision making – where on the continuum
from informed decision making to paternalism is optimal for a given patient and
situation, and how to go about determining an empathic approach to decision-making, is
another ripe area for research.
Research questions:
1) In a given clinical scenario, what factors influence the decision to obtain
advanced imaging?
2) To what degree does each of these factors influence decision-making – and to
what degree should each of the factors influence the decision to obtain imaging?
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3) What affect would alignment of incentives of key stakeholders – patients,
clinicians, radiologists, and policymakers/payers – have on diagnostic imaging
utilization in the emergency setting?
4) What approaches might effectively align incentives such that the rate of imaging
is more closely tailored to both disease risk and risk-informed patient
preferences?
5) For a given clinical scenario, what risk levels are appropriate for SDM?
6) What clinical scenarios in the ED setting are most appropriate and feasible to
employ a SDM approach?
7) In which clinical scenarios, if any, is taking an assertive, paternalistic approach an
optimal contextually sensitive approach to decision making?
Post-ED setting:
After a patient is discharged from the ED, additional follow-up and care may be
needed. A research agenda related to these issues is explored in greater detail elsewhere.
(reference manuscript #2)
What research methods optimally facilitate the development and assessment of
patient-centered outcomes in emergency diagnostic imaging?
While there have been tremendous recent advancements in health care treatments
and delivery, there have similarly been strides in patient-centered outcomes research
(PCOR). Outcomes-driven, patient-centered methods may help improve the ability to
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understand and balance alternative diagnostic and management strategies for some
emergency medicine patients (Gabriel 2012; Lee 2014; Meisel 2012).
The historic approach to assessing the contribution of diagnostic imaging to
patient management is outlined in Table 3 (left side) (Fryback 1991). This traditional
conceptual hierarchical model of imaging efficacy is a helpful tool, beginning with the
premise that a valuable diagnostic radiology test should offer both high-quality images
that can be reliably interpreted and an accurate diagnosis. However, the hierarchy extends
beyond technical and diagnostic accuracy, by considering more broadly how the
diagnostic test affects clinicians’ decision-making, patient management, patient
outcomes, and societal benefit.
The key concept, as noted in Figure 1, is that not every normal or abnormal
imaging result will alter the subsequent diagnostic or therapeutic approach of the
clinician. Furthermore, every abnormal finding does not correspond to a therapy that can
or should be recommended, based upon available treatments, other acute threats to health,
patient priorities, and cost. Furthermore, available therapies that are based on surrogate
outcomes often lack direct evidence of benefit for patient-important outcomes (Montori
2012). Additionally, consider a patient who experiences a mild head injury and is found
to have a minor traumatic intracranial bleed on neuroimaging. The neuroimaging study
will likely result in hospital admission and potentially repeat imaging and thus certainly
affect the patient management plan (Level IV evidence); however, as is often the case
with small traumatic bleeds, the patient does not require neurosurgical intervention
(Jagoda 2009; Kuppermann 2009). Thus, one could argue that neuroimaging did not
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ultimately affect the patient’s outcome (Level V evidence). In other words, subsets of
patients who derive benefit at higher levels of the diagnostic evidence hierarchy are
usually less than the subset deriving measurable benefit from lower levels. Unfortunately,
clinicians often cannot distinguish in real-time which patients will benefit from imaging
and which will not.
Importantly, however, the traditional approach does not provide sufficient
guidance regarding whether, how, when, or why to address patient-centered outcomes,
particularly in chaotic, time-limited acute care situations such as those that occur in
emergency medicine. We suggest a modified approach to understanding the ultimate
value of emergency diagnostic imaging, one that involves patient-centered outcomes, and
integrates patient values and preferences in diagnostic imaging decisions (see Table 3,
right side).
