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Arandomized trial examining the effect of pretreatment point-of-care computed tomography imaging on the management of patients with chronic rhinosinusitis symptoms.

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ORIGINAL ARTICLE
A randomized trial examining the effect of pretreatment point-of-care
computed tomography imaging on the management of patients with chronic
rhinosinusitis symptoms
Bruce K. Tan, MD, Rakesh K. Chandra, MD, David B. Conley, MD, Robin Smolak Tudor, PA-C,
Robert C. Kern, MD
Background: Recent consensus statements on the diagnosis of chronic rhinosinusitis (CRS) now require endoscopic
or radiographic evidence of paranasal sinus inflammation.
The timing of point-of-care (POC) computed tomography
(CT) scan in the workup of these patients remains to be
elucidated, particularly when endoscopy is negative. The
objective of this research was to prospectively evaluate
2 algorithms for the initial management of patients with
symptoms of CRS who manifest a normal nasal endoscopic
examination.
Methods: A total of 40 such patients were randomized to 1
of 2 pathways: POC-CT at the initial visit followed by medical therapy based upon CT results (pre-CT group; n = 20),
or empiric medical therapy (EMT) followed by POC posttreatment CT if symptoms persisted (EMT group; n = 20).
Results: The 2 groups were demographically and symptomatically similar with regard to 2003 Task Force major
criteria. Otolaryngology follow-up was recommended in 11
of 20 pre-CT patients, all of whom (100%) returned. In contrast, only 10 of 20 EMT patients (50%) followed up as instructed (p < 0.05). Radiographic confirmation of CRS was
found in 8 of 20 pre-CT patients, and only 2 of 9 patients
T
he availability of cone beam computed tomography
(CT) and the miniaturization of CT technology currently allows the rapid acquisition of high-resolution images of the paranasal sinuses at the point of service in the
Department of Otolaryngology, Head and Neck Surgery, Northwestern
University Feinberg School of Medicine, Chicago, IL
Correspondence to: Bruce K. Tan, MD, Assistant Professor, Department of
Otolaryngology–Head and Neck Surgery, Northwestern University Feinberg
School of Medicine, 676 N. St. Clair, Suite 1325, Chicago, IL 60611; e-mail:
btan@nmff.org
Potential conflict of interest: None provided.
Received: 30 August 2010; Revised: 30 November 2010; Accepted: 7
December 2010
DOI: 10.1002/alr.20044
View this article online at wileyonlinelibrary.com.
229
International Forum of Allergy & Rhinology, Vol. 1, No. 3, May/June 2011
aer EMT (p = 0.61). EMT patients received more antibiotic
prescriptions (relative ratio [RR], 2.50; 95% CI, 1.46–4.27),
while pre-CT patients received more CT scans (RR, 2.22;
95% CI, 1.37–3.61). Overall prescriptions costs were similar
to the EMT group ($253 vs $218; p = 0.37) and the overall
number of otolaryngology visits was similar.
Conclusion: In patients with symptoms of CRS but negative endoscopy, POC at initial presentation results in substantially less unnecessary antibiotic prescriptions and significantly greater compliance with otolaryngology care but
does result in a higher utilization of radiographic imaging.
C 2011 ARS-AAOA, LLC.
Key Words:
chronic rhinosinusitis; diagnostic imaging; physician’s practice paerns; point-of-care systems; sinusitis
How to Cite this Article:
Tan BK, Chandra RK, Conley DB, Tudor RS, Kern RC. A
randomized trial examining the effect of pretreatment
point-of-care computed tomography imaging on the management of patients with chronic rhinosinusitis symptoms.
