Antibiotic use and serious complications following acute otitis media and acute sinusitis: a retrospective cohort study

Rebecca Cushen; Nick A Francis

doi:10.3399/bjgp20X708821

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Figure 1.
CONSORT flow diagram for acute otitis media (AOM). CONSORT = Consolidated Standards of Reporting Trials. CPRD = Clinical Practice Research Datalink.
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Figure 2.
CONSORT flow diagram for acute sinusitis (AS). CONSORT = Consolidated Standards of Reporting Trials. CPRD = Clinical Practice Research Datalink.

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Concern about reducing the risk of serious complications can drive antibiotic prescribing for common infections, such as acute otitis media (AOM) and acute sinusitis (AS), and use of antibiotics is the major driver of antibiotic resistance. The association between use of antibiotics for AOM and AS, and the subsequent risk of acute mastoiditis, brain abscess, and orbital cellulitis, has not been adequately explored. This study demonstrates that these serious complications are extremely uncommon. Antibiotic use was associated with a lower risk of acute mastoiditis following AOM and brain abscess following AS, but for both conditions thousands of patients would need to be treated to prevent a single instance of one complication.

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Table 1.

Baseline characteristics of the acute otitis media cohort

Characteristic, n (%)	Whole sample, N = 286 574	Prescribed antibiotics, N = 249 086 (86.9%)	Not prescribed antibiotics, N = 37 488 (13.1%)
Sex
Male	140 787 (49.1)	122 352 (49.1)	18 435 (49.2)
Female	145 787 (50.9)	126 734 (50.9)	19 053 (50.8)

Age, years
Median^a	6	6	6
Interquartile range	3–20	3–19	3–23

Age, years
0–2	55 999 (19.5)	49 262 (19.8)	6737 (18.0)
3–5	72 164 (25.2)	62 704 (25.2)	9460 (25.2)
6–10	55 968 (19.5)	48 226 (19.4)	7742 (20.7)
11–20	32 318 (11.3)	28 577 (11.5)	3741 (10.0)
21–30	16 050 (5.6)	13 984 (5.6)	2066 (5.5)
31–40	18 510 (6.5)	16 029 (6.4)	2481 (6.6)
41–50	14 040 (4.9)	12 095 (4.9)	1945 (5.2)
51–60	10 427 (3.6)	8954 (3.6)	1473 (3.9)
61–70	6527 (2.3)	5543 (2.2)	984 (2.6)
71–80	3334 (1.2)	2731 (1.1)	603 (1.6)
≥81	1237 (0.4)	981 (0.4)	256 (0.7)

Asplenic	47 (0.02)	45 (0.02)	2 (0.005)
Chronic kidney disease	95 (0.03)	81 (0.03)	14 (0.04)
CSF shunt	61 (0.02)	49 (0.02)	12 (0.03)
HIV	15 (0.005)	14 (0.006)	1 (0.003)
Immunocompromised	151 (0.05)	137 (0.06)	14 (0.04)
Smoker	14 990 (5.2)	12 948 (5.2)	2042 (5.4)
Transplanted organ	89 (0.03)	78 (0.03)	11 (0.03)
Diabetes mellitus	3485 (1.2)	2980 (1.2)	505 (1.3)

↵a Median was used to describe summary of age as data were skewed to the left. CSF = cerebrospinal fluid.

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Table 2.

Baseline characteristics of the acute sinusitis cohort

Characteristic, n (%)	Whole sample N = 441 873	Prescribed antibiotics N = 407 030 (92.1%)	Not prescribed antibiotics N = 34 843 (7.9%)
Sex
Male	124 781 (28.2)	113 934 (28.0)	10 847 (31.1)
Female	317 091 (71.8)	293 096 (72.0)	23 995 (68.9)
Unknown	1 (0.0002)	0 (0)	1 (0.002)

Age, years
Mean	45.6	45.8	43.8
SD	16.4	16.4	16.4

Age, years, n (%)
0–2	342 (0.1)	314 (0.1)	28 (0.1)
3–5	832 (0.2)	732 (0.2)	100 (0.3)
6–10	2835 (0.6)	2479 (0.6)	356 (1.0)
11–20	22 281 (5.0)	19 968 (4.9)	2313 (6.6)
21–30	53 078 (12.0)	47 976 (11.8)	5102 (14.6)
31–40	99 511 (22.5)	91 277 (22.4)	8234 (23.6)
41–50	95 828 (21.7)	89 020 (21.9)	6808 (19.5)
51–60	81 055 (18.3)	75 465 (18.5)	5590 (16.0)
61–70	54 158 (12.3)	50 442 (12.4)	3716 (10.7)
71–80	24 418 (5.5)	22 549 (5.5)	1869 (5.4)
≥81	7535 (1.7)	6808 (1.7)	727 (2.1)