To ensure that imaging efficacy is coupled with patient-centered care, we must
first work as a research community to develop tools that reliably and accurately measure
and assess patient-centered outcomes. This must be accomplished across a variety of
healthcare settings and include a diversity of patient populations with differing
experiences of access to care and patient/provider health literacy and numeracy ability
(Carpenter 2014; Griffey 2014). There is a broad spectrum of methodological tools, both
qualitative and quantitative, that can be rigorously applied to realize this goal, and to
address the topics and questions posed in this article (Fleurence 2015; Gabriel 2012;
Meisel 2012; Hickman 2013; Lee 2014)._
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Qualitative methods, ideally developed in collaboration with social scientists,
have recently been recognized as an essential component of radiology-related patientcentered outcomes research. They may be used to identify outcomes and issues most
important to patients (Lee 2014). For example, semi-structured interviews, focus groups,
and surveys that engage patients and their caretakers could be used to gain an in-depth
understanding of what outcomes are truly important to patients (Robey 2014; Sommers
2012; Karpas 2013). Mello and colleagues recently provided an overview of important
considerations for emergency medicine researchers doing survey research (Mello 2013),
and the value of qualitative techniques will be enhanced with a commitment to robust
methodology (Creswell 2012; Groves 2009; Remler 2011), including the use of welldesigned tools, high-yield sampling strategies, and excellent response rates.
At a minimum, such methods can be used to better understand what factors in
emergency imaging – whether related to efficient evaluation, anxiety, reassurance,
potential adverse effects, incidental findings, cost, or convenience – are noticed and
considered most important to patients. If done in a rigorous manner, such qualitative
techniques can be coupled with psychometric evaluation to develop validated patientreported outcome measures, as advocated by the National Institutes of Health (NIH)sponsored Patient Reported Outcomes Measurement Information Systems (PROMIS)
(PROMIS report; Cella 2007).
We distinguish patient-centered outcomes, as described in the introduction, from
patient-reported outcomes, which the U.S. Department of Health and Human Services
and the Food and Drug Administration define as “any report of the status of a patient’s
15
health condition that comes directly from the patient, without interpretation of the
patient’s response by a clinician or anyone else (Health Qual Life Outcomes 2006).”
Patient reported outcomes commonly assess patients’ satisfaction with care, the perceived
value of treatment, and health-related quality of life (Fleurence 2015; Calvert 2013). For
example, if initial investigations determine that anxiety surrounding diagnostic imaging is
important to patients – as related to a new diagnosis, an incidental finding, an incomplete
understanding of a radiology report, or a decision to pursue a period of observation
instead of immediate imaging – researchers could develop and/or use existing scales to
assess patient anxiety in this context. Patient reported outcomes with feedback to
physicians helps improve patient-physician communication and patient satisfaction (Chen
2013) which may enhance the overall patient experience and facilitate a shared view
between a patient and provider regarding care goals. Thus, developing and using valid,
reliable, patient-reported outcomes is one important component of advancing patientcentered care (Fleurence 2015).
Two principal features of radiology-related patient-centered outcomes research
entail an enhanced use of mixed methods techniques and head-to-head comparative trials
(Lee 2014). If done effectively and purposively, the combined use of qualitative and
quantitative research can lead to more insightful results than either methodology alone
(Lee 2014; Albright 2013). Additionally, such an approach can help elucidate why a
given recommended practice (e.g., ultrasound for initial evaluation of pediatric
appendicitis) is not implemented in a real-world setting and identify ways to overcome
barriers to successful implementation (e.g., increased ultrasound technician training and
expanded hours of availability) (Lee 2014).
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While qualitative techniques can help establish an improved understanding of
outcomes important to patients, quantitative methods essential to comparative
effectiveness research (CER) are needed to advance patient-centered care in emergency
imaging (Flourence 2015; Lee 2014; Meisel 2012; Montori 2012; Hickman 2013; Remler
2011). Outcome-driven, patient-oriented CER could include controlled studies,
experiments, quasi-experiments, randomized trials, secondary database analyses, and
systematic reviews to determine what work best between multiple approaches to
diagnostic imaging. For example, because any decision regarding medical imaging has its
own potential benefit/harm profile, comparing the influence of different risk
communication strategies on outcomes such as patient knowledge, understanding,
decision quality, and resource use would be invaluable. Similarly, experimental testing of
well-designed decision-aids is needed for imaging decisions, especially where clinical
equipoise exists. Incorporating patient/caregiver preferences and values into the decision
to image versus observe for certain pediatric patients after minor head injury, for
example, could facilitate improvement of outcomes most important to those
patients/caregivers.4 PCORI consistently highlights rigorous CER as essential to advance
and improve patient-centered care (Flourence 2015; Hickman 2013). Moreover, multiple
opportunities exist for CER involving diagnostic imaging in emergency medicine (Lee
2014; Meisel 2012; Montori 2012).