Int Forum Allergy Rhinol, 2011; 1:229–234
otolaryngologist’s office. The information acquired enables
the physician to diagnose endoscopically undetectable sinus disease, assess the extent of sinusitis, and has applications for preoperative planning and intraoperative surgical
guidance. Additionally, this point of care CT (POC-CT) allows the physician to acquire information to direct precise
therapy and recognize otherwise intangible inflammation
during the patient encounter.1 In light of numerous studies
demonstrating a poor correlation between the symptoms
and the presence of inflammation in chronic rhinosinusitis
(CRS),2–6 both the American Academy of Otolaryngology–
Head and Neck Surgery (AAO-HNS) and the European
Position Paper on Rhinosinusitis have updated their definitions of CRS to require evidence of inflammation within
the paranasal sinuses.7,8
Tan et al.
Despite the current recommendations, clinical guidelines
do not provide guidance regarding the timing of a CT
scan for primary providers or otolaryngologists. Consequently, patients presenting with symptoms of CRS are
routinely treated with empiric medical therapy (EMT) consisting of antibiotics and/or corticosteroids prior to demonstrating objective evidence of inflammatory disease.9 This
phenomenon has significant implications regarding antibiotic overuse in this disease.10 Indeed, some payors still require documentation of failure of prior medical therapy
before permitting reimbursement for the use of CT imaging for the diagnosis of CRS. This study seeks to randomize
and prospectively investigate 2 alternative diagnostic algorithms for managing patients presenting with CRS symptoms patients who have no objective evidence of inflammation on nasal endoscopy with the aim of determining the
most effective means of managing these patients.
Patients and methods
Patients presenting to a tertiary care sinus and allergy practice were screened by 1 of 3 otolaryngologists for persisting
symptoms of CRS lasting at least 12 weeks as defined by the
2003 Task Force updated definitions of CRS.7 A complete
history and examination was obtained, followed by anterior rhinoscopy and nasal endoscopy to evaluate for the
presence of nasal polyps, middle meatal edema, purulent
drainage, or other intranasal pathology. Nasal endoscopy
was performed as follows: after prior application of atomized topical neosynephrine and xylocaine, a flexible nasal
endoscope was used in 3 passes to examine the floor of the
nasal cavity, middle meatus, and sphenoethmoid recesses,
respectively.
Exclusion criteria were prior sinus surgery or a definitive diagnosis of CRS through endoscopic exam or sinus
imaging within the previous 6 months. Previously treated
but persistently symptomatic patients were not excluded
from this study. After examination, eligible patients who
met Task Force criteria for CRS and had normal nasal endoscopy were offered enrollment in this study. Patients gave
informed consent to participate and had the risks and benefits of either diagnostic algorithm explained to them. They
were then randomized to either a pretreatment CT scan
(pre-CT) or EMT using a blocked randomization protocol
to ensure equal group sizes of 20. This protocol was approved by the Institutional Review Board of Northwestern
University Feinberg School of Medicine.
In the pre-CT group, patients received a diagnostic CT
scan at the time of the initial encounter in order to direct
medical therapy. Those with radiographic evidence of inflammation within the paranasal sinuses were offered an
extended course of broad-spectrum antibiotic therapy plus
appropriate anti-inflammatory medications. Patients without radiographic evidence of CRS were treated as medically
appropriate for other conditions (such as a deviated nasal
septum, vasomotor or allergic rhinitis), and those with
a significant atopic history were provided with referrals
to allergy-immunology. Patients with no radiographic evidence for CRS, in whom facial pain was a significant
complaint, were provided with neurology referrals. In
the EMT group, all patients were given a 3-week course
of broad-spectrum antibiotic therapy together with antiinflammatory medications and were encouraged to followup 4 to 6 weeks later. Persistently symptomatic patients
would be scanned using a POC-CT and the results of the
TM
scan used to direct further therapy. A XoranMiniCAT
flat-panel scanner (Xoran Technologies, Ann Arbor, MI)
using the 40-second protocol compatible with image guidance was used for all patients. The radiographic results and
images obtained from the CT scan were reviewed and discussed with the patients. For the purposes of this study, a
Lund-Mackay score of 3 or more was defined as positive.11
Within each group, demographic data, presenting symptoms, prescriptions, and posttreatment outcomes were retrospectively collected based on recorded histories. LundMackay scores were tabulated for each of the patients who
received a CT scan. Lund-Mackay scoring was performed
by a single otolaryngologist who was blinded to the patients’ group assignment. Medication costs were obtained
from the local Walgreens pharmacy and individually calculated for the prescriptions each patient received. Comparisons between groups were performed by the Fisher’s
exact test on constructed contingency tables and the Student t test where appropriate. All analysis was performed
using software provided by GraphPad Prism (La Jolla,
CA) and publically available online statistical tools (StatTools; http://obg.cuhk.edu.hk). A p value of less than 0.05
was considered statistically significant; the p values were
2-tailed.
