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Original article
Original article
Reporting of Diagnostic Accuracy principles.11 We prospectively otolaryngologists (TaF and KI) classified the findings according
recruited consecutive adult patients (>15 years old) whom had to Katori’s laryngoscopic grading system: grade 1: the patient’s
undergone LNR to evaluate supraglottitis. LNR were performed epiglottis is slightly swollen with the entire length of the vocal
if patients had a sore throat, odynophagia, drooling, voice folds visible by scope; grade 2: the patient’s epiglottis is moder-
change or dyspnoea. The emergency department physicians ately swollen with more than half of the posterior vocal folds
decided whether the patients needed LNR, and trained radio- visible by scope; and grade 3: the patient’s epiglottis is severely
logical technologists performed the LNR. Nasopharyngeal laryn- swollen with less than half of the posterior vocal folds visible by
goscopy was performed in patients with radiographic scope (figure 1).14 Emergency department physicians decided
abnormalities, as well as in those without abnormalities but in whether to prescribe antibiotics before or after the laryngoscopy
whom the emergency physician still suspected supraglottitis. All or if the patient did not undergo the procedure. For those who
enrolled patients were followedup by telephone interview after did not undergo nasopharyngeal laryngoscopy during the visit,
7–30 days. Planned exclusions were patients who did not provide we conducted a follow-up telephone interview after 7 days
consent or who were not followed up by telephone interview. because supraglottitis generally worsens within 7 days. If we did
For each enrolled patient, data on patient characteristics, not reach participants at this time, we called repeatedly in an
symptoms and the presence of supraglottitis were collected from attempt to reach them within 30 days of the visit. If the patient’s
the medical records. The institutional review board of Kurashiki symptoms had resolved, we defined the outcome as negative for
Central Hospital approved the study. supraglottitis. If the patient visited the emergency department
In contrast with therapeutic or interventional studies, formal repeatedly, we defined the outcome as positive or negative based
sample size calculations based on power assumptions for diag- on the diagnosis at the subsequent emergency department visits.
nostic modelling cohort studies do not exist. As we intended to We also asked whether patients were prescribed antibiotics from
roughly calculate the sensitivity and specificity of LNR in the other hospitals or physicians.
clinical setting, we defined the sample size as 18 patients with
supraglottitis; this number is similar to the numbers in previous
Statistical analysis
studies.5–7 The incidence of supraglottitis in adults is 1–3 per
Using the laryngoscopic diagnosis of supraglottitis or the tele-
100 000/year.12 13 Kurashiki Central Hospital is an urban hos-
phone interview as the standard, we calculated the test
pital that serves 800 000 people in the western area of Okayama
characteristics (sensitivity, specificity, predictive value and likeli-
prefecture, and there are approximately 70 000 visits to the hos-
hood ratios) of LNR with 95% CI using the normal approxima-
pital emergency department annually. At Kurashiki Central
tion. All statistical analyses were performed using SPSS software
Hospital, 10–15 patients with supraglottitis were hospitalised
V.19.0 (SPSS Inc, Chicago, Illinois, USA). The first author (TaF)
annually from 2000 to 2010, and about 20% were diagnosed
had full access to all study data and analyses.
without LNR. We set a 2 year study duration to enroll a suffi-
cient number of patients with disease.
RESULTS
From 16 April 2011 to 31 March 2013, 140 LNR were per-
Index and reference standard formed to rule out supraglottitis, and 105 LNR met the inclu-
The index test was the LNR. A trained radiological technologist sion and exclusion criteria of the study. Thirty-five patients
performed all LNR. One emergency physician (HO) and one (25%) were excluded because they did not give consent. No
radiologist (YO) independently interpreted each LNR. HO and patient had respiratory obstruction precipitated by LNR.
YO were blind to the patient’s history, symptoms and laryngo- Nasopharyngeal laryngoscopy was performed in 71 (67.6%)
scopic results. Disagreement was resolved by discussion, and the patients, 34 (32.4%) patients were followed-up by telephone
presence of a ‘thumb sign’ and ‘vallecula sign’ were recorded. interview. (figure 2). The characteristics and symptoms of the
Interobserver differences between HO and YO were analysed 105 enrolled patients are shown in table 1.
using k statistics, including 95% CI. Twenty-nine patients had positive LNR. Interobserver agree-
The reference standard was the findings of nasopharyngeal ment for the thumb sign was substantial, at 92.1% (12.1%
laryngoscopy or follow-up telephone interview after 7 days. agreement on positive ratings and 80.0% agreement on negative
The laryngoscopies were performed in the emergency depart- ratings), with a κ value of 0.71 (95% CI 0.55 to 0.87).
ment or otolaryngology department by otolaryngologists. Two Interobserver agreement for the vallecula sign was substantial, at
Figure 1 Katori’s scope grading of supraglottitis. (A) Grade 1: the patient’s epiglottis is slightly swelled and the entire length of the vocal folds
can be seen with the scope. (B) Grade 2: the patient’s epiglottis is moderately swelled and more than half of the posterior vocal folds can be seen
with the scope. (C) Grade 3: the patient’s epiglottis is severely swelled and only less than half of the posterior vocal folds can be seen with the
scope.