The final stage of all research is dissemination and implementation (Knowledge
Translation) of high quality, reliable clinical data to diverse healthcare settings. A
research agenda related to Knowledge Translation developed in another breakout session
is described elsewhere (reference AEM CC KT manuscript).
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All of the methodological approaches mentioned here would benefit from
stakeholder engagement, with true patient and community partnership throughout the
entire research process (Flourence 2015; Lee 2014; Hickman 2013; Wells 2009). This
approach will have many long-term benefits, including helping to identify what outcomes
are most valued by patients and how best to disseminate such information to the public
(Flourence 2015). It may also be worthwhile for researchers to collaborate with groups
such as PCORI (http://www.pcori.org/), the Informed Medical Decision Foundation
(http://www.informedmedicaldecisions.org/), the Preventing Overdiagnosis movement
(http://www.preventingoverdiagnosis.net/), and the Lown Institute Right Care Alliance
(http://lowninstitute.org/take-action/join-the-right-care-alliance/), given their ongoing
dedication towards similar efforts.
Finally, while we have focused largely on engaging patients in research aimed to
advance patient-centered care with respect to imaging, stakeholders at the provider and
health systems levels must also be engaged. Emergency physicians will play a critical
role in the success of these efforts, and helping them overcome perceived obstacles with
respect to over-imaging and patient engagement will be required (Kanzaria 2015a,
Kanzaria 2015b). However, input must also be sought from radiologists, consulting and
referring clinicians, and hospital leadership in the form of adequate infrastructure for
health information technology and care coordination.
Research Questions
1. When considering the impact of imaging on patient management, how
can the traditional (Fryback + Thornbury) frameworks for diagnostic
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efficacy accurately and reliably incorporate and measure patient-centered
care in the acute care setting?
2. Can we use patient-reported outcome assessment tools, developed and
validated in other settings, for diagnostic imaging in the emergency
department/acute care setting?
3. How can we use patient-reported outcome tools to advance patientcentered care?
4. How can comparative effectiveness research be used to advance patientcentered care in emergency imaging when comparing imaging modalities
that are both already considered efficacious?
5. Which stakeholders need to be engaged to enhance patient-centered
outcomes research on emergency diagnostic imaging?
6. What is an effective approach to identifying and engaging key
stakeholders?
7. How can patient and community stakeholders be better engaged in
patient-centered research efforts on diagnostic imaging in the emergency
department?
8. What is the optimal role of the patient or advocate in decision-making
(e.g., on obtaining imaging or not, on the selection of a given diagnostic
imaging study etc.) in the ED?
9. How can the NIH framework for dissemination and implementation be
adapted for diagnostic imaging in the emergency department so the
patient’s voice is heard through this process?
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10. How can uncertainty be communicated when there is limited evidence
about the best clinical evaluation strategy?
11. When limited evidence exists, how should this impact the decision to
engage patients in share decision-making around diagnostic imaging in
the ED? Specifically, should patients be engaged in shared decisionmaking when there is limited evidence on the best diagnostic approach? If
so, how can we accomplish this?
12. Given the uncertain external and internal validity of prognostic models,
when can shared decision-making investigators be sufficiently confident
in model-derived prognostic estimates to incorporate these estimates into
shared decision-making studies of patient-centered care?
13. When improved evidence becomes available, how should patient
decision-tools be updated? Can the older/inferior models be adapted, or
would new decision- tools need to be created?
14. How would updating the decision-aids with more refined or reliable
models impact the effectiveness of decision tools? Would these updates
compromise the prior patient-centered diagnostic efficacy research that
was based upon the inferior model?
What research methods facilitate the development and assessment of tools and
approaches to enhance risk/benefit communication and patient engagement?
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SDM was initially conceptualized as a single event in time, applied to a one-time
decision (e.g., total knee surgery) and a reasonable amount of time (i.e. days, weeks) to
engage in the process and make a decision. A decade ago, Montori and colleagues
focused on SDM in chronic care and highlighted the importance of the patient-clinician
partnership as a prerequisite for SDM in this setting.6 Inherent to decision making in this
context was the opportunity to use the experience of outcomes from prior choices or other
new information to revise decisions. Recently, SDM has been applied in the ED setting,
where time is of the essence and the importance of quickly establishing a patient-clinician
partnership are crucial to the decision-making process and patient care. (Pitts, Health
Affairs) The extent to which this newer conceptualization of SDM can be appropriately
measured with instruments developed for previous concepts of SDM is currently
unknown.