Results
Patient characteristics
The 2 groups were similar with regard to age, gender distribution, and the recorded symptoms at presentation. Table 1
summarizes the patient characteristics in each group. There
was a female predominance noted in both groups, reflecting the clinical experience treating patients presenting for
evaluation of nonpolypoid CRS.12 The most common presenting symptom was nasal congestion followed by facial
pain and nasal discharge, respectively. There were more patients in the EMT group who had headaches as a presenting
complaint, but this did not reach statistical significance.
CT scan results
Patients in the pre-CT group all received a CT scan on
the date of initial evaluation as dictated by the protocol;
Figure 1 is a pictorial representation of these results. Of the
20 patients scanned, 8 (40%) had a positive study. In the
EMT group, only 10 patients returned to clinic following
completion of medical therapy and 9 had persistent symptoms; Figure 2 is a pictorial representation of these results.
Of the 9 scans performed for these patients, 2 (22%) were
International Forum of Allergy & Rhinology, Vol. 1, No. 3, May/June 2011
230
Effect of CT-scan for diagnosing CRS Symptoms
TABLE 1. Demographic and presenting symptoms of the
TABLE 2. CT scan utilization and radiographic findings
enrolled patients∗
Pre-CT, n (%)
EMT, n (%)
39
39
Male
7 (35)
4 (20)
Female
13 (65)
16 (80)
Total (n)
20
20
Congestion
17 (85)
16 (80)
Facial pain
14 (70)
12 (60)
Postnasal drip
12 (60)
13 (65)
Recurrent infection
5 (25)
5 (25)
Hyposomia/anosmia
3 (15)
2 (10)
Fatigue
3 (15)
3 (15)
Headaches
4 (20)
10 (50)
Average age (years)
Presenting complaint
∗
p < 0.05.
EMT = Empiric medical therapy followed by posttreatment imaging diagnostic
algorithm; Pre-CT = Pretreatment computed tomographic diagnostic algorithm.
positive. The average Lund-Mackay score of patients in
the EMT group who were scanned was 2.2 while those in
the pre-CT group had an average Lund-Mackay score of
2.65 (p = 0.65). As expected, patients in the pre-CT group
were more likely to receive more CT scans than patients
in the EMT group (relative ratio [RR], 2.2222; 95% CI,
1.3689–3.6076). The number of CT scans performed for
each radiographically proven case of CRS was 2.5 in the
pre-CT group and 4.5 in the EMT group. These results are
summarized in Table 2.
CT scans performed, n (%)a
Radiographic CRS, n (%)
Average L-M score
a
Pre-CT (n = 20)
EMT (n = 20)
20 (100)
9 (45)
8 (40)
2 (10)
2.7 ± 2.2
2.2 ± 3.3
p < 0.05.
CRS = chronic rhinosinusitis; EMT = empiric medical therapy followed by posttreatment imaging diagnostic algorithm; L-M, Lund-Mackay; Pre-CT = pretreatment computed tomography diagnostic algorithm.
Health resource utilization
In the pre-CT group, 9 of the 12 patients (75%) with negative scans were referred to neurology or their primary
providers for further workup and management of atypical
facial pain (Fig. 1). In the EMT group, neurology referrals
were made for 2 of the 7 patients with negative CT scans
(28.5%) (Fig. 2). Patients with negative scans in the pre-CT
group were more likely to receive referrals for atypical facial pain (p = 0.031). The frequency of allergy-immunology
referrals was similar. The treatment decisions and interventional outcomes by the consultant specialists were not
tracked in this study.