Fujiwara T, et al. Emerg Med J 2015;32:348–352. doi:10.1136/emermed-2013-203340 349
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Original article
92.9% agreement (13.6% agreement on positive ratings and department physicians in four cases before the subsequent laryn-
79.3% agreement on negative ratings), with a κ value of 0.75 goscopy, while six patients who did not undergo laryngoscopy
(95% CI 0.60 to 0.90). Of the 29 patients with an abnormal were treated with antibiotics.
radiograph, 26 underwent LNR and 3 were discharged by the A radiographic abnormality was seen in 57.1% of the radio-
emergency physician. Of the 76 patients with a normal radio- graphs with grade 1 supraglottitis. Four patients (19%) with
graph, 45 underwent LNR and the rest were discharged. Among supraglottitis had false negative LNR; 3 of these were grade 1.
patients who had normal LNR and were discharged with phone All patients with grade 3 supraglottitis, which is an indication
follow-up, 71.0% had a sore throat and 41.9% had odynopha- for artificial airway management,15 had an abnormality on x-ray
gia, while among those who had a normal x-ray and laryngos- (positive thumb or vallecula sign).; 87.5% (7/8) of grade 2
copy, 100% had a sore throat and 68.9% had odynophagia. In supraglottitis patients had detectable radiographic abnormalities.
sum, 71 patients underwent laryngoscopy, and supraglottitis was (table 2). In all patients who were followed-up by telephone
diagnosed in 21 (grade 1=7, grade 2=8, grade 3=6) (table 2), interview, symptoms had resolved.
for a total incidence of 20% (figure 2). Supraglottitis was diag- The test characteristics of the LNR using the final interpret-
nosed in 17 of the 26 (65%) patients who had abnormal x-rays, ation agreed on by both the emergency physician and radiologist
and four of the patients (13%) who had normal xrays. No are displayed in Table 3. The LR positive of the LNR was 5.67
patients who were discharged had supraglottitis. (95% CI 3.27, 9.82) and the LR negative was 0.22 (95% CI
Half of the laryngoscopies were performed within 1 h of the 0.10, 0.51). The sensitivity of the emergency physician's inter-
LNR. The median time interval from LNR to laryngoscopy was pretation was slightly higher than the radiologist's 81% (62.2,
1 h (mean±SD, 3.6±5.2). Laryngoscopies were delayed in 97.8) vs. 66.7% (95% CI 46.5, 86.8), but specificity was similar
patients who had normal radiographs and were less likely to (84.5% vs. 85.7%).
have supraglottitis and in those who underwent radiographs on Six of the patients with negative LNR who did not undergo
the weekend. All of the laryngoscopies were performed within larygnoscopy were treated with antibiotics. The diagnoses of
24 h of the LNR. Antibiotics were prescribed by emergency these patients were acute pharyngitis (n=4), tonsillitis (n=1)
and intestinal perforation (n=1). We could not be certain if
these six patients had supraglottitis. If we re-analysed the results
Table 1 Demographics and clinical symptoms of enrolled patients without these six patients, specificity decreased from 85.7% to
84.6 (76.6 to 92.6)%.
Enrolled Laryngoscope Telephone
patients follow-up interview
(n=105) (n=71) follow-up (n=34) DISCUSSION
In this prospective study, LNR had relatively low sensitivity and
Age (years) 42.8±18.1 43.8±17.6 40.7±19.1
specificity for supraglottitis in adults. Previous studies reported
Males (n (%)) 56 (53.3) 43 (60.6) 13 (38.2)
a sensitivity and specificity of the classic thumb sign of 83–
Symptoms (n (%))
100% and 87–100%, respectively.6 8 In 1997, Ducic et al7
Sore throat 95 (90.5) 70 (98.6) 25 (73.5)
reported a new radiographic sign, vallecula sign, which had
Odynophagia 69 (65.7) 53 (74.6) 16 (47.1)
98.2% sensitivity and 99.5% specificity in their report. Based
Dyspnoea 13 (12.4) 5 (7.0) 8 (23.5)
on these findings, some authors suggested that the LNR might
Voice change 8 (7.6) 8 (11.3) 0 (0.0)
obviate the use of routine laryngoscopy. However, these retro-
Fever (37.5°C) 40 (38.1) 26 (36.6) 14 (41.2)
spective studies were at high risk of overestimating the diagnos-
Enrolled patients (n=105) included patients followed by laryngoscopy (n=71) and tic value, and no validation study of the vallecula sign has been
those followed by telephone (n=34).
reported.
350 Fujiwara T, et al. Emerg Med J 2015;32:348–352. doi:10.1136/emermed-2013-203340
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Original article
Sensitivity (%) 81.0 (64.2 to 97.8) 66.7 (46.5 to 86.8) 71.4 (52.1 to 90.8)
Specificity (%) 85.7 (78.2 to 93.2) 94.0 (89.0 to 99.1) 88.1 (81.2 to 95.0)
Positive predictive value (%) 58.6 (40.7 to 76.5) 73.7 (53.9 to 93.5) 60.0 (40.8 to 79.2)
Negative predictive value (%) 94.7 (89.7 to 99.8) 91.9 (86.1 to 97.6) 92.5 (86.7 to 98.3)
Positive likelihood ratio 5.67 (3.27 to 9.82) 11.2 (4.74 to 26.5) 6.00 (3.21 to 11.20)
Negative likelihood ratio 0.22 (0.10 to 0.51) 0.35 (0.20 to 0.63) 0.32 (0.17 to 0.62)
Values are median (95% CIs).
Original article
Emerg Med J 2015 32: 348-352 originally published online August 20,
2014
doi: 10.1136/emermed-2013-203340
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Notes