SDM should ensure evidence-based, patient-centered, high quality decisions.
Decision making quality outcomes hence reflect the extent to which patients are
knowledgeable about the current decision at stake, are clear about their values and
preferences in this context, are meaningfully engaged in the decision making process, and
are comfortable with the decision taken.7,8 Scholl and colleagues proposed a framework
mapping decision making quality according to decisional needs/ antecedents (prior to the
encounter), decision-making process (during the encounter), and decisional outcome
(post encounter/decision).9 Table 4 includes examples of validated measures associated
with each of these categories.
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To date, there is still no consensus as to the best decision-making quality outcome
or set of outcome measures. In a review of 35 SDM trials, Kryworuchko and colleagues
identified 35 unique primary outcome measures and eight different instruments,
highlighting challenges in the selection of relevant high quality outcome measures.20 The
most recent review of SDM instruments by Scholl and colleagues reported 28 measures
that had undergone psychometric testing.9 This review revealed the poor quality of
reporting of psychometric evaluation of these available instruments, limited validation of
most, and the need for a consistent measurement framework in the field. Moreover,
despite the patient-centered nature of SDM, patients and their clinicians have not
participated - to the best of our knowledge - in the development of currently available
patient-centered SDM outcome measures. These findings suggest poor agreement about
optimal SDM outcome measures and dissatisfaction with the ability of available
measures to validly measure SDM, let alone SDM in the fast-paced setting of the
emergency department.
To date, two of the most used scales in SDM remain the Decisional Conflict
Scale, 13 which assesses a patient’s decisional conflict defined as personal uncertainty
about which course of action to take when choice among competing options involves
risk, regret, or challenge to personal life values, and the OPTION scale, a third observer
scale that assesses the extent to which clinicians engage patients in the decision making
process.15{Couet, 2013 #6904}
The recent 2014 Cochrane Collaborative systematic review on patient decision
aids including 115 randomized trials reported that the use of decision aids increases
22
patients’ knowledge [mean difference (MD) 13.34 out of 100; 95% CI 11.17 to 15.51]
and the accuracy of risk perception (RR 1.82; 95% CI 1.52 to 2.16) and decreases the
proportion of patients who were passive in decision making (RR 0.66; 95% CI 0.53 to
0.81), or who decided to undergo major elective surgery in favor of more conservative
options (RR 0.79; 95% CI 0.68 to 0.93).8
Another systematic review by Flynn et al. found only 5 studies that aim to engage
patients in the decision-making process in the ED. Of those, only one trial evaluated a
decision aid for the emergency department, and there were no decisions aids for engaging
patients in the decision to undergo imaging.21 This trial reported increased patients’
knowledge [effect size, MD 0.67; 95% CI, 0.34-1.0] and an increase in engaged decision
making process [effect size, MD 19.6; 95% CI, 1.6-21.6].
In summary, the proliferation and variation of measures, and the largely untested
use of these measures in emergency settings provide significant opportunity for methods
development for patient-centered outcomes in emergency care research. Moreover,
because choices to obtain diagnostic imaging remain core decisions in emergency care,
patient-centered outcome measure development and validation that focus on acute care
diagnostic testing will doubtless add significant value to research and patient care in this
arena.
Research Questions
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1. Among the existing measures used to determine decisional needs, the quality of
the decision-making process itself and decisional outcomes, which are
potentially applicable for use in PCOR conducted in the ED setting?
2. What is the validity of the existing PCOR measures when applied in the ED
context?
3. Which of the applicable existing decision-making measures require refinement
(or development of new suitable measures) to optimally measure decisionmaking in the ED setting?
4. What key components of decision-making around diagnostic imaging in the ED
setting are inadequately captured by existing applicable measures?
5. What patient-reported outcomes applicable to emergency diagnostic imaging are
inadequately captured by existing decision-making measures?
6. How do we incorporate additional patient reported outcomes that go beyond
decisional outcomes?