Asplenic	285 (0.1)	266 (0.1)	19 (0.1)
Chronic kidney disease	472 (0.1)	437 (0.1)	35 (0.1)
CSF shunt	102 (0.02)	94 (0.02)	8 (0.02)
HIV	73 (0.02)	67 (0.02)	6 (0.02)
Immunocompromised	681 (0.2)	631 (0.2)	50 (0.1)
Smoker	82 188 (18.6)	76 006 (18.7)	6182 (17.7)
Transplanted organ	326 (0.1)	301 (0.1)	25 (0.1)
Diabetes mellitus	19 477 (4.4)	18 077 (4.4)	1400 (4.0)

CSF = cerebrospinal fluid.

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Table 3.

Association between antibiotic prescription and complications

Complication	Complications, n			Incidence^a (95% CI)			OR (95% CI)
Complication	Total	Antibiotics	No antibiotics	Overall incidence	Antibiotics	No antibiotics	Crude	Adjusted^b	NNT
Brain abscess following AOM	1	1	0	0.03 (0.01 to 0.20)	0.04 (0.03 to 0.05)	N/A	N/A	N/A	N/A
Acute mastoiditis following AOM	161	125	36	5.62 (4.81 to 6.56)	5.02 (4.21 to 5.98)	9.60 (6.94 to 13.29)	0.52 (0.36 to 0.76)	0.54 (0.37 to 0.79)	2181 (1196 to 5709)
Brain abscess following AS	5	3	2	0.11 (0.05 to 0.26)	0.07 (0.03 to 0.22)	0.57 (0.16 to 2.10)	0.13 (0.02 to 0.77)	0.12 (0.02 to 0.70)	19 988 (4951 to 167 099)
Orbital cellulitis following AS	66	57	9	1.50 (1.17 to 1.90)	1.40 (1.08 to 1.81)	2.58 (1.36 to 4.91)	0.54 (0.27 to 1.10)	0.56 (0.27 to 1.12)	N/A

↵a Per 10 000 AOM/AS primary care consultations.
↵b Adjusted for patient’s age at the time of consultation. AOM = acute otitis media. AS = acute sinusitis. CI = confidence interval. N/A = not applicable. NNT = numbers needed to treat. OR = odds ratio.

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Table 4.

Association between antibiotic prescription and complications in those aged ≤20 years and >20 years

Patients aged ≤20 years
Complication	Complications, n			Incidence^a (95% CI)			OR (95% CI)	NNT (95% CI)
Complication	Total	On antibiotics	No antibiotics	Overall incidence	On antibiotics	No antibiotics	OR (95% CI)	NNT (95% CI)
Acute mastoiditis following AOM	81	61	20	3.74 (3.01 to 4.65)	3.23 (2.52 to 4.15)	7.23 (4.68 to 11.16)	0.45 (0.27 to 0.74)	2504 (1251–7776)
Brain abscess following AS	0	N/A	N/A	N/A	N/A	N/A	N/A	N/A
Orbital cellulitis following AS	13	8	5	4.94 (2.89 to 8.46)	3.41 (1.73 to 6.72)	17.88 (7.64 to 41.78)	0.19 (0.06 to 0.58)	691 (260–2695)

Patients aged >20 years
Complication	Number of complications			Incidence^a (95% CI)			OR (95% CI)	NNT (95% CI)
Complication	Total	On antibiotics	No antibiotics	Overall incidence	On antibiotics	No antibiotics	OR (95% CI)	NNT (95% CI)
Acute mastoiditis following AOM	80	64	16	11.41 (9.17 to 14.19)	10.61 (8.31 to 13.55)	16.31 (10.04 to 26.48)	0.65 (0.37 to 1.13)	N/A
Brain abscess following AS	5	3	2	0.12 (0.11 to 0.13)	0.08 (0.07 to 0.09)	0.62 (0.54 to 0.72)	0.13 (0.02 to 0.75)	18 319 (4549–146 666)
Orbital cellulitis following AS	53	49	4	1.28 (1.17 to 1.39)	1.28 (1.17 to 1.40)	1.25 (1.13 to 1.38)	1.02 (0.37 to 2.84)	N/A

↵a Per 10 000 AOM/AS primary care consultations. AOM = acute otitis media. AS = acute sinusitis. CI = confidence interval. N/A = not applicable. NNT = numbers needed to treat.
OR = odds ratio.