In the pre-CT group, the 8 patients who were found to
have radiographic evidence of CRS were treated as outlined above. Another 3 with negative scans were treated
with various anti-inflammatory medications (without antibiotics) and asked to follow-up after therapy. These 11
patients who received medical therapy all returned for posttherapy follow-up (Fig. 1). In the EMT group, 10 patients
did not return as instructed following medical therapy despite emphasizing the need for posttherapy evaluation. This
FIGURE 1. Scan results and treatment decisions for patients in the pre-CT diagnostic algorithm. pre-CT = pretreatment computed tomography.
231
International Forum of Allergy & Rhinology, Vol. 1, No. 3, May/June 2011
Tan et al.
resulted in a compliance rate of only 50% in the EMT
group, which was significantly less than that observed in
the pre-CT group, where 100% followed-up as instructed
(p = 0.004). Of the 10 patients that did return, 1 patient
reported complete relief from symptoms and did not receive further intervention, and among the remaining 9,
only 2 had evidence of inflammation on CT scan (Fig. 2).
Consequently, the average number of otolaryngology visits in the EMT group and the pre-CT group were grossly
similar (1.55 vs 1.71 clinical visits), although the EMT
group had higher rates of noncompliance with prescribed
care.
While this study was not designed to detect differences
in treatment efficacy, we collected data regarding the patients overall relief from their presenting symptoms. In the
EMT group, 6 of 14 contactable patients reported some
relief from their symptoms while 8 of 11 tracked patients in the pre-CT group reported some relief from their
symptoms (p = 0.589). Only 1 patient in each group had
medically refractory CRS requiring surgical management.
Table 3 presents a summary of the treatment compliance
and outcomes.
Medication utilization
In the EMT group, all patients received antibiotics as dictated by the protocol while only 8 of 20 patients received
antibiotics in the pre-CT group (RR, 2.5; 95% CI, 1.4616–
4.276). There was a trend toward higher utilization of topical antihistamine medications in the pre-CT group but this
did not reach statistical significance. The use of oral corticosteroids, oral antihistamines, antileukotriene, and pro-
TABLE 3. Patient compliance and treatment outcomes of
the pre-CT and EMT diagnostic algorithms
Pre-CT
EMT
0 (0)
10 (50)
Uncontactable, n (%)
0 (0)
6 (30)
Telephone follow-up only, n (%)
0 (0)
4 (20)
2 (18.2)
2 (14.3)
Compliance with care
Did not follow up as directed, n (%)a
Treatment outcome (% tracked patients)
Improved to baseline, n (%)
Partially improved, n (%)
6 (54.5)
4 (28.6)
No change, n (%)
2 (18.2)
7 (50.0)
Surgery, n (%)
1 (9.1)
1 (7.1)
11
14
Total patients tracked
a
p < 0.05.
EMT = empiric medical therapy followed by posttreatment imaging diagnostic
algorithm; pre-CT = pretreatment computed tomography diagnostic algorithm.
ton pump inhibitor medications was similar across groups.
The average total medication costs were slightly higher in
the EMT group compared with the pre-CT group ($253
vs $218, respectively, p = 0.36). The patients in the EMT
group spent more on antibiotics ($145 vs $53, p < 0.05) reflecting the higher rate of antibiotic utilization in this group.
However, patients in both groups spent a similar amount
($166 vs $121, p = 0.12) on nonantibiotic medications
such as oral and nasal corticosteroids, antihistamines, and
antileukotriene medications. Table 4 summarizes the medication utilization and costs within each group.
FIGURE 2. Treatment outcomes for patients in the EMT diagnostic algorithm. EMT = empiric medical therapy.