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Table 1. Definition of Patient-centered Outcomes Research (PCOR) proposed by
the Patient Centered Outcomes Research Institute (PCORI) after considerable
patient, stakeholder, and public input and approved by the PCORI Board of
Governors on March 5, 2012.
PCOR helps people and their caregivers communicate and make informed healthcare
decisions, allowing their voices to be heard in assessing the value of healthcare options.
This research answers 4 patient-centered questions, such as:
1. “Given my personal characteristics, conditions, and preferences, what should I expect
will happen to me?”
2. “What are my options, and what are the potential benefits and harms of those options?”
3. “What can I do to improve the outcomes that are most important to me?”
4. “How can clinicians and the care delivery systems they work in help me make the best
decisions about my health and health care?”
To answer these questions, PCOR:
Assesses the benefits and harms of preventive, diagnostic, therapeutic, palliative, or
health delivery system interventions to inform decision-making, highlighting
comparisons and outcomes that matter to people;
Is inclusive of an individual's preferences, autonomy, and needs, focusing on outcomes
that people notice and care about such as survival, function, symptoms, and health-related
quality of life;
Incorporates a wide variety of settings and diversity of participants to address individual
differences and barriers to implementation and dissemination; and
Investigates (or may investigate) optimizing outcomes while addressing burden to
individuals, availability of services, technology, and personnel, and other stakeholder
perspectives.
25
Table 2. Factors potentially influencing the decision to obtain diagnostic imaging in
a given patient in the emergency department setting.*
Patient factors
Acuity
Decision-making capacity
Willingness to engage in the decision-making process
Socioeconomic, ethnic, and educational disparities
Clinician factors
Willingness to engage patients in shared decision-making
Cognitive load at that moment in time
Perceived equipoise of the decision
Understanding of the evidence relevant to the decision at hand
Ability to rapidly and succinctly recall and communicate the benefits and trade-offs of
the decision from a patient-centered perspective
Ability to create a safe environment so patients feel comfortable asking questions
regarding their management options
System/healthcare delivery context factors
Population responsibility
Undifferentiated symptoms: focus on diagnosis and disposition
Availability of follow-up structures
Time available to communicate with patients
Strengths and limitations of the scientific evidence base
Strength of the evidence establishing the benefits and trade-offs of the available
management options
Is the evidence base established on outcomes that matter to patients?
Availability of robust risk prediction tools to guide decision-making
Availability of decision aids to facilitate shared decision-making
Approaches to risk communication that best facilitate knowledge transfer and accurate
risk perception
*Modified from Hess et al.2
26
Table 3. Comparison of Traditional and Patient-Centered Model of Imaging
Efficacy
Traditional Approach to Diagnostic Imaging
Efficacy (Frybach 1991)
Level 1 – Technical
Efficacy
Is the technical quality of images high?
Example: An interpretable cranial computed
tomography (CT) scan can be obtained without
excessive radiation exposure to the patient.
Level 2 – Diagnostic
Accuracy Efficacy
Level 3 – Diagnostic
Thinking Efficacy
Example unchanged since this is a technical and not
patient-centric issue, however cannot proceed to
subsequent levels without this level of efficacy: An
interpretable cranial computed tomography (CT) scan
can be obtained without excessive radiation exposure to
the patient.
Does the imaging technique have excellent diagnostic
test characteristics?
Example: The cranial CT distinguishes
intracranial hemorrhage from no intracranial
hemorrhage in trauma patients, but whether this
diagnostic accuracy changes subsequent clinical
actions or outcomes is not the issue.
Example unchanged since this is a technical and not
patient-centric issue, however cannot proceed to
subsequent levels without this level of efficacy: The
cranial CT distinguishes intracranial hemorrhage from
no intracranial hemorrhage in trauma patients, but
whether this diagnostic accuracy changes subsequent
clinical actions or outcomes is not the issue.
Does the imaging result produce a change in the
physician’s diagnostic thinking?
Do patient-centered outcomes, as well as patient values
and preferences, influence the physician’s approach to
diagnostic imaging?
How does the imaging study affect the patient
management plan?
Example: The subset of patients identified by the
cranial CT (who would otherwise not have been
identified) have an available therapy or action that
would have been neglected or less likely were they
not identified by the cranial CT, but whether the
intervention improves outcomes is not the issue.