International Forum of Allergy & Rhinology, Vol. 1, No. 3, May/June 2011
232
Effect of CT-scan for diagnosing CRS Symptoms
TABLE 4. Health resource and medication utilization in
each diagnostic algorithm group
Pre-CT
EMT
Clinical visits
1.71
1.51
Neurology/PCP referrals, n (%)
9 (45)
2 (10)
Allergy referral, n (%)
7 (35)
5 (25)
Antibiotics, n (%)a
8 (40)
20 (100)
Antihistamine, n (%)
12 (60)
6 (30)
Medications
PPI, n (%)
0 (0)
1 (5)
Antileukotriene, n (%)
1 (5)
2 (10)
Nasal steroid, n (%)
16 (80)
15 (75)
Oral steroids, n (%)
6 (30)
7 (35)
Average medication costs
$218 ± $139
$253 ± $89
$53 ± $88
$153 ± $36
Average antibiotic costs
a
p < 0.05.
EMT = empiric medical therapy followed by posttreatment imaging diagnostic
algorithm; PCP = primary care physician; PPI, proton pump inhibitor; pre-CT =
pretreatment computed tomography diagnostic algorithm.
Discussion
Determining the optimal diagnostic algorithm for patients
with symptoms of CRS enables the otolaryngologist to direct patients to the most effective therapy for their condition. Previous studies by others demonstrate that only 53%
to 65% of patients meeting symptomatic criteria of CRS as
defined by the 1997 Task Force have radiographic evidence
of inflammation on CT scans.4,5,13 These studies examined
radiographic results in patients presenting for evaluation
of CRS symptoms regardless of endoscopic findings. Our
current study compared a pretreatment CT diagnostic algorithm against EMT, the current standard of care, for
evaluating a challenging group of patients who meet symptomatic criteria for CRS but have no evidence of inflammation on endoscopy. We emphasize that the results of
this study are not generalizable to all patients with rhinosinusitis complaints since the patients enrolled in this study
met AAO-HNS symptomatic criteria for CRS, and had an
endoscopic nasal examination demonstrating no evidence
of inflammation. We believe this study is the first study to
directly evaluate the effect of a diagnostic CT scan as a
component of the initial encounter upon the choice of therapeutic intervention, patient interaction, and medication
costs in a randomized controlled fashion.
Since all the patients enrolled in this study were examined
by an otolaryngologist and found to have negative endoscopic examinations, we had anticipated a low incidence of
radiographic proven CRS. Indeed, only 37% of the patients
who were scanned demonstrated evidence of inflammation.
As expected, these results are lower than the rate of positive radiographic findings in studies that examined symptomatic patients regardless of endoscopic findings. The low
positive predictive value of CRS symptoms is not surprising
233
International Forum of Allergy & Rhinology, Vol. 1, No. 3, May/June 2011
given the significant overlap between the symptomatology
of CRS and the various chronic forms of rhinitis (eg, vasomotor and allergic), atypical facial pain syndromes, and
migraines.14,15 For example, in radiographically-negative
and endoscopically-negative patients being evaluated for a
“sinus headache,” a recent study by Kari and DelGaudio12
demonstrated a response rate of 82% to triptans suggestive of the prevalence of migraine in this population. Other
population-based studies demonstrate that 88% of patients
with a physician-assigned or patient-assigned diagnosis of
“sinus headaches” meet the International Headache Society
(IHS) guidelines for migraine headaches.16
This study reveals that for endoscopically-negative patients with positive CRS symptoms, utilizing a POCCT scan during the initial encounter reduces unnecessary antibiotic prescriptions by 60%. These patients
were subsequently redirected toward nonantibiotic-based
therapies appropriate for migraine headaches and rhinitis. These treatments differ significantly from that of
chronic sinusitis therapy, as migraine therapy emphasizes the use of migraine preventive and abortive medications whereas rhinitis therapy emphasizes identification of
rhinitic triggers, immunomodulation, and other pharmacologic interventions.8,17 In light of recent studies demonstrating particularly high rates of antibiotic overutilization in treating sinusitis, the results of this diagnostic
randomized trial illustrate the extent to which pretreatment
CT scan can help otolaryngologists avoid fostering drugresistant microorganisms and reduce the risks of side effects
from unindicated antibiotics.10 Due to the small size of this
clinical trial, study design and the high rate of medical noncompliance, this study was unable to measure the effect of
a pre-CT scan on therapeutic success. A further limitation
of this study was that it was not powered, or designed, to
evaluate quality-of-life improvements and rates of symptomatic resolution using either treatment arm. However,
we are confident that directing patients toward the appropriate therapy for their illness ultimately improves patient
outcomes and therapeutic success.