Level 5 – Patient
Outcome Efficacy
Is the technical quality of images adequate to lead to a
diagnosis?
Does the imaging technique have excellent
diagnostic test characteristics?
Example: The cranial CT identifies subsets of
patients with traumatic intracranial hemorrhage
that existing, traditional, often cheaper and more
readily available diagnostic tests like history,
physical exam, and clinician gestalt would not
already identify, but whether this new knowledge
creates actionable steps is not the issue.
Level 4 –
Therapeutic
Efficacy
Patient-Centered Approach to Diagnostic Imaging
Efficacy
Can we measure the effect of imaging on the
patient outcome?
Example: In contemplating whether or not to order the
cranial CT to identify subsets of patients with traumatic
intracranial hemorrhage that existing, traditional, often
cheaper and more readily available diagnostic tests like
history, physical exam, and clinician gestalt would not
already identify, test-ordering clinicians incorporate
patient values, preferences, and outcome goals.
How do patient-centered outcomes, as related to
available therapies based on diagnostic imaging,
influence the patient management plan?
Example: In evaluating whether or not to order the
cranial CT, test-ordering and treating clinicians
contemplate the subset of patients who may not
otherwise be identified, and these clinicians incorporate
patient-centered outcomes in contemplating next steps
with any CT finding before ordering the CT.
Can we measure the effect of imaging on patientcentered outcomes?
27
Level 6 – Societal
Efficacy
Example: The newly identified subset of patients
who receive the intervention derive some
measurable benefit, but this benefit might be a
surrogate measure or of lesser importance to
patients.
Example: In both a) evaluating whether or not to order
the cranial CT, and in b) obtaining a CT to identify the
subset of patients who receive the intervention and will
derive some measurable benefit, clinicians contemplate
and ascertain patient-centric outcomes like pain,
disability, and mortality.
Can we analyze societal costs and benefits of
diagnostic imaging technology?
Can we analyze both individual and societal costs,
harms, and benefits of diagnostic imaging technology?
Example: The subset of patients who are newly
identified, receive the subsequent intervention, and
derive measurable (albeit not necessarily patientcentric) benefit ultimately also benefit society in
terms of less lost work-days, less healthcare
dollars spent, or reduced disability.
Example: The subset of patients who are newly
identified, receive the subsequent intervention, and
derive measurable patient-centric benefit ultimately also
benefit society in terms of less lost work-days, less
healthcare dollars spent, or reduced disability.
28
Table 4. Validated measures of decisional quality according to decisional needs/
antecedents (prior to the encounter), the decision-making process (during the encounter),
and decisional outcome (post encounter/decision).
Decisional needs/
antecedents
Control Preference Scale10
Preparation for decision
making scale11
Decision self-efficacy
Scale12
Decision-making process
Decisional Conflict Scale13
Knowledge14
OPTION Scale15
SDMQ-916
Decisional outcome
Decisional Regret Scale17
Satisfaction with decision
Scale18
COMRADE scale19
29
Figure 1: Hierarchy of Diagnostic Efficacy Venn Diagram. Diagnostic tests (whether
history, physical exam, labs or imaging) attain different levels of efficacy and impact different proportions
of patients depending upon the outcome. In radiology, the first level of efficacy is the ability to obtain and
interpret images. All subsequent levels of efficacy must attain this first level, but not all patients in whom
Level I efficacy are attainable will benefit from higher levels. This Venn diagram depicts the concept that
each higher level of efficacy described in Table 3 loses a portion of patients from the preceding lower level
of efficacy. How many patients lose benefit as higher levels of efficacy are attained is unknown and
probably varies from study-to-study and across populations. Need to obtain permission to reproduce this
Figure.
Level I
Images Obtainable & Reliably
Interpreted
Level II
Images Accurately Rule-In or
Rule-Out Diagnosis
Level III
Image Results Alter Subsequent Physician
Diagnostic and/or Therapeutic Options
Level IV
Available & Acceptable Therapy with Any
Measurable Outcomes for Subset Now
Diagnosed Who Would Otherwise Be Missed
Level V
Patient-Centric Therapeutic
Benefits Measurable
Level VI
Societal Level
Benefits Measurable
30
Figure 2: The National Institute of Health Framework for Dissemination and
Implementation Research
31
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