An unanticipated finding in this study was the effect that
a pretreatment POC-CT scan had upon improving patient
compliance with follow-up care. We observed that 100%
of patients treated medically in the pre-CT group returned
for follow-up when directed to, while 50% of those receiving EMT were lost to follow-up despite repeated encouragement to return. We believe this difference stems
from the effect of POC-CT scanning has on promoting disease understanding and subsequent willingness to adhere
to the prescribed medical therapy. In the pre-CT group,
CRS patients had radiographic evidence for inflammation
illustrated to them during the clinical encounter while those
who had no evidence of CRS had visual evidence for completely normal, aerated sinuses to help them redirect their
attention toward seeking alternative therapeutic avenues. In
the EMT group, we suspect that many patients did not adhere to prescribed medical therapy because it was either not
efficacious, or because the prescribed medical therapy was
Tan et al.
similar to their prior experience with unsuccessful medical
therapy. It is doubtful that the patients in the EMT group
who were lost to follow-up had a complete resolution of
their symptoms since all 4 patients contacted by telephone
reported persistent symptoms. However, another possibility that cannot be excluded is a negative psychological effect
in which the EMT group patients felt they received suboptimal care after being informed of the benefits of a pre-CT
algorithm. Regardless, it was interesting to the authors that
the high rate of medical noncompliance in the EMT group
resulted in similar numbers of otolaryngology clinic visits as in the pre-CT group, even though all the patients in
the EMT group were expected to be evaluated twice by an
otolaryngologist.
In this study, the pre-CT diagnostic strategy did result
in twice as many CT scans as the group treated using
EMT—although this was largely driven by the high rate of
nonreturning patients in that group. This result highlights
the need for minimizing the radiation exposure involved,
particularly when using a pre-CT algorithm. In our study,
a cone beam CT scan was used, delivering an averaged
absorbed dose of 0.17 mSv, which is significantly lower
than the typical doses from a conventional CT scanner.1
In addition to radiation exposure, the pre-CT diagnostic
strategy will result in approximately double the radiologyassociated costs, which is not fully offset by the nonsignificant decrease in medications costs as illustrated in this
study. This finding supports a previous retrospective cost
analysis study by Stankiewicz and Chow18 that similarly
demonstrated that an EMT algorithm was marginally less
costly but significantly more inaccurate and resulted in
higher levels of unnecessary antibiotics. Based on our study
design, we would also have predicted a higher number of
clinical visits in the EMT group since all patients using that
algorithm were scheduled for 2 clinical visits. However, as
our results suggest, the 2 diagnostic algorithms resulted in
a similar number of clinical visits since one-half of the patients in the EMT group failed to follow-up after completing medical therapy. These considerations should further
be weighed against the intangible benefits of minimizing
the development of antibiotic resistance resulting from the
high rate of unnecessary antibiotic use in these patients.
Conclusion
A diagnostic algorithm employing a pretreatment POC-CT
scan for evaluating a patient with CRS symptoms but normal nasal endoscopy during the initial encounter results
in significantly lower antibiotic overuse and higher rates of
compliance to medical therapy. Clinical resource utilization
associated with this diagnostic strategy is similar to employing EMT prior to imaging although this was largely driven
by a significantly higher rate of nonreturning patients. Radiology utilization and consequent radiation exposure is
higher using this strategy but these risks may be mitigated
through the use of lower-emission CT scans, better patient
compliance, more accurate selection of medical therapy,
and decreased antibiotic overuse.
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